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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, including the recruitment and consent process as well as adherence to the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographical regions. This kind of heterogeneity, that is crucial for a pragmatic trial to be reliable and reduce bias in results, is also necessary. However excessive heterogeneity could result in issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are typically commissioned by practitioners and policy makers to guide their decision-making. They can also be used to determine the causal relationship between an intervention with its outcomes. However, they shouldn't be used to substitute for explanation trials.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they should serve as a complement to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic research study, including recruitment, design, implementation of the intervention and follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.