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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are often described by their focus on practical aspects of designing a study that include the recruitment and consent process, as well as adherence and 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 a variety of investigators and participants from different geographical regions. This kind of heterogeneity is required for pragmatic trials to be valid and also reduces bias in the results. However, too much heterogeneity can cause issues with the design of the trial.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. Usually, they are requested by practitioners and policymakers in order to guide their decisions. They also provide a useful method to determine the causal relationship between an intervention and its results. However, they shouldn't be used to substitute for explanatory studies.
The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study that includes recruitment, design, implementation of the intervention, and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming more acquaint to the issue of pragmatics. However, it is important to remember that the majority of these studies were conducted in primary care settings.