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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on practical aspects of the study design, such as recruitment and consent, adherence, and the use of standard equipment.

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A pragmatic study that involves various investigators and participants from various geographical regions is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be valid and reduces bias in the results. However, too much heterogeneity can result in problems with the design of the trial.

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Legality

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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are usually requested by practitioners and policy makers to inform their decision making. 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 the use of explanation studies.

The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should be an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove the clinical or physiological hypothesis and pragmatic trials, which inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study that includes recruitment, design, implementation of the intervention and follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) produced 34 articles, as shown in red in Figure 2. This indicates that the health science community is becoming increasingly sensitized to the subject of pragmatism. However, it is important to note that the majority of these studies were conducted in primary care settings.