Biomaterial Database

Which outcome measures should be used in rheumatoid arthritis clinical trials? Clinical and quality-of-life measures' responsiveness to treatment in a randomized controlled trial. 1995

R Buchbinder, and C Bombardier, and M Yeung, and P Tugwell

Wellesley Hospital Research Institute, University of Toronto, Ontario, Canada.

OBJECTIVE To determine the discriminant validity of the core set of outcome measures proposed by the American College of Rheumatology (ACR) and the Outcome Measures in Clinical Trials (OMERACT) conference committee to be used in clinical trials of rheumatoid arthritis (RA). METHODS Utilizing data from a multicenter randomized double-blind clinical trial of low-dose cyclosporine and placebo in RA, we estimated the relative efficiency (RE) of measures to detect a treatment effect (relative to tender joint count, which was assigned a value of 1). Four pain measures (10-cm visual analog scale [VAS], 5-point categorical scale, Health Assessment Questionnaire [HAQ] pain index, Arthritis Impact Measurement Scales [AIMS] pain score) and 3 quality-of-life measures (Problem Elicitation Technique [PET], HAQ, AIMS) were compared. RESULTS Physician and patient global measures were the most responsive instruments, although neither was statistically superior to tender joint count. Swollen joint count, grip strength, pain measured on a 10-cm VAS, and functional status as measured by the PET and HAQ were all of intermediate responsiveness. Morning stiffness, 5-point pain scale, and erythrocyte sedimentation rate were the least responsive instruments. CONCLUSIONS This study provides further evidence to support the core set of outcome measures proposed by the ACR and OMERACT:

UI	MeSH Term	Description	Entries
D007206	Individuality	Those psychological characteristics which differentiate individuals from one another.	Individual Differences,Difference, Individual,Differences, Individual,Individual Difference
D008297	Male		Males
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260	Female		Females
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000293	Adolescent	A person 13 to 18 years of age.	Adolescence,Youth,Adolescents,Adolescents, Female,Adolescents, Male,Teenagers,Teens,Adolescent, Female,Adolescent, Male,Female Adolescent,Female Adolescents,Male Adolescent,Male Adolescents,Teen,Teenager,Youths
D000328	Adult	A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available.	Adults
D001172	Arthritis, Rheumatoid	A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.	Rheumatoid Arthritis
D016572	Cyclosporine	A cyclic undecapeptide from an extract of soil fungi. It is a powerful immunosupressant with a specific action on T-lymphocytes. It is used for the prophylaxis of graft rejection in organ and tissue transplantation. (From Martindale, The Extra Pharmacopoeia, 30th ed).	Cyclosporin A,Ciclosporin,CsA-Neoral,CyA-NOF,Cyclosporin,Cyclosporine A,Neoral,OL 27-400,Sandimmun,Sandimmun Neoral,Sandimmune,CsA Neoral,CsANeoral,CyA NOF,OL 27 400,OL 27400