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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically described as a focus on the practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use routinely 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 participants from different geographic areas. This kind of heterogeneity is necessary for pragmatic trials to be valid, and it also helps reduce the chance of bias in the results. However, too much heterogeneity can lead to issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are usually commissioned by policymakers and practitioners to inform their decisions. They also provide a useful way to identify the causality between an intervention and its outcomes. They should not, however, be used to replace explanation studies.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study that includes the recruitment, design, and delivery of the intervention and its follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.