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.

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.

Methods for Phenotyping Adult Patients in Sepsis and Septic Shock: A Scoping Review.

Despite its heterogeneous phenotypes, sepsis or life-threatening dysfunction in response to infection is often treated empirically. Identifying patient subgroups with unique pathophysiology and treatment response is critical to the advancement of sepsis care. However, phenotyping methods and results are as heterogeneous as the disease itself. This scoping review evaluates the prognostic capabilities and treatment implications of adult sepsis and septic shock phenotyping methods. DATA SOURCES: Medline and Embase. STUDY SELECTION: We included clinical studies that described sepsis or septic shock and used any clustering method to identify sepsis phenotypes. We excluded conference abstracts, literature reviews, comments, letters to the editor, and in vitro studies. We assessed study quality using a validated risk of bias tool for observational cohort and cross-sectional studies. DATA EXTRACTION: We extracted population, methodology, validation, and phenotyping characteristics from 17 studies. DATA SYNTHESIS: Sepsis phenotyping methods most frequently grouped patients based on the degree of inflammatory response and coagulopathy using clinical, nongenomic variables. Five articles clustered patients based on genomic or transcriptomic data. Seven articles generated patient subgroups with differential response to sepsis treatments. Cluster clinical characteristics and their associations with mortality and treatment response were heterogeneous across studies, and validity was evaluated in nine of 17 articles, hindering pooled analysis of results and derivation of universal truths regarding sepsis phenotypes, their prognostic capabilities, and their associations with treatment response. CONCLUSIONS: Sepsis phenotyping methods can identify high-risk patients and those with high probability of responding well to targeted treatments. Research quality was fair, but achieving generalizability and clinical impact of sepsis phenotyping will require external validation and direct comparison with alternative approaches.