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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized as focusing on practical aspects of study design that include recruitment and consent, adherence and the use of routinely available equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and participants from various geographical areas. This kind of heterogeneity, which is essential for pragmatic trials to be valid and to reduce bias in the results is also essential. However excessive heterogeneity could result in problems 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 policy makers and practitioners to inform their decision making. They can be used to determine the causal relationship between an intervention with its outcomes. However, they should not be used to substitute for explanation studies.

The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a practical trial which includes the recruitment process, the design and implementation of the intervention, as well as the follow-up.

The number of pragmatic trials is increasing. 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 suggests 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 these studies were conducted in primary care settings.