Reliability of major bleeding events in UK routine data versus clinical trial adjudicated follow-up data.

ABSTRACT:

Objective

To assess how reliable UK routine data are for ascertaining major bleeding events compared with adjudicated follow-up.

Methods

The ASCEND (A Study of Cardiovascular Events iN Diabetes) primary prevention trial randomised 15 480 UK people with diabetes to aspirin versus matching placebo. The primary safety outcome was major bleeding (including intracranial haemorrhage, sight-threatening eye bleeding, serious gastrointestinal bleeding and other major bleeding (epistaxis, haemoptysis, haematuria, vaginal and other bleeding)) ascertained by direct-participant mail-based follow-up, with >90% of outcomes undergoing adjudication. Nearly all participants were linked to routinely collected hospitalisation and death data (ie, routine data). An algorithm categorised bleeding

SUBMITTER: Harper C 

PROVIDER: S-EPMC10511984 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature