Abstract
Background: Road traffic injury (RTI) is the largest cause of death amongst 15-39-year-old people worldwide, and the burden of injuries such as open tibia fractures are rapidly increasing in Malawi. This study aims to investigate disability and economic outcomes of people with open tibia fractures in Malawi and improve these with locally delivered implementation of open fracture guidelines. Methods: This is a prospective cohort study describing function, quality of life and economic burden of open tibia fractures in Malawi. In total, 160 participants will be recruited across six centres and will be followed-up with face-to-face interviews at six weeks, three months, six months and one year following injury. The primary outcome will be function at one year measured by the short musculoskeletal functional assessment (SMFA) score. Secondary outcomes will include quality of life measured by EuroQol EQ-5D-3L, catastrophic loss of income and implementation outcomes (acceptability, adoption, appropriateness, costs, feasibility, fidelity, penetration, and sustainability) at one year. A nested pilot pre-post implementation study of an interventional bundle for all open fractures will be developed based on other implementation studies from low- and middle-income countries (LMICs). Regression analysis will be used to model and investigate associations between SMFA score and fracture severity, infection and the pre- and post-training course period. Outcome: This prospective cohort study will report patient reported outcomes from open tibia fractures in low-resource settings. Subsequent detailed evaluation of both the clinical and implementation components of the study will promote sustainability of improved open fractures management in the study sites and further scale-up of open fracture management guidelines. Ethics: Ethics approval has been obtained from the Liverpool School of Tropical Medicine and College of Medicine Research and Ethics committee.
Highlights
Trauma in low-income countries Road traffic injury (RTI) is the largest cause of death amongst 15–39 year old people worldwide and disability from open tibia fractures is rapidly increasing in low-income countries (LICs)
Assuming we have a model with 10 parameters, and we find a model that accounts for 20% of the variance in the short musculoskeletal functional assessment (SMFA) scores, with 80% power at the 0.01 significance level, sample size was computed using R version 4.0.3 (10 variables, effect size = 0.2/(1-0.2), significance level = 0.01, power = 0.8)
Disability measured by patient reported outcomes should be used to evaluate health care interventions and complement conventional outcome measures such as mortality, as they may demonstrate the impact of injury on other areas of life from the patient’s perspective
Summary
1. Chris Lavy, University of Oxford, Oxford, UK Any reports and responses or comments on the article can be found at the end of the article. Severity, infection and the pre- and post-training course period. Outcome: This prospective cohort study will report patient reported outcomes from open tibia fractures in low-resource settings. Subsequent detailed evaluation of both the clinical and implementation components of the study will promote sustainability of improved open fractures management in the study sites and further scale-up of open fracture management guidelines. Ethics: Ethics approval has been obtained from the Liverpool School of Tropical Medicine and College of Medicine Research and Ethics committee. Open fractures, low and middle income countries, implentation. This article is included in the Malawi-Liverpool Wellcome Trust Clinical Research Programme gateway
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