Translating complex behavior change interventions into practice can be accompanied by a loss of fidelity and effectiveness. We present the evaluation of two sequential phases of implementation of a complex evidence-based community workshop to reduce falls, using the Replicating Effective Programs Framework. Between the two phases, workshop training and delivery were revised to improve fidelity with key elements.

Stepping On program participants completed a questionnaire at baseline (phase 1: n = 361; phase 2: n = 2219) and 6 months post-workshop (phase 1: n = 232; phase 2: n = 1281). Phase 2 participants had an additional follow-up at 12 months (n = 883). Outcomes were the number of falls in the prior 6 months and the Falls Behavioral Scale (FaB) score.

Workshop participation in phase 1 was associated with a 6% reduction in falls (RR = 0.94, 95% CI 0.74–1.20) and a 0.14 improvement in FaB score (95% CI, 0.11– 0.18) at 6 months. Workshop participation in phase 2 was associated with a 38% reduction in falls (RR = 0.62, 95% CI 0.57–0.68) and a 0.16 improvement in FaB score (95% CI 0.14–0.18) at 6 months, and a 28% reduction in falls (RR = 0.72, 95% CI 0.65–0.80) and a 0.19 score improvement in FaB score (95% CI 0.17–0.21) at 12-month follow-up.

Effectiveness can be maintained with widespread dissemination of a complex behavior change intervention if attention is paid to fidelity of key elements. An essential role for implementation science is to ensure effectiveness as programs transition from research to practice.

Medical research strives to improve health; community-engaged research (CEnR) supports translation to the community.

This article describes the use of andragogical theory to develop asynchronous CEnR training.

A total of 43 researchers and community members completed at least one module. The majority (67%–100%) stated that training met their educational needs and noted a desire for more information.

The curriculum reinforced CEnR principles to enhance medical research.

To study the effectiveness of any educational intervention for faculty requires first that they attend the training. Using attendance as a measure of faculty engagement, this study examined factors associated with the percentage of faculty in divisions of departments of medicine who attended a workshop as part of a multisite study.

Between October 2018 and March 2020, 1675 of 4767 faculty in 120 divisions of 14 departments of medicine attended a 3-hour in-person workshop as part of the Bias Reduction in Internal Medicine (BRIM) initiative. This paper describes the workshop development and study design. The number of faculty per division ranged from 5 to 296. Attendance rates varied from 2.7% to 90.1%. Taking a quality improvement approach, the study team brainstormed factors potentially related to variations in workshop attendance, constructed several division- and institution-level variables, and assessed the significance of factors on workshop attendance with hierarchical linear models.

The following were positively associated with workshop attendance rate: the division head attended the workshop, the BRIM principal investigator gave Medical Grand Rounds, and the percentage of local workshop presenters who completed training. Workshop attendance rates fell when departments identified more than five on-site study leaders.

Factors associated with higher workshop attendance may have increased the perceived status and value of attending the workshop, leading faculty to choose the workshop over other competing demands. For future investigators studying educational interventions that require participation of faculty in clinical departments at multiple sites, this work offers several valuable lessons.

The Clinical and Translational Science Awards (CTSA) program of the National Center for Advancing Translational Sciences (NCATS) seeks to improve population health by accelerating the translation of scientific discoveries in the laboratory and clinic into practices for the community. CTSAs achieve this goal, in part, through their pilot project programs that fund promising early career investigators and innovative early-stage research projects across the translational research spectrum. However, there have been few reports on individual pilot projects and their impacts on the investigators who receive them and no studies on the long-term impact and outcomes of pilot projects.

The Georgia CTSA funded 183 pilot projects from 2007 to 2015. We used a structured evaluation framework, the payback framework, to document the outcomes of 16 purposefully-selected pilot projects supported by the Georgia CTSA. We used a case study approach including bibliometric analyses of publications associated with the selected projects, document review, and investigator interviews.

These pilot projects had positive impact based on outcomes in five “payback categories”: (1) knowledge; (2) research targeting, capacity building, and absorption; (3) policy and product development; (4) health benefits; and (5) broader economic benefits.

Results could inform our understanding of the diversity and breadth of outcomes resulting from Georgia CTSA-supported research and provide a framework for evaluating long-term pilot project outcomes across CTSAs.

Area-level social determinants of health (SDoH) and individual-level social risks are different, yet area-level measures are frequently used as proxies for individual-level social risks. This study assessed whether demographic factors were associated with patients being screened for individual-level social risks, the percentage who screened positive for social risks, and the association between SDoH and patient-reported social risks in a nationwide network of community-based health centers.

Electronic health record data from 1,330,201 patients with health center visits in 2021 were analyzed using multilevel logistic regression. Associations between patient characteristics, screening receipt, and screening positive for social risks (e.g., food insecurity, housing instability, transportation insecurity) were assessed. The predictive ability of three commonly used SDoH measures (Area Deprivation Index, Social Deprivation Index, Material Community Deprivation Index) in identifying individual-level social risks was also evaluated.

Of 244,155 (18%) patients screened for social risks, 61,414 (25.2%) screened positive. Sex, race/ethnicity, language preference, and payer were associated with both social risk screening and positivity. Significant health system-level variation in both screening and positivity was observed, with an intraclass correlation coefficient of 0.55 for social risk screening and 0.38 for positivity. The three area-level SDoH measures had low accuracy, sensitivity, and area under the curve when used to predict individual social needs.

Area-level SDoH measures may provide valuable information about the communities where patients live. However, policymakers, healthcare administrators, and researchers should exercise caution when using area-level adverse SDoH measures to identify individual-level social risks.

COVID-19 altered research in Clinical and Translational Science Award (CTSA) hubs in an unprecedented manner, leading to adjustments for COVID-19 research.

CTSA members volunteered to conduct a review on the impact of CTSA network on COVID-19 pandemic with the assistance from NIH survey team in October 2020. The survey questions included the involvement of CTSAs in decision-making concerning the prioritization of COVID-19 studies. Descriptive and statistical analyses were conducted to analyze the survey data.

60 of the 64 CTSAs completed the survey. Most CTSAs lacked preparedness but promptly responded to the pandemic. Early disruption of research triggered, enhanced CTSA engagement, creation of dedicated research areas and triage for prioritization of COVID-19 studies. CTSAs involvement in decision-making were 16.75 times more likely to create dedicated diagnostic laboratories (95% confidence interval [CI] = 2.17–129.39; P < 0.01). Likewise, institutions with internal funding were 3.88 times more likely to establish COVID-19 dedicated research (95% CI = 1.12–13.40; P < 0.05). CTSAs were instrumental in securing funds and facilitating establishment of laboratory/clinical spaces for COVID-19 research. Workflow was modified to support contracting and IRB review at most institutions with CTSAs. To mitigate chaos generated by competing clinical trials, central feasibility committees were often formed for orderly review/prioritization.

The lessons learned from the COVID-19 pandemic emphasize the pivotal role of CTSAs in prioritizing studies and establishing the necessary research infrastructure, and the importance of prompt and flexible research leadership with decision-making capacity to manage future pandemics.

Community Health Workers and Promotoras (CHW/Ps) are valued for their role in helping to engage community members in research. CHW/Ps have traditionally received variable training in research fundamentals, including importance and promotion of research rigor to establish consistency in the methods used over time. Research best practices training exists for research professionals, but no standard training is provided as part of the CHW/P job role. To develop this CHW/P research best practices training, our team engaged English- and Spanish-speaking CHW/Ps to watch an early version of an online module and to examine perceptions of the relevance of such a training and optimal delivery methods.

Six virtual focus group discussions were conducted (three in English and three in Spanish) across different US geographic regions with currently employed CHW/Ps.

Forty CHW/Ps participated (95% female, mean age 44 years, 58% identifying as Hispanic/Latino). Four themes emerged: relevance of training, benefits of providing a certificate of completion, flexible training delivery modalities, and peer-led training.

With participation from representatives of the intended learner group of CHW/Ps, our team found that CHW/Ps valued learning about research best practices. They perceived culturally- and linguistically appropriate health research training to be highly relevant to their role, particularly for communicating key information to community members about their participation in health research. Additionally, participants provided input on effective dissemination of the training including the benefit of having proof of course completion, involvement of peer trainers, and value of providing the option to participate in online training.

To examine research participants’ levels of satisfaction and perceptions and aid researchers to better engage research volunteers from all racial and ethnic populations in clinical trials. A participant satisfaction survey was developed that focused on three domains to reflect satisfaction with delivery of care, environment, and center operations. In addition, the survey contained open-ended questions to reflect overall experiences and perceptions. Two hundred and seventy-eight participants (55% African American and 29% non-Hispanic Whites) with an average age of 52 years completed the survey.

The results indicated that the majority of the participants rated their satisfaction very highly across all domains. Ninety percent stated they were very satisfied/satisfied or very strongly agreed/agreed in the three domains. Obtaining high-quality care/access to health care professionals (60%), learning more about their illness/disease (60%), and helping others (57%) were noted as important factors in choosing to participate in a trial. Regarding overall experience, majority of respondents stated that friendliness, expertise of staff, learning more about their disease, and contributing to science were important. Further, financial compensation was not a primary motivation for participation. A majority of participants stated that they would participate in future studies and would recommend a friend or a family member to participate in clinical trials.

The findings indicate that the degree of satisfaction with the research staff and with the specific trial itself are important determinants for enrolling, completing a study, and for participating in future trials.

There has been a recent trend in medical research towards a more collaborative relationship between statisticians and clinical investigators. This has led to an increased focus on the most efficient and effective ways to structure, conduct, and measure the impact of organizations that provide statistical services to clinical investigators. Several recent guidelines and recommendations on the conduct of statistical consulting services(SCSs) have been made in response to this need, focusing on larger SCSs consisting primarily of faculty and staff statisticians. However, the application of these recommendations to consulting services primarily staffed by graduate students, which have the dual role of providing a professional service and training, remains unclear.

Guidelines and recommendations, primarily from the Clinical and Translational Science (CTSA) consortium, were applied to a SCS staffed primarily by graduate students in an academic health center. A description of the organizational structure and outcomes after 3 years of operation is presented.

The guidelines recommended by the CTSA consortium and other groups were successfully incorporated into the graduate consulting laboratory. At almost one new project request per week, the consulting laboratory demonstrated a large bandwidth and had an excellent feedback from investigators.

Guidelines developed for larger statistical consulting organizations are able to be applied in student-led consultation organizations. Outcomes and recommendations from 3.5 years of operation are used to describe the successes and challenges we have encountered.

Clinical Research Coordinators (CRCs) are key members of research teams who ensure rigorous conduction of clinical studies and quality standard compliance. Yet, their roles and responsibilities are still not well defined, and formal recognition of their professional profile is lacking in Italy. This survey of Italian healthcare institutions collected data on centers’ research activities number of CRCs and tasks they performed and explored factors associated with CRC employment.

Cross-sectional study using a brief questionnaire. Data were analyzed by means of graphical representations, histogram, scatter, and polar plots. Multivariable linear regression was specified to test the association between the number of CRCs and a subset of factors.

Data collection took place from February to December 2020. 62/143 institutions (43.4%) responded. Median number of ongoing studies reported by centers was 65 (IQR 29–205); of these, median of sponsored and interventional studies was 32 and 35, respectively. Median number of CRCs employed at each center was 6 (IQR 2–9). The frequency with which activities were reported to be performed by CRCs overlapped with those of Data Managers. Linear multivariable regression analysis revealed a statistically significant association between the number of employed CRCs and the number of sponsored studies (P = 0.01), but not with the total number of studies, geographical location, or institution type.

The association between industry funding and the number of CRCs observed in this study should be further explored to understand the direction of this relationship and to verify whether this may influence compliance with quality standards.

Research Electronic Data Capture (REDCap) is a secure, web-based electronic data capture application for building and managing surveys and databases. It can also be used for study management, data transfer, and data export into a variety of statistical programs. REDcap was developed and supported by the National Center for Advancing Translational Sciences Program and is used in over 3700 institutions worldwide. It can also be used to track and measure stakeholder engagement, an integral element of research funded by the Patient-Centered Outcomes Research Institute (PCORI). Continuously and accurately tracking and reporting on stakeholder engagement activities throughout the life of a PCORI-funded trial can be challenging, particularly in complex trials with multiple types of engagement.

In this paper, we show our approach for collecting and capturing stakeholder engagement activities using a shareable REDCap tool in one of the PCORI’s first large pragmatic clinical trials (the Comprehensive Post-Acute Stroke Services) to inform other investigators planning cluster-randomized pragmatic trials. Benefits and challenges are highlighted for researchers seeking to consistently monitor and measure stakeholder engagement.

We describe how REDCap can provide a time-saving approach to capturing how stakeholders engage in a PCORI-funded study and reporting how stakeholders influenced the study in progress reports back to PCORI.

Statistical literacy is essential in clinical and translational science (CTS). Statistical competencies have been published to guide coursework design and selection for graduate students in CTS. Here, we describe common elements of graduate curricula for CTS and identify gaps in the statistical competencies.

We surveyed statistics educators using e-mail solicitation sent through four professional organizations. Respondents rated the degree to which 24 educational statistical competencies were included in required and elective coursework in doctoral-level and master’s-level programs for CTS learners. We report competency results from institutions with Clinical and Translational Science Awards (CTSAs), reflecting institutions that have invested in CTS training.

There were 24 CTSA-funded respondents representing 13 doctoral-level programs and 23 master’s-level programs. For doctoral-level programs, competencies covered extensively in required coursework for all doctoral-level programs were basic principles of probability and hypothesis testing, understanding the implications of selecting appropriate statistical methods, and computing appropriate descriptive statistics. The only competency extensively covered in required coursework for all master’s-level programs was understanding the implications of selecting appropriate statistical methods. The least covered competencies included understanding the purpose of meta-analysis and the uses of early stopping rules in clinical trials. Competencies considered to be less fundamental and more specialized tended to be covered less frequently in graduate courses.

While graduate courses in CTS tend to cover many statistical fundamentals, learning gaps exist, particularly for more specialized competencies. Educational material to fill these gaps is necessary for learners pursuing these activities.