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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are typically described as focusing on practical aspects of design, including the recruitment process and consent, adhering and 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 included participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and reduces bias in the results. However excessive heterogeneity could cause issues with the design of the trial.
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Legality
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners to help inform their decisions. They are also a good way to identify the cause-effect relationship between the intervention and its effects. They should, however, not, be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate a physiological or clinical hypothesis, and pragmatic trials, which guide policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study that includes the recruitment, design, and delivery of the intervention, and follow-up.
There is an encouraging trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs), yielded 34 articles, as shown in red in Figure 2. This is an indication that the health science community is becoming more sensitive to the issue of pragmatics. However, it is important to note that the majority of these trials were conducted in primary care settings.