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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of study design which include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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A practical trial that employs various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for pragmatic trials to be valid and to reduce bias in the results is also essential. However, too much heterogeneity, can cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually requested by practitioners and policymakers in order to guide their decisions. They can also be used to determine the cause-effect relationship of an intervention and its results. However, they should not be used to replace explanation studies.
The pragmatism idea is controversial, and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also suggested a framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a pragmatic study, including the recruitment process, the design and delivery of the intervention, as well as follow-up.
There is a positive increase in the number pragmatic trials published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.