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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described by their focus on practical aspects of designing a study which include the recruitment process and consent, adhering and the use routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be valid and also reduces bias in the results. However, too much heterogeneity can lead to problems with the design of the trial.
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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners to help guide their decisions. They are also a good way to identify the causality between an intervention and its results. They should, however, not be used to replace explanatory studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study that includes the recruitment, design, and delivery of the intervention and follow-up.
There is a growing increase in the number pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.