Process evaluation in randomised controlled trials of complex interventions - PubMed (original) (raw)
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Process evaluation in randomised controlled trials of complex interventions
Ann Oakley et al. BMJ. 2006.
Abstract
Most randomised controlled trials focus on outcomes, not on the processes involved in implementing an intervention. Using an example from school based health promotion, this paper argues that including a process evaluation would improve the science of many randomised controlled trials
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Baby talk: the most effective sex education? Credit: TONY KYRIACOU/REX
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References
- Gueron JM. The politics of random assignment: implementing studies and affecting policy. In: Mosteller F, Boruch R, eds. Evidence matters: randomized trials in education research. Washington, DC: Brookings Institution Press, 2002: 15-49.
- Wight D, Obasi A. Unpacking the “black box”: the importance of process data to explain outcomes. In: Stephenson J, Imrie J, Bonell C, eds. Effective sexual health interventions: issues in experimental evaluation. Oxford: Oxford University Press, 2002: 151-66.
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