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Pragmatic trials are those that are designed to inform real-world clinical practice. They are often characterized by a focus on practical aspects of the study design, including the recruitment process and consent in adherence, as well as the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and included participants from various geographical areas. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and lessen the chance of bias, is also necessary. However, too much heterogeneity can cause issues with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They can be used to determine the causal relationship between an intervention and its results. However, they should not be used to replace the need for explanation studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate 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 traits of a practical study, including the recruitment, design, and delivery 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, which are shown in red in Figure 2. This is a sign that the health sciences community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.
