1. RCT versus real-world cohorts: Differences in patient characteristics drive associations with outcome after EVT
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Fanny Quandt, Nina Meißner, Teresa A Wölfer, Fabian Flottmann, Milani Deb-Chatterji, Lars Kellert, Jens Fiehler, Mayank Goyal, Jeffrey L Saver, Christian Gerloff, Götz Thomalla, and Steffen Tiedt
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Neurology (clinical) ,Cardiology and Cardiovascular Medicine - Abstract
Background: The selection of patients with large-vessel occlusion (LVO) stroke for endovascular treatment (EVT) depends on patient characteristics and procedural metrics. The relation of these variables to functional outcome after EVT has been assessed in numerous datasets from both randomized controlled trials (RCT) and real-world registries, but whether differences in their case mix modulate outcome prediction is unknown. Methods: We leveraged data from individual patients with anterior LVO stroke treated with EVT from completed RCTs from the Virtual International Stroke Trials Archive ( N = 479) and from the German Stroke Registry ( N = 4079). Cohorts were compared regarding (i) patient characteristics and procedural pre-EVT metrics, (ii) these variables’ relation to functional outcome, and (iii) the performance of derived outcome prediction models. Relation to outcome (functional dependence defined by a modified Rankin Scale score of 3–6 at 90 days) was analyzed by logistic regression models and a machine learning algorithm. Results: Ten out of 11 analyzed baseline variables differed between the RCT and real-world cohort: RCT patients were younger, had higher admission NIHSS scores, and received thrombolysis more often (all p Conclusions: RCT and real-world cohorts considerably differ in patient characteristics, individual outcome predictor strength, and overall outcome prediction model performance.
- Published
- 2022
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