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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described as a focus on the 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 trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used different investigators and had participants from different geographic areas. This type of heterogeneity which is essential for pragmatic trials to be valid and lessen the chance of bias is also essential. However excessive heterogeneity could cause issues with the design of the trial.

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The aim of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. They are usually requested by policy makers and practitioners to inform their decision making. They can also be used to assess the causal relationship between an intervention with its outcomes. They should, however, not be used to replace the need for explanation studies.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate the clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic research study, including recruitment, design, delivery of the intervention and follow-up.

There is an encouraging increase in the number pragmatic trials published. A recent Medline query using the keywords 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 sensitive to the subject of pragmatism. It is important to keep in mind that the majority of these studies were conducted in primary care settings.