Final Accreditation Report

Transcription

1 Guidance producer: Healthcare Infection Society Guidance product: Clinical Guidelines Date: 23 March 2015 Version: 1.6 Final Accreditation Report Page 1 of 19

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 19

3 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 accredited the process used by the Healthcare Infection Society to produce its clinical guidelines. Accreditation is valid for 5 years from March 2015 and is applicable to guidance produced using the processes described in the Healthcare Infection Society Guideline Development Manual (V9) February Background to the guidance producer The Healthcare Infection Society (HIS) was established in 1980 as a specialist society to advance knowledge in the prevention and control of healthcare acquired infections (HCAI). As of August 2014 HIS became a charity. HIS also represents professionals in the field of infection prevention and control (IPC). The primary objectives of HIS are to improve knowledge, increase scientific interest and disseminate information about the prevention and control of hospital and other HCAI, to medical and allied professionals. The membership of HIS is principally consultant microbiologists and trainees. Associate membership is open to nurses and other health professionals with a special interest in infection control. Page 3 of 19

4 Summary The Accreditation Advisory Committee considered that the processes used by the Healthcare Infection Society to produce their clinical guidelines complied with 24 of the 25 accreditation criteria. The processes used to develop clinical guidelines are detailed in the Healthcare Infection Society Guideline Development Manual V9 (February 2015). The process used to produce Healthcare Infection Society clinical guidelines is rigorous, transparent and systematic and results in clearly identifiable, easy to understand recommendations. Relevant professional and lay members are involved in development, including intended users of the guidance. All guidelines are developed through a robust method that identifies the best evidence available. Details of the search strategy are provided, along with what evidence was included and excluded. The guidelines are clear and presented in a format suitable for target users with consideration of the financial and organisational barriers included. A variety of supporting tools are available to aid implementation and audit measures are provided. Guideline development is editorially independent and accounts for the possibility of bias. Advice to improve the process used to produce Healthcare Infection Society clinical guidelines is to clarify in the guideline development manual and in the guidance, the process and triggers for ad hoc updates. Professor Martin Underwood Chair, Accreditation Advisory Committee March 2015 Page 4 of 19

5 Implementation Following accreditation, guidance from the accredited producer will be identified on NICE 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 NICE 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 NICE Accreditation Mark Page 5 of 19

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 is shown below. Criterion Evidence for meeting the criterion Accreditation 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 Section 4.3 of the process manual 1 states that each guideline should include its objectives. The guidance example 2 details the overall objectives in section 4.1 Aim and section 2 Lay summary. Healthcare Infection Society: Final Accreditation Report Page 6 of 19

7 Criterion Evidence for meeting the criterion Accreditation 1.2 The clinical, healthcare or social questions covered Section 2.2 of the process manual 1 provides information on drafting the scope of the guideline, including the need to identify key issues and list the key questions that will be considered. Section 4.3 of the process manual 1 states that the scope and purpose should clearly indicate the clinical questions addressed. Appendix 3 of the Process manual 1 contains a checklist for all guidelines and included is an entry which asks if the clinical, healthcare or social questions are covered. The guideline 2 details the questions covered in appendix 5 using the population, intervention, comparison and outcome (PICO) framework. 1.3 Population and/or target audience to whom the guidance applies Section 1.1 of the process manual 1 describes the main target audience as professionals looking for evidence-based interventions to decrease HCAI. Section 3.1 of the process manual 1 states that the relevant populations for the guideline are adult or paediatric patients in hospital or in the community. The populations and target audience are stated in section 4 of the guideline Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances Appendix 3 of the process manual 1 contains a checklist for all guidelines. It asks if the recommendations are in reference to specific clinical, healthcare or social circumstances. The recommendations in the guideline 2 are clear and users can identify when they should be used. Page 7 of 19

8 Criterion Evidence for meeting the criterion Accreditation Stakeholder involvement 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 Section 2.4 of the process manual 1 advises that the chair and members of the working groups should be selected on the basis of their expertise. The working group will usually contain at least one lay representative and representatives from nursing and other professional groups. Appendix 3 of the Process manual 1 provides a checklist and includes the question Has there been adequate involvement of patient and stakeholder groups in development? A list of members of the working group is provided at the start of the guideline 2 and includes relevant professional and patient representatives. 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance Sections 2.2 and 3.3 of the process manual 1 require a search for information on the views and experiences of people using the services, their family members or carers, or the public. The consultation process is described in section 3.6 and invites views on a range of aspects of the guideline including patient acceptability. Patient representatives are invited to all meetings and involved in the writing and drafting of the guidelines. The working group included 3 patients and a representative from a patient charity. Page 8 of 19

9 Criterion Evidence for meeting the criterion Accreditation 2.3 Representative intended users in developing guidance. Section 2.4 of the process manual 1 describes the composition of the working group. The chair and other members are selected on the basis of their expertise and track record of interest in the sub-speciality area. If guidelines are developed in collaboration with other infection societies then representatives of these organisations will be selected for the working group according to their expertise. Section 4 and appendix 3 of the guideline 2 provide details of target user involvement. 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 3.2 Requires the guidance producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review Section 3.2 and appendix 6 of the process manual 1 describes the systematic literature review which as a minimum involves searching Medline or PubMed, EMBASE and the Cochrane database. Section 12.2 of the guideline describes the search process and appendix C contains review protocols with examples of searches in appendix D. Section 3.2 of the process manual 1 explains the process of evidence selection with clear inclusion and exclusion criteria. Search strategies, included and excluded evidence, with a rationale for exclusion, are required in appendices in the guidance and on the HIS website. The guideline 2 provides this information along with a flowchart in Appendix 2 which includes the number of records excluded at each stage. Page 9 of 19

10 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 Sections 3.2 and 3.4 of the process manual 1 describe the grading of evidence using Scottish Intercollegiate Guidelines Network (SIGN) methodology. Checklists are available for different study types. The guidance example 2 has discussion of the strengths, weaknesses and areas of uncertainty for all evidence detailed in Appendix G. 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 process manual 1 describes the grading process for recommendations. The assessment of the strength of recommendations was adopted from the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Any disagreements between members are resolved by discussion. The guidance example 2 shows that this process was followed. 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations Section 3.5 of the process manual 1 describes the process of grading the recommendations indicating that the strength of recommendations consider the balance of risks and benefits. Appendix 2 of the guidance example 2 shows that the systematic review questions consider risks and benefits. The rationale for the recommendations also show that risks and benefits have been considered. Page 10 of 19

11 Criterion Evidence for meeting the criterion Accreditation 3.6 Describes the processes of external peer review Section 3.6 of the process manual 1 describes the consultation process with stakeholders, peer reviewers and the public. The guideline 2 shows that this process was followed, and details are provided in Appendix K. 3.7 Describes the process of updating guidance and maintaining and improving guidance quality The process manual 1 indicates that review and possible update of the guideline will be 4 years after publication and explains the process for this. However there is no description of how an ad hoc review may be identified, for example if important new evidence emerges, and how this will be done. Criterion not fully met Clarity and presentation Does the guidance producer ensure that: 4.1 Recommendations are specific, unambiguous and clearly identifiable Section 4.1 of the process manual 1 provides a standard format for the guidelines and specifies inclusion of a summary of all clinical practice recommendations in a format suitable for lay people. Section 5 of the guideline 2 gives a summary of the recommendations which are both specific and unambiguous. 4.2 Different options for the management of the condition or options for intervention are clearly presented The process manual 1 requires that the different options for management or intervention are considered and clearly presented. The guidance 2 clearly presents the options for management or intervention. Page 11 of 19

12 Criterion Evidence for meeting the criterion Accreditation 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated Section 4.3 of the process manual 1 requires the dates of publication, expiry and proposed review be clearly stated in the scope and purpose section and on the HIS website 3. Section 4.6 indicates that the dates of searches should be included in the methodology section. Dates of planned guidelines are also published on the HIS website 3. These items are provided in the guidance assessed 2, with a location for publication date, which has not yet taken place 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. Section 4.4 of the process manual 1 states that the summary of the recommendations should be given at the start of the guideline and that a lay summary should be included and available on the HIS website 3. Section 5.1 of the process manual 1 states that a patient friendly version of the guidelines will be produced in conjunction with the community for dissemination to service users. The content of the guidance example assessed 2 is suitable for both the professional target audience and lay people. Page 12 of 19

13 Criterion Evidence for meeting the criterion Accreditation Applicability Does the guidance producer routinely consider: 5.1 Publishing support tools to aid implementation of guidance The process manual 1 indicates that a patient friendly version of the recommendations will be produced and freely available. It also describes various dissemination and implementation initiatives, including continuing professional development (CPD) accredited material, audit measures and e-learning tools. These implementation tools are described in sections 5 and 6 and appendix 4 of the guideline Discussion of potential organisational and financial barriers in applying its recommendations Section 4.5 of the process manual 1 requires discussion of barriers to implementation and section 6.2 specifically covers the costs of implementation. The guidance example 2 discusses both the costs of implementation and the cost consequences of outbreaks arising from nonimplementation, including financial, physical and psychological costs. 5.3 Review criteria for monitoring and/or audit purposes within each product. Section 4.5 of the process manual 1 requires the guidelines to include various audit measures to help implement the guideline, promote improvement in the quality of care and allow comparative audit. The audit parameters should be measurable, achievable and act as evidence-based criteria for ongoing quality improvement. Audit measures for national audits should be identified. Section 6.3 of the guidance example 2 provides a summary of audit measures. Page 13 of 19

14 Criterion Evidence for meeting the criterion Accreditation Editorial Does the guidance producer: independence 6.1 Ensure editorial independence from the funding body HIS is a charity and is not funded by any commercial organisation. The working party was funded by a grant from the British Infection Association (BIA), HIS and the British Society for Antimicrobial Chemotherapy (BSAC). Members receive travel expenses but no remuneration for participation. The views expressed are those of the authors who include patient representatives. In the guideline 2 the names and affiliations of members of the working group are given along with any declarations of interest. The names of organisations providing comments during consultation are also included. 6.2 Demonstrate transparency about the funding mechanisms for its guidance Information on the charity commission website 4 confirms the charitable status of the HIS and gives a breakdown of its income and expenditure. The HIS website 3 states that the HIS is a charity and provides the registration number and recent annual accounts. Costs were incurred in collating and grading evidence and some administrative support, provided by HIS, who received a funding grant from 3 organisations (BIA, HIS and BSAC) to support the guideline development working party. Section 4.2 of the process manual 1 details what should be included in the acknowledgement and declaration of interest section of the guideline, including sources of funding. Page 14 of 19

15 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 2.5 of the process manual 1 requires those involved in development to declare any potential interests, in accordance with the policy detailed in Appendix 4. This includes financial and non-financial interests. Appendix B in the guideline example 2 provides details of individual declarations and any actions arising. 6.4 Take account of any potential for bias in the conclusions or recommendations of the guidance The process 1 requires transparency over the methods used to identify evidence and to indicate the quality of the evidence underpinning the recommendations. Guidance is developed by members who are not paid and they are all required to declare any conflicts of interest, including both financial and non-financial interests. The HIS is a charity and is transparent about its funding. Overall the process is systematic, includes a range of appropriate stakeholders and has safeguards in place to minimise opportunities for bias. The guideline 2 confirms this. Documents referenced above: 1 Healthcare Infection Society Guideline Development Manual (v9) Feb Prevention and control of multi-resistant Gram-negative bacteria recommendations from a Joint Working Party (late draft, December 2014) 3 Healthcare Infection Society (HIS) website 4 Charity commission website Page 15 of 19

16 Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the committee. Document name Description Location Healthcare Infection Society guideline development manual (v9) February 2015 Process manual Provided by guidance producer, final version not yet published. Prevention and control of multiresistant Gram-negative bacteria Guidance example Supplied by producer, not yet published. recommendations from a Joint Working Party (late draft, December 2014) Appendices (A-K) to support the guideline Details of review including searches, inclusions, exclusions, Provided by guidance producer at feedback stage grading etc HIS website HIS website Healthcare Infection Society: Final Accreditation Report Page 16 of 19

17 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 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. Title Name Surname Role Organisation Ms Judy Birch Lay member Lay Member Dr Adrian Brown Public Health Specialist Principal Screening Advisor, Public Health England and NHS England (London) Ms Susan Cervetto Nursing and Allied Health Professional Senior Appraisal Pharmacist, All Wales Therapeutics & Toxicology Centre Page 17 of 19

18 Ms Ailsa Donnelly Lay member Lay member Ms Joyce Epstein Lay member Lay member Ms Diana Gordon Social Care Practitioner Company Director Ms Barbara Graham Health Economist Information Consultant/Senior Health Economist, PHI NHS Scotland Ms Angela Green Nursing and Allied Health Professional Lead clinical research therapist, Hull and East Yorkshire Hospitals NHS Trust Dr Steve Hajioff Public Health Specialist General Practitioner and Public Health Consultant Dr Anthony Larkin General Practitioner General Practitioner Professor Donal O'Donoghue Senior Medical Professional Dr Mahendra Patel Academic & Consultant Pharmacist Consultant Renal Physician, Salford Royal NHS Foundation Trust and Honorary Professor of Renal Medicine, University of Manchester Principal Enterprise Fellow in Pharmacy University of Huddersfield Pharmacy Research Champion CRN (NIHR) Ms Mandy Sainty Social Care Practitioner Research and Development Manager, College of Occupational Therapists Professor Sasha Shepperd Methodological Expert Professor of Health Services Research, Nuffield Department of Population Health, University of Oxford Professor Martin Underwood Chair Director, Warwick Clinical Trials Unit, University of Warwick Dr Charles Young Methodological Expert VP and Publishing director, Global clinical solutions; Editorin-Chief Clinical Case Reports; Emergency Physician, Guys and St Thomas' NHS Trust Page 18 of 19

19 External Advisers for this accreditation application Dr Kristiina Patja, Director, Association for Continuous Professional Development in Finland (Pro Medico), Finland Nigel Beasley FRCS (ORL HNS), Consultant in ENT Surgery, Nottingham University Hospitals NHS Trust, Nottingham, UK NICE Accreditation team for this accreditation application Helen Eaton, Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK John Huston, Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK Deborah Collis, Associate Director Accreditation and Quality Assurance, National Institute for Health and Care Excellence, Manchester, UK Page 19 of 19