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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized as a focus on the practical aspects of study design that include the recruitment and consent process, as well as adherence and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and participants from various geographical areas. This kind of heterogeneity is required 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 trial design.
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The goal of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. They are typically commissioned by policymakers and practitioners to help inform their decisions. They can also be used to assess the cause-effect relationship of an intervention and its results. They should not, however be used to replace explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they are an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study which includes the recruitment, design, and delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed 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, however, that the majority were conducted in primary-care settings.