Citation

Madden K. Pilot Feasibility Stud. 2018; 4: 115.

Affiliation

Department of Health Research Methods, Evidence, and Impact, McMaster University, 293 Wellington St N Suite 110, Hamilton, ON L8L 8E7 Canada.

Copyright

(Copyright © 2018, Holtzbrinck Springer Nature Publishing Group - BMC)

DOI

10.1186/s40814-018-0301-9

PMID

29946480

PMCID

PMC6003159

Abstract

BACKGROUND: One third of women experience intimate partner violence (IPV) in their lifetime. Orthopaedic health care professionals are in a good position to identify women experiencing escalating physical violence and act to promote their immediate safety, connect them to IPV resources, and reduce the risk of further harm. However, there have been no studies that explore whether experiencing a musculoskeletal injury can trigger or worsen IPV, and there have been no studies on how experiences of IPV affect orthopaedic outcomes. The primary objective of the PRAISE-2 pilot study is to assess the feasibility of conducting a large cohort study to determine the association between IPV and injury-related complications. The secondary clinical objectives are to preliminarily explore how a history of IPV affects orthopaedic outcomes and how patterns of IPV change over time following an orthopaedic injury.

METHODS: We will complete a pilot multicentre prospective cohort study of 250 women with musculoskeletal injuries to determine the feasibility of a multinational prospective cohort study that will determine if prior or ongoing IPV affects orthopaedic outcomes following an injury, and how patterns of IPV change over time. Our primary outcome is feasibility measured using recruitment rate (success criterion 50 patients/site in 12 months), adherence to visit windows (success criterion 75%), participant retention (success criterion 85%), and data completeness (success criterion 80%). Our secondary exploratory clinical outcomes are injury-related complications, return to function, new IPV disclosures, utilization and cost of support services, changes in abuse patterns, quality of life, and readiness to make relationship changes. We will assess feasibility based on pre-defined criteria for feasibility success and we will analyze secondary outcomes in an exploratory fashion.

DISCUSSION: The PRAISE-2 pilot study is the first step toward determining how experiences of IPV affect orthopaedic outcomes such as injury-related complications. This study will determine feasibility and assist in the development of large-scale multinational prospective IPV studies for our future IPV research program. This study will engage health care professionals from around the world to increase awareness of how IPV affects patients' musculoskeletal and injury outcomes. TRIAL REGISTRATION: clinicaltrials.gov NCT02529267. Registered 20 Aug 2015.

Language: en

Keywords

Cohort studies; Domestic violence; Feasibility; Intimate partner violence; Orthopaedic surgery; Protocol