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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of design, including the recruitment process and consent, adhering and the use of routinely available equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and participants from different geographic areas. This type of heterogeneity, which is vital for pragmatic trials to be valid and lessen the chance of bias is also essential. Too much heterogeneity, however, can cause problems with the trial design.
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The goal of pragmatic trials is to simulate real-life scenarios and to achieve the highest level of validity externally. Usually, they are ordered by policymakers and practitioners in order to guide their decisions. They can also be used to assess the cause-effect relationship of an intervention and its effects. However, they shouldn't be used in lieu for explanatory trials.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace tests for explanations or if they are a complement to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which prove the validity of a clinical or physiological hypothesis, and pragmatic trials, which guide policy and practice decisions. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic research study which includes the recruitment, design, and delivery of the intervention, and follow-up.
The number of pragmatic trials is increasing. A recent Medline search using the words pragmatic and naturalistic, limited to randomised controlled trials (RCTs) returned 34 articles. These are highlighted in red on Figure 2. This is a sign that the health sciences community is becoming more sensitive to the issue of pragmatics. It is important to keep in mind that the majority were conducted in primary care settings.