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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized as a focus on the practical aspects of study design, including the recruitment process and consent, adhering and the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and reduces bias in the results. However excessive heterogeneity could lead to issues with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually requested by policy makers and practitioners to inform their decision making. They can also be used to assess the causal relationship between an intervention with its outcomes. However, they should not be used to replace explanatory studies.
The pragmatism concept 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 prove a physiological or clinical hypothesis and pragmatic trials, which guide the practice and policy decisions. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a practical trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.
There is a growing trend in the number of pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the issue of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary-care settings.