Why Is Pragmatic Free Trial So Effective In COVID-19
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Pragmatic trials are studies designed to inform real-world clinical practice. They are often described by their focus on practical aspects of design, including 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 a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for a pragmatic trial to be valid and lessen the chance of bias, is also necessary. A high degree of heterogeneity, however, can cause problems with the trial design.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are usually commissioned by practitioners and policy makers to inform their decision making. They can be used to determine the cause-effect relationship of an intervention and its results. However, they should not be used to substitute for the use of explanation studies.
The pragmatism concept is controversial, and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, which inform policy and practice decision-making. They also proposed an approach to pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a pragmatic study that include the recruitment process, the design and delivery of the intervention, and monitoring.
There is a positive trend in the number of pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the subject of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.