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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are usually characterized by a focus on the practical aspects of research design, like the recruitment process and consent, adherence, and the use of commonly available equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be valid, and it also helps reduce the chance of bias in the results. However, too much heterogeneity could cause issues with the trial design.
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The aim of pragmatic trials is to mimic 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 can also be used to determine the cause-effect relationship of an intervention and its results. However, they should not be used in lieu for explanatory trials.
The concept of pragmatism is controversial and there are doubts 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 prove the clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the characteristics of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials randomized to control (RCTs) resulted in 34 articles, as shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.