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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often characterized as a focus on the practical aspects of study design which include the recruitment process and consent, adhering and the use routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed various investigators and participants from different geographical regions. This type of heterogeneity, which is essential for a pragmatic trial to be valid and to reduce bias in the results, is also necessary. However, too much heterogeneity can result in problems with the trial design.
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The purpose of pragmatic trials is to replicate 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 be used to determine the causal relationship between an intervention with its outcomes. They should not, however be used to replace explanatory studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace tests for explanations or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis, and 프라그마틱 pragmatic trials, which inform policy and practice decisions. They also suggested an approach to pragmatic trials, dubbed PRECIS.2 This tool was designed to define the features of a practical trial which includes recruitment, design and delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) produced 34 articles, which are shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.