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What should you do when your random assignment gets compromised?

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The New York Times recently had a piece on the retraction and re-issuance of a study in Spain based on a randomized trial of the Mediterranean Diet’s effect on heart disease. The original study was meant to be an individualized random assignment of 7,447 people aged 55 to 80 to one of three different diets – a control diet (advice to just reduce fat content), or two variants of the Mediterranean Diet (in which they were given free olive oil or free nuts). The study was originally published in the New England Journal of Medicine (NEJM) in 2013. The authors then appear to have been surprised to find their study on a list of suspicious trials.  There are several parts to this story I thought would be of interest for doing impact evaluations in development, which I discuss below.


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