Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study

Abstract

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).

Keywords: prospective study; rehabilitation; screening; stroke; trial design.

Figures

Figure 1

Overview of exclusion reasons for non-eligible patients (N = 814). Exclusion reasons arranged in descending order based on their prevalence. Stroke localization (bihemispheric) and recurrent stroke refer to the inclusion criterion “first-ever unilateral ischemic stroke.” The criterion “comorbidity” was divided into general comorbidity (e.g., Morbus Parkinson) and specific upper limb comorbidity (e.g., arthrosis of the hand, humerus fracture). Patients not residing in Switzerland could not be enrolled, as they would not be able to return for the follow-up visits. Four patients fulfilling the criteria could not be enrolled due to time constraints of researchers (N = 3) or patient (N = 1). h, hours; NIHSS, National Institutes of Health Stroke Scale; mRS, modified Rankin Scale; *One data point missing.

Figure 2

Overview of cumulative exclusion reasons. Light-green bars indicate the number of patients fulfilling all previous criteria but not the current criterion. Dark-green bars indicate number of patients fulfilling all previous criteria including the current criterion. Exclusion reasons arranged in ascending order based on their prevalence. Stroke localization (bihemispheric) and recurrent stroke refer to the inclusion criterion “first-ever unilateral ischemic stroke.” The criterion “comorbidity” was divided into general comorbidity (e.g., Morbus Parkinson) and specific upper limb comorbidity (e.g., arthrosis of the hand, humerus fracture). Patients not residing in Switzerland could not be enrolled, as they would not be able to return for the follow-up visits. h, hours; NIHSS, National Institutes of Health Stroke Scale; mRS, modified Rankin Scale; *One data point missing.