Suchergebnisse

IMPORTANCE: Although female representation has increased in clinical trials, little is known about how clinical trial representation compares with burden of disease or is associated with clinical trial features, including disease category. OBJECTIVE: To describe the rate of sex reporting (ie, the presence of clinical trial data according to sex), compare the female burden of disease with the female proportion of clinical trial enrollees, and investigate the associations of disease category and clinical trial features with the female proportion of clinical trial enrollees. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional study included descriptive analyses and logistic and generalized linear regression analyses with a logit link. Data were downloaded from the Aggregate Analysis of ClinicalTrials.gov database for all studies registered between March 1, 2000, and March 9, 2020. Enrollment was compared with data from the 2016 Global Burden of Disease database. Of 328 452 clinical trials, 70 095 were excluded because they had noninterventional designs, 167 936 because they had recruitment sites outside the US, 69 084 because they had no reported results, 1003 because they received primary funding from the US military, and 314 because they had unclear sex categories. A total of 20 020 interventional studies enrolling approximately 5.11 million participants met inclusion criteria and were divided into those with and without data on participant sex. EXPOSURES: The primary exposure variable was clinical trial disease category. Secondary exposure variables included funding, study design, and study phase. MAIN OUTCOMES AND MEASURES: Sex reporting and female proportion of participants in clinical trials. RESULTS: Among 20 020 clinical trials from 2000 to 2020, 19 866 studies (99.2%) reported sex, and 154 studies (0.8%) did not. Clinical trials in the fields of oncology (46% of disability-adjusted life-years [DALYs]; 43% of participants), neurology (56% of DALYs; 53% of participants), immunology (49% of DALYs; 46% of ...

OBJECTIVE: To assess whether postpartum hemorrhage management or subsequent morbidity differs based on whether delivery occurred during the day or night. METHODS: We conducted a secondary analysis of a multicenter observational obstetric cohort of more than 115,000 mother-baby pairs from 25 hospitals (2008–2011). This analysis included women delivering singleton or twin births who experienced postpartum hemorrhage (estimated blood loss [EBL] >500cc for vaginal delivery, EBL >1000cc for cesarean delivery, or documented treatment for postpartum hemorrhage). Nighttime delivery was defined as that occurring between 8pm and 6am. The primary outcome was a composite of maternal morbidity (death, hysterectomy, intensive care unit admission, transfusion, or unanticipated procedure for bleeding). Secondary outcomes included EBL, uterotonic use, and procedures to treat bleeding that occurred during the postpartum hospitalization. Multivariable logistic, linear, quantile, and multinomial regression models were used to assess associations between nighttime delivery and outcomes, adjusting for potential patient-level confounders and hospital as a fixed effect. RESULTS: In total, 2,709 (34.2%) of 7,917 women with postpartum hemorrhage delivered at night. Women who delivered at night were younger, had a lower body mass index, and were more likely to have government-sponsored insurance, be nulliparous, have hypertension, use neuraxial analgesia, and deliver vaginally. After adjusting for potential confounders, the primary composite outcome of maternal morbidity was similar regardless of night vs. day delivery (15.5% night vs. 17.5% day; aOR 0.89, 95% CI 0.77–1.03). Some secondary outcomes, including mean EBL, frequency of uterotonic use, and time from delivery to first uterotonic dose differed on unadjusted analyses but, these associations did not persist in multivariable analysis. The study had limited power to assess differences in uncommon outcomes. CONCLUSION: Nighttime delivery was not associated with significant ...