Assessment of Adverse Events From the Patient Perspective in a Phase 3 Metastatic Castration-Resistant Prostate Cancer Clinical Trial

IMPORTANCE Standard adverse event (AE) reporting in oncology clinical trials has historically relied on clinician grading, which prior research has shown can lead to underestimation of rates of symptomatic AEs. Industry sponsors are beginning to implement in trials the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE), which was developed to allow patients to self-report symptomatic AEs and improve the quality of symptomatic AE detection. OBJECTIVES To evaluate the feasibility of implementing PRO-CTCAE in a prespecified correlative analysis of the phase 3 COMET-2 trial and enumerate statistically significant between-group differences in symptomatic AEs using PRO-CTCAE and the CTCAE. DESIGN, SETTING, AND PARTICIPANTS This correlative study of 119 men in the randomized, double-blind, placebo-controlled phase 3 COMET-2 trial with metastatic castration-resistant prostate cancer who had undergone at least 2 prior lines of systemic treatment was conducted from March 2012 to July 2014. Participants completed PRO-CTCAE items using an automated telephone system from home prior to treatment and every 3 weeks during treatment. Statistical analysis was performed from May 2018 to June 2019. MAIN OUTCOMES AND MEASURES The proportion of patients who completed expected PRO-CTCAE self-reports was computed as a measure of feasibility. RESULTS Among the 119 men in the study (median age, 65 years [range, 44-80 years]), 534 of 587 (91.0%) expected PRO-CTCAE self-reports were completed, with consistently high rates of completion throughout participation. Rates of self-report adherence were similar between groups (cabozantinib s-maleate, 286 of 317 [90.2%]; and mitoxantrone hydrochloride-prednisone, 248 of 270 [91.9%]). Of 12 measured, patient-reported PRO-CTCAE symptomatic AEs, 4 reached statistical significance when comparing the proportion of patients with at least 1 postbaseline score greater than 0 between groups (differences ranged from 20.1% to 34.1% with higher proportions in the cabozantinib group; all P < .05), and use of a method for accounting for preexisting symptoms at baseline yielded 7 AEs with statistically significant differences between groups (differences ranged from 20.5%to 41.2%with higher proportions in the cabozantinib group; all P < .05). In the same analysis using investigator-reported CTCAE data, no statistically significant differences were found between groups for any symptomatic AEs. CONCLUSIONS AND RELEVANCE PRO-CTCAE data collection was feasible and improved the accuracy of symptomatic AE detection in a phase 3 cancer trial. This analysis adds to mounting evidence of the feasibility and value of patient-reported AEs in oncology, which should be considered for inclusion in cancer trials that incorporate AE evaluation

Trajectories of Familism Values and the Prosocial Tendencies of Mexican American Adolescents

We examined how the development of familism values from 5th to 10th grade relates to 12th-grade prosocial tendencies (after controlling for 10th-grade prosocial tendencies) using a stratified random sample of 749 Mexican American adolescents (M = 10.42 years of age at 5th grade; 48.9% girls) from 35 culturally and economically diverse neighborhoods. Most of the families (44.3%) were at or below $25,000 in annual income. A 2nd-order linear growth model represented adolescents' familism values at 5th grade (intercepts) and change in familism values from 5th to 10th grade (slopes), with the vast majority of slopes being negative. Higher intercepts predicted greater compliant and emotional prosocial tendencies, and higher (i.e., more positive or less negative) slopes predicted greater dire (female adolescents only) and public prosocial tendencies at 12th grade. The results underscore the important role of familism values in prosocial development among Mexican American adolescents. (PsycINFO Database Recor

Addressing Item-Level Missing Data: A Comparison of Proration and Full Information Maximum Likelihood Estimation

<div><p>Often when participants have missing scores on one or more of the items comprising a scale, researchers compute prorated scale scores by averaging the available items. Methodologists have cautioned that proration may make strict assumptions about the mean and covariance structures of the items comprising the scale (Schafer & Graham, <a href="#cit0036" target="_blank">2002</a>; Graham, <a href="#cit0015" target="_blank">2009</a>; Enders, <a href="#cit0010" target="_blank">2010</a>). We investigated proration empirically and found that it resulted in bias even under a missing completely at random (MCAR) mechanism. To encourage researchers to forgo proration, we describe a full information maximum likelihood (FIML) approach to item-level missing data handling that mitigates the loss in power due to missing scale scores and utilizes the available item-level data without altering the substantive analysis. Specifically, we propose treating the scale score as missing whenever one or more of the items are missing and incorporating items as auxiliary variables. Our simulations suggest that item-level missing data handling drastically increases power relative to scale-level missing data handling. These results have important practical implications, especially when recruiting more participants is prohibitively difficult or expensive. Finally, we illustrate the proposed method with data from an online chronic pain management program.</p></div

A large-scale analysis of test-retest reliabilities of self-regulation measures

The ability to regulate behavior in service of long-term goals is a widely studied psychological construct known as self-regulation. This wide interest is in part due to the putative relations between self-regulation and a range of real-world behaviors. Self-regulation is generally viewed as a trait, and individual differences are quantified using a diverse set of measures including self-report surveys and behavioral tasks. Accurate characterization of individual differences requires measurement reliability, a property frequently characterized in self-report surveys, but rarely assessed in behavioral tasks. We remedy this gap by (1) providing a comprehensive literature review on an extensive set of self-regulation measures, and (2) empirically evaluating retest reliability in this battery of measures in a new sample. We find that self-report survey measures of self-regulation have high test-retest reliability while measures derived from behavioral tasks do not. This holds both in the literature and in our sample. We confirm that this is due to differences in between-subjects variability. We also compare different types of task measures (e.g., model parameters vs. raw response times) in their suitability as individual difference measures, finding that certain model parameters are as stable as raw measures. Our results provide greater psychometric footing for the study of self-regulation and provide guidance for future studies of individual differences in this domain

Tobacco use in the Myeloproliferative neoplasms: symptom burden, patient opinions, and care

Abstract Background Patients with Philadelphia-negative Myeloproliferative Neoplasms (MPN) suffer from numerous symptoms and decreased quality of life. Smoking is associated with an increased symptom burden in several malignancies. The aim of this study was to analyze the association between smoking and MPN-related symptom burden and explore MPN patients’ opinions on smoking. Methods A total of 435 patients with MPN participated in a cross-sectional internet-based survey developed by the Mayo Clinic and the Myeloproliferative Neoplasm Quality of Life Group. Patients reported their demographics, disease characteristics, tobacco use, and opinions on tobacco use. In addition, MPN-related symptoms were reported via the validated 10-item version of the Myeloproliferative Neoplasms Symptom Assessment Form. Results Current/former smokers reported worse fatigue (mean severity 5.6 vs. 5.0, p = 0.02) and inactivity (mean severity 4.0 vs. 3.4, p = 0.03) than never smokers. Moreover, current/former smokers more frequently experienced early satiety (68.5% vs. 58.3%, p = 0.03), inactivity (79.9% vs. 71.1%, p = 0.04), and concentration difficulties (82.1% vs. 73.1%, p = 0.04). Although not significant, a higher total symptom burden was observed for current/former smokers (mean 30.4 vs. 27.0, p = 0.07). Accordingly, overall quality of life was significantly better among never smokers than current/former smokers (mean 3.5 vs. 3.9, p = 0.03). Only 43.2% of the current/former smokers reported having discussed tobacco use with their physician, and 17.5% did not believe smoking increased the risk of thrombosis. Conclusion The current study suggests that smoking may be associated with increased prevalence and severity of MPN symptoms and underscores the need to enhance patient education and address tobacco use in the care of MPN patients

Streamlined Prevention and Early Intervention for Pediatric Anxiety Disorders: A Randomized Controlled Trial

There is a need to optimize the fit between psychosocial interventions with known efficacy and the demands of real-word service delivery settings. However, adaptation of evidence-based interventions (EBI) raises questions about whether effectiveness can be retained. This randomized controlled trial (RCT) evaluated a streamlined package of cognitive, behavior, and social skills training strategies known to prevent and reduce anxiety symptom and disorder escalation in youth. A total of 109 youth (Mage = 9.72; 68% girls; 54% Latinx) at risk based on high anxiety were randomized to the streamlined prevention and early intervention (SPEI) (n = 59) or control (n = 50) and were assessed at pretest, posttest, and 12-month follow-up. A main objective was to determine whether our redesign could be delivered by community providers, with acceptable levels of fidelity, quality, and impact. In terms of process evaluation results, there was high protocol fidelity, excellent clinical process skills, few protocol adaptations, and high satisfaction with the SPEI. In terms of outcomes, there were no significant main or moderated effects of the SPEI at the immediate posttest. However, at the follow-up, youth in the SPEI reported greater self-efficacy for managing anxiety-provoking situations, greater social skills, and fewer negative cognitive errors relative to controls. Collectively, findings suggest that the redesigned SPEI might be an attractive and efficient solution for service delivery settings

Momentary Self-regulation: Scale Development and Preliminary Validation

BackgroundSelf-regulation refers to a person’s ability to manage their cognitive, emotional, and behavioral processes to achieve long-term goals. Most prior research has examined self-regulation at the individual level; however, individual-level assessments do not allow the examination of dynamic patterns of intraindividual variability in self-regulation and thus cannot aid in understanding potential malleable processes of self-regulation that may occur in response to the daily environment. ObjectiveThis study aims to develop a brief, psychometrically sound momentary self-regulation scale that can be practically administered through participants’ mobile devices at a momentary level. MethodsThis study was conducted in 2 phases. In the first phase, in a sample of 522 adults collected as part of a larger self-regulation project, we examined 23 previously validated assessments of self-regulation containing 594 items in total to evaluate the underlying structure of self-regulation via exploratory and confirmatory factor analyses. We then selected 20 trait-level items to be carried forward to the second phase. In the second phase, we converted each item into a momentary question and piloted the momentary items in a sample of 53 adults over 14 days. Using the results from the momentary pilot study, we explored the psychometric properties of the items and assessed their underlying structure. We then proposed a set of subscale and total score calculations. ResultsIn the first phase, the selected individual-level items appeared to measure 4 factors of self-regulation. The factors identified were perseverance, sensation seeking, emotion regulation, and mindfulness. In the second phase of the ecological momentary assessment pilot, the selected items demonstrated strong construct validity as well as predictive validity for health risk behaviors. ConclusionsOur findings provide preliminary evidence for a 12-item momentary self-regulation scale comprising 4 subscales designed to capture self-regulatory dynamics at the momentary level