Karen Albert

Therapeutic Misconception in Research Subjects: Development and Validation of a Measure

Background Therapeutic misconception (TM), which occurs when research subjects fail to appreciate the distinction between the imperatives of clinical research and ordinary treatment, may undercut the process of obtaining meaningful consent to clinical research participation. Previous studies have found that TM is widespread, but progress in addressing TM has been stymied by the absence of a validated method for assessing its presence. Purpose The goal of this study was to develop and validate a theoretically grounded measure of TM, assess its diagnostic accuracy, and test previous findings regarding TM’s prevalence. Methods A total of 220 participants were recruited from clinical trials at four academic medical centers in the United States. Participants completed a 28-item Likert-type questionnaire to assess the presence of beliefs associated with TM, and a semistructured TM interview designed to elicit their perceptions of the nature of the clinical trial in which they were participating. Data from the questionnaires were subjected to factor analysis, and items with poor factor loadings were excluded. This resulted in a 10-item scale, with three strongly correlated factors and excellent internal consistency; the fit indices of the model across 10 training sets were consistent with the original results, suggesting a stable factor solution. Results The scale was validated against the TM interview, with significantly higher scores among subjects coded as displaying evidence of TM. Receiver operating curve (ROC) analysis based on a 10-fold internal cross-validation yielded area under the ROC (AUC) = 0.682 for any evidence of TM. When sensitivity (0.72) and specificity (0.61) were both optimized, positive predictive value was 0.65 and negative predictive value was 0.68, with a positive likelihood ratio of 1.89 and a negative likelihood ratio of 0.47. In all, 50.5% (n = 101) of the participants manifested evidence of TM on the TM interview, a somewhat lower rate than in most previous studies. Limitations The predictive value of the scale compared with the ‘gold standard’ clinical interview is modest, although similar to other instruments based on self-report assessing states of mind rather than discrete symptoms. Thus, although the scale can offer evidence of which subjects are at risk for distortions in their decisions and to what degree, it will not allow researchers to conclude definitively that TM is present in a given subject. Conclusions The development of a reliable and valid TM scale, even with modest predictive power, should permit investigators in clinical trials to identify subjects with tendencies to misinterpret the nature of the situation and to provide additional information to them. It should also stimulate research on how best to decrease TM and facilitate meaningful informed consent to clinical research.

Family options for parents with mental illnesses: a developmental, mixed methods pilot study.

OBJECTIVE The objective of this paper is to provide a description of Family Options, a rehabilitation intervention for parents with serious mental illnesses and their children focusing on recovery and resilience, and to report the findings from a pilot study at 6-months post-enrollment for participating mothers. METHODS A developmental design, and mixed quantitative and qualitative methods facilitate an in-depth understanding of Family Options and its impact on parents early in the implementation process. RESULTS Participating families faced significant challenges, including long-term mental health conditions in adults, and emotional and behavioral difficulties in children. Data from mothers (n = 22) demonstrate significant improvements in well-being, functioning, and supports and resources at 6 months post-enrollment in Family Options. Mothers report help from Family Options staff consistent with the intervention as conceptualized, and high levels of satisfaction with the intervention as delivered. CONCLUSIONS Innovative study design and analytic strategies are required to build the evidence base and promote rapid dissemination of effective interventions. Findings from this study will assist purveyors in refining the intervention, and will lay the groundwork for further replication and testing to build the evidence base for parents with serious mental illnesses and their families.

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials

Background Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. Methods This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10–50), and willingness to participate in the clinical trial. Results 154 participants completed the study (age range, 23–87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. Conclusions An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.

Developing Family Options: Outcomes for mothers with severe mental illness at twelve months of participation

ABSTRACT Family Options is a psychiatric rehabilitation intervention for parents with severe mental illness and their children who work with family coaches to set and achieve goals. The objective of this study is to compare changes in well-being, functioning, and supports and resources achieved from enrollment to 12 months by mothers participating in Family Options (N = 22) with changes from enrollment to 6 months. Mothers’ scores are compared on standardized measures of psychological distress, trauma symptom severity, mental and physical health status, social support, and the number of services needed but not received from enrollment to 6 months, and from enrollment to 12 months. Data were also obtained about help received and satisfaction with Family Options. Mothers achieved significant improvements in well-being at 12 months, as measured in terms of reductions in psychological distress and symptom severity scores. Significant improvements in social support and services received were reported at 6 months but not at 12 months. Mothers received help obtaining services and benefits for themselves and their children and were satisfied with the intervention. Findings underscore the importance of further refinements to the intervention and larger-scale, rigorous testing of Family Options.

Clinical Concerns and the Validity of Clinical Trials

Background: The validity of results from clinical trials depends on both clinical researchers and participants consistently and strictly following research protocols. However, clinical trial researchers are also expected to provide excellent medical care to the participants. These two commitments may conflict under some circumstances. Methods: A questionnaire previously used for a national Internet-based survey was adapted to conduct in-depth, semistructured interviews in order to further explore reported attitudes and/or behaviors that indicated that patient well-being sometimes took precedence over strict adherence to the study protocol. We conducted 96 interviews with researchers working on Phase II and/or Phase III clinical trials in a variety of medical fields at four major academic medical centers. Results: Due to concerns for the welfare of their patients, the researchers we interviewed described decisions that involved “individualized” rather than protocol-driven decisions about recruitment, protocol implementation, and termination. The individualized decisions could threaten the validity of the trials. Conclusions: Clinical researchers should be strongly encouraged to carefully document and report selective recruitment, implementation, and termination decisions so that it will be easier to evaluate to whom the results of research studies apply. Those who design clinical trials should be careful to construct them so that the clinicians who carry them out will not feel that implementing the protocol will violate their commitments to good clinical care.