The Importance of Pragmatic Study Design to the Scholarly Influence of Surgical Hip Fracture Randomized Controlled Trials

Abstract

Background: Surgical randomized controlled trials (RCTs) have potential drawbacks, leading some to question their role in filling the information gap in orthopaedic surgery. Pragmatism in study design was introduced to increase the clinical applicability of study results. The purpose of this study was to examine how pragmatism affects the scholarly influence of surgical RCTs. Methods: A search for surgical hip fracture-related RCTs published between 1995 and 2015 was done. Journal impact factor, citation number, research question, significance and type of outcome, number of centers involved, and the Pragmatic-Explanatory Continuum Indicator Summary-2 level of pragmatism score were recorded for each study. Scholarly influence was estimated by a study's inclusion into orthopaedic literature or guidelines or through the study's average yearly citation rate. Results: One hundred sixty RCTs were included in the final analysis. A multivariate logistic regression identified large study sample size as the only predictor of an RCT being used in clinical guidance texts. Large sample size and multicenter RCTs were predictors of high yearly citation rates. The level of pragmatism in study design did not predict scholarly influence. Conclusions: Pragmatic design is not independently associated with increased scholarly influence; however, large study sample size was the most important study characteristic affecting scholarly influence.T he primary goal of clinical research is to effectively translate clinical evidence into practice. Randomized controlled trials (RCTs) together with RCT-based systematic reviews and meta-analyses are considered the highest level of evidence for therapeutic research. 1,2 Randomization is the best research strategy to reduce bias in clinical research by virtue of its ability to distribute known and unknown confounding