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Pragmatic trials are studies 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, including the recruitment process and consent, adhering and the use of standard equipment.

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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for pragmatic trials to be valid and to reduce bias in the results, is also necessary. However too much heterogeneity could lead to problems with the design of the trial.

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The aim of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They also provide a useful method to determine the causal relationship between an intervention and its outcomes. 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 or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic study which includes recruitment, design, implementation of the intervention and its follow-up.

There is a growing increase in the number pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to note that the majority of studies were conducted in primary care settings.