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Trials designed to inform clinical practice in the real world are referred to as pragmatic trials. They are often characterized as a focus on the practical aspects of design that include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A pragmatic study that involves various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. However excessive heterogeneity could cause issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum validity externally. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can also be a great way to identify the causal relationship between the intervention and its effects. However, they shouldn't be used to substitute for explanation trials.
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 a distinction between explanatory trials, which prove the clinical or physiological hypothesis and 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 traits of a pragmatic research study that includes recruitment, design, delivery of the intervention and its follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to note, however, that the majority of studies were conducted in primary-care settings.