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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically focused on the practical aspects of study design, such as recruitment and consent as well as adherence to 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 employed different investigators and included participants from different geographic areas. This type of heterogeneity, that is crucial for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However, too much heterogeneity can lead to problems with the design of the trial.
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The aim of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. Usually, they are ordered by policymakers and practitioners in order to inform their decisions. They can also be used to assess the causal relationship between an intervention with its outcomes. However, they should not, be used to replace explanatory studies.
The concept 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 a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis, and pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a practical study which includes the recruitment, design, and delivery of the intervention and its follow-up.
There is a growing increase in the number of pragmatic trials that have been published. A recent Medline search using the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatism. It is important to remember, however, that the majority of studies were conducted in primary-care settings.