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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are usually focused on the practical aspects of study design, including the recruitment and consent process as well as adherence to the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and had participants from different geographic areas. This type of heterogeneity, that is crucial for a pragmatic trial to be reliable and reduce bias in results is also essential. However, too much heterogeneity, can cause problems with the trial design.
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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. They are usually ordered by policymakers and practitioners to inform their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they shouldn't be used to substitute for explanation studies.
The idea of pragmatism is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a pragmatic trial, including the recruitment process, the design and delivery of the intervention, as well as the follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words 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 pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.