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Trials designed to inform clinical practice in the real world are called pragmatic trials. They are typically focused on practical aspects of the study design, including the recruitment process and consent, adherence, and 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 a variety of investigators and participants from various geographical areas. This kind of heterogeneity is required for practical trials to be valid and also helps to reduce the chance of bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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The aim of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. They are usually requested by practitioners and policymakers to inform their decisions. They can also be used to assess the causality of an intervention and its effects. However, they shouldn't be used as a substitute for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials can replace tests for explanations or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which confirm the clinical or physiological hypothesis, and pragmatic trials that inform the policy and practice of. They also proposed a framework for pragmatic trials, called PRECIS.2 This tool attempted to define the elements of a pragmatic trial that include recruitment, design and delivery of the intervention, as well as the follow-up.
There is a growing trend in the number of pragmatic trials that are published. A recent Medline query that used the words pragmatic and 슬롯 naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health science community is becoming more sensitive to the issue of pragmatics. It is important to remember that the majority of these studies were conducted in primary-care settings.