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As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical and regulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team's experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as part of informed consent.

P ragmatic clinical trials (PCTs) are used to generate data to inform health care decision-making. PCTs are often embedded in routine clinical care to increase the real-world applicability of the findings. Although PCTs tend to use streamlined methods and to evaluate interventions that seem consistent with standard care, like other research, they are associated with various regulatory, ethical, and operational challenges. 1 PCTs often rely on clinical staff members to support implementation and data collection efforts rather than maintaining a separate research infrastructure with a dedicated research staff. 2 While doing so introduces efficiency, it can complicate the application of regulations and requirements regarding informed consent and standards for privacy. 3 In this article, we describe challenges with regulatory compliance during a multicenter PCT, the Trauma Survivors Outcomes and Support (TSOS) effectiveness-implementation trial, which led to the need for a study-wide internal audit and corrective action. 4 Based on the lessons learned, we offer recommendations for future PCTs and relevant stakeholders, including institutional review boards (IRBs), data safety and monitoring boards (DSMBs), institutions, and trial sponsors. THE TSOS TRIAL T he TSOS study was a National Institutes of Health (NIH) Health Care Systems Research Collaboratory PCT designed to test delivery of screening and intervention for post-traumatic stress disorder (PTSD) and related comorbidities in 25 level-I trauma centers in the United States. Participants were enrolled at trauma center sites while hospitalized after injury. 5 After providing written consent, participants were assessed for elevated early post-traumatic stress symptoms. Participants with early post-traumatic stress symp-ABSTRACT The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25-site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance.

background Traumatic injury requiring hospitalization is common in the USA and frequently related to alcohol consumption. The American College of Surgeons requires that Level I and II verified trauma centers implement universal alcohol screening and brief intervention for injured patients. We examined whether Level I trauma center provider skill in patient-centered alcohol brief interventions improved after training and whether professional role (eg, nursing, social work) and education were associated with these skills. Methods We present evaluation data collected as part of training in alcohol brief interventions embedded within a larger clinical trial of a collaborative care intervention targeting posttraumatic stress disorder and related comorbidities. Sixty-five providers from 25 US Level I trauma centers engaged in a 1-day workshop, with 2 hours dedicated to training in patient-centered alcohol brief interventions followed by 6 months of weekly coaching in a collaborative care model. Providers completed standardized patient role-plays prior to and 6 months after the workshop training. The standardized patient actors rated provider quality of alcohol brief interventions immediately after each role-play using the Behavior Change Counseling Index (BECCI), a pragmatic measure designed to assess the quality of behavior change counseling, an adaptation of motivational interviewing suitable for brief healthcare consultations about behavior change. results Seventy-two percent of providers completed both standardized patient role-play assessments. A statistically significant improvement in overall BECCI scores (t(41)=−2.53, p=0.02, Cohen's d=−0.39) was observed among those providers with available pre-post data. Provider professional role was associated with BECCI scores at pre-training (F(3, 58)=11.25, p<0.01) and post-training (F(3, 41)=8.10, p<0.01). Discussion Findings underscore the need for training in patient-centered alcohol brief interventions and suggest that even a modest training helps providers engage in a more patient-centered way during a role-play assessment. Level of evidence Level V, therapeutic/care management. bACkgrounD

Introduction Depression is common among community-dwelling older adults who make use of senior centre services yet remains undertreated due to a lack of acceptable and available treatments. Emerging evidence suggests that lay health providers can offer psychosocial interventions for mental health disorders experienced by older adults. We developed a streamlined Behavioural Activation intervention (called ‘Do More, Feel Better’; DMFB) to be delivered by older adult volunteers and propose to compare its effectiveness to that of clinician-delivered behavioural activation (BA). Methods and analysis This study is a type I collaborative randomised effectiveness trial testing the effect of DMFB in comparison to BA among 288 senior centre clients (aged 60+). Participant clients will be recruited from 6 Seattle, 6 New York City and 6 Tampa area senior centres serving economically and ethnically diverse communities. Primary outcomes will be increased activity level (target) and decreased depressive symptoms. Secondary outcomes will be functioning and client satisfaction, and an exploratory outcome will be treatment fidelity. Ethics and dissemination The study received ethics approval from the University of Washington Institutional Review Board (STUDY00011434). Client, volunteer and clinician participants will all provide informed consent for study procedures through in-person or remote contact with investigators. Results of this study will be presented in peer-reviewed journals and at professional conferences. Trial registration number NCT04621877; ClinicalTrials.gov.

BackgroundHealthcare providers frequently engage patients in conversations about health behavior change and are encouraged to use patient-centered approaches, such as Motivational Interviewing. Training in and sustainment of these skills are known to require feedback based on actual or role-played patient encounters. The behavior change counseling index (BECCI) is a pragmatic measure to assess healthcare providers’ patient-centered behavior change counseling skills that was developed as an alternative to resource-intensive “gold standard” measures, which are difficult to use in routine practice. We are not aware of any studies that examine the criterion-related validity of this measure using an alternative gold standard measure. We examined the criterion-related validity of the BECCI as rated by a simulated patient actor immediately after a brief behavior change intervention role-play using objective ratings on the motivational interviewing treatment integrity (MITI) scale.MethodsWe conducted a secondary analysis of data from a 25-site clinical trial of screening and intervention for posttraumatic stress disorder and comorbidities with patients at level I trauma centers in the USA. Participants were 64 providers representing diverse professional roles trained to deliver a multi-component intervention with study patients. As part of the training, providers role-played counseling a patient to reduce risky alcohol use with a simulated patient actor. These 20-min role-plays were conducted by telephone and audio recorded. Immediately after the role-play, the simulated patient actor rated the quality of the providers’ patient-centered behavior change counseling skills using the BECCI. A third-party expert MITI rater later listened to the audio recordings of the role-plays and rated the quality of the providers’ patient-centered behavior change counseling skills using the MITI 3.1.1.ResultsAll correlations observed were statistically significant. The overall BECCI score correlated strongly (≥ 0.50) with five of the six MITI scores and moderately (0.33) with MITI percent complex reflections.ConclusionsThis study provides evidence of criterion-related validity of the BECCI with a sample of healthcare providers representing a range of professional roles. Simulated patient actor rating using the BECCI is a pragmatic approach to assessing the quality of brief behavior change interventions delivered by healthcare providers.

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