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1. Safety and long-term immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in adults in Sierra Leone: a combined open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2 trial

Author

David Ishola, Daniela Manno, Muhammed O Afolabi, Babajide Keshinro, Viki Bockstal, Baimba Rogers, Kwabena Owusu-Kyei, Alimamy Serry-Bangura, Ibrahim Swaray, Brett Lowe, Dickens Kowuor, Frank Baiden, Thomas Mooney, Elizabeth Smout, Brian Köhn, Godfrey T Otieno, Morrison Jusu, Julie Foster, Mohamed Samai, Gibrilla Fadlu Deen, Heidi Larson, Shelley Lees, Neil Goldstein, Katherine E Gallagher, Auguste Gaddah, Dirk Heerwegh, Benoit Callendret, Kerstin Luhn, Cynthia Robinson, Maarten Leyssen, Brian Greenwood, Macaya Douoguih, Bailah Leigh, Deborah Watson-Jones, M Kargbo, E Bockarie, N L James, A Kabbah, A Kamara, K H Koroma, S O Langley, N William, R Kessebeh, T Mooney, L Conteh, E Smout, K Allieu, K Bangura, M S Bangura, M A Bangura, H Jalloh, A B Jalloh, I Kamara, M Kamara, A Konteh, S Koroma, C Marrah, M Sesay, M T Sesay, A T Deen, A Jalloh, R M Kaimbay, D Kain, E L Kamara, M P Kamara, O J Kamara, S L M Kamara, M Kanneh, A H Koroma, D Lahai, I S Mansaray, W S Marah, M J Massaquoi, A Nabie, N S Saidu, I Samai, J N Tengheh, A S Turay, A Fornah, F Sesay, A Sow, E Swaray, F Mansaray, T Ade-Cole, L M Bangura, M L Conteh, A M Koroma, M Koroma, A Sam, T Scott, T Sessie, J-H C Sunders, S I-S Turay, J Weekes, M Sheku, L Gibson, D Kowuor, I Ahamed, W Allieu, D U Kabba, F J Kamara, M S Kebbie, M Pessima, A Wurie, F Bah, A I Bangura, R A S Bangura, L Blango, S Boima, M Conteh, Y Conteh, M L Daramy, O Fofanah, E George, T F Hanson, M I Jalloh, M Kalawa, A M Kamara, F E Kamara, G M Kamara, H M Kamara, P B D Kamara, R T Kamara, R Kamara, D P Kanneh, I Komeh, M Kuyateh, F F Mansaray, M M Mansaray, A B Sillah, M A Tarawally, O S Turya, J B Yawmah, B Leigh, D Watson-Jones, B Greenwood, M H Samai, G F Deen, D Marke, P Piot, P Smith, J Edmunds, S Lees, H Larson, H Weiss, P Wilson, C Maxwell, D Ishola, M Afolabi, F Baiden, P Akoo, K Owusu-Kyei, D Tindanbil, H Bower, J Stuart, O M Bah, B T Rogers, A Serry-Bangura, I B Swaray, A Bangura, I J David, D G M Davies, J A Kallon, A B Kamara, I F Kamara, M M Kamara, F E Morovia, F B Suma, F Thompson, M Murray, I Sesay, O Kakay, F Suma, J Foster, R Philips, D Manno, K Gallager, S Cox, N Howard, M Cesay, P Torrani, S Sharma, E Snowden, T Banks, T Harber, J Brown, K Howard, N Melton, S Malcolm, S Welsh, R Eggo, M Jendrossek, C Pearson, J Van Hoof, M Douoguih, K Offergelt, C Robinson, B Keshinro, M Van Alst, N Mahajan, V Bockstal, N Goldstein, A Gaddah, D Heerwegh, K Luhn, M Leyssen, B Lowe, K Awuondo, H Hafezi, E Hancox, B Kohn, G O Tuda, F Koroma, G Bangura, M T Kroma, L Fofanah, A Pessima, M Rogers, O Sheriff, T W Ajala, J Fangawa, S Foday Jr, I Jabbie, B Mansaray, H A Mansaray, K Sesay, M K Charles, P C Heroe, M L Karbo, IS Yansaneh, S G Egoeh, A Trye, M Amponsah, N D Alghali, A Bah, IJ Bangura, A C Cole, K Fofanah, S Fofanah, H U Jalloh, K F N Jalloh, N Jalloh, H U Kabba, J N Kabba, M Kabba, J S Kamara, F Kanjie, A P Kanu, I Kargbo, G Kassa-Koroma, S B Koroma, A Sankoh, T Sankoh, O D Sesay, H Wilhem, C T Williams, I Bangura, Y Ben-Rogers, F J Jamboria, N Kamara, I Kanawah, A T Kargbo, I Swaray, L Amara, I Bundu, H B Jakema, K Kamara, M F Sheku, Q Adeleye, I Akhigbe, R Bakalemwa, N P Chami, T Sylvester, L Altmann, B Kamara, K van Roey, P Conteh, M Samura, V Gandie, M Marrah, E Moinina, J Kalokoh, M I Bangura, S Bosompem, T Hilton, M O Jusu, P Borboh, A S Brima, A F Y Caulker, A Kallon, B Koroma, RC Macauley, T M D Saquee, H I Williams, A R Bangura, J Fornah, B Idriss, M Sillah, W Mackay, B Aleghen, T Murray, J Edem-Hotah, T Fatorma, F Amara, S Bangura, E Bonnie, M Sannoh, A Donaldson, S Ndingi, D Nyaberi, M Pereira, A Rothwell, V Vy, L Nyallay, A Fombah, S Saidu, N Connor, T P Dambo, P J Fakaba, M M E Fatorma, C L Johnson, D B Kogba, A Lahai, W Vincent, N Yambasu, M Bangura, A Tengbeh, R Kabia, AM Nyakoi, M Callaghan, L Enria, and S Lee

Subjects
Adult, Male, medicine.medical_specialty, Modified vaccinia Ankara, Booster dose, Antibodies, Viral, Sierra Leone, Sierra leone, Immunogenicity, Vaccine, Double-Blind Method, Viral Envelope Proteins, Internal medicine, Vaccines, DNA, Humans, Medicine, Ebola Vaccines, Adverse effect, Heterologous vaccine, Ebola vaccine, business.industry, Vaccination, Viral Vaccines, Hemorrhagic Fever, Ebola, Ebolavirus, Immunity, Humoral, Regimen, Infectious Diseases, Democratic Republic of the Congo, Female, business
Abstract

Background: The Ebola epidemics in west Africa and the Democratic Republic of the Congo highlight an urgent need for safe and effective vaccines to prevent Ebola virus disease. We aimed to assess the safety and long-term immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in Sierra Leone, a country previously affected by Ebola. Methods: The trial comprised two stages: an open-label, non-randomised stage 1, and a randomised, double-blind, controlled stage 2. The study was done at three clinics in Kambia district, Sierra Leone. In stage 1, healthy adults (aged ≥18 years) residing in or near Kambia district, received an intramuscular injection of Ad26.ZEBOV (5 × 1010 viral particles) on day 1 (first dose) followed by an intramuscular injection of MVA-BN-Filo (1 × 108 infectious units) on day 57 (second dose). An Ad26.ZEBOV booster vaccination was offered at 2 years after the first dose to stage 1 participants. The eligibility criteria for adult participants in stage 2 were consistent with stage 1 eligibility criteria. Stage 2 participants were randomly assigned (3:1), by computer-generated block randomisation (block size of eight) via an interactive web-response system, to receive either the Ebola vaccine regimen (Ad26.ZEBOV followed by MVA-BN-Filo) or an intramuscular injection of a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo on day 57 (second dose; control group). Study team personnel, except those with primary responsibility for study vaccine preparation, and participants were masked to study vaccine allocation. The primary outcome was the safety of the Ad26.ZEBOV and MVA-BN-Filo vaccine regimen, which was assessed in all participants who had received at least one dose of study vaccine. Safety was assessed as solicited local and systemic adverse events occurring in the first 7 days after each vaccination, unsolicited adverse events occurring in the first 28 days after each vaccination, and serious adverse events or immediate reportable events occurring up to each participant's last study visit. Secondary outcomes were to assess Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second vaccine in a per-protocol set of participants (ie, those who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response) and to assess the safety and tolerability of the Ad26.ZEBOV booster vaccination in stage 1 participants who had received the booster dose. This study is registered at ClinicalTrials.gov, NCT02509494. Findings: Between Sept 30, 2015, and Oct 19, 2016, 443 participants (43 in stage 1 and 400 in stage 2) were enrolled; 341 participants assigned to receive the Ad26.ZEBOV and MVA-BN-Filo regimen and 102 participants assigned to receive the MenACWY and placebo regimen received at least one dose of study vaccine. Both regimens were well tolerated with no safety concerns. In stage 1, solicited local adverse events (mostly mild or moderate injection-site pain) were reported in 12 (28%) of 43 participants after Ad26.ZEBOV vaccination and in six (14%) participants after MVA-BN-Filo vaccination. In stage 2, solicited local adverse events were reported in 51 (17%) of 298 participants after Ad26.ZEBOV vaccination, in 58 (24%) of 246 after MVA-BN-Filo vaccination, in 17 (17%) of 102 after MenACWY vaccination, and in eight (9%) of 86 after placebo injection. In stage 1, solicited systemic adverse events were reported in 18 (42%) of 43 participants after Ad26.ZEBOV vaccination and in 17 (40%) after MVA-BN-Filo vaccination. In stage 2, solicited systemic adverse events were reported in 161 (54%) of 298 participants after Ad26.ZEBOV vaccination, in 107 (43%) of 246 after MVA-BN-Filo vaccination, in 51 (50%) of 102 after MenACWY vaccination, and in 39 (45%) of 86 after placebo injection. Solicited systemic adverse events in both stage 1 and 2 participants included mostly mild or moderate headache, myalgia, fatigue, and arthralgia. The most frequent unsolicited adverse event after the first dose was headache in stage 1 and malaria in stage 2. Malaria was the most frequent unsolicited adverse event after the second dose in both stage 1 and 2. No serious adverse event was considered related to the study vaccine, and no immediate reportable events were observed. In stage 1, the safety profile after the booster vaccination was not notably different to that observed after the first dose. Vaccine-induced humoral immune responses were observed in 41 (98%) of 42 stage 1 participants (geometric mean binding antibody concentration 4784 ELISA units [EU]/mL [95% CI 3736–6125]) and in 176 (98%) of 179 stage 2 participants (3810 EU/mL [3312–4383]) at 21 days after the second vaccination. Interpretation: The Ad26.ZEBOV and MVA-BN-Filo vaccine regimen was well tolerated and immunogenic, with persistent humoral immune responses. These data support the use of this vaccine regimen for Ebola virus disease prophylaxis in adults. Funding: Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.

Published
2022

2. Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in children in Sierra Leone: a randomised, double-blind, controlled trial

Author

Muhammed O Afolabi, David Ishola, Daniela Manno, Babajide Keshinro, Viki Bockstal, Baimba Rogers, Kwabena Owusu-Kyei, Alimamy Serry-Bangura, Ibrahim Swaray, Brett Lowe, Dickens Kowuor, Frank Baiden, Thomas Mooney, Elizabeth Smout, Brian Köhn, Godfrey T Otieno, Morrison Jusu, Julie Foster, Mohamed Samai, Gibrilla Fadlu Deen, Heidi Larson, Shelley Lees, Neil Goldstein, Katherine E Gallagher, Auguste Gaddah, Dirk Heerwegh, Benoit Callendret, Kerstin Luhn, Cynthia Robinson, Brian Greenwood, Maarten Leyssen, Macaya Douoguih, Bailah Leigh, Deborah Watson-Jones, M Kargbo, E Bockarie, N L James, A Kabbah, A Kamara, K H Koroma, S O Langley, N William, R Kessebeh, T Mooney, L Conteh, E Smout, K Allieu, K Bangura, M S Bangura, M A Bangura, H Jalloh, A B Jalloh, I Kamara, M Kamara, A Konteh, S Koroma, C Marrah, M Sesay, M T Sesay, A T Deen, A Jalloh, R M Kaimbay, D Kain, E L Kamara, M P Kamara, O J Kamara, S L M Kamara, M Kanneh, A H Koroma, D Lahai, I S Mansaray, W S Marah, M J Massaquoi, A Nabie, N S Saidu, I Samai, J N Tengheh, A S Turay, A Fornah, F Sesay, A Sow, E Swaray, F Mansaray, T Ade-Cole, L M Bangura, M L Conteh, A M Koroma, M Koroma, A Sam, T Scott, T Sessie, J-H C Sunders, S I-S Turay, J Weekes, M Sheku, L Gibson, D Kowuor, I Ahamed, W Allieu, D U Kabba, F J Kamara, M S Kebbie, M Pessima, A Wurie, F Bah, A I Bangura, R A S Bangura, L Blango, S Boima, M Conteh, Y Conteh, M L Daramy, O Fofanah, E George, T F Hanson, M I Jalloh, M Kalawa, A M Kamara, F E Kamara, G M Kamara, H M Kamara, P B D Kamara, R T Kamara, R Kamara, D P Kanneh, I Komeh, M Kuyateh, F F Mansaray, M M Mansaray, A B Sillah, M A Tarawally, O S Turya, J B Yawmah, B Leigh, D Watson-Jones, B Greenwood, M H Samai, G F Deen, D Marke, T Sesay, P Piot, P Smith, J Edmunds, S Lees, H Larson, H Weiss, P Wilson, R Phillips, C Maxwell, D Ishola, M Afolabi, F Baiden, P Akoo, K Owusu-Kyei, D Tindanbil, H Bower, J Stuart, O M Bah, B T Rogers, A Serry-Bangura, I B Swaray, A Bangura, I J David, D G M Davies, J A Kallon, A B Kamara, I F Kamara, M M Kamara, F E Morovia, F B Suma, F Thompson, M Murray, O Kakay, F Suma, I Sesay, J Foster, D Manno, K Gallagher, S Cox, N Howard, M Cesay, P Torrani, S Sharma, E Snowden, T Banks, T Harber, J Brown, K Howard, N Melton, S Malcolm, S Welsh, R Eggo, M Jendrossek, C Pearson, K Offergeld, C Ferrault, M Van Alst, N Mahajan, M Van Looveren, S Van Ballaert, T De Cnodder, N Grobler, L Roza, T Liberi, L Armishaw, C Verkleij, T Henrick, A Banaszkiewicz, B Lowe, K Awuondo, H Hafezi, E Hancox, B Kohn, G O Tuda, G Bangura, M T Kroma, L Fofanah, A Pessima, M Rogers, O Sheriff, T W Ajala, J Fangawa, S Foday Jr, I S F Koroma, B Mansaray, H A Mansaray, K Sesay, M K Charles, P C Heroe, M Lamin Karbo, I S Yansaneh, S Gogo Egoeh, A Trye, M Amponsah, L Donelson, T Sylvester, V Owira, G Onyuka, L Nambuchi, A Oburu, D Apollo, L Vandi, N D Alghali, A Bah, I J Bangura, A C Cole, S Fofanah, H U Jalloh, K F N Jalloh, N Jalloh, H U Kabba, J N Kabba, M Kabba, J S Kamara, F Kanjie, A P Kanu, I Kargbo, G Kassa-Koroma, S B Koroma, A Sankoh, T Sankoh, O D Sesay, H Wilhem, C T Williams, I Bangura, Y Ben-Rogers, F J Jamboria, N Kamara, I Kanawah, A T Kargbo, I Swaray, L Amara, I Bundu, H B Jakema, K Kamara, M F Sheku, Q Adeleye, I Akhigbe, R Bakalemwa, N P Chami, L Altmann, B Kamara, K van Roey, P Conteh, M Samura, V Gandie, M Marrah, E Moinina, J Kalokoh, S Bosompem, T Hilton, M O Jusu, P Borboh, A S Brima, A F Y Caulker, A Kallon, B Koroma, R C Macauley, T M D Saquee, H I Williams, A R Bangura, J Fornah, B Idriss, M Sillah, W Mackay, B Aleghen, T Murray, J Edem-Hotah, T Fatorma, F Amara, S Bangura, E Bonnie, M Sannoh, A Donaldson, S Ndingi, D Nyaberi, M Pereira, A Rothwell, V Vy, L Nyallay, A Fombah, S Saidu, T P Dambo, P J Fakaba, M M E Fatorma, R H Freeman, C L Johnson, D B Kogba, A Lahai, W Vincent, N Yambasu, M Bangura, A Tengbeh, R Kabia, A M Nyakoi, M Callaghan, L Enria, and S Lee

Subjects
Male, Modified vaccinia Ankara, Pediatrics, medicine.medical_specialty, Adolescent, Antibodies, Viral, medicine.disease_cause, Injections, Intramuscular, Drug Administration Schedule, Sierra Leone, Sierra leone, Immunogenicity, Vaccine, Vaccines, DNA, Humans, Medicine, Ebola Vaccines, Child, Reactogenicity, Heterologous vaccine, Ebola virus, Ebola vaccine, business.industry, Infant, Viral Vaccines, Ebolavirus, Vaccination, Regimen, Infectious Diseases, Child, Preschool, Female, business
Abstract

Summary Background Children account for a substantial proportion of cases and deaths from Ebola virus disease. We aimed to assess the safety and immunogenicity of a two-dose heterologous vaccine regimen, comprising the adenovirus type 26 vector-based vaccine encoding the Ebola virus glycoprotein (Ad26.ZEBOV) and the modified vaccinia Ankara vector-based vaccine, encoding glycoproteins from the Ebola virus, Sudan virus, and Marburg virus, and the nucleoprotein from the Tai Forest virus (MVA-BN-Filo), in a paediatric population in Sierra Leone. Methods This randomised, double-blind, controlled trial was done at three clinics in Kambia district, Sierra Leone. Healthy children and adolescents aged 1–17 years were enrolled in three age cohorts (12–17 years, 4–11 years, and 1–3 years) and randomly assigned (3:1), via computer-generated block randomisation (block size of eight), to receive an intramuscular injection of either Ad26.ZEBOV (5 × 1010 viral particles; first dose) followed by MVA-BN-Filo (1 × 108 infectious units; second dose) on day 57 (Ebola vaccine group), or a single dose of meningococcal quadrivalent (serogroups A, C, W135, and Y) conjugate vaccine (MenACWY; first dose) followed by placebo (second dose) on day 57 (control group). Study team personnel (except for those with primary responsibility for study vaccine preparation), participants, and their parents or guardians were masked to study vaccine allocation. The primary outcome was safety, measured as the occurrence of solicited local and systemic adverse symptoms during 7 days after each vaccination, unsolicited systemic adverse events during 28 days after each vaccination, abnormal laboratory results during the study period, and serious adverse events or immediate reportable events throughout the study period. The secondary outcome was immunogenicity (humoral immune response), measured as the concentration of Ebola virus glycoprotein-specific binding antibodies at 21 days after the second dose. The primary outcome was assessed in all participants who had received at least one dose of study vaccine and had available reactogenicity data, and immunogenicity was assessed in all participants who had received both vaccinations within the protocol-defined time window, had at least one evaluable post-vaccination sample, and had no major protocol deviations that could have influenced the immune response. This study is registered at ClinicalTrials.gov , NCT02509494 . Findings From April 4, 2017, to July 5, 2018, 576 eligible children or adolescents (192 in each of the three age cohorts) were enrolled and randomly assigned. The most common solicited local adverse event during the 7 days after the first and second dose was injection-site pain in all age groups, with frequencies ranging from 0% (none of 48) of children aged 1–3 years after placebo injection to 21% (30 of 144) of children aged 4–11 years after Ad26.ZEBOV vaccination. The most frequently observed solicited systemic adverse event during the 7 days was headache in the 12–17 years and 4–11 years age cohorts after the first and second dose, and pyrexia in the 1–3 years age cohort after the first and second dose. The most frequent unsolicited adverse event after the first and second dose vaccinations was malaria in all age cohorts, irrespective of the vaccine types. Following vaccination with MenACWY, severe thrombocytopaenia was observed in one participant aged 3 years. No other clinically significant laboratory abnormalities were observed in other study participants, and no serious adverse events related to the Ebola vaccine regimen were reported. There were no treatment-related deaths. Ebola virus glycoprotein-specific binding antibody responses at 21 days after the second dose of the Ebola virus vaccine regimen were observed in 131 (98%) of 134 children aged 12–17 years (9929 ELISA units [EU]/mL [95% CI 8172–12 064]), in 119 (99%) of 120 aged 4–11 years (10 212 EU/mL [8419–12 388]), and in 118 (98%) of 121 aged 1–3 years (22 568 EU/mL [18 426–27 642]). Interpretation The Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen was well tolerated with no safety concerns in children aged 1–17 years, and induced robust humoral immune responses, suggesting suitability of this regimen for Ebola virus disease prophylaxis in children. Funding Innovative Medicines Initiative 2 Joint Undertaking and Janssen Vaccines & Prevention BV.

Published
2022

3. Lessons identified in delivering an orthopaedic training course in Freetown, Sierra Leone as part of the NIHR Global Health Research Group FIXT trial

Author

David Jayne, I Bundu, T J Chippendale, A J H Howard, A C W Santos, Alexander M. Wood, and William Bolton

Subjects
Service (business), Medical education, business.industry, Training course, 030208 emergency & critical care medicine, General Medicine, Sierra leone, Clinical trial, 03 medical and health sciences, Navy, 0302 clinical medicine, Software deployment, Political science, Global health, 030212 general & internal medicine, Human resources, business
Abstract

Aims There are many challenges in delivering an orthopaedic training programme in Sierra Leone, West Africa, including human resource and equipment constraints. We provide a reflective analysis of adaptive strategies to overcome these. Methods An orthopaedic surgical training course was delivered in preparation for a clinical trial in Connaught Hospital, Freetown, Sierra Leone. The trial examines the implementation of Ilizarov frame fixation for tibia fractures in adults. Results Whilst it is possible to deliver a high-quality course in Sierra Leone, a significant amount of prior planning and preparation, including adaptive and contingency strategies, is required to achieve the desired outcome. Conclusions With the Royal Navy increasing its global reach, including deployment of new aircraft carriers, there are increasing opportunities to deliver medical training in low and middle-income countries in both the military and civilian sector. We believe this article may be useful for service and civilian practitioners intending to deliver education and training around the world.

Published
2019

4. Disseminating technology in global surgery

Author

A. Quyn, William Bolton, David Jayne, Noel Aruparayil, I Bundu, Julia Brown, Julian Scott, Alexander M. Wood, and J Gnanaraj

Subjects
Laparoscopic surgery, medicine.medical_specialty, Emerging technologies, medicine.medical_treatment, Biomedical Technology, 030230 surgery, Global Health, 03 medical and health sciences, 0302 clinical medicine, Surgical technology, medicine, Global health, Humans, Human resources, Developing Countries, Dissemination, business.industry, Surgical care, Surgery, Immersive technology, General Surgery, 030220 oncology & carcinogenesis, Diffusion of Innovation, business, Delivery of Health Care
Abstract

Background Effective dissemination of technology in global surgery is vital to realize universal health coverage by 2030. Challenges include a lack of human resource, infrastructure and finance. Understanding these challenges, and exploring opportunities and solutions to overcome them, are essential to improve global surgical care. Methods This review focuses on technologies and medical devices aimed at improving surgical care and training in low- and middle-income countries. The key considerations in the development of new technologies are described, along with strategies for evaluation and wider dissemination. Notable examples of where the dissemination of a new surgical technology has achieved impact are included. Results Employing the principles of frugal and responsible innovation, and aligning evaluation and development to high scientific standards help overcome some of the challenges in disseminating technology in global surgery. Exemplars of effective dissemination include low-cost laparoscopes, gasless laparoscopic techniques and innovative training programmes for laparoscopic surgery; low-cost and versatile external fixation devices for fractures; the LifeBox pulse oximeter project; and the use of immersive technologies in simulation, training and surgical care delivery. Conclusion Core strategies to facilitate technology dissemination in global surgery include leveraging international funding, interdisciplinary collaboration involving all key stakeholders, and frugal scientific design, development and evaluation.

Published
2019

5. No frugal innovation without frugal evaluation: the Global IDEAL Sub-Framework.

Author

Bolton WS, Aruparayil NK, Cundill B, McCulloch P, Gnanaraj J, Bundu I, Culmer PR, Brown JM, Scott J, and Jayne DG

Abstract

Objective: The Global IDEAL Sub-Framework Study aimed to combine the intended effects of the 2009/2019 IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework recommendations on evaluating surgical innovation with the vision outlined by the 2015 Lancet Commission on Global Surgery to provide recommendations for evaluating surgical innovation in low-resource environments., Design: A mixture of methods including an online global survey and semistructured interviews (SSIs). Quantitative data were summarized with descriptive statistics and qualitative data were analyzed using the Framework Method., Participants: Surgeons and surgical researchers from any country., Main Outcome Measures: Findings were used to suggest the nature of adaptations to the IDEAL Framework to address the particular problems of evaluation in low-resource settings., Results: The online survey yielded 66 responses representing experience from 40 countries, and nine individual SSIs were conducted. Most respondents (n=49; 74.2%) had experience evaluating surgical technologies across a range of life cycle stages. Innovation was most frequently adopted based on colleague recommendation or clinical evaluation in other countries. Four themes emerged, centered around: frugal innovation in technological development; evaluating the same technology/innovation in different contexts; additional methodologies important in evaluation of surgical innovation in low/middle-income countries; and support for low-income country researchers along the evaluation pathway., Conclusions: The Global IDEAL Sub-Framework provides suggestions for modified IDEAL recommendations aimed at dealing with the special problems found in this setting. These will require validation in a stakeholder consensus forum, and qualitative assessment in pilot studies. From assisting researchers with identification of the correct evaluation stage, to providing context-specific recommendations relevant to the whole evaluation pathway, this process will aim to develop a comprehensive and applicable set of guidance that will benefit surgical innovation and patients globally., Competing Interests: Competing interests: PM is an editor-in-chief., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Published
2024
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6. There is a great variety of orthopaedic conditions presenting to a large hospital in Sierra Leone: a 3-year prospective study.

Author

Howard A, Bolton W, Wood A, Hodgson H, Scott J, Jayne D, and Bundu I

Subjects
Humans, Young Adult, Adult, Sierra Leone epidemiology, Prospective Studies, Hospitals, Orthopedics, Musculoskeletal Diseases
Abstract

Purpose: In Sierra Leone there is a large void in orthopaedic research into the type of orthopaedic injuries, both acute and chronic. Improved data collection is essential in providing insight to guide health care planning and research. This study aims to outline the types of orthopaedic injury sustained., Method: Data were prospectively collected by local surgeons in the Orthopaedic outpatient department at a large hospital between January 2016 and January 2019., Results: The orthopaedic department saw a mean 728 patients per year, with mean age 24.0 years. The workload comprised of 64.92% acute orthopaedic conditions or their complications, with 35.08% elective orthopaedics. Fractures made up the largest proportion of clinical appointments, annually 244.33 fractures; however there was a high incidence of osteomyelitis., Conclusion: The study gives an important insight into the types and distribution of elective and trauma orthopaedic injuries sustained in Sierra Leone, which has not been previously reported, and highlights key areas where resources may be focused in order to improve clinical outcomes., (© 2022. The Author(s).)

Published
2023
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7. Changes in surgical volume, workforce, and productivity in Sierra Leone between 2012 and 2017.

Author

Lindheim-Minde B, Gjøra A, Bakker JM, van Duinen AJ, van Leerdam D, Smalle IO, Bundu I, and Bolkan HA

Subjects
Health Facilities statistics & numerical data, Health Services Needs and Demand organization & administration, Humans, Retrospective Studies, Sierra Leone epidemiology, Workforce statistics & numerical data, Efficiency, Organizational, Surgical Procedures, Operative statistics & numerical data, Workforce organization & administration
Abstract

Background: The Lancet Commission on Global Surgery recommends a minimum of 20 surgical specialists and 5,000 annual operations per 100,000 population by 2030. In 2012, Sierra Leone was far from reaching these targets. This study aimed to assess the changes in surgical activity, surgical workforce, and surgical productivity between 2012 and 2017., Methods: A nationwide, retrospective mapping of surgical activity and workforce in 2012 was repeated in 2017. All 60 facilities performing comprehensive surgery in Sierra Leone in 2017 were identified and data was obtained from surgical records and through structured interviews with facility directors. Annual estimates were calculated and compared with 2012., Results: The surgical workforce increased from 164.5 to 312.8 full-time positions. The annual volume of surgeries was enhanced by 15.6% (95% CI: 7.8-23.4%) from 24,152 to 27,928 (26,048-29,808) operations. With simultaneous population growth, this led to a decrease in surgical volume from 400 to 372 procedures per 100,000 population and an unmet operative need of 92.7%. The mean productivity of surgical providers went from 2.8 to 1.7 surgeries per week per full-time position. An increasing number of caesarean deliveries were performed in public institutions, by associate clinicians., Conclusion: The unmet need for surgery in Sierra Leone remains very high, despite an increase in the surgical workforce, subsidizing maternal healthcare, and initiation of a surgical task-sharing program. The decline in surgical productivity with simultaneous increases in the surgical workforce calls for further exploration of the barriers to access and delivery of surgical care in Sierra Leone., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Published
2021
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8. The burden of trauma presenting to the government referral hospital in Freetown, Sierra Leone: An observational study.

Author

Bundu I, Lowsby R, Vandy HP, Kamara SP, Jalloh AM, Scott COS, and Beynon F

Abstract

Introduction: Trauma accounts for a significant proportion of the global burden of disease, with highest mortality rates seen in Africa. This epidemic is predicted to increase with urbanisation and an aim of the Sustainable Development Goals is to reduce deaths and trauma caused by road accidents. Data available on urban trauma in Sierra Leone is limited., Methods: We conducted a retrospective observational study of trauma and injury related presentations to the emergency centre (EC) of Connaught Hospital, the principal adult tertiary referral centre in Freetown, Sierra Leone between January and March 2016. Patient demographics are described with mechanism of injury. Additional data on length of stay and surgical procedures were recorded for admissions to the trauma ward., Results: During the 3-month period, a total of 340 patients with injury presented to the EC, accounting for 11.6% of total attendances and 68% of adult surgical admissions. The majority were male (66%) and mean age was 26 years (IQR 15-40). The proportion of trauma presentations were higher in the evening and at weekends and 41% of patients were triaged as emergency or very urgent cases. Road traffic accidents were the most frequent cause of injury (55%) followed by falls (17%) and assaults (14%). Burns were more common in children. Head and lower limbs were the most commonly injured body parts and a minority of patients underwent surgical procedures. Median length of stay for adult patients was 4.5 days (IQR 2-11) and 7 days (IQR 4-14) for children., Discussion: Injury accounts for a high burden of disease at Connaught Hospital and consumes a significant proportion of EC and hospital resources. Efforts should be directed towards strengthening the pre-hospital and emergency trauma systems with accurate, formal data collection as well as targeting injury prevention initiatives and improving road safety to reduce morbidity and mortality.

Published
2019
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9. Disseminating technology in global surgery.

Author

Bolton WS, Aruparayil N, Quyn A, Scott J, Wood A, Bundu I, Gnanaraj J, Brown JM, and Jayne DG

Subjects
Delivery of Health Care standards, Developing Countries, Global Health, Humans, Biomedical Technology methods, Delivery of Health Care methods, Diffusion of Innovation, General Surgery methods
Abstract

Background: Effective dissemination of technology in global surgery is vital to realize universal health coverage by 2030. Challenges include a lack of human resource, infrastructure and finance. Understanding these challenges, and exploring opportunities and solutions to overcome them, are essential to improve global surgical care., Methods: This review focuses on technologies and medical devices aimed at improving surgical care and training in low- and middle-income countries. The key considerations in the development of new technologies are described, along with strategies for evaluation and wider dissemination. Notable examples of where the dissemination of a new surgical technology has achieved impact are included., Results: Employing the principles of frugal and responsible innovation, and aligning evaluation and development to high scientific standards help overcome some of the challenges in disseminating technology in global surgery. Exemplars of effective dissemination include low-cost laparoscopes, gasless laparoscopic techniques and innovative training programmes for laparoscopic surgery; low-cost and versatile external fixation devices for fractures; the LifeBox pulse oximeter project; and the use of immersive technologies in simulation, training and surgical care delivery., Conclusion: Core strategies to facilitate technology dissemination in global surgery include leveraging international funding, interdisciplinary collaboration involving all key stakeholders, and frugal scientific design, development and evaluation., (© 2019 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Published
2019
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10. Comparison of surgical skill acquisition by UK surgical trainees and Sierra Leonean associate clinicians in a task-sharing programme.

Author

Liu B, Hunt LM, Lonsdale RJ, Narula HS, Mansaray AF, Bundu I, and Bolkan HA

Subjects
Adult, Attitude of Health Personnel, Cross-Cultural Comparison, Education, Medical, Continuing statistics & numerical data, Female, General Surgery statistics & numerical data, Humans, Male, Sierra Leone, Surgeons psychology, Time Factors, United Kingdom, Clinical Competence statistics & numerical data, Education, Medical, Continuing organization & administration, General Surgery education, International Cooperation, Surgeons statistics & numerical data
Abstract

Background: Task-sharing in surgery is well established, with associate clinicians performing successful surgery in many countries. Little is known about the process of surgical skill acquisition by associate clinicians, or whether this differs from that of doctors., Methods: A blinded experimental study compared surgical skill acquisition by Sierra Leonean associate clinicians enrolled in an essential and emergency surgery training programme with that of a matched group of UK surgical trainees. After identical instruction, practice time and with identities disguised, trainees were videoed performing simulated surgery. Trainees were marked on 12 performance parameters and five behaviour characteristics using validated tools and qualitative comment., Results: The Sierra Leonean group comprised 19 associate clinicians and one doctor; the UK group comprised 20 doctors in their first 5 years of training. The UK group had significantly more surgical and postgraduate experience than the Sierra Leonean group. The Sierra Leonean trainees outperformed the UK trainees on three of the 12 performance parameters and four of the five behaviour characteristics. UK trainees did not outperform Sierra Leonean trainees on any parameter or characteristic. Qualitative differences in learning style were observed., Conclusion: Sierra Leonean associate clinicians demonstrated equal or superior skill in all objective parameters tested, despite having less experience than the UK doctors.

Published
2018
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11. Safety, productivity and predicted contribution of a surgical task-sharing programme in Sierra Leone.

Author

Bolkan HA, van Duinen A, Waalewijn B, Elhassein M, Kamara TB, Deen GF, Bundu I, Ystgaard B, von Schreeb J, and Wibe A

Subjects
Adult, Cesarean Section education, Cesarean Section mortality, Clinical Competence, Female, Herniorrhaphy education, Herniorrhaphy mortality, Hospital Mortality, Humans, Laparotomy education, Laparotomy mortality, Male, Program Development, Prospective Studies, Sierra Leone, Surgical Procedures, Operative mortality, Medical Staff, Hospital education, Surgical Procedures, Operative education
Abstract

Background: Surgical task-sharing may be central to expanding the provision of surgical care in low-resource settings. The aims of this paper were to describe the set-up of a new surgical task-sharing training programme for associate clinicians and junior doctors in Sierra Leone, assess its productivity and safety, and estimate its future role in contributing to surgical volume., Methods: This prospective observational study from a consortium of 16 hospitals evaluated crude in-hospital mortality over 5 years and productivity of operations performed during and after completion of a 3-year surgical training programme., Results: Some 48 trainees and nine graduated surgical assistant community health officers (SACHOs) participated in 27 216 supervised operations between January 2011 and July 2016. During training, trainees attended a median of 822 operations. SACHOs performed a median of 173 operations annually. Caesarean section, hernia repair and laparotomy were the most common procedures during and after training. Crude in-hospital mortality rates after caesarean sections and laparotomies were 0·7 per cent (13 of 1915) and 4·3 per cent (7 of 164) respectively for operations performed by trainees, and 0·4 per cent (5 of 1169) and 8·0 per cent (11 of 137) for those carried out by SACHOs. Adjusted for patient sex, surgical procedure, urgency and hospital, mortality was lower for operations performed by trainees (OR 0·47, 95 per cent c.i. 0·32 to 0·71; P < 0·001) and SACHOs (OR 0·16, 0·07 to 0·41; P < 0·001) compared with those conducted by trainers and supervisors., Conclusion: SACHOs rapidly and safely achieved substantial increases in surgical volume in Sierra Leone., (© 2017 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.)

Published
2017
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12. Surgery in the time of Ebola: how events impacted on a single surgical institution in Sierra Leone.

Author

Bundu I, Patel A, Mansaray A, Kamara TB, and Hunt LM

Subjects
Hemorrhagic Fever, Ebola mortality, Hemorrhagic Fever, Ebola transmission, Hospitals, Teaching, Humans, Infectious Disease Transmission, Patient-to-Professional, Retrospective Studies, Sierra Leone epidemiology, Surgical Procedures, Operative trends, Tertiary Care Centers, Workforce, Epidemics, General Surgery statistics & numerical data, Hemorrhagic Fever, Ebola epidemiology, Surgeons supply & distribution, Surgical Procedures, Operative statistics & numerical data
Abstract

Introduction: The mortality and morbidity of Ebola extends far wider than those contracting the disease. Surgical activity in Sierra Leone has been severely disrupted by the epidemic., Method: This is a retrospective study examining the effect of the 2014-2015 Ebola virus epidemic on surgical activity in a Sierra Leone's main teaching hospital., Results: The impact of national and local events on surgical provision is illustrated by the experience of Connaught Hospital, Freetown Sierra Leone. Surgical activity fell dramatically in August 2014, the month when the most health care workers died and continued to fall to just 3% of expected activity. Two of eight surgeons at Connaught Hospital died of Ebola., Discussion: The example of Connaught Hospital serves as a graphic and poignant illustration of the difficulties faced by surgeons in low resource settings when dealing with the acute effects of a natural disaster. In any future epidemic, high levels of preparedness, training and protection, in addition to liaison with public health teams early in an epidemic, may allow surgeons to carry out at least some of their duties without the very high levels of personal risk seen here.In a country with so few specialists the loss of 25% is disastrous and will result in long term capacity reduction., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Published
2016
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