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. (shrink)

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. (shrink)

Volume 19, Issue 11, November 2019, Page 78-80.

Patient noncompliance with physician prescriptions, especially in nonsymptomatic chronic diseases, is frequently characterized in the literature as harmful and economically costly (Miller 1997).1 Nancy Houston Miller views patient noncompliance as harmful because noncompliance can result in continued or new health problems leading to hospital admissions. Further, she places the annual monetary cost of noncompliance at $100 billion.Patient noncompliance with prescribed treatment is considered the least understood form of health behavior (Coons 2001). Despite the plethora of attention in journal articles, the (...) issue of noncompliance remains unresolved even in terms of understanding the main correlates to .. (shrink)

The case of Twin B involves the decision to send a newborn to a less intensive Level 2 special care nursery (SCN) than to the Level 3 neonatal intensive care unit (NICU) that is considered optimal by the physician. The physician’s acceptance of the transfer is against the child’s best interest and is due to parental convenience. In analyzing the case, we reject the best interest standard. Our rejection is partly supported by the views of Douglas Diekema, John Hardwig, and (...) Lannie Ross. Instead of the best interest standard, we offer and defend an approach we base on a microeconomic analysis of externalities, such as those involved with automobile emissions. This extends our previously presented general microeconomic approach to patient decision-making. It provides a clearer way to evaluate situations, like those of Twin B, in which burdens faced by family members may be used to determine the appropriate level of treatment for a decisionally incapable patient. (shrink)