Final Accreditation Report

Guidance producer: Royal College of Surgeons of England: Surgical Specialty Associations Guidance product: Clinical Commissioning Guides Date: 28 February 2013 Version: 1.3 Final Accreditation Report Royal College of Surgeons of England: Surgical Specialty Associations Clinical Commissioning Guides: Final Accreditation Report Page 1 of 20

Contents Introduction... 3 Accreditation recommendation... 3 Background to the producer... 3 Implementation... 5 Appendix A: NICE Accreditation analysis... 6 Appendix B: Bibliography... 15 Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team... 18 Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 2 of 20

Introduction The NICE Accreditation Programme recognises organisations that demonstrate high standards in producing health or social care. Users of the accredited can therefore have high confidence in the quality of the information. Organisations may publicly display a seal of approval called an Accreditation Mark for 5 years after their processes have been accredited. The process for accrediting producers of and recommendations for practice is described in the process manual. Accreditation recommendation NICE has accredited the process used by the Royal College of Surgeons of England: Surgical Specialty Associations to produce clinical Commissioning Guides. Accreditation is valid for 5 years from February 2013 and is applicable to produced using the processes described in the Commissioning process manual (2012). Background to the producer The Royal College of Surgeons of England (RCSEng) aims to enable surgeons to achieve and maintain the highest standards of surgical practice and patient care. The College is made up of 10 directorates, known as the Surgical Specialty Associations (SSA). Each of these 10 directorates is responsible for a different surgical area. The commissioning programme was established in 2011 as an outcome of the Department of Health s Quality, Innovation, Productivity and Prevention (QIPP) Right Care Elective Surgery Report, which proposed that the NHS Commissioning Board support the development of Value Based Clinical Commissioning Guidance for elective surgical care pathways. Each Clinical Commissioning Guide describes how to commission a service for a particular specialty. From April 2013 funding will come from the NHS Commissioning Board. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 3 of 20

Summary The Accreditation Advisory Committee considered that the processes used by the Royal College of Surgeons of England: Surgical Specialty Associations to produce Clinical Commissioning Guides demonstrated compliance with all of the 25 criteria for accreditation. The Clinical Commissioning Guides are clear in their scope and purpose and the development process includes a variety of professional stakeholders and target users, with lay input at all stages of development. The Clinical Commissioning Guides result from a systematic process that considers the risks and benefits of recommendations. The guides show consideration of the likely impact of the recommendation from a clinical and patient perspective, the population affected, and resource implications and the potential organisational, economic, cultural and political barriers to implementation. Suggestions to improve the process used to produce the Royal College of Surgeons of England: Surgical Specialty Associations Clinical Commissioning Guides include: ensuring the conflicts of interest declarations are publicly available strengthening the process for how peer reviewers are selected. Professor David Haslam, CBE Chair, Accreditation Advisory Committee February 2013 Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 4 of 20

Implementation Following accreditation, from the accredited producer will be identified on NHS Evidence by the Accreditation Mark. The accredited producer is also granted a royalty-free, worldwide licence to use the NICE Accreditation Mark in accordance with the Conditions and Terms of Use. Providing these conditions are met, a producer s accreditation will last for 5 years from the date accreditation was awarded. Accredited producers must take reasonable steps to ensure the accredited processes are followed when generating the type of evidence for which they are accredited. Accredited producers should have quality assurance mechanisms in place and must inform NICE Accreditation within 30 days if any significant change is made to a process. Figure 1: The Accreditation Mark Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 5 of 20

Appendix A: NICE Accreditation analysis The Accreditation Advisory Committee considered the following analysis of the producer s compliance with NICE Accreditation criteria, which covers 6 discrete domains. The full analysis leading to the accreditation decision is shown below. Criterion Evidence for meeting the criterion Accreditation decision Does the producer have a policy in place and adhered to that requires them to explicitly detail: 1.1 Overall objective Section 1 of the process manual a specifies the overall aims of the commissioning guides and the commissioning guide programme, describing what is within and outside the scope for the commissioning guide programme. Scope and purpose 1.2 The clinical, healthcare or social questions covered Section 2 of the process manual a states that the development of Clinical Commissioning Guides is prioritised against criteria such as the burden of disease, clinical priority or NHS Commissioning Board priority area. In addition, the manual states that commissioning covers care pathways for patients with conditions amenable to surgical intervention. The questions are generic commissioning questions aligned with the pathway for a surgical speciality. The clinical Commissioning guide examples b g reviewed give the pathway in section 1 High value care pathway along with the context for commissioners in the Introduction. Royal College of Surgeons of England: Surgical Specialty Associations Clinical Commissioning Guides: Final Accreditation Report Page 6 of 20

Criterion Evidence for meeting the criterion Accreditation decision 1.3 Population and/or target audience to whom the applies 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances Section 2 of the process manual a explains that the intended audience is primarily commissioning staff in primary care organisations, local health authorities and clinical commissioning groups (CCGs) across a care pathway for a surgical intervention. The examples b g reviewed all indicate the target audience and population covered by the in the titles and this population is further subdivided within the guide in specific circumstances. Section 6 of the process manual a describes the process for structuring recommendations and what should be considered when formulating the recommendations. Appendix 3 is the template for commissioning, which demonstrates the format for the Clinical Commissioning Guides. Does the producer have a policy in place and adhered to that means it includes: Stakeholder involvement 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing Section 3 of the process manual a describes the roles and composition of the Guideline Development Group (GDG). A terms of reference template for GDGs is provided in Appendix 1. The process states that 2 lay members will be part of each GDG. In all examples b g reviewed, section 7.4 Guideline Development Group contains a table with the headings Name, Job title and Affiliation, which demonstrates evidence of the process in practice. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 7 of 20

Criterion Evidence for meeting the criterion Accreditation decision 2.2 Patient and service user representatives and seeks patient views and preferences in developing 2.3 Representative intended users in developing Section 3 of the process manual a states that at least 2 patient representatives form part of the GDG. Patient involvement is secured through contact with patient representative groups linked to the relevant surgical specialty association or through a patient organisation linked to the topic under consideration. Patient representatives are afforded equal standing to their clinical counterparts. Section 8 describes the peer reviewers, one of whom must be a patient. Section 3 of the process manual a describes the proposed composition of the GDG, which includes commissioners. Section 8 indicates that a CCG commissioner is essential for the composition of the peer reviewers. Evidence of commissioner involvement was provided for the examples b g reviewed. Does the producer have a clear policy in place that: Rigour of development 3.1 Requires the producer to use systematic methods to search for evidence and provide details of the search strategy Section 4 of the process manual a describes the steps that need to be taken by the information specialists performing the systematic literature search on a topic. The information specialists provide details of the systematic literature search, including the search strategy, databases and dates searched. In addition, section 4 describes the use of the questions in informing the search. If the search retrieves only a small number of relevant results, the GDG will widen the search to include grey literature. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 8 of 20

Criterion Evidence for meeting the criterion Accreditation decision 3.2 Requires the producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review 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 manual a states that evidence should be selected according to defined inclusion and exclusion criteria. All evidence is appraised and included or excluded in accordance with the relevance to the questions and search strategy. In addition, section 5 of the manual explains how evidence is graded according to its strength and any specific exclusions arising from this grading should be recorded. Section 5 of the process manual a describes the producer s approach to grading the strength of the evidence. The SIGN 50 criteria are documented for use as well as the need for critical appraisal of evidence. A number of checklists have been provided covering a range of studies, such as case control studies, cohort studies and economic evaluation studies. Examples of completed critical appraisal checklists and evidence tables were provided to demonstrate compliance with the documented process. Sections 5 and 6 of the process manual a describe the process followed to arrive at recommendations, namely informal consensus based on the evidence. In circumstances when consensus cannot be achieved, the GDG may proceed to a vote. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 9 of 20

Criterion Evidence for meeting the criterion Accreditation decision 3.5 Requires the 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 and maintaining and improving quality Section 7 of the process manual a verifies the submission by the producer above. In addition, Appendix 3 of the manual indicates where the risks and benefits will be presented in the clinical Commissioning guides. In all examples b g reviewed, section 6 documents any benefits and risks found under the headings: patient outcome, patient safety, patient experience, equity of access and resource impact. Section 8 of the process manual a states that formal peer review is required for each guide by at least 3 independent referees who have had no prior involvement in the development process. Reviewers are appointed by the sponsoring organisation and will include 1 patient, 1 commissioner and 1 clinician, and piloting. Draft is made available for comment for at least 4 weeks, inviting comments from key stakeholders. The manual also describes the circumstances under which piloting occurs. Clinical Commissioning Guides are reviewed every 3 years from the date of publication, although interim updates within this period may be required. At the time of preparing this accreditation report (February 2013), no guide has been updated because the guides have only recently been produced, however the process for updating is in place and is given consideration during development. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 10 of 20

Criterion Evidence for meeting the criterion Accreditation decision Does the producer ensure that: 4.1 Recommendations are specific, unambiguous and clearly identifiable Section 6 of the process manual a describes how the recommendations should be structured. It also states that the language used in the clinical Commissioning guides should be clear and unambiguous, using clearly defined terms to ensure shared understanding by all users. Appendix 3 of the manual clarifies the format for recommendations. All examples b g reviewed demonstrate implementation of this process and all recommendations made by the are specific and identifiable. Clarity and presentation 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 is suitable for the specified target audience. If patients or service users are part of this audience, the language should be appropriate Section 6 of the process manual a describes how the options for treatment or intervention should be documented in the guides. Clinical Commissioning guide examples b g suggest more than 1 approach to treatment or management of a condition, if relevant. The front page of Clinical Commissioning Guides gives the date of the evidence search, date of publication and proposed date for review, as documented in Appendix 3 of the process manual a. Sections 3 and 8 of the process manual a state that CCG commissioners are core members of the GDG and peer reviewers. The intended audience is primarily commissioning staff in primary care organisations, local health authorities and clinical commissioning groups across a care pathway for a surgical intervention. All examples b g reviewed are written using language suitable for all these professionals. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 11 of 20

Criterion Evidence for meeting the criterion Accreditation decision Does the producer routinely consider: 5.1 Publishing support tools to aid implementation of Section 6 of the process manual a states that support tools to aid implementation of high-value care pathways should be included. In addition, section 9 of the manual describes the dissemination strategy of the guides and shows how the producer encourages implementation of the guides through initiatives such as speaking at conferences, writing articles for journals, supporting workshops and other events. All examples b g reviewed contain topic-specific information in sections such as: procedures explorer, quality dashboard and levers for implementation. Applicability 5.2 Discussion of potential organisational and financial barriers in applying its recommendations Section 6 of the process manual a documents the information described by the producer above. Discussion of potential financial and organisational barriers to implementation is critical for to be effective. The GDG considers the likely impact of the recommendations from a clinical and patient perspective, the population affected, resource implications and the potential organisational, economic, cultural and political barriers to implementation. All examples b g include information about the evidence and recommendations in relation to QIPP when possible. 5.3 Review criteria for monitoring and/or audit purposes within each product Section 6 of the process manual a explains how the interventions are linked with the procedures explorer, quality dashboards and levers for implementation in order to provide CCG commissioners with the means to monitor and/or audit progress against specific clinical Commissioning guides recommendations. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 12 of 20

Criterion Evidence for meeting the criterion Accreditation decision Does the producer: 6.1 Ensure editorial independence from the funding body The Department of Health provided the RCSEng with funding for this project and has no influence over the content of the clinical Commissioning guides. From April 2013 the funding will come from the NHS Commissioning Board. The RCSEng provides project management and coordination support to the SSA, but again does not influence the content of the clinical Commissioning guides because this is entirely the responsibility of the SSA. Editorial independence 6.2 Demonstrate transparency about the funding mechanisms for its Section 11 of the process manual a states that any sources of funding received towards the development of Clinical Commissioning Guides will be explicitly mentioned in the published clinical Commissioning guide. Accountability arrangements include a governance framework that handles potential conflicts of interest. 6.3 Record and state any potential conflicts of interest of individuals involved in developing the recommendations Sections 3 and 8 of the process manual a describe the conflict of interest policy, and give the Conflicts of interest form in Appendix 2. The declaration of interests process does not preclude the individual from taking part in the development process and does not imply that they have been influenced by their interest. This approach allows the GDG to see any potential conflicts of interest and take this into account when considering an individual s contribution The conflicts of interest process used by the SSA is specific to its development process, inclusive of all involved in guideline development, divided into categories, up to date and clear in how conflicts are taken into account. Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 13 of 20

Criterion Evidence for meeting the criterion Accreditation decision 6.4 Take account of any potential for bias in the conclusions or recommendations of the The funding source is transparent. The process manual requires a systematic evidence search and recommendations are reached by a multidisciplinary group before consultation and peer review by a large number of specialists, which helps to reduce the potential for bias from any individual. a Commissioning process manual (2012) b Clinical Commissioning guide for foreskin conditions c Clinical Commissioning guide for inguinal hernia d Clinical Commissioning guide for lower urinary tract symptoms e Clinical Commissioning guide for obesity f Clinical Commissioning guide for scrotal swelling g Clinical Commissioning guide for rectal bleeding Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 14 of 20

Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the Committee. Document name Description Location Commissioning Guidance Process Manual Process manual Clinical Commissioning guide for foreskin conditions Draft commissioning Clinical Commissioning guide for inguinal hernia Draft commissioning Clinical Commissioning guide for Lower Urinary Tract Symptoms Draft commissioning Clinical Commissioning guide for obesity Draft commissioning Clinical Commissioning guide for rectal bleeding Draft commissioning Clinical Commissioning guide for scrotal swelling Draft commissioning Conflict of Interest Declaration Supporting process document Royal College of Surgeons of England: Surgical Specialty Associations Clinical Commissioning Guides: Final Accreditation Report Page 15 of 20

Document name Description Location Feedback Form Supporting process document Peer Review Form 2 Supporting process document CASP_Case- Control_Appraisal_Che cklist_14oct10 Checklist used for evidence assessment CASP_Cohort_Apprais al_checklist_14oct10 Checklist used for evidence assessment CASP_Diagnostic_Appr aisal_checklist_14oct1 0 Checklist used for evidence assessment CASP_Economic_Evalu ation_checklist_14oct1 0 Checklist used for evidence assessment CASP_Qualitative_Appr aisal_checklist_14oct1 0 Checklist used for evidence assessment CASP_RCT_Appraisal_ Checklist_14oct10 Checklist used for evidence assessment CASP_Systematic_Revi ew_appraisal_checklist _14oct10 Checklist used for evidence assessment Clinical-Prediction-Rule- Checklist used for evidence Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 16 of 20

Document name Description Location CASP-checklist assessment LOWER URINARY TRACT SYMPTOMS doc Workshop findings for evidence searching LOWER URINARY TRACT SYMPTOMS ppt Presentation of the evidence Three peer review feedback form Complete peer review form Four feedback requests Email requesting feedback Three conflict of interest declaration forms Completed conflict of interest form Feedback and actions_draft_lower URINARY TRACT SYMPTOMS Comments and actions on feedback Final draft_lower URINARY TRACT SYMPTOMS Draft for signoff Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 17 of 20

Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team NICE Accreditation Advisory Committee The NICE 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. 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 Publications 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 producer to be accredited. If it is considered that there is a conflict of interest, the member(s) is excluded from participating further in the discussions. Committee members who took part in the discussions for this accreditation decision are listed below. Title Name Surname Role Organisation Mr Jim Blair Consultant Nurse Learning Disabilities Dr Adrian Brown Consultant in Public Health Medicine Professor Ann Caress Professor of Nursing/Director of Postgraduate Research Programmes St. George s Healthcare NHS Trust Inner North West London PCTs University of Manchester Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 18 of 20

Ms Ailsa Donnelly Lay member Ms Amanda Edwards Deputy Chief Executive Ms Joyce Epstein Lay member Social Care Institute for Excellence Professor David Haslam National Clinical Adviser Care Quality Commission Dr Bobbie Jacobson Director of London Health Observatory and Vice Chair of London Health Observatory PH Observatories Professor Monica Lakhanpaul Consultant Community Paediatrician/Senior Lecturer Leicestershire Partnership Trust in Child Health Dr Edward Ng General Practitioner Ley Hill Surgery Dr Donal O Donoghue National Clinical Director for Kidney Care and Consultant Renal Physician Salford Royal NHS Foundation Trust Professor Sandy Oliver Professor of Public Policy, Deputy Director, Social Science Research Unit, Cochrane Consumers and University of London Communications Review Group Dr Carl Parker Primary Care Medical Adviser North Tees and Hartlepool Foundation Trust Dr Mahendra Patel Research Fellow, Senior Lecturer and Community Pharmacist Dr Karen Ritchie Head of Knowledge Management Professor Sasha Shepperd Professor of Health Services Research Universities of Huddersfield and Bradford Healthcare Improvement Scotland University of Oxford Dr Mark Strong MRC Fellow Section of Public Health, SCHARR Ms Gill Swash Head of Knowledge and Library Services NHS Western Cheshire Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 19 of 20

External Advisers for The Royal College of Surgeons of England, Surgical Specialty Associations Clinical Commissioning Guides accreditation application Helen Crisp, Assistant Director Research and Evaluation, The Health Foundation, London, UK Karen Macpherson, Lead Health Services Researcher, Healthcare Improvement Scotland, Edinburgh, UK Adrian Reyes-Hughes, Clinical Consultant (Clinical Strategy & Health Information Services), Hampshire, UK Victoria Wilkinson, Primary Care Research Network NW Manager, NHS Halton & St Helens, Newton Le Willows, UK NICE Accreditation team for The Royal College of Surgeons of England, Surgical Specialty Associations Clinical Commissioning Guides accreditation application Stephanie Birtles, Accreditation Technical Analyst, National Institute for Health and Clinical Excellence, Manchester, UK Paul Chrisp, Associate Director, Accreditation, National Institute for Health and Clinical Excellence, Manchester, UK Royal College of Surgeons of England: Surgical Specialty Associations commissioning guides: Final Accreditation Report Page 20 of 20