Final Accreditation Report

Guidance producer: The Royal College of Physicians of London Guidance product: National Clinical Guideline for Stroke Date: 19 September 2016 Version: 1.2 Final Accreditation Report Report Page 1 of 21

Contents Introduction... 3 Accreditation recommendation... 3 Background to the guidance producer... 3 Summary...3 Implementation... 5 Appendix A: NICE Accreditation analysis... 6 Appendix B: Bibliography... 16 Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team... 19 Report Page 2 of 21

Introduction The NICE Accreditation Programme 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 5 years after their processes have been accredited. The process for accrediting producers of guidance and recommendations for practice is described in the process manual. Accreditation recommendation NICE has renewed accreditation of the process used by The Royal College of Physicians of London to produce the National Clinical Guideline for Stroke. Accreditation is valid for 5 years from 13 September 2016 and is applicable to guidance produced using the processes described in National Clinical Guideline for Stroke process manual (2016). The original accreditation term began on 10 June 2010. Background to the guidance producer The Royal College of Physicians of London (more commonly known as the Royal College of Physicians; RCP) is a registered charity that aims to improve care quality through education, training, standards and audit. As part of this work, the RCP runs an integrated stroke quality improvement programme, comprising the National Clinical Guideline for Stroke (NCGS), a national audit and a peer review scheme run jointly with British Association of Stroke Physicians and the Stroke Association. The NCGS is a single publication covering the management of transient ischaemic attack, stroke and subarachnoid haemorrhage primarily in adults aged over 16 years from onset to long-term including death. It covers acute diagnosis and treatment, rehabilitation, long-term care and support, secondary prevention and prevention of complications. Report Page 3 of 21

Summary The Accreditation Advisory Committee considered that the processes used by the Royal College of Physicians of London to produce the National Clinical Guideline for Stroke demonstrated compliance with 25 of the 25 criteria for accreditation. The scope and purpose of the guideline is clear. Development involves relevant stakeholders and target users including professionals caring for stroke patients, those responsible for organising and managing care, and patient representatives. The gathering and appraisal of evidence is systematic and transparent. Benefits and risks are discussed. The guidance is subject to public consultation and there are processes for regular and unscheduled review. The guidance provides clear recommendations including any options where applicable, and the content is suitable for the specified target audiences. Organisational and financial barriers are considered in detail and concise guides are in development to support implementation. The guideline recommendations underpin a national stroke audit. No external funding is used and development of the guideline is editorially independent. There are policies to declare and manage any conflicts of interest, and the potential for bias is accounted for. A suggestion to improve the process used to develop the National Clinical Guideline for Stroke is to explicitly state in the process manual that the dates of search, publication and review should be stated in the guideline. Professor Martin Underwood Chair, Accreditation Advisory Committee September 2016 Report Page 4 of 21

Implementation Following accreditation, guidance from the accredited producer will be identified on NICE Evidence Search by the Accreditation Mark. The accredited guidance 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 guidance producer's accreditation will last for 5 years from the date of the accreditation decision. 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 NICE accreditation within 30 days if any significant change is made to a process. Figure 1: The NICE Accreditation Mark Report Page 5 of 21

Appendix A: NICE Accreditation analysis The Accreditation Advisory Committee considered the following analysis of the guidance 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 Scope and purpose Does the guidance producer have a policy in place and adhered to that requires them to explicitly detail: 1.1 Overall objective The scope is agreed by the guideline development group 1. The process 1 requires that the overall aims of the guideline are explained in the introductory sections. The guideline 2 describes the overall objectives. 1.2 The clinical, healthcare or social questions covered The process 1 states that the scope is translated into a list of key questions to inform systematic searches. Key questions follow the population, intervention, comparator, outcomes (PICO) format. The process 1 states that key questions should be stated in the Evidence to recommendations section of the recommendations. The key questions are detailed in the guideline 2 and on the www.strokeaudit.org website 3. Report Page 6 of 21

Criterion Evidence for meeting the criterion Accreditation decision 1.3 Population and/or target audience to whom the guidance applies The process 1 requires key questions to be developed using the PICO format, which requires the identification of patient populations. The process 1 states that the target populations should be stated in the recommendations. The target audiences for the guideline are varied as it covers many aspects of stroke care. The guideline 2 describes both the patient populations and the various target audiences at which it is aimed. 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances The process 1 provides requirements around the wording of recommendations to help ensure they are clear and in reference to particular circumstances. These include defining the target population, the who, what, where and how of any actions and any qualifiers. The guideline 2 recommendations are clear and in reference to specific circumstances, for example the condition or diagnosis of the patient, their point in the care pathway, and the location or availability of services. Stakeholder Does the guidance producer have a policy in place and adhered to that means it includes: Report Page 7 of 21

Criterion Evidence for meeting the criterion Accreditation decision involvement 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance The guideline development group (GDG) consists of the Chair, relevant professionals, representatives of patient and carer organisations, and patient members 1. The GDG agree the scope, develop key questions and search strategies, review the evidence and develop recommendations 1. Attachment A ICSWP active members 4 details the members of the GDG. It includes professional members caring for patients along the stroke pathway. It also includes 3 lay members and 2 representatives of the Stroke Association, a charity that funds research and supports people affected by stroke. 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance The process 1 requires the GDG to include patient and carer representative organisations in addition to patient members. It states that at least 2 members should be people using services, family members or carers, or lay members with relevant experience. Attachment A ICSWP active members 4 details the names and affiliations of the GDG. The list includes 3 lay members and 2 representatives of the Stroke Association, a charity that funds research and supports people affected by stroke. Report Page 8 of 21

Criterion Evidence for meeting the criterion Accreditation decision 2.3 Representative intended users in developing guidance. The process 1 states that the GDG should include relevant professionals from the stroke care pathway. The guideline 2 details those involved who are representative target users. This includes stroke physicians, speech and language therapists, nurses, paramedics, neuro-radiologists, neurologists, occupational therapists, physiotherapists, psychologists and directors of strategic clinical networks. Rigour of development 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 The process 1 explains how search strategies are developed from the key questions and names the databases in which the searches are run. The process 1 requires that the key stages of guidance development, including searching the literature, should be detailed in the guidance. The guideline 2 provides an overview of the search process and links to the detailed search strategies. 3.2 Requires the guidance producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review Abstracts are selected from initial searches based on relevance and study characteristics such as study size 1. The quality of evidence is then assessed using specified checklists and tools, with low-quality evidence being excluded 1. The process 1 states that the guideline should outline the stages of including and excluding evidence. The guideline 2 includes a section on the selection of studies, in which the inclusion and exclusion criteria are stated. Report Page 9 of 21

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 process 1 specifies tools to assess the quality of different kinds of evidence and states that the results should be documented in evidence tables. The process 1 states that Evidence to recommendations sections should discuss the strengths and weaknesses of the evidence. The guideline 2 describes how evidence was appraised and recommendations graded, in addition to discussing the strengths, weaknesses and areas of uncertainty of the evidence. 3.4 Describes the method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) The process 1 states that any contentious recommendations are escalated to the topic editors, an editorial group and finally to a quarterly GDG meeting if required, where the issue is discussed and voted upon. The process 1 states that the guideline should explain how decisions were reached. The guideline 2 describes the processes of developing recommendations and making decisions where consensus was not possible. 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations The processes for considering benefits, risks and side effects are documented primarily in the retrospective Methods section of the guideline 2. The Evidence to recommendations section of the guideline 2 provides discussions of risk stratification and management strategies, secondary risk reduction, and a discussion of the risks and benefits of specific interventions such as anticoagulants, antiplatelets, carotid stents and some screening approaches. Report Page 10 of 21

Criterion Evidence for meeting the criterion Accreditation decision 3.6 Describes the processes of external peer review The process 1 requires a period of public consultation on the guidance. Invitations to comment are sent to key stakeholders identified during scoping, development and by stakeholders. The process 1 requires that an outline of the external review process is provided in the guidance. The guideline 2 states that independent experts in both the UK and internationally, including patient and carer organisations, were invited to comment. The guidance producer provided details of comments received 5. 3.7 Describes the process of updating guidance and maintaining and improving guidance quality The process 1 states that the guideline is updated every 4 years. The section Out of cycle review of the Guideline states that research evidence changes continuously and therefore evidence will be reviewed annually in response to submissions from members and constituent organisations. It states that interim updates will be published in response to significant advances in the clinical evidence. The guideline 2 section Updating of the guideline explains this process. Clarity and Does the guidance producer ensure that: Report Page 11 of 21

Criterion Evidence for meeting the criterion Accreditation decision presentation 4.1 Recommendations are specific, unambiguous and clearly identifiable The process 1 specifies the format of recommendations to help ensure they are specific and unambiguous. These include defining the target population, the who, what, where and how of any actions and any qualifiers. A standard layout 1 is provided that places the recommendations in their own clearly identifiable sections. In the guideline 2 the recommendations for each topic are easy to identify and are specific and unambiguous. 4.2 Different options for the management of the condition or options for intervention are clearly presented The PICO framework for key questions requires the consideration of evidence around different options through the identification of comparators 1. This informs the search strategies and the context of the recommendations. The process 1 provides explicit requirements to present clear recommendations. The guideline 2 provides clear options for antiplatelet or anticoagulant therapy, imaging options, and alternative strategies for enabling feeding and communication in people with different levels of ability following a stroke. 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated The process 1 states the anticipated date of publication of the guideline, the search dates and the proposed dates for review. It does not explicitly state that these items should be included in the guideline, however the guideline 2 provides the search dates and the proposed date for review. The publication date will be added at publication. Report Page 12 of 21

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. The process 1 specifies the main items that should be included in the guideline and the format of the recommendations. This helps to ensure the content is useful to the target audience. This is supported by the involvement and consultation of professional and patient groups during development 1. The content of the guideline 2 is suitable for the specified target audiences. Applicability Does the guidance producer routinely consider: 5.1 Publishing support tools to aid implementation of guidance The process 1 requires the development of concise guides for different professions and a version for patients and carers. The guidance producer has provided drafts 6,7 of these resources and they will be published following publication of the guideline 2. 5.2 Discussion of potential organisational and financial barriers in applying its recommendations The process 1 requires the detailed consideration of organisational and financial barriers during development. A discussion of these issues is provided in Implications sections for each topic 1. The guideline 2 provides discussions of the likely costs and workforce issues, and actions local teams need to take, to implement the recommendations. It states where there may be net costs or savings. Report Page 13 of 21

Criterion Evidence for meeting the criterion Accreditation decision 5.3 Review criteria for monitoring and/or audit purposes within each product. The process 1 states that the guideline is used as the basis for the national audit for stroke; currently the Sentinel Stroke National Audit Programme (SSNAP). The guideline 2 provides information on the SSNAP and states that the audit is carried out against recommendations in the guideline. The SSNAP website 3 provides details of the audit programme and instructions for registering. Data is collected and published at regular intervals and users can view reports and compare performance in different service or geographical areas 3. Editorial Does the guidance producer: independence 6.1 Ensure editorial independence from the funding body The process 1 states that development of the guideline was funded by the RCP, with no external funding sought. It would not be practical to develop the guidance without members of the RCP, who are physicians in relevant disciplines. The inclusion of a wide variety of professional organisations in guidance development and consultation 1,4,5 helps to avoid undue influence by any one organisation. 6.2 Demonstrate transparency about the funding mechanisms for its guidance The process 1 states that the funding source should be explained in the guideline. The guideline 2 states that development was funded by the RCP and no external funding was sought or received. Report Page 14 of 21

Criterion Evidence for meeting the criterion Accreditation decision 6.3 Record and state any potential conflicts of interest of individuals involved in developing the recommendations The process 1 provides a policy for declaring and managing conflicts of interest that applies to all members of the guideline group and the RCP stroke programme. The policy 1 defines personal, non-personal, financial and non-financial interests, and distinguishes between specific and nonspecific interests. It requires transparent declarations of interest and defines what constitutes a conflict and how conflicts are managed 1. The Chair cannot have any conflicts of interest 1. An appendix 8 detailing the declarations of interest has been provided and will be published alongside the guideline 1. 6.4 Take account of any potential for bias in the conclusions or recommendations of the guidance The process 1 is systematic in gathering and appraising evidence and developing recommendations. Guideline development is editorially independent from any external funding source and the guideline is subject to external review by many individuals and organisations 1,5. All those involved in development must make transparent declarations of interest which are managed appropriately 1. Overall the possibility of bias is accounted for. Documents referenced above: 1 National Clinical Guideline for Stroke process manual (2016) 2 National Clinical Guideline for Stroke (2016) 3 www.strokeaudit.org 4 Attachment A ICSWP active members 5 Public consultation comments received 6 Profession-specific concise guides (draft) 7 Guide for patients (draft) 8 Attachment B - Declarations of Interest Report Page 15 of 21

Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the committee. Document name Description Location 2012 NCGS 2012 version of guideline Supplied Attachment A - ICSWP Membership list of ICSWP Supplied Active Members Attachment B - Declarations of interest of Supplied Declarations of Interest ICSWP and reviewers Concordance Q16 Example search strategy Supplied Draft_2016 Guidance example (late draft Supplied NCGS_updated 12.8.16 supplied during guidance producer feedback) DRAFTS - Concise Drafts of support tools Supplied Guidelines and Patient version Echocardiography Q1b Example search strategy Supplied Evidence Tables - all Evidence tables including Supplied listed sources comments on quality Fabry disease Q1a Example search strategy Supplied Final version of Key questions Supplied questions v2 ICSWP 9th Dec 14 List of Public Details of responding external Supplied Consultation Reviewers reviewers NCGS 2016 - Public Consultation Contact List Details of those contacted for external review Supplied RCP NCGS Draft Guidance example (late draft) Supplied Report Page 16 of 21

Document name Description Location 31.5.16 RCP NCGS- NICE Accreditation application form Supplied accred application 31.5.16 RCP NCGS Process Manual 2016_7.6.16 Process manual Supplied RCP NCGS Process Manual 2016_updated 12.8.16 Stroke guideline for web navigable version FINAL TOC Revised_19.1.16 Attachment A - ICSWP Active Members Attachment B - Declarations of Interest Process manual (supplied at Supplied guidance producer feedback) 2012 guideline used as Supplied template Table of contents for body of Supplied guideline Membership list of ICSWP Supplied Declarations of interest of Supplied ICSWP and reviewers Concordance Q16 Example search strategy Supplied Echocardiography Q1b Example search strategy Supplied Evidence Tables - all Evidence tables including Supplied listed sources comments on quality Fabry disease Q1a Example search strategy Supplied Final version of Key questions Supplied questions v2 ICSWP 9th Dec 14 List of Public Details of responding external Supplied Consultation Reviewers reviewers NCGS 2016 - Public Consultation Contact Details of those contacted for external review Supplied Report Page 17 of 21

Document name Description Location List RCP NCGS Draft Guidance example (late draft) Supplied 31.5.16 RCP NCGS- NICE Accreditation application form Supplied accred application 31.5.16 RCP NCGS Process Process manual Supplied Manual 2016_7.6.16 Stroke guideline for web 2012 guideline used as Supplied navigable version FINAL template TOC Revised_19.1.16 Table of contents for body of guideline Supplied Report Page 18 of 21

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 Care 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 Martin Underwood. 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 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. Committee members who took part in the discussions for this accreditation decision are listed below. Title Name Surname Role Organisation Mrs Lynda Cox Knowledge and Information Lead NHS England Ms Ailsa Donnelly Lay member N/A Ms Joyce Epstein Lay Member N/A Report Page 19 of 21

Dr Elvira Garcia Consultant in Public Health Medicine - Health Protection Lead Ms Barbara Graham Information Consultant/Senior Health Economist NHS Ayrshire & Arran Public Health Intelligence, NHS National Services Scotland Dr Anthony Larkin General Practitioner The Alexandra Practice Ms Mandy Sainty Research and Development Manager College of Occupational Therapists Mr Duncan Service Evidence Manager Scottish Intercollegiate Guidelines Network Dr Sara Twaddle Director of Evidence Healthcare Improvement Scotland Prof. Martin Underwood Professor of Primary Care Research, Director of Warwick Clinical Trials Unit Ms Ruth Wakeman Assistant Director of Professional Development and Support The University of Warwick Royal Pharmaceutical Society External Advisers for this accreditation application Dr Patrick Hamilton, Glomerular Diseases and Vasculitis Fellow, Manchester Royal Infirmary, UK Ms Cheryl Harding-Trestrail, Senior Commissioning Manager: Planned Care (Acute), West Hampshire Clinical Commissioning Group, Hampshire, UK NICE Accreditation team for this accreditation application James Stone, Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK Report Page 20 of 21

Victoria Carter, Senior Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK Report Page 21 of 21