Schade, Alexander Thomas, Nyamulani, Nohakhelha, Banza, Leonard Ngoe, Metcalfe, Andrew John, Leather, Andrew, Madan, Jason J., Lallloo, David G., Harrison, Williams James and MacPherson, Peter (2021) Protocol for a prospective cohort study of open tibia fractures in Malawi with a nested implementation of open fracture guidelines. Wellcome Open Research, 6 . 228. doi:10.12688/wellcomeopenres.17145.1 ISSN 2398-502X. [ 🗎 Public]. [ (🔓): Yes ].

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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.

Item Type:	Journal Article
Subjects:	R Medicine > RA Public aspects of medicine R Medicine > RD Surgery
Divisions:	Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Crash injuries -- Patients -- Malawi -- Economic aspects, Traffic accidents -- Malawi, Fractures, Open , Tibia -- Fractures
Journal or Publication Title:	Wellcome Open Research
Publisher:	F1000Research
ISSN:	2398-502X
Official Date:	13 September 2021
Dates:	Date Event 13 September 2021 Available 13 September 2021 Accepted
Volume:	6
Number of Pages:	14
Article Number:	228
DOI:	10.12688/wellcomeopenres.17145.1
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Open Access (Creative Commons)
Date of first compliant deposit:	6 June 2022
Date of first compliant Open Access:	7 June 2022
RIOXX Funder/Project Grant:	Project/Grant ID RIOXX Funder Name Funder ID 203919 Wellcome Trust http://dx.doi.org/10.13039/100010269

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