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Pragmatic trials are trials designed to provide information for the practice of clinical trials in real life. They are often characterized as focusing on practical aspects of designing a study which include recruitment and consent, adherence and the use routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed a variety of investigators and had participants from different geographical regions. This type of heterogeneity is essential for pragmatic trials to be valid and reduces the chance of bias in the results. However too much heterogeneity could cause problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They also provide a useful method to determine the causality between an intervention and its outcomes. However, they shouldn't be used to substitute for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove a physiological or clinical hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic study that includes recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority of studies were conducted in primary-care settings.