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Studies designed to provide insight into 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 trial that uses various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for pragmatic trials to be reliable and to reduce bias in the results is also essential. However, too much heterogeneity can cause problems 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 typically ordered by policymakers and practitioners to help guide their decisions. They can also be used to determine the causality of an intervention with its outcomes. They should not, however, be used to replace explanation studies.

The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis as well as pragmatic trials that inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic research study that includes recruitment, design, implementation of the intervention and follow-up.

There is a positive increase in the number pragmatic trials that are published. A recent Medline search using the words pragmatic and naturalistic, limited 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 remember that the majority of studies were conducted in primary-care settings.