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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are typically characterized by a focus on the practical aspects of the study design, including recruitment and consent as well as adherence to the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized a variety of investigators and had participants from different geographical regions. This type of heterogeneity, which is vital for a pragmatic trial to be reliable and lessen the chance of bias is also essential. Too much heterogeneity, however could cause issues with the design of the trial.
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The aim of pragmatic trials is to replicate real-life scenarios and to achieve maximum validity externally. Usually, they are commissioned by policymakers and practitioners to help guide their decisions. They also provide a useful method to determine the cause-effect relationship between the intervention and its effects. However, they shouldn't be used as a substitute for explanation studies.
The idea of pragmatism is controversial and there are doubts about whether pragmatic trials can replace tests for explanations or if they are an addition to them. Schwartz and Lellouch1 made the distinction between explanation studies, which prove the validity of a physiological or clinical hypothesis, as well as pragmatic trials, that inform the decision-making process for policy and practice. They also suggested a framework known as PRECIS for pragmatic trials.2 The tool was designed to define the traits of a pragmatic study which includes the recruitment, design, and delivery of the intervention, and follow-up.
There is an encouraging increase in the number pragmatic trials that have been published. A recent Medline query that used the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more acquaint to the issue of pragmatics. It is important to note that the majority were conducted in primary-care settings.