Risk of selection bias assessment in the NINDS rt‑PA stroke study
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Date
2022
Authors
Journal Title
Journal ISSN
Volume Title
Publisher
BMC
Abstract
The NINDS rt-PA Stroke Study is frequently cited in support of alteplase for acute ischemic stroke within
3 h of symptom onset. Multiple post-hoc reanalyses of this trial have been published to adjust for a baseline imbalance
in stroke severity. We performed a risk of selection bias assessment and reanalyzed trial data to determine if the
etiology of this baseline imbalance was more likely due to random chance or randomization errors. A risk of selection bias assessment was conducted using signaling questions from the Cochrane Risk of
Bias 2 (ROB 2) tool. Four sensitivity analyses were conducted on the trial data based on the randomization process:
assessment of imbalances in allocation in unique strata; adherence to a pre-specified restriction on randomization
between time strata at each randomization center; assessment of differences in baseline computed tomography (CT)
results in unique strata; and comparison of baseline characteristics between allocation groups within each time strata.
A multivariable logistic regression model was used to compare reported treatment effects with revised treatment
effects after adjustment of baseline imbalances identified in the sensitivity analyses.
Description
Keywords
Acute ischemic stroke, Alteplase, Stroke
Citation
Garg, R., & Mickenautsch, S. (2022). Risk of selection bias assessment in the NINDS rt‑PA stroke study. BMC Medical Research Methodology, 22(1), 172. https://doi.org/10.1186/s12874-022-01651-4