SIGN 50: A guideline developer's handbook

Section 1: Introduction

Meeting the AGREE appraisal criteria

SIGN 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 below.

		SIGN 50 chapter
Scope and purpose
1	The overall objective(s) of the guideline should be specifically described	9.1
2	The clinical question(s) covered by the guideline should be specifically described	6.3
3	The patients to whom the guideline is meant to apply should be specifically described	9.1
Stakeholder involvement
4	The guideline development group should include individuals from all the relevant professional groups	5
5	The patients’ views and preferences should be sought	4
Rigour of development
6	Systematic methods should be used to search for evidence	6
7	The criteria for selecting the evidence should be clearly described	6.3, 6.4
8	The methods used for formulating the recommendations should be clearly described	7.1
9	The health benefits, side effects and risks should be considered in formulating the recommendations	7.2
10	here should be an explicit link between the recommendations and the supporting evidence	7.2
11	The guideline should be externally reviewed by experts prior to publication	8.2
12	A procedure for updating the guideline should be provided	3.4
Clarity of presentation
13	The recommendations should be specific and unambiguous	9.1
14	The different options for diagnosis and/or treatment of the condition should be clearly presented	9.1
15	Key recommendations should be easily identifiable	7.2.3
Applicability
16	The target users of the guideline should be clearly defined	9.1
17	The potential organisational barriers in applying the recommendations should be discussed	10
18	The potential cost implications of applying the recommendations should be considered	7.4
19	The guideline should be supported with tools for application	10
20	The guideline should present key review criteria for monitoring and audit purposes	9.1, 9.7
21	The guideline should be piloted among end users	8.1
Editorial independence
22	The guideline should be editorially independent from the funding body	1.1
23	Conflicts of interest of guideline development members should be recorded	2.4

1.1 CLINICAL GUIDELINES AND SIGN

The 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 Scotland.^1,2 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 produces.

Clinical practice guidelines have been defined as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances”.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 patients.

The accepted criteria for validity of guidelines have evolved from the ‘essential elements of good guidelines’ identified by the US Institute of Medicine in 1990.³ These recommended ‘attributes of good guidelines’ included validity, reliability, clinical applicability, clinical flexibility, clarity, multidisciplinary process, scheduled review, and documentation. The recommendations were underpinned by the twin themes of credibility and accountability: “The link between a set of guidelines and the scientific evidence must be explicit, and scientific and clinical evidence should take precedence over expert judgement.” SIGN’s original Criteria for Appraisal of Clinical Guidelines for National Use,⁴ and the more recent AGREE (Appraisal of Guidelines, Research and Evaluation for Europe) guideline appraisal instrument⁵ are based on these founding principles of guideline development.

The AGREE criteria are reproduced in the introductory material to this manual, with links to those manual chapters that explain how SIGN addresses each criterion. The only area where SIGN does not comply with the AGREE criteria is in relation to the piloting of guidelines. The full appraisal instrument can be downloaded from the AGREE website: www.agreetrust.org

1.2 AIM AND STRUCTURE OF THIS MANUAL

This is the third revision of SIGN 50, previous versions having been issued in 2002 and 2004. SIGN methodology has continued to develop and since the previous version of this manual there have been significant developments in the procedures for reviewing guidelines, the involvement of patients and carers, and extending the range of evidence considered.

The principal aim of this manual is to provide a reference tool that may be used by individual members of guideline development groups as they work through the development process. Guidelines are intended for use by healthcare practitioners who are inevitably busy, with limited time available to read publications such as guidelines. Rather than overload every guideline with methodological details, SIGN 50 outlines the key elements of the development process common to all SIGN guidelines. Only where aspects of the topic under consideration require a variation from the standard process will these be reported in the guidelines themselves.

Guideline developers have an increasing obligation to be transparent about the methods they have used to develop their guideline. A secondary aim of this manual is to allow users to see how SIGN guidelines are developed, and instil confidence that the potential biases of guideline development have been addressed adequately, and that the recommendations are both internally and externally valid, and feasible for practice.

SIGN 50 is structured to follow the guideline development process from beginning to end, taking each step in turn. It starts with the context of guideline development in Scotland, and progresses from first proposal of a new topic to final publication and implementation of the guideline. Hyperlinks are provided in the text to guide the user to related topics where there is overlap between different chapters.

1.3 GUIDELINES IN CONTEXT

Guideline development, implementation, and review should be seen not as a linear process, but as a cycle of interdependent activities. These in turn are part of a range of complementary activities to translate evidence into practice, set and monitor standards, and promote clinical excellence in NHSiS, as illustrated in Figure 1.

Figure 1: Guideline and audit cycles

[Figure 1: Guideline and audit cycles]

Guidelines frequently look at medicines, interventions and technologies that are also the subject of individual review with authorities responsible for approving their use in the NHS. In this respect SIGN takes account of the reviews carried out by the Scottish Medicines Consortium (SMC) and the National Institute for Health and Clinical Excellence (NICE). The close relationship between SIGN and other parts of NHS Quality Improvement Scotland facilitates these processes. The highest standards of patient care and improved outcomes are the ultimate goal.

Guidelines can achieve better treatment outcomes and care for patients, but local ownership of the implementation process is crucial to success in changing practice. For this reason, SIGN is responsible for the development of national guidelines and their implementability, but not directly for their implementation into practice. This is a responsibility of each individual NHS Board, and is now reinforced by the twin ‘levers’ of clinical governance and the standard setting and review components of NHS Quality Improvement Scotland. However, there is a role for national facilitation of local guideline implementation activities, and this is discussed in Chapter 10.

Links with local and national audit projects are also an essential part of guideline implementation, and SIGN has been working closely with the Information and Statistics Division (ISD) to develop the audit component of guidelines and, where possible, to develop minimum datasets to facilitate prospective audit. This is discussed in Chapter 9.

1.4 MEDICO-LEGAL IMPLICATIONS OF SIGN GUIDELINES

The potential medico-legal implications of clinical guidelines have been of ongoing concern to medical practitioners since the establishment of a Scottish national guideline development programme was first proposed. Dr Pamela Abernethy of Simpson and Marwick WS, one of the leading Scottish experts on medical negligence, provided an initial paper on the legal implications of guidelines to SIGN and NHS Scotland in December 1995.⁶ In this paper she concluded that clinical guidelines do not rob clinicians of their freedom, nor relieve them of their responsibility to make appropriate decisions based on their own experience and according to the particular circumstances of each patient. It is stressed that the standard of care required by law derives from customary and accepted practice rather than from the imposition of practices through clinical guidelines.

Dr Abernethy refers to the 1955 case of Hunter v Hanley as establishing the standard of care required under Scottish Law and describes the three-step test used to establish the liability of a healthcare professional where it is alleged that (s)he has deviated from normal practice. The Central Legal Office (CLO) advised SIGN in 2006⁷ that the Hunter v Hanley test is still the appropriate test in Scotland for liability for clinical negligence, ie it must be established that the course the healthcare professional has adopted “is one which no professional man of ordinary skill would have taken if he had been acting with ordinary care”. This test was developed further by the Bolam test, ie a healthcare professional is not guilty of negligence if “he has acted in accordance with a practice accepted as proper by a responsible body of men skilled in that particular art”. A healthcare professional may therefore defend a charge of negligence with evidence that (s)he acted in conformity with the practice accepted by another body of opinion. The test applied by the Court is therefore based on what is actually done in practice rather than on a prescription of what should be done as proposed by guidelines.

Dr Abernethy states also that customary and accepted practice will be established in court by introduction of expert testimony. Although clinical guidelines will not be introduced as a substitute for expert testimony, they may be referred to by an expert witness as evidence of such customary and accepted practice. The CLO has advised SIGN that this is still the case.

The Hunter v Hanley test has been developed since 1995 by the 1997 case of Bolitho v City and Hackney Health Authority. This case introduced a more critical approach to the evidence supplied by expert witnesses and provided that where it can be demonstrated that professional opinion is not capable of withstanding logical analysis, the judge would be entitled to determine that the opinion was not reasonable or responsible.

The CLO advice to SIGN following this case is that the opinions of medical experts may not be regarded as final and authoritative.⁷ Although a defendant may present expert opinion that his practice was sound, the judge may look at additional evidence to determine whether the practice was in fact logical. It may be that evidence based guidelines will be referred to as part of that additional evidence and the court may require to know why such guidelines were not followed and the reasoning behind the decision not to follow them. There is consequently greater potential for clinical guidelines to have a greater role in identifying the standard of care.

In addition to this legal development in the determination of the duty of care, the origins of some guidelines which have been produced since 1995 may be relevant in the future in determining their legal status. There is an argument that some guidelines produced by organisations such as SIGN and NICE could come to be regarded as authoritative guidance in view of the robust methods used in their production and also in view of the national status of these organisations.

Some established national guidelines may be referred to by the court at present as a starting point from which to consider a healthcare professional’s conduct. The Hunter v Hanley test does of course still apply in determining the standard of care and at present such guidelines do not set the standard of care. (This is stated in each SIGN guideline).

If the law were to develop in the future to accredit a more authoritative status to guidelines of this nature, the burden of proof, in the opinion of some commentators, may move to the healthcare professional where such a guideline is not adhered to. Instead of the plaintiff being required to prove that the healthcare professional failed to provide a minimum standard of care in accordance with the Hunter v Hanley Test, the healthcare professional may be required to prove that the care met the required standard of the Hunter v Hanley test although the guideline has not been applied. This is, however, only conjecture and at present the burden of proof remains with the plaintiff.

The CLO has advised SIGN that there has to date been no reference to SIGN guidelines in any reported cases of medical negligence.⁷

It is important to emphasise that SIGN guidelines are intended as an aid to clinical judgement not to replace it. Guidelines do not provide the answers to every clinical question, nor guarantee a successful outcome in every case. The ultimate decision about a particular clinical procedure or treatment will always depend on each individual patient’s condition, circumstances and wishes, and the clinical judgement of the healthcare team.

Guidelines are, however, intended to address variation in practice. While there is no compulsion to implement any SIGN guideline or individual recommendations, NHS Boards, clinical teams, and individual practitioners in primary and secondary care should all be able to define the standard of care which they provide, and to justify if necessary why these do not meet nationally agreed recommendations.

1.5 REVIEW AND UPDATING OF THIS MANUAL

It is intended that SIGN 50 should be a ‘living’ publication, continually revised to reflect future developments in SIGN methodology. For this reason the definitive version of this handbook is that published on the SIGN website. Printed versions are produced for use as required by SIGN guideline development groups. Comments on either content or presentation of this document are welcome and should be sent to the SIGN Executive, 28 Thistle Street, Edinburgh EH2 1JQ. Email: sign@sign.ac.uk