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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized by a focus on the practical aspects of study design, such as recruitment and consent in adherence, as well as the use of standard equipment.
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A pragmatic study that involves various investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be able to prove their validity, and it also reduces the chance of bias in the results. However, too much heterogeneity, can cause problems with the design of the trial.
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Legality
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The aim of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policymakers to inform their decisions. They also provide a useful way to identify the cause-effect relationship between the intervention and its effects. However, they should not be used in lieu for explanatory studies.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate a physiological or clinical hypothesis as well as pragmatic trials that inform the policy and practice of. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the traits of a practical 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 published. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the subject of pragmatics. It is important to note that the majority were conducted in primary care settings.