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Pragmatic trials are trials designed to provide information for real-world clinical practice. They are often focused on practical aspects of the research design, like the recruitment and consent process, adherence, and 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 a variety of investigators and had participants from different geographical regions. This kind of heterogeneity is necessary for pragmatic trials to be valid, and it also helps to reduce bias in the results. Too much heterogeneity, however, can cause problems with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum credibility externally. They are usually requested by practitioners and policy makers to aid in their decision-making. They are also a good method to determine the causal relationship between an intervention and its outcomes. However, they should not be used to substitute for explanatory 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 suggested a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic study which includes recruitment, design, delivery of the intervention and follow-up.
There is a positive increase in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are shown in red on Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the subject of pragmatic thinking. It is important to remember, however, that the majority of these studies were conducted in primary-care settings.