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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often characterized as focusing on practical aspects of study design, including recruitment and consent, adherence and the use of standard 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 geographical regions. This type of heterogeneity is essential for pragmatic trials to be valid and helps to reduce bias in the results. However excessive heterogeneity could 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. Usually, they are requested by practitioners and policymakers to inform their decisions. They can also be used to assess the causality of an intervention and its effects. 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 should be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 proposed an distinction between explanation-based studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a practical trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.
There is a positive trend in the number of pragmatic trials published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority of these trials were conducted in primary care settings.