Risk of selection bias assessment in the NINDS rt‑PA stroke study

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dc.contributor.authorGarg, Ravi
dc.contributor.authorMickenautsch, Steffen
dc.date.accessioned2022-10-03T09:48:36Z
dc.date.available2022-10-03T09:48:36Z
dc.date.issued2022
dc.description.abstractThe 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.en_US
dc.identifier.citationGarg, 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/s12874-022-01651-4en_US
dc.identifier.issn1471-2288
dc.identifier.urihttps://doi.org/10.1186/s12874-022-01651-4
dc.identifier.urihttp://hdl.handle.net/10566/7995
dc.language.isoenen_US
dc.publisherBMCen_US
dc.subjectAcute ischemic strokeen_US
dc.subjectAlteplaseen_US
dc.subjectStrokeen_US
dc.titleRisk of selection bias assessment in the NINDS rt‑PA stroke studyen_US
dc.typeArticleen_US

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