Evidence map›Paper›PMID 38306502›Full record

ArticleClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Participant Diversity in United States Randomized Controlled Trials of Antibacterials for Staphylococcus aureus Infections, 2000-2021.

Jiye Kwon, William Pelletiers, Jessica Galloway Peña, David van Duin, Leila Ledbetter, Keri Baum, Felicia Ruffin, Jane M Knisely, Erica Bizzell, Vance G Fowler and 2 more

Open access · bronzeAbstract read
In one paragraph

Article in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 1 country.

Jiye KwonDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.
William PelletiersDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.
Jessica Galloway PeñaDepartment of Veterinary Pathobiology, Texas A&M University, College Station, Texas, USA.
David van DuinDivision of Infectious Diseases, Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.ORCID 0000-0003-4784-3227
Leila LedbetterDepartment of Research and Education, Duke University Medical Center Library & Archives, Durham, North Carolina, USA.
Keri BaumDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Felicia RuffinDivision of Infectious Diseases, Department of Medicine, Duke University School of Medicine, Durham, North Carolina, USA.
Jane M KniselyNational Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Erica BizzellOffice of Scientific Program and Policy Analysis, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland, USA.
Vance G FowlerDuke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA.
Henry F ChambersDivision of Infectious Diseases, Department of Medicine, University of California, San Francisco, San Francisco, California, USA.ORCID 0000-0001-5317-4491
Melinda M PettigrewDepartment of Epidemiology of Microbial Diseases, Yale School of Public Health, New Haven, Connecticut, USA.
Duke University · USYale University · USNational Institutes of Health · USTexas A&M University · USUniversity of California, San Francisco · USUniversity of North Carolina at Chapel Hill · US

Funding

Antibacterial Resistance Leadership Group (ARLG)UM1AI104681 · NIAID · DUKE UNIVERSITY · PI Vance G. Fowler, Henry F HENRY CHAMBERS · 2013 to 2026
$180.8M
National Institute of Allergy and Infectious DiseasesNIAID NIH HHS UM1 AI104681NIH HHS UM1AI104681
6 · The paper itself

Abstract

backgroundEquitable 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.

methodsWe 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 < 0.8.

resultsOf 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 < .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: 1.14-18.3).

conclusionsStandardized 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.

Indexed as

Anti-Bacterial AgentsRandomized Controlled Trials as TopicStaphylococcal InfectionsStaphylococcus aureusEthnicityFemaleHumansMaleRacial GroupsUnited StatesAnti-Bacterial Agentsanti-bacterial agentsclinical trialsethnicityracial groupsStaphylococcus aureus

Identifiers

PMID38306502
PMCPMC11259209
OpenAlexW4391463668

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.