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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of designing a study, including the recruitment process and consent, adhering and the use routinely available equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity which is essential for a pragmatic trial to be reliable and to reduce bias in the results is also essential. However too much heterogeneity could result in problems with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are usually commissioned by policymakers and practitioners to help guide their decisions. They can also be used to assess the causal relationship between an intervention and its results. However, they should not be used to replace explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials can be used to replace explanation tests or if they should serve as a complement to them. Schwartz and Lellouch1 suggested the distinction between explanatory trials, which validate 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 tried to define the characteristics of a practical study which includes recruitment, design, delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs) resulted in 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.