As research continues to confirm the value of clinical practice guidelines as an important element of good medical decision making, Australia's National Health and Medical Research Council has published a revised edition of A Guide to the Development, Implementation and Evaluation of Clinical Practice Guidelines. Below we reproduce extracts covering key principles, guideline development, levels of evidence and dissemination. The Guide's development was prompted by concern over unjustifiable variations in clinical practice; the increasing availability of new treatments and technology; uncertainty as to the effectiveness of many interventions; and a desire to make the best use of available resources. Traditionally, guidelines have been based on the development of consensus among experts, although this process has limitations and can lead to flawed conclusions. There is growing recognition that guidelines should be based, where possible, on the systematic identification and synthesis of the best available scientific evidence. This revised edition of the Guide also reflects concern that greater emphasis should be placed on guideline implementation and evaluation.

Key principles for developing guidelines

There are nine basic principles for developing guidelines:

1. Processes for developing and evaluating clinical practice guidelines should focus on outcomes. Outcome measures can range from survival rates to quality-of-life attributes.

2. Clinical practice guidelines should be based on the best available evidence and include a statement about the strength of their recommendations. Evidence can be graded according to its level, quality, relevance and strength. The "level" of evidence refers to the study design used to minimise bias: the highest level involves a systematic review of randomised controlled clinical trials (see Box 1). "Quality" refers to the methods used to minimise bias in the design and conduct of a study. "Relevance" refers to the extent to which research findings can be applied in other settings. The "strength" of evidence relates to the magnitude and reliability of the treatment effect seen in clinical studies: strong effects are more likely to be real and more likely to be clinically important. Ideally, recommendations would be based on the highest level of evidence, but this may be difficult to achieve in public health and social science interventions.

3. The method used to synthesise the available evidence should be the strongest applicable. Taking the evidence - of whatever level, quality, relevance or strength - and turning it into a clinically useful recommendation depends on the judgement, experience and good sense of the group developing the guidelines. Evidence from a high-level study does not automatically result in a good clinical recommendation.

Encouraging a team approach is an important element in guideline development

Commonwealth Dept. of Human Ser vices and Health, Australia

4. The process of guideline development should be multidisciplinary and should include consumers. If guidelines are to be relevant, those who are expected to use them or to benefit from their use should play a part in their conception and development. Involving a range of generalist and specialist clinicians, allied health professionals, experts in methodology, and consumers will improve the quality and continuity of care and make it more likely that the guidelines will be adopted.

5. Guidelines should be flexible and adaptable to varying local conditions. They should include evidence relevant to different target populations and geographic and clinical settings, take into account costs and constraints, and make provision for accommodating the different values and preferences of patients.

6. Guidelines should be developed with resource constraints in mind. They should incorporate an economic appraisal, which may be helpful for choosing between treatment options.

7. Guidelines are developed to be disseminated and implemented taking into account their target audiences. They should also be disseminated in such a way that practitioners and consumers become aware of them and use them.

8. The implementation and impact of guidelines should be evaluated.

9. Guidelines should be revised regularly.

Guideline development

When selecting guideline topics there must be a clear problem or concern that would be redressed if guidelines were developed. A multidisciplinary panel should clarify the purpose of the guidelines - such as specifying what conditions and clinical problems they will cover - and identify the desired health outcomes. Rigorous and systematic review of the scientific evidence is essential (see Box 2).

Box 1
Designation of levels of evidence*

 

* These levels of evidence ratings have been adapted from: US Preventive Services Task Force. Guide to clinical preventive services: an assessment of the effectiveness of 169 interventions, (ed. M Fisher). Baltimore: Williams and Williams; 1989. Appendix A, p388.

All members of guideline development groups should make declarations of their interests available to appropriate bodies. Both personal and non personal interests should be declared; for example, personal shares in companies, consultancies to companies, corporate support for specific research, or general departmental activity.

Box 2
The role of a multidisciplinary panel

If consensus-based recommendations are to be issued, they should acknowledge the desirability of developing evidence based recommendations. Where non consensus-based statements are issued, there should be clear reference to each of the schools of thought, and consumers should be made aware of the lack of consensus.

Different versions of the guidelines should be developed for different audiences - consumers, general practitioners, specialist nurses, and so on.

During the guideline development phase the panel should also develop a plan for disseminating and implementing the guidelines, and a plan to ensure that the guidelines are evaluated properly and revised as necessary.

Once drafted, the guidelines document should be assessed to determine whether it conforms to the principles outlined in this guide. The draft should be referred for consultation to a wide range of interested parties.

Strategies for dissemination and implementation

Although the guideline document may support a specific strategy for adapting guidelines to local conditions, the guideline development panel may need to help local groups with the adaptation process.

There is evidence that a range of dissemination and implementation strategies can be effective.2 It is probable, however, that those strategies will depend on the nature of the guidelines and which group is being targeted. Possible strategies include:

• producing short summaries for use in a range of forums, including on the Internet and web sites;

• using the media - local, regional or national, or a combination - to publicise both the development process and the availability of the guidelines;

• asking respected clinical leaders to promote the guidelines;

• providing economic incentives;

• using the educational processes of relevant colleges, professional organizations and consumer groups, including conferences, workshops, seminars and specialist journals;

• incorporating the guidelines in routine procedures - such as quality assurance and review processes - of institutions and organizations that provide care;

• piloting the draft guidelines in practices, clinics or hospitals, to facilitate assessment of their relevance, applicability, comprehensiveness and flexibility.

Dissemination of the guidelines alone will not change practitioners' behaviour. Doctors and other clinicians are most likely to change if they themselves are involved in the change process, and if that process involves interventions that directly affect consultation between patient and practitioner. A variety of approaches have been shown to change behaviour or health outcomes, including educating patients, endorsement of the guidelines by key clinical groups, and reminder systems incorporated in clinicians' daily work.

Workshops for members of guideline development working parties may be beneficial in bringing together multidisciplinary groups as well as consumers to consider the need for clinical practice guidelines, and the methods to be used in their preparation, dissemination, implementation, evaluation and revision.

References

1. National Health and Medical Research Council. A guide to the development, implementation and evaluation of clinical practice guidelines. Canberra: National Health and Medical Research Council; 1999. Commonwealth of Australia copyright, reproduced by permission.

2. Implementing clinical practice guidelines. Effective Health Care Bulletin, University of Leeds, UK 1994;6.

Clinical practice guidelines flow chart