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Post hoc blinded adjudication of all deaths, MIs, and strokes was performed using prespecified endpoint definitions by an independent clinical events committee (CEC).
Safety assessments included blinded adjudication of each cardiovascular (CV) adverse event (AE) and death.
However, blinded adjudication of test interpretation and diagnoses was not performed in any of the studies.
Definite and probable STs were defined according to the Academic Research Consortium (ARC) 16 and diagnosed by the authors without blinded adjudication.
However, the pre-specified design of the present meta-analysis involved prospective and blinded adjudication of CV events, which should strengthen the validity of the current findings.
Major adverse cardiovascular events (MACE; a composite of total cardiovascular death, non-fatal myocardial infarction and non-fatal stroke) were evaluated and classified by an independent, blinded adjudication committee.
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We also discuss specific details of trial execution, in particular randomization, blinded outcome adjudication and analysis of the results, which are key to avoiding bias in the design and interpretation of such trials.
We designated studies as level I if all of the following criteria were fulfilled: concealed randomization, blinded outcome adjudication and an ITT analysis, which are the strongest methodological tools to reduce bias.
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).
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).
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