Draft Accreditation Report for consultation

Transcription

1 Guidance producer: Guidance product: NHS Fetal Anomaly Screening Programme (FASP) UK National Screening Committee (NSC) NHS Fetal Anomaly Screening Programme Screening for Down s syndrome: UK NSC Policy recommendations : Model of Best Practice Date: 13 September 2011 Draft Accreditation Report for consultation

2 Contents Introduction... 3 Accreditation recommendation... 3 Background to guidance producer... 3 Implementation... 7 Reapplication for accreditation... 8 Appendix A NHS Evidence accreditation analysis... 9 Appendix B Bibliography Appendix C NHS Evidence Accreditation Advisory Committee, external advisers and NHS Evidence accreditation team Draft Accreditation Report Page 2 of 22

3 Introduction The NHS Evidence Accreditation Scheme recognises organisations that demonstrate high standards in producing health or social care guidance. Users of the accredited guidance can therefore have high confidence in the quality of the information. Organisations may publicly display a seal of approval called an Accreditation Mark for 3 years after their processes have been accredited. The process for accrediting producers of guidance and recommendations for practice is described in the process manual 1. Accreditation recommendation We propose that the process used by the NHS Fetal Anomaly Screening Programme UK National Screening Committee to produce 'Screening for Down s syndrome: UK NSC policy recommendations : model of best practice' is recommended for NHS Evidence accreditation. This draft decision is subject to public consultation before a final decision is made. Background to guidance producer The NHS Fetal Anomaly Screening Programme (FASP) is part of the NHS UK National Screening Programmes Directorate, and is overseen by the UK National Screening Committee (NSC) policy team at the Department of Health, which advises UK health ministers. The specific programme considered in this submission is the Down s syndrome screening programme. One output of this programme is 'Screening for Down s syndrome: UK NSC policy recommendations : model of best practice'. This document recommends targets for screening services and describes the screening strategies that may be used to achieve them, as well as strategies that are not recommended, according to the evidence base. The 1 Draft Accreditation Report Page 3 of 22

4 model of best practice is reviewed every 3 years, and the edition assessed for this application is the version. The process for producing this guidance was last updated in 2010, and therefore accreditation will apply only to the model. Summary The Accreditation Advisory Committee considered that the processes used by the UK NSC to produce 'Screening for Down s syndrome: UK NSC policy recommendations : model of best practice' demonstrated compliance with 22 of the 25 accreditation criteria. The process used to develop the guidance is detailed primarily in the SOP NHS FASP policy standards review process (2010), with additional process information provided in a large number of supporting documents detailed in appendix B of this document. This is a single guideline application, so any elements of process not explicit in the process documentation have been inferred from the guidance or supporting documents if sufficient evidence of implementation is available. The views of healthcare professionals are well represented in the development of the guidance. The committee agreed with the guidance producer that representatives of national patient advocacy groups were sufficient and appropriate to represent the views and preferences of patients in guidance development. This is because of the sensitivity of the subject matter and the difficulty of identifying individual patients who fairly represent diverse points of view. Systematic methods are used to search for evidence of both clinical and cost effectiveness, with defined inclusion and exclusion criteria. The committee was satisfied that appropriate methods were used to identify and assess evidence, but the process of assessing strengths, weaknesses and areas of uncertainty needs to be clearly described in the literature review and the cost analysis. Both the literature review and the cost analysis need to be clearly visible alongside the guidance on the host website. Draft Accreditation Report Page 4 of 22

5 The process used does not currently specify that everyone involved in developing the recommendations is required to declare conflicts of interest. However, the process takes account of any potential for bias by involving many stakeholders, peer review, transparency of funding and independence from the funding body. Suggestions for improvement to strengthen the process include the following: Everyone involved in the process, including peer reviewers, should declare conflicts of interest. The process should state how to reach recommendations if there is disagreement. The literature review and costing tool should be clearly visible alongside the guidance on the host website. The guidance should make it explicit which parts are based on the most upto-date Health Technology Assessments and NICE guidance. If possible, the evidence base should be clearly referenced in the guidance recommendations. There are several areas where the process used needs to be explicitly stated in the guidance production manual, rather than in supporting documents specific to this edition of the guidance. These include: what the guidance should contain and how it should be presented how the literature review is conducted how the economic evidence is developed how the strengths, weaknesses and areas of uncertainty in the evidence base (both clinical and economic) are assessed how benefits, risks and side effects are weighed up in developing the recommendations, and how these should be communicated in the guidance. This draft decision is subject to consultation, and the committee will review the decision in the light of any feedback received before making a final recommendation. Draft Accreditation Report Page 5 of 22

6 David Haslam Chair, Accreditation Advisory Committee September 2011 Draft Accreditation Report Page 6 of 22

7 Implementation If accreditation is awarded, guidance from the accredited producer will be identified on NHS Evidence by the Accreditation Mark. Accredited guidance producers are also granted a royalty-free, worldwide licence to use the NHS Evidence Accreditation Mark in accordance with the conditions and terms of use 2. Providing these conditions are met, a guidance producer's accreditation will last for 3 years from publication of approval on the NHS Evidence website. Accredited guidance producers must take reasonable steps to ensure the accredited processes are followed when generating the type of evidence for which they are accredited. Accredited guidance producers should have quality assurance mechanisms in place and must inform NHS Evidence within 30 days if any significant change is made to a process. Figure 1: The NHS Evidence Accreditation Mark 2 Draft Accreditation Report Page 7 of 22

8 Reapplication for accreditation Following a final decision in which accreditation has not been granted, guidance from the non-accredited producer will still be available on the NHS Evidence site but will not be identified by the accreditation mark graphic. Guidance producers that have not been awarded accreditation may reapply from 1 year after the previous assessment. The organisation should address any concerns highlighted in the original assessment before reapplying. The NHS Evidence team will provide detailed feedback and advice on areas in which improvement is needed to meet the criteria in a future application. Draft Accreditation Report Page 8 of 22

9 Appendix A NHS Evidence accreditation analysis The Accreditation Advisory Committee considered the following analysis of the guidance producer s compliance with NHS Evidence accreditation criteria, which covers six discrete domains. The full analysis leading to the accreditation recommendation is shown below. Domain Criterion Evidence for meeting the criterion Accreditation decision Scope and purpose 1. Does the guidance producer have a policy in place and adhered to that requires them to explicitly detail: 1.1. Overall objective The objective of the model of best practice a is to make policy recommendations and set standards for antenatal screening for Down s syndrome, as stated in the opening Background section of the guidance. Because this is the only guidance produced according to the process under consideration, it is possible to confirm that the objectives are clearly stated, which is sufficient to meet this criterion The clinical, healthcare or social questions covered Examination of the model of best practice a shows that the clinical and healthcare questions are stated in appendix 2 of the guidance, and addressed throughout. Because this guidance is the only product of the process under consideration it is possible to verify that the clinical and healthcare questions are stated in the guidance, which is sufficient to meet this criterion. Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 9 of 22

10 Domain Criterion Evidence for meeting the criterion Accreditation decision Stakeholder involvement 1.3. Population and/or target audience to whom the guidance applies 1.4. Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances A process requirement to clearly state the target audience is provided by the Department of Health coversheet for the model of best practice a, which includes a summary table detailing the target audience for the model a. The target population is defined in the model a which is fit for purpose and the criterion is met. Recommendations in reference to specific clinical or healthcare circumstances are provided in the model of best practice a. Some recommendations in the main text of the guidance are not explicitly linked to the evidence base because they are not referenced. Although this would be welcome, clear recommendations are provided in reference to specific clinical and healthcare circumstances, so this criterion is met. 2. Does the guidance producer have a policy in place and adhered to that means it includes: 2.1. People from all relevant stakeholder groups, including patient groups, in developing guidance 2.2. Patient and service user representatives, and seeks patient views and preferences in developing guidance Healthcare professionals and patient groups are represented during guidance development c and also have the opportunity to review the guidance through the Steering Group before external review. Patient groups are represented in the decision making process c, and routinely contribute to the development of the recommendations. Given the sensitive nature of the subject and the difficulty of identifying individuals who fairly represent all viewpoints, this approach is fit for purpose. Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 10 of 22

11 Domain Criterion Evidence for meeting the criterion Accreditation decision Rigour of development 2.3. Representative intended users in developing guidance A wide variety of healthcare professionals are included in guidance development through their membership of the National Working Group c. Pregnant women and their partners are not listed in the target audience section of the Department of Health coversheet for the model of best practice a but it is clear that the guidance is aimed primarily at healthcare professionals. Therefore the membership of the working group is sufficient to meet this criterion. 3. Does the guidance producer have a clear policy in place that: 3.1. Requires the guidance producer to use systematic methods to search for evidence and provide details of the search strategy 3.2. Requires the guidance producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review There is evidence of a systematic method for searching for evidence with a defined search strategy for the literature review d and audit data from the Down s Syndrome Screening Quality Assurance Support Service (DQASS). The literature review d is available from the guidance producer s website. In addition a systematic method was provided for obtaining evidence for the decision planning tool e that informed the evidence of cost effectiveness. The process described b requires that a literature review be undertaken with agreed criteria. Examination of the literature review d shows published inclusion and exclusion criteria. Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 11 of 22

12 Domain Criterion Evidence for meeting the criterion Accreditation decision 3.3. Describes the strengths and limitations of the body of evidence and acknowledges any areas of uncertainty 3.4. Describes the method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) The process b does not require the guidance producer to describe the strengths and limitations of the body of evidence or acknowledge areas of uncertainty in the guidance. However, there is some evidence that this has been done in the model of best practice a or in the literature review d. Uncertainty around key assumptions is built into the decision planning tool e, used for cost effectiveness analysis, but this is not clearly described in the process or the guidance. Because the process for critically appraising evidence is not defined and it is not transparent in the model of best practice a, literature review d or decision planning tool e, this criterion is not fully met. The process for arriving at recommendations is outlined in the SOP NHS FASP policy standards review process document b, with further detail provided in the PID MoBP 2010 document f and appendix 2 of the model of best practice a. Recommendations were arrived at by consensus. The process b does not describe how to make decisions in the event of deadlock or disagreement so the criterion is not fully met, although the guidance producer stated that they managed to reach consensus without disagreement. Not fully met Not fully met Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 12 of 22

13 Domain Criterion Evidence for meeting the criterion Accreditation decision 3.5. Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations 3.6. Describes the processes of external peer review 3.7. Describes the process of updating guidance and maintaining and improving guidance quality Side effects and risks are discussed in the model of best practice a. It is difficult to assess the health benefits of Down s syndrome screening because it is not an intervention designed to increase health, but rather a tool to help pregnant women and their partners make informed decisions. However, the recommendations aim to reduce the number of miscarriages, which can be considered a health benefit. The process requires public consultation on the draft recommendations a,b,f. In addition, sequential peer review of the final recommendations is provided by the FMCH, the UK NSC and the Department of Health. The model of best practice a is updated every 3 years as stated in the SOP NHS FASP policy standards review process document b. This process involves a complete revision of the guidance including a literature review, identification of stakeholders, review of the evidence, development of recommendations and public consultation before signoff by the Department of Health. Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 13 of 22

14 Domain Criterion Evidence for meeting the criterion Accreditation decision Clarity and 4. Does the guidance producer ensure that: presentation 4.1. Recommendations are specific, unambiguous and clearly identifiable 4.2. Different options for the management of the condition or options for intervention are clearly presented 4.3. The date of search, the date of publication or last update and the proposed date for review are clearly stated 4.4. The content of the guidance is suitable for the specified target audience (if patients or service users are part of this audience, the language should be appropriate) No process governing the presentation of the recommendations has been provided, but this is a single guideline application so evidence of implementation is sufficient to meet this criterion. The recommendations in the model of best practice a are specific and unambiguous, presented in tables or in the main text of the document. Style and font changes are not used to highlight the recommendations, which might make them easier to identify, although the individual sections have clear headings. The different options for screening and confirmatory testing are clearly presented within the text of the model of best practice a The Department of Health coversheet requires the date of publication to be given. Both the date range covered by the search strategy and the date the search was performed are stated in appendix 3 of the model of best practice a, which is fit for purpose. The title of the model a clearly indicates that the guidance is valid from 2011 to It is clear from examination of the model of best practice a that the content is suitable for healthcare professionals who are the primary target audience. The content and language is necessarily technical given the subject matter. Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 14 of 22

15 Domain Criterion Evidence for meeting the criterion Accreditation decision Applicability 5. Does the guidance producer routinely consider: Editorial independence 5.1. Publishing support tools to aid implementation of guidance 5.2. Potential organisational and financial barriers in applying its recommendations 5.3. Review criteria for monitoring and/or audit purposes within each product 6. Does the guidance producer: 6.1. Ensure editorial independence from the funding body Support tools are routinely published to aid implementation of the guidance e,g. The NHS FASP website contains a range of support tools for both healthcare professionals and the public that specifically relate to screening for Down s syndrome g. The decision planning tool e allows decisionmakers to conduct economic analyses of different screening strategies. No process requirement has been provided that requires the discussion of organisational and financial barriers in the model, but these issues are discussed in the model of best practice a and supporting tools. Review criteria for audit are discussed in the model of best practice a, in the section Quality assurance. Key audit criteria such as the detection rate and screen positive rate are provided, along with recommendations to help achieve these targets. Responsibility for external audit lies with DQASS, as explained in the model of best practice a. The funding source is the Department of Health h. Although the Department retains final sign-off of the guidance, the process minimises the potential for undue influence. This is achieved by commissioning an independent literature review and using increasingly larger groups of experts and stakeholders to develop the recommendations, culminating in public consultation. Given the non-commercial nature of the funding source, this is considered fit for purpose. Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 15 of 22

16 Domain Criterion Evidence for meeting the criterion Accreditation decision 6.2. Demonstrate transparency about the funding mechanisms for its guidance 6.3. Record and state any potential conflicts of interest of individuals involved in developing the recommendations 6.4. Take account of any potential for bias in the conclusions or recommendations of the guidance The publically available document FASP_Annual_Report_09-10LR h confirms that the model of best practice is funded by the Department of Health. There is a conflicts of interest policy i. The guidance producer confirmed that all members of the National Working Group and the Steering Group, including patient group representatives, and all independent consultants are required to declare conflicts of interest. A minority of people, including peer reviewers, were not required to declare conflicts of interest so this criterion remains not fully met. The guidance producer acknowledges this oversight and will amend the process for the next update. The process ensures editorial independence from the funding source by the development of recommendations by a wide range of stakeholders. This approach minimises the potential for bias from any one stakeholder while ensuring the consideration of a variety of viewpoints. The potential for bias arising from undeclared conflicts of interest by a minority of individuals noted in criterion 6.3 is accounted for by the wide range of stakeholders involved and the extensive review process before publication b,f. Not fully met Documents submitted: a Screening policy for Down s syndrome: UK NSC policy recommendations : model of best practice b SOP NHS FASP policy standards review process c 8th June Attendee List members of the Steering Group and National Working Group attending the guidance development meeting d Bryant et al. (2010) Literature Survey for the Review of Down s Syndrome Screening Policy 2010, Socio-economic Research and Intelligence Observatory, University of Plymouth e Decision planning tool Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 16 of 22

17 Documents submitted: f PID MoBP 2010 g h FASP Annual Report 2009/10 i Conflicts of interest policy Down s syndrome: UK NSC policy recommendations : model of best practice': Draft Accreditation Report Page 17 of 22

18 Appendix B Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the Committee. Document name Description Location 8th June 2010 Attendee List a_programme 8th June 2010 Accreditation Form May 2011 v.2 DK b_mobp round table groups 8 June 2010 Brandguidelines_Final_V5 _MWL_[FASP14] c_mobp questions for round table discussion groups June d_down's Presentation (2) Lyn Bryant Diagnostic Procedures Nov 2010 e_mobp NATIONAL WORKING GROUP LIST CHERUBS teleconference April 2010 f_isuog invitation to 8 June MoBP stakeholder meeting 2010 FASP_Annual_Report_09-10LR g_hewison[1] ppp h_agenda 22 SEPT 2010 i_fasp STEERING GRP minutes Nov 2010 Attendee list for the 8 June 2010 meeting to review the evidence base and draft recommendations Agenda for the Down s syndrome model of best practice review meeting on 8 June 2010 Application form for NHS Evidence accreditation Participants in round table discussions on 8 June 2010 Branding guidelines for NHS FASP guidance Model of best practice questions for working groups on 8 June 2010, covering possible stakeholder issues and resource implications Presentation: Literature survey for the review of Down s syndrome screening Policy 2010 Association of Clinical Cytogeneticists invasive procedures data Membership of the national working group for guidance development Details of teleconference with CHERUBS (congenital diaphragmatic hernia support charity) Invitation to the International Society for Ultrasound in Obstetrics and Gynaecology 8 June 2010 National Stakeholder Meeting National report, including statement that the guidance is funded by the Department of Health Presentation: Psychosocial aspects of genetic screening of pregnant women and newborns: a systematic review Agenda for Down s syndrome screening model of best practice review meeting Minutes of the steering group meeting on 26 November 2010 Draft Accreditation Report Page 18 of 22

19 i_letter to PETER S MoBP review group re cons feedback DK j_decision analysis tool draft j_spr by cycle l_mobp consultation (2) DK letter to UKNSC and FMCH Jan 2011 Minutes Downs policy review final Model of Best Practice - v3 FASP75 NHS FASP Steering Group Membership NR1 MoBP 12pp A4[1] final o_fasp & Elfrieda DS_Book_August_09[1] p_key messages slides March 2011 PID MoBP 2010 DK q_education and training template r_rosco Manual FINAL s_dqass_working_structur e[1] SERIO SURVEY (2) SOP NHS FASP policy standards review process Stakeholder comments returns log t_ultrasound_survey_200 8_Report[1] u_antenatal ultrasound survey 2005 Whittle v_declaration of interests form Letter showing model of best practice stakeholder comments to be discussed by review group Paper outlining development of analysis relating to T21 screening Evidence supporting harm and cost reduction if recommendations are followed Letter to all UKNSC and FMCH members inviting consultation comments on the model of best practice Minutes of the review of Down s syndrome screening policy 2010 meeting on 7 April 2010 The edition of the model of best practice confirming role and membership of the NHS FASP Steering Group Model of best practice policy and standards Patient information presentation on Down s syndrome screening Slides on NHS antenatal screening programmes Project initiation document for the model of best practice guidance review Overview of obstetric ultrasound study day, training programme for midwives as part of continuous professional development Regional Obstetric Ultrasound Support Coordinator manual Down s Syndrome Screening Quality Assurance Support Service working structure Literature review for the review of Down s syndrome screening policy 2010 Standard Operating Procedure for producing NHS FASP guidance Log of model of best practice stakeholder comment forms Antenatal ultrasound survey of England 2008: mapping the provision of 1st and 2nd trimester ultrasound screening for fetal abnormality in England Survey of ultrasound use in England Declaration of interests form supplied supplied Draft Accreditation Report Page 19 of 22

20 Appendix C: NHS Evidence Advisory Committee, external advisers and NHS Evidence accreditation team NHS Evidence Accreditation Advisory Committee The NHS Evidence Accreditation Advisory Committee operates as a standing advisory committee of the Board of the National Institute for Health and Clinical Excellence (NICE). The Committee provides advice to NICE on a framework for accrediting sources of evidence that should be recognised as trusted sources of information for the NHS. The chair of the Committee is appointed by the NICE Board and the meetings are conducted by the chair, or in his/her absence the vice chair. The current Chair is David Haslam. A full list of the Accreditation Advisory Committee membership is available on the NICE website 3. Members are appointed for a period of 3 years. This may be extended by mutual agreement for a further 3 years, up to a maximum term of office of 10 years. The decisions of the Committee are arrived at by a consensus of the members present. The quorum is set at 50% of committee membership. The Committee submits its recommendations to the NICE Publication Executive which acts under delegated powers of the NICE Board in considering and approving its recommendations. Committee members are asked to declare any interests in the guidance producer to be accredited. If it is considered that there is a conflict of interest, the member is excluded from participating further in the discussions. Committee members who took part in the discussions for this accreditation decision are listed below. 3 Draft Accreditation Report Page 20 of 22

21 Title Name Surname Role Organisation Ms Judy Birch Lay Member Mr Jim Blair Consultant Nurse Learning Disabilities Mr Richard Brownhill Unscheduled Care Lead Ms Lynda Cox Head of Transformation Ms Amanda Edwards Deputy Chief Executive Ms Joyce Epstein Lay Member St. George's Healthcare NHS Trust Stepping Hill Hospital Stockport Foundation Trust NHS North East Social Care Institute for Excellence Professor David Haslam President British Medical Association Dr Bobbie Jacobson Director London Health Observatory Dr Monica Lakhanpaul Senior Lecturer / Consultant Paediatrician Ms Ruth Liley Assistant Director of Quality Improvement Professor Stuart Logan Professor of Paediatric Epidemiology Dr Donal O'Donoghue National Clinical Director for Kidney Care & Consultant Renal Physician Professor Sandy Oliver Professor of Public Policy, Deputy Director Dr Carl Parker Primary Care Medical Advisor Dr Karen Ritchie Head of Knowledge Management Professor Sasha Shepperd University Research Lecturer Ms Ann Slee Director of Pharmacy and Medicines Management Leicester Children's Community Health Service Marie Curie Cancer Care Peninsula College of Medicine & Dentistry Salford Royal NHS Foundation Trust Cochrane Consumers and Communication Review Group, University of London North Tees and Hartlepool Foundation Trust Healthcare Improvement Scotland University of Oxford University Hospitals Birmingham NHS Foundation Trust Draft Accreditation Report Page 21 of 22

22 Dr Peter Smith Vice President National Association of Primary Care Ms Gill Swash Head of Knowledge and Library Services NHS Western Cheshire External advisers for the NHS Fetal Anomaly Screening Programme UK National Screening Committee Screening for Down s syndrome: UK NSC policy recommendations : model of best practice accreditation application Professor António Vaz Carneiro, Head of Centre for Evidence Based Medicine, University of Lisbon, Portugal Dr Claire Harris, Director, Centre for Clinical Effectiveness, Southern Health, Melbourne, Australia. Adjunct Associate Professor, School of Public Health and Preventive Medicine, Monash University, Australia Anne Thurston, Health Sector Relations Officer, National Osteoporosis Society, UK NHS Evidence accreditation team for the NHS Fetal Anomaly Screening Programme UK National Screening Committee Screening for Down s syndrome: UK NSC policy recommendations : model of best practice application James Stone, Accreditation Technical Analyst, NHS Evidence, National Institute for Health and Clinical Excellence, Manchester, UK Stephanie Birtles, Accreditation Technical Analyst, NHS Evidence, National Institute for Health and Clinical Excellence, Manchester, UK Draft Accreditation Report Page 22 of 22