{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,24]],"date-time":"2026-04-24T09:38:05Z","timestamp":1777023485911,"version":"3.51.4"},"reference-count":16,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2017,8,24]],"date-time":"2017-08-24T00:00:00Z","timestamp":1503532800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Therap Adv Gastroenterol"],"published-print":{"date-parts":[[2017,9]]},"abstract":"<jats:sec><jats:title>Background:<\/jats:title><jats:p> To evaluate the psychometric properties of the newly developed seven-item Irritable Bowel Syndrome \u2013 Diarrhea predominant (IBS-D) Daily Symptom Diary and four-item Event Log using phase II clinical trial safety and efficacy data in patients with IBS-D. This instrument measures diarrhea (stool frequency and stool consistency), abdominal pain related to IBS-D (stomach pain, abdominal pain, abdominal cramps), immediate need to have a bowel movement (immediate need and accident occurrence), bloating, pressure, gas, and incomplete evacuation. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods:<\/jats:title><jats:p> Psychometric properties and responsiveness of the instrument were evaluated in a clinical trial population [ ClinicalTrials.gov identifier: NCT01494233]. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results:<\/jats:title><jats:p> A total of 434 patients were included in the analyses. Significant differences were found among severity groups ( p &lt; 0.01) defined by IBS Patient Global Impression of Severity (PGI-S) and IBS Patient Global Impression of Change (PGI-C). Severity scores for each Diary and Event Log item score and five-item, four-item, and three-item summary scores were calculated. Between-group differences in changes over time were significant for all summary scores in groups stratified by changes in PGI-S ( p &lt; 0.05), two of six Diary items, and three of four Event Log items; a one-grade change in PGI-S was considered a meaningful difference with mean change scores on all Diary items \u22120.13 to \u22120.86 [standard deviation (SD) 0.79\u20131.39]. Similarly, for patients who reported being \u2018slightly improved\u2019 (considered a clinically meaningful difference) on the PGI-C, mean change scores on Diary items ranged from \u22120.45 to \u22121.55 (SD 0.69\u20131.39). All estimates of clinically important change for each item and all summary scores were small and should be considered preliminary. These results are aligned with the previous standalone psychometric study regarding reliability and validity tests. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions:<\/jats:title><jats:p> These analyses provide evidence of the psychometric properties of the IBS-D Daily Symptom Diary and Event Log in a clinical trial population. <\/jats:p><\/jats:sec>","DOI":"10.1177\/1756283x17726018","type":"journal-article","created":{"date-parts":[[2017,8,25]],"date-time":"2017-08-25T04:27:42Z","timestamp":1503635262000},"page":"673-687","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":6,"title":["Evaluation and performance of a newly developed patient-reported outcome instrument for diarrhea-predominant irritable bowel syndrome in a clinical study population"],"prefix":"10.1177","volume":"10","author":[{"given":"Leticia","family":"Delgado-Herrera","sequence":"first","affiliation":[{"name":"Astellas Pharma Global Development, Inc., One Astellas Way, Northbrook, IL 60062, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathryn","family":"Lasch","sequence":"additional","affiliation":[{"name":"Pharmerit International, Newton, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bernhardt","family":"Zeiher","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anthony J.","family":"Lembo","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center, Boston, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Douglas A.","family":"Drossman","sequence":"additional","affiliation":[{"name":"Drossman Center for the Education and Practice of Biopsychosocial Care, UNC Center for Functional GI and Motility Disorders, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA, and Drossman Gastroenterology PLLC, Chapel Hill, NC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Banderas","sequence":"additional","affiliation":[{"name":"Adelphi Values, Boston, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kathleen","family":"Rosa","sequence":"additional","affiliation":[{"name":"Adelphi Values, Boston, MA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christopher","family":"Lademacher","sequence":"additional","affiliation":[{"name":"Astellas Pharma Global Development, Inc., Northbrook, IL, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rob","family":"Arbuckle","sequence":"additional","affiliation":[{"name":"Adelphi Values, Bollington, Cheshire, UK"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2017,8,24]]},"reference":[{"key":"bibr1-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2005.11.061"},{"key":"bibr2-1756283X17726018","unstructured":"U.S. Department of Health and Human Services Food and Drug Association. Guidance for industry: patient-reported outcome measures: use in medical product development to support labeling claims. https:\/\/www.fda.gov\/downloads\/drugs\/guidances\/ucm193282.pdf, 2009."},{"key":"bibr3-1756283X17726018","unstructured":"U.S. Department of Health and Human Services Food and Drug Association. Guidance for industry irritable bowel syndrome \u2013 clinical evaluation of drugs for treatment. www.fda.gov\/downloads\/Drugs\/Guidances\/UCM205269.pdf, 2012."},{"key":"bibr4-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1038\/ajg.2010.12"},{"key":"bibr5-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(11)62532-8"},{"key":"bibr6-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1038\/ctg.2014.7"},{"key":"bibr7-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-016-1335-1"},{"key":"bibr8-1756283X17726018","first-page":"00084","volume":"4","author":"Lasch K","year":"2016","journal-title":"Gastroenterol Hepatol"},{"key":"bibr9-1756283X17726018","unstructured":"Lexicon Pharmaceuticals I. Lexicon completes phase 2 study of LX1033 in IBS-D 2014, http:\/\/www.lexpharma.com\/news\/press-releases\/2309-lexicon-completes-phase-2-study-of-lx1033-in-ibs-d.html."},{"key":"bibr10-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.3109\/00365529709011203"},{"key":"bibr11-1756283X17726018","volume-title":"Clinical trials methods and practice","author":"Hays RD","year":"1998"},{"key":"bibr12-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1081\/COPD-200050663"},{"key":"bibr13-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2009.01.024"},{"key":"bibr14-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1037\/10694-000"},{"key":"bibr15-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2036.1997.142318000.x"},{"key":"bibr16-1756283X17726018","doi-asserted-by":"publisher","DOI":"10.1111\/nmo.12624"}],"container-title":["Therapeutic Advances in Gastroenterology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756283X17726018","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/1756283X17726018","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/1756283X17726018","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,3,1]],"date-time":"2025-03-01T16:58:28Z","timestamp":1740848308000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/1756283X17726018"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,8,24]]},"references-count":16,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2017,9]]}},"alternative-id":["10.1177\/1756283X17726018"],"URL":"https:\/\/doi.org\/10.1177\/1756283x17726018","relation":{},"ISSN":["1756-2848","1756-2848"],"issn-type":[{"value":"1756-2848","type":"print"},{"value":"1756-2848","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,8,24]]}}}