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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are often described as focusing on practical aspects of study design, including recruitment and consent, adherence and the use routinely available equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from different geographical regions. This type of heterogeneity is necessary for practical trials to be valid, and it also helps reduce the chance of bias in the results. However excessive heterogeneity could lead to issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are usually commissioned by practitioners and policy makers to aid in their decision-making. They can be used to determine the causal relationship between an intervention and its effects. They should, however, not be used to replace explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, as well as pragmatic trials, which inform the practice and policy decision-making. They also suggested a framework dubbed PRECIS for pragmatic trials.2 This tool attempted to define the characteristics of a pragmatic research study that includes the recruitment, design, and delivery of the intervention and follow-up.
There is an encouraging increase in the number of pragmatic trials published. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs) produced 34 articles, shown in red in Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary-care settings.