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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of study design which include recruitment and consent, 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 utilized a variety of investigators and participants from different geographical regions. This type of heterogeneity, which is essential for pragmatic trials to be valid and lessen the chance of bias is also essential. Too much heterogeneity, however could cause issues 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 typically commissioned by policymakers and practitioners in order to inform their decisions. They can be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used in lieu for explanatory trials.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can be used to replace explanation tests or if they should be an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic research study, including recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority of these studies were conducted in primary care settings.
