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Pragmatic trials are studies designed to provide information for the real-world practice of clinical. They are usually characterized by a focus on practical aspects of the study design, including recruitment and consent in adherence, as well as the use of standard equipment.
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A practical trial that employs a variety investigators and includes participants from diverse geographical locations is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be able to prove their validity, and it also reduces the chance of bias in the results. However too much heterogeneity could cause issues with the design of the trial.
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Legality
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The purpose of pragmatic trials is to replicate real-life scenarios and to achieve maximum credibility externally. They are usually requested by practitioners and policymakers in order to inform their decisions. They can also be used to assess the causality of an intervention with its outcomes. However, they should not be used to replace explanation studies.
The pragmatism concept is controversial and there are concerns about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 made the distinction between explanation studies, which confirm the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in the decision-making process for policy and practice. They also suggested the framework for pragmatic trials, which they called PRECIS.2 This tool was designed to define the characteristics of a pragmatic trial, including the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is increasing. 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 science community is becoming more sensitive to the subject of pragmatic thinking. It is important to remember, however, that the majority of studies were conducted in primary-care settings.