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Trials designed to inform clinical practice in the real world are known as pragmatic trials. They are typically described as focusing on practical aspects of design that include the recruitment process and consent, adhering and the use of standard equipment.
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A pragmatic trial that uses different investigators and participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is essential for pragmatic trials to be valid and reduces the chance of bias in the results. However, too much heterogeneity can lead to problems with the design of the trial.
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The goal of pragmatic trials is to mimic real-life scenarios and to achieve the highest level of validity externally. Usually, they are requested by practitioners and policymakers to help inform their decisions. They can also be a great method of determining the causal relationship between an intervention and its outcomes. However, they shouldn't be used to substitute for explanatory trials.
The pragmatism idea is controversial and there are doubts regarding whether pragmatic trials could be used to replace explanation tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which validate the validity of a clinical or physiological hypothesis as well as pragmatic trials, which inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic study that includes the recruitment, design, and delivery of the intervention and follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline query using the keywords naturalistic and pragmatic, restricted to randomised controlled trials (RCTs), returned 34 articles. These are highlighted in red on Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatism. However, it is important to remember that the majority of these trials were conducted in primary care settings.