Developing meaningful clinical guidelines in MCOs

Guidelines must have validity, evidence

By Joseph E. Biskupiak, PhD, MBA

Director of Technology Assessment

Hastings Healthcare Group

Pennington, NJ

Peter Chodoff, MD, MPH

Professor of Anesthesia

Jefferson Medical College


David B. Nash, MD, MBA, FACP

Director, Office of Health Policy

and Clinical Outcomes

Thomas Jefferson University


Many of the disease management programs currently being developed and implemented by managed care organizations (MCOs) rely on providers’ use of clinical practice guidelines (CPGs). Most of those efforts are focused on high-cost chronic diseases such as diabetes, asthma, and to a much less extent, hypertension. MCOs are implementing CPGs to standardize the management of targeted conditions (that is, reduce unexplained clinical variation) as an initial approach to disease management.

Most of those CPGs also include patient education programs stressing the importance of lifestyle, drug compliance, and patient self-management and testing. Critics of disease management question whether MCOs will be successful in convincing physicians to adhere to those "best practices." Some of the early disease management programs that focused heavily on the use of CPGs by primary care physicians yielded disappointing results. It is worth repeating that considerable progress has been made in the quality and accessibility of CPGs.

Currently, 2,000 CPGs have been developed by various governmental agencies, academic medical centers, specialty societies, and other organizations. The American Medical Association maintains a registry of about 2,000 practice parameters developed by 75 national physician specialty organizations.

Follow certain attributes for CPGs

Importantly, CPGs that are chosen to be incorporated into disease management activities need to possess certain attributes that will facilitate their use by clinicians. Those attributes have been specified by the Institute of Medicine and are presented in this list:1

Validity — Guidelines are valid if they lead to the health outcomes they project.

Strength of evidence — A description of how the strength of evidence was weighed should accompany each statement in the guideline. Those statements vary in the strength of their evidence and therefore in their acceptability. One must distinguish among care for which there is good scientific evidence, care for which there is good consensus but limited or no evidence, and care for which there is neither evidence nor consensus. It is interesting to note that in the Agency for Health Care Policy and Research’s strength-of-evidence scheme, expert opinion is at the bottom of the list.2 (See chart, above.)

Outcomes — Guidelines should include an estimate of the expected health and cost outcomes, including patient preferences.

Reliability — CPGs are reliable if, when given the same circumstances, another group of experts produces essentially the same set of statements. In addition, they are reliable if the guidelines are interpreted consistently in the same set of clinical circumstances by different practitioners.

Applicability — The population(s) to which the guidelines apply should be explicitly defined.

Flexibility — CPGs should identify areas of known controversy and discuss how patient preferences are to be identified and considered.

Clarity — Guidelines must be concise, use unambiguous language, and be easy to follow.

Multidisciplinary process — The guideline development process must include all members of the group providing services for the particular clinical circumstance.

Review — CPGs must include statements defining the process by which they will be reviewed and kept up to date.

It is interesting to point out that although those attributes were developed for CPGs, many apply equally well to disease management programs.

MCOs that develop disease management programs using CPGs will need to be cognizant of the attributes that facilitate provider implementation. Similarly, developers of disease management programs will need to develop programs that possess many of those same attributes if they hope to have providers adopt and successfully implement their programs.


1. Field MJ, Lohr KN. Guidelines for Clinical Practice — From Development to Use. Washington, DC: National Academy Press; 1992.

2. Konstam MA, Dracup K, et al. Heart Failure: Evaluation and Care of Patients with Left-Ventricular Systolic Dysfunction. June 1994. Agency for Health Care Policy and Research, Publication No. 94-0612.