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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are often described as focusing on practical aspects of study design that include the recruitment process and consent, adhering and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and had participants from various geographical areas. This kind of heterogeneity is essential for pragmatic trials to be valid and also helps to reduce the chance of bias in the results. However too much heterogeneity could result in problems with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. Usually, they are ordered by policymakers and practitioners to inform their decisions. They can also be used to determine the causal relationship between an intervention with its outcomes. They should not, however be used to replace explanatory studies.
The concept of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also proposed an approach to pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic study, including recruitment, design and delivery of the intervention, and the follow-up.
There is a positive trend in the number of pragmatic trials published. A recent Medline query using the keywords 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 is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority were conducted in primary-care settings.