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.

Why is therapeutic misconception so prevalent?

Therapeutic misconception (TM)-when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care-has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants' incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers' frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.

Competing commitments in psychiatric research: an examination of psychiatric researchers' perspectives.

Clinician-researchers have responsibilities both to seek the best interests of the people they treat and to advance scientific knowledge. The purpose of this study was to examine researchers' beliefs and behaviors regarding areas of tension between their clinical and scientific roles. We conducted and analyzed 19 in-depth interviews with psychiatric clinical researchers to explore these issues. Responses usually indicated that researchers recognize limits on their abilities to be helpful to patients, since they cannot know in advance whether a specific research intervention will help and whether participation is in the patient's best interest. Hence, most researchers did not make special efforts to recruit patients doing poorly in standard care, although they occasionally tolerated minor deviations from recruitment and treatment protocols when they might be in participants' interests. Often respondents asked the IRB to approve these deviations or change the protocol for all subjects, though it was unclear how often they may have acted without this approval. Despite researchers' high regard for following the research protocol, clinical judgment remained the ultimate guide if patients were not doing well and needed alternative care. Hence, respondents expressed a strong commitment both to protecting patients' interests and to advancing science. In cases of direct conflict between the two, many of the researchers tended to promote patients' best interests even at some cost to scientific research.

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.

Synchrotron-based highest resolution Fourier Transform infrared spectroscopy of naphthalene (C10H8) and indole (C8H7N) and its application to astrophysical problems.

We report a rotationally resolved analysis of the high resolution FTIR spectrum of naphthalene which can be considered as a prototypical molecule for polycyclic aromatic hydrocarbons (PAHs), and a similar analysis for the prototypical heterocyclic aromatic molecule indole. The spectra have been measured using a resolution of 0.0008 cm(-1) (21 MHz) with the new high resolution FTIR prototype spectrometer of the Molecular Kinetics and Spectroscopy Group at ETH Zürich. The spectrometer is connected to the infrared port available at the Swiss Light Source (SLS) at the Paul-Scherrer-Institute (PSI). Due to the high brightness of the synchrotron radiation in the spectral region of interest, effectively up to 20 times brighter than thermal sources, and the high resolution of the new interferometer, it was possible to record the rotationally resolved infrared spectra of naphthalene and indole at room temperature, and to analyse the ν46 c-type band (ν̃(0) = 782.330949 cm(-1)) of naphthalene as well as the ν35 c-type band (ν̃(0) = 738.483592 cm(-1)) of indole and an a-type band at ν̃(0) = 790.864370 cm(-1) tentatively assigned as the overtone 2ν(40) of indole. The results of the naphthalene band analysis are discussed in relation to the Unidentified Infrared Band (UIB) found in interstellar spectra at 12.8 µm.

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.

Integrating knowledge-based resources into the electronic health record: history, current status, and role of librarians.

Satisfying clinical information needs remains a major challenge in medicine, underscored by recent studies showing high medical error rates and suboptimal physician adherence to evidence-based practice guidelines. Advanced clinical decision support systems can improve practitioner performance and patient outcomes. Similarly, integrating online information resources into electronic health records (EHRs) shows great potential for positively impacting health care quality. This paper explores the evolution and current status of knowledge-based resource linkages within EHRs, including the benefits and drawbacks, as well as the important role librarians can play in this process.

Open access: implications for scholarly publishing and medical libraries.

PURPOSE: The paper reviews and analyzes the evolution of the open access (OA) publishing movement and its impact on the traditional scholarly publishing model. PROCEDURES: A literature survey and analysis of definitions of OA, problems with the current publishing model, historical developments, funding agency responses, stakeholder viewpoints, and implications for scientific libraries and publishing are performed. FINDINGS: The Internet's transformation of information access has fueled interest in reshaping what many see as a dysfunctional, high-cost system of scholarly publishing. For years, librarians alone advocated for change, until relatively recently when interest in OA and related initiatives spread to the scientific community, governmental groups, funding agencies, publishers, and the general public. CONCLUSIONS: Most stakeholders acknowledge that change in the publishing landscape is inevitable, but heated debate continues over what form this transformation will take. The most frequently discussed remedies for the troubled current system are the "green" road (self-archiving articles published in non-OA journals) and the "gold" road (publishing in OA journals). Both movements will likely intensify, with a multiplicity of models and initiatives coexisting for some time.