Held Jeremia P O, van Duinen Jannie, Luft Andreas R, Veerbeek Janne M
Division of Vascular Neurology and Neurorehabilitation, Department of Neurology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.
Cereneo, Center for Neurology and Rehabilitation, Vitznau, Switzerland.
Front Neurol. 2019 Jul 2;10:683. doi: 10.3389/fneur.2019.00683. eCollection 2019.
Stroke rehabilitation should start early in order to optimize patients' outcomes, but most trials include subacute or chronic patients. Although suggested that early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low recruitment rates, no systematically collected information regarding screening and associated costs has been published. Such knowledge is essential for optimizing enrollment. Therefore, this study evaluated screening procedures for an early upper limb rehabilitation study including first-ever ischemic stroke patients <48 h after onset. Screening data for a monocentric longitudinal observational cohort study was prospectively collected. Researchers screened health-care records, during the morning round and face-to-face at the stroke-unit on working days. Outcomes were the recruitment rate, reasons for non-enrollment, and screening costs. Over 15 months, 27 out of 845 screened ischemic stroke patients were enrolled, equaling a recruitment rate of 1.8/month. Main reasons for non-enrollment were no upper limb paresis ( = 456), >48 h post-stroke ( = 257), general comorbidity ( = 150), unable to follow commands ( = 148), and recurrent stroke ( = 146). Four patients were missed due to time constraints of the personnel or patient. The recruitment rate would have been 1.2 higher if also patients with recurrent strokes but without residual motor deficits or pre-stroke mRS ≥2 were considered eligible. Screening costed € 7.48 per patient. Screening at working days is sufficient to enroll patients in early stroke rehabilitation trials. Inclusion criteria regarding recurrent strokes should be less stringent to boost recruitment rates without increasing bias. Multicenter collaborations are needed to finish well-powered early stroke rehabilitation studies within a reasonable time. Authorization from the local ethical committee was not required, as this study does not fall within the scope of the Human Research Act (BASEC Identifier: Req-2017-00844). The project was registered at http://www.clinicaltrials.gov (Identifier: NCT03633422).
中风康复应尽早开始以优化患者预后，但大多数试验纳入的是亚急性或慢性患者。尽管有人提出早期中风康复试验在患者招募方面面临困难，招募率相应较低，但尚未有关于筛查及相关成本的系统收集信息发表。此类知识对于优化入组至关重要。因此，本研究评估了一项早期上肢康复研究的筛查程序，该研究纳入首次发生缺血性中风且发病后<48小时的患者。前瞻性收集了一项单中心纵向观察队列研究的筛查数据。研究人员在工作日的早查房期间及在卒中单元面对面筛查医疗记录。结果指标为招募率、未入组原因及筛查成本。在15个月期间，845名接受筛查的缺血性中风患者中有27名入组，招募率为每月1.8例。未入组的主要原因是无上肢轻瘫（n = 456）、中风后>48小时（n = 257）、一般合并症（n = 150）、无法听从指令（n = 148）及复发性中风（n = 146）。有4名患者因工作人员或患者的时间限制而被遗漏。如果将复发性中风但无残留运动功能缺损或卒中前改良Rankin量表评分≥2的患者也视为 eligible，则招募率会高出1.2。每位患者的筛查成本为7.48欧元。在工作日进行筛查足以使患者入组早期中风康复试验。关于复发性中风的纳入标准应放宽以提高招募率而不增加偏倚。需要多中心合作以便在合理时间内完成有充分统计学效力的早期中风康复研究。本研究不属于《人类研究法》范围，因此无需获得当地伦理委员会的授权（瑞士联邦公共卫生办公室标识符：Req-2017-00844）。该项目已在http://www.clinicaltrials.gov注册（标识符：NCT03633422）。
