Is there an ethical obligation to disclose controversial risk? A question from the ACCORD Trial.

Researchers designing a clinical trial may be aware of disputed evidence of serious risks from previous studies. These researchers must decide whether and how to describe these risks in their model informed consent document. They have an ethical obligation to provide fully informed consent, but does this obligation include notice of controversial evidence? With ACCORD as an example, we describe a framework and criteria that make clear the conditions requiring inclusion of important controversial risks. The ACCORD model consent document did not include notice of prior trials with excess death. We develop and explain a new standard labeled risk in equipoise. We argue that our approach provides an optimal level of integrity to protect the informational needs of the reasonable volunteers who agree to participate in clinical trials. We suggest language to be used in a model consent document and the informed consent discussion when such controversial evidence exists.

Rational noncompliance with prescribed medical treatment.

Despite the attention that patient noncompliance has received from medical researchers, patient noncompliance remains poorly understood and difficult to alter. With a better theory of patient noncompliance, both greater success in achieving compliance and greater respect for patient decision making are likely. The theory presented, which uses a microeconomic approach, bridges a gap in the extant literature that has so far ignored the contributions of this classic perspective on decision making involving the tradeoff of costs and benefits. The model also generates a surprising conclusion: that patients are typically acting rationally when they refuse to comply with certain treatments. However, compliance is predicted to rise with increased benefits and reduced costs. The prediction that noncompliance is rational is especially true in chronic conditions at the point that treatment begins to move closer to the medically ideal treatment level. Although the details of this theory have not been tested empirically, it is well supported by existing prospective and retrospective studies.

An economic theory of patient decision-making.

Patient autonomy, as exercised in the informed consent process, is a central concern in bioethics. The typical bioethicist's analysis of autonomy centers on decisional capacity--finding the line between autonomy and its absence. This approach leaves unexplored the structure of reasoning behind patient treatment decisions. To counter that approach, we present a microeconomic theory of patient decision-making regarding the acceptable level of medical treatment from the patient's perspective. We show that a rational patient's desired treatment level typically departs from the level yielding an absence of symptoms, the level we call ideal. This microeconomic theory demonstrates why patients have good reason not to pursue treatment to the point of absence of physical symptoms. We defend our view against possible objections that it is unrealistic and that it fails to adequately consider harm a patient may suffer by curtailing treatment. Our analysis is fruitful in various ways. It shows why decisions often considered unreasonable might be fully reasonable. It offers a theoretical account of how physician misinformation may adversely affect a patient's decision. It shows how billing costs influence patient decision-making. It indicates that health care professionals' beliefs about the 'unreasonable' attitudes of patients might often be wrong. It provides a better understanding of patient rationality that should help to ensure fuller information as well as increased respect for patient decision-making.