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Background Given the advantages of the randomised controlled trial (RCT) design for the evaluation of therapeutic interventions, it is tempting to assume that the same approach must be the gold standard for the evaluation of testing strategies. Such trials present considerable challenges, due to the complex nature of the decision–making process. To interpret how changes in testing strategies create observed effects, trials must pre–specify how test results should inform diagnostic and management decisions and treatment plans.

trials

How well documented are testing strategies and outcome measurement methods in trials of tests? A comparison of reporting quality in test-treatment and monitoring RCTS