The Reasons Pragmatic Free Trial Is Tougher Than You Think

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Pragmatic trials are those that are designed to inform real-world clinical practice. They are typically described as a focus on the practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use of standard equipment.

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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which used different investigators and had participants from various geographical areas. This kind of heterogeneity is necessary for pragmatic trials to be valid, and it also helps reduce the chance of bias in the results. However, too much heterogeneity, can cause problems with the trial design.

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The aim of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are usually commissioned by practitioners and policy makers to guide their decision-making. They are also a good method to determine the causality between an intervention and its outcomes. However, they should not be used in lieu for explanation studies.

The pragmatism idea is controversial and there are doubts regarding whether pragmatic trials could replace tests for explanations or if they should be a complement to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the validity of a clinical or physiological hypothesis and pragmatic trials, which guide policy and practice decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the characteristics of a practical trial that include the recruitment process, the design and delivery of the intervention, as well as follow-up.

The number of pragmatic trials is increasing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to note that the majority of these trials were conducted in primary care settings.