Preventive Misconception and Risk Behaviors in a Multinational HIV Prevention Trial.

Background: Some HIV prevention research participants may hold a "preventive misconception" (PM), an overestimate of the probability or level of personal protection afforded by trial participation. However, these reports typically rely upon small, retrospective qualitative assessments that did not use a standardized approach.

Methods: We administered a measure of PM called PREMIS, during Microbicide Trials Network 020-A Study to Prevent Infection with a Ring for Extended Use, a large, multicenter, placebo-controlled, phase III trial evaluating the safety and efficacy of a dapivirine vaginal ring among women at risk for HIV infection in Malawi, South Africa, Uganda, and Zimbabwe.

Using Cognitive Interviews to Enhance Measurement in Empirical Bioethics: Developing a Measure of the Preventive Misconception in Biomedical HIV Prevention Trials.

Background: We describe our use of cognitive interviews in developing a measure of "preventive misconception" to demonstrate the importance of this approach to researchers developing surveys in empirical bioethics. The preventive misconception involves research participants' false beliefs about a prevention trial, including beliefs that the interventions being tested will certainly be effective.

Methods: We developed and refined a measure of the preventive misconception using qualitative interviews that focused on cognitive testing of proposed survey items with HIV prevention trial participants.

Research participants' high expectations of benefit in early-phase oncology trials: are we asking the right question?

Purpose: To determine whether patients' expectations of benefit in early-phase oncology trials depend on how patients are queried and to explore whether expectations are associated with patient characteristics.

Patients And Methods: Participants were 171 patients in phase I or II oncology trials in the United States. After providing informed consent for a trial but before receiving the investigational therapy, participants answered questions about expectations of benefit.

The culture of faith and hope: patients' justifications for their high estimations of expected therapeutic benefit when enrolling in early phase oncology trials.

Background: Patients' estimates of their chances of therapeutic benefit from participation in early phase trials greatly exceed historical data. Ethicists worry that this therapeutic misestimation undermines the validity of informed consent.

Methods: The authors interviewed 45 patients enrolled in phase 1 or 2 oncology trials about their expectations of therapeutic benefit and their reasons for those expectations.

Decisional conflict among patients who accept or decline participation in phase I oncology studies.

WE COMPARED DECISIONAL CONFLICT among adults with advanced cancer who had accepted or declined participation in phase I cancer clinical trials. Respondents completed a 121-item questionnaire that included the Decisional Conflict Scale (DCS), which was designed to measure uncertainty in making health decisions. We used standardized effect sizes to compare the DCS scores of accepters (n = 250) and decliners (n = 65).