ArticleContemporary clinical trials communications2017
The distribution of the modified Rankin scale scores change according to eligibility criteria in acute ischemic stroke trials: A consideration for sample size calculations when using ordinal regression analysis.
Article in Contemporary clinical trials communications, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- INFOMATAS multi-center systematic review and meta-analysis individual patient data of dynamic cerebral autoregulation in ischemic stroke.International journal of stroke : official journal of the International Stroke Society · 2020Pooled it
- Tree-Based Risk Factor Identification and Stroke Level Prediction in Stroke Cohort Study.BioMed research international · 2023Article
- Observational
- Actigraphic Measurement of the Upper Limbs for the Prediction of Ischemic Stroke Prognosis: An Observational Study.Sensors (Basel, Switzerland) · 2021Observational
- Article
- Mechanical thrombectomy for vertebral and basilar artery occlusions: An institutional experience with 17 patients.Medicine internationalArticle
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDistribution shifts of the modified Rankin scale (mRs) is used as outcome measure in acute ischemic stroke (AIS) randomized controlled trials (RCT). Distribution across strata of mRs is relevant for sample size calculations and may be affected by eligibility criteria.
aimWe aimed to assess the distribution of mRs scores across its different strata in AIS according to usual eligibility criteria.
methodsWe computed follow-up mRs strata distribution between an unselected cohort and samples with (a) time from symptom onset < 6 h (b) National Institutes of Health Stroke Scale (NIHSS) scores > 3 and < 25, and (c) both criteria combined. We compared distributions with the Mann-Whitney
resultsWe included 5849 AIS patients. The unselected sample had a non-normal distribution with a median of 2. All selection criteria yielded significantly different distributions of mRs (p = 004, 0.02 and 0.02 respectively). This resulted in a significant variation in the calculated sample size when applying different selection criteria, with smaller numbers when RCT selection criteria are used (3616 versus 1553).
conclusionsThe use of usual RCT eligibility criteria result in significant differences in mRs distribution and smaller sample sizes compared to unselected AIS samples.
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