The Barrett s dysplasia and cancer taskforce (BAD CAT) consensus group

Transcription

1 Guidance producer: The Barrett s dysplasia and cancer taskforce (BAD CAT) consensus group Guidance product: Consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma Date: 2 October 2012 Version: 1.5 Final Accreditation Report The BAD CAT consensus group: Consensus statements: Final Accreditation Report Page 1 of 16

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

3 Introduction The NICE Accreditation Scheme recognises organisations that demonstrate high standards in producing health or social care guidance. Users of the accredited guidance can therefore have high confidence in the quality of the information. Organisations may publicly display a seal of approval called an Accreditation Mark for 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 on the NHS Evidence website. Accreditation recommendation NICE has accredited the process used by the BAD CAT (BArrett s Dysplasia and CAncer Taskforce) consensus group to produce its guidelines using consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma. Accreditation is valid for 5 years from September 2012 and is retrospectively applicable to guidance produced using the processes described in the International consensus of the management of dysplastic Barrett s and cancer (2010). Background to the guidance producer The BAD CAT consensus group, established in 2009, aims to produce evidence-based guidelines for the best clinical and cost-effective management of high-grade dysplasia and early mucosal cancer in Barrett's oesophagus. The group comprises 13 international medical societies in gastroenterology. It consists of a core group of 19 experts and a working consensus panel of over 50 gastroenterology specialists from 12 countries. More than half of the consensus panel are from the UK and the guideline is UK-led. Page 3 of 16

4 Summary NICE has accredited the process used by the BAD CAT consensus group to produce consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma. The Accreditation Advisory Committee considered that the processes used by BAD CAT to produce the guideline complied with 24 of the 25 criteria for accreditation. The evidence-based guideline was developed to improve clinical and cost-effective management of high-grade dysplasia in Barrett's oesophagus. To do this the group used the process detailed in the International consensus of the management of dysplastic Barrett s and cancer (2010). Intended users and patients are represented in the development of the guidelines. The strengths and limitations of the evidence were assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system. The systematic approach to gathering evidence and deriving recommendations through the use of Delphi consensus and a consensus conference complements the search methodology. A suggestion to improve the consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma is to ensure that the expected date for review is clearly shown on the guideline. Although the approach employed to manage potential conflicts of interest are systematic and transparent, it would be helpful if additional detail of the methods used could be included in the process manual used to develop the guidance. Professor David Haslam, CBE Chair, Accreditation Advisory Committee September 2012 Page 4 of 16

5 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 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 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 NICE Accreditation within 30 days if any significant change is made to a process. Figure 1: The Accreditation Mark Page 5 of 16

6 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 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 process document a states that the aim is to produce evidence-based 1.2 The clinical, healthcare or social questions covered 1.3 Population and/or target audience to whom the guidance applies guidelines for best clinical and cost-effective management of high-grade dysplasia and early mucosal cancer in Barrett's oesophagus. The method by which questions are established is described in the process document a. A core group and consensus panel comprises 50 people in total. Groups between 5 to 8 people for each topic are created. Questions are only approved as consensus statements if 80% consensus is reached. Recommendations are formed later. The guideline b shows that 82 of the 91 statements achieved consensus. The process document a states that the target population is patients over 18 years with a diagnosis of Barrett's oesophagus with high-grade dysplasia or intramucosal cancer (T1m1 3) or early invasive cancer (T1sm1). The guidance b is authored to assist clinicians. The BAD CAT consensus group: Consensus statements: Final Accreditation Report Page 6 of 16

7 Criterion Evidence for meeting the criterion Accreditation decision 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances The process document a shows that the clinical questions posed during the guidelines development follow a logical mechanism. The recommendations made in the guideline b are specific to the topic and link to the references identified by the evidence search. Does the guidance producer have a policy in place and adhered to that means it includes: 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance The process document a states that the guideline is developed by a consensus group of international medical societies in gastroenterology. It consists of a core group of experts and a working consensus panel of experts from 12 countries. The denominations of members of both the core group and panel are provided. Patients are active participants in the development of the guideline at each stage of its production. Stakeholder involvement 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance The names of patients involved in the production of this guideline are listed in the process document a and guideline b. Patients with the condition and patient representatives are active participants in the development of the guideline. 2.3 Representative intended users in developing guidance. The affiliations and areas of expertise for end users who are members of the core group and consensus panel are clear. Page 7 of 16

8 Criterion Evidence for meeting the criterion Accreditation decision 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 3.2 Requires the guidance 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 explains that information science experts: undertake searches; define how the search strategy is devised; and state which databases should be queried. The search terms and free text keywords employed are provided. The process document details scoping search information and example database search strategies along with search results. The guideline b explains the search strategy employed. The process document a explains the inclusion and exclusion of evidence in the development of this guideline b. Only studies from 1990 onwards are considered for inclusion as the clinical condition covered by the guideline has only been accurately diagnosed and documented from this date. The process document a describes how evidence is evaluated using the Grading of Recommendations Assessment, Development and Evaluation GRADE system. The guideline b includes discussion about the variation in the quality of the evidence base, and acknowledges the difficulty in performing well designed studies in this specialty. The process document a explains that a Delphi mechanism and a consensus conference are used to set recommendations A majority decision is accepted if a unanimous vote is not possible. If no majority consensus is possible, the core group will formulate a final decision. Page 8 of 16

9 Criterion Evidence for meeting the criterion Accreditation decision 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations 3.6 Describes the processes of external peer review 3.7 Describes the process of updating guidance and maintaining and improving guidance quality The process document a outlines that the risks, benefits, morbidity and mortality for each treatment option should be considered. Each option has its own benefits, side effects and risks. The guideline b shows that where relevant the balance of health benefits is considered against the likely side effects or safety concerns of recommendations. Both the process document a and guideline b state that peer review was performed by 4 individuals. The names of reviewers and their affiliations are provided. A formal update to the guideline will take place every 2 years and the process for updating is described in the process document document a The guideline is available for download from and the date of publication is clearly shown. Does the guidance producer ensure that: Clarity and presentation 4.1 Recommendations are specific, unambiguous and clearly identifiable 4.2 Different options for the management of the condition or options for intervention are clearly presented The process document a explains that statements should contain a single message and should not be complicated by too many conditions. The guideline shows that the process is being implemented and clearly details specific recommendations that can be traced back to the key questions posed at the consensus conference. Statements are worded succinctly. The process document a shows that different options for the management of the condition are presented which can be traced through to the recommendations made in the guideline b. Options for investigations and treatments are considered when relevant. Page 9 of 16

10 Criterion Evidence for meeting the criterion Accreditation decision 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated 4.4 The content of the guidance is suitable for the specified target audience. If patients or service users are part of this audience, the language should be appropriate. The date of publication is provided on the guideline b.. The date that searches were performed was between June 2009 and December 2010 and the publication date was August However the date of expected review is not shown. Does the guidance producer routinely consider: It is clear from the content of the process document a and guideline b that it is aimed at professionals working in the field. Not fully met Applicability 5.1 Publishing support tools to aid implementation of guidance 5.2 Discussion of potential organisational and financial barriers in applying its recommendations The guideline b includes an abstract which provides a summary of the guideline along with the key recommendations thus allowing users to determine relevance. Implementation will be aided by circulation by the BAD CAT task force which represents a consensus group of the leading international medical societies in gastroenterology. The process manual a provides information relating to financial barriers. It is clear that barriers to implementation have been discussed by BAD CAT and 2 examples were provided. Page 10 of 16

11 Criterion Evidence for meeting the criterion Accreditation decision 5.3 Review criteria for monitoring and/or audit purposes within each product. An audit proforma is available for use with the BAD CAT guideline. The results of the first survey BAD CAT Audit Summary (May 2012) has been received by the accreditation team as evidence of implementation. Does the guidance producer: Editorial independence 6.1 Ensure editorial independence from the funding body BAD CAT is funded entirely by voluntary contributions from professional bodies such as the World Gastroenterology Organisation, and various societies and charities for gastroenterology around the world including the British Society of Gastroenterology and FORT. A robust peer review process, the involvement of an international group of multidisciplinary clinicians and a rigorous Delphi consensus method to set recommendations ensures editorial independence. 6.2 Demonstrate transparency about the funding mechanisms for its guidance The process document a lists the organisations that contributed financial assistance to produce the guideline. The costs of teleconferences, conferences and administration are provided. Page 11 of 16

12 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 conflict of interests policy is described in the process manual a under the section headed Timescales. Any conflicts were requested at both the beginning and end of the guideline development process. The chair reviewed all potential conflicts and if concern occurred over impartiality they were discussed by a subset of core team members. A total of 104 people were approached, of whom 95 took active part in the consensus process. 92 completed conflict of interest forms. Three contributors of the active participants did not complete a declaration and were therefore not listed as authors. Nine respondents took no part in the process or withdrew early. Authors disclosed conflicts and this information is shown in the guideline b. In any cases of apparent conflict an independent person with no stated conflicts chaired the particular area. 6.4 Take account of any potential for bias in the conclusions or recommendations of the guidance A systematic approach to gathering evidence and deriving recommendations using Delphi consensus helps to prevent bias. The potential for further bias is reduced by multidisciplinary working groups, core group and consensus panel, a robust peer review process and a transparent conflict of interest policy. There is also transparency and editorial independence from the funding body which helps minimise bias. a. International consensus of the management of dysplastic Barrett s and cancer (2010) b. Consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma, based on a Delphi process (Aug 2012). Page 12 of 16

13 Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the Committee. Document name Description Location International Consensus of the Management of Dysplastic Barrett s and Cancer, 2010 Consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma, based on a Delphi process (August 2012). Process manual Guideline assessed as evidence Supplied by guidance producer The BAD CAT consensus group: Consensus statements: Final Accreditation Report Page 13 of 16

14 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 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 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 Ms Judy Birch Lay member Dr Adrian Brown Consultant in Public Health Medicine Ms Ailsa Donnelly Lay member Inner North West London PCTs Ms Amanda Edwards Deputy Chief Executive Social Care Institute for Excellence Page 14 of 16

15 Joyce Epstein Lay member Professor David Haslam National Clinical Adviser Care Quality Commission Dr Bobbie Jacobson Director London Health Observatory Professor Monica Lakhanpaul Professor of Integrated Community Child Health University College London (Institute of Child Health) Ruth Liley Assistant Director of Quality Improvement Professor Stuart Logan Professor of Paediatric Epidemiology Marie Curie Cancer Care Peninsula College of Medicine and Dentistry Dr Edward Ng General Practitioner Ley Hill Surgery Professor Sandy Oliver Prof of Public Policy, Deputy Director Dr Mahendra Patel Senior Lecturer and Consultant Pharmacist Dr Karen Ritchie Head of Knowledge Management Professor Sasha Shepperd Professor of Health Services Research University of London Universities of Huddersfield and Bradford Healthcare Improvement Scotland University of Oxford Dr Peter Smith Vice President National Association of Primary Care Dr Mark Strong MRC Fellow School of Health and Related Research (ScHARR) University of Sheffield Ms Gill Swash Head of Knowledge and Library Services NHS Western Cheshire Dr Sara Twaddle Director Scottish Intercollegiate Guidelines Network Page 15 of 16

16 External Advisers for the BAD CAT consensus group to produce consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma accreditation application Dr Robert Wilson, MRCGP, FFPH, Consultant in Public Health Medicine, NHS Lincolnshire, UK Dr Zoe Stamataki, PhD, MSc, RN, Research Strategy Manager, The Christie NHS Foundation Trust. Manchester, UK NICE Accreditation team for the BAD CAT consensus group to produce consensus statements for management of Barrett's dysplasia and early-stage oesophageal adenocarcinoma accreditation application John Huston, Accreditation Technical Analyst, National Institute for Health and Clinical Excellence, Manchester, UK. Stephanie Birtles, Accreditation Technical Analyst, National Institute for Health and Clinical Excellence, Manchester, UK. Page 16 of 16