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Studies designed to provide insight into clinical practice in the real world are referred to as pragmatic trials. They are typically described as focusing on practical aspects of study design, including the recruitment process and consent, adhering 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 used different investigators and participants from various geographical areas. This kind of heterogeneity, which is essential for pragmatic trials to be reliable and to reduce bias in the results is also essential. Too much heterogeneity, however, can cause problems with the trial design.
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The aim of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. They are usually requested by practitioners and policymakers to help guide their decisions. They also provide a useful way to identify the cause-effect relationship between an intervention and its outcomes. However, they should not, be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are concerns regarding whether pragmatic trials could replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 made an distinction between explanation-based studies, which prove the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform the decision-making process for policy and practice. They also suggested a framework dubbed PRECIS for pragmatic trials.2 The tool was designed to define the characteristics of a pragmatic study which includes the recruitment, design, and delivery of the intervention, and follow-up.
There is a growing trend in the number of pragmatic trials that have been published. 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 is a sign that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to keep in mind that the majority of these studies were conducted in primary care settings.