Outcome measures, pooled index and quality of life instruments in rheumatoid arthritis

Abstract

Summary Background and objective: A variety of outcome measures are used in evaluating disease activity and therapeutic efficacy in rheumatoid arthritis (RA) studies, and this makes comparisons of drug efficacy difficult. Some of the endpoints used are not standardized and/or are insensitive to change. The purpose of this report is to present a critical appraisal of outcome measures and quality of life assessments in RA studies. Method: An overview of the literature was undertaken to determine the extent to which there is consensus among experts in this area of research. Results: The data suggest that the core set of endpoints in RA clinical studies should include tender joint count, swollen joint count, patients' assessment of pain, patients' and physicians' global assessments, patients' assessment of physical function and acute phase reactant level. When trials of disease‐modifying antirheumatic drugs (DMARD) last for more than a year, radiography may be useful. A ‘pooled index’ may be valuable, and its construction is discussed. Quality of life (QoL) instruments facilitate a fuller examination of the effects of health care interventions and these should be used to complement the more traditional clinical endpoints in the core set. The instruments most commonly used in RA research are identified. Conclusions: We conclude that randomized clinical trials of treatments in RA should now ideally use the core set of clinical endpoints and validated QoL instruments for assessing safety and efficacy.

Quality of Life in Indian Patients with Rheumatoid Arthritis

“…There was a negative influence (moderate correlation) of disease activity scores on the physical and psychological domains in our cohort (Table 3). Disease activity has been shown to adversely affect physical and psychological QOL in earlier studies also [4,11,[27][28][29][30][31]. Disease activity did not affect the social and environmental domains in our patient with RA.…”

Clinical characteristics of psoriatic arthritis and psoriasis in dermatologists' offices

“…Psoriatic arthritis subtypes also were evaluated, and physicians were allowed to document multiple subtypes, if present, and not just the predominant subtype. Patients provided a patient global assessment of joint disease, patient global assessment of joint pain, patient assessment of the duration of morning stiffness, and HAQ-DI score (24)(25)(26). The patient global assessment of joint disease instrument is a patient-reported outcome assessment that asks, 'How active do you feel your joint disease is today?'…”

“…Joint disease parameters assessed included swollen and tender/painful joint counts (24), presence of spondylitis, history (duration) of joint disease, and prior treatments. Psoriatic arthritis subtypes also were evaluated, and physicians were allowed to document multiple subtypes, if present, and not just the predominant subtype.…”

Recent-onset rheumatoid arthritis: a 1-year observational study of correlations between health-related quality of life and clinical/laboratory data

“…A variety of outcome measures have been used to evaluate disease activity and quality of life in patients with RA (2,3). The Outcome Measures for Arthritis Clinical Trials (OMERACT) have recommended 5 domains to be included in outcome measures in RA for use in longitudinal observational studies, i.e.…”