BACKGROUND & AIMS:Adverse events (AEs) including reactivation of herpes zoster (HZ) and venous thromboembolism (VTE) have been reported from clinical trials of tofacitinib in ulcerative colitis (UC). We investigated the incidence rates of AEs in a real-world study of UC patients given tofacitinib. METHODS:We collected data from 260 patients with UC in the Tofacitinib Real-world Outcomes in Patients with ulceratIve colitis and Crohn's disease consortium study, performed at 6 medical centers in the United States. Patients were followed up for a median of 6 months (interquartile range, 2.7-11.5 mo). AEs were captured using a standardized data collection instrument before study

BackgroundNumerous digital health interventions have been developed for mental health promotion and intervention, including eating disorders. Efficacy of many interventions has been evaluated, yet knowledge about reasons for dropout and poor adherence is scarce. Most digital health intervention studies lack appropriate research design and methods to investigate individual engagement issues. User engagement and program usability are inextricably linked, making usability studies vital in understanding and improving engagement.ObjectiveThe aim of this study was to explore engagement and corresponding usability issues of the Healthy Body Image Program—a guided online intervention for individuals with body image concerns or eating disorders. The secondary aim was to demonstrate the value of usability research in order to investigate engagement.MethodsWe conducted an iterative usability study based on a mixed-methods approach, combining cognitive and semistructured interviews as well as questionnaires, prior to program launch. Two separate rounds of usability studies were completed, testing a total of 9 potential users. Thematic analysis and descriptive statistics were used to analyze the think-aloud tasks, interviews, and questionnaires.ResultsParticipants were satisfied with the overall usability of the program. The average usability score was 77.5/100 for the first test round and improved to 83.1/100 after applying modifications for the second iteration. The analysis of the qualitative data revealed five central themes: layout, navigation, content, support, and engagement conditions. The first three themes highlight usability aspects of the program, while the latter two highlight engagement issues. An easy-to-use format, clear wording, the nature of guidance, and opportunity for interactivity were important issues related to usability. The coach support, time investment, and severity of users’ symptoms, the program’s features and effectiveness, trust, anonymity, and affordability were relevant to engagement.ConclusionsThis study identified salient usability and engagement features associated with participant motivation to use the Healthy Body Image Program and ultimately helped improve the program prior to its implementation. This research demonstrates that improvements in usability and engagement can be achieved by testing and adjusting intervention design and content prior to program launch. The results are consistent with related research and reinforce the need for further research to identify usage patterns and effective means for reducing dropout. Digital health research should include usability studies prior to efficacy trials to help create more user-friendly programs that have a higher likelihood of “real-world” adoption.

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The graft-versus-leukemia (GVL) effect after allogeneic hematopoietic cell transplant (HCT) can prevent relapse but the risk of severe graft-vs-host disease (GVHD) leads to prolonged intensive immunosuppression and possible blunting of the GVL effect. Strategies to reduce immunosuppression in order to prevent relapse have been offset by increases in severe GVHD and non-relapse mortality (NRM). We recently validated the MAGIC algorithm probability (MAP) that predicts the risk for severe GVHD and NRM in asymptomatic patients using serum biomarkers. In this study we tested whether the MAP could identify patients whose risk for relapse is higher than their risk for severe GVHD and NRM. The multicenter study population (n=1604) was divided into two cohorts: historical (2006–2015, n=702) and current (2015–2017, n=902) with similar non-relapse mortality, relapse, and survival. On day 28 post-HCT, patients who had not developed GVHD (75% of the population) and who possessed a low MAP were at much higher risk for relapse (24%) than severe GVHD and NRM (16% and 9%); this difference was even more pronounced in patients with a high disease risk index (relapse 33%, NRM 9%). Such patients are good candidates to test relapse prevention strategies that might enhance GVL.