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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are often characterized by their focus on practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a pragmatic 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 necessary for pragmatic trials to be able to prove their validity and also helps to reduce bias in the results. A high degree of heterogeneity, however, can cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-life settings and achieve maximum external validity. They are usually commissioned by policy makers and practitioners to inform their decision making. They can also be used to assess the causality of an intervention with its outcomes. They should, however, not, be used to replace the need for explanation studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed a framework called PRECIS for 슬롯 pragmatic trials.2 The tool was designed to define the traits of a pragmatic study which includes the recruitment, 프라그마틱 홈페이지 design, and delivery of the intervention and follow-up.
There is a growing trend in the number of pragmatic trials that are 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 suggests that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.