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Pragmatic trials are studies designed to inform real-world clinical practice. They are typically focused on the practical aspects of the study design, such as recruitment and consent as well as adherence to the use of standard equipment.
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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for a pragmatic trial to be valid and reduce bias in results is also essential. However, too much heterogeneity can cause issues with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are typically requested by practitioners and policymakers to help guide their decisions. They can be used to determine the causality of an intervention and its results. However, they should not be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate a physiological or clinical hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed an approach to pragmatic trials, 프라그마틱 슬롯 하는법 called PRECIS.2 This tool sought to define the features of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as the follow-up.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, shown in red in Figure 2. This is an indication that the health science community is becoming more acquaint to the subject of pragmatism. It is important to remember that the majority of these studies were conducted in primary care settings.