Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis
Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end point...
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| Veröffentlicht in: | Gut 2005-06, Vol.54 (6), p.782-788 |
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| description | Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1–14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were determined (St Mark’s 20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis. |
| doi_str_mv | 10.1136/gut.2004.056358 |
| format | Article |
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There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1–14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were determined (St Mark’s <3.5, ulcerative colitis disease activity index <2.5, simple clinical colitis activity index (SCCAI) <2.5, Seo <120, and inflammatory bowel disease quality of life index (IBDQ) >205). These cut offs also identified patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease >1.5, Seo decrease >30, IBDQ increase >20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis.</description><identifier>ISSN: 0017-5749</identifier><identifier>EISSN: 1468-3288</identifier><identifier>EISSN: 1458-3288</identifier><identifier>DOI: 10.1136/gut.2004.056358</identifier><identifier>PMID: 15888785</identifier><identifier>CODEN: GUTTAK</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd and British Society of Gastroenterology</publisher><subject>Adult ; Biological and medical sciences ; Clinical trials ; Colitis, Ulcerative - therapy ; Colon ; disease activity ; end points ; Endoscopy ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; IBDQ ; Inflammatory Bowel Disease ; inflammatory bowel disease quality of life index ; Laboratories ; Male ; Medical sciences ; Other diseases. Semiology ; Patients ; Prognosis ; Quality of Life ; receiver operating characteristic ; remission ; Remission Induction ; ROC ; ROC Curve ; SCCAI ; Sensitivity and Specificity ; simple clinical colitis activity index ; Stomach. Duodenum. Small intestine. Colon. Rectum. Anus ; UCDAI ; ulcerative colitis ; ulcerative colitis disease activity index</subject><ispartof>Gut, 2005-06, Vol.54 (6), p.782-788</ispartof><rights>Copyright 2005 by Gut</rights><rights>2005 INIST-CNRS</rights><rights>Copyright: 2005 Copyright 2005 by Gut</rights><rights>Copyright © Copyright 2005 by Gut 2005</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-b588t-871ac43962d9993d617ddab929f6baaddcb4b1ec8037bee824539b51198e9c343</citedby></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1774553/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC1774553/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16846735$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15888785$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Higgins, P D R</creatorcontrib><creatorcontrib>Schwartz, M</creatorcontrib><creatorcontrib>Mapili, J</creatorcontrib><creatorcontrib>Krokos, I</creatorcontrib><creatorcontrib>Leung, J</creatorcontrib><creatorcontrib>Zimmermann, E M</creatorcontrib><title>Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis</title><title>Gut</title><addtitle>Gut</addtitle><description>Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1–14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were determined (St Mark’s <3.5, ulcerative colitis disease activity index <2.5, simple clinical colitis activity index (SCCAI) <2.5, Seo <120, and inflammatory bowel disease quality of life index (IBDQ) >205). These cut offs also identified patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease >1.5, Seo decrease >30, IBDQ increase >20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis.</description><subject>Adult</subject><subject>Biological and medical sciences</subject><subject>Clinical trials</subject><subject>Colitis, Ulcerative - therapy</subject><subject>Colon</subject><subject>disease activity</subject><subject>end points</subject><subject>Endoscopy</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>IBDQ</subject><subject>Inflammatory Bowel Disease</subject><subject>inflammatory bowel disease quality of life index</subject><subject>Laboratories</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Other diseases. Semiology</subject><subject>Patients</subject><subject>Prognosis</subject><subject>Quality of Life</subject><subject>receiver operating characteristic</subject><subject>remission</subject><subject>Remission Induction</subject><subject>ROC</subject><subject>ROC Curve</subject><subject>SCCAI</subject><subject>Sensitivity and Specificity</subject><subject>simple clinical colitis activity index</subject><subject>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</subject><subject>UCDAI</subject><subject>ulcerative colitis</subject><subject>ulcerative colitis disease activity index</subject><issn>0017-5749</issn><issn>1468-3288</issn><issn>1458-3288</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqFkctv1DAYxC0EokvhzA1ZQnBAytaO49cFCS2vSi0gnkfLsZ3WS2IvdrJq_3scZdUCF04-zM-jmW8AeIzRGmPCTi6mcV0j1KwRZYSKO2CFGyYqUgtxF6wQwryivJFH4EHOW4SQEBLfB0eYCiG4oCtgPunRuzBC6zofnIXWm8s4xiFOGbpg4S76MGbYxQSTG3zOPgaoi2B6H7zRPfTDLsW9G2YXH-DUG5eK6d5BE3s_-vwQ3Ot0n92jw3sMvr1983Xzvjr7-O508-qsakucsRIca9MQyWorpSSWYW6tbmUtO9Zqba1pmxY7IxDhrXOibiiRLcVYCicNacgxeLn47qZ2cNaUQEn3apf8oNO1itqrv5XgL9VF3CvMeUMpKQbPDwYp_ppcHlUpbFzf6-DKPRTjosa4ZgV8-g-4jVMKpdzsJQnBFM12JwtlUsw5ue4mCkZqnk-V-dQ8n1rmKz-e_Nnglj_sVYBnB0Dncvsu6WB8vuWYaBgnM1ctnM-ju7rRdfpZShBO1YfvG_UFifPXPzafFS78i4Vvh-1_U_4GGWrCAQ</recordid><startdate>20050601</startdate><enddate>20050601</enddate><creator>Higgins, P D R</creator><creator>Schwartz, M</creator><creator>Mapili, J</creator><creator>Krokos, I</creator><creator>Leung, J</creator><creator>Zimmermann, E M</creator><general>BMJ Publishing Group Ltd and British Society of Gastroenterology</general><general>BMJ</general><general>BMJ Publishing Group LTD</general><general>Copyright 2005 by Gut</general><scope>BSCLL</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>88I</scope><scope>8AF</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>BTHHO</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M2P</scope><scope>M7P</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20050601</creationdate><title>Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis</title><author>Higgins, P D R ; Schwartz, M ; Mapili, J ; Krokos, I ; Leung, J ; Zimmermann, E M</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b588t-871ac43962d9993d617ddab929f6baaddcb4b1ec8037bee824539b51198e9c343</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Biological and medical sciences</topic><topic>Clinical trials</topic><topic>Colitis, Ulcerative - therapy</topic><topic>Colon</topic><topic>disease activity</topic><topic>end points</topic><topic>Endoscopy</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>IBDQ</topic><topic>Inflammatory Bowel Disease</topic><topic>inflammatory bowel disease quality of life index</topic><topic>Laboratories</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Other diseases. Semiology</topic><topic>Patients</topic><topic>Prognosis</topic><topic>Quality of Life</topic><topic>receiver operating characteristic</topic><topic>remission</topic><topic>Remission Induction</topic><topic>ROC</topic><topic>ROC Curve</topic><topic>SCCAI</topic><topic>Sensitivity and Specificity</topic><topic>simple clinical colitis activity index</topic><topic>Stomach. Duodenum. Small intestine. Colon. Rectum. Anus</topic><topic>UCDAI</topic><topic>ulcerative colitis</topic><topic>ulcerative colitis disease activity index</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Higgins, P D R</creatorcontrib><creatorcontrib>Schwartz, M</creatorcontrib><creatorcontrib>Mapili, J</creatorcontrib><creatorcontrib>Krokos, I</creatorcontrib><creatorcontrib>Leung, J</creatorcontrib><creatorcontrib>Zimmermann, E M</creatorcontrib><collection>Istex</collection><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Science Database (Alumni Edition)</collection><collection>STEM Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>BMJ Journals</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Science Database</collection><collection>Biological Science Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Gut</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Higgins, P D R</au><au>Schwartz, M</au><au>Mapili, J</au><au>Krokos, I</au><au>Leung, J</au><au>Zimmermann, E M</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis</atitle><jtitle>Gut</jtitle><addtitle>Gut</addtitle><date>2005-06-01</date><risdate>2005</risdate><volume>54</volume><issue>6</issue><spage>782</spage><epage>788</epage><pages>782-788</pages><issn>0017-5749</issn><eissn>1468-3288</eissn><eissn>1458-3288</eissn><coden>GUTTAK</coden><abstract>Background and aims: Ulcerative colitis disease activity indices offer good statistical power but small changes in these indices may not be clinically important. There are no validated definitions of remission or of significant improvement for these indices. The use of clinically important end points would strengthen the validity of study outcomes. Our aims were to identify objective end points in standard disease activity indices for remission and for improvement in ulcerative colitis. Methods: Sixty six consecutive patients with ulcerative colitis provided information about remission status and their disease activity. At a return visit 1–14 months later, these patients provided information about the change in their disease activity, and non-invasive indices were measured. Results: Specific objective end points for determining remission with four standard indices and a quality of life instrument were determined (St Mark’s <3.5, ulcerative colitis disease activity index <2.5, simple clinical colitis activity index (SCCAI) <2.5, Seo <120, and inflammatory bowel disease quality of life index (IBDQ) >205). These cut offs also identified patients who met a regulatory definition of remission. Specific objective end points for clinical improvement in two non-invasive indices and a quality of life instrument were determined with good sensitivity and specificity (SCCAI decrease >1.5, Seo decrease >30, IBDQ increase >20). Conclusions: We found specific cut off values for disease activity indices that identify patients who have significantly improved or achieved remission in an objective, sensitive, and specific manner. These cut offs should help in the interpretation of the outcomes of clinical trials in ulcerative colitis.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd and British Society of Gastroenterology</pub><pmid>15888785</pmid><doi>10.1136/gut.2004.056358</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Biological and medical sciences Clinical trials Colitis, Ulcerative - therapy Colon disease activity end points Endoscopy Female Gastroenterology. Liver. Pancreas. Abdomen Humans IBDQ Inflammatory Bowel Disease inflammatory bowel disease quality of life index Laboratories Male Medical sciences Other diseases. Semiology Patients Prognosis Quality of Life receiver operating characteristic remission Remission Induction ROC ROC Curve SCCAI Sensitivity and Specificity simple clinical colitis activity index Stomach. Duodenum. Small intestine. Colon. Rectum. Anus UCDAI ulcerative colitis ulcerative colitis disease activity index |
| title | Patient defined dichotomous end points for remission and clinical improvement in ulcerative colitis |
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