{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T15:50:34Z","timestamp":1786981834643,"version":"build-2736575974"},"reference-count":31,"publisher":"Springer Science and Business Media LLC","issue":"3","license":[{"start":{"date-parts":[[2021,1,4]],"date-time":"2021-01-04T00:00:00Z","timestamp":1609718400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,1,4]],"date-time":"2021-01-04T00:00:00Z","timestamp":1609718400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/100011096","name":"Jazz Pharmaceuticals","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100011096","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Sleep Breath"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>This study estimated thresholds for clinically important responses and minimally important differences for two indicators of improvement for the 10-item version of the functional outcomes of sleep questionnaire (FOSQ-10).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Participants with excessive daytime sleepiness with narcolepsy or obstructive sleep apnea received 12\u00a0weeks of solriamfetol treatment. Participants completed the FOSQ-10 and other patient-reported outcome measures, including the single-item patient global impression of change (PGI-C) assessment. Clinicians completed the single-item clinician global impression of change (CGI-C) for each participant. Data from the two studies were analyzed separately, both without regard to treatment assignment. In total, 690 participants (47% female, mean age 48\u00a0years, 77% Caucasian, 91% from North America) were enrolled. Two clinically important changes, defined as a minimally important difference and a clinically important response, were determined using distribution and anchor-based analyses. A receiver operating characteristic analysis was used to determine the optimal FOSQ-10 change threshold.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Spearman correlations between change in FOSQ-10 scores and PGI-C and CGI-C were \u2212\u20090.57 and \u2212\u20090.49 for participants with narcolepsy and \u2212\u20090.42 and \u2212\u20090.37 for participants with obstructive sleep apnea. Receiver operating characteristic analysis suggested minimally important difference and clinically important response estimates of 1.7 and 2.5 and 1.8 and 2.2 points in narcolepsy and obstructive sleep apnea, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Minimally important difference and clinically important response estimates for the FOSQ-10 for adults with excessive daytime sleepiness in narcolepsy or obstructive sleep apnea will be helpful for interpreting changes over time and defining a clinical responder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/clinicaltrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      identifiers\n                    <\/jats:title>\n                    <jats:p>NCT02348593 (first submitted January 15, 2015) and NCT02348606 (first submitted January 15, 2015)<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s11325-020-02270-3","type":"journal-article","created":{"date-parts":[[2021,1,4]],"date-time":"2021-01-04T01:03:29Z","timestamp":1609722209000},"page":"1707-1715","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea"],"prefix":"10.1007","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4680-5766","authenticated-orcid":false,"given":"Terri E.","family":"Weaver","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane M.","family":"Menno","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Morgan","family":"Bron","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ross D.","family":"Crosby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan","family":"Morris","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan D.","family":"Mathias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,1,4]]},"reference":[{"issue":"3","key":"2270_CR1","doi-asserted-by":"publisher","first-page":"351","DOI":"10.5665\/sleep.4488","volume":"38","author":"J Fernandez-Mendoza","year":"2015","unstructured":"Fernandez-Mendoza J, Vgontzas AN, Kritikou I, Calhoun SL, Liao D, Bixler EO (2015) Natural history of excessive daytime sleepiness: role of obesity, weight loss, depression, and sleep propensity. Sleep 38(3):351\u2013360. https:\/\/doi.org\/10.5665\/sleep.4488","journal-title":"Sleep"},{"issue":"3","key":"2270_CR2","doi-asserted-by":"publisher","first-page":"323","DOI":"10.1016\/j.jsmc.2017.03.008","volume":"12","author":"J Zhang","year":"2017","unstructured":"Zhang J, Han F (2017) Sleepiness in narcolepsy. Sleep Med Clin 12(3):323\u2013330. https:\/\/doi.org\/10.1016\/j.jsmc.2017.03.008","journal-title":"Sleep Med Clin"},{"issue":"9","key":"2270_CR3","doi-asserted-by":"publisher","first-page":"1217","DOI":"10.1164\/rccm.2109080","volume":"165","author":"T Young","year":"2002","unstructured":"Young T, Peppard PE, Gottlieb DJ (2002) Epidemiology of obstructive sleep apnea: a population health perspective. Am J Respir Crit Care Med 165(9):1217\u20131239","journal-title":"Am J Respir Crit Care Med"},{"issue":"17","key":"2270_CR4","doi-asserted-by":"publisher","first-page":"1230","DOI":"10.1056\/NEJM199304293281704","volume":"328","author":"T Young","year":"1993","unstructured":"Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S (1993) The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med 328(17):1230\u20131235. https:\/\/doi.org\/10.1056\/NEJM199304293281704","journal-title":"N Engl J Med"},{"issue":"45","key":"2270_CR5","doi-asserted-by":"publisher","first-page":"79693","DOI":"10.18632\/oncotarget.19113","volume":"8","author":"Y Fu","year":"2017","unstructured":"Fu Y, Xu H, Xia Y, Qian Y, Li X, Zou J, Wang Y, Meng L, Tang X, Zhu H, Zhou H, Su K, Yu D, Yi H, Guan J, Yin S (2017) Excessive daytime sleepiness and metabolic syndrome in men with obstructive sleep apnea: a large cross-sectional study. Oncotarget 8(45):79693\u201379702. https:\/\/doi.org\/10.18632\/oncotarget.19113","journal-title":"Oncotarget"},{"issue":"4","key":"2270_CR6","doi-asserted-by":"publisher","first-page":"389","DOI":"10.1111\/jsr.12039","volume":"22","author":"M Gasa","year":"2013","unstructured":"Gasa M, Tamisier R, Launois SH, Sapene M, Martin F, Stach B, Grillet Y, Levy P, Pepin JL, Scientific Council of the Sleep Registry of the French Federation of Pneumology-FFP (2013) Residual sleepiness in sleep apnea patients treated by continuous positive airway pressure. J Sleep Res 22(4):389\u2013397. https:\/\/doi.org\/10.1111\/jsr.12039","journal-title":"J Sleep Res"},{"issue":"2","key":"2270_CR7","doi-asserted-by":"publisher","first-page":"144","DOI":"10.1097\/JOM.0b013e3181c99505","volume":"52","author":"B Dean","year":"2010","unstructured":"Dean B, Aguilar D, Shapiro C, Orr WC, Isserman JA, Calimlim B, Rippon GA (2010) Impaired health status, daily functioning, and work productivity in adults with excessive sleepiness. J Occup Environ Med 52(2):144\u2013149. https:\/\/doi.org\/10.1097\/JOM.0b013e3181c99505","journal-title":"J Occup Environ Med"},{"key":"2270_CR8","doi-asserted-by":"publisher","unstructured":"Bioulac S, Micoulaud-Franchi JA, Arnaud M, Sagaspe P, Moore N, Salvo F, Philip P (2017) Risk of motor vehicle accidents related to sleepiness at the wheel: a systematic review and meta-analysis. Sleep 40(10). https:\/\/doi.org\/10.1093\/sleep\/zsx134","DOI":"10.1093\/sleep\/zsx134"},{"issue":"10","key":"2270_CR9","first-page":"835","volume":"20","author":"TE Weaver","year":"1997","unstructured":"Weaver TE, Laizner AM, Evans LK, Maislin G, Chugh DK, Lyon K, Smith PL, Schwartz AR, Redline S, Pack AI, Dinges DF (1997) An instrument to measure functional status outcomes for disorders of excessive sleepiness. Sleep 20(10):835\u2013843","journal-title":"Sleep"},{"issue":"7","key":"2270_CR10","doi-asserted-by":"publisher","first-page":"915","DOI":"10.1093\/sleep\/32.7.915","volume":"32","author":"ER Chasens","year":"2009","unstructured":"Chasens ER, Ratcliffe SJ, Weaver TE (2009) Development of the FOSQ-10: a short version of the functional outcomes of sleep questionnaire. Sleep 32(7):915\u2013919","journal-title":"Sleep"},{"key":"2270_CR11","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1186\/1477-7525-4-69","volume":"4","author":"JL Brozek","year":"2006","unstructured":"Brozek JL, Guyatt GH, Schunemann HJ (2006) How a well-grounded minimal important difference can enhance transparency of labelling claims and improve interpretation of a patient reported outcome measure. Health Qual Life Outcomes 4:69. https:\/\/doi.org\/10.1186\/1477-7525-4-69","journal-title":"Health Qual Life Outcomes"},{"key":"2270_CR12","doi-asserted-by":"publisher","first-page":"62","DOI":"10.1186\/1477-7525-4-62","volume":"4","author":"HJ Schunemann","year":"2006","unstructured":"Schunemann HJ, Akl EA, Guyatt GH (2006) Interpreting the results of patient reported outcome measures in clinical trials: the clinician's perspective. Health Qual Life Outcomes 4:62. https:\/\/doi.org\/10.1186\/1477-7525-4-62","journal-title":"Health Qual Life Outcomes"},{"issue":"1","key":"2270_CR13","doi-asserted-by":"publisher","first-page":"22","DOI":"10.1177\/2168479015622667","volume":"50","author":"CD Coon","year":"2016","unstructured":"Coon CD, Cappelleri JC (2016) Interpreting change in scores on patient-reported outcome instruments. Ther Innov Regul Sci 50(1):22\u201329. https:\/\/doi.org\/10.1177\/2168479015622667","journal-title":"Ther Innov Regul Sci"},{"issue":"3","key":"2270_CR14","doi-asserted-by":"publisher","first-page":"359","DOI":"10.1002\/ana.25423","volume":"85","author":"MJ Thorpy","year":"2019","unstructured":"Thorpy MJ, Shapiro C, Mayer G, Corser BC, Emsellem H, Plazzi G, Chen D, Carter LP, Wang H, Lu Y, Black J, Dauvilliers Y (2019) A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Ann Neurol 85(3):359\u2013370. https:\/\/doi.org\/10.1002\/ana.25423","journal-title":"Ann Neurol"},{"issue":"11","key":"2270_CR15","doi-asserted-by":"publisher","first-page":"1421","DOI":"10.1164\/rccm.201806-1100OC","volume":"199","author":"PK Schweitzer","year":"2019","unstructured":"Schweitzer PK, Rosenberg R, Zammit GK, Gotfried M, Chen D, Carter LP, Wang H, Lu Y, Black J, Malhotra A, Strohl KP (2019) Solriamfetol for excessive sleepiness in obstructive sleep apnea (TONES 3): a randomized controlled trial. Am J Respir Crit Care Med 199(11):1421\u20131431. https:\/\/doi.org\/10.1164\/rccm.201806-1100OC","journal-title":"Am J Respir Crit Care Med"},{"issue":"6","key":"2270_CR16","doi-asserted-by":"publisher","first-page":"658","DOI":"10.1016\/0013-4694(82)90142-0","volume":"53","author":"MM Mitler","year":"1982","unstructured":"Mitler MM, Gujavarty KS, Browman CP (1982) Maintenance of wakefulness test: a polysomnographic technique for evaluation treatment efficacy in patients with excessive somnolence. Electroencephalogr Clin Neurophysiol 53(6):658\u2013661","journal-title":"Electroencephalogr Clin Neurophysiol"},{"issue":"6","key":"2270_CR17","doi-asserted-by":"publisher","first-page":"540","DOI":"10.1093\/sleep\/14.6.540","volume":"14","author":"MW Johns","year":"1991","unstructured":"Johns MW (1991) A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep 14(6):540\u2013545","journal-title":"Sleep"},{"key":"2270_CR18","unstructured":"Cohen J (1988) Statistical power analysis for the behavioral sciences, 2nd edn. Lawrence Erlbaum, Hillsdale, NJ"},{"issue":"8","key":"2270_CR19","first-page":"889","volume":"134","author":"GH Guyatt","year":"1986","unstructured":"Guyatt GH, Bombardier C, Tugwell PX (1986) Measuring disease-specific quality of life in clinical trials. CMAJ 134(8):889\u2013895","journal-title":"CMAJ"},{"key":"2270_CR20","doi-asserted-by":"publisher","first-page":"108","DOI":"10.1016\/j.sleep.2017.07.006","volume":"38","author":"L Scrima","year":"2017","unstructured":"Scrima L, Emsellem HA, Becker PM, Ruoff C, Lankford A, Bream G, Khayrallah M, Lu Y, Black J (2017) Identifying clinically important difference on the Epworth sleepiness scale: results from a narcolepsy clinical trial of JZP-110. Sleep Med 38:108\u2013112. https:\/\/doi.org\/10.1016\/j.sleep.2017.07.006","journal-title":"Sleep Med"},{"issue":"4","key":"2270_CR21","doi-asserted-by":"publisher","DOI":"10.1111\/jsr.12628","volume":"27","author":"AD Steffen","year":"2018","unstructured":"Steffen AD, Lai C, Weaver TE (2018) Criteria for gauging response to sodium oxybate for narcolepsy. J Sleep Res 27(4):e12628. https:\/\/doi.org\/10.1111\/jsr.12628","journal-title":"J Sleep Res"},{"issue":"5","key":"2270_CR22","doi-asserted-by":"publisher","first-page":"395","DOI":"10.1016\/S0895-4356(03)00044-1","volume":"56","author":"RD Crosby","year":"2003","unstructured":"Crosby RD, Kolotkin RL, Williams GR (2003) Defining clinically meaningful change in health-related quality of life. J Clin Epidemiol 56(5):395\u2013407","journal-title":"J Clin Epidemiol"},{"issue":"3","key":"2270_CR23","doi-asserted-by":"publisher","first-page":"221","DOI":"10.1007\/BF00435226","volume":"2","author":"E Lydick","year":"1993","unstructured":"Lydick E, Epstein RS (1993) Interpretation of quality of life changes. Qual Life Res 2(3):221\u2013226","journal-title":"Qual Life Res"},{"issue":"3","key":"2270_CR24","first-page":"307","volume":"29","author":"JA Hanley","year":"1989","unstructured":"Hanley JA (1989) Receiver operating characteristic (ROC) methodology: the state of the art. Crit Rev Diagn Imaging 29(3):307\u2013335","journal-title":"Crit Rev Diagn Imaging"},{"issue":"3","key":"2270_CR25","doi-asserted-by":"publisher","first-page":"335","DOI":"10.1016\/s0959-8049(02)00628-7","volume":"39","author":"DL Patrick","year":"2003","unstructured":"Patrick DL, Gagnon DD, Zagari MJ, Mathijs R, Sweetenham J (2003) Assessing the clinical significance of health-related quality of life (HrQOL) improvements in anaemic cancer patients receiving epoetin alfa. Eur J Cancer 39(3):335\u2013345. https:\/\/doi.org\/10.1016\/s0959-8049(02)00628-7","journal-title":"Eur J Cancer"},{"issue":"5","key":"2270_CR26","doi-asserted-by":"publisher","first-page":"469","DOI":"10.1097\/00005650-199905000-00006","volume":"37","author":"KW Wyrwich","year":"1999","unstructured":"Wyrwich KW, Nienaber NA, Tierney WM, Wolinsky FD (1999) Linking clinical relevance and statistical significance in evaluating intra-individual changes in health-related quality of life. Med Care 37(5):469\u2013478","journal-title":"Med Care"},{"issue":"9","key":"2270_CR27","doi-asserted-by":"publisher","first-page":"861","DOI":"10.1016\/S0895-4356(99)00071-2","volume":"52","author":"KW Wyrwich","year":"1999","unstructured":"Wyrwich KW, Tierney WM, Wolinsky FD (1999) Further evidence supporting an SEM-based criterion for identifying meaningful intra-individual changes in health-related quality of life. J Clin Epidemiol 52(9):861\u2013873","journal-title":"J Clin Epidemiol"},{"issue":"10","key":"2270_CR28","doi-asserted-by":"publisher","first-page":"2921","DOI":"10.1111\/j.1572-0241.2001.04682.x","volume":"96","author":"SL Jowett","year":"2001","unstructured":"Jowett SL, Seal CJ, Barton JR, Welfare MR (2001) The short inflammatory bowel disease questionnaire is reliable and responsive to clinically important change in ulcerative colitis. Am J Gastroenterol 96(10):2921\u20132928. https:\/\/doi.org\/10.1111\/j.1572-0241.2001.04682.x","journal-title":"Am J Gastroenterol"},{"issue":"7","key":"2270_CR29","doi-asserted-by":"publisher","first-page":"1478","DOI":"10.1002\/1529-0131(200007)43:7<1478::AID-ANR10>3.0.CO;2-M","volume":"43","author":"M Kosinski","year":"2000","unstructured":"Kosinski M, Zhao SZ, Dedhiya S, Osterhaus JT, Ware JE Jr (2000) Determining minimally important changes in generic and disease-specific health-related quality of life questionnaires in clinical trials of rheumatoid arthritis. Arthritis Rheum 43(7):1478\u20131487","journal-title":"Arthritis Rheum"},{"issue":"1","key":"2270_CR30","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1023\/A:1014485627744","volume":"11","author":"KW Wyrwich","year":"2002","unstructured":"Wyrwich KW, Tierney WM, Wolinsky FD (2002) Using the standard error of measurement to identify important changes on the asthma quality of life questionnaire. Qual Life Res 11(1):1\u20137","journal-title":"Qual Life Res"},{"key":"2270_CR31","doi-asserted-by":"publisher","unstructured":"Weaver TE, Mathias SD, Crosby RD, Bron M, Bujanover S, Menno D, Villa KF, Drake C (2020) Relationship between sleep efficacy endpoints and measures of functional status and health-related quality of life in participants with narcolepsy or obstructive sleep apnea treated for excessive daytime sleepiness. J Sleep Res:e13210. https:\/\/doi.org\/10.1111\/jsr.13210","DOI":"10.1111\/jsr.13210"}],"container-title":["Sleep and Breathing"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11325-020-02270-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s11325-020-02270-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s11325-020-02270-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,19]],"date-time":"2021-08-19T08:16:08Z","timestamp":1629360968000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s11325-020-02270-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,1,4]]},"references-count":31,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2021,9]]}},"alternative-id":["2270"],"URL":"https:\/\/doi.org\/10.1007\/s11325-020-02270-3","relation":{},"ISSN":["1520-9512","1522-1709"],"issn-type":[{"value":"1520-9512","type":"print"},{"value":"1522-1709","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,1,4]]},"assertion":[{"value":"22 September 2020","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"18 November 2020","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"8 December 2020","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"4 January 2021","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Compliance with ethical standards"}},{"value":"TEW has received royalty fees for the use of the FOSQ-10 from Jazz Pharmaceuticals, ResMed, Bayer AD, Cook Medical, Nyxoah, RWS, Merck & Co. Inc., Verily Life Science, WCG MedAvante Prophase, Stratevi, Evidation Health, and Philips Respironics. RDC is a consultant to Health Outcomes Solutions, which received funding from Jazz Pharmaceuticals for conducting these analyses. DMM, MB, and SM are employees of Jazz Pharmaceuticals who, in the course of their employment, have received stock options exercisable for, and other stock awards of, ordinary shares of Jazz Pharmaceuticals, LLC. SDM is an employee of Health Outcomes Solutions, which received funding from Jazz Pharmaceuticals for conducting these analyses.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"These studies were conducted in line with the principles of the Declaration of Helsinki and were approved by institutional review board or ethics committees at each site.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"All participants provided written informed consent.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"All authors granted final approval of the manuscript for submission.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Not applicable.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}}]}}