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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often characterized by their focus on practical aspects of study design which include recruitment and consent, adherence and the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and had participants from different geographical regions. This type of heterogeneity, that is crucial for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. Too much heterogeneity, however can result in problems with the design of the trial.
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The purpose of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. They are usually commissioned by policy makers and practitioners to inform their decision making. They can also be used to determine the causality of an intervention and its results. They should, however, not, be used to replace explanatory studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic study, including recruitment, design, implementation of the intervention, and follow-up.
There is a positive increase in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatic thinking. It is important to remember that the majority were conducted in primary care settings.