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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often characterized by a focus on the practical aspects of the study design, including the recruitment process and consent, adherence, and the use of routinely available equipment.
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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for pragmatic trials to be valid and helps to reduce the chance of bias in the results. However, too much heterogeneity can result in problems 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 ordered by policymakers and practitioners to help guide their decisions. They are also a good method of determining the causality between the intervention and its effects. However, they should not be used as a substitute for explanatory trials.
The idea of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study which includes recruitment, design, implementation of the intervention, and follow-up.
There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the terms naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs), yielded 34 articles, shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the subject of pragmatism. It is important to note, however, that the majority of these studies were conducted in primary-care settings.