{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T21:02:05Z","timestamp":1792443725408,"version":"4.5.0"},"reference-count":19,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2014,10,27]],"date-time":"2014-10-27T00:00:00Z","timestamp":1414368000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2015,1]]},"abstract":"Summary<\/jats:title>\n \n Background<\/jats:title>\n \n The Crohn's Disease Activity Index (\n CDAI<\/jats:styled-content>\n ) is a measure of disease activity based on symptoms, signs and a laboratory test. The\n US<\/jats:styled-content>\n Food and Drug Administration has indicated that patient reported outcomes (\n PRO<\/jats:styled-content>\n s) should be the primary outcome in randomised controlled trials for Crohn's disease (\n CD<\/jats:styled-content>\n ).\n <\/jats:p>\n <\/jats:sec>\n \n Aim<\/jats:title>\n \n As no validated\n PRO<\/jats:styled-content>\n exists for\n CD<\/jats:styled-content>\n , to investigate whether\n CDAI<\/jats:styled-content>\n diary card items could be modified for this purpose.\n <\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n \n Data from a trial of rifaximin\u2010extended intestinal release were used to identify cut\u2010points for stool frequency, pain and general well\u2010being using receiver operating characteristic curves with\n CDAI<\/jats:styled-content>\n <150 as criterion. The operating properties of 2\u2010 and 3\u2010item\n PRO<\/jats:styled-content>\n were evaluated using data from a trial of methotrexate in\n CD<\/jats:styled-content>\n . Regression analysis determined\n PRO<\/jats:styled-content>\n 2 and\n PRO<\/jats:styled-content>\n 3 scores that correspond to\n CDAI<\/jats:styled-content>\n \u2010defined thresholds of 150, 220 and 450 and changes of 50, 70 and 100 points.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Optimum cut\u2010points for\n CDAI<\/jats:styled-content>\n remission were mean daily stool frequency \u22641.5, abdominal pain \u22641, and general well\u2010being score of \u22641 (areas under the\n ROC<\/jats:styled-content>\n curve 0.79, 0.91 and 0.89, respectively). The effect estimates were similar using 2\u2010 and 3\u2010item\n PRO<\/jats:styled-content>\n s or\n CDAI<\/jats:styled-content>\n .\n PRO<\/jats:styled-content>\n 2 and\n PRO<\/jats:styled-content>\n 3 values corresponding to\n CDAI<\/jats:styled-content>\n scores of 150, 220 and 450 points were 8, 14, 34 and 13, 22, 53. The corresponding values for\n CDAI<\/jats:styled-content>\n changes of 50, 70 and 100, were 2, 5, 8 and 5, 9, 14. Responsiveness to change was similar for both\n PRO<\/jats:styled-content>\n s.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n \n Patient reported outcomes derived from\n CDAI<\/jats:styled-content>\n diary items may be appropriate for use in clinical trials for\n CD<\/jats:styled-content>\n .\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1111\/apt.13001","type":"journal-article","created":{"date-parts":[[2014,10,27]],"date-time":"2014-10-27T21:15:22Z","timestamp":1414444522000},"page":"77-86","source":"Crossref","is-referenced-by-count":227,"title":["A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn's disease activity"],"prefix":"10.1111","volume":"41","author":[{"given":"R.","family":"Khanna","sequence":"first","affiliation":[{"name":"Department of Medicine University of Western Ontario London ON Canada"},{"name":"Robarts Clinical Trials Inc. University of Western Ontario London ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Zou","sequence":"additional","affiliation":[{"name":"Robarts Clinical Trials Inc. University of Western Ontario London ON Canada"},{"name":"Department of Epidemiology and Biostatistics University of Western Ontario London ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"D'Haens","sequence":"additional","affiliation":[{"name":"Robarts Clinical Trials Inc. University of Western Ontario London ON Canada"},{"name":"Inflammatory Bowel Disease Centre Academic Medical Centre Amsterdam The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. G.","family":"Feagan","sequence":"additional","affiliation":[{"name":"Department of Medicine University of Western Ontario London ON Canada"},{"name":"Robarts Clinical Trials Inc. University of Western Ontario London ON Canada"},{"name":"Department of Epidemiology and Biostatistics University of Western Ontario London ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. J.","family":"Sandborn","sequence":"additional","affiliation":[{"name":"Robarts Clinical Trials Inc. University of Western Ontario London ON Canada"},{"name":"Division of Gastroenterology University of California San Diego La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. K.","family":"Vandervoort","sequence":"additional","affiliation":[{"name":"Robarts Clinical Trials Inc. University of Western Ontario London ON Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"R. L.","family":"Rolleri","sequence":"additional","affiliation":[{"name":"SALIX Pharmaceuticals, Inc. Raleigh NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"E.","family":"Bortey","sequence":"additional","affiliation":[{"name":"SALIX Pharmaceuticals, Inc. Raleigh NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Paterson","sequence":"additional","affiliation":[{"name":"SALIX Pharmaceuticals, Inc. Raleigh NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"W. P.","family":"Forbes","sequence":"additional","affiliation":[{"name":"SALIX Pharmaceuticals, Inc. Raleigh NC USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B. G.","family":"Levesque","sequence":"additional","affiliation":[{"name":"Robarts Clinical Trials Inc. University of Western Ontario London ON Canada"},{"name":"Division of Gastroenterology University of California San Diego La Jolla CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,10,27]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/0016-5085(79)90384-6"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0016-5085(76)80163-1"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(80)92767-1"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/0895-4356(88)90046-7"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ibd.21400"},{"key":"e_1_2_7_7_1","volume-title":"Guidance for Industry: Patient\u2010Reported Outcome Measures Use in Medical Product Development to Support Labeling Claims","author":"US Food and Drug Administration (FDA)","year":"2009"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jval.2011.06.014"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.gastro.2011.11.032"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199502023320503"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/0021-9681(87)90080-4"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1177\/0962280210383082"},{"key":"e_1_2_7_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0895-4356(99)00206-1"},{"key":"e_1_2_7_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/apt.12262"},{"key":"e_1_2_7_15_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa043335"},{"key":"e_1_2_7_16_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa067594"},{"key":"e_1_2_7_17_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa041109"},{"key":"e_1_2_7_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2008.06.010"},{"key":"e_1_2_7_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0904492"},{"key":"e_1_2_7_20_1","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2013-304984"}],"container-title":["Alimentary Pharmacology & Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fapt.13001","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/apt.13001","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,5]],"date-time":"2023-10-05T10:48:01Z","timestamp":1696502881000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/apt.13001"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,10,27]]},"references-count":19,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2015,1]]}},"alternative-id":["10.1111\/apt.13001"],"URL":"https:\/\/doi.org\/10.1111\/apt.13001","archive":["Portico"],"relation":{},"ISSN":["0269-2813","1365-2036"],"issn-type":[{"value":"0269-2813","type":"print"},{"value":"1365-2036","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,10,27]]}}}