Inconsistency prevents the valuable synergism of explanatory and pragmatic trails.

ABSTRACT

OBJECTIVE: To assess review articles on pragmatic trials in order to describe how authors define the aim of this type of study, how comprehensive methodological topics are covered, and which topics are most valued by authors. METHODS: Review articles were selected from Medline Database, based on the expression "pragmatic trial" in the titles. Five trained medical students evaluated the articles, based on a list of 15 self-explanatory methodological topics. Each article was evaluated regarding topics covered. Baseline statements on the aim of pragmatic trials were derived. RESULTS: Among 22 articles identified, there was general agreement that the aim of a pragmatic trial is to evaluate if the intervention works under real-world conditions. The mean number of methodological topics addressed by each article was 7.6 ± 3.1. Only one article covered all 15 topics, three articles (14%) responded to at least 75% of topics and 13 articles (59%) mentioned at least 50% of the topics. The relative frequency each of the 15 topics was cited by articles had a mean of 50% ± 25%. No topic was addressed by all articles, only three (20%) were addressed by more than 75% of articles. CONCLUSIONS: There is agreement on the different aims of explanatory and pragmatic trials. But there is a large variation on methodological topics used to define a pragmatic trial, which led to inconsistency in defining the typical methodology of a pragmatic trial.