Randomized evaluation of trial acceptability by INcentive (RETAIN): Study protocol for two embedded randomized controlled trials.

INTRODUCTION: The most common and conceptually sound ethical concerns with financial incentives for research participation are that they may (1) represent undue inducements by blunting peoples' perceptions of research risks, thereby preventing fully informed consent; or (2) represent unjust inducements by encouraging enrollment preferentially among the poor. Neither of these concerns has been shown to manifest in studies testing the effects of incentives on decisions to participate in hypothetical randomized clinical trials (RCTs), but neither has been assessed in real RCTs. METHODS AND ANALYSES: We are conducting randomized trials of real incentives embedded within two parent RCTs. In each of two trials conducted in parallel, we are randomizing 576 participants to one of three incentive groups. Following preliminary determination of patients' eligibility in the parent RCT, we assess patients' research attitudes, demographic characteristics, perceived research risks, time spent reviewing consent documents, ability to distinguish research from patient care, and comprehension of key trial features. These quantitative assessments will be supplemented by semi-structured interviews for a selected group of participants that more deeply explore patients' motivations for trial participation. The trials are each designed to have adequate power to rule out undue and unjust inducement. We are also exploring potential benefits of incentives, including possible increased attention to research risks and cost-effectiveness.

Development of a Self-Rated Mixed Methods Skills Assessment: The National Institutes of Health Mixed Methods Research Training Program for the Health Sciences.

INTRODUCTION: Demand for training in mixed methods is high, with little research on faculty development or assessment in mixed methods. We describe the development of a self-rated mixed methods skills assessment and provide validity evidence. The instrument taps six research domains: "Research question," "Design/approach," "Sampling," "Data collection," "Analysis," and "Dissemination." Respondents are asked to rate their ability to define or explain concepts of mixed methods under each domain, their ability to apply the concepts to problems, and the extent to which they need to improve. METHODS: We administered the questionnaire to 145 faculty and students using an internet survey. We analyzed descriptive statistics and performance characteristics of the questionnaire using the Cronbach alpha to assess reliability and an analysis of variance that compared a mixed methods experience index with assessment scores to assess criterion relatedness. RESULTS: Internal consistency reliability was high for the total set of items (0.95) and adequate (≥0.71) for all but one subscale. Consistent with establishing criterion validity, respondents who had more professional experiences with mixed methods (eg, published a mixed methods article) rated themselves as more skilled, which was statistically significant across the research domains. DISCUSSION: This self-rated mixed methods assessment instrument may be a useful tool to assess skills in mixed methods for training programs. It can be applied widely at the graduate and faculty level. For the learner, assessment may lead to enhanced motivation to learn and training focused on self-identified needs. For faculty, the assessment may improve curriculum and course content planning.

Twitter as a Potential Data Source for Cardiovascular Disease Research.

IMPORTANCE: As society is increasingly becoming more networked, researchers are beginning to explore how social media can be used to study person-to-person communication about health and health care use. Twitter is an online messaging platform used by more than 300 million people who have generated several billion Tweets, yet little work has focused on the potential applications of these data for studying public attitudes and behaviors associated with cardiovascular health. OBJECTIVE: To describe the volume and content of Tweets associated with cardiovascular disease as well as the characteristics of Twitter users. DESIGN, SETTING, AND PARTICIPANTS: We used Twitter to access a random sample of approximately 10 billion English-language Tweets originating from US counties from July 23, 2009, to February 5, 2015, associated with cardiovascular disease. We characterized each Tweet relative to estimated user demographics. A random subset of 2500 Tweets was hand-coded for content and modifiers. MAIN OUTCOMES AND MEASURES: The volume of Tweets about cardiovascular disease and the content of these Tweets. RESULTS: Of 550 338 Tweets associated with cardiovascular disease, the terms diabetes (n = 239 989) and myocardial infarction (n = 269 907) were used more frequently than heart failure (n = 9414). Users who Tweeted about cardiovascular disease were more likely to be older than the general population of Twitter users (mean age, 28.7 vs 25.4 years; P < .01) and less likely to be male (59 082 of 124 896 [47.3%] vs 8433 of 17 270 [48.8%]; P < .01). Most Tweets (2338 of 2500 [93.5%]) were associated with a health topic; common themes of Tweets included risk factors (1048 of 2500 [41.9%]), awareness (585 of 2500 [23.4%]), and management (541 of 2500 [21.6%]) of cardiovascular disease. CONCLUSIONS AND RELEVANCE: Twitter offers promise for studying public communication about cardiovascular disease.

A hybrid effectiveness-implementation trial of an evidence-based exercise intervention for breast cancer survivors.

BACKGROUND: The primary aims of this hybrid Type 1 effectiveness-implementation trial were to quantitatively assess whether an evidence-based exercise intervention for breast cancer survivors, Strength After Breast Cancer, was safe and effective in a new setting and to qualitatively assess barriers to implementation. METHODS: A cohort of 84 survivors completed measurements related to limb volume, muscle strength, and body image at baseline, 67 survivors completed measurements 12 months later. Qualitative methods were used to understand barriers to implementation experienced by referring oncology clinicians and physical therapists who delivered the program. RESULTS: Similar to the efficacy trial, the revised intervention demonstrated safety with regard to lymphedema, and led to improvements in lymphedema symptoms, muscular strength, and body image. Comparison of effects in the effectiveness trial to effects in the efficacy trial revealed larger strength increases in the efficacy trial than in the effectiveness trial (P < .04), but few other differences were found. Qualitative implementation data suggested significant barriers around intervention characteristics, payment, eligibility criteria, the referral process, the need for champions (ie, advocates), and the need to adapt during implementation of the intervention, which should be considered in future dissemination and implementation efforts. CONCLUSIONS: This trial successfully demonstrated that a physical therapy led strength training program for breast cancer survivors can be implemented in a community setting while retaining the effectiveness and safety of the clinical trial. However, during the translation process, strategies to reduce barriers to implementation are required. This new program can inform larger scale dissemination and implementation efforts.