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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are typically described by their focus on practical aspects of study design 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 practical trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and had participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and also helps reduce bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by policy makers and practitioners to aid in their decision-making. They can also be used to assess the causality of an intervention and its results. However, they shouldn't be used to substitute for explanatory trials.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic study, including the recruitment process, the design and implementation of the intervention, and the follow-up.
There is a positive increase in the number of pragmatic trials published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.