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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described as a focus on the practical aspects of design which include recruitment and consent, adherence and the use of standard equipment.
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A pragmatic study that involves different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity, which is essential for pragmatic trials to be valid and to reduce bias in the results is also essential. However too much heterogeneity could cause issues with the design of the trial.
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The goal of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They can be used to determine the causality of an intervention with its outcomes. However, they shouldn't be used to substitute for explanatory trials.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials can replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm a physiological or clinical hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool tried to define the elements of a pragmatic study which includes recruitment, design, delivery of the intervention, and follow-up.
There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) produced 34 articles, as shown in red in Figure 2. This is a sign that the health sciences community is becoming more acquaint to the issue of pragmatics. It is important to remember that the majority of these studies were conducted in primary care settings.