Evidence map›Paper›PMID 34607469›Full record

Trial reportStroke2022

Added Value of a Blinded Outcome Adjudication Committee in an Open-Label Randomized Stroke Trial.

Nadinda A M van der Ende, Bob Roozenbeek, Olvert A Berkhemer, Peter J Koudstaal, Jelis Boiten, Ewoud J van Dijk, Yvo B W E M Roos, Robert J van Oostenbrugge, Charles B L M Majoie, Wim van Zwam and 4 more

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Stroke, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 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

3 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Should we adjudicate outcomes in stroke trials? A systematic review.International journal of stroke : official journal of the International Stroke Society · 2023
    Pooled it
  2. Trial
  3. Article
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

14 authors.

Nadinda A M van der EndeDepartments of Neurology (N.A.M.v.d.E., B.R., O.A.B., P.J.K., D.W.J.D.), Erasmus MC University Medical Center, Rotterdam, the Netherlands.ORCID 0000-0003-4681-8388
Bob RoozenbeekDepartments of Neurology (N.A.M.v.d.E., B.R., O.A.B., P.J.K., D.W.J.D.), Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Olvert A BerkhemerDepartments of Neurology (N.A.M.v.d.E., B.R., O.A.B., P.J.K., D.W.J.D.), Erasmus MC University Medical Center, Rotterdam, the Netherlands.ORCID 0000-0002-2212-6128
Peter J KoudstaalDepartments of Neurology (N.A.M.v.d.E., B.R., O.A.B., P.J.K., D.W.J.D.), Erasmus MC University Medical Center, Rotterdam, the Netherlands.ORCID 0000-0003-4998-9609
Jelis BoitenDepartment of Neurology, Haaglanden Medical Center, the Hague, the Netherlands (J.B.).
Ewoud J van DijkDepartment of Neurology, Radboud University Medical Center, Nijmegen, the Netherlands (E.J.v.D.).
Yvo B W E M RoosNeurology (O.A.B., Y.B.W.E.M.R.), Amsterdam UMC, University of Amsterdam, the Netherlands.ORCID 0000-0001-9205-5882
Robert J van OostenbruggeDepartments of Neurology (R.J.v.O.), Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands.ORCID 0000-0003-1032-9099
Charles B L M MajoieDepartments of Radiology and Nuclear Medicine (O.A.B., C.B.L.M.M.), Amsterdam UMC, University of Amsterdam, the Netherlands.ORCID 0000-0002-7600-9568
Wim van ZwamRadiology and Nuclear Medicine (W.v.Z.), Cardiovascular Research Institute Maastricht, Maastricht University Medical Center, the Netherlands.ORCID 0000-0003-1631-7056
Hester F LingsmaPublic Health (H.F.L.), Erasmus MC University Medical Center, Rotterdam, the Netherlands.
Aad van der LugtRadiology and Nuclear Medicine (N.A.M.v.d.E., B.R., O.A.B., A.v.d.L.), Erasmus MC University Medical Center, Rotterdam, the Netherlands.ORCID 0000-0002-6159-2228
Diederik W J DippelDepartments of Neurology (N.A.M.v.d.E., B.R., O.A.B., P.J.K., D.W.J.D.), Erasmus MC University Medical Center, Rotterdam, the Netherlands.ORCID 0000-0002-9234-3515
MR CLEAN Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

background and purposeBlinded outcome assessment in trials with prospective randomized open blinded end point design is challenging. Unblinding can result in misclassified outcomes and biased treatment effect estimates. An outcome adjudication committee assures blinded outcome assessment, but the added value for trials with prospective randomized open blinded end point design and subjective outcomes is unknown. We aimed to assess the degree of misclassification of modified Rankin Scale (mRS) scores by a central assessor and its impact on treatment effect estimates in a stroke trial with prospective randomized open blinded end point design.

methodsWe used data from the MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands). The primary outcome was the mRS at 90 days. Standardized, algorithm-based telephone interviews to assess the mRS were conducted from a central location by an experienced research nurse, unaware but not formally blinded to treatment allocation (central assessor). Masked reports of these interviews were adjudicated by a blinded outcome committee. Misclassification was defined as an incorrect classification of the mRS by the central assessor. The effect of endovascular treatment on the mRS was assessed with multivariable ordinal logistic regression.

resultsIn MR CLEAN, 53/500 (10.6%) of the mRS scores were misclassified. The degree and direction of misclassification did not differ between treatment arms (

conclusionsMisclassification by the central assessor was small, randomly distributed over treatment arms, and did not affect treatment effect estimates. This study suggests that the added value of a blinded outcome adjudication committee is limited in a stroke trial with prospective randomized open blinded end point design applying standardized, algorithm-based outcome assessment by a central assessor, who is unaware but not formally blinded to treatment allocation. Registration: URL: https://www.isrctn.com; Unique identifier: ISRCTN10888758.

Indexed as

Advisory CommitteesAgedBrain IschemiaFemaleHumansIschemic StrokeMaleMiddle AgedNetherlandsProspective StudiesSingle-Blind MethodTreatment Outcomealgorithmclinical trialischemic strokeodds ratiotelephone

Identifiers

PMID34607469
PMCPMC8700318

What OpenQuestion holds

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Registered trials

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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.