Trial reportInternational journal of stroke : official journal of the International Stroke Society2023
Blinding of outcome assessors and its association with outcome in a randomized open-label stroke trial.
Trial report in International journal of stroke : official journal of the International Stroke Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00359424 (Interventional Management of Stroke Trial), which is not on this map. Cited by 8 papers.
What it found
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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.
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.
Interventional Management of Stroke Trial (IMS III): A Phase III Clinical Trial Examining Whether a Combined Intravenous (IV) and Intra-Arterial (IA) Approach to Recanalization is Superior to Standard IV Rt-PA (Activase®) Alone
Who cites it
8 citing papers in PubMed.
- Effects of Acupuncture-Combined Tuina on Patients With Knee Osteoarthritis: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2026Trial
- Enhancing open clinical trials through blinded evaluations: an exploration with diabetic foot infections.Trials · 2023Trial
- Measuring and appraising placebo effects in clinical trials: contemporary challenges and approaches in psychiatry.The lancet. Psychiatry · 2026Review
- Methodological Considerations on "Postoperative Analgesia and Recovery with Liposomal Bupivacaine TAP/RSB Block in Elderly Patients Undergoing Laparoscopic Inguinal Hernia Repair: A Randomized Controlled Trial": A Comment on the Study by Gu et al [Letter].Drug design, development and therapy · 2026Article
- Applications and implementation considerations for stepped-wedge designs in sub-Saharan Africa: a systematic review.Frontiers in epidemiology · 2026Review
- Multistate Markov model for functional recovery in stroke: probability of state transition and prognosis prediction.Scientific reports · 2025Article
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Corrections and comments
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Authors and funding
6 authors.
Funding
Abstract
backgroundIt is challenging for outcome assessors to remain blinded during outcome assessment in trials with prospective randomized open blinded endpoint (PROBE) design. If assessors are able to guess the correct treatment allocation more often than expected based on chance, the assessors may have been not properly blinded.
aimsWe aimed to assess blinding of outcome assessors in a stroke trial with PROBE design and its association with outcome.
methodsWe used data of the Interventional Management of Stroke (IMS) III trial. The modified Rankin Scale (mRS) at 90 days was assessed by local assessors who were unaware of treatment allocation. To assess success of blinding, each assessor was asked to guess the patient's treatment allocation. We assessed whether the percentage of correct guesses was higher than chance (i.e. 50%). The association between correctly guessed treatment allocation and the mRS at 90 days was analyzed with ordinal logistic regression stratified by treatment allocation. We tested for interaction of correctly versus incorrectly guessed treatment allocation with actual treatment allocation on the mRS. Patients with missing data on guessed treatment allocation and patients who died prior to 90-day assessment were excluded.
resultsIn total, 459 patients were included in this study. The assessors guessed the correct treatment allocation significantly more often than expected (267/459, 58.2%, one-sided p = 0.0003). Correctly guessed treatment allocations were associated with better mRS scores in the intervention group (common odds ratio (cOR): 2.28, 95% confidence interval (CI): 1.50-3.48) and with worse mRS scores in the control group (cOR: 0.47, 95% CI: 0.27-0.83) (p
conclusionsAssessors may not always be truly blinded for treatment allocation in clinical trials, and their guesses may be associated with outcome. Although causality between the assessors' guess and patient outcome cannot be determined, future trials with subjective outcome should make efforts to ensure blinding and should report their blinding method and the success of blinding like the IMS III trial. CLINICAL
trial registrationURL: https://clinicaltrials.gov. Unique identifier: NCT00359424.
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