Appraising RCTs

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Randomised Controlled Trials (RCTs)

First be aware of their likely limitations as published which are summarised well in On Limitations. Bandolier 161 2007;14(7):1-4.

EPIQ at the University of Auckland provide interactive excel spreadsheets to guide critical appraisal of RCTs and other study designs.

Another limitation is that trials usually take about 2 years to be published. With the increasing frequency of pre-registration the never published group becomes easier to evaluate[1]. Good clinical practice in drug trials will increasingly lead to more data being in the public domain.

Another approach:

SERIBCOAA or (Aims. Authors’ conclusions. Methods (as below). Outcomes. Analysis.)

  • Selection of patients
  • Ethics, informed consent
  • Randomisation
  • Intention to treat, drop-out rate, compliance
  • Blinding, bias
  • Cost implications of the different treatments
  • Outcomes - relevance, standard? Objective?, appropriate to the aims? Open to biases?
  • Analysis - pragmatic or explanatory; how are drop-outs etc. handled?
  • Aims of study - stated?, the right aims?, achieved?

Yet another approach is advocated by CASP who have produced a number of critical appraisal tools including Appraising RCTs

See Also