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Pragmatic trials are those that are designed to inform the real-world practice of clinical. They are often described as focusing on practical aspects of study design, including recruitment and consent, adherence and the use of standard equipment.
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A pragmatic study that involves different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for practical trials to be valid, and it also reduces 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 situations and attain maximum external validity. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They are also a good method to determine the causal relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for explanation trials.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis and pragmatic trials, which guide the policy and practice of. They also proposed the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, and monitoring.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline query that used the words naturalistic and pragmatic, restricted 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 aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary care settings.