Evidence map›Paper›PMID 26138130›Full record

SynthesisStroke2015

Adopting a Patient-Centered Approach to Primary Outcome Analysis of Acute Stroke Trials Using a Utility-Weighted Modified Rankin Scale.

Napasri Chaisinanunkul, Opeolu Adeoye, Roger J Lewis, James C Grotta, Joseph Broderick, Tudor G Jovin, Raul G Nogueira, Jordan J Elm, Todd Graves, Scott Berry and 5 more

Abstract readMeta-Analysis
In one paragraph

Synthesis in Stroke, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 85 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
85citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

85 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
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  5. Health economic impact of Nerinetide in addition to mechanical thrombectomy without concurrent alteplase.Interventional neuroradiology : journal of peritherapeutic neuroradiology, surgical procedures and related neurosciences · 2026
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25 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Napasri ChaisinanunkulFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Opeolu AdeoyeFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Roger J LewisFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
James C GrottaFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Joseph BroderickFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Tudor G JovinFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Raul G NogueiraFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Jordan J ElmFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Todd GravesFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Scott BerryFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Kennedy R LeesFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Andrew D BarretoFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.).
Jeffrey L SaverFrom the Department of Neurology and Comprehensive Stroke Center, University of California, Los Angeles (N.C., J.L.S.); Phyathai Stroke Center, Department of Neurology, Phyathai 1 Hospital, Bangkok, Thailand (N.C.); Departments of Emergency Medicine and Neurosurgery, Neuroscience Institute (O.A.) and Department of Neurology and Rehabilitation Medicine (J.B.), University of Cincinnati, OH; Department of Emergency Medicine at Harbor-UCLA Medical Center, Berry Consultants, LLC, Austin, TX (R.J.L.); Clinical Innovation & Research Institute, Memorial Hermann Hospital-Texas Medical Center, Houston (J.C.G.); Department of Neurology, University of Pittsburgh Medical Center, PA (T.G.J.); Department of Neurology, Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, Emory University, Atlanta, GA (R.G.N.); Department of Public Health Sciences, Medical University of South Carolina, Charleston (J.J.E.); Berry Consultants, LLC, Austin, TX (T.G., S.B.); Department of Stroke Research, University of Glasgow, Glasgow, United Kingdom (K.R.L.); and Department of Neurology, Stroke Division, University of Texas Health Science Center at Houston (A.D.B.). jsaver@mednet.ucla.edu.
DAWN Trial and MOST Trial Steering Committees
Additional contributors from DAWN Trial Steering Committee

Funding

LCenter for Clinical and Translational Science and TrainingUL1TR001425 · NCATS · UNIVERSITY OF CINCINNATI · PI HEUBI, JAMES E., KISSELA, BRETT M · 2015 to 2024
$37.5M
UCLA SPOTRIAS CENTER APPLICATION RENEWAL-PROGRAM PROJECTP50NS044378 · NINDS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI SAVER, JEFFREY L · 2003 to 2012
$17.2M
THE RELATIONSHIP OF SERUM PROTEINS TO STROKE SEVERITYP50NS044283 · NINDS · UNIVERSITY OF CINCINNATI · PI FLATHERY, MATHEW · 2002 to 2012
$17.1M
University of Cincinnati NETT Network Hub and Spoke SystemU10NS058982 · NINDS · UNIVERSITY OF CINCINNATI · PI ADEOYE, OPEOLU M, PANCIOLI, ARTHUR MARTIN · 2007 to 2016
$2.6M
NCATS NIH HHS UL1 TR001425NINDS NIH HHS P50 NS044283NINDS NIH HHS P50 NS044378NINDS NIH HHS U10 NS058982
6 · The paper itself

Abstract

background and purposeAlthough the modified Rankin Scale (mRS) is the most commonly used primary end point in acute stroke trials, its power is limited when analyzed in dichotomized fashion and its indication of effect size challenging to interpret when analyzed ordinally. Weighting the 7 Rankin levels by utilities may improve scale interpretability while preserving statistical power.

methodsA utility-weighted mRS (UW-mRS) was derived by averaging values from time-tradeoff (patient centered) and person-tradeoff (clinician centered) studies. The UW-mRS, standard ordinal mRS, and dichotomized mRS were applied to 11 trials or meta-analyses of acute stroke treatments, including lytic, endovascular reperfusion, blood pressure moderation, and hemicraniectomy interventions.

resultsUtility values were 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. For trials with unidirectional treatment effects, the UW-mRS paralleled the ordinal mRS and outperformed dichotomous mRS analyses. Both the UW-mRS and the ordinal mRS were statistically significant in 6 of 8 unidirectional effect trials, whereas dichotomous analyses were statistically significant in 2 to 4 of 8. In bidirectional effect trials, both the UW-mRS and ordinal tests captured the divergent treatment effects by showing neutral results, whereas some dichotomized analyses showed positive results. Mean utility differences in trials with statistically significant positive results ranged from 0.026 to 0.249.

conclusionsA UW-mRS performs similar to the standard ordinal mRS in detecting treatment effects in actual stroke trials and ensures the quantitative outcome is a valid reflection of patient-centered benefits.

Indexed as

Severity of Illness IndexClinical Trials as TopicHumansPatient-Centered CareStrokeTreatment Outcomeblood pressurestrokestroke managementthrombolysis

Identifiers

PMID26138130
PMCPMC4519373

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.