10 Pragmatic Free Trial Tricks All Experts Recommend
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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 usually characterized by a focus on the practical aspects of the study design, including recruitment and consent, adherence, and the use of routinely available equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which utilized different investigators and had participants from different geographical regions. This type of heterogeneity which is essential for pragmatic trials to be valid and reduce bias in results, is also necessary. A high degree of heterogeneity, however could cause issues with the trial design.
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Legality
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The goal of pragmatic trials is to mimic real-life scenarios and gain maximum validity externally. Usually, they are ordered by policymakers and practitioners to guide their decisions. They can also be used to determine the causality of an intervention with its outcomes. However, they shouldn't be used in lieu for explanation studies.
The concept of pragmatism is controversial and there are doubts about whether pragmatic trials should be used to replace explanatory trials or complement them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials that inform policy and practice decisions. They also suggested a framework known as PRECIS for pragmatic trials.2 This tool tried to define the traits of a pragmatic research study which includes recruitment, design, implementation of the intervention and its follow-up.
There is a positive increase in the number pragmatic trials that have been published. A recent Medline search using the keywords naturalistic and pragmatic, limited to controlled trials that are randomized (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the subject of pragmatics. It is important to keep in mind that the majority of these trials were conducted in primary care settings.