Journal Article > ResearchFull Text
PLOS One. 2013 May 3; Volume 8 (Issue 5); DOI:10.1371/journal.pone.0062767
Grellety E, Luquero FJ, Mambula C, Adamu HH, Elder G, et al.
PLOS One. 2013 May 3; Volume 8 (Issue 5); DOI:10.1371/journal.pone.0062767
The Sahel is subject to seasonal hungry periods with increasing rates of malnutrition. In Northern Nigeria, there is no surveillance system and surveys are rare. The objectives were to analyse possible observational bias in a sentinel surveillance system using repeated mixed longitudinal/cross-sectional data and estimate the extent of seasonal variation.
Journal Article > ResearchFull Text
Epidemiol Infect. 2013 October 11; Volume 142 (Issue 8); DOI:10.1017/S0950268813002562
Grandesso F, Allan M, Jean-Simon PSJ, Boncy J, Blake A, et al.
Epidemiol Infect. 2013 October 11; Volume 142 (Issue 8); DOI:10.1017/S0950268813002562
SUMMARY Two community-based density case-control studies were performed to assess risk factors for cholera transmission during inter-peak periods of the ongoing epidemic in two Haitian urban settings, Gonaives and Carrefour. The strongest associations were: close contact with cholera patients (sharing latrines, visiting cholera patients, helping someone with diarrhoea), eating food from street vendors and washing dishes with untreated water. Protective factors were: drinking chlorinated water, receiving prevention messages via television, church or training sessions, and high household socioeconomic level. These findings suggest that, in addition to contaminated water, factors related to direct and indirect inter-human contact play an important role in cholera transmission during inter-peak periods. In order to reduce cholera transmission in Haiti intensive preventive measures such as hygiene promotion and awareness campaigns should be implemented during inter-peak lulls, when prevention activities are typically scaled back.
Journal Article > ResearchAbstract Only
Prehosp Disaster Med. 2014 January 15; Volume 29 (Issue 1); 21-26.; DOI:10.1017/S1049023X13009278
Teicher CL, Alberti KP, Porten K, Elder G, Baron E, et al.
Prehosp Disaster Med. 2014 January 15; Volume 29 (Issue 1); 21-26.; DOI:10.1017/S1049023X13009278
INTRODUCTION
During January 2010, a 7.0 magnitude earthquake struck Haiti, resulting in death and destruction for hundreds of thousands of people. This study describes the types of orthopedic procedures performed, the options for patient follow-up, and limitations in obtaining outcomes data in an emergency setting.
PROBLEM
There is not a large body of data that describes larger orthopedic cohorts, especially those focusing on internal fixation surgeries in resource-poor settings in postdisaster regions. This article describes 248 injuries and over 300 procedures carried out in the Médecins Sans Frontières-Orthopedic Centre Paris orthopedic program.
METHODS
Surgeries described in this report were limited to orthopedic procedures carried out under general anesthesia for all surgical patients. Exclusion factors included simple fracture reduction, debridement, dressing changes, and removal of hardware. This data was collected using both prospective and retrospective methods; prospective inpatient data were collected using a data collection form designed promptly after the earthquake and retrospective data collection was performed in October 2010.
RESULTS
Of the 264 fractures, 204 were fractures of the major long bones (humerus, radius, femur, tibia). Of these 204 fractures of the major long bones, 34 (16.7%) were upper limb fractures and 170 (83.3%) were lower limb fractures. This cohort demonstrated a large number of open fractures of the lower limb and closed fractures of the upper limb. Fractures were treated according to their location and type. Of the 194 long bone fractures, the most common intervention was external fixation (36.5%) followed by traction (16.7%), nailing (15.1%), amputation (14.6%), and plating (9.9%).
CONCLUSION
The number of fractures described in this report represents one of the larger orthopedic cohorts of patients treated in a single center in the aftermath of the 2010 earthquake in Haiti. The emergent surgical care described was carried out in difficult conditions, both in the hospital and the greater community. While outcome and complication data were limited, the proportion of patients attending follow-up most likely exceeded expectations and may reflect the importance of the rehabilitation center. This data demonstrates the ability of surgical teams to perform highly-specialized surgeries in a disaster zone, and also reiterates the need for access to essential and emergency surgical programs, which are an essential part of public health in low- and medium-resource settings.
During January 2010, a 7.0 magnitude earthquake struck Haiti, resulting in death and destruction for hundreds of thousands of people. This study describes the types of orthopedic procedures performed, the options for patient follow-up, and limitations in obtaining outcomes data in an emergency setting.
PROBLEM
There is not a large body of data that describes larger orthopedic cohorts, especially those focusing on internal fixation surgeries in resource-poor settings in postdisaster regions. This article describes 248 injuries and over 300 procedures carried out in the Médecins Sans Frontières-Orthopedic Centre Paris orthopedic program.
METHODS
Surgeries described in this report were limited to orthopedic procedures carried out under general anesthesia for all surgical patients. Exclusion factors included simple fracture reduction, debridement, dressing changes, and removal of hardware. This data was collected using both prospective and retrospective methods; prospective inpatient data were collected using a data collection form designed promptly after the earthquake and retrospective data collection was performed in October 2010.
RESULTS
Of the 264 fractures, 204 were fractures of the major long bones (humerus, radius, femur, tibia). Of these 204 fractures of the major long bones, 34 (16.7%) were upper limb fractures and 170 (83.3%) were lower limb fractures. This cohort demonstrated a large number of open fractures of the lower limb and closed fractures of the upper limb. Fractures were treated according to their location and type. Of the 194 long bone fractures, the most common intervention was external fixation (36.5%) followed by traction (16.7%), nailing (15.1%), amputation (14.6%), and plating (9.9%).
CONCLUSION
The number of fractures described in this report represents one of the larger orthopedic cohorts of patients treated in a single center in the aftermath of the 2010 earthquake in Haiti. The emergent surgical care described was carried out in difficult conditions, both in the hospital and the greater community. While outcome and complication data were limited, the proportion of patients attending follow-up most likely exceeded expectations and may reflect the importance of the rehabilitation center. This data demonstrates the ability of surgical teams to perform highly-specialized surgeries in a disaster zone, and also reiterates the need for access to essential and emergency surgical programs, which are an essential part of public health in low- and medium-resource settings.
Journal Article > CommentaryFull Text
Bull World Health Organ. 2019 October 28; Volume 97 (Issue 12); 851-853.; DOI:10.2471/BLT.18.228585
Elder K, Saitta B, Ducomble T, Alia M, Close R, et al.
Bull World Health Organ. 2019 October 28; Volume 97 (Issue 12); 851-853.; DOI:10.2471/BLT.18.228585
Vaccination is an effective intervention to reduce disease, disability, death and health inequities worldwide. Over the last two decades, vaccines have become more accessible in low-income countries; however, significant gaps remain, particularly in humanitarian emergencies, where populations face increased risks of many diseases. In 2013, the World Health Organization (WHO) published "Vaccination in acute humanitarian emergencies: a framework for decision-making," to provide guidance on which vaccines to prioritize during emergencies. However, substantial obstacles, especially high prices for new vaccines, hinder implementation of this framework and of critical vaccination activities in emergency settings.
In response to these challenges, global health stakeholders held a series of consultations in 2016 and proposed a WHO-based mechanism, the Humanitarian Mechanism, for the rapid procurement of affordable vaccines during emergencies, to be used by nongovernmental organizations (NGOs), civil society organizations, United Nations (UN) agencies and governments. Here we present the background of the creation of the mechanism from the perspective of Médecins Sans Frontières (MSF), including a description of our past challenges in accessing affordable pneumococcal conjugate vaccine (PCV), a critical vaccine during many emergencies. We then describe how the mechanism has so far facilitated access to more affordable PCV and outline steps that could increase its potential for saving lives.
In response to these challenges, global health stakeholders held a series of consultations in 2016 and proposed a WHO-based mechanism, the Humanitarian Mechanism, for the rapid procurement of affordable vaccines during emergencies, to be used by nongovernmental organizations (NGOs), civil society organizations, United Nations (UN) agencies and governments. Here we present the background of the creation of the mechanism from the perspective of Médecins Sans Frontières (MSF), including a description of our past challenges in accessing affordable pneumococcal conjugate vaccine (PCV), a critical vaccine during many emergencies. We then describe how the mechanism has so far facilitated access to more affordable PCV and outline steps that could increase its potential for saving lives.
Journal Article > CommentaryFull Text
Lancet. 2003 July 5; Volume 362 (Issue 9377); 74-75.; DOI:10.1016/S0140-6736(03)13813-5
Checchi F, Elder G, Schäfer M, Drouhin E, Legros D
Lancet. 2003 July 5; Volume 362 (Issue 9377); 74-75.; DOI:10.1016/S0140-6736(03)13813-5
Journal Article > CommentaryFull Text
Surgery. 2015 July 1; Volume 158 (Issue 1); 33-36.; DOI:10.1016/j.surg.2015.04.006
Elder G, Murphy RA, Herard P, Dilworth K, Olson D, et al.
Surgery. 2015 July 1; Volume 158 (Issue 1); 33-36.; DOI:10.1016/j.surg.2015.04.006
Conference Material > Abstract
Gotham D, Martin M, Barber M, Kazounis E, Batts C, et al.
MSF Scientific Day International 2024. 2024 May 16; DOI:10.57740/aMphKRQ
INTRODUCTION
Clinical trials are a cornerstone of medical innovation. Nonetheless, little information on the cost of conducting clinical trials is available, especially for clinical trials in the global south. This lack of data and transparency hinders the creation of reliable cost estimates and adequate funding of clinical trials in resource- limited settings. Following the recent adoption of the Médecins Sans Frontières (MSF) Clinical Trial Transparency Policy, we present a detailed cost report for TB-PRACTECAL.
METHODS
TB-PRACTECAL was an open-label, phase 2–3, multicentre randomised trial of all-oral regimens for the treatment of drug- resistant tuberculosis. Trial planning began in 2013 and work on publications continued into 2023. The trial took place in six sites across Belarus, South Africa, and Uzbekistan, and enrolled 552 patients. We analysed accounting data for the TB-PRACTECAL project, comprehensively including different costs, presented into 27 categories, by site, and by year, and at the per-patient level.
RESULTS
Total costs for TB-PRACTECAL were €33.9 million, of which 26% were at central level (costs incurred by the UK clinical trial team including trial planning, management, quality assurance, and analysis of results), while 72% were at the trial site level (across all six sites) and 2% were uncategorisable. At trial sites, the largest cost category was staff (43%), followed by external diagnostic services (11%), medicines (9%), other medical consumables (7%), external non-medical services (6%), and transport and travel (6%). Among medicines, the costliest were bedaquiline (46% of medicine costs), linezolid (16%), imipenem/ cilastatin (10%), and delamanid (9%). The mean cost per patient enrolled was €61,460 across the whole trial (including trial management overhead). When only site-level costs were considered, per-patient costs ranged between €19,998 and €45,942 across the six sites.
CONCLUSION
The costs of TB-PRACTECAL were similar to previously reported estimates for comparable clinical trials. However, TB- PRACTECAL included additional costs that would not typically be incurred in a commercial trial, such as investments in clinical research infrastructure and purchase of investigative medical products. To our knowledge, this is the first time MSF, or any other entity, published and analysed the disaggregated costs of a specific clinical trial. These data could help generate reliable predictions for future clinical trials and support planning and involvement, particularly in low-resource settings. Additionally, this study highlights the role of clinical trial cost disclosure in supporting both practical and policy discussions around the development of a more equitable system of biomedical R&D and fairer medicine pricing. Additionally, we developed a financial reporting template to facilitate future reporting of clinical trial cost by MSF and other entities investing in research.
Clinical trials are a cornerstone of medical innovation. Nonetheless, little information on the cost of conducting clinical trials is available, especially for clinical trials in the global south. This lack of data and transparency hinders the creation of reliable cost estimates and adequate funding of clinical trials in resource- limited settings. Following the recent adoption of the Médecins Sans Frontières (MSF) Clinical Trial Transparency Policy, we present a detailed cost report for TB-PRACTECAL.
METHODS
TB-PRACTECAL was an open-label, phase 2–3, multicentre randomised trial of all-oral regimens for the treatment of drug- resistant tuberculosis. Trial planning began in 2013 and work on publications continued into 2023. The trial took place in six sites across Belarus, South Africa, and Uzbekistan, and enrolled 552 patients. We analysed accounting data for the TB-PRACTECAL project, comprehensively including different costs, presented into 27 categories, by site, and by year, and at the per-patient level.
RESULTS
Total costs for TB-PRACTECAL were €33.9 million, of which 26% were at central level (costs incurred by the UK clinical trial team including trial planning, management, quality assurance, and analysis of results), while 72% were at the trial site level (across all six sites) and 2% were uncategorisable. At trial sites, the largest cost category was staff (43%), followed by external diagnostic services (11%), medicines (9%), other medical consumables (7%), external non-medical services (6%), and transport and travel (6%). Among medicines, the costliest were bedaquiline (46% of medicine costs), linezolid (16%), imipenem/ cilastatin (10%), and delamanid (9%). The mean cost per patient enrolled was €61,460 across the whole trial (including trial management overhead). When only site-level costs were considered, per-patient costs ranged between €19,998 and €45,942 across the six sites.
CONCLUSION
The costs of TB-PRACTECAL were similar to previously reported estimates for comparable clinical trials. However, TB- PRACTECAL included additional costs that would not typically be incurred in a commercial trial, such as investments in clinical research infrastructure and purchase of investigative medical products. To our knowledge, this is the first time MSF, or any other entity, published and analysed the disaggregated costs of a specific clinical trial. These data could help generate reliable predictions for future clinical trials and support planning and involvement, particularly in low-resource settings. Additionally, this study highlights the role of clinical trial cost disclosure in supporting both practical and policy discussions around the development of a more equitable system of biomedical R&D and fairer medicine pricing. Additionally, we developed a financial reporting template to facilitate future reporting of clinical trial cost by MSF and other entities investing in research.
Journal Article > CommentaryFull Text
BMJ Glob Health. 2022 April 19; Volume 7 (Issue 4); e007490.; DOI:10.1136/bmjgh-2021-007490
Perrin C, Athersuch K, Elder G, Martin M, Alsalhani A
BMJ Glob Health. 2022 April 19; Volume 7 (Issue 4); e007490.; DOI:10.1136/bmjgh-2021-007490
Two drugs with novel mechanisms of action, the diarylquinoline bedaquiline and the nitroimidazole delamanid—as well as pretomanid from the same class of drugs as delamanid—have recently become available to treat drug-resistant tuberculosis (DR-TB) after many decades of little innovation in the field of DR-TB treatment. Despite evidence of improved efficacy and reduced toxicity of multidrug regimens including the two agents, access to bedaquiline and delamanid has been limited in many settings with a high burden of DR-TB and consistently poor treatment outcomes. Aside from regulatory, logistic and cost barriers at country level, uptake of the novel agents was complicated by gaps in knowledge for optimal use in clinical practice after initial market approval. The main incentives of the current pharmaceutical research and development paradigm are structured around obtaining regulatory approval, which in turn requires efficacy and safety data generated by clinical trials. Recently completed and ongoing clinical trials did not answer critical questions of how to provide shorter, less toxic treatment DR-TB treatment regimens containing bedaquiline and delamanid and improve patient outcomes. Voluntary generation of evidence that is not part of this process—yet essential from a clinical or policy perspective—has been left to non-sponsor partners and researchers, often without collaborative efforts to improve post-regulatory approval access to life-saving drugs. Additionally, these efforts are currently not recognised in the value chain of the research and development process, and there are no incentives to make this critical research happen in a coordinated way.
Journal Article > ResearchFull Text
Malar J. 2017 May 23; Volume 16 (Issue 1); 218.; DOI:10.1186/s12936-017-1869-x
Coldiron ME, Lasry E, Bouhenia M, Das D, Okui P, et al.
Malar J. 2017 May 23; Volume 16 (Issue 1); 218.; DOI:10.1186/s12936-017-1869-x
Northern Uganda hosts a large population of refugees from South Sudan, and malaria is one of the major health problems in the area. In 2015, intermittent preventive treatment for malaria (IPTc) was implemented in two refugee camps among children aged 6 months to 14 years. Three distributions of dihydroartemisinin-piperaquine (DP) were conducted at 8-week intervals. The first dose was directly administered at IPTc distribution sites and the second and third doses were given to caregivers to administer at home. A multi-faceted evaluation was implemented, including coverage surveys, malaria prevalence surveys, reinforced surveillance, and pharmacovigilance. Programme coverage exceeded 90% during all three distributions with a total of 40,611 participants. Compared to same period during the previous year (only available data), the incidence of malaria in the target populations was reduced (IRR 0.73, 95% CI 0.69-0.77 among children under 5 years old; IRR 0.70, 95% CI 0.67-0.72 among children aged 5-14 years). Among those not targeted for intervention, the incidence between the 2 years increased (IRR 1.49, 95% CI 1.42-1.56). Cross-sectional surveys showed a prevalence of parasitaemia (microscopy or PCR) of 12.9-16.4% (95% CI 12.6-19.3) during the intervention, with the highest prevalence among children aged 5-14 years, but with a large increase 8 weeks after the final distribution. A total of 57 adverse events were reported during the intervention period, including one severe adverse event (death from varicella). Adverse events were of mild to moderate severity, and were mainly dermatologic and gastrointestinal. This is the first documentation of an IPTc programme in a refugee camp. The positive impact of DP on the incidence of malaria, together with its favourable safety profile, should lead to further use of IPTc in similar settings. Expanding coverage groups and decreasing intervals between distributions might provide more benefit, but would need to be balanced with the operational implications of a broader, more frequent distribution schedule.
Journal Article > ResearchFull Text
Epidemiol Infect. 2016 August 11; Volume 144 (Issue 16); 3520-3526.; DOI:10.1017/S0950268816001758
Murphy RA, Okoli O, Essien I, Teicher CL, Elder G, et al.
Epidemiol Infect. 2016 August 11; Volume 144 (Issue 16); 3520-3526.; DOI:10.1017/S0950268816001758
The epidemiology of surgical site infections (SSIs) in surgical programmes in sub-Saharan Africa is inadequately described. We reviewed deep and organ-space SSIs occurring within a trauma project that had a high-quality microbiology partnership and active follow-up. Included patients underwent orthopaedic surgery in Teme Hospital (Port Harcourt, Nigeria) for trauma and subsequently developed a SSI requiring debridement and microbiological sampling. Data were collected from structured chart reviews and programmatic databases for 103 patients with suspected SSI [79% male, median age 30 years, interquartile range (IQR) 24-37]. SSIs were commonly detected post-discharge with 58% presenting >28 days after surgery. The most common pathogens were: Staphylococcus aureus (34%), Pseudomonas aeruginosa (16%) and Enterobacter cloacae (11%). Thirty-three (32%) of infections were caused by a multidrug-resistant (MDR) pathogen, including 15 patients with methicillin-resistant S. aureus. Antibiotics were initiated empirically for 43% of patients and after culture and sensitivity report in 32%. The median number of additional surgeries performed in patients with SSI was 5 (IQR 2-6), one patient died (1%), and amputation was performed or recommended in three patients. Our findings suggest the need for active long-term monitoring of SSIs, particularly those associated with MDR organisms, resulting in increased costs for readmission surgery and treatment with late-generation antibiotics.