Using randomised controlled trials to evaluate the clinical effectiveness of diagnostic tests: how useful are test-treatment RCTs?

Ferrante di Ruffano, Lavinia (2013). Using randomised controlled trials to evaluate the clinical effectiveness of diagnostic tests: how useful are test-treatment RCTs? University of Birmingham. Ph.D.

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Abstract

Background: Decisions on which tests to use should be informed by evidence that they do more good than harm. Test-treatment RCTs are recommended as the ‘gold–standard’ approach, but have attracted criticism that question whether they are fit for purpose. Confronting this question, the thesis investigates four key challenges by finding and analysing all identifiable test-treatment RCTs (2004–2007).
Methods: Capture–recapture analysis estimated the total population of trials; descriptive analysis characterised the diagnostic questions evaluated by RCT; reviews of reporting and methodological quality investigated how informative and valid trials are; analytic induction was used to develop a theoretical framework linking tests to health outcomes, from which a tool was designed.
Results: Published trials were poor quality, and found to be highly complex studies that will be challenging to evaluate reliably: interventions are difficult to capture and translate into protocols; several methods traditionally used to eliminate bias are more difficult to implement; test-treatment strategies impact on patient health in numerous and highly complicated ways.
Conclusion: Test-treatment trials have the potential to be very useful instruments, and though highly challenging they could be both reliable and informative. However, it must be acknowledged that trials will not be suited to all comparisons.

Type of Work:

Thesis (Doctorates > Ph.D.)

Award Type:

Doctorates > Ph.D.

Supervisor(s):