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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are often focused on the practical aspects of research design, like recruitment and consent in adherence, as well as the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and had participants from different geographical regions. This type of heterogeneity is essential for pragmatic trials to be able to prove their validity and helps to reduce the chance of bias in the results. Too much heterogeneity, however, can cause problems with the design of the trial.
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The aim of pragmatic trials is to replicate real-life situations and achieve the highest level of validity externally. They are usually commissioned by policy makers and practitioners to inform their decision making. They can also be used to determine the causal relationship between an intervention and its results. However, they should not be used as a substitute for explanation trials.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the clinical or physiological hypothesis, and pragmatic trials that inform the policy and practice of. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study, including recruitment, design, implementation of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.