
pmid: 34746964
pmc: PMC8572691
Abstract Background and objectives The modified Rankin Scale (mRS) is one of the most frequently used outcome measures in trials in patients with an aneurysmal subarachnoid hemorrhage (aSAH). The assessment method of the mRS is often not clearly described in trials, while the method used might influence the mRS score. The aim of this study is to evaluate the inter-method reliability of different assessment methods of the mRS. Methods This is a prospective, randomized, multicenter study with follow-up at 6 weeks and 6 months. Patients aged ≥ 18 years with aSAH were randomized to either a structured interview or a self-assessment of the mRS. Patients were seen by a physician who assigned an mRS score, followed by either the structured interview or the self-assessment. Inter-method reliability was assessed with the quadratic weighted kappa score and percentage of agreement. Assessment of feasibility of the self-assessment was done by a feasibility questionnaire. Results The quadratic weighted kappa was 0.60 between the assessment of the physician and structured interview and 0.56 between assessment of the physician and self-assessment. Percentage agreement was, respectively, 50.8 and 19.6%. The assessment of the mRS through a structured interview and by self-assessment resulted in systematically higher mRS scores than the mRS scored by the physician. Self-assessment of the mRS was proven feasible. Discussion The mRS scores obtained with different assessment methods differ significantly. The agreement between the scores is low, although the reliability between the assessment methods is good. This should be considered when using the mRS in clinical trials. Trial registration www.trialregister.nl; Unique identifier: NL7859.
Radboudumc 18: Healthcare improvement science RIHS: Radboud Institute for Health Sciences, TELEPHONE, Neurosurgery - Radboud University Medical Center, Modified Rankin Scale, Orthopaedics - Radboud University Medical Center, Radboudumc 16: Vascular damage RIHS: Radboud Institute for Health Sciences, Outcome Assessment, Health Care, Humans, Subarachnoid hemorrhage, Prospective Studies, OUTCOMES, Original Communication, Neurology - Radboud University Medical Center, Reproducibility of Results, Radboudumc 3: Disorders of movement DCMN: Donders Center for Medical Neuroscience, Subarachnoid Hemorrhage, Reliability, IQ Healthcare - Radboud University Medical Center, Treatment Outcome, AGREEMENT, Radboudumc 0: Other Research RIHS: Radboud Institute for Health Sciences, STROKE, Radboudumc 10: Reconstructive and regenerative medicine RIHS: Radboud Institute for Health Sciences
Radboudumc 18: Healthcare improvement science RIHS: Radboud Institute for Health Sciences, TELEPHONE, Neurosurgery - Radboud University Medical Center, Modified Rankin Scale, Orthopaedics - Radboud University Medical Center, Radboudumc 16: Vascular damage RIHS: Radboud Institute for Health Sciences, Outcome Assessment, Health Care, Humans, Subarachnoid hemorrhage, Prospective Studies, OUTCOMES, Original Communication, Neurology - Radboud University Medical Center, Reproducibility of Results, Radboudumc 3: Disorders of movement DCMN: Donders Center for Medical Neuroscience, Subarachnoid Hemorrhage, Reliability, IQ Healthcare - Radboud University Medical Center, Treatment Outcome, AGREEMENT, Radboudumc 0: Other Research RIHS: Radboud Institute for Health Sciences, STROKE, Radboudumc 10: Reconstructive and regenerative medicine RIHS: Radboud Institute for Health Sciences
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