A first step to assess harm and benefit in clinical trials in one scale.

Objective: To develop a simple system to assess benefit and harm of treatment on a single scale. Harm and benefit signals from trials need to be placed in the proper perspective to decide on the value of a treatment. Several systems have been developed for assessment, but few attempt to incorporate both benefit and risk in the same metric while retaining enough simplicity to aid patients and clinicians in their decision making.

Study Design And Setting: We designed a very simple 3 x 3 table (Outcome Measures in Rheumatology [OMERACT] 3 x 3) that comprises three ranks for both beneficial and harm outcomes: for benefit, these are "none," "substantial," and "(near) remission"; for harm, these are "none," "severe," and "(near) death." Patients are ranked both for benefit and harm and subsequently counted in a 3 x 3 table.

Results: The system was feasible when applied to one trial dataset (patient-level information) and a meta-analysis. To become applicable as a tool, several issues need to be resolved in further development, especially the definitions and cutoffs for the ranks.

Conclusion: A simple 3 x 3 table to rank both benefit and harm outcomes is feasible. For rheumatology this will be further developed in the context of the OMERACT initiative.