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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of designing a study 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 employed various investigators and participants from different geographical regions. This type of heterogeneity, which is essential for pragmatic trials to be valid and reduce bias in results is also essential. However too much heterogeneity could lead to problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They can also be a great way to identify the cause-effect relationship between an intervention and its outcomes. They should, however, not, be used to replace explanation studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study that includes recruitment, design, delivery of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary care settings.