scholarly journals Conducting clinical research in a resource-constrained setting: lessons from a longitudinal cohort study in The Gambia

2021 ◽  
Vol 6 (8) ◽  
pp. e006419
Author(s):  
Abdulazeez Imam ◽  
Oghenebrume Wariri ◽  
Tida Dibbasey ◽  
Abdoulie Camara ◽  
Anthony Mendy ◽  
...  
Keyword(s):  
Clinical Research ◽  
Low Income ◽  
Newborn Infants ◽  
Good Clinical Practice ◽  
The Gambia ◽  
London School ◽  
Resource Constrained ◽  
Middle Income ◽  
The Usa ◽  
Expanded Program On Immunization

Clinical research conducted to Good Clinical Practice (GCP) standards is increasingly being undertaken in resource-constrained low-income and middle-income countries (LMICs) settings. This presents unique challenges that differ from those faced in high-income country (HIC) contexts, due to a dearth of infrastructure and unique socio-cultural contexts. Field experiences by research teams working in these LMIC contexts are thus critical to advancing knowledge on successful research conduct in these settings. The Medical Research Council Unit The Gambia at London School of Hygiene and Tropical Medicine has operated in The Gambia, a resource-constrained LMIC for over 70 years and has developed numerous research support platforms and systems. The unit was the lead clinical collaborator in a recently completed Expanded Program on Immunization Consortium (EPIC) study, involving a multicountry collaboration across five countries including the USA, Canada, Belgium, Papua New Guinea and The Gambia. The EPIC study recruited and completed follow-up of 720 newborn infants over 2 years. In this paper, we provide in-depth field experience covering challenges faced by the Gambian EPIC team in the conduct of this study. We also detail some reflections on these challenges. Our findings are relevant to the international research community as they highlight practical day-to-day challenges in conducting GCP standard clinical research in resource-constrained LMIC contexts. They also provide insights on how study processes can be adapted early during research planning to mitigate challenges.

scholarly journals Global palliative care research (2002-2020): bibliometric review and mapping analysis

2021 ◽  
pp. bmjspcare-2021-002982
Author(s):  
Hammoda Abu-Odah ◽  
Alex Molassiotis ◽  
Justina Yat Wa Liu
Keyword(s):  
Palliative Care ◽  
Low Income ◽  
Research Field ◽  
Cancer Prognosis ◽  
Inclusion Criteria ◽  
Middle Income ◽  
Global Trends ◽  
Related Research ◽  
The Usa ◽  
Bibliometric Review

Background and objectiveDespite the important benefits of a bibliometric approach on mapping a research field, relatively little efforts have previously been conducted to map and analyse the global trends of palliative care (PC)-related research. This bibliometric review aimed to provide an overall picture and systematic mapping of the state of research trends within the field of PC internationally.MethodsScopus and Web of Science databases were searched to retrieve original articles focusing on PC between 2002 and 2020. Searching was conducted on 5 May 2020, and was updated on 6 May 2021. All retrieved articles were assessed by title and abstract, and the bibliometric metadata of those that met the inclusion criteria were downloaded for analysis. The results were analysed by VOSviewer and Gephi software.ResultsA total of 19,199 articles met the inclusion criteria. Significant growth of the number of published articles was reported by around five-fold from 2002 to 2020. The USA and UK were the most productive countries in terms of the number of papers published and citations. Weak collaborations were observed between low-income or middle-income countries and high-income countries. Cancer-related PC research was the most common focus. Seven clusters of research were identified and included heart failure and cancer prognosis, nursing home, pain and symptoms management, PC knowledge and attitudes, quality improvement of services, PC ethics, and the ongoing assessment of PC services.ConclusionsThere is a need to expand PC-related research to non-cancer diseases. More international research and cross-institutional cooperation is required to address more global PC issues and benefit from wider sharing of expertees, potentially leading to higher quality or more impactful studies. Setting up research agendas and priorities from funding bodies and institutions may also enhance cooperation among researchers.

Envisioning Workforce Training Differently: The Obama ‘Free’ Community College Initiative

2015 ◽  
Vol 29 (4) ◽  
pp. 249-252 ◽  
Author(s):  
Brian Holland
Keyword(s):  
Community College ◽  
Low Income ◽  
Workforce Training ◽  
President Obama ◽  
Middle Income ◽  
Post Secondary ◽  
Time Period ◽  
Programme Design ◽  
The Usa ◽  
Tuition Costs

Education, particularly at the post-secondary level, does not come cheaply in the USA, with the increase in annual tuition costs far outpacing the inflation rate during the same time period. A core tenet of US President Obama's domestic policy agenda is the belief that increased educational attainment can potentially lead to better economic prospects. As a result of the financial hardship that higher education brings to low-income and middle-income individuals and families, access to these educational opportunities and their benefits are not then fully realized. In response, President Obama has called for a ‘universal community college’, where tuition costs are reduced to zero. The intent and effect of the ‘universal community college’ initiative are identified and this commentary also suggests that additional scrutiny is needed with four questions to ensure that the programme design will later translate into meaningful outcomes, if this policy were to pass in Congress.

scholarly journals Newborn self-inflating manual resuscitators: precision robotic testing of safety and reliability

2018 ◽  
pp. fetalneonatal-2018-315391 ◽  
Author(s):  
Mark B Tracy ◽  
Robert Halliday ◽  
Sally K Tracy ◽  
Murray K Hinder
Keyword(s):  
Low Income ◽  
Coefficient Of Variation ◽  
Repeated Measures ◽  
Newborn Infants ◽  
International Standards ◽  
Lung Model ◽  
Bench Test ◽  
Positive Pressure ◽  
Human Hand ◽  
Middle Income

AimA controlled bench test was undertaken to determine the performance variability among a range of neonatal self-inflating bags (SIB) compliant with current International Standards Organisation (ISO).IntroductionUse of SIB to provide positive pressure ventilation during newborn resuscitation is a common emergency procedure. The United Nations programmes advocate increasing availability of SIB in low-income and middle-income nations and recommend devices compliant with ISO. No systematic study has evaluated variance in different models of neonatal SIB.Methods20 models of SIB were incrementally compressed by an automated robotic device simulating the geometry and force of a human hand across a range of precise distances in a newborn lung model. Significance was calculated using analysis of variance repeated measures to determine the relationship between distance of SIB compression and delivered ventilation. A pass/fail was derived from a composite score comprising: minimum tidal volume; coefficient of variation (across all compression distances); peak pressures generated and functional compression distance.ResultsTen out of the 20 models of SIB failed our testing methodology. Two models could not provide safe minimum tidal volumes (2.5–5 mL); six models exceeded safety inflation pressure limit >45 cm H2O, representing 6% of their inflations; five models had excessive coefficient of variation (>30% averaged across compression distances) and three models did not deliver inflation volumes >2.5 mL until approximately 50% of maximum bag compression distance was reached. The study also found significant intrabatch variability and forward leakage.ConclusionCompliance of SIBs with ISO standards may not guarantee acceptable or safe performance to resuscitate newborn infants.

scholarly journals Clinical emergency care research in low-income and middle-income countries: opportunities and challenges

2019 ◽  
Vol 4 (Suppl 6) ◽  
pp. e001289 ◽  
Author(s):  
Adam R Aluisio ◽  
Shahan Waheed ◽  
Peter Cameron ◽  
Jermey Hess ◽  
Shevin T Jacob ◽  
...  
Keyword(s):  
Clinical Research ◽  
Emergency Care ◽  
Low Income ◽  
Communicable Disease ◽  
Middle Income ◽  
Middle Income Countries ◽  
Disease States ◽  
Design Characteristics ◽  
Minimal Research ◽  
Clinical Emergency

Disease processes that frequently require emergency care constitute approximately 50% of the total disease burden in low-income and middle-income countries (LMICs). Many LMICs continue to deal with emergencies caused by communicable disease states such as pneumonia, diarrhoea, malaria and meningitis, while also experiencing a marked increase in non-communicable diseases, such as cardiovascular diseases, diabetes mellitus and trauma. For many of these states, emergency care interventions have been developed through research in high-income countries (HICs) and advances in care have been achieved. However, in LMICs, clinical research, especially interventional trials, in emergency care are rare. Furthermore, there exists minimal research on the emergency management of diseases, which are rarely encountered in HICs but impact the majority of LMIC populations. This paper explores challenges in conducting clinical research in patients with emergency conditions in LMICs, identifies examples of successful clinical research and highlights the system, individual and study design characteristics that made such research possible in LMICs. Derived from the available literature, a focused list of high impact research considerations are put forth.

Estimating effects of Uber ride-sharing service on road traffic-related deaths in South Africa: a quasi-experimental study

2019 ◽  
Vol 73 (3) ◽  
pp. 263-271 ◽  
Author(s):  
Jonathan Yinhao Huang ◽  
Farhan Majid ◽  
Mark Daku
Keyword(s):  
South Africa ◽  
Low Income ◽  
Road Traffic ◽  
Road Traffic Injury ◽  
Health Improvement ◽  
Adult Males ◽  
Middle Income ◽  
Ride Sharing ◽  
Quasi Experimental ◽  
The Usa

BackgroundRoad traffic deaths are a substantial barrier to population health improvement in low-income and middle-income countries (LMICs). In South Africa, the road-traffic injury mortality (RTM) rate of 27 per 100 000 population is twice the global average, over 60% of which are alcohol-related. Recent US studies suggest the Uber ride-sharing service may reduce alcohol-related RTM, however RTM burden in the USA is relatively low and transport behaviours differ from LMICs.MethodsUsing certification data from all deaths occurring in South Africa in the years 2010–2014 (n=2 498 216), we investigated the relative change in weekly road traffic-related death counts between provinces which received Uber services (beginning in 2013) against those that did not using a difference-in-differences approach.ResultsWeekly road traffic-related deaths in provinces with Uber were lower following Uber introduction than in comparison provinces without Uber. The effect size was larger in the province which had Uber the longest (Gauteng) and among young adult males (aged 17–39 years). However, the absolute effects were very small (<2 deaths per year) and may coincide with seasonal variation.ConclusionsOverall, findings did not support either an increase or large decrease in province-level road traffic-related deaths associated with Uber introduction to South Africa. More localised investigations in South Africa and other LMICs are needed.

scholarly journals Norrie disease gene polymorphism in Indonesian infants with retinopathy of prematurity

2019 ◽  
Vol 4 (1) ◽  
pp. e000211
Author(s):  
J Edy Siswanto ◽  
Sudarto Ronoatmodjo ◽  
Rita S Sitorus ◽  
Ag Soemantri ◽  
Iswari Setijaningsih ◽  
...  
Keyword(s):  
Low Income ◽  
Retinopathy Of Prematurity ◽  
Genetic Factors ◽  
Population Sample ◽  
Newborn Infants ◽  
Control Group ◽  
Preterm Newborn ◽  
Middle Income ◽  
Norrie Disease ◽  
Middle Income Countries

ObjectiveRetinopathy of prematurity (ROP) is a major cause of blindness in newborn infants, which also occurs in low-income and middle-income countries. Why ROP progresses in some infants while it regresses in others is still presently unknown. Studies suggest that genetic factors might be involved. Mutations in the Norrie disease (ND) gene are suspected to be related to advanced ROP development. Indonesia is a country with relatively high incidence of ROP, yet the role of these genetic factors in the pathogenesis of ROP cases is still unknown. The study aimed to investigate the presence of mutations in ND on the X chromosome in infants with both non-advanced and advanced ROP in Indonesia.Methods and AnalysisThis is a case–control study of polymorphisms in six variants within the ND gene in exon 3, C597A, L108P, R121W, A105T, V60E and C110G, in preterm newborn infants in four major hospitals in Greater Jakarta, Indonesia.ResultsWe included 162 preterm newborn infants. ROP was diagnosed in 83 infants, and 79 infants served as controls. Among those with ROP, 57 infants had type 2, while others had type 1. We did not find any gene polymorphisms in any of the infants with ROP nor in the control group.ConclusionWe conclude that it is very unlikely that the six polymorphisms in exon 3 of the ND gene studied in this paper are involved in the development or progression of ROP in preterm infants in our population sample in Indonesia.

scholarly journals Establishing and operating a ‘virtual ward’ system to provide care for patients with COVID-19 at home: experience from The Gambia

2021 ◽  
Vol 6 (6) ◽  
pp. e005883
Author(s):  
Oghenebrume Wariri ◽  
Uduak Okomo ◽  
Carla Cerami ◽  
Emmanuel Okoh ◽  
Francis Oko ◽  
...  
Keyword(s):  
Low Income ◽  
Emerging Infectious Diseases ◽  
The Gambia ◽  
Sub Saharan Africa ◽  
Additional Stress ◽  
London School ◽  
Endemic Diseases ◽  
Hospital Beds ◽  
Sub Saharan ◽  
At Home

Health systems in sub-Saharan Africa have remained overstretched from dealing with endemic diseases, which limit their capacity to absorb additional stress from new and emerging infectious diseases. Against this backdrop, the rapidly evolving COVID-19 pandemic presented an additional challenge of insufficient hospital beds and human resource for health needed to deliver hospital-based COVID-19 care. Emerging evidence from high-income countries suggests that a ‘virtual ward’ (VW) system can provide adequate home-based care for selected patients with COVID-19, thereby reducing the need for admissions and mitigate additional stress on hospital beds. We established a VW at the Medical Research Council Unit, The Gambia at the London School of Hygiene and Tropical Medicine, a biomedical research institution located in The Gambia, a low-income west African country, to care for members of staff and their families infected with COVID-19. In this practice paper, we share our experience focusing on the key components of the system, how it was set up and successfully operated to support patients with COVID-19 in non-hospital settings. We describe the composition of the multidisciplinary team operating the VW, how we developed clinical standard operating procedures, how clinical oversight is provided and the use of teleconsultation and data capture systems to successfully drive the process. We demonstrate that using a VW to provide an additional level of support for patients with COVID-19 at home is feasible in a low-income country in sub-Saharan Africa. We believe that other low-income or resource-constrained settings can adopt and contextualise the processes described in this practice paper to provide additional support for patients with COVID-19 in non-hospital settings.

scholarly journals Protocol for a realist synthesis of health systems responsiveness in low-income and middle-income countries

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e046992
Author(s):  
Tolib Mirzoev ◽  
Anna Cronin de Chavez ◽  
Ana Manzano ◽  
Irene Akua Agyepong ◽  
Mary Eyram Ashinyo ◽  
...  
Keyword(s):  
Health Systems ◽  
Low Income ◽  
Empirical Studies ◽  
Grey Literature ◽  
Realist Synthesis ◽  
Vulnerable Groups ◽  
Primary Data ◽  
London School ◽  
Middle Income ◽  
Middle Income Countries

IntroductionHealth systems responsiveness is a key objective of any health system, yet it is the least studied of all objectives particularly in low-income and middle-income countries. Research on health systems responsiveness highlights its multiple elements, for example, dignity and confidentiality. Little is known, however, about underlying theories of health systems responsiveness, and the mechanisms through which responsiveness works. This realist synthesis contributes to bridging these two knowledge gaps.Methods and analysisIn this realist synthesis, we will use a four-step process, comprising: mapping of theoretical bases, formulation of programme theories, theory refinement and testing of programme theories using literature and empirical data from Ghana and Vietnam. We will include theoretical and conceptual pieces, reviews, empirical studies and grey literature, alongside the primary data. We will explore responsiveness as entailing external and internal interactions within health systems. The search strategy will be purposive and iterative, with continuous screening and refinement of theories. Data extraction will be combined with quality appraisal, using appropriate tools. Each fragment of evidence will be appraised as it is being extracted, for its relevance to the emerging programme theories and methodological rigour. The extracted data pertaining to contexts, mechanisms and outcomes will be synthesised to identify patterns and contradictions. Results will be reported using narrative explanations, following established guidance on realist syntheses.Ethics and disseminationEthics approvals for the wider RESPONSE (Improving health systems responsiveness to neglected health needs of vulnerable groups in Ghana and Vietnam) study, of which this review is one part, were obtained from the ethics committees of the following institutions: London School of Hygiene and Tropical Medicine (ref: 22981), University of Leeds, School of Medicine (ref: MREC19-051), Ghana Health Service (ref: GHS-ERC 012/03/20) and Hanoi University of Public Health (ref: 020-149/DD-YTCC).We will disseminate results through academic papers, conference presentations and stakeholder workshops in Ghana and Vietnam.PROSPERO registration numberCRD42020200353. Full record: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020200353.

scholarly journals Regulating international clinical research: an ethical framework for policy-makers

2020 ◽  
Vol 5 (5) ◽  
pp. e002287
Author(s):  
Bernardo Aguilera ◽  
David DeGrazia ◽  
Annette Rid
Keyword(s):  
Clinical Research ◽  
Low Income ◽  
Local Population ◽  
Ethical Framework ◽  
Freedom Of Information ◽  
Middle Income ◽  
Policy Makers ◽  
Trade Off ◽  
Ethical Trade ◽  
International Clinical Research

The global distribution of clinical trials is shifting to low-income and middle-income countries (LMICs), and adequate regulations are essential for protecting the rights and interests of research participants in these countries. However, policy-makers in LMICs can face an ethical trade-off: stringent regulatory protections for participants can lead researchers or sponsors to conduct their research elsewhere, potentially depriving the local population of the opportunity to benefit from international clinical research. In this paper, we propose a three-step ethical framework that helps policy-makers to navigate this trade-off. We use a recent set of regulatory protections in Chile to illustrate the practical value of our proposed framework, providing original ethical analysis and previously unpublished data from Chile obtained through freedom of information requests.

scholarly journals Neurosurgeons’ experiences of conducting and disseminating clinical research in low-income and middle-income countries: a reflexive thematic analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e051806
Author(s):  
Charlotte Jane Whiffin ◽  
Brandon George Smith ◽  
Ignatius N Esene ◽  
Claire Karekezi ◽  
Tom Bashford ◽  
...  
Keyword(s):  
Clinical Research ◽  
Thematic Analysis ◽  
Low Income ◽  
Demographic Data ◽  
Middle Income ◽  
Survey Tool ◽  
Middle Income Countries ◽  
Specific Effects ◽  
The Impact

ObjectivesLow-income and-middle-income countries (LMICs) are increasing investment in research and development, yet there remains a paucity of neurotrauma research published by those in LMICs. The aim of this study was to understand neurosurgeons’ experiences of, aspirations for, and ability to conduct and disseminate clinical research in LMICs.DesignThis was a two-stage inductive qualitative study situated within the naturalistic paradigm. This study committed to an interpretivist way of knowing (epistemology), and considered reality subjective and multiple (ontology). Data collection used online methods and included a web-based survey tool for demographic data, an asynchronous online focus group and follow-up semistructured interviews. Data were analysed using Braun and Clarke’s Reflexive Thematic Analysis supported by NVivo V.12.SettingLMICs.ParticipantsIn April–July 2020, 26 neurosurgeons from 11 LMICs participated in this study (n=24 in the focus groups, n=20 in follow-up interviews).ResultsThe analysis gave rise to five themes: The local landscape; creating capacity; reach and impact; collaborative inquiry; growth and sustainability. Each theme contained an inhibitor and stimulus to neurosurgeons conducting and disseminating clinical research, interpreted as ‘the neurosurgical research potential in LMICs’. Mentorship, education, infrastructure, impact and engagement were identified as specific accelerators. Whereas lack of generalisability, absence of dissemination and dissemination without peer review may desensitise the impact of research conducted by neurosurgeons.ConclusionThe geographical, political and population complexities make research endeavour challenging for neurosurgeons in LMICs. Yet in spite of, and because of, these complexities LMICs provide rich opportunities to advance global neurosurgery. More studies are required to evaluate the specific effects of accelerators of research conducted by neurosurgeons and to understand the effects of desensitisers on high-quality, high-impact clinical research.

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