Data from: Scholarly influence of surgical hip randomized controlled trials

Background: Randomized control trials (RCTs) are considered the highest level of evidence for therapeutic research. Surgical RCTs, however, have 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. However, there is a paucity of studies examining the effects of pragmatism on surgical RCTs. The purpose of this study was to examine how pragmatism affects the scholarly influence of surgical RCTs. Hip fracture surgical RCTs were used as an example. We hypothesized that a more pragmatic design would result in increased scholarly influence. Methods: A search for surgical hip fracture-related RCTs published between 1995-2015 was done in both PubMed and EMBASE. Journal impact factor, citation number, research question, significance and type of outcome, number of centers involved, and the PRECIS-2 level of pragmatism score were recorded for each study. A study was estimated to have scholarly influence if it was incorporated into clinical practice guidelines, professional societies' recommended readings, or included professional textbooks' references. A secondary estimate for scholarly influence was the study's average yearly citation rate. Results: 160 RCTs were included in the final analysis. The number of yearly surgical hip fracture RCTs increased over the study period and the most common research question examined the best surgical implant. A multivariate logistic regression identified high study sample size as the only predictor of an RCT being used in clinical guidance texts. Large sample size and multi-center RCTs were predictors of high average yearly citation rates. The level of pragmatism in study design did not independently predict scholarly influence. Conclusions: Pragmatic design, as measured by the PRECIS2 score, is not independently associated with increased scholarly influence. However, since high study sample size was the most important study characteristic affecting scholarly influence, a pragmatic design with broad inclusion criteria may increase scholarly influence by increasing enrollment numbers