Reliability of routine data
bleeding
BLEEDING, GASTROINTESTINAL BLEEDING, EVENT, SENSITIVITY, INTRACRANIAL HAEMORRHAGE, EVENTS
Of the 1690 participants with a bleeding event identified from routine data sources, 599 (35.4%) were categorised as major by the routine data algorithm (Agreement between routine data and adjudicated direct follow-upPercentages in parentheses are % of total number of ASCEND participants. Sensitivity and specificity statistics calculated using adjudicated direct follow-up as the reference dataset.For the components of the major bleeding composite outcome, agreement between adjudicated direct-participant follow-up and routine data was strongest for intracranial haemorrhage (kappa 0.73, 95% CI 0.67 to 0.80) and serious gastrointestinal bleeding (0.56, 95% CI 0.50 to 0.62; For the 241 major bleeding events identified in adjudicated direct-participant follow-up alone, within 90 days, 74 (30.7%) had a bleeding code recorded in the routine data but did not meet the algorithm’s definition for major bleeding, 93 (38.6%) had a routine data hospitalisation record but no bleeding code recorded and 74 (30.7%) had no routine data hospitalisation record (