The Legal Status of Clinical Practice Parameters: An Annotated Bibliography

Abstract

An important recent development in American medicine has been the strong push in the last few years toward the formal creation, dissemination, and enforcement of explicit clinical practice guidelines or parameters relating to the quality and efficacy of various medical interventions, parameters that would guide the decisions and actions of physicians and other health care providers (1-3). Medical societies (4), governmental agencies such as the federal Agency for Health Care Policy and Research, and insurers are utilizing a variety of approaches to the development of practice parameters for medical diagnosis and intervention, including informal consensus development, formal consensus development, evidence-based guideline development, and explicit guideline development (5). The number and variety of practice parameters has burgeoned in response to the wide national variations in medical practice patterns, without corresponding differences in clinical outcomes, that have been documented by health services researchers. Several commentators have expressed serious skepticism about the probable impact of practice parameters, surmising that they will be used extensively in a negative manner in medical malpractice litigation (6, 7). Many physicians in particular have asked "how they [practice parameters] can be implemented without courting the ruin of the individual practitioner" (8). In response to these anxieties, a new medicolegal literature has arisen to address the relationship between the development of clinical practice parameters and the physician's exposure to malpractice litigation and adverse judgments, as well as the implications for malpractice insurance premiums. This growing literature has now achieved a critical mass. The major contributions to this corpus at present are listed and annotated below.

Motivating physician behaviour change: social influence versus financial contingencies

“…Outcomes and effectiveness research uses information derived from such heterogeneous sources as cost‐effectiveness studies, clinical trials, health outcome studies, and biomedical ethics in an effort to identify those medical care services that are both clinically effective and cost‐effective[1]. Clinical practice guidelines (CPGs) have grown out of these research efforts, and represent an important heuristic trend in American medicine in terms of the quality and efficacy of various medical interventions.…”

The Legal Status of Clinical Practice Parameters: An Updated Annotated Bibliography

“…In response to extensive speculation about the probable liability implications for health care providers of the formal creation and dissemination of explicit practice parameters or guidelines, I prepared several years ago an annotated bibliography of emerging literature on that topic (1). Since preparation of that catalogue, little meaningful clarification of these issues has emerged from the courts, legislatures, or regulatory agencies.…”