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1 SIGN 50A guideline developer s handbookRevised editionNovember 201150 NHS Quality Improvement Scotland (NHS QIS) is committed to equality and diversity. This guideline has been assessed for its likely impact on the six equality groups defined by age, disability, gender, race, religion/belief, and sexual orientation. For the full equality and diversity impact assessment report please see the published guidelines section of the SIGN website at The full report in paper form and/or alternative format is available on request from the NHS QIS Equality and Diversity Intercollegiate Guidelines NetworkSIGN 50A guideline developer s handbookJanuary 2008bSIGN 50.

2 A GUIDELINE DEVELOPER S HANDBOOK Scottish Intercollegiate Guidelines NetworkISBN 978 1 905813 25 4 First published 2008 Revised November 2011 SIGN consents to the photocopying of this guideline for the purpose of implementation in NHSS cotlandScottish Intercollegiate Guidelines Network Elliott House, 8 -10 Hillside Crescent Edinburgh EH7 UPDATED NOVEMBER 2011 CONTENTSC ontents1 Introduction .. Clinical guidelines and SIGN .. Aim and structure of this Guidelines in context .. Medico-legal implications of SIGN guidelines.

3 Review and updating of this manual ..52 Organisation of guideline development .. The Scottish Intercollegiate Guidelines Network .. Funding for guideline development .. Timescale for guideline development .. Influence of financial and other interests ..113 Selection of guideline topics .. The SIGN programme .. Criteria for selection of topics .. Topic selection process .. Updating published Involving patients and their representatives .. Patient involvement in guideline Identifying patients views.

4 Recruitment of patients to guideline development groups .. Role of patient representatives on guideline development groups .. Support for patient representatives on guideline development groups .. Wider consultation with patients and carers ..225 The guideline development group .. Composition of the guideline development group .. Responsibilities of development group members ..256 Systematic literature review .. Addressing patient issues in the literature search .. Using existing guidelines .. Defining key Identifying and selecting the evidence.

5 Evaluating the evidence ..32 SIGN 50: A GUIDELINE DEVELOPER S HANDBOOK7 Forming guideline recommendations .. Synthesising the evidence .. Considered judgement .. Levels of evidence and grades of recommendation .. Resource implications .. Current areas for development ..378 Consultation and peer review .. National open meeting .. Peer review ..389 Presentation and dissemination .. Content and presentation of the guideline .. Recommendations for research .. Quick reference guides and key Electronic publishing.

6 Information for patients .. Dissemination .. Links with audit ..4210 Implementation .. Getting guidelines into practice .. identifying barriers to implementation .. Implementation initiatives .. Practical steps .. Monitoring implementation ..47 Annexes ..48 References ..103111 INTRODUCTIONM eeting the agree appraisal criteriaSIGN methodology complies with the criteria used by the AGREE ( appraisal of Guidelines for Research and Evaluation in Europe) to identify good quality guidelines. The chapters of this manual that describe how SIGN addresses each criterion are identified 50 chapterScope and overall objective(s) of the guideline should be specifically clinical question(s)

7 Covered by the guideline should be specifically patients to whom the guideline is meant to apply should be specifically guideline development group should include individuals from all the relevant professional patients views and preferences should be of methods should be used to search for criteria for selecting the evidence should be clearly , methods used for formulating the recommendations should be clearly health benefits, side effects and risks should be considered in formulating the should be an explicit link between the recommendations and the supporting guideline should be externally reviewed by experts prior to publication.

8 Procedure for updating the guideline should be of recommendations should be specific and unambiguous. different options for diagnosis and/or treatment of the condition should be clearly presented. recommendations should be easily target users of the guideline should be clearly potential organisational barriers in applying the recommendations should be potential cost implications of applying the recommendations should be guideline should be supported with tools for guideline should present key review criteria for monitoring and audit , guideline should be piloted among end guideline should be editorially independent from the funding of interest of guideline development members should be 50.

9 A GUIDELINE DEVELOPER S HANDBOOK1 CLINICAL GUIDELINES AND SIGNThe Scottish Intercollegiate Guidelines Network (SIGN) was established in 1993 by the Academy of Royal Colleges and their Faculties in Scotland, to develop evidence based clinical guidelines for the National Health Service in ,2 Since January 2005, SIGN has been part of NHS Quality Improvement Scotland, though under the transfer agreement with the Academy SIGN retains editorial independence in relation to the guidelines it practice guidelines have been defined as systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.

10 3 They are designed to help practitioners assimilate, evaluate and implement the ever increasing amount of evidence and opinion on best current practice. Clinical guidelines are intended as neither cookbook nor textbook but, where there is evidence of variation in practice which affects patient outcomes and a strong research base providing evidence of effective practice, guidelines can assist healthcare professionals in making decisions about appropriate and effective care for their accepted criteria for validity of guidelines have evolved from the essential elements of good guidelines identified by the US Institute of Medicine in These recommended attributes of good guidelines included validity, reliability, clinical applicability, clinical flexibility, clarity, multidisciplinary process, scheduled review, and documentation.