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Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries
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Review
Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries Alexander T. Schade a,∗, Jamie Hind b, Chetan Khatri a, Andrew J. Metcalfe a, William J. Harrison c a b c
University of Warwick Medical School, United Kingdom Worcestershire Acute Hospitals NHS Trust, United Kingdom Countess of Chester Hospital NHS Trust, United Kingdom
a r t i c l e
i n f o
Article history: Accepted 9 November 2019 Available online xxx Keywords: Open fractures Low and middle income countries Patient reported outcomes Lower limb trauma
a b s t r a c t Background: Open tibia fractures are a common cause of admission following road traffic accidents in low and middle income countries (LMICs), resulting in substantial mortality and disability. It is important to summarise the clinical course of this injury using patient reported scores in order to assess best treatment in LMICs. Objectives: To summarise the disability after sustaining an open tibia fracture in LMICs Methods: All studies were identified from a systematic search of Medline, Embase and the Cochrane Central Register of Controlled Trials. We included any human with a diagnosed open tibia fracture, following any intervention. Studies were performed in a low or middle income country. The primary outcome was any validated patient reported outcome score reported after three months. Secondary outcomes included economic impact and complications such as infection, non-union and amputation. Data was extracted and summarised. Results: We reviewed 3,593 articles from our search. A total of 18 studies were included from 10 countries with 8 different outcome scores. The average age was 35 years old and 86% of the patients were male. Thirty-one percent were Gustilo I, 28% Gustilo II, 19% Gustilo IIIA, 17% Gustilo IIIB and 5% Gustilo IIIC. The most common complications reported were 18% infection, 15% non-union and 15% amputation. Economic impact was reported in only one study with 100% patients working pre-injury and 20% postinjury at 12 months. Mean follow-up duration for outcome scores was 19.8 months. There was heterogeneity between the studies in terms of subject of the studies, outcome criteria, fracture type, surgical technique and length of follow-up. Therefore, no meta-analysis could be performed. Conclusion: The clinical history of open tibia fractures in low or middle income countries remains largely unknown in terms of patient reported outcomes. Further studies are required to define these outcomes in open tibia fractures before best treatments can be assessed. © 2019 Elsevier Ltd. All rights reserved.
Background Road traffic accidents are rising globally and are now the largest single cause of death amongst 15–29 year olds [1]. Open tibia fractures are a common cause of admission following road traffic injuries and are associated with increased mortality and morbidity [2]. The tibia is one of the most commonly injured long bones [3] and, due to its superficial location, it is more susceptible to becoming an open fracture with bone loss [4]. Reported incidence varies from 8.1 to 37.0 per 10 0,0 0 0 patients [5]. The Lancet Commission on Global Surgery recognises the importance of early ∗
Corresponding author. E-mail address: [email protected] (A.T. Schade).
treatment of open fractures and suggests they should be treated in all first-level hospitals to avoid delays [6]. There is agreement that research is needed to estimate the burden of surgical disorders especially with regards to disability-adjusted life-years outcomes [7]. In high-income countries (HIC), functional outcomes following open tibia fracture treatment have been reviewed elsewhere [8], but this only includes three low or middle income countries (LMICs) out of 28 and does not report patient reported outcomes specifically. Assessment of open fracture treatment in LMICs has traditionally focused on clinical outcomes such as mortality, complications (i.e., infection, mal-union), and length of hospital stay, with limited attention to functional recovery [9]. Patient reported outcome measures (PROM) are gaining popularity and there is a growing opinion that measures of quality of life should be used to
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Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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evaluate health care interventions [10]. The vast burden of trauma (90%) occurs in LMICs [1] and there is a pressing need to describe the impact to patients in this setting [11]. In this study, we systematically reviewed PROM data for open tibia fractures from LMICs. Aims To assess the outcome of open tibia fractures in LMICs using patient reported outcome measures. Methods This systematic review was reported in accordance with the PROSPERO (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. The systematic review protocol was predefined and can be found at: http://www.crd.york.ac.uk/PROSPERO/ display_record.php?ID=CRD42018106399. This systematic review was also written in accordance with the PRISMA checklist (http://www.prisma-statement.org/). Inclusion criteria Inclusion criteria were as follows: 1) Any study-design (randomised controlled trials, cohort study, case control, case series, case report), 2) Full-text clinical studies in the English language, 3) Any humans of any age with an open tibia fracture, 4) Treated in a low or middle income country according to the OECD list, 5) Reporting a validated patient reported outcome measure (PROM). Exclusion criteria Exclusion criteria included: 1) Studies reporting clinical or radiologic outcomes only, 2) Abstract publication only, 3) Patients injured in a LMIC, but treated in a HIC. Up to three attempts were made to contact the corresponding author for additional information if 1) Further information was required about study design to confirm inclusion, 2) There was missing data for unreported or partially unreported outcomes, or 3) Outcomes were for the open tibia sub-population where the study population was mixed (open fractures, tibia fractures, amputations or lower limb injuries). Outcome measures The primary outcome measure was any PROM over three months from injury. The secondary outcome measures included mention of the following: infection rates, non-union and malunion rates, amputation, economic impact.
Data extraction Information retrieved from each study included: 1) Study characteristics – country and publication year, 2) Study population demographics, 3) Injury characteristics: Gustilo grade of open fracture, 4) Complications: malunion, non-union, infection and amputation. In addition, patient reported outcome scores at each average time point were extracted for each study. Where data in studies was not represented in numeric format, 2 authors (A.S. and J.H.) extracted data from graphs. For random control trials, data was extracted by pooling outcomes from each arm. Statistical analysis We extracted the outcome data from each study according to the follow-up period. As there was often wide heterogeneity in follow-up, the exact time point was recorded. Meta-analysis was planned only if populations and outcomes were heterogenous, however, it was recognised that for lower extremity trauma, meta-analysis is often not feasible because the outcome data is not reported consistently using standardised measures. Simple baseline data (such as gender, injury grading) was pooled where the data was available. Results Study retrieval and characteristics A total of 3593 citations were received from our search strategy. After the removal of duplicates (n = 1447) and screening of studies by title and abstract, 74 full-text papers were retrieved, of which 10 papers met our inclusion criteria. Of the remaining 64 studies, 27 studies had mixed population data and 37 studies had no mention of open tibia fractures. The authors were contacted for further information (n = 64), 11 responded. Of the 11 that responded, 1 was able to provide open tibia data specifically, 10 were unable to assist. A further 8 studies were included from the references and literature review. This gave a total of 18 studies included for analysis and data extraction. A flow diagram of our selection process is presented in Appendix A. Of the included 18 studies, one was a randomised controlled trial, five were prospective cohort studies and the remaining 12 were case series. Studies were conducted in 9 different countries (Iraq, Malaysia, Sierra Leone, Afghanistan, Turkey, China, Uganda, Nepal, and 4 studies from India). The quality of the randomised controlled trial was judged to be poor, whereas quality was judged to be good for three cohort studies [12, 13, 14], poor for two cohort studies [15, 16] and poor for the case series (see appendix for quality scores).
Search strategy and quality assessment Patient and injury characteristics We searched Medline, Embase and Cochrane Central Register of Controlled Trials, from inception to August 28th 2018 and imported citations into EndNote X7 reference management software. A full search strategy can be found in the appendix. After removal of duplicates, citations were screened with title and abstract as per the applied inclusion criteria. For those studies that potentially met eligibility criteria, full texts were obtained. Two authors (A.S. and J.H.) independently assessed each paper, with any discrepancies being resolved through discussion with the senior authors (W.H. & A.M.). From this pool, full-text articles were retrieved and reviewed in duplicate with disagreements resolved by consensus using a third reviewer (C.K.). Quality assessments were done using the Cochrane and Newcastle-Ottawa Scale independently by two authors (A.S. & C.K.). As there is no validated quality score for case-series, the Newcastle-Ottawa scale was used for these studies.
A total of 766 patients with open tibia fractures were included in this review. The mean number of participants in each study was 43 (7–162). The mean age of patients was 35.0 years old and averages ranged from 24.5 to 48 (n = 490). The injuries across all reviewed articles were incurred predominantly by males with a mean of 87% (range 71–100%, n = 400). Gustilo grading [17] of open fractures was available in 11 studies (n = 531) and this included 31% type I, 28% type II, 19% type IIIA, 17% type IIIB and 5% type IIIC (see Table 1). Some studies were predominantly grade III fractures [12, 18, 19, 20] while others were predominantly grade I-II [12, 15, 16, 21]. Mechanism of injury was available for 11 studies (n = 336). Common mechanisms reported were 73% road traffic injuries, 18% war-related (inc. bullet injuries), 7% fall from height, 2% work-related, 1% assault. In the majority of studies, the mecha-
Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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Table 1 Summary of patient demographics.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Author
Year
Country
N
Doshi Fakri Joshi Joshi Ong Pal Pedrini Tunali Xiao O’Hara Devkota Kumar Shivannna Gondalia Vinchhi Kayali 0 Gaurav Agrawal TOTAL
2017 2012 2004 2016 2002 2015 2011 2015 2011 2016 2014 2016 2017 2015 2017 2009 0 2017 2013
India Iraq India India Malaysia India Sierra Leone & Afghanistan Turkey China Uganda Nepal India India India India Turkey 0 India India
162 53 56 48 29 32 20 22 68 14 7 12 12 4 20 35 12 24 766
Mean Gustilo classification (%) Male% age I II IIIA IIIB
IIIC
41 0 54 0 7
27
17
13
1
32 0 7
7 73 55
7 27 0
0 0 0
94 93 93 81 71 71 77
31 30 48 34 40 25 31
0 0
0 0
0 0
100 0
0 100
93 71 85 92 96 100 84
31 45 29
36
64
0
0
0
36 36 41
0
52
12
34
2
53
47
83
32
87
35
48 33 31
25 23 28
18 10 19
10 23 17
0 10 5
Table 2 Summary of patient reported outcomes from all included studies. (DI: dysfunctional index, BI: bothersome index, MPH: mean physical health, MMH: mean mental health).
Author
Year
Reporting system
1 2
Doshi Fakri
2017 2012
EQ-5D SMFA
3 4 5 6 7 8
Joshi Joshi Ong Pal Pedrini Tunali
2004 2016 2002 2015 2011 2015
Modified Ketenjian’s criteria Johner Wruh’s criteria ASAMI criteria ASAMI criteria Enneking Score SF-36
9 10 11 12 13 14 15 16 17 18
Xiao O’Hara Devkota Kumar Shivannna Gondalia Vinchhi Kayali Gaurav Agrawal
2011 2016 2014 2016 2017 2015 2017 2009 2017 2013
Johner Wruh’s criteria EQ-5D Knee Society score Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria
nism was predominantly road traffic incidents, however, one study [13] reported all war-related injuries. Patient reported scores The mean follow-up for the studies was 21.7 months and ranged from 4 to 63.4 months. A total of 9 different outcome scores were used (see Table 2). Table 3 EQ-5D [22] was used in two studies and reported as 0.8712 at 12 month follow-up and 0.6623 at 24 month follow-up. Johner Wruh’s criteria [24] were reported as good and excellent in a tertiary centre in India [14] and predominantly poor in earthquake survivors [25]. The Association for the Study and Application of Methods of Ilizarov (ASAMI) score was used in 2 studies [18, 26]. Both studies showed predominantly good and excellent scores. Other scoring systems used included the short musculoskeletal function assessment (SMFA) [27]. Fakri et al. report the disability index as 27 and the bothersome index as 30.5 in Iraqi civilians at 24 months [13].
Score 0.91 DI 27
MPH 40.5
Scale (%) Poor Fair BI 30.5 11 0 7 15 30 MMH 35 41
Good
Excellent
4 8 0 85 70
18 17 21
68 75 72
15
26
18
7 84 9 10 9 18 10
14
75
29 20 16 20 23
56 56 49 53 60
0.66 88.71 4 16 7 14 4 10 7
In most studies, outcomes of the Ketenjian’s criteria [28] were reported as good and excellent by eight authors (n = 319) [15, 16, 21, 29, 30, 31, 32, 33]. One study reports the Musculoskeletal Tumour Society rating scale (Enneking score) [34]. Seventy percent were reported as good or excellent in Afghanistan at 4 month follow-up [19]. One study used the SF-36, which is a set of administered quality-of-life measures. Tunali et al. report the score as 40.5 for mean physical health and 35 for mean mental health, which was below the population average. One study reported the Knee Society Score (KSS); Devkota et al. report this score as 88.71/100 in seven individuals in Nepal at 29 months [35]. Complications: infection, non-union and amputation Infection rates were available for 15 studies (n = 686) with a mean of 18% infections (both superficial and deep). The incidence varied widely from 7%−85%, as some studies reported tibia nonunions where infection is a known risk factor.
Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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A.T. Schade, J. Hind and C. Khatri et al. / Injury xxx (xxxx) xxx Table 3 Summary of complications (data was not available for the other studies included in the review). Blank spaces have been left were no data was available. Author
Year
Infection (%)
Doshi Fakri Joshi Joshi Ong Pal Pedrini Tunali Kumar Shivannna Gondalia Vinchhi Kayali Gaurav Agrawal TOTAL
2017 2012 2004 2016 2002 2015 2011 2015 2016 2017 2015 2017 2009 2017 2013
8 85 11 29 7 16 5 14 7 12 26 9 16 13 10 18
Non-unions (%)
Amputations (%)
100 11
17 2
0 5 18 11 8 12 7 0 10 3 15
5 36
15
Rates of non-unions were available for 12 studies (n = 444), with a pooled mean of 27% (range 0–100%). One of the studies reported outcome scores for non-unions that were all from open tibia fractures [13]. Rates of amputation were available for 4 studies (n = 144). The pooled mean for these four studies was 15% (range 2–36%).
injuries) from different environments may have biased the outcomes reported, therefore we are not able to separate out their influence on the overall results. These were not reported separately in any paper and a sub-analysis was not possible. The same was true of mechanism of injury, we were not able to separate results by mechanism of injury, although it should be noted that the majority were from motor vehicle accidents, an increasing epidemic in LMICs [1]. The fact that so many scoring systems were used did not enable us to perform a statistical analysis beyond description and summarisation. Most PROMs assessed similar patient outcomes such as pain, gait and functional independence, but the heterogeneity of scoring systems means these PROMs were hard to compare. Some of the scoring systems used a combination of functional, radiological and patient reported scores. Therefore, these scores might have clinical input as well as patient input. As no sub-analysis was possible, we were unable to draw any conclusions on the various treatments included in this review. Others have suggested the use of low cost external fixators and vacuum therapy devices in LMICs [36,37]. However, the paucity of studies with PROMs, and the heterogeneity of measures used, suggests a need for the development of a core outcome set for open tibial fractures that is appropriate for use in studies in LMICs. The development of these core outcomes should include patients and clinicians from LMICs to ensure feasibility and relevance to these regions.
Economic impact Only one study reported economic impact as well as patient reported outcomes and this open tibia fracture data was provided by the authors [23]. In this case series of 14 patients, all were working prior to injury, whereas only 20% were working at 12 months and 71% at 24 months post-injury. Average earning prior to injury was 199USD, whereas it was reported as 19USD at 12 months and 82USD at 24 months post-injury. 88% of patients (n = 7) were the main household income earner prior to the injury, which reduced to 63% of patients (n = 5) post injury. Discussion We aimed to collate the evidence of the medium-term natural history of patients with open tibia fractures from low or middle income countries, regardless of the treatment received. This study was conducted and reported in accordance with the PRISMA guidelines for complete transparency. We found that most patient reported outcomes were good or excellent, but with a wide range of reported scores. The demographics of open tibia fracture patients predominantly affected young males with a mean age of 35 year old, 87% affecting males and 73% from road traffic incidents. Rates of complications were 18% for infections, 15% for non-unions and 15% for amputations. Low income countries are underrepresented compared to middle income countries. Only two studies were performed in low income countries (Nepal, Sierra Leone), whereas 16 were performed in middle income countries. Furthermore, some of the studies mention their results might not be representative of a typical LMIC situation, as they have benefited from foreign volunteer staff or are in a modern tertiary hospital [12, 13]. There was much heterogenicity in the study environments. On the one hand, some studies were set in low income countries, war zones or following natural disasters and on the other hand, some were set in upper middle income countries or in modern hospitals in middle income countries. This may represent a research design bias, as hospitals in low-income countries may not have the appropriate research methods, training, or financial support to publish their outcome sets. Comorbidities (including other significant
Strengths and limitations This study used a broad search term, which included patient populations with multiple injuries, including open tibia fractures. It enabled us to include papers that do not specifically mention open tibia fractures in the title or abstract [13], allowing us to capture a greater population that would otherwise be missed. In addition, by contacting individual authors, we were able to obtain novel data not previously published, to be included in this review [23]. Snowballing was also effectively used and generated a further eight studies. This may be due to the fact that some studies from LMICs are published in lower impact journals and in the future, there should be more representation of LMICs studies in high impact journals.
Conclusions This is the first study to summarise patient reported outcomes in low or middle income countries for open tibia fractures. Most studies assessed in this review described the natural course of an open tibia fracture in LMICs as excellent or good in terms of patient reported outcomes, irrespective of treatment. However, as the setting and outcome measures were so varied, the natural course remains still largely unknown and patient-reported measures are particularly poorly reported in the literature. The very limited studies published were unable to show significant influence from any factors due to the wide variety of scores that have been used. There is also an underrepresentation of low income countries compared to middle income countries and outcomes from public hospitals in the lowest income countries are particularly poorly described. Research in this field is desperately needed to understand this important injury and to evaluate the best treatments.
Declaration of Competing Interest None
Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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Injury journal homepage: www.elsevier.com/locate/injury
Review
Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries Alexander T. Schade a,∗, Jamie Hind b, Chetan Khatri a, Andrew J. Metcalfe a, William J. Harrison c a b c
University of Warwick Medical School, United Kingdom Worcestershire Acute Hospitals NHS Trust, United Kingdom Countess of Chester Hospital NHS Trust, United Kingdom
a r t i c l e
i n f o
Article history: Accepted 9 November 2019 Available online xxx Keywords: Open fractures Low and middle income countries Patient reported outcomes Lower limb trauma
a b s t r a c t Background: Open tibia fractures are a common cause of admission following road traffic accidents in low and middle income countries (LMICs), resulting in substantial mortality and disability. It is important to summarise the clinical course of this injury using patient reported scores in order to assess best treatment in LMICs. Objectives: To summarise the disability after sustaining an open tibia fracture in LMICs Methods: All studies were identified from a systematic search of Medline, Embase and the Cochrane Central Register of Controlled Trials. We included any human with a diagnosed open tibia fracture, following any intervention. Studies were performed in a low or middle income country. The primary outcome was any validated patient reported outcome score reported after three months. Secondary outcomes included economic impact and complications such as infection, non-union and amputation. Data was extracted and summarised. Results: We reviewed 3,593 articles from our search. A total of 18 studies were included from 10 countries with 8 different outcome scores. The average age was 35 years old and 86% of the patients were male. Thirty-one percent were Gustilo I, 28% Gustilo II, 19% Gustilo IIIA, 17% Gustilo IIIB and 5% Gustilo IIIC. The most common complications reported were 18% infection, 15% non-union and 15% amputation. Economic impact was reported in only one study with 100% patients working pre-injury and 20% postinjury at 12 months. Mean follow-up duration for outcome scores was 19.8 months. There was heterogeneity between the studies in terms of subject of the studies, outcome criteria, fracture type, surgical technique and length of follow-up. Therefore, no meta-analysis could be performed. Conclusion: The clinical history of open tibia fractures in low or middle income countries remains largely unknown in terms of patient reported outcomes. Further studies are required to define these outcomes in open tibia fractures before best treatments can be assessed. © 2019 Elsevier Ltd. All rights reserved.
Background Road traffic accidents are rising globally and are now the largest single cause of death amongst 15–29 year olds [1]. Open tibia fractures are a common cause of admission following road traffic injuries and are associated with increased mortality and morbidity [2]. The tibia is one of the most commonly injured long bones [3] and, due to its superficial location, it is more susceptible to becoming an open fracture with bone loss [4]. Reported incidence varies from 8.1 to 37.0 per 10 0,0 0 0 patients [5]. The Lancet Commission on Global Surgery recognises the importance of early ∗
Corresponding author. E-mail address: [email protected] (A.T. Schade).
treatment of open fractures and suggests they should be treated in all first-level hospitals to avoid delays [6]. There is agreement that research is needed to estimate the burden of surgical disorders especially with regards to disability-adjusted life-years outcomes [7]. In high-income countries (HIC), functional outcomes following open tibia fracture treatment have been reviewed elsewhere [8], but this only includes three low or middle income countries (LMICs) out of 28 and does not report patient reported outcomes specifically. Assessment of open fracture treatment in LMICs has traditionally focused on clinical outcomes such as mortality, complications (i.e., infection, mal-union), and length of hospital stay, with limited attention to functional recovery [9]. Patient reported outcome measures (PROM) are gaining popularity and there is a growing opinion that measures of quality of life should be used to
https://doi.org/10.1016/j.injury.2019.11.015 0020-1383/© 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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evaluate health care interventions [10]. The vast burden of trauma (90%) occurs in LMICs [1] and there is a pressing need to describe the impact to patients in this setting [11]. In this study, we systematically reviewed PROM data for open tibia fractures from LMICs. Aims To assess the outcome of open tibia fractures in LMICs using patient reported outcome measures. Methods This systematic review was reported in accordance with the PROSPERO (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement. The systematic review protocol was predefined and can be found at: http://www.crd.york.ac.uk/PROSPERO/ display_record.php?ID=CRD42018106399. This systematic review was also written in accordance with the PRISMA checklist (http://www.prisma-statement.org/). Inclusion criteria Inclusion criteria were as follows: 1) Any study-design (randomised controlled trials, cohort study, case control, case series, case report), 2) Full-text clinical studies in the English language, 3) Any humans of any age with an open tibia fracture, 4) Treated in a low or middle income country according to the OECD list, 5) Reporting a validated patient reported outcome measure (PROM). Exclusion criteria Exclusion criteria included: 1) Studies reporting clinical or radiologic outcomes only, 2) Abstract publication only, 3) Patients injured in a LMIC, but treated in a HIC. Up to three attempts were made to contact the corresponding author for additional information if 1) Further information was required about study design to confirm inclusion, 2) There was missing data for unreported or partially unreported outcomes, or 3) Outcomes were for the open tibia sub-population where the study population was mixed (open fractures, tibia fractures, amputations or lower limb injuries). Outcome measures The primary outcome measure was any PROM over three months from injury. The secondary outcome measures included mention of the following: infection rates, non-union and malunion rates, amputation, economic impact.
Data extraction Information retrieved from each study included: 1) Study characteristics – country and publication year, 2) Study population demographics, 3) Injury characteristics: Gustilo grade of open fracture, 4) Complications: malunion, non-union, infection and amputation. In addition, patient reported outcome scores at each average time point were extracted for each study. Where data in studies was not represented in numeric format, 2 authors (A.S. and J.H.) extracted data from graphs. For random control trials, data was extracted by pooling outcomes from each arm. Statistical analysis We extracted the outcome data from each study according to the follow-up period. As there was often wide heterogeneity in follow-up, the exact time point was recorded. Meta-analysis was planned only if populations and outcomes were heterogenous, however, it was recognised that for lower extremity trauma, meta-analysis is often not feasible because the outcome data is not reported consistently using standardised measures. Simple baseline data (such as gender, injury grading) was pooled where the data was available. Results Study retrieval and characteristics A total of 3593 citations were received from our search strategy. After the removal of duplicates (n = 1447) and screening of studies by title and abstract, 74 full-text papers were retrieved, of which 10 papers met our inclusion criteria. Of the remaining 64 studies, 27 studies had mixed population data and 37 studies had no mention of open tibia fractures. The authors were contacted for further information (n = 64), 11 responded. Of the 11 that responded, 1 was able to provide open tibia data specifically, 10 were unable to assist. A further 8 studies were included from the references and literature review. This gave a total of 18 studies included for analysis and data extraction. A flow diagram of our selection process is presented in Appendix A. Of the included 18 studies, one was a randomised controlled trial, five were prospective cohort studies and the remaining 12 were case series. Studies were conducted in 9 different countries (Iraq, Malaysia, Sierra Leone, Afghanistan, Turkey, China, Uganda, Nepal, and 4 studies from India). The quality of the randomised controlled trial was judged to be poor, whereas quality was judged to be good for three cohort studies [12, 13, 14], poor for two cohort studies [15, 16] and poor for the case series (see appendix for quality scores).
Search strategy and quality assessment Patient and injury characteristics We searched Medline, Embase and Cochrane Central Register of Controlled Trials, from inception to August 28th 2018 and imported citations into EndNote X7 reference management software. A full search strategy can be found in the appendix. After removal of duplicates, citations were screened with title and abstract as per the applied inclusion criteria. For those studies that potentially met eligibility criteria, full texts were obtained. Two authors (A.S. and J.H.) independently assessed each paper, with any discrepancies being resolved through discussion with the senior authors (W.H. & A.M.). From this pool, full-text articles were retrieved and reviewed in duplicate with disagreements resolved by consensus using a third reviewer (C.K.). Quality assessments were done using the Cochrane and Newcastle-Ottawa Scale independently by two authors (A.S. & C.K.). As there is no validated quality score for case-series, the Newcastle-Ottawa scale was used for these studies.
A total of 766 patients with open tibia fractures were included in this review. The mean number of participants in each study was 43 (7–162). The mean age of patients was 35.0 years old and averages ranged from 24.5 to 48 (n = 490). The injuries across all reviewed articles were incurred predominantly by males with a mean of 87% (range 71–100%, n = 400). Gustilo grading [17] of open fractures was available in 11 studies (n = 531) and this included 31% type I, 28% type II, 19% type IIIA, 17% type IIIB and 5% type IIIC (see Table 1). Some studies were predominantly grade III fractures [12, 18, 19, 20] while others were predominantly grade I-II [12, 15, 16, 21]. Mechanism of injury was available for 11 studies (n = 336). Common mechanisms reported were 73% road traffic injuries, 18% war-related (inc. bullet injuries), 7% fall from height, 2% work-related, 1% assault. In the majority of studies, the mecha-
Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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Table 1 Summary of patient demographics.
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18
Author
Year
Country
N
Doshi Fakri Joshi Joshi Ong Pal Pedrini Tunali Xiao O’Hara Devkota Kumar Shivannna Gondalia Vinchhi Kayali 0 Gaurav Agrawal TOTAL
2017 2012 2004 2016 2002 2015 2011 2015 2011 2016 2014 2016 2017 2015 2017 2009 0 2017 2013
India Iraq India India Malaysia India Sierra Leone & Afghanistan Turkey China Uganda Nepal India India India India Turkey 0 India India
162 53 56 48 29 32 20 22 68 14 7 12 12 4 20 35 12 24 766
Mean Gustilo classification (%) Male% age I II IIIA IIIB
IIIC
41 0 54 0 7
27
17
13
1
32 0 7
7 73 55
7 27 0
0 0 0
94 93 93 81 71 71 77
31 30 48 34 40 25 31
0 0
0 0
0 0
100 0
0 100
93 71 85 92 96 100 84
31 45 29
36
64
0
0
0
36 36 41
0
52
12
34
2
53
47
83
32
87
35
48 33 31
25 23 28
18 10 19
10 23 17
0 10 5
Table 2 Summary of patient reported outcomes from all included studies. (DI: dysfunctional index, BI: bothersome index, MPH: mean physical health, MMH: mean mental health).
Author
Year
Reporting system
1 2
Doshi Fakri
2017 2012
EQ-5D SMFA
3 4 5 6 7 8
Joshi Joshi Ong Pal Pedrini Tunali
2004 2016 2002 2015 2011 2015
Modified Ketenjian’s criteria Johner Wruh’s criteria ASAMI criteria ASAMI criteria Enneking Score SF-36
9 10 11 12 13 14 15 16 17 18
Xiao O’Hara Devkota Kumar Shivannna Gondalia Vinchhi Kayali Gaurav Agrawal
2011 2016 2014 2016 2017 2015 2017 2009 2017 2013
Johner Wruh’s criteria EQ-5D Knee Society score Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria Modified Ketenjia’s criteria
nism was predominantly road traffic incidents, however, one study [13] reported all war-related injuries. Patient reported scores The mean follow-up for the studies was 21.7 months and ranged from 4 to 63.4 months. A total of 9 different outcome scores were used (see Table 2). Table 3 EQ-5D [22] was used in two studies and reported as 0.8712 at 12 month follow-up and 0.6623 at 24 month follow-up. Johner Wruh’s criteria [24] were reported as good and excellent in a tertiary centre in India [14] and predominantly poor in earthquake survivors [25]. The Association for the Study and Application of Methods of Ilizarov (ASAMI) score was used in 2 studies [18, 26]. Both studies showed predominantly good and excellent scores. Other scoring systems used included the short musculoskeletal function assessment (SMFA) [27]. Fakri et al. report the disability index as 27 and the bothersome index as 30.5 in Iraqi civilians at 24 months [13].
Score 0.91 DI 27
MPH 40.5
Scale (%) Poor Fair BI 30.5 11 0 7 15 30 MMH 35 41
Good
Excellent
4 8 0 85 70
18 17 21
68 75 72
15
26
18
7 84 9 10 9 18 10
14
75
29 20 16 20 23
56 56 49 53 60
0.66 88.71 4 16 7 14 4 10 7
In most studies, outcomes of the Ketenjian’s criteria [28] were reported as good and excellent by eight authors (n = 319) [15, 16, 21, 29, 30, 31, 32, 33]. One study reports the Musculoskeletal Tumour Society rating scale (Enneking score) [34]. Seventy percent were reported as good or excellent in Afghanistan at 4 month follow-up [19]. One study used the SF-36, which is a set of administered quality-of-life measures. Tunali et al. report the score as 40.5 for mean physical health and 35 for mean mental health, which was below the population average. One study reported the Knee Society Score (KSS); Devkota et al. report this score as 88.71/100 in seven individuals in Nepal at 29 months [35]. Complications: infection, non-union and amputation Infection rates were available for 15 studies (n = 686) with a mean of 18% infections (both superficial and deep). The incidence varied widely from 7%−85%, as some studies reported tibia nonunions where infection is a known risk factor.
Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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A.T. Schade, J. Hind and C. Khatri et al. / Injury xxx (xxxx) xxx Table 3 Summary of complications (data was not available for the other studies included in the review). Blank spaces have been left were no data was available. Author
Year
Infection (%)
Doshi Fakri Joshi Joshi Ong Pal Pedrini Tunali Kumar Shivannna Gondalia Vinchhi Kayali Gaurav Agrawal TOTAL
2017 2012 2004 2016 2002 2015 2011 2015 2016 2017 2015 2017 2009 2017 2013
8 85 11 29 7 16 5 14 7 12 26 9 16 13 10 18
Non-unions (%)
Amputations (%)
100 11
17 2
0 5 18 11 8 12 7 0 10 3 15
5 36
15
Rates of non-unions were available for 12 studies (n = 444), with a pooled mean of 27% (range 0–100%). One of the studies reported outcome scores for non-unions that were all from open tibia fractures [13]. Rates of amputation were available for 4 studies (n = 144). The pooled mean for these four studies was 15% (range 2–36%).
injuries) from different environments may have biased the outcomes reported, therefore we are not able to separate out their influence on the overall results. These were not reported separately in any paper and a sub-analysis was not possible. The same was true of mechanism of injury, we were not able to separate results by mechanism of injury, although it should be noted that the majority were from motor vehicle accidents, an increasing epidemic in LMICs [1]. The fact that so many scoring systems were used did not enable us to perform a statistical analysis beyond description and summarisation. Most PROMs assessed similar patient outcomes such as pain, gait and functional independence, but the heterogeneity of scoring systems means these PROMs were hard to compare. Some of the scoring systems used a combination of functional, radiological and patient reported scores. Therefore, these scores might have clinical input as well as patient input. As no sub-analysis was possible, we were unable to draw any conclusions on the various treatments included in this review. Others have suggested the use of low cost external fixators and vacuum therapy devices in LMICs [36,37]. However, the paucity of studies with PROMs, and the heterogeneity of measures used, suggests a need for the development of a core outcome set for open tibial fractures that is appropriate for use in studies in LMICs. The development of these core outcomes should include patients and clinicians from LMICs to ensure feasibility and relevance to these regions.
Economic impact Only one study reported economic impact as well as patient reported outcomes and this open tibia fracture data was provided by the authors [23]. In this case series of 14 patients, all were working prior to injury, whereas only 20% were working at 12 months and 71% at 24 months post-injury. Average earning prior to injury was 199USD, whereas it was reported as 19USD at 12 months and 82USD at 24 months post-injury. 88% of patients (n = 7) were the main household income earner prior to the injury, which reduced to 63% of patients (n = 5) post injury. Discussion We aimed to collate the evidence of the medium-term natural history of patients with open tibia fractures from low or middle income countries, regardless of the treatment received. This study was conducted and reported in accordance with the PRISMA guidelines for complete transparency. We found that most patient reported outcomes were good or excellent, but with a wide range of reported scores. The demographics of open tibia fracture patients predominantly affected young males with a mean age of 35 year old, 87% affecting males and 73% from road traffic incidents. Rates of complications were 18% for infections, 15% for non-unions and 15% for amputations. Low income countries are underrepresented compared to middle income countries. Only two studies were performed in low income countries (Nepal, Sierra Leone), whereas 16 were performed in middle income countries. Furthermore, some of the studies mention their results might not be representative of a typical LMIC situation, as they have benefited from foreign volunteer staff or are in a modern tertiary hospital [12, 13]. There was much heterogenicity in the study environments. On the one hand, some studies were set in low income countries, war zones or following natural disasters and on the other hand, some were set in upper middle income countries or in modern hospitals in middle income countries. This may represent a research design bias, as hospitals in low-income countries may not have the appropriate research methods, training, or financial support to publish their outcome sets. Comorbidities (including other significant
Strengths and limitations This study used a broad search term, which included patient populations with multiple injuries, including open tibia fractures. It enabled us to include papers that do not specifically mention open tibia fractures in the title or abstract [13], allowing us to capture a greater population that would otherwise be missed. In addition, by contacting individual authors, we were able to obtain novel data not previously published, to be included in this review [23]. Snowballing was also effectively used and generated a further eight studies. This may be due to the fact that some studies from LMICs are published in lower impact journals and in the future, there should be more representation of LMICs studies in high impact journals.
Conclusions This is the first study to summarise patient reported outcomes in low or middle income countries for open tibia fractures. Most studies assessed in this review described the natural course of an open tibia fracture in LMICs as excellent or good in terms of patient reported outcomes, irrespective of treatment. However, as the setting and outcome measures were so varied, the natural course remains still largely unknown and patient-reported measures are particularly poorly reported in the literature. The very limited studies published were unable to show significant influence from any factors due to the wide variety of scores that have been used. There is also an underrepresentation of low income countries compared to middle income countries and outcomes from public hospitals in the lowest income countries are particularly poorly described. Research in this field is desperately needed to understand this important injury and to evaluate the best treatments.
Declaration of Competing Interest None
Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015
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Please cite this article as: A.T. Schade, J. Hind and C. Khatri et al., Systematic review of patient reported outcomes from open tibia fractures in low and middle income countries, Injury, https://doi.org/10.1016/j.injury.2019.11.015