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Pragmatic trials are studies designed to inform the practice of clinical trials in real life. They are often characterized by a focus on the practical aspects of the study design, such as the recruitment and consent process, adherence, and the use of standard equipment.
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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for practical trials to be valid and also reduces the chance of bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policy makers to guide their decision-making. They can be used to determine the causality of an intervention with its outcomes. They should, however, not be used to replace explanation studies.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool sought to define the features of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, and monitoring.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of studies were conducted in primary-care settings.