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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically described as a focus on the practical aspects of study design that include recruitment and consent, adherence and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and had participants from different geographic areas. This type of heterogeneity, which is essential for pragmatic trials to be reliable and reduce bias in results, is also necessary. However, too much heterogeneity can lead to problems with the design of the trial.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually commissioned by policy makers and practitioners to aid in their decision-making. They can be used to determine the cause-effect relationship of an intervention with its outcomes. However, they should not be used to substitute for explanation trials.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate a physiological or clinical hypothesis as well as pragmatic trials, which inform the policy and practice of. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic trial that include recruitment, design and delivery of the intervention, and 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 shown in red on Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the subject of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary-care settings.