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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often focused on practical aspects of the research design, like recruitment and consent as well as adherence to the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and included participants from different geographical regions. This type of heterogeneity is required for pragmatic trials to be able to prove their validity and helps reduce bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life scenarios and gain maximum validity externally. They are usually commissioned by policy makers and practitioners to inform their decision making. They can be used to determine the causality of an intervention and its effects. They should not, however, be used to replace explanatory studies.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool sought to define the features of a pragmatic study that include the recruitment process, the design and delivery of the intervention, and monitoring.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the issue of pragmatics. It is important to note that the majority of these trials were conducted in primary care settings.