Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study.
Introduction: 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. Methods: 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. Results: 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 (N = 456), >48 h post-stroke (N = 257), general comorbidity (N = 150), unable to follow commands (N = 148), and recurrent stroke (N = 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. Discussion: 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. Ethics and Study Registration: 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).
['Held|Jeremia P O|JPO|', 'van Duinen|Jannie|J|', 'Luft|Andreas R|AR|', 'Veerbeek|Janne M|JM|']
screening stroke rehabilitation prospective study trial design