There is no correlation between differences in adverse events and differences in patient-reported outcome measures in orthopaedic trauma randomized controlled trials: A systematic review

Introduction: A recovery without adverse events is a top priority of orthopaedic trauma patients, however many randomized controlled trials (RCTs) are only powered to detect a difference in patient-reported outcome measures (PROMs). While it may be assumed that differences in major adverse event rates between treatment groups will result in differences in PROMs, this has not been established. The purpose of this study was to perform a systematic review of RCTs to evaluate if differences in these outcomes were correlated.

Methods: A systematic search was conducted of online databases to identify RCTs in orthopaedic trauma fracture management that reported both major adverse events and PROMs. Adverse events included secondary surgeries or complications that could negatively affect long-term outcomes (nonunion, chronic regional pain syndrome, etc.). The correlation between a difference (p < 0.05) in adverse events and a difference in PROMs was assessed.

Results: The systematic review yielded 30 RCTs involving 6,769 patients. The primary outcome was a continuous PROM in 70.0 % (21/30). A difference in major adverse events was reported in 23.3 % (7/30) and a difference in PROMs was reported in 6.7 % (2/30). Studies reporting a difference in adverse events, compared to those that did not, were not more likely to report a difference in PROMs (14.3 % (1/7) vs. 4.3 % (1/23); p = 0.42).

Conclusions: There was no correlation between differences in adverse event rates and differences in PROMs in orthopaedic trauma RCTs. Investigators should consider powering studies to detect differences in the major adverse events that both patients and surgeons wish to avoid.

Level of evidence: Level I.