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Not receiving a DPT-containing vaccine in early childhood indicates an absence of routine immunization, which puts children at an elevated risk of mortality, morbidity, and worse human development over the life course. We estimated the percentage of children 12-35 months who did not receive a dose of DPT-containing vaccine (termed zero-dose children) using household surveys from 81 low- and middle-income countries conducted between 2014 and 2023. For 68 countries with more than one survey (with the earlier survey conducted 2000-2013), we estimated the average annual percentage point change in prevalence of zero-dose children between the earliest and latest surveys. We also explored the association of zero-dose prevalence with postneonatal and child mortality, health expenditure, and Gavi-eligibility. Overall, 16% of children in our pooled sample had not received a dose of DPT-containing vaccine. There was a 0.8% point decline in zero-dose prevalence per year on average across the period studied. A single percentage point average annual decline in zero-dose prevalence was associated with an average annual decrease of 1.4 deaths in the postneonatal and childhood period per 1000 live births. Gavi-eligible countries had a much faster decline in zero-dose prevalence than other countries. Large gains have been made in reducing the percentage of children who did not receive a DPT-containing vaccine. Efforts to reduce the number of zero-dose children should focus on countries with high prevalence to achieve the Immunization Agenda 2030. Healthcare spending could be prioritized so that the prevalence of zero-dose children is reduced., (© 2024. The Author(s).)

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.)

The study explored women's experiences of their community reintegration process after surgical repair of obstetric fistula at Jean Paul 2 Hospital in Conakry, Guinea. The study examined how lived experiences of the disease impacted on the community reintegration of treated women. Using a qualitative research methodology, ten women participated after giving informed consent. Semi- structured interviews, lasting an average of 30 to 60 minutes were guided by an interview guide. The main themes covered were experiences with the disease, perceived social support and reintegration into the community. According to the participants, delays in obstetric care were the main cause of obstetric fistula. Socio- economic, cultural and medical factors such as early marriage, lack of education and poverty contributed to these delays. Even after surgical repair, women continued to endure the physical and psychosocial consequences of the disease, exposing them to stigma, discrimination and even rejection within the community. Study participants also reported a lack of social support. The little support perceived by these women concerned food and medical needs. This made the women dependent on their families. Reintegration into the community also proved difficult due to the persistent silence and stigma surrounding their situation. The study results highlight the complexity of the challenges faced by women with obstetric fistula in their journey towards integration. Effective management of obstetric fistula requires a holistic approach victims, their communities, health professionals and decision-makers in solving this problem. So, to improve women's reintegration after treatment for obstetric fistula, it is vital to raise awareness of the causes and consequences of the disease among the women concerned and their families, and to provide rapid access to emergency obstetric care, reinforce social support and set up economic empowerment programs., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Kaba et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Promotive social protection programs aim to increase income and capabilities and could help address structural drivers of HIV-vulnerability like poverty, lack of education and gender inequality. Unemployed and out-of-school young women bear the brunt of HIV infection in Botswana, but rarely benefit from such economic empowerment programs. Using a qualitative exploratory study design and a participatory research approach, we explored factors affecting perceived program benefit and potential solutions to barriers. Direct stakeholders (n = 146) included 87 unemployed and out-of-school young women and 59 program and technical officers in five intervention districts. Perceived barriers were identified in 20 semi-structured interviews (one intervention district) and 11 fuzzy cognitive maps. Co-constructed improvement recommendations were generated in deliberative dialogues. Analysis relied on Framework and the socioecological model. Overall, participants viewed existing programs in Botswana as ineffective and inadequate to empower vulnerable young women socially or economically. Factors affecting perceived program benefit related to programs, program officers, the young women, and their social and structural environment. Participants perceived barriers at every socioecological level. Young women's lack of life and job skills, unhelpful attitudes, and irresponsible behaviors were personal-level barriers. At an interpersonal level, competing care responsibilities, lack of support from boyfriends and family, and negative peer influence impeded program benefit. Traditional venues for information dissemination, poverty, inequitable gender norms, and lack of coordination were community- and structural-level barriers. Improvement recommendations focused on improved outreach and peer approaches to implement potential solutions. Unemployed and out-of-school young women face multidimensional, interacting barriers that prevent benefit from available promotive social protection programs in Botswana. To become HIV-sensitive, these socioeconomic empowerment programs would need to accommodate or preferentially attract this key population. This requires more generous and comprehensive programs, a more client-centered program delivery, and improved coordination. Such structural changes require a holistic, intersectoral approach to HIV-sensitive social protection., Competing Interests: The authors have declared no competing interest exist., (Copyright: © 2024 van der Wal et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Background: Women with a previous caesarean delivery face a difficult choice in their next pregnancy: planning another caesarean or attempting vaginal delivery, both of which are associated with potential maternal and perinatal complications. This trial aimed to assess whether a multifaceted intervention, which promoted person-centred decision making and best practices, would reduce the risk of major perinatal morbidity among women with one previous caesarean delivery., Methods: We conducted an open, multicentre, cluster-randomised, controlled trial of a multifaceted 2-year intervention in 40 hospitals in Quebec among women with one previous caesarean delivery, in which hospitals were the units of randomisation and women the units of analysis. Randomisation was stratified according to level of care, using blocked randomisation. Hospitals were randomly assigned (1:1) to the intervention group (implementation of best practices and provision of tools that aimed to support decision making about mode of delivery, including an estimation of the probability of vaginal delivery and an ultrasound estimation of the risk of uterine rupture), or the control group (no intervention). The primary outcome was a composite risk of major perinatal morbidity. This trial was registered with ISRCTN, ISRCTN15346559., Findings: 21 281 eligible women delivered during the study period, from April 1, 2016 to Dec 13, 2019 (10 514 in the intervention group and 10 767 in the control group). None were lost to follow-up. There was a significant reduction in the rate of major perinatal morbidity from the baseline period to the intervention period in the intervention group as compared with the control group (adjusted odds ratio [OR] for incremental change over time, 0·72 [95% CI 0·52-0·99]; p=0·042; adjusted risk difference -1·2% [95% CI -2·0 to -0·1]). Major maternal morbidity was significantly reduced in the intervention group as compared with the control group (adjusted OR 0·54 [95% CI 0·33-0·89]; p=0·016). Minor perinatal and maternal morbidity, caesarean delivery, and uterine rupture rates did not differ significantly between groups., Interpretation: A multifaceted intervention supporting women in their choice of mode of delivery and promoting best practices resulted in a significant reduction in rates of major perinatal and maternal morbidity, without an increase in the rate of caesarean or uterine rupture., Funding: Canadian Institutes of Health Research (CIHR, MOP-142448)., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved.)

Background While immunization programs across the world have made considerable progress, children and communities continue to be beyond the reach of healthcare services. Globally, they are now referred to as zero-dose (ZD) children (those who have not received a single dose of diphtheria, pertussis, and tetanus-containing vaccine). Pre-COVID-19 pandemic analyses suggest that nearly 50% of vaccine-preventable deaths occur among ZD children. Two-thirds of these children live in extremely poor households suffering from multiple deprivations including lack of access to reproductive health services, water, and sanitation. Hence, ZD children have now been prioritized as a key cohort for identification and integration with the health systems as we build back from the pandemic. Methodology Extracting data from the last two National Family Health Survey (NFHS) rounds (NFHS 4, 2015-2016 and NFHS 5, 2019-2021), this study aims to ascertain the status of ZD children aged 12-23 months in India, the challenges, and the necessary action agenda going forward. Data were analyzed for equity determinants such as gender, place of residence, religion, birth order, caste, and mother's schooling. Key determinants included the change in ZD prevalence at the national, state, and district levels; variations across equity parameters and states with maximum improvements; and disparity across these indicators. A correlation analysis was also conducted to understand the nature of the association between ZD prevalence and critical maternal and child health indicators. Results The overall ZD prevalence between the two rounds was reduced by 4.1% (10.5-6.4%). A total of 26 states in the country reported a ZD prevalence of <10% in NFHS 5 compared to 18 in NFHS 4. In total, 324 districts reported a ZD prevalence of <5%, and 145 districts reported a prevalence of >10%. The equity parameters reflected a slow-footed reduction among ZD for girl children, across urban geographies, firstborn children, mothers with 12 or more years of schooling, and children in families with the highest wealth quintiles. A negative correlation accentuated between the two NFHS rounds was established between first-trimester registration, four or more antenatal visits, institutional deliveries, and ZD prevalence. Conclusions The findings point toward sustained improvement across key equity parameters, however, challenges do exist. Moreover, the impact of the pandemic on immunization programs across the globe and in India is bound to halt and reverse the progress and potentiate further inequities. It is thus imperative that continued and augmented efforts are continued to identify, integrate, and immunize ZD children, families, and communities., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Taneja et al.)

Reaching zero-dose (ZD) children, operationally defined as children who have not received a first dose of the diphtheria, tetanus, and pertussis (DTP1) vaccine, is crucial to increase equitable immunisation coverage and access to primary health care. However, little is known about the approaches already taken by countries to improve immunisation equity. We reviewed all Health System Strengthening (HSS) proposals submitted by Gavi-supported countries from 2014 to 2021 inclusively and extracted information on interventions favouring equity. Pro-equity interventions were mapped to an analytical framework representing Gavi 5.0 programmatic guidance on reaching ZD children and missed communities. Data from keyword searches and manual screening were extracted into an Excel database. Open format responses were analysed using inductive and deductive thematic coding. Data analysis was conducted using Excel and R. Of the 56 proposals included, 51 (91%) included at least one pro-equity intervention. The most common interventions were conducting outreach sessions, tailoring the location of service delivery, and partnerships. Many proposals had "bundles" of interventions, most often involving outreach, microplanning and community-level education activities. Nearly half prioritised remote-rural areas and only 30% addressed gender-related barriers to immunisation. The findings can help identify specific interventions on which to focus future evidence syntheses, case studies and implementation research and inform discussions on what may or may not need to change to better reach ZD children and missed communities moving forward.

Importance: Children who do not receive any routine vaccinations (ie, who have 0-dose status) are at elevated risk of death, morbidity, and socioeconomic vulnerabilities that limit their development over the life course. India has the world's highest number of children with 0-dose status; analysis of national and subnational patterns is the first important step to addressing this problem., Objectives: To examine the patterns among children with 0-dose immunization status across all 36 states and union territories (UTs) in India over 29 years, from 1993 to 2021, and to elucidate the relative share of multiple geographic regions in the total geographic variation in 0-dose immunization., Design, Setting, and Participants: This repeated cross-sectional study analyzed all 5 rounds of India's National Family Health Survey (1992-1993, 1998-1999, 2005-2006, 2015-2016, and 2019-2021) to compare the prevalence of children with 0-dose status across time-space and geographic regions. The Integrated Public Use of Microdata Series was used to construct comparable geographic boundaries for states and UTs across surveys. The study included a total of 125 619 live children aged 12 to 23 months who were born to participating women., Main Outcomes and Measures: The outcome was a binary indicator of children's 0-dose vaccination status, coded as children aged 12 to 23 months at the time of the survey who had not received the first dose of the diphtheria-tetanus-pertussis-containing vaccine. The significance of each geographic unit was computed using the variance partition coefficient (VPC)., Results: Among 125 619 children, the national prevalence of those with 0-dose status in India decreased from 33.4% (95% CI, 32.5%-34.2%) in 1993 to 6.6% (95% CI, 6.4%-6.8%) in 2021. A substantial reduction in the IQR of 0-dose prevalence across states from 30.1% in 1993 to 3.1% in 2021 suggested a convergence in state disparities. The prevalence in the northeastern states of Meghalaya (17.0%), Nagaland (16.1%), Mizoram (14.3%), and Arunachal Pradesh (12.6%) remained relatively high in 2021. Prevalence increased between 2016 and 2021 in 10 states, including several traditionally high-performing states and UTs, such as Telangana (1.16 percentage points) and Sikkim (0.92 percentage points). In 2021, 53.0% of children with 0-dose status resided in the populous states of Uttar Pradesh, Bihar, and Maharashtra. A multilevel analysis comparing the share of variation at the state, district, and cluster (primary sampling unit) levels revealed that clusters accounted for the highest share of the total variation in 2016 (44.7%; VPC [SE], 1.04 [0.32]) and 2021 (64.3%; VPC [SE], 0.38 [0.12])., Conclusions and Relevance: In this cross-sectional study, findings from approximately 3 decades of analysis suggest the need for sustained efforts to target populous states like Uttar Pradesh and Bihar and northeastern parts of India. The resurgence of 0-dose prevalence in 10 states highlights the importance of programs like Intensified Mission Indradhanush 4.0, a major national initiative to improve immunization coverage. Prioritizing small administrative units will be important to strengthening India's efforts to bring every child into the immunization regime.

Objective: To document the evolution of socioeconomic and geographical inequalities in childhood vaccination in Mexico from 2012 to 2021., Methods: Repeated cross-sectional analysis using three rounds of National Health and Nutrition Surveys (2012, 2018, and 2021). Dichotomous variables were created to identify the proportion of children who received no dose of each vaccine included in the national immunization schedule (BCG; diphtheria, pertussis, and tetanus-containing; rotavirus; pneumococcal conjugate; and measles, mumps, and rubella [MMR]), and the proportion completely unvaccinated. The distribution of unvaccinated children was analyzed by state, and by socioeconomic status using the concentration index., Results: The prevalence of completely unvaccinated children in Mexico was low, with 0.3% children in 2012 and 0.8% children in 2021 receiving no vaccines ( p = 0.070). Notwithstanding, for each vaccine, an important proportion of children missed receiving any dose. Notably, the prevalence of MMR unvaccinated children was 10.2% (95% CI 9.2-11.1) in 2012, 22.3% (95% CI 20.9-23.8) in 2018, and 29.1% (95% CI 26.3-31.8) in 2021 ( p < 0.001 for the difference between 2012 and 2021). The concentration index indicated pro-rich inequalities in non-vaccination for 2 of 5 vaccines in 2012, 3 of 5 vaccines in 2018, and 4 of 5 vaccines in 2021. There were marked subnational variations. The percentage of MMR unvaccinated children ranged from 3.3% to 17.9% in 2012, 5.5% to 36.5% in 2018, and 13.1% to 72.5% in 2021 across the 32 states of Mexico., Conclusions: Equitable access to basic childhood vaccines in Mexico has deteriorated over the past decade. Vigilant equity monitoring coupled with tailored strategies to reach those left out is urgently required.

Background: Global immunization inequities persist, reflected in the 25 million underimmunized and 18 million zero-dose children in 2021. To identify country approaches to reach underimmunized and zero-dose children, we undertook a structured synthesis of pro-equity strategies across 61 countries receiving programmatic support from Gavi, the Vaccine Alliance., Methods: We extracted data from 174 Country Joint Appraisals and Multi-Stakeholder Dialogue reports (2016-2020). We identified strategies via a targeted keyword search, informed by a determinants of immunization coverage framework. Strategies were synthesized into themes consolidated from UNICEF's Journey to Health and Immunization (JTHI) and the Global Routine Immunization Strategies and Practices (GRISP) frameworks., Results: We found 607 unique strategies across 61 countries and 24 themes. Strategies to improve care at the point of service (44%); to improve knowledge, awareness and beliefs (25%); and to address preparation, cost and effort barriers (13%) were common. Fewer strategies targeted experience of care (8%), intent, (7%) and after-service (3%). We also identified strategies addressing gender-related barriers to immunization and targeting specific types of communities., Conclusions: We summarize the range of pro-equity immunization strategies employed in Gavi-supported countries and interpret them thematically. Findings are incorporated into a searchable database which can be used to inform equity-driven immunization programs, policies and decision-making which target underimmunized and zero-dose communities.

Poverty, lack of education and gender inequality make unemployed and out-of-school young women extremely vulnerable to HIV infection. Promotive social protection programmes aim to increase livelihood and capabilities and could empower this priority population to act on HIV prevention choices. In Botswana, they rarely benefit from such programmes.A modified Policy Delphi engaged a panel of 22 unemployed and out-of-school young women and eight frontline service providers to consider alternative policy and practice options, and tailor available programmes to their own needs and social situation. The panel assessed the desirability and feasibility of improvement proposals and, in a second round, ranked them for relative importance.Nearly all 40 improvement proposals were considered very desirable and definitely, or possibly, feasible, and panellists prioritised a wide range of proposals. Frontline service providers stressed foundational skills, like life skills and second chance education. Young women preferred options with more immediate benefits. Overall, panellists perceived positive role models for programme delivery, access to land and water, job skills training, and stipends as most important to empower HIV-vulnerable young women. Results suggest ample policy space to make existing social protection programmes in Botswana more inclusive of unemployed and out-of-school young women, hence more HIV-sensitive.

In India, strict public health measures to suppress COVID-19 transmission and reduce burden have been rapidly adopted. Pandemic containment and confinement measures impact societies and economies; their costs and benefits must be assessed holistically. This study provides an evolving portrait of the health, economic and social consequences of the COVID-19 pandemic on vulnerable populations in India. Our analysis focuses on 100 days early in the pandemic from 13 March to 20 June 2020. We developed a conceptual framework based on the human right to health and the UN Sustainable Development Goals (SDGs). We analysed people's experiences recorded and shared via mobile phone on the voice platforms operated by the Gram Vaani COVID-19 response network, a service for rural and low-income populations now being deployed to support India's COVID-19 response. Quantitative and visual methods were used to summarize key features of the data and explore relationships between factors. In its first 100 days, the platform logged over 1.15 million phone calls, of which 793 350 (69%) were outbound calls related largely to health promotion in the context of COVID-19. Analysis of 6636 audio recordings by network users revealed struggles to secure the basic necessities of survival, including food (48%), cash (17%), transportation (10%) and employment or livelihoods (8%). Themes were mapped to shortfalls in 10 SDGs and their associated targets. Pre-existing development deficits and weak social safety nets are driving vulnerability during the COVID-19 crisis. For an effective pandemic response and recovery, these must be addressed through inclusive policy design and institutional reforms., (© The Author(s) 2021. Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Reaching zero-dose children (infants who receive no routine vaccinations) is a global strategic priority. We studied zero-dose children in India over 24 years to clarify aggregate trends and the contribution of large-scale social, economic, and geographical inequalities to these., Methods: We did a multilevel, geospatial analysis of repeated cross-sectional surveys of all four rounds (1992-2016) of India's National Family Health Survey to study the prevalence, distribution, and drivers of zero-dose (no first dose of diphtheria, tetanus, and pertussis) vaccination status. We included all children born to participating women who were aged 12-23 months at the time of the survey, as this is the standard age at which immunisation data are assessed. Children who died before the survey and those missing data on key outcomes or correlates were excluded. The outcome was child zero-dose vaccination status. We also compared the prevalence of nutritional deficits among zero-dose versus vaccinated children. For the most recent survey, we produced geospatial estimates identifying the prevalence of zero-dose children across states and districts and used these to project head count., Findings: We examined 393 167 children for eligibility. 72 848 children were included in the final analytic data set. The proportion of zero-dose children in India declined from 33·4% (95% CI 32·5-34·2) in 1992 to 10·1% (9·8-10·4) in 2016. Progress notwithstanding, in 2016, zero-dose children remained concentrated among disadvantaged groups (prevalence in the bottom wealth quintile 15·3%, 95% CI 14·6-16·0; prevalence among mothers with no education 16·8%, 16·1-17·4). Compared with vaccinated children, zero-dose children were more likely to suffer from malnutrition in all survey rounds (prevalence of severe stunting in 1992: zero dose 41·3%, 95% CI 39·2-43·8 vs vaccinated 28·5%, 27·2-29·7; 2016: zero dose 24·9%, 23·6-26·2 vs vaccinated 18·7%, 18·3-19·1). In 2016, there were an estimated 2·88 (95% CI 2·86-2·89) million zero-dose children in India, concentrated in less developed states and districts and several urban areas., Interpretation: Over a 24-year period in India, child zero-dose status was shaped by large-scale social inequalities and remained a consistent marker of generalised vulnerability. Interventions that address this cycle of intergenerational inequities should be prioritised., Funding: None., Translations: For the French, Spanish, and Hindi translations of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Social protection programmes are considered HIV-sensitive when addressing risk, vulnerability or impact of HIV infection. Socio-economic interventions, like livelihood and employability programmes, address HIV vulnerabilities like poverty and gender inequality. We explored the HIV-sensitivity of socio-economic interventions for unemployed and out-of-school young women aged 15 to 30 years, in East and Southern Africa, a key population for HIV infection., Methods: We conducted a systematic review using a narrative synthesis method and the Mixed Methods Appraisal Tool for quality appraisal. Interventions of interest were work skills training, microfinance, and employment support. Outcomes of interest were socio-economic outcomes (income, assets, savings, skills, (self-) employment) and HIV-related outcomes (behavioural and biological). We searched published and grey literature (January 2005 to November 2019; English/French) in MEDLINE, Scopus, Web of Science and websites of relevant international organizations., Results: We screened 3870 titles and abstracts and 188 full-text papers to retain 18 papers, representing 12 projects. Projects offered different combinations of HIV-sensitive social protection programmes, complemented with mentors, safe space and training (HIV, reproductive health and gender training). All 12 projects offered work skills training to improve life and business skills. Six offered formal (n = 2) or informal (n = 5) livelihood training. Eleven projects offered microfinance, including microgrants (n = 7), microcredit (n = 6) and savings (n = 4). One project offered employment support in the form of apprenticeships. In general, microgrants, savings, business and life skills contributed improved socio-economic and HIV-related outcomes. Most livelihood training contributed positive socio-economic outcomes, but only two projects showed improved HIV-related outcomes. Microcredit contributed little to either outcome. Programmes were effective when (i) sensitive to beneficiaries' age, needs, interests and economic vulnerability; (ii) adapted to local implementation contexts; and (iii) included life skills. Programme delivery through mentorship and safe space increased social capital and may be critical to improve the HIV-sensitivity of socio-economic programmes., Conclusions: A wide variety of livelihood and employability programmes were leveraged to achieve improved socio-economic and HIV-related outcomes among unemployed and out-of-school young women. To be HIV-sensitive, programmes should be designed around their interests, needs and vulnerability, adapted to local implementation contexts, and include life skills. Employment support received little attention in this literature., (© 2021 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Background: The Tika Vaani intervention, an initiative to improve basic health knowledge and empower beneficiaries to improve vaccination uptake and child health for underserved rural populations in India, was assessed in a pilot cluster randomized trial. The intervention was delivered through two strategies: mHealth (using mobile phones to send vaccination reminders and audio-based messages) and community mobilization (face-to-face meetings) in rural Indian villages from January to September 2018. We assessed acceptability and implementation fidelity to determine whether the intervention delivered in the pilot trial can be implemented at a larger scale., Methods: We adapted the Conceptual Framework for implementation fidelity to assess acceptability and fidelity of the pilot interventions using a mixed methods design. Quantitative data sources include a structured checklist, household surveys, and mobile phone call patterns. Qualitative data came from field observations, intervention records, semi-structured interviews and focus groups with project recipients and implementers. Quantitative analyses assessed whether activities were implemented as planned, using descriptive statistics to describe participant characteristics and the percentage distribution of activities. Qualitative data were analyzed using content analysis and in the light of the implementation fidelity model to explore moderating factors and to determine how well the intervention was received., Results: Findings demonstrated high (86.7%) implementation fidelity. A total of 94% of the target population benefited from the intervention by participating in a face-to-face group meeting or via mobile phone. The participants felt that the strategies were useful means for obtaining information. The clarity of the intervention theory, the motivation, and commitment of the implementers as well as the periodic meetings of the supervisors largely explain the high level of fidelity obtained. Geographic distance, access to a mobile phone, level of education, and gender norms are contextual factors that contributed to heterogeneity in participation., Conclusions: Although the intervention was evaluated in the context of a randomized trial that could explain the high level of fidelity obtained, this evaluation provides confirmatory evidence that the results of the study reflect the underlying theory. The mobile platform coupled with community mobilization was well-received by the participants and could be a useful way to improve health knowledge and change behavior., Trial Registration: ISRCTN 44840759 (22 April 2018)., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: In resource-poor settings, lack of awareness and low demand for services constitute important barriers to expanding the coverage of effective interventions. In India, childhood immunization is a priority health strategy with suboptimal uptake., Objective: To assess study feasibility and key implementation outcomes for the Tika Vaani model, a new approach to educate and empower beneficiaries to improve immunization and child health., Methods: A cluster-randomized pilot trial with a 1:1 allocation ratio was conducted in rural Uttar Pradesh, India, from January to September 2018. Villages were randomly assigned to either the intervention or control group. In each participating village, surveyors conducted a complete enumeration to identify eligible households and requested participation before randomization. Interventions were designed through formative research using a social marketing approach and delivered over 3 months using strategies adapted to disadvantaged populations: (1) mobile health (mHealth): entertaining educational audio capsules (edutainment) and voice immunization reminders via mobile phone and (2) face-to-face: community mobilization activities, including 3 small group meetings offered to each participant. The control group received usual services. The main outcomes were prespecified criteria for feasibility of the main study (recruitment, randomization, retention, contamination, and adoption). Secondary endpoints tested equity of coverage and changes in intermediate outcomes. Statistical methods included descriptive statistics to assess feasibility, penalized logistic regression and ordered logistic regression to assess coverage, and generalized estimating equation models to assess changes in intermediate outcomes., Results: All villages consented to participate. Gaps in administrative data hampered recruitment; 14.0% (79/565) of recorded households were nonresident. Only 1.4% (8/565) of households did not consent. A total of 387 households (184 intervention and 203 control) with children aged 0 to 12 months in 26 villages (13 intervention and 13 control) were included and randomized. The end line survey occurred during the flood season; 17.6% (68/387) of the households were absent. Contamination was less than 1%. Participation in one or more interventions was 94.0% (173/184), 78.3% (144/184) for the face-to-face strategy, and 67.4% (124/184) for the mHealth strategy. Determinants including place of residence, mobile phone access, education, and female empowerment shaped intervention use; factors operated differently for face-to-face and mHealth strategies. For 11 of 13 intermediate outcomes, regression results showed significantly higher basic health knowledge among the intervention group, supporting hypothesized causal mechanisms., Conclusions: A future trial of a new intervention model is feasible. The interventions could strengthen the delivery of immunization and universal primary health care. Social and behavior change communication via mobile phones proved viable and contributed to standardization and scalability. Face-to-face interactions remain necessary to achieve equity and reach, suggesting the need for ongoing health system strengthening to accompany the introduction of communication technologies., Trial Registration: International Standard Randomized Controlled Trial Number (ISRCTN) 44840759; https://doi.org/10.1186/ISRCTN44840759., (©Mira Johri, Dinesh Chandra, Karna Georges Kone, Marie-Pierre Sylvestre, Alok K Mathur, Sam Harper, Arijit Nandi. Originally published in JMIR mHealth and uHealth (http://mhealth.jmir.org), 21.09.2020.)

Background: Social, behavioural and community engagement (SBCE) interventions are essential for global maternal, newborn and child health (MNCH) strategies. Past efforts to synthesise research on SBCE interventions identified a need for clear priorities to guide future research. WHO led an exercise to identify global research priorities for SBCE interventions to improve MNCH., Methods: We adapted the Child Health and Nutrition Research Initiative method and combined quantitative and qualitative methods to determine MNCH SBCE intervention research priorities applicable across different contexts. Using online surveys and meetings, researchers and programme experts proposed up to three research priorities and scored the compiled priorities against four criteria - health and social impact, equity, feasibility, and overall importance. Priorities were then ranked by score. A group of 29 experts finalised the top 10 research priorities for each of maternal, newborn or child health and a cross-cutting area., Results: A total of 310 experts proposed 867 research priorities, which were consolidated into 444 priorities and scored by 280 experts. Top maternal and newborn health priorities focused on research to improve the delivery of SBCE interventions that strengthen self-care/family care practices and care-seeking behaviour. Child health priorities focused on the delivery of SBCE interventions, emphasising determinants of service utilisation and breastfeeding and nutrition practices. Cross-cutting MNCH priorities highlighted the need for better integration of SBCE into facility-based and community-based health services., Conclusions: Achieving global targets for MNCH requires increased investment in SBCE interventions that build capacities of individuals, families and communities as agents of their own health. Findings from this exercise provide guidance to prioritise investments and ensure that they are best directed to achieve global objectives. Stakeholders are encouraged to use these priorities to guide future research investments and to adapt them for country programmes by engaging with national level stakeholders.

Background: Village Health and Nutrition Days (VHNDs) are a cornerstone of the Government of India's strategy to provide first-contact primary health care to rural areas. Recent government programmes such as the Janani Suraksha Yojana (JSY) and Mission Indradhanush (MI) have catalysed important changes impacting VHNDs. To learn how VHNDs are currently being delivered, we assessed the fidelity of services provided as compared to government norms in a priority district of Uttar Pradesh., Methods: We fielded a cross-sectional study of VHNDs to provide a snapshot of health services functioning. Process evaluation data were collected via administrative sources, non-participant observation using a standardised form, and structured questionnaires. Questionnaires were designed using a framework to assess implementation fidelity. Key respondents were VHND participants, front-line workers involved in VHND delivery, and VHND non-participants (pregnant women due for antenatal care or children due for vaccination as per administrative records). Results were summarised as counts, frequencies, and proportions., Results: In the 30 villages randomly selected for inclusion, 36 VHNDs were scheduled but four (11.1%) were cancelled and one VHND was not surveyed. Vaccination and antenatal care were offered at 96.8% (30/31) and child weighing at 83.9% (26/31) of VHNDs. Other normed services were infrequently provided or completely absent. Health education and promotion were particularly weak; institutional delivery was the only topic discussed in a majority of VHNDs. The true proportion of any serious problem impeding vaccine delivery was 47.2% (17/36), comprising 4 VHND cancellations and 13 VHNDs experiencing vaccine shortages. Of the 13 incidents of vaccine shortage, 11 related to an unexpected global shortage of injectable polio vaccine (IPV). Over the 31 VHNDs, 37.8% (171 of the 452 scheduled beneficiaries) did not participate. Analysis of missed opportunities for vaccination highlighted inaccuracies in beneficiary identification and tracking and demand side-factors., Conclusions: The transformative potential of VHNDs to improve population health is only partially being met. A core subset of high-priority services for antenatal care, institutional delivery, and vaccination associated with high-priority government programmes (JSY, MI) is now being provided quite successfully. Other basic health promotion and prevention services are largely not provided, constituting a critical missed opportunity.

Context: Recent randomised controlled trials in Bangladesh and Kenya concluded that household water treatment, alone or in combination with upgraded sanitation and handwashing, did not reduce linear growth faltering or improve other child growth outcomes. Whether these results are applicable in areas with distinct constellations of water, sanitation and hygiene (WaSH) risks is unknown. Analysis of observational data offers an efficient means to assess the external validity of trial findings. We studied whether a water quality intervention could improve child growth in a rural Indian setting with higher levels of circulating pathogens than the original trial sites., Methods: We analysed a cross-sectional dataset including a microbiological measure of household water quality. All households accessed water from an improved source. We applied propensity score methods to emulate a randomised trial investigating the hypothesis that receipt of drinking water meeting Sustainable Development Goal (SDG) 6.1 quality standards for absence of faecal contamination leads to improved growth. Growth outcomes (stunting, underweight, wasting, and their corresponding Z-scores) were assessed in children 12-23 months of age. For each outcome, we estimated the mean and 95% confidence interval of the absolute risk difference between treatment groups., Findings: Of 1088 households, 442 (40.62%) received drinking water meeting SDG 6.1 standards. The adjusted risk of child underweight was 7.4% (1.3% to 13.4%) lower among those drinking water satisfying SDG 6.1 norms than among controls. Evidence concerning the relationship of drinking water meeting SDG 6.1 norms to length-for-age and weight-for-age was inconclusive, and there was no apparent relationship with stunting or wasting., Conclusions: In contexts characterised by high pathogen transmission, water quality improvements have the potential to reduce the proportion of underweight children, but are unlikely to impact stunting or wasting. Further research is required to assess how these modelled benefits can best be achieved in real world settings., Competing Interests: The authors have declared that no competing interests exist.

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.

Introduction: audits of indications for cesarean section (CS), feedback for health professionals, and implementation of best practices, as compared with usual care (QUARISMA study), resulted in a small reduction in the rate of CS in Quebec and important cost savings from a health care payer perspective. Determining the budget impact would enable estimation of the financial consequences if the program is extended nationwide., Material and Methods: a retrospective pre-post study design was used to estimate cost prior to and after the implementation of QUARISMA in Quebec (105,351 subjects). A prospective analysis was performed to measure the budget impact in Canada's provinces. The primary analytic perspective was that of the Minister of Health, for a 4-year time horizon. Data were taken from the trial for Quebec and extrapolated to Canada's provinces. A sensitivity analysis was conducted by varying more than one probability at a time., Findings: over 4 years, there was a decrease of more than $7.8 million in CS burden in Quebec, $11.9 million in vaginal birth and $9.8 million for neonatal complications. The impact on high-risk women was lower than that on low-risk. In years 1 and 2, the provinces would have to cover the cost of program implementation., Conclusions: QUARISMA led to savings of $27 million in Quebec over 4 years. In the short to medium term, extending the QUARISMA program nationwide could lead to savings of $150.5 million., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Decreasing trends in measles mortality have been reported in recent years. However, such estimates of measles mortality have depended heavily on assumed regional measles case fatality risks (CFRs) and made little use of mortality data from low- and middle-income countries in general and India, the country with the highest measles burden globally, in particular., Methods: We constructed a dynamic model of measles transmission in India with parameters that were empirically inferred using spectral analysis from a time series of measles mortality extracted from the Million Death Study, an ongoing longitudinal study recording deaths across 2.4 million Indian households and attributing causes of death using verbal autopsy. The model was then used to estimate the measles CFR, the number of measles deaths, and the impact of vaccination in 2000-2015 among under-five children in India and in the states of Bihar and Uttar Pradesh (UP), two states with large populations and the highest numbers of measles deaths in India., Results: We obtained the following estimated CFRs among under-five children for the year 2005: 0.63% (95% confidence interval (CI): 0.40-1.00%) for India as a whole, 0.62% (0.38-1.00%) for Bihar, and 1.19% (0.80-1.75%) for UP. During 2000-2015, we estimated that 607,000 (95% CI: 383,000-958,000) under-five deaths attributed to measles occurred in India as a whole. If no routine vaccination or supplemental immunization activities had occurred from 2000 to 2015, an additional 1.6 (1.0-2.6) million deaths for under-five children would have occurred across India., Conclusions: We developed a data- and model-driven estimation of the historical measles dynamics, CFR, and vaccination impact in India, extracting the periodicity of epidemics using spectral and coherence analysis, which allowed us to infer key parameters driving measles transmission dynamics and mortality.

Background: Widespread increases in caesarean section (CS) rates have sparked concerns about risks to mothers and infants and rising healthcare costs. A multicentre, two-arm, cluster-randomized trial in Quebec, Canada assessed whether an audit and feedback intervention targeting health professionals would reduce CS rates for pregnant women compared to usual care, and concluded that it reduced CS rates without adverse effects on maternal or neonatal health. The effect was statistically significant but clinically small. We assessed cost-effectiveness to inform scale-up decisions., Methods: A prospective economic evaluation was undertaken using individual patient data from the Quality of Care, Obstetrics Risk Management, and Mode of Delivery (QUARISMA) trial (April 2008 to October 2011). Analyses took a healthcare payer perspective. The time horizon captured hospital-based costs and clinical events for mothers and neonates from labour onset to 3 months postpartum. Resource use was identified and measured from patient charts and valued using standardized government sources. We estimated the changes in CS rates and costs for the intervention group (versus controls) between the baseline and post-intervention periods. We examined heterogeneity between clinical subgroups of high-risk versus low-risk pregnancies and estimated the joint uncertainty in cost-effectiveness over 20,000 trial simulations. We decomposed costs to identify drivers of change., Results: The intervention group experienced per-patient reductions of 0.005 CS (95% confidence interval (CI): -0.015 to 0.004, P = 0.09) and $180 (95% CI: -$277 to - $83, P < 0.001). Women with low-risk pregnancies experienced statistically significant reductions in CS rates and costs; changes for the high-risk subgroup were not significant. The intervention was "dominant" (effective in reducing CS and less costly than usual care) in 86.08% of simulations. It reduced costs in 99.99% of simulations. Cost reductions were driven by lower rates of neonatal complications in the intervention group (-$190, 95% CI: -$255 to - $125, P < 0.001). Given 88,000 annual provincial births, a similar intervention could save $15.8 million (range: $7.3 to $24.4 million) in Quebec annually., Conclusions: From a healthcare payer perspective, a multifaceted intervention involving audits and feedback resulted in a small reduction in caesarean deliveries and important cost savings. Cost reductions are consistent with improved quality of care in intervention group hospitals., Trial Registration: International Clinical Trials Registry Platform, ISRCTN95086407 . Registered on 23 October 2007.

Background: Diabetes mellitus (DM) is one of the most burdensome chronic diseases and is associated with shorter lifetime, diminished quality of life and economic burdens on the patient and society as a result of healthcare, medication, and reduced labor market participation. We aimed to estimate the direct (medical and non-medical) and indirect costs of DM and compare them with those of people without DM (ND), as well as the cost predictors., Methods and Findings: Observational retrospective case-control study performed in Mali. Participants were identified and randomly selected from diabetes registries. We recruited 500 subjects with DM and 500 subjects without DM, matched by sex and age. We conducted structured, personal interviews. Costs were expressed for a 90-day period. Direct medical costs comprised: inpatient stays, ICU, laboratory tests and other hospital visits, specialist and primary care doctor visits, others, traditional practitioners, and medication. Direct non-medical costs comprised travel for treatment and paid caregivers. The indirect costs include the productivity losses by patients and caregivers, and absenteeism. We estimate a two-part model by type of service and a linear multiple regression model for the total cost. We found that total costs of persons with DM were almost 4 times higher than total cost of people without DM. Total costs were $77.08 and $281.92 for ND and DM, respectively, with a difference of $204.84., Conclusions: Healthcare use and costs were dramatically higher for people with DM than for people with normal glucose tolerance and, in relative terms, much higher than in developed countries.

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., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

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., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

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.

Objective: To determine whether an intervention based on patient-practitioner communication is more effective than usual care in improving diabetes self-management in patients with type 2 diabetes with low educational level., Methods: 12-month, pragmatic cluster randomised controlled trial. Nine physicians and 184 patients registered at two practices in a deprived area of Granada (Andalusia, Spain) participated in the study. Adult patients with type 2 diabetes, low educational level and glycated haemoglobin (HbA1c) > 7% (53.01 mmol/mol) were eligible. The physicians in the intervention group received training on communication skills and the use of a tool for monitoring glycaemic control and providing feedback to patients. The control group continued standard care. The primary outcome was difference in HbA1c after 12 months. Dyslipidaemia, blood pressure, body mass index and waist circumference were also assessed as secondary outcomes. Two-level (patient and provider) regression analyses controlling for sex, social support and comorbidity were conducted., Results: The HbA1c levels at 12 months decreased in both groups. Multilevel analysis showed a greater improvement in the intervention group (between-group HbA1c difference= 0.16; p=0.049). No statistically significant differences between groups were observed for dyslipidaemia, blood pressure, body mass index and waist circumference., Conclusions: In this pragmatic study, a simple and inexpensive intervention delivered in primary care showed a modest benefit in glycaemic control compared with usual care, although no effect was observed in the secondary outcomes. Further research is needed to design and assess interventions to promote diabetes self-management in socially vulnerable patients., (Copyright © 2016 SESPAS. All rights reserved.)

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.

Objective: To quantify the impact on mortality of offering a hypothetical set of technically feasible, high-impact interventions for maternal and child survival during India's 2010-2013 measles supplementary immunization activity., Methods: We developed Lives Saved Tool models for 12 Indian states participating in the supplementary immunization, based on state- and sex-specific data on mortality from India's Million Deaths Study and on health services coverage from Indian household surveys. Potential add-on interventions were identified through a literature review and expert consultations. We quantified the number of lives saved for a campaign offering measles vaccine alone versus a campaign offering measles vaccine with six add-on interventions (nutritional screening and complementary feeding for children, vitamin A and zinc supplementation for children, multiple micronutrient and calcium supplementation in pregnancy, and free distribution of insecticide-treated bednets)., Findings: The measles vaccination campaign saved an estimated 19 016 lives of children younger than 5 years. A hypothetical campaign including measles vaccine with add-on interventions was projected to save around 73 900 lives (range: 70 200-79 300), preventing 73 700 child deaths (range: 70 000-79 000) and 300 maternal deaths (range: 200-400). The most effective interventions in the whole package were insecticide-treated bednets, measles vaccine and preventive zinc supplementation. Girls accounted for 66% of expected lives saved (12 712/19 346) for the measles vaccine campaign, and 62% of lives saved (45 721/74 367) for the hypothetical campaign including add-on interventions., Conclusion: In India, a measles vaccination campaign including feasible, high-impact interventions could substantially increase the number of lives saved and mitigate gender-related inequities in child mortality.

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., (© 2016 American Society for Nutrition.)

Objective. To summarize key findings of economic evaluations of lifestyle interventions for the primary prevention of type 2 diabetes (T2D) in high-risk subjects. Methods. We conducted a systematic review of peer-reviewed original studies published since January 2009 in English, French, and Spanish. Eligible studies were identified through relevant databases including PubMed, Medline, National Health Services Economic Evaluation, CINHAL, EconLit, Web of sciences, EMBASE, and the Latin American and Caribbean Health Sciences Literature. Studies targeting obesity were also included. Data were extracted using a standardized method. The BMJ checklist was used to assess study quality. The heterogeneity of lifestyle interventions precluded a meta-analysis. Results. Overall, 20 studies were retained, including six focusing on obesity control. Seven were conducted within trials and 13 using modeling techniques. T2D prevention by physical activity or diet or both proved cost-effective according to accepted thresholds, except for five inconclusive studies, three on diabetes prevention and two on obesity control. Most studies exhibited limitations in reporting results, primarily with regard to generalizability and justification of selected sensitivity parameters. Conclusion. This confirms that lifestyle interventions for the primary prevention of diabetes are cost-effective. Such interventions should be further promoted as sound investment in the fight against diabetes.

Objective: With the aim of conducting a future cluster randomised trial to assess intervention impact on child vaccination coverage, we designed a pilot study to assess feasibility and aid in refining methods for the larger study., Trial Design: Cluster-randomised design with a 1:1 allocation ratio., Methods: Clusters were 12 villages in rural Uttar Pradesh. All women residing in a selected village who were mothers of a child 0-23 months of age were eligible; participants were chosen at random. Over 4 months, intervention group (IG) villages received: (1) home visits by volunteers; (2) community mobilisation events to promote immunisation. Control group (CG) villages received community mobilisation to promote nutrition. A toll-free number for immunisation was offered to all IG and CG village residents. Primary outcomes were ex-ante criteria for feasibility of the main study related to processes for recruitment and randomisation (50% of villages would agree to participate and accept randomisation; 30 women could be recruited in 70% of villages), and retention of participants (50% of women retained from baseline to endline). Clusters were assigned to IG or CG using a computer-generated randomisation schedule. Neither participants nor those delivering interventions were blinded, but those assessing outcomes were blinded to group assignment., Results: All villages contacted agreed to participate and accepted randomisation. 36 women were recruited per village; 432 participants were randomised (IG n=216; CG n=216). No clusters were lost to follow-up. The main analysis included 86% (373/432) of participants, 90% (195/216) from the IG and 82% (178/216) from the CG., Conclusions: Criteria related to feasibility were satisfied, giving us confidence that we can successfully conduct a larger cluster randomised trial. Methodological lessons will inform design of the main study., Trial Registration Number: ISRCTN16703097., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: Education of mothers may improve child health. We investigated whether maternal health literacy, a rapidly modifiable factor related to mother's education, was associated with children's receipt of vaccines in two underserved Indian communities., Methods: Cross-sectional surveys in an urban and a rural site. We assessed health literacy using Indian child health promotion materials. The outcome was receipt of three doses of diphtheria-tetanus-pertussis (DTP3) vaccine. We used multivariate logistic regression to investigate the relationship between maternal health literacy and vaccination status independently in each site. For both sites, adjusted models considered maternal age, maternal and paternal education, child sex, birth order, household religion and wealth quintile. Rural analyses used multilevel models adjusted for service delivery characteristics. Urban analyses represented cluster characteristics through fixed effects., Results: The rural analysis included 1170 women from 60 villages. The urban analysis included 670 women from nine slum clusters. In each site, crude and adjusted models revealed a positive association between maternal health literacy and DTP3. In the rural site, the adjusted OR was 1.57 (95% CI 1.11 to 2.21, p=0.010) for those with medium health literacy, and OR=1.30 (95% CI 0.89 to 1.91, p=0.172) for those with high health literacy. In the urban site, the adjusted OR was 1.10 (95% CI 0.65 to 1.88, p=0.705) for those with medium health literacy, and OR=2.06 (95% CI 1.06 to 3.99, p=0.032) for those with high health literacy., Conclusions: In these study settings, maternal health literacy is independently associated with child vaccination. Initiatives targeting health literacy could improve vaccination coverage., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

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.

Background: The Measles & Rubella Initiative, a broad consortium of global health agencies, has provided support to measles-burdened countries, focusing on sustaining high coverage of routine immunization of children and supplementing it with a second dose opportunity for measles vaccine through supplemental immunization activities (SIAs). We estimate optimal scheduling of SIAs in countries with the highest measles burden., Methods: We develop an age-stratified dynamic compartmental model of measles transmission. We explore the frequency of SIAs in order to achieve measles control in selected countries and two Indian states with high measles burden. Specifically, we compute the maximum allowable time period between two consecutive SIAs to achieve measles control., Results: Our analysis indicates that a single SIA will not control measles transmission in any of the countries with high measles burden. However, regular SIAs at high coverage levels are a viable strategy to prevent measles outbreaks. The periodicity of SIAs differs between countries and even within a single country, and is determined by population demographics and existing routine immunization coverage., Conclusions: Our analysis can guide country policymakers deciding on the optimal scheduling of SIA campaigns and the best combination of routine and SIA vaccination to control measles., (Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Introduction: Accurate measurement of health inequities is indispensable to track progress or to identify needs for health equity policy interventions. A key empirical task is to measure the extent to which observed inequality in health - a difference in health - is inequitable. Empirically operationalizing definitions of health inequity has generated an important question not considered in the conceptual literature on health inequity. Empirical analysis can explain only a portion of observed health inequality. This paper demonstrates that the treatment of unexplained inequality is not only a methodological but ethical question and that the answer to the ethical question - whether unexplained health inequality is unfair - determines the appropriate standardization method for health inequity analysis and can lead to potentially divergent estimates of health inequity., Methods: We use the American sample of the 2002-03 Joint Canada/United States Survey of Health and measure health by the Health Utilities Index (HUI). We model variation in the observed HUI by demographic, socioeconomic, health behaviour, and health care variables using Ordinary Least Squares. We estimate unfair HUI by standardizing fairness, removing the fair component from the observed HUI. We consider health inequality due to factors amenable to policy intervention as unfair. We contrast estimates of inequity using two fairness-standardization methods: direct (considering unexplained inequality as ethically acceptable) and indirect (considering unexplained inequality as unfair). We use the Gini coefficient to quantify inequity., Results: Our analysis shows that about 75% of the variation in the observed HUI is unexplained by the model. The direct standardization results in a smaller inequity estimate (about 60% of health inequality is inequitable) than the indirect standardization (almost all inequality is inequitable)., Conclusions: The choice of the fairness-standardization method is ethical and influences the empirical health inequity results considerably. More debate and analysis is necessary regarding which treatment of the unexplained inequality has the stronger foundation in equity considerations.

Background: The rate of avoidable caesarean sections (CS) could be reduced through multifaceted strategies focusing on the involvement of health professionals and compliance with clinical practice guidelines (CPGs). Quality improvements for CS (QICS) programmes (QICS) based on this approach, have been implemented in Canada and Spain., Objectives: Their objectives are as follows: 1) Toto identify clusters in each setting with similar results in terms of cost-consequences, 2) Toto investigate whether demographic, clinical or context characteristics can distinguish these clusters, and 3) Toto explore the implementation of QICS in the 2 regions, in order to identify factors that have been facilitators in changing practices and reducing the use of obstetric intervention, as well as the challenges faced by hospitals in implementing the recommendations., Methods: Descriptive study with a quantitative and qualitative approach. 1) Cluster analysis at patient level with data from 16 hospitals in Quebec (Canada) (n = 105,348) and 15 hospitals in Andalusia (Spain) (n = 64,760). The outcome measures are CS and costs. For the cost, we will consider the intervention, delivery and complications in mother and baby, from the hospital perspective. Cluster analysis will be used to identify participants with similar patterns of CS and costs based, and t tests will be used to evaluate if the clusters differed in terms of characteristics: Hospital level (academic status of hospital, level of care, supply and demand factors), patient level (mother age, parity, gestational age, previous CS, previous pathology, presentation of the baby, baby birth weight). 2) Analysis of in-depth interviews with obstetricians and midwives in hospitals where the QICS were implemented, to explore the differences in delivery-related practices, and the importance of the different constructs for positive or negative adherence to CPGs. Dimensions: political/management level, hospital level, health professionals, mothers and their birth partner., Discussion: This work sets out a new approach for programme evaluation, using different techniques to make it possible to take into account the specific context where the programmes were implemented.

Introduction: Measurement of health inequities is fundamental to all health equity initiatives. It is complex because it requires considerations of ethics, methods, and policy. Drawing upon the recent developments in related specialized fields, in this paper we incorporate alternative definitions of health inequity explicitly and transparently in its measurement. We propose a three-stage approach to measuring health inequities that assembles univariate health inequality, univariate health inequity, and bivariate health inequities in a systematic and comparative manner., Methods: We illustrate the application of the three-stage approach using the Joint Canada/United States Survey of Health, measuring health by the Health Utilities Index (HUI). Univariate health inequality is the distribution of the observed HUI across individuals. Univariate health inequity is the distribution of unfair HUI--components of HUI associated with ethically unacceptable factors--across individuals. To estimate the unfair HUI, we apply two popular definitions of inequity: "equal opportunity for health" (health outcomes due to factors beyond individual control are unfair), and "policy amenability" (health outcomes due to factors amenable to policy interventions are unfair). We quantify univariate health inequality and inequity using the Gini coefficient. We assess bivariate inequities using a regression-based decomposition method., Results: Our analysis reveals that, empirically, different definitions of health inequity do not yield statistically significant differences in the estimated amount of univariate inequity. This derives from the relatively small explanatory power common in regression models describing variations in health. As is typical, our model explains about 20% of the variation in the observed HUI. With regard to bivariate inequities, income and health care show strong associations with the unfair HUI., Conclusions: The measurement of health inequities is an excitingly multidisciplinary endeavour. Its development requires interdisciplinary integration of advances from relevant disciplines. The proposed three-stage approach is one such effort and stimulates cross-disciplinary dialogues, specifically, about conceptual and empirical significance of definitions of health inequities.

Objective: To estimate the impact on maternal and child mortality after eliminating user fees for pregnant women and for children less than five years of age in Burkina Faso., Methods: Two health districts in the Sahel region eliminated user fees for facility deliveries and curative consultations for children in September 2008. To compare health-care coverage before and after this change, we used interrupted time series, propensity scores and three independent data sources. Coverage changes were assessed for four variables: women giving birth at a health facility, and children aged 1 to 59 months receiving oral rehydration salts for diarrhoea, antibiotics for pneumonia and artemesinin for malaria. We modelled the mortality impact of coverage changes in the Lives Saved Tool using several scenarios., Findings: Coverage increased for all variables, however, the increase was not statistically significant for antibiotics for pneumonia. For estimated mortality impact, the intervention saved approximately 593 (estimate range 168-1060) children's lives in both districts during the first year. This lowered the estimated under-five mortality rate from 235 deaths per 1000 live births in 2008 to 210 (estimate range 189-228) in 2009. If a similar intervention were to be introduced nationwide, 14,000 to 19,000 (estimate range 4000-28,000) children's lives could be saved annually. Maternal mortality showed a modest decrease in all scenarios., Conclusion: In this setting, eliminating user fees increased use of health services and may have contributed to reduced child mortality.

Background: Children unreached by vaccination are at higher risk of poor health outcomes and India accounts for nearly a quarter of unvaccinated children worldwide. The objective of this study was to investigate compositional and contextual determinants of non-receipt of childhood vaccines in India using multilevel modelling., Methods and Findings: We studied characteristics of unvaccinated children using the District Level Health and Facility Survey 3, a nationally representative probability sample containing 65 617 children aged 12-23 months from 34 Indian states and territories. We developed four-level Bayesian binomial regression models to examine the determinants of non-vaccination. The analysis considered two outcomes: completely unvaccinated (CUV) children who had not received any of the eight vaccine doses recommended by India's Universal Immunization Programme, and children who had not received any dose from routine immunisation services (no RI). The no RI category includes CUV children and those who received only polio doses administered via mass campaigns. Overall, 4.83% (95% CI: 4.62-5.06) of children were CUV while 12.01% (11.68-12.35) had received no RI. Individual compositional factors strongly associated with CUV were: non-receipt of tetanus immunisation for mothers during pregnancy (OR = 3.65 [95% CrI: 3.30-4.02]), poorest household wealth index (OR = 2.44 [1.81-3.22] no maternal schooling (OR = 2.43 [1.41-4.05]) and no paternal schooling (OR = 1.83 [1.30-2.48]). In rural settings, the influence of maternal illiteracy disappeared whereas the role of household wealth index was reinforced. Factors associated with no RI were similar to those for CUV, but effect sizes for individual compositional factors were generally larger. Low maternal education was the strongest risk factor associated with no RI in all models. All multilevel models found significant variability at community, district, and state levels net of compositional factors., Conclusion: Non-vaccination in India is strongly related to compositional characteristics and is geographically distinct. Tailored strategies are required to overcome current barriers to immunisation.

This Guidance for Priority Setting in Health Care (GPS-Health), initiated by the World Health Organization, offers a comprehensive map of equity criteria that are relevant to health care priority setting and should be considered in addition to cost-effectiveness analysis. The guidance, in the form of a checklist, is especially targeted at decision makers who set priorities at national and sub-national levels, and those who interpret findings from cost-effectiveness analysis. It is also targeted at researchers conducting cost-effectiveness analysis to improve reporting of their results in the light of these other criteria. THE GUIDANCE WAS DEVELOP THROUGH A SERIES OF EXPERT CONSULTATION MEETINGS AND INVOLVED THREE STEPS: i) methods and normative concepts were identified through a systematic review; ii) the review findings were critically assessed in the expert consultation meetings which resulted in a draft checklist of normative criteria; iii) the checklist was validated though an extensive hearing process with input from a range of relevant stakeholders. The GPS-Health incorporates criteria related to the disease an intervention targets (severity of disease, capacity to benefit, and past health loss); characteristics of social groups an intervention targets (socioeconomic status, area of living, gender; race, ethnicity, religion and sexual orientation); and non-health consequences of an intervention (financial protection, economic productivity, and care for others).

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.

Background: Post-thrombotic syndrome (PTS) is a common and burdensome complication of deep venous thrombosis (DVT). Previous trials suggesting benefit of elastic compression stockings (ECS) to prevent PTS were small, single-centre studies without placebo control. We aimed to assess the efficacy of ECS, compared with placebo stockings, for the prevention of PTS., Methods: We did a multicentre randomised placebo-controlled trial of active versus placebo ECS used for 2 years to prevent PTS after a first proximal DVT in centres in Canada and the USA. Patients were randomly assigned to study groups with a web-based randomisation system. Patients presenting with a first symptomatic, proximal DVT were potentially eligible to participate. They were excluded if the use of compression stockings was contraindicated, they had an expected lifespan of less than 6 months, geographical inaccessibility precluded return for follow-up visits, they were unable to apply stockings, or they received thrombolytic therapy for the initial treatment of acute DVT. The primary outcome was PTS diagnosed at 6 months or later using Ginsberg's criteria (leg pain and swelling of ≥1 month duration). We used a modified intention to treat Cox regression analysis, supplemented by a prespecified per-protocol analysis of patients who reported frequent use of their allocated treatment. This study is registered with ClinicalTrials.gov, number NCT00143598, and Current Controlled Trials, number ISRCTN71334751., Findings: From 2004 to 2010, 410 patients were randomly assigned to receive active ECS and 396 placebo ECS. The cumulative incidence of PTS was 14·2% in active ECS versus 12·7% in placebo ECS (hazard ratio adjusted for centre 1·13, 95% CI 0·73-1·76; p=0·58). Results were similar in a prespecified per-protocol analysis of patients who reported frequent use of stockings., Interpretation: ECS did not prevent PTS after a first proximal DVT, hence our findings do not support routine wearing of ECS after DVT., Funding: Canadian Institutes of Health Research., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Background. Point-of-care (POC) diagnostics for syphilis can contribute to epidemic control by offering a timely knowledge of serostatus. Although accuracy data on POC syphilis tests have been widely published, few studies have evaluated broader outcomes beyond accuracy that impact patients and health systems. We comprehensively reviewed evidence and reporting of these implementation research outcomes (IROs), and proposed a framework to improve their quality. Methods. Three reviewers systematically searched 6 electronic databases from 1980 to 2014 for syphilis POC studies reporting IROs. Data were abstracted and findings synthesised narratively. Results. Of 71 studies identified, 38 documented IROs. IROs were subclassified into preference (7), acceptability (15), feasibility (15), barriers and challenges (15), impact (13), and prevalence (23). Using our framework and definitions, a pattern of incomplete documentation, inconsistent definitions, and lack of clarity was identified across all IROs. Conclusion. Although POC screening tests for syphilis were generally favourably evaluated across a range of outcomes, the quality of evidence was compromised by inconsistent definitions, poor methodology, and documentation of outcomes. A framework for standardized reporting of outcomes beyond accuracy was proposed and considered a necessary first step towards an effective implementation of these metrics in POC diagnostics research.