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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are usually characterized by a focus on practical aspects of the study design, including the recruitment and consent process, adherence, and the use of commonly available equipment.
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A pragmatic trial that uses different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid, and it also reduces bias in the results. However too much heterogeneity could lead to problems with the design of the trial.
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The aim of pragmatic trials is to simulate real-life scenarios and to achieve maximum validity externally. Usually, they are commissioned by policymakers and practitioners to inform their decisions. They can also be used to determine the causality of an intervention and its results. However, they should not be used to substitute for explanation studies.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials can be used to replace explanation tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials,
프라그마틱 플레이 which validate the clinical or physiological hypothesis, and pragmatic trials, which inform policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the elements of a pragmatic research study that includes recruitment, design, implementation of the intervention and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs) produced 34 articles, as shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind that the majority of studies were conducted in primary-care settings.
