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Pragmatic trials are those that are designed to provide information for the practice of clinical trials in real life. They are often characterized by a focus on practical aspects of the study design, including the recruitment and consent process in adherence, as well as the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed various investigators and participants from different geographic areas. This kind of heterogeneity, that is crucial for pragmatic trials to be valid and lessen the chance of bias is also essential. However excessive heterogeneity could lead to issues with the design of the trial.
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Legality
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The aim of pragmatic trials is to mimic real-life scenarios and to achieve maximum credibility externally. They are usually commissioned by policy makers and practitioners to guide their decision-making. They are also a good method to determine the causality between an intervention and its results. However, they should not be used in lieu for the use of explanation trials.
The pragmatism idea is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they are a complement to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which prove a physiological hypothesis or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a practical study that includes recruitment, design, implementation of the intervention and follow-up.
There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the terms pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs), yielded 34 articles, shown in red in Figure 2. This indicates that the health sciences community has become 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.