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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized by their focus on practical aspects of designing a study, including recruitment and consent, adherence and the use of standard equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity that is crucial for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials are designed to replicate real-life situations and attain maximum external validity. They are usually commissioned by policy makers and practitioners to inform their decision making. They can also be a great way to identify the cause-effect relationship between an intervention and its results. They should not, however be used to replace explanation studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should be used to replace explanation tests or if they should be a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the validity of a 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 tried to define the characteristics of a pragmatic study which includes recruitment, design, delivery of the intervention and follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 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 note, however, that the majority were conducted in primary-care settings.