第三世界的神经康复转化研究：参与试验的障碍能告诉我们什么。
Translational neurorehabilitation research in the third world: what barriers to trial participation can teach us.
机构信息
From the Neurology Clinical Division, Neurology Department, Hospital das Clínicas, São Paulo University, São Paulo, Brazil (S.M.A., K.N.F.d.A., A.B.C.); Human Cortical Physiology and Stroke Rehabilitation Section, National Institutes of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD (L.G.C.); School of Psychology, University of Surrey, Guildford, United Kingdom (A.S.); and Hospital Israelita Albert Einstein, São Paulo, Brazil (A.B.C.).
出版信息
Stroke. 2014 May;45(5):1495-7. doi: 10.1161/STROKEAHA.113.003572. Epub 2014 Mar 18.
BACKGROUND AND PURPOSE
Most stroke rehabilitation studies have been performed in high-income countries. The aim of this study was to identify the main barriers for patient inclusion in a research protocol performed in Brazil.
METHODS
We evaluated reasons for exclusion of patients in a pilot, randomized, double-blinded clinical trial of stroke rehabilitation. Descriptive statistical analysis was performed.
RESULTS
Only 5.6% of 571 screened patients were included. Recurrent stroke was responsible for exclusion of 45.4% of potentially eligible patients.
CONCLUSIONS
Recurrent stroke represented a big barrier to enroll patients in the protocol. External validity of rehabilitation trials will benefit from definition of study criteria according to regional characteristics of patients, including rates of recurrent stroke.
CLINICAL TRIAL REGISTRATION URL
http://www.clinicaltrials.gov. Unique identifier: NCT01333579.
背景与目的
大多数中风康复研究都是在高收入国家进行的。本研究的目的是确定在巴西进行的研究方案中患者纳入的主要障碍。
方法
我们评估了一项中风康复的试点、随机、双盲临床试验中患者排除的原因。进行了描述性统计分析。
结果
在 571 名筛选出的患者中，只有 5.6%被纳入。复发性中风导致 45.4%可能符合条件的患者被排除在外。
结论
复发性中风是将患者纳入方案的一个主要障碍。根据患者的区域特征（包括中风复发率）来定义研究标准，将有助于康复试验的外部有效性。
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