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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often focused on the practical aspects of the research design, like the recruitment process and consent, adherence, 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 utilized a variety of investigators and participants from various geographical areas. This type of heterogeneity is necessary for pragmatic trials to be valid and helps to reduce 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 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 can also be a great way to identify the causal relationship between the intervention and its effects. They should not, however be used to replace the need for explanation studies.

The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate a physiological or clinical hypothesis and pragmatic trials that inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study that includes the recruitment, design, and delivery of the intervention, and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatics. However, it is important to remember that the majority of these trials were conducted in primary care settings.