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Pragmatic trials are trials designed to provide information for real-world clinical practice. They are usually characterized by a focus on the practical aspects of study design, such as the recruitment and consent process in adherence, as well as the use of commonly 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 participants from different geographic areas. This type of heterogeneity, that is crucial for pragmatic trials to be valid and to reduce bias in the results is also essential. A high degree of heterogeneity, however can result in problems with the design of the trial.
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Legality
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve maximum validity externally. They are typically commissioned by policymakers and practitioners to help inform their decisions. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used to replace explanation studies.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool sought to define the elements of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, and the follow-up.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming increasingly sensitized to the subject of pragmatics. It is important to remember, however, that the majority were conducted in primary-care settings.