Abstract

Purpose The objectives of this study are to describe the outcome measures used in orthopaedic fracture care trials, with a particular focus on patient-reported outcome measures (PROMs), and to determine which study characteristics are associated with number of citations. Methods We retrieved randomized clinical trials on fracture care between 2012 and 2017 from Embase, Medline and CENTRAL databases. Data collected included study characteristics (e.g., region, design, setting, sample size) and outcome measures (e.g., primary variable, measurement perspective, use of PROMs, study results and number of citations). Results We identified a total of 8,580 articles in the initial search. After title screening, abstract screening and full-text review, we included 416 articles for analysis. 58.4% (243) of the studies clearly defined a primary outcome measure and 56.3% (234) reported sample size justifications for outcome selection. The most common primary outcome reported was a visual analogue scale for pain; used in 21 of the 243 (8.6%) studies that defined a primary outcome. At least one PROM was used in 68.5% (285) of the papers included. Conclusions A large proportion of studies reporting on PROMs for orthopaedic trauma patients do not provide key information on the outcome selection process; a step of utmost importance in and the designing and reporting of RCTs. There is substantial heterogeneity in the selection of PROMs for fracture care trials, which limits the ability to compare and summarize across studies. Future research in fracture care should strive towards improving the reporting of informative PROMs, with rationale that demonstrates understating of the injury, intervention and patient values.