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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are typically focused on the practical aspects of the study design, such as recruitment and consent as well as adherence to the use of standard equipment.

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A pragmatic study that involves different investigators and participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is necessary for practical trials to be valid and reduces the chance of bias in the results. A high degree of heterogeneity, however can result in problems with the design of the trial.

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Legality

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The purpose of pragmatic trials is to mimic real-life situations and achieve maximum credibility externally. They are typically requested by practitioners and policymakers to inform their decisions. They also provide a useful way to identify the causal relationship between the intervention and its effects. However, they should not, be used to replace explanatory studies.

The pragmatism idea is controversial and there are concerns about whether pragmatic trials should be used to replace explanation tests 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 that inform the practice and policy decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the elements of a practical study, including recruitment, design, delivery of the intervention, and follow-up.

There is a positive increase in the number of pragmatic trials that are published. 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 a sign that the health sciences community is becoming more acquaint to the subject of pragmatic thinking. It is important to note that the majority of studies were conducted in primary care settings.