THU0266 Determining the Absolute Change in the Clinical Disease Activity Index (CDAI) to Define A Minimally Important Difference
Background Simplified measures to quantify rheumatoid arthritis (RA) disease activity are increasing in clinical practice. The absolute minimally important difference (MID) in these measures, such as the clinical disease activity index (CDAI), has not been well defined in real-world settings, especi...
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| Veröffentlicht in: | Annals of the rheumatic diseases 2014-06, Vol.73 (Suppl 2), p.275-275 |
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| creator | Curtis, J.R. Yang, S. Chen, L. Pope, J.E. Keystone, E.C. Haraqui, B. Boire, G. Thorne, J.C. Tin, D. Hitchon, C.A. Bingham, C.O. Bykerk, V.P. |
| description | Background Simplified measures to quantify rheumatoid arthritis (RA) disease activity are increasing in clinical practice. The absolute minimally important difference (MID) in these measures, such as the clinical disease activity index (CDAI), has not been well defined in real-world settings, especially for early RA patients (ERA) with low or moderate disease activity. Objectives To determine the MID for improvement of the CDAI in a “real world” setting using an cohort of patients with ERA. Methods Data from the Canadian CATCH cohort of patients with ERA were used to identify pairs of rheumatology visits 3 months apart occurring within 12 months of cohort entry. Patients with concomitant fibromyalgia (8%) were excluded. Absolute change in CDAI was examined between visit pairs and correlated with relevant changes corresponding to MIDs in patient self-reported improvement (better vs. same/worse), patient pain (>1 vs. ≤1, and >2 vs. ≤2) and HAQ (>0.22 vs. ≤22, and >0.30 vs. ≤0.30). The 10th and 90th percentile of the CDAI distributions for EULAR good response vs. non-response in DAS28 ESR (>1.2 vs. |
| doi_str_mv | 10.1136/annrheumdis-2014-eular.2945 |
| format | Article |
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The absolute minimally important difference (MID) in these measures, such as the clinical disease activity index (CDAI), has not been well defined in real-world settings, especially for early RA patients (ERA) with low or moderate disease activity. Objectives To determine the MID for improvement of the CDAI in a “real world” setting using an cohort of patients with ERA. Methods Data from the Canadian CATCH cohort of patients with ERA were used to identify pairs of rheumatology visits 3 months apart occurring within 12 months of cohort entry. Patients with concomitant fibromyalgia (8%) were excluded. Absolute change in CDAI was examined between visit pairs and correlated with relevant changes corresponding to MIDs in patient self-reported improvement (better vs. same/worse), patient pain (>1 vs. ≤1, and >2 vs. ≤2) and HAQ (>0.22 vs. ≤22, and >0.30 vs. ≤0.30). The 10th and 90th percentile of the CDAI distributions for EULAR good response vs. non-response in DAS28 ESR (>1.2 vs. <0.6 units improvement) determine proposed CDAI cutpoints to define MID, overall and stratified by initial CDAI disease activity categories (low <10; moderate 10≤–≤22; high >22). Discrimination of these cutpoints was examined using area under receiver operator curves (AUROC). These CDAI cutpoints describe the Sensitivity (Se), Specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of the CDAI cutpoints for patient pain and HAQ. Results A total of 1191 unique CATCH patients (mean ± SD age 53.5±15.1 years; 72% women, median RA disease duration 5.8±3.0 months and contributed 3262 visit pairs within 12 months of enrollment. Among those with available serologic results (91% of cohort for RF, 67% of cohort for anti-CCP), 70% were RF positive and 60% anti-CCP antibody positive. Overall, there was excellent discrimination between DAS28 responders using a CDAI cutpoint of 5 units; the AUROC was 0.87. CDAI cutpoints for patients who started in low, moderate, or high disease were 2, 6, and 10, respectively. The Se, Sp, PPV and NPVs for the outcomes in the Table and the alternate pain and HAQ cutpoints (not shown) had acceptable performance characteristics using these proposed CDAI cutpoints. Improvement in CDAI cutpoint and starting disease activity Sensitivity Specificity PPV NPV Patient self-reported improvement 5 (all data) 76 53 56 74 (better vs. same/worse) 2 (low) 84 58 42 90 6 (moderate) 76 82 57 72 11 (high) 82 73 88 63 Pain (>1 vs. ≤1) 5 (all data) 45 85 55 80 2 (low) 33 92 54 83 6 (moderate) 46 75 52 70 11 (high) 52 77 71 61 HAQ (>0.22 vs. ≤0.22) 5 (all data) 57 80 69 71 2 (low disease) 28 87 40 79 6 (moderate) 46 73 58 64 11 (high) 70 64 77 55 Conclusions These minimally important absolute differences in CDAI can be used to evaluate improvement and increase the usefulness of this clinical simplified disease activity measure in real-world settings. Disclosure of Interest : J. Curtis Grant/research support: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, Consultant for: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, S. Yang: None declared, L. Chen: None declared, J. Pope: None declared, E. Keystone: None declared, B. Haraqui: None declared, G. Boire: None declared, J. Thorne: None declared, D. Tin: None declared, C. Hitchon: None declared, C. Bingham III: None declared, V. Bykerk: None declared, S. Yang: None declared DOI 10.1136/annrheumdis-2014-eular.2945</description><identifier>ISSN: 0003-4967</identifier><identifier>EISSN: 1468-2060</identifier><identifier>DOI: 10.1136/annrheumdis-2014-eular.2945</identifier><identifier>CODEN: ARDIAO</identifier><language>eng</language><publisher>London: BMJ Publishing Group LTD</publisher><ispartof>Annals of the rheumatic diseases, 2014-06, Vol.73 (Suppl 2), p.275-275</ispartof><rights>2014, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><rights>Copyright: 2014 (c) 2014, Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttp://ard.bmj.com/content/73/Suppl_2/275.1.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttp://ard.bmj.com/content/73/Suppl_2/275.1.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>114,115,315,782,786,3198,23578,27931,27932,77608,77639</link.rule.ids></links><search><creatorcontrib>Curtis, J.R.</creatorcontrib><creatorcontrib>Yang, S.</creatorcontrib><creatorcontrib>Chen, L.</creatorcontrib><creatorcontrib>Pope, J.E.</creatorcontrib><creatorcontrib>Keystone, E.C.</creatorcontrib><creatorcontrib>Haraqui, B.</creatorcontrib><creatorcontrib>Boire, G.</creatorcontrib><creatorcontrib>Thorne, J.C.</creatorcontrib><creatorcontrib>Tin, D.</creatorcontrib><creatorcontrib>Hitchon, C.A.</creatorcontrib><creatorcontrib>Bingham, C.O.</creatorcontrib><creatorcontrib>Bykerk, V.P.</creatorcontrib><title>THU0266 Determining the Absolute Change in the Clinical Disease Activity Index (CDAI) to Define A Minimally Important Difference</title><title>Annals of the rheumatic diseases</title><description>Background Simplified measures to quantify rheumatoid arthritis (RA) disease activity are increasing in clinical practice. The absolute minimally important difference (MID) in these measures, such as the clinical disease activity index (CDAI), has not been well defined in real-world settings, especially for early RA patients (ERA) with low or moderate disease activity. Objectives To determine the MID for improvement of the CDAI in a “real world” setting using an cohort of patients with ERA. Methods Data from the Canadian CATCH cohort of patients with ERA were used to identify pairs of rheumatology visits 3 months apart occurring within 12 months of cohort entry. Patients with concomitant fibromyalgia (8%) were excluded. Absolute change in CDAI was examined between visit pairs and correlated with relevant changes corresponding to MIDs in patient self-reported improvement (better vs. same/worse), patient pain (>1 vs. ≤1, and >2 vs. ≤2) and HAQ (>0.22 vs. ≤22, and >0.30 vs. ≤0.30). The 10th and 90th percentile of the CDAI distributions for EULAR good response vs. non-response in DAS28 ESR (>1.2 vs. <0.6 units improvement) determine proposed CDAI cutpoints to define MID, overall and stratified by initial CDAI disease activity categories (low <10; moderate 10≤–≤22; high >22). Discrimination of these cutpoints was examined using area under receiver operator curves (AUROC). These CDAI cutpoints describe the Sensitivity (Se), Specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of the CDAI cutpoints for patient pain and HAQ. Results A total of 1191 unique CATCH patients (mean ± SD age 53.5±15.1 years; 72% women, median RA disease duration 5.8±3.0 months and contributed 3262 visit pairs within 12 months of enrollment. Among those with available serologic results (91% of cohort for RF, 67% of cohort for anti-CCP), 70% were RF positive and 60% anti-CCP antibody positive. Overall, there was excellent discrimination between DAS28 responders using a CDAI cutpoint of 5 units; the AUROC was 0.87. CDAI cutpoints for patients who started in low, moderate, or high disease were 2, 6, and 10, respectively. The Se, Sp, PPV and NPVs for the outcomes in the Table and the alternate pain and HAQ cutpoints (not shown) had acceptable performance characteristics using these proposed CDAI cutpoints. Improvement in CDAI cutpoint and starting disease activity Sensitivity Specificity PPV NPV Patient self-reported improvement 5 (all data) 76 53 56 74 (better vs. same/worse) 2 (low) 84 58 42 90 6 (moderate) 76 82 57 72 11 (high) 82 73 88 63 Pain (>1 vs. ≤1) 5 (all data) 45 85 55 80 2 (low) 33 92 54 83 6 (moderate) 46 75 52 70 11 (high) 52 77 71 61 HAQ (>0.22 vs. ≤0.22) 5 (all data) 57 80 69 71 2 (low disease) 28 87 40 79 6 (moderate) 46 73 58 64 11 (high) 70 64 77 55 Conclusions These minimally important absolute differences in CDAI can be used to evaluate improvement and increase the usefulness of this clinical simplified disease activity measure in real-world settings. Disclosure of Interest : J. Curtis Grant/research support: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, Consultant for: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, S. Yang: None declared, L. Chen: None declared, J. Pope: None declared, E. Keystone: None declared, B. Haraqui: None declared, G. Boire: None declared, J. Thorne: None declared, D. Tin: None declared, C. Hitchon: None declared, C. Bingham III: None declared, V. Bykerk: None declared, S. Yang: None declared DOI 10.1136/annrheumdis-2014-eular.2945</description><issn>0003-4967</issn><issn>1468-2060</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNqVkLtOwzAUhi0EEuXyDpZYYAjYTmK7YqpSLpWKWMpsOckxTZU4xXYQ3RASL8qT4FIGVibrHP-fj8-H0Bkll5Sm_Epb65YwdHXjE0ZolsDQanfJxlm-h0Y04zK2OdlHI0JImmRjLg7RkferWBJJ5Qh9LO6fCOP86_1zCgFc19jGPuOwBDwpfd8OAXCx1PYZcGN_2kUbI5Vu8bTxoH3MVaF5bcIGz2wNb_i8mE5mFzj0eAqmsfEeP0Si020bI926d0HbEGljwIGt4AQdGN16OP09j9HT7c2iuE_mj3ezYjJPSspEnsg0TZkRlBvIckNSIFRqJirBQEtDgQGpWcnj6qWUJsuJzAnUXMjajElt6vQYne3eXbv-ZQAf1KofnI0jFRVCjEUuWR5T17tU5XrvHRi1dvHzbqMoUVvp6o90tZWufqSrrfRI8x1ddqt_gd9VoI3C</recordid><startdate>201406</startdate><enddate>201406</enddate><creator>Curtis, J.R.</creator><creator>Yang, S.</creator><creator>Chen, L.</creator><creator>Pope, J.E.</creator><creator>Keystone, E.C.</creator><creator>Haraqui, B.</creator><creator>Boire, G.</creator><creator>Thorne, J.C.</creator><creator>Tin, D.</creator><creator>Hitchon, C.A.</creator><creator>Bingham, C.O.</creator><creator>Bykerk, V.P.</creator><general>BMJ Publishing Group LTD</general><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>K9.</scope><scope>LK8</scope><scope>M0R</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></search><sort><creationdate>201406</creationdate><title>THU0266 Determining the Absolute Change in the Clinical Disease Activity Index (CDAI) to Define A Minimally Important Difference</title><author>Curtis, J.R. ; Yang, S. ; Chen, L. ; Pope, J.E. ; Keystone, E.C. ; Haraqui, B. ; Boire, G. ; Thorne, J.C. ; Tin, D. ; Hitchon, C.A. ; Bingham, C.O. ; Bykerk, V.P.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b1275-83332f716fe45f03e018a27c72ea8f1e2e0d2b6945b88f450850ed678df90dfd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Curtis, J.R.</creatorcontrib><creatorcontrib>Yang, S.</creatorcontrib><creatorcontrib>Chen, L.</creatorcontrib><creatorcontrib>Pope, J.E.</creatorcontrib><creatorcontrib>Keystone, E.C.</creatorcontrib><creatorcontrib>Haraqui, B.</creatorcontrib><creatorcontrib>Boire, G.</creatorcontrib><creatorcontrib>Thorne, J.C.</creatorcontrib><creatorcontrib>Tin, D.</creatorcontrib><creatorcontrib>Hitchon, C.A.</creatorcontrib><creatorcontrib>Bingham, C.O.</creatorcontrib><creatorcontrib>Bykerk, V.P.</creatorcontrib><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>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</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><jtitle>Annals of the rheumatic diseases</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Curtis, J.R.</au><au>Yang, S.</au><au>Chen, L.</au><au>Pope, J.E.</au><au>Keystone, E.C.</au><au>Haraqui, B.</au><au>Boire, G.</au><au>Thorne, J.C.</au><au>Tin, D.</au><au>Hitchon, C.A.</au><au>Bingham, C.O.</au><au>Bykerk, V.P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>THU0266 Determining the Absolute Change in the Clinical Disease Activity Index (CDAI) to Define A Minimally Important Difference</atitle><jtitle>Annals of the rheumatic diseases</jtitle><date>2014-06</date><risdate>2014</risdate><volume>73</volume><issue>Suppl 2</issue><spage>275</spage><epage>275</epage><pages>275-275</pages><issn>0003-4967</issn><eissn>1468-2060</eissn><coden>ARDIAO</coden><abstract>Background Simplified measures to quantify rheumatoid arthritis (RA) disease activity are increasing in clinical practice. The absolute minimally important difference (MID) in these measures, such as the clinical disease activity index (CDAI), has not been well defined in real-world settings, especially for early RA patients (ERA) with low or moderate disease activity. Objectives To determine the MID for improvement of the CDAI in a “real world” setting using an cohort of patients with ERA. Methods Data from the Canadian CATCH cohort of patients with ERA were used to identify pairs of rheumatology visits 3 months apart occurring within 12 months of cohort entry. Patients with concomitant fibromyalgia (8%) were excluded. Absolute change in CDAI was examined between visit pairs and correlated with relevant changes corresponding to MIDs in patient self-reported improvement (better vs. same/worse), patient pain (>1 vs. ≤1, and >2 vs. ≤2) and HAQ (>0.22 vs. ≤22, and >0.30 vs. ≤0.30). The 10th and 90th percentile of the CDAI distributions for EULAR good response vs. non-response in DAS28 ESR (>1.2 vs. <0.6 units improvement) determine proposed CDAI cutpoints to define MID, overall and stratified by initial CDAI disease activity categories (low <10; moderate 10≤–≤22; high >22). Discrimination of these cutpoints was examined using area under receiver operator curves (AUROC). These CDAI cutpoints describe the Sensitivity (Se), Specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of the CDAI cutpoints for patient pain and HAQ. Results A total of 1191 unique CATCH patients (mean ± SD age 53.5±15.1 years; 72% women, median RA disease duration 5.8±3.0 months and contributed 3262 visit pairs within 12 months of enrollment. Among those with available serologic results (91% of cohort for RF, 67% of cohort for anti-CCP), 70% were RF positive and 60% anti-CCP antibody positive. Overall, there was excellent discrimination between DAS28 responders using a CDAI cutpoint of 5 units; the AUROC was 0.87. CDAI cutpoints for patients who started in low, moderate, or high disease were 2, 6, and 10, respectively. The Se, Sp, PPV and NPVs for the outcomes in the Table and the alternate pain and HAQ cutpoints (not shown) had acceptable performance characteristics using these proposed CDAI cutpoints. Improvement in CDAI cutpoint and starting disease activity Sensitivity Specificity PPV NPV Patient self-reported improvement 5 (all data) 76 53 56 74 (better vs. same/worse) 2 (low) 84 58 42 90 6 (moderate) 76 82 57 72 11 (high) 82 73 88 63 Pain (>1 vs. ≤1) 5 (all data) 45 85 55 80 2 (low) 33 92 54 83 6 (moderate) 46 75 52 70 11 (high) 52 77 71 61 HAQ (>0.22 vs. ≤0.22) 5 (all data) 57 80 69 71 2 (low disease) 28 87 40 79 6 (moderate) 46 73 58 64 11 (high) 70 64 77 55 Conclusions These minimally important absolute differences in CDAI can be used to evaluate improvement and increase the usefulness of this clinical simplified disease activity measure in real-world settings. Disclosure of Interest : J. Curtis Grant/research support: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, Consultant for: Roche/Genentech, UCB, Janssen, CORRONA, Amgen, Pfizer, BMS, Crescendo, AbbVie, S. Yang: None declared, L. Chen: None declared, J. Pope: None declared, E. Keystone: None declared, B. Haraqui: None declared, G. Boire: None declared, J. Thorne: None declared, D. Tin: None declared, C. Hitchon: None declared, C. Bingham III: None declared, V. Bykerk: None declared, S. Yang: None declared DOI 10.1136/annrheumdis-2014-eular.2945</abstract><cop>London</cop><pub>BMJ Publishing Group LTD</pub><doi>10.1136/annrheumdis-2014-eular.2945</doi><tpages>1</tpages></addata></record> |
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| title | THU0266 Determining the Absolute Change in the Clinical Disease Activity Index (CDAI) to Define A Minimally Important Difference |
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