Patient based methods for assessing adverse events in clinical trials in rheumatology. Progress report for the OMERACT drug toxicity working party

There has been increasing recognition in recent years that the measurement of drug related toxicities in rheumatology clinical trials has been sub-opt imal. The OMERACT Drug Toxicity Working Party was established to address th is issue. The first task of the working party was to identify a minimum set of attributes of drug related toxicity that would be important to patients , clinicians, investigators, and policymakers. The working party then devel oped consensus on a standard set of properties for instruments to measure t hese attributes. Existing instruments in the field of rheumatology were asc ertained by literature review and by contact with experts in the field. Fou r instruments were ascertained and evaluated using the guidelines developed by the working party. This report outlines the progress and preliminary re sults of these activities.