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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are often described as a focus on the practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and had participants from various geographical areas. This kind of heterogeneity, which is vital for pragmatic trials to be valid and reduce bias in results is also essential. A high degree of heterogeneity, however could cause issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are usually requested by practitioners and policy makers to guide their decision-making. They are also a good way to identify the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for explanation studies.
The pragmatism concept 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 validate the validity of a clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a pragmatic trial that include the recruitment process, the design and delivery of the intervention, and monitoring.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatism. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.