Prospective abuse and intimate partner violence surgical evaluation (PRAISE-2 pilot): Statistical analysis plan for a pilot prospective cohort study

Background. Intimate partner violence (IPV) is a prevalent social issue that affects the health and well-being of women globally. In orthopaedics, the prevalence of women who have experienced abuse in the past year is as high as 1 in 6. PRAISE-2 is a multi-centre pilot prospective cohort study of 250 women with musculoskeletal injuries to determine how IPV experiences affect injury-related outcomes, and how patterns of IPV change over a 12 month period of time following a musculoskeletal injury. The current report is a description of the statistical analysis plan for the PRAISE-2 pilot study. Methods. This study is a pilot multicentre prospective cohort study to primarily assess feasibility of our recruitment, retention and data collection strategies, and to collect preliminary data on orthopaedic outcomes after experiencing IPV, as well as changes in IPV patterns following an injury. Included participants will be adult females presenting to participating fracture clinics for a fracture and/or dislocation requiring orthopaedic care. Participants will be followed for one year. The primary analysis will be descriptive. We will report recruitment, missed visits, out of window visits, participant completion data, and completed form data as counts and percentages with 95% confidence intervals. Based on the primary analyses, we will report whether the feasibility criteria have been met, and recommend modifications to the protocol for any planned definitive studies, if needed. All secondary (clinical) analyses are exploratory. Discussion. In order for surgeons to be as effective as possible in assisting and advocating for women who have experienced abuse, we need more information on how IPV experiences are associated with musculoskeletal outcomes. Both the feasibility and clinical information gained from this pilot study will be instrumental in informing future observational and interventional IPV studies. By reporting our statistical analysis plan before the study ends, we hope to improve the transparency, integrity, and reproducibility of our study findings. Trial registration. This study is registered on clinicaltrials.gov NCT02529267 on 20 August 2015, before the first participant was enrolled