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巴西一项卒中后神经康复多中心试验中患者招募的障碍。

Barriers to patient recruitment in a poststroke neurorehabilitation multicenter trial in Brazil.

机构信息

Departamento de Clínica Médica, Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, Botucatu, SP, Brasil.

Departamento de Reabilitação, Hospital das Clínicas, Faculdade de Medicina de Botucatu, Universidade Estadual Paulista, Botucatu, SP, Brasil.

出版信息

Braz J Med Biol Res. 2023 Jan 27;56:e12326. doi: 10.1590/1414-431X2023e12326. eCollection 2023.

Abstract

There is a high demand for stroke rehabilitation in the Brazilian public health system, but most studies that have addressed rehabilitation for unilateral spatial neglect (USN) after stroke have been performed in high-income countries. Therefore, the aim of this study was to analyze USN patient recruitment in a multicenter noninvasive brain stimulation clinical trial performed in Brazil and to provide study design recommendations for future studies. We evaluated the reasons for exclusion of patients from a multicenter, randomized, double-blinded clinical trial of rehabilitation of USN patients after stroke. Clinical and demographic variables were compared between the included and excluded patients. A descriptive statistical analysis was performed. Only 173 of the 1953 potential neglect patients (8.8%) passed the initial screening. After screening evaluation, 87/173 patients (50.3%) were excluded for clinical reasons. Cognitive impairment led to the exclusion of 21/87 patients (24.1%). Low socioeconomic status led to the exclusion of 37/173 patients (21.4%). Difficulty obtaining transportation to access treatment was the most common reason for their exclusion (16/37 patients, 43.3%). The analyzed Brazilian institutions have potential for conducting studies of USN. The recruitment of stroke survivors with USN was restricted by the study design and limited financial support. A history of cognitive impairment, intracranial stenting or craniectomy, and lack of transportation were the most common barriers to participating in a multicenter noninvasive brain stimulation trial among patients with USN after stroke.

摘要

巴西公共卫生系统对中风康复的需求很高,但大多数针对中风后单侧空间忽略(USN)康复的研究都是在高收入国家进行的。因此,本研究旨在分析在巴西进行的一项多中心非侵入性脑刺激临床试验中 USN 患者的招募情况,并为未来的研究提供研究设计建议。我们评估了将患者排除在中风后 USN 患者康复的多中心、随机、双盲临床试验之外的原因。比较了纳入和排除患者的临床和人口统计学变量。进行了描述性统计分析。在 1953 名潜在忽略患者中,只有 173 名(8.8%)通过了初步筛选。经过筛选评估,87/173 名患者(50.3%)因临床原因被排除。认知障碍导致 21/87 名患者(24.1%)被排除。低社会经济地位导致 37/173 名患者(21.4%)被排除。难以获得交通来接受治疗是导致他们被排除的最常见原因(37 名患者中有 16 名,占 43.3%)。分析中的巴西机构有进行 USN 研究的潜力。USN 中风幸存者的招募受到研究设计和有限的资金支持的限制。认知障碍史、颅内支架或颅骨切除术以及缺乏交通工具是中风后 USN 患者参与多中心非侵入性脑刺激试验的最常见障碍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/efdb/9883007/9164a04c6b14/1414-431X-bjmbr-56-e12326-gf001.jpg

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