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.