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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized as a focus on the practical aspects of study design, including 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 a variety of investigators and had participants from different geographical regions. This kind of heterogeneity, which is vital for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity can result in issues with the design of the trial.

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The aim of pragmatic trials is to mimic real-life scenarios and gain the highest level of validity externally. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They can also be used to assess the causality of an intervention and its results. They should not, however be used to replace the need for explanation studies.

The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the clinical or physiological hypothesis and pragmatic trials that inform the policy and practice of. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study, including recruitment, design, implementation of the intervention and its follow-up.

There is a growing 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 is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatism. However, it is important to remember that the majority of these studies were conducted in primary care settings.