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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on the practical aspects of the research design, like the recruitment and consent process 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 employed different investigators and included participants from different geographical regions. This kind 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 result in problems with the design of the trial.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually ordered by policymakers and practitioners to help inform their decisions. They also provide a useful method of determining the cause-effect relationship between an intervention and its outcomes. They should not, however be used to replace the need for explanation studies.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which guide policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic study, including recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.