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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 as a focus on the practical aspects of designing a study, including the recruitment and consent process, as well as adherence and the use routinely available equipment.

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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which employed various investigators and participants from different geographical regions. This type of heterogeneity which is essential for a pragmatic trial to be valid and lessen the chance of bias is also essential. Too much heterogeneity, however, can cause problems with the design of the trial.

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The aim of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. They are usually requested by policy makers and practitioners to guide their decision-making. They are also a good method to determine the causal relationship between an intervention and its outcomes. They should, however, not, be used to replace explanatory studies.

The pragmatism idea is controversial, and there are questions about whether pragmatic trials should replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which validate a physiological or clinical hypothesis as well as pragmatic trials, which guide the practice and policy decisions. They also proposed a framework called PRECIS for pragmatic trials.2 The tool was designed to define the elements of a pragmatic study that includes the recruitment, design, and delivery of the intervention and its follow-up.

There is a growing increase in the number of pragmatic trials that have been published. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the subject of pragmatism. It is important to remember that the majority of studies were conducted in primary-care settings.