Professor Alex McMahon, NHS Lothian Catriona Renfrew, NHS Greater Glasgow & Clyde David Steel, NHS National Services Scotland

Transcription

1 Professor Alex McMahon, NHS Lothian Catriona Renfrew, NHS Greater Glasgow & Clyde David Steel, NHS National Services Scotland Cleft Lip and Palate Surgical Service Options Appraisal Report November 2015

2 Contents 1. Introduction The Cleft Surgical Service Options Appraisal Process Previous Review Process 2011/12 Cleft Lip & Palate Review 5 4. Current position - Background to the requirement for Option Appraisal Options Appraisal Process.7 6. Discussion of Options Scoring Options & Outcome Conclusions

3 1. Introduction 1.1 Following the 2011/12 Review of the Cleft Lip & Palate Surgical Service the NHS Board Chief Executives asked NSD to work with NHS Greater Glasgow and Clyde and NHS Lothian to set up a single surgical service over two surgical sites to meet the needs of all patients with a cleft lip and or palate resident in Scotland. A Cleft Management Board was set up led by NHS Greater Glasgow and Clyde, chaired by Jonathan Best with management representation from NHS GG&C, NHS Lothian, National Services Division with representation from CleftSiS (now Cleft Care Scotland) the managed clinical network for all involved in delivering local services for patients with cleft lip and palate and from CLAPA the main patient group. Despite some progress it became apparent in early 2015 that major challenges remained unresolved which meant that despite 2 ½ years work the revised service had not been delivered. 1.2 The Cleft Management Board took a position paper to the National Specialist Services Committee in June 2015 proposing a number of options for the way forward for the specialist surgical component of the designated cleft lip and palate service commissioned by National Services Division of NHS National Services Scotland (NSD) on behalf of NHS Boards in Scotland. It was noted that all other components of the specialist service, including support for outreach clinics, and the delivery of local services, including orthodontics, speech and language therapy and specialist nursing, were not subject to this additional review. 1.3 The National Specialist Services Committee asked that National Services Division, as commissioners of the service, NHS Greater Glasgow and Clyde and NHS Lothian consider these options, with the exclusion of the possibility of de-designation of the service as a possible recommendation, to determine a way forward to allow implementation of the recommendation of the initial review: to commission a single service to provide specialist cleft lip and palate surgery for patients of all ages in Scotland. 1.4 The three NHS Boards established a Review group to make recommendations on the way forward The Review group issued a position paper on 18 August 2015, which detailed the current position of the service, and invited comment on this document to inform the process. This paper was distributed through the Cleft Care Scotland Network and CLAPA, the established patients and parents group representing patients with a cleft lip and/or palate Comments were received from a wide range of professional and public stakeholders and these were collated in a paper presented to the Options Appraisal Group A public engagement meeting was held on 27 October 2015, in the Scottish Health Services Centre in Edinburgh. This was organised with the support of CLAPA and also included an observer from Scottish Health Council. Patients and family members attended from across Scotland although the majority of those present were more familiar with the surgical service currently provided by NHS Lothian The Review Group also established an Options Appraisal exercise which was undertaken on 28 October

4 2. The Cleft Surgical Service Options Appraisal Process 2.1 To take forward the work requested by NSSC, NHS National Services Scotland, NHS Greater Glasgow & Clyde and NHS Lothian convened an Options Appraisal Group with membership ensuring appropriate clinical interest and expertise, and a range of NHS management and lay representation that provided a geographical balance. The membership of the Options Appraisal Group is detailed below. Dr Andrew Russell, Medical Director of NHS Tayside, agreed to act as the independent chair of the Options Appraisal Group. 2.2 Membership of the Options Appraisal Group: Dr Andrew Russell scoring) NHS Board Medical Director, NHS Tayside (Chair) (Non Ms Gillian McCarthy CLAPA Scotland Ms Iona Wallace CLAPA, Patient Service User - Adult user (West) Ms Mandy Temple CLAPA, Patient Service User - Parent Representative (East) Mr Adrian Sugar Cleft and Oral & Maxillofacial Surgeon, NHS Wales Ms Rona Slator Cleft and Plastic Surgeon, NHS England Mr Stephen Robinson Chair- UK Cleft Development Group, Orthodontic Surgeon, NHS England Ms Kerry Russell North of Scotland Planning Group Dr Edward Doyle NHS Lothian, Associate Medical Director (clinical management) Ms Fiona Mitchell NHS Lothian, Service Management Prof Alex McMahon NHS Lothian, Director of Strategic Planning & Modernisation Dr Catriona Renfrew NHS Greater Glasgow & Clyde, Director of Corporate Planning and Policy Mrs Julia Muirhead NHS Greater Glasgow & Clyde, Service Management Mr Jonathan Best NHS Greater Glasgow & Clyde, Senior Management Mr Toby Gillgrass Cleft Care Scotland, Lead Clinician and Consultant Orthodontist Ms Lisa Crampin Cleft Care Scotland (West), Speech & Language Therapy Mr Grant McIntyre Cleft Care Scotland (East), Consultant Orthodontist Mr David Steel Dr Mike Winter Programme Associate Director, NSD Medical Director, NSD In Attendance (non scoring) Mrs Gillian Gunn Ms Lyn Hutchison Ms Sharyn Montgomery Scottish Government Representative Senior Programme Manager, NSD Programme Support Officer, NSD 2.3 The Options Appraisal Group met on 28 October The rest of this report sets out the process which was followed to assess the three proposed options for service delivery for cleft surgical services using a recognised NHS Options Appraisal methodology; and the outcome. 4

5 2.4 The group were provided with the information set out below in advance of the workshop Cleft Lip and Palate Surgical Service and CleftSiS National Managed Clinical Network Review Report (Annex 1) Cleft Lip and Palate Surgical Service Position Paper July 2015 (Annex 2) Stakeholder comments Received (Anonymised) on Position Paper (Annex 3) Cleft Care Scotland Audit Report (Annex 4) Cleft Lip and Palate Surgical Service Specification (Annex 5) Guide to Options Appraisal Criteria and Weighting (Annex 6) 2.5 The Group also received submissions from NHS Lothian and NHS Greater Glasgow and Clyde which were tabled on the day. NHS Lothian provided submissions for: Option 1 status quo (Annex 7) Option 2 single surgical service provided from NHS Lothian (Annex 8) NHS GG&C provided a submission for: Option 3 single surgical service provided from NHS GG&C (Annex 9) 2.6 The Options Appraisal Group also received a summary of the comments received from the patients and parents engagement event from the night before the workshop. (Annex 10). 3. Previous process /12 Cleft Lip and Palate service Review 3.1 The workshop started with a briefing on the previous review process and its recommendations (as detailed in Annex 1 and 2). This review had been a planned follow up to the review that had taken place 2006, which had recommended a reduction in the number of surgical sites from three to two, and had advised that further work be undertaken to move towards a single surgical service, providing cover for each other as well working to develop a case for inclusion of adults within the Cleft Surgical Service. Progress was to be reviewed in 5 years. 3.2 The review in 2011/12 concluded the previous recommendations had only been partially achieved; the surgical service formerly provided in NHS Grampian had been successfully transferred to NHS Lothian; but the paediatric surgical service was not working as a single service, the teams were not working to the same protocols, there had been no progress toward inclusion of adult cleft care within the service and there were ongoing challenges in getting full co-operation with the CleftSiS audit programme. 3.3 The 2011/12 review recommended that the existing model of 2 separate paediatric surgical services should be developed into a single surgical service on one site and should provide expert care for adult patients as well as for the 100 children born in Scotland each year with a cleft lip and or palate. 5

6 4. Current position - Background to the requirement for Option Appraisal 4.1 The Group received a presentation on the Management Board s attempts to establish a single surgical service over two sites as requested by the NHS Board Chief Executives and why this further Options Appraisal exercise was required. 4.2 The Group were informed that, as detailed in the Position Paper (Annex 2), in 2013 Board Chief Executives had recommended that a single cleft surgical service should be established for NHS Scotland based on two surgical sites (NHS GG&C and NHS Lothian), rather than invite a competitive assessment of whether the service should be consolidated in either Edinburgh or Glasgow. 4.3 Some progress had been achieved: The Cleft Management Board had been set up with managerial and clinical representation from NHS Lothian, NHS GG&C, and NSD; chaired by NHS GG&C as the host Board providing the operational management of the integrated specialist service. Lead Clinician for the surgical service appointed following appropriate open recruitment process. Mapping of all existing outreach specialist cleft clinics and agreement on the provision of multidisciplinary outreach clinics as an integral aspect of the single service approach. Recruitment of additional clinical psychologists to support cleft care across NHS Scotland Agreement to funding the establishment of 24 specialist cleft surgical sessions based on three surgeons with 8 sessions each. This linked to high level agreement to develop job plans which demonstrated commitment to joint working in both surgical sessions and in MDT outreach clinics. 4.4 Despite this progress, the two surgical sites continued to operate as stand alone services and while a lead clinician had been appointed he did not have a role within the East coast service, nor in the job planning of the Consultant employed in NHS Lothian. 4.5 There was a single national clinical pathway for surgical services, agreed through Cleft Care Scotland based on UK standards, but this was not yet universally implemented. 4.6 A single Service Agreement had been agreed and was held by NHS GG&C, as lead NHS Board, however the two surgical sites continued to retain separate budget and line management structures. 4.7 All 3 surgeons hold honorary contracts with the other sites; and the Glasgow surgeons had covered periods of leave for the consultant in Lothian; however true joint working and cross cover had not been achieved and individual rotas are retained. 4.8 There was no single waiting list, nor any shared distribution of referrals or for new births and as result different waiting times. 4.9 Full multidisciplinary team case review, sharing best practice, working together, supporting and learning to drive continuous improvement in the Scottish cleft service is not in place; differential outcomes continue to be seen as a source of division, not an opportunity for learning and improvement. 6

7 4.10 The Management Board and the three constituent parts, NHS GG&C, NHS Lothian and NSD, had agreed that this lack of progress meant that this model of delivery was not a viable way forward for the service There was discussion about the points from the presentation. 5. Options Appraisal Process 5.1 The Group were then advised about the procedure for an Options Appraisal - this required the agreement on the criteria on which the options would be assessed and the weightings that should be applied to that criteria. The Group would then discuss each of the options against the agreed criteria and score each option against that criteria based on the evidence provided. 5.2 The criteria and weightings from the 2011/12 Options Appraisal had been circulated and following discussion there was agreement that the six criteria to be used to assess the current options should mirror the previous review. The criteria used are set out in Table 1 Table 1: Criteria Criteria Structure 1. Clinical sustainability (Attract and retain skilled staff) Definition The availability of the full range of skilled staff. Opportunities for training and development and collaborative team working between clinicians. 2. Capacity Process 3. Timely and Efficient 4. Patient Centred, Equitable Outcome 5. Meets National clinical standards 6. Safe and Clinically Effective Physical capacity/flexibility to meet all surgical needs with strength and depth in clinical staffing and collaborative team working between clinicians. The service needs to be adaptable in order to provide the most appropriate interventions and treatments at the right time to everyone who will benefit and wasteful variation will be eradicated. There will be the same equality of opportunity to receive high quality surgical services regardless of where patients, from any background, live in Scotland whilst being responsive and respectful to their needs and values. Degree to which the configuration is able to comply with National standards such as Cleft Care Scotland (formerly CleftSiS), Clinical Standards Advisory Group (CSAG) and National Institute for Clinical Excellence (NICE). Includes both short-term safe outcomes such as avoiding harm and complications, and long term outcomes as determined by CSAG and Cleft Care Scotland. 7

8 5.3 There then followed discussion around the weighting of the criteria. The scoring of the criteria total 100 and the greater the perceived importance the higher the weight assigned. The Group agreed that Clinical Sustainability should be weighted more heavily and the weighting for capacity should be decreased. 5.4 The weights applied are set out in table 2 below. Table 2: Weighting Criteria Weight 1 Clinical sustainability 20 2 Capacity 10 3 Timely and Efficient 10 4 Patient Centred and Equitable 20 5 Meets national clinical standards 20 6 Safe and Clinically Effective Discussion of Options 6.1 The Group was reminded that the options that they were being asked to evaluate were: 1. Status Quo: Continue to seek to implement the previous NHS Board Chief Executives direction to commission a single surgical service provided on two sites. 2. Plan and implement a single surgical service for all ages provided in NHS Lothian This proposal would mean all specialist cleft lip and palate surgery being performed by NHS Lothian. Local clinics and Multi Disciplinary Team clinics would still be provided and supported across NHS Scotland. 3. Plan and implement a single surgical service for all ages provided in NHS Greater Glasgow & Clyde - This proposal would mean all specialist cleft lip and palate surgery being performed by NHS Greater Glasgow & Clyde. Local clinics and Multi Disciplinary Team clinics would still be provided and supported across NHS Scotland. 6.2 Clarity was sought on what was meant by a single surgical service This was described as a service provided by a multidisciplinary team that collaborated to provide cross cover to each other and could deliver a resilient and sustainable service. With even distribution of referrals and new births and able to provide support to all MDTs involved in providing aspects of cleft care at a local level It was acknowledged that there could still be variation between surgeons in their clinical approach at times; however it was expected that there would be shared decision making within a team working collaboratively 6.3 Other staff There was confirmation that at present there continues to be separate caseloads and no cross cover in respect of the east and west specialist cleft teams and in particular between the surgical staff. It was acknowledged that cleft care was delivered by a much wider multidisciplinary team and there was 8

9 no expectation of their having to move base locations or to routinely provide cross cover outwith their employing NHS Board There were incidences where on occasions the specialist cleft nurses and speech and language therapist from Glasgow had provided support to Lothian to cover short term staff shortages, but this was in response to individual requests rather than a planned cross cover arrangement. 6.4 Outcomes There was detailed discussion about the outcome data and a number of specific questions were asked in relation to the outcome data presented. It was noted that the services had good outcomes and that Scotland benchmarked well against similar UK units and excelled in some areas It was emphasised that the option appraisal had not arisen because of concern about the service provided by either of the surgical teams or as a result of any of the outcomes shared. 6.4,3 It was also highlighted that audit outcome data is normally used to support service improvement and it was a concern that some of the data is being highlighted as a means of division, and this was symptomatic of the service not working as a Single Surgical Service There were areas of strength and excellence in different areas of clinical practice between the East and West services the aim should be that the whole service focussed on providing a resilient and sustainable cleft service with every discipline collaborating and learning from each other to achieve the best outcomes possible for every patient in Scotland regardless of where they live It was reported that other disciplines do discuss the outcome data as a means to drive improvements across Scotland within their spheres of practice and not in an adversarial way. 6.5 A number of the specific clinical outcomes were reviewed by the external clinical experts and further detail provided. This reinforced the summary given that there are differences between current service provision but all care in Scotland is delivered safely and is of good quality, there remains an opportunity for improvement if the service were to be working as a single team and using outcomes information as a means of understanding where change could be made. 6.6 Discussion of options It was queried whether it was worth scoring option 1 (single service delivered on 2 sites) as this had not been achieved despite the time and effort already invested. It was emphasised that scoring should be based on how well the individual member feels that option meets each criterion to assess which would best meet the requirements of the service going forward to meets the needs of patients with a cleft in Scotland It was noted that the NHS Lothian submission for Option 2 was only available from late 2017 when the new paediatric hospital would be opened on the site of the Edinburgh Royal Infirmary. Whilst it was acknowledged that the Options Appraisal had been asked to evaluate options on the current situation 9

10 it was also noted that it was to provide a clinically sustainable service for the future. There was discussion around the fact that action may be required before 2017 to ensure the sustainability of the service but agreed that the Lothian option should be considered as tabled. Therefore the Group agreed to evaluate that option as tabled from NHS Lothian. 6.7 It was queried what would happen for patients with complex co-morbidities, who had been operated by the service in the West due to availability of co-located specialty services that were not available in the East. It was confirmed that if it was recommended that the service move to Lothian the cleft service would not be colocated with a paediatric cardiology centre or paediatric complex airways service. However if a child needed access to these specialities then bespoke arrangements could be made to ensure correct care was provided for an individual child. 6.8 It was noted that adult procedures are already being carried out in multiple locations. In clarification it was pointed out that the expectation for the adult service was to ensure that procedures that required a specialist cleft surgeon intervention would be provided centrally; and those procedures that were currently appropriately undertaken by other disciplines would be supported in continuing to provide locally. 6.9 It was also emphasised that the Group were only asked to consider the cleft surgical service in this option appraisal and the other services provided within NHS Lothian, NHS GG&C and the other NHS Boards were not being considered by this process. 7. Scoring Options & Outcome 7.1 The Group were then taken through the scoring process and advised that against each criteria each option should be scored between 0 (where this represented the least benefit of an option against the criteria) and 10 (where this represented that best possible benefit of an option against the criteria). 7.2 The Options Appraisal was conducted by going through each criterion and scoring each option against this criterion and each of the 18 members who scored did so independently of each other. 7.3 The Group were then asked to hand in their scoring sheets at the end of the process for the scores to be assessed. The scores were then analysed and reported on as agreed by the Group. 7.4 The scores provided by each individual are detailed in Annex 11. Each individual was given a copy of their score with their identifier to check that they had been recorded accurately. 7.5 The following Graph shows the total weighted scores for each option. 10

11 Graph: Total weighted scores Option 1 Option 2 Option Outcome of option appraisal scoring: Option 3, a single surgical service based within NHS GG&C, received the highest weighted score. Option 1, a single surgical service based on two surgical sites, the status quo, received the second highest weighted score, Option 2, a single surgical service based and providing surgery in NHS Lothian having the third highest weighted score. 7.7 In order to test whether this was the outcome across the group in relation to the groupings of people within the Options Appraisal it was agreed to analyse this based on similar groupings to the 2011/12 exercise. The lay representatives are included with the Cleft Care Scotland Representatives. The table below demonstrates the voting patterns of the different groups.. Option 1 Option 2 Option 3 NHS Board Reps Independent Experts Cleft Care staff & Patient/Public Reps NSD Option 3 was scored 2 nd by the Cleft Care and Patient/Public representatives. It should also be noted that one of the scorers in this group only offered scores against Option One and if this assessment was excluded Option 3 would have scored highest in all 4 groups. 7.9 As a further test if the highest two scores for Option 3 were excluded from the total score; Option 3 would still be the highest total weighted score of the three Options. 11

12 8. Conclusions 8.1 The Options Appraisal Group assessed Option 3 to be the preferred option. A single surgical service based in NHS GG&C would be best placed to provide a safe, sustainable and quality service for all patients with clefts within NHS Scotland with three surgeons working together as a surgical team. 12

13 Review of Cleft Lip and Palate Surgical Service and the Scottish CLEFTSiS National Managed Clinical Network Release: Final v1.1 Date: June 2012 Review Lead: Deirdre Evans Director Author: Lyn Hutchison

14 Review of Cleft Lip & Palate Surgical Service and National Managed Clinical Network (NMCN) in Scotland 2012: EXECUTIVE SUMMARY Background This report records the outcome of a review of the designated National Cleft Lip and Palate Paediatric Surgical Service and the designated National Managed Clinical Network CLEFTSiS. The current designated national specialist service is commissioned by National Services Division (NSD) and comprises a paediatric surgical service provided by NHS Greater Glasgow & Clyde at RHSC, Yorkhill, and NHS Lothian at RHSC, Edinburgh; as well as outreach clinics in NHS Grampian and NHS Tayside. The designated surgical service sits within wider multi-disciplinary cleft services provided locally by NHS Boards across Scotland encompassing speech and language therapy, orthodontics, and other specialties - which are brought together through CLEFTSiS, the National Managed Clinical Network for all cleft care. CLEFTSiS is supported by a network office in NHS Tayside, commissioned by NSD. Whilst the primary focus of the review was current service provision and the functioning of the network, a key element was to explore to what extent the recommendations from the previous (2006) review of the national cleft surgical service had been implemented. The review was overseen by an expert group under the independent clinical chair of Ms Kathryn Harley, Consultant Paediatric Dental Surgeon in NHS Lothian, nominated by the Royal College of Surgeons of England. The current service providers were invited to present to the expert panel and contributed to evidence gathering throughout the process. Patients, families and other stake holders were provided a number of opportunities to contribute to the work of the review, as well as having representatives sitting on the expert panel. Current Service Around 100 children are born with some form of cleft lip/palate in Scotland each year - approximately equal numbers are treated by the surgical services in East and West of Scotland. There is no single care pathway for the surgical management of cleft lip and palate - diagnosis covers a wide range of presentations, each requiring a bespoke and personalised approach under the guidance of an expert clinician, and delivered by a multi-disciplinary team. Initial assessment and diagnosis of children with a cleft is undertaken by locally based teams, with access to an expert clinician. It is recognised that as the young person moves into adulthood, there are often reasons to continue to provide continuing expert input, but at present this is beyond the scope of the commissioned service. The care pathway, within which surgical intervention is offered, is prolonged over many years, and significant input is required from other professionals through this time, including orthodontics, paediatric and restorative dentistry, speech and language therapy, specialist nursing, paediatricians, clinical psychology and ENT/audiology. 2

15 Evidence demonstrates that children benefit from access to services which meet agreed UK clinical standards. Concern was expressed by the expert group that the information gathered to confirm the above from the Scottish service was variable year on year, and continued to be provided in different formats from the East and West of Scotland, which made direct comparison of achievement in terms of meeting care pathway milestones and clinical outcomes difficult. When outcomes in Scotland were compared with centres in north of England, no major issues were identified. The cost of the current surgical service in 2011/12 was 1.07 million. CLEFTSiS The CLEFTSiS national Managed Clinical Network was last reviewed, along with 8 other MCNs, in 2009, following which intensive work was undertaken to improve its role in coordinating audit, and reporting outcomes, for the Cleft Service in Scotland. NSD recognised in 2011 that significant improvement had been achieved, and it was agreed that CLEFTSiS should continue to operate as an MCN, pending the outcome of this review. Whilst significant improvements had been achieved, there were continuing challenges in ensuring that all members fully participated in the agreed clinical audit programmes. In part, this has been linked to challenges in using the current Axsys electronic patient record system, and progress is being made in transferring the capture of information under the new Clinical Audit System (CAS) supported by NHS National Services Scotland (NSS). The expert group noted that the surgical services in Scotland, and others involved in cleft care, have been active participants in benchmarking and comparative audit, led by the Norcleft Group, which includes 3 major cleft service providers in the North of England. The cost of the CLEFTSiS NMCN in 2011/12 was 84,693, of which 21,373 was for hosting and maintenance of the Axsys electronic patient records database (now being replaced by the CAS which has minimal running costs). Conclusions Surgical service In summary, the expert Review Group concluded that the current configuration of cleft lip and palate surgical services for Scotland was not sustainable, and the recommendations of the 2006 review had not been fully achieved. There was a significant risk of major breakdown of the surgical service if the status quo was continued. In terms of clinical outcomes both existing services provided high quality services. There was inequity of access and of the standard of clinical care for adults across NHS Scotland. Whilst a view was expressed that all cleft care in Scotland might be considered appropriate for national commissioning, it was agreed that the wider cleft service did not meet the criteria for national designation although it should be guided by clear care pathways and clinical standards communicated and monitored through CLEFTSiS. From the information gathered a long list of commissioning options was developed. All of those shortlisted included an extension of the commissioned surgical service, from birth to throughout adulthood. 3

16 The favoured option of the review group was for a single surgical service for all ages with one management structure and one clinical lead, additional outreach assessment and follow up clinics, working to a uniform set of clinical standards. In the light of the good clinical outcomes delivered on both sites; the differences in the surgical services currently delivered in Glasgow and Edinburgh; and the absence of robust comparative cost information, the final conclusion of the Review Group was that all interested NHS Boards should be invited to submit a business case to deliver a single service to an agreed specification, with a single management structure and clinical leadership. The business cases would be subject to an independent evaluation to determine the future location(s) of the surgical service. National Managed Clinical Network The information provided by the surveys of patient users and other stake holders highlighted there is a strong view that there should remain a national coordinating network, both to ensure a voice for users of cleft services, as well as guiding and reporting on the delivery of best practice through clinical audit; development of care pathways; and the identification of key quality performance indicators. CLEFTSiS should focus on: o empowering patients and families through a provision of information regarding the expected care pathway, o education, o updating all health professionals involved in delivering, or supporting, the delivery of cleft care, o leading on clinical audit, and o reporting clinical outcomes of cleft care in Scotland. o The network should also ensure that NHS Boards are informed timeously of any failure to meet agreed standards of care. The Review Group considered that other aspects of cleft care that were not part of the nationally designated service, and were provided locally, were also highly specialised, and patients should have equity of access to the appropriately trained members of the multidisciplinary team required to meet their individual care needs. This might involve shared care arrangements between some NHS Boards, and the further development of outreach clinics and tele-health to support delivery of ongoing care as locally as possible. RECOMMENDATIONS The paediatric surgical cleft lip and palate service in Scotland should continue to be designated as a national specialist service on the grounds that it meets the criteria for national designation. The surgical service, currently commissioned only for paediatric care (up to age 16), should be extended to provide surgical care for cleft lip and palate for all ages. The future configuration of the cleft surgical service for Scotland should be a single surgical service for all ages with one management structure and one clinical lead, with additional outreach assessment and follow up clinics, working to a uniform set of clinical standards. All interested NHS Boards should be invited to submit a fully costed business case to deliver a single cleft lip and palate service for Scotland to an agreed specification, with a single management structure and clinical leadership. The business cases should be subject to an independent evaluation to determine the future location(s) of the surgical service. 4

17 As only the cleft surgical service is to be nationally commissioned, rather than wider cleft services, the Review Group concluded that CLEFTSiS should continue to be designated and supported as a designated national managed clinical network. 5

18 Table of Contents Contents EXECUTIVE SUMMARY... 2 RECOMMENDATIONS INTRODUCTION BACKGROUND The National Paediatric Surgical Service The NMCN REVIEW OBJECTIVES REVIEW METHODOLOGY LITERATURE REVIEW Extract/Summary Overview The Eurocleft project Management of Care Conclusion of the literature review CURRENT SERVICE Commissioning arrangements Current configuration Births in Scotland Equity of Access Types of cleft lip and/or palate diagnosed ACTIVITY Total procedures Primary procedures Secondary procedures AUDIT Indicator 1: % First Contact Indicator 2: % completed lip repairs Indicator 3: % completed palate repairs Indicator 4: % completed Alveolar Bone Grafts Indicator 5: % completed Secondary surgeries QUAD CENTRE AUDIT DATA Bone Graft Data Orthodontic Outcomes Year Speech Audit Paediatric Dental Audit ADDITIONAL INFORMATION PROVIDED AS PART OF ANNUAL REPORT Complaints Mortality Complications and critical/adverse incidents Hospital Acquired Infections (HAI) USER FEEDBACK Methodology Demographic information Preferences for the service CLEFTSiS user feedback Conclusions from user feedback STAKEHOLDER VIEWS Objectives of obtaining stakeholder feedback

19 13. SHORTLISTING OPTIONS Option Option Option Option Option Option Option Option Option Shortlisting conclusions Cleft surgical service Shortlisting conclusions CLEFTSiS FINANCIAL INFORMATION Funded staffing levels Costs OPTIONS APPRAISAL Issues Final short list of options for consideration Criteria Scoring the options CONCLUSIONS RECOMMENDATIONS Appendix 1: Review Group membership Appendix 2: Literature Review Appendix 3: User Survey Appendix 4: Additional User comments re service and network Appendix 5: Stakeholder feedback outputs Cleft surgical service and CLEFTSiS Appendix 6: Financial profiles

20 1. INTRODUCTION National Services Division (NSD) commissions highly specialist services on behalf of NHS Scotland, and is required to review all designated national specialist services, and national managed clinical networks, every 3-5 years to ensure that services meet needs, provide equitable access, are clinically and cost-effective, and continue to require national designation. This report records the outcome of a review of the Paediatric Cleft Lip and Palate surgical service and of the CLEFTSiS (Cleft Service in Scotland) National Managed Clinical Network (NMCN). In addition to the aims outlined above, the review also assessed whether the recommendations of the previous 2006 review had been implemented, and whether the anticipated benefits had been achieved. 2. BACKGROUND 2.1 The National Paediatric Surgical Service Paediatric cleft surgery was nationally designated in 2004 with three centres: Aberdeen, Glasgow and Edinburgh. This was rationalised to two centres (Glasgow and Edinburgh) in 2008 as a result of the recommendation of the 2006 Cleft lip and Palate surgical service review with a further aim that there should be a single surgical service for Scotland, being delivered across 2 surgical sites, working to the same protocols with cross cover between centres being provided. This review found that the latter aim had not been achieved and at present there were two surgical centres in Scotland performing primary cleft surgery. In Glasgow the service is based at the Royal Hospital for Sick Children at Yorkhill (Yorkhill) with the surgical service provided by a maxillofacial surgeon and a plastic surgeon. In Edinburgh the service is located at the Royal Hospital for Sick Children and the surgery is performed by a plastic surgeon who works only on CLEFT patients. All other aspects of cleft care are delivered as local as possible to the child s home by a wide range of health professionals working within the local NHS Board and linking together as part of the CLEFTSiS network. 2.2 The NMCN CLEFTSiS was established on 1 April 2000 as a result of the acute services review report of Cleft Lip and Palate Services (1998) 1. CLEFTSiS was the first NMCN to be designated; this was before the current national designation process was established. CLEFTSiS was reviewed in 2009 in conjunction with 8 other NMCNs. That review concluded that the network had made an enormous contribution in the first few years to the improvement of care for their patients; however, the review group identified significant shortcomings in both audit activity and compliance with the core principles of networks. The review group recommended that designation and national funding should continue for a further year, to 31 March 2011, to provide an opportunity for the network to work with patients, other stakeholders, and network members, to reflect on the further contribution that the network might make to improving CLEFT care in Scotland and specifically to address the current weaknesses in terms of audit activity, monitoring of clinical outcomes, and compliance with the core principles of networks. NSD made a further assessment in 2011 and concluded that very substantial progress has been made by the CLEFTSiS network towards achieving the objectives contained in the work plan developed to address the shortcomings identified by the 2009 review. NSD advised that the CLEFTSiS network should have its national designation continued until the completion of this review of the cleft surgical services and within this consider the future role that the CLEFTSiS NMCN will have in supporting both the surgical service and the quality of all aspects of cleft care in Scotland. 1 The Scottish Office Department of Health (1998) Acute Services Review Report. The Stationary Office 8

21 3. REVIEW OBJECTIVES The main objective of this review is to assess the service against the National Services Advisory Group (NSAG) criteria for designation as a National Specialist Service; and make recommendations as to a future service configuration. In recognition that both the CLEFTSiS NMCN and the national cleft lip and palate surgical service have evolved over recent years and are now closely related it was agreed appropriate to review options in respect of the best way forward for both the national surgical service and the national MCN. The review takes into account: Assessment of the current service against national need Continuing improvement in the Scottish service to the best international standards Local/regional delivery and access against national delivery Need to respond to changing conditions potential development of the age range and the treatment options included within the national service, changing working patterns, and ensuring sustainability of the service as a result. Following discussion at the first steering group meeting, acknowledging the strength of feeling from the service and users, it was agreed that it was necessary that the review gave consideration to the current surgical service being extended to include all surgical cleft services including that required for adults. In view of this, all options were appraised on the assumption of the provision of a comprehensive cleft service to be delivered to all age groups in Scotland. 4. REVIEW METHODOLOGY The review was undertaken using a standard NSD protocol for a major review. An Expert Group was formed under an independent clinical chair, with membership as listed at appendix 1. The group met on three occasions to reflect on evidence and to consider options as part of an option appraisal for the future delivery of the service. The work was supported by a team from NSD, assisted by Colleagues from the CLEFTSiS NMCN. The recommendations of the Expert Group will be considered by NSAG prior to be taken to the NHS Scotland Chief Executives Group and to Scottish Government Health and Social Care Directorate (SGHSC). Representatives of the current surgical service providers, and from CLEFTSiS, provided detailed information to the Expert Group, this included their view on how services should be configured to meet future needs. The current providers were also provided an opportunity to comment on the emerging findings. The evidence gathered included: A literature review on current UK and international opinion on surgical practice and advisory levels of surgeon experience, Statistics and information provided by CLEFTSiS (see section 7, 8, 9 and 10). Data from an online user questionnaire (see section 11), and stakeholder workshops A user survey for Health Professionals involved in the delivery of any aspect of Cleft care (see section 12) 5. LITERATURE REVIEW Extract/Summary (The Full Literature Review can be found at Appendix 2) 9

22 5.1 Overview Cleft lip and/or palate are the most common craniofacial anomalies with about 100 new cases occurring each year in Scotland (SNAP ). From birth to maturity, children with orofacial clefts undergo many surgical and non-surgical procedures that can cause disruption to their life and the lives of their family members. There are often psychological consequences of both this treatment and the deformity itself. The contemporary keystone of cleft management is the multidisciplinary team (Witt and Marsh ). Highly specialised care is required from birth to the late teens and occasionally into young adulthood. This care starts with neonatal nursing and primary surgery, usually followed by further surgery, speech and language therapy, orthodontics, preventative and restorative dental care, otolaryngology for hearing problems and genetic and psychological counselling (CSAG ). 5.2 The Eurocleft project The absence of a sound evidence base for selection of treatment protocols is shown by a striking diversity of practice across Europe for surgical care of just one cleft subtype -unilateral complete cleft of lip, alveolus, and palate (UCLP). Of 201 teams doing primary surgical repair for this defect type, 194 different protocols were being practised. Even though 86 (43%) groups closed the lip at the first operation and the hard and soft palate together at the second, 17 possible sequences of operation to close the cleft were being used. One operation was needed to completely close the cleft in ten protocols (5%), two were needed in 144 (71%), three operations were used in 43 (22%), and four were needed in four protocols (2%). Around half used presurgical orthopaedic techniques with mostly passive plates and some teams also used a plate to assist with feeding. These uncertainties in treatment indicate the paucity of published randomised trials of cleft care. Five such studies present particular challenges for planning and recruitment in comparison of surgical techniques, because trial protocols must take account of the surgical learning curve. However, several well-planned, large-scale, surgical randomised controlled trials including the Scandcleft RCT are now in follow-up periods and preliminary results should emerge in So far, only a brief systematic review of cleft care has been published, as has a systematic review of prevalence of dental caries in children with clefts. 5.3 Management of Care The aim of the management of cleft lip and palate patients at the completion of treatment is to make these children anatomically and functionally as near normal as possible, and the basis of treatment is the surgical closure of the cleft (Watson ). The most usual timing for the repair of the cleft lip is between 6 and 12 weeks. The type and timing of the repair depend on the protocol of the unit and/or the preference of the surgeon. The aim of the surgery is to produce a lip of good length, which looks good, that is not tight and functions as normally as possible (CSAG 1998). The timing of cleft palate repair is balanced between the need for velopharyngeal closure for normal speech development and the risk of disruption of facial growth. Most UK surgeons perform a palate repair around the age of 12 months. This conforms to evidence from a study by Dorf and Curtin (1982) as cited in Rohrich et al ( ) 12 months of age was used as an arbitrary dividing point between early and late palatal closure. Successful management of children born with cleft lip/palate requires multidisciplinary and highly specialised treatment from birth to late teens early twenties (CSAG, 1998). These multidisciplinary teams need to meet regularly to allow for the exchange of ideas and expert input from not just the 2 Scottish Needs Assessment Programme. Cleft Lip and Palate Scottish Forum for Public Health Medicine, 69 Oakfield Avenue, Glasgow, November Witt, P. D. & Marsh, J. L. (1997). Advances in assessing outcome of surgical repair of cleft lip and cleft palate. Plastic and Reconstructive Surgery 100: Clinical Standards Advisory Group Report on Cleft Lip and Palate. (1998) HMSO London 5 Watson ACH in Watson ACH, Sell DA and Grunwell P (2001) Management of Cleft Lip and Palate Whurr Publishers London 6 Rohrich RJ et al (2000) Optimal Timing of Cleft Palate Closure Plastic and Reconstructive Surgery Vol106 ( 2) pp

23 surgeon, but also specialist nurses, paediatric dentists, orthodontists, speech therapists, paediatricians, clinical psychologists and clinical geneticists. Access to other experts such as ENT surgeons and social workers should also be available. The benefits of these health care teams include their ability to coordinate complex services, meet the psychosocial needs of families, and provide multifaceted evaluations. 5.4 Conclusion of the literature review The aim of clinical management is to achieve normal face, lip and nasal appearance; normal speech and hearing; good dental occlusion - appearance and function; maxillofacial growth; and psychosocial well-being. The benefits of the multidisciplinary team approach to care have been recognised since the 1930s. The most appropriate timing, staging and method of surgical intervention continue to be developed, but trends in patterns of care have emerged. Improvements in outcome when measured by speech, velopharyngeal function and need for revision have been linked to surgeon experience. Centralised care in regional centres has also been demonstrated to improve results and lead to fewer revisions. It is also important to acknowledge the efforts of the Scottish cleft teams in supporting OFC research initiatives which are aimed at 2 major outcomes: (a) improving quality of care and (b) prevention of complications. Very significant progress has been made on both fronts in recent years, and it is noteworthy that researchers in Scotland are contributing to these initiatives. A multidisciplinary approach with standardisation of data collection is a key objective in continuing these research efforts. 11

24 6. CURRENT SERVICE 6.1 Commissioning arrangements National Services Division currently commissions the paediatric surgical element of the cleft lip and palate service as a designated national service for residents within Scotland (up to 16 years of age). This includes the surgical input to all stages of assessment, all aspects of the inpatient hospital stay, and to surgical follow-up. This has been designated as a national service since 2004 on the basis that the service fits the criteria for designation in that it: is low volume, less than 200 new patients each year; requires a specialist multi-disciplinary team with rare skills; requires concentration of effort because there appears to be improved outcome if individual surgeons treat over 40 cases a year each. All other aspects of assessment and follow-up care are funded by the local NHS Boards and are co-ordinated via the CLEFTSiS managed clinical network. The NSD Service Agreements require the providers of the cleft surgical service to produce a detailed annual report with specific reference to the quality of the service provided and to work within the CLEFTSiS national managed clinical network to ensure the quality of the service is evaluated through systematic clinical audit and to continue to develop and refine clinical performance indicators. NSD also funds the administrative management infrastructure of the CLEFTSiS managed clinical network. The role of CLEFTSiS is detailed later in the report. 6.2 Current configuration At the present there are two surgical centres in Scotland performing primary cleft surgery. In Glasgow the service is based at the Royal Hospital for Sick Children at Yorkhill (Yorkhill). A maxiofacial surgeon and a plastic surgeon perform surgery. In addition there is currently an Advanced Trainee Fellow. In Edinburgh the service is located at the Royal Hospital for Sick Children and the surgery is performed by a plastic surgeon working wholly on cleft surgery. Suitable secondary procedures have the potential to also be carried out in Aberdeen, with the surgeon from Edinburgh primarily covering this workload. All other aspects of cleft care are delivered as locally as possible to the child s home by professionals as part of the CLEFTSiS network. RHSC Edinburgh and RHSC Yorkhill both being tertiary paediatric facilities, have access to all other clinical disciplines (staff) and equipment for the comprehensive investigation and treatment of these patients, and to Paediatric Intensive Care should this be required. Both hospitals provide a facility to allow a parent/guardian to stay beside the child on the ward when necessary. 6.3 Births in Scotland As the two sites who undertake primary surgery are situated in the East (hosted by NHS Lothian), and the West (hosted by NHS Greater Glasgow and Clyde) the comparison data shall be presented as the data of either the East or West of Scotland. Table 1 below illustrates which NHS Boards are served by each surgical site. Table 1: NHS Boards served by each surgical site EAST WEST NHS Borders NHS Ayrshire and Arran NHS Fife NHS Dumfries and Galloway NHS Grampian NHS Forth Valley NHS Highland NHS Greater Glasgow and Clyde NHS Lothian NHS Lanarkshire NHS Orkney NHS Western Isles NHS Shetland NHS Tayside 12

25 Overall, available findings indicate that oro-facial clefts arise in about 1 in 700 livebirths, but with considerable variation geographically and ethnically. The 1998 Scottish Needs Assessment Programme into Cleft Lip and Palate assessed that for the birth rate at that time, it could be anticipated that there would be approximately 100 live births with a Cleft lip and/or palate. It should be noted that the birth rate in Scotland at that time was following a downward trend until 2002 when there was just over 50,000 live births recorded. Since then there has been a steady year on year increase to a peak in 2008 of 60,041 live births. The 2010 provisional National Register of Scotland figures show that the number of live births was 58,791, representing a decrease of 2.1% from It could therefore be assumed that there could be in excess of 100 new births with a cleft lip and/or palate anticipated. Chart 1 - Total Births ( ) Chart 1 illustrates that the total number of babies born in Scotland with a cleft lip and/or palate has remained lower than the predicted 100 births per year, with the exception of 2008/09 when cases peaked at 113. The incidence of babies with a cleft lip and/or palate born from 2006 to 2011 continues to be slightly higher in the West of Scotland than in the East. Chart 2 below shows the percentage of babies born categorised by surgical service Chart 2 - % of babies born with a cleft lip and/or palate by surgical site % of babies born with a cleft lipand/or palate % Year West East 13

26 6.4 Equity of Access Chart 3 illustrates the incidence of babies born cleft lip and/or palate by NHS Board of residence Chart 3: NHS Board of Residence of babies born with cleft lip and/or palate Rate per 100, NHS Ayrshire and Arran NHS Borders NHS Dumfries and Galloway NHS Fife NHS Forth Valley NHS Grampian NHS Greater Glasgow and Clyde NHS Highland NHS Lanarkshire NHS Lothian NHS Board of residence NHS Orkney NHS Shetland NHS Tayside NHS Western Isles NHS Scotland Number of Births 2006/11 Scotland average rate referrals per 100,000 95% confidence interval The figures draw from five years of data ( ) and were constructed showing upper and lower confidence intervals (CIs) indicating the level of chance variation around the rates for each health board. The rates were derived from 2008 health board populations from General Registrars Office and assuming a Poisson distribution for the numbers. The Scotland average is shown as a horizontal line. If the NHS Board is contained within the upper and lower limits of the CIs, then we cannot say that the NHS Board appears to have a significantly higher or lower rate than the Scottish average. There are no significant variations in referral patterns between all NHS Boards except NHS Highland where the referral rate is demonstrably lower than average although only marginally. This could reflect a difference in epidemiology, or that patients are under-diagnosed as having a cleft lip and/or palate. 6.5 Types of cleft lip and/or palate diagnosed The number of babies diagnosed with Unilateral Cleft Lip and Palate (UCLP) has remained fairly consistent, average over the period was The results show a peak in 08/09 with 24 babies born diagnosed. Again babies born with Unilateral Cleft Lip (UCL) peaked in 08/09 (24 babies born). The average for this period equates to 16.4 cases. In 10/11 the number of babies born with this diagnosis was lower than average at 12. The number of babies born with a Bilateral Cleft Lip and Palate (BCLP) averages at 10.2 cases per year, 06/07 and 07/08 show peaks at 14 babies born however in 10/11 the number was lower than average at 7 babies born. The number of babies born with Bilateral Cleft Lip (BCL) remains fairly consistent and the average incidence over the period was 2.4 cases. Chart 4 shows the types of cleft lip and/or palate diagnosis referred to the surgical sites between 2006 and The most common diagnosis over the period was cleft palate (CP) the average number of diagnosis over the period equates to 49.4 births per annum. 14

27 Chart 4: Types of cleft lip and/or palate diagnosed by surgical site Number of babies East West East West East West East West East West Year Unilateral Cleft Lip Bilateral Cleft Lip Cleft Palate Unilateral Cleft lip and Palate Bilateral Cleft Lip and Palate 7. ACTIVITY Data collection on cleft patients has proven to be challenging both within the Boards and through the National Managed Clinical network. It is recognised that the information provided within the statistics reported for Glasgow is incomplete this was due to some procedures being undertaken within the Southern General and Glasgow Royal Infirmary which were not recorded on the Exelicare system or noted within the Annual Reports submitted to National Services Division. NHS Greater Glasgow and Clyde reviewed this information for 2010/11 and advised a further 3 procedures were carried out on patients aged on the Southern General site, however this information is not available for any other period and has therefore been discounted from the statistics. NHS Lothian had counted assessment, follow up and removal of sutures within their activity information. As these were neither primary nor secondary procedures and had not been recorded in Glasgow these have been removed to allow direct comparison of data. Grampian/Lothian figures refer to procedures on Grampian patients that were carried out in Lothian. 7.1 Total procedures Table 2 and chart 5 shows the total procedures carried out for the period by surgical site. Table 2: Total procedures by site Surgical Site 2006/ / / / /11 Glasgow Grampian Lothian Grampian/Lothian From 08/09 the reconfiguration of surgical service was implemented as recommended by the 2006 service review, the purple line above shows procedures undertaken by the East Coast service for both Lothian and Grampian patients. The number of procedures performed has been consistently higher within the West coast service; this may be a direct correlation to the higher level of births. 15

28 Chart 5: Total Procedures By Site 250 Number of Procedures Glasgow Grampian Gramp/Loth Lothian Lothian (+ Gramp and Gramp/Loth) / / / / /11 Year 7.2 Primary procedures Primary procedures are defined as those procedures required to reconstruct the malformation, the types of primary procedures carried out by surgical site is laid out in chart 6. Chart 6: Primary Procedures By Site ( ) 70 Number of Procedures Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Gramp Lothian Glasgow Grampian Gramp Lothian Glasgow Grampian Gramp Lothian Lip repairs Palate Repairs Primary Repairs Sub-mucous Cleft Alveolar bone grafts 2006/ / / / /11 Year and Site From 06/07 to 07/08 Glasgow carried out more primary procedures than the other two sites. From 08/09 Grampian ceased carrying out primary procedures and these patients have in effect been integrated into the Lothian service. It can be seen from the figures in table 3 that the number of primary procedures within the service in the East remains lower than the number carried out in the West. Table 3: Primary procedures by site 2006/ / / / /11 Glasgow Grampian Grampian/Lothian Lothian Table 4 illustrates that the most prevalent procedure undertaken within all of the services was for palate repairs. Again, it is evident from the figures in table 4 that from 06/07 to 07/08 Glasgow carried out more primary procedures than the other two sites. 16

29 Table 4: Total primary procedures by type ( ) Glasgow Grampian Grampian /Lothian Lothian Lip repairs Palate Repairs Primary Repairs Sub-mucous Cleft Alveolar bone grafts Secondary procedures Secondary procedures are defined as those procedures which cannot be predicted at birth but may be required to reconstruct the malformation. Even from 08/09 following integration of Grampian patients into the Lothian service the number of secondary procedures within the service in the East remains lower than the number of procedures carried out in the West. These are shown with the caveat that there are some discrepancies noted in the classification of procedures submitted by the different sites, which hinders direct comparison. Chart 7: Secondary Procedures By Site ( ) Number of Procedures Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Gramp Lothian Glasgow Grampian Gramp Lothian Glasgow Grampian Gramp Lothian 2006/ / / / /11 Year and Site Pharyngoplasty Secondary Palate Surgery Fistula Repair Minor Revisions Major Revisions Revisions Other Table 5 indicates that the most prevalent secondary procedure undertaken within Glasgow was minor revisions and within Lothian it was procedures classed as other. Table 5: Total secondary procedures by year 2006/ / / / /11 Glasgow Grampian Grampian/Lothian Lothian Following integration of Grampian patients into the Lothian service in 08/09, ten Grampian patients were treated in Lothian for secondary procedures. Since integration only 3 secondary procedures have been carried out in Grampian. 17

30 Table 6:Total secondary procedures by type ( ) Glasgow Grampian Grampian /Lothian Lothian Pharyngoplasty Secondary Palate Surgery Fistula Repair Minor Revisions Major Revisions Revisions AUDIT As part of the audit commitment the services collaborate with the CLEFTSiS network to report on specific performance against agreed Key Performance Indicators (KPIs). For the period the information below was taken from reports by the CLEFTSiS network. In 2010/11 there have been issues in regard to data collection in some locations, and therefore some figures for this year are incomplete. As part of the process of moving to the generic clinical audit system, the network are reconsidering the data requirements including standardising terminology/coding used in each centre. It is also proposed that the key performance areas that should be reported on should be revisited going forward, as many feel that some are not the best reflection of performance. These will also be influenced by the outcome of the Cleft Surgical and CLEFTSiS review. 8.1 Indicator 1: % First Contact 80% of babies and their parents will be visited by a designated cleft health professional within 24 hours of birth This information is collated by the CLEFTSiS network on an all Scotland basis. As shown in table 7, within Scotland the service has struggled to meet the first contact target. This has been for a variety of reasons including that there is not always weekend cover, late diagnosis following birth, and co-morbidities taking priority over cleft referral. This is one of the indicators that will be reviewed as the feeling is that the target should be from when referral is made to the service rather than from birth. Table 7: % of babies seen within 24hrs of birth 2006/ / / / /11 Scotland Wide Scotland Wide Scotland Wide Scotland Wide Scotland Wide New Babies 34% 67% 57% 76% 64*% *No information available on this indicator for 2 babies 8.2 Indicator 2: % completed lip repairs Lip repairs should be completed by the age of 5 months Chart 8 shows that the Glasgow and Lothian services have not consistently achieved this target. Following the integration of the Grampian and Lothian services in 08/09 this was achieved in only 83% of cases in Grampian; previously this was achieved in 100% of cases, the Lothian data was not available for that year. In 2009/10 the service in the East did not achieve this target. The target has been achieved by both the East and West services for 2010/11. 18

31 Chart 8: % within Target for Cleft Lip Repair Surgery % achieved 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 96% 100%100% 100% 100%100% 93% 83% 73% 35% 33% 25% 0 Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Lothian West East 2006/ / / / /11 Year and Site 8.3 Indicator 3: % completed palate repairs Palate repairs should be completed between the age of 6 12 months Again this target has not been consistently met by the service; however, ongoing monitoring and waiting time challenges have resulted in a significant increase in attainment. In 08/09 Lothian data was not available to the CLEFTSiS network and therefore this section is incomplete. It would appear from the chart there was significant challenges in 09/10 within Lothian as only 55% of patients met the target within this year, the situation appears to have been resolved now. % achieved 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Chart 9: % within Target for Cleft Palate Repair 100% 95% 100% 96% 100%100% 83% 73% Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Lothian 0 100%100% Glasgow Grampian 55% Lothian 94% 100% 2006/ / / / /11 Year and Site West East 8.4 Indicator 4: % completed Alveolar Bone Grafts Alveolar bone grafts should be completed within 3 months of patient being added to the waiting list Information in relation to Chart 10 was not available for 08/09 for Grampian and Lothian or in 09/10 for Lothian. As demonstrated, from the available information, this target is not being achieved with the exception of Grampian in 2006/07; this may be due to a clinical decision in relation to dental maturity however the reasons for non achievement of this target were not provided in the CLEFTSiS reports. 19

32 Chart 10: % completed within 3 months of entry to waiting list Alveolar bone grafts % achieved 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 38% 29% 35% 50% 64% 88% % 86% 0 Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Lothian 2006/ / / /10 Year and Site 8.5 Indicator 5: % completed Secondary surgeries Secondary surgery should be completed within 6 months of patient being added to the waiting list. Data for this indicator was not available for from Lothian. From the data available this standard has been achieved or close to achieved from , with the exception of 06/07 in Lothian, the CLEFTSiS report did not advise of the reason for this. Chart 11: % Secondary surgery completed within 6 months of entry to waiting list % achieved 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% 100% 90% 60% 93% 100%100% 97% 100% 0 98% 100% 0 Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Lothian Glasgow Grampian Lothian 2006/ / / /10 Year and Site 9. QUAD CENTRE AUDIT DATA For education purposes and benchmarking of outcomes with other centres, NHS Scotland participates in a quad centre audit on the following outcomes. The quad centre consists of the North and North East (Newcastle and Leeds); North West (Liverpool and Manchester); Trent (Sheffield and Nottingham) and Scotland (Glasgow and Lothian). The data below was presented at the quad centre meeting for last year for patients from It should be noted that there are issues of data completeness, as highlighted. This is consistent with other centres and the services have and continue to work to improve on data collection and audit. It is anticipated that the proposed new audit database will assist in this. 20

33 9.1 Bone Graft Data Alveolar bone grafting has become a commonly performed procedure over the last 25 years for children born with cleft lip and/or palate. The data demonstrates the independently assessed radiographic outcome for alveolar bone grafting from This was judged using the Kindelan index which is a semi-quantitative subjective two-dimensional assessment of bone filling the cleft alveolar defect. Kindelan Index Score Bone levels Assessment 1 > 75% Success % Success 3 < 50% Failure 4 No bone bridge Failure The first Graph shows the types of cleft grafted by centre for 2008 with the Scottish data broken down into the East and West surgical services. Graph 1: Type of Cleft grafted Graph 2 shows the percentage of Bone Graft cases where a prior orthodontic expansion was carried out. This can be influenced by an individual surgeon s preference and practice varies across the centres. It should be noted that data for the East of Scotland is incomplete as no information was available on this field for 3 patients. Graph 2: % prior orthodontic expansion Graph 3 shows the age of the child when the bone graph was performed. In the East of Scotland this is performed later than the other centres. As illustrated, practice varies across the centres. In this data set there was no information available for 2 patients in the West of Scotland. 21

34 Graph 3: Age graph performed Graph 4 is the time in months and the number of appointments taken for expansion to be carried out. There was no data available in regard to appointments for the East of Scotland. Graph 4: Time (months) and number of appointments for expansion Exp time appts 2 0 CLEFTSiS West (23) CLEFTSiS East (5) Centre 1 (24) Centre 2 (43) Centre 3 (50) Graph 5 shows the assessed scores for the bone graph outcomes using the Kindelan Index. It should be noted that data for 3 patients for the East of Scotland was not available for scoring CLEFTSiS West (23) CLEFTSiS East (6) Centre 1 (24) Centre 2 (43) Centre 3 (50) 1&2 3 4 Graph 5: Bone graft outcomes (Kindelan) 22

35 Graph 6 gives the overall percentage of eligible patient records available for assessment CLEFTSiS West (23) CLEFTSiS East (9) Centre 1 (24) Centre 2 (43) Centre 3 (50) Graph 6: % of records available 9.2 Orthodontic Outcomes The orthodontic assessments are judged by Peer Assessment Rating (PAR) scores. There are 5 components of occlusal features to this and the scores are summated. The five components are: o o o o o Upper & lower anterior segments Left & right buccal occlusion Overjet & anterior crossbite Overbite & anterior open bite Centrelines The PAR Index UK weightings are as follows: Upper and lower anterior segments 1 Left and right buccal occlusion 1 Overjet 6 Overbite 2 Centrelines 4 The Scottish data for this assessment for the audit of the 2008 cohort was only available from the following orthodontic centres in Scotland. NHS Greater Glasgow and Clyde; NHS Grampian; NHS Tayside and NHS Ayrshire and Arran. Centre GGC 16 Grampian 4 Tayside 4 A & A 1 Number of cases In Scotland the Cleft lip and Palate: Cleft palate ratio is approximately 50/50. Cleft lip only and cleft palate only may have limited dental effects. The types of cleft treated are shown in graph 8. It should be noted that peripheral units do not see full range of cases as the numbers are limited. Graph 9 shows this in comparison to the other centres participating in the Quad audit, with similar breakdown to those down South utilising peripheral centres. 23

36 Graph 7: Types of cleft treated Graph 8 shows the Age at start of treatment. The Scottish centres with the exception of Grampian commence treatment earlier than the centres in the South. Graph 8: Age at start of treatment Graph 9 illustrates treatment times. Treatment times for standard fixed appliances range from months and orthagnathic surgery from months. Graph 9: Treatment times Graph 10 shows the PAR scores for mal-alignment prior to treatment. The start PAR score should be >21 to achieve significant improvement. A >70% reduction is suggested as a good definitive result. 24

37 Graph 10: PAR scores prior to treatment Graph 11 illustrates the PAR outcome scores. Graph 11: PAR outcome scores Year Speech Audit From the 2004 cohort of surgical patients there were 72 births (38 East and 34 West) with cleft palate involvement in that calendar year. Thirteen patients (9 East and 4 West) were excluded from participating in the audit (3 unable to complete the audit, 5 had a diagnosed syndrome, and 6 transferred out of area/deceased). Of the 59 eligible for audit (29 East and 30 West), 47 were offered appointments (25 East and 22 West) 8 were not used and 4 patients did not attend. The total number of speech assessments submitted for audit was 35 (22 for the East and 13 for the West). Of these 8 had a unilateral cleft lip and palate (7 East and 1 West) 1 patient based in the East had a Bilateral Cleft Lip and Palate and 26 had a cleft palate only (14 East and 12 West). It should be noted that maternity leave had significant impact on the total audits that were submitted which has skewed results and therefore this may not be a true reflection of performance. Speech was analysed using the Cleft Audit Protocol for Speech Augmented (CAPS-A). The Speech sample contained spontaneous speech, automatic speech and sentence repetition. There are a number of process standards in regard to the audit o 100% of children with cleft palate (+/- cleft lip/alveolus) who are eligible are offered assessment by a specialist SLT before 27 months old and this offer documented. In Scotland this was achieved in 80% of eligible cases overall (86% in the East and 73% in the West). 25

38 o Speech records are taken in line with national audit recommendations and reported locally and nationally for all non-syndromic children with UCLP, BCLP, isolated cleft palate (including PRS) who are able to complete audit. Any exclusions are reported with reasons. In Scotland this was achieved in 100% of eligible cases. o All audit recordings will be analysed by consensus by at least 2 CAPS-A trained listeners. In Scotland this was achieved in 100% of eligible cases. o A minimum of 10 consecutive recordings per centre will involve a listener external to the centre either as part of the consensus group or independently. In Scotland this was achieved in 100% of eligible cases. The CAPS-A rating outcomes are classified as: Dark green = normal/no errors Light green = minor errors, may occur within range of normal non-cleft speech Amber = potential problems requiring monitoring Red = unsatisfactory outcome, where therapy and/or structural investigations (and possible surgical intervention) are likely to be required In regard to the outcome standards the following results were achieved. o By years 50% of children will have speech within the normal range, i.e. green profiles on CAPS-A. In Scotland this was achieved in 46% of eligible cases (55% in the East and 31% in the West). o o o o o 70% of children have speech with no evidence of a structurally related speech problem and have not had VP surgery or fistula repair. In Scotland this was achieved in 77% of eligible cases (86% in the East and 62% in the West). 10% of children have had VP surgery or fistula repair and speech now has no evidence of a structurally related problem. In Scotland this was achieved in 11% of eligible cases (9% in the East and 15% in the West). 10% of children have had VP surgery or fistula repair & still have speech indicative of a structurally related problem. In Scotland this was achieved in 6% of eligible cases (0% in the East and 15% in the West). 10% of children have had no VP surgery or fistula repair and have current evidence of a structurally related problem. In Scotland this was achieved in 6% of eligible cases (5% in the East and 8% in the West). By years more than 50% of children have no cleft type articulation difficulties which require therapy or surgery. In Scotland this was achieved in 57% of eligible cases (59% in the East and 54% in the West). 9.4 Paediatric Dental Audit The following is the tri-centre paediatric dentistry audit of 5 year olds looking at dental status in terms of decay for babies born in This is measured by the number of primary teeth observed to be decayed, missing or filled (DMFT). The data set being: decayed teeth/surfaces = dt missing teeth/surfaces = mt filled teeth/surfaces = ft dmft = average number of teeth affected by caries % caries free Care index ft/dmft 26

39 The table below shows the births per NHS Board and the number and percentage of assessments achieved in NHS Scotland in 2009 and the other participating centres from England (assessment carried out in 2008). Table 8: Dental assessments Area Births 2004 Number examined Highland Grampian Tayside + Fife Forth Valley Lothian +Borders Ayrshire and Arran Greater Glasgow & Clyde Lanarkshire +Dumfries & Galloway Total NHS Scotland % achieved North North East Newcastle Leeds North West Manchester Liverpool As demonstrated below, NHS Scotland has achieved fewer percentage examinations of eligible patients than those in Northern-Yorkshire and slightly more than North West (9% v. 81% v. 44%). Of these the Scottish patients have less caries experience than those in Northern-Yorkshire and North West (dmft of 2.52 v v. 4.23). The children in Scotland were observed to have a higher Care index than those in Northern-Yorkshire and North West (11.8 v. 7.5 v. 11.0). Table 9: Dental indices Indices CLEFTSiS 2009 North East 2008 North West 2008 % caries free 54% N/A N/A dt 1.14 N/A N/A mt 1.10 N/A N/A ft 0.31 N/A N/A dmft Care index dt/dmft It should be noted that the dental services are not part of the nationally funded cleft service and that data collection is currently not possible in all areas of Scotland. It is difficult to draw accurate conclusions about level of disease and care provided for CLEFTSiS children over all Scotland. 27

40 10. ADDITIONAL INFORMATION PROVIDED AS PART OF ANNUAL REPORT As part of the service agreement with NSD, the services provide information on the following for the period 1 April March 2011: 10.1 Complaints No complaints were reported within the period from either NHS Greater Glasgow and Clyde or NHS Grampian. NHS Lothian reported three complaints in 2009/10. Two of the complaints were in relation to delays in surgery and 1 in regard to the clinic facilities. The service advised that these complaints were suitably resolved. In 10/11 NHS Lothian received 1 complaint in relation to orthodontics and paediatric dentistry again it was noted that the issue had been addressed to the satisfaction of the parties involved Mortality The services are expected to report on all deaths within 30 days of the operation/intervention and all hospital deaths related to the service irrespective of the timing. No deaths were reported by any of the NHS Boards in the years Complications and critical/adverse incidents There were no complications or critical/adverse incidents reported within the period by either NHS Greater Glasgow and Clyde or NHS Grampian. In 2010/11 advised of a wound dehiscence. A management plan was agreed, and the issue was successfully resolved Hospital Acquired Infections (HAI) There were no hospital acquired infections within the period reported by NHS Greater and Clyde or NHS Grampian. In 2008/09 in NHS Lothian there were 4 HAI cases, 3 babies and 1 parent all of whom contracted Norovirus. A deep clean of the ward was carried out as recommended by the NHS Lothian infection control team; no further issues have been reported. 28

41 11. USER FEEDBACK 11.1 Methodology For the 2006 review a public consultation was undertaken by an external market research company and involved inviting parents to take part in focus groups looking at issues such as patient choice, importance of distance to families, and necessary and desired elements of services. Eight focus groups were conducted in different locations in an attempt to capture both rural and urban areas. Two groups were held in Edinburgh Perth Aberdeen and Glasgow. All participants were volunteers, who were chosen at random within geographical areas, from the more than one hundred people responded to a request sent out through CLP clinics. The focus groups were asked to rate the importance of a list of priorities. The Statements used as a stimulus: Being able to choose my / my child s surgeon Being able to choose when I / my child has surgery Being involved in decision making about my / my child s treatment Being able to choose where the surgery will take place Can the centre provide my / my child s long term care needs How accessible is the hospital to where our family live Availability of the surgical service at the hospital Availability of the multidisciplinary team speech and language therapist, orthodontist, specialist nurses, paediatric dentist, psychologist Availability of written information to take away and read with my family Availability of patient / family support groups Availability of accommodation for families The researchers then applied a qualitative research methodology to derive the following conclusions from the discussions that took place in the eight focus groups. The views and opinions expressed by the parents were very similar in all the groups, with no disparity found for the three different centres. The only notable difference was where a family had two CLP children, and therefore their experience and knowledge gained from their first child affected their response to the treatment of their second child Although the service was considered to be excellent, there was an identified gap in the provision of professional information and support between leaving the hospital after the birth of the baby and the child s first operation The first priority for parents is that their child receives the best possible surgical treatment, regardless of where this is provided. Their second priority is for their child to continuity of care throughout the often very long course of their treatment. In an ideal world all care would be provided close to parent s homes, however all the parents recognise and accept that this is not realistic. All support the idea of greater specialisation the part of CLP surgeons and accept that this will inevitably mean more centralisation of services. It is more important that non-surgical aspects of their child s care are provided close to home. This is particularly important for families with more than one child. It was decided, as part of the review, to retest the findings of the previous public consultation undertaken as part of the 2006 review to determine if the findings are still valid. This was through use of a user questionnaire (Appendix 3) that was distributed through CLAPA and the CLEFTSiS network and made available online. 29

42 11.2 Demographic information In total eighty three responses to the survey were returned either online or by post. Approximately 66% of the respondents reported that they were a parent/carer of a child with a cleft, 16% were adults with a cleft, and 5% stated they were a child with a cleft (up to and including 16 years). The remainder of the respondents stated other. Of the respondents that indicated other, one was a grandparent of a child with a cleft palate, and the remaining five stated they were clinicians or cleft care workers. There were respondents from all NHS Boards except Borders, Shetland and Western Isles with 7% choosing not to respond to this question. The majority of the respondents were parents of a child with a cleft. There appears to have been some confusion regarding the question to determine age range of respondent and some respondents may have listed their child s age rather than their own in this field. For those respondents with a child/children that has a cleft lip and/or palate the range of the child/children s ages are detailed below. 18 respondents chose not to give their child s age. Table 10: Age of child(ren) Child 1 Child 2 Child m m yrs yrs yrs yrs The type(s) of cleft either the respondent or their child/children reported are stated below. In addition to those listed one respondent listed under other a notch on gum/partial cleft deformity and another that their child has a hair lip. Table 11: Type of cleft Unilateral Cleft Lip Bilateral Cleft Lip Cleft Palate Sub Mucous Cleft Palate Pierre Robin Self Child Child Child

43 11.3 Preferences for the service In respect to their or their child s surgical care the respondents were asked to rank the following aspects in regard to level of importance, using the same themes used in the 2006 review: Being able to chose my/my child(s) surgeon Being able to chose at which age I/my child has surgery Being involved in decision making about my/my child s treatment Being able to choose where the surgery will take place Whether the centre can provide my/my child s long term surgical care needs How accessible the hospital is to where I/our family live Whether my/my child s follow up and ongoing care is available locally Availability of accommodation for my family Availability of patient/family support groups From the respondents that chose to answer this section all aspects were rated by the majority to be either fairly or very important. The aspects judged to be either fairly or very important by the largest number of respondents were (in order): being involved in decision making about my/my child s treatment; whether the centre can provide my/my child s long term surgical care needs; whether my/my child s follow up and ongoing care is available locally, how accessible the hospital is to where I/our family live. Availability of accommodation for my family had the fewest respondents ranking it either fairly or very important. Similar findings were demonstrated when the respondents were asked to rank the aspects in order of importance. Table 12: Preferences Being involved in decision making about my / my child s treatment 1 Whether the centre can provide my / my child s long term surgical care needs 2 Being able to choose my/my child s surgeon 3 How accessible the hospital is to where I / our family live 4 Being able to choose where the surgery will take place 5 Whether my / my child s follow up and ongoing care is available locally 6 Being able to choose at what age I / my child has surgery 7 Availability of patient / family support groups 8 Availability of accommodation for my family 9 These findings seem to be consistent with the findings of the previous focus groups conducted as part of the 2006 review of the Cleft surgical service. It still appears to be the case that the top priorities of patients and their parents are that they receive the best possible surgical treatment available regardless of the location and that continuity of care is very important. It is also clear that whilst prepared to travel for the surgical elements where required, it is still very important that the follow on non surgical care is delivered as close to home as possible. An additional priority identified in this piece of work is that patients/parents feel very strongly about being involved in the decision making process regarding care. It is important that processes are strengthened to ensure that the patient/parent is empowered to be an active participant in decisions regarding all aspects of their/their child s clinical pathway. The additional comments received in relation to the future provision of cleft surgical care echoed the importance of continuity of care with an expert multi disciplinary team, accessibility of advice and support, involvement in decisions and timing of surgery and clear information. One respondent highlighted difficulties accessing care as an adult. It should be noted that at the first steering group meeting it was noted that the group strongly felt that it should be 31

44 recommended that the nationally designated surgical service for cleft should be extended to include all age groups not just paediatrics. The additional comments received are included in Appendix 4 Respondents were asked to indicate whether they personally or their child had problems accessing NHS treatment for any aspects of multi-disciplinary cleft care in the last 5 years. The following responses were received: Table 13: Access to multi disciplinary cleft care No problems Didn t know it existed Problems accessing it Not needed No answer Cleft Nurse Specialist Genetic Specialist Paediatrician Audiology Returning to treatment as adult Psychology Referral to Cleft Service Dental Care Speech and Language Therapy Surgery Information about patient pathway Orthodontics Diagnosis of Cleft Palate In regard to the low knowledge of the genetic specialist, it may be that a referral to this discipline is not always appropriate; however the service should ensure that patients/parents are given the opportunity to access this service where appropriate. Access to clinical psychology is a known issue which is reflected in the responses above. The services are endeavouring to address this and NHS Greater Glasgow and Clyde have just secured dedicated sessions for the cleft service. The most surprising finding was in regard to the low level of knowledge of the patient pathway. The ideal Patient Care Pathway was one of the work streams of the CLEFTSiS network last year and going forward further work should be undertaken to keep patients/parents informed and involved regarding their/their child s clinical care pathway. It is not clear what the issue has been in regard to being seen in audiology and this should be investigated further. In relation to difficulties in accessing Speech and Language therapy, there was an issue in NHS Lothian due to staffing issues and this has since been resolved. Nonetheless the service should not be complacent and continue to monitor access to any of the multi-disciplinary services. 32

45 11.4 CLEFTSiS user feedback Of the responses received there does seem to be further work required to publicise the network amongst users and to ascertain and address their needs wherever possible. Chart 12: Are you aware of the CLEFTSiS Network 25% 30% Yes (Y) No (N) No answer 45% The network currently uses a variety of mediums to communicate with users. The following demonstrates the awareness and usage of each by the respondents. Table 14: CLEFTSiS communications Yes No Uncertain No Answer Website Newsletter Patient Event Patient Survey Feedback through Patient Rep Education Meeting When asked if there were any other methods that the network could use to engage with patients, many responded that they either were unaware of the network or that they had only fleeting contact at the start of their care and thought it no longer existed. Suggestions received included raising the profile of the network and what they can offer through any contact with the multidisciplinary team, use of or even facebook/social media. It would seem that there is some way to go in terms of engagement with users. Whilst the respondents are only a portion of the patient/parent group the network should study the findings of this questionnaire, and refocus their efforts in engaging with the users of the service to better meet their needs. Further comments/observations received in regard to the work of the cleft surgical service or the CLEFTSiS network are included in Appendix 4 33

46 11.5 Conclusions from user feedback From the responses received, the main findings from the previous patient/parent engagement conducted for the 2006 review of Cleft surgical services still hold true. The main priorities for patients/parents is that they/their child receives the best possible surgical treatment, regardless of where this is provided and that they are closely involved in decision making. It is still very important that non-surgical aspects of their child s care are provided close to home. Work is still required in regard to meeting patient s needs in regard to information and understanding what their/their child s clinical care pathway is likely to be. There seems to be gaps in the provision of adult services from responses received and this endorses the view of the current review steering group that a recommendation be made that the current designated service should be extended to include all age groups not just paediatrics. Issues re access to speech and language therapy especially in NHS Lothian has been a recurrent theme and whilst the staffing issues that contributed to this have been addressed, a watching brief should be continued to ensure that there is adequate coverage provided to meet demand. Whilst the CLEFTSIS network has worked hard to engage with users there is further work required to meet their needs, and will require all members of the multidisciplinary team to continue to raise the profile of the network and determine information/education requirements of users. 34

47 12. STAKEHOLDER VIEWS As part of the review stakeholders of the service and network were given the opportunity to view the long listed options to comment on the pros and cons of each from a service viewpoint. Comments were received both through the use of a questionnaire and also through 3 stakeholder meetings held in NHS Lothian, NHS Greater Glasgow and Clyde and NHS Grampian. The questionnaire was widely circulated by the CLEFTSiS Network and the services themselves to all Health Professionals involved in or who have an interest in the provision of any aspect of Cleft surgical care. In total 34 people attended the 3 workshops and there were 66 responses to the questionnaire. The workshops and questionnaire were made available to anyone with an interest in cleft care and of the participants that indicated which NHS Board they were employed by 8 of the 14 NHS Boards were represented. Nine respondents to the questionnaire chose not to answer this question. The respondents/attendees were from a variety of disciplines including surgeons, specialist nurses, management, administrators, orthodontics, paediatric dentistry, speech and language therapy, audiology and paediatric anaesthetics. Eight respondents declined to state their discipline. The feedback was used to establish a shortlist of options for the review group to assess and ensure stakeholder s views were paramount when the steering group made a recommendation on the best outcome for the service as a whole. All detail relating to the Stakeholder workshops and the long listed options and feedback is provided at Appendix Objectives of obtaining stakeholder feedback In summary the objectives of obtaining stakeholder feedback were to:- 1. Ensure engagement with wider stakeholder group on the cleft surgical service and CLEFTSiS NMCN options for service commissioning and configuration in Scotland. 2. Gain valuable input on a range of wider issues around the proposed options for commissioning and configuration. Ensuring stakeholders had the opportunity to review & input to the long listed commissioning and configuration options. 3. Formulate a short list for the Review Group to assess at their meeting on the 27 February 2012 and ensure stakeholder s views were paramount when the review group makes a recommendation on the best outcome for the service and network as a whole. 4. Allow the review group to address any outlying questions / issues stakeholders had regarding the review, process and options. The long listed options were:- 1. Status Quo: Two surgical services managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. 2. Two surgical services, managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde and NHS Lothian Board areas with additional outreach assessment and follow up clinics. 3. One surgical service based in NHS Lothian, carrying out surgery in NHS Lothian, NHS Grampian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. 35

48 4. One surgical service based in NHS Greater Glasgow and Clyde, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. 5. One surgical service based in NHS Lothian, carrying out surgery in NHS Lothian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. 6. One surgical service based in NHS Greater Glasgow and Clyde, carrying out surgery in NHS Greater Glasgow and Clyde and NHS Lothian Board areas with additional outreach and follow up assessment clinics. 7. One surgical service based and providing surgery in NHS Lothian, with additional outreach assessment and follow up clinics. 8. One surgical service based and providing surgery in NHS Greater Glasgow and Clyde, with additional outreach assessment and follow up clinics. 9. De-designation Notes All options including the status quo are for both paediatric and adult surgery provision # All options including surgery in Grampian are for secondary procedures # It should be noted that when the review group met in September 2011 to agree the scope, objectives, aims of the review and a long list of options, it was also agreed that it should be a recommendation that all potential options should be to cover all age groups not just the paediatric component of the service currently commissioned 13. SHORTLISTING OPTIONS Using the comments and views obtained from the Users and Stakeholders, the Johnson, Scholes and Whittington framework of strategic choice 7 was used to apply a methodological evaluation of each of the long listed options in order to present a shortlist of options for the review group to consider. In this model each option is evaluated against three key success criteria. Suitability: Will the option work within the current and future environment Feasibility: Is this option capable of working within resources that are available, or can be developed/obtained Acceptability: How will this option affect stakeholders and what reactions can be anticipated Option 1 Is the development of the status quo to encompass the adult procedures in addition to the current paediatric workload. Suitability: As this is the current operational model it still seems to be perceived to be suitable at present, and there was overwhelming support recommending that the age range of the service be extended. Many people expressed a view that the current model was working and should be maintained to minimise disruption to the service, however, a significant proportion of the feedback received indicated concerns that this option is not sustainable in its present form in the long term. One of the main reasons cited for this option not to be sustainable in the longer term were in regard to there not being sufficient surgical procedures to maintain the level of surgical skills as outlined by the UK 7 Johnson, G, Scholes, K, Whittington, R (2008) Exploring Corporate Strategy, 8th Edition, FT Prentice Hall, Essex 36

49 Clinical Standards Advisory Group (CSAG) Cleft Lip and Palate for the current workforce. If this option were to be endorsed then consideration of the distribution of workload and assessment of workforce requirements is needed using an accredited workforce planning tool. Additionally the inequity in regard to amount and types of staff funded between the services in the East and West has been raised and this would also have to be addressed. The availability of secondary surgery in Grampian and choice of surgical sites for primary procedures for those patients in this option was seen to be a plus by some, but others felt that this duplication of resources was not cost effective or the best use of resources. Grampian strongly expressed a desire for the option of secondary procedures to continue to be available where clinically appropriate. The distance that patients have to travel for care was also repeatedly raised as an important issue. It should be noted that it has been commented on that very few secondary surgeries have taken place in the Grampian site since the previous reconfiguration of services, and also that in effect patients are not given a choice in the surgical site for primary procedures most convenient for their needs at present. If this proves to be the preferred option, this should be evaluated as part of the review of workloads for the surgical sites. Regardless of which option chosen regarding surgical care provision it is essential that provision of follow up care should be delivered as locally as possible where clinically appropriate. A recurrent theme in the feedback is in regard to the fact that the recommendation from the 2006 review that the surgical sites should provide cross cover has never been realised. The two surgical services work independently of each other with many respondents raising the issue that there is little interaction between the surgeons in the East and West and that there are variations in surgical care provision and patient pathways, this is despite the efforts of the CLEFTSiS network to gain consensus on a National Ideal Care Pathway and to standardise care for the patients in NHS Scotland. It does seem that this is less of an issue in regards to the other disciplines involved in the Cleft service. Regardless of the outcome of this review, work will need to be undertaken to address the fractured working relationships and rebuild trust between the surgical services in order to provide a comprehensive, equitable service for NHS Scotland. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the national cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. This is true of all of the options. In regard to the feasibility, as the current model this option remains a viable option in the short term, but if endorsed the issues already highlighted under suitability will need to be tackled. In regard to distribution of workload, some restructuring may be required to ensure the clinical skill standards can be met and the service is sustainable in the long term. Also the discrepancies in regard to what elements are funded in the East and West services should be revisited and resolved where needed. As previously stated work to restore relationships and trust between the surgical elements of the service will require to be undertaken. Acceptability Whilst many people have expressed a view that they no longer feel that this option is sustainable in the longer term. It is currently operating reasonably well and is acceptable and advocated by many of the stakeholders who have commented. Therefore it would seem that if the current areas of concern regarding this option were resolved then this could be an acceptable service model. CLEFTSiS network The majority of respondents expressed that there was still a role for the network if this was the preferred option. It is recognised that in the absence of the entire service being nationally commissioned, the role of the network would be to share expertise, agree standards and discuss issues and new ways of working to continually improve patient outcomes. It was noted to play a major role in the data collection and scrutiny of the performance and quality of the service, ongoing 37

50 education and it facilitates research. It is also seen as the mode in which to liaise with and provide support and information to patients and patient groups such as CLAPA. There were also some issues raised in terms of the network, it was raised that the network had few options to enforce clinical standards and act on audit results at present. There have been reported issues regarding compliance in data submission impacting on the robustness of audit. Others have indicated that the processes in regard to access is overcomplicated by the network which may have impacted on peoples willingness to participate in data collection it they felt there needs in regard to outcome reports were not being met. There have been particular long-term issues in regard to the current database and going forward the network are moving to the generic clinical audit system for networks that has been developed so it is hoped that this will improve the ease of data submission and the accessibility of data outcomes to all network members encouraging compliance and improving data quality. There have been criticisms with the level of communication from the network by some respondents and similarly the lack of engagement and participation by some parties has also been raised. This reflects the fragmented relationships between some elements of the cleft service and going forward these issues will need to be addressed. From the outcomes of the user survey while some progress has been made to improve engagement with users there is further work required to meet their needs, and this will require all members of the multidisciplinary team to continue to raise the profile of the network and determine and fulfil the information/education requirements of users Option 2 Is a modification of the status quo with two surgical services continuing one in NHS Lothian and one in NHS Greater Glasgow and Clyde but with no provision for secondary surgeries to be carried out in NHS Grampian (it is also proposed to encompass the adult procedures in addition to the current paediatric workload). Suitability: In practice this is virtually the current operational model as very few secondary procedures have been carried out in NHS Grampian since the previous review recommendations were fully implemented. As with option 1 there is overwhelming support recommending that the age range of the service to be extended. As noted regarding option 1, many people expressed that to a large extent a two centre site is working and should be maintained to minimise disruption to the service, however, for the same reasons detailed in option one regarding sufficient workload to maintain clinical skills and the inequity of resources provided between the two centres others did not feel that this model is sustainable in the longer term. An additional issue in relation to this option is the removal of the option for secondary surgery to take place in NHS Grampian when clinically appropriate. Such is the strength of feeling regarding this and the potential effects on support services, given that the savings achieved would be so marginal it does not seem justifiable to disenfranchise so many to pursue such a minor change to service delivery. The issue highlighted in regard to the lack of cross cover and interaction between the two surgical services is a significant concern. As stated before work would need to be undertaken to address the fractured working relationships and rebuild trust between the surgical services in order to provide a comprehensive, equitable service for NHS Scotland. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the National cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. In regard to the feasibility, as in practice this is the current model this option could be considered to remain viable in the short term, but the removal of any option of secondary procedures in NHS Grampian is likely to be robustly challenged and as noted under suitability given the potential 38

51 effects on support services and that the savings achieved would be so marginal it does not seem justifiable to disenfranchise so many to pursue such a minor change to service delivery. If endorsed, the issues already highlighted under suitability will need to be tackled. In regard to distribution of workload, some restructuring may be required to ensure the clinical skill standards can be met and the service is sustainable in the long term. Also the discrepancies in regard to what elements are funded in the East and West services should be revisited and resolved where needed. As previously stated work to restore relationships and trust between the surgical elements of the service will require to be undertaken. Acceptability As this is virtually the current status quo, it is currently operating reasonably well and is acceptable to many of the stakeholders who have commented, however there is a strong feeling that any removal of the option for secondary surgery taking place is NHS Grampian is unacceptable. Additionally the issues that other respondents have highlighted in regard to the long term suitability and sustainability of this option would require to be addressed. CLEFTSiS network As with option 1 the majority of respondents expressed that there was still a role for the network if this was the preferred option. Similar views on what the role of the network should be were expressed. Additionally the same issues were raised Option 3 One surgical service based and managed in NHS Lothian, carrying out surgery in NHS Lothian, NHS Grampian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. Suitability: This option would retain the option of surgical services in the three current locations, in theory causing minimum disturbance for patients and could potentially address the issues raised regarding the lack of cross cover and integration of the current surgical services. In practice however, most of the respondents felt that the logistical issues of making this option work would be too complex for this to be a viable option. It was felt to be unattractive to the surgical staff, and the responsible management team. Some of the current surgeons are not employed on cleft services on a full time basis therefore they potentially would be managed by one site for one part of their job and another for the remaining sessions. There could also be conflicting demands on time and given the added complexity of the geographical areas to cover this option may not prove to be workable without a lot of goodwill on behalf of the staff and the management teams involved and would require close coordination of clinical demands. Again the difficulties in the relationships and trust issues of the surgical services would also need to be addressed. Clinical safety was also felt to be an issue, as potentially the operating surgeon may not be easily accessible if they did not live in the area and complications arose when they were off-site. This is one of the main reasons cited for all but the most straightforward of secondary procedures not to be carried out in NHS Grampian at present. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the national cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. In view of the concerns raised in relation to management of staff, conflicting work priorities and issues of clinical safety, this option does not appear to be feasible to take forward. 39

52 Acceptability For patients this may be an acceptable option as it should have minimal impact on where they could potentially access their surgical care. It has been raised however, that due to the complexity of managing this service and the potential workload conflicts, patient safety concerns and the inefficiencies caused by having to travel between multiple sites, this option is unlikely to be viewed favourably by either management or the surgical services. CLEFTSiS network As with previous options the majority of respondents expressed that there was still a role for the network if this was the preferred option. Even though there would be a unified surgical service, it was recognised that there would be no other funded forum for all disciplines to share expertise and collate and scrutinise data on all aspects of cleft care, not just the surgical elements. Similar views on what the role of the network should be were expressed. The issues raised were similar to before Option 4 Option 4 would be one surgical service based and managed in NHS Greater Glasgow and Clyde, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. Suitability: As with option 3 this option would retain the option of surgical services in the three current locations, in theory causing minimum disturbance for patients and could potentially address the issues raised regarding the lack of cross cover and integration of the current surgical services. In practice however, most of the respondents felt that the logistical issues of making this option work would be too complex for this to be a viable option. It was felt to be unattractive to the surgical staff, and the responsible management team. Some of the current surgeons are not employed on cleft services on a full time basis therefore they potentially would be managed by one site for one part of their job and another for the remaining sessions. There could also be conflicting demands on time and given the added complexity of the geographical areas to cover this option may not prove to be workable without a lot of goodwill on behalf of the staff and the management teams involved and would require close coordination of clinical demands. Again the difficulties in the relationships and trust issues of the surgical services would also need to be addressed. Clinical safety was also felt to be an issue, as potentially the operating surgeon may not be easily accessible if they did not live in the area and complications arose when they were off-site. This is one of the main reasons cited for all but the most straightforward of secondary procedures not to be carried out in NHS Grampian at present. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the national cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. In view of the concerns raised in relation to management of staff, conflicting work priorities and issues of clinical safety, this option does not appear to be feasible to take forward. Acceptability For patients this may be an acceptable option as it should have minimal impact on where they could potentially access their surgical care. It has been raised however, that due to the complexity of managing this service and the potential workload conflicts, patient safety concerns and the inefficiencies caused by having to travel between multiple sites, this option is unlikely to be viewed favourably by either management or the surgical services. 40

53 CLEFTSiS network As with previous option 3 the majority of respondents expressed that there was still a role for the network if this was the preferred option. Even though there would be a unified surgical service, it was recognised that there would be no other funded forum for all disciplines to share expertise and collate and scrutinise data on all aspects of cleft care, not just the surgical elements. Similar views on what the role of the network should be were expressed. The issues raised were similar to before Option 5 One surgical service based in NHS Lothian, carrying out surgery in NHS Lothian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. Suitability: This option would retain the option of surgical services in two of the current locations, but without the option of suitable secondary procedures being performed in NHS Grampian. This could potentially address the issues raised regarding the lack of cross cover and integration of the current surgical services. In practice however, as with options 3 and 4 most of the respondents felt that the logistical issues of making this option work would be too complex for this to be a viable option. It was felt to be unattractive to the surgical staff, and the responsible management team. Some of the current surgeons are not employed on cleft services on a full time basis therefore they potentially would be managed by one site for one part of their job and another for the remaining sessions. There could also be conflicting demands on time and given the added complexity of the geographical areas to cover this option may not prove to be workable without a lot of goodwill on behalf of the staff and the management teams involved and would require close coordination of clinical demands. Again the difficulties in the relationships and trust issues of the surgical services would also need to be addressed. Clinical safety was also felt to be an issue, as potentially the operating surgeon may not be easily accessible if they did not live in the area and complications arose when they were off-site. Furthermore the removal of the potential to perform clinically suitable procedures in NHS Grampian will be a disappointment to staff and patients in that area. In regard to actual number of patients affected this is very small, but it will have an impact on the associated health professionals involved in the service in NHS Grampian. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the national cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. In view of the concerns raised in relation to management of staff, conflicting work priorities and issues of clinical safety, this option does not appear to be feasible to take forward. Acceptability For patients this may be an acceptable option as the number of patients affected in NHS Grampian are so small, it should have minimal impact on where the majority could access their surgical care. It has been raised however, that due to the complexity of managing this service and the potential workload conflicts, patient safety concerns and the inefficiencies caused by having to travel between multiple sites, this option is unlikely to be viewed favourably by either management or the surgical services. It is also unlikely to be viewed favourably by the staff in NHS Grampian. CLEFTSiS network As with previous option 3 and 4 the majority of respondents expressed that there was still a role for the network if this was the preferred option. Even though there would be a unified surgical service, it was recognised that there would be no other funded forum for all disciplines to share expertise and collate and scrutinise data on all aspects of cleft care, not just the surgical elements. Similar views on what the role of the network should be were expressed. The issues raised were similar to before. 41

54 13.6 Option 6 One surgical service based in NHS Greater Glasgow and Clyde, carrying out surgery in NHS Greater Glasgow and Clyde and NHS Lothian Board areas with additional outreach assessment and follow up clinics. Suitability: This option as with option 5 would retain the option of surgical services in two of the current locations, but without the option of suitable secondary procedures being performed in NHS Grampian. As stated above, this could potentially address the issues raised regarding the lack of cross cover and integration of the current surgical services. In practice however, as with options 3 and 4 most of the respondents felt that the logistical issues of making this option work would be too complex for this to be a viable option. It was felt to be unattractive to the surgical staff, and the responsible management team. Some of the current surgeons are not employed on cleft services on a full time basis therefore they potentially would be managed by one site for one part of their job and another for the remaining sessions. There could also be conflicting demands on time and given the added complexity of the geographical areas to cover this option may not prove to be workable without a lot of goodwill on behalf of the staff and the management teams involved and would require close coordination of clinical demands. Again the difficulties in the relationships and trust issues of the surgical services would also need to be addressed. Clinical safety was also felt to be an issue, as potentially the operating surgeon may not be easily accessible if they did not live in the area and complications arose when they were off-site. Furthermore the removal of the potential to perform clinically suitable procedures in NHS Grampian will be a disappointment to staff and patients in that area. In regard to actual number of patients affected this is very small, but it will have an impact on the associated health professionals involved in the service in NHS Grampian. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the national cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. In view of the concerns raised in relation to management of staff, conflicting work priorities and issues of clinical safety, this option does not appear to be feasible to take forward. Acceptability Again as with option 5, for patients this may be an acceptable option as the number of patients affected in NHS Grampian are so small, it should have minimal impact on where the majority could access their surgical care. It has been raised however, that due to the complexity of managing this service and the potential workload conflicts, patient safety concerns and the inefficiencies caused by having to travel between multiple sites, this option is unlikely to be viewed favourably by either management or the surgical services. It is also unlikely to be viewed favourably by the staff in NHS Grampian. CLEFTSiS network As with options 3, 4 and 5 the majority of respondents expressed that there was still a role for the network if this was the preferred option. Even though there would be a unified surgical service, it was recognised that there would be no other funded forum for all disciplines to share expertise and collate and scrutinise data on all aspects of cleft care, not just the surgical elements. Similar views on what the role of the network should be were expressed. The issues raised were similar to before Option 7 One surgical service based and providing surgery in NHS Lothian, with additional outreach assessment and follow up clinics. 42

55 Suitability: This option would mean only one site for surgery in NHS Scotland and would require all patients to travel here which may negatively impact on a significant portion of patients, however from the feedback received in the public engagement exercise conducted as part of the 2006 review and the follow up survey for this review patients and parents have indicated that they would be prepared to travel for the best possible surgical treatment. This currently is the case in other international models of service delivery. It has been raised by NHS Glasgow and Clyde that by placing the central service in NHS Lothian potentially this removes the service from the main patient base and therefore this would mean the larger proportion of patients having further to travel for surgical treatment. In terms of the surgical service, this option would address the issues raised regarding the lack of cross cover, integration of the current surgical services, differing patient pathways and audit difficulties. It has also been reported by several respondents that a single surgical centre of excellence in terms of recruitment would be more attractive in terms of future recruitment to vacancies. Work would need to be undertaken to determine the workforce required for the workload and to ensure that the clinical skills particularly in regard to adult surgery in NHS Lothian are available, potentially some staff may not be prepared/be able to change their working base and this may be a significant issue. There would be some cost savings achieved through reducing the need for duplication of some facilities in the two other surgical sites and this could potentially be reinvested in other aspects of the service. In terms of the wider cleft services and associated disciplines there would be an impact and staff may be displaced and communication networks would need to be established to support any reconfiguration of service along these lines. The impact of the withdrawal of funding from the other NHS Boards would also need to be taken into consideration. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the national cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. Despite the issues described under suitability, there does seem to be some merit in considering this further as a potential option for the future delivery of the service. Acceptability For patients this may be an acceptable option as it has been demonstrated in services abroad and through feedback from the public consultation exercises for this and the previous review, patients/parents are willing to travel to receive the best surgical treatment available. Many of the respondents have indicated that given the workload of NHS Scotland it makes more sense and is a better use of scarce resources to only have one surgical site, with good follow up care available as locally as practicable. It should not be underestimated however, how disruptive this will be to staff in the other NHS Board areas and also the effect of a portion of funding being removed from an NHS Board. As stated previously NHS Grampian would not be supportive of any option that did not retain the option of secondary procedures where clinically suitable being carried out in the area. CLEFTSiS network As with previous options the majority of respondents expressed that there was still a role for the network if this was the preferred option. Even though there would be a unified surgical service, it was recognised that there would be no other funded forum for all disciplines to share expertise and collate and scrutinise data on all aspects of cleft care, not just the surgical elements. Similar views on what the role of the network should be were expressed. Additionally the network could have a role in smoothing the transition processes as surgery ceases in the other locations. The issues raised were similar to before. 43

56 13.8 Option 8 Option 8 is for one surgical service based and providing surgery in NHS Greater Glasgow and Clyde, with additional outreach assessment and follow up clinics. Suitability: As with option 7 this would mean only one site for surgery in NHS Scotland and would require all patients to travel here which may negatively impact on a significant portion of patients, however from the feedback received in the public engagement exercise conducted as part of the 2006 review and the follow up survey for this review patients and parents have indicated that they would be prepared to travel for the best possible surgical treatment. This currently is the case in other international models of service delivery. In terms of the surgical service, this option would address the issues raised regarding the lack of cross cover, integration of the current surgical services, differing patient pathways and audit difficulties. It has also been reported by several respondents that a single surgical centre of excellence in terms of recruitment would be more attractive in terms of future recruitment to vacancies. Work would need to be undertaken to determine the workforce required for the workload and to ensure that the clinical are available, potentially some staff may not be prepared/be able to change their working base and this may be a significant issue. There would be some cost savings achieved through reducing the need for duplication of some facilities in the two other surgical sites and this could potentially be reinvested in other aspects of the service. Again in terms of the wider cleft services and associated disciplines there would be an impact and staff may be displaced and communication networks would need to be established to support any reconfiguration of service along these lines. The impact of the withdrawal of funding from the other NHS Boards would also need to be taken into consideration. NHS Grampian feel very strongly that the option of secondary surgery where clinically suitable should be retained. Feasibility: N.B. Scoping of the resource requirements for the proposal to extend the age range of the national cleft surgical service to encompass all age groups would be required to be undertaken, should this recommendation be endorsed. Despite the issues, there does seem to be some merit in considering this further as a potential option for the future delivery of the service. Acceptability For patients this may be an acceptable option as it has been demonstrated in services abroad and through feedback from the public consultation exercises for this and the previous review, patients/parents are willing to travel to receive the best surgical treatment available. Many of the respondents have indicated that given the workload of NHS Scotland it makes more sense and is a better use of scarce resources to only have one surgical site, with good follow up care available as locally as practicable. It should not be underestimated however, how disruptive this will be to staff in the other NHS Board areas and also the effect of a portion of funding being removed from an NHS Board. NHS Lothian has indicated that they feel politically it will have a greater impact on them as they currently house fewer national services than NHS Greater Glasgow and Clyde. As stated previously NHS Grampian would not be supportive of any option that did not retain the option of secondary procedures where clinically suitable being carried out in the area. CLEFTSiS network As with previous options the majority of respondents expressed that there was still a role for the network if this was the preferred option. Even though there would be a unified surgical service, it was recognised that there would be no other funded forum for all disciplines to share expertise and collate and scrutinise data on all aspects of cleft care, not just the surgical elements. Similar views on what the role of the network should be were expressed. Additionally the network could have a 44

57 role in smoothing the transition processes as surgery ceases in the other locations. The issues raised were similar to before Option 9 Option 9 would mean that the surgical element of care would be de-designated and be directly commissioned by the NHS Boards in line with the non surgical elements of Cleft care. Suitability: A large proportion of the respondents felt that this would be a backward move and would lead to a fragmented and variable service; some however felt it would be an opportunity to design the service to meet individual NHS Board needs and have more of a say on how the service is delivered. It would also felt that the delivering NHS Boards would gain direct access to the funding and they could use this in consideration of the service needs as a whole, such as additional investment in specialist nursing from savings achieved elsewhere. With no dedicated funding it was raised that the service would need to compete with funding with other specialities and some aspects may not be prioritised leading to a deterioration of service provision in some areas. Potentially the surgical element could continue to be delivered on the current sites and also if workload was sufficient in additional NHS Boards to meet clinical standards. This could mean that care remained as local as it is at present, with the potential for it to be delivered in further areas. Conversely many felt that this would be a concern as surgical skills may be diluted further with potentially fewer procedures being carried out by an increasing surgical workforce and clinical standards may not be achieved. It was also raised that with no national role the credibility of the surgical posts may be impacted and it may be difficult to recruit high calibre candidates to surgical vacancies in the future. Another issue in regard to this option was the loss of national data collection and scrutiny. It would also not address the lack of interaction between the current surgical services. Potentially the variation in care offered in Scotland could increase. Some of the concerns could be addressed by increasing the authority of the CLEFTSiS network in regard to clinical governance, and audit of the services. With delegated responsibility it could hold services and delivering NHS Boards to account in regard to deficiencies in service provision and not meeting clinical standards. Feasibility: All NHS Boards currently have separate arrangements for the delivery of the adult cleft services and in this case it would be extending this service to accommodate the paediatric elements of the service. Again most non surgical elements of the cleft service are not nationally designated and potentially it would not be a major stretch to incorporate the surgical aspects within the current services/service agreements with the host Boards. It should be noted that there is reported to be some variation in regard to the current levels of service for some aspects of cleft care across the NHS Board areas. There are concerns that if designated funding for cleft surgical services is no longer guaranteed, there is a risk that these services may be vulnerable in some areas if not prioritised over competing services. Acceptability This option has had a mixed reaction from respondents, with some being totally opposed to this option and feeling it would be very detrimental to the current standards of care delivered, whilst others felt that it has potential and the possibility should at least be explored before being dismissed. As noted before the non surgical elements are already commissioned directly by the NHS Boards, although as stated there are issues reported in regard to this, and perceived vulnerabilities without the assurance of dedicated funding streams. As noted earlier some of these concerns could potentially be addressed if the role of the CLEFTSiS network in regard to clinical governance was strengthened. 45

58 CLEFTSiS network As with previous options the majority of respondents expressed that there was still a role for the network if this was the preferred option. With this option no aspects of the service would be funded nationally and a funded forum for all disciplines to share expertise and collate and scrutinise data on all aspects of cleft care, would still be required and arguably there would be a greater need to ensure there was no loss of quality to the service in the absence of any national funding or clinical governance. Similar views on what the role of the network should be were expressed as before. The issues raised were similar to before Shortlisting conclusions Cleft surgical service In conclusion for the reasons detailed above the shortlist of options put to the review steering group to be considered in more depth were: Option 1: Status Quo: Two surgical services managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. Option 7: One surgical service based and providing surgery in NHS Lothian, with additional outreach assessment and follow up clinics. Option 8: One surgical service based and providing surgery in NHS Greater Glasgow and Clyde, with additional outreach assessment and follow up clinics. Option 9: De-designation Shortlisting conclusions CLEFTSiS Whilst there are identified areas for improvement to be addressed in regard to the network, in general from the responses returned regardless of which is the preferred option for delivery of the surgical element of cleft care in the future there appears to still be a role for the CLEFTSiS network. From the feedback received from stakeholders and the survey of users, identified the following areas to be considered for review and action Communication networks and users to be reviewed and strengthened The network to be given a stronger role in regard to compliance issues in terms of data submission, participation in audit and also in holding Services and NHS Boards accountable for care delivered Work to rebuild the fragmented relationships and trust within some elements of the cleft service Streamline processes to allow easier access for individuals to their own data 46

59 14. FINANCIAL INFORMATION The cost of the current surgical service in 2011/12 was 1.07 million as follows: NHS GG&C - 516,242 NHS Lothian - 540,595 NHS Grampian - 15,630 The cost of the CLEFTSiS NMCN in 2011/12 was 84,693, of which 21,373 was for hosting and maintenance of the Axsys electronic patient records database (now being replaced by the CAS which has minimal running costs). It should be noted that the levels of staffing included in the funding for each centre relates to the historical requirements set out in the business case by each of the host NHS Board at the time of designation and as a result there are discrepancies in regard to types and levels of staffing included in the service level agreements between NSD (on behalf of the Scottish Government) and NHS Lothian and NHS Greater Glasgow and Clyde. The arrangements with NHS Lothian were revised when they absorbed the workload of NHS Grampian in Funded staffing levels The table below sets out the current staffing arrangement of the surgical centres. Table 15: Staffing profiles Specialty Area Grade Nursing West WTE East WTE Cleft Lip and Palate nurse specialist Band Total Ward Band Band Band Band Total Theatres Band Band Band Band Band Band Band Total HDU Band Band Band Band Total Medical Surgical Cons Anaesthesia Cons Total Admin Asst Service Mgr Band Co-ordinator Band Clerical Band Band Band Total

60 The East coast service includes the nursing and administrative support provided in NHS Grampian. It can be seen that the service in the East has more medical (surgery and anaesthesia), administrative support, theatre and Cleft Lip and Palate specialised nursing time funded than the service in the West although the service in the West has more nursing support overall. The service in the West had 26% more cleft births from than the East and completed 23% more procedures within the same period. The service in the East however, covers two surgical sites that are separated geographically by a great distance and this requires considerable travelling time and duplication of some staffing resources Costs Due to the differing staffing arrangements and that some elements of the financial profile (full profiles attached in appendix 6) are coded in different ways, it has been difficult to do direct comparisons of all aspects of service delivery. With investigation and by only assessing the elements within the profiles that are directly comparable the cost per case for each site has been estimated below, based on the financial returns submitted to NSD by each of the services. Table 16: Cost per case: NHS Greater Glasgow and Clyde Year Activity Per Case 5yr Ave 2006/ , / , / , / , / ,818 3,881 Table 17: Cost per case: NHS Lothian Year Activity Per Case 5yr Ave 2006/ , / , / , / , / ,523 5,378 NHS Lothian has an additional cost of travel to carry out secondary procedures in NHS Grampian and attend surgical assessment clinics. This cost was removed from the equation and is shown below. Table 18: Grampian travel costs 05/06 06/07 07/08 08/09 09/10 10/11 3,602 3,701 3,803 3,907 10,616 11,811 48

61 15. OPTIONS APPRAISAL 15.1 Issues At the review group meeting held on the 27 February 2012 it was acknowledged that the recommendation of the 2006 Cleft surgical service review that there should be a single service delivered across 2 surgical sites, working to the same protocols with cross cover provision, had not been achieved. It was agreed that one of the main outcomes of this review should be to make recommendations to address the current variation in practice between the two sites. It was felt there was an opportunity to streamline practice to improve delivery of the whole clinical pathway. It was acknowledged that appropriate leadership was essential to make one service work effectively. A single clinical director and service manager would be required with the relevant infrastructure in place to support them. This included well organised out-reach services with a consistent approach to local care and building appropriate relationships where required. The 2008 Clinical Services Advisory Group report recommended that all surgeons involved in the care of cleft lip and palate patients should be performing surgery on new patients annually. The issue of the ideal number of surgical procedures carried out by surgeons to be deemed to maintain sufficient expertise was revisited by the review group. It was confirmed following discussion by the review group that the optimum workload was still considered to be 40 primary procedures as recommended by CSAG, it was however recognised that the evidence base supporting this figure was sparse. On this basis, theoretically only two surgeons would be required for Scotland, but it was agreed a minimum of three surgeons performing surgery in Scotland would be necessary to provide a sustainable and effective cleft service. It was highlighted that not all cleft surgeons in the UK devote 100% to cleft surgery. There was also some discussion regarding the differences in cleft surgeon work plans noting the importance of including surgeons who do not devote their full time to cleft care in order to ensure innovation is maintained within the service. It was agreed the time devoted to cleft care would not be prescribed in order to provide scope within the role. It was agreed this was acceptable as long as it ensured the service had the appropriate capability to fulfil a certain number of procedures each year. Overall it was agreed if the preferred option was for a single surgical service it was not necessarily the review group s role to decide the location(s) and therefore an additional option of a single surgical service with location(s) to be determined was added to the shortlist of options to be scored by the group. This was in addition to the Edinburgh and Glasgow single site options which were still scored to inform future decision making. The level of authority CLEFTSiS had in implementing standards if it continued as a National Managed Clinical Network (NMCN) and the risk of providing a postcode lottery of care was queried. It was reported that a proposed outcome from the recent review of NMCNs was the reendorsement of NMCN influence in terms of planning systems. It was anticipated that the central role of CLEFTSiS would allow genuine comparisons to be made and would provide a broader base for improving delivery of quality care in the long term Final short list of options for consideration The following options agreed by the review group to be scored were as follows: 1. Status Quo: Two surgical services, managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. 2. One surgical service with one management structure with additional outreach assessment and follow up clinics location(s) to be determined. 49

62 3. One surgical service based and providing surgery in NHS Lothian, with additional outreach assessment and follow up clinics. 4. One surgical service based and providing surgery in NHS Greater Glasgow and Clyde, with additional outreach assessment and follow up clinics. 5. De-designation It should be noted that all options including that of status quo was for both paediatric and adult surgical provision. Additionally all options including surgery in Grampian are for secondary procedures Criteria The 6 criteria selected against which each option would be assessed followed a standardised approach based on NHS Scotland quality strategy incorporating the Institute of Medicines domains of quality. Table 19: Criteria Criteria Structure 1. Clinical sustainability (Attract and retain skilled staff) Definition The availability of the full range of skilled staff. Opportunities for training and development and collaborative team working between clinicians. 2. Capacity Process 3. Timely and Efficient Physical capacity/flexibility to meet all surgical needs with strength and depth in clinical staffing and collaborative team working between clinicians. The service needs to be adaptable in order to provide the most appropriate interventions and treatments at the right time to everyone who will benefit and wasteful variation will be eradicated. 4. Patient Centred, Equitable Outcome 5. Meets National clinical standards 6. Safe and Clinically Effective There will be the same equality of opportunity to receive high quality surgical services regardless of where patients, from any background, live in Scotland whilst being responsive and respectful to their needs and values. Degree to which the configuration is able to comply with National standards such as CLEFTSiS, CSAG and NICE. Includes both short-term safe outcomes such as avoiding harm and complications, and long term outcomes as determined by CSAG and CLEFTSiS. 50

63 15.4 Weighting the criteria The weighting criteria were agreed through discussion and consensus. The scoring of the criteria had to total 100 and the greater the perceived importance the higher the weight assigned. The weights applied were as follows. Table 20: Weighting Criteria Weight 1 Clinical sustainability 15 2 Capacity 15 3 Timely and Efficient 10 4 Patient Centred and Equitable 20 5 Meets national clinical standards 20 6 Safe and Clinically Effective Scoring the options The members of the group present to score the options are detailed in Appendix 1. Members unable to attend on the day were offered the opportunity to score remotely but all declined in the absence of participation in the discussions of the group on the day. The members of the group in attendance at the meeting reviewed each option individually referring to the relevant evidence prior to scoring same. The following Graph shows the total weighted scores for each option Option 2, a single surgical service with one management structure with location(s) to be determined, received the highest weighted total score. Option 4, a single surgical service based and providing surgery in NHS Greater Glasgow and Clyde received the second highest score, with option 3 a single surgical service based and providing surgery in NHS Lothian having the third highest weighted score. Option 1 status quo and option 5 de-designation scored significantly lower than the other options. 51

64 The following table shows the total weighted score awarded by each person scoring for each option. Table 21: Total weighted individual scores Option 1 Option 2 Option 3 Option 4 Option 5 ID ID ID ID ID ID ID ID ID ID ID ID ID As illustrated of the 13 members of group, option 2 was given the highest (or joint highest score) by 11 scorers. It was second favoured choice by one scorer and third favoured choice of the remaining scorer, and can be deemed as the preferred option from the aggregated group. The table below demonstrates the voting patterns of the different representatives. Table 22: Voting preferences by groupings Option 1 Option 2 Option 3 Option 4 Option 5 NSD Patient/Public Reps Board Reps Independent Experts With the exception of the Independent experts option 2 (one surgical service with one management structure with additional outreach assessment and follow up clinics location(s) to be determined) was ranked first with option 4 second (one surgical service based and providing surgery in NHS Greater Glasgow & Clyde) and option 3 (one surgical service based and providing surgery in NHS Lothian) third. As can be seen the independent experts ranked option 4 first and option 2 second with all other results in the same order of preference as the other groups. Whilst not unanimously ranked number 1, it has been by the vast majority of respondents and it could be deemed the preferred option. 52

65 Graph 13 and table 23 look at how each option performed on each of the criterion to assess particular strengths and weaknesses as this information might help inform future decisions in regard to preferred location. From the scoring all sub groups favoured a single site in NHS Greater Glasgow & Clyde on each of the criterion, ranking either second or first place for all.. Table 23: Options 3 and 4 ranking against each criterion Criterion Option 3 Option 4 Top ranked option Clinical Sustainability 3 2 Option 2 Capacity 3 2 Option 2 Timely and Efficient 3 2 Option 2 Patient centred and Equitable 3 2 Option 2 Meets national standards 3 2 Option 2 Safe and Clinically Effective 3 1 Option 4 53

66 16. CONCLUSIONS The cleft lip and palate surgical service has been a designated national specialist service since Due to the low volume and complexity of the cases, and in light of the opinions of the stakeholders and outcome of the scoring in the options appraisal, it still fulfils the criteria for designation and there is strong support for national designation to continue. The review of the service in 2006 recommended a single service being delivered across 2 surgical sites working to the same protocols and cross cover being provided. This has not been achieved. The view of the review group was that there is a need for one centrally managed service to help resolve current issues. From the options appraisal exercise the favoured option of the group was for a surgical service with one management structure and clinical lead with additional outreach assessment and follow up clinics working to uniform clinical standards. In regard to the location of the surgical service the majority of the group felt that it was not necessarily the review group s role to decide the location(s) and that business cases should be submitted for consideration by the successor to the National Services Advisory Group (NSAG). In order to inform this process, the Edinburgh and Glasgow single site options were still scored as part of the option appraisal. From the scoring all sub groups represented on the group favoured a single site in NHS Greater Glasgow & Clyde on each of the criterion, ranking them either second or first place for all. A recommendation of the 2006 review was for a business case to be submitted to NSAG in regard to extending the national designated surgical service to adulthood. This was not pursued but there is overwhelming support from all stakeholders for this to be taken forward as part of the recommendations of this review. In regard to CLEFTSiS the review group endorsed the view that emerged from the stakeholder consultations that while there were areas for improvement to be addressed in regard to the network, there appears to still be a role for the CLEFTSiS network. It was noted however that work is required to repair and strengthen relationships and improve communication. It was also felt that the network should take a stronger role in regard to compliance issues in terms of data submission, participation in audit and also in holding Services and NHS Boards accountable for the care delivered. 54

67 17. RECOMMENDATIONS The paediatric surgical cleft lip and palate service in Scotland should continue to be designated as a national specialist service on the grounds that it meets the criteria for national designation. The surgical service, currently commissioned only for paediatric care (up to age 16), should be extended to provide surgical care for cleft lip and palate for all ages. The future configuration of the cleft surgical service for Scotland should be a single surgical service for all ages with one management structure and one clinical lead, with additional outreach assessment and follow up clinics, working to a uniform set of clinical standards. All interested NHS Boards should be invited to submit a fully costed business case to deliver a single cleft lip and palate service for Scotland to an agreed specification, with a single management structure and clinical leadership. The business cases should be subject to an independent evaluation to determine the future location(s) of the surgical service. As only the cleft surgical service is to be nationally commissioned, rather than wider cleft services, the Review Group concluded that CLEFTSiS should continue to be designated and supported as a designated national managed clinical network. 55

68 Appendix 1: Review Group membership Chair: NSD Review Support: Lay representation: Patient representation: *Ms Kathryn Harley, Consultant in Paediatric Dentistry, RCE Mrs Deirdre Evans, Director, NSD Dr Mike Winter, Medical Director, NSD *Mr David Steel, Programme Director, NSD *Miss Lyn Hutchison, Programme Manager, NSD Mr Gordon Kirkpatrick, Commissioning accountant, NSD *Mrs Anne Simpson. Member of NSD Public Reference Group *Rosanna Preston, CLAPA *Rachelle Cardno, CLAPA *Gillian McKenzie, CLAPA NHS Board Medical Director: *Dr Brian Montgomery Independent Clinical Experts: *Mr Adrian Sugar - Oral and Maxillofacial Surgery (Cleft) *Ms Rona Slator - Plastic surgery (Cleft) *Mr Stephen Robinson - Orthodontics Regional planning representation: *Roseanne Urquhart, Regional Planning Directors Group Finance representation: *Dawn Carmichael, Directors of Finance Group Director of Planning representation: *Dr Brian Montgomery, Directors of Planning Group SGHD Representation: Mr David Cline *Members present for scoring of options 56

69 Appendix 2: Literature Review Overview Cleft lip and/or palate are among the most common malformations in the cranio facial region with about 100 new cases occurring each year in Scotland (SNAP 1998). From birth to maturity, children with orofacial clefts undergo many surgical and non-surgical procedures that can cause disruption to their life and the lives of their family members. There are often psychological consequences of both this treatment and the deformity itself. The contemporary keystone of cleft management is the multidisciplinary team (Witt and Marsh 1997). Highly specialised care is required from birth to the late teens. This care starts with neonatal nursing and primary surgery, usually followed by further surgery, speech and language therapy, orthodontics, preventative and restorative dental care, otolaryngology for hearing problems and genetic and psychological counselling (CSAG 1998). Descriptive epidemiology Overall, available findings indicate that orofacial clefts arise in about 1 in 700 livebirths, but with considerable variation geographically and ethnically. International data from 57 registries for suggest a variation in prevalence at birth of cleft lip with or without cleft palate (CL(P)) of per births, and an even more pronounced variation for isolated cleft palate (CP), with prevalence of per births. Within Europe rates of CLP are highest in the Scandinavian countries, lowest in the Mediterranean countries, with intermediate rates in the UK. In Scotland isolated CP is more prevalent than in England and the ratio of CP: CL(P) is almost 1:1 whereas in England CP is around %. CL(P) is most frequent in males (M:F ratio about 2:1), and isolated CP is most typical in females (M:F ratio about 2:3) in all ethnic groups; and the sex ratio varies with severity of the cleft, presence of additional malformations and number of affected siblings in a family. In combined data from European registries for , 3.5% of babies with cleft lip with or without cleft palate were stillborn and 9.4% were from terminated pregnancies; respective proportions for isolated cleft palate were 2.4% and 8.1%. No consistent time trends or seasonal patterns in prevalence at birth of either defect have been recorded. In the UK, the number of reported cases of clefts fell from 759 in 1990 (1:930 live births to 630 in 1995 to 630 in 1995 (1:1054 live births). In Scotland the trend in prevalence of both CL(P) and CP has remained fairly static (SNAP) Isolated, multi-malformed and syndromic clefts Cleft lip with or without cleft palate (CL(P)) and isolated cleft palate (CP) are associated frequently with other major congenital anomalies either as part of a syndrome or as a non-syndromic multimalformed infant. The proportion of individuals with additional anomalies varies greatly between studies but, in general, further defects seem to be more frequent for those with isolated cleft palate than for those with cleft lip with or without cleft palate. In a study of almost 4000 individuals with isolated cleft palate in Europe, 55% of cases were isolated, 18% were recorded in association with other anomalies, and 27% were noted as part of recognised syndromes. For cleft lip with or without cleft palate, in more than 5000 patients, 71% of cases were isolated and 29% were seen in association with other anomalies. Presence of an anomaly of another system might stimulate a detailed clinical examination, leading to detection of mild cleft palate that otherwise might not have been reported had it arisen in isolation. Classification of clefts Orofacial clefting is a group of congenital abnormalities that show a wide variety of anatomical disruptions with varying frequencies and association with other congenital abnormalities, some part 57

70 of a recognised syndrome as described above. There are a range of different classification schemes, none universally accepted but the Striped Y as described by Kernahan and Stark (1971) and a related scheme referred to as the LAHSAL classification (Kriens, 1989) both provides a good basis for accurately recording cleft data (Watson 2001). Adoption of a universally accepted standardised classification of clefts, that encompasses all cleft types such as that suggested by Tolarova and Cervenka (1998), would be helpful. Aetiology and primary prevention of orofacial clefts Genetic influence Cleft lip with or without cleft palate is listed as a feature of more than 200 specific genetic syndromes, and isolated cleft palate is recorded as a component of more than 400 such disorders. Among non-syndromic clefts, the recurrence risk to siblings is greater than that predicted by familial aggregation of environmental risk factors and concordance rates for cleft lip, cleft lip and palate, and cleft palate alone are higher in monozygotic twin pairs than in dizygotic pairs. The familial clustering and concordance recorded in twins with cleft lip with or without cleft palate and isolated cleft palate is specific for each defect, and therefore the anomalies are thought to have heterogeneous causes. Predominance of left-sided clefting and the male excess of cleft lip with or without cleft palate also imply genetic susceptibility, and recent advances in molecular biology and genomics is progressing gene identification in OFC. It is now possible to implicate specific gene loci, such as IRF6, MSX1 and FGFR1 as predisposing to OFC at a population and perhaps in future at an individual level. Environmental factors The proportion of clefts attributable to maternal smoking in populations with a high prevalence of smoking in women of reproductive age was estimated at 22%. Multivitamin and mineral supplements are associated consistently with reduced risk of cleft lip, cleft lip and palate, and cleft palate alone. However, adverse effects of long-term use of supplements containing antioxidant vitamins have been reported; therefore, clarification of the specific nutrients and minerals that account for this apparent inverse association is important. The next reasonable step for research into orofacial clefts might be observational studies of nutrients and food groups, genes, and metabolism to narrow the range of candidate nutrients. Primary prevention Identification of modifiable risk factors for oral clefts is the first step towards primary prevention. Such preventive efforts might entail manipulation of maternal lifestyle, improved diet, use of multivitamin and mineral supplements, avoidance of certain drugs and medicines and general awareness of social, occupational, and residential risk factors. Clinical management Services and treatment protocols for management of children with cleft lip and palate can differ remarkably within and between developed countries. In Europe, a networking initiative funded by the European Union in the late 1990s, Eurocleft reached consensus on a set of recommendations for cleft care delivery, which were subsequently adopted by WHO. The Eurocleft project The absence of a sound evidence base for selection of treatment protocols was shown by a striking diversity of practices across Europe for surgical care of just one cleft subtype -unilateral complete cleft of lip, alveolus, and palate (UCLP). Of 201 teams doing primary surgical repair for 58

71 this defect type, 194 different protocols were being practised. Even though 86 (43%) groups closed the lip at the first operation and the hard and soft palate together at the second, 17 possible sequences of operation to close the cleft were being used. One operation was needed to completely close the cleft in ten protocols (5%), two were needed in 144 (71%), three operations were used in 43 (22%), and four were needed in four protocols (2%). Around half used presurgical orthopaedic techniques with mostly passive plates and some teams also used a plate to assist with feeding. These uncertainties in treatment indicate the paucity of published randomised trials of cleft care. Five such studies present particular challenges for planning and recruitment in comparison of surgical techniques, because trial protocols must take account of the surgical learning curve. However, several well-planned, large-scale, surgical randomised controlled trials including the Scandcleft RCT are now in follow-up periods and preliminary results should emerge in So far, only a brief systematic review of cleft care has been published, as has a systematic review of prevalence of dental caries in children with clefts. Cleft services in Europe Service organisation, inequality of care, and treatment uncertainty are widespread issues, and scarce resources put basic surgical treatment beyond the reach of thousands of children in developing countries. Accordingly, WHO have highlighted the need for effective international collaboration on strategies to enhance clinical care, through interaction of regional cooperatives such as the Eurocran project. Several research priorities were noted by WHO, including: surgical repair of different orofacial cleft subtypes; surgical methods for correction of velopharyngeal insufficiency; methods for management of perioperative pain, swelling, and infection; and nursing. Clinical trials of these issues would need to include sufficient numbers of patients to be of adequate power. Other multidisciplinary studies of cleft care might include: use of prophylactic ventilation tubes (grommets) for middle-ear disease; presurgical orthopaedic techniques; methods to achieve optimum feeding before and after surgery; and different approaches to speech therapy. In developing countries, trials need to address affordable surgical, anaesthetic, and nursing care. International adoption of guidelines for provision of clinical services and for maintenance and analysis of minimum clinical records of cleft care is desirable to hasten cohort studies across centres. Various registries of clinical outcomes have emerged and are working independently. Efforts should be made to harmonise these initiatives. Reliability of prenatal ultrasonographic diagnosis has been increasing, although sensitivity is still low, particularly for cleft palate (CP). The rate of termination of pregnancy because of presence of a cleft varies between countries, but it remains generally low. Genetic testing in the future could enhance sensitivity and specificity of prenatal diagnosis for syndromic and non-syndromic orofacial clefts. The UK CSAG study In 1996, the Clinical Standards Advisory Group (CSAG) undertook to review the treatment of cleft lip and palate in the UK through a postal survey. The CSAG report, published in 1998 indicated that the state of cleft care was not acceptable in many areas; i.e. a number of children did not receive their surgery within an appropriate timeframe and an unacceptable number of children had significant difficulties with speech and feeding and many did not achieve a good outcome in terms of facial appearance, dental occlusion and bone grafting. Following the 1998 CSAG report cleft care in the UK was reorganised so that the expertise and resources were concentrated regionally taking into account population needs and accessibility. Over the next seven years the number of centres was reduced from 57 to 13 including a Scottish network of three centres. Each centre was required to provide services in accordance with strict protocols, set out in a Department of Health circular in 1998 (HSC 238). 59

72 Ten years later, in 2006, CLAPA carried out a follow-up survey to study parents experiences of their child s cleft care with the majority of CSAG driven changes having been implemented. Main findings of the CLAPA survey It was reported that the changes in cleft care as a result of CSAG mean that the needs of families and children born with clefts are better catered for than before. Specialist cleft nurses provide early care and better surgical protocols are in place meaning that babies receive surgery to a high standard, provided by an experienced high volume surgeon. However, there was still room for improvement, and the 2006 survey drew particular attention to the following: Lack of knowledge of the condition both at the point of antenatal diagnosis and at the maternity wards; hospital staff were unaware where to refer parents for feeding advice in 25% of cases. Delay in meeting a cleft service member after the diagnosis as only 48% of parents had seen a cleft service member within 48 hours after the diagnosis with 7% waiting up to six months Delayed diagnoses, 14% of cases had been diagnosed more than 24 hours after birth. Intimidating and overpowering visits to the multi-disciplinary cleft clinic. Lack of information on how their child s looks would change after surgery. Not all the parents had been offered overnight accommodation when their child was in hospital for surgery. Insufficient pain control after surgery. Only a minority encouraged to try breastfeeding. Management of Care The aim of the management of cleft lip and palate patients at the completion of treatment is to make these children anatomically and functionally as near normal as possible, and the basis of treatment is the surgical closure of the cleft (Watson 2001). In the 1930s the multidisciplinary approach to care began, but the appropriate timing, staging and method of intervention continue to be debated (Arosarena 2002, Schnitt et al 2004). Of the 201 centres that are registered in Eurocleft (see below), 194 have different treatment protocols for unilateral clefts (Nollet 2005a). Arosarena (2002) does however say that despite the controversies there are several identifiable trends in the management of cleft lip / palate. The most usual timing for the repair of the cleft lip is between 6 and 12 weeks. The type and timing of the repair depend on the protocol of the unit and/or the preference of the surgeon. The aim of the surgery is to produce a lip of good length, which looks good, that is not tight and functions as normally as possible (CSAG 1998). The timing of cleft palate repair is balanced between the need for velopharyngeal closure for normal speech development and the risk of disruption of facial growth. Most UK surgeons perform a palate repair around the age of 12 months. This conforms to evidence from a study by Dorf and Curtin (1982) as cited in Rohrich et al (2000) 12 months of age was used as an arbitrary dividing point between early and late palatal closure. They found a 10% incidence of articulation abnormalities in those children who had surgery before 12 months of age and an 86% incidence in children whose surgery was performed after 12 months of age. In (1996) Rohrich published the results of a long-term multidisciplinary study that described 44 patients who were similarly matched except for the timing and technique of palate repair. The study revealed significantly greater speech deficiencies with delayed hard palate closure. Rohrich also noted a persistent palatal fistula rate in the late closure group of 35% in comparison with 5%in the early closure group. 60

73 The Eurocleft Study The Eurocleft Study began as an intercentre comparison of the orthodontic records of 8-10 year old children with complete unilateral cleft lip and palate. Its underlying goal was to apply a more rigorous methodology to intercenter comparison than was customary at the time. It sought to overcome, at least in part, some of the limitations and potential biases inherent in comparing outcomes reported in the literature from single centre reports. A multidimensional comparison of the patients identified clinically important and statistically significant differences between the centres. Shaw, Brattstrom and Molsted K et al (2003) Semb, Brattstrom, Molstead, Prahl-Andersen, Shaw (2005) Successful management of children born with cleft lip/palate requires multidisciplinary and highly specialised treatment from birth to late teens early twenties (CSAG, 1998). These multidisciplinary teams need to meet regularly to allow for the exchange of ideas and expert input from not just the surgeon, but also specialist nurses, paediatric dentists, orthodontists, speech therapists, paediatricians, clinical psychologists and clinical geneticists. Access to other experts such as ENT surgeons and social workers should also be available. The benefits of these health care teams include their ability to coordinate complex services, meet the psychosocial needs of families, and provide multifaceted evaluations. Mulliken (2004) has written on the need for all children with a cleft lip, with or without a cleft palate to be treated in a regional cleft lip and palate centre. He cites the Scandinavian tradition of centralised care with one centre in Denmark, two in Finland, two in Norway and six in Sweden and results from the 1992 Eurocleft study as demonstrating that standardisation, centralisation and the participation of surgeons in a high volume of procedures as being associated with better results and fewer revisions (Shaw et al {1992} as cited in Mulliken 2004). Some general conclusions based on dentoskeletal outcomes can be drawn from the Eurocleft Study. Two centres achieved equally good results but one employed a more expensive and complex treatment program. The centre with by far the worst outcome had no standardised policy for surgery. There is a strong suggestion that organisational factors are important, with the best centres, centralised and uniform in approach. The efficacy of individual elements of different treatment programs could not be determined. (Mars, Asher-Dade, Brattstrom, Dahl et al 1992) Witt et al (1998) studied a series of palate repairs for 401 patients. Post operative velopharyngeal dysfunction and the need for secondary management were used as outcome measures. The results were analysed by year of operation, surgeon and number of operations per surgeon to determine the need for total and individual surgeon rates of secondary palatal management. The research found the total numbers of procedures was statistically important whereas procedures per 61

74 year was not, suggesting that the key to a surgeon s improvement was cumulative experience rather than frequency of performance of the operation. However Nollet et al (2005a) conducted a study on treatment outcomes using the GOSLON Yardstick. They could not determine the number of surgeons at a centre (as a proxy for experience) as a measure of treatment outcome. In 1998 the Clinical Standards Advisory Group undertook an extensive review of cleft lip and palate services in the UK. One of the areas the review considered was the relationship between volume and outcome. They found that when results were measured using dental arch relationship there was little relationship between volume and outcome (see table 1). However when speech was used as the outcome indicator, three out of the four determinants used were statistically better for high volume operators. (High volume was five or more UCLP repairs per year). Table A: Dental arch relationship in 5-year-old children with UCLP treated by different groups of surgeons (CSAG 1998) No No of Dental arch relationship % operations over a 2- year period surgeons Excellent Good Fair Poor Very Poor (a) (b) CSAG (1998) noted that the four surgeons in group 10-19(a) all performed late primary surgery. Two of the three surgeons in group 10-19(b) carried out all their lip repairs in the neo-natal period; the third performed 70% of cases in the neo-natal period. Table B: Relationship between Volume and Speech Outcome Mean outcome score related to surgeon volumes (lower scores denote better outcome)(csag1998) 5UCLP per year 5 UCLP per year 5 year cohort Intelligibility Hypernasality year cohort Intelligibility Hypernasality CSAG (1998) explained that scores for intelligibility and hypernasality were calculated relative to the caseload of each surgeon who undertook primary palate repair. Three of the four speech indicators were statistically significant in favour of the high-volume operator. In the whole cohort 31% had poor speech overall in the low-volume group compared with 16% who had poor speech overall in the high-volume group. Conclusion of the literature review The aim of management is normal face, lip and nasal appearance, speech, hearing, dental occlusion appearance and function, maxillofacial growth and psychosocial well-being. The benefits of the multidisciplinary team approach to care have been recognised since the 1930s. The most appropriate timing, staging and method of surgical intervention continue to be developed but trends 62

75 in patterns of care have emerged. Improvements in outcome when measured by speech, velopharyngeal function and need for revision have been linked to surgeon experience. Centralised care in regional centres has also been demonstrated to improve results and lead to fewer revisions. It is also important to acknowledge the efforts of cleft teams in supporting OFC research initiatives which are aimed at 2 major outcomes: (a) improving quality of care and (b) prevention. Very significant progress has been made on both fronts in recent years, and it is noteworthy that researchers in Scotland are contributing to these initiatives. A multi-disciplinary approach with standardisation of data collection is a key objective in continuing these research efforts. 63

76 Appendix 3: User Survey NHS Scotland - Review of Cleft Surgical Service and CLEFTSiS Network Thank you for agreeing to participate in this survey, which will take about 5 minutes to complete. The results will be used to help ensure the cleft surgical service is designed to meet the needs of cleft lip and palate patients, and their families in Scotland. Background Information It helps us to know your particular involvement with the cleft lip and palate service so that we can ensure all views are being represented. We would appreciate if you could answer the following background questions. This information will only be used for the purpose of this review. 1. Which of the following best describes you? (Please tick all that apply) Other (please specify) Child with a cleft (up to and incl Adult with a cleft 16 years) Parent/Carer of a child/children with a cleft 2. Within which of the following NHS Boards are you resident? Please choose only one of the following: NHS Ayrshire and Arran NHS Dumfries and Galloway NHS Forth Valley NHS Greater Glasgow & Clyde NHS Lanarkshire NHS Orkney NHS Tayside NHS Borders NHS Fife NHS Grampian NHS Highland NHS Lothian NHS Shetland NHS Western Isles 3. Please indicate your age range Please choose only one of the following:

77 4. We would like to know if you or your child has a cleft lip and/or palate:- (Please tick all that apply, you only need to tell us about any children who have a cleft) Self Child 1 Child 2 Child 3 Unilateral cleft lip Bilateral cleft lip Cleft Palate Sub Mucous Cleft Palate Pierre Robin Sequence Other (please specify) 5. Please give your child (ren) s ages, by putting a tick in the relevant box:- Child 1 Child 2 Child m 7 11 m 1 4 yrs 5 8 yrs 9 12 yrs yrs Preferences for the Service These questions relate to how you would like your service provided. 6. When thinking about you / your child s surgical care, how important is the following things to you personally? 6.1 Being able to choose my / my child s surgeon: Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 6.2 Being able to choose at what age I / my child has surgery: Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 6.2 Being involved in decision making about my / my child s treatment: Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 6.4 Being able to choose where the surgery will take place: Please choose only one of the following:

78 Not at all Important Not very Important Fairly Important Very Important Not applicable 6.5 Whether the centre can provide my / my child s long term surgical care needs: Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 6.6 How accessible the hospital is to where I / our family live: Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 6.7 Whether my / my child s follow up and ongoing care is available locally? e.g speech and language therapy, clinical support Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 6.8 Availability of accommodation for my family: Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 6.9 Availability of patient / family support groups: Please choose only one of the following: Not at all Important Not very Important Fairly Important Very Important Not applicable 7. Of the 9 categories above, please can you rank these in order of importance to you / your child? (Please rank from 1 to 9-1 = most important to 9 = least important, please do not give the same number to 2 areas) 66

79 Being able to choose my/my child s surgeon Being able to choose at what age I / my child has surgery Being involved in decision making about my / my child s treatment Being able to choose where the surgery will take place Whether the centre can provide my / my child s long term surgical care needs How accessible the hospital is to where I / our family live Whether my / my child s follow up and ongoing care is available locally Availability of accommodation for my family Availability of patient / family support groups Any other comments you wish to make about future provision of cleft surgical care. 9. If you have had problems accessing NHS treatment for any aspect of multi disciplinary cleft care in the last FIVE years please indicate the areas of treatment/consultation (Tick any that apply) Cleft specialist Nurse Genetic specialist Paediatrician Audiology Returning to treatment as an adult Psychology Referral to cleft service No problems Didn t know it existed Problems accessing it Not needed 67

80 Dental care Speech and Language therapy Surgery Information about the patient pathway Orthodontics Diagnosis of cleft palate If you wish to please expand:- 10. Are you aware of the CLEFTSiS National Managed Clinical Network? Yes 11. The network aims to communicate with patients and access their views. Have you accessed / received any of the following? (Please tick all that apply) No Website Patient Event Feedback through Patient Representative Newsletter Patient Survey Education Meeting 12. Are there any other methods which you feel the network could use to engage with patients? 13. Do you have any other comments/observations you would like to make about the cleft surgical service or the work of the CLEFTSiS network? 68

81 Appendix 4: Additional User comments re service and network Additional comments received from users regarding future provision of cleft surgical care I am 23 have been waiting since November 2009 for surgery to repair a fistula remaining from my cleft palate. I'm currently waiting to go for a sleep assessment before the surgery can take place. My last appointment was in July 2011 in Edinburgh (live 40 miles North of Aberdeen) and I haven't received an update since. I would like things to move quicker. When my daughter was born we came under Highlands and Islands. She had 2 operations and the hospital was over 120 miles away, no accommodation available and all follow up appointments, speech therapy etc was the hospital 120 miles away so our answers at that time would be totally different. My daughter is now fifteen we stay in Motherwell but she was treated in Glasgow I had great care and contact with nursing staff anytime. Even when she was home the ENT surgeon was excellent could be contacted very easily. We saw the cleft palate nurse twice could never seem to find or contact them easily. Our experience with cleft services so far has been very positive and although a lot of the things I said are important, I would trust the decisions made by the surgical team at Edinburgh. More locally available cleft specialist speech therapist required fully supported with modern technology/ equipment. To reduce lost school time travelling to appointments some distance from home. A good cleft team is vitally important to the care of children with cleft. Due to demands on services we were often given short notice of my son's surgery, 10 days on one occasion - more notice should be available given some parents work. North Ayrshire has very limited cleft care having to travel to Glasgow. More funds made available to be able to provide a dedicated unit for Cleft services and a true multidisciplinary approach. Edinburgh has a fabulous team but lacks resources. Small expert well resourced local teams in Scotland's main cities that provide surgical and associated therapy in a joined-up way The Edinburgh based cleft team is beyond reproach, and should under no circumstances be thinned out or moved to the West. Without their help I don't know how we would have coped, and I'm certain our son would not be doing so well. Our daughter was born in Edinburgh and subsequently all her treatment has been undertaken at the Sick Children's Hospital. The service we have received from her birth onwards has been outstanding. We have always been thankful that she is under the care of Dr Mehendale, and we shall be eternally grateful for what she was able to do for our little girl. I did not receive enough information when my son was born in hospital. 69

82 As our daughter grows and any future treatment required we would very much want her to be involved with the team that have followed her progress since birth. Aged 8 years now and we know the next few years will bring about more potential treatment. Further comments/observations received from users in regard to the work of the cleft surgical service or the CLEFTSiS network. The surgical service we received from Edinburgh Sick Kids Hospital was excellent and we would have no complaints about it, however we have always found it difficult getting appointments and feedback from the speech therapy service. I think the annual meetings with all relevant individuals are a good idea and I can understand that they make sense for the service but it can be overwhelming particularly for young children. I think that we need a lot more cleft speech therapists to speed up diagnosis and to help the progress of the patient. We are concerned with lack of access to speech therapist in Lothian with cleft experience and the team of two we met on initial diagnosis and clinics in 2009 have not been replaced, now only 1 ST with little cleft experience. Our surgery experience and aftercare at Yorkhill was excellent however my daughter is 7 now (her surgery was at 7mths) and although she is fine we have not had any checkups for over a year. Surgical service provided is excellent but sadly often let down by bureaucracy & inadequate clerical back up. Also lack of suitable equipment in shared consultancy rooms (dental chairs) and access to equipment especially specialist electronic speech therapy I was fortunate to deal with Orla Duncan and Felicity Mehendale and her amazing team. I couldn t have wished for better care or treatment for my daughter Lily. All the after care has been amazing and we have a great bond with everyone, this makes a massive difference, I believe that without this particular team my daughter and I wouldn t have been able to grow in strength and understand so much. I am truly grateful to the Edinburgh cleft specialist team. More help for 40yrs and over Very supportive, personable, reassuring and there when they were needed. A valuable service during an uncertain period. Attempts are always made to try and condense appointments as much as possible but this should be as standard particularly for school age children. As my son's school is some distance from Glasgow it necessitates a full day off school for every appointment. Also because of the heavy demand on services waiting times at the hospital can be excessive I would like to know more about genetic specialist as both myself and son born with clefts and there is a history of clefts in my family. There have been hints about the possibility of moving the Edinburgh cleft team to Glasgow, and/or restructuring the team itself. This would be a horrific turn of events for us, and countless local families. Our experiences with our surgeon, the cleft nurses, orthodontics, etc. have truly shown us the best side of the NHS. They have made a 70

83 genuine difference to our lives. From conversations I've had with other families it is clear that this is a universal sentiment. Now that my son is 7 I sometimes feel it would be nice to have more information but don t seem to get any now. With the increased incidence of babies being born with cleft lip and/or palate it is vital that we have a strong cleft service available throughout the whole of Scotland. Whilst I appreciate the benefits of satellite services from one main centre, as a user of the services available in Edinburgh we have access to all the specialists available within cleft care and do not wish to lose this. I would like to say that my sons cleft team has been amazing and I don't know what we would have done without any part of them. I would like to say that my sons cleft team has been amazing and I don't know what we would have done without any part of them. My son is now 16 and he has not been to a cleft clinic in a good few years as I have been told that they have lost the book that tells the hospital when a follow up is due. Since our daughter was born the team who have worked with her (mostly Mr Morrant and Mr Ray) have been superb. We feel that things have been well explained at every step and that we have access to such a strong team of specialists covering all aspects of cleft related issues. 71

84 Appendix 5: Stakeholder feedback outputs Cleft surgical service and CLEFTSiS NB: If the comment/view was repeated either through the online survey or at the stakeholder workshops, and the meaning/wording was the same then some editing has taken place for ease of review. OPTION 1 Status Quo: Two surgical services, managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. PROS CONS Minimal service disruption May not be able to sustain the necessary workforce Established patient pathways in place May not complete enough surgeries to comply with clinical skill Surgical services already have links with the Regions - working relationships (good networks) Travel distance Multidisciplinary care both In and Outpatient Outcomes of service Continuity of care Good service/facilities in NHS Grampian Importance of working as a multi disciplinary care service NMCN data useful and improving care No complaints regarding travelling to Lothian (some issues re accommodation but resolved now sharing accommodation is main issue) Important to take Grampian patients views on Board Opportunity to develop working relationships Patients can choose their closest centre. Patients do not necessarily have to travel a long distance for outpatient appointments. Cleft services are better spread across the country to reach patients easier Reasonably high volume operators and patients able to standards Some patients may be required to undergo final procedures by a different surgeon when they reach adulthood/full range of procedures not available in all areas at present Patients needing assessment by National airways/craniofacial services need to be seen in Glasgow which requires additional travel for some patients Disengagement between services Variations between surgical care provision/patient pathways Variations in personnel provision Duplication of resources Poor value for money More personnel required for administration/management roles Does not attract senior staff when vacancies arise Present situation unsustainable in long term Goodwill dependant on non-nationally designated services Issues re current transition processes Importance of improving multi disciplinary care (feedback from last review) Not getting current status quo no secondary surgery at 72

85 access care more locally Still one service and there would be few changes to be made. If adequately resourced in terms of clinical manpower and support services then I feel this is the best option building on the existing network arrangement. The geography of Scotland also fits this model with an east/west split which also facilitates easier management of review clinics at peripheral sites. Networks take time to evolve and become established forging close working relationships between clinicians/ good communication at all levels being the key for smooth working. To disrupt the existing network with further changes will only lead to confusion particularly with patients who have taken time to adapt to the current network. no more uncertainty for families about change the current system seems to work so why change it Established services and model. Care delivered closer to patients with less travel and providing continuity of care with familiar healthcare professionals There aren't clear reasons why this might be a good option beyond it requiring no change. Not entirely sure that the description reflects the true situation with regard to Grampian cases. Parents would be able to choose the nearest hospital site where their child would have surgery and for attending joint cleft clinics after surgery. There is no reason why the two services cannot work in parallel. I presume that the population of Highland and Grampian would benefit from having as much of their service delivered locally. Previously all changes a have been evolutionary. There is no appetite for revolutionary Grampian Dips and rises in cleft care Is there enough work to support all surgeons Equity of access inadequate parent accommodation plus travel issues May not be enough flexibility and capacity within this option for increasing population in Grampian Clinical sustainability 2 units working independently retiral issues Not always enough numbers in each particular centre to be classified as a Specialist Centre. Problems of inequity between the services in terms of audit and clinical outcomes Clashes between different services Existing problems with collaboration between east and west remain Currently there are issues with collaboration between locations. It doesn't currently work. Requires close working and communication within the network particularly between the two surgical services so both are working together ultimately for improved patient care. Surgeons don't work together as a 'united' service (although everyone else seems happy to work together) Potential for inequality of provision if services have different training and experience. Service members may also have other clinical commitments. There is an inherent inequity for staff parents and patients with the current system. There is also the issue of discrepancies in funding across the services which would need to be addressed. Duplication of effort means that this provides poor value for money Parents would be able to have more support from extended family 73

86 change. No disruption to service. Recently purchased equipment to allow VP function clinic to take place in Grampian. Established pathways retained. Care provided locally Range of options within Scotland Patient care closer to home Patients can be operated upon more locally with less distance to travel. Both PICU's in Scotland and associated Respiratory Teams are served with the presence of a cleft surgeon for contributory neonatal cleft airway management and for postoperative care in older babies and children. This is also beneficial when both PICU's are working at capacity. Minimal disruption to service No major costs, staff well established, experienced service exist in the West of Scotland Shared expertise easier access for surgery to local populations Still provides a partially local service in Grampian. Very good outcomes currently achieved for primary repairs - why change. Local access Very little. Surgery is not performed in NHS Grampian at present despite this being the plan. Dysfunctional arrangement Outreach provided to local areas to prevent children from the North of Scotland from having to always travel to the Central Belt NHS Grampian retains option of surgery in Aberdeen the cleft support service in Grampian is well established, with good links with services in other areas and maintaining up to date skills and expertise. Maintaining the possibility of secondary cleft surgery in living in the area of the surgical site e.g. with looking after other siblings who may be attending nursery/school or under school age. Not enough patients in Grampian to justify. This requires the surgical services to work together with outcomes shared at National Meetings. National Airways Service and National Craniofacial Service are situated in Glasgow Split service. Difficulty in ensuring equality of service across Scotland. Risk to service continuity at single surgeon sites Cross cover virtual impossibility Patient numbers not high enough for individual sites service patients receive different between sites Patient numbers not high enough in each site service provision not consistent between sites Low numbers per surgical service backup service duplication small number of patients in any area so unlikely active local support groups Does not make best use of limited financial resource? Glasgow and, in particular, Lothian exceptionally well funded. Grampian dependent upon high quality service from Lothian. Is this being delivered? Isolated surgeon in the East Unlikely to change arrangements for Grampian patients. Clinics are overbooked. Cleft service meetings are difficult to arrange due to clinical pressure. Communication between service members not ideal. The theory is that surgery should be done in RACH (and procedures have been agreed) but this has not actually happened. Country the size of Scotland perhaps only needs one cleft surgical service? difficulty ensuring equity of all aspects of care across sites The situation with a single individual providing a service 74

87 Grampian, especially with the review encompassing adults as well as children, supports specialist services for the North East of Scotland, where historically it can be difficult to attract high calibre colleagues. Losing secondary cleft surgery from Grampian may have a negative impact on Maxillo-facial services in Grampian. Having cleft surgery on two sites would enable a trainee in cleft surgery to have a broader experience in patient care within Scotland, and would provides greater exposure of cleft surgery to theatre teams within Scotland. Anecdotal evidence suggests patients from Grampian are receiving a world class standard of care, with high levels of satisfaction and excellent outcomes. Political direction and development within Scotland suggests an increasing population, with housing and infrastructure for a growth in population in the north east of Scotland. Having two surgical units offers more flexibility to respond to this predictable increased workload. The hospital, HDU and operating facilities at the Royal Aberdeen Children s Hospital provide a further resource which has previously sustained cleft surgery and in which capacity potentially exists. If needed it might be possible to extend cleft surgery in Grampian to include surgery on patient s outwith Grampian or primary cleft surgery not involving complex surgical techniques, equipment or post operative care. Parents of children with clefts have become accustomed to travelling to Edinburgh for the primary surgery. Family accommodation in Edinburgh has been adequate, although one grandmother had to be put up in a hotel as independently is inherently vulnerable. This would be improved by closer working relationships by surgeons across the country or a national appointment rather than localised to region. The main area of weakness from NHS Grampians perspective relates to the vulnerability of service reliant on a single surgeon. It may be possible to look at breaking down the conceptual barriers between the Glasgow and Edinburgh service by the next appointment for cleft surgery in Scotland being a national appointment administered outwith Edinburgh or Glasgow, by joint operating by the surgeons, or by developing individual areas of sub-interest and expertise. Some areas of Grampian relate more to west than east services in Scotland Outreach surgery leaves distant support team isolated for post operative care 75

88 she wasn t prepared to share a room in parent accommodation. Providing secondary surgery on several sites heightens awareness of the service and may facilitate patients, especially adults requiring secondary surgery, accessing this. Holding regular clinics locally with a visiting surgeon is now working well and enabling a focused multidisciplinary team meeting. Plans are underway to establish further specialist speech assessments in Grampian which will save patients travelling to Edinburgh. This is being achieved through an additional commitment by Miss Mehendale and the speech and language therapist in Aberdeen. +VE -VE 76

89 OPTION 2 Two surgical services, managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde and NHS Lothian Board areas with additional outreach assessment and follow up clinics. PROS CONS Better utilisation of equipment Additional operating slots may need to be made available which Better utilisation of staff through reduced travelling times Sufficient numbers to meet clinical skill standards provided there is a fair split of patients between the two surgical centres If child needs additional surgery the service is available on site. Minimise the burden of care The surgical staff will be well trained for cleft patients as there are fewer sites. Higher volume operators Separation between east and west Each area could focus on their own caseload and not be concerned with what is being done elsewhere. Similar to option 1 except no secondary procedures carried out in Grampian. More efficient use of resources by operating on two sites only It would not have a major impact on the patient pathway as Grampian patients already travel to Lothian for primary surgery. Established pathways retained. Care provided locally More efficient use of resources and sufficient numbers at each site to maintain standards Services of expertise already in place on both these sites. Hospitals already set up to manage required number of cases. Patients don't have to travel long distances to only one specialist centre could be challenging Some patients may be required to undergo final procedures by a different surgeon when they reach adulthood/full range of procedures not available in all areas at present. Associated services impacted for example additional HDU bed days may be required for the increased workloads Issue of disengagement between the surgical services will continue Continuing issues regarding cross cover Variations between surgical care provision/patient pathways Variations in personnel provision Duplication of resources More personnel required for administration/management roles Does not attract senior staff when vacancies arise Poor value for money Patients in the North may be unhappy there is no longer an option for secondary surgery to be carried out nearer home Long travel distances for some patients (however this does already happen for some surgical procedures that cannot be done in Aberdeen) Losing good service/facilities in Grampian Delivering locally Loss of MDT working Deskilling of some staff Grampian do not support removal of real option of secondary care taking place

90 Patients can be operated upon more locally with less distance to travel. Both PICUs and Respiratory Teams are served with the presence of a cleft surgeon for contributory neonatal cleft airway management and for postoperative care in older babies and children. This is also beneficial when both PICUs are working at capacity. Same as 1 with proviso that very little secondary surgery actually being carried out in Grampian minimal travel for patients less duplication than options one more cases per surgical service Would expect economies of scale both financially and clinically. This is essentially what is happening now so should be called the Status Quo No pro's as far as Grampian is concerned, as the commitment has been made to providing surgery locally where this is clinically appropriate. Small number of surgeons operating on larger numbers, maintaining and developing skills. Multidisciplinary links established. Outreach clinics well established in some area although need developed in other areas Practicality v. difficult May not be enough flexibility and capacity within this option for increasing population in Grampian Issues re current transition processes Importance of improving multi disciplinary care (feedback from last review) Dips and rises in cleft care Concern re sustainability key issue (2006 review) Is there enough work to support all surgeons Equity of access inadequate parent accommodation plus travel issues Clinical sustainability 2 units working independently retiral issues Losing clinical skill base Loss of collaborative working and experience for trainees Affects recruitment in Grampian in the future (sustainability) impact on outreach/follow up clinics Disparity complications in running clinics Loss of surgeon s time loss of continuity + options to access secondary surgery in Grampian. separation between east and west - looks bad that Scotland can't coordinate a single service -less numbers for audit/research It doesn't look good that Scotland can't coordinate twin sites. There would be even less collaboration and peer review which is a vital part of our work. If there is no secondary surgery carried out in Grampian this will lead to increased disruption for patients in relation to travel, home/family life, and extra appointments out of region that could be avoided with a local service. Also against the model of providing equitable access to local services irrespective of geographical location i.e. more convenient for patients in the 78

91 central region of Scotland than those in the North of Scotland. In a true clinical network sense patients in Highland and Tayside could also be offered secondary surgery in Grampian if this was more convenient for the family than travel to Edinburgh or Glasgow Again duplication of resourcing etc makes this poor value for money This requires the surgical services to work together with outcomes shared at National Meetings. National Airways service and National Craniofacial Service are situated in Glasgow Working relationship between sites would need to be maintained and agreement for cross cover Removing Grampian service will involve more travel for some, but concentrates expertise in two sites with larger throughput of cases. patient numbers not high enough for individual sites service patients receive different between sites Still an expensive option. lack of local surgical options in Aberdeen Variations in care pathways. Patients having to travel for primary surgery Grampian would not support a further withdrawal of cleft surgery from the north east of Scotland. This would have a negative impact on flexibility, capacity, and sustainability for the service throughout Scotland. This option fails to address the vulnerabilities of east and west working independently. +VE -VE 79

92 OPTION 3 One surgical service based in NHS Lothian, carrying out surgery in NHS Lothian, NHS Grampian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. PROS CONS Management would be central and consistent. Patients may be operated on by a surgeon who does not live in Workload would meet clinical skill standards area and significant delay in returning to operating unit should Patient pathway agreed and adhered to by whole service complications occur post-operatively Potential to standardise care received across NHS Increased travelling times for some staff Scotland One service may be more attractive to fill future vacancies Better cross cover and flexibility Supportive management Possible to meet clinical skill workload standards in any option dependant on surgery numbers Grampian wholly support continued option of secondary surgery locally Builds on existing structure Flexibility provided from Grampian to support surgery in Lothian connection already established One centre would mean that the referral numbers would be higher to classify it as a Specialist Centre. Patients would still be able to choose the closest surgical centre. I think if this is felt best for the surgical service then much of the other specialities would buy in and probably would have little impact on what is done in Glasgow. Perhaps if the surgical services were based in one centre and the multidisciplinary clinics are based there may be equity for all patients in terms of what they receive? Much higher volume of patients seen by the surgeons with potentially improved surgical outcomes Dilutes expertise Working relationships within wider multi-disciplinary teams and associated national specialist services maybe lost in NHS Board where surgeries cease/disruption of established services National airways and craniofacial services both based in Glasgow. If service based in Lothian and only through for surgeries there may be less opportunities for MDT meetings/collaborative working with these specialities - leading to a less joined up service Service will be sited away from main patient workload Difficult logistically management wise as some personnel would be managed by different Health Boards for different parts of their job plan which may lead to conflicting priorities/ time lost travelling between workstreams. Unclear how this option could work May not appeal to existing staff to change location Duplication of resources Clinicians not necessarily WTE which makes separation challenging Funding would be lost from a Board Could be very difficult to manage Job planning Non predictable service Not efficient use of resource

93 Politically attractive but not clinically More opportunity for audit and research. Can see none only cons apart from shared admin support at one site option. Potential cost savings through centralisation of the service but my experience of this process in the NHS is that savings do not materialise. Increased numbers treated by one surgical service would increase experience and possibly improve standard of care. A single surgical site is the only service model that makes sense. Therefore, this option has little to commend it except that having one service would allow clarity of direction and accountability Clinical standards would be met due to workload. Centralised management. Single site service would have economies. NHS Lothian has a good integrated service with medical support of patients in hospital and PICU/HDU/ENT input. During early life the airway support of children with Pierre Robin in NHS Lothian is and has been better integrated than most centres in the UK. Multidisciplinary clinic and support services in Lothian work well for services across Scotland. NHS Lothian demonstrates good multidisciplinary working for other NSD supported services, in particular the Scoliosis service. This would be a cheaper option than two sites. Consistent care for all Patients can be operated upon more locally with less distance to travel. Management cost savings More opportunity for Surgeon contact and service development What would happen if there were post op complications and the surgeon(s) lived out of area and not readily available You would disrupt the excellent communication work with other disciplines built up by services Isolation of staff + losing patients Loss of benchmarking /comparing related standards Equity of access and local support Staffing/theatre issue centralising resources - impact on speech and language therapists, orthodontics etc Differing standards of care between the different surgical sites. Placement of service members & therefore communication between members based at different sites. Adult surgery options are currently less than ideal in NHS Lothian. We have a multiple number of multidisciplinary clinics including adult, bone graft, nideofluoroscopy that have made a real difference to outcomes etc they require surgical input and would require significant input from the surgeons which would probably increase their travel to these clinics if they were presumably based in Lothian. Most patients in Glasgow area, therefore travel for the majority not the minority Reliance on the surgical service being able to travel to other areas Depends on who the surgeon is - Lothian does not have a full multidisciplinary team - no adult service in Lothian Lothian doesn't have a comprehensive birth to adulthood service. Less access to surgeons for discussion and collaboration, joint appointments. This would require movement of surgeons and support staff to one main site and provide an offsite or visiting surgical service at the other main sites. Major disruption for surgeons in terms of loss of current surgical services and possible reduced local infra-structure 81

94 Consistency of approach adequate patient numbers for specialist services Single, central surgical base. Concentration of national expertise all in one service One surgical service, presumably involving 2 or 3 surgeons, working together to agreed protocols, providing peer review and support. Better opportunities for a trainee post. Good chance to develop a sustainable service. Surgery carried out relatively close to home for majority of patients. Lower management costs and support services at other sites - much more distant from location of other locally based cleft service members e.g. Speech therapist /orthodontist. More travel for surgeons with increased peripheral clinic activity i.e. very large clinics in the west of Scotland or all patients travel from Glasgow/West of Scotland to Edinburgh for clinics - don t think this would be popular with patients!! (Never mind the parking/transport costs etc). Forcing surgeons to work together may lead to greater conflict than at present Travelling time for surgical service and logistics of operating in three locations. Out of hour s service if service operates in one hospital but is based in different hospital. Most patients based in Glasgow and West Delivery via a single NHS Board would lead to gradual contraction of the service to one place, putting many patients at a disadvantage. Who would deal with post op complications when the surgeon leaves the region? Facilitating theatre times could be challenging. Not enough patients in Grampian to justify surgical service. National Airways Service and National Craniofacial Service are situated in Glasgow How efficient is the administrative service in Lothian? Audit datasets are not always produced at the moment. Focus of the service in one centre (NHS Lothian) would be a difficult choice, but would once again provide balance to paediatric services in Scotland and help maintain levels of specialist skills to support not only cleft service. Movement of services between three sites would be expensive and may not give best outcomes to patients as service would need to return to base before full surgical recovery. Not manageable with current staffing levels to provide service for whole of Scotland from one centre Only the Edinburgh PICU will be served with a cleft surgeon. 82

95 Surgeon will need to travel and will need to stay local to the hospital to deliver postop care. Likely to be more expensive. Work life balance of the surgeon would be affected Increase in travelling time and therefore costs of surgeons. i.e. less clinical service time within working week Not local to either craniofacial service or national airways service travel implications for staff and patients patient safety if surgeon not on site based in smaller population centre for Scotland lacks some support services e.g. specialist dental services, transport for patients, accommodation for patients Is Lothian the best place to site this facility? Travel to the centre from other Boards. However, this did not appear to be a problem for Grampian parents at the time of the last review. Unrealistic option Lothian not the biggest surgical service in terms of activity currently, therefore not the obvious choice to be the national "centre" relocation for existing NHS GGC members possible change of job role for certain members less peripheral services available in NHS Lothian than in NHS GGC Outreach work would require to be very carefully co-ordinated. Challenging, but not impossible, to build up good links and working relationships with local multidisciplinary team providing ongoing care and management Basing cleft surgery services in only one site in Scotland is injurious to the existing links within the established networks. It cannot be assumed that the cleft surgeons currently working would be prepared to re-locate, requiring new appointments to be made, with significant lag time before a new individual is established in post. +VE -VE 83

96 OPTION 4 One surgical service based in NHS Greater Glasgow & Clyde, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. Pros CONS Management would be central and consistent. Patients may be operated on by a surgeon who does not live in Workload would meet clinical skill standards area and significant delay in returning to operating unit should Patient pathway agreed and adhered to by whole service Potential to standardise care received across NHS Scotland One service may be more attractive to fill future vacancies Retains the close working relationships/proximity to National Airways and Craniofacial service Grampian wholly support option of secondary surgery remaining locally cross cover Importance of maintaining Ideal Care Pathway and standards As a Board (Grampian) relationships already established re surgery One centre would mean that the referral numbers would be higher to classify it as a Specialist Centre. Patients would still be able to choose the closest surgical centre. Adult provision is better placed in NHS GG&C. Well run service already exists and the majority of patients are located in the West. Perhaps if the surgical services were based in one centre and the multidisciplinary clinics are based there may be equity for all patients in terms of what they receive? High volume operators with potentially improved surgical outcomes complications occur post-operatively Patients may be operated on by a surgeon who does not live in area and significant delay in returning to operating unit should complications occur post-operatively Increased travelling times for some staff Dilutes expertise Working relationships within wider multi-disciplinary teams maybe lost in NHS Board where surgeries cease/disruption of established services Difficult logistically management wise as some personnel may be managed by different Health Boards for different parts of their job plan which may lead to conflicting priorities/time lost travelling between workstreams. Unclear how this option could work May not appeal to existing staff to change location Duplication of resources/not efficient use of resource Clinicians not necessarily WTE which makes separation challenging Funding would be lost from a Board Could be very difficult to manage Job planning Non predictable service You would disrupt the excellent communication work with other disciplines built up by services Difference between option 3 and option 4 this is a bigger service 84

97 more equitable service across Scotland - based where already is a comprehensive service - patients not having to travel so far for surgery (surgeons would have to comment on outcomes of having surgery on different sites) Already a cohesive multidisciplinary team. There is already a comprehensive adult service in place. Potential cost savings through centralisation but my experience of this process in the NHS is that savings do not materialise Much like my response to option 3 (except the service would be based in Lothian in that) having one service is a positive. Clinical standards would be met due to workload. Organisation and teamwork in the Glasgow service (with significantly less funding than that given to Edinburgh) National Airways Service and National Craniofacial Service are situated in Glasgow Single site service would have similar economies to that described for NHS Lothian. Patients can be operated upon more locally with less distance to travel. As for above but with the advantage of being located in same city as the craniofacial and national airway services with whom team working does occur All patients receive the same care craniofacial team, airways service and cardiac service based in Glasgow. Based in major population base backup of specialist services adequate patient numbers for specialist service Single, central surgical base. Should have been the "onestep" move when the service was nationally reviewed 2/3 years ago. Local of greatest activity therefore assume change Disruptive to service if changed to Glasgow Geographical impact on surgeons Complicates structure Less continuity Impact of accommodation availability Increased number of outreach clinics?issue re provision Impact on ICP May not be enough flexibility and capacity within this option for increasing population in Grampian As above, for Option 3, but a service based in the West would be on site for a larger number of patient Differing standards of care between the different surgical sites. Placement of service members & therefore communication between members based at different sites Depends on who the surgeon is - more centralised surgery is good but doesn't address workload of other disciplines - resources need to follow patients - all other specialists in the cleft service need to be considered Would need resources to follow patients such as admin, accommodation, staffing. SLT currently working to capacity. Forcing surgeons to work together may lead to greater conflict than at present Providing out of hours care when operating on different sites would be difficult The service would be too widely spread on a regular basis. Delivery via a single NHS Board would lead to gradual contraction of the service to one place, putting many patients at a disadvantage. More administrative load on Glasgow. No current funding for an administrator. 85

98 most experience and clinical skill with regard to this type of surgery. Single service in reality as opposed to theory This has the potential to offer a better service for Grampian patients. With better engagement and collaboration a proper outreach service could be developed with potential for development As with Lothian option. Glasgow also the biggest centre so it would be the obvious choice to be the one national service One central hub with the additional bonus of extra services available in NHS GGC One surgical service, presumably involving 2 or 3 surgeons, working together to agreed protocols, providing peer review and support. Better opportunities for a trainee post. Good chance to develop a sustainable service. Surgery carried out relatively close to home for majority of patients. The balance of specialist service provision within Scotland requires careful consideration. With only one dedicated full time consultant cleft surgeon in east and west, the balance of decision is evenly placed at present. Movement of services between three sites would be expensive and may not give best outcomes to patients as service would need to return to base before full surgical recovery. Only the Glasgow PICU will be served with a cleft surgeon. Surgeon will need to travel and will need to stay local to the hospital to deliver postop care. Likely to be more expensive. Work life balance of the surgeon would be affected. Outreach commitment dilutes in house availability for the service, takes major time commitment and may not include full specialist service for follow up Travel to the centre from other Boards. However, this did not appear to be a problem for Grampian parents at the time of the last review. Likely to very difficult to merger the services in Glasgow and Edinburgh. Risk of destabilising current arrangements and producing a dysfunctional service. Outreach work would require to be very carefully co-ordinated. Challenging, but not impossible, to build up good links and working relationships with local multidisciplinary team providing ongoing care and management. Basing cleft surgery services in only one site in Scotland is injurious to the existing links within the established networks. It cannot be assumed that the cleft surgeons currently working would be prepared to re-locate, requiring new appointments to be made, with significant lag time before a new individual is established in post. +VE -VE 86

99 OPTION 5 One surgical service based in NHS Lothian, carrying out surgery in NHS Lothian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. PROS CONS Management would be central and consistent. Workload would meet clinical skill standards Patient pathway agreed and adhered to by whole service Potential to standardise care received across NHS Scotland One service may be more attractive to fill future vacancies Better utilisation of staff through reduced travelling times to carry out surgeries in Grampian Better utilisation of equipment If child needs additional surgery the service is available on site. Minimise the burden of care Better cross cover and flexibility Supportive management One centre would mean that the referral numbers would be higher to classify it as a Specialist Centre. Patients would still be able to choose the closest surgical centre. more service approach to surgery and cross cover Good for governance same as for options 3 and 4 Consolidating support/admin services at one centre greater potential cost savings through centralisation but my experience of this process in the NHS is that savings do not materialise Potential to develop an experienced service One service in the central belt makes sense Some patients may have further to travel for surgical procedures Patients may be operated on by a surgeon who does not live in area and significant delay in returning to operating unit should complications occur post-operatively Increased travelling times for some staff Dilutes expertise Working relationships within wider multi-disciplinary teams and associated national specialist services maybe lost in NHS Board where surgeries cease/disruption of established services National airways and craniofacial services both based in Glasgow. If service based in Lothian and only through for surgeries there may be less opportunities for MDT meetings/collaborative working with these specialities - leading to a less joined up service Service will be sited away from main patient workload Difficult logistically management wise as some personnel would be managed by different Health Boards for different parts of their job plan which may lead to conflicting priorities/ time lost travelling between workstreams. Unclear how this option could work May not appeal to existing staff to change location Duplication of resources Clinicians not necessarily WTE which makes separation challenging Funding would be lost from a Board Additional operating slots may need to be made available which could be challenging 87

100 Patients can be operated upon more locally with less distance to travel. Surgeon won't need to travel to Aberdeen to operate necessitating overnight stays in Aberdeen. Little disruption to the hospitals currently providing the service reduced management and administration costs All patients receive same care Equitable care Single specialist service for maintaining skills All above in option 4 plus provision of non primary surgery would be ideal. Follow up assessments needing done in theatre could be easily provided for One surgical service, presumably involving 2 or 3 surgeons, working together to agreed protocols, providing peer review and support. Better opportunities for a trainee post. Good chance to develop a sustainable service. Surgery carried out relatively close to home for majority of patients, although those north of the central belt will have considerable distance to travel. Associated services impacted for example additional HDU bed days may be required for the increased workloads Patients in the North may be unhappy there is no longer an option for secondary surgery to be carried out nearer home Not efficient use of resource Long travel distances for some patients Equity of access inadequate parent accommodation plus travel issues Losing good service/facilities in Grampian Concern Grampian not receiving any secondary surgeries. Do not support removal of real option of secondary care taking place Loss of MDT working Importance of improving multi disciplinary care (feedback from last review) Deskilling of some staff Could be very difficult to manage Job planning Non predictable service You would disrupt the communication networks with other disciplines built up by services Impact on theatre availability Grampian always made available to prioritise patients if cease secondary surgery then have to reinstate Associated services impacted Will lose skill set and diminish service in the short term Clinical sustainability 2 units working independently retiral issues Facilitate ways for secondary surgery from Lothian taking place here already happening May not be enough flexibility and capacity within this option for increasing population in Grampian 88

101 Potential issues re geographical spread of services and logistics between management of multiple surgical sites Standards of care differ between the different surgical sites. Placement of service members & therefore communication between members based at different sites. Patients may have to travel a long distance to have surgery (however this does already happen for some surgical procedures that cannot be done in Aberdeen). Adult surgery options are currently less than ideal in NHS Lothian. Travel for majority rather than minority Increased travel of surgical service to other large surgical centre on a very frequent basis. Also more travel etc for patients (particularly patients from the North if no secondary surgery in Grampian.) No surgery in Aberdeen forcing surgeons to work together may lead to greater conflict than at present Problems with operating on two sites and out of hours cover but less than covering three sites Extra travel for Highland and Grampian patients Splitting the surgical service between two sites represents poor value and a greater risk of inequity Even worse for patients than option 3 Only the Edinburgh PICU will be served with a cleft surgeon. Surgeon will need to travel and will need to stay local to the hospital to deliver postop care. Likely to be more expensive. Work life balance of the surgeon would be affected. Potential for need for surgeon relocation. Potential for clinicians to feel isolated from management structures, difficulties in service working with surgeons as even though offices may be adjacent they are unlikely to be adjacent at any other time Only the Edinburgh PICU will be served with a cleft surgeon. 89

102 Surgeon will need to travel and will need to stay local to the hospital to deliver postop care. Likely to be more expensive. Work life balance of the surgeon would be affected. Travel implications for staff and patients patient safety if surgeon not on site not in main population base, lack of specialist services for dental, outreach would take up more time than in house demand for the service Not realistic Decision making for who get s done where still out of NHS Grampian control or influence. Unwillingness for NHS GGC members to relocate service to NHS Lothian change of job role for some members Outreach work would require to be very carefully co-ordinated. Challenging, but not impossible, to build up good links and working relationships with local multidisciplinary team providing ongoing care and management. No secondary surgery in Aberdeen Grampian would not support a further withdrawal of cleft surgery from the north east of Scotland. For reasons outlined above this would have a negative impact on flexibility, capacity, and sustainability for the service throughout Scotland. Basing cleft surgery services in only one site in Scotland is injurious to the existing links within the established networks. It cannot be assumed that the cleft surgeons currently working would be prepared to re-locate, requiring new appointments to be made, with significant lag time before a new individual is established in post. +VE -VE 90

103 OPTION 6 One surgical service based in NHS Greater Glasgow and Clyde, carrying out surgery in NHS Greater Glasgow and Clyde and NHS Lothian Board areas with additional outreach and follow up assessment clinics. PROS CONS Management would be central and consistent. Some patients may have further to travel for surgical Workload would meet clinical skill standards procedures (however this does already happen for some Patient pathway agreed and adhered to by whole service Potential to standardise care received across NHS Scotland One service may be more attractive to fill future vacancies Better utilisation of staff through reduced travelling times Management would be central and consistent. Workload would meet clinical skill standards Better utilisation of equipment If child needs additional surgery the service is available on site. Minimise the burden of care One centre would mean that the referral numbers would be higher to classify it as a Specialist Centre. Patients would still be able to choose their closest surgical centre. Adult provision is better placed in NHS GG&C. More service approach to surgery and cross cover Good for governance Less travel for the surgical service Potential cost savings through centralisation but my experience of this process in the NHS is that savings do not materialise As option 5, plus service would be situated in the most populous area. Much like option 5 places one service within the central belt, where the vast majority of patients originate surgical procedures that cannot be done in Aberdeen). Patients may be operated on by a surgeon who does not live in area and significant delay in returning to operating unit should complications occur post-operatively Increased travelling times for some staff Dilutes expertise/ Deskilling of some staff Working relationships within wider multi-disciplinary teams maybe lost in NHS Board where surgeries cease/disruption of established services Difficult logistically management wise as some personnel may be managed by different Health Boards for different parts of their job plan which may lead to conflicting priorities/time lost travelling between workstreams. Unclear how this option could work May not appeal to existing staff to change location Duplication of resources Clinicians not necessarily WTE which makes separation challenging Funding would be lost from a Board Additional operating slots may need to be made available which could be challenging Associated services impacted for example additional HDU bed days may be required for the increased workloads Patients in the North may be unhappy there is no longer an option for secondary surgery to be carried out nearer home 91

104 Clinical standards would be met due to workload. Centralised management. Organisation and teamwork in the Glasgow service (with significantly less funding than that given to Edinburgh) National Airways Service and National Craniofacial Service are situated in Glasgow Patients can be operated upon more locally with less distance to travel. Surgeon won't need to travel to Aberdeen to operate necessitating overnight stays in Aberdeen All patients receive the same care craniofacial service, airways service and cardiac service based in Glasgow. specialist service in major population base with adequate patient lead for skills and cover None for NHS Grampian Better standardised protocol with both services being combined. New hospital plans would be ideal for newly combined cleft service. One surgical service, presumably involving 2 or 3 surgeons, working together to agreed protocols, providing peer review and support. Better opportunities for a trainee post. Good chance to develop a sustainable service. Surgery carried out relatively close to home for majority of patients, although those north of the central belt will have considerable distance to travel. Lower management costs Some patients may have further to travel for surgical procedures Additional operating slots may need to be made available which could be challenging Losing good service/facilities in Grampian Could be very difficult to manage Job planning Non predictable service Not efficient use of resource You would disrupt the excellent communication work with other disciplines built up by services Concern Grampian not receiving any secondary surgeries. Do not support removal of real option of secondary care taking place Practicality v. difficult May not be enough flexibility and capacity within this option for increasing population in Grampian Importance of improving multi disciplinary care (feedback from last review) Dips and rises in cleft care Concern re sustainability key issue (2006 review) 2 units working independently retiral issues Is there enough work to support all surgeons Equity of access is there sufficient parent accommodation plus travel issues Loss of collaborative working and experience for trainees Affects recruitment in Grampian in the future (sustainability) - Impacts on outreach + follow up clinics Standards of care differ between the different surgical sites. Placement of service members & therefore communication between members based at different sites. 92

105 No surgery in Aberdeen forcing surgeons to work together may lead to greater conflict than at present Poor value for money, inequity possible Even worse for patients than option 4 More administrative load on Glasgow. No current funding for an administrator. Only the Glasgow PICU will be served with a cleft surgeon. Surgeon will need to travel and will need to stay local to the hospital to deliver postop care. Likely to be more expensive. Work life balance of the surgeon would be affected. Few surgical sites for post operative care skills and support and time for outreach Difficulty for NHS Lothian to relocate more resources would be required for NHS GGC for combined service job roles may change with combined staffing level Outreach work would require to be very carefully co-ordinated. Depends on where outreach clinics will be held. Challenging, but not impossible, to build up good links and working relationships with local multidisciplinary team providing ongoing care and management. Grampian would not support a further withdrawal of cleft surgery from the north east of Scotland. For reasons outlined above this would have a negative impact on flexibility, capacity, and sustainability for the service throughout Scotland. Basing cleft surgery services in only one site in Scotland is injurious to the existing links within the established networks. It cannot be assumed that the cleft surgeons currently working would be prepared to re-locate, requiring new appointments to be made, with significant lag time before a new individual is established in post. +VE -VE 93

106 OPTION 7 One surgical service based and providing surgery in NHS Lothian, with additional outreach assessment and follow up clinics. PROS CONS Management would be central and consistent Capacity may be an issue. Workload would meet clinical skill standards No duplication of resources/more cost effective Retain and concentrate expertise Attractive to trainees More attractive in terms of future recruitment to posts All reporting to a Single Clinical Director would ensure accountability for non compliance with protocols/pathways Better clinical governance Better surgical data collection Would only require one coordinator/manager for the service Better utilisation of resources Sustainable New children s hospital proposed so may have opportunity to design purpose built facilities Good wards Don t need as much HDU usage because of workload management Flexibility /cross cover Good medical airway care Good outreach provision (Lothian has history of this) Capacity could be managed Would work similar to Grampian and Tayside Long history of telemedicine Prepared to travel for quality of service Used to sole availability of primary surgery in Lothian - no complaints One centre would mean that the referral numbers would Some patients may have further to travel for surgical procedures National airways and craniofacial services both based in Glasgow. No patients would now have ready access to these services (Lothian patients needing access already come over to Glasgow for management ) leading to a less joined up service Places service distant from majority of workload, therefore more patients would be required to travel Moves personnel from an established MDT Less access to surgeons for other services Costs as not all current surgical staff not solely employed for cleft care would need to rebuild service/ consider reconfiguration. May not appeal to existing staff to change location More staff changing work base Impact of losing a specialised service Difficult logistically management wise as some personnel would be managed by different Health Boards for different parts of their job plan which may lead to conflicting priorities/ time lost travelling between workstreams. Increased travelling times for some staff Will have a knock on effect on other services and their capacity Capacity issues would need to be scoped out. Some patients will have further to travel for surgical procedures No local driving force for MDT in discontinued service o Less personal service/loss of local knowledge Deskilling staff in other areas Need to build/rebuild communications/links to other sites Displacement of staff 94

107 be higher to classify it as a Specialist Centre. If all service members were on one site this would better the communication and help standards of care. All surgery in one place to allow for cross cover. Centralising all key support and admin staff. Opportunity for rapid communication between service members. potential greater cost savings through centralisation but my experience of this process in the NHS is that savings do not materialise Would help to develop an experienced service and would reduce costs. Out of hours cover would be available by the service post-op One service on one site - Clarity, Value for money Clinical standards would be met due to workload. Centralised management. Economies of service, skills and experience. Would provide good balance of paediatric specialist services across Scotland's two main paediatric hospitals. Would capture and fully utilise the good interdisciplinary working and communication of NHS Lothian staff within the cleft service. All operations on one site/town. Centralisation of the surgical service is the ideal option for a number of reasons 1. Clinical governance 2. Critical threshold of case numbers 3. Efficiency of team working 4. Better cross cover arrangements possible 5. Manages risk to service from clinical illness / accident / retiral / death All patients receive same care higher patient numbers Equitable care higher numbers to maintain good quality service Single specialist service conserves resources adequate Costs for grommets etc not funded for non area patient Destabilisation of the service that is discontinued Nursing loss of continuity of care with same nurse/service from antenatal period/birth through surgery and post-operatively. Travel distance for some patients resource availability? Distance for Grampian patients - L + GGC important keeping Grampian for No s May not be enough flexibility and capacity within this option for increasing population in Grampian Importance of local surgery taking into account family commitments Change in culture impact of maintaining local care V. efficient/trained service available in Grampian will be lost May face patient challenges Impact on patient centred approach V good working relationship between Grampian and Lothian currently for secondary care Potential loss Funding issue contract with Grampian/GGC possibly funding in local Board may be restricted If staff are all based at one site this mean more travel for staff members to see patients (home visits etc). Patients will have to travel a long distance to have surgery. Adult surgery options are currently less than ideal in NHS Lothian. Depends on who the surgeon is - significant changes for clinicians and patients National services such as airway management and craniofacial service based in Glasgow. Travel for patients and surgeons. As with previous centralised options will lead to increased travel/time commitments for surgeons with very large peripheral clinic activity and follow up required in other main population 95

108 patient numbers single site for post op care, IT and follow up One surgical service, presumably involving 2 or 3 surgeons, working together to agreed protocols, providing peer review and support. Better opportunities for a trainee post. Good chance to develop a sustainable service. Lower management costs centres i.e. West of Scotland and Aberdeen, Highland and Tayside/Fife etc. Increased travel/time commitments/accommodation issues for patients from most of Scotland i.e. anyone not staying in Lothian region. Forcing families to travel to Lothian for all care - vast distances for some families facilities are unlikely to be suitable for an increase in patient numbers forcing surgeons to work together, not enough staff in Lothian for all of cleft care Extra travel for patients apart from Lothian patients. Potential for local services to be 'out of touch' with surgical service Disadvantages more patients than it helps in terms of travel. Would need significant rethink in terms of how the service functions and is delivered Centralisation to one place in Scotland would disadvantage all pts (except perhaps those in Lothian and de-skill many clinical colleagues. Surgical capacity would be a huge issue, so pts may have to wait much longer for treatment. Patients would need to move for surgery - not consistent with Kerr report, but parents of children with cleft often appear happy to travel for best service, understanding the importance of this service. Patients will travel further. Glasgow PICU without a cleft surgeon. When both PICUs working at capacity neonatal cleft airway patients can only go to Edinburgh. Costs of centralisation disruption to current consultant staff personal circumstance. service distant from associated specialties in alternate major conurbation not located geocentric to population distribution Distant from national airway and craniofacial services potentially reduced access for training / exposure to cleft care of junior nursing and medical staff bed and theatre availability - smaller hospital travel time for patients 96

109 not in main population base, parent accommodation difficulties transport, lack of dental services Unrealistic Outreach work would require to be very carefully co-ordinated. Challenging, but not impossible, to build up good links and working relationships with local multidisciplinary team providing ongoing care and management. Distances for families to travel for surgery. Grampian would not support a further withdrawal of cleft surgery from the north east of Scotland. It cannot be assumed that the cleft surgeons currently working would be prepared to re-locate, requiring new appointments to be made, with significant lag time before a new individual is established in post. For reasons outlined above this would have a negative impact on flexibility, capacity, and sustainability for the service throughout Scotland. Basing cleft surgery services in only one site in Scotland is injurious to the existing links within the established networks. This would have a negative impact on equity of access for our population, in particular as the scope of the review has been extended to cover adult cleft surgery. +VE -VE 97

110 OPTION 8 One surgical service based and providing surgery in NHS Greater Glasgow and Clyde, with additional outreach assessment and follow up clinics. PROS CONS Management would be central and consistent Capacity may be an issue. Workload would meet clinical standards Some patients may have further to travel for surgical procedures No duplication of resources/more cost effective Costs as not all current surgical staff not solely employed for Retain and concentrate expertise cleft care would need to rebuild service/ consider reconfiguration. Attractive to trainees More attractive in terms of future recruitment to posts All reporting to a Single Clinical Director would ensure accountability for non compliance with protocols/pathways Better clinical governance Better surgical data collection Would only require one coordinator/manager for the service Sustainable Moving to new premises in the near future so may have opportunity to design purpose built facilities Building on an established functioning MDT Psychology input being established into MDT Fewer patients would have additional travel Retains the close working relationships/proximity to National Airways and Craniofacial service Transitional care to adult service would be seamless as it already exists Better problem resolution Flexibility/cross cover Better clinical governance NHS Grampian prepared to commit to building a working relationship and maintaining service One centre would mean that the referral numbers would be higher to classify it as a Specialist Centre. If all service members were on one site this would better May not appeal to existing staff to change location May be difficult logistically management wise as some personnel would be managed by different Health Boards for different parts of their job plan which may lead to conflicting priorities/ time lost travelling between workstreams. Increased travelling times for some staff Will have a knock on effect on other services and their capacity No local driving force for MDT in discontinued service o Less personal service/loss of local knowledge Deskilling staff in other areas Need to build/rebuild communications/links to other sites Displacement of staff Costs for grommets etc not funded for non area patient Destabilisation of the service that is discontinued Impact of losing a specialised service from Lothian would be more significant (Glasgow have more general and specialist services) Loss of respiratory /sleep service interaction VPI clinics would they move? SALT If service moved would deskill staff and would impact on patients travelling to other site. The SALT team currently assists with the one stop VPI clinic and also provide access to other patients who are not necessarily cleft to this clinic. If service moved this would deskill staff and this service may not be made available in other site to non cleft patients. Nursing loss of continuity of care with same nurse/team from antenatal period/birth through surgery and post-operatively.

111 the communication and help standards of care. Paediatric Cardiac surgery are based in GG&C and therefore can provide better care for the patients with heart conditions coordinated and equitable service for cleft patients based where there is already a large, functioning, multidisciplinary team Comprehensive service and adult service in place. National airways service and craniofacial service based in Glasgow. Potential greater cost savings through centralisation but my experience of this process in the NHS is that savings do not materialise As Option 7. Less patients would have to travel as there is a bigger population base in the West of Scotland. One service sited within most populous area (fewer patients disadvantaged) New Children s Hospital being built Craniofacial service in Glasgow National Paediatric Airway service in Glasgow Comprehensive Adult Cleft service in Glasgow. Psychology services for cleft about to be appointed. Current Service work well with good structure to the service. Allows service development and succession planning. Clear management structure can be developed. Very little change would be required. Organisation and teamwork in the Glasgow service (with significantly less funding than that given to Edinburgh) National Airways Service and National Craniofacial Service are situated in Glasgow Predominantly as for NHS Lothian above, though with fewer specialist services our integrated working is sometimes considered more 'integrated'. All operations one site/town. As option 7 but added advantages of being more geocentric to population and adjacent to craniofacial and national airway services. Critical mass effect for research Having to start again May not be enough flexibility and capacity within this option for increasing population in Grampian Depends on who the surgeon is - significant changes for clinicians and patients - significant resources will have to follow for all specialities - takes time to reconfigure any new service No consideration of the professions other than surgery. Capacity, resources, funding, accommodation etc as in option 7 but substitute Lothian with Greater Glasgow but same issues Forcing families to travel to Glasgow for all care - vast distances for some families facilities are unlikely to be suitable for an increase in patient numbers forcing surgeons to work together not enough staff in Glasgow for all of cleft care Centralisation to one place in Scotland would disadvantage all pts (except perhaps those in GGC and de-skill many clinical colleagues. Surgical capacity would be a huge issue, so pts may have to wait much longer for treatment. Removing the option of surgery from Lothian and Grampian would lead to the deskilling of staff and loss of facilities/service. Impact on patient travel. New administrative positions required to facilitate. Change of surgical Job Plans The option could destabilise specialist children's service provision in Scotland where the balance of support services to provide specialist services is finely placed. Patients will travel further. Edinburgh PICU without a cleft surgeon. When both PICUs working at capacity neonatal cleft airway patients can only go to Glasgow. Some patients would have to travel further for the surgical aspects of their care Single site may be vulnerable if any service provision threat further for some patients to travel reduces specialty options in other parts of Scotland 99

112 audit No need for duplication of functions will allow for super specialisation One surgical service working in one area would result in the service obtaining sufficient experience to provide a consistent and good quality service. Surgeons are most comfortable working with the same regular support staff in theatre and this minimises the risk to patients. It would be most sensible to have the one Cleft Surgery service at the same location as the existing Craniofacial Service as there is a lot of overlap between these two groups of patients. equitable care higher numbers to maintain good quality service craniofacial service, airways service and cardiac service all based in Glasgow close links with these services allows greater research opportunities Single site for specialist care, surgical subspecialty care, dental care on site, population base, transport, accommodation for parents Research base in house ENT national airway service One surgical service, presumably involving 2 or 3 surgeons, working together to agreed protocols, providing peer review and support. Better opportunities for a trainee post. Good chance to develop a sustainable service. Lower management costs Centralisation of service. Withdrawal of surgical access in Lothian and Grampian No surgery in NHS Grampian is major con of this. Outreach work would require to be very carefully co-ordinated. Challenging, but not impossible, to build up good links and working relationships with local multidisciplinary team providing ongoing care and management. Distances for families to travel for surgery. Grampian would not support a further withdrawal of cleft surgery from the north east of Scotland. It cannot be assumed that the cleft surgeons currently working would be prepared to re-locate, requiring new appointments to be made, with significant lag time before a new individual is established in post. For reasons outlined above this would have a negative impact on flexibility, capacity, and sustainability for the service throughout Scotland. Basing cleft surgery services in only one site in Scotland is injurious to the existing links within the established networks. This would have a negative impact on equity of access for our population, in particular as the scope of the review has been extended to cover adult cleft surgery. +VE -VE 100

113 OPTION 9 De-designation PROS CONS Service would be provided by NHS Boards to meet individual service needs. Loss of national funding and monitoring. May not be acceptable to all 14 NHS Boards. NHS Boards could compete for business Will lead to a fragmented, variable service Budget would be accessible Is unacceptable and a backward step o Move from hybrid model Could have smaller NHS Boards doing surgery o Whole service consideration Impact on meeting clinical standards o More holistic view Cross charging for NHS Boards could be an issue Give NHS Boards opportunity to stipulate service Difficulty recruiting/retaining Cleft surgeons if no National role Skill set available High clinical risk Have say on how service is led Destabilisation: Ownership local Boards/ committed Service improvement/investment in local speech and language Staffing therapy Funding Opportunity to set own standards above CLEFTSiS Associated disciplines Benchmarking and implementing higher standards Give NHS Boards opportunity to stipulate service None Service delivered in patients local areas. May be cheaper for health boards as no 'top-slicing' which includes NSD management costs. Each board would have a say on how service is led. Individualised service requirements. Travel for patients Easy access for patients Distributes resource allocation - services the responsibility of each Health Board NHS Grampian may get a better deal from this option It is acknowledged that there are substantial benefits following on from the development of a network mentality of working both as part of a multidisciplinary team, and Impact of maintaining equity of services and protecting funding Loss of standardisation and disparity in pricing could increase (do not support costing by procedure, should be by care package) NSD look at quantative data A lot of extra local bureaucracy to manage Detrimental to smaller Boards Patients want the highest standards of care as local as possible and while high quality of care has been shown to occur in small volume centres it has also been shown that it is almost impossible to audit outcomes from such small volume centres over appropriate time scales (CSAG1) Loss of centralised commission would mean the loss of Specialist Cleft Centres and therefore the patient care would significantly decrease. Patients would not receive the correct care and care would be greatly variable from child to child. This is not really an 101

114 by providing the possibility of combining clinical experience. When this works well clinical standards are raised and interdependence allows development of sub specialist expertise, and a robust platform for sustainability, development and audit. The model of functioning as an informal network is possible. This can work as well as a formal network but requires buy-in from all members of the network. option! Risk of no surgical service as money unlikely to be ring fenced by boards Would be a backward step which would make Scotland look incompetent - would fragment the specialist care for the client group and outcomes would be poorer - would not be able to do audit and research Professions that are not centrally funded would be very vulnerable and session could be lost. Goes against CSAG A retrograde step - cleft care may not be prioritised and not receive the same level of commitment and funding as is ringfenced at present. Return to inferior quality / poorly structured care poorer audit outcomes Likely to be inequality of care with some patients having to travel to other health board areas as skills required are not available in all areas. Likely to be poorer quality standard of care for patients in smaller health board areas. This represents the biggest risk to patient care possible and should not be considered as an option in my view!! The national cleft care service that has been developed over the last 20 years would just disintegrate, and patients would face postcode differences in access to treatment. It would be completely counter to everything that has been developed in cleft care in the UK and Europe. Scotland would be seen as a laughing stock in the UK and Europe. Disaster. A National embarrassment and shame in comparison to England. I imagine poorer outcomes Lack of National oversight. This is a retrograde step and would expose patients to unnecessary and unquantifiable risk. Denmark a country of similar size to Scotland took the bold decision to centralise services in

115 Very low patient numbers resulting in poor quality of service. reduced networking replication of negotiation with each HB lack of awareness of specialty needs may delay or prevent appropriate service planning and provision poor coordination of services especially for patients who move area of residence Unmanaged provision. Inequity of access. Back to the bad old days. Small numbers, surgical governance, CLEFTSiS pressure against this. Lack of funding available Not enough throughput in many Boards to maintain and develop skills. Not sustainable Unfair on smaller trusts. De-designation might risk the loss of centrally supported NDP posts and administrative support that can be used for auditing a national standard and reporting national outcomes +VE -VE 103

116 General comments regarding surgical service There was a strong feeling expressed that the entire cleft service should be nationally commissioned not just the surgical element. It was pointed out that the English and Welsh as well as other international cleft lip and palate services are successfully commissioned in totality. The impact on the working life of staff should not be underestimated for any of the options that change current working practices For the future sustainability of the service and to be credible/attract high quality candidates in the future the current model is unsustainable. Incorporation of adult service into current paediatric service would it impact on pressure on service and NSD role Surgery could help adult patients currently no opportunity to CLAPA supportive of adult care being incorporated Importance of promoting care available but make sure does not put too much pressure on the service Sharing of data and looking for ways to improve cleft care CLAPA adult service circulating availability of care Less amount of care required for adults usually The advantages of moving towards the single surgical service would be as follows: o Standardisation of treatment protocols (surgical and non-surgical) o Increased volume and therefore increased expertise among specialist staff treating cleft patients o Consistency of record taking o Eliminate duplication of facilities and infrastructure o Potential efficiencies in personnel and administration o Audit and governance simplified o Simpler / training succession planning Re the options where there is one surgical service but multiple surgical sites including Grampian, while it would be regarded as a long trip from areas of Grampian Highland and Islands for the primary surgery, this is what happens in other parts of the world such as Norway and Brazil (two places where I have firsthand experience) and the service in these places is among the best in the world. It would therefore be a question of whether patients are prepared to travel to obtain the best possible treatment in a Centre of Excellence rather than have surgery carried out locally that may not have the same support, infrastructure of perhaps expertise amongst all members of the service. The inception of the National MCN in 2006 was based around weighted criteria for deciding the structure of cleft surgery in Scotland. The criteria were, in decreasing order of importance:- 1. Clinical sustainability 2. Clinical effectiveness 3. Physical Infrastructure 4. Flexibility / capacity 5. Equity of access 6. Meets national clinical standards. Out of this process Grampian ceased to have a surgical service, and instead cleft surgery for patients from Highland and North East of Scotland was centralised to Edinburgh. Grampian provides the majority of other cleft related care centred around the hospitals in Aberdeen. Antenatal and immediate post natal counselling is

117 provided by the cleft nurse specialist with support as required. Monthly cleft clinics are provided in Grampian with Miss Mehendale travelling up to attend There were naturally some initial difficulties accommodating this new way of working. A considerable amount of effort has been spent including the appointment of a new cleft nurse specialist and cleft Speech and Language specialist. The initial problems with overrunning clinics precluding some of the cleft service discussions; however these have been addressed with changes to the clinic day etc. Initially it was anticipated that secondary cleft surgery would continue to be undertaken in Grampian, however there have not been any patients that have required this service. The anticipated subsequent move onto alveolar bone grafts has therefore not occurred. Speaking with members of the local cleft service there seems to be satisfaction with the teamwork that has been developed. Patient satisfaction seems to be high and, in the absence of outcome data being available, anecdotal outcomes would appear to be excellent. At a nursing and speech and language therapist level there is interaction between the different areas within Scotland. This does not seem to be the case for cleft surgeons. The surgeons in Glasgow and Edinburgh seem to have no meaningful clinical interaction, but rather operate quite independently. This seems to relate to personalities and historic and cultural differences. The status quo is currently providing Grampian patients an excellent surgical service and patients accept travelling to Edinburgh for primary surgery. Any reduction in cleft surgery in Grampian for adults and children cannot be supported. A further loss of operating in any of the areas represents a loss of capacity, flexibility and sustainability of allied surgical disciplines. In any option maintaining an outreach commitment to the multidisciplinary network is a pre-requisite. The main risk of the status quo is the isolation of surgical units in Edinburgh and Glasgow. The challenge to National services Scotland is to find ways to nurture closer working relationships between these two services. This might be achieved through changes in referral patterns, development and cross-referral of sub specialist areas, having a shared on-call rota for Scotland cleft support to nurse specialists, providing a joint national report of cleft outcome or making the next cleft surgeon as a national appointment. 105

118 Stakeholder feedback outputs CLEFTSiS If Option 1 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? Status Quo: Two surgical services, managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns Ring fenced funding Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed Continue to attempt to get some parity between services and irrespective of outcomes there will need to be treatment carried out locally and thus this allows engagement of local clinicians The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join 106

119 Providing a form for the services to meet and agree care pathways Wide ranging - -Managing the audit resource/it resource which can facilitate improved patient care as well as coordinating communication between the different clinicians involved in cleft care. - co-ordinating education - liaising and providing support for patients and patient groups e.g. CLAPA As at present co-ordinating audit and management of the network, and hopefully education and continuing professional development Ensuring that both services support each other and standards are maintained. Continuing to audit Scottish outcomes and promote joint research. The Network provides a forum for discussion and a route to externally quality assure the cleft service. There needs to be a co-ordinating body if the service essentially is a national service. Much of the co-ordination of the audit data is done via a central office. CLEFTSiS is seen as neutral ground. Setting and maintaining national standards for cleft care ensures universal and equitable care for cleft patients throughout Scotland. CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved No change to current Collaboration. Education. Role needs increased to have powers of sanction to ensure services are being delivered equally by both surgical services and non surgical services demonstrate Importance of engaging with Exelicare No role in improving standards Look to UK SALT group and specialist interest groups for standards Meetings arranged by Grampian no two way relationship If the Exelicare system is no longer in use and audit records are no longer stored centrally, but held at individual centres I am unsure if there would be a role for the CLEFTSiS network. As all CLEFTSiS members don't support its work at present its role is weakened Status quo has not ensured collaboration. Network is toothless 107

120 equality across all boards Important for networking between cleft professionals Coordinating activity ensuring uniform standards in all areas facilitating communication and information sharing Ensuring the same standard of service and access across Scotland and auditing outcomes. Co-ordination of network and assistance with ensuring the same standard of care across Scotland Quality Assurance across sites. Audit. Improving networking of professions working within cleft services +VE -VE 108

121 If option 2 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? Two surgical services, managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde and NHS Lothian Board areas with additional outreach assessment and follow up clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed Uniting the services It needs to be more than it is just now. It would be useful for sharing of information for ALL the other professions that are not being considered by this review. As at present co-ordinating audit and management of the network, and hopefully education and continuing The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare No role in improving standards Look to UK SALT group and

122 professional development The Network provides a forum for discussion and a route to externally quality assure the cleft service. CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved Education. Collaboration. CLEFTSiS is essential as its role covers more than just surgery. It is essential for all the subspecialty areas involved in cleft care out-with surgery e.g. dentistry/ orthodontics / nursing / speech therapy / genetics / psychology / ENT / Audiology etc. Cleft care is not just surgery! Important for networking between cleft professionals Important for all cleft care professionals to network Communication quality assurance, support for stakeholders, avoiding conflict between services for best practice Still about ensuring quality of service and standards Quality Assurance across sites. Audit specialist interest groups for standards Meetings arranged by Grampian no two way relationship If the Exelicare system is no longer in use and audit records are no longer stored centrally, but held at individual centres I am unsure if there would be a role for the CLEFTSiS network. Wouldn't be one service for them to administer If only two centres then CLEFTSiS may not be necessary +VE -VE 110

123 If option 3 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? One surgical service based in NHS Lothian, carrying out surgery in NHS Lothian, NHS Grampian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed Treatment would still be carried out locally and the operators would value that input The service would need to be administered and managed. Not necessarily by CLEFTSiS More limited than at present - inevitably focusing more around surgical services and less on other services. The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare No role in improving standards Look to UK SALT group and

124 The Network provides a forum for discussion and a route to externally quality assure the cleft service. CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved Education. Collaboration. Important for networking between cleft professionals Coordination, quality standards, audit, stakeholder support specialist interest groups for standards Meetings arranged by Grampian no two way relationship As there would only be one base centre for the whole of Scotland all audit records etc would be held there and would therefore replace the need for the CLEFTSiS network. One surgical service but there may be some merit in having a limited network with local professionals CLEFTSiS would not be required in its current form. A good network of communication could be established via NHS Lothian site. Surgeons, if working from one base should be able to sort out standards, QA etc. May be a role for the co-ordination of multidisciplinary work across Health Board Areas. +VE -VE 112

125 If option 4 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? One surgical service based in NHS Greater Glasgow & Clyde, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed Treatment would still be carried out locally and the operators would value that input Service would need administration and not being based at the surgical centre would be good The service would need to be administered and managed. Not necessarily by CLEFTSiS The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare No role in improving standards Look to UK SALT group and 113

126 more limited than at present - inevitably focusing more around surgical services and less on other services The Network provides a forum for discussion and a route to externally quality assure the cleft service CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved Collaboration. Education Important for networking between cleft professionals specialist interest groups for standards Meetings arranged by Grampian no two way relationship As there would only be one base centre for the whole of Scotland all audit records etc would be held there and would therefore replace the need for the CLEFTSiS network. For reasons stated above for NHS Lothian single option - communication via NHS GG&C could be made available in same fashion. +VE -VE 114

127 If option 5 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? One surgical service based in NHS Lothian, carrying out surgery in NHS Lothian and NHS Greater Glasgow and Clyde Board areas with additional outreach assessment and follow up clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed Service would need administration and not being based at the surgical centre would be good More limited than at present - inevitably focusing more around surgical services and less on other services The Network provides a forum for discussion and a route The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare 115

128 to externally quality assure the cleft service. CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved Education. Collaboration. Important for networking between cleft professionals Co-ordinating patients record of care across sites, Audit of outcomes Only one surgical service but a network may help support local healthcare teams No role in improving standards Look to UK SALT group and specialist interest groups for standards Meetings arranged by Grampian no two way relationship As there would only be one base centre for the whole of Scotland all audit records etc would be held there and would therefore replace the need for the CLEFTSiS network. +VE -VE 116

129 If option 6 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? One surgical service based in NHS Greater Glasgow and Clyde, carrying out surgery in NHS Greater Glasgow and Clyde and NHS Lothian Board areas with additional outreach and follow up assessment clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed More limited than at present - inevitably focusing more around surgical services and less on other services The Network provides a forum for discussion and a route to externally quality assure the cleft service CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare 117

130 specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved Education. Collaboration. Important for networking between cleft professionals as before and to ensure equality of services No role in improving standards Look to UK SALT group and specialist interest groups for standards Meetings arranged by Grampian no two way relationship As there would only be one base centre for the whole of Scotland all audit records etc would be held there and would therefore replace the need for the CLEFTSiS network. +VE -VE 118

131 If option 7 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? One surgical service based and providing surgery in NHS Lothian, with additional outreach assessment and follow up clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Increased need for network to help smooth patient pathways/communication between MDT Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed Need to have more power but important as forum for all professionals. The Network provides a forum for discussion and a route to externally quality assure the cleft service. CLEFTSiS is absolutely essential to cleft outcome The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Focus and attitude would need to change Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare No role in improving standards Look to UK SALT group and 119

132 because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved Collaboration. Education. Important for networking between cleft professionals As before to ensure equity of service and standards maintained specialist interest groups for standards Meetings arranged by Grampian no two way relationship As there would only be one base centre for the whole of Scotland all audit records etc would be held there and would therefore replace the need for the CLEFTSiS network If based on one site the service would be more likely to operate as a national service providing outreach support As above - much of the role could be consumed within an effective NHS Lothian based communication team +VE -VE 120

133 If option 8 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? One surgical service based and providing surgery in NHS Greater Glasgow and Clyde, with additional outreach assessment and follow up clinics. Yes No Until service is commissioned in totality there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Increased need for network to help smooth patient pathways/communication between MDT Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Problems with joint clinics in Grampian have and are being addressed As there would only be one base centre for the whole of Scotland all audit records etc would be held there and would therefore replace the need for the CLEFTSiS network For similar reasons as above NHS Lothian. The Network provides a forum for discussion and a route to externally quality assure the cleft service. The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Focus and attitude would need to change Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare No role in improving standards Look to UK SALT group and specialist interest groups for standards Meetings arranged by Grampian no two way relationship

134 CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the framework upon which a good outcome can be achieved Collaboration. Education. Important for networking between cleft professionals As before to ensure equity of service and standards maintained As there would only be one base centre for the whole of Scotland all audit records etc would be held there and would therefore replace the need for the CLEFTSiS network. +VE -VE 122

135 If option 9 is the preferred option is there a role for the CLEFTSiS network and what is the rationale for this answer? De-designation Yes No If the surgical service is not commissioned there would be no other funded forum for all the multi-disciplinary teams to share expertise and debate and agree optimum models of care/clinical standards. Need for a central body to pull together audit data Forum to discuss clinical issues Facilitates multidisciplinary working and education If to continue would need to put processes in place for data collection and for individual sites to have more access to their own data Forum for multidisciplinary teams to meet/share good practice/concerns. Ring fenced funding Increased need for network to help smooth patient pathways/communication between MDT Formalises data and network well Nationally specialist nurses communicate well Grampian welcome relationship and availability of resource if explained Opportunity to network Good to know what resources available Only hope is good will of clinicians continuing to provide some cleft service Chance for those in cleft to meet up to discuss issues. A network with regular MDT meetings to help support all areas would be desirable but difficult to organise. CLEFTSiS is absolutely essential to cleft outcome because outcome is dependent upon the multidisciplinary specialties that work within CLEFTSiS. Surgery alone does not produce a good outcome. It produces the The network has limited powers to influence clinical practice and compliance with data submission. If every service not participating/being selective in compliance re best practice models and data collection it negatively impacts on the value of the network Processes felt to be more complicated and less efficient by having network especially in regard to accessing data Focus and attitude would need to change Lack of quality in data impact of networking relationships and standard of quality and collaboration? No outcomes shared unethical Lack of communication contact operationally regionally operate unilaterally Grampian no contact with CLEFTSiS at all no representation Question what CLEFTSiS deliver not aware of objectives/purpose not clear What is the added value? Potential to operate faster without No extra audit occurs because of CLEFTSiS happens anyway More contact from operational service 2 years ago was better before Not consulted on work plan Quality of care/icp acknowledged in work plan? (Grampian receive work plan but done at an executive level) Attendance at meetings low Have to be included in distribution/join Importance of engaging with Exelicare No role in improving standards Look to UK SALT group and specialist interest groups for standards Meetings arranged by Grampian no two way relationship 123

136 framework upon which a good outcome can be achieved Important for networking between cleft professionals Standard setting, Quality Assurance, Clinical Governance, monitoring equity of service. No centralised commission would mean no specialist centres and therefore no need for the CLEFTSiS network. Can we have no more uncertainty for the network please - is there any need for review after review? How much valuable time has been spent on these reviews? There would be no service +VE -VE 124

137 General comments re CLEFTSiS The network needs to be given more teeth and have more influence re strategic decisions such as future appointments, performance management etc CLEFTSiS may be more effective and powerful if it was a Managed Clinical Service rather than a network I could see the CLEFTSiS network having a similar function to what it has currently with all the various sub-specialities contributing to the discussions on providing the best possible service, continuing the audit and contributing to ongoing education and research. These are essential components to the quality service. If the decision is for either Glasgow or Edinburgh to become the primary provider, in either case there will be an ongoing role for the CLEFTSiS network as the additional outreach and follow up assessment clinics will be located across the country and to abandon the network would be seen as downgrading the quality of the service. The network was established prior to the introduction of the SGHD principles for Managed Clinical Networks (MCNs). The core CLEFTSiS network team had from the establishment of the network been involved in the operational aspects of the Cleft operational service. With the outcomes of the NSD review of 9 National MCNs and the introduction of new post holders the roles and remit of the network Manager and Administrators was reviewed. This resulted in the cessation of the operational focus for the core network team and redirection of capacity to support the implementation of the networks objectives and audit. The operational role was referred back to the Cleft Co-ordinator for the East of Scotland. The ethos of MCNs outlined in the SGHD principles is inclusive. This promotes engagement opportunities for the cleft multidisciplinary team to share practice, evidence and outcomes. Engagement in the network by clinicians involved in cleft care varies. Individual speciality groups can actively engage in the network and support and progress agreed objectives however this open contribution can be minimised, at times, in the wider Executive Group. It, also, has to be recognised that there are differences in the levels of engagement between the East and West of Scotland services with the majority of feedback and engagement coming from the latter. The network has progressed and fulfilled the review recommendations, concluding in May This has involved continued open communication and consultation with network members in all the cleft centres to progress objectives however varied feedback has impacted on the progress of objectives and audit. This varying engagement has an ongoing effect on the network as a whole, the network team, Executive Group and the timely fulfilment of objectives and audit. The network office support that there is a positive and purposeful role for the network to support and underpin the outcome of the surgical review. Moving forward engagement by all cleft colleagues will be essential to support collaborative working underpinned by individual and collective positive leadership behaviours to continue to support high quality cleft care in Scotland.

138 Appendix 6: Financial profiles Greater Glasgow and Clyde Full Financial Profile (*subject to agreement) 2011/12 WTE ( ) Nursing CL&P nurses Band , ,682 Ward 4B Band ,106 Band ,766 Band ,885 Band , ,033 HDU Band ,397 Band ,832 Band ,420 Band , , ,467 Medical Consultants (Surgery) ,959 Consultants (Anaesthesia) ,146 Total Medical Salaries ,105 Fixed Salary Costs ,572 Other Costs Direct costs: Theatres (Band5) ,484 CL&P 2,370 Other Costs Total ,855 INDIRECT, FIXED Clerical/ward clerk/ess (Band2) ,807 Capital Charges 14,279 Fixed Indirect Costs ,086 Total Fixed Costs ,513 Variable Direct Costs Theatres Theatre Manager (Band8a) ,653 Band ,722 Band ,189 Band ,184 Band ,191 Total Theatres ,939 Ward 4B 26,362 HDU 11,883 Theatres 55,545 Variable Direct Costs Total 93,790 Total Variable Costs ,729 TOTAL COSTS ,242 Fixed Nursing/PAM ,467 Medical ,105 Other direct ,

139 Capital charges 0 14,279 Indirect ,807 Total Fixed ,513 Variable ,729 TOTAL ,242 * The Glasgow profile is the proposed profile which has been adjusted for Agenda for Change revisions. These have not been ratified by NHS Greater Glasgow and Clyde as yet. NHS Lothian Full Financial Profile 2011/12 WTE DIRECT, Fixed CL&P nurses Band ,852 Ward 3 Band ,777 Band ,743 Band ,916 Total Ward ,436 Theatres Band ,331 Band ,445 Band ,006 Band ,662 Band ,834 Band ,122 Total theatres ,400 TOTAL NURSING ,688 Consultants ,713 Anaesthesia Consultants ,416 TOTAL MEDICAL ,129 OTHER CL&P Travel 3,985 Pharmacy 19,927 Bacteriology 216 Radiology 5,944 TOTAL OTHER 30,072 TOTAL DIRECT, Fixed ,889 DIRECT, Variable Ward 4B 42,343 HDU 0 Theatres 39,853 TOTAL DIRECT/Variable 82,196 TOTAL DIRECT ,085 INDIRECT, Fixed Clerical Band ,736 Coordinator Band 4/5 (Note 1) ,472 Asst Service Mger Band 7(Note 2) ,176 Lease Nasendoscope 9,752 Maintenance for one Nasendescope 1,

140 Capital Charges 0 TOTAL INDIRECT ,510 TOTAL ,

141 Professor Alex McMahon, NHS Lothian Catriona Renfrew, NHS Greater Glasgow & Clyde David Steel, National Services Division Cleft Lip and Palate Surgical Service Position Paper

142 Contents 1. Introduction Background Current Configuration Activity in Scotland Outcome of the 2011/12 review of the Cleft Surgical Service options appraisal Service changes since 2011/12 review Proposed way forward Next steps

143 1. Introduction 1.1 Following the 2011/12 Review of the Cleft Lip & Palate Surgical Service the NHS Board Chief Executives asked NSD to work with NHS Greater Glasgow and Clyde and NHS Lothian to set up a single surgical service over two surgical sites to meet the needs of patients within Scotland. Subsequently a Management Board was set up led by NHS Greater Glasgow and Clyde, chaired by Jonathan Best with management representation from NHS GG&C, NHS Lothian, National Services Division and also representation from CleftSiS (now Cleft Care Scotland) and CLAPA the main patients group for Cleft Lip and Palate. Despite progress being made it became apparent that major challenges remained unresolved which meant that 2 and a half years later the complete service had not been delivered. 1.2 The Cleft Management Board took a position paper to the National Specialist Services Committee with 3 possible options for the way forward. The National Specialist Services Committee asked that NHS Greater Glasgow and Clyde and NHS Lothian supported by National Services Division consider these options, with the exclusion of de-designation, and find a way forward to implementing the recommendations of the initial review. 1.3 This paper is a product of initial discussions and provides a background of the process to date and the current position. The proposal is to share this paper with stakeholders and to convene discussion on the current position and a revised option appraisal during autumn The purpose of this paper is to begin that process. 2. Background 2.1 CleftSiS was designated as a National Managed Clinical Network in April 2000 to establish best practice and clinical care across Scotland for patients with cleft lips and palates. In 2004 there was a concern over the future sustainability of cleft surgical care in Scotland due to the resignation of one single handed surgeon in Lothian and the surgical service was nationally designated to address this issue. 2.2 Due to these issues and the imminent retirement of surgeons in Aberdeen and Glasgow a review was set up in 2006 to make recommendations on the future configuration and commissioning arrangements of the cleft surgical service to ensure a safe, sustainable and high quality service across Scotland. An independent expert review group chaired by Arthur Morris, a retired cleft surgeon and former clinical lead of CleftSiS, with three independent clinical experts from NHS England, patient and patient group involvement (CLAPA) and NHS managers and planners from across NHS Scotland. 2.3 The Review Group considered evidence based on the UK Clinical Standards Advisory Group on Cleft, Lip & Palate (CSAGS, 1998) which made recommendations on the number of surgeon per patients in relation to good clinical outcomes and the Scottish Needs Assessment Programme (SNAP, 1998) for Cleft services in Scotland. The Review Group also took evidence from the three NHS Board providers at the time on how they could best provide a service that met the recommendations. 2.4 The Review Group then carried out an option appraisal on the best configuration of the service for the following five years in Scotland. 3

144 2.5 The recommendation of the Review Group in 2006 was that the cleft surgical service should continue to be nationally designated for paediatric patients. It also recommended that due to the small number of patients: 2.6 The service should operate as one surgical service in Scotland being delivered on two surgical sites (Edinburgh and Glasgow), following the same protocols and fully participating in the CleftSiS audit programme to support quality performance monitoring. There should be cross cover arrangements between the surgeons on the two sites. 2.7 The Review Group further recommended that once the configuration changes had been implemented the service be reviewed again after 5 years to assess whether any further changes were required to improve sustainability and achieve the best clinical standards possible. 2.8 The Review Group also agreed that there was a strong argument for the inclusion of adults in the surgical service and recommended that those involved in providing the service develop a business case for National Services Advisory Group (now replaced by the National Specialist Services Committee) on the scope and cost benefits of including adults and non-cleft velopharyngael insufficiency (VPI) within the nationally designated service. 2.9 Subsequently a review was conducted in 2011/12 following a similar methodology and this time being chaired by Ms Kathryn Harley, Consultant in Paediatric Dentistry, and again including independent clinical experts from NHS England and NHS Wales as well as CLAPA and patient representatives and NHS Board managers and planners from NHS Scotland. This Review Group considered how well the recommendations of the previous review had been achieved and heard evidence from the two main providers and the CleftSiS network The Review Group noted that whilst significant progress had been made it was obvious that the service was not working as a single surgical service, not working to the same protocols and that there were challenges in getting full co-operation with the CleftSiS audit programme The review group concluded that the current configuration of surgical services was not sustainable and the recommendations of the 2006 review had not been fully achieved. There was a significant risk of major breakdown of the surgical service if the status quo was continued The Review Group then conducted an option appraisal on the best configuration of the service and commissioning arrangements to achieve best clinical outcomes for patients in Scotland. The Review Groups recommendations were accepted by National Specialist Advisory Group and then taken to the NHS Board Chief Executives for approval The recommendations were: The paediatric surgical cleft lip and palate service in Scotland should continue to be designated as a national specialist service on the grounds that it meets the criteria for national designation. (The numbers of new patients requiring treatment each year are low - around 100 a year - and unpredictable; outcomes are good; a specialist team is required to deliver effective surgery.) The surgical service, currently commissioned only for paediatric care (up to age 16), should be extended to provide surgical care for cleft lip and palate 4

145 for all ages. (There is evidence of inequitable access at present. This is likely to require additional top-sliced funding.) The future configuration of the cleft surgical service for Scotland should be a single surgical service for all ages with one management structure and one clinical lead, with additional outreach assessment and follow up clinics, working to a uniform set of clinical standards. All interested NHS Boards should be invited to submit a fully costed business case to deliver a single cleft lip and palate service for Scotland to an agreed specification, with a single management structure and clinical leadership. The business cases should be subject to an independent evaluation to determine the future location(s) of the surgical service In principle most of the recommendations were supported, however, the NHS Board Chief Executives decided that National Services Division should, instead of inviting business cases, assist the NHS Boards which currently provided the service to work together to develop a collaborative proposal for a single surgical service with one management structure, working to one set of clinical standards, with one clinical lead but on more than one surgical site Since then NHS Greater Glasgow & Clyde, NHS Lothian and NSD have been working together to bring together the service as required and to ensure that the aligned services were co-ordinated in a way that would establish a safe, sustainable and effective services for all cleft patients within NHS Scotland. Significant progress has been achieved: Management Board set up chaired by NHS GG&C as agreed host NHS Board for management of the service Lead Clinician has been appointed following appropriate open recruitment process (Mark Devlin, Cleft Surgeon, NHS GG&C) Recruitment of Clinical Psychologists to support cleft care across NHS Scotland The establishment of 24 surgical sessions based on three surgeons with 8 sessions each. Extension of the service to cover adult procedures 2.16 Nonetheless despite progress in these areas there has been significant challenges in fully establishing a fully operational, functioning, sustainable, single surgical service across two surgical sites as required by the NHS Boards. The process has been punctuated with considerable delay and periods of significant stagnation with considerable amounts of senior management time being deployed to attempt to resolve issues. Whilst significant progress seemed to be made at the end of 2014 and into beginning of 2015, in terms of agreeing the way forward major challenges remained unresolved to prevent the single surgical service being delivered The Cleft Management Board which comprised NHS Greater Glasgow and Clyde, NHS Lothian and National Services Division representation, then proposed 3 possible options for a way forward for consideration by the National Specialist Services Committee. The first option was to continue to try to implement a single 5

146 service on 2 sites, the second was to go back to the recommendations of the review to progress a potential single site for the service (at 100 children needing surgery a year, even one single service would be a small centre in the UK context), and the third option was to de-designate and allow the services to remain separate providing respectively for the East and West Coasts of Scotland. This however, had issues of sustainability and there would be no cover on the East Coast if the single surgeon was on annual/study/sick leave NSSC asked for the final option to be removed because it was not acceptable. It was agreed that this issue now needed to be raised with the Boards of NHS Lothian and NHS Greater Glasgow and Clyde, to consider the remaining 2 options and to make recommendations to the next NSSC meeting on the preferred way forward. 3. Current Configuration 3.1 At the present there are two surgical centres in Scotland performing primary cleft surgery. In Glasgow the paediatric cleft surgical service has recently been relocated from Yorkhill Hospital to the Royal Hospital for Children in Glasgow within the new Queen Elizabeth University Hospital Campus along with all other paediatric services. A maxillofacial surgeon and a plastic surgeon specialising in Cleft Care perform the surgery. In Edinburgh the service is located at the Royal Hospital for Sick Children and the surgery is performed by a plastic surgeon working wholly on cleft surgery. All other aspects of cleft care are delivered as locally as possible to the child s home by professionals as part of a Managed Clinical Network. 3.2 In Glasgow, where the majority of the adult surgical procedures are performed, the adult service is now co-located with the paediatric service within the Queen Elizabeth University Hospital Glasgow, the work is undertaken by the same surgical team with the Institute of Neurological Sciences. In Edinburgh the procedures would be undertaken at St John s Hospital, Livingston some of which would be undertaken by the cleft surgeon and others by the wider maxillofacial and plastic surgery team. There is a coordinator in post based in the Lothian site and it is intended that this post should cover the whole service but negotiations to progress this are still ongoing and as it stands the postholder only covers the paediatric elements of the Lothian site. 3.3 Multidisciplinary combined outpatient clinics are held in Ayr, Aberdeen, Dundee, Edinburgh, Glasgow, Kirkcaldy, Inverness, Larbert and Perth. 3.4 Prior to the review, suitable secondary procedures had the potential to also be carried out in Aberdeen, with the surgeon from Edinburgh primarily covering this workload. On review very few secondary surgical procedures were actually carried out in Grampian since the previous review and it was agreed surgical procedures should no longer be carried out outwith the two surgical centres. RHSC Edinburgh and RHC Glasgow both being tertiary paediatric facilities, have access to all other clinical disciplines (staff) and equipment for the comprehensive investigation and treatment of these patients, and to Paediatric Intensive Care should this be required. 3.5 Both hospitals provide a facility to allow a parent/guardian to stay beside the child on the ward when necessary. 4. Activity in Scotland 4.1 Overall, available findings indicate that orofacial clefts arise in about 1 in 700 live births, but with considerable variation geographically and ethnically. The

147 Scottish Needs Assessment Programme into Cleft Lip and Palate assessed that for the birth rate at that time, it could be anticipated that there would be approximately 100 live births with a Cleft lip and/or palate. It should be noted that the birth rate in Scotland at that time was following a downward trend until 2002 when there was just over 50,000 live births recorded. Since then there has been a steady year on year increase to a peak in 2008 of 60,041 live births. The 2010 provisional National Register of Scotland figures show that the number of live births was 58,791, representing a decrease of 2.1% from It could therefore be assumed that there could be in excess of 100 new births with a cleft lip and/or palate anticipated. It should be noted that in the 2014/15 period there were only 78 new births recorded. In this period 55 adult procedures were carried out, all in Glasgow. 4.2 Following the review the recommendation that the commissioned national service should be extended to encompass the adult surgical aspects of cleft care was agreed. It was thought that extending the existing paediatric pathway into adulthood was relatively straightforward, as this work is predominantly carried out by the teams responsible for paediatric care. Around 40 cases per annum had been identified from figures available. Transition of children/young people to adult services was to be planned and managed well in advance of the actual transfer to ensure that the service remained responsive to the specific needs of this patient group and that they continued to have access to cleft surgical services. 4.3 In addition it was recognised that there would be a secondary group of activity, new presentations as adults. This level of activity was more difficult to forecast. It was expected that there may be an initial surge of patients who had not previously presented for treatment, but it was anticipated that this would plateaux over time. It was agreed that any adult who had missed out on the care pathway should be assessed and treated in so far as that is clinically possible and appropriate regardless of age, according to clinical need and in an appropriate environment as in some cases there would be benefit to the patient of having these procedures performed on a specialised site. It was noted that many of those presenting would not pursue a surgical intervention following consultation and others would only need interventions from the non commissioned elements of the service. The proposal was therefore that there should be two levels of nationally-funded adult cleft provision: Alveolar bone graft Other complex cleft procedure requiring inpatient admission 4.4 It was agreed that all adult workload should be funded on a cost-per-case basis to reflect the variable nature of the service. 5. Outcome of the 2011/12 review of the Cleft Surgical Service options appraisal 5.1 As part of the review of the cleft surgical service a long list of nine options were initially assessed. Using the comments and views obtained from the Users and Stakeholders, the Johnson, Scholes and Whittington framework of strategic choice 1 was used to apply a methodological evaluation of each of the long listed options in order to present a shortlist of options for the review group to consider. In this model each option was evaluated against three key success criteria. Suitability: Would the option work within the current and future environment 1 Johnson, G, Scholes, K, Whittington, R (2008) Exploring Corporate Strategy, 8th Edition, FT Prentice Hall, Essex 7

148 Feasibility: Was this option capable of working within resources that are available, or could be developed/obtained Acceptability: How would this option affect stakeholders and what reactions can be anticipated. 5.2 The shortlists of options put to the review steering group to be considered in more depth were: 1. Status Quo: Two surgical services, managed in each location, carrying out surgery in NHS Greater Glasgow and Clyde, NHS Grampian and NHS Lothian Board areas with additional outreach assessment and follow up clinics. 2. One surgical service with one management structure with additional outreach assessment and follow up clinics location(s) to be determined. 3. One surgical service based and providing surgery in NHS Lothian, with additional outreach assessment and follow up clinics. 4. One surgical service based and providing surgery in NHS Greater Glasgow and Clyde, with additional outreach assessment and follow up clinics. 5. De-designation 5.3 The six criteria selected against which each option would be assessed followed a standardised approach based on NHS Scotland quality strategy incorporating the Institute of Medicines domains of quality. Table 1: Criteria Criteria Structure 1. Clinical sustainability (Attract and retain skilled staff) Definition The availability of the full range of skilled staff. Opportunities for training and development and collaborative team working between clinicians. 2. Capacity Process 3. Timely and Efficient Physical capacity/flexibility to meet all surgical needs with strength and depth in clinical staffing and collaborative team working between clinicians. The service needs to be adaptable in order to provide the most appropriate interventions and treatments at the right time to everyone who will benefit and wasteful variation will be eradicated. 4. Patient Centred, Equitable There will be the same equality of opportunity to receive high quality surgical services regardless of where patients, from any background, live in Scotland whilst being responsive and respectful to their needs and values. Outcome 5. Meets National clinical standards Degree to which the configuration is able to comply with National standards such as CLEFTSiS, Clinical Standards Advisory Group (CSAG) and National 8

149 Institute for Clinical Excellence (NICE). 6. Safe and Clinically Effective Includes both short-term safe outcomes such as avoiding harm and complications, and long term outcomes as determined by CSAG and CLEFTSiS. The weighting criteria were agreed through discussion and consensus. The scoring of the criteria had to total 100 and the greater the perceived importance the higher the weight assigned. The weights applied were as follows. Table 2: Weighting Criteria Weight 1 Clinical sustainability 15 2 Capacity 15 3 Timely and Efficient 10 4 Patient Centred and Equitable 20 5 Meets national clinical standards 20 6 Safe and Clinically Effective The following Graph shows the total weighted scores for each option 5.5 Option 2, a single surgical service with one management structure with location(s) to be determined, received the highest weighted total score. Option 4, a single surgical service based and providing surgery in NHS Greater Glasgow and Clyde received the second highest score, with option 3 a single surgical service based and providing surgery in NHS Lothian having the third highest weighted score. Option 1 status quo and option 5 de-designation scored significantly lower than the other options. 5.6 The table below demonstrates the voting patterns of the different representatives. Table 3: Voting preferences by groupings Option 1 Option 2 Option 3 Option 4 Option 5 NSD Patient/Public Reps Board Reps Independent Experts

150 With the exception of the Independent experts, option 2 (one surgical service with one management structure with additional outreach assessment and follow up clinics location(s) to be determined) was ranked first with option 4 second (one surgical service based and providing surgery in NHS Greater Glasgow & Clyde) and option 3 (one surgical service based and providing surgery in NHS Lothian) third. As can be seen the independent experts ranked option 4 first and option 2 second with all other results in the same order of preference as the other groups. Whilst Option 2 was not unanimously ranked number 1, it was by the vast majority of respondents and therefore it was deemed the preferred option. 5.7 Graph 2 and table 4 look at how each option performed on each of the criterion to assess particular strengths and weaknesses to help inform future decisions in regard to preferred location. From the scoring all sub groups favoured a single site in NHS Greater Glasgow & Clyde on each of the criterion, ranking either second or first place for all. Table 4: Options 3 and 4 ranking against each criterion Criterion Option 3 Option 4 Top ranked option Clinical Sustainability 3 2 Option 2 Capacity 3 2 Option 2 Timely and Efficient 3 2 Option 2 Patient centred and Equitable 3 2 Option 2 Meets national standards 3 2 Option 2 Safe and Clinically Effective 3 1 Option 4 6. Service changes since 2011/12 review. 6.1 Following the review of Cleft Lip & Palate Services, the NHS Board Chief Executives tasked the two host NHS Boards with developing a single service for both adults and children, with one management structure and one clinical lead for primary and secondary paediatric services but also to incorporate adult surgical services where it required the work of a dedicated cleft surgeon. A Management Board was 10

151 established led by NHS GG&C as the agreed host NHS Board for the management of the single surgical service but with the involvement of NHS Lothian Senior Management colleagues, Regional Planning Group colleagues and NSD colleagues. Mr Mark Devlin, Cleft Surgeon NHS GG&C was appointed to the position of Clinical Lead following an open recruitment process. 6.2 Two main patient pathways had been identified: New patients identified at, or before, birth New patients presenting as adults 6.3 The patient pathway for new cases identified at birth was clear and agreed by all clinicians in Scotland. To ensure maximal care through to adulthood which was now nationally commissioned, there was only a need to extend the current surgical provision through to final definitive surgery. For most patients, this was already before their sixteenth birthday; for others, it would be in their late teens or early twenties. 6.4 The second group covers patients who had previously been treated outwith Scotland and patients treated in Scotland who may come forward seeking revisional surgery after being lost to follow up; and adults who have received no treatment prior to presenting. Since the review the long planned move of the existing paediatric hospital (Yorkhill) to a new facility co-located with adult services within the Queen Elizabeth University Hospital Campus has taken place. In Lothian the paediatric service is still located at the Royal Hospital for Sick Children but there are plans for the paediatric hospital to be moved to a new build within the Little France campus and it would then also be co-located with adult services but this is not scheduled until In regard to staffing changes one of the existing cleft surgeons based in NHS GG&C retired from the service to concentrate on his core speciality and his post was recruited to with another plastic surgeon with a sub specialty in cleft, lip and palate surgery. Benchmark reviews with English services had indicated that a cleft surgeon should ideally have 7 Direct Clinical Care Professional Activities (DCC PAs) + 1 Supportive Professional Activity (SPA) built into their job plan to cover assessment, operating, outpatients and all other follow-up, including outreach clinics, Multi Disciplinary Teams (MDT), etc. (with the balance of 2+ DCC PAs in the contract in the host specialty, including on-call, in order to maintain wider skills). To cover the full cleft service, the funded surgeon PAs was increased from the existing 13 DCC PAs funded across both sites to 24 PAs - 21 DCC / 3 SPA, distributed equally among the three surgeons. 6.6 Due to ongoing difficulties experienced by all of the NHS Boards in providing clinical psychology input to the surgical cleft service and given that clinical psychology care is seen as essential for a functional cleft service, the recommendation that clinical psychology input should be included in the commissioned service was agreed. Following consultation with the wider service a change to the original proposal of 1.6wte at Band 8a agreed by the NHS Board Chief Executives was being actioned instead; 0.4 of a band 8c based in Glasgow to provide clinical leadership has been recruited to, with 1wte band 8a post (potentially split into two band 0.5wte Band 8a posts). 6.7 A mapping exercise to fully understand the current service provision including outreach and Multi Disciplinary Team clinics across Scotland was conducted to inform the optimum configuration to provide outreach clinics and MDT clinics to ensure good patient flow in line with the clinical patient pathway within the clinical 11

152 sessions and resources available. A small team of managers from both NHS GG&C and NHS Lothian, the lead clinician and the Cleft Care Scotland Network Manager were involved in the mapping of the current service provision. 6.8 This exercise included visiting the MDTs being run within NHS Scotland for cleft patients and also consideration of the current surgical theatre sessions available to the service. The team reporting on the provision of MDTs/out-patient clinics as they were currently constructed to the Management Board. Suggestions for how changes might be taken forward were then discussed by the Lead Clinician with the Cleft Care Scotland Network in February This was on the background that there were to be 24 sessions for the surgeons to be spread evenly over the three cleft surgeons currently employed within NHS Scotland. With the advice of the lead clinician following consultation with the other surgeons this broke down as follows for each surgeon: 1. Paediatric operating (2.25) sessions* 2. Adult Operating (1.25 session) * 3. Admin (1 session) 4. SPA (1 session, Flexible) 5. Out-patient Clinic (2.5) sessions 6.10 The prospect of changes to the current configuration of Multi Disciplinary Team clinics has created a good deal of anxiety for some clinicians within local clinics. However it has been emphasised that this suggestion is only for the MDT clinics and will not affect the provision of speciality review clinics provided by local specialities for clinical care within the NHS Boards. It may be that the timing of the MDTs would require some changes locally to allow these to occur at agreed times but it is hoped that the 12 month period for introduction would be sufficient to allow time for NHS Board to accommodate any changes locally. 7. Proposed way forward 7.1 Throughout this extended period of planning a new service model the existing provision of 2 separate paediatric services (one for East of Scotland, the other for West of Scotland) have continued to deliver a safe and effective service. Nonetheless despite the progress toward delivery of the agreed model that has been detailed; the fundamental requirement of a single surgical service based on two sites, with discretely line managed surgeons, has proven extremely difficult to progress. It is now proposed that a further options appraisal is conducted. The options for consideration are: 1. Continue to seek to implement the current NHS Board Chief Executives direction for a single surgical service provided on two sites. 2. Plan and implement a single surgical service for all ages provided in NHS Lothian. This proposal would mean all surgery being performed by NHS Lothian with the three surgeons being under the NHS Lothian management responsibility. Local clinics and Multi Disciplinary Team clinics would still be provided and supported across NHS Scotland. 3. Plan and implement a single surgical service for all ages provided in NHS Greater Glasgow & Clyde - This proposal would mean all surgery being performed by NHS Greater Glasgow & Clyde with the three surgeons being under the NHS Greater Glasgow & Clyde management responsibility. Local 12

153 clinics and Multi Disciplinary Team clinics would still be provided and supported across NHS Scotland. 8. Next steps 8.1 It was agreed that an inclusive process would be put in place to rerun the previous option appraisal with stakeholder involvement. 8.2 The next step is therefore to have comment on this paper from stakeholders. 8.3 The steering groups of this review will then consider the best way to carry out an objective, independent option appraisal as soon as practical. The stakeholders will be advised of the process and outcome as it proceeds 13

154 Glossary of Terms Clinical Standards Advisory Group: In 1996, the Clinical Standards Advisory Group (CSAG) undertook to review the treatment of cleft lip and palate in the UK through a postal survey. The CSAG report, published in 1998 indicated that the state of cleft care was not acceptable in many areas; i.e. a number of children did not receive their surgery within an appropriate timeframe and an unacceptable number of children had significant difficulties with speech and feeding and many did not achieve a good outcome in terms of facial appearance, dental occlusion and bone grafting. Following the 1998 CSAG report cleft care in the UK was reorganised so that the expertise and resources were concentrated regionally taking into account population needs and accessibility. National Services Division: National Services Division (NSD) is a directorate within NHS National Services Scotland (NSS) and is based at Gyle Square in Edinburgh. Each year, NSD receives top-sliced, ringfenced funding from the Scottish Government Health and Social Care Directorates (SGHSCD) to commission and performance manage nationally designated specialist services and screening programmes, National Managed Clinical & Diagnostic Networks and National Network Management Service. National Specialist Services Committee: The overarching governance group for national specialist services which is composed of senior health care medical and operational managers, planners and finance representatives from each of the NHS Boards and Scottish Government and is chaired by an NHS Board Chief Executive. It provides advice and recommendations to the NHS Scotland Chief Executive Group. NSSC meets quarterly and considers proposals for national commissioning of highly specialist health services, and services for people with rare disease and /or complex needs. It provides oversight of existing nationally commissioned services, and reviews these every 3-5 years. Non-Cleft Velopharyngael Insufficiency (VPI): VPI is a failure of the separation between the nose and mouth which can lead to functional problems with speech, eating and breathing. Option Appraisal: An Option Appraisal is a process that is often used when considering a new way to provide services. Option Appraisals allow a wide number of views to be considered and as robust an assessment of options as possible to be created. Option Appraisals look at the ways in which a service could be provided and the most promising options are then assessed by comparing their benefits, risks and costs. The aim is to develop the best possible model for the service within the resources available. Professional Activity (PA): A Professional Activity is a period of consultant work session (about 4 hours). A Direct Clinic Care is a period where the consultant is providing care to patients including, out patient clinics, inpatient care and theatre sessions. A Supportive Activity is a period where the Consultant is doing other work like research or educational activity. 14

155 CLEFT SURGICAL SERVICES OPTIONS APPRAISAL COMMENTS RECEIVED ON POSITION PAPER FROM PATIENTS, PARENTS AND OTHER STAKEHOLDERS

156 Summary Below is summary of the emerging themes from the comments received from the Position Paper and the Options Appraisal process. General Document difficult to understand. Not enough information/too much detail. Needs to be clarity on the reason why the two surgical site model is not working. Why change something that works? ( If it ain t broke why fix it? ) Clinically Sustainable/Capacity Potential Loss of surgical expertise. Capacity at any centre to accommodate workload. Timely Ability to meet waiting times. Patient centred Concern that the proposals include centralising all services on one site/nhs Board. Access to any of the centres from parents/patients from the other side of the country. Family support arrangements. Accommodation arrangements at any one site for patients and parents Will parents/patients have to travel more? Extra expense of travel for patients. Choice of surgeon for the patients continuity of care Equity of Access Access to any of the centres from parents/patients from the other side of the country. Impact on outreach/outpatient clinics. Clinically Effective/Safe Quality of Outcomes needs to be central to the process. 2

157 Comment 1: I have been prompted to write to you having been forwarded the document Cleft Lip and Palate Surgical Service Position Paper (no date) from the CLAPA Edinburgh branch outlining the review of cleft services in Scotland. I am a parent of a child aged four with a cleft lip and palate. Firstly, I would like to stress how cumbersome this document is and yet it omits crucial information for those who are not working within cleft services. I feel strongly that such major proposed changes should take into account the voice of patients, and the parents of patients. After all, surely the single most important factor in caring for a cleft patient is the end result, and who better to comment on that than those receiving treatment and their carers. I am intrigued to read that the current configuration of management is not working and yet there is no explanation of this. I only have my own experiences to refer to but that experience is of an extremely professional team who cannot hide their respect for each other. I find it hard to believe that there are difficulties within the team at the point of delivery. I am also intrigued that the new Management Board is chaired by the Glasgow team and that it has been agreed that they host the NHS Board for the management of the service. It is also interesting that the lead clinician has already been appointed, yet again from the Greater Glasgow team. Reading the paper it seems there is an obvious bias towards Glasgow leading the cleft services in Scotland. I see the lengthy detail given to show how the voting was conducted but unless there is an even playing field in the first place, I fail to see how this can be a fair way of coming to a beneficial conclusion for everyone. Indeed, I wonder if the decision has already been made. My family have been very lucky to have the cleft services on the doorstep. There is no doubt that if surgery shifted to Glasgow it would incur greater expense to us as well as dividing the family (I also have a daughter) at a time when the family needs to be together. Moreover, I am concerned at how these changes will effect single parent families, or those whose clefts are part of a bigger medical picture (meaning that they have many more appointments to attend), or those on a low income. I understand that in this latter instance there is some assistance but I suspect not enough to cover additional expenses. Ultimately however, my primary concern is for the care of my son. If these changes are implemented I cannot imagine that his experience will continue as it is now. We were extremely fortunate that we had a diagnosis prior to his birth and, on the same day, we received a visit by the cleft nurse from the Edinburgh team. This may seem like an insignificant point but that was the day where our confidence in the Edinburgh Team began. The cleft nurse couldn t speak highly enough of our surgeon and was able to talk specifically about the professionals who would be involved in our son s journey. We met with our surgeon before the birth and we couldn t have been more impressed with how caring she was for our concerns. I am sure that putting parents at ease by allowing trust to build has to be paramount in the development of a child with a cleft lip and palate. Our speech and language therapist knows our surgeon s procedures and opinions exceptionally well, as does the orthodontist. We are often reassured and advised at our outreach assessments and we can see that the whole team is there for us - and at hand. I would ask you not to underestimate the benefits of feeling that these people are all part of the family dealing with our son s development. 3

158 I have absolutely no idea of our surgeon s thoughts on the proposed changes but I would be curious to know how well the surgeons have been consulted on the paper. I would be very disappointed if Edinburgh lost such a high calibre surgeon because of a reorganisation. The continuity of care is paramount and we are clear that we have a leading cleft surgeon caring for our son. There is no question of the quality of her work and the dedication that she shows the service. I feel that continuity is absolutely crucial in our son s care and that these changes put that continuity in serious jeopardy. I see from the paper that there is a large amount of weight placed on the importance of a new service being Patient Centred and Equitable as well as Safe and Clinically Effective. I fail to see how a single service based in Glasgow can do this for all patients across Scotland. Forgive me for writing from the heart. I am no more used to writing a letter like this than I am reading fourteen pages of an NHS document. I am concerned that Edinburgh does not have a voice in this procedure and I am concerned that I am not being made aware of why these changes are taking place. Mostly, I am concerned that quality of care of my son and others affected will not continue in the very positive way that it has so far. I would be grateful if you could acknowledge receipt of my letter. Yours sincerely, 4

159 Comment 2 We are the parents of a child born with a unilateral cleft lip and palate. We live in Highland region and our daughter, now aged 6, received surgery in Edinburgh in her first year under the care of Dr Mehendale. We are extremely concerned about the proposed changes to cleft surgical services in Scotland, about which, without CLAPA, we would have been completely unaware. NSS have made no attempt whatsoever to notify patients and families directly about the review process, which is in our opinion unacceptable. With respect to the options laid out in section 7 of the position paper, we are strongly in favour of option 1, trying to implement the current setup of a single surgical service across two sites (Edinburgh and Glasgow). Our reasons for this are as follows: The position paper does not present any evidence to demonstrate why the current setup is not working, despite requests from CLAPA for this information, or set out the reasons for the proposed changes to the surgical services. Therefore we are unable to make an informed decision about the alternative options. Provision of a single surgical service across two sites is a model that is successfully operated in England, therefore there is no reason per se why it should not be successfully used here in Scotland. Section 7.1 states that the existing provision of 2 separate paediatric services (one for East of Scotland, the other for West of Scotland) have continued to deliver a safe and effective service. If this is the case, why move to change this? Section 2.16 states that significant progress seemed to be made at the end of 2014 and into the beginning of 2015 if this is the case, surely this is the time to consolidate this progress and not abandon it altogether? We are concerned that our daughter will lose continuity of care if there is a change to the current setup. Our daughter had two surgical procedures performed by Dr Mehendale in her first year. However, she will require an alveolar bone graft sometime in the next few years and we would like to see this performed by the same surgeon who operated on her previously and is therefore familiar with her history. In addition, we have a number of serious concerns should option 3 be implemented (which according to recent newspaper articles and the position paper seems to be the favoured option). Option 3 states that This proposal would mean all surgery being performed by NHS Greater Glasgow & Clyde with the three surgeons being under the NHS Greater Glasgow & Clyde management responsibility. It is our understanding that Dr Mehendale is internationally renowned in her field and is the top cleft surgeon in the UK, under no circumstances do we wish to lose her services to the Scottish cleft community. For this option to succeed Dr Mehendale would have to be willing to transfer to NHS Greater Glasgow & Clyde responsibility and travel to Glasgow to perform surgery. If not, implementing option 3 would inevitably mean that we would lose arguably the greatest asset to the Scottish cleft community. Under option 2 or 3, apparently local clinics would still be provided and supported across NHS Scotland. Without a surgeon based in the two main population centres in Scotland this will result in surgeons spending their valuable time travelling to and from either Glasgow or Edinburgh this seems far from cost-effective or efficient. 5

160 As we stated earlier, the position paper does not fully explain the rational behind the proposed changes to cleft surgical services in Scotland. However, the position paper states that there were only 78 live births with a cleft lip and/or palate recorded in 2014/15. These figures suggest that there may be insufficient cases to support three surgeons in cleft surgical services in Scotland. The treatment of Cleft Lip and Palate: a parents guide produced by The Royal College of Surgeons of England states that a framework document for cleft services was drawn up which stipulates that surgeons should manage at least 40 new patients a year in order to gain the level of expertise necessary in this area. Teams are required to undertake clinical audit of all cleft lip and palate patients. How many procedures are currently being performed by each of the three surgeons within Scotland each year? What are the audit results and outcome figures for procedures performed by each of the three surgeons? If there is a need to reduce the number of surgeons within Cleft surgical services in Scotland, then surely we should be looking to retain those surgeons that produce the best outcomes for patients. Finally, it is our understanding that there are no representatives of the Edinburgh Cleft team invited to the meeting on the 28 th if this is correct, why is this the case? We have had very limited time to respond to the position paper and have been given no proper opportunity, other than through CLAPA, to provide comment on the options under consideration. As parents we want the best for our child, therefore we sincerely hope that you will give due consideration to our comments and concerns. Yours faithfully 6

161 Comment 3 I refer to the Cleft Lip and Palate Surgical Service Position Paper and the various options contained within. Although not specifically stated I can t help but feel that my reading between the lines interpretation is that regardless of the 3 options given now there is a long term goal of one site and that site is Glasgow. Despite the claims it is only referring to surgical services. I have serious concerns that if that were to happen it would only be a matter of time before local clinics were closed and all routine appointments would be in Glasgow. The report says option 1 has proven extremely difficult to progress, or succeed - mainly in reference to merging adult services with paediatric but has not explained why this is difficult. So as a parent out of the loop I have no idea what they are referring to and although I am being asked to give an opinion on the way forward it s a bit difficult without knowing what is stopping the merger. I cannot understand why this option is being dismissed and as it isn t explained can t help think that this is deliberate act to encourage voting for a single site. I personally as the parent of a child with cleft would opt for option 1. Continue to seek to implement the current NHS Board Chief Executives direction for a single surgical service provided on two sites. I would hope that whatever is allegedly stopping this from working is resolved sooner rather than later. My reasons for this are explained below. I live in Dunfermline and I am the parent of a cleft child. My son is nearly 18 and just started University; his next operation will be jaw re-alignment. He has for the last 17 years been under the care of the cleft team in Lothian with clinics in Dunfermline and Kirkcaldy. When he was very small he even saw the then plastic surgeon in Dunfermline at a plastics clinic in the Queen Margaret hospital (his work was not exclusive to Cleft). This was great as it reduced our travelling time/costs and the time off work to attend the appointment. My husband and I are non-drivers and like many of the parents using the cleft service rely on public transport to get us to and from hospital appointments/ admissions. We and many other families are not on benefits and do not get our travel reimbursed. This can be very expensive (even more so If both parents and siblings are attending) and places a huge burden on a family. This burden is not just monetary but in terms of time travelling and possibly time absent from work or other family commitments. If we had to go to Glasgow instead of Edinburgh/ St John it would mean a longer commute and it would be slightly more expensive. University/work however would be greatly affected by any change as currently my son & husband can limit time off to 2/3 hours and for some appointments to just half an hour (we live a few minutes from Queen Margaret Hospital) but if he had to go to Glasgow for every appointment they would lose a whole day. In addition to the costs already mentioned above the support available to families may be greatly reduced or no longer available as longer childcare for siblings would be required (possibly more financial expense if not provided by family), support visits to a hospital further away may be more difficult or even impossible for grandparents, aunts, friends etc. e.g. whenever my son is in hospital in Edinburgh his aunt would stop by and visit every night after work before going home. If this was in Glasgow she would not be able to do this and her important emotional support, care packages, food (essential as so expensive to eat at the hospital for every meal) clean clothes etc. would not be available as her work commitments and own family commitments would make it very difficult to go to Glasgow instead of Edinburgh. 7

162 Many cleft children require long term treatment for other medical issues. To have the cleft team working from local hospitals where the child is already attending would help the child feel more comfortable or in my son s case regularly allowed me to arrange multiple appointments on the same day thereby reducing financial, emotional, work and domestic costs. There is no doubt that a family currently attending the Glasgow hospital would face similar difficulties if they had to change to Edinburgh. A quick look at Scotrail website would suggest patients travelling from Aberdeen or the new border station of Tweedbank can get to Edinburgh Hospital quicker and cheaper than going to the Glasgow Hospital, so it would seem to support from a patient s viewpoint the need for 2 sites. In my opinion it is vital that we keep local clinics, mainly for the reasons already explained: - cost in monetary, time, child care etc. however I am also concerned that a decision to centralise care regardless of the site could result in losing the cleft knowledge and expertise of specialist nurses, ENT staff, hygienist, orthodontist, Speech and Language, sleep study and special respiratory staff associated with cleft care. How many would not be transferring as cleft care is only part of their duties or family commitments prevent a change of hospital? The support staff are just as important as the surgeons as they see the child more often than the surgeon and a good rapport is vital in the continuing care of a cleft child. My son is near the end of his cleft surgical journey and ultimately whatever changes are made will not have as much of an effect on him or us as a family as a young baby and family just joining the world of Cleft Care. Whilst an unwelcome change to Glasgow would impact on my son as mentioned above, in comparison to children in remote areas the impact would be small. I would hate to be the parent of a cleft baby now facing possibly 20 plus years travelling for routine appointments to Edinburgh or Glasgow rather than Aberdeen, Inverness, Dundee or Fife the thought alone would fill me with dread never mind the financial, time and emotional costs. Can you really imagine travelling every few weeks from one of the Islands to Edinburgh or Glasgow for Hygienist or orthodontist treatment? My son needed several emergency appointments when wearing his braces. What would patients in remote areas be expected to do? Travel to Edinburgh/ Glasgow? Emergency repairs to braces would be a nightmare! Would this extra financial burden mean that they were financially unable to attend appointments resulting in a reduced care for their cleft child? I know how financially draining it is for us to attend appointments and our journeys would be classed as short in comparison. NHS has fiscal responsibilities to comply with, as each local Health Board is contributing to Cleft care how will they be able to claim that the East of Scotland service will be cost effective and meeting Joined up Care if they change to a single site in Glasgow? Patients will not have joined up care, Cleft Care contributions will have to be increased and patients will no longer have a local service and potentially forced to travel hundreds of miles for the service. In additional to fiscal responsibility there is also the need to comply with the policy Getting It Right For Every Child (GIRFEC). How can centralising Cleft Care to one site possibly achieve this when the wellbeing of the child/family would be greatly affected? I repeat as the parent of a child with cleft I would opt for option 1. Continue to seek to implement the current NHS Board Chief Executives direction for a single surgical service provided on two sites. I would expect every effort be made to make this work. 8

163 Comment 4 - Subject: Surgical Service - Glasgow Having scanned over the sent re proposed changes to cleft surgical services in Scotland, as a parent of a 10 year old Cleft patient in Glasgow, I would urge the review panel to consider further working on the provision of a surgical team in both Glasgow and Edinburgh as opposed to in one or the other locations. If my son had had to undergo all his surgical procedures in Edinburgh it would have been very difficult with the poorly connected motorway provision for my husband to be there with us throughout the procedures. My husband used to go home at night and return early the next morning. The distance between Glasgow and Edinburgh is too great and the motorway very crowded. Should only one location be offered it really would make the surgery even more stressful for the one parent who can't stay and has to commute. Hope further work can be done to maintain and better manage both locations. Best Wishes, 9

164 Comment 5: We live in Broxburn, West Lothian and my son is 8 years old. (Child s name) is currently going through Palette Expander Brace Procedure in order to have his bone graft early next year. Arthur is a Unilateral Cleft Lip and Palette. (Child s name) has currently had 13 surgical procedures to date due to complications and is deaf with a digital hearing aid plus wears glasses. We have another son who is 10 years old also plus there dad works away from home during the week. I need a CLEFT Surgical Service which is local to me. When (Child s name) has surgeries my parents (69 & 79 who don't drive but live in Edinburgh) do the school run for his brother via bus plus come in during the day to RHSC in order for me to grab a bite to eat etc. My sister (lives/works in Edinburgh) also comes in to stay over with Arthur at nights so I can be home for his older brother. My husband doesn't take the time off as I feel spending surgery time with (Child s name) would mean during school holidays his big brother then misses out on Daddy time as it's used up for (Child s name) surgeries. All this would not be practical in Glasgow. (Child s name) and I would be alone with no family due to the age on my parents and not driving they couldn't visit our help out. My sister wouldn't be able to visit as she would need to look after my other son along with my parents. Children need reassurance and family around them not isolation and a lone parent. Moving CLEFT Surgeries to Glasgow would impact and isolate us along with all the other families who used the RHSC. This is very bias plan for parents who live in Edinburgh/Lothians. We need local services for our children with as little disruption to their everyday life for both them and their families. Glasgow is not practical for Schooling, Siblings, Family plus assumes we all DRIVE. Centralisation only works for those who live nearest thus is not an inclusive service for all families and children. Money and Budgets don't matter to CLEFT Family's is our CLEFT Children who's needs come first. 10

165 Comment 6: Happy for my details to be included. My husband's comment later last night was that it also seems a shame when in Edinburgh we are getting the brand new sick kids hospital and yet it could be losing some specialist surgeries-what's next?! We both work in big, national companies so we understand that in some cases centralisation is a sensible move both for the service provider and 'customer'. However when it comes to medical care, particularly of children, then surely making every effort to keep things as local as possible is best for the patient and their families, especially when such an excellent service already exists in the East of Scotland. Hopefully that articulates things a bit better than my emotional gut reaction last night! Happy for you to include all comments. I've just been reading the paper regarding cleft services in Scotland (from Facebook link). Extremely disappointed to think that Cleft surgery could be removed from the Sick Kids in Edinburgh. On a purely personal basis, it was extremely handy having 'local' surgery! When our son had his first op it meant disruption to our other child was minimised, and would also mean minimal change/disruption to him when going for future surgery-simply a trip to the local hospital rather than to a different city. The prospect of travelling to Glasgow also adds another whole layer of worries and stress for me as a parent which I have not had to consider until now. I was delighted with our experiences at the sick kids and while it may sound silly, the idea of moving under the care of a different nhs board is a slightly daunting prospect (fear of the unknown!). While the thought of any future surgeries our son may require can be worrying, knowing we would be under the care of the sick kids team is comforting. While I'm sure care would be equally good in Glasgow, it is unknown to me. I guess what I'm trying to say is that the prospect of this change leaves me feeling a little like I did in the early days after his cleft diagnosis-uncertain and worried about what the future holds whereas for some time now it had just been part of life. > I would also be sad to lose that link with the 'Sick Kids' - it helps when fundraising for them to have a personal reason! > While it has not been decided yet, I get the distinct impression from the report that surgery will move to Glasgow. It's very sad that we can't have this surgery from a fantastic team in our capital city. > Sorry for rambling on, finding it hard to articulate my feelings on this! 11

166 Comment 7: My son is currently 2 and has had 1 surgery in Glasgow so far. We know there is likely to be at least one more. We as a family would like this to be in Glasgow. We stay in Stirling and our extended family is split between Stirling and Balloch. As we do not drive we need to get the train to Glasgow for appointments and surgeries and then rely on a member of family (my dad usually) to come and get us in the car to get home after surgery. Glasgow is easier financially for us and is closer for us. As our family members who would bring us home are also based closer to Glasgow than Edinburgh then this is again the better option to have cleft surgeries for our family. Both sides of our family would not be willing to travel to Edinburgh to bring our son home which would leave us stuck in Edinburgh. Cleft surgery in Glasgow would be our choice. I hope this helps! Comment 8: Subject: RE: A concerned mum I'm from the Fife area and travel to Glasgow for meetings and my daughters operations, most times I have to arrange child care for my other two kids so we make appointments but if having to travel to Glasgow I'm having to leave alot earlier, I don't always have child care as my husband works away from home, so it's also going to disrupt things for them. Sent from my Xperia Z3 on O2 12

167 Comment 9: I really value the service we have in Glasgow, the whole team work well together from a patient perspective. I feel it is Important to have consistency of the current service for patients and their families. To ensure the best possible support for patients and to serve the whole of Scotland there is a need for both surgical locations to cover such a large area. There should be surgery held in both central locations Glasgow and Edinburgh as some patients and their families may have a quite a travelling distance to one of the locations, where having it in one location in Scotland would add at least another hour onto their journey, therefore worsening their situation. Comment 10: I support the idea of centralising surgical services in Glasgow, with clinics being held in a variety of locations (Edinburgh, Dundee, Aberdeen, Inverness etc). One reason for this, I was under Glasgow for treatment, and used to travel hours for clinics and operations. As an adult I've moved to Dundee, have been referred back to Glasgow as that was my team and who I have confidence in and so will need to travel cross country to be seen. I am aware this is my choice, but the Edinburgh service has a clinic in Dundee, but I can't be seen there as am under Glasgow. A single surgical site with satellite clinics over Scotland would hopefully go some way to provide a cohesive service to all over Scotland, and have patients seen in the location closest to home, only needing to travel to Glasgow for surgery. A single surgical site and unified service would also ensure equality in services provided across the country and hopefully increase support available to those affected and their families as more likely to meet others at localised satellite clinics. This is of course just my views on it all, and know others may and will disagree! 13

168 Comment 11: I was given a letter regarding moving surgical services to Glasgow from Edinburgh. I would like the service to stay in Edinburgh as it has been. Our son was born with bilateral cleft lip and palate. He has had 2 surgeries so far and I am more than happy with the team/ premises and the results. I don't even want to think about going to glasgow in the future as Edinburgh team is like a family to us. Hope we get to keep it in Edinburgh!! Comment 12: After reading the proposed changes that have been outlined within review paper, We would wish to express our concerns over the proposal under section 7 of a single surgical service. Our daughter is currently awaiting her surgery under the team at the sick children's hospital in Edinburgh, Both myself and my husband work in Edinburgh and therefore travelling to the sick children's for appointments and indeed when surgery is upon is is far more accessible in Edinburgh than in Glasgow. While we appreciate the need to review services and where required make improvements and changes, in this instance we feel that a single surgical provision would be greatly limiting to the current service. While we understand that the support from the multi disciplinary network would remain local the continuity of care we feel would be lost between surgery and before and after support that is currently provided to families. Cleft lip and palate surgery like any surgical procedure comes with its stresses this we feel would be enhanced by the prospect of having to travel further to Glasgow, having appointments in different hospitals and limiting the personalisation that is currently provided, by having multi disciplinary clinics, surgical advice and procedures all commencing in the one place. As I'm sure that putting all surgical aspects under one area will have a clear impact on appointments, waiting times and before and aftercare provided to patients and families in Edinburgh, Lothian's and Glasgow. 14

169 Comment 13: I hope this finds you well. I am getting in touch with you following your recent s with regards to the Surgical cleft services paper. As a parent of a son with a cleft lip and palette who has had some surgery and still due to receive further surgery/treatments in the coming years I have been very happy with the current set up and service we have received at Edinburgh sick kids. We are lucky geographically where we live that we could easily travel to either site to receive treatment if needed. However my concern with potentially having only one surgical service based in Glasgow with associated treatments continuing in Edinburgh would be that there could be potential for the complete treatment package to become a bit disjointed. At the moment I get a lot of comfort knowing the current surgeon Dr Mehendale is in contact directly and regularly with all the other associated cleft care teams to make sure all treatment is complementing each other and working together to get the best possible results. Also I would be concerned that condensing the surgical service down to one site this might have an impact on waiting times for surgery and make the system less flexible. Thanks for bring our attention to the paper. Look forward to hearing what the decision is following the review. Kind regards Comment 14: If I had to choose between Option 2 and 3 - I would choose 2 speaking as a parent myself I would have no hesitation in putting my child in the hands of the Edinburgh Surgeon and her surgical team. Her outcomes are really very good with hardly any re-repairs required. She is also very passionate and dedicated to improving patient care and I cannot see how having one site will improve this, yes you need cover for Annual leave etc but that can be worked by the 2nd surgeon in Glasgow covering the East coast when required. There should also be an ongoing training programme so we are never left short of cleft surgeons. 15

170 Comment 15: I have had the opportunity to review the Cleft Lip and Palate Surgical Service Position Paper and as a parent of a child with a cleft lip and palate, I am most disappointed that the service is under review for not meeting required recommendations. My view is that Scotland covers a vast area and cleft patients will come from the full length and breadth of the country. From my own experience the reduction of the service to one site would create additional stresses to include: Costs of additional travel Other cost implications as a result of additional travel - this could be the difference of a parent having to take half day holiday from work to attend appointments with their child compared to a full days holiday. Increase of child's time out of school to attend appointments due to increased travel Family members being able to easily visit the patient following surgery Parents being local to spend time with their other dependents/children pre and post surgery/during surgical admissions. The rapport which has been established with the surgeon from birth could be lost. This is an important point for me as I met my son's surgeon within a week of finding out about his cleft at ante-natal stage. The expertise, confidence and compassion of the surgeon and the team gave me focus and knowledge that my son would be in excellent care. Immediate neo-natal care in the event of complications - neo natal staff wrongly suggested my son had Pierre Robin Sequence; with the benefit of the local cleft team, the correct diagnosis and care was established within hours of his birth. My firm opinion is that option 1 is the preferred option, namely to continue to seek to implement the current NHS Board Chief Executives direction for a single surgical service provided on two sites. I trust my comments will be given strong consideration by the Board and I look forward to receiving the outcome of the consultation following completion. Finally, I can confirm that my son comes under the care of NHS Lothian. Kind regards, 16

171 Comment 16: With regards to the potential changes in cleft care in Scotland, I would like to express my opinion as follows: I was diagnosed at my 20 week scan that my child would be born with a cleft lip and possible cleft palate. At the time there was still a surgeon in Aberdeen, however he was due to retire and we were advised that surgery would be performed in Edinburgh with all other clinical appointments remaining in Aberdeen. This news came as a bit of a blow, however we were accepting in the fact that the surgery would take place many miles from home and without the support network of our family. We were the first family from Aberdeen to travel to Edinburgh for surgery and while it is a long distance to travel to either Edinburgh or Glasgow, the care and precision in the way Dr Mehendale works is outstanding. If surgery was to be moved to a single site how can families, particularly those who are travelling hundreds of miles be assured that the same level of care would be given with an increase in patients in a single site? I understand that cleft surgery is specialist and that surgeons need to develop and enhance their skills but this makes it sound as if those born with a cleft would become guinea pigs in order for said surgeons to enhance their skills and may take away from the fine balance of getting to know their cleft patients while retaining the same high standard of professionalism. With regards to the actual travel itself, Edinburgh is much easier to travel to for those living in the east and therefore I would like to see cleft surgery remain over the two sites and for surgery to continue in Edinburgh for patients in living in the East of Scotland. This will also provide a continuity of care for those who have already been to Edinburgh and still have more surgery to come. It would also mean that older patients who had previously had their cleft care in Aberdeen aren t being disrupted again to move to yet another hospital. 17

172 Comment 17: Comment on proposed changes. We feel as a family with 2 children, youngest born with cleft lip & palate that it would be detrimental to our family as a whole if the services were changed to one place of care for Scotland. We are based in Currie, Edinburgh and are currently looked after by the Sick Kids Team. We currently manage to juggle our appointments for speech, hearing, dentist, cleft reviews and other appointments (Child s name)needs to attend on the basis we are roughly 30 minutes commute for all these aspects of care. Ourselves as parents have to take unpaid leave/holidays to accompany our child to these appointments and we also have to make arrangements for other child when we both feel it's important to support (Child s name) at various times. (Child s name) struggles at school and already can miss time at school for attending local appointments which affects his school week. We feel it would be a huge disadvantage to our family as a whole if services were centrally located in Glasgow. In the last 2 weeks (Child s name) has missed 3 mornings of school due to appointments which if moved to Glasgow would have cost him 3 days to catch up on which is not acceptable. We trust our comments will be of interest. Comment 18: Trying to understand the paper I would agree there's no real details on what the 'challenges' are? Think there should be information on why the agreed proposed solutions have not managed to be implemented and that that's what should be focused on sorting out and keeping the service in both Glasgow and Edinburgh. The other main point on the paper seems to be that adult surgery and care will be combined with paediatric service. Which I'm not sure how these where cared for before this proposal but seems to be adding extra work and care onto original service. 18

173 Comment 19: I thought I would try and read the NSS position paper on the future options for Cleft Surgical Services in Scotland but found it incredibly vague on the reasons for the review or factors that are going to weigh on the decision to be made. Since CLAPA are looking for comments I will try and provide some including our preference on the proposed way forward however I am uncertain if this will make any difference to the process at all. The TL;DR (too long didn't read) version is that I agree there is not enough information and both sites should stay until evidence why that won't work is presented. I am interested in trying to get to the bottom of why the position paper is so vague/incomplete and what CLAPA and others thinks should be the response to this. I am worried that this consultation is merely a cover to allow the NSS to make a broad decision and then implement it any way they like which seems to include reducing the number of surgical sites which will adversely affect parents that are further away. Before I get to my preference here are my concerns/comments: 1. It is unacceptable that a position paper setting out the reasons for review should go into no detail at all as to why the current setup of two surgical sites agreed at a previous review is no longer fit for purpose. A short statement that there have been "significant challenges" in establishing a single surgical service is insufficient when no further evidence is offered up to describe even in a top level what progress that expected to see that wasn't met. There are hints that a project that was stalled has picked up at the end of 2014/start of 2015 but then again it fails to outline what major challenges remain unresolved. 2. Not only do the NSS refuse to outline the nature of the challenges they do even seek to rule out some potentially issues the service may be facing. If CLAPA is represented at the meeting on the 28th I would want to them to seek answers on the following areas: - Are there staffing reasons why the NSS want to consolidate on two sites? Options 2 and 3 seem to suggest the three cleft surgeons would still exist under either NHS Lothian or Glasgow but does one site reduce the need for other support staff such as managers, nurses, administrators? - Are there are any budgetary pressures that would mean one site is required over two in terms of efficiency/saving. Recently as you probably know Glasgow lost a number of its hospitals to be consolidated into a super hospital with the promise that a single site would be better - is this a similar situation? - Are there personality or management problems between the two surgical sites? Are Edinburgh and Glasgow advocating different approaches that are irreconcilable? What are we supposed to make of the statement "considerable amounts of senior management time being deployed to attempt to resolve issues" except that management are hoping that by having just one site their own management problems will be simplified regardless of the impact on parents. 3. On a positive note I am pleased with the recommendation that services should be extended into adulthood especially for those who have been supported as children and then could feel vulnerable and abandoned when they get to 16/ The evaluation of the options using various frameworks is useless without seeing what evidence they were presented with and the reasons for rating each number on numeric 19

174 scales from 1 to 5. If independent experts can be given enough information to evaluate options what is the reason that other stakeholders including CLAPA cannot be given anything even in a summary/non-technical form. Without context the graphs of scores of options just tells us that a process has been followed. On the detail why is Option 2 a single surgical service with one management service with undetermined location score higher than the two Options 3 and 4 which are surely the only likely locations for such a site unless there is a mythical Brigadoon site which outperforms both Glasgow and Edinburgh? Again why is no detail from the independent experts offered is their report in the public domain, can it be obtained by Freedom of Information requests, what is the reason for only including their conclusions and not their reasoning? 5. What is the point of the consultation? If stakeholders are to comment on the proposals then as CLAPA have stated the only conclusion that can be reached is that the information is insufficient to make a judgement. I would go further and suggest that the actual reasons for this review are being withheld from those being asked to consider the options which is no good for the level of trust which has so far been excellent between the NHS and stakeholders such as parents. Do the steering groups have to pay attention to what any stakeholders say and if not why are parents and adults with clefts being drawn into this? Do they consider requests for more information? The position paper only states they will consider the best way of carrying out AN objective and that stakeholders will be advised of the outcome at the end. 6. What is CLAPA's position on this? I agree with the broad conclusion that there is insufficient evidence/detail for anyone to make a judgement but if you share the concerns of the rest of the cleft community that consultation on an incomplete consultation is just frustrating for all involved and shutting a surgical site will potentially adversely affect the same community what more can be said or done? I'm sure CLAPA is applying more pressure behind the scenes but I have no knowledge of how successful you have been in these sorts of situations before in changing outcomes of NHS decision making. So in the absence of any evidence or analysis of current problems my preferences would be ranked in order FIRST PREFERENCE: 1. Continue to seek to implement the current single surgical service provided on two sites. I have no personal evidence in any clinics I have been to or any of the two surgeries (Child s name) has had that the current setup is not working, nor has the position paper set out any specific reasons why it will fail. Indeed if progress has been made in 2014/15 with increased management support who is to say it cannot continue to work. I don't see why any parent or adult with cleft issues would vote for a reduction in surgical sites when it reduces the care for someone somewhere in Scotland. SECOND BEST PREFERENCE: 3. Single surgical service in Glasgow. We have been very fortunate to live in Knightswood,Glasgow which is only 20 minutes away from Yorkhill, the Southern General (or whatever its current name is) and the Glasgow Dental Hospital so until now (and (Child s name) is about to be 7) we have never had an issue with travelling far for appointments and surgeries. Therefore Glasgow is best for us. WORST PREFERENCE: 2 Single surgical service in Edinburgh. When (Child s name) has a bone graft aged 9 he will require a period in a children's hospital. Knowing that Glasgow or Edinburgh provide facilities to allow one parent to stay with him is okay but he has never had a surgery where he has been aware of what is going on and if the surgery is in Edinburgh then the other parent will not be able to be present as often as we have another child in 20

175 school in Glasgow and we would have to make decisions as to who cared for her. Such a family separation would be difficult at an already difficult time. I have gone on too long so let me say that I have enormous respect for all the NHS doctors and nurses I have met so far in relation to Cleft services and I'm sure they will do a professional job whatever option is decided on. I would like to know the truth behind this but I may have to be content with not knowing and doing the best with whatever happens. Best Regards Comment 20: I am sending this letter in relation to the the review regarding the cleft surgical services in scotland as wanting to obtain more information regarding this issue as it related to my childs treatment. I received the review document from CLAPA and I am concerned that families that obtain treatment from the cleft team are not receiving this information direct from nhs Lothian. I am concerned about this review as it affects my childs treatment, and would like information regarding this as my child is due to have a bone graft and we have received amazing treatment from the Edinburgh surgical cleft team and as a family have built a great family bond with the team over the last 10 years we as a family would like to know what is happening in the treatment of our child and feel NHS lothian should be informing the families involved in the cleft treatment. I have read the full review document and have concerns regarding this document, i do not think the patients well being has been looked in to regarding this review and the distress this will cause the children and families with the not knowing what is happening my child is due a bone graft and this is only going to delay the surgery that she needs. I feel that changing the service to one site would not be good for my childs treatment or wellbeing and how would this effect my childs treatment? how will this change the wait lists? extended time for treatment and appointments? waitlist for patent appointments? how to patients get to appointments that live in the lothians to glasgow and vice versa? distress to the child meeting a new team? how will these changes effect the patients nothing in the review regarding the patents and what is needed for them and there wellbeing and there families. I would like to be informed on all aspects of this Cleft review as this effect my family, and the way this has been handled internally within the NHS not informing families concerned is very unfair. I look forward to response regarding this review, and would like to get the correct contacts within the NHS regarding the reveiw so that this issue can be taken further. 21

176 Comment 21: As the parent of a cleft child in Ellon, Aberdeenshire, we would be very concerned if there was any change to the local provision of clinic and other specialist support through Aberdeen Children's Hospital. We would be hoping for a cast-iron guarantee with whatever is decided - Edinburgh, Glasgow or both for surgery - that local clinics and support services will be maintained. Also, it is worrying that with only a short time left in the consultation, it is still not clear why the current sent-up is not working. Comment 22: I hope all well with you. Just a few comments on the paper below. I hope you have had a lot of parents feedback. 1. Overall I still don't think that there has been enough evidence and detail in the paper to make an informed decision. 2. Page 5, what have the significant challenges been and how do they know that these challenges will not be faced on the 3 potential outcomes 3. If it goes to 1 single site, then would there be staff redundancies and what would the staff set up be in that site 4. If a child/adult had issues after operation would they have to travel to the site that they had surgery in( if it went to 1 site) or could they be seen by local team 5. If they went to one site, is there a guarantee that 1 parent could stay ( what if child was in high dependency? For parents who were on low income would there be assistance for accommodation to stay if they had to travel 6. If it went to one site and parents having to travel further( either way) would this delay being discharged from hospital due to longer journey times 7. Not to do with the paper, but I note that the parents meeting is only in Edinburgh. I know that they have offered a telephone dial in but considering that the 2 options being considered are Glasgow and Edinburgh then I feel that it should be offered in both locales. Overall I actually feel very disappointed with the paper. I am able to understand the paper, but I am sure that there may be some parents who did not and I know that CLAPA put together a good sheet with a breakdown of what it meant, but I think this should have came from the NHS. It lacks an evidence base and does not feel patient centred at all. It concerns me about the challenges that they are having and based on the outcome could we potentially lose some highly qualified and passionate staff. Hope this makes sense. Thanks 22

177 Comment 23: Our son is 6 years old and currently under the care of Dr Mehendale and her team at sick kids Edinburgh. My husband and I have thought about the possible change in moving to Glasgow and are concerned greatly about this. When we found out at our 20 wks scan that our baby would be born with a cleft lip and palate we were terrified, not knowing anything about this and what it would mean for our child along with untrained staff at st John's who had us thinking about our baby also having different syndromes etc. Two weeks after finding out and st John's not putting us in direct contact with a cleft team we met Orla from Edinburgh who was so calming and helped greatly with what to expect with feeding, operations etc. Because we put our trust in Dr Mehendale and her team it helped us prepare for ours son's ops and the care was fantastic. (Child s name) is very comfortable with all his follow up appointments and is made at ease as we know all the team. We are concerned if the cleft team is changed to Glasgow it would undue all this and put stress on him getting to know a new team/surgeon. Why change/fix something that isn't broken? The team at Edinburgh are amazing, not saying they are not at Glasgow but we don't know any of them or how they work their routine check ups not to mention the extra expense to travel there? Our son still has at least one major surgery to go through and all the dental work and do not see any benefit of moving him to Glasgow, we as a family surely need to feel comfortable with the hospital, surgeon and team performing these ops?. I hope our comments are helpful when making this decision. Comment 24: As parents of a young cleft boy (nearly 6 months old now) I have become aware through the CLAPA (Edinburgh) Facebook page of the current consideration of moves to change the way in which parents like ourselves will see their child receive this invaluable surgical service. We have read the position paper that the management board has put to the NSS and have some concerns. We are also aware we are not alone to having these concerns. We will explain our concerns further however its probably best we explain a bit about ourselves. Firstly we would like you to fully recognise how wonderful the surgery went for our child and from the first moment of finding out at the 20 week scan until our recent post operation clinic the service provided by the NHS has been fantastic. A true statement of what this country has done so very well for its citizens since its inception. We live in Ceres, Fife and as such received antenatal and other services related to our child's birth and subsequent cleft care from NHS Fife, Tayside and Lothian. The communication between these various bodies has been seamless and at every stage ensured we were very well supported, assured and put at ease with the condition our boy, (Child s name), has. Felicity Mehendale as the lead clinician and surgeon who would carry out the initial operation on (Child s name) is truly a wonderful human being and unbelievable surgeon. Genius would be a good word to describe her however this may belie her gentle and loving manner for her patient and us the parents. The team she has around her also speak of what a great person she is. The support pre and post op has been first class and we are humbled and honoured to have received such care. The service as we experienced it and the outcome for (Child s name) has been without flaw. We have also been involved with a recent BBC television production called Countdown to life: The extraordinary making of you which focused on various ante and neo natal 23

178 conditions through the 9 months development of the baby in the womb (and sometimes outwith). They chose (Child s name) to tell the story of the development in utero of the face and the problem when the developmental parts of the face don t join and the baby is left with a cleft. The BBC also chose Felicity to explain the condition and the surgery as her renown in the field of cleft surgery are unmatched nationally and internationally. The experience of working with the BBC in this production has been great and feedback from friends, family, other cleft baby parents, Facebook, Twitter and strangers across the country (the programme also featured on Channels 4 s Gogglebox ) has been so touching and has clearly done wonders to raise awareness of how common the conditions is and how with surgery the cleft is repaired. Moreover it also speaks of the appreciation of the skill of the surgeon, Felicity Mehendale. And so to the issues we feel need brought to the table and hopefully discussed at the meeting on Thursday. Our concerns are chiefly related to the statements made in the position paper and further to this make clear our support for the current situation for a single service over two sites which is the service under which we received the care for (Child s name) and hopefully will do until his final surgery anywhere between years time. The lack of clarity of the detail of the major challenges which remain unresolved is a prime concern. Further detail of these challenges, what their effect on patient outcome are, clearly needs tabled. Full details of how the single service (across 2 sites) is not working needs tabled. Having a single service managed from one location (trust i.e. HNS GG) makes sense but to then appoint someone as clinical lead from the same trust reeks of nepotism/cronyism and clearly has a negative/biased influence on the position paper and the implied favourance of the move to a single service, single site based in Glasgow. Full details of the way in which the same protocols are not being adhered too need tabled. Indeed for us the public these protocols may not need tabled as they will be more than likely beyond our understanding however description of what is not working should be. Full details of the CleftSIS audit programme and its measurable effect on patient outcome should also be tabled. As to the cooperation with same, this need further explained too. Audit programmes should effect improved patient outcome and not just be a management took to beat the incumbent auditee with or please the management system for its on sake. The position of the need for clinical psychological support for this surgery also needs queried and clarified. The reasons why this is necessary needs tabled as we (Child s name and ourselves) never felt at any time the need for psychological support as Felicity and her team provided (especially at RHSC) everything we need, emotional, intellectually and physically ( the cup of tea provided by the night warden at 1am from his own supplies is a fond memory.) Finally we look forward to the rerun of the appraisal of the options and as a stakeholder look forward to being included in the process. Its worth stating the old adage if aint broke don t try and fix it.' I trust you can bring this message to the attention of the meeting and our views and concerns tabled to ensure that the process is both open and inclusive. 24

179 Comment 25: Cleft surgical review NHS Grampian Under the cleft surgical review it is proposed that surgeons attend one outreach joint clinic per month. This was shared at a cleft care Scotland meeting but it wasn t made clear that this provision would be for the whole of Scotland. As there are currently 6 outreach clinics across Scotland, this would mean that Aberdeen would have a surgeon present at only two clinics per year. I don t think there has been sufficient consideration of the impact of this for our patients and families. I would like to clarify the current provision in NHSg On average the cleft surgeon attends: Joint Cleft Palate Clinic 10 monthly joint clinics per year held on Friday, from 8.30 to 5pm. Team meeting 8.30, clinic starts The joint clinic involves surgeon, orthodontics, audiology, specialist nurse, SLT, photographer and outpatient nurses. ENT are available on bleep if required and attend pm for joint discussion of patients with ENT involvement. It has been identified that psychology input is required and funding has been secured for this. This funding has gone to Glasgow rather than being used to provide services locally. We don t run joint clinics which do not require the surgeon s presence. I have detailed patient consultations from the October clinic in Aberdeen as an example. Aberdeen clinic October x post surgery follow up 2 x baby / family first clinic visits Baby with prs, cleft palate, trachea, for consideration of readiness for palate repair and discussion about surgery Multidisciplinary consultation with teenager to consider options for; lip and nose revision, surgery for VPD, and orthognathic surgery. 2 x Teenage girls with VPD for discussion about surgical options 15 year old transfer from another cleft centre 3 x routine review and audit 2 x unable to attend VP Function clinics On average the surgeon attends 8 one-stop velopharyngeal (VP) function clinics held on the Thursday afternoon before JCPC on Friday. This clinic is run by SLT and surgeon, and involves speech assessment, lateral videofluoroscopy in radiology, and if required nasendoscopy. The surgeon being present enables full assessment and discussion of management and surgical options with the patients at one appointment. Patients from Tayside and Highland can also be seen at this clinic. Previously all NHSg patients requiring assessment of velopharyngeal function had to go to Edinburgh for this assessment. Funding was acquired and nasendoscopy equipment purchased for RACH, enabling patients to be seen locally. SLT led VP function clinics are run separately and assessments reviewed with 25

180 the surgeon at the one-stop clinic. Below are details of patients seen by surgeon and SLT at the October one stop VP function clinic. VP function clinic in October 2015 One child with cleft palate having nasendoscopy to inform, discuss and decide on surgery for palate re repair with buccinators flaps. One patient with VPD following oncology treatment speech assessment, lateral VF and nasendoscopy One patient with non cleft VPD requiring partial adenoidectomy speech assessment and lateral VF Joint review of three assessments from SLT led VP function clinic Partial Adenoidectomies ENT consultants see patients with repaired cleft palates or non cleft palatal dysfunction, who require adenoidectomy due to hearing/airway issues. As a full adenoidectomy could compromise velopharyngeal closure, an effective multidisciplinary assessment and discussion between SLT (who does speech assessment and lateral VF), cleft surgeon and ENT consultant, is carried out. The patients are then offered partial adenoidectomy to improve airway/ hearing issues whilst not compromising velar function. This is currently arranged towards the end of the JCPC clinic and where appropriate the patient is in attendance again providing a truly multidisciplinary service. New Born Babies One of cleft care Scotland standards is that new born babies with cleft are seen, within 8 weeks of birth, by the surgeon and cleft team who will be looking after their care. Unless we have a visiting surgeon around the time of birth how can this standard be achieved? If the families have to travel to Glasgow to see a surgeon they would not be receiving the current multidisciplinary standards being provided currently in Aberdeen. Summary I cannot envisage how NHSg patient needs can be met with the cleft surgeon attending on ly 2 joint clinics per year in Aberdeen. Would patients be asked to attend clinics in Glasgow? The service provided on the east coast works well for our patients and their families, with excellent surgical outcomes and regular joint multidisciplinary consultations and associated services. If these are compromised by the proposed surgical review this would not beneficial to NHSg or the national cleft service. Surgery is one part of cleft care and these proposals will have a massive impact on the current provision of cleft services in NHSg. 26

181 Comment 26: Scottish Surgical Service - Response As a patient, my main concern regarding the surgical changes are that quality care is delivered within a high standard team. Although I am an adult, I am speaking in retrospect as well as thinking about if I would want if I was the parent of a child with a cleft. Firstly, the main issue regarding the surgical paper which I would like to be addressed before an informed decision can be made is the unidentified 'major issues'. Until these are addressed, uncertainty and inaccurate presumptions could mislead lay people in the decision making process. Despite these issues, I have proposed my views on the future of the service. My main comments are: Unequal distribution of services Edinburgh is not as well-resourced as Glasgow surgically which has been addressed in the paper. Although Edinburgh have a sufficient plastics service, the more mature service in Glasgow because they have both plastics and maxfax and is more beneficial to surgical care. By centralising in Glasgow, it would add to the strength of the existing service but by going to Edinburgh it would mean establishing a new service because they do not currently have a maxillofacial cleft specialist. Clinical lead is in Glasgow The surgical lead for the service is based in Glasgow. Although under the current pathway, the provision of surgery should be the same, it isn't. Therefore, to deliver a gold standard for care, a centre for excellence should deliver this care under the guidance from the clinical surgical lead. Following this in Glasgow would be most beneficial because a service under the clinical lead is familiar and it will facilitate a better transition of services to where the clinical lead is. Adult Transition Although the adult pathway is not a key focus of the paper as much as paediatric surgical services, Glasgow has a more mature and established adult surgical pathway. This is only set to increase as more adults returning to treatment so further improving Glasgow can only be a benefit to allow the best care to follow into adulthood. More so, having the surgical service based in Glasgow would allow children to transition into adult services more smoothly whereas as Edinburgh doesn't have such a good adult service this wouldn't result in as good an outcome. Sick Children s Hospitals Edinburgh sick children's hospital is due to re-locate sight in This transition would 27

182 interrupt services regardless of what efforts are made to minimise this. Also, the outcome of the service at a new sight is unpredictable and this would be a gamble when considering a single surgical service sight. This is in comparison with Glasgow who have a new sick children s hospital that has a more reliable future. Transport to both Glasgow and Edinburgh hospitals are reasonable. Centralising services to Glasgow would allow for an uninterrupted provision but this cannot be guaranteed for Edinburgh. Other Factors The decision of which site surgery should be based doesn't just depend on the provision of care from the service provider but must consider socio-economic factors of the service users. Factors that should be considered include where is more socially deprived and who travel would be more of an issue for in terms of feasibility. Conclusion Taking all this into account, I feel that the best place for a surgical sight would be Glasgow. It is unavoidable that one current sight will be disappointed in a relocation but this cannot distract from the decision to be made. In this case, support can be focused on those who need to travel, possibly by the collaboration of Health services and the cleft lip and Palate assassination. In conclusion, Glasgow is a site which has a mature service for both paediatric and adult services and which the surgical lead is based. Glasgow has a new children's hospital which will allow for a centre of excellence to be developed and thrive in whereas Edinburgh sick kid s relocation doesn't provide guaranteed stability in transitions. Glasgow proves to be a good choice but socioeconomic factors must also be considered when making a decision. 28

183 Comment 27 : Having read the proposals from the Cleft Services Surgical review and associated documentation, I would like to express my concerns at some of the potential changes. My son was born with PRS and a cleft palate in 2003 and, living in the North East of Scotland, we have been looked after by the excellent teams based at Aberdeen and Edinburgh. It is my opinion that having my son's care planned, reviewed and co-ordinated by the multi-disciplinary team at the RACH Cleft Clinics, always with the surgeon in attendance, has delivered the first-rate results we have experienced. It would seem to be a backward step to reduce the opportunity for patients, their carers and the WHOLE support team to communicate so conveniently, frequently and effectively sometimes at short notice. Of the three options being considered, I would consider the status quo (where surgery continues at both Edinburgh and Glasgow hospitals) to be the most obvious choice. Indeed, paragraph 7.1 of the proposal document states Throughout this extended period of planning a new service model the existing provision of 2 separate paediatric services (one for East o f Scotland, the other for West of Scotland) have continued to deliver a safe and effective service.. Why put this at risk? As a lay-man, the proposal document seems to have a noticeable bias towards the centralisation of surgical services in Glasgow and I am left with the feeling that, perhaps, this decision has already been made. It was also disappointing to note that there seems to be little mention of individual surgical outcomes being taken into account when developing the assessment criteria I feel this might strengthen the case for any centralisation to take place in Edinburgh. I will be unable to attend the consultation meeting on the 27 th and would appreciate if you could consider my comments - thank you. Comment 28 : I am writing to you as the Programme Director for National Services Division. I appreciate you will be inundated with s, letters and correspondence each and every day but I would be grateful if you could take the time to read my letter regarding the proposed changes to the cleft surgical service in the east of Scotland which is currently based in Edinburgh. I personally believe that the process currently underway in respect of the review of the cleft service is very underhand with a degree of stealth to rush through these changes without proper dialogue and taking into account the views of parents living in the east of Scotland. My first son was born in May 2012 with a rare genetic condition called Treacher Collins Syndrome. This affects one in 50,000 people and we were unaware of (Child s name) having this condition until he was born. He requires a significant amount of medical intervention on a daily basis. Due to his condition he has a tracheostomy in situ to support his breathing and 29

184 his done since he was two weeks old. He also has a nasal-gastric feeding tube and wears a bone conduction hearing aid. The complexity of his medical condition means he requires a significant amount of medical care and attends frequent appointments at hospital and numerous community based appointments every month. As a consequence of his medical needs we cannot leave our son in the care of any untrained person which is currently just my wife and her parents. In spite of this is he is a happy and inquisitive 3 year old who is developing and reaching his milestones in line with his peers. He is stable in terms of his health and requires little unexpected medical intervention. We have as a family had magnificent support from NHS, community nursing and other agencies throughout these last 3.5 years and I am proud to say that my son (Child s name) is attending mainstream nursery (with the support of a community nurse) and is thriving in this environment. This is something we as a family could never envisage as parents to a newly born child with huge additional needs but he is a doing amazingly at the moment and we are so proud of him. Part of (Child s name) s condition is that he was born with a cleft palette and because of this I am part of the Edinburgh Branch of CLAPA (Cleft Lip And Palatte Association). A cleft lip and/or palette occurs in 1 in 700 children so is something that does happen on a regular basis each year. (Child s name) s cleft was repaired by Ms Felicity Mehendale when he was a year old at The Royal Hospital for Sick Children in Edinburgh. The service provided from the Royal Hospital for Sick Kids (RHSC) has been exemplary. Having a cleft means that there is ongoing support needed (depending on the type) which can include further surgeries, speech and language therapy, bone grafts etc. these supports can be required from birth, through childhood and into adulthood. The consultation paper which was recently issued to some members of child with children born with a cleft lip and/or palette suggests that the service is not working and there are 3 proposals to change the service and there is a strong underlying current in the paper of a bias towards the Glasgow site as the choice for any future change. This is in stark contradiction to the minutes of a meeting on 22 nd June 2015 which was with Jonathan Best (chair of Cleft Surgical Board) and Majorie Johns (Planning Manager, Greater Glasgow & Clyde) with concerned parents saying that there would be no reduction in quality of care and that surgery would continue to be carried out in the two sites and there could be more of a presence at the new kid s hospital for cleft operations. As you will know the RHSC will be moving to a state of the art hospital at the Edinburgh Royal Infirmary (ERI) and why there would be an implied desire to move the service to Glasgow is beyond me. As I have said earlier there can be considerable amount of operations for children born with a cleft lip and/or palette. It is a traumatic time for parents and I know that having a service located in nearer where you live makes this process easier and we are very unhappy at any threat to what is a fantastic and dedicated level of service already in Edinburgh at the RHSC. Felicity Mehendale is the cleft surgeon and is a unique talent and I and all the concerned parents I have spoken to want her as the surgeon to operate on their child. Mrs Mehendale is one of the top female surgeons in the world and is the only person to have been awarded the Craniofacial Society of Great Britain and Ireland Arnold Huddart Medal twice. When you have a child in hospital it can be a very worrying time for any parent. The added stress of travelling to the other side of Glasgow, securing overnight accommodation, having to take additional time off work, trying if possible to arrange cover for any of your other children amongst other considerations is a lot to merely expect the rest of Scotland to adhere to if these changes are implemented. I appreciate this may be what other people currently have to do if they are out with the 2 main cities of Glasgow or Edinburgh however these are the biggest population centres and as such this will be the same rationale be where the majority 30

185 of children with clefts are based (i.e.: both Edinburgh and Glasgow). The old adage of don t fix it if it s not broken is particularly appropriate for this current set of circumstances in my opinion. Mr Steele I would appreciate any guidance, assistance and support you can offer with regard to these circumstances that I have outlined above and to ensure all children in the east of Scotland are afforded the best possible service to ensure they all reach their full potential in a new and vibrant Scotland. I am happy to be contacted by telephone, or by post on this matter and will attend the meeting in Edinburgh next Tuesday 27 th October. I have copied in Gillian McCarthy from CLAPA to this and know there have been a number of concerned parents who have contacted their local MP/MSP about this threat and I personally have written to both the First Minister and Minister of Health in Scotland about this potential threat to what is a magnificent service in Edinburgh. Comment 29: Threat to Cleft Services Edinburgh I am writing to you to with concerns I have after reading the document Cleft Lip and Palate Surgical Service Position Paper. As a parent of a child who was born with both a cleft lip and palate, I feel we should have been consulted and been given a voice before major changes were proposed about the provision in Edinburgh. Surely, the patients and in my experience, the parent of a patient, are the people who would have valuable opinions and insights into the service. After all, the care and welfare of every individual cleft patient should be the top of any agenda regarding change. The document seems very heavily favoured towards changing surgery to take place Glasgow, and is interesting to see several posts within the management of the service are professionals from the Glasgow team. Although, the voting process is shown I query the fairness of how even the playing field was in the first place and ultimately how much of a voice the Edinburgh team have towards the proposed changes. My son is currently 4 and we have had many dealings with the team in Edinburgh and also in Kirkcaldy. Our experience with the cleft team started the day after our 20 week scan with our son when a cleft was diagnosed. I would be concerned this vital piece of the jigsaw would not be as quick if the main service was to relocate to Glasgow. Before my son was born I was assured a Cleft Nurse would be to see us as soon as possible providing essential feeding and emotional support. Short staffing in Edinburgh meant we had to wait over 48 hours after he was born in Forth Park hospital, for a member of the Glasgow team to see us. We were told this was an unusually long wait in the vital first few hours of our son s life. I would be concerned that support in Fife and in the East would not be as quick and efficient if the surgical provision moved to Glasgow. It is clear to see the respect each individual in the Edinburgh team has for each other and the work that they do. For example, it was very reassuring after speaking to the Speech and Language Therapist recently that she could talk through the orthodontist s procedures and 31

186 also that of the surgeon, discussing any concerns I had for the future. This feeling of reassurance and trust is not to be underestimated. So far, our son has experienced two surgeries in Edinburgh at the Sick Kids Hospital. Both were a very emotional time but different members of the team were there every step of the way with reassurance and confidence in our surgeon. Although I am unsure of the position of our surgeon in the proposed changes I would be interested to know how much input they and the other professionals in the Edinburgh team had on this paper. I would be extremely disappointed and angry if Edinburgh lost such a well-regarded surgeon due to any reorganisation. Not only for the future care for our son but also for any other child who would be lucky enough to have her as a surgeon. The dedication she shows to the service and each child as an individual is clear to see. I am concerned our positive journey with the service will not continue in the way it has so far. I also want to express my disappointment in the fact there is a meeting on the 27 th October providing a chance to raise questions and concerns, which is a week after the deadline to share which surgical option we would prefer and concerns we have. Surely this meeting should have taken place before the change in the service was considered and a document produced. I am at a loss why this exceptional service in Edinburgh may be reorganised and not be valuable enough to continue as it is. In conclusion, I would propose the surgery for Cleft Lip and Palate provision continue over 2 sites. Yours sincerely, Comment 30: I am the parent of a cleft patient and I wanted to send you some thoughts on the position paper regarding cleft services in Scotland. I feel it would be detrimental to the cleft service to be situated in one site and I think it should remain based in Glasgow and Edinburgh. I wonder whether the capacity would be an issue being based at just one hospital, I know when my son was going in for surgery there were issues around beds not being available and if every patient is going to one hospital surely this would be more of a problem. Also Glasgow is a long way to travel for some patients and while services are obviously going to be based in the central belt I think it is better to be able to offer people a hospital closer to them. We lived in Perth when my son had his surgery and while Edinburgh was not perfect for us it did work better as we have family here. I did think the position paper did not make a very good job of explaining why a single service across two sites is not working, I think perhaps people need to understand this to see why these decisions are being made as personally I think the service works very well at the moment (although my son's surgery was 6 years ago) but we were very happy with his care. I am hoping to attend the public meeting next week too. 32

187 Comments received from Mr Mark Devlin, Clinical Lead for Single Surgical Service Option Appraisal for Commissioned Cleft Surgical Service in Scotland As the appointed Clinical Lead for this service I would have liked to have been more directly involved in this process. A decision has been taken that the Lead Clinician for the service will not be a member of the option s panel and I am therefore restricted to forwarding my feedback to the Position Paper as a stakeholder in the same way as any clinician in Scotland, regardless of the level of their involvement in cleft care. This decision means that there is no direct input from the surgical team to the panel process and has been taken with reference to the personalities involved rather than the responsibility of the Lead Clinician position. I would be delighted to discuss this exclusion with the panel members should they so desire it. For over a year we have had a single commissioned national cleft surgical service for Scotland. Since November of 2014 I have been the Clinical Lead for this service. I was challenged to deliver job plans for the 3 surgeons and develop a vision for a single, safe and sustainable service that uses our finite resources responsibly. I have taken this responsibility seriously and have been supported in my efforts by managerial colleagues in Greater Glasgow and Clyde and at the National Services Scotland offices. We have been unable to progress the twin-site-single-service option. The options now before the panel still include the proposed model of a single service twin site approach. I, along with the colleagues who have supported me, do not now believe that this is deliverable. There has been a political, and personality, perspective to the decisions that have been taken up until this point but I am hopeful that we will now proceed on the basis of what is best for our patients. With this in mind, I would like to present my view in response to the Position Paper. I consider that a single surgical site option is optimal for the following reasons: Safety Robust, sustainable, cleft-specific on call can be provided by the surgical team. Surgical team-work between the cleft surgeons becomes a possibility for complex cleft cases. Governance meeting and Morbidity & Mortality activity can be carried out as a team. Co-located and related specialties can contribute to the care of the most vulnerable children within our patient group Surgeon-specific interests and strengths can be developed to benefit all children. Sustainability Periods of absence can be covered. The coordination of the service will be more straightforward both clinically and administratively. Job planning, peer support and succession planning are all improved with a single site model. 33

188 Input to clinics across Scotland can be supported (with 2 cleft surgeons timetabled to these clinics, when they happen, thus improving the sustainability for other Health Boards) whilst maintaining clinical presence at the surgical site. This also contributes to safety. Fiscal Responsibility/Management Less duplication of effort than present currently. Rationalisation of the service administrative support. Clear line-management. Ease of producing annual and mid-year reporting. Greater ability for the service to prioritise funds to those patients or groups of patients that may need it most. Audit/Research Single site for the generation of surgical outcome data. Surgical team are able to work together on projects including all appropriate patients. Improved interface between the Managed Clinical Network and the surgical service. Surgical Team Work This represents one of the most important professional aspects of moving to a single surgical site. Peer support is something that professionals rely upon and the opportunity for the surgeons to provide this to each other will be markedly improved by having a single base. There are likely to be arguments against such reconfiguration. Anyone involved in UK cleft care in the last 20 years will realise that they are well-rehearsed and mainly reflect the fears of clinicians who believe they may be marginalised by such a change. I actually believe that the opposite is true. I believe that a safer, more sustainable and more cost-effective surgical service will lend more support to colleagues who work across the country providing specialty-specific cleft care close to the patients homes. I also believe that a thriving and succeeding commissioned cleft surgical service may challenge these clinicians to adapt and develop but that will only be good for the patients in the longer term. Some of the arguments against change are set out below (bold type), with my perspective (bullet points): Travelling to Central Locations (The implication being that patients will have more travelling to do) Wherever the surgical site is based there will be some travel implication for patients and parents. Following the reconfiguration of cleft services in England and Wales this issue has been surveyed repeatedly. The evidence would suggest that parents (and patients) are happy to travel as long as they get appropriate treatment in the best facility available. 34

189 It is our responsibility to make sure that every journey is worthwhile and provides added value. There is good evidence that patients seen exclusively in peripheral clinics are seen more often (i.e. travel more often). Audit return is patchy from a lot of these areas. The surgical episodes represent a small amount of treatment time. The bulk of cleft care is delivered close to the patients homes within their own Health Board. We should seek to optimise this care. Why change something that works? ( If it ain t broke why fix it? ) This can seem like a compelling argument if you believe that perfection exists. We don t have perfection in Scottish cleft care and therefore change/development is required. The treatment that is offered to a patient by a team of clinicians should be comprehensive. If there is clinical isolation then the patients are offered only what specific clinicians (rather than a team of colleagues working together) can provide. This may not reflect the most comprehensive care option. Surgeons working as part of a team are more likely to offer a comprehensive package of surgical care. This may remain an unknown to clinicians and parent who have known only one system. Surgeon contractual changes This is an ongoing source of anxiety for all the surgeons. I believe that this will persist until a decision is taken. There will be an inevitable change to one, two or all of the current surgical contracts. Colleagues in England and Wales went through this process many years ago. Continuity of Care (I only want Dr X to treat my child) This issue has been raised. Concerned parents have expressed a desire to have named surgeons treat their children. This is understandable of course and would be an almost ubiquitous sentiment amongst any parent group. A service that has surgeons working together offers many more safeguards to the patients than perhaps parents sometimes realise. I would not expect any change to a single site surgical service to affect this continuity in any way. The service has to be designed without named surgeons in mind for it to be sustainable. As to which site should be chosen? In my view the site that best delivers what this service requires is Glasgow. A new Children s Hospital has just been opened. The Queen Elizabeth University Hospital campus is the base for Paediatric Cardiac Surgery Services, the National Airways Service and the Craniofacial Service. There is a mature Adult Cleft service in Glasgow with designated operating on the same surgical site as the paediatric service. This is delivered by the cleft surgeons working as a team. Glasgow already deals with the most complex cleft 35

190 cases as things stand. If the Glasgow site were not to be chosen as the single site it would remain likely that certain cases would nevertheless have to be treated in Glasgow. The Craniofacial Service has a significant overlap with the cleft service and indeed both services are enhanced by this link. Many of the clinicians involved in the cleft team are also involved in the craniofacial team and we would hope to strengthen these links. In terms of which site may best reflect the population in relation to travelling involved for patients and parents then, again, Glasgow would emerge as the best option. Feedback from parents and patients has been sought via CLAPA. I am delighted to say that on September 10 th 2015 the West of Scotland CLAPA group was reformed. It will be interesting for the panel to get feedback from across the country and it may be interesting to consider how clinicians may have sought to influence these views. Where this has happened, and it has happened, I judge this behaviour to have been irresponsible and unprofessional. I look forward to leading this service beyond the panel decision and with the support of my colleagues. I don t imagine that the next steps for our service will be without challenge, but I do believe that the decision to be made by the panel is straightforward. Mark Devlin Consultant Cleft Surgeon Lead Clinician, National Cleft Surgical Service for Scotland 36

191 Dr. DEBBIE SELL OBE, PhD. Reg MRCSLT. FRCSLT. Independent Consultant Speech and Language Therapist Principal Speech and Language Therapist, North Thames Cleft Lip & Palate Service Senior Research Fellow, ORCHID, Great Ormond Street Hospital NHS Trust 76 Hungerford Road London N7 9LP Tel: Work: Fax: Mobile To Whom it May Concern I am a speech and Language therapist who has worked in cleft lip and palate since the mid- 1980s. Previously the Head of Speech and Language Therapy Department at Great Ormond Street Hospital NHS Foundation Trust, and the Lead SLT for the North Thames Regional Service, I led the speech element of the UK CSAG investigation, was involved in the national reorganisation of services and the recent re-evaluation of outcomes in the UK since centralisation, led by Professor Ness at the University of Bristol,. I am most concerned to hear of the potential threat to cleft services in Lothian. The surgeon there is a very dedicated, highly experienced clinician and researcher who commands much international respect. Indeed she worked endlessly to secure the hosting of the World Congress in Edinburgh in This in itself is a major achievement, and is indicative of this respect. Of even greater significance are the outcomes of surgery, and these are vital to take into account when designating services. Speech is one of the primary outcome measures of cleft surgery. Although we know that there are many factors which affect outcomes the most significant factor is primary successful surgery. Poor surgery and subsequent outcomes result in very much more expensive services, apart from the huge personal costs to parents, families and the patients themselves, leading to more appointments, more surgeries, with a significant impact on education and psychosocial well-being in many instances. The Edinburgh team has presented the surgeon s primary speech results, which importantly have been independently assessed by speech and language therapists external to that centre. They are the most impressive set of results I have seen over many years and match those of Mr Brian Sommerlad, widely recognised as a, even the, world leader in this field. This has huge importance in a field in which speech results vary a great deal and shows that the surgical techniques are replicable. I would urge the reviewers to ensure outcomes are given sufficient consideration in the decisions and that this unique set of skills is not lost. 37

192 Dr Debbie Sell OBE PhD FRCSLT Reg MRCSLT 38

193 Cleft Care Scotland Annual Audit Report Cleft Care Scotland Network Office Room 1017 Kings Cross Hospital Clepington Road Dundee DD3 8EA Tel:

194 INDEX 1. Executive Summary Page 2 2. Introduction Page 3 3. Audit Timetable Page 5 4. Individual Audit Report Audit 1 Page 6 Audit 2 Page 8 Audit 3 Page 10 Audit 4 Page 12 Audit 5 Page 14 Audit 6 Page 16 Audit 7 Page 17 Audit 8 Page 19 Audit 9 Page 20 Audit 10 Page 21 Audit 11 Page 22 Audit 12 Page 24 Audit 13 Page 26 Audit 14 Page 28 Audit 15 Page 29 Audit 16 Page Summary Page Audit Timetable Page 32 1

195 1. Executive Summary This is the first annual audit report from Cleft Care Scotland. Cleft Care Scotland, was launched in September 2014 to re-invigorate a network (CleftSIS) that had a difficult time over the past 2-3 years following reviews of both the network activities and the nationally commissioned surgical service and the introduction of a new IT Audit system. Delays in the dissemination of the surgical service report and the response to it, led to a great deal of uncertainty as to the future structure of cleft care in Scotland. With the introduction of a single managed national surgical service for cleft care in April of 2014 and the appointment of a clinical lead for this service in September 2014 many of these uncertainties are beginning to be addressed. With this in place it is hoped that a clear structure for surgical cleft care in Scotland will emerge that allows for the most efficient and effective care to be delivered to a very deserving population. It is a reflection of the professionalism of the clinicians and administrative teams from across Scotland, and their dedication to high quality care, that despite the uncertainty of the last few years this report and the depth of information it contains can be presented to you today. This report demonstrates that cleft care in Scotland is at least comparable to that delivered in the rest of the United Kingdom and in many instances demonstrates beacons of excellence. Furthermore, despite this favourable comparison with cleft care in the rest of the UK, the clinicians in Cleft Care Scotland commit to continual improvement in the care they deliver. Development of care of the highest order that is delivered in a timely and efficient manner that also reduces the burden of care can only be achieved through the rigorous use of audit information and the application of contemporary research. The clinical team from the network has spent much time this year looking at how the audit information included in this report is used. The network recognises that much effort of the last few years has been spent trying to improve the quantity and quality of the data recorded. The network now is committed to taking audit activity forward and to use the information in a systematic way to work on continual improvement in both process and outcomes of care for patients across Scotland. In so doing, the network commits to providing transparent information to each Health Board that demonstrates both the process and outcome of care provided for patients that reside in their area. This is the first attempt to provide Health Board specific data. Where dissection of this year s data allows presentation by Health Board area, this has been done; however as a network we commit to providing Health Board specific presentation of all data in future. Furthermore we commit to providing year on year standardised reports that include both Pan-Scotland and Health Board specific data in addition to historical summaries that will allow Health Board officials (and anyone with interest) easy comparison. We commend this audit report to you. Mr Craig Russell MA MB BChir FRCS(Plast) Mr Toby Gillgrass BDS FDSRCSEdin MOrth Network Audit Lead Network Lead Clinician 2

196 2. Introduction Clinical services for people living in Scotland with cleft lip and/or palate have been subject to significant change over recent history. The last 3 years has seen The National Managed Clinical Network for Cleft Services in Scotland go through a process of review and renewal. This process resulted in a re-launch of the network as Cleft Care Scotland at the annual national meeting in Perth in September The relaunch of the network in 2014 occurred shortly following the coming into being of the fully commissioned single national cleft surgical service for Scotland. Despite anxiety and concern as to the nature and structure of these changes the clinicians of the network have continued to provide un-interrupted service to the population of patients in Scotland who have a cleft of the lip and /or palate. This report includes data from the 16 nationally agreed audits that cover the full spectrum of the multi-disciplinary care provided for cleft patients. Until April 2014 the network and the surgical services for cleft patients across Scotland were commissioned only to provide care up to the age of 16. Following this, patients with clefts had to seek ongoing care and input from the relevant clinicians in their local Health Boards. In April 2014 the Health Boards form across Scotland agreed to nationally commission surgical care from cradle to grave. With this decision the Health Boards have provided a focal point around which to structure the other aspects of multi-disciplinary cleft care for patients of all ages. The structure of how surgical care is delivered is still in development. No matter how this turns out, the next few years will provide an exciting opportunity to use the information obtained from the coherent treatment of adult patients to not only improve the processes and outcome of their care but also to inform care for children and adolescents with clefts. Currently clinicians from Cleft Care Scotland contribute to 16 nationally agreed Audits (See Audit timetable on page 5). Clinicians have invested significant time to the development of the cleft-specific components of the national clinical audit system (NCAS) that now is the workhorse of all audit data storage for national managed clinic networks. As we move forward with increasing experience of the new clinical audit IT system, it is expected that the information required for completion of audit returns will be available much more efficiently and will come with greater confidence in accuracy. However as with all data storage systems information retrieved relies on the quality of the information entered. To this end the network continues to stress the need for its clinicians to be provided with adequate administrative support and / or the time necessary to ensure that all relevant data is entered on the system. Over the last few years much work has been undertaken to improve the return and quality of data entered on the audit system. While this work is not yet complete improvement in returns has allowed the network the time to begin to look systematically at the results of the audits and how this information can be used to develop cleft care coherently across Scotland. Until recently individual clinicians have used this network audit information to improve the service they offer to their own local patients. The network recognises that this is inefficient way of improving the delivery and outcomes of cleft care across Scotland and the network has now challenged each specialty sub-group to interrogate the audit information available to develop Pan- Scotland strategies for clinical care improvement. In the report of each audit, space will be dedicated to discuss following:- 3

197 1. Success identified in the previous audit year 2. Areas where improvement can be sought 3. Strategies to improve audit target compliance 4. Resource gaps that require filling. It is hoped that by returning such information to our commissioners (National Services Scotland) and individual Health Boards that potential postcode differences in service provision can be eradicated and in the future, patients with clefts can expect equity of service delivery and outcome no matter where they reside within Scotland. Where possible comparative benchmarking data from our sister cleft teams that form the NORCLeft audit group (North West/ North Wales cleft team, Northern and Yorkshire Cleft team and the Trent team) will be alluded to. Currently we do not have agreement that the detail Norcleft data can be included. Before inclusion in a public document such as this agreement will need be sought from the clinical directors of each of the NORcleft teams clinical directors. Such agreement will be tabled for discussion at the next NORcleft meeting in June

198 3. Audit Timetable CLEFTSiS NATIONAL MANAGED CLINICAL NETWORK AUDIT TIMETABLE 2013/2014 Audit Deadline Coordinator Data Collection Quality Indicator 1: First Contact % of parents contacted by Cleft 31 March 2014 Cleft Specialist Specialist Nurse within 24 hours of Nurses/MCN Office antenatal diagnosis % babies/parents visited by Cleft Specialist Nurse within 24 hours of birth. 31 March 2014 Cleft Specialist Nurses/MCN Office First Contact data to be input into NCAS. First Contact data to be input into NCAS. Quality Indicator 2: All patients/parents/ carers are offered a patient satisfaction questionnaire at key points during the patient journey. [MCN Standard 2b.3] 3. Patient Engagement Questionnaire currently being reviewed in line with work of the Patient Experience Project Group. Quality Indicator 3: All children with Cleft lip and or Palate should have attended the Multidisciplinary Team Review within the first 2 months of birth. [MCN Standard 7b.3] 4. Attendance at MT Review <2 months. 31 March /14 births date of attendance at first MDT clinic to be uploaded to NCAS. Quality Indicator 4: All specialist group clinical protocols should be reviewed and assessed on a yearly basis with an audit of protocol compliance/adherence carried out within the network yearly. [MCN Standard 3a.4] 5. Alveolar bone grafting for all 31 March 2014 MCN Office Audit of patients turning 12 in 2012 with details of UCLP/BCLP/CL <12years 6. Children who have an alveolar defect are assessed by a cleft team orthodontist and the surgeon responsible for alveolar bone grafting between 7-9 years of age. date of ABG from NCAS. 31 March 2014 MCN Office 2003 births 7. Palate Closure <13 months 31 March 2014 MCN Office 2012/13 data to be input into NCAS. 8. Lip closure <6 months 31 March 2014 MCN Office 2012/13 data to be input into NCAS. Quality Indicator 5: All Special interest groups should produce a key audit based on their audit protocol/ year as part of the endorsed audit timetable. [MCN Standard 5a.2] 9. 5 Year Speech year CLP/CP CAPS-A 10. Fistula audits Prospective audit - All CP/CLP repairs Retrospective audit fistula incidence in 3 year olds ( births with CP/CLP) Year Oral Health year CL CLP dmft Year Index Births yr SM s or photos 13. Alveolar Bone Graft 2011 post-op +/- pre rads 14. Orthodontic Outcome Scores 2011 PAR treated cleft cases 15. Audiology yr cond./typm./otosc 16. Audit of Antenatal Diagnosis, including missed diagnosis, accuracy of diagnosis and false positives. 1 Feb 2014 Chair of SLT Sub- Group 31 March 2014 Chair of Surgical Sub- (For presentation Group at Norcleft - June 2014) 1 Dec 2013 Chair of Paed Dentistry Sub-Group 29 Nov 2013 Chair of Orthodontic Sub-Group 29 Nov 2013 Chair of Orthodontic Sub-Group 29 Nov 2013 Orthodontic Sub- Group Chair 1 Feb 2014 Chair of Audiology Sub-Group 31 Mar 2014 Chair of Nursing Sub- Group List of 2007 audit records ed to each centre. Ongoing data collection at the following time points - 1) CP repair 2) 6 wk post-op review 3) 3 yr old review List of 2007 audit records ed to each centre. List of 2007 audit records ed to each centre. List of CL and UCLP who turned 12 in ed to each centre. List of 2011 audit records ed to each centre. List of 2007 audit records ed to each centre for completion. 2012/13 births NATIONAL AUDIT INVOLVEMENT: CSAG II, OSIG 5yr index, CAPS A, OSIG PAR Score 5

199 4. Individual Audit Returns Audit 1 Title: 100% of Parents Contacted by Cleft Specialist Nurse within 24 Hours of Antenatal Diagnosis. Background: Antenatal diagnosis of cleft lips is possible and the national pre-natal screening programme includes face examination within its protocol. In fact it indicates that a minimum target of 75% of all cleft lips should be diagnosed antenatal. Early referral to specialists with the appropriate knowledge and experience to counsel prospective parents appropriately is important to ensure that prospective parents are fully informed with all their decision making. Results: In the year % of all parents of a foetus diagnosed with a cleft lip at anomaly scan were contacted by a specialist nurse from the cleft team within 24 hours of the diagnosis being made. This was slightly less in than our sister cleft teams from the NORcleft group who ranged from 89 to 97% (NORcleft agreed minimum standard is 80%) These teams have 7 day a week on call cleft nurse specialist cover. This is not currently the case for Scotland. Successes: While Tayside and Highland do not meet the wording of the agreed audit standard, a Specialist Cleft Speech and Language therapist saw these families within 24 hours of diagnosis. In Ayrshire some of the families were seen by a specialist Cleft Orthodontist within the 24 hour window. The other failures were due to late or no referral to the service being made. Area for Improvement: Improve knowledge of service and service referral guidelines in screening units with aim of reducing late referrals. 6

200 Strategy: Increase number of awareness raising visits to antenatal screening units by Cleft Nurse Specialists. Within this will be distribution of pens / post-it notes indicating the importance of early contact with the cleft teams. Letter to Head of Antenatal Screening for each Health Board highlighting benefits of early support from cleft team in cases of antenatally diagnosed cleft lips. To include in this letter information about the accuracy of the diagnosis to help close their experience loop (Cleft CNS are also auditing accuracy and missed diagnoses rates). With the launch of Cleft Care Scotland an invitation from the new Network Lead to lead Sonographers and Obsetricians in all Health Boards to form a new sub-group under the Cleft Care Scotland umbrella. Resource Gap: Currently no pan-scotland Cleft CNS on-call service that would be necessary to reliably achieve the NORcleft agreed target of 80% of prospective parents contact within 24 hours of their foetuses diagnosis of cleft lip. Current scanning techniques cannot reliably identify clefts of the palate. 7

201 Audit 2 Title: 100% of newly born babies diagnosed with a cleft reviewed by a Cleft Specialist Nurse within 24 Hours birth. Background: Early intervention by a trained and experienced cleft CNS has been shown to be beneficial to parents in whom there was no antenatal diagnosis. Furthermore specialist feeding advice (breast and bottle feeding) and early recognition of babies at risk of developing airway issues helps alleviate stresses on the both the referring clinical team (who may only see a couple of babies with clefts per year) and can go some way to reassuring parents that having a baby with a cleft need not be a stressful and worrying experience. Experience has shown that support particularly with feeding helps maternal baby bonding. Given that this audit target is from birth it is influenced not only by Cleft Specialist Nurse availability but also by the timely diagnosis and referral by midwife and obstetric teams. Results: While Cleft Care Scotland has an aspirational target of 100%, as the benefits of early support and intervention are well recognised the current NORcleft target for attendance within 24 hours of birth is 80%. This is despite the rest of the NORcleft teams having funding for 7 day nursing on call cover and much less diverse geography. In the last reporting year, Scotland achieved 76% attendance by a Cleft Specialist Nurse within 24 hours of referral. Tayside and Highland babies were seen by Cleft Specialist Speech and Language Therapists and as such even though these dedicated individuals gave appropriate support, the audit standards were not met in these Health Boards. Similarly Ayrshire and Arran did not meet the necessary standard as a Specialist Consultant Orthodontist is on call for new baby referrals. In the west of Scotland Health Boards where there is no funded CNS cover at weekends the NORcleft standards were only just met. 8

202 Successes: Overall, 76% of babies seen within 24 hrs by CNS. This is despite no current funding for an on-call nurse service and certain Health Boards having clinicians other than Cleft Specialist Nurses as the person of referral and first contact. If a Saturday on-call service and Cleft Specialist Nurse cover was provided across Scotland, then the figure achieved would have been 96%, which compares very favourably with our partner teams in the NORcleft group (89-97%). Areas for Improvement: Pan-Scotland organisation of Cleft Specialist Nurse provision would go a long way to ensuring equality and sustainability of service. Currently there are no clear robust arrangements across Scotland to cover CNS leave / absence, nor that of non-cns cleft clinicians who provide a similar service. A pan-scotland on-call service that covers temporally and geographically all births should be developed. Strategy: This should be a key area of attention for the management of the developing cleft surgical service for Scotland in partnership with the network as the funding for the surgical service in part supports the funding of the cleft CNS service. There needs to be put in place agreed development plans that will ensure appropriate cover for illness, resignation, leave and retirement of all the clinicians (where CNS s or not) who provide this essential first contact service. This will include definition of the skill set that is required to provide this service. Where any current clinician providing this service finds that they have gaps in the defined they should be supported in either developing this skill or there should be practices put in place whereby they can work in parallel with a colleague who compliments their skills. To help achieve this the CNS SIG have agreed to provide the Surgical Service Lead detailed information on the benefit of early Cleft Specialist Nurse contact and the Surgical Service lead will take forward the development of this service with the full support of the Clinical lead and management of Cleft Care Scotland. Resource Gap: Geographical and temporal gaps in CNS service. 9

203 Audit 3 Title: All patients/parents/carers are offered the opportunity to contribute to patient experience questionnaires at key time points. Background: For every organisation to best serve its customer base it must know both what the customer expects and wants from the service and also what they think of the service that is provided at the current time. Results: Given that the patient questionnaires previously used by the Network were due for review it was agreed to obtain patient/carer feedback on their key priorities when coming into clinic/hospital in order to inform the production of new questionnaires. The Cleft Care Scotland NMCN Network Manager visited 5 MDT clinics across Scotland and obtained feedback from patients using a survey developed on an ipad. The survey was conducted from 24 parents/patients/carers who attended cleft MDT clinics in The Royal Aberdeen Children s Hospital, Glasgow Royal Hospital for Sick Children (Yorkhill), Edinburgh Royal Hospital for Sick Children, Forth Valley Royal Hospital, Larbert and Ninewells Hospital, Dundee. Patient/carers were asked to name their top 3 priorities when coming into clinic/hospital: Priority 1: Effectiveness of treatment and good communication were indicated as top priorities for patients/carers attending clinic/hospital. Priority 2: Communication and being taken promptly were indicated as the second top priorities for patients/carers attending clinic/hospital. Priority 3: Staff Attitude and communication were indicated as the third top priorities for patients/carers attending clinic/hospital. 10

204 Successes: Face to face questionnaires have been performed across 5 MDT Clinics in Scotland and data analysed. Strategy: Network will work with CLAPA and patients/carers to develop new questionnaires for cleft patients in Scotland. Make both electronic and paper feedback available to patients/carers. Feedback to be reviewed on an annual basis and an action plan documented in the annual audit report. 11

205 Audit 4 Title: All New Patients reviewed at MDT within 2 months of birth. Background: Early review by the full MDT allows for opportunity for parents / carers to be introduced to all members of the team that will be looking after their child for the immediate future. Not only does this provide the opportunity to reassure the family group that all care needs will be addressed it also allows for the team to review the baby. In so doing they can assess the clinical condition of the baby from the point of view of delivery of timely and appropriate cleft care and communicate the clinical plan to the family members/carers concerned. It also allows for the requesting of specialist investigations as determined by both the baby s presentation and the current clinical condition. Percentage of patients reviewed within the cleft MDT setting by Health Board of residence. Results: 93% of patients either had or were offered an appointment in the MDT clinic within 2 months of birth. This number drops to 83% if DNA s, cancellations by carer/ parent or not seen as baby currently in-patient were included. Successes: Greater than 80% of all patients seen within the MDT setting within 2 months of birth despite the challenges posed by the geography of Scotland. Areas for Improvement: Reduce clinic cancellations (affected 6 patients) Reduce DNA / patient cancellations (affected 5 patients) 12

206 Strategy: Review of all cleft clinics in Scotland by the Surgical Service management board in conjunction with the Lead Clinician and Network Manger recently completed. Formal report of these visits is awaited. Audit of reasons for cancellation / DNA. Resource Gap: Cleft Specialist Nurse time to stress need for MDT attendance. Need for development of Specialist New Baby clinics across Scotland that have appropriate geographical location and temporal occurrence to allow all babies and their parent/carers access. Need for video link development. 13

207 Audit 5 Title: All Patients appropriate for alveolar bone grafting have procedures undertaken before the age of 12. Background: Alveolar bone grafting has three main aims. Closure of any residual alveolar cleft gap, the creation of a one-piece maxilla that will allow the eruption of teeth and facilitate any requirement for future orthognathic surgery and finally the creation of enough bone stock within the cleft to facilitate definitive orthodontics to produce satisfactory functional, aesthetic and stable dental occlusion. ABG is most useful if undertaken in advance of the permanent canine erupting as the process of canine eruption leads to augmentation of bone in the grafted site. The normal permanent canine eruption is complete by 12 years of age though this often is slightly delayed in children with clefts. The reason for performing grafting by age 12 is to utilise the most appropriate opportunity for graft success. Percentage of patients bone grafted before age 12 by Health Board of residence. Results: 88% of children that may have benefited from an alveolar bone graft either had or were deemed not appropriate for the procedure. Successes: More than 80% of children with a potential alveolar defect were assessed for and either had ABG by age 12 or clinical decision had been taken that it was not appropriate. Areas for Improvement: Data collection was identified as an area for improvement. 4 patients who were of the appropriate age for grafting did not have data returned. 1 patient had multiple DNA s for clinics. In this era, multiple DNA s for children must be addressed and appropriate use of a social service referral and escorted appointments should be used. 14

208 Strategy: Use of NCAS to identify, create and pass on patient details who have become appropriate for this stage of care to each treatment centre. Improved use of 3 strikes (DNA s) and out policy (social services referral). Resource Gap: Funding for a co-ordinator who has responsibility to ensure that all patients are seen in a timely fashion in relation to their stage on the cleft care pathway and who highlights to parents/carers that they are approaching the social services referral threshold. 15

209 Audit 6 Title: Have all patients with cleft lip +/- palate patients had an assessment to plan ABG treatment between the ages of 7 and 9. Background: This audit / standard was introduced due to a historical realisation that patients were not having treatment plans determined at early enough age to allow all preparative treatment to be complete by the onset of the ideal window of opportunity for bone grafting. Data has demonstrated that prophylactic extraction of cleft erupting deciduous teeth, supernumerary teeth and any adult tooth adjacent to the cleft site not deemed suitable for retention have a beneficial effect on ABG success. It is thought that this effect is due to better quality gingival tissue for closure over the bone graft and removal of any carious teeth that may contribute to surgical site infection. Further to preparation of the surgical site by dental extractions, it is sometimes necessary to orthodontically expand the distance between the lesser segment and the pre-maxilla to allow for satisfactory surgical access particularly in those cases where the nasal floor defect is required to be closed. Without expansion it is impossible to do in some cases. Assessment between 7 and 9 is an ideal time to do this as it is then possible to determine the developing canines on conventional orthodontic radiographs. Determination of the degree of canine root development allows a prediction of the optimal timing of grafting which is usually when the canine root is two thirds formed. Results: Unfortunately it is impossible to write a query that can interrogate the clinical audit system in a way that will provide such data. Successes: Flaw identified within the development of NCAS that does not allow for either the appropriate storage of this information or its retrieval. Areas for Improvement: Need to agree wording of the audit that can allow the reliable collection of data of merit. Strategy: Orthodontic sub-group tasked with re-wording the audit to provide accurate interrogation of data held on the NCAS. Resource Gap: At the time of the audit returns the Orthodontic Sub-Group Chair had indicated his intention to retire. This role has now been filled and has been addressed by the new joint chairs. 16

210 Audit 7 Title: All patients with clefts have their palate reconstruction complete by age 13 months. Background: There are competing interests affecting the timing of palate closure. Data relating to speech development indicates that better results are achieved the earlier the palate is reconstructed. Certainly babies begin to learn to use their palate effectively when they begin canonical babbling. (Ma-ma, Da-da, ta etc). However the earlier we try to reconstruct the palate the smaller all the structures are and the greater the technical challenge of the surgery. Furthermore prior to age 6 months babies are considered obligate nasal breathers, so if a procedure was to be undertaken there is greater risk to the baby s airway due to compromise secondary to surgical swelling. % of babies with cleft palate who have completed palatal reconstruction by age 13 months. Results: 87% of all patients had their palates reconstructed by age 13 months. The remaining 13% all had valid medical reasons delaying their palatal repair. Successes: 80% threshold for achieving palatal complete palatal reconstruction achieved with some leeway. Area for improvement: It is not certain if the patients who do not have their palatal reconstruction complete by 13 months could have had their medical co-morbidities managed in a more efficient way to facilitate repair within the agree timeframe. Strategy: Non-compliant patients to be discussed within the surgical morbidity meeting to ensure that any lessons to be learned can be appropriately disseminated to the surgical sub group members. 17

211 Resource gap: Clinical co-ordinator required to help identify such patients and to provide all the access to hospital notes and information systems required to facilitate case presentation and discussion. Appropriate allocation of surgeon DCC time to morbidity and mortality discussions. 18

212 Audit 8 Title: All patients with clefts requiring lip repair have the procedure complete by 6 months of age. Background: There is no sound surgical or physiological reason as to the necessity of lip repair by 6 months of age. Much of the pressure to complete repair is societal, in addition to data on maternal baby bonding. Though with improved antenatal diagnosis, antenatal counseling of prospective parents and psychological support / intervention in the perinatal period this may be less important. % of Babies With a Cleft Lip Who Have Their Lip Repair by 6 Months of Age By Health Board of Residence Results: 86% of patients have had their cleft lip repaired within the appropriately agreed timeframe. Successes: 80% threshold target achieved. Those that did not did so either due to parent choice or medical issues. Areas for Improvement: Question as to whether co-morbidities could be more efficiently managed to facilitate repair in line with Guidelines. Strategy: Commitment to discuss medical and social reasons for non-compliance at Surgical M&M to better understand the issues leading to patient care delays. Resource Gap: Clinical co-ordinator required to help identify such patients and to provide all the access to hospital notes and information systems required to facilitate case presentation and discussion. Appropriate allocation of surgeon DCC time to morbidity and mortality discussions. 19

213 Audit 9 Title: Cleft Speech Outcomes Background: The UK standards for cleft speech outcomes have been developed and used consistently since The standards have been published in peer reviewed literature (Briton et al, CPCJ, Vol. 15: issue 4, July 2014)). These outcomes are based on consensus listened speech data, following an agreed national protocol. Births Standard 1 : By years over 50% of children have speech within the normal range Standard 2a: By years over 70% of children have speech with no evidence of a structurally related problem and have not had VP surgery or fistula repair for speech Standard 3: By years more than 50% of children have no cleft type articulation difficulties which require therapy or surgery Successes: There has been an increase in audit completion for children eligible for audit. The cumulative data has allowed more detailed analysis, e.g. by cleft type. Areas for Improvement: Ensure that the quality of audit recordings meet the agreed national standards. Introduction of consensus listening for 10 year audits. As a clinical group continue to develop intervention for those children not meeting standard 3c at 5 years. Strategy: Standardise equipment across all clinical sites. Develop collection and consensus listening of 10 year audit data. Continue to maintain and develop support for community Speech and Language Therapists working with children with cleft speech characteristics. Resource Gap: Funding for recording equipment and IT support. 20

214 Audit 10 Title: Audit of palatal fistula rates following last surgical procedure with intention of closing the palate. Background: One of the difficulties with relevant surgical audit in cleft care is that measurable relevant results are only usually available at a time distant form the surgical intervention. Recent years has seen the NORCleft group of surgeons had been undertaking a substitute outcome audit looking at fistula rate following definitive palate repair. After the last round of audit when results indicated repeated low fistulation rates the NORCleft group discontinued the fistula audit. We have continued to collect the fistula data to allow surveillance of changes in fistulation rates on a year on year rather than subject to audit as there is currently nothing to help guide how to change practices with an aim of improving outcomes as is required in true audit. The last 12 months saw a fistula rate of less than 5% that continued to below that of the most recent meta-analysis of published data that indicates a fistula rate of 8.9% with confidence intervals of 6-11% Given that publication bias is likely to result in the meta-analysis having a calculated fistula rate that is lower than would be found if all procedures were examined in a prospective way the current fistula rate below the confidence intervals of this study is excellent. 21

215 Audit 11 Title: Audit of the dmft scores of 5 year old Cleft Lip +/- Palate patients across Scotland. Background: dmft is a global score of dental health in children. d stands for decayed, m stands for missing (through extraction due to caries) and f stands for filled or restored. A perfect score is 0 with no decayed teeth, no missing (extracted) teeth and no filled teeth. Historically cleft lip +/- palate children have had worse dmft scores when compared to the general population. This may be due to a poorer diet, difficulty in brushing teeth in the cleft site, underlying increases in deprivation in the cleft population as compared to the population in general, or for an as yet unrecognised reason. A recent publication suggests that the presence of oronasal fistula may contribute to increases in dental decay however with low fistula rates in our population; this is unlikely but may be worth exploring further. One of the difficulties with the dental audit for Scotland over the last few years has been a paucity of data collection and return. In fact returns have only been regularly provided for one region. This is primarily because there is difficulty in identifying the clinician that is responsible for co-ordinating and delivering paediatric dental care, not all patients with clefts are registered with a dentist and many parents do not treat appointments for dental audit data collection as importantly as those for other aspects of cleft care. In comparison, the majority of the clinicians in the NORCleft region who provide the dental services for the paediatric cleft population are on the specialist register and in Consultant positions. For the one region in Scotland that regularly returns data the service is headed by an academic consultant clinician who provides the inpatient GA service as required. Outpatient reviews and treatment are delivered by part-time Public Dental Service dentists who have specialist interest and training in the delivery of dental services for children with clefts. It is important to recognise that Paediatric Dentistry care could be delivered in all Health Board areas by generalists, specialists or consultants but requires appropriate resources to help them return data. Furthermore, many have competing interests in regards individual job planning. Therefore a clear picture of the oral health in the wider Scottish cleft population cannot, at this time be delivered. Current NORCleft standards indicate that 80% of all eligible children should have been examined during the year following their 5 th birthday. 22

216 Results: % of children examined within the appropriate time window for the returning REGION BIRTHS EXAMINED % EXAMINED Scotland (One Health Board ) Audit Return Data Indicies Scotland (One Health Board) NDIP Data 2010 BASCD data England 2007/8 %caries free Mean dmft Treatment index dmft for those over Successes: Where Paediatric Dentistry is provided and data returned Cleft Care Scotland is outperforming our benchmarking units within NORCleft. The data provided is for the 2007 births and these data are significant improvement on the data before the introduction of the preventative cleft dental clinic and there appears to be improvements year on year with the mean dmft for the population now approaching that of the general paediatric population on Scotland (NDIP data 2010). Not only has there been general improvement in the dmft scores, the fact that for those children a dmft greater than zero, the burden of disease for the first time is below that of the general population. This is a huge achievement for a population that is both skewed in regards deprivation and also skewed towards poorer overall oral health. These data indicate that an intensive preventative approach to dental care in this population is effective and that this will both have a benefit to other aspects of their cleft care (reduced risk of infection at surgery and ability to provide definitive orthodontic care without fear of caries progression) and their overall health in the long term. Areas for Improvement: Lack of identified Specialist Paediatric Dentists Scotland. Oral health across Scotland still requires further improvement. Strategy: Network Lead and Surgical Service Lead to write to all Health Board Chief Executives and Oral Health Directors highlighting the importance of oral health in cleft care. During the review of clinics across Scotland, the Network Manager to attempt to identify a named Paediatric Dentist in each Health Board area with the responsibility for coordinating and delivering paediatric dental care to the cleft population. Resource Gap: Funded Paediatric Dentistry clinical time. 23

217 Audit 12 Title: Audit of the maxillary growth pattern in 5 year old cleft children. Background: It has long been recognised that patients with treated clefts have restricted growth of the maxillary bone complex and it is believed that the extent of scarring following surgical repair of clefts contributes to this restriction in growth. Multiple methods of scoring maxillary growth and dental occlusion have been developed. As always in cleft there is a compromise as to what is an ideal measure of growth, and what is practically possible to do as temporally near to the intervention in question so as an adequate audit cycle can be followed. The Craniofacial Society of Great Britain has for some time been keeping records of maxillary growth patterns in Unilateral cleft lip and palate patients at age 5 years using a validated scoring system called the 5 year index. The results below show the outcomes of the 5 year index for Scotland against the UK results. The 5 year index is broken down into 5 groups (1&2 good result : Green, 3 moderate result : Amber, and 4&5 Poor results : Red, missing results are shown in Black). 24

218 Successes: Scotland s 2007 births show best growths results in the NORCleft group. There has been significant improvement in the results in Scotland over the last 5 years. Average results for the show that 30% of patient data were missing and that only 30% of patients were getting good results. Missing results have been reduced to less than 20% of the population and over 60% of the whole population are now getting favourable growth results at 5 years. The implications of this are that as in this population who invariably require Orthodontics, not only are their teeth in better condition (audit 11) but the number of patients requiring orthognathic surgery for restricted maxillary growth should reduce.thereby the extent of orthodontic treatment should also decrease over time Areas for Improvement: More progress on the missing data points to ensure validity of these data. Strategy: Obtaining models for this scoring system requires taking intra-oral impressions and this is not a pleasant experience for the children and is an issue for the family in terms of the burden of care. Scoring can be done from photographs but this requires the expertise of specialist medical illustration photographers who have experience of working with children. Currently investigation of an intra-oral digital scanning device for children with clefts is being undertaken by academics at the University of Dundee in conjunction with the Glasgow Cleft Orthodontic service. The results of this project will be published in Resource Gap: Capital funds to purchase intra-oral scanners for MDT clinic sites. 25

219 Audit 13 Title: Audit of the alveolar bone graft results in of children who have undergone alveolar bone grafting in Background: Alveolar bone grafting in children with clefts has 3 main functions (see Audit 5). Historically results for Scotland have been variable but over the last decade there has seen significant improvement in the results. Results are measured on a 4 point scale known as the Kindelan bone-fill scale. While it still has some detractors (principally around the fact that it relies on 2D imaging to look at a 3D issue) it is still widely accepted as the most appropriate standard. Kindelan 1 and 2 results are clinically acceptable as they indicate that enough cleft bone is present post-grafting to facilitate definitive orthodontics. Bonegrafting should ideally be undertaken before eruption of the permanent to benefit from the tooth erupting through the grafted site and remodelling and consolidation of the bone in the cleft site as it erupts. Normally, the canine erupts by age 12 and is usually slightly delayed in patients with cleft hence the standard is ABG surgery grafting by age 12. Results : Returns indicate that there were 19 potential patients who underwent alveolar bone grafting in Of the 19, 18 had radiographs available to assess the quality and result of the ABG process. 4 were patients were on the BCLP spectrum and 14 were on the UCLP/CLP spectrum. The Kindelan scoring system is only validated for UCLP alveolar defects. However using the same method of assessment for the BCLP patients indicates that both patients having good results with 100% of the alveolar defects being Kindelan score 1 or 2 Kindelan scores for the 14 patients undergoing Unilateral bone grafting were all patients being Kindelan score 1 or 2 which is deemed as successful. Previous year s results are shown in the graph below (in previous years only partial data submitted). Successes Consistently good results for patients with UCL / UCLP over the last five reported years. 89% of all procedures result in clinically relevant good result (Kindelan 1 and 2). 26

220 Areas for Improvement BCLP outcomes were not quite as good as those for UCLP but it is accepted that alveolar bone grafting in this patient group presents a significantly greater challenge.. There is some concern as to whether the Kindelan index is really fit for purpose as it does not provide a description of the bone volume deficit or a description of graft volume retention. Cone-beam CT is rapidly becoming the gold standard in the assessment of the cleft defect. Work has been undertaken in Scotland to determine the best way to measure the volume defect and is expected to be published in Strategy: Introduction of Cone Beam CT in ABG assessment where possible. Identify features / process in the good results for patients with BCLP to inform surgical practice. Produce a scoring system for CBCT outcome in ABG. Orthodontic Sub-group has invited the surgeons to meet in October 2015 to discuss areas of good practice and areas for improvement. Resource Gap: CBCT scanners at all MDT clinic centres. 27

221 Audit 14 Title: Outcome of definitive orthodontic treatment in all patients with clefts de-bonded in Background: Non-cleft orthodontic treatment is measured using the PAR scoring system that rates the difference in the alignment of the teeth and occlusion before and after orthodontic treatment. There has been some concern as to the appropriateness of using PAR scores to audit cleft orthodontic treatment. In cases where treatment is discontinued, or a clinically appropriate decision was taken to not correct reverse overjet PAR score would compare poorly in comparison to those who underwent orthognathic surgery. Given that orthognathic surgery rates vary significantly around the UK and abroad, the use of PAR as an orthodontic outcome measure in patients with clefts is flawed. Currently no weightings are available to account for the deficiencies in PAR scoring for cleft care. Results: PAR % Improvement As a result of concern regarding a specific orthodontic outcome measure, the NORCleft group is currently investigating the possibility of orthodontic specific patient reported outcome measures (PROMS). Par Scores in excess of 70% are considered good for non- cleft cases. Given that cleft orthodontics is significantly more complex getting such results for cleft patients is excellent Cleft Care Scotland 76% 69% 72% Successes: Approximately 70% improvement in scores. Area for Improvement: More appropriate outcome assessment required. Strategy: Orthodontic Sub-group to lead. Resource Gap: Funding to develop new appropriate tool. 28

222 Audit 15 Title: Current Hearing levels in children with clefts who have their 5 th birthday in Background: Clefts that affect the palate have the potential to affect hearing as the levator and tensor muscles originate, in part, from the cartilaginous portion of the eustachian tube. Part of the function of the Eustachian tube is to allow ventilation and drainage of the middle ear. Without proper Eustachian tube function, fluid can build up in the middle ear leading to a condition known as glue ear or Otitis Media with Effusion (OME). Such a situation can also lead to more frequent episodes of acute suppuritive otitis media (middle ear infection) if the fluid becomes infected. OME leads to dampening of normal sound transmission to the choclea and as such reduced hearing levels in those affected. Hearing is essential to the normal social, psychological, language and cognitive development in children and as such active management of hearing loss in children under 5 when global development is at such an important stage is crucial. While thresholds for intervention are defined nationally, the best method of intervention that gives the affected children the best outcome is still moot. Currently the Healing Foundation Centre Clinical Studies Group based at the University of Manchester is supporting the development of studies in this area. Results: 5 year old audiology results not obtainable from the national clinical audit system. Successes: In the last 12 months, the Audiology SIG have streamlined the audit data collection. This should make it easier and less onerous for identified board clinicians to ensure appropriate data is uploaded to the clinical audit system. Areas for Improvement: ENT surgeons and Audiologists to further discuss the lack of data collection further Strategy: CCS Network Manager to identify within each Health Board the appointed clinician for cleft audiology during visits to each MDT Cleft Clinic. ENT / Audiology Sub-Group to then engage with all concerned clinicians to address current shortfall in audit data collection and return. Resource Gap: Lack of engaged Audiologists in each Health Board. 29

223 Audit 16 Title: Antenatal diagnosis of cleft lip defects. Background: Scotland has only recently introduced a detailed anomaly scan to the normal obstetric care pathway. England and Wales have had such care for some time. Given that identification of cleft lips antenatally can have a hugely beneficial effect on parental birth experience as the birth of a child with a cleft is expected. Parents can also be counselled in advance. The network wished to determine how a fledgling obstetric anomaly screening service in Scotland was performing against accepted Standards from E&W. Currently the E&W programme is targeted with identifying 70% of all identifiable congenital anomalies. It should be noted that current scanning techniques cannot reliable identify cleft palates. Results: Percentages of Cleft Lips diagnosed at antenatal anomaly scan Successes: Greater than 80% of cleft lips accurately identified at the anomaly screening scan. Areas for improvement: Aim for all units to make the E&W minimum of identifying 70% of cleft lip anomalies. Strategy: Check that check of lip anatomy is part of the standard anomalies scanning in all antenatal scanning departments. Lead Clinician to write with individual health board and Scottish average results to the lead sonographers and clinical directors for obstetrics in each health board. Develop improved links with Obstetric / Scanning departments across the country special interest group under the Cleft Care Scotland Umbrella. Resource Gap Adequate Cleft CNS time for regular visits to Scanning departments to maintain links and knowledge in sonographer pool across Scotland. 30

224 5. Summary The production of this first dedicated audit report is of massive importance to the staff and patients of Cleft Care Scotland. Significant effort has been made over the last few years to improve the quantity and quality of information collected by network clinicians. This information has been presented internally within the network and each clinician has been free to use this information as they individually see fit. With the structuring of a report for publication, clinicians from the network have been looking at how the data presented can be used to drive systematic change in how cleft services are delivered across Scotland. Where it has been possible, the outcomes obtained have been benchmarked against the outcomes from the NORCleft group of cleft centres. Where this has been done results have compared very favourably. Furthermore in certain health board areas and specialties beacons of excellence have developed. The challenge now is to use the information we have obtained for the systematic betterment of all patients across Scotland. Cleft Care Scotland clinicians are committed to developing plans for service improvement that is based on the data included within this report and the reports of future years. Only by going through such a process can we reach our aspiration of a truly world class service that is efficient in its use of healthcare resources and effective in achieving the aim of supporting our patients to be happy and productive members of society. 31

225 6. Audit Timetable 2014/15 Cleft Care Scotland National Managed Clinical Network Audit Timetable 2014/2015 Audit Deadline Coordinator Data Collection PROCESS AUDITS % of parents contacted by Cleft Specialist Nurse within 24 hours of antenatal diagnosis. 31-Mar-15 Cleft Specialist Nurses/MCN Office First Contact data to be input into NCAS. 2. Audit of Antenatal Diagnosis, including missed diagnosis, accuracy of diagnosis and false positives % babies/parents visited by Cleft Specialist Nurse within 24 hours of birth. 31-Mar-15 Cleft Specialist Nurses/MCN Office 31-Mar-15 Cleft Specialist Nurses/MCN Office First Contact data to be input into NCAS. (2014/15 births) 4. Attendance at MT Review <2 months. 31-Mar-15 MCN Office 2014/15 births date of attendance at first MDT clinic to be uploaded to NCAS. 5. Lip closure <6 months 31-Mar-15 MCN Office 2013/14 data to be input into NCAS. 6. Palate Closure <13 months 31-Mar-15 MCN Office 2013/14 data to be input into NCAS. 7. Children who have a UCLP/BCLP are assessed between the ages of 7&9 for an alveolar defect requiring bone graft by a cleft team orthodontist and the surgeon responsible for subsequent alveolar bone grafting. 8. Alveolar bone grafting for all UCLP/BCLP <12years 9. Surgical Audit - Prospective Process Audit of defined secondary surgical procedures being undertaken on patients with a cleft by cleft and non-cleft surgeons. 31-Mar-15 MCN Office 31-Mar-15 MCN Office 31-Mar-15 Chair of Surgical Sub-Group 2003/04/05 births. Date on which the OPG, forming part of the pre ABG screening assessment, was taken. Audit of patients turning 12 in 2013 with details of date of ABG from NCAS. Audit Deadline Coordinator Data Collection OUTCOME AUDITS 10. Breast Feeding Audit 31-Mar-15 Chair of Nursing Sub- Group Year Speech year CLP/CP CAPS-A Year Oral Health year CL CLP dmft Year Index Births yr SM s or photos (UCLP/BCLP) 14. Audiology yr cond./typm./otosc (CP/CLP) 15. Alveolar Bone Graft post-op +/- pre rads 16. Orthodontic Outcome Scores PAR treated cleft cases 01-Feb-15 Chair of SLT Sub- Group 01-Dec-14 Chair of Paed List of 2008 audit records ed to each centre. Dentistry Sub-Group Nov-14 Chair of Orthodontic Sub-Group 01-Feb-15 Chair of Audiology Sub-Group Nov-14 Chair of Orthodontic Sub-Group Nov-14 Orthodontic Sub- Group Chair List of 2008 audit records ed to each centre. List of 2008 audit records ed to each centre. List of 2008 audit records ed to each centre for completion. 17. Patient Experience Questionnaires NATIONAL AUDIT INVOLVEMENT: CSAG II, OSIG 5yr index, CAPS A, OSIG PAR Score 32

226 Service Specification Cleft Lip and Palate Surgical Service Release: v1.0 Date: October 2015

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228 1. Aims and Objectives of the Cleft lip and/or palate service Cleft Lip and/or Palate (CLP) is a congenital anomaly resulting from failure of fusion of embryological parts forming the lip, nose and palate, with about 100 new cases occurring each year in Scotland (SNAP ). Its management requires the multidisciplinary involvement of many specialties from the prenatal period, birth and, through the growth and development of the child and young person to the age of at least 20 years, as well as treatment of adults of any age. Techniques in cleft surgical care have advanced over recent years and adult patients who have received surgery in the past sometimes require further specific intervention from the CLP teams to optimise previous procedures. From birth to maturity, children with orofacial clefts require to undergo a large number of interventions that can cause disruption to their life and the lives of their family members. There are often psychological consequences arising from both the treatments provided and from the deformity itself. Care for the person with a cleft lip and/or palate covers pre-natal and post-natal diagnosis and advice including help with feeding, primary corrective lip and palate repair surgery including the provision of specialist and outreach nursing, speech assessment, paediatric dentistry, bone grafting, orthodontics, dento-alveolar surgery, restorative dentistry including implant treatment, rhinoplasty, orthagnathic surgery, audiology/ent (hearing and ENT problems), clinical psychology, genetics, and, where required any additional surgical revision. The aim of the clinical management of cleft lip and palate patients, through delivery of a comprehensive package of treatment; is to ensure that patients achieve an aesthetic and functional facial appearance, and to maximise oral feeding, hearing, speech and psycho-social well being. 2. Cleft lip and/or palate surgical service description The surgical service will be provided (where clinically appropriate) at times and ages advised by agreed clinical protocols and within national waiting times on the basis of equity of access based on clinical need for the population served. Surgical service providers will contribute to and participate in local and national audits and contribute data as required to the clinical audit system (CAS), and to the Quad centre audit group via the Cleft Care Scotland National Managed Clinical Network (NMCN). The surgical service will strive to contribute to clinical research and when possible basic research into aetiology of cleft lip and / or palate and the best means of treating the conditions. The nationally commissioned surgical element of the cleft lip and palate service covers specialist cleft surgery for residents within Scotland. This includes the specialist surgical input to all stages of assessment, all aspects of the inpatient hospital stay, and to surgical follow-up. All other aspects of the comprehensive package of assessment, interventions, and follow-up care are funded by the local NHS Boards and are co-ordinated via the Cleft Care Scotland NMCN. This local care will be supported by the nationally commissioned specialist cleft surgical team who will work on an outreach basis to minimise the need for patients and their families to travel to the surgical site. It is expected that all primary surgical interventions and major secondary surgical treatment will be delivered within a named specialist unit. 1 Scottish Needs Assessment Programme. Cleft Lip and Palate Scottish Forum for Public Health Medicine, 69 Oakfield Avenue, Glasgow, November 1998 K:\07 Health Support Ser\Specialist & Screening\Spec\Cleft Lip & Palate\Scottish Cleft Surgical Service\Options appraisal \Papers 3

229 A comprehensive cleft lip and palate service comprises of the following elements: - Prenatal and postnatal diagnosis Pre- and post natal specialist cleft nursing including support of newborn feeding and on-going assessment and management Hospital and community paediatric care Genetic assessment and chromosomal studies Multi-disciplinary pre-surgery assessment Initial lip and/or palate surgery and post-operative assessment Paediatric dentistry including dental health education and oral promotion Alveolar cleft bone grafting and associated orthodontics Cleft-related dento-alveolar surgery Velopharyngeal dysfunction (VPD) investigations, therapy, surgery and/or prosthetics with follow-up Speech and language assessment and therapy Audiology and otology assessment and treatment for hearing problems Orthodontics Restorative dentistry including implants and prosthetics Orthagnathic surgery/distraction osteogenesis techniques to correct cleft related jaw deformities, and associated orthodontics Rhinoplasty Cleft lip and palate revisions and fistula repair Revision treatment, which may include surgery, orthodontics and restorative dentistry, in adulthood Psychological care for children, adults and their families Locally-provided services (e.g. health visitors, children s community services, education, speech and language therapy, primary dental care) supported by the specialist cleft centre team 2.1 Service model The cleft lip and palate service will work as a Hub and Spoke model with all specialist cleft surgery taking place in the designated national service (paediatric and adult) surgery site(s). Outreach (Outpatient and Multidisciplinary care planning) clinics will be organised by the national service in other locations in agreement with the local NHS Boards. Clinics will be delivered by local specialist clinicians for example in SLT, dentistry, orthodontics, ENT/Audiology in partnership with members the specialist cleft surgical team. (Further details are set out below in paragraph 2.5.) Treatment will be co-ordinated through a dedicated multidisciplinary team of clinicians to achieve optimum outcomes. The team will work with locally identified specialist clinicians (for example SLT, orthodontics, ENT and audiology) and national service clinicians to ensure the care pathway is in place. Cleft Care Scotland will have shared responsibility with the national surgical service to monitor outcomes and ensure the pathway continues to be based on national policy, guidelines and best practice. Timely referral and treatment to achieve optimal outcomes across the patient pathway will be required as will close liaison with the patient s General Practitioner and General Dental Practitioner, and non-healthcare professionals, e.g. school authorities. K:\07 Health Support Ser\Specialist & Screening\Spec\Cleft Lip & Palate\Scottish Cleft Surgical Service\Options appraisal \Papers 4

230 Commissioning arrangements Nationally Commissioned NHS Board Commissioned Pre and post-natal specialist cleft nursing Prenatal and Postnatal diagnosis Specialist support (Nursing, Hospital & Community Paediatric Care Psychological and AHPs) for Board staff involved in Cleft care Pre-surgery assessment and Post surgical follow-up within Outreach clinics Primary lip and/or palate surgery Alveolar Cleft Bone Grafting Cleft related dentoalveolar surgery Velopharyngeal Dysfunction (VPD) investigations and surgery Cleft Surgical element of orthagnathic surgery/distraction osteogenesis techniques to correct cleft related jaw deformity Rhinoplasty CLP revisions and fistula repairs Cleft revision treatment in adulthood Cleft related Genetics Tests (under Genetics Laboratory consortium) Speech and Language Therapy & Assessment Paediatric dentistry including dental health education and oral promotion Audiology and otology assessment and treatment Orthodontics Orthognathic associated orthodontics Orthodontics and restorative dentistry in adulthood Restorative Dentistry Psychological Care Clinical Genetic Assessment Locally provided services e.g. HVs, S&LT, Primary Dental care 2.2 Care Pathway The Cleft Care pathway was agreed by a multidisciplinary team of specialists and other staff, and is offered as a guide to all staff involved in the managed of a patient with a cleft lip and or palate. It is a guide and the care offered to an individual patient will be prescribed by the named lead surgeon for that patient. Interventions and the outcomes achieved will be recorded and subject to the agreed audit programme managed by Cleft Care Scotland. K:\07 Health Support Ser\Specialist & Screening\Spec\Cleft Lip & Palate\Scottish Cleft Surgical Service\Options appraisal \Papers 5

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