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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often described as a focus on the practical aspects of designing a study which 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 used different investigators and had participants from various geographical areas. This type of heterogeneity that is crucial for a pragmatic trial to be reliable and reduce bias in results is also essential. A high degree of heterogeneity, however can result in problems with the trial design.
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Legality
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The purpose 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 aid in their decision-making. They can be used to determine the causality of an intervention with its outcomes. However, they should not, be used to replace explanatory studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they should be an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, as well as the follow-up.
There is an encouraging trend in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is an indication that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.