Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2025 May;56(5):1280-1284.
doi: 10.1161/STROKEAHA.124.049825. Epub 2025 Mar 24.

Comparison of Local and Centrally Adjudicated Modified Rankin Scale Scores in the MOST Trial

Adham Shawkat  1 , Andrew D Barreto  2 , Joseph P Broderick  3 , Colin P Derdeyn  4 , James C Grotta  5 , Pooja Khatri  3 , Stephanie Pizzella  6 , Ian Rines  7 , Akash Roy  7 , Alastair Wilson  8 , Max Wintermark  9 , Opeolu M Adeoye  6
Affiliations
Clinical Trial

Comparison of Local and Centrally Adjudicated Modified Rankin Scale Scores in the MOST Trial

Adham Shawkat et al. Stroke. 2025 May.

Abstract

Background: The modified Rankin Scale (mRS) is a key measure of functional outcomes in stroke trials. To minimize variability, structured tools like the Rankin Focused Assessment and central adjudication are recommended. This study compares local versus centrally adjudicated mRS scores in the MOST trial (Multi-Arm Optimization of Stroke Thrombolysis).

Methods: MOST was a phase 3, single-blind, randomized trial evaluating argatroban, eptifibatide, or placebo in addition to intravenous thrombolysis. The primary outcome, 90-day mRS score, was gathered through in-person video recordings by blinded local personnel. Recordings were sent to central adjudicators for final scoring. As in-person visits became limited due to SARS-CoV-2, remote interviews were allowed. We hypothesized that local mRS scores would be moderately associated with central scores. Fleiss-Cohen quadratic weighted κ statistics were used to determine the strength of agreement.

Results: Out of 514 participants, 378 had recorded visits available (121 in-person video, 157 remote video, 100 remote audio). Local assessors were blinded 96.8% of the time and 85.4% of visits used the Rankin Focused Assessment. Overall agreement between local and central mRS scores was excellent (weighted κ, 0.87 [95% CI, 0.83-0.90]). A nonsignificant decrease in strength of agreement was noted for those with a nonzero baseline mRS (mRS score=0, 0.87 [95% CI, 0.84-0.91] versus mRS score >0, 0.80 [95% CI, 0.68-0.91]). Trial conclusions were unchanged when utilizing the local mRS versus central adjudication.

Conclusions: Local mRS scores demonstrated strong agreement with central scores across all assessment modes. With blinded end point assessments, central mRS adjudication in acute stroke trials may not be necessary.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03735979.

Keywords: argatroban; clinical trials; eptifibatide; ischemic stroke; thrombolysis.

PubMed Disclaimer

Conflict of interest statement

Dr Barreto reports grants from National Institutes of Health (NIH) Clinical Center. Dr Broderick reports compensation from F. Hoffmann-La Roche, Kroger Prescription Plans Inc, BrainsGate, and Basking Biosciences for consultant services and grants from Genentech and Novo Nordisk to other. Dr Derdeyn reports stock options in Euphrates Vascular and compensation from Silk Road Medical Inc and Penumbra Inc for data and safety monitoring services. Dr Grotta reports compensation from Alva Health, Prolong Pharma, Acticor, and Frazer, Ltd for consultant services. Dr Khatri reports compensation from F. Hoffmann-La Roche, Lumosa, Shionogi, and Basking Biosciences as a scientific advisor; drug and assays from Translational Sciences in support of the NIH-funded SISTER trial (Strategy for Improving Stroke Treatment Response); royalty from UpToDate Inc for online publication; and an investigator-initiated grant from Johnson & Johnson Health Care Systems Inc. She received service fees from Genentech for leading the PRISMS trial (Potential of rtPA for Ischemic Strokes With Mild Symptoms) >5 years ago. Dr Wintermark reports compensation from Subtle Medical, Magnetic Insight, and Icometrix for consultant services. Dr Adeoye reports service as Chief Medical Officer for Sense Diagnostics. The other authors report no conflicts.

References

    1. Quinn TJ, Dawson J, Walters M. Dr John Rankin; his life, legacy and the 50th anniversary of the Rankin Stroke Scale. Scott Med J. 2008;53(1):44–47. doi:10.1258/RSMSMJ.53.1.44 - DOI - PubMed
    1. Duncan PW, Jorgensen HS, Wade DT. Outcome measures in acute stroke trials: a systematic review and some recommendations to improve practice. Stroke. 2000;31(6):1429–1438. doi:10.1161/01.str.31.6.1429 - DOI - PubMed
    1. van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. Interobserver agreement for the assessment of handicap in stroke patients. Stroke. 1988;19(5):604–607. doi:10.1161/01.str.19.5.604 - DOI - PubMed
    1. Wilson JT, Hareendran A, Grant M, et al. Improving the assessment of outcomes in stroke: use of a structured interview to assign grades on the modified Rankin Scale. Stroke. 2002;33(9):2243–2246. doi:10.1161/01.str.0000027437.22450.bd - DOI - PubMed
    1. Hanley DF, Lane K, McBee N, et al. Thrombolytic removal of intraventricular haemorrhage in treatment of severe stroke: results of the randomised, multicentre, multiregion, placebo-controlled CLEAR III trial. Lancet. 2017;389(10069):603–611. doi:10.1016/S0140-6736(16)32410-2 - DOI - PMC - PubMed

Publication types

Associated data