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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are usually focused on the practical aspects of study design, including the recruitment process and consent as well as adherence to the use of commonly available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used different investigators and had participants from various geographical areas. This type of heterogeneity is necessary for pragmatic trials to be valid and also reduces the chance of bias in the results. Too much heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually commissioned by practitioners and policy makers to guide their decision-making. They also provide a useful way to identify the cause-effect relationship between an intervention and its outcomes. They should not, however be used to replace explanatory studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study, including recruitment, design, implementation of the intervention, and follow-up.
There is a growing trend in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary care settings.