A multicenter study found ECE to be safe, well tolerated, and accurate; however, a post hoc adjudication process was used that may have biased results.
The very strong agreement between the experts, blinded to each other for the adjudication of the primary endpoint, may be seen as an argument for the validity of our process, although we cannot exclude the fact that both reviewers were biased simultaneously in the same way.
To limit the minimal risk of bias that unblinded adjudication can create, a CAC will be used and consensus will be required on all adjudication events.
In his book Cricket and the Law: The Man in White Is Always Right, David Fraser writes that umpires' lbw decisions are frequently criticised and "arguments about bias and incompetence in adjudication inform almost every discussion about lbw decisions".
The leading treatise on U.S. administrative law devotes many chapters to such procedural topics as rule making, requirement of opportunity to cross-examine and rebut, adjudication procedure, examiners, bias, evidence, official notice, findings, reasons, and opinions.
We decreased the risk of selection bias by using randomisation with minimisation, the risk of evaluation bias by selecting objective clinical endpoints and using independent adjudication, and the risk of confusion bias by using randomisation with minimisation and a pre-specified multivariate analysis to correct for any baseline between-group imbalances.
3 25262727 Several trials lacked independent adjudication of events, therefore bias in either direction cannot be excluded, including bias towards the null owing to non-differential misclassification of events or assessor bias in trials without independent adjudication.
Other limitations of our study include the lack of formal adjudication of cancer diagnoses, information bias, and potential for bias due to missing data.
