Better information on the global epidemiology of sepsis can guide future research but barriers include the high costs of typical cohort studies and the lack of incentives for participation. PROGRESS is designed to overcome these barriers and provide a representative, contemporary description of sepsis worldwide.
PROGRESS is a prospective, observational registry. The key novel feature is that all data handling is by secure website. The website obviates the need for paper case report forms and has built-in live auditing, thus reducing data management costs. All patient data is de-identified. The principal incentive for site participation is that the website offers customized, on-demand, automated reports back to ICUs, comparing their data to local, national, and global averages. The software development and website maintenance was funded by Eli Lilly. An independent advisory committee with professional society representation governs PROGRESS, including oversight of data quality, access, and analysis.
The first patient was entered December 19, 2002 and 9 ICUs in 3 countries (Germany, Australia, Argentina) enrolled 80 patients by April 18, 2003. Preliminary analysis showed results typical of severe sepsis patients (male 66% [55%-76%]; ICU mortality rate 39% [28%-50%]). Approximately 250 additional ICUs in 31 countries have expressed interest. One national society has adopted the tool for a specific sepsis project.CONCLUSIONS: Development of an international web-based sepsis database to provide ICUs with methodologically consistent benchmarking and on-demand reporting appears feasible.
Low-cost registry participation with automated reporting may facilitate greater understanding of the incidence and mortality of sepsis worldwide, improved patient care, and aid the design of future clinical trials. Major challenges are to expand the number of participating ICUs and ensure system longevity.
R. Beale, served as a paid consultant to Eli Lilly & Co. and is currently an investigator in ongoing clinical trials sponsored by Eli Lilly & Co.