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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 often characterized as focusing on practical aspects of study design, including the recruitment and consent process, as well as adherence and the use routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and participants from various geographical areas. This kind of heterogeneity, that is crucial for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However, too much heterogeneity can lead to problems with the design of the trial.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to inform their decision making. They are also a good way to identify the cause-effect relationship between the intervention and its effects. However, they should not be used as a substitute for explanatory studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study, including recruitment, design, implementation of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming more acquaint to the subject of pragmatics. It is important to keep in mind that the majority of these studies were conducted in primary care settings.