Are large randomised controlled trials in severe sepsis and septic shock statistically disadvantaged by repeated inadvertent underestimates of required sample size?

ABSTRACT:

Objectives

We sought to understand why randomised controlled trials in septic shock have failed to demonstrate effectiveness in the face of improving overall outcomes for patients and seemingly promising results of early phase trials of interventions.

Design

We performed a retrospective analysis of large critical care trials of severe sepsis and septic shock. Data were collected from the primary trial manuscripts, prepublished statistical plans or by direct communication with corresponding authors.

Setting

Critical care randomised control trials in severe sepsis and septic shock.

Participants

14 619 patients randomised in 13 trials published between 2005 and 2015, enrolling greater than 500 patients and powered to a primary outcome of mortality.

Intervention

SUBMITTER: Wong JLC 

PROVIDER: S-EPMC6119416 | biostudies-literature | 2018 Aug

REPOSITORIES: biostudies-literature