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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 often focused on the practical aspects of the research design, like recruitment and consent in adherence, as well as the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used different investigators and participants from various geographical areas. This type of heterogeneity, which is essential for a pragmatic trial to be reliable and lessen the chance of bias is also essential. However too much heterogeneity could result in issues with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain maximum credibility externally. They are usually commissioned by policy makers and practitioners to aid in their decision-making. They can also be used to assess the causal relationship between an intervention and its effects. However, they should not be used to replace explanation studies.
The pragmatism concept 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 trials, which confirm the clinical or physiological hypothesis as well as pragmatic trials, which inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool attempted to define the traits of a pragmatic research study which includes recruitment, design, delivery of the intervention and follow-up.
The number of pragmatic trials is growing. A recent Medline query using the keywords pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs) returned 34 articles. They are displayed in red on Figure 2. This is an indication that the health sciences community is becoming increasingly sensitized to the issue of pragmatic thinking. It is important to remember that the majority of these studies were conducted in primary care settings.