Initial experience of a digital training resource for modified Rankin scale assessment in clinical trials

Quinn, T.J. , Lees, K.R., Hardemark, H.G., Dawson, J. and Walters, M.R. (2007) Initial experience of a digital training resource for modified Rankin scale assessment in clinical trials. Stroke, 38(8), pp. 2257-2261. (doi: 10.1161/STROKEAHA.106.480723)




<p><b>Background and Purpose:</b> The modified Rankin Scale (mRS) is the preferred measure of disability in cerebrovascular clinical trials, but its value is restricted by interobserver variability. Poor reliability reduces the statistical power of clinical trials and leads to underestimation of effect size. Strategies to improve mRS grading are required. Video training has previously improved application of the National Institutes of Health Stroke Scale in clinical research. We developed an mRS training resource in an attempt to minimize interobserver variability.</p> <p><b>Methods:</b> We produced a complete training resource comprising an instructional DVD with accompanying written materials and assessment recordings of patient interviews. Formal assessment of training involved grading of real-life cases. Results of initial training and recertification were collected centrally and scored.</p> <p><b>Results:</b> Data from 1564 assessments are presented. The majority of assessors were participating in 2 large prospective clinical stroke trials. Assessors represented a mixed group of disciplines and nationalities. After training, most trainees (90%) achieved certification in mRS assessment. The majority (85%) of investigators who did not reach an acceptable score on initial testing achieved certification after further exposure to the package.</p> <p><b>Conclusions:</b> Mass training in mRS assessment for clinical trials is possible. We outline the development of a video-based training package, including technical issues, patient selection procedures, and methods of scoring and assessment. Certification results suggest that use of the resource can improve mRS grading. Acceptability of the training has been demonstrated by its successful use in 2 international acute stroke trials, SAINT 1 and CHANT.</p>

Item Type:Articles
Glasgow Author(s) Enlighten ID:Lees, Professor Kennedy and Dawson, Professor Jesse and Walters, Professor Matthew and Quinn, Professor Terry
Authors: Quinn, T.J., Lees, K.R., Hardemark, H.G., Dawson, J., and Walters, M.R.
Subjects:R Medicine > R Medicine (General)
College/School:College of Medical Veterinary and Life Sciences
College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health
College of Medical Veterinary and Life Sciences > School of Medicine, Dentistry & Nursing
Journal Name:Stroke
Publisher:American Heart Association
ISSN (Online):1524-4628
Published Online:28 June 2007
Copyright Holders:Copyright © 2007 American Heart Association
First Published:First published in Stroke 38(8):2257-2261
Publisher Policy:Reproduced in accordance with the copyright policy of the publisher

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