Stroke, Acute Clinical Trial
Official title:
Evaluation of Stroke Patient Screening in an Acute Stroke Setting
Background and Rationale:
Traditionally, stroke rehabilitation studies have been performed in stroke patients beyond
the first one to three months poststroke [Stinear et al. 2013; Veerbeek et al. 2014].
Acknowledging that early stroke rehabilitation should be initiated soon after stroke onset to
optimize stroke outcomes, it is has been stressed that stroke rehabilitation trials should be
initiated within the first month [Stinear 2013].
Early stroke rehabilitation trials face difficulties regarding patient recruitment with
corresponding low enrollment rates [AVERT 2015; Winters 2015]. Explanations are for example
priority given to (sub)acute medical interventions, highly dynamic situation at a stroke
unit, and a more rapid change in patients' abilities when compared to patients in later
stages poststroke. With the low enrollment rates (~7%), the generalizability of study results
is questionable.
Participant screening methods and procedures for research eligibility are part of the patient
selection and recruitment process in clinical trials. However, no information is available
regarding screening procedures and methods for these early initiated stroke rehabilitation
trials, including reasons for not enrolling patients. This knowledge is essential to improve
screening procedures and methods, in order to optimize patient enrollment and with that,
increase the generalizability of study results.
Objective:
The objective of this project is to evaluate screening methods and procedures for stroke
rehabilitation research.
Study Design:
Observational study
Objective:
The objective of this project is to evaluate screening methods and procedures for stroke
rehabilitation research in the Department of Neurology, University Hospital Zurich.
Outcome:
Enrollment rates (defined as the number of patients enrolled per month of recruitment),
reasons for non-enrollment, and estimated costs for screening for early stroke rehabilitation
studies.
Study Design:
Observational study
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