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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are typically focused on the practical aspects of research design, like the recruitment and consent process, adherence, and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and had participants from various geographical areas. This kind of heterogeneity is required for pragmatic trials to be valid, and it also reduces the chance of bias in the results. However, too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually commissioned by policy makers and practitioners to guide their decision-making. They are also a good way to identify the cause-effect relationship between the intervention and its effects. They should, however, not be used to replace explanation studies.
The idea of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they should be an alternative to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic study which includes the recruitment, design, and delivery of the intervention and follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the words naturalistic and pragmatic, restricted 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 pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.