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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, such as the recruitment and consent process, adherence, and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and included participants from various geographical areas. This kind of heterogeneity, which is essential for a pragmatic trial to be reliable and to reduce bias in the results is also essential. A high degree of heterogeneity, however, can cause problems with the trial design.
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The purpose of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. They are usually requested by policy makers and practitioners to inform their decision making. They also provide a useful way to identify the causal relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for the use of explanation trials.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm 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 The tool was designed to define the elements of a pragmatic research study that includes recruitment, design, implementation of the intervention and its follow-up.
There is click the following post in the number of pragmatic trials published. A recent Medline search using the terms naturalistic and pragmatic, limited to randomized controlled trials (RCTs), yielded 34 articles, as shown in red in Figure 2. This is an indication that the health science community is becoming more acquaint to the subject of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.