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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically described as a focus on the practical aspects of designing a study which include the recruitment process and consent, adhering and the use routinely available equipment.
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A practical trial that employs 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 able to prove their validity and also reduces the chance of bias in the results. Too much heterogeneity, however can result in problems with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They can also be used to assess the cause-effect relationship of an intervention with its outcomes. However, they should not be used to replace the need for explanation studies.
The concept of pragmatism is controversial, and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials, which guide the policy and practice of. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic research study, including recruitment, design, delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to remember that the majority of studies were conducted in primary-care settings.