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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 typically characterized by a focus on practical aspects of the research design, like the recruitment and consent process in adherence, as well as the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and included participants from various geographical areas. This type of heterogeneity that is crucial for pragmatic trials to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity can lead to problems with the design of the trial.
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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 policy makers and practitioners to inform their decision making. They are also a good way to identify the causal relationship between an intervention and its results. However, they shouldn't be used as a substitute for the use of explanation trials.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide policy and practice decisions. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the elements of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, as well as the follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.