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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized by a focus on practical aspects of the study design, such as the recruitment process and consent as well as adherence to 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 utilized different investigators and had participants from different geographic areas. This type of heterogeneity, that is crucial for pragmatic trials to be valid and reduce bias in results, is also necessary. A high degree of heterogeneity, however could cause issues with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually commissioned by policy makers and practitioners to aid in their decision-making. They also provide a useful method of determining the causality between the intervention and its effects. They should, however, not be used to replace explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials, which inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed 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 have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community is becoming more acquaint to the subject of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.