Guidelines for Clinical Practice: What They are and Why They Count

The Institute of Medicine was chartered in 1970 as a part of the National Academy of Sciences, a private, nonprofit society devoted to promoting science and technology and their use for the general welfare. The IOM, also a self-perpetuating society of distinguished scholars in all areas relating to health and medical science, enlists distinguished members of the appropriate professions in examining policy matters pertaining to public health. It acts under both the Academy's 1863 charter from the United States Congress to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education to which it should devote its attention and resources. Its work is done chiefly through expert committee, such as those that guided the work reported here on clinical practice guidelines. The author wishes to express her great appreciation to and respect for her colleague Field Marilyn J. , Ph.D., director of the studies in question. See Institute of Medicine, Marilyn Field J. Lohr Kathleen N. , eds., Clinical Practice Guidelines: Directions for a New Program (Washington: National Academy Press, 1990); and Institute of Medicine, Field Marilyn J. Lohr Kathleen N. , eds., Guidelines for Clinical Practice: From Development to Use (Washington: National Academy Press, 1992).

Portions of this paper draw on Lohr Kathleen N. , “Guidelines for Clinical Practice: Applications for Primary Care,” International Journal of Quality Assurance in Health Care, 6 (1994): 17–25.

See Institute of Medicine (1992), supra note 1, p. 27.

Appropriateness denotes that “health benefits from the use of a service exceed its health risks by a sufficiently wide margin that the service is worth performing.” See Brook Robert H. , “Maintaining Hospital Quality. The Need for International Cooperation,” JAMA, 270 (1993): 985–87; see also Brook Robert H. , “A Method for the Detailed Assessment of the Appropriateness of Medical Technologies,” International Journal of Technology Assessment in Health Care, 2 (1986): 53–63.

See Institute of Medicine (1992), supra note 1, esp. App. A (pp. 243–345).

As of winter 1995, AHCPR guidelines have been published on the following topics: Acute pain management (for operative or medical procedures and trauma); urinary incontinence in adults; prediction and prevention of pressure ulcers in adults; management of functional impairment due to cataracts; depression in primary care (both detection and diagnosis, and treatment); sickle cell disease (screening, diagnosis, management, and counseling in newborns and infants); evaluation and management of early infection with the human immunodeficiency virus; diagnosis and treatment of benign prostatic hyperplasia; management of cancer pain; diagnosis and management of unstable angina; evaluation and care of patients with heart failure (left ventricular systolic dysfunction); otitis media with effusion in young children; quality determinants of mammography; acute low back problems in adults; and treatment of pressure ulcers. Topics under development (with expected dates of release extending into 1996) include: Post-stroke rehabilitation; cardiac rehabilitation; recognition and initial assessment of Alzheimer's and related dementias; smoking prevention and cessation; screening for colorectal cancer; chronic headache pain; and an update on urinary incontinence in adults. Under consideration are guidelines for panic disorder, osteoporosis, and early detection of breast cancer.

U.S. Preventive Services Task Force, Guide to Clinical Preventive Services: An Assessment of the Effectiveness of 169 Interventions (Baltimore: Williams & Wilkins, 1989).

Sox Harold C. Jr. , ed., Common Diagnostic Tests (Philadelphia: American College of Physicians, 1987; 2nd ed., 1990); and Eddy David M. , ed., Common Screening Tests (Philadelphia: American College of Physicians, 1991).

Agency for Health Care Policy and Research, Depression in Primary Care. Volume 1. Detection and Diagnosis (Rockville: Public Health Service, U.S. Dept. of Health and Human Services, AHCPR Pub. No. 93-0550, Apr. 1993); and Agency for Health Care Policy and Research, Depression in Primary Care. Volume 2. Treatment of Major Depression (Rockville: Public Health Service, U.S. Dept. of Health and Human Services, AHCPR Pub. No. 93-0551, Apr. 1993).

Harvard Community Health Plan. See Institute of Medicine (1992), supra note 1, pp. 333–35.

See Institute of Medicine (1992), supra note 1, pp. 169–70.

Enkin M. Keirse M.J.N.C. Chalmers Iain , A Guide to Effective Care in Pregnancy and Childbirth (Oxford: Oxford University Press, 1990).

Vickery D.M. Fries James F. , Take Care of Yourself (Reading: Addison-Wesley, 1990).

Agency for Health Care Policy and Research, Acute Pain Management: Operative or Medical Procedures and Trauma (Rockville: Public Health Service, U.S. Dept. of Health and Human Services, AHCPR Pub. No. 92-0032, Feb. 1992).

Agency for Health Care Policy and Research, Management of Cancer Pain (Rockville: Public Health Service, U.S. Dept. of Health and Human Services, AHCPR Pub. No. 92-0592, Mar. 1994).

Institute of Medicine, Durch Jane S. Lohr Kathleen N. , eds., Emergency Medical Services for Children (Washington, D.C.: National Academy Press, 1993).

Id., pp. 156–67.

Id., pp. 167–70.

See Institute of Medicine (1992), supra note 1, pp. 28–32 and App. B, pp. 346–410.

Institute of Medicine, Lohr Kathleen N. , ed., Medicare: A Strategy for Quality Assurance (Washington, D.C.: National Academy Press, Vols. I, II, 1990).

Institute of Medicine, Effectiveness Initiative: Setting Priorities for Clinical Conditions (Washington, D.C.: National Academy Press, 1989); Institute of Medicine, Mattingly Patrick Lohr Kathleen N. , eds., Acute Myocardial Infarction: Setting Priorities for Effectiveness Research (Washington, D.C.: National Academy Press, 1990); Institute of Medicine, Heithoff Kim A. Lohr Kathleen N. , eds., Hip Fracture: Setting Priorities for Effectiveness Research (Washington, D.C.: National Academy Press, 1990); and Institute of Medicine, Lohr Kathleen N. , ed., Breast Cancer: Setting Priorities for Effectiveness Research (Washington, D.C.: National Academy Press, 1990).

Institute of Medicine, Field Marilyn J. Lohr Kathleen N. Yordy Karl D. , eds., Assessing Health Care Reform (Washington, D.C.: National Academy Press, 1993).

Institute of Medicine, Hogness John R. Van Antwerp Malin , eds., The Artificial Heart. Prototypes, Policies, and Patients (Washington, D.C.: National Academy Press, 1991).

Rettig Richard A. Lohr Kathleen N. , “Measuring, Managing, and Improving Quality in the End-Stage Renal Disease Treatment Setting. Conference Overview,” American Journal of Kidney Diseases, 24 (1994): 228–34; and Schrier Robert W. , “Measuring, Managing, and Improving Quality in the End-Stage Renal Disease Treatment Setting. Committee Statement,” American Journal of Kidney Diseases, 24 (1994): 383–88.

See Institute of Medicine (1992), supra note 1, App. B.

Institute of Medicine, Donaldson Molla S. Sox Harold C. Jr. , eds., Setting Priorities for Health Technology Assessment. A Model Process (Washington, D.C.: National Academy Press, 1992).

This phrase was coined by Roper, then administrator of the Health Care Financing Administration, in a celebrated article: Roper William L. Winkenwerder Warren Hackbarth Glen H. Krakauer Henry J. , “Effectiveness in Health Care: An Initiative to Evaluate and Improve Medical Practice,” N. Engl. J. Med., 319 (1988): 1197–202.

See Institute of Medicine (1992), supra note 1, p. 34.

Recognition of the importance of these elements of the health services research field is growing. For example, appropriations for AHCPR, which is responsible for the majority of public sector support for health services research and training health services researchers, grew from just over $100 to $166 million between FY 1990 and FY 1994. See Association for Health Services Research, HSR Reports, October 1994 (Washington: The Association, 1994).

See Institute of Medicine (1990), supra note 16, p. 4.

Several approaches to ethics, morality, and considered reasoning about theory, social conventions, and approved norms of conduct can be brought to bear on practice guidelines (or public policy more generally), and this paper makes no attempt to cover them all. The model applied for the IOM's work in practice guidelines, as set forth here, essentially reflects the model laid out more than a decade ago by philosophers such as Childress and Beauchamp ( Beauchamp Tom L. Childress James F. , Principles of Biomedical Ethics (New York: Oxford University Press, 1979)). The IOM's work emerged initially in a paper studying the Medicare quality assurance system ( Povar Gail J. , “What Does ‘Quality’ Mean? Critical Ethical Issues for Quality Assurance,” in Palmer R.H. Donabedian A. Povar G.J. , Striving for Quality in Health Care. An Inquiry into Policy and Practice (Ann Arbor: Health Administration Press, 1991), pp. 129–68). More recently, Beauchamp and Childress (in Principles of Biomedical Ethics (New York: Oxford University Press, 4th ed., 1994)) characterize these ideas as “four clusters of principles” in a broader discussion of approaches to ethics and the common morality, moral and practical dilemmas, norms for human conduct, and ways of reaching considered judgments about guides to action. Although the entire field of medical ethics is rich in debate about definitions, starting points for theory, methods of reasoning, and other emphases, the model used here has proven useful for the deliberations about professional and public policy in which IOM committees often must engage.