Impact of Modifying Abicipar Manufacturing Process in Patients with Neovascular Age-Related Macular Degeneration: MAPLE Study Results.

Purpose: To evaluate the impact of modifying the abicipar pegol (abicipar) manufacturing process on the safety and treatment effect of abicipar in patients with neovascular age-related macular degeneration (nAMD). Methods: A new process for manufacturing abicipar was developed to reduce host cell impurities. In a prospective, Phase 2, multicenter, open-label, 28-week clinical trial, patients (n=123) with active nAMD received intravitreal injections of abicipar 2 mg at baseline (day 1) and weeks 4, 8, 16, and 24. Outcome measures included proportion of patients with stable vision (<15-letter loss from baseline; primary endpoint), change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), and adverse events. Results: Overall, 8.9% (11/123) of patients experienced intraocular inflammation (IOI) and discontinued treatment. IOI cases were assessed as mild (2.4% [3/123]), moderate (4.9% [6/123]), or severe (1.6% [2/123]) and resolved with steroid treatment. Visual acuity in most patients with IOI (8 of 11) recovered to baseline BCVA or better by study end. No cases of endophthalmitis or retinal vasculitis were reported. Stable vision was maintained for ≥95.9% (≥118/123) of patients at all study visits. At week 28, treatment-naïve patients showed a greater mean improvement from baseline in BCVA compared with previously treated patients (4.4 vs 1.8 letters) and a larger mean CRT reduction from baseline (98.5 vs 45.5 µm). Conclusion: Abicipar produced using a modified manufacturing process showed a moderately lower incidence and severity of IOI compared with Phase 3 abicipar studies. Beneficial effects of treatment were demonstrated.

Two-Year Results of the Phase 3 Randomized Controlled Study of Abicipar in Neovascular Age-Related Macular Degeneration.

PURPOSE: To report the 2-year efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) compared with monthly ranibizumab in patients with treatment-naïve neovascular age-related macular degeneration (nAMD). DESIGN: Two multicenter, randomized, phase 3 clinical trials with identical protocols (CEDAR and SEQUOIA). Analyses used pooled trial data. PARTICIPANTS: The trials enrolled 1888 patients (1 eye/patient) with active choroidal neovascularization secondary to age-related macular degeneration and best-corrected visual acuity (BCVA) of 24 to 73 Early Treatment Diabetic Retinopathy Study letters. METHODS: At enrollment, patients were assigned to study eye treatment with abicipar 2 mg every 8 weeks after initial doses at baseline and weeks 4 and 8 (abicipar Q8, n = 630), abicipar 2 mg every 12 weeks after initial doses at baseline and weeks 4 and 12 (abicipar Q12, n = 628), or ranibizumab 0.5 mg every 4 weeks (ranibizumab Q4, n = 630). MAIN OUTCOME MEASURES: Efficacy measures included stable vision (<15-letter loss in BCVA from baseline) and change from baseline in BCVA and central retinal thickness (CRT). Safety measures included adverse events (AEs). RESULTS: For patients who completed the study, efficacy of abicipar after initial doses was maintained through week 104. At week 104, the proportion of patients with stable vision was 93.0% (396/426), 89.8% (379/422), and 94.4% (470/498); mean change in BCVA from baseline was +7.8 letters, +6.1 letters, and +8.5 letters, and mean change in CRT from baseline was -147 µm, -146 µm, and -142 µm in the abicipar Q8 (14 injections), abicipar Q12 (10 injections), and ranibizumab Q4 (25 injections) groups, respectively. The overall incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3% from baseline through week 52 and 16.2%, 17.6%, and 1.3% from baseline through week 104 in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. CONCLUSIONS: Two-year results show efficacy of abicipar Q8 and Q12 in nAMD. First onset of IOI events with abicipar was much reduced in the second year and comparable with ranibizumab (0.8% and 2.3% vs. 1.0%). The extended duration of effect of abicipar allows for quarterly dosing and reduced treatment burden.

Which Surgical Operations Should be Performed in District Hospitals in East, Central and Southern Africa? Results of a Survey of Regional Clinicians.

BACKGROUND: In East, Central and Southern Africa (ECSA), district hospitals (DH) are the main source of surgical care for 80% of the population. DHs in Africa must provide basic life-saving procedures, but the extent to which they can offer other general and emergency surgery is debated. Our paper contributes to this debate through analysis and discussion of regional surgical care providers' perspectives. METHODS: We conducted a survey at the College of Surgeons of East, Central and Southern Africa Conference in Kigali in December 2018. The survey presented the participants with 59 surgical and anaesthesia procedures and asked them if they thought the procedure should be done in a district level hospital in their region. We then measured the level of positive agreement (LPA) for each procedure and conducted sub-analysis by cadre and level of experience. RESULTS: We had 100 respondents of which 94 were from ECSA. Eighteen procedures had an LPA of 80% or above, among which appendicectomy (98%), caesarean section (97%) and spinal anaesthesia (97%). Twenty-one procedures had an LPA between 31 and 79%. The surgical procedures that fell in this category were a mix of obstetrics, general surgery and orthopaedics. Twenty procedures had an LPA below 30% among which paediatric anaesthesia and surgery. CONCLUSION: Our study offers the perspectives of almost 100 surgical care providers from ECSA on which surgical and anaesthesia procedures should be provided in district hospitals. This might help in planning surgical care training and delivery in these hospitals.

Evaluation of a Managed Surgical Consultation Network in Malawi.

BACKGROUND: Access to surgery is a challenge for low-income countries like Malawi due to shortages of specialists, especially in rural areas. District hospitals (DH) cater for the immediate surgical needs of rural patients, sending difficult cases to central hospitals (CH), usually with no prior communication. METHODS: In 2018, a secure surgical managed consultation network (MCN) was established to improve communication between specialist surgeons and anaesthetists at Queen Elizabeth and Zomba Central Hospitals, and surgical providers from nine DHs referring to these facilities. RESULTS: From May to December 2018, DHs requested specialist advice on 249 surgical cases through the MCN, including anonymised images (52% of cases). Ninety six percent of cases received advice, with a median of two specialists answering. For 74% of cases, a first response was received within an hour, and in 68% of the cases, a decision was taken within an hour from posting the case on MCN. In 60% of the cases, the advice was to refer immediately, in 26% not to refer and 11% to possibly refer at a later stage. CONCLUSION: The MCN facilitated quick access to consultations with specialists on how to manage surgical patients in remote rural areas. It also helped to prevent unnecessary referrals, saving costs for patients, their guardians, referring hospitals and the health system as a whole. With time, the network has had spillover benefits, allowing the Ministry of Health closer monitoring of surgical activities in the districts and to respond faster to shortages of essential surgical resources.

Characteristics of interpersonal violence in adult victims at the Adult Emergency Trauma Centre (AETC) of Queen Elizabeth Central Hospital.

Introduction: Globally, the burden of interpersonal violence and its significant impact on mortality, morbidity and disability makes it a major public health problem which necessitates intervention. This article examines characteristics of victims of interpersonal violence and violent events in Malawi. The focus is on a population that has been traditionally neglected in literature. Methods: Queen Elizabeth Central Hospital (QECH) maintains a trauma registry with data that is prospectively collected. Patients offered trauma care after interpersonal violence from May 2013 to May 2015 were evaluated. Results: There were 1431 patients with violent events recorded at the Adult Emergency Trauma Centre (AETC) with a male predominance of 79.5%. The dominant age group was young adults between 25-29 years old (22%). Most attacks occurred during cold and dry season (46.9%) and most common location was on the road (37.2%). Alcohol use by victims was recorded in 10.5% of cases. Soft tissue injuries were the most common injuries sustained (74.1%). Most patients were treated as outpatients (80.9%). There were two deaths. At multivariate analysis, women had a lower risk of interpersonal violence as compared to men, (OR 0.82 [0.69-0.98]). Victims' use of alcohol was associated with increased risk of assault (OR 1.63 [1.27-2.10]). As compared to other places, odds of being assaulted were higher at home (OR 1.62 [1.27-2.06]) but lower at work (OR 0.68 [0.52-0.89) and on the road (OR 0.82 [0.65-1.03]). Odds of being assaulted were higher in the cold and dry season as compared to hot and dry season, (OR 1.26 [1.08-1.47]). Conclusion: Young males were most involved in interpersonal violence. Location of injury and seasonal variation were significant factors associated with interpersonal violence and most commonly sustained injuries were soft tissue injuries. These findings will help in identifying targeted interventions for interpersonal violence in Malawi and other low-and-middle-income countries (LMICs).

Efficacy and Safety of Abicipar in Neovascular Age-Related Macular Degeneration: 52-Week Results of Phase 3 Randomized Controlled Study.

PURPOSE: To compare the efficacy and safety of abicipar every 8 weeks and quarterly (after initial doses) versus ranibizumab every 4 weeks in treatment-naïve patients with neovascular age-related macular degeneration (AMD). DESIGN: Two randomized, multicenter, double-masked, parallel-group, active-controlled, phase 3 clinical trials (CEDAR, SEQUOIA) with identical protocols were conducted. Data from both trials were pooled for analysis. PARTICIPANTS: Patients with active choroidal neovascularization secondary to AMD and best-corrected visual acuity (BCVA) of 24-73 Early Treatment Diabetic Retinopathy Study letters in the study eye were enrolled. METHODS: Patients (n = 1888) were randomized in a 1:1:1 ratio to study eye treatment with abicipar 2 mg every 8 weeks after 3 initial doses at baseline and weeks 4 and 8 (Q8), abicipar 2 mg every 12 weeks after 3 initial doses at baseline and weeks 4 and 12 (Q12), or ranibizumab 0.5 mg every 4 weeks (Q4). MAIN OUTCOME MEASURES: The primary efficacy end point was proportion of patients with stable vision (defined as <15-letter loss in BCVA from baseline) in the study eye at week 52. Secondary end points included change from baseline in BCVA and central retinal thickness (CRT) at week 52. Safety measures included adverse events (AEs). RESULTS: The proportion of patients with stable vision at week 52 was 93.2%, 91.3%, and 95.8% in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively, with both abicipar Q8 and Q12 noninferior to ranibizumab Q4. Week 52 mean change from baseline in BCVA was 7.5, 6.4, and 8.4 letters and in CRT was -144, -145, and -144 µm in the abicipar Q8, abicipar Q12, and ranibizumab Q4 groups, respectively. Incidence of intraocular inflammation (IOI) AEs was 15.4%, 15.3%, and 0.3%, respectively. The IOI AEs were typically mild or moderate in severity and treated with topical corticosteroids; 62 of 192 patients (32.3%) received oral and/or injectable corticosteroids. CONCLUSIONS: Abicipar Q8 and Q12 were both noninferior to ranibizumab Q4 in the primary end point of stable vision at week 52. Intraocular inflammation was more frequent with abicipar. Quarterly and Q8 abicipar reduce nAMD disease and treatment burden compared with monthly treatment.

Anesthesia Capacity of District-Level Hospitals in Malawi, Tanzania, and Zambia: A Mixed-Methods Study.

BACKGROUND: District-level hospitals (DLHs) are the main providers of surgical services for rural populations in Sub-Saharan Africa (SSA). Skilled teams are essential for surgical care, and gaps in anesthesia impact negatively on surgical capacity and outcomes. This study, from a baseline of a project scaling-up access to safe surgical and anesthesia care in Malawi, Tanzania, and Zambia, illustrates the deficit of anesthesia care in DLHs. METHODS: We undertook an in-depth investigation of anesthesia capacity in 76 DLHs across the 3 countries, July to November 2017, using a mixed-methods approach. The quantitative component assessed district-level anesthesia capacity using a standardized scoring system based on an adapted and extended Personnel, Infrastructure, Procedures, Equipment and Supplies (PIPES) Index. The qualitative component involved semistructured interviews with providers from 33 DLHs, exploring how weaknesses in anesthesia impacted district surgical team practices and quality, volume, and scope of service provision. RESULTS: Anesthesia care at the district level in these countries is provided only by nonphysician anesthetists, some of whom have no formal training. Ketamine anesthesia is widely used in all hospitals, compensating for shortages of other forms of anesthesia. Pediatric size supplies/equipment were frequently missing. Anesthesia PIPES index scores in Malawi (M = 8.0), Zambia (M = 8.3), and Tanzania (M = 8.4) were similar (P = .59), but an analysis of individual PIPES components revealed important cross-country differences. Irregular availability of reliable equipment and supply is a particular priority in Malawi, where only 29% of facilities have uninterrupted access to electricity and 23% have constant access to water, among other challenges. Zambia is mostly affected by staffing shortages, with 30% of surveyed hospitals lacking an anesthesia provider. The challenge that stood out in Tanzania was nonavailability of functioning anesthesia machines among frequent shortages of staff and other equipment. CONCLUSIONS: Tanzania, Malawi, and Zambia are falling far short of ensuring universal access to safe and affordable surgical and anesthesia care for district and rural populations. Mixed-methods situation analyses, undertaken in collaboration with anesthesia specialists-measuring and understanding deficits in district hospital anesthetic staff, equipment, and supplies-are needed to address the critical neglect of anesthesia that is essential to providing surgical responses to the needs of rural populations in SSA.

Evaluation of a surgical supervision model in three African countries-protocol for a prospective mixed-methods controlled pilot trial.

BACKGROUND: District-level hospitals (DLHs) can play an important role in the delivery of essential surgical services for rural populations in sub-Saharan Africa if adequately prepared and supported. This article describes the protocol for the evaluation of the Scaling up Safe Surgery for District and Rural Populations in Africa (SURG-Africa) project which aims to strengthen the capacity in district-level hospitals (DLHs) in Malawi, Tanzania and Zambia to deliver safe, quality surgery. The intervention comprises a programme of quarterly supervisory visits to surgically active district-level hospitals by specialists from referral hospitals and the establishment of a mobile phone-based consultation network. The overall objective is to test and refine the model with a view to scaling up to national level. METHODS: This mixed-methods controlled pilot trial will test the feasibility of the proposed supervision model in making quality-assured surgery available at DLHs. Firstly, the study will conduct a quantitative assessment of surgical service delivery at district facilities, looking at hospital preparedness, capacity and productivity, and how these are affected by the intervention. Secondly, the study will monitor changes in referral patterns from DLHs to a higher level of care as a result of the intervention. Data on utilisation of the mobile based-support network will also be collected. The analysis will compare changes over time and between intervention and control hospitals. The third element of the study will involve a qualitative assessment to obtain a better understanding of the functionality of DLH surgical systems and how these have been influenced by the intervention. It will also provide further information on feasibility, impact and sustainability of the supervision model. DISCUSSION: We seek to test a model of district-level capacity building through regular supervision by specialists and mobile phone technology-supported consultations to make safe surgical services more accessible, equitable and sustainable for rural populations in the target countries. The results of this study will provide robust evidence to inform and guide local actors in the national scale-up of the supervision model. Lessons learned will be transferred to the wider region.

Establishment of trauma registry at Queen Elizabeth Central Hospital (QECH), Blantyre, Malawi and mapping of high risk geographic areas for trauma.

BACKGROUND: Less attention is directed toward gaining a better understanding of the burden and prevention of injuries, in low and middle income countries (LMICs). We report the establishment of a trauma registry at the Adult Emergency and Trauma Centre (AETC) at Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi and identify high risk geographic areas. METHODS: We devised a paper based two-page trauma registry form. Ten data clerks and all AETC clinicians were trained to complete demographic and clinical details respectively. Descriptive data, regression and hotspot analyses were done using STATA 15 statistical package and ArcGIS (16) software respectively. RESULTS: There were 3,747 patients from May 2013 to May 2015. The most common mechanisms of injury were assault (38.2%), and road traffic injuries (31.6%). The majority had soft tissue injury (53.1%), while 23.8% had no diagnosis indicated. Fractures (OR 19.94 [15.34-25.93]), head injury and internal organ injury (OR 29.5 [16.29-53.4]), and use of ambulance (OR 1.57 [1.06-2.33]) were found to be predictive of increased odds of being admitted to hospital while assault (OR 0.69 [0.52-0.91]) was found to be associated with less odds of being admitted to hospital. Hot spot analysis showed that at 99% confidence interval, Ndirande, Mbayani and Limbe were the top hot spots for injury occurrence. CONCLUSION: We have described the process of establishing an integrated and potentially sustainable trauma registry. Significant data were captured to provide details on the epidemiology of trauma and insight on how care could be improved at AETC and surrounding health facilities. This approach may be relevant in similar poor resource settings.

The feasibility of a training course for clubfoot treatment in Africa: A mixed methods study.

BACKGROUND: There is no available training programme with standard elements for health workers treating clubfoot in Africa. Standardised training with continued mentorship has the potential to improve management of clubfoot. We aimed to evaluate the feasibility of such a training programme among clubfoot providers in Africa, and assess implications for training effectiveness and scale up. METHOD: We used participatory research with trainers from 18 countries in Africa over two years to devise, pilot and refine a 2-day basic and a 2-day advanced clubfoot treatment course. (The Africa Clubfoot Training or 'ACT' Course.) The pilots involved training 113 participants. Mixed methods (both qualitative and quantitative) were used for evaluation. We describe and synthesise the results using the eight elements proposed by Bowen et al (2010) to assess feasibility. All participants completed feedback questionnaires, and interviews were conducted with a subset of participants. We undertook a narrative description of themes raised in the participant questionnaires and interviews. Descriptive statistics were used to compare pre- and post-course scores for confidence and knowledge. RESULTS: 113 participants completed pre and post-course measures (response rate = 100%). Mean participant confidence increased from 64% (95%CI: 59-69%) to 88% (95%CI: 86-91%) post course. Mean participant knowledge increased from 55% (95%CI: 51-60%) to 78% (95%CI: 76-81%) post course. No difference was found in mean for either subscale of cadre or sex. The qualitative analysis generated themes under four domains: 'practical learning in groups', 'interactive learning', 'relationship with the trainer' and 'ongoing supervision and mentorship'. CONCLUSION: The Africa Clubfoot Training package to teach health care workers to manage clubfoot is likely to be feasible in Africa. Future work should evaluate its impact on short and long term treatment outcomes and a process evaluation of implementation is required.

The development of a training course for clubfoot treatment in Africa: learning points for course development.

BACKGROUND: Clubfoot is a common congenital musculoskeletal disorder that causes mobility impairment. There is a lack of trained mid-level personnel to provide clubfoot treatment in Africa and there is no standard training course. This prospective study describes the collaborative and participatory approach to the development of a training course for the treatment of clubfoot in children in resource constrained settings. METHODS: We used a systems approach to evaluate the development of the training course. Inputs: The research strategy included a review of context and available training materials, and the collection of data on current training practices. Semi-structured interviews were conducted with seven expert clubfoot trainers. A survey of 32 international and regional trainers was undertaken to inform practical issues. The data were used to develop a framework for training with advice from two technical groups, consisting of regional and international stakeholders and experts. PROCESS: A consensus approach was undertaken during workshops, meetings and the sharing of documents. The design process for the training materials took twenty-four months and was iterative. The training materials were piloted nine times between September 2015 and February 2017. Processes and materials were reviewed and adapted according to feedback after each pilot. RESULTS: Fifty-one regional trainers from Africa (18 countries), 21 international experts (11 countries), 113 local providers of clubfoot treatment (Ethiopia, Rwanda and Kenya) and local organising teams were involved in developing the curriculum and pilot testing. The diversity of the two technical advisory groups allowed a wide range of contributions to the collaboration. Output: The resulting curriculum and content comprised a two day basic training and a two day advanced course. The basic course utilised adult learning techniques for training novice providers in the treatment of idiopathic clubfoot in children under two years old. The advanced course builds on these principles. CONCLUSION: Formative research that included mixed methods (both qualitative and quantitative) was important in the development of an appropriate training course. The process documentation from this study provides useful information to assist planning of medical training programmes and may serve as a model for the development of other courses.

Systemic absorption of nicotine following acute secondhand exposure to electronic cigarette aerosol in a realistic social setting.

Evidence suggests exposure of nicotine-containing e-cigarette aerosol to nonusers leads to systemic absorption of nicotine. However, no studies have examined acute secondhand exposures that occur in public settings. Here, we measured the serum, saliva and urine of nonusers pre- and post-exposure to nicotine via e-cigarette aerosol. Secondarily, we recorded factors affecting the exposure. Six nonusers of nicotine-containing products were exposed to secondhand aerosol from ad libitum e-cigarette use by three e-cigarette users for 2 h during two separate sessions (disposables, tank-style). Pre-exposure (baseline) and post-exposure peak levels (Cmax) of cotinine were measured in nonusers' serum, saliva, and urine over a 6-hour follow-up, plus a saliva sample the following morning. We also measured solution consumption, nicotine concentration, and pH, along with use behavior. Baseline cotinine levels were higher than typical for the US population (median serum session one = 0.089 ng/ml; session two = 0.052 ng/ml). Systemic absorption of nicotine occurred in nonusers with baselines indicative of no/low tobacco exposure, but not in nonusers with elevated baselines. Median changes in cotinine for disposable exposure were 0.007 ng/ml serum, 0.033 ng/ml saliva, and 0.316 ng/mg creatinine in urine. For tank-style exposure they were 0.041 ng/ml serum, 0.060 ng/ml saliva, and 0.948 ng/mg creatinine in urine. Finally, we measured substantial differences in solution nicotine concentrations, pH, use behavior and consumption. Our data show that although exposures may vary considerably, nonusers can systemically absorb nicotine following acute exposure to secondhand e-cigarette aerosol. This can particularly affect sensitive subpopulations, such as children and women of reproductive age.

Is overseas volunteering beneficial to the NHS? The analysis of volunteers' responses to a feedback questionnaire following experiences in low-income and middle-income countries.

INTRODUCTION: Locally requested and planned overseas volunteering in low-income and middle-income countries by National Health Service (NHS) staff can have benefits for the host or receiving nation, but its impact on the professional development of NHS staff is not proven. The Knowledge and Skills Framework (KSF) and Leadership Framework (LF) are two tools used by employers as a measure of individuals' development. We have used dimensions from both tools as a method of evaluating the benefit to NHS doctors who volunteer overseas. METHODS: 88 NHS volunteers participating with local colleagues in Primary Trauma Care and orthopaedic surgical training courses in sub-Saharan Africa were asked to complete an online self-assessment questionnaire 6 months following their return to the UK. The survey consisted of questions based on qualities outlined in both the KSF and LF. RESULTS: 85 completed responses to the questionnaire were received. In every KSF domain assessed, the majority of volunteers agreed that their overseas volunteering experience improved their practice within the NHS. Self-assessed pre-course and post-course scores evaluating the LF also saw a universal increase, notably in the 'working with others' domain. DISCUSSION: There is a growing body of literature outlining the positive impact of overseas volunteering on NHS staff. Despite increasing evidence that such experiences can develop volunteers' essential skills, individuals often find it difficult to gain support of their employers. Our study, in line with the current literature, shows that overseas volunteering by NHS staff can provide an opportunity to enhance professional and personal development. Skills gained from volunteering within international links match many of the qualities outlined in both KSF and LF, directly contributing to volunteers' continued professional development.

Do trauma courses change practice? A qualitative review of 20 courses in East, Central and Southern Africa.

BACKGROUND: Trauma courses have been shown to improve clinical knowledge and patient outcomes. However, little is known about the individual drivers of change in practice amongst course participants in their home clinic environment. METHODS: Front-line healthcare workers participated in a two-day Primary Trauma Care (PTC) course. Immediately after the course participants completed an evaluation survey on intended change in the management of trauma patients. Six months after the course, participants completed a survey on actual changes that had occurred. RESULTS: A total of 451 participants were sampled, with 321 responding at 6 months, from 40 courses across East, Central and Southern Africa. The most commonly reported intended change was the adoption of an ABCDE/systematic approach (53%). Six months after the course, 92.7% of respondents reported that they had made changes in their management, with adoption of an ABCDE/systematic approach (50.0%) remaining most common. 77% of participants reported an improvement in departmental trauma management, 26% reported an increase in staffing, 29% an increase in equipment and 68% of participants had gone on to train other healthcare workers in PTC. CONCLUSION: The findings suggest that PTC courses not only improve individual management of trauma patients but also but is also associated with beneficial effects for participants' host institutions with regards to staffing, equipment and training.

A review of existing trauma and musculoskeletal impairment (TMSI) care capacity in East, Central, and Southern Africa.

BACKGROUND: We conducted an assessment of orthopaedic surgical capacity in the following countries in East, Central, and Southern Africa: Burundi, Ethiopia, Kenya, Malawi, Mozambique, Rwanda, Tanzania, Uganda, Zambia, and Zimbabwe. METHODS: We adapted the WHO Tool for Situational Analysis to Assess Emergency and Essential Surgical Care with questions specific to trauma and orthopaedic care. In May 2013-May 2014, surgeons from the College of Surgeons of East, Central and Southern Africa (COSECSA) based at district (secondary) and referral (tertiary) hospitals in the region completed a web-based survey. COSECSA members contacted other eligible hospitals in their country to collect further data. FINDINGS: Data were collected from 267 out of 992 (27%) hospitals, including 185 district hospitals and 82 referral hospitals. Formal accident and emergency departments were present in 31% of hospitals. Most hospitals had no general or orthopaedic surgeons or medically-qualified anaesthetists on staff. Functioning mobile C-arm X-ray machines were available in only 4% of district and 27% of referral hospitals; CT scanning was available in only 3% and 26%, respectively. Closed fracture treatment was offered in 72% of the hospitals. While 20% of district and 49% of referral hospitals reported adequate instruments for the surgical treatment of fractures, only 4% and 10%, respectively, had a sustainable supply of fracture implants. Elective orthopaedic surgery was offered in 29% and Ponseti treatment of clubfoot was available at 42% of the hospitals. INTERPRETATION: The current capacity of hospitals in sub-Saharan Africa to manage traumatic injuries and orthopaedic conditions is significantly limited. In light of the growing burden of trauma and musculoskeletal impairment within this region, concerted efforts should be made to improve hospital capacity with equipment, trained personnel, and specialist clinical services.

Trauma and orthopaedic capacity of 267 hospitals in east central and southern Africa.

BACKGROUND: Trauma and road traffic accidents are predicted to increase significantly in the next decade in low-income and middle-income countries. The College of Surgeons of East, Central, and Southern Africa (COSECSA) covers Ethiopia, Kenya, Tanzania, Uganda, Rwanda, Burundi, Mozambique, Malawi, Zimbabwe, and Zambia. Ministry of Health websites for these ten countries show that 992 hospitals are covering an estimated 318 million people. METHODS: The WHO Tool for Situational Analysis to Assess Emergency and Essential Surgical Care was used with added questions relevant to trauma and orthopaedic care. A web-based survey platform was used and hospitals were contacted via COSECSA representatives. Consent to share data was requested, anonymised for country and hospital. FINDINGS: 267 (27%) of 992 hospitals completed the survey. 185 were district level hospitals and 82 were referral or tertiary level hospitals. Formal accident and emergency departments were present in only 29% of district hospitals (95% CI 22·5-35·5) and 35% (24·7-45·3) of referral or tertiary level hospitals. The mean number (SD) of surgeons was 1·4 (3·0) in district hospitals and 2·6 (4·6) in referral or tertiary level hospitals. The mean number (SD) of orthopaedic surgeons was 0·3 (0·9) in district hospitals and 0·5 (0·9) in referral or tertiary level hospitals. Medically qualified anaesthetists were available in 16% (95% CI 10·7-21·3) of district hospitals and 20% (11·4-28·6) of referral or tertiary level hospitals. C arm radiography was available in 3% (95% CI 0·5-5·5) of district hospitals and 32% (21·9-42·1) of referral or tertiary level hospitals. CT scanning was available in 6% (95% CI 2·6- 9·4) of district hospitals and 21% (12·2-29·8) of referral or tertiary level hospitals. Closed fracture treatment was offered in 75% (95% CI 68·8- 81·2) of district hospitals and 82% (73·7-90·3) of referral or tertiary level hospitals. 37% (95% CI 30·1-43·9) of district hospitals and 40% (29·4-50·6) of referral or tertiary level hospitals had adequate instruments for the surgical treatment of fractures, but only 7% (3·4-10·6) of district hospitals and 8% (2·1-13·9) of referral or tertiary level hospitals had a sustainable supply of fracture implants. Elective orthopaedic surgery took place in 30% (95% 23·4- 36·6) of district hospitals and 34% (23·8-44·2) of referral or tertiary level hospitals. Ponseti treatment of clubfoot was available at 46% (95% 38·8-53·2) of district hospitals and 44% (33·3-54·7) of referral or tertiary level hospitals. INTERPRETATION: This study has limitations in that only 27% of eligible hospitals completed the survey, and it is certainly possible that there could be bias in that the less well resourced institutions could also be less likely to cooperate with data collection. Thus, it is possible that the figures we present overestimate the resources available in the region as a whole. However, despite the limitations in data quality, it is clear that current capacity to treat trauma and orthopaedic conditions is very limited, with particular areas of concern being manpower, training, facilities, and equipment. COSECSA will use these data as a baseline for further surveys and to develop a strategy to improve trauma and orthopaedic care in the region. FUNDING: UK Department for International Development (DFID).

A multicountry health partnership programme to establish sustainable trauma training in east, central, and southern African countries using a cascading trauma management course model.

BACKGROUND: Injury accounts for 267 000 deaths annually in the nine College of Surgeons of East, Central, and Southern Africa (COSECSA-ASESA) countries, and the introduction of a sustainable standardised trauma training programme across all cadres is essential. We have delivered a primary trauma care (PTC) programme that encompasses both a "provider" and "training the trainers" course using a "cascading training model" across nine COSECSA countries. The first "primary course" in each country is delivered by a team of UK instructors, followed by "cascading courses" to more rural regions led by newly qualified local instructors, with mentorship provided by UK instructors. This study examines the programme's effectiveness in terms of knowledge, clinical confidence, and cost-effectiveness. METHODS: We collected pre-training and post-training data from 1030 candidates (119 clinical officers, 540 doctors, 260 nurses, and 111 medical students) trained over 28 courses (nine primary and 19 cascading courses) between Dec 5, 2012, and Dec 19, 2013. Knowledge was assessed with a validated PTC multiple choice questionnaire and clinical confidence ratings of eight trauma scenarios, measured against covariants of sex, age, clinical experience, job roles, country, and health institution's workload. FINDINGS: Post-training, a significant improvement was noted across all cadres in knowledge (19% [95% CI 18·0-19·5]; p<0·05) and clinical confidence (22% [20·3-22·3]; p<0·05). Non-doctors showed a greater improvement in knowledge (22% vs 16%; p<0·05) and confidence (24% vs 20%; p<0·05) than doctors. Candidates attending cascading courses also showed larger improvements in knowledge (21% vs 15%; p<0·002) and clinical confidence (23% vs 19%; p<0·002) than their primary course counterparts. Multivariate regression analysis showed that attending cascading courses (Coef=4·83, p<0·05), being a nurse (Coef=3·89, p=0·007) or a clinical officer (Coef=4·11, p=0·015), and attending a course in Kenya (Coef=9·55, p<0·002) or Tanzania (Coef=9·40, p<0·002) were strong predictors to improvement in multiple choice questionnaire performance. However, improvement in clinical confidence was affected by the job-role of the clinical officer (Coef=6·49, p=0·002) and attending a course in Kenya (Coef=16·12, p<0·02) or Tanzania (Coef=7·01, p<0·05). Cascading courses were on average £2000 less expensive than primary care courses. INTERPRETATION: To the best of our knowledge, this is the largest series in the literature on multicountry trauma management training in sub-Saharan Africa. Our study supports the concept of cascading courses as an educationally and cost-effective method in delivering vital trauma training in low-resource settings led by local clinicians. FUNDING: Health Partnership Scheme through the UK Department for International Development (DFID).

Delivering trauma training to multiple health-worker cadres in nine sub-Saharan African countries: lessons learnt from the COOL programme.

BACKGROUND: Africa has one of the highest road-traffic mortality rates in the world. Nurses and clinical officers play a pivotal part in trauma care as a result of substantial shortage of doctors. The COOL (COSECSA-Oxford-Orthopaedic-Link) programme has delivered primary trauma care (PTC) training in nine sub-Saharan African countries across a wide cadre of health-workers (540 doctors, 260 nurses, 119 clinical officers, and 111 medical students). This prospective study investigates the effect of 28 consecutive PTCs and the training challenges that exist between different cadres and health institutions. METHODS: The course trains delegates in key trauma concepts: primary survey, airway management, chest injuries, major haemorrhage, and paediatric trauma. Candidates' knowledge of these concepts was assessed before and after the course with a validated 30 Single-Best-Answer multiple choice questionnaire. Assessment scores were analysed by cadre, urban (383 candidates) or rural institutions (647 candidates), and sex (657 men, 373 women). A concept was categorised as being poorly understood when half the candidates achieved less than 50% of the correct answers. Descriptive statistics and MANOVA analysis were used, with an alpha level set at 0·05. FINDINGS: 1030 PTC providers were trained between Dec 5, 2012, and Dec 19, 2013. There was significant increase in multiple choice questionnaire (58% to 77%, p<0·05) and clinical confidence (68% to 90%, p<0·05) scores among delegates post course, with independent covariants of institution location and cadre significantly affecting post-course scores. Doctors achieved satisfactory scores on all key concepts (67% to 84%, p<0·05). Clinical officers (all concepts 53% to 76%, p<0·05) particularly struggled with paediatric trauma (94 candidates <50%, mean 24·23 [95% CI 19-30]). Nurses (all concepts 42% to 64%, p<0·05) had difficulty with chest injuries (203 pre-course to 153 post-course candidates <50%, mean 49% [95% CI 45-52]) and paediatric trauma (212 pre-course to 161 post-course candidates ≤50%, post course mean 46% [95% CI 43-53]). Medical students achieved satisfactory scores in all concepts (overall 53% to 74%, p<0·05). Health-workers based in urban hospitals (82%) outperformed those in rural hospitals (72%) (p=0·001) and sex had no significant effect on performance (p=0·07). INTERPRETATION: Our study shows that PTC courses led to improvement in trauma management knowledge and clinical confidence among a wide cadre of health-workers. However, these are new concepts for many front-line health-workers, and regular refresher training will be required. There is also a difference in understanding of key trauma concepts among the different cadres. Future training in this region should address areas of weakness unique to each cadre, particularly paediatric trauma care. FUNDING: Health Partnership Scheme through the UK Department for International Development (DFID).

How useful are Primary Trauma Care courses in sub-Saharan Africa?

INTRODUCTION: More than five million deaths occur each year from injury with the vast majority occurring in low and middle-income countries (LMICs). Africa bears the highest road traffic related mortality rates in the world. Despite this, formal training in trauma management is not widely adopted in these countries. We report our results of 10 consecutive Primary Trauma Care (PTC) courses delivered in seven East and Central African countries, as part of the COSECSA Oxford Orthopaedic Link (COOL) initiative. METHODS: Candidate's knowledge and clinical confidence in trauma management were assessed using a multiple-choice questionnaire and a confidence matrix rating of eight clinical scenarios. We performed descriptive statistical analysis on knowledge and clinical confidence scores of candidates before and after the course. We sub-analysed these scores, examining specifically the difference that exist between gender, job-roles and instructors versus non-instructors. RESULTS: We have trained 345 new PTC providers and 99 new PTC instructors over the 10 courses. Data sets were complete for 322 candidates. Just under a third of candidates were women (n=94). Over two-thirds of candidates (n=240) were doctors, while the remainder comprised of nurses, medical students and clinical officers. Overall, the median pre-course MCQ score was 70% which increased to 87% post course (p<0.05). Men achieved a higher MCQ score both pre- and post-course compared to women (p<0.05); however there was no significant difference in the degree of improvement of MCQ scores between gender. Instructors outperform non-instructors (p<0.05), and similarly doctors outperform non-doctors on final MCQ scores (post-course). However, it was the non-doctors who showed a statistically significant improvement in scores before and after the course (20% non-doctors vs 16% doctors, p<0.05). Candidate's clinical confidence also demonstrated significant improvement following the course (p<0.05). CONCLUSION: Our work demonstrates that COOL-funded PTC courses in the COSECSA region delivered to front-line health staff have helped improve their knowledge and confidence in trauma management, irrespective of their job-roles and gender. Further follow-up is needed to establish the long-term impact of PTC courses in this region.