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Studies designed to provide insight into clinical practice in the real world are called pragmatic trials. They are often characterized by a focus on practical aspects of the research design, like the recruitment process and consent as well as adherence to the use of commonly available equipment.
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A practical trial that employs a variety investigators and includes participants from different geographical areas is the Home Blood Pressure Management study (HBPM). This kind of heterogeneity is required for pragmatic trials to be valid and also reduces the chance of bias in the results. However excessive heterogeneity could result in problems with the design of the trial.
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The purpose of pragmatic trials is to mimic real-life situations and achieve the highest level of validity externally. They are usually requested by practitioners and policy makers to inform their decision making. They can be used to determine the causal relationship between an intervention with its outcomes. They should, however, not, be used to replace explanation studies.
The pragmatism idea is controversial and there are doubts regarding whether pragmatic trials could replace explanatory tests or if they should serve as an alternative to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which support the physiological hypothesis or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also proposed a framework called PRECIS for pragmatic trials.2 This tool tried to define the characteristics of a pragmatic study that includes recruitment, design, implementation of the intervention and its follow-up.
There is a positive trend in the number of pragmatic trials that are published. A recent Medline search using the terms pragmatic and naturalistic, restricted to randomized controlled trials (RCTs) produced 34 articles, which are shown in red in Figure 2. This is a sign that the health science community is becoming more acquaint to the issue of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary-care settings.
