American College of Rheumatology classification criteria for Sjögren's syndrome: a data-driven, expert consensus approach in the Sjögren's International Collaborative Clinical Alliance cohort.
ABSTRACT We propose new classification criteria for Sjögren's syndrome (SS), which are needed considering the emergence of biologic agents as potential treatments and their associated comorbidity. These criteria target individuals with signs/symptoms suggestive of SS.
Criteria are based on expert opinion elicited using the nominal group technique and analyses of data from the Sjögren's International Collaborative Clinical Alliance. Preliminary criteria validation included comparisons with classifications based on the American–European Consensus Group (AECG) criteria, a model-based “gold standard”obtained from latent class analysis (LCA) of data from a range of diagnostic tests, and a comparison with cases and controls collected from sources external to the population used for criteria development.
Validation results indicate high levels of sensitivity and specificity for the criteria. Case definition requires at least 2 of the following 3: 1) positive serum anti-SSA and/or anti-SSB or (positive rheumatoid factor and antinuclear antibody titer >1:320), 2) ocular staining score >3, or 3) presence of focal lymphocytic sialadenitis with a focus score >1 focus/4 mm2 in labial salivary gland biopsy samples. Observed agreement with the AECG criteria is high when these are applied using all objective tests. However, AECG classification based on allowable substitutions of symptoms for objective tests results in poor agreement with the proposed and LCA-derived classifications.
These classification criteria developed from registry data collected using standardized measures are based on objective tests. Validation indicates improved classification performance relative to existing alternatives, making them more suitable for application in situations where misclassification may present health risks.
Article: Preliminary criteria for the classification of Sjögren's syndrome. Results of a prospective concerted action supported by the European Community.[show abstract] [hide abstract]
ABSTRACT: Different sets of diagnostic criteria have been proposed for Sjögren's syndrome (SS), but none have been validated with a large series of patients or in a multicenter study. We conducted the present study involving 26 centers from 12 countries (11 in Europe, plus Israel), with the goals of reaching a consensus on the diagnostic procedures for SS and defining classification criteria to be used in epidemiologic surveys and adopted by the scientific community. The study protocol was subdivided into two parts. For part I, questionnaires regarding both ocular and oral involvement were developed; they included 13 questions and 7 questions, respectively. For part II a limited set of diagnostic tests was selected, and the exact procedure to be followed in performing these tests was defined. Part I of the study included 240 patients with primary SS and 240 age- and sex-matched controls. Two hundred forty-six patients with primary SS, 201 with secondary SS, 113 with connective tissue diseases but without associated SS, and 133 control patients were studied in part II. The study resulted in (a) the validation of a simple 6-item questionnaire for determination of dry eyes and dry mouth, which showed good discriminant power between patients and controls, to be used in the initial screening for sicca syndrome; and (b) the definition of a new set of criteria for the classification of SS. The sensitivity and specificity of the criteria in correctly identifying patients with either the primary or the secondary variant of SS were also determined. Using the findings of this prospective multicenter European study, general agreement can be reached on the diagnostic procedures to be used for patients with SS. Final validation of the preliminary classification criteria for SS is underway.Arthritis & Rheumatism 04/1993; 36(3):340-7. · 7.87 Impact Factor
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ABSTRACT: Consensus methods are being used increasingly to solve problems in medicine and health. Their main purpose is to define levels of agreement on controversial subjects. Advocates suggest that, when properly employed, consensus strategies can create structured environments in which experts are given the best available information, allowing their solutions to problems to be more justifiable and credible than otherwise. This paper surveys the characteristics of several major methods (Delphi, Nominal Group, and models developed by the National Institutes of Health and Glaser) and provides guidelines for those who want to use the techniques. Among the concerns these guidelines address are selecting problems, choosing members for consensus panels, specifying acceptable levels of agreement, properly using empirical data, obtaining professional and political support, and disseminating results.American Journal of Public Health 10/1984; 74(9):979-83. · 3.93 Impact Factor
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ABSTRACT: The authors have recently reported that rose bengal is not a vital dye, and stains whenever the cultured cells are not covered by such components as albumin and mucin, and such a tear substitute as carboxycellulose. In this report, using cultured cells as well as normal rabbit corneas, they characterize and correlate the staining differences between rose bengal and fluorescein with the differences in their chemical structures. Fluorescein differs from rose bengal in its lack of intrinsic toxicity, photodynamic action, and ability to be blocked by the above-mentioned substances. Fluorescein staining is increased by rapid stromal diffusion and hence can manifest whenever there is disruption of cell-cell junctions. In contrast, rose bengal staining ensues whenever there is deficiency of preocular tear film protection. These experimental data may help interpret the clinical staining properties of these two dyes and enhance the understanding of the pathogenesis of various ocular surface disorders.Ophthalmology 05/1992; 99(4):605-17. · 5.45 Impact Factor