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Enrollment bias: frequency and impact on patient selection in endovascular stroke trials.

Abstract：

BACKGROUND:Selection bias may have affected enrollment in first generation endovascular stroke trials. We investigate, evaluate, and quantify such bias for these trials at our institution. METHODS:Demographic, clinical, imaging, and angiographic data were prospectively collected on a consecutive cohort of patients with acute ischemic stroke who were enrolled in formal trials of endovascular stroke therapy (EST) or received EST in clinical practice outside of a randomized trial for acute cerebral ischemia at a single tertiary referral center from September 2004 to December 2012. RESULTS:Among patients considered appropriate for EST in practice, 47% were eligible for trials, with rates for individual trials ranging from 17% to 70%. Compared with trial ineligible patients treated with EST, trial eligible patients were younger (67 vs. 74 years; p<0.05), more often treated with intravenous tissue plasminogen activator (53% vs. 34%; p<0.01), and had shorter last known well to puncture times (328 vs. 367 min; p<0.05). Focusing on the largest trial with a non-interventional control arm, compared with trial eligible patients treated with EST outside the trial, enrolled patients presented later (274 vs. 163 min; p<0.001), had higher National Institutes of Health Stroke Scale scores (20 vs. 17; p<0.05), and larger strokes (diffusion weighted imaging volumes 49 vs. 18; p<0.001). CONCLUSIONS:The majority of patients felt suitable for EST at our institution were excluded from recent trials. Formal entry criteria succeeded in selecting patients with better prognostic features, although many of these patients were treated outside of trials. Acknowledging and mitigating these biases will be crucial to ongoing investigations.

journal_name

J Neurointerv Surg

journal_title

Journal of neurointerventional surgery

authors

Sheth SA,Saver JL,Starkman S,Grunberg ID,Guzy J,Ali LK,Kim D,Gonzalez NR,Jahan R,Tateshima S,Duckwiler G,Liebeskind DS

doi

10.1136/neurintsurg-2014-011628

subject

Has Abstract

pub_date

2016-04-01 00:00:00

pages

353-9

issue

eissn

1759-8478

issn

1759-8486

pii

neurintsurg-2014-011628

journal_volume

pub_type

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Enrollment bias: frequency and impact on patient selection in endovascular stroke trials.