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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often described as focusing on practical aspects of design, including the recruitment process and consent, adhering and the use of routinely available equipment.
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A pragmatic study that involves a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be able to prove their validity, and it also reduces bias in the results. Too much heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are typically commissioned by practitioners and policy makers to inform their decision making. They are also a good way to identify the causality between an intervention and its outcomes. However, they shouldn't be used as a substitute for the use of explanation trials.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis as well as pragmatic trials that inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic research study which includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to keep in mind, however, that the majority were conducted in primary-care settings.