Generating real-world evidence compatible with evidence from randomized controlled trials: a novel observational study design applicable to surgical transfusion research.

ABSTRACT:

Background

Numerous observational studies have revealed an increased risk of death and complications with transfusion, but this observation has not been confirmed in randomized controlled trials (RCTs). The "transfusion kills patients" paradox persists in real-world observational studies despite application of analytic methods such as propensity-score matching. We propose a new design to address this long-term existing issue, which if left unresolved, will be deleterious to the healthy generation of evidence that supports optimized transfusion practice.

Methods

In the new design, we stress three aspects for reconciling observational studies and RCTs on transfusion safety: (1) re-definition of the study population according to a stable hemoglobin range (gray zone of transfusi

SUBMITTER: Yu X 

PROVIDER: S-EPMC9724333 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature