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

Alexander Thomas Schade; Nohakhelha Nyamulani; Leonard Ngoe Banza; Andrew John Metcalfe; Andrew Leather; Jason J. Madan; David G. Lallloo; Williams James Harrison; Peter MacPherson

doi:10.12688/wellcomeopenres.17145.1

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

Alexander Thomas Schade^*, Nohakhelha Nyamulani, Leonard Ngoe Banza, Andrew John Metcalfe, Andrew Leather, Jason J. Madan, David G. Lallloo, Williams James Harrison, Peter MacPherson

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

7 Citations (Scopus)

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.

Original language	English
Article number	228
Journal	Wellcome Open Research
Volume	6
DOIs	https://doi.org/10.12688/wellcomeopenres.17145.1
Publication status	Published - 2021

Keywords

Implentation
Injury
Low and middle income countries
Open fractures

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.12688/wellcomeopenres.17145.1

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@article{03fca6a859a14a2082baa0369203effb,

title = "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.",

keywords = "Implentation, Injury, Low and middle income countries, Open fractures",

author = "Schade, {Alexander Thomas} and Nohakhelha Nyamulani and Banza, {Leonard Ngoe} and Metcalfe, {Andrew John} and Andrew Leather and Madan, {Jason J.} and Lallloo, {David G.} and Harrison, {Williams James} and Peter MacPherson",

note = "Publisher Copyright: {\textcopyright} 2021 Schade AT et al.",

year = "2021",

doi = "10.12688/wellcomeopenres.17145.1",

language = "English",

volume = "6",

journal = "Wellcome Open Research",

issn = "2398-502X",

publisher = "F1000 Research Ltd.",

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TY - JOUR

T1 - Protocol for a prospective cohort study of open tibia fractures in Malawi with a nested implementation of open fracture guidelines

AU - Schade, Alexander Thomas

AU - Nyamulani, Nohakhelha

AU - Banza, Leonard Ngoe

AU - Metcalfe, Andrew John

AU - Leather, Andrew

AU - Madan, Jason J.

AU - Lallloo, David G.

AU - Harrison, Williams James

AU - MacPherson, Peter

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - Implentation

KW - Injury

KW - Low and middle income countries

KW - Open fractures

UR - http://www.scopus.com/inward/record.url?scp=85129955242&partnerID=8YFLogxK

U2 - 10.12688/wellcomeopenres.17145.1

DO - 10.12688/wellcomeopenres.17145.1

M3 - Article

AN - SCOPUS:85129955242

SN - 2398-502X

VL - 6

JO - Wellcome Open Research

JF - Wellcome Open Research

M1 - 228

ER -

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

Abstract

Keywords

UN SDGs

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