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

The cost-effectiveness of the SPHERE intervention for the secondary prevention of coronary heart disease

Objectives: The Secondary Prevention of Heart disEase in geneRal practicE (SPHERE) trial has recently reported. This study examines the cost-effectiveness of the SPHERE intervention in both healthcare systems on the island of Ireland.Methods: Incremental cost-effectiveness analysis. A probabilistic model was developed to combine within-trial and beyond-trial impacts of treatment to estimate the lifetime costs and benefits of two secondary prevention strategies: Intervention - tailored practice and patient care plans; and Control - standardized usual care.Results: The intervention strategy resulted in mean cost savings per patient of €512.77 (95 percent confidence interval [CI], −1086.46–91.98) and an increase in mean quality-adjusted life-years (QALYs) per patient of 0.0051 (95 percent CI, −0.0101–0.0200), when compared with the control strategy. The probability of the intervention being cost-effective was 94 percent if decision makers are willing to pay €45,000 per additional QALY.Conclusions: Decision makers in both settings must determine whether the level of evidence presented is sufficient to justify the adoption of the SPHERE intervention in clinical practice.</jats:p

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

Marital status and its effect on lung cancer survival

Abstract Purpose The purpose of this study was to determine if marital status, including specific types of single status categories, is associated with length of survival in lung cancer patients. Methods Data from the 1996–2007 Florida Cancer Data System were linked with Agency for Health Care Administration data and U.S. Census data. Patients with both small cell and non-small cell lung cancer were identified (n = 161,228). Marital status was characterized by married, widowed, separated/divorced, and never married. We compared median survival time and 1, 3, and 5-year post diagnosis survival rates. Results Overall, 54.6% were married, 19.1% were widowed, 13.5% were separated/divorced, and 12.7% had never married. Median survival in months was longest for married (9.9) and widowed (7.7) patients, and shortest for never married (4.9) and separated/divorced (4.1) patients. Five-year survival rates were 14.2% for married, 10.7% for widowed, 8.9% for separated/divorced, and 8.4% for never married. In univariate Cox regression, marital status was a significant predictor of better survival for married (HR = 0.70; p &lt; 0.001) and widowed (HR = 0.81; p &lt; 0.001) patients compared with never married patients, but worse for separated/divorced patients (HR = 1.03; p = 0.003). Multivariate models demonstrated sustained survival benefits for married (HR = 0.86; p &lt; 0.001) and widowed (HR = 0.88; p &lt; 0.001) patients, and detriments for separated/divorced patients (HR = 1.05; p &lt; 0.001) after adjusting for extensive confounders including demographics; tumor stage, grade, and morphology; comorbidities; treatment; and smoking status. Conclusions Our study demonstrated that married or widowed lung cancer patients have better survival compared to patients who were never married or separated/divorced. Research to understand the mechanism of this effect, and how the beneficial effect can be extended to those who have never married or have had the marital relationship severed through divorce or separation is needed. </jats:sec