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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are usually focused on the practical aspects of study design, including recruitment and consent in adherence, as well as the use of routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and participants from various geographical areas. This type of heterogeneity, that is crucial for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. However, too much heterogeneity can lead to issues with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are usually commissioned by practitioners and policy makers to guide their decision-making. They can also be used to assess the causality of an intervention with its outcomes. However, they shouldn't be used as a substitute for explanation studies.
The concept of pragmatism is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials that inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic research study that includes recruitment, design, delivery of the intervention and follow-up.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.