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Pragmatic trials are trials designed to provide information for real-world clinical practice. They are usually focused on the practical aspects of the study design, such as the recruitment process and consent as well as adherence to the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from different geographic areas. This type of heterogeneity is required for pragmatic trials to be valid and also helps reduce the chance of bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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The aim of pragmatic trials is to replicate real-life scenarios and gain maximum validity externally. Usually, they are requested by practitioners and policymakers to help guide their decisions. They can be used to determine the causality of an intervention and its effects. However, they shouldn't be used as a substitute for the use of explanation trials.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic study which includes the recruitment, design, and delivery of the intervention and its follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, 프라그마틱 데모 shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatism. It is important to remember that the majority of these trials were conducted in primary care settings.