The principle of informed consent obligates physicians to explain possible side effects when prescribing medications. This disclosure may itself induce adverse effects through expectancy mechanisms known as nocebo effects, contradicting the principle of nonmaleficence. Rigorous research suggests that providing patients with a detailed enumeration of every possible adverse event—especially subjective self-appraised symptoms—can actually increase side effects. Describing one version of what might happen (clinical “facts”) may actually create outcomes that are different from what would have happened without this information (another (...) version of “facts”). This essay argues that the perceived tension between balancing informed consent with nonmaleficence might be resolved by recognizing that adverse effects have no clear black or white “truth.” This essay suggests a pragmatic approach for providers to minimize nocebo responses while still maintaining patient autonomy through “contextualized informed consent,” which takes into account possible side effects, the patient being treated, and the particular diagnosis involved. (shrink)

The American Journal of Bioethics, Volume 12, Issue 3, Page 31-33, March 2012.

The American Journal of Bioethics, Volume 12, Issue 3, Page 33-34, March 2012.

Nocebo effects occur when an adverse effect on the patient arises from the patient's own negative expectations. In accordance with informed consent, providers often disclose information that results in unintended adverse outcomes for the patient. While this may adhere to the principle of autonomy, it violates the doctrine of “primum non nocere,” given that side-effect disclosure may cause those side effects. In this article we build off previous work, particularly by Wells and Kaptchuk and by Cohen :3–11.[Taylor & Francis Online], (...) [Web of Science ®] [Google Scholar]), to suggest ethical guidelines that permit nondisclosure in the case when a nocebo effect is likely to occur on of the basis of nonmaleficence. We accept that that autonomy vis-à-vis informed consent must be forestalled, but salvage much of its role by elaborating a practical clinical approach to postencounter follow-up. In doing so, we reconcile a clinically practicable process of determining conditions of disclosure with long-standing ethical commitments to patients. (shrink)

The authors interpret the data to mean that patients think that their physicians should make relevant decisions in Learning Health System based trials, and label that as being of 'utmost importance'. However, the patients themselves (in the excerpts provided) emphasize that trust in physicians is instrumental for obtaining protection of patient's bests interests (which seems to be of utmost importance for patients). Furthermore, the perceived bias regarding outcome certainty deserves more discussion. Namely, the decision to defer to physician's opinion is (...) linked to perceived certainty of best clinical outcomes and instrumental for protection of best interest, while it lacks appreciation of the level of uncertainty that exists in clinical decision-making. Finally, a discussion on what are the implications of patient perspectives for individual, vs. relational autonomy is something the authors don't pursue, but instead use "physician-patient autonomy" throughout the paper. (shrink)