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PLOS One logoLink to PLOS One
. 2025 Sep 5;20(9):e0331569. doi: 10.1371/journal.pone.0331569

Economic burden and cost-effectiveness of treatments for open tibia fractures in Malawi: Economic analysis of a multicentre prospective cohort study

Alexander Thomas Schade 1,2,3,*, Linda Alinafe Sande 1, Ewan Tomeny 2, Maureen Sabawo 4, Nyamulani Nohakhelha 3, Kaweme Mwafulirwa 3, Leonard Banza Ngoie 5, Andrew John Metcalfe 6, David Griffith Lalloo 2, William James Harrison 7,8, Jason J Madan 6, Peter MacPherson 9,10
Editor: Xiaoen Wei11
PMCID: PMC12413004  PMID: 40911543

Abstract

Background

Open tibia fractures result in substantial lifelong disability for patients, and are expensive to treat. As the injury typically affects young working men, the societal costs from open tibia fractures are likely to also be high in low income countries, but remain largely unknown. We therefore investigated the overall societal costs and cost-effectiveness of different orthopaedic treatments at one year following an open tibia fracture in Malawi.

Methods

This study was a cost-utility analysis nested in a prospective cohort study from the healthcare- and societal-payer perspectives with a one-year time horizon. We obtained quality-adjusted life years (QALYs) from the EuroQoL 5 Dimension 3 Level (EQ-5D-3L) and patient lost productivity estimates at 6 weeks, and 3, 6, and 12 months post-injury. QALYs were calculated from utility scores were modelled within a hierarchical Bayesian multivariate modelling framework that jointly estimated individual-level trajectories in EQ-5D-3L scores and costs over follow-up. Direct treatment costs were obtained from a micro-costing study, and staff interviews at tertiary and district hospitals. Cost-effectiveness was reported in terms of societal cost per quality-adjusted life year (QALY). All costs were reported in 2021 United States dollars (USD).

Results

Between February 2021 and March 2022, 287 participants with open tibia fractures were included. There were substantial costs to participants one year following injury with 42% (n = 112) working with a median monthly household income of US$40 (IQR: US$7−90) compared to 89% (n = 255) working pre-injury, with a median monthly household income of US$60 (IQR: US$36−144). The posterior median of societal costs at one year varied between US$751 (80% credible intervals [CrIs]: US$-751−2,389) for treatment with plaster of Paris (POP) in a district hospital for a Gustilo III injury, to US$2,428 (80% CrIs: US$995−5027) for intramedullary nail in central hospital for a Gustilo III injury. The largest cost-effectiveness from a societal perspective was between an intramedullary nail and amputation for a Gustilo III injury with a posterior mean of US$2,290 (95%HDI: 36−4,547) per QALY.

Conclusion

The main finding was that open tibia fractures result in significant costs to patients, the healthcare system and society in Malawi. Although the funding of orthopaedic treatment can be difficult in countries with very limited healthcare budgets, the costs to society of ignoring this issue are very high. A re-balancing of health budgets (including from government and donors) is needed to prioritise trauma care to reduce the growing societal economic burden from injury.

Background

Globally, road traffic injuries are predicted to cost the world economy US$7·86 trillion between 2015–30, which is equivalent to an annual loss of 0.12% in global gross domestic product [1]. This includes an estimated US$180 billion likely to be lost annually due to injury in low and middle-income countries (LMICs) [2], higher than the WHO estimates for cancer ($100 billion per year), respiratory disease ($106 billion) or diabetes ($28 billion) in LMICs [3]. Road traffic injuries are in the top ten causes for Disability-adjusted life years (DALYs) in Malawi in 2021 [4].

Open tibia fractures (where the tibia is fractured and protrudes through the skin) are common following road traffic injuries and are a major driver of household poverty as they are often extremely debilitating and typically affect young working people, especially men [5]. The Lancet Commission on Global Surgery has prioritized protection against catastrophic expenditure following fractures as an important measure of financial access to essential surgical and anaesthesia care [6]. In high-income countries, open tibia fractures are expensive to treat, and only 60% of participants fully return to work at one year after injury [7,8]. In low-income countries, hospitals have fewer resources [9] and the impact on patients is likely to be even more severe, but has not been previously investigated [8].

Malawi is one of the poorest countries in the world (GDP per capita of $396 in 2021 [10]) and the economy largely depends on substantial multilateral economic assistance from the International Monetary Fund, the World Bank, and bilateral assistance from donor nations; an estimated 80% of healthcare treatment in Malawi is funded from international donors [11]. Injury in global health still disproportionately lacks investment in trauma care as it received less than 1.0% of all disease specific global health assistance, while HIV/AIDs, tuberculosis and malaria received 36.0% of disease specific global health assistance in 2017 [12]. The large majority of the Malawi population is rural, but urbanisation is rising and, coupled with the increased availability of motor vehicles – particularly motorbikes – is contributing to the increasing burden of injury in cities [13]. The public health system is government funded, but has one of the lowest per capita expenditures on health in Africa and a total expenditure on health of 9.8% of GDP (far less than the 15% WHO recommendations [14,15]). The health system consists of three levels of healthcare facilities: primary care is provided in health centres; fracture care is provided at secondary care in district hospitals (typically rural); and tertiary care in referral hospitals (typically urban). Most fractures in Malawi are treated non-operatively by non-physicians called Clinical Officers [16]; national guidelines recommend that open tibia fractures should receive antibiotics, debridement, definitive fixation, and soft tissue coverage [17].

Economic evaluations of health interventions are important to inform policy decisions for healthcare funding and resource allocation. A systematic review of reported costs for open tibia fractures suggested that the initial hospitalisation costs varied widely in terms of measurement and setting and almost half of the studies (47%, n = 16/34) were conducted in the United States [8]. Therefore, we aimed to investigate the economic burden of open tibia fractures from a patient, healthcare and societal perspective and describe the cost-effectiveness of different orthopaedic treatments in Malawi to help inform policymakers.

Methods

Setting and population

This was an economic analysis that was part of a national multicentre prospective cohort study conducted in Malawi. The study took place at six hospitals, including two central hospitals (Queen Elizabeth Central Hospital [QECH] and Kamuzu Central Hospital [KCH]) and four district hospitals (Dedza District Hospital, Ntcheu District Hospital, Balaka District Hospital, and Machinga District Hospital). The study protocol was previously published in 2021 [18]. The participants included adults (18 years or older) who had open tibia fractures classified as Arbeitsgemeinschaft für Osteosynthesefrage (AO) Foundation/Orthopaedic Trauma Association class 42 [19] between 12th February 2021 and 15th March 2022. Individuals who were unable to provide consent or complete patient-reported outcome questionnaires were excluded from the study.

Procedures

District hospitals

Each of the 28 districts in Malawi has its own government district hospital (each with approximately 140 beds and a catchment area of ~714,000 people on average). All study participants admitted to one of the study district hospitals received intravenous ceftriaxone, analgesia and temporary immobilisation, and were entirely managed by orthopaedic Clinical Officers working for the public health system. Patients were managed with irrigation and debridement under local anaesthetic in a minor theatre. Patients that needed operative fixation (intramedullary nail or external fixation) or soft tissue procedures (flap or skin graft) were transferred after debridement to tertiary hospitals. After wound review at 48 hours post-operatively, a plaster technician would apply full cast above knee plaster with a window to monitor the wound. This would be changed at 6 weeks follow-up.

Tertiary hospitals

Each of the four regions in Malawi has one tertiary referral government hospital (with an estimated 1,000 beds and a catchment population of five million people on average). All study participants admitted to a tertiary hospital received intravenous antibiotics, analgesia and temporary immobilisation in the emergency department [20]. They were reviewed by the orthopaedic team on call and transferred to the orthopaedic ward. All patients were managed with irrigation and debridement under spinal/general anaesthesia. During admission, the patient had a daily junior doctor review and a senior consultant review once a week. Definitive operative treatment occurred a median 4 days (interquartile range (IQR): 1–9) after injury; fractures were managed with plaster of Paris, intramedullary nail, external fixation, or amputation based on clinical decision and theatre availability. All patients would buy crutches before discharge, as these were not provided by the hospital. All patients were advised to keep non-weight-bearing for 6 weeks.

Effectiveness: Health-related quality of life (EQ-5D-3L)

We measured the effectiveness of each treatment strategy (amputation, external fixation, intramedullary nail, POP in central hospitals and POP in district hospitals) using quality-adjusted life years (QALYs) based on the EQ-5D-3L [21]. At recruitment, participants were asked to retrospectively complete the questionnaire for their health state pre-injury and at each subsequent follow-up visit, study. Research Assistants administered the EQ-5D-3L to the study participants. The EQ-5D-3L is a tool used to measure health-related quality of life (HRQoL) that has been translated to Chichewa (the local language) and validated for use in Malawian orthopaedic patients [22]. Utility scores were calculated from EQ-5D-3L responses using the Zimbabwean tariff, as no Malawi set exists [23]. QALYs were calculated from the utility scores using the area under the curve (AUC) method [24]. We calculated QALYs for each treatment split by fracture Gustilo grade, a grading system for open fracture severity, with Gustilo I the least severe, and Gustilo III the most severe fracture type [25]. We included the standard and common treatment modalities for each Gustilo grade. For Gustilo I and II, we calculated the healthcare costs for POP in the central hospital, POP in the district hospital and intramedullary nailing, whereas for Gustilo III, we calculated for amputation, external fixator, and intramedullary nailing. The presence of a fracture-related infection [26] was verified by examining the medical records for confirmatory clinical signs including purulent discharge, the presence of sinus/fistula, or wound breakdown. In cases where the patient couldn’t attend the clinic, they were asked about the presence of purulent discharge during a telephone interview or home tracing visit.

Costing

Direct medical and overhead costs, as well as indirect patient costs, were calculated. For treatments performed in central hospitals, we used micro-costing methods [27] to quantify the direct and indirect hospital costs associated with different open tibia treatments stratified by fracture Gustilo I/II and Gustilo III grade. Each procedure was observed between 1–3 times. For treatment in district hospitals, interviews were conducted with hospital staff (orthopaedic clinical officers, anaesthetic clinic officers, ward managers, plaster technicians and the District Health Officer) to estimate the direct and indirect hospital costs associated with orthopaedic treatment strategies.

Direct medical costs included: procedure personnel salaries and supplies; medications and investigations; surgical implants; and instruments, walking aids, extra investigations or medications associated with hospital stay and follow-up visits. No discounting was performed as follow-up was at most one year after injury. Outpatient costs included clinic personnel and radiography costs. Any participant that was readmitted had details of reason, length of stay and operations recorded. Direct non-medical costs included patient transportation and food whilst away from home. Participants reported household income and working status at baseline and each follow-up visit. Indirect costs included loss of productivity which was estimated by calculating the difference between pre-injury household income for a year and the reported household income at each follow-up.

Cost-effectiveness

Cost-utilities were calculated by dividing the healthcare and societal costs by the QALY of each orthopaedic treatment. QALYs are calculated by multiplying the duration of time spent in a health state by the utility score (EQ-5D) associated with that health state, whereas DALYs are calculated using age-weighting, discounting of future DALY losses and broad survey methods for calculating disability weights [28]. Currently, DALY weights do not exist for open tibia fracture in Malawi [29]. DALYs and QALYs willingness to pay are similar for interventions and recent work suggests that the willingness to pay in Malawi might be as low as US$61 per DALY averted [30,31].

Statistical analysis

To investigate trajectories in household income and the percentage of households reporting an income of US$0 per month, we constructed a hierarchical Bayesian multivariable model with inference drawn using Markov chain Monte Carlo (MCMC) sampling. Models were fit using the R `brms` package as an interface to CmdStanR in R [32]. We modelled household income and the percentage of households reporting an income of $0 per month using a hurdle gamma distribution, and included participant-level random intercepts to account for autocorrelation. We drew 4000 samples for each parameter from posterior distributions summarised the household income and percentage of participants reporting an income of US$0 pre-injury up to one-year post-injury using means and quantile-based uncertainty intervals. Separately, we modelled the percentage of participants who reported being in work at each time point using a binomial distribution.

We additionally constructed Bayesian multivariate regression models to jointly estimate healthcare costs, societal costs, and HRQoL, accounting for within-participant correlation, allowing us to predict trajectories in cost-utility following orthopaedic interventions. Because treatments were guided by setting (district or central hospital) and injury severity (Gustilo grade), we fitted models for participants with Gustilo I/II and Gustilo III fractures separately. Initial hospital costs were included at the closest follow-up (6 weeks). Readmission costs were added to the closest follow-up visit. The difference between one year societal costs and HRQoL for different interventions was calculated. Code and data are available at (https://doi.org/10.17605/OSF.IO/N36EG).

Ethics statement

The study was approved by the College of Medicine Research and Ethics Committee (COMREC Ref number: P.09/20/3130) in Malawi, and the Liverpool School of Tropical Medicine Research Ethics Committee (Reference number: 20–068). Written informed consent was obtained from all participants.

Results

We recruited 287 participants including 224 participants from tertiary hospitals and 63 participants from district hospitals. Most participants in tertiary and district hospitals (255/287, 89%) reported being in work prior to injury, with 59% (170/287) reporting their occupation as “casual labour/business”. Overall, the pre-injury median monthly household income was US$60 (IQR: US$36–144) and one year post-injury median monthly household income was US$40 (IQR: US$7–90). Only 42% (n = 112) were working at one year after injury.

We included data from 253 participants who completed one-year follow-up, including 140 participants with Gustilo I or II injuries, and 113 participants with Gustilo III injuries; the main reasons for non-inclusion in outcome analysis were: non-standard, rare treatment modalities or missing hospital length of stay. Cases involving amputation (n = 5), plates (n = 2) and external fixation (n = 17) for Gustilo I or II injuries and cases involving plates (n = 3) for grade III fractures were excluded in the models. Seven cases were missing length of hospital stay. Empirical healthcare costs and societal costs are shown in Table 1. In summary, healthcare costs at one year post injury ranged from US$86 (IQR: 84–104) for plaster of Paris (POP) in a district hospital for a Gustilo I or II injury to US$348 (285–435) for an intramedullary nail in a central hospital for a Gustilo III injury. Median empirical hospital costs for participants with fracture-related infections were higher at one year (median: US$494, IQR:368–626) than those with no fracture-related infection (median: US$345; IQR:159–415). Median empirical hospital costs increased with the severity of injury: Gustilo I (median: US$196, IQR: 105–411), Gustilo II (US$363, IQR:192–459), Gustilo III (US$404, IQR:317–548).

Table 1. Empirical patient and hospital costs (2021 USD).

Patient costs Central Hospital (n = 224) District hospital (n = 63) TOTAL
Occupation:
 • Casual labour/business 136 (61%) 34 (54%) 170 (59%)
 • Farmer 22 (10%) 17 (27%) 39 (14%)
 • Corporate employee 26 (12%) 3 (5%) 29 (10%)
 • Driver 11 (5%) 08 (13%) 11 (4%)
 • Student/unemployed 24 (11%) 1 (2%) 32 (11%)
 • other 5 (2%) 6 (2%)
Health insurance 9 (4%) 1 (2%) 10 (4%)
Poorest Quintile 175 (78%) 63 (100%) 238 (83%)
Median monthly Household costs (2021 USD)
Baseline 72 (36-144) 60 (24-120) 60 (36-144)
6 weeks 9 (0-60) 15 (0-60) 12 (0-60)
3 months 14 (0-61) 0 (0-60) 12 (0-60)
6 months 30 (0-72) 12 (0-60) 24 (0-60)
1 year 48 (9-84) 53 (8-114) 40 (7-90)
Working status
Baseline 200 (89%) 55 (87%) 255 (89%)
6 weeks 28 (15%) 3 (5%) 31 (13%)
3 months 24 (12%) 6 (11%) 30 (12%)
6 months 35 (17%) 9 (15%) 44 (17%)
1 year 87 (42%) 25 (42%) 112 (42%)
Median hospital costs Central Hospitals (n = 198) District Hospitals (n = 55) TOTAL
Gustilo III (n = 106) Gustilo I&II (n = 92) Gustilo III (n = 6) Gustilo I &II (n = 49)
Nail (n = 44) ExFix (n = 50) Amputation (n = 12) Nail (n = 66) POP (n = 26) POP (n = 6) POP (n = 49)
Length of stay 15 (8–23) 23 (13-39) 29 (17-40) 11 (8–17) 7 (4–11) 25 (13-44) 9 (7–15)
Inpatient costs (2021 USD):
Ward personnel 115 154 141 75 52 23 9
Overhead 6 10 12 5 3 15 5
Surgical implants 150 11 0 150 0 0 0
Investigations 36 36 18 36 36 17 17
Procedure personnel 8 11 73 8 6 4 4
Procedure supplies 39 47 44 30 26 53 47
Instruments 1 <1 28 1 <1 <1 <1
Medication 7 11 17 6 4 14 4
TOTAL 348 (285-435) 280 (191-427) 333 (263-493) 311 (287-358) 127 (104-158) 125 (97-172) 86 (84-104)
Outpatient costs:
Clinic personnel 6 6 6 6 6 1 1
Radiography 54 54 0 54 54 17 17
Transportation 21 36 18 22 17 15 31
Mean costs of re-admissions (SD) 11 (31) 29 (87) 0 22 (71) 51 (129) 0 0
Indirect costs (2021 USD)
Lost productivity 422 334 476 243 613 959 283
% of total societal cost 46 44 49 36 63 81 64
TOTAL societal costs (2021 USD) 916 (471−1,365) 762 (504−1,318) 966 (751−1,020) 671 (291−1,380) 970 (293−1,464) 1,178 (312−1,867) 445 (182-872)

From a societal perspective (healthcare and patient costs), the median empirical societal costs ranged from US$445 (IQR: 182−872) for plaster of Paris treatment (POP) in a district hospital for participants with a Gustilo I or II injury to US$1,178 (312−1,867) for POP treatment in a district hospital for a Gustilo III injury (See Table 1).

Regression modelling demonstrated substantial costs to patients in the year following their injury. Modelled household income was lower one year after injury (posterior mean: US$22.8; 95% CrIs: S$8.0-US$101.9) compared to pre-injury (posterior mean: US$75.8; 95% CrIs: US$18-US$569) (Fig 1). The posterior mean for patients reporting a monthly household income of USD$0 at one year post-injury was 20.5% (95% CrIs: 15.8-25.6%) compared to only 0.1% (95% CrIs: 0.0-0.5%) pre-injury. There were also substantial declines in the proportion of participants who reported being in work one year post-injury (posterior mean: 41%, 95% CrIs: 40.7- 42.5%) compared to being in work pre-injury (posterior mean: 88%, 95%CrIs: 87.5-88.7%) (Fig 2).

Fig 1. Household income.

Fig 1

Fig 2. Participants’ working status.

Fig 2

(Green stars represent mean empirical percentage in work at each timepoint).

After exclusions of rare treatments, we included data from 253 participants who completed one-year follow-up, with data and inference from models summarised in Fig 3. The median posterior distribution for healthcare costs at one year ranged from US$112 (80% CrIs: US$84−148) for a patient with a POP in a district hospital with a Gustilo I/II injury to US$456 (80% CrIs: US$347−699) for a patient with a nail in a central hospital for a Gustilo III injury. Similarly, the median posterior distribution for societal costs at one year ranged from US$803 (80% CrI: US$-329–1,966) for a patient with a POP in a tertiary hospital with a Gustilo I/II injury to US$2,428 (80% CrIs: US$996 − 5,027) for a participant with a nail in a central hospital for a Gustilo III injury.

Fig 3. Modelled healthcare and societal costs and EQ-5D index values for Gustilo I/II and Gustilo III for different orthopaedic treatments.

Fig 3

The smallest difference in cost-effectiveness from a societal perspective was between a POP in a district hospital and amputation for a participant with a Gustilo III injury with a posterior mean of US$-90 (95%HDI: −3,561–341) per QALY. The largest difference in cost-effectiveness from a societal perspective was between a nail and amputation for a Gustilo III injury with a posterior mean of US$2,290 (95%HDI: 36–4,547) per QALY (Table 2).

Table 2. Modelled costs and cost-effectiveness of orthopaedic treatment strategies; Median posterior Healthcare and societal costs are reported in 2021 US$ (80% credible intervals); Mean posterior healthcare and societal costs per QALY are reported in US$ per QALY (95% Highest density intervals; POP = plaster of Paris, Differences comparisons are absolute differences.

Treatment or comparison Healthcare cost (US$) Societal costs (US$) Healthcare cost per QALY (US$) Societal cost per QALY (US$)
Gustilo I&II
POP (district) 115 (89-141) 1,383 (874−1,910) 505 (441-569) 1 (−11–19)
POP (tertiary) 208 (169-249) 972 (210−1,743) 719 (642-799) 1,527 (482−2,566)
Intramedullary nailing 406 (386-427) 1,126 (700−1,548) 932 (883-983) 1,684 (872−2,499)
POP (district) vs POP (tertiary) −169 (−225—115) 404 (−565−1,408) −214 (−284 - −144) 375 (−827−1,577)
Intramedullary nailing vs POP (tertiary) 184 (131-234) 152 (798−1,098) 213 (142-281) 135 (−1023−1,274)
intramedullary nail vs POP (district) 353 (312-395) −251 (1,034-512) 427 (371-484) −240 (−1178−683)
Gustilo III
External Fixators 386 (231-720) 1,116 (−221−2,657) 400 (347-452) 933 (−1,328–3,145)
Intramedullary nailing 456 (374-699) 2,428 (996−5,027) 451 (343-557) 3,161 (738−5,636)
Amputation 394 (218-642) 1,182 (−237−2,701) 373 (220-525) 479 (−2,2718–3,686)
POP (district) 164 (85-216) 1,111 (−532−2,761) 45 (−165–250) −39 (−220–144)
POP (district) vs amputation −279 (−479 - −76) −26 (−3,090–2957) −329 (−560 - −98) −90 (−3,561 - −3,341)
External Fixator vs amputation 18 (−102–140) 17 (−1,780–1,836) 26 (−116–171) 43 (−2,071–2,196)
Intramedullary nailing vs amputation 67 (−54–194) 1,973 (20 –3 ,856) 77 (−70–228) 2,290 (36 –4 ,547)
External fixation vs POP (district) 299 (115–476) 89 (2,658–2,825) 355 (151–561) 133 (−2959–3,220)
Intramedullary nail vs POP (district) 346 (164–524) 2,000 (−693–4,683) 407 (200–612) 2,380 (−734–5,428)
Intramedullary nail vs external fixator 49 (−34–130) 1,942 (721–3,134) 51 (−44–146) 2,247 (819–3,673)

Discussion

Our main finding was that open tibia fractures result in significant costs to patients, the healthcare system and society in Malawi. Orthopaedic interventions might not be affordable to the Malawi government, but substantial investment in trauma care will be required from government and stakeholders to reduce the large societal impact of injury [31]. Although the funding of orthopaedic treatment can be difficult in countries with very limited healthcare budgets, a re-balancing of health budgets (including from government and donors) is needed to prioritise trauma care to reduce the growing societal economic burden from injury.

We found that open tibia fractures are associated with very high societal costs ($904−3,405) irrespective of treatment modality. These high societal costs from open tibia fractures have also been reported from a systematic review in HICs (£27,123 to £50,197 [8]) and $2,560.81 to $2,664.59 in Tanzania [33]. Similarly, closed femoral shaft fractures in Malawi, had societal costs of $1,035 for early intramedullary nailing [34]. Furthermore, patients with open tibia fractures in Malawi who had an infection or Gustilo III injuries were associated with even higher healthcare costs which has also been reported in a cost-analysis of patient with open tibia fractures in Belgium [7]. The societal costs of open tibia fractures and other musculoskeletal injuries are higher than some infectious diseases in Malawi for example, Enterobacterales bloodstream infections: US$626.06 (SE 93.1) [35]). Funding for trauma care is lower than some other global health interventions, therefore, the prioritisation of healthcare interventions in global health does not match the societal costs [2]. More research needs to be conducted on the societal costs of different injuries to inform policymakers on prioritising healthcare budgets.

Open tibia fractures have devastating economic consequences on patients and their households too [5]. Indeed, despite 89% of participants having been working pre-injury, only 42% reported working at one-year post-injury and 18% of households reported no income compared to 0.1% pre-injury. A prospective cohort study of patients with open tibia fractures in Uganda reported 100% of participants working prior to injury and only 20% working one year after injury, but this increased to 71% two years after injury [36] but may be less in Malawi. Qualitative interviews with patients with injuries in Ghana found that most financial losses for patients were due to loss of working wages rather than direct costs of medical treatment [37]. Indeed, patients with open tibia fractures in Malawi reported substantial loss of productivity wages between US$243 and US$959. This indirect cost from injury might be underestimated as the follow-up was one year and a substantial number of participants has not returned to work. Most participants were in the poorest poverty quintile and the injury drives households further into poverty and exacerbates inequalities further. The process of returning to work after sustaining severe open tibia fractures poses significant challenges for individuals in Malawi and more work needs to be done to protect against catastrophic financial expenditure [6]. A qualitative study exploring disability following an open tibia fracture in Malawi suggests that injury has a wide impact on the societal role of participants including family relocation, hunger and stigmatisation [5]. Further research should focus on factors and outcomes that improve the return of income such as social support and rehabilitation on injury [38].

As LMIC economies grow and motor transport becomes more common, fractures are placing a large financial strain on the economies [39]. The cost-effectiveness of orthopaedic treatment for patients with open tibia fractures was very high compared to non-operative management in district hospitals. Other orthopaedic treatments have been suggested to be cost-effective such as femoral shaft nailing compared to skeletal traction and the orthopaedic clinical officer programme compared to oral rehydration solution for diarrhoea or breast feeding promotion in Malawi [34,40,41]. Malawi is one of the poorest countries in the world with one of the lowest per capita expenditures on health in Africa [42]. Recent work in Malawi would suggest the willingness to pay threshold is very low which would suggest the Malawi government cannot afford many healthcare interventions including trauma care [31]. However, if the growing high societal costs from injury are to be reduced, investment in trauma care will need to be prioritised. This highlights the importance of government-donor collaboration and the need for more research on cost-effectiveness of trauma care.

There are several limitations of this study. Firstly, the payer’s perspective includes government and internal donor costs. SIGN (Surgical Implant Generation Network) Fracture Care International currently donates intramedullary (IM) nails free of charge to many hospitals in LMICs, including Malawi [43]. This could lead to even greater cost savings for the Malawi health service than this study’s estimates, as our analysis included the cost of the IM nail (US $150). Interventions are not always affordable and accessible in Malawi, where operative fracture treatment is not universally available in public hospitals. Future studies should include budget impact analyses assessing the affordability of adopting a new intervention from the payer’s perspective [44]. Secondly, the limitations include that hospital costs were only estimated from Malawi and might not be generalisable to other LMICs which may include patient fees. Very few participants reported having health insurance, but our study was conducted in Government hospitals and therefore is not reflective of private hospitals in Malawi.

We did not consider the costs of building theatres or surgical training, which might increase the societal costs further. In Malawi, improved surgical training and expanding surgical capacity to manage the injury burden has been shown to reduce amputation rates [45]. The Lancet Commission on Global Surgery reported a global shortage of 1.1 million surgical and anaesthetic providers in 2015, most of whom are required in low- and middle-income countries (LMICs) [6]. The Commission’s recommendation was to expand the surgical and anaesthetic workforce to at least a minimum density of 20 providers for every 100,000 population by 2030, as lower densities were correlated with increased maternal mortality [46]. Meeting this goal would involve enrolling an extra 1.27 million providers and a total investment of about $45 billion—an aspiration that is perhaps unattainable for most LMICs considering current resource limitations. Despite this, the high societal and economic price for treating injuries conservatively is too great. The WHO Economic Cost of Ill-Health Model estimates that an economic loss from unattended surgical conditions of $20.7 trillion will occur in 128 countries from 2015 to 2030, with over half ($12.3 trillion) occurring in LMICs [3].

In conclusion, open tibia fractures result in significant societal costs in Malawi one year after injury both from the patients’ and societal perspectives. Although the funding of orthopaedic treatment can be difficult in countries with very limited healthcare budgets, the costs to society of ignoring this issue are very high. A re-balancing of health budgets (including from government and donors) is needed to prioritise trauma care to reduce the growing societal economic burden from injury

Supporting information

S1 File. Topic guide for information collection.

(DOCX)

pone.0331569.s001.docx (76.8KB, docx)
S2 File. Inclusivity in global research.

(DOCX)

pone.0331569.s002.docx (69.8KB, docx)

Data Availability

All relevant data can be found via the OSF repository using the following URL: https://osf.io/8fz6x.

Funding Statement

This research was funded in whole by Wellcome [Grant number 203919]. For the purpose of open access, the author has applied a CC BY public copyright licence to any Author Accepted Manuscript version arising from this submission. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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Decision Letter 0

Xiaoen Wei

4 Apr 2025

Dear Dr. Schade,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

The study suggests that intramedullary nailing is the most cost-effective treatment for open tibia fractures in Malawi. However, the practical implementation of this finding might require further discussion:

- Training of orthopedic surgeons: Given the shortage of trained orthopedic surgeons in Malawi, the feasibility of expanding surgical treatments should be addressed. If intramedullary nailing is to be widely adopted, investment in surgeon training and infrastructure is necessary.

- Accessibility of surgical care: Since most fractures in Malawi are treated non-operatively by Clinical Officers, the study should discuss whether a shift toward surgical management is realistically achievable within the current healthcare system.

These aspects would strengthen the clinical relevance of the study and help translate findings into practical recommendations.

Please submit your revised manuscript by May 19 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

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If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols .

We look forward to receiving your revised manuscript.

Kind regards,

Xiaoen Wei

Academic Editor

PLOS ONE

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Additional Editor Comments:

The study suggests that intramedullary nailing is the most cost-effective treatment for open tibia fractures in Malawi. However, the practical implementation of this finding might require further discussion:

Given the shortage of trained orthopedic surgeons in Malawi, the feasibility of expanding surgical treatments should be addressed. If intramedullary nailing is to be widely adopted, investment in surgeon training and infrastructure is necessary.

Since most fractures in Malawi are treated non-operatively by Clinical Officers, the study should discuss whether a shift toward surgical management is realistically achievable within the current healthcare system.

These aspects would strengthen the clinical relevance of the study and help translate findings into practical recommendations.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #1: Yes

**********

3. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #1: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

**********

Reviewer #1: The study suggests that intramedullary nailing is the most cost-effective treatment for open tibia fractures in Malawi. However, the practical implementation of this finding might require further discussion:

- Training of orthopedic surgeons: Given the shortage of trained orthopedic surgeons in Malawi, the feasibility of expanding surgical treatments should be addressed. If intramedullary nailing is to be widely adopted, investment in surgeon training and infrastructure is necessary.

- Accessibility of surgical care: Since most fractures in Malawi are treated non-operatively by Clinical Officers, the study should discuss whether a shift toward surgical management is realistically achievable within the current healthcare system.

These aspects would strengthen the clinical relevance of the study and help translate findings into practical recommendations.

**********

what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy

Reviewer #1: Yes:  Gianmarco Vavalle

**********

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While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/ . PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org

PLoS One. 2025 Sep 5;20(9):e0331569. doi: 10.1371/journal.pone.0331569.r002

Author response to Decision Letter 1


31 May 2025

I write on behalf of my co-authors to thank the reviewers for their careful review and appreciate the opportunity to respond with a revised submission.

The authors have declared that no competing interests exist.

Please see the point-by-point responses below.

Attachment

Submitted filename: PLOS_one_revisions_4.4.25.docx

pone.0331569.s003.docx (1.1MB, docx)

Decision Letter 1

Xiaoen Wei

21 Jun 2025

Dear Dr. Schade,

Please submit your revised manuscript by Aug 05 2025 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org . When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

  • A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.

  • A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.

  • An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols . Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols .

We look forward to receiving your revised manuscript.

Kind regards,

Xiaoen Wei

Academic Editor

PLOS ONE

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

Reviewer #2: (No Response)

Reviewer #3: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions??>

Reviewer #2: Yes

Reviewer #3: Partly

**********

3. Has the statistical analysis been performed appropriately and rigorously? -->?>

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available??>

The PLOS Data policy

Reviewer #2: Yes

Reviewer #3: (No Response)

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #2: Yes

Reviewer #3: Yes

**********

Reviewer #2:  While I give kudos to the authors, I think the discussion could be more robust judging by data analysis provided. So, I suggest the author beef up the discussion section with relevant citations. This will justify the data analysis provided.

Reviewer #3:  Abstract

- Open tibia fracture can have an equal impact on women, what makes it more detrimental to men according to your research?

- We obtained quality adjusted life years (QALYs) from the EuroQoL 5 Dimension 3 Level (EQ-5D-3L)…

- Why were costs reported in 2021; at least inflate to 2024, or better still, report using 2024 costs.

Background

Method

- The study protocol was published -------include date it was published. Ln 99

- Write the statement to make meaning or remove the bracket and let it be a complete sentence: At recruitment …. study. Lns 133-135

- Each procedure was observed between 1-3 times. - What was observed? Ln 154

- Did the difference in the way the costs were collected impact the study?

- How was missing data inputted?

Result

- What was the incremental change in Costs and QALYs. Can the QALY per treatment type and location (central vs district) be included? What is the difference between costs and QALYs based on where the treatment took place?

- Can you include a table showing the costs, QALYs, Incremental Costs, Incremental QALYs and ICER values

-

**********

what does this mean? ). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy

Reviewer #2: Yes:  Anthony Olasinde

Reviewer #3: No

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/ . PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org . Please note that Supporting Information files do not need this step.

Attachment

Submitted filename: review for PlosOne.docx

pone.0331569.s004.docx (15.3KB, docx)
PLoS One. 2025 Sep 5;20(9):e0331569. doi: 10.1371/journal.pone.0331569.r004

Author response to Decision Letter 2


17 Jul 2025

1. Reviewer 2

Comment #1:

Reviewer #2: While I give kudos to the authors, I think the discussion could be more robust judging by data analysis provided. So, I suggest the author beef up the discussion section with relevant citations. This will justify the data analysis provided.

Author’s Response: We thank the reviewer for their positive feedback and constructive suggestion. In response, we have substantially revised and expanded the Discussion section to better contextualise our findings and strengthen the link between the data analysis and its implications. Specifically, we have incorporated additional references to relevant literature (1-4), including recent studies in similar settings, to support our interpretations and highlight the significance of our results.

Lines: 275

“Orthopaedic interventions might not be affordable to the Malawi government, but substantial investment in trauma care will be required from government and stakeholders to reduce the large societal impact of injury (1)”

Line 296

Open tibia fractures have devastating economic consequences on patients and their households too (2).

Line 313

Further research should focus on factors and outcomes that improve the return of income such as social support and rehabilitation on injury (3).

Line 315

As LMIC economies grow and motor transport becomes more common, fractures are placing a large financial strain on the economies (4).

Reviewer #3:

Comment #1:

Open tibia fracture can have an equal impact on women, what makes it more detrimental to men according to your research?

Author’s Response: Thank you for your comment. Open tibia fractures can indeed have a significant impact on both men and women. However, in our cohort, 84% of patients were male, which is consistent with global data showing that traumatic injuries disproportionately affect young men (4). In the Malawian context, cultural norms often position men as the primary income earners (5). As a result, the economic consequences of injury may be more pronounced for men, particularly in terms of lost income and reduced household stability. To our knowledge, this socioeconomic impact has not been previously documented in this setting and warrants further investigation.

Comment #2:

We obtained quality adjusted life years (QALYs) from the EuroQoL 5 Dimension 3 Level (EQ-5D-3L)…

Author’s Response: Many thanks, we have amended the abstract accordingly.

Comment #2:

Why were costs reported in 2021; at least inflate to 2024, or better still, report using 2024 costs.

Author’s Response: Thank you for your comment. As outlined in the methods section, recruitment took place between 12 February 2021 and 15 March 2022. To reflect the timing of data collection and ensure consistency, costs were reported in 2021 values.

Comment #3:

The study protocol was published -------include date it was published. Ln 99

Author’s Response: Thank you for highlighting this. The study protocol was published in 2021, and we have now included the publication year at line 99 in the Methods section for clarity.

Lines: 100

“The study protocol was previously published in 2021”

Comment #3:

Write the statement to make meaning or remove the bracket and let it be a complete sentence: At recruitment …. study. Lns 133-135

Author’s Response: Thank you for your suggestion. We have revised and completed the sentence for clarity.

Line 134

“At recruitment, participants were asked to retrospectively complete the questionnaire for their health state pre-injury and at each subsequent follow-up visit, study.”

Comment #3:

Each procedure was observed between 1-3 times. - What was observed? Ln 154

Author’s Response: Thank you for highlighting this point. We have revised the manuscript to clarify what aspects of the procedure were observed. Specifically, we have added a description of the patient treatment pathway in the main text and detailed which procedures were directly observed in Appendix A. This should make the scope and focus of the observations clearer to the reader.

Comment #3:

- Did the difference in the way the costs were collected impact the study?

Author’s Response: Thank you for your comment. Due to the lower frequency of open tibia fractures in district hospitals, we were unable to conduct time-and-motion analyses at those sites. This difference in data collection methods may have introduced some limitations, which we have now acknowledged and discussed in the limitations section of the manuscript.

Comment #4

- How was missing data inputted?

Thank you for your question. Observations with missing data were excluded from the relevant analyses. Given the small number of missing values, we did not attempt formal imputation. Where appropriate, we conducted sensitivity analyses to assess the potential impact of missing data on our findings.

Comment #5

- What was the incremental change in Costs and QALYs. Can the QALY per treatment type and location (central vs district) be included? What is the difference between costs and QALYs based on where the treatment took place?

- Can you include a table showing the costs, QALYs, Incremental Costs, Incremental QALYs and ICER values

Thank you for your helpful comments. As clarified in the revised manuscript, Table 2 presents the total costs, incremental costs, and cost per QALY (ICER) for each treatment type, stratified by treatment location (central vs district hospitals). This allows for direct comparison of cost-effectiveness across settings. QALYs and incremental QALYs were reported in our previous publication (7) and are not reproduced in full here to avoid duplication. However, the ICER values in Table 2 incorporate these published QALY estimates to provide a comprehensive assessment of cost-utility.

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Decision Letter 2

Xiaoen Wei

19 Aug 2025

Economic burden and cost-effectiveness of treatments for open tibia fractures in Malawi: economic analysis of a multicentre prospective cohort study

PONE-D-24-40054R2

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Acceptance letter

Xiaoen Wei

PONE-D-24-40054R2

PLOS ONE

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Associated Data

    This section collects any data citations, data availability statements, or supplementary materials included in this article.

    Supplementary Materials

    S1 File. Topic guide for information collection.

    (DOCX)

    pone.0331569.s001.docx (76.8KB, docx)
    S2 File. Inclusivity in global research.

    (DOCX)

    pone.0331569.s002.docx (69.8KB, docx)
    Attachment

    Submitted filename: PLOS_one_revisions_4.4.25.docx

    pone.0331569.s003.docx (1.1MB, docx)
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    Submitted filename: review for PlosOne.docx

    pone.0331569.s004.docx (15.3KB, docx)
    Attachment

    Submitted filename: PLOSONE_responses.docx

    pone.0331569.s005.docx (1.1MB, docx)

    Data Availability Statement

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