Guidance producer: Royal College of Physicians (RCP) Guidance product: National Clinical Guidelines for Stroke Date: 29 June 2010 Final Accreditation Report
Contents Contents... 2 Introduction... 3 Implementation... 6 Appendix A: NHS Evidence accreditation analysis... 7 Appendix B: Bibliography... 15 Appendix C: Advisory Committee members, external advisers and NHS Evidence accreditation team... 16
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 can publicly display a seal of approval called an Accreditation Mark for three 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 NHS Evidence has accredited the process used by the Royal College of Physicians (RCP) to produce the National Clinical Guideline for Stroke. Accreditation is valid for three years from June 2010 and is retrospectively applicable to guidance produced using the processes described in The NICE Technical Manual 2007 and the SIGN 50: A guideline developer s handbook manual, 2008. Background to the guidance producer The Royal College of Physicians is a registered charity that plays a leading role in supporting high quality patient care, by setting standards of medical practice and promoting clinical excellence. The Royal College of Physicians is involved in developing a wide range of clinical guidelines and guidance for physicians. These include NICE guidelines (developed by the National Clinical Guideline Centre [NCGC] which is hosted by the Royal College of Physicians), concise guidelines in collaboration with specialist societies, UK guidelines 1 http://www.nice.org.uk/nhsevidence/aboutaccreditation/aboutaccreditation.jsp?domedia=1&mid= 27C232A0-19B9-E0B5-D4A11FA899F4C219
and working party reports. This accreditation submission is only for the unique process used to develop the Stroke guideline. Other guidelines are produced using a range of different processes. Summary The Advisory Committee considered that the Royal College of Physicians Stroke guideline demonstrates compliance with 24 of the 25 criteria for accreditation. Processes for the production of the Royal College of Physicians Stroke guideline are described in the The NICE Technical Manual 2007 and the SIGN 50: A guideline developers handbook manual. The Royal College of Physicians Stroke guideline is produced using processes from NICE and SIGN that have already been accredited. The Royal College of Physicians Stroke guideline also incorporates the guideline on acute management of Stroke developed by the NCGC for NICE. The Stroke guideline is clearly presented and up to date. Multiple stakeholders, including patients, are involved in developing this guideline and there is a comprehensive peer review process. Systematic methods are used to identify evidence for the guideline s development. However, there is no information on the dates of the search strategy used to identify evidence considered in the guideline. Suggestions to further strengthen Royal College of Physicians processes for developing the Stroke guideline include: The dates of search used in the search strategy should be clearly stated within the guideline or the associated documentation. There should be greater clarity around which specific aspects of the manuals are used at which steps in the process to develop the guideline. David Haslam Chair, Advisory Committee
June 2010
Implementation Following accreditation, guidance from the accredited producer will be identified on NHS Evidence by the Accreditation Mark. The accredited guidance producer is 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 three 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 of any significant change to a process within 30 days. Figure: The NHS Evidence Accreditation Mark 2 http://www.nice.org.uk/nhsevidence/?domedia=1&mid=5ae1d938-19b9-e0b5- D471CA81220F57DA
Appendix A: NHS Evidence accreditation analysis The 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 decision is shown below. Domain Criterion Evidence for meeting the criterion Accreditation decision Does the guidance producer have a policy in place and adhered to that requires them to explicitly detail: 1.1 Overall objective The overall objective is clearly defined and implemented in the Stroke c guideline as described in the process manuals a, b. The objective of the guideline is stated on page 6 section 1.4 of the Stroke guideline. Scope and purpose 1.2 The clinical, healthcare or social questions covered The clinical questions are clearly defined and implemented in the Stroke c guideline as described in the process manuals a, b. Section 2 of the Stroke guideline documents the Scope. This shows what clinical areas will and will not be covered by the guideline. 1.3 Population and/or target audience to whom the guidance applies The population and target audience is clearly defined and implemented in the Stroke c guideline as described in the process manuals a, b. The information provided by the guidance producer in its response to this criterion can be found in section 1.4 of the Stroke guideline.
Domain Criterion Evidence for meeting the criterion Accreditation decision 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances The recommendations are clearly linked to specific clinical circumstances in the Stroke c guideline as described in the process manuals a, b. The structure of the guideline means that the clinical question is indicated as the title, the patient population and situation is indicated in the introduction and the recommendations for this specific set of circumstances are stated. Does the guidance producer have a policy in place and adhered to that means it includes: Stakeholder 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance The production of the Stroke c guideline includes individuals from relevant stakeholder groups including patients, as described in the process manuals a, b. The composition of the guideline development group is documented on page viii of the Stroke guideline which shows the wide involvement range of disciplines represented and documents the member affiliations to the professional bodies. 2.2 Patient and service user representatives and seeks patients views and preferences in developing guidance The production of the Stroke c guideline includes patients views as described in the process manuals a, b. Organisations represented include groups such as the Stroke Association and Speakablity.
Domain Criterion Evidence for meeting the criterion Accreditation decision 2.3 Representative intended users in developing guidance. Intended users are involved in the development of the Stroke c guideline described in the process manuals a, b. Representative intended users involvement in the production of the guideline is shown in the composition of the guideline development group, the peer reviewers and the evidence table reviewers. Does the guidance producer have a clear policy in place that: Rigour of development 3.1 Requires the guidance producer to use systematic methods to search for evidence and provide details of the search strategy Systematic methods are used to search for evidence on which the Stroke c guideline is based and the search strategy detailed as described in the process manuals a, b. The evidence tables and information about which databases are used in the production of the guideline satisfy this criterion. 3.2 Requires the guidance producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review The inclusion and exclusion criteria are defined in the production of the Stroke c guideline as described in the process manuals a, b. A set of validated checklists are used to assess the evidence quality and the inclusion and exclusion criteria are noted.
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 The strength and limitations of the evidence are defined in the production of the Stroke c guideline as described in the process manuals a, b. Sections 1.6.5 and 1.6.6 of the Stoke guideline explain how the recommendations are reached from the evidence and how the strength of the recommendations is derived. 3.4 Describes the method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) 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 The method used to arrive at recommendations in the Stroke c guideline is explained in the process manuals a, b. Consensus recommendations are based on the collective views of the guideline development group. The risks versus health benefits are considered in the production of the Stroke c guideline as described in the process manuals a, b. The risks/ benefits are assessed during the development of the clinical questions using the model documented in the process manuals a,b. The peer review process used in the production of the Stroke c guideline is clearly defined as described in the process manuals a, b. Section 1.6.7 of the Stroke c guideline explains the peer review process. The peer reviewers are listed on pages 147-148.
Domain Criterion Evidence for meeting the criterion Accreditation decision 3.7 Describes the process of updating guidance and maintaining and improving guidance quality The process of updating and maintaining guidance quality is observed in the Stroke c guideline as described in the process manuals a, b. The guideline is updated on a four year cycle and therefore the date for review documented on the inside cover of the Stroke guideline is 2012. Does the guidance producer ensure that: 4.1 Recommendations are specific, unambiguous and clearly identifiable All recommendations in the Stroke c guideline are specific, unambiguous and clearly identifiable as described in the process manuals a, b. Section 1.7.1 of the Stroke c guideline states that recommendations are labelled as such and are designed to be specific and unambiguous. 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 Different options for the management of Stroke c are clearly presented in the guideline as described in the process manuals a, b. Different options for the management of each aspect of stroke are clearly presented. No dates of search used when gathering the evidence on which the Stroke c guideline is based could be found. The criterion requires that the date of search is clearly stated and therefore due to the omission of these dates from the guidelines and evidence tables means this criterion is not Not fully met fully met.
Domain Criterion Evidence for meeting the criterion Accreditation decision 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. Does the guidance producer routinely consider: The content of the Stroke c guideline is suitable for its target audience as described in the process manuals a, b. 5.1 Publishing support tools to aid implementation of guidance Support tools are published to aid implementation of the Stroke c guideline by the Royal College of Physicians. For example the profession specific concise guidelines are from page 110 to 144 of the Stroke c guideline. Applicability 5.2 Discussion of potential organisational and financial barriers in applying its recommendations Potential barriers to applying the recommendations in the Stroke c guideline have been considered during its production. For example, chapter 2 of the guideline addresses Commissioning, and Section 1.12 discusses the Cost of stroke care. 5.3 That their guidance is current, with review criteria for monitoring and/or audit purposes within each product. The Stroke c guideline is current and audit of the uptake and use of this guideline is undertaken. Comprehensive information detailing the monitoring of implementation activities run by the Stroke Programme at the Royal College of Physicians can be found on the website.
Domain Criterion Evidence for meeting the criterion Accreditation decision Does the guidance producer: 6.1 Ensure editorial independence from the funding body The Stroke c guideline is editorially independent from the funding body. The guideline development group oversees development, and the methodology ensures all views are considered appropriately. Use of external peer review is also considered as part of the governance. Editorial independence 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 funding mechanism for the production of the Stroke c guideline is transparent. The details of the funding for the Stroke c guideline can be found in section 1.16 of the guideline. Conflicts of interest are stated and recorded as described in the process manuals a, b. Section 1.16 of the Stroke c guideline gives the details of the conflicts of interest policy followed for the production of this guideline The Stroke c guideline production minimises bias via a combination of the composition of the GDG, declaration of interests, stakeholder consultation and review, as described in the process manuals a, b. a The NICE Technical Manual 2007 b SIGN 50: A guideline developer s handbook c National Clinical Guideline for Stroke
Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the Committee. Document name Description Location National clinical guideline for stroke, Guideline assessed as evidence third edition Evidence Table third Evidence table for the edition guideline above NICE The guidelines The third edition of the NICE manual 2007 guideline manual 2007. SIGN 50: A guideline The 2008 guideline developers handbook development manual from SIGN Stroke NCGC guideline for comparison. http://www.rcplondon.ac.uk/pubs/contents/6 ad05aab-8400-494c-8cf4-9772d1d5301b.pdf http://www.rcplondon.ac.uk/pubs/contents/f5 3c6451-69e0-44aa-959f-4b5ecbb85435.pdf http://www.nice.org.uk/aboutnice/howwewor k/developingniceclinicalguidelines/clinicalgui delinedevelopmentmethods/theguidelinesm anual2007/the_guidelines_manual_2007.jsp http://www.sign.ac.uk/pdf/sign50.pdf http://www.rcplondon.ac.uk/pubs/contents/9 c4488ac-d8f1-43d8-b9da-b801441bcdfb.pdf
Appendix C: Advisory Committee members, external advisers and NHS Evidence accreditation team NHS Evidence Advisory Committee Members The NHS Evidence 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 the Institute 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 Institute s 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 Advisory Committee membership is available on the NICE website 3. The members have been appointed for a period of 18 months. This may be extended by mutual agreement to a further term of 3 years and up to a maximum term of office of 10 years. The decisions of the Committee are arrived at by a consensus of those members present. The quorum is set at 50% of committee membership. The Committee submits its recommendations to the Institute s Guidance executive which acts under delegated powers of the Institute s 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(s) is excluded from participating further in the discussions. A list of the committee members who took part in the discussions for this accreditation decision appears below. 3 http://www.nice.org.uk/nhsevidence/nhseac.jsp
Title Name Surname Role Organisation Ms Judy Birch Lay member Mr Richard Brownhill Clinical Development & Nurse practitioner Calderdale and Huddersfield NHS Trust and Kirklees PCT Ms Amanda Edwards Head of Knowledge Services Social Care Institute for Excellence (SCIE) Ms Joyce Epstein Lay member Dr Brian Fisher General Practitioner NHS Alliance (GP and national patient/public lead) Professor David Haslam National Clinical Advisor Care Quality Commission Dr Bobbie Jacobson Dr Monica Lakhanpaul Professor Stuart Logan Dr Donal O Donoghue Professor Sandy Oliver Dr Mahendra Patel Director of London Health Observatory, Vice Chair of Association of PH Observatories Senior Lecturer / Consultant Paediatrician / Clinical Director Professor of Paediatric Epidemiology National Clinical Director for Kidney Care and consultant renal physician Professor of Public Policy, Deputy Director, Social Science Research Unit Senior lecturer in pharmacy practice, school of applied sciences/consultant Pharmacist London Health Observatory Health Education Research and Development Unit (HERADU), Department of Medical Education and Social Care, University of Leicester Peninsula College of Medicine and Dentistry Salford Royal NHS Foundation Trust Cochrane Consumers and Communication Review Group, University of London University of Huddersfield
Mr Adrian Reyes- Hughes Associate Clinical Director NHS Direct Dr Karen Ritchie Ms Sasha Shepperd Dr Mark Strong Ms Gill Swash Lead Health Services Researcher Senior Research Scientist, Department of Public Health MRC Fellow, Section of Public Health Head of knowledge and Library Services NHS Quality Improvement Scotland University of Oxford School of Health and Related Research (ScHARR) University of Sheffield NHS Western Cheshire Dr Sara Twaddle Director Scottish Intercollegiate Guidelines Network Advisory Committee Deputies Title Name Surname Role Organisation Deputising for Ms Lynda Cox Head of Knowledge Sharing and Learning North East Strategic Health Authority Stephen Singleton External Advisers for Royal College of Physicians Stroke guideline accreditation application Sara Twaddle, Director, SIGN, Chair of Guidelines International Network, Edinburgh, UK Minna Kaila, Senior Medical Officer and Adjunct Professor University of Tampere, Tampere, Finland; Finnish Office for Healthcare Technology Assessment
NHS Evidence accreditation team for Royal College of Physicians Stroke guideline accreditation application Stephanie Birtles, Accreditation Technical Analyst, NHS Evidence, National Institute for Health and Clinical Excellence, Manchester, UK Dr Paul Chrisp, Associate Director Accreditation, NHS Evidence, National Institute for Health and Clinical Excellence, Manchester, UK