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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are typically described as focusing on practical aspects of designing a study that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from various geographical areas. This type of heterogeneity is required for pragmatic trials to be valid and also helps to reduce the chance of bias in the results. However, too much heterogeneity, can cause problems with the trial design.
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can also be a great method to determine the causality between an intervention and its results. They should, however, not be used to replace explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic research study which includes recruitment, design, implementation of the intervention and follow-up.
There is a positive trend in the number of pragmatic trials that have been published. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these studies were conducted in primary care settings.