2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data‐Driven Methodology Involving Three International Patient Cohorts
Objective To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with si...
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| Published in | Arthritis & rheumatology (Hoboken, N.J.) Vol. 69; no. 1; pp. 35 - 45 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article Conference Proceeding |
| Language | English |
| Published |
United States
Wiley Subscription Services, Inc
01.01.2017
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| Subjects | |
| Online Access | Get full text |
| ISSN | 2326-5191 2326-5205 |
| DOI | 10.1002/art.39859 |
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| Abstract | Objective
To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with signs and/or symptoms suggestive of SS.
Methods
We assigned preliminary importance weights to a consensus list of candidate criteria items, using multi‐criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non‐SS controls, with case/non‐case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients.
Results
The final classification criteria are based on the weighted sum of 5 items: anti‐SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of ≥1 foci/4 mm2, each scoring 3; an abnormal ocular staining score of ≥5 (or van Bijsterveld score of ≥4), a Schirmer's test result of ≤5 mm/5 minutes, and an unstimulated salivary flow rate of ≤0.1 ml/minute, each scoring 1. Individuals with signs and/or symptoms suggestive of SS who have a total score of ≥4 for the above items meet the criteria for primary SS. Sensitivity and specificity against clinician‐expert–derived case/non‐case status in the final validation cohort were high, i.e., 96% (95% confidence interval [95% CI] 92–98%) and 95% (95% CI 92–97%), respectively.
Conclusion
Using methodology consistent with other recent ACR/EULAR‐approved classification criteria, we developed a single set of data‐driven consensus classification criteria for primary SS, which performed well in validation analyses and are well‐suited as criteria for enrollment in clinical trials. |
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| AbstractList | Objective To develop and validate an international set of classification criteria for primary Sjogren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with signs and/or symptoms suggestive of SS. Methods We assigned preliminary importance weights to a consensus list of candidate criteria items, using multi-criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non-SS controls, with case/non-case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients. Results The final classification criteria are based on the weighted sum of 5 items: anti-SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of greater than or equal to 1 foci/4 mm super(2), each scoring 3; an abnormal ocular staining score of greater than or equal to 5 (or van Bijsterveld score of greater than or equal to 4), a Schirmer's test result of less than or equal to 5 mm/5 minutes, and an unstimulated salivary flow rate of less than or equal to 0.1 ml/minute, each scoring 1. Individuals with signs and/or symptoms suggestive of SS who have a total score of greater than or equal to 4 for the above items meet the criteria for primary SS. Sensitivity and specificity against clinician-expert-derived case/non-case status in the final validation cohort were high, i.e., 96% (95% confidence interval [95% CI] 92-98%) and 95% (95% CI 92-97%), respectively. Conclusion Using methodology consistent with other recent ACR/EULAR-approved classification criteria, we developed a single set of data-driven consensus classification criteria for primary SS, which performed well in validation analyses and are well-suited as criteria for enrollment in clinical trials. ObjectiveTo develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with signs and/or symptoms suggestive of SS.MethodsWe assigned preliminary importance weights to a consensus list of candidate criteria items, using multi‐criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non‐SS controls, with case/non‐case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients.ResultsThe final classification criteria are based on the weighted sum of 5 items: anti‐SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of ≥1 foci/4 mm2, each scoring 3; an abnormal ocular staining score of ≥5 (or van Bijsterveld score of ≥4), a Schirmer's test result of ≤5 mm/5 minutes, and an unstimulated salivary flow rate of ≤0.1 ml/minute, each scoring 1. Individuals with signs and/or symptoms suggestive of SS who have a total score of ≥4 for the above items meet the criteria for primary SS. Sensitivity and specificity against clinician‐expert–derived case/non‐case status in the final validation cohort were high, i.e., 96% (95% confidence interval [95% CI] 92–98%) and 95% (95% CI 92–97%), respectively.ConclusionUsing methodology consistent with other recent ACR/EULAR‐approved classification criteria, we developed a single set of data‐driven consensus classification criteria for primary SS, which performed well in validation analyses and are well‐suited as criteria for enrollment in clinical trials. To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with signs and/or symptoms suggestive of SS. We assigned preliminary importance weights to a consensus list of candidate criteria items, using multi-criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non-SS controls, with case/non-case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients. The final classification criteria are based on the weighted sum of 5 items: anti-SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of ≥1 foci/4 mm , each scoring 3; an abnormal ocular staining score of ≥5 (or van Bijsterveld score of ≥4), a Schirmer's test result of ≤5 mm/5 minutes, and an unstimulated salivary flow rate of ≤0.1 ml/minute, each scoring 1. Individuals with signs and/or symptoms suggestive of SS who have a total score of ≥4 for the above items meet the criteria for primary SS. Sensitivity and specificity against clinician-expert-derived case/non-case status in the final validation cohort were high, i.e., 96% (95% confidence interval [95% CI] 92-98%) and 95% (95% CI 92-97%), respectively. Using methodology consistent with other recent ACR/EULAR-approved classification criteria, we developed a single set of data-driven consensus classification criteria for primary SS, which performed well in validation analyses and are well-suited as criteria for enrollment in clinical trials. Objective To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with signs and/or symptoms suggestive of SS. Methods We assigned preliminary importance weights to a consensus list of candidate criteria items, using multi-criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non-SS controls, with case/non-case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients. Results The final classification criteria are based on the weighted sum of 5 items: anti-SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of ≥1 foci/4 mm2, each scoring 3; an abnormal ocular staining score of ≥5 (or van Bijsterveld score of ≥4), a Schirmer's test result of ≤5 mm/5 minutes, and an unstimulated salivary flow rate of ≤0.1 ml/minute, each scoring 1. Individuals with signs and/or symptoms suggestive of SS who have a total score of ≥4 for the above items meet the criteria for primary SS. Sensitivity and specificity against clinician-expert-derived case/non-case status in the final validation cohort were high, i.e., 96% (95% confidence interval [95% CI] 92-98%) and 95% (95% CI 92-97%), respectively. Conclusion Using methodology consistent with other recent ACR/EULAR-approved classification criteria, we developed a single set of data-driven consensus classification criteria for primary SS, which performed well in validation analyses and are well-suited as criteria for enrollment in clinical trials. Objective To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of Rheumatology (ACR) and the European League Against Rheumatism (EULAR). These criteria were developed for use in individuals with signs and/or symptoms suggestive of SS. Methods We assigned preliminary importance weights to a consensus list of candidate criteria items, using multi‐criteria decision analysis. We tested and adapted the resulting draft criteria using existing cohort data on primary SS cases and non‐SS controls, with case/non‐case status derived from expert clinical judgment. We then validated the performance of the classification criteria in a separate cohort of patients. Results The final classification criteria are based on the weighted sum of 5 items: anti‐SSA/Ro antibody positivity and focal lymphocytic sialadenitis with a focus score of ≥1 foci/4 mm2, each scoring 3; an abnormal ocular staining score of ≥5 (or van Bijsterveld score of ≥4), a Schirmer's test result of ≤5 mm/5 minutes, and an unstimulated salivary flow rate of ≤0.1 ml/minute, each scoring 1. Individuals with signs and/or symptoms suggestive of SS who have a total score of ≥4 for the above items meet the criteria for primary SS. Sensitivity and specificity against clinician‐expert–derived case/non‐case status in the final validation cohort were high, i.e., 96% (95% confidence interval [95% CI] 92–98%) and 95% (95% CI 92–97%), respectively. Conclusion Using methodology consistent with other recent ACR/EULAR‐approved classification criteria, we developed a single set of data‐driven consensus classification criteria for primary SS, which performed well in validation analyses and are well‐suited as criteria for enrollment in clinical trials. |
| Author | Daniels, T. Akpek, E Wu, A. Shiboski, Caroline H. Segal, B Vivino, F Labetoulle, Marc Stone, D Carteron, N Bombardieri, S Sivils, K Sumida, T Shiboski, Stephen C. Ng, F St.Clair, E. W. Kirkham, B Illei, G Vollenweider, C Atkinson, J Bowman, Simon J. Fisher, B Baer, A. N. Schiødt, M. Gottenberg, J. E Challacombe, S Criswell, Lindsey A. Kitagawa, K Scofield, Hal Umehara, H Pincemin, Maggy Dörner, T. Bootsma, H Rauz, S Seror, Raphaèle Lietman, Thomas M. Jonsson, R Theander, E Devauchelle, V Mariette, Xavier Vitali, Claudio Greenspan, J Heidenreich, A. M. Vissink, A Parke, A Kruize, A. A. Carsons, S Nelson, D Baldini, C Tzoufias, A De Vita, S. Fox, B Larkin, G Saraux, A Radstake, T. R. Ramos‐Casals, M. Lanfranchi, H. Rasmussen, Astrid Pillemer, S |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/27785888$$D View this record in MEDLINE/PubMed |
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| Copyright | 2016 The Authors. Arthritis & Rheumatology published by Wiley Periodicals, Inc. on behalf of the American College of Rheumatology. 2017, American College of Rheumatology |
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| Notes | This article is published simultaneously in the January 2017 issue of The patient cohorts involved in this research were funded by the NIH (grants from the National Institute of Dental and Craniofacial Research [NIDCR], the National Eye Institute, and the Office of Research on Women's Health; contract N01‐DE‐32636 and NIDCR contract HHSN26S201300057C for the Sjögren's International Collaborative Clinical Alliance cohort; and grants AR‐053483, AR‐050782, DE‐018209, DE‐015223, AI‐082714, GM‐104938, and 1P50‐AR‐060804). Support for the Oklahoma Medical Research Foundation cohort was provided by the Oklahoma Medical Research Foundation, the Phileona Foundation, and the Sjögren's Syndrome Foundation. Dr. C. H. Shiboski has received consulting fees from the Pasteur Institute (less than $10,000). Dr. S. C. Shiboski has received textbook royalties from Springer Publishing (less than $10,000). Dr. Labetoulle has received consulting fees from Alcon, Allergan, MSD, Sanofi, Santen, and Thea (less than $10,000 each). Dr. Scofield has received consulting fees from UCB and Eli Lilly (less than $10,000 each). Dr. Bowman has received consulting fees from Celgene, Eli Lilly, Glenmark, GlaxoSmithKline, MedImmune, Novartis, Ono, Pfizer, Roche, Takeda, and UCB (less than $10,000 each). Drs. C. H. Shiboski and S. C. Shiboski contributed equally to this work. Drs. Bowman and Mariette contributed equally to this work. . Annals of the Rheumatic Diseases ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-News-1 ObjectType-Feature-4 ObjectType-Conference-2 SourceType-Conference Papers & Proceedings-1 ObjectType-Undefined-5 content type line 25 ObjectType-Article-3 content type line 23 |
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To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American... To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College of... Objective To develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American... ObjectiveTo develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College... OBJECTIVETo develop and validate an international set of classification criteria for primary Sjögren's syndrome (SS) using guidelines from the American College... Objective To develop and validate an international set of classification criteria for primary Sjogren's syndrome (SS) using guidelines from the American... |
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| Title | 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjögren's Syndrome: A Consensus and Data‐Driven Methodology Involving Three International Patient Cohorts |
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