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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often focused on the practical aspects of study design, including the recruitment and consent process as well as adherence to the use of commonly available equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be valid and helps to reduce bias in the results. A high degree of heterogeneity, however could cause issues with the design of the trial.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are usually requested by practitioners and policymakers to inform their decisions. They also provide a useful way to identify the causality between the intervention and its effects. They should, however, not, be used to replace explanatory studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials that inform the practice and policy decisions. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the elements of a pragmatic study, including the recruitment process, the design and delivery of the intervention, and follow-up.
There is a growing increase in the number of pragmatic trials that are 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 is an indication that the health science community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.