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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are usually characterized by a focus on the practical aspects of research design, like the recruitment and consent process as well as adherence to the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and participants from different geographical regions. This type of heterogeneity is necessary for practical trials to be valid, and it also helps reduce bias in the results. However, too much heterogeneity can result in problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners in order to inform their decisions. They can be used to determine the causal relationship between an intervention and its effects. However, they should not, be used to replace explanatory studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials that inform the policy and practice of. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the characteristics of a pragmatic study which includes the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline query that used the words naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is a sign that the health sciences community is becoming increasingly sensitized to the subject of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary care settings.