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Pragmatic trials are studies designed to inform real-world clinical practice. They are often described as a focus on the practical aspects of designing a study, including recruitment and consent, 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 various investigators and included participants from various geographical areas. This kind of heterogeneity, which is vital for a pragmatic trial to be reliable and lessen the chance of bias, is also necessary. Too much heterogeneity, however could cause issues with the design of the trial.

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The goal of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually commissioned by policymakers and practitioners to help inform their decisions. They also provide a useful method of determining 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 concept is controversial, and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis and pragmatic trials that inform policy and practice decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool attempted to define the characteristics of a practical trial, including recruitment, design and delivery of the intervention, as well as monitoring.

There is a positive increase 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 randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.