Tags

Type your tag names separated by a space and hit enter

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.
Ann Rheum Dis. 2017 Jan; 76(1):9-16.AR

Abstract

OBJECTIVES

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 judgement. 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 five 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 min and an unstimulated salivary flow rate of ≤0.1 mL/min, 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, that is, 96% (95% CI92% to 98%) and 95% (95% CI 92% to 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 enrolment in clinical trials.

Authors+Show Affiliations

University of California, San Francisco, California, USA.University of California, San Francisco, California, USA.Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Paris, France.University of California, San Francisco, California, USA.Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Paris, France.University of California, San Francisco, California, USA.Oklahoma Medical Research Foundation, Oklahoma City, Oklahoma, USA.Department of Veterans Affairs Medical Center, Oklahoma Medical Research Foundation, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.Istituto Villa San Giuseppe, Como, Italy. Casa di Cura di Lecco, Lecco, Italy.University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.Université Paris-Sud, AP-HP, Hôpitaux Universitaires Paris-Sud, INSERM U1184, Paris, France.No affiliation info available

Pub Type(s)

Journal Article
Validation Study

Language

eng

PubMed ID

27789466

Citation

Shiboski, Caroline H., et al. "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." Annals of the Rheumatic Diseases, vol. 76, no. 1, 2017, pp. 9-16.
Shiboski CH, Shiboski SC, Seror R, et al. 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. Ann Rheum Dis. 2017;76(1):9-16.
Shiboski, C. H., Shiboski, S. C., Seror, R., Criswell, L. A., Labetoulle, M., Lietman, T. M., Rasmussen, A., Scofield, H., Vitali, C., Bowman, S. J., & Mariette, X. (2017). 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. Annals of the Rheumatic Diseases, 76(1), 9-16. https://doi.org/10.1136/annrheumdis-2016-210571
Shiboski CH, et al. 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. Ann Rheum Dis. 2017;76(1):9-16. PubMed PMID: 27789466.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Shiboski,Caroline H, AU - Shiboski,Stephen C, AU - Seror,Raphaèle, AU - Criswell,Lindsey A, AU - Labetoulle,Marc, AU - Lietman,Thomas M, AU - Rasmussen,Astrid, AU - Scofield,Hal, AU - Vitali,Claudio, AU - Bowman,Simon J, AU - Mariette,Xavier, AU - ,, Y1 - 2016/10/26/ PY - 2016/09/21/accepted PY - 2016/11/1/pubmed PY - 2017/6/7/medline PY - 2016/11/1/entrez KW - Disease Activity KW - Sjøgren's Syndrome KW - Treatment SP - 9 EP - 16 JF - Annals of the rheumatic diseases JO - Ann Rheum Dis VL - 76 IS - 1 N2 - OBJECTIVES: 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 judgement. 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 five 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 min and an unstimulated salivary flow rate of ≤0.1 mL/min, 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, that is, 96% (95% CI92% to 98%) and 95% (95% CI 92% to 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 enrolment in clinical trials. SN - 1468-2060 UR - https://www.unboundmedicine.com/medline/citation/27789466/2016_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_ L2 - https://ard.bmj.com/lookup/pmidlookup?view=long&pmid=27789466 DB - PRIME DP - Unbound Medicine ER -