TY - JOUR
T1 - Preliminary core set of domains and reporting requirements for longitudinal observational studies in rheumatology
AU - Wolfe, Frederick
AU - Lassere, Marissa
AU - Van Der Heijde, Désirée
AU - Stucki, Gerold
AU - Suarez-Almazor, Maria
AU - Pincus, Theodore
AU - Eberhardt, Kerstin
AU - Kvien, Tore K.
AU - Symmons, Deborah
AU - Silman, Alan
AU - Van Riel, Piet
AU - Tugwell, Peter
AU - Boers, Maarten
N1 - Copyright:
Copyright 2007 Elsevier B.V., All rights reserved.
PY - 1999
Y1 - 1999
N2 - Observational and longitudinal observational studies (LOS) provide essential information about the course and outcome of rheumatic disorders that cannot be provided by randomized controlled trials, and they constitute the major clinical scientific communication in rheumatology. There has been no consensus 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 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs, variables, and outcomes of rheumatology by using introductory lectures, nominal groups, and plenary sessions. The result of this process was to identify 5 'core' domains that should be included in every LOS: Health Status, Disease Process, Damage, Mortality, and Toxicity/Adverse Reactions. Two additional domains, Work Disability and Costs, were recognized as important, but need not be used in all LOS. Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units. A set of reporting requirements was also determined. The core recommendations, which follow on the WHO ICIDH-2 outline, are not disease-specific; the substitution of different 'disease process' and 'damage' measures make them suitable for many rheumatic disorders. The core set is intended to sere as a core for LOS in almost all rheumatic conditions.
AB - Observational and longitudinal observational studies (LOS) provide essential information about the course and outcome of rheumatic disorders that cannot be provided by randomized controlled trials, and they constitute the major clinical scientific communication in rheumatology. There has been no consensus 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 OMERACT IV Conference a consensus process evaluated the literature of rheumatology in light of the constructs, variables, and outcomes of rheumatology by using introductory lectures, nominal groups, and plenary sessions. The result of this process was to identify 5 'core' domains that should be included in every LOS: Health Status, Disease Process, Damage, Mortality, and Toxicity/Adverse Reactions. Two additional domains, Work Disability and Costs, were recognized as important, but need not be used in all LOS. Eleven subdomains were identified that divided the domains into convenient clinical and conceptual units. A set of reporting requirements was also determined. The core recommendations, which follow on the WHO ICIDH-2 outline, are not disease-specific; the substitution of different 'disease process' and 'damage' measures make them suitable for many rheumatic disorders. The core set is intended to sere as a core for LOS in almost all rheumatic conditions.
KW - Longitudinal and observational studies
KW - Omeract
KW - Rheumatic diseases
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M3 - Article
C2 - 9972992
AN - SCOPUS:0032948151
SN - 0315-162X
VL - 26
SP - 484
EP - 489
JO - Journal of Rheumatology
JF - Journal of Rheumatology
IS - 2
ER -