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Clinical trials that are designed to help inform 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 and consent process, as well as adherence and the use of routinely available equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, that is crucial for pragmatic trials to be valid and to reduce bias in the results is also essential. However, too much heterogeneity, can cause problems with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by policy makers and practitioners to inform their decision making. They can also be used to assess the causal relationship between an intervention and its effects. They should, however, not, be used to replace explanatory studies.
The pragmatism idea is controversial and there are concerns about whether pragmatic trials should replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials, which guide the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study which includes the recruitment, design, and delivery of the intervention, and follow-up.
There is an encouraging increase in the number of pragmatic trials published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming more sensitive to the subject of pragmatics. It is important to remember that the majority of these studies were conducted in primary-care settings.