title: 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.
authors.affiliation: Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Lie
authors.affiliation: Division of Rheumatology, UCLA, Los Angeles, California, USA.
authors.forename: Thasia G
authors.initials: TG
authors.lastname: Woodworth
authors.affiliation: Departmant of Rheumatology, MSU, The Parker Institute, Copenhagen University Hospital, Frederiksberg, Copenhagen, Denmark.
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.affiliation: Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.
authors.forename: Tore K
authors.initials: TK
authors.lastname: Kvien
authors.affiliation: Department of Rheumatology Hospital for Special Surgery, New York, New York, USA.
authors.forename: Vivien
authors.initials: V
authors.lastname: Bykerk
authors.affiliation: Division of Rheumatology, UCLA, Los Angeles, California, USA.
authors.forename: Daniel E
authors.initials: DE
authors.lastname: Furst
authors.affiliation: Division of Rheumatology, Johns Hopkins University, Baltimore, Maryland, USA.
authors.forename: Clifton O
authors.initials: CO
authors.lastname: Bingham
authors.affiliation: Section of Rheumatology, Institute of Infection and Immunity, Cardiff University School of Medicine, Cardiff, UK.
authors.forename: Ernest H
authors.initials: EH
authors.lastname: Choy
mesh_terms: D000328:Adult; D000368:Aged; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001172:Arthritis, Rheumatoid / Q000175:diagnosis* / Q000188:drug therapy*; D001688:Biological Products / Q000627:therapeutic use; D059026:Diagnostic Self Evaluation; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D015203:Reproducibility of Results; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D001688:Biological Products
keywords: Outcomes research; Patient perspective; Rheumatoid Arthritis