Sensitivity to change of rheumatoid arthritis clinical trial outcome measures.
OBJECTIVE
To present the properties of an efficiency measure that may be used to make statistical comparisons of sensitivities of trial outcome measures. To use this measure to examine the relative sensitivities of several common rheumatoid arthritis (RA) trial outcome measures in 2 different trial settings.


METHODS
Efficiency is expressed as the mean change divided by the standard deviation of change. Variability and correlations of efficiencies for typical RA trial outcomes are described.


RESULTS
From among a variety of joint assessments and other clinical measures, pain and global measures, and health status and laboratory measures, the joint tenderness and pain measures were the most sensitive, both in a trial of nonsteroidal antiinflammatory drugs (NSAID) and in a set of second-line drug trials. Measures with rather different sensitivities in the 2 types of trials were erythrocyte sedimentation rate (low sensitivity in the NSAID trial) and physician and patient global measures (higher sensitivity in the NSAID trial).


CONCLUSIONS
The use of statistical information on efficiency estimates allows for a variety of comparisons of measures and may inform the selection of outcome measures for clinical trials.
Anderson
J J
JJ
Boston University Arthritis Center, Boston University School of Medicine, MA 02118.
Chernoff
M C
MC
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000592:standards* / Q000627:therapeutic use; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D001799:Blood Sedimentation; D002986:Clinical Trials as Topic; D006801:Humans; D007596:Joints / Q000473:pathology / Q000503:physiopathology; D017063:Outcome Assessment, Health Care; D010147:Pain Measurement; D015203:Reproducibility of Results; D013223:Statistics as Topic; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal