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BACKGROUND: 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. METHODS: 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 < 0.8. RESULTS: 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 < .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). CONCLUSIONS: 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.
Assuntos
Antibacterianos , Ensaios Clínicos Controlados Aleatórios como Assunto , Infecções Estafilocócicas , Staphylococcus aureus , Humanos , Antibacterianos/uso terapêutico , Infecções Estafilocócicas/tratamento farmacológico , Infecções Estafilocócicas/epidemiologia , Estados Unidos/epidemiologia , Staphylococcus aureus/efeitos dos fármacos , Feminino , Masculino , Etnicidade , Grupos RaciaisRESUMO
BACKGROUND: In spring and summer 2022, an outbreak of mpox occurred worldwide, largely confined to men who have sex with men (MSM). There was concern that mpox could break swiftly into congregate settings and populations with high levels of regular frequent physical contact, like university campus communities. OBJECTIVE: To estimate the likelihood of an mpox outbreak and the potential effect of mitigation measures in a residential college setting. DESIGN: A stochastic dynamic SEIR (susceptible, exposed but not infectious, infectious, or recovered) model of mpox transmission in a study population was developed, composed of: a high-risk group representative of the population of MSM with a basic reproductive number (R 0) of 2.4 and a low-risk group with an R 0 of 0.8. Base input assumptions included an incubation time of 7.6 days and time to recovery of 21 days. SETTING: U.S. residential college campus. PARTICIPANTS: Hypothetical cohort of 6500 students. INTERVENTION: Isolation, quarantine, and vaccination of close contacts. MEASUREMENTS: Proportion of 1000 simulations producing sustained transmission; mean cases given sustained transmission; maximum students isolated, quarantined, and vaccinated. All projections are estimated over a planning horizon of 100 days. RESULTS: Without mitigation measures, the model estimated an 83% likelihood of sustained transmission, leading to an average of 183 cases. With detection and isolation of 20%, 50%, and 80% of cases, the average infections would fall to 117, 37, and 8, respectively. Reactive vaccination of contacts of detected cases (assuming 50% detection and isolation) reduced mean cases from 37 to 17, assuming 20 vaccinated contacts per detected case. Preemptive vaccination of 50% of the high-risk population before outbreak reduced cases from 37 to 14, assuming 50% detection and isolation. LIMITATION: A model is a stylized portrayal of behavior and transmission on a university campus. CONCLUSION: Based on our current understanding of mpox epidemiology among MSM in the United States, this model-based analysis suggests that future outbreaks of mpox on college campuses may be controlled with timely detection and isolation of symptomatic cases. PRIMARY FUNDING SOURCE: National Institutes of Health National Institute on Drug Abuse and National Institute of Allergy and Infectious Diseases.
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COVID-19 , Mpox , Minorias Sexuais e de Gênero , Masculino , Humanos , Estados Unidos/epidemiologia , Homossexualidade Masculina , UniversidadesRESUMO
Antibiotic-associated diarrhea (AAD) is a common side effect of antibiotics. We examined the gastrointestinal microbiota in children treated with ß-lactams for community-acquired pneumonia. Data were from 66 children (n = 198 samples), aged 6-71 months, enrolled in the SCOUT-CAP trial (NCT02891915). AAD was defined as ≥1 day of diarrhea. Stool samples were collected on study days 1, 6-10, and 19-25. Samples were analyzed using 16S ribosomal RNA gene sequencing to identify associations between patient characteristics, microbiota characteristics, and AAD (yes/no). Nineteen (29%) children developed AAD. Microbiota compositional profiles differed between AAD groups (permutational multivariate analysis of variance, P < .03) and across visits (P < .001). Children with higher baseline relative abundances of 2 Bacteroides species were less likely to experience AAD. Higher baseline abundance of Lachnospiraceae and amino acid biosynthesis pathways were associated with AAD. Children in the AAD group experienced prolonged dysbiosis (P < .05). Specific gastrointestinal microbiota profiles are associated with AAD in children.
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Antibacterianos , Infecções Comunitárias Adquiridas , Diarreia , Microbioma Gastrointestinal , Pneumonia , Antibacterianos/efeitos adversos , Pré-Escolar , Infecções Comunitárias Adquiridas/tratamento farmacológico , Diarreia/induzido quimicamente , Diarreia/tratamento farmacológico , Microbioma Gastrointestinal/efeitos dos fármacos , Humanos , Lactente , Pneumonia/tratamento farmacológico , beta-Lactamas/uso terapêuticoRESUMO
OBJECTIVES: Using Twitter, we aim to (1) define and quantify the prevalence and evolution of facets of social distancing during the COVID-19 pandemic in the US in a spatiotemporal context and (2) examine amplified tweets among social distancing facets. MATERIALS AND METHODS: We analyzed English and US-based tweets containing "coronavirus" between January 23-March 24, 2020 using the Twitter API. Tweets containing keywords were grouped into six social distancing facets: implementation, purpose, social disruption, adaptation, positive emotions, and negative emotions. RESULTS: A total of 259,529 unique tweets were included in the analyses. Social distancing tweets became more prevalent from late January to March but were not geographically uniform. Early facets of social distancing appeared in Los Angeles, San Francisco, and Seattle: the first cities impacted by the COVID-19 outbreak. Tweets related to the "implementation" and "negative emotions" facets largely dominated in combination with topics of "social disruption" and "adaptation", albeit to lesser degree. Social disruptiveness tweets were most retweeted, and implementation tweets were most favorited. DISCUSSION: Social distancing can be defined by facets that respond to and represent certain events in a pandemic, including travel restrictions and rising case counts. For example, Miami had a low volume of social distancing tweets but grew in March corresponding with the rise of COVID-19 cases. CONCLUSION: The evolution of social distancing facets on Twitter reflects actual events and may signal potential disease hotspots. Our facets can also be used to understand public discourse on social distancing which may inform future public health measures.
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COVID-19/prevenção & controle , Pandemias , Mídias Sociais , COVID-19/epidemiologia , COVID-19/virologia , Humanos , SARS-CoV-2/isolamento & purificaçãoRESUMO
Objective: Non-disease-specific WHO-CHOICE unit costs are often used in cost and cost-effectiveness studies in the absence of country-specific data. This study aims to compare reported country-specific disease costs and the corresponding WHO-CHOICE estimates. We use generically defined "diarrhea" (including rotavirus diarrhea) and pathogen-specific "respiratory syncytial virus (RSV)" disease as examples. Methods: We updated systematic reviews for both diseases in low-income (LICs), lower-middle-income (LMICs) and upper-middle-income (UMICs) countries. Diarrheal (including a sub-analysis of rotavirus-specific) and RSV-specific outpatient and inpatient costs per episode were extracted and compared with WHO-CHOICE estimates in the same countries. If a consistent pattern of under- or over-estimation was identified, we quantified the magnitude of the discrepancy. All costs were updated to 2022 international dollar values. Results: Out of 1975 new records identified, 23 new cost studies were included. Including previous reviews, we retained 31 diarrhea and 16 RSV studies for comparison. WHO-CHOICE based direct medical costs were similar for diarrheal disease including rotavirus diarrhea, but lower for RSV-related disease. We estimated the cost per episode of diarrhea and RSV in 128 countries. RSV outpatient cost were adjusted by multiplying WHO-CHOICE costs by 6.89 (95% uncertainty interval: 5.58-8.58) in LICs and LMICs and 5.87 (4.95-6.96) in UMICs; RSV inpatient costs were multiplied by 1.43 (1.01-2.01) and 1.36 (0.82-2.27), respectively. Conclusion: WHO-CHOICE based costs should be used cautiously. They aligned well with studies for diarrheal disease, but underestimate costs of RSV-related disease. More country- and disease-specific cost data are needed, especially for RSV in LICs.
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This decision analytic model estimates the levels of community testing, contract tracing, and vaccination required to reduce the effective reproduction number of the mpox virus among the high-risk group of men who have sex with men.