Randomized clinical trials and longitudinal observational studies in systemic lupus erythematosus: Consensus on a preliminary core set of outcome domains

The OMERACT module on systemic lupus erythematosus (SLE) dealt with the def inition of preliminary core sets of outcome domains for randomized clinical trials (RCT) and longitudinal observational studies (LOS), After lectures introducing the problems and addressing the key issues, 6 discussion groups , 3 each for LOS and RCT, discussed and weighted more than a dozen possible items for use as outcome domains, The means of the respective 3 groups wer e calculated, For both RCT and LOS the same outcome domains received more t han IO of a total maximum of 100 points: disease activity, health related q uality of life (HRQOL), damage, and toxicity/adverse events. However, the w eights for HRQOL and damage were different for LOS and RCT. A final vote le d to the acceptance of these 4 variables as a preliminary core set fur outc ome in SLE by more than 80% of the participants. This core set will allow f or improved design, performance, and evaluation of future studies in SLE, H owever, a number of domains not included in the core set were regarded as i mportant for further analysis and research.