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Objective: Cluster randomised trials (CRTs) are used for evaluating health-related interventions in low-income and middle-income countries (LMICs) but raise complex ethical issues. To inform the development of future ethics guidance, we aim to characterise CRTs conducted exclusively in LMICs by examining the types of clusters, settings, author affiliations and primary clinical focus and to evaluate adherence to trial registration and ethics reporting requirements over time., Design: A systematic scoping review using the Preferred Reporting Items for Systematic Review and Meta-Analyses Extension for Scoping Reviews., Data Sources: We searched MEDLINE between 1 January 2017 and 17 August 2022., Eligibility Criteria for Selecting Studies: We included primary reports of CRTs evaluating health-related interventions, conducted exclusively in LMICs and published in English between 2017 and 2022., Data Extraction and Synthesis: Data were extracted by one reviewer; a second reviewer verified accuracy by extracting data from 10% of the reports. Results were summarised overall and categorised by country's economic level or publication year., Results: Among 800 identified CRTs, 400 (50.0%) randomised geographical areas and 373 (46.6%) were conducted in Africa. 30 (3.7%) had no authors with an LMIC affiliation, and 246 (30.8%) had neither first nor last author with an LMIC affiliation. The relative frequency of first or last authors holding an LMIC affiliation increases as a country's economic level increases. Most CRTs focused on reducing maternal and neonatal disorders (106, 13.3%). 670 (83.8%) CRTs reported trial registration, 786 (98.2%) reported research ethics committee review and 757 (94.6%) reported consent statements. Among the 757 CRTs, 46 (6.1%) reported a waiver or no consent and, among these, 10 (21.7%) did not provide a rationale. Gatekeepers were identified in 403 (50.4%) CRTs. No meaningful trends were observed in adherence to trial registration or ethics reporting requirements over time., Conclusion: Our findings suggest existing inequity in authorship practices. There is high adherence to trial registration and ethics reporting requirements, although greater attention to reporting a justification for using a waiver of consent is needed., Competing Interests: Competing interests: CW receives consulting income from Cardialen and Eli Lilly & Company. Other authors declare no competing interests., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Cluster randomised trials (CRTs) are a key instrument to evaluate public health interventions. Fidelity assessment examines study processes to gauge whether an intervention was delivered as initially planned. Evaluation of implementation fidelity (IF) is required to establish whether the measured effects of a trial are due to the intervention itself and may be particularly important for CRTs of complex interventions conducted in low- and middle-income countries (LMICs). However, current CRT reporting guidelines offer no guidance on IF assessment. The objective of this review was to study current practices concerning the assessment of IF in CRTs of public health interventions in LMICs., Methods: CRTs of public health interventions in LMICs that planned or reported IF assessment in either the trial protocol or the main trial report were included. The MEDLINE/PubMed, CINAHL and EMBASE databases were queried from January 2012 to May 2016. To ensure availability of a study protocol, CRTs reporting a registration number in the abstract were included. Relevant data were extracted from each study protocol and trial report by two researchers using a predefined screening sheet. Risk of bias for individual studies was assessed., Results: We identified 90 CRTs of public health interventions in LMICs with a study protocol in a publicly available trial registry published from January 2012 to May 2016. Among these 90 studies, 25 (28%) did not plan or report assessing IF; the remaining 65 studies (72%) addressed at least one IF dimension. IF assessment was planned in 40% (36/90) of trial protocols and reported in 71.1% (64/90) of trial reports. The proportion of overall agreement between the trial protocol and trial report concerning occurrence of IF assessment was 66.7% (60/90). Most studies had low to moderate risk of bias., Conclusions: IF assessment is not currently a systematic practice in CRTs of public health interventions carried out in LMICs. In the absence of IF assessment, it may be difficult to determine if CRT results are due to the intervention design, to its implementation, or to unknown or external factors that may influence results. CRT reporting guidelines should promote IF assessment., Trial Registration: Protocol published and available at: https://doi.org/10.1186/s13643-016-0351-0.

Equity monitoring is a priority for Gavi, the Vaccine Alliance, and for those implementing The 2030 agenda for sustainable development . For its new phase of operations, Gavi reassessed its approach to monitoring equity in vaccination coverage. To help inform this effort, we made a systematic analysis of inequalities in vaccination coverage across 45 Gavi-supported countries and compared results from different measurement approaches. Based on our findings, we formulated recommendations for Gavi's equity monitoring approach. The approach involved defining the vulnerable populations, choosing appropriate measures to quantify inequalities, and defining equity benchmarks that reflect the ambitions of the sustainable development agenda. In this article, we explain the rationale for the recommendations and for the development of an improved equity monitoring tool. Gavi's previous approach to measuring equity was the difference in vaccination coverage between a country's richest and poorest wealth quintiles. In addition to the wealth index, we recommend monitoring other dimensions of vulnerability (maternal education, place of residence, child sex and the multidimensional poverty index). For dimensions with multiple subgroups, measures of inequality that consider information on all subgroups should be used. We also recommend that both absolute and relative measures of inequality be tracked over time. Finally, we propose that equity benchmarks target complete elimination of inequalities. To facilitate equity monitoring, we recommend the use of a data display tool - the equity dashboard - to support decision-making in the sustainable development period. We highlight its key advantages using data from Côte d'Ivoire and Haiti.

Background: Birth Preparedness and Complication Readiness (BPCR) interventions are widely promoted by governments and international agencies to reduce maternal and neonatal health risks in developing countries; however, their overall impact is uncertain, and little is known about how best to implement BPCR at a community level. Our primary aim was to evaluate the impact of BPCR interventions involving women, families and communities during the prenatal, postnatal and neonatal periods to reduce maternal and neonatal mortality in developing countries. We also examined intervention impact on a variety of intermediate outcomes important for maternal and child survival., Methods: We conducted a systematic review and meta-analysis of randomized trials of BPCR interventions in populations of pregnant women living in developing countries. To identify relevant studies, we searched the scientific literature in the Pubmed, Embase, Cochrane library, Reproductive health library, CINAHL and Popline databases. We also undertook manual searches of article bibliographies and web sites. Study inclusion was based on pre-specified criteria. We synthesised data by computing pooled relative risks (RR) using the Cochrane RevMan software., Results: Fourteen randomized studies (292 256 live births) met the inclusion criteria. Meta-analyses showed that exposure to BPCR interventions was associated with a statistically significant reduction of 18% in neonatal mortality risk (twelve studies, RR = 0.82; 95% CI: 0.74, 0.91) and a non-significant reduction of 28% in maternal mortality risk (seven studies, RR = 0.72; 95% CI: 0.46, 1.13). Results were highly heterogeneous (I2 = 76%, p < 0.001 and I2 = 72%, p = 0.002 for neonatal and maternal results, respectively). Subgroup analyses of studies in which at least 30% of targeted women participated in interventions showed a 24% significant reduction of neonatal mortality risk (nine studies, RR = 0.76; 95% CI: 0.69, 0.85) and a 53% significant reduction in maternal mortality risk (four studies, RR = 0.47; 95% CI: 0.26, 0.87).Pooled results revealed that BPCR interventions were also associated with increased likelihood of use of care in the event of newborn illness, clean cutting of the umbilical cord and initiation of breastfeeding in the first hour of life., Conclusions: With adequate population coverage, BPCR interventions are effective in reducing maternal and neonatal mortality in low-resources settings.

Abstract Background The governments and citizens of the developed nations are increasingly called upon to contribute financially to health initiatives outside their borders. Although international development assistance for health has grown rapidly over the last two decades, austerity measures related to the 2008 and 2011 global financial crises may impact negatively on aid expenditures. The competition between national priorities and foreign aid commitments raises important ethical questions for donor nations. This paper aims to foster individual reflection and public debate on donor responsibilities for global health. Methods We undertook a critical review of contemporary accounts of justice. We selected theories that: (i) articulate important and widely held moral intuitions; (ii) have had extensive impact on debates about global justice; (iii) represent diverse approaches to moral reasoning; and (iv) present distinct stances on the normative importance of national borders. Due to space limitations we limit the discussion to four frameworks. Results Consequentialist, relational, human rights, and social contract approaches were considered. Responsibilities to provide international assistance were seen as significant by all four theories and place limits on the scope of acceptable national autonomy. Among the range of potential aid foci, interventions for health enjoyed consistent prominence. The four theories concur that there are important ethical responsibilities to support initiatives to improve the health of the worst off worldwide, but offer different rationales for intervention and suggest different implicit limits on responsibilities. Conclusions Despite significant theoretical disagreements, four influential accounts of justice offer important reasons to support many current initiatives to promote global health. Ethical argumentation can complement pragmatic reasons to support global health interventions and provide an important foundation to strengthen collective action.

Background Important inequalities in childhood vaccination coverage persist between countries and population groups. Understanding why some countries achieve higher and more equitable levels of coverage is crucial to redress these inequalities. In this study, we explored the country-level determinants of (1) coverage of the third dose of diphtheria-tetanus-pertussis- (DTP3) containing vaccine and (2) within-country inequalities in DTP3 coverage in 45 countries supported by Gavi, the Vaccine Alliance. Methods We used data from the most recent Demographic and Health Surveys (DHS) conducted between 2005 and 2014. We measured national DTP3 coverage and the slope index of inequality in DTP3 coverage with respect to household wealth, maternal education, and multidimensional poverty. We collated data on country health systems, health financing, governance and geographic and sociocultural contexts from published sources. We used meta-regressions to assess the relationship between these country-level factors and variations in DTP3 coverage and inequalities. To validate our findings, we repeated these analyses for coverage with measles-containing vaccine (MCV). Results We found considerable heterogeneity in DTP3 coverage and in the magnitude of inequalities across countries. Results for MCV were consistent with those from DTP3. Political stability, gender equality and smaller land surface were important predictors of higher and more equitable levels of DTP3 coverage. Inequalities in DTP3 coverage were also lower in countries receiving more external resources for health, with lower rates of out-of-pocket spending and with higher national coverage. Greater government spending on heath and lower linguistic fractionalization were also consistent with better vaccination outcomes. Conclusion Improving vaccination coverage and reducing inequalities requires that policies and programs address critical social determinants of health including geographic and social exclusion, gender inequality and the availability of financial protection for health. Further research should investigate the mechanisms contributing to these associations. [ABSTRACT FROM AUTHOR]

Background: Cluster randomised trials (CRTs) are a key instrument to evaluate public health interventions, particularly in low- and middle-income countries (LMICs). Fidelity assessment examines study processes to gauge whether an intervention was delivered as initially planned. Evaluation of implementation fidelity (IF) is required to establish whether the measured effects of a trial are due to the intervention itself and may be particularly important for CRTs of complex interventions. Current CRT reporting guidelines offer no guidance on IF assessment. We will systematically review the scientific literature to study current practices concerning the assessment of IF in CRTs of public health interventions in LMICs. Methods: We will include CRTs of public health interventions in LMICs that planned or assessed IF in either the trial protocol or the main trial report (or an associated document). Search strategies use Medical Subject Headings (MESH) and text words related to CRTs, developing countries, and public health interventions. The electronic database search was developed first for MEDLINE and adapted for the following databases: EMBASE, CINAHL, PubMed, and EMB Reviews, to identify CRT reports in English, Spanish, or French published on or after January 1, 2012. To ensure availability of a study protocol, we will include CRTs reporting a registration number in the abstract. For each included study, we will compare planned versus reported assessment of IF, and consider the dimensions of IF studied, and data collection methods used to evaluate each dimension. Data will be synthesised using quantitative and narrative techniques. Risk of bias for individual studies will be assessed using the Cochrane Collaboration Risk of Bias Tool criteria and additional criteria related to CRT methods. We will investigate possible sources of heterogeneity by performing subgroup analysis. This review was not eligible for inclusion in the PROSPERO registry. Discussion: Fidelity assessment may be a key tool for making studies more reliable, internally valid, and externally generalizable. This review will provide a portrait of current practices related to the assessment of intervention fidelity in CRTs and offer suggestions for improvement. Results will be relevant to researchers, those who finance health interventions, and for decision-makers who seek the best evidence on public health interventions. [ABSTRACT FROM AUTHOR]

Background: The global burden of child undernutrition is concentrated in South Asia, where gender inequality and female educational disadvantage are important factors. Maternal health literacy is linked to women's education and empowerment, can influence multiple malnutrition determinants, and is rapidly modifiable.Objective: This study investigated whether maternal health literacy is associated with child undernutrition in 2 resource-poor Indian populations.Methods: We conducted cross-sectional surveys in an urban and a rural site, interviewing 1 woman with a child aged 12-23 mo/household. Multivariate logistic regression analyses were conducted independently for each site. The main exposure was maternal health literacy. We assessed respondents' ability to understand, appraise, and apply health-related information with the use of Indian health promotion materials. The main outcomes were severe stunting, severe underweight, and severe wasting. We classified children as having a severe nutritional deficiency if their z score was <-3 SDs from the WHO reference population for children of the same age and sex. Analyses controlled for potential confounding factors including parental education and household wealth.Results: Rural and urban analyses included 1116 and 657 mother-child pairs, respectively. In each site, fully adjusted models showed that children of mothers with high health literacy had approximately half the likelihood of being severely stunted (rural adjusted OR: 0.50; 95% CI: 0.33, 0.74; P = 0.001; urban adjusted OR: 0.58; 95% CI: 0.35, 0.94; P = 0.028) or severely underweight (rural adjusted OR: 0.57; 95% CI: 0.38, 0.87; P = 0.009; urban adjusted OR: 0.48; 95% CI: 0.25, 0.91; P = 0.025) than children of mothers with low health literacy. Health literacy was not associated with severe wasting.Conclusions: In resource-poor rural and urban settings in India, maternal health literacy is associated with child nutritional status. Programs targeting health literacy may offer effective entry points for intervention. [ABSTRACT FROM AUTHOR]

Objective To investigate which strategies to increase demand for vaccination are effective in increasing child vaccine coverage in low- and middle-income countries. Methods We searched MEDLINE, EMBASE, Cochrane library, POPLINE, ECONLIT, CINAHL, LILACS, BDSP, Web of Science and Scopus databases for relevant studies, published in English, French, German, Hindi, Portuguese and Spanish up to 25 March 2014. We included studies of interventions intended to increase demand for routine childhood vaccination. Studies were eligible if conducted in low- and middle-income countries and employing a randomized controlled trial, non-randomized controlled trial, controlled before-and-after or interrupted time series design. We estimated risk of bias using Cochrane collaboration guidelines and performed random-effects meta-analysis. Findings We identified 11 studies comprising four randomized controlled trials, six cluster randomized controlled trials and one controlled before-and-after study published in English between 1996 and 2013. Participants were generally parents of young children exposed to an eligible intervention. Six studies demonstrated low risk of bias and five studies had moderate to high risk of bias. We conducted a pooled analysis considering all 11 studies, with data from 11 512 participants. Demand-side interventions were associated with significantly higher receipt of vaccines, relative risk (RR): 1.30, (95% confidence interval, CI: 1.17-1.44). Subgroup analyses also demonstrated significant effects of seven education and knowledge translation studies, RR: 1.40 (95% CI: 1.20-1.63) and of four studies which used incentives, RR: 1.28 (95% CI: 1.12-1.45). Conclusion Demand-side interventions lead to significant gains in child vaccination coverage in low- and middle-income countries. Educational approaches and use of incentives were both effective strategies. [ABSTRACT FROM AUTHOR]

Abstract: Measles supplementary immunization activities (SIAs) offer children in countries with weaker immunization delivery systems like India a second opportunity for measles vaccination. They could also provide a platform to deliver additional interventions, but the feasibility and acceptability of including add-ons is uncertain. We surveyed Indian programme officers involved in the current (2010–2012) measles SIAs concerning opportunities and challenges of using SIAs as a delivery platform for other maternal and child health interventions. Respondents felt that an expanded SIA strategy including add-ons could be of great value in improving access and efficiency. They viewed management challenges, logistics, and safety as the most important potential barriers. They proposed that additional interventions be selected using several criteria, of which importance of the health problem, safety, and contribution to health equity figured most prominently. For children, they recommended inclusion of basic interventions to address nutritional deficiencies, diarrhoea and parasites over vaccines. For mothers, micronutrient interventions were highest ranked. [Copyright &y& Elsevier]

Background: Although highly effective prevention interventions exist, the epidemic of paediatric HIV continues to challenge control efforts in resource-limited settings. We reviewed the cost-effectiveness of interventions to prevent mother-to-child transmission (MTCT) of HIV in low- and middle-income countries (LMICs). This article presents syntheses of evidence on the costs, effects and cost-effectiveness of HIV MTCT strategies for LMICs from the published literature and evaluates their implications for policy and future research. Methods: Candidate studies were identified through a comprehensive database search including PubMed, Embase, Cochrane Library, and EconLit restricted by language (English or French), date (January 1st, 1994 to January 17th, 2011) and article type (original research). Articles reporting full economic evaluations of interventions to prevent or reduce HIV MTCT were eligible for inclusion. We searched article bibliographies to identify additional studies. Two authors independently assessed eligibility and extracted data from studies retained for review. Study quality was appraised using a modified BMJ checklist for economic evaluations. Data were synthesised in narrative form. Results: We identified 19 articles published in 9 journals from 1996 to 2010, 16 concerning sub-Saharan Africa. Collectively, the articles suggest that interventions to prevent paediatric infections are cost-effective in a variety of LMIC settings as measured against accepted international benchmarks. In concentrated epidemics where HIV prevalence in the general population is very low, MTCT strategies based on universal testing of pregnant women may not compare well against cost-effectiveness benchmarks, or may satisfy formal criteria for cost-effectiveness but offer a low relative value as compared to competing interventions to improve population health. Conclusions and Recommendations: Interventions to prevent HIV MTCT are compelling on economic grounds in many resource-limited settings and should remain at the forefront of global HIV prevention efforts. Future cost-effectiveness analyses can help to ensure that pMTCT interventions for LMICs reach their full potential by focussing on unanswered questions in four areas: local assessment of rapidly evolving HIV MTCT options; strategies to improve coverage and reach underserved populations; evaluation of a more comprehensive set of MTCT approaches including primary HIV prevention and reproductive counselling; integration of HIV MTCT and other sexual and reproductive health services. [ABSTRACT FROM AUTHOR]

Objectives (1) To conduct a systematic analysis of inequalities in childhood vaccination coverage in Gavi-supported countries; (2) to comparatively assess alternative measurement approaches and how they may affect cross-country comparisons of the level of inequalities. Methods Using the most recent Demographic and Health Surveys (2005–2014) in 45 Gavi-supported countries, we measured inequalities in vaccination coverage across seven dimensions of social stratification and of vulnerability to poor health outcomes. We quantified inequalities using pairwise comparisons (risk differences and ratios) and whole spectrum measures (slope and relative indices of inequality). To contrast measurement approaches, we pooled the estimates using random-effects meta-analyses, ranked countries by the magnitude of inequality and compared agreement in country ranks. Results At the aggregate level, maternal education, multidimensional poverty, and wealth index poverty were the dimensions associated with the largest inequalities. In 36 out of 45 countries, inequalities were substantial, with a difference in coverage of 10 percentage points or more between the top and bottom of at least one of these social dimensions. Important inequalities by child sex, child malnutrition and urban/rural residence were also found in a smaller set of countries. The magnitude of inequality and ranking of countries differed across dimension and depending on the measure used. Pairwise comparisons could not be estimated in certain countries. The slope and relative indices of inequality were estimated in all countries and produced more stable country rankings, and should thus facilitate more reliable international comparisons. Conclusions Inequalities in vaccination coverage persist in a large majority of Gavi-supported countries. Inequalities should be monitored across multiple dimensions of vulnerability. Using whole spectrum measures to quantify inequality across multiple ordered social groups has important advantages. We illustrate these findings using an equity dashboard designed to support decision-making in the Sustainable Development Goals period. [ABSTRACT FROM AUTHOR]