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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 characterized by their focus on practical aspects of designing a study which include the recruitment and consent process, as well as adherence and the use of standard equipment.
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A practical trial that employs a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This type of heterogeneity is required for practical trials to be valid and helps reduce bias in the results. However too much heterogeneity could lead to issues with the design of the trial.
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Pragmatic trials seek to replicate real-life situations and attain maximum external validity. They are usually requested by practitioners and
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https://anotepad.com/notes/H6Ndxs96) policy makers to inform their decision making. They can be used to determine the causal relationship between an intervention and its results. However, they should not be used in lieu for explanatory trials.
The concept of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace tests for explanations or if they should be an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove a physiological or clinical hypothesis as well as pragmatic trials that inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the traits of a practical study which includes recruitment, design, delivery of the intervention, and follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs), yielded 34 articles, shown in red in Figure 2. This suggests that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to note that the majority of these trials were conducted in primary care settings.
