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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are typically described as a focus on the practical aspects of design, including the recruitment and consent process, as well as adherence and the use of standard equipment.
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A pragmatic trial that uses different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is essential for a pragmatic trial to be reliable and to reduce bias in the results is also essential. Too much heterogeneity, however, can cause problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life scenarios and gain 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 assess the cause-effect relationship of an intervention and its effects. However, they should not be used as a substitute for explanation studies.
The pragmatism idea is controversial, and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which guide policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic research study, including recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, which are shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.