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Classification Criteria for Systemic Sclerosis Subsets

SINDHU R. JOHNSON, BRIAN M. FELDMAN, and GILLIAN A. HAWKER

ABSTRACT.

Objective.
To evaluate the measurement properties of criteria for systemic sclerosis (SSc) subsets for classification of patients in SSc trials, and to determine if any one criteria set confers measurement advantage over others.

Methods. A systematic review of articles describing classification criteria for SSc subsets was performed. Evidence supporting the sensibility (statement of purpose for which the criteria will be used, population, setting, face and content validity, and feasibility), validity, and reliability of the criteria was evaluated.

Results. Fourteen sets of criteria for SSc subsets were identified. There is variability in the intended purpose and setting for which criteria sets are to be applied. Although face validity improves with the addition of less commonly encountered subsets or disease manifestations as criteria, the feasibility of implementing such criteria is conversely limited. Content validity for most criteria sets has not been evaluated due to lack of an explicitly stated conceptual framework for SSc. The criteria with 3 or more subsets do not provide incremental predictive validity over the 2-subset criteria. Our ability to compare subset criteria on divergent validity and reliability is limited by a lack of data.

Conclusion. The 2-subset criteria of LeRoy, et al have good feasibility, acceptable face validity, and good predictive validity. Further research is needed to compare the content validity, divergent validity, and reliability of these with other subset criteria for use in SSc trials. (First Release August 1 2007; J Rheumatol 2007;34:1855-63)

Key Indexing Terms:

SYSTEMIC SCLEROSIS
SCLERODERMA
CRITERIA
VALIDITY
RELIABILITY


From the Division of Rheumatology, University Health Network; The Hospital for Sick Children; Women's College Hospital; Departments of Health Policy, Management and Evaluation, Public Health Sciences, and Pediatrics, University of Toronto, Toronto, Ontario, Canada.

Dr. Johnson has been awarded an Abbott Scholar Award in Rheumatology Research and Canadian Arthritis Network Fellowship. Dr. Hawker is a Senior Distinguished Rheumatologist Investigator of The Arthritis Society and is the F. M. Hill Chair in Academic Women's Medicine, University of Toronto. Dr. Feldman holds the Canada Research Chair in Childhood Arthritis.

S.R. Johnson, MD, FRCPC, Division of Rheumatology, University Health Network, The Hospital for Sick Children, and Department of Health Policy, Management and Evaluation; B.M. Feldman, MD, MSc, FRCPC, Division of Rheumatology, The Hospital for Sick Children, and Departments of Health Policy, Management and Evaluation, Public Health Sciences, and Pediatrics; G.A. Hawker, MD, MSc, FRCPC, Division of Rheumatology, Women's College Hospital, and Department of Health Policy, Management and Evaluation, University of Toronto.

Address reprint requests to Dr. S. Johnson, Division of Rheumatology, Ground Floor, East Wing, Toronto Western Hospital, 399 Bathurst Street, Toronto, Ontario M5T 2S8, Canada. E-mail: Sindhu.Johnson@uhn.on.ca

Accepted for publication May 23, 2007.




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