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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often described as a focus on the practical aspects of study design that include the recruitment process and consent, adhering and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used different investigators and included participants from different geographical regions. This kind of heterogeneity, which is vital for pragmatic trials to be valid and to reduce bias in the results is also essential. Too much heterogeneity, however, can cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually requested by practitioners and policy makers to guide their decision-making. They also provide a useful way to identify the cause-effect relationship between an intervention and its results. They should, however, not, be used to replace explanatory studies.
The pragmatism idea 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 validate the validity of a clinical or physiological hypothesis and pragmatic trials, which guide the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study that includes the recruitment, design, and delivery of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown 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 remember, however, that the majority were conducted in primary-care settings.