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Pragmatic trials are those that are designed to inform the practice of clinical trials in real life. They are often characterized by a focus on practical aspects of the study design, including recruitment and consent in adherence, as well as the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and participants from various geographical areas. This type of heterogeneity, which is essential for pragmatic trials to be reliable and reduce bias in results, is also necessary. 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 requested by practitioners and policymakers in order to inform their decisions. They can also be a great way to identify the causal relationship between an intervention and its outcomes. However, they should not be used to replace explanation studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study, including the recruitment, design, and delivery of the intervention and follow-up.
There is a positive increase in the number pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited 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 keep in mind that the majority of these trials were conducted in primary care settings.