Added Value of a Blinded Outcome Adjudication Committee in an Open-Label Randomized Stroke Trial
| Autor: | 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, Hester F. Lingsma, Aad van der Lugt, Diederik W.J. Dippel, Puck S.S. Fransen, Debbie Beumer, Lucie A. van den Berg, Albert J. Yoo, Wouter J. Schonewille, Jan Albert Vos, Paul J. Nederkoorn, Marieke J.H. Wermer, Marianne A.A. van Walderveen, Julie Staals, Jeannette Hofmeijer, Jacques A. van Oostayen, Geert J. Lycklama a Nijeholt, Patrick A. Brouwer, Bart J. Emmer, Sebastiaan F. de Bruijn, Lukas C. van Dijk, L. Jaap Kappelle, Rob H. Lo, Joost de Vries, Paul L.M. de Kort, Willem Jan J. van Rooij, Jan S.P. van den Berg, Boudewijn A.A.M. van Hasselt, Leo A.M. Aerden, Rene J. Dallinga, Marieke C. Visser, Joseph C.J. Bot, Patrick C. Vroomen, Omid Eshghi, Tobien H.C.M.L. Schreuder, Roel J.J. Heijboer, Koos Keizer, Alexander V. Tielbeek, Heleen M. den Hertog, Dick G. Gerrits, Renske M. van den Berg-Vos, Giorgos B. Karas, Ewout W. Steyerberg, H. Zwenneke Flach, Henk A. Marquering, Marieke E.S. Sprengers, Sjoerd F.M. Jenniskens, Ludo F.M. Beenen, Rene van den Berg |
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| Přispěvatelé: | Radiology and Nuclear Medicine, Amsterdam Neuroscience - Cellular & Molecular Mechanisms, Neurology, ACS - Atherosclerosis & ischemic syndromes, Amsterdam Neuroscience - Neurovascular Disorders, ACS - Microcirculation, Radiology & Nuclear Medicine, Public Health, Klinische Neurowetenschappen, MUMC+: MA Neurologie (3), RS: Carim - B05 Cerebral small vessel disease, MUMC+: Hersen en Zenuw Centrum (3), Beeldvorming, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: Carim - B06 Imaging |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
Male
IMPACT Original Contributions Vascular damage Radboud Institute for Health Sciences [Radboudumc 16] Outcome assessment Outcome (game theory) Brain Ischemia odds ratio Single-Blind Method Prospective Studies Stroke SCALE Netherlands MISCLASSIFICATION clinical trial Middle Aged Disorders of movement Donders Center for Medical Neuroscience [Radboudumc 3] Treatment Outcome BIAS AGREEMENT RELIABILITY ComputingMethodologies_DOCUMENTANDTEXTPROCESSING Female telephone Open label Cardiology and Cardiovascular Medicine CLINICAL-TRIALS medicine.medical_specialty Advisory Committees TRAUMATIC BRAIN-INJURY Clinical and Population Sciences All institutes and research themes of the Radboud University Medical Center Added value medicine ischemic stroke Humans Aged Advanced and Specialized Nursing algorithm business.industry Other Research Radboud Institute for Health Sciences [Radboudumc 0] Odds ratio medicine.disease ADJUDICATION COMMITTEE Clinical trial Physical therapy Neurology (clinical) MEASUREMENT ERROR business |
| Zdroj: | Stroke, 53(1), 61-69. LIPPINCOTT WILLIAMS & WILKINS Stroke, 53(1), 61-69. Lippincott Williams and Wilkins Stroke, 53, 61-69 Stroke Stroke, 53(1), 61-69. Lippincott Williams & Wilkins Stroke, 53, 1, pp. 61-69 |
| ISSN: | 0039-2499 |
| DOI: | 10.1161/strokeaha.121.035301 |
| Popis: | Supplemental Digital Content is available in the text. Background and Purpose: Blinded 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. Methods: We 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. Results: In MR CLEAN, 53/500 (10.6%) of the mRS scores were misclassified. The degree and direction of misclassification did not differ between treatment arms (P=0.59). Benefit of endovascular treatment was shown on the mRS when scored by the central assessor (adjusted common odds ratio, 1.60 [95% CI, 1.16–2.21]) and the outcome adjudication committee (adjusted common odds ratio, 1.67 [95% CI, 1.21–2.20]). Conclusions: Misclassification 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. |
| Databáze: | OpenAIRE |
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