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Pragmatic trials are those that are designed to inform real-world clinical practice. They are usually characterized by a focus on the practical aspects of the study design, including recruitment and consent, adherence, and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is necessary for pragmatic trials to be able to prove their validity and also helps reduce the chance of bias in the results. Too much heterogeneity, however can result in problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually commissioned by policy makers and practitioners to aid in their decision-making. They can be used to determine the cause-effect relationship of an intervention and its results. They should, however, not be used to replace explanatory studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials should replace explanatory tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic research study which includes recruitment, design, delivery of the intervention and its follow-up.
There is a positive increase in the number pragmatic trials published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community is becoming more acquaint to the subject of pragmatism. It is important to keep in mind that the majority of these trials were conducted in primary care settings.