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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 focused on the practical aspects of study design, such as the recruitment and consent process, adherence, and the use of commonly available equipment.
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A pragmatic study that involves a variety investigators and includes participants from various geographical regions 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 can cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. Usually, they are ordered 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 shouldn't be used as a substitute for the use of explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they should serve as an addition to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study, including recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to remember that the majority of studies were conducted in primary-care settings.