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Pragmatic trials are trials designed to inform the practice of clinical trials in real life. They are typically focused on the practical aspects of research design, like the recruitment and consent process in adherence, as well as the use of standard equipment.
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A pragmatic study that involves a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for pragmatic trials to be valid and also reduces the chance of bias in the results. A high degree of heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually requested by policy makers and practitioners to inform their decision making. They can also be used to assess the causal relationship between an intervention with its outcomes. However, they should not, be used to replace explanation studies.
The pragmatism idea is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they should be an addition 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 dubbed PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study which includes the recruitment, design, and delivery of the intervention and its follow-up.
There is a positive increase in the number of pragmatic trials published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority were conducted in primary care settings.