Final Accreditation Report

Guidance producer: British National Formulary Publications Guidance product: Nurse Prescribers Formulary Date: 10 March 2014 Final Accreditation Report Page 1 of 28

Contents Introduction... 3 Accreditation recommendation... 3 Background to the guidance producer... 3 Reapplication for accreditation... 6 Appendix A: NICE Accreditation analysis... 7 Appendix B: Bibliography... 19 Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team... 26 Page 2 of 28

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 not accredited the process used by British National Formulary Publications to produce the Nurse Prescribers Formulary. Background to the guidance producer The Nurse Prescribers Formulary is published by the British Medical Association (BMA) and the Royal Pharmaceutical Society (RPS) in association with the Community Practitioners and Health Visitors Association and the Royal College of Nursing. The NPF is published through the British Medical Journal (BMJ) Group and the Pharmaceutical Press. ). BNF Publications is a consortium of the RPSGB, BMJ Publishing Group and RCPCH Publications. The NPF is derived from the BNF and BNFC. The Nurse Prescribers Advisory Group (NPAG) advise which items in the BNF and BNFC can be included in the NPF. The NPAG also formats the content for the target audience of the NPF which includes nurses and health visitors who have received nurse prescribed training. The NPF aims to provide accurate and up-to-date information about the use of medicines, including key information on selection, prescribing, dispensing and administration. This includes categorical information specific to individual medicines (termed medicines information in this report), and more general information about conditions, classes of medicines and Page 3 of 28

when it is appropriate to use them (termed clinical information in this report). This information is advice designed to guide the decision making of prescribers, and is developed according to a standard process which can be assessed using the accreditation criteria. Summary The Accreditation Advisory Committee considered that the processes used by BNF Publications to produce the NPF demonstrated compliance with 18 of the 25 criteria for accreditation, with 6 criteria not fully met, and 1 criterion not met. Overall the scope and purpose of the NPF is clear. The publication is based on a systematic search for evidence that takes into account the risks, benefits and side effects of different treatment options. The advice is presented clearly and a variety of support tools are available to aid implementation. Whilst the process has strengths, there are concerns about the lack of involvement of some stakeholders, such as patients or their representatives, and the lack of a process for systematically assessing the strengths, weaknesses and areas of uncertainty in the evidence. Peer review is external to the group developing recommendations but internal to the organisation, without a clear reason why it is not completely external. In addition, the end user cannot tell when different sections were last updated or reviewed. The assessment identified several areas where processes fall short of the required standard for guidance production. The main improvements that must be made are: to demonstrate a robust process to systematically and transparently assess the strengths, weaknesses and areas of uncertainty in the evidence base to develop a process for communicating the strengths, weaknesses and areas of uncertainty in the evidence base to the end user Further recommendations for improvement of the process include: Page 4 of 28

continuing with the recruitment of lay members to the formulary committees and ensuring they are supported to fully participate alongside professional members. involving all relevant stakeholder groups and target users in developing recommendations ensuring external peer review of the recommendations ensuring the end user knows when content was last updated or reviewed providing some discussion of barriers to implementation in applying the recommendations in the NPF. Although accreditation has not been granted, the NPF development process has many strengths. The publication will remain available in print but will not be identified by the accreditation mark graphic. Professor Martin Underwood Chair, Advisory Committee March 2014 Page 5 of 28

Reapplication for accreditation Guidance producers that are not accredited following the accreditation process have the opportunity to reapply from 1 year after the previous assessment, or sooner under exceptional circumstances. This is to ensure that there is sufficient time to provide evidence of implementation of any required changes to the process. Because the BNF and BNFC (upon which the NPF is based) are updated monthly online, it may be possible to provide this evidence sooner than 1 year. NICE would therefore welcome an application before 1 year has elapsed, if evidence can be provided that the required improvements have been made. The NICE Accreditation team will provide detailed feedback and advice on areas where improvement is required to meet the criteria in a future application. Page 6 of 28

Appendix A: NICE Accreditation analysis The Accreditation Advisory Committee considered the following analysis of the guidance producer s compliance with NICE Accreditation criteria, which covers 6 discrete domains. The full analysis leading to the accreditation decision is shown below. Criterion Evidence for meeting the criterion Accreditation decision Scope and purpose Does the guidance producer have a policy in place and adhered to that requires them to explicitly detail: 1.1 Overall objective There is evidence of a standard format for presenting the overall objective as the aim of the NPF is stated in the preface and on the rear cover of the publication 1, in common with the BNF 2 and BNFC 3. 1.2 The clinical, healthcare or social questions covered The NPF 1 aims to address high-level questions of drug safety, effectiveness, appropriateness, dosage and adverse effects for all medications covered. Information relating to these key questions such as cautions, contraindications and side effects is provided in a standard format for each medicine or class of medicine, as evidenced by the consistency of format throughout the publication 1. Clinical questions are addressed by the clinical information provided at the start of each chapter or section 1. Page 7 of 28

Criterion Evidence for meeting the criterion Accreditation decision 1.3 Population and/or target audience to whom the guidance applies There is evidence of a standard format as the target audience for the NPF is stated on the rear cover 1 in common with the BNF 2 and BNFC 3. The overall target population is broad given the variety of medicines covered, but specific populations are defined by the indications for each medicine 1. 1.4 Guidance includes clear recommendations in reference to specific clinical, healthcare or social circumstances There is evidence of a standard format for recommendations in the NPF as they are consistently provided for individual medicines in the context of the indications, contraindications and cautions for that medicine 1. These provide the clinical circumstances in which a medicine is recommended or not. Stakeholder Does the guidance producer have a policy in place and adhered to that means it includes: Page 8 of 28

Criterion Evidence for meeting the criterion Accreditation decision involvement 2.1 Individuals from all relevant stakeholder groups, including patient groups, in developing guidance The document Standing Orders of the Formulary Committees of the British National Formulary 4 details the composition of the Nurse Prescribers Advisory Group (NPAG), which advises on which items in the BNF 2 and BNFC 3 should be included in the NPF 1 and how the content Not fully met should be presented. The NPAG contains a variety of nursing representatives. The NPAG does not develop recommendations as that occurs in the development of the BNF 2 and BNFC 3, upon which the NPF 1 is based 6. The Joint Formulary Committee (JFC) of the BNF and the Paediatric Formulary Committee (PFC) of the BNFC are responsible for developing the recommendations 4. Public consultation comments 5 indicate that nurse prescribers have been recruited to the JFC and PFC and a process for recruiting lay members is indicated, but no examples of recommendations produced with their input are available in February 2014. 2.2 Patient and service user representatives and seeks patient views and preferences in developing guidance The NPF 1 draws upon some sources of evidence that involve patients in their development, as described in Standard reference sources 7, but not all. There are no lay or patient representatives on the JFC or PFC however 4, so some recommendations are developed without lay or patient Not fully met input. The public consultation comments 5 indicate that recruitment of lay members to the JFC and PFC is underway, but no examples of guidance developed with their input are currently available. Page 9 of 28

Criterion Evidence for meeting the criterion Accreditation decision 2.3 Representative intended users in developing guidance. The document Standing Orders of the Formulary Committees of the British National Formulary 4 details the composition of the JFC and the PFC who develop the recommendations used in the NPF 1. The BNF 2 and BNFC 3 detail the membership of the committees and do not include community practitioner nurse prescribers. The public consultation comments 5 indicate that nurse prescribers have been recruited to the committees, but no examples of guidance produced with their input were available in February 2014. Not fully met 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 Standard reference sources 7 and Journal allocation list 8 provide lists of key sources of evidence which are scanned regularly for new medicines and clinical information. This includes updated summaries of product characteristics (SPC), drug safety updates (DSU), guidelines and journals. NICE also regularly notifies the guidance producer of any new relevant evidence it produces. This process is another systematic route to identify new evidence. Evidence of regular scanning of sources is provided by an internal tracking spreadsheet 9. Page 10 of 28

Criterion Evidence for meeting the criterion Accreditation decision 3.2 Requires the guidance producers to state the criteria and reasons for inclusion or exclusion of evidence identified by the evidence review Inclusion and exclusion criteria are detailed in the document Criteria for inclusion and exclusion of products in BNF and BNF for Children 10. This applies to the NPF because it is derived from the BNF and BNFC. The NPAG advises on which items in the BNF and BNFC should be included in the NPF 4. 3.3 Describes the strengths and limitations of the body of evidence and acknowledges any areas of uncertainty Many sources of evidence are included in the development of the NPF 1, so it is vital there is an appropriate processes to appraise different types of evidence. The document Standard reference sources 7 ranks sources of evidence according to how accurate and reliable the guidance producer considers the information from those sources to be, but there is no systematic process to appraise individual items of evidence from those sources. The transcripts 11 of discussions by expert advisers, the JFC and PFC do not demonstrate systematic consideration of the strengths and weaknesses of items of evidence. However, there is no process for communicating the strengths, weaknesses and areas of uncertainty in the evidence base to the end user, which might influence treatment decisions if provided. For the NPF 1 this concerns the clinical information as nurse prescribers may not prescribe off-label, and therefore medicines information is taken directly from SPCs. Criterion not met Page 11 of 28

Criterion Evidence for meeting the criterion Accreditation decision 3.4 Describes the method used to arrive at recommendations (for example, a voting system or formal consensus techniques like Delphi consensus) The recommendations in the NPF 1 are originally developed in the production of the BNF 2 and BNFC 3, for which there is a documented process 12. Content changes based on updated SPC or DSUs are made by the editorial team. Any other evidence is first examined by the editorial team, then expert advisers who are practising clinicians, then the JFC or PFC 12. The document Standing orders of the formulary committees of the British National Formulary 4 explains that consensus is used to reach decisions. Where consensus is not possible a voting system is used. Transcripts of conversations demonstrate this process in action 11. The NPAG advises on which medicines and associated recommendations in the BNF and BNFC are presented in the NPF 1,4. 3.5 Requires the guidance producers to consider the health benefits against the side effects and risks in formulating recommendations The NPF 1 presents medicines information in a standard format in common with the BNF 2 and BNFC 3, which details contraindications and side effects. The clinical information also discusses the risks and side effects of classes of medicines for different conditions 1. Recommendations are developed by the JFC and PFC following input from external advisers 12. The transcripts of these discussions 11 show consideration of the risks, benefits and side effects in reaching recommendations for both medicines and clinical information. Page 12 of 28

Criterion Evidence for meeting the criterion Accreditation decision 3.6 Describes the processes of external peer review The recommendations in the NPF 1 are developed by the JFC and PFC, so the peer review process for those recommendations therefore applies to the NPF content. Recommendations from the JFC and PFC are reviewed by editors who work for BNF Publications with no prior involvement in assessing the evidence or developing the recommendations. A screenshot of an internal content change tracker 13 provides evidence of this process. Whilst external to the group developing the recommendations, the reviewing editors are not external to the guidance producer. There is no reason that necessitates such a system of internal peer review in this case as the evidence considered is not confidential or otherwise restricted. Not fully met 3.7 Describes the process of updating guidance and maintaining and improving guidance quality The NPF is produced in hard copy every 2 years. Medicines information is reviewed at least every 3 years 12 in the BNF and BNFC, which the NPF is based on. Important changes since the last edition are indicated in the NPF 1. Clarity and presentation Does the guidance producer ensure that: 4.1 Recommendations are specific, unambiguous and clearly identifiable Medicines and clinical information in the NPF 1 is presented in a standard format throughout the publication. Examination of the NPF 1 shows that the recommendations are specific, unambiguous and clearly identifiable. Page 13 of 28

Criterion Evidence for meeting the criterion Accreditation decision 4.2 Different options for the management of the condition or options for intervention are clearly presented The format of the NPF 1 ensures a range of medicines are presented where available, allowing the prescriber to select the most appropriate medicine. Examination of the NPF 1 shows that the options for management or intervention are clearly presented. 4.3 The date of search, the date of publication or last update and the proposed date for review are clearly stated The NPF 1 is a printed publication with a copyright statement on the first page containing the year of publication. 2011-2013 is printed on the front cover and the rear cover states that the NPF is issued every 2 years. The NPF 1 does not state however when each section was last reviewed or updated, which is important because not all information is reviewed with each update. Not fully met 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 NPF 1 content is derived from the BNF 2 and BNFC 3. The process 12 includes multidisciplinary committees 4 to help ensure the content is suitable for the target audience. Whilst no examples of recommendations developed with the input of nurse prescribers are currently available, public consultation comments 5 indicate the language and format of the NPF 1 is suitable for nurse prescribers. Page 14 of 28

Criterion Evidence for meeting the criterion Accreditation decision Applicability Does the guidance producer routinely consider: 5.1 Publishing support tools to aid implementation of guidance The NPF 1 is designed as a succinct reference tool. It includes guidance on how to write prescriptions, prescribing for children, and details of major changes since the last edition 1. Online versions of the BNF 2 and BNFC 3 are available 14 to subscribers or those with an NHS Athens account that contain recent updates and provide a quick way to find medicines information. The BNF is also available as an application for smartphones 15 which may assist prescribers who do not have access to a hard copy whilst working. 5.2 Discussion of potential organisational and financial barriers in applying its recommendations There is no specific process requiring the discussion of potential organisational or financial barriers in the NPF 1. Some barriers are discussed in the BNF 2 and BNFC 3, which the NPF is intended to be used 1. However, users without access to the BNF or BNFC cannot see that content. Not fully met 5.3 Review criteria for monitoring and/or audit purposes within each product. The NPF 1 contains MHRA yellow cards for reporting suspected adverse reactions to medicines. This demonstrates a form of monitoring included within the guidance product as yellow cards are important for monitoring medicines in the marketplace. Editorial Does the guidance producer: Page 15 of 28

Criterion Evidence for meeting the criterion Accreditation decision Independence 6.1 Ensure editorial independence from the funding body The health services of the 4 home countries of the UK are the funding source but it is necessary to include a variety of health service employees in development of the BNF 2, BNFC 3 and NPF 1. In practice the NHS employees who sit on the JFC, PFC and NPAG are not responsible for purchasing the NPF. BNF Publications is also independent of the pharmaceutical industry and receives no funding from them. The NPF does not include adverts for any products 1. All committee members and external advisers are required to declare any conflicts of interest 4,17. 6.2 Demonstrate transparency about the funding mechanisms for its guidance The prime funding source of the NPF is the health services of the 4 home countries of the UK, and the contract is managed by NICE. BNF Publications receives funding for content development and also revenue from print sales. The recommendations in the NPF 1 are taken from the BNF 2 and BNFC 3 which include a statement that they are funded by sales to the health service. Page 16 of 28

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 standing orders of the formulary committees 4 (which also explicitly covers the NPAG), terms of reference for expert advisers 16 and declaration of interests form for expert advisers 17 provide comprehensive, appropriate policies for declaring and managing conflicts of interest. BNF editorial staff are required to declare conflicts through the Royal Pharmaceutical Society register of interests 18. Both the policies and declarations are available upon request. 6.4 Take account of any potential for bias in the conclusions or recommendations of the guidance The process of evidence identification is systematic. Funding is transparent, editorial independence from the funding source is achieved, and there is a comprehensive policy for declaring conflicts of interest 4,16,17,18. Together these steps help to ensure the possibility of bias is reduced. Page 17 of 28

Criterion Evidence for meeting the criterion Accreditation decision 1 Nurse Prescribers Formulary 2 British National Formulary 3 British National formulary For Children 4 Standing orders of the formulary committees of the British National Formulary 5 Accreditation decision consultation comments table for BNF Publications 6 Processing the Nurse Prescribers Formulary lists 7 Standard reference sources 8 Journal allocation list 9 Logs of systematic searches 10 Criteria for inclusion and exclusion of products in BNF and BNF for Children 11 Transcripts of discussions by expert advisers, the JFC and PFC 12 Creating content for referential (human readable) BNF and BNFC 13 screenshot of an internal content change tracker 14 Online versions of the BNF and BNFC 15 BNF application for smart-phones 16 BNF and BNFC Advisors Terms of Reference 17 Declaration of Interests Form Advisor 18 Royal Pharmaceutical Society register of interests Page 18 of 28

Appendix B: Bibliography Appendix B lists the additional information taken into account in the analysis and considered by the committee. Document name Description Location Accreditation decision consultation comments table for BNF Publications Pubic consultation comments received for the decision not to accredit the processes used to produce the BNF and BNFC Appendix 1: BNF and Scenarios demonstrating use BNFC Use Cases of the BNF Appendix 2: When to Explains when expert seek expert input on advisers and committees are clinical issues used Appendix 3: Creating Process document for content for referential creating BNF and BNFC (human readable) BNF content and BNFC Appendix 4: Example of expert adviser Discussions: JFC Use discussion over content of aminoglycosides with ototoxic diuretics Appendix 5: Recruiting Procedure for recruiting a new adviser expert advisers Appendix 6: Standard List of sources and quality reference sources criteria used by the BNF Appendix 7: Readability Demonstrates patient Testing report for BNF involvement in developing Appendix 9 - Cautionary patient information Available via the table of accreditation decisions Page 19 of 28

Document name Description Location and advisory labels for dispensed medicines Appendix 8: BNF: latest User research findings user research Oct 2012 Appendix 9: BNF List of journal sources journal allocation 11/2012 Appendix 10: Procedure Procedure for processing for processing SPCs SPCs Appendix 11: Example of processed SPC Processed SPC for Exembol [argatroban] Appendix 12: BNF SOP SOP for checking doses Checking doses Appendix 13: BNF and BNFC Advisors Terms of Reference Appendix 14: BNF Standing Orders of the Formulary Committees of the British National Formulary Appendix 15: Criteria for inclusion and exclusion of products in BNF and BNFC Appendices 16a-d: Email correspondence related to NYDA Terms of Reference for expert advisors Standing Orders of the Formulary Committees of the British National Formulary Information on what types of products are covered Email correspondence related to NYDA Page 20 of 28

Document name Description Location Appendix 17: BNF SOP Information on how the list of Processing the Nurse medicines and devices in the Prescribers Formulary NPF is arrived at lists Appendix 18: BNF SOP Processing the Dental Practitioners Formulary lists Appendix 19: BNF Style guide Appendix 20: BNFC Style guide Appendix 21: Style guide for hepatic, renal, pregnancy, and breastfeeding messages in BNF and BNFC Appendix 22: BNF Sideeffects help guide Appendix 23: BNF ACBS Product placement decision guide Appendix 24: BNF ACBS Style guide Appendix 25: Google analytics of BNF website Information on how the list of dental medicines in the BNF and BNFC is arrived at BNF Style guide BNFC Style guide BNFC Style guide BNFC Style guide Editorial guide Style guide Website statistics for BNF website Page 21 of 28

Document name Description Location Appendix 26: Royal Declaration of interests form Pharmaceutical Society for the RPS Register of Interests form Appendix 27: British Society of Antimicrobial Chemotherapy guidelines for the antibiotic treatment of endocarditis in adults 2012 Appendix 28: BNF endocarditis Appendix 29: BNF Standing Orders of the Formulary Committees of the British National Formulary Appendix 30: BNF and BNFC Advisors Terms of Reference Appendix 31: Declaration of Interests Form Advisor Appendix 32: BNF SOP Creating content for the Nurse Prescribers Formulary for Community Practitioners Sample of evidence identified by searches BSAC Endocarditis BNF analysis (2012) Standing orders Terms of reference Declaration of interests form SOP for developing the NPF Supplied Page 22 of 28

Document name Description Location Appendix 33: Extract of Sample of evidence identified NICE CG102: Bacterial by searches meningitis and meningococcal septicaemia in children: full guideline Appendix 34: BNFC Expert advisers review of Adviser questions evidence posted on pre-hospital antibiotics for meningitis Appendix 35: JFC JFC review of evidence paper on pre-hospital antibiotics for meningitis Appendix 36: PFC PFC review of evidence paper on pre-hospital antibiotics for meningitis Appendix 37: PFC PFC review of evidence paper on maximum dose of adenosine Appendix 38: PFC PFC review of evidence paper on lisinopril heart failure dose Appendix 39: PFC PFC review of evidence paper on the role of spironolactone in nephrotic syndrome Appendix 40: PFC PFC review of evidence paper on the nebulised dose of colistimethate sodium Page 23 of 28

Document name Description Location Appendix 41: JFC JFC review of evidence paper tiotropium Appendix 42: BNFC Expert advisers review of Adviser discussion on evidence plasma concentration monitoring of colistimethate Appendix 43: BNFC Expert advisers review of Adviser discussion on evidence benzylpenicillin dose in neonates Appendix 44: BNFC Expert advisers review of Adviser discussion on evidence intravenous infusion dose of metronidazole in neonates Appendix 45: UK Expert adviser review of BNF Ophthalmic Pharmacy chapter Group comments on chapter 11, BNF 64 Appendix 46: BNF and Terms of reference BNFC Advisors Terms of Reference Appendix 47: Drug Drug safety update Safety Update March 2013 vol. 6, issue 8 Appendix 48: BNF and Update of changes for BNF BNF for Children and BNFC update for health professionals Page 24 of 28

Document name Description Location Monthly important new Letter from NICE detailing information.pdf changes to medicines information of interest to the BNF Page 25 of 28

Appendix C: NICE Accreditation Advisory Committee, external advisers and NICE Accreditation team NICE Accreditation Advisory Committee The 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 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 is excluded from participating further in the discussions. Committee members who took part in the decision making for this accreditation application are listed below. Title Name Surname Role Organisation Ms Judy Birch Lay member Lay member Dr Adrian Brown Principal Screening Advisor NHS England Mr Richard Brownhill Deputy General Manager for Emergency Care Sheffield Teaching Hospitals NHS Trust Professor Ann Caress Professor of Nursing University of Manchester Page 26 of 28

Ms Ailsa Donnelly Lay member Lay member Ms Joyce Epstein Lay member Lay member Ms Gail Fortes Mayer Lead Commissioner Sandwell and West Birmingham clinical commissioning group Dr Elvira Garcia Public Health Medicine Consultant Locum Dr Bobbie Jacobson Public Health Consultant Institute of Health Equity Ms Ruth Liley Assistant Director of Quality Improvement Marie Curie Cancer Care Dr Edward Ng General Practitioner Ley Hill Surgery Sutton Coldfield Professor Sandy Oliver Professor of Public Policy University of London Dr Mahendra Patel Senior Lecturer & Consultant Pharmacist Dr Karen Ritchie Head of Knowledge Management Ms Mandy Sainty Research and Development Manager Professor Sasha Shepperd Professor of Health Services Research Dr Sara Twaddle Head of Evidence & Technologies / Director of SIGN Professor Martin Underwood Head of Division of Health Sciences, Professor of Primary Care Research Dr Stephen Webb Consultant in Anaesthesia & Intensive Care Medicine Universities of Huddersfield and Bradford Healthcare Improvement Scotland College of Occupational Therapists University of Oxford Healthcare Improvement Scotland The University of Warwick Papworth Hospital NHS Foundation Trust Dr Charles Young Emergency Physician St Thomas' Hospital, London External Advisers for this application Dr Andrea Hilton, Lecturer and practising pharmacist, University of Hull, UK Dr Marlies Ostermann, Consultant in Critical Care and Nephrology, Guy's & St Thomas' Hospital, London, UK Page 27 of 28

Adrian Palfreeman, Consultant Physician University Hospitals Leicester, UK Adrian Reyes-Hughes, Clinical Consultant, Clinical Strategy & Health Information Services, UK NICE Accreditation team for this application James Stone, Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK Stephanie Birtles, Accreditation Technical Analyst, National Institute for Health and Care Excellence, Manchester, UK Page 28 of 28