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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically described by their focus on practical aspects of design that include the recruitment process and consent, adhering and 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 utilized a variety of investigators and participants from various geographical areas. This type of heterogeneity, which is essential for pragmatic trials to be valid and lessen the chance of bias, is also necessary. Too much heterogeneity, however could 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. 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 effects. However, they should not be used as a substitute for explanatory 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 prove a physiological or clinical hypothesis, and pragmatic trials, which guide the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study which includes recruitment, design, delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to remember that the majority of these studies were conducted in primary care settings.