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Background Although regulatory changes towards correcting the underrepresentation of women in randomized controlled trials (RCTs) occurred (National Institutes of Health 1994), concerns exist about whether an improvement is taking place. In this systematic review and meta-analysis, we aimed to assess the inclusion rates of women in recent RCTs and to explore the potential barriers for the enrollment of women. Methods RCTs published in 2017 examining any type of intervention in adults were searched in PubMed and Cochrane Library. The following predefined medical fields were included: cardiovascular diseases, neoplasms, endocrine system diseases, respiratory tract diseases, bacterial and fungal infections, viral diseases, digestive system diseases, and immune system diseases. Studies were screened independently by two reviewers, and an equal number of studies was randomly selected per calendric month. The primary outcome was the enrollment rate of women, calculated as the number of randomized women patients divided by the total number of randomized patients. Rates were weighted by their inverse variance; statistical significance was tested using general linear models (GLM). Results Out of 398 RCTs assessed for eligibility, 300 RCTs were included. The enrollment rate of women in all the examined fields was lower than 50%, except for immune system diseases [median enrollment rate of 68% (IQR 46 to 81)]. The overall median enrollment rate of women was 41% (IQR 27 to 54). The median enrollment rate of women decreased with older age of the trials’ participants [mean age of trials’ participants ≤ 45 years: 47% (IQR 30–64), 46–55 years: 46% (IQR 33–58), 56–62 years: 38% (IQR 27–50), ≥ 63 years: 33% (IQR 20–46), p < 0.001]. Methodological quality characteristics showed no significant association with the enrollment rates of women. Out of the 300 included RCTs, eleven did not report on the number of included women. There was no significant difference between these studies and the studies included in the analysis. Conclusions Women are being inadequately represented, in the selected medical fields analyzed in our study, in recent RCTs. Older age is a potential barrier for the enrollment of women in clinical trials. Low inclusion rates of elderly women might create a lack of crucial knowledge in the adverse effects and the benefit/risk profile of any given treatment. Factors that might hinder the participation of women should be sought and addressed in the design of the study.
Background Short-term readmission is an important outcome reflecting the poor trajectory of sepsis survivors. The aim of this study was to identify the major risk factors for 30 day-readmission among patients with Gram-negative bacteremia. Methods Retrospective cohort study including all consecutive adults hospitalized in the medical departments in a referral hospital in Israel with Gram-negative bacteremia between 2011 to 2020, who were discharged alive. Predictors for 30-day readmission were investigated, considering death after discharge as a competing event. Cephalosporin resistance was our predictor of interest. Sub-distribution hazard ratios (HR) of the cumulative incidence function were investigated using the Fine and Gray multivariable competing-risk regression model. The prediction models were cross-validated using the k-fold method. Results Among 2,196 patients surviving hospitalization with Gram-negative bacteremia, the mean age was 70±16 years and 432 (19.6%) were readmitted within 30 days. Variables associated readmission hazards included were Arab ethnicity, active malignancy, conditions requiring immune-suppression, anxiolytics or hypnotics, anticoagulant or antiplatelet therapy, discharge with a nasogastric tube, higher pre-discharge heart rate, duration of antibiotic therapy during hospitalization and bacteremia caused by cephalosporin-resistant bacteria (HR 1.23, 95% CI 0.99-1.52). The area under the receiver-operating characteristics curve for this model was 75.5% (95% CI 71.3-79.1%). In secondary models, cephalosporin resistance and inappropriate empirical antibiotic treatment and lower pre-discharge albumin, were significantly associated with re-admission. Conclusion 30-day re-admissions among patients with Gram-negative bacteremia surviving the index admission are high. Readmission was related to comorbidities and infections caused by multidrug-resistant infections.
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