Journal of Clinical and Translational Science - Latest issue

It is increasingly essential for medical researchers to be literate in statistics, but the requisite degree of literacy is not the same for every statistical competency in translational research. Statistical competency can range from ‘fundamental’ (necessary for all) to ‘specialized’ (necessary for only some). In this study, we determine the degree to which each competency is fundamental or specialized.

We surveyed members of 4 professional organizations, targeting doctorally trained biostatisticians and epidemiologists who taught statistics to medical research learners in the past 5 years. Respondents rated 24 educational competencies on a 5-point Likert scale anchored by ‘fundamental’ and ‘specialized.’

There were 112 responses. Nineteen of 24 competencies were fundamental. The competencies considered most fundamental were assessing sources of bias and variation (95%), recognizing one’s own limits with regard to statistics (93%), identifying the strengths, and limitations of study designs (93%). The least endorsed items were meta-analysis (34%) and stopping rules (18%).

We have identified the statistical competencies needed by all medical researchers. These competencies should be considered when designing statistical curricula for medical researchers and should inform which topics are taught in graduate programs and evidence-based medicine courses where learners need to read and understand the medical research literature.

Efforts to address health disparities and achieve health equity are critically dependent on the development of a diverse research workforce. However, many researchers from underrepresented backgrounds face challenges in advancing their careers, securing independent funding, and finding the mentorship needed to expand their research.

Faculty from the University of Maryland at College Park and the University of Wisconsin-Madison developed and evaluated an intensive week-long research and career-development institute—the Health Equity Leadership Institute (HELI)—with the goal of increasing the number of underrepresented scholars who can sustain their ongoing commitment to health equity research.

In 2010-2016, HELI brought 145 diverse scholars (78% from an underrepresented background; 81% female) together to engage with each other and learn from supportive faculty. Overall, scholar feedback was highly positive on all survey items, with average agreement ratings of 4.45-4.84 based on a 5-point Likert scale. Eighty-five percent of scholars remain in academic positions. In the first three cohorts, 73% of HELI participants have been promoted and 23% have secured independent federal funding.

HELI includes an evidence-based curriculum to develop a diverse workforce for health equity research. For those institutions interested in implementing such an institute to develop and support underrepresented early stage investigators, a resource toolbox is provided.

Space matters. We read space like we read people’s faces. Space is an instrument of collaboration and innovation. At the University of Michigan’s Institute for Clinical and Health Research (MICHR), a team was created to creatively and economically enhance our operating space into a flexible workspace that supports privacy, innovation, creativity, and most important, a culture of collaboration.

The team used a human-centered design process to creatively engage the staff at large into analyzing our existing space, identifying latent needs, proposing solutions, generating feedback, and economically building the rethought process.

The redesigned workspace embraces the differences among MICHR’s teams while encouraging collaboration and teamwork and keeping costs at a minimum. It has resulted in a flexible space that includes co-located teams, spaces dedicated to different work goals, an open area for collaboration, quiet zones for focused work, and better wayfinding.

Through our Rethink Space project, we hope to have demonstrated that, by initiating the project internally and by engaging the users of the space themselves in an empathetic, visual, and human-centered way, a space redesign can be undertaken economically while also leading to improved levels of employee and team satisfaction.

The Resource Centers for Minority Aging Research (RCMAR) program was launched in 1997. Its goal is to build infrastructure to improve the well-being of older racial/ethnic minorities by identifying mechanisms to reduce health disparities.

Its primary objectives are to mentor faculty in research addressing the health of minority elders and to enhance the diversity of the workforce that conducts elder health research by prioritizing the mentorship of underrepresented diverse scholars.

Through 2015, 12 centers received RCMAR awards and provided pilot research funding and mentorship to 361 scholars, 70% of whom were from underrepresented racial/ethnic groups. A large majority (85%) of RCMAR scholars from longstanding centers continue in academic research. Another 5% address aging and other health disparities through nonacademic research and leadership roles in public health agencies.

Longitudinal, team-based mentoring, cross-center scholar engagement, and community involvement in scholar development are important contributors to RCMAR’s success.

Clinical research involving humans is critically important, but it is a lengthy and expensive process. Most studies require institutional review board (IRB) approval. Our objective is to identify predictors of delays or accelerations in the IRB review process and apply this knowledge to inform process change in an effort to improve IRB efficiency, transparency, consistency and communication.

We analyzed timelines of protocol submissions to determine protocol or IRB characteristics associated with different processing times. Our evaluation included single variable analysis to identify significant predictors of IRB processing time and machine learning methods to predict processing times through the IRB review system. Based on initial identified predictors, changes to IRB workflow and staffing procedures were instituted and we repeated our analysis.

Our analysis identified several predictors of delays in the IRB review process including type of IRB review to be conducted, whether a protocol falls under Veteran’s Administration purview and specific staff in charge of a protocol's review.

We have identified several predictors of delays in IRB protocol review processing times using statistical and machine learning methods. Application of this knowledge to process improvement efforts in two IRBs has led to increased efficiency in protocol review. The workflow and system enhancements that are being made support our four-part goal of improving IRB efficiency, consistency, transparency, and communication.

We describe the effectiveness of community outreach and engagement in supporting recruitment for the US National Children’s Vanguard Study between 2009 and 2012.

Thirty-seven study locations used 1 of 4 strategies to recruit 18–49-year-old pregnant or trying to conceive women: (1) Initial Vanguard Study used household-based recruitment; (2) Direct Outreach emphasized self-referral; (3) Enhanced Household-Based Recruitment enhanced Initial Vanguard Study strategies; and (4) Provider-Based Recruitment recruited through healthcare providers. Outreach and engagement included advance letters, interactions with healthcare providers, participation in community events, contacts with community organizations, and media outreach.

After 1–2 years, 41%–74% of 9844 study-eligible women had heard about the National Children’s Vanguard Study when first approached. Women who heard were 1.5–3 times more likely to consent. Hearing via word-of-mouth or the media most frequently predicted consent. The more sources women heard from the higher the odds of consent.

We conclude that tailored outreach and engagement facilitate recruitment in cohort studies.

The time required to obtain Institutional Review Board (IRB) approval is a frequent subject of efforts to reduce unnecessary delays in initiating clinical trials. This study was conducted by and for IRB directors to better understand factors affecting approval times as a first step in developing a quality improvement framework.

807 IRB-approved clinical trials from 5 University of California campuses were analyzed to identify operational and clinical trial characteristics influencing IRB approval times.

High workloads, low staff ratios, limited training, and the number and types of ancillary reviews resulted in longer approval times. Biosafety reviews and the need for billing coverage analysis were ancillary reviews that contributed to the longest delays. Federally funded and multisite clinical trials had shorter approval times. Variability in between individual committees at each institution reviewing phase 3 multisite clinical trials also contributed to delays for some protocols. Accreditation was not associated with shorter approval times.

Reducing unnecessary delays in obtaining IRB approval will require a quality improvement framework that considers operational and study characteristics as well as the larger institutional regulatory environment.

Although classical randomized clinical trials (RCTs) are the gold standard for proof of drug efficacy, randomized discontinuation trials (RDTs), sometimes called “enriched” trials, are used increasingly, especially in psychiatric maintenance studies.

A narrative review of two decades of experience with RDTs.

RDTs in psychiatric maintenance trials tend to use a dependent variable as a predictor: treatment response. Treatment responders are assessed for treatment response. This tautology in the logic of RDTs renders them invalid, since the predictor and the outcome are the same variable. Although RDTs can be designed to avoid this tautologous state of affairs, like using independent predictors of outcomes, such is not the case with psychiatric maintenance studies

Further, purported benefits of RDTs regarding feasibility were found to be questionable. Specifically, RDTs do not enhance statistical power in many settings, and, because of high dropout rates, produce results of questionable validity. Any claimed benefits come with notably reduced generalizability.

RDTs appear to be scientifically invalid as used in psychiatric maintenance designs. Their purported feasibility benefits are not seen in actual trials for psychotropic drugs. There is warrant for changes in federal policy regarding marketing indications for maintenance efficacy using the RDT design.

Social media is increasingly being used in research, including recruitment.

For the Bayley Short Form Formative Study, which was conducted under the the National Children’s Study, traditional methods of recruitment proved to be ineffective. Therefore, digital media were identified as potential channels for recruitment.

Results included successful recruitment of over 1800 infant and toddler participants to the Study.

This paper outlines the methods, results, and future research opportunities.