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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often focused on the practical aspects of the study design, such as the recruitment process and consent in adherence, as well as the use of commonly available equipment.
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A practical trial that employs a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid, and it also reduces the chance of bias in the results. However, too much heterogeneity can result in issues with the design of the trial.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are typically commissioned by practitioners and policy makers to guide their decision-making. They are also a good way to identify the cause-effect relationship between an intervention and its outcomes. However, they should not be used to substitute for explanation trials.
The idea of pragmatism is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they should serve as an addition to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which confirm the clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a practical study, including the recruitment, design, and delivery of the intervention and follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This indicates that the health science community is becoming more acquaint to the subject of pragmatism. However, it is important to remember that the majority of these studies were conducted in primary care settings.