Eligibility Screening for an Early Upper Limb Stroke Rehabilitation Study
Jeremia P O Held1, Jannie van Duinen1, Andreas R Luft1,2
1Division of Vascular Neurology and Neurorehabilitation, Department of Neurology, University of Zurich and University Hospital Zurich, Zurich, Switzerland.
Frontiers in Neurology
|July 18, 2019
Summary
Early stroke rehabilitation trials face recruitment challenges. This study found a low recruitment rate but identified key reasons for non-enrollment, suggesting less stringent inclusion criteria could improve enrollment for stroke patients.
Area of Science:
- Neurology
- Rehabilitation Medicine
- Clinical Trials
Background:
- Early stroke rehabilitation is crucial for optimal patient outcomes but often delayed.
- Existing trials frequently exclude early-stage stroke patients, hindering research.
- Systematic data on screening challenges and costs in early stroke rehabilitation trials is lacking.
Purpose of the Study:
- To evaluate screening procedures for an early upper limb stroke rehabilitation study.
- To assess recruitment rates and identify reasons for non-enrollment in first-ever ischemic stroke patients within 48 hours of onset.
- To determine the associated costs of screening for early stroke rehabilitation trials.
Main Methods:
- Prospective data collection for a monocentric longitudinal observational cohort study.
- Screening of health records and face-to-face assessments on working days at a stroke unit.
- Analysis of recruitment rates, reasons for exclusion, and screening costs (€7.48 per patient).
Main Results:
- A low recruitment rate of 1.8 patients per month was observed over 15 months (27/845 screened).
- Primary reasons for non-enrollment included no upper limb paresis (456), >48 hours post-stroke (257), and comorbidities (150).
- Screening costs were €7.48 per patient; recruitment could increase by 1.2/month with relaxed criteria for recurrent strokes.
Conclusions:
- Screening on working days is adequate for early stroke rehabilitation trial enrollment.
- Less stringent inclusion criteria for recurrent strokes could enhance recruitment without introducing bias.
- Multicenter collaborations are essential for conducting well-powered early stroke rehabilitation studies efficiently.
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