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Introduction

The CMA's mission is to "provide leadership for physicians and to promote the highest standard of health and health care for Canadians". In fulfilling this mandate, the CMA is collaborating with other organizations to facilitate and coordinate the clinical practice guideline process in Canada.

The rapidly increasing volume and complexity of medical research makes it difficult for physicians to incorporate research data into their daily practice. Guidelines have been proposed as a way to assist physicians in the clinical decision-making process and hence improve the quality of care. Guidelines have the potential to improve outcomes, minimize risk and enhance efficiency. However the guidelines process -- which includes needs assessment, development, implementation, evaluation and revision -- is complex and requires a great deal of expertise and experience, not only to create a guideline but also to ensure that it is implemented and effective. Thus, a set of guiding principles is needed to foster quality in the guideline process.

The CMA in collaboration with the NAPAQH (the Association of Canadian Medical Colleges, the Canadian Council on Health Facilities Accreditation, the CMA, the College of Family Physicians of Canada, the Federation of Medical Licensing Authorities of Canada and the Royal College of Physicians and Surgeons of Canada) developed these guiding principles for the clinical practice guidelines process through an extensive collaboration process.

Six background research papers were commissioned whose recommendations were the basis for the first draft of the guidelines presented at the Workshop on Clinical Practice Guidelines (15-17 November 1992). The workshop was attended by those active or interested in becoming active in the guideline process -- CMA divisions; medical specialty societies; licensing authorities; student organizations; national health organizations; federal, provincial and territorial governments; and the Federal/Provincial/Territorial Advisory Committee on Health Services. On the basis of the deliberations at this workshop, a second draft of the guidelines was prepared and then reviewed and revised by the NAPAQH. The third draft was sent to organizations that participated at the workshop for review and feedback. The fourth and final draft was reviewed internally by the CMA and received endorsement by the CMA Board of Directors in October 1993. The Guidelines for Canadian Clinical Practice Guidelines was then sent to participating organizations for endorsement.

The document consists of 14 guidelines in three categories: philosophy and ethics; methods; and implementation and evaluation. These guidelines are intended to refer only to the clinical practice guideline process for physicians and their interaction and decision making with patients. They are intended as principles upon which to base the formulation of individual clinical practice guidelines. They are not intended to direct or dictate any specific or exclusive course of action or to take the place of existing recognized standards. They reflect the consensus of those health organizations that endorsed them. Due to a relative paucity of scientific evidence, the guidelines are based on expert opinion and are subject to change with emerging knowledge and experience.

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Philosophy and Ethics

Guideline 1
The goal of clinical practice guidelines should be to improve quality of health care.

Guideline 2
Clinical practice guidelines should be sufficiently flexible to allow patients and physicians to exercise judgement when choosing available options.

Guideline 3
Clinical practice guidelines should enable informed decision making by patients and physicians by enhancing professional learning, patient education and patient-physician communication.

Guideline 4
Clinical practice guidelines should recognize that the physician's primary responsibility is to his or her own patient, although it may have to be balanced against the needs of other people and society in general.

Guideline 5
Ethical issues should be considered in all phases of the clinical practice guidelines process.

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Methods

Guideline 6
Organizations with clinical practice guideline programs should articulate clear goals and use and explicitly document processes for setting priorities and assigning resources to the development, implementation, evaluation and revision of guidelines.

Guideline 7
Clinical practice guidelines should be developed by physicians in collaboration with representatives of those who will be affected by the specific intervention(s) in question, including relevant physician groups, patients and other health care providers as appropriate.

Guideline 8
Developers of clinical practice guidelines should state the objectives and methods and identify the intended users before the guideline is developed.

Guideline 9
Clinical practice guidelines should:
(a) cite the specific evidence bearing upon the conclusion
(b) indicate the strength of the evidence
(c) specify the date of the most recent evidence considered

Guideline 10
Before implementation, clinical practice guidelines should be reviewed by expert and user groups and, if possible, tested through such mechanisms as field trials.

Guideline 11
When appropriate, the developers of a clinical practice guideline should use a standardized summary to report the development process and key considerations.

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Implementation and Evaluation

Guideline 12
The clinical practice guideline process should include specifically tailored, effective and coordinated strategies for voluntary implementation that emphasize patient, physician and other health care provider involvement.

Guideline 13
The effectiveness of the clinical practice guideline process should be assessed with a well-designed program evaluation that incorporates user feedback.

Guideline 14
Clinical practice guidelines should be reviewed and revised as advances in medical knowledge occur.

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Reference

1. Committee to advise the Public Health Service on Clinical Practice Guidelines, Institute of Medicine: Clinical Practice Guidelines: Directions for a New Program, Natl Acad Pr, Washington, 1990: 38

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Appendix 1

The standardized summary, also called a structured abstract, was developed by Hayward and associates in association with the US National Library of Medicine (NLM) and has been approved for online abstracts in NLM databases.

Proposed format for structured abstracts of clinical practice guidelines

1. Objective: the primary objective of the guideline, including the health problem and the targetted patients, providers and settings.
2. Options: the clinical practice options considered in formulating the guideline
3. Outcomes: significant health and economic outcomes considered in comparing alternative practices
4. Evidence: how and when evidence was gathered, selected, and synthesized
5. Values: disclosure of how values were assigned to potential outcomes of practice options and who participated in the process
6. Benefits, harms and costs: the type and magnitude of benefits, harms and costs expected for patients from guideline implementation
7. Recommendations: summary of key recommendations
8. Validation: report of any external review, comparison with other guidelines or clinical testing of guideline use
9. Sponsors: disclosure of the person(s) who developed, funded, or endorsed the guideline

Reproduced with permission from Hayward RSA, Wilson MD, Tunis SR et al: More informative abstracts of articles on clinical practice guidelines. Ann Intern Med 1993; 118: 731-737.