Collective Equipoise, Disappointment and the Therapeutic Misconception: On the Consequences of Selection for Clinical Research

Private information induces individuals to self-select as subjects into clinical research trials, and it induces researchers to select which trials they conduct. We show that selection can induce ex ante therapeutic misconception and ex post disappointment among research subjects; and it undermines it the rationale of collective equipoise as an ethical basis for clinical trials. Selection provides a reason to make non-trivial payments to subjects and it implies that researchers should not design experiments to maximize statistical power.clinical trials, therapeutic misconception, equipoise, selection

Collective Equipoise, Disappointment and the Therapeutic Misconception: On the Consequences of Selection for Clinical Research

Private information induces individuals to self-select as subjects into clinical research trials, and it induces researchers to select which trials they conduct. The authors show that selection can induce ex ante therapeutic misconception and ex post disappointment among research subjects, and it undermines the rationale of collective equipoise as an ethical basis for clinical trials. Selection provides a reason to make nontrivial payments to subjects, and it implies that researchers should not design experiments to maximize statistical power

Decision aids can support cancer clinical trials decisions: Results of a randomized trial

BACKGROUND. Cancer patients often do not make informed decisions regarding clinical trial participation. This study evaluated whether a web-based decision aid (DA) could support trial decisions compared with our cancer center’s website. METHODS. Adults diagnosed with cancer in the past 6 months who had not previously participated in a cancer clinical trial were eligible. Participants were randomized to view the DA or our cancer center’s website (enhanced usual care [UC]). Controlling for whether participants had heard of cancer clinical trials and educational attainment, multivariable linear regression examined group on knowledge, self-efficacy for finding trial information, decisional conflict (values clarity and uncertainty), intent to participate, decision readiness, and trial perceptions. RESULTS. Two hundred patients (86%) consented between May 2014 and April 2015. One hundred were randomized to each group. Surveys were completed by 87 in the DA group and 90 in the UC group. DA group participants reported clearer values regarding trial participation than UC group participants reported (least squares [LS] mean = 15.8 vs. 32, p < .0001) and less uncertainty (LS mean = 24.3 vs. 36.4, p = .025). The DA group had higher objective knowledge than the UC group’s (LS mean = 69.8 vs. 55.8, p < .0001). There were no differences between groups in intent to participate. CONCLUSIONS. Improvements on key decision outcomes including knowledge, self-efficacy, certainty about choice, and values clarity among participants who viewed the DA suggest web-based DAs can support informed decisions about trial participation among cancer patients facing this preference-sensitive choice. Although better informing patients before trial participation could improve retention, more work is needed to examine DA impact on enrollment and retention. IMPLICATIONS FOR PRACTICE: This paper describes evidence regarding a decision tool to support patients’ decisions about trial participation. By improving knowledge, helping patients clarify preferences for participation, and facilitating conversations about trials, decision aids could lead to decisions about participation that better match patients’ preferences, promoting patient-centered care and the ethical conduct of clinical research

Lung Cancer Screening in a Community Setting: Characteristics, Motivations, and Attitudes of Individuals Being Screened

We describe the characteristics of individuals being screened in community settings including factors influencing screening decisions and the level of information sought prior to screening. Individuals from two community-based radiology clinics (N = 27) were surveyed after screening. Screening efficacy and salience were the most important factors in screening decisions, whereas healthcare provider recommendations were rated not important. Half of participants reported no or little conversation about screening with their primary care provider, and 61.5 percent had not sought any information on screening. Individuals being screened in a community setting are unlikely to have sufficient information for an informed decision about screening

Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial

Objective To test the effectiveness of a complex intervention designed, within a theoretical framework, to improve outcomes for patients with coronary heart disease

Shoreline Situation Report Cities of Chesapeake, Norfolk, and Portsmouth

It i s the objective of this report to supply an assessment, and at least a partial integration, of those important shoreland parameters and characteristics which will aid the planners and the managers of the shorelands in making the best decisions for the utilization of this limited and very valuable resource. The report gives particular attention to the problem of shore erosion and to recommendations concerning the alleviation of the impact of this problem. In addition, we have tried to include in our assessment a discussion of those factors which might significantly limit development of the shoreline and, in some instances, a discussion of some of the potential or alternate uses of the shoreline, particularly with respect to recreational use, since such information could aid potential users in the perception of a segment of the shoreline