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Clinical trials that are designed to help inform practice in the real world are referred to as pragmatic trials. They are typically characterized by a focus on practical aspects of the study design, such as recruitment and consent in adherence, as well as the use of standard equipment.
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Another example of a practical trial is the Home Blood Pressure Management (HBPM) study, which employed different investigators and participants from various geographical areas. This type of heterogeneity is required for pragmatic trials to be able to prove their validity and reduces the chance of bias in the results. However excessive heterogeneity could cause problems with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are usually commissioned by policymakers and practitioners in order to inform their decisions. They can be used to determine the cause-effect relationship of an intervention with its outcomes. However, they should not be used to substitute for the use of explanation studies.
The pragmatism idea is controversial and there are doubts about whether pragmatic trials can replace tests for explanations or if they are an alternative to them. Schwartz and Lellouch1 made a distinction between explanatory studies, which confirm the validity of a physiological or clinical hypothesis, as well as pragmatic trials that aid in policy and practice decision-making. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool sought to define the characteristics of a pragmatic study, including the recruitment process, the design and delivery of the intervention, as well as follow-up.
There is a growing increase in the number pragmatic trials that have been published. A recent Medline search using the keywords pragmatic and naturalistic, restricted to controlled trials randomized to control (RCTs), yielded 34 articles, as shown in red in Figure 2. This is an indication that the health science community is becoming increasingly sensitized to the issue of pragmatic thinking. However, it is important to note that the majority of these studies were conducted in primary care settings.