Process evaluation in randomised controlled trials of complex interventions

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Process evaluation in randomised controlled trials of complex interventions.

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Randomised controlled trials of complex interventions

Although all randomised controlled trials (RCT) share much in common in terms of design, conduct, analysis and reporting, trials of complex interventions (loosely “interventions with several interacting components”) can have special issues which need appropriate consideration to deliver high quality and credible evidence to change or inform practice. For example, blinding the intervention may b...

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Analysis and comment Health services research Process evaluation in randomised controlled trials of complex interventions

“Complex interventions” are health service interventions that are not drugs or surgical procedures, but have many potential “active ingredients.” A complex intervention combines different components in a whole that is more than the sum of its parts. Randomised controlled trials (RCTs) are the most rigorous way to evaluate the effectiveness of interventions, regardless of their complexity. Becau...

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Mediation and moderation of treatment effects in randomised controlled trials of complex interventions.

Complex intervention trials should be able to answer both pragmatic and explanatory questions in order to test the theories motivating the intervention and help understand the underlying nature of the clinical problem being tested. Key to this is the estimation of direct effects of treatment and indirect effects acting through intermediate variables which are measured post-randomisation. Using ...

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ژورنال

عنوان ژورنال: BMJ

سال: 2006

ISSN: 0959-8138,1468-5833

DOI: 10.1136/bmj.332.7538.413