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Pragmatic Play Free Trial
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Pragmatic trials are studies designed to provide information for the practice of clinical trials in real life. They are often focused on the practical aspects of the research design, like the recruitment process and consent in adherence, as well as the use of commonly available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used various investigators and included participants from different geographical regions. This kind of heterogeneity is required for practical trials to be valid, and it also helps reduce the chance of bias in the results. However excessive heterogeneity could result in issues with the design of the trial.
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Pragmatic trials aim to mimic real-life settings and achieve maximum external validity. They are typically commissioned by practitioners and policy makers to aid in their decision-making. They can also be used to assess the causal relationship between an intervention with its outcomes. However, they shouldn't be used in lieu for the use of explanation studies.
The idea of pragmatism is controversial and there are concerns about whether pragmatic trials can replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which confirm a physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also suggested a framework for pragmatic trials, dubbed PRECIS.2 This tool was designed to define the features of a pragmatic trial which includes the recruitment process, the design and implementation of the intervention, as well as the 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) resulted in 34 articles, shown in red in Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.