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 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 its prevalence. Methods 220 participants were recruited from clinical trials at 4 academic medical centers in the U.S. Participants completed a 28-item Likert-type questionnaire to assess the presence of beliefs associated with TM, and a semi-structured 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 3 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. ROC analysis based on a 10-fold internal cross-validation yielded AUC=.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. 50.5% (n=101) of 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.

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BackgroundTo explore the existing evidence of the real-world implementation of patient-reported outcomes (PROs) in oncology clinical practice and address two aims: (1) summarize available evidence of PRO use in clinical practice using a framework based on the International Society for Quality of Life Research (ISOQOL) PRO Implementation Guide; and (2) describe reports of real-world, standardized PRO administration in oncology conducted outside of scope of a research study.MethodsA Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) protocol was developed to guide the systematic literature review (SLR) that was conducted in MEDLINE and Embase databases. A two step search strategy was implemented including two searches based on previously completed reviews. Studies published from 2006 to 2017 were synthesized using a framework based on the ISOQOL PRO Implementation Guide.ResultsAfter screening 4427 abstracts, 36 studies met the eligibility criteria. Most elements of the ISOQOL PRO Implementation Guide were followed. Two notable exceptions were found: 1) providing PRO score interpretation guidelines (39% of studies); and 2) providing patient-management guidance for addressing issues identified by PROs (25% of studies). Of the 22 studies with an intervention component, 19 (86%) reported intervention effects on study outcomes. The European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Core 30 (EORTC QLQ-C30) was the most commonly used PRO (n = 10, 28%); use of 38 other PRO measures was also reported. Only three studies (8%) reported real-world PRO implementation.ConclusionReports of real-world PRO implementation are limited. Reports from studies conducted in clinical settings suggest gaps in information on PRO score interpretation and the use of PRO results to inform patient management. Before the promise of practice-based PRO assessment in oncology can be truly realized, investigators need to advance the state-of-the-art of real-time PRO score interpretation as well as developing guidance on how to use PRO insights to drive clinically-meaningful patient-management strategies.

Background Cardiovascular disease continues to cause significant morbidity, mortality, and impaired quality of life, with unrealized health gains from the underuse of available evidence. The Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education (TRACE-CORE) aims to advance the science of acute coronary syndromes (ACS) by examining the determinants and outcomes of the quality of the transition from the hospital to the community and by quantifying the impact of potentially-modifiable characteristics associated with decreased quality of life, rehospitalization, and mortality. Methods and Results TRACE-CORE is composed of a longitudinal multi-racial cohort of patients hospitalized with ACS, two research projects, and development of a nucleus of early stage investigators. We are currently enrolling 2,500 adults hospitalized for ACS at 6 hospitals in the northeastern and southeastern United States. We will follow these patients for 24 months after hospitalization through medical record abstraction and six patient interviews focusing on quality of life, cardiac events, rehospitalizations, mortality, and medical, behavioral, and psychosocial characteristics. The Transitions Project studies determinants of and disparities in outcomes of the quality of patients’ transition from the hospital to the community. Focusing on potentially modifiable factors, the Action Scores Project will develop and validate action scores to predict recurrent cardiac events, death, and quality of life, describe longitudinal variation in these scores, and develop a dashboard for patient and provider action based on these scores. Conclusions In TRACE-CORE, sound methodologic principles of observational studies converge with outcomes and effectiveness research approaches. We expect that our data, research infrastructure, and research projects will inform the development of novel secondary prevention approaches and underpin the careers of CVD outcomes researchers.

BackgroundThe quality of transitional care is associated with important health outcomes such as rehospitalization and costs. The widely used Care Transitions Measure (CTM‐15) was developed with a classic test theory approach; its short version (CTM‐3) was included in the CAHPS Hospital Survey. We conducted a psychometric evaluation of both measures and explored whether item response theory (IRT) could produce a more precise measure.Methods and ResultsAs part of the Transitions, Risks, and Actions in Coronary Events Center for Outcomes Research and Education, 1545 participants were interviewed during an acute coronary syndrome hospitalization, providing information on general health status (Short Form‐36), CTM‐15, health utilization, and care process questions at 1 month postdischarge. We used classic and IRT analyses and compared the measurement precision of CTM‐15–, CTM‐3–, and CTM‐IRT–based score using relative validity.Participants were 79% non‐Hispanic white and 67% male, with an average age of 62 years. The CTM‐15 had good internal consistency (Cronbach's α=0.95) but demonstrated acquiescence bias (8.7% participants responded “Strongly agree” and 19% responded “Agree” to all items) and limited score variability. These problems were more pronounced for the CTM‐3. The CTM‐15 differentiated between patient groups defined by self‐reported health status, health care utilization, and care transition process indicators. Differences between groups were small (2 to 3 points). There was no gain in measurement precision from IRT scoring. The CTM‐3 was not significantly lower for patients reporting rehospitalization or emergency department visits.ConclusionWe identified psychometric challenges of the CTM, which may limit its value in research and practice. These results are in line with emerging evidence of gaps in the validity of the measure.

The cluster patterns closely replicate earlier findings and provide evidence for the existence of clusters subtypes within the Contemplation stage of change.

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IntroductionPatient-reported outcome measures (PROs) specific for genital psoriasis (GenPs) have not been described.MethodsIn this cross-sectional, qualitative study in patients with moderate-to-severe GenPs, we sought to develop a PRO useful for GenPs symptom assessment. A literature review was performed to identify relevant psoriasis or GenPs symptoms and existing PROs that may be useful in the evaluation of symptom severity in GenPs patients. The literature review findings were discussed with clinicians, and then patients with GenPs.ResultsRelevant psoriasis or GenPs symptoms from the literature review included itch, pain, scaling, redness/erythema, and stinging/burning. The validity of these symptoms for GenPs and potentially relevant PROs was corroborated by clinical experts. After gap analysis, a draft symptom scale consisting of Numeric Rating Scale (NRS) items was constructed. We then conducted interviews with GenPs patients (n = 20) to support content validity and use of the draft symptom NRS items in routine practice and in clinical trials. Participants identified and confirmed relevant symptoms and evaluated the utility of the draft PRO. A new PRO was developed: the Genital Psoriasis Symptoms Scale (GPSS). Cognitive debriefing and cultural adaptation/translation interviews with a second group of patients confirmed cultural appropriateness of the GPSS.ConclusionThe GPSS may be useful for assessing symptoms before, during, and after treatment in routine clinical practice and in clinical trials involving patients with GenPs.FundingEli Lilly & Company.Plain Language SummaryPlain language summary available for this article.Electronic supplementary materialThe online version of this article (10.1007/s13555-017-0213-2) contains supplementary material, which is available to authorized users.