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Ethical challenges in global research on health system responses to violence against women: a qualitative study of policy and professional perspectives.
Get PDFBACKGROUND: Studying global health problems requires international multidisciplinary teams. Such multidisciplinarity and multiculturalism create challenges in adhering to a set of ethical principles across different country contexts. Our group on health system responses to violence against women (VAW) included two universities in a European high-income country (HIC) and four universities in low-and middle-income countries (LMICs). This study aimed to investigate professional and policy perspectives on the types, causes of, and solutions to ethical challenges specific to the ethics approval stage of the global research projects on health system responses to VAW. METHODS: We used the Network of Ethical Relationships model, framework method, and READ approach to analyse qualitative semi-structured interviews (n = 18) and policy documents (n = 27). In March-July 2021, we recruited a purposive sample of researchers and members of Research Ethics Committees (RECs) from the five partner countries. Interviewees signposted policies and guidelines on research ethics, including VAW. RESULTS: We developed three themes with eight subthemes summarising ethical challenges across three contextual factors. The global nature of the group contributed towards power and resource imbalance between HIC and LMICs and differing RECs' rules. Location of the primary studies within health services highlighted differing rules between university RECs and health authorities. There were diverse conceptualisations of VAW and vulnerability of research participants between countries and limited methodological and topic expertise in some LMIC RECs. These factors threatened the timely delivery of studies and had a negative impact on researchers and their relationships with RECs and HIC funders. Most researchers felt frustrated and demotivated by the bureaucratised, uncoordinated, and lengthy approval process. Participants suggested redistributing power and resources between HICs and LMICs, involving LMIC representatives in developing funding agendas, better coordination between RECs and health authorities and capacity strengthening on ethics in VAW research. CONCLUSIONS: The process of ethics approval for global research on health system responses to VAW should be more coordinated across partners, with equal power distribution between HICs and LMICs, researchers and RECs. While some of these objectives can be achieved through education for RECs and researchers, the power imbalance and differing rules should be addressed at the institutional, national, and international levels. Three of the authors were also research participants, which had potential to introduce bias into the findings. However, rigorous reflexivity practices mitigated against this. This insider perspective was also a strength, as it allowed us to access and contribute to more nuanced understandings to enhance the credibility of the findings. It also helped to mitigate against unequal power dynamics
Artificial Intelligence-Based Radiotherapy Contouring and Planning to Improve Global Access to Cancer Care.
Get PDFPURPOSE: Increased automation has been identified as one approach to improving global cancer care. The Radiation Planning Assistant (RPA) is a web-based tool offering automated radiotherapy (RT) contouring and planning to low-resource clinics. In this study, the RPA workflow and clinical acceptability were assessed by physicians around the world. METHODS: The RPA output for 75 cases was reviewed by at least three physicians; 31 radiation oncologists at 16 institutions in six countries on five continents reviewed RPA contours and plans for clinical acceptability using a 5-point Likert scale. RESULTS: For cervical cancer, RPA plans using bony landmarks were scored as usable as-is in 81% (with minor edits 93%); using soft tissue contours, plans were scored as usable as-is in 79% (with minor edits 96%). For postmastectomy breast cancer, RPA plans were scored as usable as-is in 44% (with minor edits 91%). For whole-brain treatment, RPA plans were scored as usable as-is in 67% (with minor edits 99%). For head/neck cancer, the normal tissue autocontours were acceptable as-is in 89% (with minor edits 97%). The clinical target volumes (CTVs) were acceptable as-is in 40% (with minor edits 93%). The volumetric-modulated arc therapy (VMAT) plans were acceptable as-is in 87% (with minor edits 96%). For cervical cancer, the normal tissue autocontours were acceptable as-is in 92% (with minor edits 99%). The CTVs for cervical cancer were scored as acceptable as-is in 83% (with minor edits 92%). The VMAT plans for cervical cancer were acceptable as-is in 99% (with minor edits 100%). CONCLUSION: The RPA, a web-based tool designed to improve access to high-quality RT in low-resource settings, has high rates of clinical acceptability by practicing clinicians around the world. It has significant potential for successful implementation in low-resource clinics
Effect of lipid-based nutrient supplements on micronutrient status and hemoglobin among children with stunting: secondary analysis of a randomized controlled trial in Uganda.
Get PDFBACKGROUND: Micronutrient deficiencies and anemia are widespread among children with stunting. OBJECTIVES: We assessed the effects of lipid-based nutrient supplements (LNS) containing milk protein (MP) and/or whey permeate (WP) on micronutrient status and hemoglobin (Hb) among children with stunting. METHODS: This was a secondary analysis of a randomized controlled trial. Children aged 12-59 mo with stunting were randomly assigned to LNS (100 g/d) with milk or soy protein and WP or maltodextrin for 12 wk, or no supplement. Hb, serum ferritin (S-FE), serum soluble transferrin receptor (S-TfR), plasma cobalamin (P-Cob), plasma methylmalonic acid (P-MMA), plasma folate (P-Fol), and serum retinol-binding protein (S-RBP) were measured at inclusion and at 12 wk. Data were analyzed using linear and logistic mixed-effects models. RESULTS: Among 750 children, with mean age ± SD of 32 ± 11.7 mo, 45% (n = 338) were female and 98% (n = 736) completed follow-up. LNS, compared with no supplementation, resulted in 43% [95% confidence interval (CI): 28, 60] greater increase in S-FE corrected for inflammation (S-FEci), 2.4 (95% CI: 1.2, 3.5) mg/L greater decline in S-TfR, 138 (95% CI: 111, 164) pmol/L greater increase in P-Cob, 33% (95% CI: 27, 39) reduction in P-MMA, and 8.5 (95% CI: 6.6, 10.3) nmol/L greater increase in P-Fol. There was no effect of LNS on S-RBP. Lactation modified the effect of LNS on markers of cobalamin status, reflecting improved status among nonbreastfed and no effects among breastfed children. LNS increased Hb by 3.8 (95% CI: 1.7, 6.0) g/L and reduced the odds of anemia by 55% (odds ratio: 0.45, 95% CI: 0.29, 0.70). MP compared with soy protein increased S-FEci by 14% (95% CI: 3, 26). CONCLUSIONS: LNS supplementation increases Hb and improves iron, cobalamin, and folate status, but not vitamin A status among children with stunting. LNS should be considered for children with stunting. This trial was registered at ISRCTN as 13093195
Impact of the COVID-19 pandemic on the real-world diagnostic infrastructure for tuberculosis-An ESGMYC collaborative study.
Get PDFWe determined the impact of the COVID-19 pandemic on mycobacterial diagnostic services. 40 laboratories from 22 countries completed an online questionnaire covering the redeployment of the laboratory infrastructure and/or staff for SARS-CoV-2 testing, staff shortages and supply chain disruptions. 28 laboratories reported monthly numbers of samples processed for mycobacterial investigations and monthly numbers of M. tuberculosis complex (MTBC) PCRs performed between October 1st 2018 and October 31st 2020. More than half (23/40) of the participating TB laboratories reported having performed COVID-19 diagnostics in the early phase of the pandemic, in part with negative impact on the mycobacterial service activities. All participating laboratories reported shortages of consumables and laboratory equipment due to supply chain issues. Average monthly sample numbers decreased by 24% between January 2020 and October 2020 compared to pre-pandemic averages. At the end of the study period, most participating laboratories had not returned to pre-pandemic average MTBC PCR throughput
A story of (in)coherence: climate adaptation for health in South African policies.
Get PDFClimate adaptation strengthens and builds the resilience of health systems to future climate-related shocks. Adaptation strategies and policies are necessary tools for governments to address the long-term impacts of climate change and enable the health system to respond to current impacts such as extreme weather events. Since 2011 South Africa has national climate change policies and adaptation strategies, yet there is uncertainty about: how these policies and plans are executed; the extent to which health policies include adaptation; and the extent of policy coherence across sectors and governance levels. A policy document analysis was conducted to examine how South African climate change, development and health policy documents reflect the health adaptation response across national and Western Cape levels and to assess the extent of coherence across key health and environment sector policy documents, including elements to respond to health-related climate risks, that can support implementation. Our findings show that overall there is incoherence in South African climate adaptation within health policy documents. Although health adaptation measures are somewhat coherent in national level policies, there is limited coherence within Western Cape provincial level documents and limited discussion on climate adaptation, especially for health. Policies reflect formal decisions and should guide decision-makers and resourcing, and sectoral policies should move beyond mere acknowledgement of adaptation responses to a tailored plan of actions that are institutionalized and location and sector specific. Activities beyond documents also impact the coherence and implementation of climate adaptation for health in South Africa. Clear climate risk-specific documents for the health sector would provide a stronger plan to support the implementation of health adaptation and contribute to building health system's resilience
Artificial intelligence-supported diabetic retinopathy screening in Tanzania: rationale and design of a randomised controlled trial.
Get PDFINTRODUCTION: Globally, diabetic retinopathy (DR) is a major cause of blindness. Sub-Saharan Africa is projected to see the largest proportionate increase in the number of people living with diabetes over the next two decades. Screening for DR is recommended to prevent sight loss; however, in many low and middle-income countries, because of a lack of specialist eye care staff, current screening services for DR are not optimal. The use of artificial intelligence (AI) for DR screening, which automates the grading of retinal photographs and provides a point-of-screening result, offers an innovative potential solution to improve DR screening in Tanzania. METHODS AND ANALYSIS: We will test the hypothesis that AI-supported DR screening increases the proportion of persons with true referable DR who attend the central ophthalmology clinic following referral after screening in a single-masked, parallel group, individually randomised controlled trial. Participants (2364) will be randomised (1:1 ratio) to either AI-supported or the standard of care DR screening pathway. Participants allocated to the AI-supported screening pathway will receive their result followed by point-of-screening counselling immediately after retinal image capture. Participants in the standard of care arm will receive their result and counselling by phone once the retinal images have been graded in the usual way (typically after 2-4 weeks). The primary outcome is the proportion of persons with true referable DR attending the central ophthalmology clinic within 8 weeks of screening. Secondary outcomes, by trial arm, include the proportion of persons attending the central ophthalmology clinic out of all those referred, sensitivity and specificity, number of false positive referrals, acceptability and fidelity of AI-supported screening. ETHICS AND DISSEMINATION: The London School of Hygiene & Tropical Medicine, Kilimanjaro Christian Medical Centre and Tanzanian National Institute of Medical Research ethics committees have approved the trial. The results will be submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: ISRCTN18317152
A new neonatal BCG vaccination pathway in England: a mixed methods evaluation of its implementation.
Get PDFINTRODUCTION: The introduction of a national evaluation of newborn screening for Severe Combined Immunodeficiency (SCID) in England triggered a change to the selective Bacillus Calmette-Guerin (BCG) vaccination programme delivery pathway, as this live attenuated vaccine is contraindicated in infants with SCID. The neonatal BCG vaccination programme is a targeted programme for infants at increased risk of tuberculosis and used to be offered shortly after birth. Since September 2021 the BCG vaccine is given to eligible infants within 28 days of birth, when the SCID screening outcome is available. We explore the experiences of those implementing the new pathway, and how they made sense of, engaged with, and appraised the change. METHODS: A mixed-methods evaluation was conducted between October 2022 and February 2023. This involved national online surveys with BCG commissioners and providers and qualitative semi-structured interviews with commissioners, providers, and Child Health Information System stakeholders in two urban areas. Survey data was analysed using descriptive statistics and interview data was analysed thematically. The data was triangulated using Normalization Process Theory as a guiding framework. RESULTS: Survey respondents (n = 65) and qualitative interviewees (n = 16) revealed that making sense of the new pathway was an iterative process. Some expressed a desire for more direction on how to implement the new pathway. The perceived value of the change varied from positive, ambivalent, to concerned. Some felt well-prepared and that improvements to data capture, eligibility screening, and accountably brought by the change were valuable. Others were concerned about the feasibility of the 28-day target, reductions in vaccination coverage, increased resource burden, and the outcome of the SCID evaluation. New collaborations and communities of practice were required to facilitate the change. Three main challenges in implementing the pathway and meeting the 28-day vaccination target were identified: appointment non-attendance; appointment and data systems; and staffing and resourcing. Feedback mechanisms were informal and took place in tandem with implementation. CONCLUSION: The new NHS neonatal BCG service specification has created an effective structure for monitoring and managing the BCG vaccination programme, but further work is required to support delivery of the 28-day vaccination target and improve uptake rates
Implementing and evaluating integrated care models for non-communicable diseases in fragile and humanitarian settings.
Get PDFIn this commentary, we advocate for the wider implementation of integrated care models for NCDs within humanitarian preparedness, response, and resilience efforts. Since experience and evidence on integrated NCD care in humanitarian settings is limited, we discuss potential benefits, key lessons learned from other settings, and lessons from the integration of other conditions that may be useful for stakeholders considering an integrated model of NCD care. We also introduce our ongoing project in North Lebanon as a case example currently undergoing parallel tracks of program implementation and process evaluation that aims to strengthen the evidence base on implementing an integrated NCD care model in a crisis setting
Effective coverage of antenatal care services in Ethiopia: a population-based cross-sectional study.
Get PDFBACKGROUND: Antenatal care (ANC) is a principal component of safe motherhood and reproductive health strategies across the continuum of care. Although the coverage of antenatal care visits has increased in Ethiopia, there needs to be more evidence of effective coverage of antenatal care. The 'effective coverage' concept can pinpoint where action is required to improve high-quality coverage in Ethiopia. Effective coverage indicates a health system's performance by incorporating need, utilization, and quality into a single measurement. The concept includes the number of contacts, facility readiness, interventions received, and components of services received. This study aimed to measure effective antenatal care coverage in Ethiopia. METHODS: A two-stage cluster sampling method was used and included 2714 women aged 15-49 years and 462 health facilities from six Ethiopian regions from October 2019 to January 2020. The effective coverage cascade was analyzed among the targeted women by computing the proportion who received four or more antenatal care visits where the necessary inputs were available, received iron-folate supplementation and two doses of tetanus vaccination according to process quality components of antenatal care services. RESULTS: Of all women, 40% (95%CI; 38, 43) had four or more visits, ranging from 3% in Afar to 74% in Addis Ababa. The overall mean health facility readiness score of the facilities serving these women was 70%, the vaccination and iron-folate supplementation coverage was 26%, and the ANC process quality was 64%. As reported by women, the least score was given to the quality component of discussing birth preparedness and complication readiness with providers. In the effective coverage cascade, the input-adjusted, intervention-adjusted, and quality-adjusted antenatal coverage estimates were 28%, 18%, and 12%, respectively. CONCLUSION: The overall effective ANC coverage was low, primarily due to a considerable drop in the proportion of women who completed four or more ANC visits. Improving quality of services is crucial to increase ANC up take and completion of the recommended visits along with interventions increasing women's awareness
Novel point-of-care cytokine biomarker lateral flow test for the screening for sexually transmitted infections and bacterial vaginosis: study protocol of a multicentre multidisciplinary prospective observational clinical study to evaluate the performance and feasibility of the Genital InFlammation Test (GIFT).
Get PDFINTRODUCTION: A prototype lateral flow device detecting cytokine biomarkers interleukin (IL)-1α and IL-1β has been developed as a point-of-care test-called the Genital InFlammation Test (GIFT)-for detecting genital inflammation associated with sexually transmitted infections (STIs) and/or bacterial vaginosis (BV) in women. In this paper, we describe the rationale and design for studies that will be conducted in South Africa, Zimbabwe and Madagascar to evaluate the performance of GIFT and how it could be integrated into routine care. METHODS AND ANALYSIS: We will conduct a prospective, multidisciplinary, multicentre, cross-sectional and observational clinical study comprising two distinct components: a biomedical ('diagnostic study') and a qualitative, modelling and economic ('an integration into care study') part. The diagnostic study aims to evaluate GIFT's performance in identifying asymptomatic women with discharge-causing STIs (Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG)) and BV. Study participants will be recruited from women attending research sites and family planning services. Several vaginal swabs will be collected for the evaluation of cytokine concentrations (ELISA), STIs (nucleic acid amplification tests), BV (Nugent score) and vaginal microbiome characteristics (16S rRNA gene sequencing). The first collected vaginal swab will be used for the GIFT assay which will be performed in parallel by a healthcare worker in the clinic near the participant, and by a technician in the laboratory. The integration into care study aims to explore how GIFT could be integrated into routine care. Four activities will be conducted: user experiences and/or perceptions of the GIFT device involving qualitative focus group discussions and in-depth interviews with key stakeholders; discrete choice experiments; development of a decision tree classification algorithm; and economic evaluation of defined management algorithms. ETHICS AND DISSEMINATION: Findings will be reported to participants, collaborators and local government for the three sites, presented at national and international conferences, and disseminated in peer-reviewed publications.The protocol and all study documents such as informed consent forms were reviewed and approved by the University of Cape Town Human Research Ethics Committee (HREC reference 366/2022), Medical Research Council of Zimbabwe (MRCZ/A/2966), Comité d'Ethique pour la Recherche Biomédicale de Madagascar (N° 143 MNSAP/SG/AMM/CERBM) and the London School of Hygiene and Tropical Medicine ethics committee (LSHTM reference 28046).Before the start, this study was submitted to the Clinicaltrials.gov public registry (NCT05723484). TRIAL REGISTRATION NUMBER: NCT05723484