Multiple existing, independent datasets will contribute de novo analysis results for meta-analysis, following coordinated meta-analysis protocols we have developed and implemented previously [37-39]. Extensive meetings between the leaders of the contributing studies have focused on effective ways to harmonize the available variables across the studies (see “Data Harmonization” below) to minimize heterogeneity across the resulting analyses. Following the common protocol, each contributing group will format their data for analysis by a common analysis script. Analyses will be performed by each individual data contributing site, using standardized scripts developed by the coordinating site at Washington University in consultation with the entire consortium. Beta-testing of these scripts will be performed both by the coordinating team and individual study teams. These scripts will ensure consistent analyses across sites. Results will be returned to the coordinating site for meta-analysis. The results of the meta-analyses will be interpreted by the consortium and a collaborative publication reporting the results will be produced.
