Outcomes Research and the Quality of Health Care:

Abstract

Beyond the dazzling achievements of high-technology medicine, the spiraling cost of health care and lack of access for many have long been the subject of national debate. Driven by the interaction of powerful economic forces, managed care is now taking over the health care system, while there is growing popular interest in alternative medicine. But amid the changing structures and financial incentives, much uncertainty still remains concerning the safety and effectiveness of medical interventions. The author, a mathematical scientist engaged in medical research and education for more than 30 years, has proposed the "ethics of evidence" as an approach to medical uncertainty, to be adopted as a vital component of biomedical ethics. The ethics of evidence comprises two imperatives. The first imperative calls for the creation, dissemination, and use of the best possible scientific evidence as a basis for every phase of medical decision making. Complementing it, the second imperative focuses on the need to increase awareness of, and come to terms with, the extent and ultimately irreducible nature of uncertainty. After a brief sketch of the genesis of this concept, the ethics of evidence is further explored here in the context of current outcomes research, the focus on quality of health care, and related problems of contemporary medicine.

Ethical Dimensions in the Borderland Between Conventional and Complementary/Alternative Medicine

“…Evolving as they have out of ancient traditions of healing, comfort measures and shamanic arts, factors such as trust, relationship, and transmission of healing energy are an inherent component of the therapeutic, not something from which it can be isolated to remove the contaminating effect (Glik, 2000;Rose, 1998). Thus the philosophical origins of CAM practices often make them inappropriate for simple RCT testing and, if such trials are conducted, can render the results meaningless (Linde and Jonas, 1999;Mike, 1999). More elaborate RCT designs or alternative ways of estimating effect may be more appropriate, and inquiry methods that can reconcile public safety with public demand must be developed and agreed on.…”

“…Thus, mathematical probabilities calculated from large populations are used to determine whether, across the entire group, the innovation is more or less effective than the standard. This model of evaluation becomes problematic in CAM research because it assumes a relative equivalence of all cases with a particular condition, and therefore averages out the uncertainty factor (Mike, 1999). In so doing, it provides no mechanism by which interactions between the intervention itself and the key person-practitioner-setting-context variables can be studied.…”

“…Thus, beyond the obvious matters of ensuring that CAM recipients are treated ethically and respectfully, that their rights and safety are not violated, and they have access to the information that they require with which to make decisions pertaining to their own health care, thoughtful commentators suggest that CAM raises ethical issues that challenge the very standards on which we currently develop evidence for clinical practice (Glik, 2000;Jonas, 1998;Mike, 1999). These issues are as germane to many conventional as well as complementary practices, but the emergence of the CAM debate brings them into sharp focus.…”

From evidence-based medicine to patient-centered medicine: legal medicine considerations about professional responsibility

“…The proof in question has a status based on probability and because of this it can be reversed, moved or replaced in the light of new discoveries [10]. In some cases, important areas of uncertainty will remain, together with large ''grey zones'' [11,12], with proves coming from under-dimensioned, badly planned and badly performed researches which produce results of doubted scientific effectiveness [13]. Even as far as RCT is concerned, high quality proof is often incomplete, inconsistent or absent [5].…”

Ethical Obligations for the Use of Evidence-Based Methods in Dentistry

“…14 Valerie Miké proposes an ethics of evidence that has as its principle imperative ''the creation, dissemination, and use of the best possible scientific evidence as a basis for every phase of medical decision-making.'' 15 As part of living up to this ethical obligation, he asserts that there must be informed action toward ''scientific and technological literacy'' for both health professionals and the public at large. Though dental educators must take seriously the obligation to prepare oral health professionals, an effective strategy for motivating this action within and for the public at large is unclear.…”