Division of Neurology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada; Institute of Health Policy, Management and Evaluation, University of Toronto, Toronto, Ontario, Canada.
Health Sciences Program, McMaster University, Hamilton, Ontario, Canada.
J Neurol Sci. 2018 Nov 15;394:107-111. doi: 10.1016/j.jns.2018.09.012. Epub 2018 Sep 12.
Despite the projected increase in dementia cases affecting various ethnic groups worldwide, representation of these ethnic groups in randomized controlled trials (RCTs) of treatments to improve cognitive function in persons with dementia or mild cognitive impairment (MCI) is unclear. We aimed to quantify the inclusion of various ethnicities in dementia treatment RCTs.
RCTs published between January 1, 2000 and August 1, 2017 (inclusive) were included. Participants were community-dwelling adults with a diagnosis of either dementia or MCI randomized to receive either pharmacological or non-pharmacological interventions to improve cognitive function. Analyses were performed to determine study-level characteristics associated with recruitment of various ethnic groups. Random effects meta-analyses were conducted to determine the pooled prevalence for each ethnicity.
A total of 96 RCTs consisting of 37,278 participants (57.2% female) were included in the final analysis. Only 39 (39.4%) trials reported the ethnicity of included participants. The pooled proportion of non-Caucasian trial participants was 11.4% (95% CI, 7.5 to 15.9%). Meta-regression results showed that there has been a slow increase in representation of non-Caucasian ethnic groups over time (0.6% per year, P value = 0.041).
There is an underreporting of the ethnicity of trial participants and underrepresentation of non-Caucasian ethnic groups in RCTs designed to improve cognitive function in persons with dementia or MCI.
尽管预计全球不同种族的痴呆症病例将会增加,但在改善痴呆症或轻度认知障碍(MCI)患者认知功能的治疗方法的随机对照试验(RCT)中,这些种族的代表性尚不清楚。我们旨在量化各种族在痴呆症治疗 RCT 中的纳入情况。
纳入了 2000 年 1 月 1 日至 2017 年 8 月 1 日(含)期间发表的 RCT。参与者为被诊断为痴呆症或 MCI 的、居住在社区的成年人,他们被随机分配接受药物或非药物干预以改善认知功能。进行了分析以确定与招募各种族有关的研究水平特征。进行了随机效应荟萃分析,以确定每种族的 pooled 患病率。
共有 96 项 RCT 纳入了 37278 名参与者(57.2%为女性),最终纳入了分析。只有 39 项(39.4%)试验报告了纳入参与者的种族。非白种人试验参与者的 pooled 比例为 11.4%(95%CI,7.5%至 15.9%)。Meta 回归结果显示,非白种人群体的代表性随着时间的推移呈缓慢增长趋势(每年增长 0.6%,P 值=0.041)。
在旨在改善痴呆症或 MCI 患者认知功能的 RCT 中,参与者的种族报告不足,且非白种人群体的代表性不足。