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Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus

Objectives This study tested the concurrent validity of the systemic lupus erythematosus responder index (SRI) in assessing improvement in juvenile-onset systemic lupus erythematosus (jSLE). Methods The SRI considers changes in the SELENA–SLEDAI, BILAG and a 3-cm visual analogue scale of physician-r... Full description

Journal Title: Annals of the rheumatic diseases 2014-02, Vol.73 (2), p.401-406
Main Author: Mina, Rina
Other Authors: Klein-Gitelman, Marisa S , Nelson, Shannen , Eberhard, B Anne , Higgins, Gloria , Singer, Nora G , Onel, Karen , Tucker, Lori , O'Neil, Kathleen M , Punaro, Marilynn , Levy, Deborah M , Haines, Kathleen , Martini, Alberto , Ruperto, Nicolino , Lovell, Daniel , Brunner, Hermine I
Format: Electronic Article Electronic Article
Language: English
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Publisher: England: BMJ Publishing Group Ltd
ID: ISSN: 0003-4967
Link: https://www.ncbi.nlm.nih.gov/pubmed/23345596
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title: Validation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus
format: Article
creator:
  • Mina, Rina
  • Klein-Gitelman, Marisa S
  • Nelson, Shannen
  • Eberhard, B Anne
  • Higgins, Gloria
  • Singer, Nora G
  • Onel, Karen
  • Tucker, Lori
  • O'Neil, Kathleen M
  • Punaro, Marilynn
  • Levy, Deborah M
  • Haines, Kathleen
  • Martini, Alberto
  • Ruperto, Nicolino
  • Lovell, Daniel
  • Brunner, Hermine I
subjects:
  • Accuracy
  • Adolescent
  • Age of Onset
  • Care and treatment
  • Child
  • Children & youth
  • Clinical trials
  • Colleges & universities
  • Data collection
  • Drug Administration Schedule
  • Female
  • Glucocorticoids - administration & dosage
  • Glucocorticoids - therapeutic use
  • Health aspects
  • Hospitals
  • Humans
  • Lupus
  • Lupus Erythematosus, Systemic - diagnosis
  • Lupus Erythematosus, Systemic - drug therapy
  • Male
  • Management
  • Medical care
  • Reproducibility of Results
  • Rheumatology
  • Sensitivity and Specificity
  • Severity of Illness Index
  • Systemic lupus erythematosus
  • Teenagers
  • Treatment Outcome
  • United States
  • Usage
  • Youth
ispartof: Annals of the rheumatic diseases, 2014-02, Vol.73 (2), p.401-406
description: Objectives This study tested the concurrent validity of the systemic lupus erythematosus responder index (SRI) in assessing improvement in juvenile-onset systemic lupus erythematosus (jSLE). Methods The SRI considers changes in the SELENA–SLEDAI, BILAG and a 3-cm visual analogue scale of physician-rated disease activity (PGA) to determine patient improvement. Using prospectively collected data from 760 unique follow-up visit intervals of 274 jSLE patients, we assessed the sensitivity and specificity of the SRI using these external standards: physician-rated improvement (MD-change), patient/parent-rated major improvement of wellbeing (patient-change) and decrease in prescribed systemic corticosteroids (steroid-change). Modifications of the SRI that considered different thresholds for the SELENA–SLEDAI, BILAG and 10-cm PGA were explored and agreement with the American College of Rheumatology/PRINTO provisional criteria for improvement of jSLE (PCI) was examined. Results The sensitivity/specificity in capturing major improvement by the MD-change were 78%/76% for the SRI and 83%/78% for the PCI, respectively. There was fair agreement between the SRI and PCI (kappa=0.35, 95% CI 0.02 to 0.73) in capturing major improvement by the MD-change. Select modified versions of the SRI had improved accuracy overall. All improvement criteria tested had lower sensitivity when considering patient-change and steroid-change as external standards compared to MD-change. Conclusions The SRI and its modified versions based on meaningful changes in jSLE have high specificity but at most modest sensitivity for capturing jSLE improvement. When used as an endpoint of clinical trials in jSLE, the SRI will provide a conservative estimate regarding the efficacy of the therapeutic agent under investigation.
language: eng
source:
identifier: ISSN: 0003-4967
fulltext: no_fulltext
issn:
  • 0003-4967
  • 1468-2060
url: Link


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titleValidation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus
creatorMina, Rina ; Klein-Gitelman, Marisa S ; Nelson, Shannen ; Eberhard, B Anne ; Higgins, Gloria ; Singer, Nora G ; Onel, Karen ; Tucker, Lori ; O'Neil, Kathleen M ; Punaro, Marilynn ; Levy, Deborah M ; Haines, Kathleen ; Martini, Alberto ; Ruperto, Nicolino ; Lovell, Daniel ; Brunner, Hermine I
creatorcontribMina, Rina ; Klein-Gitelman, Marisa S ; Nelson, Shannen ; Eberhard, B Anne ; Higgins, Gloria ; Singer, Nora G ; Onel, Karen ; Tucker, Lori ; O'Neil, Kathleen M ; Punaro, Marilynn ; Levy, Deborah M ; Haines, Kathleen ; Martini, Alberto ; Ruperto, Nicolino ; Lovell, Daniel ; Brunner, Hermine I
descriptionObjectives This study tested the concurrent validity of the systemic lupus erythematosus responder index (SRI) in assessing improvement in juvenile-onset systemic lupus erythematosus (jSLE). Methods The SRI considers changes in the SELENA–SLEDAI, BILAG and a 3-cm visual analogue scale of physician-rated disease activity (PGA) to determine patient improvement. Using prospectively collected data from 760 unique follow-up visit intervals of 274 jSLE patients, we assessed the sensitivity and specificity of the SRI using these external standards: physician-rated improvement (MD-change), patient/parent-rated major improvement of wellbeing (patient-change) and decrease in prescribed systemic corticosteroids (steroid-change). Modifications of the SRI that considered different thresholds for the SELENA–SLEDAI, BILAG and 10-cm PGA were explored and agreement with the American College of Rheumatology/PRINTO provisional criteria for improvement of jSLE (PCI) was examined. Results The sensitivity/specificity in capturing major improvement by the MD-change were 78%/76% for the SRI and 83%/78% for the PCI, respectively. There was fair agreement between the SRI and PCI (kappa=0.35, 95% CI 0.02 to 0.73) in capturing major improvement by the MD-change. Select modified versions of the SRI had improved accuracy overall. All improvement criteria tested had lower sensitivity when considering patient-change and steroid-change as external standards compared to MD-change. Conclusions The SRI and its modified versions based on meaningful changes in jSLE have high specificity but at most modest sensitivity for capturing jSLE improvement. When used as an endpoint of clinical trials in jSLE, the SRI will provide a conservative estimate regarding the efficacy of the therapeutic agent under investigation.
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subjectAccuracy ; Adolescent ; Age of Onset ; Care and treatment ; Child ; Children & youth ; Clinical trials ; Colleges & universities ; Data collection ; Drug Administration Schedule ; Female ; Glucocorticoids - administration & dosage ; Glucocorticoids - therapeutic use ; Health aspects ; Hospitals ; Humans ; Lupus ; Lupus Erythematosus, Systemic - diagnosis ; Lupus Erythematosus, Systemic - drug therapy ; Male ; Management ; Medical care ; Reproducibility of Results ; Rheumatology ; Sensitivity and Specificity ; Severity of Illness Index ; Systemic lupus erythematosus ; Teenagers ; Treatment Outcome ; United States ; Usage ; Youth
ispartofAnnals of the rheumatic diseases, 2014-02, Vol.73 (2), p.401-406
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0Published 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
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13Ruperto, Nicolino
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descriptionObjectives This study tested the concurrent validity of the systemic lupus erythematosus responder index (SRI) in assessing improvement in juvenile-onset systemic lupus erythematosus (jSLE). Methods The SRI considers changes in the SELENA–SLEDAI, BILAG and a 3-cm visual analogue scale of physician-rated disease activity (PGA) to determine patient improvement. Using prospectively collected data from 760 unique follow-up visit intervals of 274 jSLE patients, we assessed the sensitivity and specificity of the SRI using these external standards: physician-rated improvement (MD-change), patient/parent-rated major improvement of wellbeing (patient-change) and decrease in prescribed systemic corticosteroids (steroid-change). Modifications of the SRI that considered different thresholds for the SELENA–SLEDAI, BILAG and 10-cm PGA were explored and agreement with the American College of Rheumatology/PRINTO provisional criteria for improvement of jSLE (PCI) was examined. Results The sensitivity/specificity in capturing major improvement by the MD-change were 78%/76% for the SRI and 83%/78% for the PCI, respectively. There was fair agreement between the SRI and PCI (kappa=0.35, 95% CI 0.02 to 0.73) in capturing major improvement by the MD-change. Select modified versions of the SRI had improved accuracy overall. All improvement criteria tested had lower sensitivity when considering patient-change and steroid-change as external standards compared to MD-change. Conclusions The SRI and its modified versions based on meaningful changes in jSLE have high specificity but at most modest sensitivity for capturing jSLE improvement. When used as an endpoint of clinical trials in jSLE, the SRI will provide a conservative estimate regarding the efficacy of the therapeutic agent under investigation.
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titleValidation of the systemic lupus erythematosus responder index for use in juvenile-onset systemic lupus erythematosus
authorMina, Rina ; Klein-Gitelman, Marisa S ; Nelson, Shannen ; Eberhard, B Anne ; Higgins, Gloria ; Singer, Nora G ; Onel, Karen ; Tucker, Lori ; O'Neil, Kathleen M ; Punaro, Marilynn ; Levy, Deborah M ; Haines, Kathleen ; Martini, Alberto ; Ruperto, Nicolino ; Lovell, Daniel ; Brunner, Hermine I
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1Adolescent
2Age of Onset
3Care and treatment
4Child
5Children & youth
6Clinical trials
7Colleges & universities
8Data collection
9Drug Administration Schedule
10Female
11Glucocorticoids - administration & dosage
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18Lupus Erythematosus, Systemic - drug therapy
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21Medical care
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0Mina, Rina
1Klein-Gitelman, Marisa S
2Nelson, Shannen
3Eberhard, B Anne
4Higgins, Gloria
5Singer, Nora G
6Onel, Karen
7Tucker, Lori
8O'Neil, Kathleen M
9Punaro, Marilynn
10Levy, Deborah M
11Haines, Kathleen
12Martini, Alberto
13Ruperto, Nicolino
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15Brunner, Hermine I
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abstractObjectives This study tested the concurrent validity of the systemic lupus erythematosus responder index (SRI) in assessing improvement in juvenile-onset systemic lupus erythematosus (jSLE). Methods The SRI considers changes in the SELENA–SLEDAI, BILAG and a 3-cm visual analogue scale of physician-rated disease activity (PGA) to determine patient improvement. Using prospectively collected data from 760 unique follow-up visit intervals of 274 jSLE patients, we assessed the sensitivity and specificity of the SRI using these external standards: physician-rated improvement (MD-change), patient/parent-rated major improvement of wellbeing (patient-change) and decrease in prescribed systemic corticosteroids (steroid-change). Modifications of the SRI that considered different thresholds for the SELENA–SLEDAI, BILAG and 10-cm PGA were explored and agreement with the American College of Rheumatology/PRINTO provisional criteria for improvement of jSLE (PCI) was examined. Results The sensitivity/specificity in capturing major improvement by the MD-change were 78%/76% for the SRI and 83%/78% for the PCI, respectively. There was fair agreement between the SRI and PCI (kappa=0.35, 95% CI 0.02 to 0.73) in capturing major improvement by the MD-change. Select modified versions of the SRI had improved accuracy overall. All improvement criteria tested had lower sensitivity when considering patient-change and steroid-change as external standards compared to MD-change. Conclusions The SRI and its modified versions based on meaningful changes in jSLE have high specificity but at most modest sensitivity for capturing jSLE improvement. When used as an endpoint of clinical trials in jSLE, the SRI will provide a conservative estimate regarding the efficacy of the therapeutic agent under investigation.
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pmid23345596
doi10.1136/annrheumdis-2012-202376