Quality issues in complex intervention randomised controlled trials

John Norrie

Robertson Centre for Biostatistics, University of Glasgow, UK

The updated MRC guidance (29 Sep 2008) reiterates the challenges faced when designing and conducting RCT involving complex interventions (usually described as interventions with several interacting components).

Since many complex interventions rely on the skills of clinical staff to deliver the interventions, or the establishment of a therapeutic alliance with the patient, inevitably questions arise about issues of standardisation of the intervention, and of quality of delivery.

The obvious concern is that an efficacious and safe intervention may appear ineffective and/or possibly harmful if delivered poorly.

This talk will consider first the issues of quality (both quality control and its demonstration quality assurance) within the randomised trials of these complex interventions (for example, physiotherapy for incontinence in men after prostate surgery the NHS HTA funded MAPS trial) and then the arguably larger issue of quality assurance of proven interventions in routine clinical practice issues surrounding successful implementation of interventions that should benefit patients.