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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 usually focused on the practical aspects of study design, such as recruitment and consent in adherence, as well as the use of commonly available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and included participants from various geographical areas. This type of heterogeneity, which is essential for pragmatic trials to be reliable and lessen the chance of bias is also essential. However too much heterogeneity could cause problems with the design of the trial.

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The goal of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually commissioned by practitioners and policy makers to inform their decision making. They can also be used to assess the causality of an intervention and its results. However, they should not be used in lieu for the use of explanation studies.

The concept of pragmatism is controversial and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove a physiological or clinical hypothesis and 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 characteristics of a practical study which includes recruitment, design, delivery of the intervention and its follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.