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Validation of OMERACT preliminary rheumatoid arthritis flare domains in the NOR-DMARD study.

Abstract：

OBJECTIVE:Domains identified as a result of qualitative research and Delphi exercises to assess rheumatoid arthritis (RA) flare include pain, function, swollen and tender joints, patient and physician global, laboratory measures, participation, stiffness, self-management and fatigue. Here we examine aspects of construct and content validity of these domains in a longitudinal observational study. METHODS:A total of 1195 patients with RA treated with non-biological disease-modifying antirheumatic drugs (DMARDs) or biologics were eligible for the analyses. Working definitions of 'flare' included patient-reported worsening between 3 and 6 months (primary) and treatment change at 6 months (DMARDs and/or systemic corticosteroids) (secondary). Available outcome measures were mapped to the flare domains. Changes between 3 and 6 months were compared between patients with and without 'flare'. Convergent and divergent construct validity and content validity were assessed by correlation analyses and logistic regression analysis, respectively. RESULTS:Applying the flare working definition based on patient-reported worsening, standardised mean differences (SMDs) were >0.5 for the majority of outcomes. The largest SMDs were observed for Pain visual analogue scale (1.30), SF-36 Bodily pain (1.24), Patient global (1.20) and morning stiffness intensity (1.17). The flare working definition based on treatment change yielded lower SMDs (<0.5 for most variables). Consistently stronger intradomain than corresponding interdomain correlations supported convergent and divergent validity of the domains. CONCLUSIONS:Probing a flare definition via outcome measures, the identified flare domains discriminated well between patients with and without worsening. Interdomain and intradomain correlation and logistic regression analyses provide further support for construct and content validity of the identified flare domains.

journal_name

Ann Rheum Dis

journal_title

Annals of the rheumatic diseases

authors

Lie E,Woodworth TG,Christensen R,Kvien TK,Bykerk V,Furst DE,Bingham CO 3rd,Choy EH,OMERACT RA Flare Working Group.

doi

10.1136/annrheumdis-2013-203496

subject

Has Abstract

pub_date

2014-10-01 00:00:00

pages

1781-7

issue

eissn

0003-4967

issn

1468-2060

pii

annrheumdis-2013-203496

journal_volume

pub_type

杂志文章,多中心研究

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Validation of OMERACT preliminary rheumatoid arthritis flare domains in the NOR-DMARD study.