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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 described as a focus on the practical aspects of study design that include the recruitment process and consent, adhering and the use routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from different geographical regions. This type of heterogeneity which is vital for pragmatic trials to be valid and to reduce bias in the results is also essential. A high degree of heterogeneity, however could cause issues with the design of the trial.

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The aim of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are typically requested by practitioners and policymakers to help inform their decisions. They can also be used to determine the causal relationship between an intervention and its results. However, they shouldn't be used in lieu 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 alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as monitoring.

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) produced 34 articles, as shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatics. However, it is important to note that the majority of these trials were conducted in primary care settings.