Outcome Prediction in Cerebral Venous Thrombosis: The IN-REvASC Score.

BACKGROUND: We identified risk factors, derived and validated a prognostic score for poor neurological outcome and death for use in cerebral venous thrombosis (CVT). METHODS: We performed an international multicenter retrospective study including consecutive patients with CVT from January 2015 to December 2020. Demographic, clinical, and radiographic characteristics were collected. Univariable and multivariable logistic regressions were conducted to determine risk factors for poor outcome, mRS 3-6. A prognostic score was derived and validated. RESULTS: A total of 1,025 patients were analyzed with median 375 days (interquartile range [IQR], 180 to 747) of follow-up. The median age was 44 (IQR, 32 to 58) and 62.7% were female. Multivariable analysis revealed the following factors were associated with poor outcome at 90- day follow-up: active cancer (odds ratio [OR], 11.20; 95% confidence interval [CI], 4.62 to 27.14; P<0.001), age (OR, 1.02 per year; 95% CI, 1.00 to 1.04; P=0.039), Black race (OR, 2.17; 95% CI, 1.10 to 4.27; P=0.025), encephalopathy or coma on presentation (OR, 2.71; 95% CI, 1.39 to 5.30; P=0.004), decreased hemoglobin (OR, 1.16 per g/dL; 95% CI, 1.03 to 1.31; P=0.014), higher NIHSS on presentation (OR, 1.07 per point; 95% CI, 1.02 to 1.11; P=0.002), and substance use (OR, 2.34; 95% CI, 1.16 to 4.71; P=0.017). The derived IN-REvASC score outperformed ISCVT-RS for the prediction of poor outcome at 90-day follow-up (area under the curve [AUC], 0.84 [95% CI, 0.79 to 0.87] vs. AUC, 0.71 [95% CI, 0.66 to 0.76], χ2 P<0.001) and mortality (AUC, 0.84 [95% CI, 0.78 to 0.90] vs. AUC, 0.72 [95% CI, 0.66 to 0.79], χ2 P=0.03). CONCLUSIONS: Seven factors were associated with poor neurological outcome following CVT. The INREvASC score increased prognostic accuracy compared to ISCVT-RS. Determining patients at highest risk of poor outcome in CVT could help in clinical decision making and identify patients for targeted therapy in future clinical trials.

Trends in recruitment of women and reporting of sex differences in large-scale published randomized controlled trials in stroke.

BACKGROUND: Understanding of sex differences, especially in terms of the influence of sex on therapeutic interventions, can lead to improved treatment and management for all. AIM: We examined temporal and regional trends in female participation and the reporting of sex differences in stroke randomized controlled trials. METHODS: Randomized controlled trials from 1990 to 2018 were identified from ClinicalTrials.gov, using keywords "stroke" and "cerebrovascular accidents." Studies were selected if they enrolled ≥100 participants, included both sexes and were published trials (identified using PubMed, Google Scholar, and Scopus). RESULTS: Of 1700 stroke randomized controlled trials identified, 277 were published and eligible for analysis. Overall, these randomized controlled trials enrolled only 40% females, and in the past 10 years, this percentage barely changed, peaking at 41% in 2008-2009 and 2012-2013. North American randomized controlled trials recruited the most women, at 43%, and Asia the lowest, at 40%. Among the 277 randomized controlled trials, 101 (36%) reported results according to sex, of which 91 (33%) were pre-specified analyses. The increasing trend in the number of studies reporting sex-differentiated results from 2008 to 2018 merely paralleled the increase in the number of papers published during the same time period. North American randomized controlled trials most often reported sex-specific results (42%), and Australia and Europe least often (31%). CONCLUSION: Little progress has been made in the inclusion of females and the reporting of sex in stroke randomized controlled trials. This highlights the need for key stakeholders, such as funders and journal editors, to provide clear guidance and effective implementation strategies to researchers in the scientific reporting of sex.