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The use of multiple, integrated approaches may be particularly useful in the evaluation of the effects of complex health and social care interventions as these involve social or behavioural processes that are difficult to explore or capture using quantitative methods alone.1Box 1 Ways in which qualitative methods can be used alongside randomised controlled trialsBefore a trialTo explore issues related to the healthcare question of interest or context of the researchTo generate hypotheses for examination in the randomised controlled trialTo develop and refine the interventionTo develop or select appropriate outcome measuresDuring a trialTo examine whether the intervention was delivered as intended, including describing the intervention as deliveredTo "unpack" processes of implementation and changeTo explore deliverers' and recipients' responses to the interventionAfter a trialTo explore reasons for the findings of the trialTo explain variations in effectiveness within the sampleTo examine the appropriateness of the underlying theoryTo generate further questions or hypothesesThe need for methodological research on the ways in which qualitative approaches should be used in randomised controlled trials has been discussed widely.6 7 8 9 10 11 However, to our knowledge no studies have attempted to examine systematically current practice on the use of qualitative approaches in randomised controlled trials of complex healthcare interventions and how they could be used to improve the usefulness and policy relevance of the findings of a trial.

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