Investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.
This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical School. It is intended to replicate, as closely as possible in healthcare insurance claims data, the trial listed below/above. Although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. Randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates through standard practice. Investigators assume that the RCT provides the reference standard treatment effect estimate and that failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original RCT finding.
Study Type
OBSERVATIONAL
Enrollment
78,605
Rivaroxaban dispensing claim is used as the exposure group
Warfarin dispensing claim is used as the reference group
Brigham and Women's Hospital
Boston, Massachusetts, United States
Time to first occurrence of venous thromboembolism
The primary outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of venous thromboembolism up to 1 year
Time frame: From 1 day after prescription fill until outcome occurrence or censoring due to end of follow-up, death, treatment discontinuation, nursing home admission, treatment augmentation, or switch to another NOAC, assessed up to 1 year.
Time to first occurrence of major bleeding
The control outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of a major bleeding event as a control outcome up to 1 year
Time frame: From 1 day after prescription fill until outcome occurrence or censoring due to end of follow-up, death, treatment discontinuation, nursing home admission, treatment augmentation, or switch to another NOAC, assessed up to 1 year.
Time to first occurrence of fracture or fall
The control outcome is the time from 1 day after prescription fill of the exposure or comparator to the first occurrence of fracture or fall as a control outcome up to 1 year
Time frame: From 1 day after prescription fill until outcome occurrence or censoring due to end of follow-up, death, treatment discontinuation, nursing home admission, treatment augmentation, or switch to another NOAC, assessed up to 1 year.
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