Final Accreditation Report

Transcription

1 Guidance producer: British HIV Association (BHIVA) Guidance product: UK national guidelines Date: 2 nd August 2012 Version: 1.4 Final Accreditation Report Page 1 of 27

2 Contents Introduction... 3 Accreditation recommendation... 3 Background to the guidance producer... 3 Implementation... 6 Appendix A: NICE Accreditation analysis... 7 Appendix B: Bibliography Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team Page 2 of 27

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 1. Accreditation recommendation NICE has accredited the process used by the British HIV Association (BHIVA) to produce UK national guidelines. Accreditation is valid for five years from 12 July 2012 and is applicable to guidance produced using the processes described in the 2011 BHIVA guideline development manual. Background to the guidance producer The British HIV Association was established in 1995 as a specialist society for clinicians caring for people living with HIV infection. It is a registered charity and acts as a national advisory body to professionals and other organisations on all aspects of HIV care. It provides a national platform for HIV care and contributes representatives for international, national and local committees dealing with HIV care. In addition, the British HIV Association works to promote undergraduate, postgraduate and continuing medical education within HIV care. To help promote and monitor standards of care, the British HIV Association publishes a range of clinical guidelines covering the treatment and management of HIV infection and associated co-morbidities including antiretroviral therapy in adults, management of pregnancy, treatment and management of viral hepatitis B and C and tuberculosis (TB) 1 Page 3 of 27

4 co-infection, management of HIV associated malignancy and opportunistic infections, immunisation and the reproductive and sexual health of HIV infected persons. The British HIV Association Executive Committee oversees the work of the association, which is run by the four subcommittees on audit and standards, conferences, education and scientific and guidelines. The general purpose of the Guidelines Subcommittee is to set standards of good clinical practice on various aspects of the treatment and care of persons infected with HIV. The terms of reference of the subcommittee are determined by the British HIV Association Executive Committee. Membership includes a chair, vice chair, ordinary members, the editor of HIV Medicine and appointed members. The chair is appointed by the British HIV Association Executive Committee and ordinary members are selected from the membership of the BHIVA Executive Committee. The appointed members are co-opted from the BHIVA membership and are selected based on their area of expertise in the field of HIV medicine. The BHIVA Guidelines Subcommittee delegate s specific functions and activities to appointed writing groups. They include for each guideline a writing committee who are responsible for drafting individual clinical guidelines. The chair of each writing group is appointed by the BHIVA Guidelines Subcommittee. Summary The Advisory Committee considered that the processes used by the British HIV Association to produce UK national guidelines demonstrated compliance with all 25 accreditation criteria. The overall objective(s) of the guidance and the clinical question(s) addressed are clear and explicit. Individuals from all relevant stakeholder groups including patients are involved in developing guidance. The methods of balancing benefits and risks in developing the recommendations are well described, as well as the process for updating, maintaining and improving the quality of the guidance and the process of external peer review. Page 4 of 27

5 A range of implementation support tools and a series of audit measures are available to aid implementation. The guidance production process maintains editorial independence and takes account of any potential for bias. Professor David Haslam Chair, Accreditation Advisory Committee July 2012 Page 5 of 27

6 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 2. 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 2 Page 6 of 27

7 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 six discrete domains. The full analysis leading to the accreditation is shown below. 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 objective(s) of the British HIV Association are documented in section 1.2 The clinical, healthcare or social questions covered 1.1 and 4.3 of the 2011 British HIV Association guideline development manual a. Both guidance examples b-c reviewed outline the overall purpose of the guidance. Section 2.1 of the 2011 British HIV Association guideline development manual a describes how and where the topics for guidance are selected. Section 3.1 of the 2011 British HIV Association guideline development manual a identifies the target population and interventions as an essential component in the development of the guideline recommendations. The guidance producer uses the PICO framework to achieve this. Page 7 of 27

8 1.3 Population and/or target audience to whom the guidance applies Section 1.1 of the 2011 British HIV Association guideline development manual a states that the target audience for the guidance is the entire HIV community caring for patients with HIV disease within the UK healthcare system. However the guidance producer recognises that these guidelines have had considerable international influence. The patient populations and target professionals are included within the Scope and Purpose section in both guidance examples b-c reviewed. 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances Section 4.4 of the 2011 British HIV Association guideline development manual a requests that a summary of the guideline recommendations is collated to provide a list of all recommendations for ease of review by the user. Section 4.5 of the 2011 British HIV Association guideline development manual a describes how the rationale and references are described separately after each recommendation or subgroup of recommendations. Detailed rationale for each recommendation or set of recommendations based on the evidence from clinical questions is specified throughout the body of each guidance document in both cases. Both guidance examples b-c reviewed include clear recommendations in reference to specific clinical circumstances. Stakeholder Does the guidance producer have a policy in place and adhered to that means it includes: Page 8 of 27

9 involvement 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance Section 2.3 of the 2011 British HIV Association guideline development manual a describes the terms of reference for the British HIV Association subcommittee are presented in appendix 2 of the manual a. Section 1.2 of the manual a states that British HIV Association guidelines are produced by HIV specialists and other healthcare professionals caring for patients with HIV disease for the benefit of peer healthcare professionals, patients and the public. Both guidance examples b-c provide details of relevant stakeholder groups, including the involvement of patient and community representatives in the guideline development process. 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance The first draft of the guidance is subject to review by all British HIV Association invited stakeholders, service users and any member of the general public. Patient views are also sought during the public consultation stage. Both guidance examples b-c demonstrate details of patient involvement. The guidance producer explained that the UK Community Advisory Board nominate a community representative who is involved at each stage of guideline development. Page 9 of 27

10 2.3 Representative intended users in developing guidance. Sections 2.3 and 3.7 of the 2011 BHIVA guideline development manual a describe the ways in which BHIVA include intended users of the guidance in the guideline production process. Details of the BHIVA Guidelines Subcommittee and terms and reference are outlined in appendix 2 of the manual a. In both guidance examples b-c reviewed evidence of the implementation of the processes described in sections 2.3 and 3.7 can be seen. Rigour of Does the guidance producer have a clear policy in place that: Page 10 of 27

11 development 3.1 Requires the guidance producer to use systematic methods to search for evidence and provide details of the search strategy Section 3.2 of the 2011 British HIV guideline development manual a describes the systematic literature review process, which includes the chair of the writing group commissioning a systematic literature search. The dates covered by the systematic literature search are stated clearly in each guideline along with specific details of the search strategy and search terms used. The guidance producer also refers to the use of grey literature to capture new developments in the rapidly evolving field of HIV medicine. Section 3.3 of the manual a goes onto describe the selection and evaluation of the evidence. Evidence of implementation is demonstrated in both guidance examples b- c, where details of the search protocol can be found in the appendices of both examples. Page 11 of 27

12 3.2 Requires the guidance producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review Section 3.3 of the 2011 British HIV Association guideline development manual a states The expert co-authors assess articles for relevance to the guideline topic, eligibility for inclusion in the evidence base for that guideline and methodological quality. Section 3.2 of the 2011 British HIV Association guideline development manual a describes some of the high level exclusion criteria. It explains that HIV medicine is a rapidly evolving field and therefore developments in treatment and care often change practice rapidly. For this reason grey literature, namely conference presentations (as opposed to abstracts) from key international meetings, is considered and reviewed. Evidence of implementation is demonstrated in both guidance examples b-c reviewed where the search protocols (including inclusion and exclusion criteria) are clearly demonstrated. 3.3 Describes the strengths and limitations of the body of evidence and acknowledges any areas of uncertainty The guidance producer uses the GRADE system to grade recommendations. This system highlights the quality of the evidence. The grading system is clearly demonstrated throughout the body of both guidance examples b-c. Page 12 of 27

13 3.4 Describes the method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) Section 3.5 of the British HIV Association manual a describes the consensus process for grading the recommendations. The manual a states Where consensus is not reached amongst the co-authors in the guidelines writing group then this should be initially resolved in the first instance by reasoned discussion until unanimous consensus is achieved. If this is not possible then the lead author should organise a vote on the contentious issue with the lead author abstaining. If the vote is tied then the lead author can use a casting vote. The vote should be recorded in the writing group minutes. 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations Section 3.12 of the 2011 BHIVA guideline development manual a the guidance producer states The co-authors should produce recommendations to follow any specified management which on balance favours health gain/patient benefit over risk/harm where there is evidence of clinical effectiveness. At the same time the co-authors may produce no recommendations, or recommendations not to follow a specified management if clinical and cost effectiveness is in doubt. The guidance will always make recommendations not to follow a specified form of treatment when the risks/harms exceed the assessed health gain. Both guidance examples b-c include recommendations followed by the rationale and references. Page 13 of 27

14 3.6 Describes the processes of external peer review Sections 3.7 and 3.8 of the 2011 BHIVA guideline development manual a describe the public and peer review process of the guideline. The peer reviewers are internationally acknowledged experts in the field free from any overt conflict of interest. They will be subject to the same policy on disclosure of conflict of interest as the writing group in accordance with the rules of the Association. 3.7 Describes the process of updating guidance and maintaining and improving guidance quality Section 3.10 of the 2011 British HIV Association guideline development manual a describes how guidance is reviewed and updated. Section 4.8 of the manual a states The expiry date of the guidelines will be stated on each guideline. This will usually be 3 years subject to review by the British HIV Association Guidelines Subcommittee but may be sooner where there is frequent change in data to inform practice. The guidance producer explained how typically guidelines are reviewed every 3 years; however interim updates maybe issued should there be any significant scientific developments which require the guidelines to be changed before then. Clarity and Does the guidance producer ensure that: Page 14 of 27

15 presentation 4.1 Recommendations are specific, unambiguous and clearly identifiable Section 4.4 of the 2011 British HIV Association guideline development manual a describes how recommendations should be collated and presented clearly. Guidance examples b-c confirm that recommendations are presented clearly followed by the rationale and references. The guidance producer has demonstrated that the recommendations are specific, unambiguous and clearly identifiable within the guidance. 4.2 Different options for the management of the condition or options for intervention are clearly presented Section 4.5 of the 2011 British HIV Association guideline development manual a describes the rationale and chain of logic for the guidance recommendations and explains how the rationale should provide support for the grading of the recommendations. Guidance examples b-c confirm that each recommendation or set of recommendations outline the different treatment or management options. Page 15 of 27

16 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated Sections 4.2 of the 2011 British HIV Association guideline development manual a describes the search strategy, with dates of search, search terminology and methods. Section 4.8 of the manual a provides details of the expiry and review date. This will usually be three (3) years subject to review by the British HIV Association Guidelines Subcommittee but may be sooner where there is frequent change in data to inform practice, e.g. antiretroviral treatment. Section 5.1 of the manual a also provides details of the notification of the e-publication and of the final version. Evidence of implementation is demonstrated in both guidance examples b-c. 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 2011 British HIV Association guideline development manual a contains a checklist (appendix 8) which states is the language appropriate for the specified target audience? Section 4.4 of the manual a states A summary of the guideline recommendations is collated to provide a list of all recommendations for ease of review by the user. Evidence of implementation is demonstrated in both guidance examples b- c. Applicability Does the guidance producer routinely consider: Page 16 of 27

17 5.1 Publishing support tools to aid implementation of guidance Section 5.1 of the 2011 British HIV Assocaition guideline development manual a describes the notification process. The manual a states The membership of British HIV Association is notified by when a final version of a clinical guideline is posted on the main guidelines page on the website: Section 5.3 of the manual a outlines dissemination and implementation initiatives. The guidance producers describe several strategies and initiatives which have been introduced to improve dissemination and implementation of the British HIV Association guidance. Evidence of implementation tools and audit measures is demonstrated in both guidance examples b-c. Page 17 of 27

18 5.2 Discussion of potential organisational and financial barriers in applying its recommendations Section 3.12 of the 2011 British HIV Association guideline development manual a states describes the potential organisational and financial barriers in the management of HIV disease. The manual a describes how coauthors of each guideline should draft and agree the recommendations within each guideline based primarily on clinical effectiveness but the use of resources and cost effectiveness should also be taken into account. There are limited data on the relative cost effectiveness of various treatments in this field. However, the available data strongly support the case that HIV treatment is cost effective in terms of Quality Added Life Years (QALYs). The co-authors produce recommendations to follow any specified management which on balance favours health gain/patient benefit over risk/harm where there is evidence of clinical effectiveness. 5.3 Review criteria for monitoring and/or audit purposes within each product. Section 4.6 of the 2011 British HIV Association guideline development manual a explains how each guideline contains a number of audit measures to assist with implementation of the guidance. Section 5.2 of the manual a goes on to describe the use of the audit measures. Evidence of implementation is demonstrated in both guidance examples b-c. Editorial Does the guidance producer: Page 18 of 27

19 independence 6.1 Ensure editorial independence from the funding body Section 2.4 of the 2011 British HIV Association guideline development manual a states The Association has had a policy on conflict of interest for members of its Executive Committee since 2005 and all guidelines published in HIV Medicine from 2000 should contain a full declaration of author s conflicts of interests. From 2011 additionally all members of the writing groups will be required to declare their potential conflicts of interest in line with the Association s policy on conflict of interest prior to the first meeting of the guidelines writing group. The conflict of interest statements will be reviewed by the chair and vice-chair of the British HIV Association Guidelines Subcommittee. If there are any concerns, these will be referred to the British HIV Association External scrutineers. The British HIV Association also use the GRADE system for the assessment, evaluation and grading of evidence and the development of recommendations, ensuring transparency and consistency in recommendation development. Both the declaration of interest and the method used to develop recommendations ensures editorial independence. Page 19 of 27

20 6.2 Demonstrate transparency about the funding mechanisms for its guidance The British HIV Association was founded in 1995 and was registered as a charity on 24 June 1996 in England and Wales with number Section 2.5 of the 2011 British HIV Association guideline development manual a describes the funding of guideline development. The guidance producer s state that guidelines are not funded by any external organisation, commercial company or charity other than British HIV Association itself. 6.3 Record and state any potential conflicts of interest of individuals involved in developing the recommendations Section 2.4 of the 2011 British HIV Association guideline development manual a states all guidelines published in HIV Medicine from 2000 should contain a full declaration of author s conflicts of interests. Published details of declarations of conflicts of interests are demonstrated in both guidance examples b-c. Page 20 of 27

21 6.4 Take account of any potential for bias in the conclusions or recommendations of the guidance The 2011 British HIV Association guideline development manual a illustrates how the guidance producer reduces the potential for bias through the guidance producer s declaration of interest policy, the composition of the guideline development group and consultation and peer review of the guideline. Section 2.3 of the 2011 British HIV Association guideline development manual a describes the composition and responsibilities of the British HIV Association Guidelines Subcommittee and writing groups. The British HIV Association also use the GRADE system for the assessment, evaluation and grading of evidence and the development of recommendations, ensuring transparency and consistency in recommendation development. Documents submitted: BHIVA guideline development manual a BHIVA guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy 2012 b Guidelines for the management of HIV infection in pregnant women 2012 c Page 21 of 27

22 Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the Committee. Document name Description Location BHIVA guideline Manual for guideline development manual a production processes BHIVA guidelines for Guideline example the treatment of HIV-1 infected adults with antiretroviral therapy 2012 b Guidelines for the Guideline example management of HIV infection in pregnant women 2012 c BHIVA_pregnancy_Sea Search method for the rch meth _DRAFT v1 Guidelines for the management of HIV infection in pregnant women 2012 BHIVA_pregnancy_Sea Search strategy for the rch Strategies_ Guidelines for the DRAFT_v1 management of HIV infection in pregnant women 2012 Guidelines_ pregnancy Search results for the and HIV_ search results Guidelines for the management of HIV infection in pregnant women 2012 literature search elopmentmanual.aspx V1_2012.aspx en2012.aspx Supplied Supplied Supplied Page 22 of 27

23 Document name Description Location HIV_OBS_allrefs_820.e nlx HIV_OBS_allrefs_abstr actlist HIV_OBS_medline_stra tegy Preg guideline_supporting info Search protocol_obs Summary recommendations v2 docx Topics for initial review and recommendation Reference list for the Supplied Guidelines for the management of HIV infection in pregnant women 2012 literature search List of all abstracts for Supplied Guidelines for the management of HIV infection in pregnant women 2012 literature search Medline search strategy for Supplied the Guidelines for the management of HIV infection in pregnant women 2012 literature search The Anti-Retroviral Supplied Pregnancy Register presentation Search protocol for the Supplied Guidelines for the management of HIV infection in pregnant women 2012 literature search Summary recommendations Supplied for the Guidelines for the management of HIV infection in pregnant women 2012 literature search Details of topics for the initial Supplied review and recommendation Page 23 of 27

24 Document name Description Location for the Guidelines for the management of HIV infection in pregnant women ART guidelines 2012 Appendices for BHIVA Supplied Appendices guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy 2012 Appendix 3.1 Grade Appendix 3.1 for BHIVA Supplied tables NRTI backbone guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy 2012 Appendicx 3.2 GRADE Appendix 3.2 for BHIVA Supplied tables which third agent guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy 2012 Appendix 3.3 GRADE tables switch studies PI monotherapy Appendix 3.3 for BHIVA guidelines for the treatment of HIV-1 infected adults with antiretroviral therapy 2012 Supplied Page 24 of 27

25 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 3. 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 s 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 are listed below. 3 Page 25 of 27

26 Title Name Surname Role Organisation Professor Ann Caress Professor of Nursing/Director of postgraduate research programmes University of Manchester Ms Alisa Donnelly Lay member Dr Carl Parker Primary Care medical adviser North Tees and Hartlepool Foundation Trust Professor David Haslam National clinical adviser Care Quality Commission Dr Donal O Donoghue National clinical director for kidney care & consultant renal physician Salford Royal NHS Foundation Trust Dr Edward Ng General Practitioner Ley Hill Surgery Ms Gill Swash Mr Jim Blair Head of Knowledge and Library Services Consultant Nurse Learning Disabilities NHS Western Cheshire St. George s Healthcare Trust Ms Joyce Epstein Lay member Dr Karen Ritchie Head of Knowledge Management Healthcare Improvement Scotland Dr Mark Strong MRC Fellow Section of Public Health, ScHARR Professor Monica Lakhanpaul Professor of Integrated Community Child Health Institute of Child Health Dr Peter Smith Vice President Mr Richard Brownhill Unscheduled care lead National Association of Primary Care Stepping Hill Hospital, Stockport Foundation Trust Ms Ruth Liley Assistant Director of Quality Improvement Marie Curie Cancer Care Ms Josephine Kavanagh Research officer Institute of Education External Advisers for the British HIV Association; UK national guidelines accreditation application Dr Safia Qureshi, Corporate Issues Director, Scottish National Blood Transfusion Service, Edinburgh. Page 26 of 27

27 Dr Mohit Sharma, Acting Consultant in Public Health, UK Cochrane Centre, Speciality Registrar in Public Health, Oxford Deanery, Teaching Fellow, Department of Public Health, University of Oxford, Oxford. Cheryl Harding-Trestrail, Cardiovascular Programme Lead, SHIP PCTs Cluster, NHS Hampshire, Hampshire. NICE Accreditation team for the British HIV Association; UK national guidelines accreditation application Mariam Bibi, Accreditation Technical Analyst, National Institute for Health and Clinical Excellence, Manchester, UK. Stephanie Birtles, Senior Technical Analyst, National Institute for Health and Clinical Excellence, Manchester, UK. Page 27 of 27