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Pragmatic trials are studies designed to provide information for the practice of clinical trials in real life. They are typically characterized by a focus on practical aspects of the study design, including the recruitment and consent process in adherence, as well as the use of standard equipment.
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A practical trial that employs a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. Too much heterogeneity, however, can cause problems with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are typically requested by practitioners and policymakers in order to guide their decisions. They can also be used to determine the cause-effect relationship of an intervention and its effects. They should, however, not be used to replace explanation studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis, and pragmatic trials that inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study that includes recruitment, design, implementation of the intervention and follow-up.
There is a growing trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these trials were conducted in primary care settings.