scholarly journals Typhoidal Salmonella human challenge studies: ethical and practical challenges and considerations for low-resource settings

Trials ◽  
2019 ◽  
Vol 20 (S2) ◽  
Author(s):  
Meriel Raymond ◽  
Malick M. Gibani ◽  
Nicholas P. J. Day ◽  
Phaik Yeong Cheah
Keyword(s):  
Careful Consideration ◽  
Human Infection ◽  
Genetic Profile ◽  
Close Monitoring ◽  
Low Resource Settings ◽  
Low Resource ◽  
Endemic Setting ◽  
High Resource ◽  
Resource Setting ◽  
The Individual

AbstractTyphoidal Salmonella is a major global problem affecting more than 12 million people annually. Controlled human infection models (CHIMs) in high-resource settings have had an important role in accelerating the development of conjugate vaccines against Salmonella Typhi.The typhoidal Salmonella model has an established safety profile in over 2000 volunteers in high-income settings, and trial protocols, with modification, could be readily transferred to new study sites. To date, a typhoidal Salmonella CHIM has not been conducted in a low-resource setting, although it is being considered.Our article describes the challenges posed by a typhoidal Salmonella CHIM in the high-resource setting of Oxford and explores considerations for an endemic setting.Development of CHIMs in endemic settings is scientifically justifiable as it remains unclear whether findings from challenge studies performed in high-resource non-endemic settings can be extrapolated to endemic settings, where the burden of invasive Salmonella is highest. Volunteers are likely to differ across a range of important variables such as previous Salmonella exposure, diet, intestinal microbiota, and genetic profile. CHIMs in endemic settings arguably are ethically justifiable as affected communities are more likely to gain benefit from the study. Local training and research capacity may be bolstered.Safety was of primary importance in the Oxford model. Risk of harm to the individual was mitigated by careful inclusion and exclusion criteria; close monitoring with online diary and daily visits; 24/7 on-call staffing; and access to appropriate hospital facilities with capacity for in-patient admission. Risk of harm to the community was mitigated by exclusion of participants with contact with vulnerable persons; stringent hygiene and sanitation precautions; and demonstration of clearance of Salmonella infection from stool following antibiotic treatment.Safety measures should be more stringent in settings where health systems, transport networks, and sanitation are less robust.We compare the following issues between high- and low-resource settings: scientific justification, risk of harm to the individual and community, benefits to the individual and community, participant understanding, compensation, and regulatory requirements.We conclude that, with careful consideration of country-specific ethical and practical issues, a typhoidal Salmonella CHIM in an endemic setting is possible.

Outcome of infants with 10 min Apgar scores of 0–1 in a low-resource setting

2021 ◽  
pp. fetalneonatal-2021-322545
Author(s):  
Thorkild Tylleskär ◽  
Francesco Cavallin ◽  
Susanna Myrnerts Höök ◽  
Nicolas J Pejovic ◽  
Clare Lubulwa ◽  
...  
Keyword(s):  
Delivery Room ◽  
Apgar Scores ◽  
Low Resource Settings ◽  
Low Resource ◽  
High Resource ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Mulago National Referral Hospital ◽  
Term Newborns

BackgroundIn high-resource settings, postponing the interruption of cardiopulmonary resuscitation from 10 to 20 min after birth has been recently suggested, but data from low-resource settings are lacking. We investigated the outcome of newborns with Apgar scores of 0–1 at 10 min of resuscitative efforts in a low-resource setting.MethodsThis observational substudy from the NeoSupra trial included all 49 late preterm/full-term newborns with Apgar scores of 0–1 at 10 min of resuscitation. The study was carried out at Mulago National Referral Hospital (Kampala, Uganda) between May 2018 and August 2019. Outcome measures were mortality and hypoxic-ischaemic encephalopathy in the first week of life. All resuscitations were video recorded and daily reviewed by trial researchers.ResultsMedian duration of resuscitation was 32 min (IQR 17–37). Advanced resuscitation was provided to 21/49 neonates (43%). Overall, 48 neonates (98%) died within 2 days of life (44 in the delivery room, three on the first day and one on the second day) and one survived at 1 week with severe hypoxic-ischaemic encephalopathy.ConclusionOur study adds information from a low-resource setting to the recent evidence from high-resource settings about prolonging the resuscitation in infants with Apgar scores of 0–1 at 10 min. The vast majority died in the delivery room despite prolonged resuscitative efforts. We confirm that duration of resuscitation should be tailored to the setting, while the focus in low-resource settings should be improving the quality of antenatal and immediately after birth care.

scholarly journals A framework for designing medical devices resilient to low-resource settings

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Davide Piaggio ◽  
Rossana Castaldo ◽  
Marco Cinelli ◽  
Sara Cinelli ◽  
Alessia Maccaro ◽  
...  
Keyword(s):  
Delphi Study ◽  
Middle Income ◽  
Low Resource Settings ◽  
Health Technologies ◽  
Low Resource ◽  
Middle Income Countries ◽  
High Resource ◽  
International Experts ◽  
Global Population ◽  
Different Parts

Abstract Background To date (April 2021), medical device (MD) design approaches have failed to consider the contexts where MDs can be operationalised. Although most of the global population lives and is treated in Low- and Middle-Income Countries (LMCIs), over 80% of the MD market share is in high-resource settings, which set de facto standards that cannot be taken for granted in lower resource settings. Using a MD designed for high-resource settings in LMICs may hinder its safe and efficient operationalisation. In the literature, many criteria for frameworks to support resilient MD design were presented. However, since the available criteria (as of 2021) are far from being consensual and comprehensive, the aim of this study is to raise awareness about such challenges and to scope experts’ consensus regarding the essentiality of MD design criteria. Results This paper presents a novel application of Delphi study and Multiple Criteria Decision Analysis (MCDA) to develop a framework comprising 26 essential criteria, which were evaluated and chosen by international experts coming from different parts of the world. This framework was validated by analysing some MDs presented in the WHO Compendium of innovative health technologies for low-resource settings. Conclusions This novel holistic framework takes into account some domains that are usually underestimated by MDs designers. For this reason, it can be used by experts designing MDs resilient to low-resource settings and it can also assist policymakers and non-governmental organisations in shaping the future of global healthcare.

scholarly journals Actions of a Brazilian public telehealth service to help coping with the new coronavirus

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
L B Silva ◽  
L A P Sousa ◽  
R E Resende ◽  
A A Fortini ◽  
C G Pessoa ◽  
...  
Keyword(s):  
Public Health ◽  
General Population ◽  
Health Professionals ◽  
Large Scale ◽  
Ventilatory Support ◽  
Medical Specialties ◽  
Low Resource Settings ◽  
Low Resource ◽  
Telehealth Service ◽  
Resource Setting

Abstract Background In January/2020 the respiratory disease caused by the new coronavirus was declared as an international public health emergency. In Brazil, until June 22nd there were 1,11 million confirmed cases. In this context, the Telehealth Network of Minas Gerais (TNMG), a large-scale public telehealth service, acted quickly to assist professionals and the population in coping with the disease, mainly in low resource settings. Aim To report the experience of a Brazilian public telehealth service in actions to manage COVID-19 and its impacts. Methods Experience report. Results The TNMG developed 15 infographics and 16 web lectures for health professionals and general population about key themes, such as respiratory syndromes, personal care and ventilatory support. Two of them were live, seen in real time by 13,422 professionals, mainly nurses (63.8%) and doctors (31.1%), from 45 medical specialties (most family physicians-34.0%), in all Brazilian states, especially the Southeast region (58.5%). All lectures were uploaded on TNMG's Youtube channel, each one reaching 5,300 viewers on average. Specific to support health professionals: 2 guidelines were developed - one for primary care units and other to emergency/intensive care; a category for offline (second opinion) teleconsultations was created for doubts about coronavirus; and a list with 39 Frequently Asked Questions (FAQs) was developed. For the general population: 65 FAQs were developed; a health team from a low resource setting was trained to provide online teleconsultations; and a chatbot was released to automatically answer COVID-19 related doubts and/or evaluate a user's health condition, indicating if emergency medical care was needed. All resources are freely available on TNMG's website and on its social networks. Conclusions Telehealth tools had a notable acceptance and were shown to be an effective way to disseminate information for professionals and lay population throughout the country. Key messages Telehealth tools have been proven to be an effective strategy to promote health education, for both professionals and the general population. Telemedicine plays a fundamental role on dealing with public health issues, especially on low resource settings.

scholarly journals Cash transfers may increase the no-show rate for surgical patients in low-resource settings: A randomized trial

2021 ◽  
Author(s):  
Mark G Shrime ◽  
Elizabeth A Harter ◽  
Becky Handforth ◽  
Christine L Phillips ◽  
Hendrika W C Bos ◽  
...  
Keyword(s):  
Conditional Cash Transfer ◽  
Cash Transfers ◽  
Cash Transfer ◽  
Surgical Patients ◽  
Control Group ◽  
Low Resource Settings ◽  
Low Resource ◽  
Resource Setting ◽  
Transfer Group ◽  
Unconditional Cash Transfer

Background: Over two-thirds of the world's population cannot access surgery when needed. Interventions to address this gap have primarily focused on surgical training and ministry-level surgical planning. However, patients more commonly cite cost--rather than governance or surgeon availability--as their primary access barrier. We undertook a randomized, controlled trial (RCT) to evaluate the effect on compliance with scheduled surgical appointments of addressing this barrier through a cash transfer. Methods: 453 patients who were deemed surgical candidates by a nursing screening team in Guinea, West Africa, were randomized into three study arms: control, conditional cash transfer, and labeled unconditional cash transfer. Arrival to a scheduled surgical appointment was the primary outcome. The study was performed in conjunction with Mercy Ships. Results: The overall no-show rate was five-fold lower in Guinea than previously published estimates, leading to an underpowered study. In a post-hoc analysis, which included non-randomized patients, patients in the control group and the conditional cash transfer group demonstrated no effect from the cash transfer. Patients in the unconditional cash transfer group were significantly less likely to arrive for their scheduled appointment. Subgroup analysis suggested that actual receipt of the unconditional cash transfer, instead of a lapse in the transfer mechanism, was associated with failure to show. Conclusion: We find that cash transfers are feasible for surgical patients in a low-resource setting, but that unconditional transfers may have negative effects on compliance. Although demand-side barriers are large for surgical patients in low-resource settings, interventions to address them must be designed with care.

scholarly journals Ethical issues raised by cluster randomised trials conducted in low-resource settings: identifying gaps in the Ottawa Statement through an analysis of the PURE Malawi trial

2019 ◽  
Vol 45 (6) ◽  
pp. 388-393 ◽  
Author(s):  
Tiwonge K Mtande ◽  
Charles Weijer ◽  
Mina C Hosseinipour ◽  
Monica Taljaard ◽  
Mitch Matoga ◽  
...  
Keyword(s):  
Ethical Issues ◽  
Health Workers ◽  
National Standards ◽  
Guidance Document ◽  
Randomised Trials ◽  
Low Resource Settings ◽  
Low Resource ◽  
Cluster Randomised Trials ◽  
Cluster Randomised ◽  
Resource Setting

The increasing use of cluster randomised trials in low-resource settings raises unique ethical issues. The Ottawa Statement on the Ethical Design and Conduct of Cluster Randomised Trials is the first international ethical guidance document specific to cluster trials, but it is unknown if it adequately addresses issues in low-resource settings. In this paper, we seek to identify any gaps in the Ottawa Statement relevant to cluster trials conducted in low-resource settings. Our method is (1) to analyse a prototypical cluster trial conducted in a low-resource setting (PURE Malawi trial) with the Ottawa Statement; (2) to identify ethical issues in the design or conduct of the trial not captured adequately and (3) to make recommendations for issues needing attention in forthcoming revisions to the Ottawa Statement. Our analysis identified six ethical aspects of cluster randomised trials in low-resource settings that require further guidance. The forthcoming revision of the Ottawa Statement should provide additional guidance on these issues: (1) streamlining research ethics committee review for collaborating investigators who are affiliated with other institutions; (2) the classification of lay health workers who deliver study interventions as health providers or research participants; (3) the dilemma experienced by investigators when national standards seem to prohibit waivers of consent; (4) the timing of gatekeeper engagement, particularly when researchers face funding constraints; (5) providing ancillary care in health services or implementation trials when a routine care control arm is known to fall below national standards and (6) defining vulnerable participants needing protection in low-resource settings.

scholarly journals Eye-tracking-based assessment of cognitive function in low-resource settings

2016 ◽  
Vol 102 (4) ◽  
pp. 301.1-302 ◽  
Author(s):  
Linda Forssman ◽  
Per Ashorn ◽  
Ulla Ashorn ◽  
Kenneth Maleta ◽  
Andrew Matchado ◽  
...  
Keyword(s):  
Cognitive Function ◽  
Eye Tracking ◽  
Low Income ◽  
Health Centre ◽  
Assessment Tools ◽  
Completion Rates ◽  
Low Resource ◽  
High Resource ◽  
Resource Setting ◽  
Test Completion

BackgroundEarly development of neurocognitive functions in infants can be compromised by poverty, malnutrition and lack of adequate stimulation. Optimal management of neurodevelopmental problems in infants requires assessment tools that can be used early in life, and are objective and applicable across economic, cultural and educational settings.Objective and designThe present study examined the feasibility of infrared eye tracking as a novel and highly automated technique for assessing visual-orienting and sequence-learning abilities as well as attention to facial expressions in young (9-month-old) infants. Techniques piloted in a high-resource laboratory setting in Finland (N=39) were subsequently field-tested in a community health centre in rural Malawi (N=40).ResultsParents' perception of the acceptability of the method (Finland 95%, Malawi 92%) and percentages of infants completing the whole eye-tracking test (Finland 95%, Malawi 90%) were high, and percentages of valid test trials (Finland 69–85%, Malawi 68–73%) satisfactory at both sites. Test completion rates were slightly higher for eye tracking (90%) than traditional observational tests (87%) in Malawi. The predicted response pattern indicative of specific cognitive function was replicated in Malawi, but Malawian infants exhibited lower response rates and slower processing speed across tasks.ConclusionsHigh test completion rates and the replication of the predicted test patterns in a novel environment in Malawi support the feasibility of eye tracking as a technique for assessing infant development in low-resource setting. Further research is needed to the test–retest stability and predictive validity of the eye-tracking scores in low-income settings.

Context

2020 ◽  
pp. 1-20
Author(s):  
Tom Bashford ◽  
Julian Gore-Booth ◽  
Jo James ◽  
Stephen Pickering ◽  
Becky Paris ◽  
...  
Keyword(s):  
Local Context ◽  
Technical Aspects ◽  
Low Resource Settings ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Clinical Background ◽  
Developmental Principles ◽  
The Way

The chapter provides the reader with information on the non-clinical background to working as an anaesthetist in a low-resource setting. It concentrates on important concepts that should inform the way you practise and teach, rather than technical aspects of anaesthesia. Although technical aspects of delivering anaesthesia are usually uppermost in the minds of anaesthetists new to working in low-resource settings, it is often the case that adapting successfully to the local context proves the more challenging aspect. Topics covered include humanitarian and developmental principles, teaching anaesthesia, looking after your own health, being a good visitor, and how to adapt your practice.

scholarly journals Unravelling ‘low-resource settings’: a systematic scoping review with qualitative content analysis

2021 ◽  
Vol 6 (6) ◽  
pp. e005190
Author(s):  
Chanel van Zyl ◽  
Marelise Badenhorst ◽  
Susan Hanekom ◽  
Martin Heine
Keyword(s):  
Content Analysis ◽  
Scoping Review ◽  
Qualitative Content Analysis ◽  
Middle Income ◽  
Low Resource Settings ◽  
Low Resource ◽  
Middle Income Countries ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Low Middle Income Countries

IntroductionThe effects of healthcare-related inequalities are most evident in low-resource settings. Such settings are often not explicitly defined, and umbrella terms which are easier to operationalise, such as ‘low-to-middle-income countries’ or ‘developing countries’, are often used. Without a deeper understanding of context, such proxies are pregnant with assumptions, insinuate homogeneity that is unsupported and hamper knowledge translation between settings.MethodsA systematic scoping review was undertaken to start unravelling the term ‘low-resource setting’. PubMed, Africa-Wide, Web of Science and Scopus were searched (24 June 2019), dating back ≤5 years, using terms related to ‘low-resource setting’ and ‘rehabilitation’. Rehabilitation was chosen as a methodological vehicle due to its holistic nature (eg, multidisciplinary, relevance across burden of disease, and throughout continuum of care) and expertise within the research team. Qualitative content analysis through an inductive approach was used.ResultsA total of 410 codes were derived from 48 unique articles within the field of rehabilitation, grouped into 63 content categories, and identified nine major themes relating to the term ‘low-resource setting’. Themes that emerged relate to (1) financial pressure, (2) suboptimal healthcare service delivery, (3) underdeveloped infrastructure, (4) paucity of knowledge, (5) research challenges and considerations, (6) restricted social resources, (7) geographical and environmental factors, (8) human resource limitations and (9) the influence of beliefs and practices.ConclusionThe emerging themes may assist with (1) the groundwork needed to unravel ‘low-resource settings’ in health-related research, (2) moving away from assumptive umbrella terms like ‘low-to-middle-income countries’ or ‘low/middle-income countries’ and (3) promoting effective knowledge transfer between settings.

scholarly journals Combination of Antibody based rapid diagnostic tests used in an algorithm may improve their performance in SARS CoV-2 diagnosis

2020 ◽  
Author(s):  
Grace Esther Kushemererwa ◽  
Ismail Kayongo ◽  
Patrick Semanda ◽  
Hellen Nansumba ◽  
Iga Tadeo ◽  
...  
Keyword(s):  
Diagnostic Methods ◽  
World Health ◽  
Microsoft Excel ◽  
Laboratory Equipment ◽  
Low Resource ◽  
Resource Setting ◽  
Low Resource Setting ◽  
Referral Hospitals ◽  
Health Organization ◽  
The Individual

AbstractBackgroundGlobally response to the SARS-CoV-2 pandemic is highly limited by diagnostic methods. Currently, World Health Organization (WHO) recommends the use of molecular assays for confirmation of SARS-CoV-2 infection which are highly expensive and require specialized laboratory equipment. This is a limitation in mass testing and in low resource settings. SARS CoV-2 IgG/IgM antibody tests have had poor diagnostic performance that do not guarantee their use in diagnostics. In this study we demonstrate a concept of using a combination of RDTs in an algorithm to improve their performance for diagnostics.MethodEighty six (86) EDTA whole blood samples were collected from SARS-CoV-2 positive cases admitted at Masaka and Mbarara Regional Referral Hospitals in Uganda. These were categorized from day when confirmed positive as follows; category A (0-3 days, 10 samples), category B (4-7 days, 20 samples), Category C (8-17 days, 11 samples) and Category D (18-28 days, 20 samples). Plasma was prepared, transported to the testing laboratory and stored at −200C prior to testing. A total of 13 RDTS were tested following manufacturer’s instructions. Data was entered in Microsoft Excel exported to STATA for computation of sensitivity and specificity. We computed for all possible combinations of 2 of the 13 RDTS (13C2) that were evaluated in parallel algorithm.ResultsThe individual sensitives of the RDTs ranged between 74% and 18% and there was a general increasing trend across the categories with days since PCR confirmation. A total of 78 possible combinations of the RDTs to be used in parallel was computated. The combinations of the 2 RDTS improved the sensitivities to 90%.DiscussionWe demonstrate that use of RDTs in combinations can improve their overall sensitivity. This approach when used on a wider range of combination of RDTs may yield combinations that can give sensitivities that are of diagnostics relevance in mass testing and low resource setting.

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