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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of designing a study that 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 trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed various investigators and participants from different geographical regions. This kind of heterogeneity, that is crucial for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However excessive heterogeneity could lead to issues with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are typically commissioned by practitioners and policy makers to inform their decision making. They can be used to determine the causal relationship between an intervention and its results. However, they shouldn't be used to substitute for the use of explanation trials.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study, including the recruitment, design, and delivery of the intervention and follow-up.
There is an encouraging increase in the number pragmatic trials that are published. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.