scholarly journals Human infection challenge studies in endemic settings and/or low-income and middle-income countries: key points of ethical consensus and controversy

2020 ◽  
Vol 46 (9) ◽  
pp. 601-609 ◽  
Author(s):  
Euzebiusz Jamrozik ◽  
Michael J Selgelid
Keyword(s):  
Low Income ◽  
Ethical Issues ◽  
Relevant Literature ◽  
Human Infection ◽  
Third Party ◽  
Future Research ◽  
Middle Income ◽  
Middle Income Countries ◽  
Trade Offs ◽  
Widespread Agreement

Human infection challenge studies (HCS) involve intentionally infecting research participants with pathogens (or other micro-organisms). There have been recent calls for more HCS to be conducted in low-income and middle-income countries (LMICs), where many relevant diseases are endemic. HCS in general, and HCS in LMICs in particular, raise numerous ethical issues. This paper summarises the findings of a project that explored ethical and regulatory issues related to LMIC HCS via (i) a review of relevant literature and (ii) 45 qualitative interviews with scientists and ethicists. Among other areas of consensus, we found that there was widespread agreement that LMIC HCS can be ethically acceptable, provided that they have a sound scientific rationale, are accepted by local communities and meet usual research ethics requirements. Unresolved issues include those related to (i) acceptable approaches to trade-offs between the scientific aim to produce generalisable results and the protection of participants, (iii) the sharing of benefits with LMIC populations, (iii) the acceptable limits to risks and burdens for participants, (iv) the potential for third-party risk and whether the degree of acceptable third-party risk is different in endemic settings, (v) the conditions under which (if any) it would be appropriate to recruit children for disease-causing HCS, (v) appropriate levels of payment to participants and (vi) appropriate governance of (LMIC) HCS. This paper provides preliminary analyses of these ethical considerations in order to (i) inform scientists and policymakers involved in the planning, conduct and/or governance of LMIC HCS and (ii) highlight areas warranting future research. Insofar as this article focuses on HCS in (endemic) settings where diseases are present and/or widespread, much of the analysis provided is relevant to HCS (in HICs or LMICs) involving pandemic diseases including COVID19.

scholarly journals Outcomes of HIV treatment from the private sector in low-income and middle-income countries: a systematic review protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (1) ◽  
pp. e031844
Author(s):  
Gitau Mburu ◽  
Ewemade Igbinedion ◽  
Sin How Lim ◽  
Aung Zayar Paing ◽  
Siyan Yi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Private Sector ◽  
Clinical Outcomes ◽  
Low Income ◽  
Hiv Treatment ◽  
Future Research ◽  
Publication Date ◽  
Middle Income ◽  
Middle Income Countries ◽  
Secondary Outcomes

IntroductionPrivate sector provision of HIV treatment is increasing in low-income and middle-income countries (LMIC). However, there is limited documentation of its outcomes. This protocol reports a proposed systematic review that will synthesise clinical outcomes of private sector HIV treatment in LMIC.Methods and analysisThis review will be conducted in accordance with the preferred reporting items for systematic review and meta-analyses protocols. Primary outcomes will include: (1) proportion of eligible patients initiating antiretroviral therapy (ART); (2) proportion of those on ART with <1000 copies/mL; (3) rate of all-cause mortality among ART recipients. Secondary outcomes will include: (1) proportion receivingPneumocystis jirovecipneumonia prophylaxis; (2) proportion with >90% ART adherence (based on any measure reported); (3) proportion screened for non-communicable diseases (specifically cervical cancer, diabetes, hypertension and mental ill health); (iv) proportion screened for tuberculosis. A search of five electronic bibliographical databases (Embase, Medline, PsychINFO, Web of Science and CINAHL) and reference lists of included articles will be conducted to identify relevant articles reporting HIV clinical outcomes. Searches will be limited to LMIC. No age, publication date, study-design or language limits will be applied. Authors of relevant studies will be contacted for clarification. Two reviewers will independently screen citations and abstracts, identify full text articles for inclusion, extract data and appraise the quality and bias of included studies. Outcome data will be pooled to generate aggregative proportions of primary and secondary outcomes. Descriptive statistics and a narrative synthesis will be presented. Heterogeneity and sensitivity assessments will be conducted to aid interpretation of results.Ethics and disseminationThe results of this review will be disseminated through a peer-reviewed scientific manuscript and at international scientific conferences. Results will inform quality improvement strategies, replication of identified good practices, potential policy changes, and future research.PROSPERO registration numberCRD42016040053.

scholarly journals Primary healthcare system performance in low-income and middle-income countries: a scoping review of the evidence from 2010 to 2017

2019 ◽  
Vol 4 (Suppl 8) ◽  
pp. e001551 ◽  
Author(s):  
Asaf Bitton ◽  
Jocelyn Fifield ◽  
Hannah Ratcliffe ◽  
Ami Karlage ◽  
Hong Wang ◽  
...  
Keyword(s):  
Service Delivery ◽  
Scoping Review ◽  
Low Income ◽  
Primary Healthcare ◽  
Recent Literature ◽  
Future Research ◽  
Topic Area ◽  
Middle Income ◽  
Ample Evidence ◽  
Middle Income Countries

IntroductionThe 2018 Astana Declaration reaffirmed global commitment to primary healthcare (PHC) as a core strategy to achieve universal health coverage. To meet this potential, PHC in low-income and middle-income countries (LMIC) needs to be strengthened, but research is lacking and fragmented. We conducted a scoping review of the recent literature to assess the state of research on PHC in LMIC and understand where future research is most needed.MethodsGuided by the Primary Healthcare Performance Initiative (PHCPI) conceptual framework, we conducted searches of the peer-reviewed literature on PHC in LMIC published between 2010 (the publication year of the last major review of PHC in LMIC) and 2017. We also conducted country-specific searches to understand performance trajectories in 14 high-performing countries identified in the previous review. Evidence highlights and gaps for each topic area of the PHCPI framework were extracted and summarised.ResultsWe retrieved 5219 articles, 207 of which met final inclusion criteria. Many PHC system inputs such as payment and workforce are well-studied. A number of emerging service delivery innovations have early evidence of success but lack evidence for how to scale more broadly. Community-based PHC systems with supportive governmental policies and financing structures (public and private) consistently promote better outcomes and equity. Among the 14 highlighted countries, most maintained or improved progress in the scope of services, quality, access and financial coverage of PHC during the review time period.ConclusionOur findings revealed a heterogeneous focus of recent literature, with ample evidence for effective PHC policies, payment and other system inputs. More variability was seen in key areas of service delivery, underscoring a need for greater emphasis on implementation science and intervention testing. Future evaluations are needed on PHC system capacities and orientation toward social accountability, innovation, management and population health in order to achieve the promise of PHC.

scholarly journals A framework for Controlled Human Infection Model (CHIM) studies in Malawi: Report of a Wellcome Trust workshop on CHIM in Low Income Countries held in Blantyre, Malawi

2017 ◽  
Vol 2 ◽  
pp. 70 ◽  
Author(s):  
Stephen B Gordon ◽  
Jamie Rylance ◽  
Amy Luck ◽  
Kondwani Jambo ◽  
Daniela M Ferreira ◽  
...  
Keyword(s):  
Low Income ◽  
Vaccine Development ◽  
Clinical Laboratory ◽  
Human Infection ◽  
Low Income Countries ◽  
Infection Model ◽  
Proof Of Concept ◽  
Middle Income ◽  
Regulatory Issues ◽  
Middle Income Countries

Controlled human infection model (CHIM) studies have pivotal importance in vaccine development, being useful for proof of concept, pathogenesis, down-selection and immunogenicity studies.  To date, however, they have seldom been carried out in low and middle income countries (LMIC), which is where the greatest burden of vaccine preventable illness is found.  This workshop discussed the benefits and barriers to CHIM studies in Malawi.  Benefits include improved vaccine effectiveness and host country capacity development in clinical, laboratory and governance domains.  Barriers include acceptability, safety and regulatory issues. The report suggests a framework by which ethical, laboratory, scientific and governance issues may be addressed by investigators considering or planning CHIM in LMIC.

scholarly journals The Magnitude of Unsafe Child Feces Disposal Practices and Its Association With Reported Diarrhea in Low-income and Middle-income Countries: A Systematic Review and Meta-analysis Protocol

2020 ◽  
Author(s):  
Negasa Eshete Soboksa ◽  
Bekam Kebede Olkeba ◽  
Dinkinesh Begna Gudeta
Keyword(s):  
Systematic Review ◽  
Low Income ◽  
Current Evidence ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Future Research ◽  
Childhood Diarrhea ◽  
Middle Income ◽  
Middle Income Countries ◽  
Google Search

Abstract Introduction:The unsafe disposal of children’s feces may be an important contaminant in household environments, posing a high risk of exposure to infants. Several studies done on the magnitude of unsafe disposal of child feces and its association with reported childhood diarrheahave variedoutcomesand no tries have been made to systematically review this. Therefore, itis necessitating a systematic review to provide an exhaustive summary of current evidence. Thus, the objective ofthis study will be to pool out the available evidence on the magnitude of unsafe child feces disposalpractices and its association with reported childhood diarrhea in low-income and middle-income countries. Methods: PubMed, Science Direct, Cochrane Library database, and Ovid Medline will be searched to identify relevant literature for this review. Moreover, Google search engine, Google Scholar, and references of other studieswill be searched from January 2000 to December 2020. The primary outcome of interest will bethe magnitude of unsafe disposal of child feces and the secondary outcome will be its association with reported diarrhea. Observationalstudies (cross-sectional studies, case-control studies, and cohort studies) written in English will be included in this review. The selected studies will be critically appraised by two independent reviewers using an appropriate tool. The pooled magnitude of unsafe disposal of child feces and its association with reported childhood diarrhea will be analyzed using Stata version 16. Heterogeneity will be assessed using the chi-square test (Q-test) statistics and inverse variance index (I2). Forest plots will be used to present the combined estimate with 95% CI.A funnel plot and Egger’s test of small study bias will be used to assess publication bias.Discussion:This systematic review will identify the evidence available on themagnitude of unsafe child fecesdisposal practicesand its associationwith reported diarrhea. The findings from this study will bemade publicly available in a repository and published in a peer-reviewed journal. The findings from this study will also provide directions for future research and public health professionals with an understanding of the importance of safe child feces disposal practices to preventingchildhood diarrhea in the community.Systematic review registrationnumber: PROSPERO CRD42020189034

scholarly journals Patient-reported outcomes for diabetes and hypertension care in low- and middle-income countries: A scoping review

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245269
Author(s):  
Sarah Masyuko ◽  
Carrie J. Ngongo ◽  
Carole Smith ◽  
Rachel Nugent
Keyword(s):  
Scoping Review ◽  
Low Income ◽  
English Language ◽  
Patient Reported Outcome Measures ◽  
Low Income Countries ◽  
Future Research ◽  
Middle Income ◽  
Middle Income Countries ◽  
Patient Reported ◽  
Low And Middle Income

Introduction Patient-reported outcome measures (PROMs) assess patients’ perspectives on their health status, providing opportunities to improve the quality of care. While PROMs are increasingly used in high-income settings, limited data are available on PROMs use for diabetes and hypertension in low-and middle-income countries (LMICs). This scoping review aimed to determine how PROMs are employed for diabetes and hypertension care in LMICs. Methods We searched PubMed, EMBASE, and ClinicalTrials.gov for English-language studies published between August 2009 and August 2019 that measured at least one PROM related to diabetes or hypertension in LMICs. Full texts of included studies were examined to assess study characteristics, target population, outcome focus, PROMs used, and methods for data collection and reporting. Results Sixty-eight studies met the inclusion criteria and reported on PROMs for people diagnosed with hypertension and/or diabetes and receiving care in health facilities. Thirty-nine (57%) reported on upper-middle-income countries, 19 (28%) reported on lower-middle-income countries, 4 (6%) reported on low-income countries, and 6 (9%) were multi-country. Most focused on diabetes (60/68, 88%), while 4 studies focused on hypertension and 4 focused on diabetes/hypertension comorbidity. Outcomes of interest varied; most common were glycemic or blood pressure control (38), health literacy and treatment adherence (27), and acute complications (22). Collectively the studies deployed 55 unique tools to measure patient outcomes. Most common were the Morisky Medication Adherence Scale (7) and EuroQoL-5D-3L (7). Conclusion PROMs are deployed in LMICs around the world, with greatest reported use in LMICs with an upper-middle-income classification. Diabetes PROMs were more widely deployed in LMICs than hypertension PROMs, suggesting an opportunity to adapt PROMs for hypertension. Future research focusing on standardization and simplification could improve future comparability and adaptability across LMIC contexts. Incorporation into national health information systems would best establish PROMs as a means to reveal the effectiveness of person-centered diabetes and hypertension care.

scholarly journals A mixed methods study to develop a tool to assess institutional readiness to conduct knowledge translation activities in low-income and middle-income countries

BMJ Open ◽  
2021 ◽  
Vol 11 (10) ◽  
pp. e050049
Author(s):  
Anna Kalbarczyk ◽  
Aditi Rao ◽  
Olakunle Alonge
Keyword(s):  
Knowledge Translation ◽  
Low Income ◽  
Future Research ◽  
Academic Institutions ◽  
Global Knowledge ◽  
Consultation Process ◽  
Middle Income ◽  
Stakeholder Consultation ◽  
Knowledge To Action ◽  
Middle Income Countries

ObjectiveThis paper describes the development of a tool for assessing organisational readiness to conduct knowledge translation (KT) among academic institutions in low-income and middle-income countries (LMICs).DesignA literature review and stakeholder consultation process were conducted to identify constructs relevant for assessing KT readiness in LMICs. These were face-validated with LMIC stakeholders and organised into a Likert-scale questionnaire.ParticipantsThe questionnaire was distributed to researchers based at six LMIC academic institutions and members of a global knowledge-to-action thematic working group.Outcome measuresAn exploratory factor analysis was used to identify underlying dimensions for assessing institutional readiness to conduct KT.Results111 respondents with varied KT experiences from 10 LMICs were included in the analysis. We selected 5 factors and 23 items, with factor loadings from 0.40 to 0.77. These factors include (1) institutional climate, (2) organisation change efficacy, (3) prioritisation and cosmopolitanism, (4) self-efficacy, and (5) financial resources. These factors accounted for 69% of the total variance, with Cronbach’s alpha coefficients of 0.78, 0.73, 0.62, 0.68 and 0.52, respectively.ConclusionsThis study identifies a tool for assessing readiness of LMIC academic institutions to conduct KT and unique opportunities for building capacity. The organisational focus of these factors underscores the need for strategies that address organisational systems and structures in addition to individual skills. Future research will be conducted to understand determinants of these factors and develop a comprehensive set of capacity building strategies responsive to academic institutions in LMICs.

scholarly journals Identifying gaps in primary healthcare policy and governance in low-income and middle-income countries: protocol for an evidence gap map

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e024316 ◽  
Author(s):  
K M Saif-Ur-Rahman ◽  
Razib Mamun ◽  
Iqbal Anwar
Keyword(s):  
Systematic Reviews ◽  
Low Income ◽  
Primary Healthcare ◽  
Health Service Delivery ◽  
Bibliographic Databases ◽  
Future Research ◽  
Potential Contribution ◽  
Middle Income ◽  
Middle Income Countries ◽  
Social Mobilisation

IntroductionThere are gaps in the primary healthcare (PHC) delivery in majority of low-income and middle-income countries (LMICs) due to epidemiological transition, emergence of outbreaks or war, and often lack of governance. In LMICs, governance is always a less focused aspect, and often limited to the role of the authority despite potential contribution of other actors. It is evident that community engagement and social mobilisation of health service delivery result in better health outcomes. Even in case of systems failure, the need for PHC services is satisfied by individuals and communities in LMICs. Available evidence including systematic reviews on PHC governance is mostly from high-income countries and there is limited work in LMICs. This evidence gap map (EGM) is a systematic exploration to identify evidence gaps in PHC policy and governance in this region.Methods and analysisDifferent bibliographic databases were explored to retrieve available studies considering the time period between 1980 and 2017, and these were independently screened by two reviewers. Screened articles will be considered for full-text extraction based on prespecified criteria for inclusion and exclusion. A modified SURE (Supporting the Use of Research Evidence) checklist will be used to assess the quality of included systematic reviews. Overview of the findings will be provided in synthesised form. Identified interventions and outcomes will be plotted in a dynamic platform to develop a gap map.Ethics and disseminationFindings of the EGM will be published in a peer-reviewed journal in a separate manuscript. This EGM aims to explore the evidence gaps in PHC policy and governance in LMICs. Findings from the EGM will highlight the gaps in PHC to guide policy makers and researchers for future research planning and development of national strategies.PROSPERO registration numberCRD42018096883.

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