Clinical guidelines

International overview

Steven H Woolf, Richard Grol, Allen Hutchinson, Martin Eccles, Jeremy Grimshaw
Department of Family Practice, Virginia Commonwealth University, Fairfax, Virginia 22033, USA

Steven H Woolf
professor of family medicine
Center for Quality of Care Research, University of Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands

Richard Grol
director
School of Health and Related Research, University of Sheffield, Sheffield S1 4DA

Allen Hutchinson
professor of public health
Centre For Health Services Research, University of Newcastle upon Tyne, Newcastle upon Tyne NE2 4AA

Martin Eccles
professor of clinical effectiveness
Health Services Research Unit, University of Aberdeen, Aberdeen AB9 2ZD

Jeremy Grimshaw
professor of public health

Correspondence to: Professor Woolf shwoolf{at}aol.com

Series editors: Martin Eccles, Jeremy Grimshaw

Clinical guidelines (CPGs), official statements from health organisations and agencies on how best to care for medical conditions or to perform clinical procedures, are increasingly common in medicine. The ascendance of clinical guidelines as a tool for improving the quality of care and controlling costs is international, stimulated by rising costs, practice variations, and the presumption that at least some of this variation stems from inappropriate care. This article, part of a series on the evolving phenomenon of clinical guidelines, examines the scope of clinical guideline activity around the world. The first paper in the series reviewed the benefits, limitations, and harms of clinical guidelines, and the rest will address their development, legal and emotional ramifications, and their implementation.

Clinical guideline activities are too extensive to be cited comprehensively in one article. Large directories are needed to catalogue the clinical guidelines of a single country. This overview characterises the scope of activity by highlighting illustrative clinical guideline programmes from selected countries, but it does not claim to describe all of the important work.

Europe

United Kingdom

Clinical guidelines have existed in England for decades, issued by the NHS, royal colleges, professional societies, audit groups, and health authorities. But recent years have heightened the interest in clinical guidelines as a tool for implementing health care based on proof of effectiveness.^(1)(2)(3) Professional bodies, encouraged by the NHS, are producing clinical guidelines for use by providers to improve care and by purchasers to guide contracting and commissioning decisions.⁽⁴⁾ The NHS is now using a critical appraisal instrument⁽⁵⁾ to determine which clinical guidelines to commend to health authorities.⁽⁴⁾

Although historically most British clinical guidelines derive from consensus conferences or expert opinion, there is growing interest in moving guidelines to firmer scientific ground.⁽⁶⁾ ⁽⁷⁾ This trend, taken up by several groups,^(8)(9)(10) is exemplified in recent clinical guidelines from the North of England project⁽¹¹⁾ ⁽¹²⁾ and Royal College of General Practitioners⁽¹³⁾ and in programmes to implement evidence based clinical guidelines at the community level (for example, the King�s Fund�s programme on promoting action on clinical effectiveness (PACE) and the framework for appropriate care throughout Sheffield (FACTS)). Preparing evidence based clinical guidelines, which begins with a synthesis of available evidence, is facilitated by high quality systematic reviews from the NHS Centre for Reviews and Dissemination⁽¹⁴⁾ and the UK Cochrane Centre⁽¹⁵⁾ and technology assessments from the NHS Research and Development programme.⁽¹⁶⁾

Within Scotland, the Scottish Intercollegiate Guideline Network, established in 1993 by the Conference of Royal Colleges and their Faculties in Scotland, uses a systematic multidisciplinary approach to prepare evidence based clinical guidelines.⁽¹⁷⁾ National guidelines are converted at the local level into formats that encourage adoption in practice.⁽¹⁸⁾

The Netherlands

In the Netherlands, the Dutch College of General Practitioners has produced clinical guidelines since 1987, issuing more than 70 clinical guidelines at a rate of 8-10 topics a year.⁽¹⁹⁾ ⁽²⁰⁾ A rigorous procedure involves an analysis of the scientific literature, combined with consensus discussions on content among ordinary general practitioners and experts.⁽²⁰⁾ ⁽²¹⁾ The systematic implementation programme that follows clinical guideline development uses various methods, such as specific educational packages for local continuing medical education and small group peer review, telephone cards for use in practices, facilitators to introduce clinical guidelines directly to practice teams, and publication of clinical guidelines in consumer journals.⁽²²⁾ ⁽²³⁾ More than 80% of Dutch family physicians are aware of clinical guidelines within a few months of publication, and an average of 70% of the recommendations are followed.⁽²⁰⁾ Updating of the clinical guidelines has recently begun, as well as collaboration with other medical specialty societies to develop guidelines for the primary-secondary care interface. Clinical guidelines figure prominently in Dutch health policy. In 1992, a landmark report proposed clinical guidelines as a tool for priority setting,⁽²⁴⁾ presaging a similar conclusion in New Zealand (see below).

Finland and Sweden

In Finland, national and local bodies have issued more than 700 clinical guidelines since 1989.⁽²⁵⁾ Although the structure and quality of the evidence supporting the clinical guidelines was limited initially,⁽²⁶⁾ a programme for evidence based clinical guideline development has recently been started. The Finnish Medical Society, Duodecim, produces print and electronic versions of primary care clinical guidelines.⁽²⁷⁾ Doctors using the computer versions reportedly consult the system an average of three times daily and change practice behaviour in half of consultations.⁽²⁵⁾ Clinical guidelines in Sweden appear in reports by the Swedish Council on Technology Assessment in Health Care, an internationally consulted technology assessment agency, and in recommendations from other government bodies.⁽²⁸⁾

France

In France, the Agence Nationale pour le Développement de l�Évaluation Médicale (ANDEM; recently renamed Agence Nationale de l�Accréditation et d�Évaluation en Santé), the governmental technology assessment agency, has published over 100 clinical guidelines based on consensus conferences or modified guidelines from other countries.^(29)(30)(31) ANDEM has also developed more than 140 références médicales, guidelines on procedural indications for use in setting coverage policy.⁽³¹⁾ ⁽³²⁾ The clinical guidelines are disseminated through networks of general practitioners, and their effectiveness is evaluated through local audits.⁽³³⁾ A collaborative network to implement cancer treatment guidelines has been highly effective.⁽³⁴⁾

Germany, Italy, and Spain

Clinical guidelines are on the rise in Germany⁽³⁵⁾ and in Italy,⁽³⁶⁾ where a guidelines database is being developed to support reform of the national healthcare system.⁽³⁷⁾ In Spain, the Catalan Agency for Health Technology Assessment has begun preparing clinical guidelines and teaches methods of guideline development.⁽³⁸⁾ ⁽³⁹⁾ Consensus guidelines figure prominently in Catalonian healthcare reform.⁽⁴⁰⁾ In 1996 alone, the technology assessment agency in Madrid distributed over 10<thin>000 copies of clinical guidelines and technology assessments.⁽⁴¹⁾

Pan-European clinical guideline programmes are also emerging. These include the European Union�s efforts to fashion a systematic approach to technology assessment, such as the EUR-ASSESS project,⁽⁴²⁾ a seven country collaboration to study clinical guideline implementation (F B Kristensen, personal communication, 1997), and the worldwide Cochrane Collaboration on Effective Professional Practice.⁽⁴³⁾ A collaboration between countries to develop and standardise a "critical appraisal" instrument for use in evaluating clinical guidelines in different countries has recently begun.

North America

The United States and Canada have amassed as many as 28<thin>000 guidelines.⁽⁴⁴⁾ Although the Agency for Health Care Policy and Research,⁽⁴⁵⁾ established by the US Congress in 1989, may be the most internationally recognised source of American clinical guidelines, its portfolio of 19 clinical guidelines constitutes a small sample of the thousands of guidelines in use in the United States (the agency terminated its clinical guideline programme in 1996). Practice guidelines, protocols, and care pathways developed by professional societies and other groups are ubiquitous in American hospitals and health plans, where they are used for quality improvement and cost control.⁽⁴⁶⁾ Over half of Americans receive care through managed care organisations, 85% of which require adherence to clinical guidelines.⁽⁴⁷⁾ Many such organisations purchase commercially produced clinical guidelines that emphasise shortened lengths of stay and other resource savings.⁽⁴⁸⁾

Canadian health care is largely state funded, but a similar proportion of organisations (82%) use clinical guidelines.⁽⁴⁹⁾ Evidence based centres, such as at McMaster University, are active in the critical appraisal of clinical guidelines and in developing lay versions for patients.

The massive clinical guideline industry in America has created special problems and a more mature audience for guidelines than exists in many other countries. One such problem is information overload. Directories and newsletters have become necessary to monitor the hundreds of guideline topics and sponsoring organisations.⁽⁴⁴⁾ ^(50)(51)(52)The Agency for Health Care Policy and Research, the American Medical Association, and the American Association for Health Plans recently established an internet clearing house for clinical guidelines (www.guidelines.gov). National groups meet regularly, both in the United States (for example, the American Medical Association�s Practice Parameters Partnership and Practice Parameters Forum) and Canada (for example, the National Partnership for Quality in Health and the Canadian Medical Association), to coordinate clinical guideline activities.

Americans have articulated evidence based methods in manuals and other reports.^{(53)(54)(55)(56)(57)(58)} This expertise has not always found its way into actual guidelines�most American clinical guidelines remain rooted in consensus or opinion�but certain guidelines (for example, those of the American College of Physicians,⁽⁵⁹⁾ US Preventive Services Task Force,⁽⁶⁰⁾ ⁽⁶¹⁾ Agency for Health Care Policy and Research, American Academy of Family Physicians⁽⁶²⁾) do reflect evidence based procedures. Other reports offer "guidelines on guidelines" on such topics as priority setting,⁽⁶³⁾ developmental methods,⁽⁶⁴⁾ ⁽⁶⁵⁾ use of language,⁽⁶⁶⁾ evaluation criteria,⁽⁶⁷⁾ ⁽⁶⁸⁾ legal implications,^(69)(70)(71) translation of clinical guidelines into review instruments,⁽⁷²⁾ ⁽⁷³⁾ and implementation.⁽⁴⁵⁾ ⁽⁶⁴⁾ ⁽⁶⁷⁾ ^(74)(75)(76)

Australia

Clinical guidelines in Australia date to the late 1970s, when the state health authority began endorsing guideline booklets,⁽⁷⁷⁾ and they continue on a large scale today. The proliferation of clinical guidelines has prompted closer study of their quality and their impact on clinicians.^(78)(79)(80) In 1995, the Quality of Care and Health Outcomes Committee of the National Health and Medical Research Council⁽⁸¹⁾ and the Australian Medical Association⁽⁷⁸⁾ each issued reports on improving methods of clinical guideline development. The Quality of Care and Health Outcomes Committee emphasises the need for evidence based methods and has established working parties for future clinical guideline preparation.⁽⁸²⁾

New Zealand

Clinical guidelines in New Zealand emanate directly from national health policy. A government committee established in 1992 to define a core list of health services recommended the use of clinical guidelines to define clinical indications for services rather than endorsing or denying services outright.⁽⁸³⁾ ⁽⁸⁴⁾ New Zealand recognised the pitfalls of rationing by exclusion and chose instead to restrict services at the point of service through clinical guidelines. This decision received international attention in debates about rationing.^(85)(86)(87) The committee has since staged consensus conferences, producing clinical guidelines on at least 11 topics.⁽⁸⁶⁾ One clinical guideline on hypertension⁽⁸⁸⁾ and a subsequent cholesterol guideline from the New Zealand National Heart Foundation⁽⁸⁹⁾ broke new ground methodologically by linking recommendations to patients� absolute risk probabilities rather than to generic treatment criteria.⁽⁹⁰⁾

Conclusion

As experience with clinical guidelines accumulates around the world, important lessons have been learnt about their potential benefits, limitations, and harms, as reviewed in the first paper of this series.⁽⁹¹⁾ Chief among these is that the recommendations contained in clinical guidelines should not be accepted at face value, especially without attention to how they were developed. Further, clinical guidelines by themselves seem to be ineffective in changing practice behaviour or improving clinical outcomes; they must be coupled with active implementation strategies to successfully change practice. The next paper in this series examines more closely the methods by which clinical guidelines are developed.⁽⁹²⁾

Funding: The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Office Department of Health. However, the views expressed are those of the authors and not the funding body.

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