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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically described by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from different geographic areas. This type of heterogeneity which is essential for pragmatic trials to be valid and reduce bias in results, is also necessary. However too much heterogeneity could lead to issues with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and gain maximum validity externally. Usually, they are requested by practitioners and policymakers to help inform their decisions. They also provide a useful way to identify the causality between an intervention and its outcomes. They should, however, not be used to replace the need for explanation studies.
pragmatic korea is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also proposed the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, and monitoring.
There is a positive increase in the number pragmatic trials published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is a sign that the health science community is becoming more acquaint to the issue of pragmatics. It is important to remember that the majority of these studies were conducted in primary care settings.