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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 focused on the practical aspects of research design, like the recruitment process and consent in adherence, as well as the use of routinely available equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity, and it also helps to reduce bias in the results. However, too much heterogeneity can result in problems with the trial design.
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The aim of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are usually requested by practitioners and policymakers to help guide their decisions. They can also be used to determine the cause-effect relationship of an intervention with its outcomes. However, they shouldn't be used in lieu for explanation trials.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a practical study that includes the recruitment, design, and delivery of the intervention and follow-up.
There is a positive increase in the number pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatics. It is important to remember, however, that the majority were conducted in primary-care settings.