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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are often characterized by their focus on practical aspects of designing a study which include the recruitment and consent process, as well as 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 had participants from different geographical regions. This kind of heterogeneity is necessary for pragmatic trials to be valid, and it also reduces the chance of bias in the results. However, too much heterogeneity can result in problems with the design of the trial.
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. Usually, they are requested by practitioners and policymakers in order to inform their decisions. They can also be used to determine the causal relationship between an intervention and its results. However, they shouldn't be used in lieu for explanation studies.
The pragmatism concept is controversial, and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which guide the policy and practice of. They also suggested an approach to pragmatic trials, called PRECIS.2 This tool was designed to define the features of a pragmatic study which includes the recruitment process, the design and delivery of the intervention, and monitoring.
There is a growing trend in the number of pragmatic trials that have been published. 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 a sign that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. However, it is important to note that the majority of these trials were conducted in primary care settings.