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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are usually characterized by a focus on the practical aspects of the research design, like recruitment and consent, adherence, 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 employed different investigators and had participants from different geographical regions. This type of heterogeneity which is vital for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. However, too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are typically commissioned by policy makers and practitioners to guide their decision-making. They can also be used to determine the cause-effect relationship of an intervention and its results. They should, however, not, be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study which includes the recruitment, design, and delivery of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary care settings.