ArticleFrontiers in neurology2026
A severity-anchored, patient-reported outcome framework for clinical trials in post-stroke dysphagia.
Article in Frontiers in neurology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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10 authors.
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Abstract
Background: Post-stroke dysphagia is common and is associated with aspiration pneumonia, malnutrition, longer hospitalization, and reduced quality of life. Trials evaluating interventions for post-stroke dysphagia face persistent challenges in selecting endpoints that are both patient-centered and methodologically robust. Objectives: To derive and justify a patient-reported outcome (PRO) endpoint for stroke-related dysphagia that supports clinically meaningful interpretation, statistical efficiency, and alignment with regulatory expectations. Methods: We synthesized regulatory guidance, outcomes-research standards, and stroke-specific evidence to develop a dichotomous, status-based PRO responder endpoint at 90 days post-stroke that integrates swallowing-specific quality of life (SWAL-QOL) and global health-related quality of life (EuroQol-5D; EQ-5D). Responder definitions were calibrated to baseline dysphagia severity using swallowing-relevant National Institutes of Health Stroke Scale (NIHSS) subcomponents assessed in the early post-acute period. Monte Carlo simulations (10,000 simulated patients with post-stroke dysphagia) compared performance of the combined responder endpoint versus (i) continuous SWAL-QOL and (ii) utility-weighted modified Rankin Scale (UW-mRS) analyses under clinically realistic severity distributions and treatment effects. Sample size requirements were estimated for individually randomized and stepped-wedge designs. Results: Severity-anchored responder endpoints were more statistically efficient and more interpretable than continuous or change-based analyses in heterogeneous acute stroke populations. In simulation, combined SWAL-QOL + EQ-5D responder rates increased from 42.7% (control) to 66.2% (treatment), an absolute difference of 23.5% (odds ratio 2.58, 95% CI 2.38-2.81; number needed to treat ≈ 4-5), with the largest effects in moderate and severe dysphagia. In contrast, mean SWAL-QOL improved by 8.3 points (near or below commonly cited minimal clinically important difference thresholds), and mean UW-mRS improved by 0.017, indicating limited sensitivity of global disability measures. Conclusion: A severity-calibrated, dichotomous PRO responder endpoint combining SWAL-QOL and EQ-5D provides a patient-centered, statistically efficient, and methodologically robust framework for evaluating therapeutic interventions in post-stroke dysphagia.
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