A critical appraisal of toxicity indexes in rheumatology

Our objective was to design a grading system to judge the methodological quality of toxicity symptoms assessment in rheumatologic randomized controlled trials, and to use this grading system to evaluate rheumatology case report forms. For comparison, we also evaluated instruments derived in other clinical specialties. To further determine whether variability seen on the rheumatology case report forms would lead to variability of side effect measurement in a clinical trial setting, we conducted a survey of investigators and their coordinators in a multicenter randomized trial. We used Feinstein's definition of sensibility and a conceptual model of the process of toxicity measurement in the clinical trial setting to develop a grading system. Thirty case report forms were obtained from a convenience sample, and 7 other instruments from other disciplines were obtained through literature review. These forms were evaluated in a blinded manner by 3 reviewers. A survey of 30 trial staff from 15 centers involved in a multicenter, randomized trial of 2 active nonsteroidal antiinflammatory drugs (NSAID) in rheumatoid arthritis (RA) was undertaken to evaluate whether the variability identified in the review of the case report forms translated into variability in the measurement of side effects in clinical trial setting. The rheumatology case report forms had a mean score of 9.1 (SD = 2.6) out of 20, where 0 is the worst score and 20 is a perfect score. The structured instruments from other disciplines had a mean score of 14.9 (SD = 2.7). These means were significantly different, with p = 0.001.(ABSTRACT TRUNCATED AT 250 WORDS)