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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, including recruitment and consent in adherence, as well as 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 employed a variety of investigators and had participants from different geographical regions. This type of heterogeneity which is vital 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 trial design.
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They are also a good method to determine the causality between an intervention and its results. However, they should not, be used to replace explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace explanatory tests or if they should be an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool sought to define the features of a pragmatic study, including the recruitment process, the design and delivery of the intervention, and monitoring.
There is an encouraging trend in the number of pragmatic trials that have been 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 suggests that the health sciences community has become more aware of the importance of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.