dc.contributor.author | Garg, Ravi | |
dc.contributor.author | Mickenautsch, Steffen | |
dc.date.accessioned | 2022-10-03T09:48:36Z | |
dc.date.available | 2022-10-03T09:48:36Z | |
dc.date.issued | 2022 | |
dc.identifier.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 | en_US |
dc.identifier.issn | 1471-2288 | |
dc.identifier.uri | https://doi.org/10.1186/s12874-022-01651-4 | |
dc.identifier.uri | http://hdl.handle.net/10566/7995 | |
dc.description.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. | en_US |
dc.language.iso | en | en_US |
dc.publisher | BMC | en_US |
dc.subject | Acute ischemic stroke | en_US |
dc.subject | Alteplase | en_US |
dc.subject | Stroke | en_US |
dc.title | Risk of selection bias assessment in the NINDS rt‑PA stroke study | en_US |
dc.type | Article | en_US |