Study strengths were the large sample size of high-risk participants analyzed, the balanced sex randomization, diverse ethnic participation, high rate of follow-up, and rigorous CVD end point adjudication procedures.
There are inherent delays between performance of procedures and public reporting of outcomes due to the rigorous data review and manual case adjudication required from both a regulatory and data quality standpoint.
A PROBE trial design assesses clinical outcomes in large simple studies that allow a broad patient population, in this case patients who require the long-term use of NSAIDs owing to chronic pain, which better reflects clinical practice but with the advantage of randomization and a rigorous evaluation of endpoints by blinded expert adjudication committees (16).
The strengths of the PROBE design are randomization, prospective follow-up, and a rigorous evaluation of study endpoints by a blinded, independent, expert adjudication committee (16).
23 Strengths of this protocol and the overall SIRS trial are generalisable estimates derived from patients recruited in 81 centres in 18 countries and rigorous randomised trial methodology (eg, concealed allocation, placebo-controlled trial, blinded central adjudication of the outcomes).
Strengths of this POISE-2 AKI protocol and the overall POISE-2 trial are generalisable estimates derived from patients recruited in an international context using rigorous randomised trial methodology (eg, concealed allocation, placebo-controlled trial, blinded central adjudication of outcomes).
Source: PCC full adjudication.
Source and full adjudication: Ipso.
