Outcomes of proximal humerus fractures in children: a study protocol for a retrospective cohort study

Abstract

IntroductionProximal humerus fractures (PHFs) comprise <3% of all fractures in children and adolescents. While it is accepted that minimally displaced PHFs can be treated conservatively, the management of severely displaced PHFs remains controversial, especially in older children. This study will aim to analyse the functional and quality-of-life outcomes of children with PHFs, in order to inform their optimal management.Methods and analysisWe will conduct a retrospective cohort study to evaluate the outcomes of patients who were diagnosed with a paediatric PHF at the Women’s and Children’s Hospital (WCH) in South Australia. The primary outcome will be each participant’s pain and quality-of-life outcome, determined by use of the Quick Disabilities of the Arm, Shoulder and Hand, Shoulder Pain and Disability Index and Paediatric Outcomes Data Collection Instrument. Secondary outcomes will include rates of non-union, persistent deformity and complications. The information for these variables will be acquired during a brief clinic appointment, and from the medical records and WCH radiology database. Multivariable logistic regression will be performed to determine the clinical variables associated with a worse clinical outcome.Ethics and disseminationThe study has been approved by the Women’s and Children’s Health Network Human Research Ethics Committee (protocol number: 2021/HRE00250). The study findings will be submitted to peer-reviewed scientific journals for publication and disseminated at conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12622000176763).

Outcomes of proximal humerus fractures in children: a retrospective cohort study

“…Of the 307 eligible participants identified, only 125 agreed to participate, such that the study was likely powered to detect only very large effect sizes in the outcomes of patients according to treatment method. In our original study protocol, a sample size of 500 participants was required to identify differences in outcomes between surgical and non‐operative patients 10 . Given the 40.7% response rate, to achieve adequate power for the study, a total of 1228 eligible participants would have needed to be identified and invited to participate.…”

“…Associations of patient and clinical variables with poorer clinical outcome were investigated. 10 Directed acyclic graphs (DAGs) were constructed to visualize assumed relationships between variables and to inform variable selection for statistical modelling (Figs. S1-S3).…”

“…Categorical and continuous variables were summarized using means and standard deviations (SDs) or median and interquartile ranges (IQRs), and frequencies and percentages, respectively. Associations of patient and clinical variables with poorer clinical outcome were investigated 10 . Directed acyclic graphs (DAGs) were constructed to visualize assumed relationships between variables and to inform variable selection for statistical modelling (Figs.…”

“…In our original study protocol, a sample size of 500 participants was required to identify differences in outcomes between surgical and non-operative patients. 10 Given the 40.7% response rate, to achieve adequate power for the study, a total of 1228 eligible participants would have needed to be identified and invited to participate. This would require a multicentre study.…”