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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are often characterized as a focus on the practical aspects of designing a study, including recruitment and consent, adherence and the use of routinely available equipment.
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A practical trial that employs various investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be able to prove their validity and helps to reduce bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and to achieve the highest level of validity externally. They are usually commissioned by policy makers and practitioners to guide their decision-making. They can also be used to assess the causal relationship between an intervention and its effects. However, they should not, be used to replace the need for explanation studies.
The pragmatism idea is controversial and there are concerns regarding whether pragmatic trials could replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 proposed a distinction between explanatory studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in the practice and policy decision-making. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the elements of a practical study which includes recruitment, design, implementation of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the keywords naturalistic and pragmatic, which was limited to controlled trials randomized to control (RCTs) produced 34 articles, shown in red in Figure 2. This suggests that the health sciences community has become more aware of the importance of pragmatic thinking. It is important to note that the majority of studies were conducted in primary care settings.
