What is the research question?

A well-articulated research question will clearly define the hypothesis, the research rationale, and core elements of the study: the population, the intervention, the comparator, the outcome, the timing or duration of study, the setting, and the effect to be estimated. Clear definition of these elements will facilitate a research design that answers the intended clinical question. This is true of all clinical research, regardless of whether it is intended to be pragmatic or not. However, the process of defining each element of the research question will help researchers determine if a randomized pragmatic trial is the best design and which elements of the design can be considered pragmatic. Research questions that are well-suited for a pragmatic trial often arise from limitations of previous randomized controlled trials and other types of studies. Pragmatic randomized clinical trials should be designed in order to best address a specific research question that is pragmatic in nature rather than adhering to a checklist of pragmatic design elements. In this chapter, we will emphasize the importance of starting with a well-defined research question and illustrate how each element of a research question translates into the design of a randomized pragmatic clinical trial.