Protocol for a prospective cohort study of open tibia fractures in Malawi with a nested implementation of open fracture guidelines

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.

An Assessment of Open Fracture Management in Hospitals in Malawi Before and Immediately After Implementing Open Fracture Guidelines

“…The most common cause of the open fractures was an RTC, at 60% (53), and half of the patients in this group (49% [26]) had been riding a motorcycle at the time of the accident (Table II). The tibia was the most commonly fractured bone, at 67% (59).…”

“…The rate of ATLS assessment and documentation significantly improved (p = 0.029) from 60% (26) to 82% (37). There was also improvement in the percentage of patients who received neurovascular status assessment and documentation, from 26% (11) to 62% (28) (p = 0.0002), and for whom wound photography was performed before debridement, from 0% (0) to 51% (23) (p = 0.01).…”

“…Data clerks recorded the demographics, disposition, and discharge and/or referral details, and OCOs recorded the clinical information in the initial management and definitive management sections. The principal investigator (PI) completed the complication section and verified each item of information captured by the data clerks and OCOs against the radiographs and wound photographs, to determine whether the patient treatment was consistence or inconsistent with the guidelines 26 . The PI also assessed wound infection using the ASEPSIS scoring system 25 , 27 .…”

Epidemiology and Management of Pediatric Fractures in Malawi

“… 20 Additional investigation is warranted to determine the number and types of open fractures that received no or late débridement and did not receive subsequent surgical fixation, even after referral to a higher level of care. 47 …”

Improving the management of open tibia fractures, Malawi

“…This implementation study was nested in a prospective multicentre cohort study conducted in six hospitals in Malawi and was conducted according to the previously published protocol. 14 …”