{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T16:45:31Z","timestamp":1791909931649,"version":"4.3.4"},"reference-count":91,"publisher":"Elsevier BV","issue":"10","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":[[2026,5,26]],"date-time":"2026-05-26T00:00:00Z","timestamp":1779753600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["cghjournal.org","clinicalkey.com","clinicalkey.com.au","clinicalkey.es","clinicalkey.fr","clinicalkey.jp","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Clinical Gastroenterology and Hepatology"],"published-print":{"date-parts":[[2026,10]]},"DOI":"10.1016\/j.cgh.2026.05.015","type":"journal-article","created":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T00:06:41Z","timestamp":1780013201000},"page":"2650-2670","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":1,"title":["Patient-Reported Outcomes in Clinical Trials of Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis"],"prefix":"10.1016","volume":"24","author":[{"given":"Jurij","family":"Hanzel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuhong","family":"Yuan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shane W.","family":"Goodwin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga Maria","family":"Nardone","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joana","family":"Roseira","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Solitano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sudheer Kumar","family":"Vuyyuru","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rupert W.","family":"Leong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E.","family":"Sands","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Turner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f8rn","family":"Moum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Millie D.","family":"Long","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David T.","family":"Rubin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corey A.","family":"Siegel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla C.","family":"Dubinsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"Halfvarson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Magro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ailsa","family":"Hart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W.","family":"Leong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E.","family":"Sands","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dan","family":"Turner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bj\u00f8rn","family":"Moum","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Millie D.","family":"Long","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edouard","family":"Louis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Rubin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Corey A.","family":"Siegel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Remo","family":"Panaccione","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marla C.","family":"Dubinsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonas","family":"Halfvarson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando","family":"Magro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ailsa","family":"Hart","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.cgh.2026.05.015_bib1","doi-asserted-by":"crossref","first-page":"571","DOI":"10.1016\/S0140-6736(23)00966-2","article-title":"Ulcerative colitis","volume":"402","author":"Le Berre","year":"2023","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib2","doi-asserted-by":"crossref","first-page":"1177","DOI":"10.1016\/S0140-6736(23)02586-2","article-title":"Crohn's disease","volume":"403","author":"Dolinger","year":"2024","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib3","doi-asserted-by":"crossref","first-page":"1570","DOI":"10.1053\/j.gastro.2020.12.031","article-title":"STRIDE-II: an update on the Selecting Therapeutic Targets In Inflammatory Bowel Disease (STRIDE) initiative of the International Organization for the Study of IBD (IOIBD): determining therapeutic goals for treat-to-target strategies in IBD","volume":"160","author":"Turner","year":"2021","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib5","doi-asserted-by":"crossref","first-page":"967","DOI":"10.1016\/j.jval.2011.06.014","volume":"14","author":"Patrick","year":"2011","journal-title":"Value Health"},{"key":"10.1016\/j.cgh.2026.05.015_bib10","doi-asserted-by":"crossref","first-page":"1299","DOI":"10.1093\/ecco-jcc\/jjaa057","article-title":"Systematic review of development and content validity of patient-reported outcome measures in inflammatory bowel disease: do we measure what we measure?","volume":"14","author":"van Andel","year":"2020","journal-title":"J Crohns Colitis"},{"key":"10.1016\/j.cgh.2026.05.015_bib11","doi-asserted-by":"crossref","first-page":"648","DOI":"10.1016\/j.cgh.2017.10.019","article-title":"Patient-reported outcome measures for use in clinical trials and clinical practice in inflammatory bowel diseases: a systematic review","volume":"16","author":"de Jong","year":"2018","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib12","doi-asserted-by":"crossref","first-page":"1820","DOI":"10.14309\/ajg.0000000000003420","article-title":"Symptom resolution and meaningful improvement in quality of life with risankizumab in patients with ulcerative colitis: post hoc analysis of the randomized INSPIRE and COMMAND studies","volume":"120","author":"Torres","year":"2025","journal-title":"Am J Gastroenterol"},{"key":"10.1016\/j.cgh.2026.05.015_bib13","doi-asserted-by":"crossref","first-page":"1044","DOI":"10.1007\/s12325-024-03081-8","article-title":"The Urgency Numeric Rating Scale: psychometric evaluation in adults with Crohn's disease","volume":"42","author":"Dubinsky","year":"2025","journal-title":"Adv Ther"},{"key":"10.1016\/j.cgh.2026.05.015_bib14","doi-asserted-by":"crossref","first-page":"3403","DOI":"10.1007\/s11136-023-03494-y","article-title":"Validation of the bowel urgency numeric rating scale in patients with Crohn's disease: results from a mixed methods study","volume":"32","author":"Dubinsky","year":"2023","journal-title":"Qual Life Res"},{"key":"10.1016\/j.cgh.2026.05.015_bib15","article-title":"Toward patient centricity: why do patients with inflammatory bowel disease participate in pharmaceutical clinical trials? A mixed-methods exploration of study participants","volume":"6","author":"Solitano","year":"2024","journal-title":"Crohns Colitis 360"},{"key":"10.1016\/j.cgh.2026.05.015_bib16","article-title":"The PRISMA 2020 statement: an updated guideline for reporting systematic reviews","volume":"372","author":"Page","year":"2021","journal-title":"BMJ"},{"key":"10.1016\/j.cgh.2026.05.015_bib17","doi-asserted-by":"crossref","first-page":"717","DOI":"10.1093\/ecco-jcc\/jjab194","article-title":"Clinical, endoscopic, and safety placebo rates in induction and maintenance trials of Crohn's disease: meta-analysis of randomised controlled trials","volume":"16","author":"Almradi","year":"2022","journal-title":"J Crohns Colitis"},{"key":"10.1016\/j.cgh.2026.05.015_bib18","doi-asserted-by":"crossref","first-page":"224","DOI":"10.1093\/ecco-jcc\/jjab135","article-title":"Systematic review and meta-analysis: clinical, endoscopic, histological and safety placebo rates in induction and maintenance trials of ulcerative colitis","volume":"16","author":"Sedano","year":"2022","journal-title":"J Crohns Colitis"},{"key":"10.1016\/j.cgh.2026.05.015_bib19","doi-asserted-by":"crossref","first-page":"1516","DOI":"10.1053\/j.gastro.2025.08.032","article-title":"Comparative efficacy of advanced therapies for management of moderate-to-severe Crohn's disease: 2025 AGA evidence synthesis","volume":"169","author":"Singh","year":"2025","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib20","doi-asserted-by":"crossref","first-page":"1460","DOI":"10.1053\/j.gastro.2024.07.046","article-title":"Comparative efficacy of advanced therapies for management of moderate-to-severe ulcerative colitis: 2024 AGA evidence synthesis","volume":"167","author":"Ananthakrishnan","year":"2024","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib21","doi-asserted-by":"crossref","first-page":"737","DOI":"10.1016\/j.jclinepi.2010.02.006","article-title":"The COSMIN study reached international consensus on taxonomy, terminology, and definitions of measurement properties for health-related patient-reported outcomes","volume":"63","author":"Mokkink","year":"2010","journal-title":"J Clin Epidemiol"},{"key":"10.1016\/j.cgh.2026.05.015_bib22","doi-asserted-by":"crossref","first-page":"2929","DOI":"10.1007\/s11136-024-03761-6","article-title":"COSMIN guideline for systematic reviews of patient-reported outcome measures version 2.0","volume":"33","author":"Mokkink","year":"2024","journal-title":"Qual Life Res"},{"key":"10.1016\/j.cgh.2026.05.015_bib23","doi-asserted-by":"crossref","first-page":"177","DOI":"10.1016\/0197-2456(86)90046-2","article-title":"Meta-analysis in clinical trials","volume":"7","author":"DerSimonian","year":"1986","journal-title":"Control Clin Trials"},{"key":"10.1016\/j.cgh.2026.05.015_bib24","series-title":"Kendall\u2019s advanced theory of statistics","author":"Stuart","year":"1994"},{"key":"10.1016\/j.cgh.2026.05.015_bib25","doi-asserted-by":"crossref","first-page":"189","DOI":"10.1186\/s12874-021-01381-z","article-title":"Conducting proportional meta-analysis in different types of systematic reviews: a guide for synthesisers of evidence","volume":"21","author":"Barker","year":"2021","journal-title":"BMC Med Res Methodol"},{"key":"10.1016\/j.cgh.2026.05.015_bib26","doi-asserted-by":"crossref","first-page":"804","DOI":"10.1016\/S0016-5085(89)80080-0","article-title":"A new measure of health status for clinical trials in inflammatory bowel disease","volume":"96","author":"Guyatt","year":"1989","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib27","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1111\/apt.13001","article-title":"A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn's disease activity","volume":"41","author":"Khanna","year":"2015","journal-title":"Aliment Pharmacol Ther"},{"key":"10.1016\/j.cgh.2026.05.015_bib28","doi-asserted-by":"crossref","first-page":"1727","DOI":"10.1007\/s11136-011-9903-x","article-title":"Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L)","volume":"20","author":"Herdman","year":"2011","journal-title":"Qual Life Res"},{"key":"10.1016\/j.cgh.2026.05.015_bib29","doi-asserted-by":"crossref","first-page":"473","DOI":"10.1097\/00005650-199206000-00002","article-title":"The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection","volume":"30","author":"Ware","year":"1992","journal-title":"Med Care"},{"key":"10.1016\/j.cgh.2026.05.015_bib30","doi-asserted-by":"crossref","first-page":"1485","DOI":"10.1016\/j.cgh.2014.01.029","article-title":"A phase 2 study of tofacitinib, an oral Janus kinase inhibitor, in patients with Crohn's disease","volume":"12","author":"Sandborn","year":"2014","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib31","first-page":"64","article-title":"The efficacy and safety of guselkumab induction therapy in patients with moderately to severely active Crohn\u2019s disease: week 12 interim analyses from the phase 2 GALAXI 1 study","volume":"8","author":"Sandborn","year":"2020","journal-title":"United European Gastroenterol J"},{"key":"10.1016\/j.cgh.2026.05.015_bib32","doi-asserted-by":"crossref","DOI":"10.1177\/1756284820938960","article-title":"Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial","volume":"13","author":"Chen","year":"2020","journal-title":"Ther Adv Gastroenterol"},{"key":"10.1016\/j.cgh.2026.05.015_bib33","doi-asserted-by":"crossref","first-page":"670","DOI":"10.1016\/j.cgh.2011.04.031","article-title":"Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial","volume":"9","author":"Sandborn","year":"2011","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib34","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1056\/NEJMoa062897","article-title":"Maintenance therapy with certolizumab pegol for Crohn's disease","volume":"357","author":"Schreiber","year":"2007","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib35","doi-asserted-by":"crossref","first-page":"228","DOI":"10.1056\/NEJMoa067594","article-title":"Certolizumab pegol for the treatment of Crohn's disease","volume":"357","author":"Sandborn","year":"2007","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib36","doi-asserted-by":"crossref","first-page":"380","DOI":"10.1053\/j.gastro.2015.10.050","article-title":"Methotrexate is not superior to placebo for inducing steroid-free remission, but induces steroid-free clinical remission in a larger proportion of patients with ulcerative colitis","volume":"150","author":"Carbonnel","year":"2016","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib37","doi-asserted-by":"crossref","first-page":"1024","DOI":"10.1016\/S2468-1253(22)00233-3","article-title":"ABX464 (obefazimod) for moderate-to-severe, active ulcerative colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension","volume":"7","author":"Vermeire","year":"2022","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib38","doi-asserted-by":"crossref","first-page":"1723","DOI":"10.1056\/NEJMoa1606910","article-title":"Tofacitinib as induction and maintenance therapy for ulcerative colitis","volume":"376","author":"Sandborn","year":"2017","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib39","doi-asserted-by":"crossref","first-page":"2372","DOI":"10.1016\/S0140-6736(21)00666-8","article-title":"Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b\/3 double-blind, randomised, placebo-controlled trial","volume":"397","author":"Feagan","year":"2021","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib40","doi-asserted-by":"crossref","first-page":"33","DOI":"10.1016\/S0140-6736(24)01927-5","article-title":"Guselkumab in patients with moderately to severely active ulcerative colitis (QUASAR): phase 3 double-blind, randomised, placebo-controlled induction and maintenance studies","volume":"405","author":"Rubin","year":"2025","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib41","doi-asserted-by":"crossref","first-page":"2444","DOI":"10.1056\/NEJMoa2207940","article-title":"Mirikizumab as induction and maintenance therapy for ulcerative colitis","volume":"388","author":"D'Haens","year":"2023","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib42","doi-asserted-by":"crossref","first-page":"1248","DOI":"10.1016\/j.cgh.2017.02.027","article-title":"Efficacy of rectal tacrolimus for induction therapy in patients with resistant ulcerative proctitis","volume":"15","author":"Lawrance","year":"2017","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib43","doi-asserted-by":"crossref","first-page":"1119","DOI":"10.1056\/NEJMoa2314076","article-title":"Phase 2 trial of anti-TL1A monoclonal antibody tulisokibart for ulcerative colitis","volume":"391","author":"Sands","year":"2024","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib44","doi-asserted-by":"crossref","first-page":"283","DOI":"10.1007\/s00535-013-0922-y","article-title":"Efficacy and safety of adalimumab in Japanese patients with moderately to severely active ulcerative colitis","volume":"49","author":"Suzuki","year":"2014","journal-title":"J Gastroenterol"},{"key":"10.1016\/j.cgh.2026.05.015_bib45","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1053\/j.gastro.2011.10.032","article-title":"Adalimumab induces and maintains clinical remission in patients with moderate-to-severe ulcerative colitis","volume":"142","author":"Sandborn","year":"2012","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib46","doi-asserted-by":"crossref","first-page":"418","DOI":"10.1093\/ecco-jcc\/jjv224","article-title":"Eldelumab [anti-IP-10] induction therapy for ulcerative colitis: a randomised, placebo-controlled, phase 2b study","volume":"10","author":"Sandborn","year":"2016","journal-title":"J Crohns Colitis"},{"key":"10.1016\/j.cgh.2026.05.015_bib47","doi-asserted-by":"crossref","first-page":"2113","DOI":"10.1016\/S0140-6736(22)00581-5","article-title":"Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials","volume":"399","author":"Danese","year":"2022","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib48","doi-asserted-by":"crossref","first-page":"688","DOI":"10.1053\/j.gastro.2007.12.012","article-title":"Rosiglitazone for active ulcerative colitis: a randomized placebo-controlled trial","volume":"134","author":"Lewis","year":"2008","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib49","doi-asserted-by":"crossref","first-page":"760","DOI":"10.1136\/gut.2009.179994","article-title":"A randomised placebo-controlled multicentre trial of intravenous semapimod HCl for moderate to severe Crohn's disease","volume":"59","author":"Dotan","year":"2010","journal-title":"Gut"},{"key":"10.1016\/j.cgh.2026.05.015_bib50","first-page":"2247","article-title":"Safety and efficacy of an oral inhibitor of the purinergic receptor P2X7 in adult patients with moderately to severely active Crohn's disease: a randomized placebo-controlled, double-blind, phase IIa study","volume":"21","author":"Eser","year":"2015","journal-title":"Inflamm Bowel Dis"},{"key":"10.1016\/j.cgh.2026.05.015_bib51","doi-asserted-by":"crossref","first-page":"1699","DOI":"10.1016\/S0140-6736(17)30570-6","article-title":"Induction therapy with the selective interleukin-23 inhibitor risankizumab in patients with moderate-to-severe Crohn's disease: a randomised, double-blind, placebo-controlled phase 2 study","volume":"389","author":"Feagan","year":"2017","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib52","doi-asserted-by":"crossref","first-page":"1966","DOI":"10.1056\/NEJMoa2212728","article-title":"Upadacitinib induction and maintenance therapy for Crohn's disease","volume":"388","author":"Loftus","year":"2023","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib53","doi-asserted-by":"crossref","first-page":"2123","DOI":"10.1053\/j.gastro.2020.01.047","article-title":"Efficacy and safety of upadacitinib in a randomized trial of patients with Crohn's disease","volume":"158","author":"Sandborn","year":"2020","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib54","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1053\/j.gastro.2021.10.050","article-title":"Efficacy and safety of mirikizumab in a randomized phase 2 study of patients with Crohn's disease","volume":"162","author":"Sands","year":"2022","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib55","doi-asserted-by":"crossref","first-page":"1461","DOI":"10.1053\/gast.2000.20196","article-title":"Safety and efficacy of recombinant human interleukin 10 in chronic active Crohn's disease. Crohn's Disease IL-10 Cooperative Study Group","volume":"119","author":"Schreiber","year":"2000","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib56","doi-asserted-by":"crossref","first-page":"239","DOI":"10.1016\/j.crohns.2012.06.006","article-title":"Efficacy and tolerability of oral budesonide in Japanese patients with active Crohn's disease: a multicentre, double-blind, randomized, parallel-group Phase II study","volume":"7","author":"Suzuki","year":"2013","journal-title":"J Crohns Colitis"},{"key":"10.1016\/j.cgh.2026.05.015_bib57","doi-asserted-by":"crossref","first-page":"1672","DOI":"10.1053\/j.gastro.2007.03.024","article-title":"Natalizumab for the treatment of active Crohn's disease: results of the ENCORE trial","volume":"132","author":"Targan","year":"2007","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib58","doi-asserted-by":"crossref","first-page":"1748","DOI":"10.1111\/j.1572-0241.2002.05835.x","article-title":"Budesonide CIR capsules (once or twice daily divided-dose) in active Crohn's disease: a randomized placebo-controlled study in the United States","volume":"97","author":"Tremaine","year":"2002","journal-title":"Am J Gastroenterol"},{"key":"10.1016\/j.cgh.2026.05.015_bib59","doi-asserted-by":"crossref","first-page":"266","DOI":"10.1016\/S0140-6736(16)32537-5","article-title":"Clinical remission in patients with moderate-to-severe Crohn's disease treated with filgotinib (the FITZROY study): results from a phase 2, double-blind, randomised, placebo-controlled trial","volume":"389","author":"Vermeire","year":"2017","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib60","doi-asserted-by":"crossref","first-page":"292","DOI":"10.1056\/NEJM199502023320503","article-title":"Methotrexate for the treatment of Crohn's disease. The North American Crohn's Study Group Investigators","volume":"332","author":"Feagan","year":"1995","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib61","doi-asserted-by":"crossref","first-page":"1029","DOI":"10.1056\/NEJM199710093371502","article-title":"A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's disease. Crohn's Disease cA2 Study Group","volume":"337","author":"Targan","year":"1997","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib62","doi-asserted-by":"crossref","first-page":"807","DOI":"10.1053\/j.gastro.2005.06.064","article-title":"A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease","volume":"129","author":"Schreiber","year":"2005","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib63","doi-asserted-by":"crossref","first-page":"233","DOI":"10.1002\/ibd.21038","article-title":"Fontolizumab in moderate to severe Crohn's disease: a phase 2, randomized, double-blind, placebo-controlled, multiple-dose study","volume":"16","author":"Reinisch","year":"2010","journal-title":"Inflamm Bowel Dis"},{"key":"10.1016\/j.cgh.2026.05.015_bib64","doi-asserted-by":"crossref","first-page":"2423","DOI":"10.1016\/S0140-6736(24)01762-8","article-title":"Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study","volume":"404","author":"Ferrante","year":"2024","journal-title":"Lancet"},{"key":"10.1016\/j.cgh.2026.05.015_bib65","doi-asserted-by":"crossref","first-page":"1946","DOI":"10.1056\/NEJMoa1602773","article-title":"Ustekinumab as induction and maintenance therapy for Crohn\u2019s disease","volume":"375","author":"Feagan","year":"2016","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib66","doi-asserted-by":"crossref","first-page":"1520","DOI":"10.1136\/gut.2010.225482","article-title":"Randomised placebo-controlled trial of rituximab (anti-CD20) in active ulcerative colitis","volume":"60","author":"Leiper","year":"2011","journal-title":"Gut"},{"key":"10.1016\/j.cgh.2026.05.015_bib67","doi-asserted-by":"crossref","first-page":"1063","DOI":"10.1016\/S2468-1253(20)30301-0","article-title":"Cobitolimod for moderate-to-severe, left-sided ulcerative colitis (CONDUCT): a phase 2b randomised, double-blind, placebo-controlled, dose-ranging induction trial","volume":"5","author":"Atreya","year":"2020","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib68","doi-asserted-by":"crossref","first-page":"85","DOI":"10.1053\/j.gastro.2013.05.048","article-title":"Subcutaneous golimumab induces clinical response and remission in patients with moderate-to-severe ulcerative colitis","volume":"146","author":"Sandborn","year":"2014","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib69","doi-asserted-by":"crossref","first-page":"699","DOI":"10.1056\/NEJMoa1215734","article-title":"Vedolizumab as induction and maintenance therapy for ulcerative colitis","volume":"369","author":"Feagan","year":"2013","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib70","doi-asserted-by":"crossref","first-page":"537","DOI":"10.1053\/j.gastro.2019.08.043","article-title":"Efficacy and safety of mirikizumab in a randomized phase 2 study of patients with ulcerative colitis","volume":"158","author":"Sandborn","year":"2020","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib71","doi-asserted-by":"crossref","first-page":"562","DOI":"10.1053\/j.gastro.2019.08.027","article-title":"Efficacy and safety of vedolizumab subcutaneous formulation in a randomized trial of patients with ulcerative colitis","volume":"158","author":"Sandborn","year":"2020","journal-title":"Gastroenterology"},{"key":"10.1016\/j.cgh.2026.05.015_bib72","doi-asserted-by":"crossref","first-page":"998","DOI":"10.1136\/gut.52.7.998","article-title":"Infliximab in moderately severe glucocorticoid resistant ulcerative colitis: a randomised controlled trial","volume":"52","author":"Probert","year":"2003","journal-title":"Gut"},{"key":"10.1016\/j.cgh.2026.05.015_bib73","doi-asserted-by":"crossref","first-page":"2616","DOI":"10.1016\/j.cgh.2022.12.029","article-title":"Oral ritlecitinib and brepocitinib for moderate-to-severe ulcerative colitis: results from a randomized, phase 2b study","volume":"21","author":"Sandborn","year":"2023","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib74","doi-asserted-by":"crossref","DOI":"10.1136\/bmjgast-2021-000680","article-title":"A randomised, placebo-controlled study of RIPK1 inhibitor GSK2982772 in patients with active ulcerative colitis","volume":"8","author":"Weisel","year":"2021","journal-title":"BMJ Open Gastroenterol"},{"key":"10.1016\/j.cgh.2026.05.015_bib75","doi-asserted-by":"crossref","first-page":"1201","DOI":"10.1056\/NEJMoa1900750","article-title":"Ustekinumab as induction and maintenance therapy for ulcerative colitis","volume":"381","author":"Sands","year":"2019","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib76","doi-asserted-by":"crossref","first-page":"616","DOI":"10.1056\/NEJMoa1112168","article-title":"Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis","volume":"367","author":"Sandborn","year":"2012","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib77","doi-asserted-by":"crossref","first-page":"2499","DOI":"10.1056\/NEJMoa042982","article-title":"Treatment of ulcerative colitis with a humanized antibody to the alpha4beta7 integrin","volume":"352","author":"Feagan","year":"2005","journal-title":"N Engl J Med"},{"key":"10.1016\/j.cgh.2026.05.015_bib78","doi-asserted-by":"crossref","first-page":"1355","DOI":"10.1046\/j.1365-2036.2003.01589.x","article-title":"Repifermin (keratinocyte growth factor-2) for the treatment of active ulcerative colitis: a randomized, double-blind, placebo-controlled, dose-escalation trial","volume":"17","author":"Sandborn","year":"2003","journal-title":"Aliment Pharmacol Ther"},{"key":"10.1016\/j.cgh.2026.05.015_bib79","doi-asserted-by":"crossref","first-page":"5239","DOI":"10.2147\/DDDT.S490772","article-title":"Fenofibrate as an adjunct therapy for ulcerative colitis: targeting inflammation via SIRT1, NLRP3, and AMPK pathways: a randomized controlled pilot study","volume":"18","author":"Alarfaj","year":"2024","journal-title":"Drug Des Devel Ther"},{"key":"10.1016\/j.cgh.2026.05.015_bib80","doi-asserted-by":"crossref","first-page":"128","DOI":"10.1016\/S2468-1253(21)00298-3","article-title":"Etrolizumab as induction and maintenance therapy for ulcerative colitis in patients previously treated with tumour necrosis factor inhibitors (HICKORY): a phase 3, randomised, controlled trial","volume":"7","author":"Peyrin-Biroulet","year":"2021","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib81","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1016\/S2468-1253(21)00338-1","article-title":"Etrolizumab versus adalimumab or placebo as induction therapy for moderately to severely active ulcerative colitis (HIBISCUS): two phase 3 randomised, controlled trials","volume":"7","author":"Rubin","year":"2021","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib82","doi-asserted-by":"crossref","first-page":"28","DOI":"10.1016\/S2468-1253(21)00295-8","article-title":"Etrolizumab for maintenance therapy in patients with moderately to severely active ulcerative colitis (LAUREL): a randomised, placebo-controlled, double-blind, phase 3 study","volume":"7","author":"Vermeire","year":"2021","journal-title":"Lancet Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib83","doi-asserted-by":"crossref","first-page":"1407","DOI":"10.1016\/j.cgh.2018.02.051","article-title":"Heterogeneity in definitions of efficacy and safety endpoints for clinical trials of Crohn\u2019s disease: a systematic review","volume":"16","author":"Ma","year":"2018","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib84","doi-asserted-by":"crossref","first-page":"637","DOI":"10.1016\/j.cgh.2017.08.025","article-title":"Heterogeneity in definitions of endpoints for clinical trials of ulcerative colitis: a systematic review for development of a core outcome set","volume":"16","author":"Ma","year":"2017","journal-title":"Clin Gastroenterol Hepatol"},{"key":"10.1016\/j.cgh.2026.05.015_bib85","doi-asserted-by":"crossref","first-page":"26","DOI":"10.1186\/s41687-018-0049-2","article-title":"Development and validation of the ulcerative colitis patient-reported outcomes signs and symptoms (UC-pro\/SS) diary","volume":"2","author":"Higgins","year":"2017","journal-title":"J Patient Rep Outcomes"},{"key":"10.1016\/j.cgh.2026.05.015_bib86","doi-asserted-by":"crossref","first-page":"24","DOI":"10.1186\/s41687-018-0044-7","article-title":"Development and validation of the Crohn's disease patient-reported outcomes signs and symptoms (CD-PRO\/SS) diary","volume":"2","author":"Higgins","year":"2017","journal-title":"J Patient Rep Outcomes"},{"key":"10.1016\/j.cgh.2026.05.015_bib87","doi-asserted-by":"crossref","first-page":"1047","DOI":"10.1111\/apt.15726","article-title":"Development of the symptoms and impacts questionnaire for Crohn's disease and ulcerative colitis","volume":"51","author":"Dulai","year":"2020","journal-title":"Aliment Pharmacol Ther"},{"key":"10.1016\/j.cgh.2026.05.015_bib88","doi-asserted-by":"crossref","first-page":"2318","DOI":"10.1007\/s10620-022-07807-y","article-title":"Ulcerative colitis-symptom questionnaire: valid for use in adults with moderately to severely active ulcerative colitis","volume":"68","author":"Panes","year":"2023","journal-title":"Dig Dis Sci"},{"key":"10.1016\/j.cgh.2026.05.015_bib89","doi-asserted-by":"crossref","first-page":"509","DOI":"10.1007\/s11136-024-03829-3","article-title":"Psychometric evaluation of the functional assessment of chronic illness therapy-fatigue (FACIT-fatigue) in adults with moderately to severely active Crohn's disease","volume":"34","author":"Regueiro","year":"2025","journal-title":"Qual Life Res"},{"key":"10.1016\/j.cgh.2026.05.015_bib90","doi-asserted-by":"crossref","first-page":"1058","DOI":"10.1097\/01.mib.0000234134.35713.d2","article-title":"Health-related quality of life correlates with clinical and endoscopic activity indexes but not with demographic features in patients with ulcerative colitis","volume":"12","author":"Zahn","year":"2006","journal-title":"Inflamm Bowel Dis"},{"key":"10.1016\/j.cgh.2026.05.015_bib91","doi-asserted-by":"crossref","first-page":"457","DOI":"10.1111\/j.1572-0241.2004.04071.x","article-title":"Assessment of the influence of disease activity on the quality of life of patients with inflammatory bowel disease using a short questionnaire","volume":"99","author":"Casellas","year":"2004","journal-title":"Am J Gastroenterol"},{"key":"10.1016\/j.cgh.2026.05.015_bib92","doi-asserted-by":"crossref","first-page":"889","DOI":"10.1111\/apt.15681","article-title":"Bowel damage and disability in Crohn's disease: a prospective study in a tertiary referral centre of the Lemann Index and Inflammatory Bowel Disease Disability Index","volume":"51","author":"Lauriot dit Prevost","year":"2020","journal-title":"Aliment Pharmacol Ther"},{"key":"10.1016\/j.cgh.2026.05.015_bib93","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1186\/s41687-025-00851-y","article-title":"A patient-reported outcome measure comprising the stool frequency and abdominal pain items from the Crohn's Disease Activity Index: psychometric evaluation in adults with Crohn's disease","volume":"9","author":"Lewis","year":"2025","journal-title":"J Patient Rep Outcomes"},{"key":"10.1016\/j.cgh.2026.05.015_bib94","first-page":"304","article-title":"Correlation of stool frequency and abdominal pain measures with Simple Endoscopic Score for Crohn's disease","volume":"26","author":"Lewis","year":"2020","journal-title":"Inflamm Bowel Dis"},{"key":"10.1016\/j.cgh.2026.05.015_bib95","doi-asserted-by":"crossref","first-page":"1232","DOI":"10.1093\/ecco-jcc\/jjy100","article-title":"Placebo effect on the health-related quality of life of inflammatory bowel disease patients: a systematic review with meta-analysis","volume":"12","author":"Estevinho","year":"2018","journal-title":"J Crohns Colitis"},{"key":"10.1016\/j.cgh.2026.05.015_bib96","doi-asserted-by":"crossref","first-page":"892","DOI":"10.1053\/j.gastro.2019.02.050","article-title":"Improving clinical trial efficiency in gastroenterology","volume":"157","author":"Ma","year":"2019","journal-title":"Gastroenterology"}],"container-title":["Clinical Gastroenterology and Hepatology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1542356526003940?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S1542356526003940?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2026,9,22]],"date-time":"2026-09-22T08:41:46Z","timestamp":1790066506000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S1542356526003940"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,10]]},"references-count":91,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2026,10]]}},"alternative-id":["S1542356526003940"],"URL":"https:\/\/doi.org\/10.1016\/j.cgh.2026.05.015","relation":{},"ISSN":["1542-3565"],"issn-type":[{"value":"1542-3565","type":"print"}],"subject":[],"published":{"date-parts":[[2026,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Patient-Reported Outcomes in Clinical Trials of Inflammatory Bowel Disease: A Systematic Review and Meta-Analysis","name":"articletitle","label":"Article Title"},{"value":"Clinical Gastroenterology and Hepatology","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.cgh.2026.05.015","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2026 The Author(s). Published by Elsevier Inc. on behalf of American Gastroenterological Association Institute.","name":"copyright","label":"Copyright"}]}}