{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,22]],"date-time":"2026-07-22T00:02:46Z","timestamp":1784678566919,"version":"3.55.0"},"reference-count":40,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2026,10,1]],"date-time":"2026-10-01T00:00:00Z","timestamp":1790812800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2026,6,11]],"date-time":"2026-06-11T00:00:00Z","timestamp":1781136000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100021055","name":"Apnimed, Inc.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100021055","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Sleep Medicine"],"published-print":{"date-parts":[[2026,10]]},"DOI":"10.1016\/j.sleep.2026.109041","type":"journal-article","created":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T15:21:18Z","timestamp":1780068078000},"page":"109041","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":0,"special_numbering":"C","title":["Content validity and clinically meaningful change on patient-reported outcome measures for use in obstructive sleep apnea"],"prefix":"10.1016","volume":"146","author":[{"given":"Joseph M.","family":"Ojile","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina S.","family":"Yu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ron","family":"Farkas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hilary H.","family":"Colwell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan D.","family":"Mathias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John","family":"Cronin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.sleep.2026.109041_bib1","doi-asserted-by":"crossref","first-page":"687","DOI":"10.1016\/S2213-2600(19)30198-5","article-title":"Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis","volume":"7","author":"Benjafield","year":"2019","journal-title":"Lancet Respir Med"},{"key":"10.1016\/j.sleep.2026.109041_bib2","doi-asserted-by":"crossref","first-page":"1093","DOI":"10.1212\/01.CON.0000522245.13784.f6","article-title":"Sleep-disordered breathing","volume":"23","author":"Foldvary-Schaefer","year":"2017","journal-title":"Continuum (Minneap Minn)"},{"key":"10.1016\/j.sleep.2026.109041_bib3","doi-asserted-by":"crossref","first-page":"1230","DOI":"10.1056\/NEJM199304293281704","article-title":"The occurrence of sleep-disordered breathing among middle-aged adults","volume":"328","author":"Young","year":"1993","journal-title":"N Engl J Med"},{"key":"10.1016\/j.sleep.2026.109041_bib4","doi-asserted-by":"crossref","DOI":"10.1016\/j.rmed.2025.108348","article-title":"Unmasking obstructive sleep apnea: estimated prevalence and impact in the United States","volume":"248","author":"S\u00f6nmez","year":"2025","journal-title":"Respir Med"},{"key":"10.1016\/j.sleep.2026.109041_bib5","doi-asserted-by":"crossref","first-page":"e127","DOI":"10.18295\/squmj.2018.18.02.001","article-title":"Sleepy drivers: high time for action","volume":"18","author":"Al-Lawati","year":"2018","journal-title":"Sultan Qaboos Univ Med J"},{"key":"10.1016\/j.sleep.2026.109041_bib6","doi-asserted-by":"crossref","first-page":"136","DOI":"10.1513\/pats.200709-155MG","article-title":"The epidemiology of adult obstructive sleep apnea","volume":"5","author":"Punjabi","year":"2008","journal-title":"Proc Am Thorac Soc"},{"key":"10.1016\/j.sleep.2026.109041_bib7","doi-asserted-by":"crossref","first-page":"70","DOI":"10.1016\/j.smrv.2016.07.002","article-title":"Prevalence of obstructive sleep apnea in the general population: a systematic review","volume":"34","author":"Senaratna","year":"2017","journal-title":"Sleep Med Rev"},{"key":"10.1016\/j.sleep.2026.109041_bib8","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1097\/MCP.0000000000000724","article-title":"Endotypes and phenotypes in obstructive sleep apnea","volume":"26","author":"Malhotra","year":"2020","journal-title":"Curr Opin Pulm Med"},{"key":"10.1016\/j.sleep.2026.109041_bib9","doi-asserted-by":"crossref","first-page":"1829","DOI":"10.1007\/s11325-023-02786-4","article-title":"Clinical phenotypes of obstructive sleep apnea: a cluster analysis based on sleep perception and sleep quality","volume":"27","author":"Wei","year":"2023","journal-title":"Sleep Breath"},{"key":"10.1016\/j.sleep.2026.109041_bib10","doi-asserted-by":"crossref","DOI":"10.3389\/fpsyt.2021.630162","article-title":"The complex interaction between the major sleep symptoms, the severity of obstructive sleep apnea, and sleep quality","volume":"12","author":"Frangopoulos","year":"2021","journal-title":"Front Psychiatr"},{"key":"10.1016\/j.sleep.2026.109041_bib11","first-page":"390","article-title":"Obstructive sleep apnea syndrome and the quality of life","volume":"89","author":"Coman","year":"2016","journal-title":"Clujul Med"},{"key":"10.1016\/j.sleep.2026.109041_bib12","doi-asserted-by":"crossref","first-page":"123","DOI":"10.1378\/chest.115.1.123","article-title":"Quality of life in patients with obstructive sleep apnea: effect of nasal continuous positive airway pressure--a prospective study","volume":"115","author":"D'Ambrosio","year":"1999","journal-title":"Chest"},{"key":"10.1016\/j.sleep.2026.109041_bib13","doi-asserted-by":"crossref","first-page":"1288","DOI":"10.1002\/ppul.26903","article-title":"Improvement in quality of life with continuous positive airway pressure outweighs the treatment burden in children with obstructive sleep apnea","volume":"59","author":"Nisbet","year":"2024","journal-title":"Pediatr Pulmonol"},{"key":"10.1016\/j.sleep.2026.109041_bib14","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1186\/s12955-025-02355-1","article-title":"Fatigue is distinct from sleepiness and negatively impacts individuals living with obstructive sleep apnea (OSA): results from qualitative research of individuals with OSA","volume":"23","author":"Emsellem","year":"2025","journal-title":"Health Qual Life Outcome"},{"key":"10.1016\/j.sleep.2026.109041_bib15","article-title":"Managements for obstructive sleep apnea in adults: review","volume":"12","author":"Tserenpil","year":"2020","journal-title":"Cureus"},{"key":"10.1016\/j.sleep.2026.109041_bib16","doi-asserted-by":"crossref","first-page":"791","DOI":"10.1177\/01945998221075298","article-title":"Patient-defined goals for obstructive sleep apnea treatment","volume":"167","author":"Cai","year":"2022","journal-title":"OtolaryngolHead Neck Surg"},{"key":"10.1016\/j.sleep.2026.109041_bib17","doi-asserted-by":"crossref","DOI":"10.1002\/cam4.7198","article-title":"Treatment of obstructive sleep apnea with CPAP improves daytime sleepiness and fatigue in cancer patients","volume":"13","author":"Ganjaei","year":"2024","journal-title":"Cancer Med"},{"key":"10.1016\/j.sleep.2026.109041_bib18","article-title":"Obstructive sleep apnea in sarcoidosis and impact of cpap treatment on fatigue. Sarcoidosis, Vasculitis, and Diffuse lung diseases","author":"Pier\u2010Valerio","year":"2020","journal-title":"Offic J WASOG"},{"key":"10.1016\/j.sleep.2026.109041_bib19","first-page":"263","article-title":"Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults","volume":"5","author":"Epstein","year":"2009","journal-title":"J Clin Sleep Med : JCSM : Off Publ Am Acad Sleep Med"},{"key":"10.1016\/j.sleep.2026.109041_bib20","doi-asserted-by":"crossref","first-page":"2837","DOI":"10.5664\/jcsm.10250","article-title":"Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA","volume":"18","author":"Rosenberg","year":"2022","journal-title":"J Clin Sleep Med"},{"key":"10.1016\/j.sleep.2026.109041_bib21","doi-asserted-by":"crossref","first-page":"1316","DOI":"10.1164\/rccm.202306-1036OC","article-title":"The combination of aroxybutynin and atomoxetine in the treatment of obstructive sleep apnea (MARIPOSA): a randomized controlled trial","volume":"208","author":"Schweitzer","year":"2023","journal-title":"Am J Respir Crit Care Med"},{"key":"10.1016\/j.sleep.2026.109041_bib23","doi-asserted-by":"crossref","DOI":"10.1016\/j.conctc.2025.101538","article-title":"Aroxybutynin and atomoxetine (AD109) for the treatment of obstructive sleep apnea: rationale, design and baseline characteristics of the phase 3 clinical trials","volume":"47","author":"Taranto-Montemurro","year":"2025","journal-title":"Contemp Clin Trials Commun"},{"key":"10.1016\/j.sleep.2026.109041_bib24","doi-asserted-by":"crossref","first-page":"665","DOI":"10.1016\/j.chest.2019.11.011","article-title":"Responsiveness of patient-reported outcomes to treatment among patients with type 2 diabetes mellitus and OSA","volume":"157","author":"Donovan","year":"2020","journal-title":"Chest"},{"key":"10.1016\/j.sleep.2026.109041_bib25","doi-asserted-by":"crossref","first-page":"Np118","DOI":"10.1177\/01455613211042126","article-title":"Clinical characteristics of older adults seeking hypoglossal nerve stimulation for the treatment of obstructive sleep apnea","volume":"103","author":"Dzierzewski","year":"2024","journal-title":"Ear Nose Throat J"},{"key":"10.1016\/j.sleep.2026.109041_bib26","doi-asserted-by":"crossref","first-page":"1041","DOI":"10.1177\/10547738231182550","article-title":"Performance of PROMIS measures to assess fatigue and sleep symptom severity among African American patients newly diagnosed with obstructive sleep apnea","volume":"32","author":"Giordano","year":"2023","journal-title":"Clin Nurs Res"},{"key":"10.1016\/j.sleep.2026.109041_bib27","doi-asserted-by":"crossref","first-page":"3483","DOI":"10.1007\/s11136-022-03199-8","article-title":"Assessing sleep and pain among adults with myalgic encephalomyelitis\/chronic fatigue syndrome: psychometric evaluation of the PROMIS\u00ae sleep and pain short forms","volume":"31","author":"Yang","year":"2022","journal-title":"Qual Life Res"},{"key":"10.1016\/j.sleep.2026.109041_bib28","doi-asserted-by":"crossref","first-page":"16","DOI":"10.1186\/s41687-019-0100-y","article-title":"An overview of using qualitative techniques to explore and define estimates of clinically important change on clinical outcome assessments","volume":"3","author":"Staunton","year":"2019","journal-title":"J Patient-Rep Outcomes"},{"key":"10.1016\/j.sleep.2026.109041_bib29","series-title":"Patient-Focused Drug Development: Methods to Identify What is Important to Patients","year":"2022"},{"key":"10.1016\/j.sleep.2026.109041_bib30","doi-asserted-by":"crossref","first-page":"1016","DOI":"10.1016\/j.clinthera.2024.09.010","article-title":"Patient experience with efanesoctocog alfa for severe Hemophilia A: results from the XTEND-1 phase 3 clinical study exit interviews","volume":"46","author":"DiBenedetti","year":"2024","journal-title":"Clin Ther"},{"key":"10.1016\/j.sleep.2026.109041_bib31","doi-asserted-by":"crossref","first-page":"367","DOI":"10.1007\/s40271-022-00578-8","article-title":"Exit interviews examining the patient experience in clinical trials of tirzepatide for treatment of type 2 diabetes","volume":"15","author":"Matza","year":"2022","journal-title":"Patient - Patient-Centered Outcomes Res"},{"key":"10.1016\/j.sleep.2026.109041_bib32","doi-asserted-by":"crossref","first-page":"45","DOI":"10.1186\/s41687-024-00712-0","article-title":"Qualitative interviews of patients with COPD and muscle weakness enrolled in a clinical trial evaluating a new anabolic treatment: patient perspectives of disease experience, trial participation and outcome assessments","volume":"8","author":"Tabberer","year":"2024","journal-title":"J Patient-Rep Outcomes"},{"key":"10.1016\/j.sleep.2026.109041_bib33","doi-asserted-by":"crossref","first-page":"134","DOI":"10.1186\/s41687-021-00404-z","article-title":"Psychometric validation and meaningful change thresholds of the worst itching intensity numerical rating scale for assessing itch in patients with chronic kidney disease-associated pruritus","volume":"5","author":"Vernon","year":"2021","journal-title":"J Patient-Rep Outcomes"},{"key":"10.1016\/j.sleep.2026.109041_bib34","doi-asserted-by":"crossref","first-page":"i1353","DOI":"10.1093\/ecco-jcc\/jjad212.0850","article-title":"P720 exit interviews exploring Crohn's disease patients' experience of changes in their bowel urgency during the mirikizumab Phase 3 clinical trial in adult patients with moderate to severe Crohn disease","volume":"18","author":"Gibble","year":"2024","journal-title":"J Crohns Colitis"},{"key":"10.1016\/j.sleep.2026.109041_bib35","doi-asserted-by":"crossref","DOI":"10.3389\/frcha.2024.1236340","article-title":"Exit interviews from two randomised placebo-controlled phase 3 studies with caregivers of young children with autism spectrum disorder","volume":"3","author":"Hawken","year":"2024","journal-title":"Front Child Adolesc Psychiatr"},{"key":"10.1016\/j.sleep.2026.109041_bib36","doi-asserted-by":"crossref","first-page":"1179","DOI":"10.1016\/j.jclinepi.2010.04.011","article-title":"The patient-reported outcomes measurement information system (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008","volume":"63","author":"Cella","year":"2010","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.sleep.2026.109041_bib38","doi-asserted-by":"crossref","first-page":"781","DOI":"10.1093\/sleep\/33.6.781","article-title":"Development and validation of patient-reported outcome measures for sleep disturbance and sleep-related impairments","volume":"33","author":"Buysse","year":"2010","journal-title":"Sleep"},{"key":"10.1016\/j.sleep.2026.109041_bib39","doi-asserted-by":"crossref","first-page":"6","DOI":"10.1080\/15402002.2012.636266","article-title":"Development of short forms from the PROMISTM sleep disturbance and sleep-related impairment item banks","volume":"10","author":"Yu","year":"2011","journal-title":"Behav Sleep Med"},{"key":"10.1016\/j.sleep.2026.109041_bib40","doi-asserted-by":"crossref","first-page":"540","DOI":"10.1093\/sleep\/14.6.540","article-title":"A new method for measuring daytime sleepiness: the Epworth sleepiness scale","volume":"14","author":"Johns","year":"1991","journal-title":"Sleep"},{"key":"10.1016\/j.sleep.2026.109041_bib42","doi-asserted-by":"crossref","first-page":"2729","DOI":"10.1007\/s11136-021-02925-y","article-title":"Minimal important change (MIC): a conceptual clarification and systematic review of MIC estimates of PROMIS measures","volume":"30","author":"Terwee","year":"2021","journal-title":"Qual Life Res"},{"key":"10.1016\/j.sleep.2026.109041_bib44","doi-asserted-by":"crossref","first-page":"4627","DOI":"10.1007\/s00405-023-08062-1","article-title":"Patient-reported outcomes with hypoglossal nerve stimulation for treatment of obstructive sleep apnea: a systematic review and meta-analysis","volume":"280","author":"Braun","year":"2023","journal-title":"Eur Arch Otorhinolaryngol"}],"container-title":["Sleep Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1389945726002807?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1389945726002807?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,7,21]],"date-time":"2026-07-21T23:29:14Z","timestamp":1784676554000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1389945726002807"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":40,"alternative-id":["S1389945726002807"],"URL":"https:\/\/doi.org\/10.1016\/j.sleep.2026.109041","relation":{},"ISSN":["1389-9457"],"issn-type":[{"value":"1389-9457","type":"print"}],"subject":[],"published":{"date-parts":[[2026,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Content validity and clinically meaningful change on patient-reported outcome measures for use in obstructive sleep apnea","name":"articletitle","label":"Article Title"},{"value":"Sleep Medicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.sleep.2026.109041","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Authors. Published by Elsevier B.V.","name":"copyright","label":"Copyright"}],"article-number":"109041"}}