6 September 2017 - The well-recognised limitations of traditional randomised, controlled trials, including their cost, the nature of the patients and providers included in them, and even the types of interventions that they can evaluate, have led to the search for alternative methods and settings for conducting these types of studies. 

Pragmatic trials, also referred to as “practical” or “effectiveness” trials, have been widely advocated as means of addressing these limitations. These designs rely on simplified data-collection processes, strategies such as broad eligibility criteria for both patients and providers, and an acceptance of protocol “violations” such as crossover, non-adherence, and loss to follow-up that make the trial conditions similar to the way in which care is delivered in routine practice.

Many of the pragmatic trials that have appeared in the peer-reviewed literature have recruited patients individually from traditional care settings such as physician offices or hospitals and have prospectively collected baseline and outcome data.

Read New England Journal of Medicine