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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 described as focusing on practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use routinely 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 had participants from different geographic areas. This kind of heterogeneity, which is vital for pragmatic trials to be valid and lessen the chance of bias, is also necessary. However, too much heterogeneity can cause issues with the design of the trial.
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can also be used to assess the cause-effect relationship of an intervention and its results. 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 or complement them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic research study which includes recruitment, design, delivery of the intervention and its follow-up.
There is a positive increase in the number of pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is an indication that the health science community is becoming more acquaint to the subject of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.