Evaluation of the reliability and validity of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in paediatric cutaneous lupus among paediatric dermatologists and rheumatologists
Summary Background The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a reliable outcome measure for cutaneous lupus erythematosus (CLE) in adults used in clinical trials. However, it has not been validated in children, limiting clinical trials for paediatric CLE. Objective...
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Veröffentlicht in: | British journal of dermatology (1951) 2019-01, Vol.180 (1), p.165-171 |
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creator | Kushner, C.J. Tarazi, M. Gaffney, R.G. Feng, R. Ardalan, K. Brandling‐Bennett, H.A. Castelo‐Soccio, L. Chang, J.C. Chiu, Y.E. Gmuca, S. Hunt, R.D. Kahn, P.J. Knight, A.M. Mehta, J. Pearson, D.R. Treat, J.R. Wan, J. Yeguez, A.C. Concha, J.S.S. Patel, B. Okawa, J. Arkin, L.M. Werth, V.P. Goldsmith, Donald Lvovich, Svetlana Curran, Megan L. Klein‐Gitelman, Marisa Kirkorian, Yasmine Sertial, Sarah |
description | Summary
Background
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a reliable outcome measure for cutaneous lupus erythematosus (CLE) in adults used in clinical trials. However, it has not been validated in children, limiting clinical trials for paediatric CLE.
Objectives
This study aimed to validate the CLASI in paediatrics.
Methods
Eleven paediatric patients with CLE, six dermatologists and six rheumatologists participated. The physicians were trained to use the CLASI and Physician's Global Assessment (PGA), and individually rated all patients using both tools. Each physician reassessed two randomly selected patients. Within each physician group, the intraclass correlation coefficient (ICC) was calculated to assess the reliability of each measure.
Results
CLASI activity scores demonstrated excellent inter‐ and intrarater reliability (ICC > 0·90), while the PGA activity scores had good inter‐rater reliability (ICC 0·73–0·77) among both specialties. PGA activity scores showed excellent (ICC 0·89) and good intrarater reliability (ICC 0·76) for dermatologists and rheumatologists, respectively. Limitations of this study include the small sample size of patients and potential recall bias during the physician rerating session.
Conclusions
CLASI activity measurement showed excellent inter‐ and intrarater reliability in paediatric CLE and superiority over the PGA. These results demonstrate that the CLASI is a reliable and valid outcome instrument for paediatric CLE.
What's already known about this topic?
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) has been established as a reliable outcome measure for CLE in adults and is used in clinical trials.
What does this study add?
This study validates the reliability of the CLASI in the paediatric population with CLE, which can manifest differently from CLE in adults.
This validation will allow clinical trials to assess treatment efficacy reliably in CLE.
Linked Comment: Chong. Br J Dermatol 2019; 180:20–21.
Plain language summary available online
Respond to this article |
doi_str_mv | 10.1111/bjd.17012 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2074137608</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2074137608</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3882-e2cb3e7d818b06a2148f4ede94fb964b2526f33d9fcddcd28d64b02e34fb630f3</originalsourceid><addsrcrecordid>eNp1kcFu1DAQhi0EokvhwAsgS1zaQ9qxnXWS47JdYNFKPRTOkRNPWq-ceLGT0n3EvhXOZqkqpPpga_755retn5CPDC5YXJfVVl-wDBh_RWZMyHnCmRCvyQwAsgQKKU7IuxC2AEzAHN6SEwEgxFzCjDyu7pUdVG9cR11D-zukHq1RlbGm31PVaRoBo8fi2F8OverQDYFuhl3cV34f5Vb1LsTqygRUAenCozqM3-A9-nF83Wl8oGfLzeJmfU5NR3cKtVG9NzWtnzztwVO1rrt9Dmj04w3W3ZrQh4Oxv8PhmfaevGmUDfjheJ6SX19XP5ffk831t_VysUlqkec8QV5XAjOds7wCqThL8yZFjUXaVIVMKz7nshFCF02tda15rqMIHEXsSwGNOCVnk-_Ou98Dhr5sTajR2ukDJYcsZSKTkEf083_o1g2-i68rOZNc5jIrRup8omrvQvDYlDtvWuX3JYNyzLeM-ZaHfCP76eg4VC3qJ_JfoBG4nIA_xuL-Zafyy4-ryfIvFb6zYQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2162686798</pqid></control><display><type>article</type><title>Evaluation of the reliability and validity of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in paediatric cutaneous lupus among paediatric dermatologists and rheumatologists</title><source>Oxford University Press Journals</source><source>MEDLINE</source><source>Wiley Online Library All Journals</source><creator>Kushner, C.J. ; Tarazi, M. ; Gaffney, R.G. ; Feng, R. ; Ardalan, K. ; Brandling‐Bennett, H.A. ; Castelo‐Soccio, L. ; Chang, J.C. ; Chiu, Y.E. ; Gmuca, S. ; Hunt, R.D. ; Kahn, P.J. ; Knight, A.M. ; Mehta, J. ; Pearson, D.R. ; Treat, J.R. ; Wan, J. ; Yeguez, A.C. ; Concha, J.S.S. ; Patel, B. ; Okawa, J. ; Arkin, L.M. ; Werth, V.P. ; Goldsmith, Donald ; Lvovich, Svetlana ; Curran, Megan L. ; Klein‐Gitelman, Marisa ; Kirkorian, Yasmine ; Sertial, Sarah</creator><creatorcontrib>Kushner, C.J. ; Tarazi, M. ; Gaffney, R.G. ; Feng, R. ; Ardalan, K. ; Brandling‐Bennett, H.A. ; Castelo‐Soccio, L. ; Chang, J.C. ; Chiu, Y.E. ; Gmuca, S. ; Hunt, R.D. ; Kahn, P.J. ; Knight, A.M. ; Mehta, J. ; Pearson, D.R. ; Treat, J.R. ; Wan, J. ; Yeguez, A.C. ; Concha, J.S.S. ; Patel, B. ; Okawa, J. ; Arkin, L.M. ; Werth, V.P. ; Goldsmith, Donald ; Lvovich, Svetlana ; Curran, Megan L. ; Klein‐Gitelman, Marisa ; Kirkorian, Yasmine ; Sertial, Sarah</creatorcontrib><description>Summary
Background
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a reliable outcome measure for cutaneous lupus erythematosus (CLE) in adults used in clinical trials. However, it has not been validated in children, limiting clinical trials for paediatric CLE.
Objectives
This study aimed to validate the CLASI in paediatrics.
Methods
Eleven paediatric patients with CLE, six dermatologists and six rheumatologists participated. The physicians were trained to use the CLASI and Physician's Global Assessment (PGA), and individually rated all patients using both tools. Each physician reassessed two randomly selected patients. Within each physician group, the intraclass correlation coefficient (ICC) was calculated to assess the reliability of each measure.
Results
CLASI activity scores demonstrated excellent inter‐ and intrarater reliability (ICC > 0·90), while the PGA activity scores had good inter‐rater reliability (ICC 0·73–0·77) among both specialties. PGA activity scores showed excellent (ICC 0·89) and good intrarater reliability (ICC 0·76) for dermatologists and rheumatologists, respectively. Limitations of this study include the small sample size of patients and potential recall bias during the physician rerating session.
Conclusions
CLASI activity measurement showed excellent inter‐ and intrarater reliability in paediatric CLE and superiority over the PGA. These results demonstrate that the CLASI is a reliable and valid outcome instrument for paediatric CLE.
What's already known about this topic?
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) has been established as a reliable outcome measure for CLE in adults and is used in clinical trials.
What does this study add?
This study validates the reliability of the CLASI in the paediatric population with CLE, which can manifest differently from CLE in adults.
This validation will allow clinical trials to assess treatment efficacy reliably in CLE.
Linked Comment: Chong. Br J Dermatol 2019; 180:20–21.
Plain language summary available online
Respond to this article</description><identifier>ISSN: 0007-0963</identifier><identifier>EISSN: 1365-2133</identifier><identifier>DOI: 10.1111/bjd.17012</identifier><identifier>PMID: 30033560</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adolescent ; Child ; Children ; Clinical trials ; Cutaneous Lupus Erythematosus ; Dermatologists ; Dermatology ; Female ; Humans ; Lupus ; Lupus Erythematosus, Cutaneous - diagnosis ; Male ; Medical screening ; Pediatrics ; Quantitative psychology ; Questionnaires ; Reproducibility of Results ; Rheumatologists ; Severity of Illness Index ; Young Adult</subject><ispartof>British journal of dermatology (1951), 2019-01, Vol.180 (1), p.165-171</ispartof><rights>2018 British Association of Dermatologists</rights><rights>2018 British Association of Dermatologists.</rights><rights>Copyright © 2019 British Association of Dermatologists</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3882-e2cb3e7d818b06a2148f4ede94fb964b2526f33d9fcddcd28d64b02e34fb630f3</citedby><cites>FETCH-LOGICAL-c3882-e2cb3e7d818b06a2148f4ede94fb964b2526f33d9fcddcd28d64b02e34fb630f3</cites><orcidid>0000-0002-7958-3186 ; 0000-0001-7535-2914</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fbjd.17012$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fbjd.17012$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,27901,27902,45550,45551</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30033560$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Kushner, C.J.</creatorcontrib><creatorcontrib>Tarazi, M.</creatorcontrib><creatorcontrib>Gaffney, R.G.</creatorcontrib><creatorcontrib>Feng, R.</creatorcontrib><creatorcontrib>Ardalan, K.</creatorcontrib><creatorcontrib>Brandling‐Bennett, H.A.</creatorcontrib><creatorcontrib>Castelo‐Soccio, L.</creatorcontrib><creatorcontrib>Chang, J.C.</creatorcontrib><creatorcontrib>Chiu, Y.E.</creatorcontrib><creatorcontrib>Gmuca, S.</creatorcontrib><creatorcontrib>Hunt, R.D.</creatorcontrib><creatorcontrib>Kahn, P.J.</creatorcontrib><creatorcontrib>Knight, A.M.</creatorcontrib><creatorcontrib>Mehta, J.</creatorcontrib><creatorcontrib>Pearson, D.R.</creatorcontrib><creatorcontrib>Treat, J.R.</creatorcontrib><creatorcontrib>Wan, J.</creatorcontrib><creatorcontrib>Yeguez, A.C.</creatorcontrib><creatorcontrib>Concha, J.S.S.</creatorcontrib><creatorcontrib>Patel, B.</creatorcontrib><creatorcontrib>Okawa, J.</creatorcontrib><creatorcontrib>Arkin, L.M.</creatorcontrib><creatorcontrib>Werth, V.P.</creatorcontrib><creatorcontrib>Goldsmith, Donald</creatorcontrib><creatorcontrib>Lvovich, Svetlana</creatorcontrib><creatorcontrib>Curran, Megan L.</creatorcontrib><creatorcontrib>Klein‐Gitelman, Marisa</creatorcontrib><creatorcontrib>Kirkorian, Yasmine</creatorcontrib><creatorcontrib>Sertial, Sarah</creatorcontrib><title>Evaluation of the reliability and validity of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in paediatric cutaneous lupus among paediatric dermatologists and rheumatologists</title><title>British journal of dermatology (1951)</title><addtitle>Br J Dermatol</addtitle><description>Summary
Background
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a reliable outcome measure for cutaneous lupus erythematosus (CLE) in adults used in clinical trials. However, it has not been validated in children, limiting clinical trials for paediatric CLE.
Objectives
This study aimed to validate the CLASI in paediatrics.
Methods
Eleven paediatric patients with CLE, six dermatologists and six rheumatologists participated. The physicians were trained to use the CLASI and Physician's Global Assessment (PGA), and individually rated all patients using both tools. Each physician reassessed two randomly selected patients. Within each physician group, the intraclass correlation coefficient (ICC) was calculated to assess the reliability of each measure.
Results
CLASI activity scores demonstrated excellent inter‐ and intrarater reliability (ICC > 0·90), while the PGA activity scores had good inter‐rater reliability (ICC 0·73–0·77) among both specialties. PGA activity scores showed excellent (ICC 0·89) and good intrarater reliability (ICC 0·76) for dermatologists and rheumatologists, respectively. Limitations of this study include the small sample size of patients and potential recall bias during the physician rerating session.
Conclusions
CLASI activity measurement showed excellent inter‐ and intrarater reliability in paediatric CLE and superiority over the PGA. These results demonstrate that the CLASI is a reliable and valid outcome instrument for paediatric CLE.
What's already known about this topic?
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) has been established as a reliable outcome measure for CLE in adults and is used in clinical trials.
What does this study add?
This study validates the reliability of the CLASI in the paediatric population with CLE, which can manifest differently from CLE in adults.
This validation will allow clinical trials to assess treatment efficacy reliably in CLE.
Linked Comment: Chong. Br J Dermatol 2019; 180:20–21.
Plain language summary available online
Respond to this article</description><subject>Adolescent</subject><subject>Child</subject><subject>Children</subject><subject>Clinical trials</subject><subject>Cutaneous Lupus Erythematosus</subject><subject>Dermatologists</subject><subject>Dermatology</subject><subject>Female</subject><subject>Humans</subject><subject>Lupus</subject><subject>Lupus Erythematosus, Cutaneous - diagnosis</subject><subject>Male</subject><subject>Medical screening</subject><subject>Pediatrics</subject><subject>Quantitative psychology</subject><subject>Questionnaires</subject><subject>Reproducibility of Results</subject><subject>Rheumatologists</subject><subject>Severity of Illness Index</subject><subject>Young Adult</subject><issn>0007-0963</issn><issn>1365-2133</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kcFu1DAQhi0EokvhwAsgS1zaQ9qxnXWS47JdYNFKPRTOkRNPWq-ceLGT0n3EvhXOZqkqpPpga_755retn5CPDC5YXJfVVl-wDBh_RWZMyHnCmRCvyQwAsgQKKU7IuxC2AEzAHN6SEwEgxFzCjDyu7pUdVG9cR11D-zukHq1RlbGm31PVaRoBo8fi2F8OverQDYFuhl3cV34f5Vb1LsTqygRUAenCozqM3-A9-nF83Wl8oGfLzeJmfU5NR3cKtVG9NzWtnzztwVO1rrt9Dmj04w3W3ZrQh4Oxv8PhmfaevGmUDfjheJ6SX19XP5ffk831t_VysUlqkec8QV5XAjOds7wCqThL8yZFjUXaVIVMKz7nshFCF02tda15rqMIHEXsSwGNOCVnk-_Ou98Dhr5sTajR2ukDJYcsZSKTkEf083_o1g2-i68rOZNc5jIrRup8omrvQvDYlDtvWuX3JYNyzLeM-ZaHfCP76eg4VC3qJ_JfoBG4nIA_xuL-Zafyy4-ryfIvFb6zYQ</recordid><startdate>201901</startdate><enddate>201901</enddate><creator>Kushner, C.J.</creator><creator>Tarazi, M.</creator><creator>Gaffney, R.G.</creator><creator>Feng, R.</creator><creator>Ardalan, K.</creator><creator>Brandling‐Bennett, H.A.</creator><creator>Castelo‐Soccio, L.</creator><creator>Chang, J.C.</creator><creator>Chiu, Y.E.</creator><creator>Gmuca, S.</creator><creator>Hunt, R.D.</creator><creator>Kahn, P.J.</creator><creator>Knight, A.M.</creator><creator>Mehta, J.</creator><creator>Pearson, D.R.</creator><creator>Treat, J.R.</creator><creator>Wan, J.</creator><creator>Yeguez, A.C.</creator><creator>Concha, J.S.S.</creator><creator>Patel, B.</creator><creator>Okawa, J.</creator><creator>Arkin, L.M.</creator><creator>Werth, V.P.</creator><creator>Goldsmith, Donald</creator><creator>Lvovich, Svetlana</creator><creator>Curran, Megan L.</creator><creator>Klein‐Gitelman, Marisa</creator><creator>Kirkorian, Yasmine</creator><creator>Sertial, Sarah</creator><general>Oxford University Press</general><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>7T5</scope><scope>H94</scope><scope>K9.</scope><scope>NAPCQ</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0002-7958-3186</orcidid><orcidid>https://orcid.org/0000-0001-7535-2914</orcidid></search><sort><creationdate>201901</creationdate><title>Evaluation of the reliability and validity of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in paediatric cutaneous lupus among paediatric dermatologists and rheumatologists</title><author>Kushner, C.J. ; Tarazi, M. ; Gaffney, R.G. ; Feng, R. ; Ardalan, K. ; Brandling‐Bennett, H.A. ; Castelo‐Soccio, L. ; Chang, J.C. ; Chiu, Y.E. ; Gmuca, S. ; Hunt, R.D. ; Kahn, P.J. ; Knight, A.M. ; Mehta, J. ; Pearson, D.R. ; Treat, J.R. ; Wan, J. ; Yeguez, A.C. ; Concha, J.S.S. ; Patel, B. ; Okawa, J. ; Arkin, L.M. ; Werth, V.P. ; Goldsmith, Donald ; Lvovich, Svetlana ; Curran, Megan L. ; Klein‐Gitelman, Marisa ; Kirkorian, Yasmine ; Sertial, Sarah</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3882-e2cb3e7d818b06a2148f4ede94fb964b2526f33d9fcddcd28d64b02e34fb630f3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Adolescent</topic><topic>Child</topic><topic>Children</topic><topic>Clinical trials</topic><topic>Cutaneous Lupus Erythematosus</topic><topic>Dermatologists</topic><topic>Dermatology</topic><topic>Female</topic><topic>Humans</topic><topic>Lupus</topic><topic>Lupus Erythematosus, Cutaneous - diagnosis</topic><topic>Male</topic><topic>Medical screening</topic><topic>Pediatrics</topic><topic>Quantitative psychology</topic><topic>Questionnaires</topic><topic>Reproducibility of Results</topic><topic>Rheumatologists</topic><topic>Severity of Illness Index</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Kushner, C.J.</creatorcontrib><creatorcontrib>Tarazi, M.</creatorcontrib><creatorcontrib>Gaffney, R.G.</creatorcontrib><creatorcontrib>Feng, R.</creatorcontrib><creatorcontrib>Ardalan, K.</creatorcontrib><creatorcontrib>Brandling‐Bennett, H.A.</creatorcontrib><creatorcontrib>Castelo‐Soccio, L.</creatorcontrib><creatorcontrib>Chang, J.C.</creatorcontrib><creatorcontrib>Chiu, Y.E.</creatorcontrib><creatorcontrib>Gmuca, S.</creatorcontrib><creatorcontrib>Hunt, R.D.</creatorcontrib><creatorcontrib>Kahn, P.J.</creatorcontrib><creatorcontrib>Knight, A.M.</creatorcontrib><creatorcontrib>Mehta, J.</creatorcontrib><creatorcontrib>Pearson, D.R.</creatorcontrib><creatorcontrib>Treat, J.R.</creatorcontrib><creatorcontrib>Wan, J.</creatorcontrib><creatorcontrib>Yeguez, A.C.</creatorcontrib><creatorcontrib>Concha, J.S.S.</creatorcontrib><creatorcontrib>Patel, B.</creatorcontrib><creatorcontrib>Okawa, J.</creatorcontrib><creatorcontrib>Arkin, L.M.</creatorcontrib><creatorcontrib>Werth, V.P.</creatorcontrib><creatorcontrib>Goldsmith, Donald</creatorcontrib><creatorcontrib>Lvovich, Svetlana</creatorcontrib><creatorcontrib>Curran, Megan L.</creatorcontrib><creatorcontrib>Klein‐Gitelman, Marisa</creatorcontrib><creatorcontrib>Kirkorian, Yasmine</creatorcontrib><creatorcontrib>Sertial, Sarah</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><collection>MEDLINE - Academic</collection><jtitle>British journal of dermatology (1951)</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Kushner, C.J.</au><au>Tarazi, M.</au><au>Gaffney, R.G.</au><au>Feng, R.</au><au>Ardalan, K.</au><au>Brandling‐Bennett, H.A.</au><au>Castelo‐Soccio, L.</au><au>Chang, J.C.</au><au>Chiu, Y.E.</au><au>Gmuca, S.</au><au>Hunt, R.D.</au><au>Kahn, P.J.</au><au>Knight, A.M.</au><au>Mehta, J.</au><au>Pearson, D.R.</au><au>Treat, J.R.</au><au>Wan, J.</au><au>Yeguez, A.C.</au><au>Concha, J.S.S.</au><au>Patel, B.</au><au>Okawa, J.</au><au>Arkin, L.M.</au><au>Werth, V.P.</au><au>Goldsmith, Donald</au><au>Lvovich, Svetlana</au><au>Curran, Megan L.</au><au>Klein‐Gitelman, Marisa</au><au>Kirkorian, Yasmine</au><au>Sertial, Sarah</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of the reliability and validity of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in paediatric cutaneous lupus among paediatric dermatologists and rheumatologists</atitle><jtitle>British journal of dermatology (1951)</jtitle><addtitle>Br J Dermatol</addtitle><date>2019-01</date><risdate>2019</risdate><volume>180</volume><issue>1</issue><spage>165</spage><epage>171</epage><pages>165-171</pages><issn>0007-0963</issn><eissn>1365-2133</eissn><abstract>Summary
Background
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a reliable outcome measure for cutaneous lupus erythematosus (CLE) in adults used in clinical trials. However, it has not been validated in children, limiting clinical trials for paediatric CLE.
Objectives
This study aimed to validate the CLASI in paediatrics.
Methods
Eleven paediatric patients with CLE, six dermatologists and six rheumatologists participated. The physicians were trained to use the CLASI and Physician's Global Assessment (PGA), and individually rated all patients using both tools. Each physician reassessed two randomly selected patients. Within each physician group, the intraclass correlation coefficient (ICC) was calculated to assess the reliability of each measure.
Results
CLASI activity scores demonstrated excellent inter‐ and intrarater reliability (ICC > 0·90), while the PGA activity scores had good inter‐rater reliability (ICC 0·73–0·77) among both specialties. PGA activity scores showed excellent (ICC 0·89) and good intrarater reliability (ICC 0·76) for dermatologists and rheumatologists, respectively. Limitations of this study include the small sample size of patients and potential recall bias during the physician rerating session.
Conclusions
CLASI activity measurement showed excellent inter‐ and intrarater reliability in paediatric CLE and superiority over the PGA. These results demonstrate that the CLASI is a reliable and valid outcome instrument for paediatric CLE.
What's already known about this topic?
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) has been established as a reliable outcome measure for CLE in adults and is used in clinical trials.
What does this study add?
This study validates the reliability of the CLASI in the paediatric population with CLE, which can manifest differently from CLE in adults.
This validation will allow clinical trials to assess treatment efficacy reliably in CLE.
Linked Comment: Chong. Br J Dermatol 2019; 180:20–21.
Plain language summary available online
Respond to this article</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>30033560</pmid><doi>10.1111/bjd.17012</doi><tpages>7</tpages><orcidid>https://orcid.org/0000-0002-7958-3186</orcidid><orcidid>https://orcid.org/0000-0001-7535-2914</orcidid><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0007-0963 |
ispartof | British journal of dermatology (1951), 2019-01, Vol.180 (1), p.165-171 |
issn | 0007-0963 1365-2133 |
language | eng |
recordid | cdi_proquest_miscellaneous_2074137608 |
source | Oxford University Press Journals; MEDLINE; Wiley Online Library All Journals |
subjects | Adolescent Child Children Clinical trials Cutaneous Lupus Erythematosus Dermatologists Dermatology Female Humans Lupus Lupus Erythematosus, Cutaneous - diagnosis Male Medical screening Pediatrics Quantitative psychology Questionnaires Reproducibility of Results Rheumatologists Severity of Illness Index Young Adult |
title | Evaluation of the reliability and validity of the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) in paediatric cutaneous lupus among paediatric dermatologists and rheumatologists |
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