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Statistical analysis of stepped-wedge trials differs from that of traditional CRTs and should account for changes in outcome measures due to the intervention separate from those due to secular or time-based trends. We conclude with an example of a stepped-wedge study at 26 hospitals that helped to establish the effectiveness and safety of the Eat, Sleep, Console approach to neonatal opioid withdrawal syndrome.<\/jats:p>","DOI":"10.1542\/hpeds.2025-009158","type":"journal-article","created":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T00:02:53Z","timestamp":1791158573000},"source":"Crossref","is-referenced-by-count":0,"title":["One Step at a Time: Design and Rationale for Stepped-Wedge Cluster Randomized Trials"],"prefix":"10.1542","author":[{"given":"Sahar N.","family":"Rooholamini","sequence":"first","affiliation":[{"name":"1Department of Pediatrics, Division of Hospital Medicine, University of Washington School of Medicine, Seattle, Washington"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corrie E.","family":"McDaniel","sequence":"additional","affiliation":[{"name":"1Department of Pediatrics, Division of Hospital Medicine, University of Washington School of Medicine, 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