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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically described as a focus on the practical aspects of study design, including the recruitment process and consent, adhering and the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and included participants from different geographic areas. This kind of heterogeneity is required for pragmatic trials to be valid and also helps reduce bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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Legality
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. Usually, they are commissioned by policymakers and practitioners to help guide their decisions. They can also be a great method of determining the cause-effect relationship between the intervention and its effects. However, they should not be used to replace explanatory studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials, which guide the practice and policy decisions. They also proposed the framework for pragmatic trials, called PRECIS.2 This tool sought to define the elements of a pragmatic trial which includes the recruitment process, the design and delivery of the intervention, and the follow-up.
There is a growing increase in the number of pragmatic trials published. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind, however, that the majority of studies were conducted in primary-care settings.