A Systematic Review on Participant Diversity in Clinical Trials-Have We Made Progress for the Management of Obesity and Its Metabolic Sequelae in Diet, Drug, and Surgical Trials.

Autor: Johnson-Mann CN; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA. Crystal.Johnson-Mann@surgery.ufl.edu.; Division of Gastrointestinal Surgery, Department of Surgery, College of Medicine, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA. Crystal.Johnson-Mann@surgery.ufl.edu., Cupka JS; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Ro A; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Davidson AE; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Armfield BA; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA., Miralles F; College of Medicine, University of Florida, Gainesville, FL, USA., Markal A; College of Medicine, University of Florida, Gainesville, FL, USA., Fierman KE; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Hough V; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Newsom M; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Verma I; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Dozic AV; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA., Bihorac A; Intelligent Critical Care Center, University of Florida, 1600 SW Archer Rd, PO Box 100109, Gainesville, FL, 32610-0109, USA.; Division of Nephrology, Hypertension and Renal Transplantation, Department of Medicine, College of Medicine, University of Florida, Gainesville, FL, USA.
Jazyk: angličtina
Zdroj: Journal of racial and ethnic health disparities [J Racial Ethn Health Disparities] 2023 Dec; Vol. 10 (6), pp. 3140-3149. Date of Electronic Publication: 2022 Dec 19.
DOI: 10.1007/s40615-022-01487-0
Abstrakt: Objective: Individuals from Black and Hispanic backgrounds represent a minority of the overall US population, yet are the populations most affected by the disease of obesity and its comorbid conditions. Black and Hispanic individuals remain underrepresented among participants in obesity clinical trials, despite the mandate by the National Institutes of Health (NIH) Revitalization Act of 1993. This systematic review evaluates the racial, ethnic, and gender diversity of clinical trials focused on obesity at a national level.
Methods: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a systematic review of clinicaltrials.gov, PubMed, Cochrane Central, and Web of Science was undertaken to locate phase 3 and phase 4 clinical trials on the topic of obesity that met associated inclusion/exclusion criteria. Ultimately, 18 studies were included for review.
Results: White non-Hispanic individuals represented the majority of clinical trial participants, as did females. No study classified participants by gender identity. Reporting of race/ethnicity was not uniform, with noted variability among racial/ethnic subgroups.
Conclusions: Our findings suggest that disparities remain in the diverse racial, ethnic, and gender representation of participants engaged in clinical trials on obesity relative to the prevalence of obesity in underrepresented populations. Commitment to inclusive and intentional recruiting practices is needed to increase the representation of underrepresented groups, thus increasing the generalizability of future research.
(© 2022. The Author(s).)
Databáze: MEDLINE