Draft Accreditation Report for consultation
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1 Guidance producer: Duchenne Muscular Dystrophy Care Considerations Working Group Guidance product: Diagnosis and Management of Duchenne Muscular Dystrophy guideline Date: 24 June 2011 Draft Accreditation Report for consultation Duchenne Muscular Dystrophy (DMD) Care Considerations Working Group - Diagnosis and Management of Duchenne Muscular Dystrophy guideline: Draft Accreditation Report Page 1 of 23
2 Contents Introduction... 3 Accreditation recommendation... 3 Implementation... 6 Reapplication for accreditation... 7 Appendix A: NHS Evidence accreditation analysis... 8 Appendix B: Bibliography Appendix C: Advisory Committee members, external advisers and NHS Evidence accreditation team Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 2 of 23
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 can 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 It is proposed that the process to produce the Diagnosis and management of Duchenne muscular dystrophy guideline by the Duchenne Muscular Dystrophy Care Considerations Working Group is recommended for NHS Evidence accreditation. This draft is subject to public consultation before a final is made. Background to the guidance producer The Duchenne Muscular Dystrophy (DMD) Care Considerations Working Group is an international collaboration of clinicians, researchers and patient groups that was convened by the US Centres for Disease Control and Prevention (CDC) to develop a guideline covering the diagnosis and management of DMD. The focus of the Diagnosis and management of Duchenne muscular dystrophy guideline is to advocate a multidisciplinary approach to the diagnosis and management of DMD, to improve life expectancy and quality of life for those with the condition. The guideline covers all the major areas of management of DMD through the disease 1 Available from Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 3 of 23
4 progression, including major body systems, psychosocial management and pharmacological intervention. Summary The Advisory Committee considered that the processes used by the Duchenne Muscular Dystrophy Care Considerations Working Group to produce the 'Diagnosis and management of Duchenne muscular dystrophy guideline demonstrated compliance with 24 of the 25 accreditation criteria. The process used to develop the guideline is detailed primarily in the Guideline Production Manual, published in This document is a retrospective summary of the process, which was initially described in the 2009 journal publication of the guideline. Because this is a single guideline application it was possible to verify the process information provided against the published guideline. Individuals from all relevant stakeholder groups including patient groups and representative intended users are involved in development of the guideline. The method employed uses expert opinion to systematically generate recommendations given the paucity of randomised controlled trials and systematic reviews, as is common for rare conditions. Both the guideline and the Guide For Families patient information are clear and comprehensive. International implementation of the recommendations is assisted by the translation of the Guide For Families into 30 languages, and through the audit schemes described for the UK, EU and US. During the analysis it was found that the proposed date for review is not clearly stated in the guidance and for this reason criterion 4.3 is considered not fully met. In summary, the process used to produce the Diagnosis and management of Duchenne muscular dystrophy guideline meets 24 of the 25 criteria for accreditation, with criterion 4.3 not fully met. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 4 of 23
5 Suggestions for improvement to strengthen the 'Duchenne Muscular Dystrophy Care Considerations Working Group s processes to produce the Diagnosis and management of Duchenne muscular dystrophy guideline includes: Stating the proposed date for review in future editions of the guideline. Explicitly stating in the guideline that all individuals involved in the guideline development were required to declare conflicts of interest. Consolidating all process information from the Guideline Production Manual, the Methodology explained document, and extra information from the guidance producer feedback stage into one process manual. This draft is now going out for consultation, and the will be reviewed by the committee in the light of any feedback received before making a final recommendation. David Haslam Chair, Advisory Committee June 2011 Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 5 of 23
6 Implementation If accreditation is awarded, 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 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 of any significant change to a process within 30 days. Figure: The NHS Evidence Accreditation Mark 2 Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 6 of 23
7 Reapplication for accreditation If accreditation is not 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 are not accredited following the accreditation process have the opportunity to reapply from 1 year after the previous assessment. It is assumed that the organisation will have addressed any concerns highlighted in the original assessment before reapplying. The NHS Evidence team will provide detailed feedback and advice on areas where improvement is required to meet the criteria in a future application. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 7 of 23
8 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 is shown below. Domain Criterion Evidence for meeting the criterion Accreditation Does the guidance producer have a policy in place and adhered to that requires them to explicitly detail: Scope and purpose 1.1 Overall objective The overall objective of the guidance is provided by both the title and the 1.2 The clinical, healthcare or social questions covered abstract of the Diagnosis and management of Duchenne muscular dystrophy (DMD) guideline a. This is fit for purpose for a single guideline application. The questions addressed by the guideline are clearly stated as headings within the main text of the article a. Under these headings more detail is provided such as the dosage regimens of drugs or clinical presentations covered by the subsequent recommendations. This is fit for purpose for a single guideline application. Duchenne Muscular Dystrophy (DMD) Care Considerations Working Group - Diagnosis and Management of Duchenne Muscular Dystrophy guideline: Draft Accreditation Report Page 8 of 23
9 Domain Criterion Evidence for meeting the criterion Accreditation 1.3 Population and/or target audience to whom the guidance applies The patient group for this guideline is clearly identified in the title and throughout the text a. The target audience is identified as the wide range of health practitioners who care for individuals with DMD. It is obvious from the title that the guideline is most relevant to healthcare professionals encountering individuals with DMD. A separate Guide For Families b has been produced as patient information to accompany the guideline, for which the target audience is clearly stated in the title. 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances Section 3.1 of the Guideline Production Manual c provides a process requirement to use diagrams and flow charts in order to display recommendations clearly, in reference to the specific clinical or healthcare circumstances. Does the guidance 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 guidance Section 4 of the Guideline Production Manual c outlines the composition of the Care Considerations Working Group, with further information provided in the Contributors section of the guideline a. It is clear from the composition of the guideline steering committee, publication committee and expert panels, that a range of medical centres, research centres and patient advocate groups were involved in development of the guidance. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 9 of 23
10 Domain Criterion Evidence for meeting the criterion Accreditation 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance Examination of the Contributor s section of part one of the guideline a shows that the Care Considerations Working Group steering committee includes lay representatives from the Muscular Dystrophy Association and Parent Project Muscular Dystrophy. These patient groups are also credited in the Guide For Families b as helping to write and produce the guide. 2.3 Representative intended users in developing guidance. The guideline a and process documentation c state that guideline development involved an international multidisciplinary group of 84 peernominated experts, representing various specialist fields relevant to the diagnosis and management of DMD. The members of the expert groups and their specialist fields are listed in the Contributors section of part one of the guideline a. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 10 of 23
11 Domain Criterion Evidence for meeting the criterion Accreditation 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 The process used by the guidance producer, the RAND Appropriateness Method (RAM), is designed to arrive at clinical recommendations in the absence of randomised controlled trials (RCTs) or other higher level evidence, as is common for rarer conditions like DMD. RAM recognises expert opinion as a level of evidence and is designed to reach recommendations based on expert opinion in a systematic way. The process involved a systematic literature search by the US Centres for Disease Control and Prevention (CDC) to establish thousands of clinical scenarios, which were then evaluated by expert panels through defined stages of consensus to arrive at the recommendations. Details of the method and the search strategy are published in the guideline a. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 11 of 23
12 Domain Criterion Evidence for meeting the criterion Accreditation 3.2 Requires the guidance producer to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review The process demonstrates inclusion and exclusion criteria on two levels. The literature search undertaken by the CDC had defined criteria for acceptance derived from the search strategy, and excluded case reports of three or fewer patients. The second stage involved the inclusion or exclusion of expert opinion. As expert opinion formed the evidence base in the absence of higher level evidence, the process included or excluded expert opinion based on a scoring system. Interventions and assessment methods were rated for appropriateness and necessity and those with high scores and agreement among experts were accepted while those with low scores or significant disagreement were excluded. This demonstrates inclusion and/or exclusion criteria for the studies informing the clinical matrices d and the individual statements of expert opinion that were obtained through RAM. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 12 of 23
13 Domain Criterion Evidence for meeting the criterion Accreditation 3.3 Describes the strengths and limitations of the body of evidence and acknowledges any areas of uncertainty The evidence base for this guideline is principally the experience and opinion of the members of the DMD Care Considerations Working Group. This is due to the paucity of systematic reviews and RCTs in the field of DMD, a fact acknowledged by the guidance producer in both the guideline a and the process documentation c. The strategy adopted through the use of RAM aims to address this issue by making the most of expert opinion to reach sound recommendations. A systematic process is used to reach conclusions and highlight areas of uncertainty, which are acknowledged in the final recommendations. 3.4 Describes the method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) The RAM process combines evidence assessment and the formation of recommendations. Clinical options are evaluated systematically through several rounds by expert panels, to decide those options that are considered both necessary and appropriate. In this manner recommendations are developed as described both in the process documentation and the Methods section of the published guideline a. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 13 of 23
14 Domain Criterion Evidence for meeting the criterion Accreditation 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations The assessment of the likely relative benefits and harms of different options is integral to the RAM approach. In evaluating appropriateness, the panellists are asked to consider if the anticipated health benefits of a course of action are likely to outweigh the health risks, irrespective of financial considerations. Examples of clinical matrices d completed by the expert panels show a systematic approach to evaluating risks, as different risk factors are incorporated. 3.6 Describes the processes of external peer review Processes of review internal to guideline development are detailed in the Methodology Explained e document, including scrutiny by both clinicians and patient groups, and coordination and facilitation by the CDC. In addition to the various stages of internal review the guideline was peer reviewed prior to publication in the journal Lancet Neurology. This demonstrates both internal and external peer review. 3.7 Describes the process of updating guidance and maintaining and improving guidance quality The information provided by the guidance producer specifies that the guideline will be updated at a minimum every 3 years, including a literature review and repeating the expert consensus process where required. In the case of significant new evidence emerging outside the scheduled update cycle, the relevant topic panels can be convened adhoc to discuss the findings and repeat the consensus process as required. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 14 of 23
15 Domain Criterion Evidence for meeting the criterion Accreditation Does the guidance producer ensure that: 4.1 Recommendations are specific, unambiguous and clearly identifiable The use of tables and diagrams helps to ensure the recommendations are clearly identifiable by presenting them in a logical flow, and the statements are unambiguous and specific. This is required by the process documentation c. Clarity and presentation 4.2 Different options for the management of the condition or options for intervention are clearly presented Section 3.1 of the Guideline Production Manual c Layout of guidance states that the guidance should be clearly laid out using flowcharts and diagrams. Examination of the published guideline a shows that different options for assessment and management of DMD are clearly presented where they are available. 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated Section 1.4 of the process manual c specifies that the guideline should be reviewed at least every 3 years. The full guideline a clearly states the date of publication and the dates covered by the search strategy, although the proposed review date is not specified. For this reason criterion 4.3 is not Not fully met fully met. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 15 of 23
16 Domain Criterion Evidence for meeting the criterion Accreditation 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. Guideline content is suitable for the diverse target audience of health professionals identified in the Guideline Production Manual c and the guideline abstract. The language is clear but necessarily technical given the subject matter and the target audience. The language used in the Guide For Families b is clear, unambiguous, and less technical than the full guideline. Specialist terms are necessary to describe the condition and are explained in a glossary of common terms. The Guide For Families b has been developed in conjunction with patient advocacy groups and is being translated into thirty languages. Applicability Does the guidance producer routinely consider: Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 16 of 23
17 Domain Criterion Evidence for meeting the criterion Accreditation 5.1 Publishing support tools to aid implementation of guidance The Guide For Families b may aid implementation of the main guideline by increasing understanding of the multi-disciplinary approach to management of DMD among a non-specialist healthcare audience. Providing support to help implement the recommendations is also achieved through the regular meetings of Muscle Groups attended by the Managing Editor of the Care Considerations Working Group or representatives of the Muscular Dystrophy Campaign who are a stakeholder in guideline development. These meetings discuss how to implement the multi-disciplinary model advocated by the guideline. The translation of the guideline into thirty languages will also aid implementation. 5.2 Discussion of potential organisational and financial barriers in applying its recommendations There is discussion in the guidance a of both the broader organisational issues surrounding DMD care, and the specific requirements for equipment and expertise that may not currently be available in a clinical setting. There is no specific discussion of financial barriers in the guidance, but it is accepted that such a discussion would be difficult given the intended international scope of the guideline. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 17 of 23
18 Domain Criterion Evidence for meeting the criterion Accreditation 5.3 Review criteria for monitoring and/or audit purposes within each product. The DMD Care Considerations Working Group is not intended to be the auditing body for the recommendations put forth in the guideline, which does not provide specific auditable criteria. The guidance producer provided further details of the UK, US and European audit programmes for the guideline in which it is involved, including national and international projects with patient organisation stakeholders. Does the guidance producer: Editorial independence 6.1 Ensure editorial independence from the funding body The funding body for the guideline was the CDC. Editorial independence was achieved as the CDC was not involved in scoring the clinical matrices which formed the basis of the recommendations. Additionally the steering and publications committees which had editorial control of the guideline were multidisciplinary groups including membership from all identified stakeholder groups. 6.2 Demonstrate transparency about the funding mechanisms for its guidance It is stated in the Acknowledgements section of the guideline a that the CDC provided funding to cover costs. The guidance producer confirmed that this included hosting meetings, providing coordination and typesetting the guideline. Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 18 of 23
19 Domain Criterion Evidence for meeting the criterion Accreditation 6.3 Record and state any potential conflicts of interest of individuals involved in developing the recommendations Section 1.3 of the Guideline Production Manual c Declaration of Interest requires all co-authors of the guideline to declare any conflicts of interest at the end of the guideline a. It has been confirmed that CDC required all individuals involved in guidance production to declare any conflicts of interest in addition to the authors. 6.4 Take account of any potential for bias in the conclusions or recommendations of the guidance The process used minimises the potential for bias through the systematic development of recommendations with oversight provided by multidisciplinary committees, and coordination by the US CDC. All individuals were required to declare conflicts of interest, and independence from the funding source has been achieved. Documents submitted: a Diagnosis and Management of Duchenne Muscular Dystrophy guideline b Duchenne Muscular Dystrophy - Guide For Families c Guideline Production Manual; provides a retrospective summary of the process used to develop the guidance d Matrices web-appendix; shows examples of clinical matrices at each stage of the scoring process e Methodology Explained; provides additional information on the methodology used in guidance development Duchenne Muscular Dystrophy Care Considerations Working Group - Diagnosis and management of Duchenne muscular dystrophy guideline: Draft Accreditation Report Page 19 of 23
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 DMD Care Considerations Working Group - Guideline Production Manual.doc dmd_us_familyguide_ju ne2010.pdf Matrices webappendix.pdf Methodology explained.doc the_diagnosis_and_ma nagement_of_dmd_lanc et_complete_with_errat um.pdf Summary of guideline development Supplied process Patient information for families Supplied affected by DMD, summarising main guideline Document provided to show use of Supplied the clinical matrices in practice, through the different rounds of RAM Further information provided by the Supplied guidance producer in response to request by the analyst on specific points of guideline development Full guideline (parts 1 and 2) as Supplied published in the journal Lancet Neurology (November 2009) Duchenne Muscular Dystrophy (DMD) Care Considerations Working Group - Diagnosis and Management of Duchenne Muscular Dystrophy guideline: Draft Accreditation Report Page 20 of 23
21 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 3 years. 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 s 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 appears below. 3 Duchenne Muscular Dystrophy (DMD) Care Considerations Working Group - Diagnosis and Management of Duchenne Muscular Dystrophy guideline: Draft Accreditation Report Page 21 of 23
22 Title Name Surname Role Organisation Ms Judy Birch Lay Member Mr Richard Brownhill Head of Nursing Jersey Unscheduled Care Ms Lynda Cox Head of Transformation NHS North East Ms Amanda Edwards Deputy Chief Executive Social Care Institute for Excellence Professor David Haslam National Clinical Advisor Care Quality Commission Dr Bobbie Jacobson Director London Health Observatory Dr Carl Parker Primary Care Medical Advisor Dr Karen Ritchie Head of Knowledge Management Ms Sasha Shepperd University Research Lecturer North Tees and Hartlepool Foundation Trust Healthcare Improvement Scotland University of Oxford Dr Pete Smith Vice President National Association of Primary Care Dr Mark Strong MRC Fellow Section of Public Health, ScHARR Ms Gill Swash Head of Knowledge and Library Services NHS Western Cheshire Advisory Committee deputies Title Name Surname Role Organisation Deputising for Mr Bill McGuire Ms Rebecca Rees Professor of Child Health RCUK Academic Fellow Hull York Medical School Social Science Research unit, University of London Stuart Logan Sandy Oliver Duchenne Muscular Dystrophy (DMD) Care Considerations Working Group - Diagnosis and Management of Duchenne Muscular Dystrophy guideline: Draft Accreditation Report Page 22 of 23
23 External Advisers for the Duchenne Muscular Dystrophy Care Considerations Working Group;Diagnosis and Management of Duchenne Muscular Dystrophy guideline accreditation application Karen Macpherson, Senior Health Services Researcher, Healthcare Improvement Scotland, UK Dr Marlies Ostermann, Consultant in Critical Care and Nephrology, Guys and St Thomas NHS Foundation Trust, London, UK NHS Evidence accreditation team for the Duchenne Muscular Dystrophy Care Considerations Working Group;Diagnosis and Management of Duchenne Muscular Dystrophy guideline accreditation 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 Duchenne Muscular Dystrophy (DMD) Care Considerations Working Group - Diagnosis and Management of Duchenne Muscular Dystrophy guideline: Draft Accreditation Report Page 23 of 23
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