Elsevier

The Lancet

Volume 356, Issue 9244, 25 November 2000, Pages 1844-1847
The Lancet

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Randomised comparisons of medical tests: sometimes invalid, not always efficient

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Randomised comparisons

Randomised comparisons have several advantages over other methods of comparing medical interventions. Random assignment of patients to the strategies under study should prevent any bias in the selection of patients: differences at baseline between groups of patients have to be attributed to chance.4, 5 This basic principle opens up the application of experimental statistical design, such as testing for significance and calculating confidence intervals. Randomised controlled trials are also

Trials of a single test

Although trials are often undertaken for issues in therapy and prevention, there is no a priori reason why they should not be used to resolve difficulties in diagnosis and monitoring. Yet one should keep in mind how tests affect patient outcome.8 The most common way tests can affect patient outcome is when the information from these tests is used to guide decisions to start, withhold, modify, or stop treatment.

Consider a hypothetical situation in which current clinical management consists of

Trials comparing two tests

Concerns of validity and efficiency also apply when two tests are compared. As an example, consider scintigraphy in patients with ischaemic heart disease, and whether or not to schedule patients for percutaneous transluminal coronary angioplasty. Scintigraphy can assess the functional impact of coronary lesions but, because of the costs, risks, and side-effects of percutaneous transluminal coronary angioplasty only patients with a lesion that sufficiently affects perfusion are referred for

Other threats to validity

There are additional difficulties for those who want to translate trial results to clinical practice. In Figure 1, Figure 2 a clear and prespecified link between test results and management decisions is shown. Test-positive patients received one treatment, test-negative patients another. In some trials, such a link is absent. A recent trial12 reported comparable pregnancy rates in couples randomised to a subfertility work-up with a post-coital test, or to the work-up without post-coital test,

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