{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,5]],"date-time":"2026-09-05T09:23:12Z","timestamp":1788600192196,"version":"build-2803163510"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2023,2,11]],"date-time":"2023-02-11T00:00:00Z","timestamp":1676073600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2023,2,11]],"date-time":"2023-02-11T00:00:00Z","timestamp":1676073600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Dig Dis Sci"],"published-print":{"date-parts":[[2023,6]]},"DOI":"10.1007\/s10620-022-07807-y","type":"journal-article","created":{"date-parts":[[2023,2,11]],"date-time":"2023-02-11T11:53:50Z","timestamp":1676116430000},"page":"2318-2332","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Ulcerative Colitis-Symptom Questionnaire: Valid for Use in Adults with Moderately to Severely Active Ulcerative Colitis"],"prefix":"10.1007","volume":"68","author":[{"given":"Julian","family":"Panes","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Otley","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuri","family":"Sanchez Gonzalez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristina","family":"Fitzgerald","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen","family":"Zhou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dapo","family":"Ilo","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5512-5420","authenticated-orcid":false,"given":"Triza","family":"Brion","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muna J.","family":"Tahir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2023,2,11]]},"reference":[{"key":"7807_CR1","first-page":"619","volume":"26","author":"Y Ye","year":"2020","unstructured":"Ye Y, Manne S, Treem WR, Bennett D. Prevalence of inflammatory bowel disease in pediatric and adult populations: recent estimates from large national databases in the United States, 2007\u20132016. Inflamm Bowel Dis. 2020;26:619\u2013625.","journal-title":"Inflamm Bowel Dis."},{"key":"7807_CR2","doi-asserted-by":"publisher","first-page":"2769","DOI":"10.1016\/S0140-6736(17)32448-0","volume":"390","author":"SC Ng","year":"2017","unstructured":"Ng SC, Shi HY, Hamidi N et al. Worldwide incidence and prevalence of inflammatory bowel disease in the 21st century: a systematic review of population-based studies. Lancet. 2017;390:2769\u20132778.","journal-title":"Lancet."},{"key":"7807_CR3","doi-asserted-by":"publisher","first-page":"100851","DOI":"10.1016\/j.disamonth.2019.02.004","volume":"65","author":"M Gajendran","year":"2019","unstructured":"Gajendran M, Loganathan P, Jimenez G et al. A comprehensive review and update on ulcerative colitis. Dis Mon. 2019;65:100851.","journal-title":"Dis Mon."},{"key":"7807_CR4","doi-asserted-by":"publisher","first-page":"212572","DOI":"10.7573\/dic.212572","volume":"8","author":"K Tripathi","year":"2019","unstructured":"Tripathi K, Feuerstein JD. New developments in ulcerative colitis: latest evidence on management, treatment, and maintenance. Drugs Context. 2019;8:212572.","journal-title":"Drugs Context."},{"key":"7807_CR5","doi-asserted-by":"publisher","first-page":"103","DOI":"10.1016\/j.cgh.2006.09.033","volume":"5","author":"D Turner","year":"2007","unstructured":"Turner D, Walsh CM, Steinhart AH, Griffiths AM. Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression. Clin Gastroenterol Hepatol. 2007;5:103\u2013110.","journal-title":"Clin Gastroenterol Hepatol."},{"key":"7807_CR6","unstructured":"US Food and Drug Administration. Ulcerative colitis: clinical trial endpoints guidance for industry. 2016."},{"key":"7807_CR7","doi-asserted-by":"publisher","first-page":"1673","DOI":"10.1016\/j.cgh.2018.10.032","volume":"17","author":"W Reinisch","year":"2019","unstructured":"Reinisch W, Gottlieb K, Colombel JF et al. Comparison of the EMA and FDA guidelines on ulcerative colitis drug development. Clin Gastroenterol Hepatol. 2019;17:1673\u20131679.","journal-title":"Clin Gastroenterol Hepatol."},{"key":"7807_CR8","unstructured":"US Food and Drug Administration. Principles for selecting, developing, modifying, and adapting patient-reported outcome instruments for use in medical device evaluation. 2020."},{"key":"7807_CR9","unstructured":"US Food and Drug Administration. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. 2009."},{"key":"7807_CR10","unstructured":"European Medicines Agency. Guideline on the development of new medicinal products for the treatment of Ulcerative Colitis. In: (CHMP) CfMPfHU, ed. CHMP\/EWP\/18463\/2006 Rev.1 ed 2018."},{"key":"7807_CR11","unstructured":"European Medicines Agency. Reflection paper on the regulatory guidance for the use of health related quality of life (HRQL) measures in the evaluation of medicinal products. 2005."},{"key":"7807_CR12","first-page":"68","volume-title":"Research methods for clinical and health psychology","author":"H Joffe","year":"2004","unstructured":"Joffe H, Yardley L. Content and thematic analysis. In: Marks DF, Yardley L, eds. Research methods for clinical and health psychology, vol56. Thousand Oaks: SAGE Publications; 2004; 68."},{"key":"7807_CR13","doi-asserted-by":"publisher","first-page":"269","DOI":"10.1586\/erp.10.30","volume":"10","author":"C Kerr","year":"2010","unstructured":"Kerr C, Nixon A, Wild D. Assessing and demonstrating data saturation in qualitative inquiry supporting patient-reported outcomes research. Expert Rev Pharmacoecon Outcomes Res. 2010;10:269\u2013281.","journal-title":"Expert Rev Pharmacoecon Outcomes Res."},{"key":"7807_CR14","doi-asserted-by":"publisher","first-page":"e007765","DOI":"10.1136\/bmjopen-2015-007765","volume":"5","author":"CR Lim","year":"2015","unstructured":"Lim CR, Harris K, Dawson J, Beard DJ, Fitzpatrick R, Price AJ. Floor and ceiling effects in the OHS: an analysis of the NHS PROMs data set. BMJ Open. 2015;5:e007765.","journal-title":"BMJ Open."},{"key":"7807_CR15","volume-title":"Psychometric theory","author":"JC Nunnally","year":"1978","unstructured":"Nunnally JC. Psychometric theory, 2nd edn. New York: McGraw-Hill; 1978.","edition":"2"},{"key":"7807_CR16","volume-title":"Psychometric theory 3E","author":"JC Nunnally","year":"1994","unstructured":"Nunnally JC. Psychometric theory 3E. New York: Tata McGraw-Hill Education; 1994."},{"key":"7807_CR17","volume-title":"Handbook of experimental psychology","author":"SS Stevens","year":"1951","unstructured":"Stevens SS. Handbook of experimental psychology. New York: Wiley; 1951."},{"key":"7807_CR18","doi-asserted-by":"publisher","first-page":"155","DOI":"10.1016\/j.jcm.2016.02.012","volume":"15","author":"TK Koo","year":"2016","unstructured":"Koo TK, Li MY. A guideline of selecting and reporting intraclass correlation coefficients for reliability research. J Chiropr Med. 2016;15:155\u2013163.","journal-title":"J Chiropr Med."},{"key":"7807_CR19","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1037\/1082-989X.1.1.30","volume":"1","author":"KO McGraw","year":"1996","unstructured":"McGraw KO, Wong SP. Forming inferences about some intraclass correlation coefficients. Psychol Methods. 1996;1:30.","journal-title":"Psychol Methods."},{"key":"7807_CR20","doi-asserted-by":"publisher","first-page":"420","DOI":"10.1037\/0033-2909.86.2.420","volume":"86","author":"PE Shrout","year":"1979","unstructured":"Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979;86:420\u2013428.","journal-title":"Psychol Bull."},{"key":"7807_CR21","doi-asserted-by":"publisher","first-page":"209","DOI":"10.1177\/009286150203600127","volume":"36","author":"O Chassany","year":"2002","unstructured":"Chassany O, Sagnier P, Marquis P, Fullerton S, Aaronson N. Patient-reported outcomes: the example of health-related quality of life\u2014a European guidance document for the improved integration of health-related quality of life assessment in the drug regulatory process. Drug Inf J. 2002;36:209\u2013238.","journal-title":"Drug Inf J."},{"key":"7807_CR22","volume-title":"Statistical power analysis for the behavioral sciences","author":"J Cohen","year":"1988","unstructured":"Cohen J. Statistical power analysis for the behavioral sciences. Hillsdale: Lawrence Erlbaum Associates, Publishers; 1988."},{"key":"7807_CR23","doi-asserted-by":"publisher","first-page":"9458","DOI":"10.3748\/wjg.v20.i28.9458","volume":"20","author":"BC da Silva","year":"2014","unstructured":"da Silva BC, Lyra AC, Rocha R, Santana GO. Epidemiology, demographic characteristics and prognostic predictors of ulcerative colitis. World J Gastroenterol. 2014;20:9458\u20139467.","journal-title":"World J Gastroenterol."},{"key":"7807_CR24","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1186\/1477-7525-6-69","volume":"6","author":"JC Joyce","year":"2008","unstructured":"Joyce JC, Waljee AK, Khan T et al. Identification of symptom domains in ulcerative colitis that occur frequently during flares and are responsive to changes in disease activity. Health Qual Life Outcomes. 2008;6:69.","journal-title":"Health Qual Life Outcomes."},{"key":"7807_CR25","unstructured":"Lynch WD, Hsu R. Ulcerative Colitis. In: StatPearls. Treasure Island: StatPearls Publishing; 2021."},{"key":"7807_CR26","doi-asserted-by":"publisher","first-page":"632","DOI":"10.1097\/00054725-200409000-00020","volume":"10","author":"RG Maunder","year":"2004","unstructured":"Maunder RG, Greenberg GR. Comparison of a disease activity index and patients\u2019 self-reported symptom severity in ulcerative colitis. Inflamm Bowel Dis. 2004;10:632\u2013636.","journal-title":"Inflamm Bowel Dis."},{"key":"7807_CR27","doi-asserted-by":"publisher","first-page":"1756","DOI":"10.1016\/S0140-6736(16)32126-2","volume":"389","author":"R Ungaro","year":"2017","unstructured":"Ungaro R, Mehandru S, Allen PB, Peyrin-Biroulet L, Colombel JF. Ulcerative colitis. Lancet. 2017;389:1756\u20131770.","journal-title":"Lancet."},{"key":"7807_CR28","doi-asserted-by":"publisher","first-page":"558","DOI":"10.1097\/MEG.0b013e328326cacb","volume":"21","author":"AK Waljee","year":"2009","unstructured":"Waljee AK, Joyce JC, Wren PA, Khan TM, Higgins PD. Patient reported symptoms during an ulcerative colitis flare: a Qualitative Focus Group Study. Eur J Gastroenterol Hepatol. 2009;21:558\u2013564.","journal-title":"Eur J Gastroenterol Hepatol."},{"key":"7807_CR29","doi-asserted-by":"publisher","first-page":"26","DOI":"10.1186\/s41687-018-0049-2","volume":"2","author":"PDR Higgins","year":"2017","unstructured":"Higgins PDR, Harding G, Revicki DA et al. Development and validation of the Ulcerative Colitis patient-reported outcomes signs and symptoms (UC-pro\/SS) diary. J Patient Rep Outcomes. 2017;2:26.","journal-title":"J Patient Rep Outcomes."}],"container-title":["Digestive Diseases and Sciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10620-022-07807-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s10620-022-07807-y\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s10620-022-07807-y.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,5,16]],"date-time":"2023-05-16T04:28:33Z","timestamp":1684211313000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s10620-022-07807-y"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,2,11]]},"references-count":29,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2023,6]]}},"alternative-id":["7807"],"URL":"https:\/\/doi.org\/10.1007\/s10620-022-07807-y","relation":{},"ISSN":["0163-2116","1573-2568"],"issn-type":[{"value":"0163-2116","type":"print"},{"value":"1573-2568","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,2,11]]},"assertion":[{"value":"6 October 2022","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"19 December 2022","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 February 2023","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Julian Panes received financial support for research from AbbVie and Pfizer; received lecture fee(s) from AbbVie, Ferring, Janssen, Takeda; and received consultancy fees from AbbVie, Arena Pharmaceuticals, Athos, Boehringer Ingelheim, Celltrion, Ferring, Galapagos, Genentech, GSK, Janssen, Mirum Pharma, Morphic Therapeutic, Origo, Pandion, Pfizer, Progenity, Robarts, Roche, Takeda, Theravance, and Wassermann. Anthony Otley receives financial support for research from AbbVie; serves on Advisory Board for AbbVie Canada, Janssen Canada; is site investigator for clinical trials for AbbVie, Pfizer, and Eli Lilly. Yuri Sanchez Gonzalez, Kristina Fitzgerald, Wen Zhou, and Dapo Ilo are full-time employees of AbbVie and may hold AbbVie stock and\/or stock options. Triza Brion and Muna J. Tahir are full-time employees of ICON and received consultancy fees from AbbVie.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by Salus IRB (May 26, 2016\/Protocol No. 8001-0424).","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}},{"value":"Ethical approval was obtained from central Ethics Committees for both Part 1 and 2 of the study (Salus IRB, Austin, TX), and the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical considerations"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}}]}}