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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often characterized as a focus on the practical aspects of design that include the recruitment and consent process, as well as adherence and the use routinely available equipment.

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A pragmatic trial that uses various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for pragmatic trials to be valid and to reduce bias in the results is also essential. A high degree of heterogeneity, however, can cause problems with the design of the trial.

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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually requested by policy makers and practitioners to aid in their decision-making. They can be used to determine the causal relationship between an intervention and its results. However, they should not be used as a substitute for explanation studies.

The idea of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as monitoring.

There is a positive 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. They are displayed in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.