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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are usually characterized by a focus on the practical aspects of study design, such as the recruitment and consent process as well as adherence to the use of routinely available 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 vital for pragmatic trials to be valid 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 settings and achieve maximum external validity. They are usually commissioned by policy makers and practitioners to inform their decision making. They can also be a great method to determine the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for the use of explanation trials.
The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm the physiological hypothesis or clinical hypothesis, as well as pragmatic trials that aid in the practice and policy decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study that includes recruitment, design, delivery of the intervention, and follow-up.
There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary care settings.