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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 characterized by a focus on the practical aspects of study design, including the recruitment process and consent as well as adherence to the use of commonly available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographical regions. This type of heterogeneity which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However excessive heterogeneity could lead to problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and gain maximum credibility externally. They are typically commissioned by practitioners and policy makers to inform their decision making. They can also be a great method of determining the causal relationship between an intervention and its outcomes. However, they should not be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study, including recruitment, design, implementation of the intervention, and follow-up.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary-care settings.