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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are usually characterized by a focus on practical aspects of the study design, including recruitment and consent as well as adherence to the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and participants from different geographic areas. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. Too much heterogeneity, however could cause issues with the trial design.
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Legality
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. Usually, they are ordered by policymakers and practitioners in order to guide their decisions. They also provide a useful way to identify the cause-effect relationship between an intervention and its outcomes. However, they shouldn't be used in lieu for explanation trials.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests or if they are an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis, and pragmatic trials, which inform the policy and practice of. They also proposed a framework for pragmatic trials, dubbed PRECIS.2 This tool attempted to define the features of a practical trial which includes recruitment, design and delivery of the intervention, as well as follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note, however, that the majority of these studies were conducted in primary-care settings.