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Studies designed to provide insight into clinical practice in the real world are known as pragmatic trials. They are often characterized by their focus on practical aspects of study design which include the recruitment and consent process, as well as adherence and the use routinely available equipment.
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A practical trial that employs different investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, that is crucial for pragmatic trials to be reliable and lessen the chance of bias is also essential. However, too much heterogeneity, can cause problems with the trial design.
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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 in order to inform their decisions. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they should not be used to substitute for explanatory 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 a complement to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study that includes recruitment, design, implementation of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline query that used the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary-care settings.