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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, such as the recruitment and consent process 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 which is vital for a pragmatic trial to be valid and reduce bias in results is also essential. Too much heterogeneity, however, can cause problems with the design of the trial.

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Legality

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Pragmatic trials aim to mimic real-world situations and have the highest external validity. They are typically commissioned by policymakers and practitioners to help inform their decisions. They can also be used to assess the causal relationship between an intervention and its effects. However, they shouldn't be used as a substitute for explanation studies.

The pragmatism idea is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis, and pragmatic trials, which inform the practice and policy decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the elements of a practical study that includes recruitment, design, delivery of the intervention and its follow-up.

There is an encouraging trend in the number of pragmatic trials that are published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health science community is becoming more sensitive to the subject of pragmatic thinking. It is important to note that the majority of these studies were conducted in primary care settings.