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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are often described as a focus on the practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed various investigators and had participants from different geographical regions. This type of heterogeneity which is vital for a pragmatic trial to be valid and reduce bias in results is also essential. However, too much heterogeneity can cause issues with the design of the trial.
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The goal of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are usually requested by policy makers and practitioners to inform their decision making. They are also a good method of determining the causal relationship between an intervention and its outcomes. They should not, however, be used to replace explanation studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which prove the physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study, including recruitment, design, delivery of the intervention and follow-up.
There is a growing trend in the number of pragmatic trials that are published. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.