Outcomes Validity and Reliability of the Modified Rankin Scale: Implications for Stroke Clinical Trials: A Literature Review and Synthesis

Banks, Jamie L.; Marotta, Charles A.

doi:10.1161/01.str.0000258355.23810.c6

Cited by 2,253Acute Ischemic Stroke ManagementStroke Rehabilitation and RecoveryHealth Education and Validation

Outcomes Validity and Reliability of the Modified Rankin Scale: Implications for Stroke Clinical Trials: A Literature Review and Synthesis

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Banks, Jamie L., Marotta, Charles A.·2007·Stroke

DOI 10.1161/01.str.0000258355.23810.c6

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Abstract

Background and Purpose— The modified Rankin scale (mRS), a clinician-reported measure of global disability, is widely applied for evaluating stroke patient outcomes and as an end point in randomized clinical trials. Extensive evidence on the validity of the mRS exists across a large but fragmented literature. As new treatments for acute ischemic stroke are submitted for agency approval, an appreciation of the mRS’s attributes, specifically its relationship to other stroke evaluation scales, would be valuable for decision-makers to properly assess the impact of a new drug on treatment paradigms. The purpose of this report is to assemble and systematically assess the properties of the mRS to provide decision-makers with pertinent evaluative information. Methods— A Medline search was conducted to identify reports in the peer-reviewed medical literature (1957–2006) that provide information on the structure, validation, scoring, and psychometric properties of the mRS and its use in clinical trials. The selection of articles was based on defined criteria that included relevance, study design and use of appropriate statistical methods. Results— Of 224 articles identified by the literature search, 50 were selected for detailed assessment. Inter-rater reliability with the mRS is moderate and improves with structured interviews (κ 0.56 versus 0.78); strong test-re-test reliability (κ=0.81 to 0.95) has been reported. Numerous studies demonstrate the construct validity of the mRS by its relationships to physiological indicators such as stroke type, lesion size, perfusion and neurological impairment. Convergent validity between the mRS and other disability scales is well documented. Patient comorbidities and socioeconomic factors should be considered in properly applying and interpreting the mRS. Recent analyses suggest that randomized clinical trials of acute stroke treatments may require a smaller sample size if the mRS is used as a primary end point rather than the Barthel Index. Conclusions— Multiple types of evidence attest to the validity and reliability of the mRS. The reported data support the view that the mRS is a valuable instrument for assessing the impact of new stroke treatments.

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Overall lesion load on T1-weighted MRI is associated with global disability, often measured by the modified Rankin Scale, and with performance on different cognitive domains in CADASIL.
“The overall lesion load observed on T1-weighted MR images has been associated with the degree of global disability, often quantified using the modified Rankin Scale [4], and with performance on different cognitive domains [18, 76].”
From Clinical and research applications of magnetic resonance imaging in the study of CADASIL (2019) · cites this paper as [4]

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Authors: Banks, J. L., & Marotta, C. A.
Affiliations: Schulman, Ronca & Bucuvalas (US)
ORCID: Banks, Jamie L.
Venue: Stroke
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2007-03
Volume: 38
Issue: 3
Pages: 1091-1096
ISSN: 0039-2499 (ISSN-L)
1524-4628
DOI: 10.1161/01.str.0000258355.23810.c6
OpenAlex: W2020074777
Cited by: 2,253
References: 70
Citations by year: 2026: 201 · 2025: 279 · 2024: 277 · 2023: 220 · 2022: 219 · 2021: 178 · 2020: 157 · 2019: 101 · 2018: 114 · 2017: 75 · 2016: 84 · 2015: 76 · 2014: 60 · 2013: 61 · 2012: 41
Type: journal article
Language: en
Open access: bronze
doi.org
Locations: Stroke (publishedVersion)
PubMed (publishedVersion)
Funders: AstraZeneca
Topics: Health Sciences › Medicine › Epidemiology › Acute Ischemic Stroke Management
Health Sciences › Medicine › Rehabilitation › Stroke Rehabilitation and Recovery
Social Sciences › Education › Health Education and Validation
Keywords: modified Rankin Scale, stroke outcome assessment, psychometric properties, inter-rater reliability, test-retest reliability, construct validity, convergent validity, acute ischemic stroke, stroke clinical trials, primary outcomes, Barthel Index, sample size determination, disability assessment
MeSH terms: Humans, Research Design, Randomized Controlled Trials as Topic, Treatment Outcome, Stroke, History, 20th Century, History, 21st Century

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Outcomes Validity and Reliability of the Modified Rankin Scale: Implications for Stroke Clinical Trials: A Literature Review and Synthesis

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