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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are typically characterized by a focus on the practical aspects of study design, including the recruitment process and consent in adherence, as well as 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 various investigators and had participants from various geographical areas. This kind of heterogeneity is required for pragmatic trials to be valid and also reduces the chance of bias in the results. However, too much heterogeneity can cause problems with the design of the trial.
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Pragmatic trials are designed to replicate real-world situations and have the highest external validity. They are typically commissioned by policy makers and practitioners to inform their decision making. They can also be a great method to determine the cause-effect relationship between the intervention and its effects. They should, however, not, be used to replace explanatory studies.
The concept of pragmatism is controversial, and there are questions about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory trials, which prove a physiological or clinical hypothesis and pragmatic trials, which inform the practice and policy decisions. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the features of a pragmatic study, including recruitment, design and delivery of the intervention, as well as follow-up.
There is a growing increase in the number of pragmatic trials that are published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials that are randomized (RCTs) produced 34 articles, which are shown in red in Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatics. It is important to remember, however, that the majority were conducted in primary-care settings.