scholarly journals Rise and Fall of Therapeutic Hypothermia in Low-Resource Settings: Lessons from the HELIX Trial

Author(s):  
Vaisakh Krishnan ◽  
Vijay Kumar ◽  
Seetha Shankaran ◽  
Sudhin Thayyil

AbstractIn the past decade, therapeutic hypothermia using a variety of low-cost devices has been widely implemented in India and other low-and middle-income countries (LMIC) without adequate evidence of either safety or efficacy. The recently reported data from the world’s largest cooling trial (HELIX - hypothermia for encephalopathy in low- and middle-income countries) in LMIC provides definitive evidence of harm of cooling therapy with increase in mortality (number to harm 9) and lack of neuroprotection. Although the HELIX participating centers were highly selected tertiary neonatal intensive care units in South Asia with facilities for invasive ventilation, cardiovascular support, and 3 Tesla magnetic resonance imaging (MRI), and the trial used state-of-the-art automated servo-controlled cooling devices, a therapy that is harmful under such optimal conditions cannot be safe in low-resource settings that cannot even afford servo-controlled cooling devices.The HELIX trial has set a new benchmark for conducting high quality randomized controlled trials in terms of research governance, consent, ethics, follow-up rates, and involvement of parents. The standard care for neonatal encephalopathy in LMIC should remain normothermia, with close attention to prevention of hyperthermia. There is no role for therapeutic hypothermia in LMIC as the efficacy of hypothermia is dependent on the population, and not merely on the level of neonatal intensive care facilities. Future research should explore timings and origins of brain injury and prevention of brain injury in LMIC, with a strong emphasis on academic research capacity building and patient and public engagement.

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Davide Piaggio ◽  
Rossana Castaldo ◽  
Marco Cinelli ◽  
Sara Cinelli ◽  
Alessia Maccaro ◽  
...  

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.


2021 ◽  
Vol 77 (1) ◽  
Author(s):  
Brittany L. Fell ◽  
Susan Hanekom ◽  
Martin Heine

Background: The 6-min walk test (6MWT) is a validated tool, of submaximal intensity, used to objectively measure functional exercise capacity. In 2002, the American Thoracic Society (ATS) developed guidelines on standardising the implementation of the 6MWT. Despite the relative ease of conducting the 6MWT as per these guidelines, adaptations are implemented.Objectives: Identify (1) what 6MWT adaptations to the ATS guidelines have been described in low-resource settings (LRS), (2) the purpose of the adapted 6MWT and (3) the reported argumentation for making these adaptations in relation to the specific context.Methods: Five databases were searched from inception until February 2021. Studies that adapted and conducted the 6MWT in LRS were included. Data concerning the study source, participants, 6MWT: purpose, variations, outcome and rationale were extracted.Results: A total of 24 studies were included. The majority of studies (n = 18; 75%) were conducted in lower-middle income countries. The most common adaptation implemented was variation to course length. Eight studies provided a rationale for adapting the 6MWT. Space constraint was the most common reason for adaptation.Conclusion: The most common reason (space constraints) for adapting the 6MWT in LRS was addressed through adaptations in course length and/or configuration. The results of this review suggest that the value of the ATS-guided 6MWT in LRS may need to be re-evaluated.Clinical implications: Using adapted forms of the 6MWT may lead to an underestimation of a patient’s abilities, misinformed discharge and developing inappropriate exercise programmes. Additionally, diverting from ATS guidelines may affect the continuity of care.


Author(s):  
Julia Johnson ◽  
Matthew L Robinson ◽  
Uday C Rajput ◽  
Chhaya Valvi ◽  
Aarti Kinikar ◽  
...  

Abstract Background Antimicrobial resistance (AMR) is a growing threat to newborns in low- and middle-income countries (LMIC). Methods We performed a prospective cohort study in 3 tertiary neonatal intensive care units (NICUs) in Pune, India, to describe the epidemiology of neonatal bloodstream infections (BSIs). All neonates admitted to the NICU were enrolled. The primary outcome was BSI, defined as positive blood culture. Early-onset BSI was defined as BSI on day of life (DOL) 0–2 and late-onset BSI on DOL 3 or later. Results From 1 May 2017 until 30 April 2018, 4073 neonates were enrolled. Among at-risk neonates, 55 (1.6%) developed early-onset BSI and 176 (5.5%) developed late-onset BSI. The majority of BSIs were caused by gram-negative bacteria (GNB; 58%); among GNB, 61 (45%) were resistant to carbapenems. Klebsiella spp. (n = 53, 23%) were the most common cause of BSI. Compared with neonates without BSI, all-cause mortality was higher among neonates with early-onset BSI (31% vs 10%, P < .001) and late-onset BSI (24% vs 7%, P < .001). Non–low-birth-weight neonates with late-onset BSI had the greatest excess in mortality (22% vs 3%, P < .001). Conclusions In our cohort, neonatal BSIs were most commonly caused by GNB, with a high prevalence of AMR, and were associated with high mortality, even in term neonates. Effective interventions are urgently needed to reduce the burden of BSI and death due to AMR GNB in hospitalized neonates in LMIC.


Author(s):  
Mari Carmen Bernal-Soriano ◽  
Francisco Barrera-Guarderas ◽  
Alfonso Alonso-Jaquete ◽  
Elisa Chilet-Rosell ◽  
Ikram Benazizi ◽  
...  

Diabetes is a major public health problem, increasingly affecting low- and middle-income countries. The project CEAD (Contextualizing Evidence for Action in Diabetes in low-resource settings) aims to evaluate the implementation of comprehensive diabetes care in two low-resource settings in Ecuador and to stimulate context-led health systems innovations to improve diabetes care and reduce inequity. The mixed-methods approach includes a 24-month retrospective study to assess the current level of implementation of comprehensive diabetes care and participants will be followed up prospectively for two years to assess changes in healthcare and clinical outcomes from the outset of the research. We will include individuals diagnosed with type-2 diabetes aged over 18 years, who are accessing diabetes care in health facilities in the study districts. Varied stakeholders (patients and family members, community members, healthcare workers and decision-makers) will interpret the underlying causes of the observed weaknesses and propose solutions to strengthen diabetes-related healthcare in focus group discussions (FG). A second set of FG will analyze perceived improvements in healthcare based on prospective cohort findings and consider the success/failure of any context-led innovations occurring throughout the research. Our study will demonstrate how evidence can be contextualized to stimulate local innovations and overcome weaknesses of diabetes-related healthcare in low resource settings.


2021 ◽  
Vol 6 (6) ◽  
pp. e005190
Author(s):  
Chanel van Zyl ◽  
Marelise Badenhorst ◽  
Susan Hanekom ◽  
Martin Heine

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.


2020 ◽  
Vol 35 (Supplement_1) ◽  
pp. i38-i50
Author(s):  
Gifty Sunkwa-Mills ◽  
Lal Rawal ◽  
Christabel Enweronu-Laryea ◽  
Matilda Aberese-Ako ◽  
Kodjo Senah ◽  
...  

Abstract Healthcare-associated infections (HAIs) remain a serious threat to patient safety worldwide, particularly in low- and middle-income countries. Reducing the burden of HAIs through the observation and enforcement of infection prevention and control (IPC) practices remains a priority. Despite growing emphasis on HAI prevention in low- and middle-income countries, limited evidence is available to improve IPC practices to reduce HAIs. This study examined the perspectives of healthcare providers (HPs) and mothers in the neonatal intensive care unit on HAIs and determined the major barriers and facilitators to promoting standard IPC practices. This study draws on data from an ethnographic study using 38 in-depth interviews, four focus group discussions and participant observation conducted among HPs and mothers in neonatal intensive care units of a secondary- and tertiary-level hospital in Ghana. The qualitative data were analysed using a grounded theory approach, and NVivo 12 to facilitate coding. HPs and mothers demonstrated a modest level of understanding about HAIs. Personal, interpersonal, community, organizational and policy-level factors interacted in complex ways to influence IPC practices. HPs sometimes considered HAI concerns to be secondary in the face of a heavy clinical workload, a lack of structured systems and the quest to protect professional authority. The positive attitudes of some HPs, and peer interactions promoted standard IPC practices. Mothers expressed interest in participation in IPC activities. It however requires systematic efforts by HPs to partner with mothers in IPC. Training and capacity building of HPs, provision of adequate resources and improving communication between HPs and mothers were recommended to improve standard IPC practices. We conclude that there is a need for institutionalizing IPC policies and strengthening strategies that acknowledge and value mothers’ roles as caregivers and partners in IPC. To ensure this, HPs should be better equipped to prioritize communication and collaboration with mothers to reduce the burden of HAIs.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Carter Cowden ◽  
Lawrence Mwananyanda ◽  
Davidson H. Hamer ◽  
Susan E. Coffin ◽  
Monica L. Kapasa ◽  
...  

Abstract Background Infants in the neonatal intensive care unit (NICU) are particularly susceptible to healthcare-associated infections (HAIs). NICUs in low- and middle income countries face additional challenges to HAI prevention. There is a need to better understand the role of the implementation context surrounding infection prevention interventions in low- and middle income countries. Aim The aim of this study was to identify NICU healthcare worker perceptions of an intervention to reduce bloodstream infections in a large Zambian NICU. Methods Semi-structured interviews were conducted with NICU staff during a prospective cohort study examining the impact of an infection prevention bundle on bloodstream infections. Interviews were analyzed using an integrated approach, combining inductive theme generation with an application of the Consolidated Framework for Implementation Research (CFIR). Results Interviews were conducted with 17 NICU staff (5 physicians and 12 nurses). Respondents believed the bundle elements were easy to use, well-designed and facilitated improved performance. Four organizational characteristics that facilitated HAI transmission were identified – (1) lack of NICU admission protocols; (2) physical crowding; (3) understaffing; and (4) equipment shortages. Respondents suggested that NICU resource constraints reflected a societal ethos that devalued the medical care of infants. Despite the challenges, respondents were highly motivated to prevent HAIs and believed this was an achievable goal. They enthusiastically welcomed the bundle but expressed serious concern about sustainability following the study. Conclusions By eliciting healthcare worker perceptions about the context surrounding an infection prevention intervention, our study identified key organizational and societal factors to inform implementation strategies to achieve sustained improvement.


2020 ◽  
pp. 229-238
Author(s):  
Lara Herbert ◽  
Ruth Tighe

The chapter covers some of the general and urological conditions likely to be encountered by anaesthetists working in low-resource settings. Some such conditions are familiar to all anaesthetists, but the resources to manage them may be different: this chapter therefore particularly includes a description of laparotomy under spinal anaesthesia and a consideration of the risks and benefits of this technique. In addition some surgeries more commonly performed in low- and middle-income countries, e.g. bladder stone excision, non-traumatic splenectomy, and hydatid cyst excision are outlined, together with appropriate approaches and techniques for the non-specialist anaesthetist. Both elective and emergency conditions are included.


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