CTSC READI Consult Service Shows and Tells How It Integrates with A Few Services
Bionutrition, REDCap, BERD, and Administration Take on READI In Unique Ways
This article is a CTSC Special Feature.
The CTSC Research Equity, Accessibility, Diversity, and Inclusion (READI) team sat down with a few CTSC service leads to understand what services they provide and how it does (or could) intersect with READI. Spoiler alert–each service has already pivoted or is pivoting.
Bionutrition | Alicia Thomas, MS
“We have over 130 years of clinical research experience in nutrition on our team. We run a tight ship in terms of data collection and data cleaning,” Alicia Thomas, Director, Bionutrition Research, Case Western Reserve University, said.
The bionutrition team uses sophisticated software (NDSR) that allows for direct-entry data collection, high sensitivity to sodium and fat, analysis, and filtering features that are user-friendly. A fee-for-service asset, the team runs a DEXA machine that uses X-ray technology to measure body composition in a research environment and bone density to help evaluate osteoporosis and osteopenia as well as bone, muscle, and fat tissue. “These metrics are valuable to investigators looking at the relationship between obesity, weight, and chronic disease,” Thomas explained.
Unique to some of our region’s core focuses, notably maternal and infant mortality and morbidity, Thomas has traveled the world teaching people how to conduct neonatal body composition. In January 2023, the bionutrition team’s metabolic research kitchen opened. Thomas shared that, “It’s like opening a restaurant because you have to go through all this minutia.” The metabolic research kitchen will provide calculated, weighed, timed, or nutrient-controlled protocol specific meals for in- and out-patients.
Bionutrition supports the accessibility pillar of READI because it addresses a barrier to research participation–transportation. In dietary recall studies, recall is done via phone. “They remember how they were treated and that is why we have longevity with our research participants,” Thomas said.
The new metabolic research kitchen's inaugural study will be a first-of-its kind controlled dietary intervention study in prostate cancer led by Drs. Nima Sharifi and Ashley E. Holly. The "DINE Study" (NCT 05590624) will look at the impact of two Mediterranean type diets (Low fat and lower carb) on host and prostate tissue metabolism as well as the microbiome and dietary behavior. This highly collaborative effort will help answer critical questions as it relates to diet and prostate cancer in efforts to propel this field forward. This work is generously supported by the 2022 Prostate Cancer Foundation Young Investigator Award (Dr. Holly), VeloSano 8 (2021) Pilot Award, and in part by NIH/NCATS, CTSA 1UL1TR002548, Cleveland, Ohio (Clinical Research Units).
Another pillar of READI that bionutrition is evident in is inclusion where many studies are investigating health disparities–with tons of data on Northeast Ohio on various populations (e.g., high school kids). “Everyone who walks through those doors said ‘yes’, so that is valuable to me. We appreciate the participants who say ‘yes’ and want to be there,” Thomas added.
Thomas’ team will host an open house for the metabolic kitchen in April 2023.
REDCap | Sheree Hemphill
A free, web-based electronic data capture tool seems too good to be true. REDCap or Research Electronic Data Capture is that tool that supports clinical and research studies with building surveys, conducting multi-site studies, secure data collection, exports to common statistics packages, and accessibility online and offline.
“I’m willing to meet with people via Zoom once they’ve begun the process of building out a survey or other tool and need support beyond the training videos,” Hemphill said. However, the REDCap team does not build projects for people or perform statistical analyses.
REDCap supports READI heavily in the accessibility and equity domains. For people with sight challenges, there is a speaker or screen reader software supported by a text-to-speech functionality when individuals take a survey. As a free platform, anyone can use it regardless of lack of financial resources.
Resources and Services | Nora Singer, MD
Nora Singer, MD, is most influenced by her childhood upbringing in how she approaches her work leading resources and services. The diversity she grew up around in New York colors how she sees the world and her passionate plea for equitable access. Dr. Singer is charged with evaluating for cores and resources are a part of how she helps connect the dots and close gaps.
“We’re the entryway for services that are needed or connections within the translational research space,” Dr. Singer shared.
Regulatory | Philip Cola, PhD
Regulatory isn’t just the institutional review board (IRB) function. Philip Cola, PhD, has invested his time and talents developing a robust infrastructure for regulatory services with impact beyond current, active research. Dr. Cola is co-instructor for a class in the CWRU School of Medicine around FDA regulation and clinical research. Regulatory encompasses: grants and contracts, the IRB, technology management or technology transfer, and education. “The IRB is about 1/6th of regulatory,” Dr. Cola advised.
Dr. Cola was instrumental with developing CREC certification as part of a group that created the program in the early 2000s after the NIH mandate. As we look toward the future with more regulation, law, and policy behind increasing diversity in clinical trials, we suspect regulatory will have even more expectations, if not requirements, that intersect with READI.
Administrative | Anita Misra-Hebert, MD
“We make sure that we understand the context of different groups so that we can target our implementation strategies appropriately,” explained Anita Misra-Hebert. Dr. Hebert explained the evaluation process for implementation using the acronym REAIM (reach, efficacy, adoption, implementation, and maintenance). “The model has been redone to have a focus on equity and sustainability,” Dr. Misra-Hebert said.
Dr. Misra-Hebert and her team help people interested in looking at a problem from an implementation standpoint, including provision of support and guidance on:
- Metrics that should be captured for a program;
- Elements that should be included in a grant application;
- Types of models that could be used; and
- Identification of the best strategies for your use case.