Are clinical trials dealing with severe infection fitting routine practices? Insights from a large registry.
Résumé
Introduction Guidelines dealing with severe sepsis and septic shock mostly rely on randomized controlled trials (RCT) to ensure the best standards of care for patients. However, patients included in high quality studies may differ with routine population and alter external validity of recommendations. We aimed to determine in what extend non-inclusion criteria of RCT dealing with severe sepsis and septic shock may affect application of their conclusions in routine care. Methods In a first step, the MEDLINE database was searched for RCT treating severe sepsis and septic shock patients between 1992 and 2008, and non-inclusion criteria for these studies were abstracted. Two reviewers independently evaluated the articles, and checked by a third reviewer. We extracted data on study design, main intervention, primary end-point, criteria for inclusion, and criteria for non-inclusion. In a second step, distribution of the non-inclusion criteria was observed in a prospective multicenter cohort of severe sepsis and septic shock patients (CUB-REA network, 1992-2008). Results We identified 96 articles out of 7,012 citations that met screening criteria. Congestive heart failure (35%) and cancer (30%) were frequent exclusion criteria in selected studies, as well of other frequent disorders like gastrointestinal and liver diseases, and all causes of immune suppression. Of the 67,717 patients with severe sepsis and septic shock in CUB-REA data base, 40,325 (60%) experienced at least one of the main exclusion criteria, including 11% of congestive heart failure and 11% of cancer patients. In addition, we observed a significant trend for increasing number of patients with these criteria along time. Conclusions Current exclusion criteria for RCT dealing with severe sepsis and septic shock excluded most patients encountered in daily practice with and limit external validity of the results of high quality studies.
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