Generic quality-of-life assessment in rheumatoid arthritis.
BACKGROUND
Generic health status measures are commonly used in the evaluation of rheumatoid arthritis (RA) patients. The reliability, validity, and sensitivity of the instruments in the assessment of quality of life (QOL) in RA, and how they correlate to other clinical measurements, have long been questioned.


OBJECTIVE
Analyze the performance of a commonly used generic health status measure, the Medical Outcomes Study 36-Item Short Form (SF-36), against the Outcome Measures in Rheumatology (OMERACT) criteria.


METHODS
Data were analyzed from 7 double-blind, randomized controlled trials that examined the effectiveness of 1 or more interventions in RA. The primary outcome measures evaluated were the Mental and Physical Component Scores of the SF-36. Comparators were 1 or more of the following: the Health Assessment Questionnaire scores, tender joint count (TJC), the Disease Activity Score, and the American College of Rheumatology Responder Index (ACR20, ACR50, ACR70). The ability to detect a treatment effect in the study outcomes was evaluated using 3 measures: treatment difference, standardized response mean, and relative efficiency in relation to the TJC.


RESULTS
As a generic QOL measure, the SF-36 is better suited to capture the holistic health of the patient, as reflected in the World Health Organization definition of health as being not only the avoidance of disease but the physical, emotional, and social well-being of the patient. Furthermore, use of the SF-36 permits comparisons of physical and mental aspects of QOL in the RA patient population, as well as comparisons of QOL parameters between patients with RA, other patient groups, and the general population.


CONCLUSIONS
The SF-36 deserves serious consideration for inclusion in the core set of outcomes in RA trials.
Tugwell
Peter
P
Centre for Global Health, University of Ottawa, 501 Smyth Rd, Rm LM12, Ottawa, ON, K1H8L6, Canada. tugwell@uottawa.ca
Idzerda
Leanne
L
Wells
George A
GA
D000203:Activities of Daily Living; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000145:classification / Q000188:drug therapy / Q000503:physiopathology; D006306:Health Surveys; D006801:Humans; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D000069283:Rituximab; D012720:Severity of Illness Index
D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D018501:Antirheumatic Agents; D000069283:Rituximab