Delta inflation: a bias in the design of randomized controlled trials in critical care medicine.

ABSTRACT:

Introduction

Mortality is the most widely accepted outcome measure in randomized controlled trials of therapies for critically ill adults, but most of these trials fail to show a statistically significant mortality benefit. The reasons for this are unknown.

Methods

We searched five high impact journals (Annals of Internal Medicine, British Medical Journal, JAMA, The Lancet, New England Journal of Medicine) for randomized controlled trials comparing mortality of therapies for critically ill adults over a ten year period. We abstracted data on the statistical design and results of these trials to compare the predicted delta (delta; the effect size of the therapy compared to control expressed as an absolute mortality reduction) to the observed delta to determine if there is a s

SUBMITTER: Aberegg SK 

PROVIDER: S-EPMC2887200 | biostudies-literature | 2010

REPOSITORIES: biostudies-literature