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The best evidence comes from the right study design, not just randomised trials

A key requirement of any research study is to ensure that the study has sufficient scientific merit to answer, in a robust way, the main question (outlined in part 1 of 2; Lane, BJOG 2018;125:1057). Paramount to this is the research design, which encompasses the methods and procedures required to conduct the study. This should provide a logical structure of enquiry for the research question and hypothesis testing. The purpose of the research design is to reduce ambiguities, including bias, and provide strong evidence to support or reject a particular hypothesis.