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
Hauptverfasser: 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
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container_end_page 171
container_issue 1
container_start_page 165
container_title British journal of dermatology (1951)
container_volume 180
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
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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 &gt; 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 &gt; 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 &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; 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 &gt; 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>
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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
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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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