{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T06:45:47Z","timestamp":1792737947132,"version":"4.5.0"},"reference-count":40,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2024,2,2]],"date-time":"2024-02-02T00:00:00Z","timestamp":1706832000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"funder":[{"DOI":"10.13039\/100000060","name":"National Institute of Allergy and Infectious Diseases","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100000060","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100000002","name":"National Institutes of Health","doi-asserted-by":"publisher","award":["UM1AI104681"],"award-info":[{"award-number":["UM1AI104681"]}],"id":[{"id":"10.13039\/100000002","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,7,19]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Equitable representation of members from historically marginalized groups is important in clinical trials, which inform standards of care. The goal of this study was to characterize the demographics and proportional subgroup reporting and representation of participants enrolled in randomized controlled trials (RCTs) of antibacterials used to treat Staphylococcus aureus infections.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We examined randomized controlled registrational and strategy trials published from 2000 to 2021 to determine the sex, race, and ethnicity of participants. Participant to incidence ratios (PIRs) were calculated by dividing the percentage of study participants in each demographic group by the percentage of the disease population in each group. Underrepresentation was defined as a PIR &amp;lt; 0.8.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Of the 87 included studies, 82 (94.2%) reported participant sex, 69 (79.3%) reported participant race, and 20 (23.0%) included ethnicity data. Only 17 (19.5%) studies enrolled American Indian\/Alaskan Native participants. Median PIRs indicated that Asian and Black participants were underrepresented in RCTs compared with the incidence of methicillin-resistant S. aureus infections in these subgroups. Underrepresentation of Black participants was associated with a larger study size, international sites, industry sponsorship, and phase 2\/3 trials compared with phase 4 trials (P &amp;lt; .05 for each). Black participants had more than 4 times the odds of being underrepresented in phase 2\/3 trials compared with phase 4 trials (odds ratio, 4.57; 95% confidence interval: 1.14\u201318.3).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Standardized reporting methods for race and ethnicity and efforts to increase recruitment of marginalized groups would help ensure equity, rigor, and generalizability in RCTs of antibacterial agents and reduce health inequities.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/cid\/ciae049","type":"journal-article","created":{"date-parts":[[2024,2,2]],"date-time":"2024-02-02T20:35:55Z","timestamp":1706906155000},"page":"141-147","source":"Crossref","is-referenced-by-count":7,"title":["Participant Diversity in United States Randomized Controlled Trials of Antibacterials for <i>Staphylococcus aureus<\/i> Infections, 2000\u20132021"],"prefix":"10.1093","volume":"79","author":[{"given":"Jiye","family":"Kwon","sequence":"first","affiliation":[{"name":"Department of Epidemiology of Microbial Diseases, Yale School of Public Health , New Haven, Connecticut , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"William","family":"Pelletiers","sequence":"additional","affiliation":[{"name":"Department of Epidemiology of Microbial Diseases, Yale School of Public Health , New Haven, Connecticut , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica","family":"Galloway Pe\u00f1a","sequence":"additional","affiliation":[{"name":"Department of Veterinary Pathobiology, Texas A&M University , College Station, Texas , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4784-3227","authenticated-orcid":false,"given":"David","family":"van Duin","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of North Carolina School of Medicine , Chapel Hill, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leila","family":"Ledbetter","sequence":"additional","affiliation":[{"name":"Department of Research and Education, Duke University Medical Center Library & Archives , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keri","family":"Baum","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University School of Medicine , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Felicia","family":"Ruffin","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jane M","family":"Knisely","sequence":"additional","affiliation":[{"name":"National Institute of Allergy and Infectious Diseases, National Institutes of Health , Bethesda, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erica","family":"Bizzell","sequence":"additional","affiliation":[{"name":"Office of Scientific Program and Policy Analysis, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health , Bethesda, Maryland , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Vance G","family":"Fowler","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute, Duke University School of Medicine , Durham, North Carolina , USA"},{"name":"Division of Infectious Diseases, Department of Medicine, Duke University School of Medicine , Durham, North Carolina , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5317-4491","authenticated-orcid":false,"given":"Henry F","family":"Chambers","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of California , San Francisco, San Francisco, California , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melinda M","family":"Pettigrew","sequence":"additional","affiliation":[{"name":"Department of Epidemiology of Microbial Diseases, Yale School of Public Health , New Haven, Connecticut , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2024,2,2]]},"reference":[{"key":"2024071918110248400_ciae049-B1","doi-asserted-by":"crossref","first-page":"2175","DOI":"10.1056\/NEJMms1604593","article-title":"Assessing the gold standard \u2014 lessons from the history of 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