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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often described as focusing on practical aspects of designing a study which include recruitment and consent, adherence and the use 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, which is vital for pragmatic trials to be reliable and lessen the chance of bias is also essential. A high degree of heterogeneity, however can result in problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life situations and achieve the highest level of validity externally. They are usually requested by policy makers and practitioners to inform their decision making. They can also be used to assess the cause-effect relationship of an intervention and its results. However, they should not be used in lieu for explanation studies.
The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could be used to replace explanation tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the validity of a clinical or physiological hypothesis and pragmatic trials that inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic research study that includes the recruitment, design, and delivery of the intervention and follow-up.
There is a positive increase in the number of pragmatic trials that are published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on 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 these studies were conducted in primary care settings.