{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T05:19:08Z","timestamp":1787548748786,"version":"build-2736575974"},"reference-count":75,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T00:00:00Z","timestamp":1787529600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"NIH","award":["U24TR004440"],"award-info":[{"award-number":["U24TR004440"]}]}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Neurol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We synthesized regulatory guidance, outcomes-research standards, and stroke-specific evidence to develop a dichotomous, status-based PRO responder endpoint at 90\u202fdays 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>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\u202f+\u202fEQ-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\u20132.81; number needed to treat \u2248 4\u20135), 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fneur.2026.1826727","type":"journal-article","created":{"date-parts":[[2026,8,24]],"date-time":"2026-08-24T04:24:29Z","timestamp":1787545469000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["A severity-anchored, patient-reported outcome framework for clinical trials in post-stroke dysphagia"],"prefix":"10.3389","volume":"17","author":[{"given":"Adnan I.","family":"Qureshi","sequence":"first","affiliation":[{"name":"Zeenat Qureshi Stroke Institute","place":["Columbia, MO, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gunjanpreet","family":"Kaur","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Missouri","place":["Columbia, MO, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lourdes","family":"Carhuapoma","sequence":"additional","affiliation":[{"name":"BIOS Clinical Trials Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine","place":["Baltimore, MD, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pashmeen","family":"Lakhani","sequence":"additional","affiliation":[{"name":"Zeenat Qureshi Stroke Institute","place":["Columbia, MO, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maureen A.","family":"Lefton-Greif","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Eudowood Division of Pediatric Respiratory Sciences, Johns Hopkins University School of Medicine","place":["Baltimore, MD, United States"]},{"name":"Department of Otolaryngology-Head and Neck Surgery, The Johns Hopkins University School of Medicine","place":["Baltimore, MD, United States"]},{"name":"Department of Physical Medicine and Rehabilitation, The Johns Hopkins University School of Medicine","place":["Baltimore, MD, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David R.","family":"Mehr","sequence":"additional","affiliation":[{"name":"Department of Family and Community Medicine, University of Missouri","place":["Columbia, MO, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa A.","family":"Royse","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery, University of Missouri","place":["Columbia, MO, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nae-Yuh","family":"Wang","sequence":"additional","affiliation":[{"name":"Johns Hopkins University School of Medicine","place":["Baltimore, MD, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kamran","family":"Zahoor","sequence":"additional","affiliation":[{"name":"Department of Neurology, University of Missouri","place":["Columbia, MO, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel F.","family":"Hanley","sequence":"additional","affiliation":[{"name":"BIOS Clinical Trials Coordinating Center, Trial Innovation Center, Johns Hopkins University School of Medicine","place":["Baltimore, MD, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,8,24]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","first-page":"106407","DOI":"10.1016\/j.jstrokecerebrovasdis.2022.106407","article-title":"Annual direct cost of dysphagia associated with acute ischemic stroke in the United States","volume":"31","author":"Qureshi","year":"2022","journal-title":"J Stroke Cerebrovasc Dis"},{"key":"ref2","doi-asserted-by":"publisher","first-page":"870","DOI":"10.1161\/STR.0b013e318284056a","article-title":"Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association\/American Stroke Association","volume":"44","author":"Jauch","year":"2013","journal-title":"Stroke"},{"key":"ref3","doi-asserted-by":"publisher","first-page":"3200","DOI":"10.1016\/j.jstrokecerebrovasdis.2018.07.022","article-title":"Predictors of percutaneous 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