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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of design which include the recruitment process and consent, adhering and the use of routinely available equipment.Free spins
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which used a variety of investigators and participants from various geographical areas. This type of heterogeneity which is vital for a pragmatic trial to be reliable and lessen the chance of bias is also essential. However, too much heterogeneity can lead to problems with the design of the trial.
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The goal of pragmatic trials is to replicate real-life scenarios and gain the highest level of validity externally. Usually, they are commissioned by policymakers and practitioners in order to inform their decisions. They can also be used to assess the causality of an intervention with its outcomes. They should, however, not, be used to replace the need for explanation studies.
The concept of pragmatism is controversial, and there are questions regarding whether pragmatic trials could replace explanatory tests or if they should be a complement to them. Schwartz and Lellouch1 proposed the distinction between explanation studies, which support a physiological hypothesis or clinical hypothesis, and pragmatic trials, that inform the decision-making process for policy and practice. They also proposed a framework for pragmatic trials, which they called PRECIS.2 This tool attempted to define the characteristics of a practical trial which includes recruitment, design and delivery of the intervention, as well as the follow-up.
There is an encouraging increase in the number pragmatic trials published. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community is becoming more aware of the importance of pragmatism. It is important to keep in mind, however, that the majority were conducted in primary-care settings.
