Abstract
Widespread gaps in evidence-based knowledge result from a paucity of randomized clinical trials of comparative effectiveness. Reliable evidence from comparative effectiveness studies is needed to improve health-care quality and to support the efficient use of limited resources. Pragmatic trials are a type of experimental comparative effectiveness research that are designed to determine the effects of an intervention under the usual condition(s) in which it is delivered in a health-care setting. Such studies are aimed at filling the evidence gap for health-care delivery. Pragmatic studies will often have a mixture of efficacy and effectiveness outcomes that carefully balance issues related to internal and external validity. In this regard, context of the trial is vitally important to the interpretation of the results and it can therefore play a large role in the external validity of the study. Pragmatically designed trials have a host of limitations that are often underappreciated, and extrapolating results can drive harmful policies. Care should be taken in interpretation of pragmatic trials. In this chapter, we define a pragmatic trial; we discuss key design and analytic features of pragmatic trials; and we discuss some of the strengths and limitations of the design.
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Ferguson, R.E., Fiore, L. (2017). Pragmatic Trials. In: Itani, K., Reda, D. (eds) Clinical Trials Design in Operative and Non Operative Invasive Procedures. Springer, Cham. https://doi.org/10.1007/978-3-319-53877-8_12
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DOI: https://doi.org/10.1007/978-3-319-53877-8_12
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