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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on the practical aspects of research design, like the recruitment process and consent in adherence, as well as the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from different geographic areas. This kind of heterogeneity is required for practical trials to be valid and also helps to reduce bias in the results. However, too much heterogeneity can result in problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life situations and achieve maximum credibility externally. They are usually commissioned by policymakers and practitioners to help guide their decisions. They can be used to determine the causal relationship between an intervention and its effects. However, they should not be used in lieu for explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a practical trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is increasing. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.
