Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology

Observational and longitudinal observational studies (LOS) provide essentia l information about the course and outcome of rheumatic disorders that cann ot be provided by randomized controlled trials, and they constitute the maj or clinical scientific communication in rheumatology. There has been no con sensus as to the full and appropriate content of LOS, This report defines a core set of domains and reporting requirements for LOS, At the 1998 OMERAC T IV Conference a consensus process evaluated the literature of rheumatolog y in light of the constructs, variables, and outcomes of rheumatology by us ing introductory lectures, nominal groups, and plenary sessions. The result of this process was to identify 5 "core" domains that should be included i n every LOS: Health Status, Disease Process, Damage, Mortality, and Toxicit y/Adverse Reactions. Two additional domains, Work Disability and Costs, wer e recognized as important, but need not be used in all LOS, Eleven subdomai ns were identified that divided the domains into convenient clinical and co nceptual units. A set of reporting requirements was also determined. The co re recommendations, which follow on the WHO ICIDH-2 outline, are not diseas e-specific: the substitution of different "disease process" and "damage" me asures make them suitable for many rheumatic disorders, The core: set is in tended to serve as a core for LOS in almost all rheumatic conditions.