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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 which include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A pragmatic trial that uses a variety investigators and includes participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for practical trials to be valid and also reduces bias in the results. However, too much heterogeneity can result in issues with the design of the trial.
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Pragmatic trials are designed to replicate real-life settings and achieve maximum external validity. They are usually requested by policy makers and practitioners to aid in their decision-making. They can also be used to determine the cause-effect relationship of an intervention and its effects. However, they should not be used as a substitute for the use of explanation trials.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace or complement them. Schwartz and 프라그마틱 플레이 Lellouch1 made an distinction between explanation-based studies, which support a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial which includes recruitment, design and delivery of the intervention, and the follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) resulted in 34 articles, 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 were conducted in primary care settings.