女性参与加拿大中风康复试验：比较试验参与者和住院康复人群

IF 1.8 4区医学 Q3 NEUROSCIENCES

Journal of Stroke & Cerebrovascular Diseases Pub Date : 2025-07-25 DOI:10.1016/j.jstrokecerebrovasdis.2025.108407

Shannon L. MacDonald MD, MSc , Amy Y.X. Yu MD MSc , Mark Bayley MD , Susan Marzolini PhD, RKin

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引用次数: 0

摘要

目的1)确定加拿大脑卒中康复试验参与者的性别分布及其他特征是否与加拿大住院脑卒中康复人群不同2)探讨试验资格标准是否可能影响女性参加脑卒中试验的比例。材料与方法本研究是一项横断面研究，采用加拿大住院脑卒中康复患者和三个脑卒中康复临床试验数据。描述了人群和试验数据的组间差异，并计算了女性参与者与患病率的比值。在住院脑卒中康复人群特征的背景下检查试验资格标准，以探讨资格标准是否可能不成比例地排除女性。结果201名试验参与者（29.4%为女性）和37,047例住院脑卒中康复患者（44.8%为女性）。女性的总体参与者与患病率之比为0.66。入院接受脑卒中康复治疗的女性比男性年龄大（p= 0.001），试验参与者的年龄没有性别差异（p= 0.114）。与接受住院康复治疗的女性相比，女性试验参与者被诊断为高血压的比例明显更小(41.4% vs 66.2%；p & lt;措施)。在男性中没有观察到这种差异。与男性相比，接受住院康复治疗的女性更频繁地具有以下特征（情绪障碍、独居、出院接受长期护理），这可能导致她们被排除在≥1项试验之外。结论与住院康复患者相比，参加脑卒中康复试验的女性人数不足。试验资格标准可能导致与男性相比不成比例地排除女性。

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Female participation in Canadian stroke rehabilitation trials: Comparing trial participants to the inpatient rehabilitation population

Objectives

1) to determine whether the sex distribution and other characteristics of Canadian stroke rehabilitation trial participants differ from the inpatient stroke rehabilitation population in Canada 2) to explore whether trial eligibility criteria may be impacting the proportion of females participating in stroke trials.

Materials and Methods

This was a cross-sectional study using Canadian inpatient stroke rehabilitation population and three stroke rehabilitation clinical trials data. Between-group differences in population and trial data were described and a participant to prevalence ratio for females was calculated. Trial eligibility criteria were examined in the context of the inpatient stroke rehabilitation population characteristics to explore whether eligibility criteria may be disproportionately excluding females.

Results

There were 201 trial participants (29.4 % female) and 37,047 patients admitted to inpatient stroke rehabilitation (44.8 % female). The overall participant to prevalence ratio for females was 0.66. Females admitted to inpatient stroke rehabilitation were older than males (p<.001), with no sex difference in age in trial participants (p=.114). A significantly smaller proportion of female trial participants had a diagnosis of hypertension compared to females admitted to inpatient rehabilitation (41.4 % vs 66.2 %; p <.001). This difference was not observed for males. Compared to males, females admitted to inpatient rehabilitation more frequently had characteristics (mood disorder, living alone, discharged to long-term care), which may have resulted in their exclusion from ≥1 of the trials.

Conclusions

Females enrolled in stroke rehabilitation trials are underrepresented compared to inpatient rehabilitation. Trial eligibility criteria may result in the disproportionate exclusion of females compared to males.

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来源期刊

Journal of Stroke & Cerebrovascular Diseases Medicine-Surgery

CiteScore

5.00

自引率

4.00%

发文量

583

审稿时长

62 days

期刊介绍： The Journal of Stroke & Cerebrovascular Diseases publishes original papers on basic and clinical science related to the fields of stroke and cerebrovascular diseases. The Journal also features review articles, controversies, methods and technical notes, selected case reports and other original articles of special nature. Its editorial mission is to focus on prevention and repair of cerebrovascular disease. Clinical papers emphasize medical and surgical aspects of stroke, clinical trials and design, epidemiology, stroke care delivery systems and outcomes, imaging sciences and rehabilitation of stroke. The Journal will be of special interest to specialists involved in caring for patients with cerebrovascular disease, including neurologists, neurosurgeons and cardiologists.