{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T12:06:15Z","timestamp":1779192375017,"version":"3.51.4"},"reference-count":21,"publisher":"Wiley","issue":"8-9","license":[{"start":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T00:00:00Z","timestamp":1775088000000},"content-version":"vor","delay-in-days":1,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"funder":[{"DOI":"10.13039\/100000066","name":"National Institute of Environmental Health Sciences","doi-asserted-by":"publisher","award":["T32 ES007018"],"award-info":[{"award-number":["T32 ES007018"]}],"id":[{"id":"10.13039\/100000066","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Statistics in Medicine"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>This paper introduces a randomization\u2010based method for covariate\u2010adjusted comparisons of restricted mean survival time (RMST) between treatment arms in randomized controlled trials. Existing approaches for covariate\u2010adjusted RMST analysis have model\u2010based assumptions that may not be compatible with the complexity of survival data. We estimate the treatment difference in RMST using randomization\u2010based analysis of covariance (RB\u2010ANCOVA) for categorized time\u2010to\u2010event data by constraining the covariate mean differences between treatment groups to zero. Accordingly, we provide corresponding confidence intervals that offer greater precision than those based on unadjusted RMST differences. The methodology is detailed for comparing two treatment groups for a single or multiple time intervals, as well as for multiple treatment groups over a single interval. We demonstrate the application of these methods using data from a randomized, double\u2010blind, placebo\u2010controlled clinical trial evaluating three doses of a test treatment for ALS.<\/jats:p>","DOI":"10.1002\/sim.70422","type":"journal-article","created":{"date-parts":[[2026,4,2]],"date-time":"2026-04-02T10:21:17Z","timestamp":1775125277000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Randomization\u2010Based Covariance Analysis for Confidence Intervals of Treatment Comparisons Based on Restricted Mean Survival Time With Categorized Time\u2010to\u2010Event Data"],"prefix":"10.1002","volume":"45","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7410-8370","authenticated-orcid":false,"given":"Taylor","family":"Krajewski","sequence":"first","affiliation":[{"name":"Department of Biostatistics University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"},{"name":"Department of Biostatistics and Bioinformatics Duke University  Durham North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gary","family":"Koch","sequence":"additional","affiliation":[{"name":"Department of Biostatistics University of North Carolina at Chapel Hill  Chapel Hill North Carolina USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,4,2]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.3348\/kjr.2022.0061"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/biom.12770"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.4274"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.64.2488"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.55.2208"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10985-004-4771-0"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/90.1.15"},{"key":"e_1_2_11_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/biostatistics\/kxt050"},{"key":"e_1_2_11_10_1","doi-asserted-by":"publisher","DOI":"10.1177\/09622802231211009"},{"key":"e_1_2_11_11_1","doi-asserted-by":"publisher","DOI":"10.1002\/sim.8206"},{"key":"e_1_2_11_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/1740774518759281"},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.0006-341X.2001.01030.x"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1998.10473722"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1987.10478555"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0258(19980815\/30)17:15\/16<1863::AID-SIM989>3.0.CO;2-M"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1080\/10543406.2017.1289954"},{"key":"e_1_2_11_18_1","doi-asserted-by":"publisher","DOI":"10.1081\/BIP-100101179"},{"key":"e_1_2_11_19_1","unstructured":"National Institute of Neurological Disorders and Stroke \u201cAmyotrophic Lateral Sclerosis (ALS)\u00a0\u2013\u00a0Fact Sheet \u201d2024 accessed February 2 2024 https:\/\/www.ninds.nih.gov\/health\u2010information\/disorders\/amyotrophic\u2010lateral\u2010sclerosis\u2010als."},{"key":"e_1_2_11_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/s0140\u20106736(96)91680\u20103"},{"key":"e_1_2_11_21_1","volume-title":"Categorical Data Analysis Using SAS","author":"Stokes M. E.","year":"2012"},{"key":"e_1_2_11_22_1","unstructured":"T.Krajewski \u201cThe Augmented Synthetic Control Method with Interference and Randomization\u2010Based Covariance Analysis for Restricted Mean Survival Time Estimates\u201d (Doctoral diss. University of North Carolina at Chapel Hill 2025)."}],"container-title":["Statistics in Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.70422","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/sim.70422","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/sim.70422","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T11:21:52Z","timestamp":1779189712000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/sim.70422"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4]]},"references-count":21,"journal-issue":{"issue":"8-9","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1002\/sim.70422"],"URL":"https:\/\/doi.org\/10.1002\/sim.70422","archive":["Portico"],"relation":{},"ISSN":["0277-6715","1097-0258"],"issn-type":[{"value":"0277-6715","type":"print"},{"value":"1097-0258","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4]]},"assertion":[{"value":"2025-05-21","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-01-19","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-04-02","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70422"}}