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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often characterized by a focus on the practical aspects of the research design, like the recruitment and consent process in adherence, as well as the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from various geographical areas. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and lessen the chance of bias is also essential. However too much heterogeneity could cause issues with the design of the trial.
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The aim of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. They are typically commissioned by practitioners and policy makers to aid in their decision-making. They can be used to determine the causality of an intervention and its effects. They should, however, not be used to replace explanatory studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study which includes recruitment, design, delivery of the intervention, and follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatics. It is important to note, however, that the majority were conducted in primary-care settings.