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Abstract:
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One strength of a well conducted randomized clinical trial, besides its use of randomization, is it follows a protocol that describes the design of the trial and a plan for its analysis. For observational studies, protocols are equally valuable but less commonly used. We will discuss methodologies for observational study protocols and open problems. We will describe certain considerations that are different for observational study protocols compared to randomized trials, such as how to handle multiplicity. The methodological issues will be illustrated in applications such as the effect of playing high school on later life mental functioning, the effect of police seizing a gun when arresting a domestic violence suspect on future domestic violence and the effect of mountaintop mining on health.
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