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Clinical trials that are designed to help inform practice in the real world are known as pragmatic trials. They are typically characterized by a focus on the practical aspects of the research design, like 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 used a variety of investigators and had participants from different geographic areas. This type of heterogeneity which is vital for pragmatic trials to be reliable and lessen the chance of bias, is also necessary. A high degree of heterogeneity, however, can cause problems with the design of the trial.
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The goal of pragmatic trials is to simulate real-life situations and achieve maximum validity externally. They are typically commissioned by practitioners and policy makers to inform their decision making. They can also be used to determine the cause-effect relationship of an intervention and its results. However, they shouldn't be used in lieu for the use of explanation trials.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials should replace explanatory trials or complement them. Schwartz and Lellouch1 suggested a distinction between explanatory studies, which support the validity of a physiological or clinical hypothesis, and pragmatic trials, that inform policy and practice decision-making. They also proposed the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a pragmatic study that include the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline search using the terms naturalistic and pragmatic, which was limited to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This is an indication that the health science community is becoming more sensitive to the subject of pragmatic thinking. However, it is important to keep in mind that the majority of these trials were conducted in primary care settings.