Academic journal article The Hastings Center Report

Outcomes Research and Practice Guidelines: Upstream Issues for Downstream Users

Academic journal article The Hastings Center Report

Outcomes Research and Practice Guidelines: Upstream Issues for Downstream Users

Article excerpt

Interest in the "outcomes movement" has never been greater. Many argue that use of outcomes data can improve clinical practice and patient outcomes by helping to close the gap between medical research and patient care. Physician receptance, however, has been mixed. Particularly troubling are the moral concerns expressed by some physicians about using the data and their resulting practice guidelines.

Why do some physicians resist? How defensible are their claims ? Are they moral problems fixed at the point where physicians choose to use or not use the data and guidelines? Or, are they problems that need to be addressed when research trials are being designed? A two-year Hastings Center project, funded by the Agency for Health Care Policy and Research, hypothesized that until these concerns are addressed many physicians will remain skeptical

The moral concerns examined by The Hastings Center are divided into three broad categories. One broad moral concern--addressed here in part by Fred Gifford--is occasioned by skepticism about the validity, reliability, and integrity of the data. Who collected and analyzed the data, whose interests are served by the research, was the methodology suitable and capably executed, and were the inferences drawn from the data defensible? Another set of moral concerns arises, not because physicians distrust the data and recommendations, but because they have more compelling reasons not to implement outcomes data, such as patients' preferences, clinical expertise, valid data irrelevant to practice, and legal concerns. The project identified a final set of "unstated" physician concerns. They nonetheless served as motivational factors in not adopting the recommendations associated with the outcomes data. All of these moral questions are addressed using practical case studies in a book to be published by Georgetown University Press in the spring of 1997.

In response to concerns about cost-containment and the quality of health care, and to the belief that variation in medical practice may be due in significant part to uncertainty, there has been a great deal of effort to generate large volumes of outcomes data and produce practice guidelines on their basis.

"Outcomes research" or that part of it called "effectiveness research," carried out to discern "what works," involves examining large amounts of data about rates of various outcomes given various treatments. It typically involves statistical analyses of outcome data drawn from very large data bases (such as hospital and insurance records). Consensus panels and input from experts complement such information. "Practice guidelines" are generated on the basis of these data and expert opinions, and serve as recommendations for practice.

There have been criticisms of both the outcomes research and practice guidelines movement and of particular studies or recommendations, and there is perceived to be a resistance to or at least lack of adherence to the recommendations. Claims that physicians often ignore or override practice guidelines or data arising from outcomes studies raise the following questions: If there is such resistance, why? In particular, do clinicians have good reasons for discounting outcomes data and practice guidelines? How should we respond to this nonadherence? Can we make clinicians more accepting of these guidelines, either by responding to their concerns with counterarguments or by addressing "upstream issues" by modifying the way the practice guidelines or outcomes assessments are generated? Or is the practice guidelines project simply misguided and doomed to failure?

A useful place to begin the discussion is this: One can imagine a number of self-interested reasons (or motives) why physicians might criticize or decline to follow practice recommendations. For instance, guidelines may be seen as a threat to clinicians' professional autonomy and thus resisted, whether in an unreflective way, or in

a planned strategy to fight the movement. …

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