Traumatic brain injuries are ignored or discriminated in prospective clinical trials on shoulder fractures: a...

Current literature suggests a significant epidemiological association between traumatic brain injury (TBI) and proximal upper limb fractures in addition to major clinical consequences. A systematic review was conducted to assess how TBI is taken into consideration in interventional studies on shoulder fractures.

The following data sources were used: MEDLINE, EMBASE, EBM Reviews, CINAHL, and OpenGrey databases. Study selection included interventional randomized clinical trials and prospective cohort studies on shoulder fractures published in English or French between 2008 and 2020. Studies on pathologic fractures, chronic fracture complications, nonhuman subjects, and biomechanics were excluded. Articles were reviewed by two independent authors according to the PRISMA guidelines. Baseline characteristics, exclusion criteria, and input relevant to TBI were recorded. Methodological quality was assessed with the Cochrane risk of bias tool for randomized clinical trials and the Newcastle-Ottawa Scale for cohort studies.

One-hundred-thirteen studies met the inclusion criteria. None discussed the possible impact of TBI on their results. Only three (2.7%) studies considered TBI relevant and included these patients in their cohort. Furthermore, 43/113 (38.1%) excluded patients with injuries or mechanisms strongly related to traumatic brain injuries: head injuries (4); moderate and/or severe TBI (7); high energy traumas (3); Polytrauma subjects (33).

TBI are ignored or discriminated in prospective clinical trials on shoulder fractures. The exclusion of these cases impacts generalizability as their prevalence is significant. Considering the major impact of TBI on important outcomes, its presence should always be assessed to ensure high quality evidence.

Systematic Review, Therapeutic Level II.