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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are typically described by their focus on practical aspects of study design, including the recruitment process and consent, adhering and the use routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be valid, and it also helps to 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 goal of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners to help inform their decisions. They can also be a great method of determining the causality between an intervention and its outcomes. However, they should not be used to substitute for explanation trials.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can be used to replace explanation tests or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove a physiological or clinical hypothesis, and pragmatic trials, which guide policy and practice decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a practical trial that include the recruitment process, the design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is increasing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is an indication 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.