Using a human-centred design approach to develop a comprehensive newborn monitoring chart for inpatient care in Kenya.

INTRODUCTION: Job aids such as observation charts are commonly used to record inpatient nursing observations. For sick newborns, it is important to provide critical information, intervene, and tailor treatment to improve health outcomes, as countries work towards reducing neonatal mortality. However, inpatient vital sign readings are often poorly documented and little attention has been paid to the process of chart design as a method of improving care quality. Poorly designed charts do not meet user needs leading to increased mental effort, duplication, suboptimal documentation and fragmentation. We provide a detailed account of a process of designing a monitoring chart. METHODS: We used a Human-Centred Design (HCD) approach to co-design a newborn monitoring chart between March and May 2019 in three workshops attended by 16-21 participants each (nurses and doctors) drawn from 14 hospitals in Kenya. We used personas, user story mapping during the workshops and observed chart completion to identify challenges with current charts and design requirements. Two new charts were piloted in four hospitals between June 2019 and February 2020 and revised in a cyclical manner. RESULTS: Challenges were identified regarding the chart design and supply, and how staff used existing charts. Challenges to use included limited staffing, a knowledge deficit among junior staff, poor interprofessional communication, and lack of appropriate and working equipment. We identified a strong preference from participants for one chart to capture vital signs, assessment of the baby, and feed and fluid prescription and monitoring; data that were previously captured on several charts. DISCUSSION: Adopting a Human-Centred Design approach, we designed a new comprehensive newborn monitoring chart that is unlike observation charts in the literature that only focus on vital signs. While the new chart does not address all needs, we believe that once implemented, it can help build a clearer picture of the care given to newborns. CONCLUSION: The chart was co-designed and piloted with the user and context in mind resulting in a unique monitoring chart that can be adopted in similar settings.

Designing paper-based records to improve the quality of nursing documentation in hospitals: A scoping review.

BACKGROUND: Inpatient nursing documentation facilitates multi-disciplinary team care and tracking of patient progress. In both high- and low- and middle-income settings, it is largely paper-based and may be used as a template for electronic medical records. However, there is limited evidence on how they have been developed. OBJECTIVE: To synthesise evidence on how paper-based nursing records have been developed and implemented in inpatient settings to support documentation of nursing care. DESIGN: A scoping review guided by the Arksey and O'Malley framework and reported using PRISMA-ScR guidelines. ELIGIBILITY CRITERIA: We included studies that described the process of designing paper-based inpatient records and excluded those focussing on electronic records. Included studies were published in English up to October 2019. SOURCES OF EVIDENCE: PubMed, CINAHL, Web of Science and Cochrane supplemented by free-text searches on Google Scholar and snowballing the reference sections of included papers. RESULTS: 12 studies met the eligibility criteria. We extracted data on study characteristics, the development process and outcomes related to documentation of inpatient care. Studies reviewed followed a process of problem identification, literature review, chart (re)design, piloting, implementation and evaluation but varied in their execution of each step. All studies except one reported a positive change in inpatient documentation or the adoption of charts amid various challenges. CONCLUSIONS: The approaches used seemed to work for each of the studies but could be strengthened by following a systematic process. Human-centred Design provides a clear process that prioritises the healthcare professional's needs and their context to deliver a usable product. Problems with the chart could be addressed during the design phase rather than during implementation, thereby promoting chart ownership and uptake since users are involved throughout the design. This will translate to better documentation of inpatient care thus facilitating better patient tracking, improved team communication and better patient outcomes. RELEVANCE TO CLINICAL PRACTICE: Paper-based charts should be designed in a systematic and clear process that considers patient's and healthcare professional's needs contributing to improved uptake of charts and therefore better documentation.

Reaching health facilities in situations of emergency: qualitative study capturing experiences of pregnant women in Africa's largest megacity.

BACKGROUND: The consequences of delays in travel of pregnant women to reach facilities in emergency situations are well documented in literature. However, their decision-making and actual experiences of travel to health facilities when requiring emergency obstetric care (EmOC) remains a 'black box' of many unknowns to the health system, more so in megacities of low- and middle-income countries which are fraught with wide inequalities. METHODS: This in-depth study on travel of pregnant women in Africa's largest megacity, Lagos, is based on interviews conducted between September 2019 and January 2020 with 47 women and 11 of their relatives who presented at comprehensive EmOC facilities in situations of emergency, requiring some EmOC services. Following familiarisation, coding, and searching for patterns, the data was analysed for emerging themes. RESULTS: Despite recognising danger signs, pregnant women are often faced with conundrums on "when", "where" and "how" to reach EmOC facilities. While the decision-making process is a shared activity amongst all women, the available choices vary depending on socio-economic status. Women preferred to travel to facilities deemed to have "nicer" health workers, even if these were farther from home. Reported travel time was between 5 and 240 min in daytime and 5-40 min at night. Many women reported facing remarkably similar travel experiences, with varied challenges faced in the daytime (traffic congestion) compared to night-time (security concerns and scarcity of public transportation). This was irrespective of their age, socio-economic background, or obstetric history. However, the extent to which this experience impacted on their ability to reach facilities depended on their agency and support systems. Travel experience was better if they had a personal vehicle for travel at night, support of relatives or direct/indirect connections with senior health workers at comprehensive EmOC facilities. Referral barriers between facilities further prolonged delays and increased cost of travel for many women. CONCLUSION: If the goal, to leave no one behind, remains a priority, in addition to other health systems strengthening interventions, referral systems need to be improved. Advocacy on policies to encourage women to utilise nearby functional facilities when in situations of emergency and private sector partnerships should be explored.

Pregnant women's experiences with an integrated diagnostic and decision support device for antenatal care in Ghana.

BACKGROUND: Quality antenatal care (ANC) is recognised as an opportunity for screening and early identification of pregnancy-related complications. In rural Ghana, challenges with access to diagnostic services demotivate women from ANC attendance and referral compliance, leading to absent or late identification and management of high-risk women. In 2016, an integrated diagnostic and clinical decision support system tagged 'Bliss4Midwives' (B4M), was piloted in Northern Ghana. The device facilitated non-invasive screening of pre-eclampsia, gestational diabetes and anaemia at the point-of-care. This study aimed to explore the experiences of pregnant women with B4M, and its influence on service utilisation ("pull effect") and woman-provider relationships ("woman engagement"). METHODS: Through an embedded study design, qualitative methods including individual semi-structured interviews and non-participant observation were employed. Interviews were conducted with 20 pregnant women and 10 health workers, supplemented by ANC observations in intervention facilities. Secondary data on ANC registrations over a one-year period were extracted from health facility records to support findings on the perceived influence of B4M on service utilisation. RESULTS: Women's first impressions of the device were mostly emotive (excitement, fear), but sometimes neutral. Although it is inconclusive whether B4M increased ANC registration, pregnant women generally valued the availability of diagnostic services at the point-of-care. Additionally, by fostering some level of engagement, the intervention made women feel listened to and cared for. Process outcomes of the B4M encounter also showed that it was perceived as improving the skills and knowledge of the health worker, which facilitated trust in diagnostic recommendations and was therefore believed to motivate referral compliance. CONCLUSIONS: This study suggests that mHealth diagnostic and decision support devices enhance woman engagement and trust in health workers skills. There is need for further inquiry into how these interventions influence maternal health service utilization and women's expectations of pregnancy care.

Mechanisms behind gender transformative approaches targeting adolescent pregnancy in low- and middle-income countries: a realist synthesis protocol.

INTRODUCTION: Adolescent pregnancy is defined as pregnancy at the age of 19 or below. Pregnancy and childbirth complications are the most significant cause of death among 15-19-year-old girls. Several studies have indicated that inequitable gender norms can increase the vulnerability of adolescent girls, including violence exposure, early marriage, and adolescent pregnancy. To address these disparities, gender transformative approaches aim to challenge and transform restrictive gender norms, roles, and relations through targeted interventions, promoting progressive changes. This realist review aims to synthesise existing evidence from a broad range of data sources to understand how, why, for whom, and in what contexts gender transformative approaches succeed in reducing adolescent pregnancy in low- and middle-income countries. METHOD AND ANALYSIS: We employ a five-step realist synthesis approach: (1) clarify the scope of review and assessment of published literature, (2) development of initial programme theories, (3) systematic search for evidence, (4) development of refined programme theories, and (5) expert feedback and dissemination of results. This protocol presents the results of the first three steps and provides details of the next steps. We extracted data from 18 studies and outlined eight initial programme theories on how gender transformative approaches targeting adolescent pregnancy work in the first three steps. These steps were guided by experts in the field of sexual and reproductive health, implementation science, and realist methodology. As a next step, we will systematically search evidence from electronic databases and grey literature to identify additional studies eligible to refine the initial programme theories. Finally, we will propose refined programme theories that explain how gender transformative approaches work, why, for whom, and under which circumstances. ETHICS AND DISSEMINATION: Ethics approval is not required because the included studies are published articles and other policy and intervention reports. Key results will be shared with the broader audience via academic papers in open-access journals, conferences, and policy recommendations. The protocol for this realist review is registered in PROSPERO (CRD42023398293).

Learning Health Systems: A Paradigm Shift in What We Can Do about Digital Health Inequities.

Learning health systems (LHSs) embed social accountability into everyday workflows and can inform how governments build bridges across the digital health divide. They shape partnerships using rapid cycles of data-driven learning to respond to patients' calls to action for equity from digital health. Adopting the LHS approach involves re-distributing power, which is likely to be met with resistance. We use the LHS example of British Columbia's 811 services to highlight how infrastructure was created to provide care and answer questions about access to digital health, outcomes from it and the financial impact passed on to patients. In the concluding section, we offer an accountability framework that facilitates partnerships in making digital health more equitable.

Experiences of community health workers on adopting mHealth in rural Malawi: A qualitative study.

Background: The use of mobile health technology (mHealth) by community health workers (CHWs) can strengthen community-based service delivery and improve access to and quality of healthcare. Objective: This qualitative study sought to explore experiences and identify factors influencing the use of an integrated smartphone-based mHealth called YendaNafe by CHWs in rural Malawi. Methods: Using pre-tested interview guides, between August and October 2022, we conducted eight focus group discussions with CHWs (n = 69), four in-depth interviews with CHW supervisors, and eight key informant interviews in Neno District, Malawi. We audio-recorded and transcribed the interviews verbatim and organized them for analysis in Dedoose V9.0.62. We used an inductive analysis technique to analyze the data. We further applied the six domains of the socio-technical system (STS) framework to map factors influencing the use of YendaNafe. Results: User experiences and facilitators and barriers were the two main themes that emerged. mHealth was reported to improve the task efficiency, competence, trust, and perceived professionalism of CHWs. CHWs less frequently referred to cultural factors influencing app uptake. However, for other social systems, they identified relationships and trust with stakeholders, availability of training and programmatic support, and performance monitoring and feedback as influencing the use of YendaNafe. From the STS technical domain, the availability and adequacy of hardware such as phones, mobile connectivity, and usability influenced the use of YendaNafe. Conclusions: Despite the initial discomfort, CHWs found mHealth helpful in supporting their service delivery tasks. Identifying and addressing social and technical factors during mHealth implementation may help improve end users' attitudes and uptake.

Geographical accessibility to functional emergency obstetric care facilities in urban Nigeria using closer-to-reality travel time estimates: a population-based spatial analysis.

BACKGROUND: Better accessibility for emergency obstetric care facilities can substantially reduce maternal and perinatal deaths. However, pregnant women and girls living in urban settings face additional complex challenges travelling to facilities. We aimed to assess the geographical accessibility of the three nearest functional public and private comprehensive emergency obstetric care facilities in the 15 largest Nigerian cities via a novel approach that uses closer-to-reality travel time estimates than traditional model-based approaches. METHODS: In this population-based spatial analysis, we mapped city boundaries, verified and geocoded functional comprehensive emergency obstetric care facilities, and mapped the population distribution for girls and women aged 15-49 years (ie, of childbearing age). We used the Google Maps Platform's internal Directions Application Programming Interface to derive driving times to public and private facilities. Median travel time and the percentage of women aged 15-49 years able to reach care were summarised for eight traffic scenarios (peak and non-peak hours on weekdays and weekends) by city and within city under different travel time thresholds (≤15 min, ≤30 min, ≤60 min). FINDINGS: As of 2022, there were 11·5 million girls and women aged 15-49 years living in the 15 studied cities, and we identified the location and functionality of 2020 comprehensive emergency obstetric care facilities. City-level median travel time to the nearest comprehensive emergency obstetric care facility ranged from 18 min in Maiduguri to 46 min in Kaduna. Median travel time varied by location within a city. The between-ward IQR of median travel time to the nearest public comprehensive emergency obstetric care varied from the narrowest in Maiduguri (10 min) to the widest in Benin City (41 min). Informal settlements and peripheral areas tended to be worse off compared to the inner city. The percentages of girls and women aged 15-49 years within 60 min of their nearest public comprehensive emergency obstetric care ranged from 83% in Aba to 100% in Maiduguri, while the percentage within 30 min ranged from 33% in Aba to over 95% in Ilorin and Maiduguri. During peak traffic times, the median number of public comprehensive emergency obstetric care facilities reachable by women aged 15-49 years under 30 min was zero in eight (53%) of 15 cities. INTERPRETATION: Better access to comprehensive emergency obstetric care is needed in Nigerian cities and solutions need to be tailored to context. The innovative approach used in this study provides more context-specific, finer, and policy-relevant evidence to support targeted efforts aimed at improving comprehensive emergency obstetric care geographical accessibility in urban Africa. FUNDING: Google.

Socio-spatial equity analysis of relative wealth index and emergency obstetric care accessibility in urban Nigeria.

BACKGROUND: Better geographical accessibility to comprehensive emergency obstetric care (CEmOC) facilities can significantly improve pregnancy outcomes. However, with other factors, such as affordability critical for care access, it is important to explore accessibility across groups. We assessed CEmOC geographical accessibility by wealth status in the 15 most-populated Nigerian cities. METHODS: We mapped city boundaries, verified and geocoded functional CEmOC facilities, and assembled population distribution for women of childbearing age and Meta's Relative Wealth Index (RWI). We used the Google Maps Platform's internal Directions Application Programming Interface to obtain driving times to public and private facilities. City-level median travel time (MTT) and number of CEmOC facilities reachable within 60 min were summarised for peak and non-peak hours per wealth quintile. The correlation between RWI and MTT to the nearest public CEmOC was calculated. RESULTS: We show that MTT to the nearest public CEmOC facility is lowest in the wealthiest 20% in all cities, with the largest difference in MTT between the wealthiest 20% and least wealthy 20% seen in Onitsha (26 vs 81 min) and the smallest in Warri (20 vs 30 min). Similarly, the average number of public CEmOC facilities reachable within 60 min varies (11 among the wealthiest 20% and six among the least wealthy in Kano). In five cities, zero facilities are reachable under 60 min for the least wealthy 20%. Those who live in the suburbs particularly have poor accessibility to CEmOC facilities. CONCLUSIONS: Our findings show that the least wealthy mostly have poor accessibility to care. Interventions addressing CEmOC geographical accessibility targeting poor people are needed to address inequities in urban settings.

Access to critical obstetric care can be lifesaving for pregnant women and their offspring. However, socioeconomic factors are known to affect accessibility to health services across different groups. Here, we assessed peak and off-peak travel times to functional health facilities for women from 15 Nigerian cities, using travel time estimates produced by Google Maps and stratified by wealth status. Travel time to the nearest hospital and the number of hospitals reachable within 60 min varied across cities. The wealthiest 20% across all cities had the shortest travel time and vice versa for the least wealthy 20%. Women who live in the suburbs particularly have poor accessibility. Tailored action is needed to improve access for vulnerable populations living in urban settings.

Factors associated with adolescent pregnancy in Maharashtra, India: a mixed-methods study.

Reducing the adolescent birth rate is paramount in achieving the health-related Sustainable Development Goals, given that pregnancy and childbirth are the leading cause of mortality among young women aged 15-19. This study aimed to explore predictors of adolescent pregnancy among girls aged 13-18 years in Maharashtra, India, during the COVID-19 pandemic. Using a mixed-methods approach, primary data were gathered from two regions in Maharashtra between February and April 2022. Quantitative data from face-to-face interviews with 3049 adolescent girls assessed various household, social, and behavioural factors, as well as the socioeconomic and health impacts of COVID-19. Qualitative data from seven in-depth interviews were analysed thematically. The findings reveal that girls from low socioeconomic backgrounds face a higher likelihood of adolescent pregnancy. Multivariable analysis identified several factors associated with increased risk, including older age, being married, having more sexual partners, and experiencing COVID-19-related economic vulnerability. On the other hand, rural residence, secondary and higher secondary education of the participants, and higher maternal education were associated with a decreased likelihood of adolescent pregnancy. In the sub-sample of 565 partnered girls, partner's emotional abuse also correlated with higher rates of adolescent pregnancy. Thematic analysis of qualitative data identified four potential pathways leading to adolescent pregnancy: economic hardships and early marriage; personal safety, social norms, and early marriage; social expectations; and lack of knowledge on contraceptives. The findings underscore the significance of social position and behavioural factors and the impact of external shocks like the COVID-19 pandemic in predicting adolescent pregnancy in Maharashtra, India.Plain Language Summary: Adolescent pregnancy is an important health issue for young girls. In South Asia, one out of every five adolescent girls becomes a mother before turning 18, and in India, around 9% of girls aged 15-19 get pregnant yearly. This study focused on understanding the factors associated with adolescent pregnancy in Maharashtra, India, especially after the COVID-19 pandemic. We collected information from both urban and rural areas in Maharashtra. A total of 3049 adolescent girls participated in a survey, and seven girls participated in detailed interviews. Our analysis showed that factors like older age, being married, having multiple sexual partners, and experiencing economic difficulties due to COVID-19 increased the chances of adolescent pregnancy. On the other hand, living in rural areas, higher education for both the girls and their mothers reduced the likelihood of adolescent pregnancy. Qualitative analysis revealed that economic challenges, concerns about safety and societal norms, early marriage, societal expectations, and lack of knowledge about contraceptives could contribute to adolescent pregnancy in Maharashtra.

Adoption of mHealth Technologies by Community Health Workers to Improve the Use of Maternal Health Services in Sub-Saharan Africa: Protocol for a Mixed Method Systematic Review.

BACKGROUND: Studies have shown that mobile health technologies (mHealth) enhance the use of maternal health services. However, there is limited evidence of the impact of mHealth use by community health workers (CHWs) on the use of maternal health services in sub-Saharan Africa. OBJECTIVE: This mixed method systematic review will explore the impact of mHealth use by CHWs on the use of the maternal health continuum of care (antenatal care, intrapartum care, and postnatal care [PNC]), as well as barriers and facilitators of mHealth use by CHWs when supporting maternal health services. METHODS: We will include studies that report the impact of mHealth by CHWs on the use of antenatal care, facility-based births, and PNC visits in sub-Saharan Africa. We will search 6 databases (MEDLINE, CINAHL, Web of Science, Embase, Scopus, and Africa Index Medicus), with additional articles identified from Google Scholar and manual screening of references of the included studies. The included studies will not be limited by language or year of publication. After study selection, 2 independent reviewers will perform title and abstract screening, followed by full-text screening to identify the final papers to be included. Data extraction and risk-of-bias assessment will be performed using Covidence software by 2 independent reviewers. We will use a Mixed Methods Appraisal Tool to perform risk-of-bias assessments on all included studies. Finally, we will perform a narrative synthesis of the outcomes, integrating information about the effect of mHealth on maternal health use and barriers and facilitators of mHealth use. This protocol follows the PRISMA-P (Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols) guidelines. RESULTS: In September 2022, we conducted an initial search in the eligible databases. After removing duplicates, we identified 1111 studies that were eligible for the title and abstract screening. We will finalize the full-text assessment for eligibility, data extraction, assessment of methodological quality, and narrative synthesis by June 2023. CONCLUSIONS: This systematic review will present new and up-to-date evidence on the use of mHealth by CHWs along the pregnancy, childbirth, and PNC continuum of care. We anticipate the results will inform program implementation and policy by highlighting the potential impacts of mHealth and presenting contextual factors that should be addressed to ensure the success of the programs. TRIAL REGISTRATION: PROSPERO CRD42022346364; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=346364. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/44066.

A geospatial database of close-to-reality travel times to obstetric emergency care in 15 Nigerian conurbations.

Travel time estimation accounting for on-the-ground realities between the location where a need for emergency obstetric care (EmOC) arises and the health facility capable of providing EmOC is essential for improving pregnancy outcomes. Current understanding of travel time to care is inadequate in many urban areas of Africa, where short distances obscure long travel times and travel times can vary by time of day and road conditions. Here, we describe a database of travel times to comprehensive EmOC facilities in the 15 most populated extended urban areas of Nigeria. The travel times from cells of approximately 0.6 × 0.6 km to facilities were derived from Google Maps Platform's internal Directions Application Programming Interface, which incorporates traffic considerations to provide closer-to-reality travel time estimates. Computations were done to the first, second and third nearest public or private facilities. Travel time for eight traffic scenarios (including peak and non-peak periods) and number of facilities within specific time thresholds were estimated. The database offers a plethora of opportunities for research and planning towards improving EmOC accessibility.

Implementing a comprehensive newborn monitoring chart: Barriers, enablers, and opportunities.

Documenting inpatient care is largely paper-based and it facilitates team communication and future care planning. However, studies show that nursing documentation remains suboptimal especially for newborns, necessitating introduction of standardised paper-based charts. We report on a process of implementing a comprehensive newborn monitoring chart and the perceptions of health workers in a network of hospitals in Kenya. The chart was launched virtually in July 2020 followed by learning meetings with nurses and the research team. This is a qualitative study involving document review, individual in-depth interviews with nurses and paediatricians and a focus group discussion with data clerks. The chart was co-designed by the research team and hospital staff then implemented using a trainer of trainers' model where the nurses-in-charge were trained on how to use the chart and they in turn trained their staff. Training at the hospital was delivered by the nurse-in-charge and/or paediatrician through a combined training with all staff or one-on-one training. The chart was well received with health workers reporting reduced writing, consolidated information, and improved communication as benefits. Implementation was facilitated by individual and team factors, complementary projects, and the removal of old charts. However, challenges arose related to the staff and work environment, inadequate supply of charts, alternative places to document, and inadequate equipment. The participants suggested that future implementation should be accompanied by mentorship or close follow-up, peer experience sharing, training at the hospital and in pre-service institutions and wider stakeholder engagement. Findings show that there are opportunities to improve the implementation process by clarifying roles relating to the filing system, improving the chart supply process, staff induction and specifying a newborn patient file. The chart did not meet the need for supporting documentation of long stay patients presenting an opportunity to explore digital solutions that might provide more flexibility and features.

Strengthening capacity in hospitals to reduce perinatal morbidity and mortality through a codesigned intervention package: protocol for a realist evaluation as part of a stepped-wedge trial of the Action Leveraging Evidence to Reduce perinatal morTality and morbidity (ALERT) in sub-Saharan Africa project.

INTRODUCTION: Despite a strong evidence base for developing interventions to reduce child mortality and morbidity related to pregnancy and delivery, major knowledge-implementation gaps remain. The Action Leveraging Evidence to Reduce perinatal morTality and morbidity (ALERT) in sub-Saharan Africa project aims to overcome these gaps through strengthening the capacity of multidisciplinary teams that provide maternity care. The intervention includes competency-based midwife training, community engagement for study design, mentoring and quality improvement cycles. The realist process evaluation of ALERT aims at identifying and testing the causal pathway through which the intervention achieves its impact. METHODS AND ANALYSIS: This realist process evaluation complements the effectiveness evaluation and the economic evaluation of the ALERT intervention. Following the realist evaluation cycle, we will first elicit the initial programme theory on the basis of the ALERT theory of change, a review of the evidence on adoption and diffusion of innovations and the perspectives of the stakeholders. Second, we will use a multiple embedded case study design to empirically test the initial programme theory in two hospitals in each of the four intervention countries. Qualitative and quantitative data will be collected, using in-depth interviews with hospital staff and mothers, observations, patient exit interviews and (hospital) document reviews. Analysis will be guided by the Intervention-Actors-Context-Mechanism-Outcome configuration heuristic. We will use thematic coding to analyse the qualitative data. The quantitative data will be analysed descriptively and integrated in the analysis using a retroductive approach. Each case study will end with a refined programme theory (in-case analysis). Third, we will carry out a cross-case comparison within and between the four countries. Comparison between study countries should enable identifying relevant context factors that influence effectiveness and implementation, leading to a mid-range theory that may inform the scaling up the intervention. ETHICS AND DISSEMINATION: In developing this protocol, we paid specific attention to cultural sensitivity, the do no harm principle, confidentiality and non-attribution. We received ethical approval from the local and national institutional review boards in Tanzania, Uganda, Malawi, Benin, Sweden and Belgium. Written or verbal consent of respondents will be secured after explaining the purpose, potential benefits and potential harms of the study using an information sheet. The results will be disseminated through workshops with the hospital staff and national policymakers, and scientific publications and conferences. TRIAL REGISTRATION NUMBER: PACTR202006793783148.

Early epidemiological investigations: World Health Organization UNITY protocols provide a standardized and timely international investigation framework during the COVID-19 pandemic.

BACKGROUND: The declaration of Coronavirus disease 2019 (COVID-19) as a Public Health Emergency of International Concern (PHEIC) on 30 January 2020 required rapid implementation of early investigations to inform appropriate national and global public health actions. METHODS: The suite of existing pandemic preparedness generic epidemiological early investigation protocols was rapidly adapted for COVID-19, branded the 'UNITY studies' and promoted globally for the implementation of standardized and quality studies. Ten protocols were developed investigating household (HH) transmission, the first few cases (FFX), population seroprevalence (SEROPREV), health facilities transmission (n = 2), vaccine effectiveness (n = 2), pregnancy outcomes and transmission, school transmission, and surface contamination. Implementation was supported by WHO and its partners globally, with emphasis to support building surveillance and research capacities in low- and middle-income countries (LMIC). RESULTS: WHO generic protocols were rapidly developed and published on the WHO website, 5/10 protocols within the first 3 months of the response. As of 30 June 2021, 172 investigations were implemented by 97 countries, of which 62 (64%) were LMIC. The majority of countries implemented population seroprevalence (71 countries) and first few cases/household transmission (37 countries) studies. CONCLUSION: The widespread adoption of UNITY protocols across all WHO regions indicates that they addressed subnational and national needs to support local public health decision-making to prevent and control the pandemic.

Protocol for a sequential, prospective meta-analysis to describe coronavirus disease 2019 (COVID-19) in the pregnancy and postpartum periods.

We urgently need answers to basic epidemiological questions regarding SARS-CoV-2 infection in pregnant and postpartum women and its effect on their newborns. While many national registries, health facilities, and research groups are collecting relevant data, we need a collaborative and methodologically rigorous approach to better combine these data and address knowledge gaps, especially those related to rare outcomes. We propose that using a sequential, prospective meta-analysis (PMA) is the best approach to generate data for policy- and practice-oriented guidelines. As the pandemic evolves, additional studies identified retrospectively by the steering committee or through living systematic reviews will be invited to participate in this PMA. Investigators can contribute to the PMA by either submitting individual patient data or running standardized code to generate aggregate data estimates. For the primary analysis, we will pool data using two-stage meta-analysis methods. The meta-analyses will be updated as additional data accrue in each contributing study and as additional studies meet study-specific time or data accrual thresholds for sharing. At the time of publication, investigators of 25 studies, including more than 76,000 pregnancies, in 41 countries had agreed to share data for this analysis. Among the included studies, 12 have a contemporaneous comparison group of pregnancies without COVID-19, and four studies include a comparison group of non-pregnant women of reproductive age with COVID-19. Protocols and updates will be maintained publicly. Results will be shared with key stakeholders, including the World Health Organization (WHO) Maternal, Newborn, Child, and Adolescent Health (MNCAH) Research Working Group. Data contributors will share results with local stakeholders. Scientific publications will be published in open-access journals on an ongoing basis.

Appraising and addressing design and implementation failure in global health: A pragmatic framework.

There have been recent concerns about the failure of several global health interventions. Interventions are considered to have failed when they are unable to achieve the intended results. Failure may be linked to how the intervention was designed (design failure) or how it was implemented (implementation failure). Recently, substantial efforts have been employed to improve the outcomes of health interventions. These efforts have led to the development of several theories, models, and frameworks in implementation science to improve the quality of implementation, bridging the divide between evidence and practice. But significant gaps still exist. Whereas much work has been done to develop frameworks and approaches to improve implementation fidelity, not as much effort has been done to guide the adherence of interventions to program theory during the design of the programs. Further, there have been concerns about the applicability of these frameworks in the real-world. This article uses examples to illustrate these gaps and further proposes a pragmatic framework to address identified gaps, thus aiding evidence-informed program design and implementation. The proposed Theory-Design-Implementation (TyDI) framework will support policymakers, program planners and implementers to address potential design and implementation failure, thus improving the fidelity of interventions.

Cost of Utilising Maternal Health Services in Low- and Middle-Income Countries: A Systematic Review.

BACKGROUND: Cost is a major barrier to maternal health service utilisation for many women in low- and middle-income countries (LMICs). However, comparable evidence of the available cost data in these countries is limited. We conducted a systematic review and comparative analysis of costs of utilising maternal health services in these settings. METHODS: We searched peer-reviewed and grey literature databases for articles reporting cost of utilising maternal health services in LMICs published post-2000. All retrieved records were screened and articles meeting the inclusion criteria selected. Quality assessment was performed using the relevant cost-specific criteria of the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. To guarantee comparability, disaggregated costs data were inflated to 2019 US dollar equivalents. Total adjusted costs and cost drivers associated with utilising each service were systematically compared. Where heterogeneity in methods or non-disaggregated costs was observed, narrative synthesis was used to summarise findings. RESULTS: Thirty-six studies met our inclusion criteria. Many of the studies costed multiple services. However, the most frequently costed services were utilisation of normal vaginal delivery (22 studies), caesarean delivery (13), and antenatal care (ANC) (10). The least costed services were post-natal care (PNC) and post-abortion care (PAC) (5 each). Studies used varied methods for data collection and analysis and their quality ranged from low to high with most assessed as average or high. Generally, across all included studies, cost of utilisation progressively increased from ANC and PNC to delivery and PAC, and from public to private providers. Medicines and diagnostics were main cost drivers for ANC and PNC while cost drivers were variable for delivery. Women experienced financial burden of utilising maternal health services and also had to pay some unofficial costs to access care, even where formal exemptions existed. CONCLUSION: Consensus regarding approach for costing maternal health services will help to improve their relevance for supporting policy-making towards achieving universal health coverage. If indeed the post-2015 mission of the global community is to "leave no one behind," then we need to ensure that women and their families are not facing unnecessary and unaffordable costs that could potentially tip them into poverty.

How do participatory methods shape policy? Applying a realist approach to the formulation of a new tuberculosis policy in Georgia.

OBJECTIVES: This paper presents the iterative process of participatory multistakeholder engagement that informed the development of a new national tuberculosis (TB) policy in Georgia, and the lessons learnt. METHODS: Guided by realist evaluation methods, a multistakeholder dialogue was organised to elicit stakeholders' assumptions on challenges and possible solutions for better TB control. Two participatory workshops were conducted with key actors, interspersed by reflection meetings within the research team and discussions with policymakers. Using concept mapping and causal mapping techniques, and drawing causal loop diagrams, we visualised how actors understood TB service provision challenges and the potential means by which a results-based financing (RBF) policy could address these. SETTING: The study was conducted in Tbilisi, Georgia. PARTICIPANTS: A total of 64 key actors from the Ministry of Labour, Health and Social Affairs, staff of the Global Fund to Fight AIDS, TB and Malaria Georgia Project, the National Centre for Disease Control and Public Health, the National TB programme, TB service providers and members of the research team were involved in the workshops. RESULTS: Findings showed that beyond provider incentives, additional policy components were necessary. These included broadening the incentive package to include institutional and organisational incentives, retraining service providers, clear redistribution of roles to support an integrated care model, and refinement of monitoring tools. Health system elements, such as effective referral systems and health information systems were highlighted as necessary for service improvement. CONCLUSIONS: Developing policies that address complex issues requires methods that facilitate linkages between multiple stakeholders and between theory and practice. Such participatory approaches can be informed by realist evaluation principles and visually facilitated by causal loop diagrams. This approach allowed us leverage stakeholders' knowledge and expertise on TB service delivery and RBF to codesign a new policy.

Time trends and determinants of breastfeeding practices among adolescents and young women in Nigeria, 2003-2018.

INTRODUCTION: Optimal breastfeeding practices have far-reaching health and economic benefits. Evidence suggests disparities in breastfeeding practices by maternal age-groups, with younger mothers often having lower rates of breastfeeding initiation, continuation and exclusivity compared with older mothers. There is limited knowledge of trends and factors associated with breastfeeding practices, particularly among adolescent and younger mothers in Nigeria. We examine key breastfeeding practices in Nigeria over a 15-year period, comparing adolescent mothers to young women. METHODS: We used four Nigeria Demographic and Health Surveys collected between 2003 and 2018. We constructed six key breastfeeding indicators to cover the time period of breastfeeding from initiation to child age 24 months in women of three maternal age groups at the time of birth: young adolescents (<18 years), older adolescents (18-19.9 years) and young women (20-24.9 years). We used logistic regression to examine the association between maternal age group and select breastfeeding behaviours on the 2018 survey. RESULTS: Analysis showed an increase in optimal breastfeeding practices across the four surveys and among all maternal age groups examined. Adolescent mothers had consistently lower prevalence for three of the six key breastfeeding indicators: early initiation of breastfeeding, exclusive breastfeeding <6 months and no prelacteal feed. Compared with young women, adolescent mothers had a higher prevalence of continued breastfeeding at 1 and 2 years. In multivariate analysis, we found that maternal age group was not associated with early breastfeeding initiation or with exclusive breastfeeding <6 months. However, several sociodemographic (ethnicity, region of residence) and healthcare-related (mode of delivery, antenatal care, postnatal breastfeeding counselling) factors were strongly associated with these two practices. CONCLUSIONS: In Nigeria, there is need to better support breastfeeding and nutritional practices in adolescents and young women focusing on ethnic groups (Hausa, Fulani, Kanuri/Beriberi) and geographic regions (South East) that are lagging behind.