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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are typically focused on practical aspects of the study design, such as the recruitment process and consent as well as adherence to the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from different geographical regions. This type of heterogeneity, which is vital for a pragmatic trial to be reliable and reduce bias in results is also essential. However, too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are usually requested by practitioners and policy makers to guide their decision-making. They can be used to determine the causal relationship between an intervention and its results. They should not, however be used to replace explanatory studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also suggested a framework for pragmatic trials, 프라그마틱 공식홈페이지 which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study that include the recruitment process, the design and delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to note that the majority of these trials were conducted in primary care settings.