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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of study design which include recruitment and consent, adherence and the use of routinely available equipment.
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A pragmatic trial that uses a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity, which is vital for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. However, too much heterogeneity can result in problems with the design of the trial.
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Legality
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Pragmatic trials aim to mimic real-life situations and attain maximum external validity. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They can also be a great way to identify the causal relationship between an intervention and its results. However, they should not be used as a substitute for the use of explanation trials.
The pragmatism idea is controversial and there are questions about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested an distinction between explanation-based 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 This tool attempted to define the traits of a practical study, including recruitment, design, implementation of the intervention and follow-up.
There is an encouraging increase in the number of pragmatic trials that are published. A recent Medline query using the keywords pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.