Data challenges for international health emergencies: lessons learned from ten international COVID-19 driver projects.

The COVID-19 pandemic highlighted the importance of international data sharing and access to improve health outcomes for all. The International COVID-19 Data Alliance (ICODA) programme enabled 12 exemplar or driver projects to use existing health-related data to address major research questions relating to the pandemic, and developed data science approaches that helped each research team to overcome challenges, accelerate the data research cycle, and produce rapid insights and outputs. These approaches also sought to address inequity in data access and use, test approaches to ethical health data use, and make summary datasets and outputs accessible to a wider group of researchers. This Health Policy paper focuses on the challenges and lessons learned from ten of the ICODA driver projects, involving researchers from 19 countries and a range of health-related datasets. The ICODA programme reviewed the time taken for each project to complete stages of the health data research cycle and identified common challenges in areas such as data sharing agreements and data curation. Solutions included provision of standard data sharing templates, additional data curation expertise at an early stage, and a trusted research environment that facilitated data sharing across national boundaries and reduced risk. These approaches enabled the driver projects to rapidly produce research outputs, including publications, shared code, dashboards, and innovative resources, which can all be accessed and used by other research teams to address global health challenges.

The impact of COVID-19 and national pandemic responses on health service utilisation in seven low- and middle-income countries.

BACKGROUND: The COVID-19 pandemic has disrupted health services worldwide, which may have led to increased mortality and secondary disease outbreaks. Disruptions vary by patient population, geographic area, and service. While many reasons have been put forward to explain disruptions, few studies have empirically investigated their causes. OBJECTIVE: We quantify disruptions to outpatient services, facility-based deliveries, and family planning in seven low- and middle-income countries during the COVID-19 pandemic and quantify relationships between disruptions and the intensity of national pandemic responses. METHODS: We leveraged routine data from 104 Partners In Health-supported facilities from January 2016 to December 2021. We first quantified COVID-19-related disruptions in each country by month using negative binomial time series models. We then modelled the relationship between disruptions and the intensity of national pandemic responses, as measured by the stringency index from the Oxford COVID-19 Government Response Tracker. RESULTS: For all the studied countries, we observed at least one month with a significant decline in outpatient visits during the COVID-19 pandemic. We also observed significant cumulative drops in outpatient visits across all months in Lesotho, Liberia, Malawi, Rwanda, and Sierra Leone. A significant cumulative decrease in facility-based deliveries was observed in Haiti, Lesotho, Mexico, and Sierra Leone. No country had significant cumulative drops in family planning visits. For a 10-unit increase in the average monthly stringency index, the proportion deviation in monthly facility outpatient visits compared to expected fell by 3.9% (95% CI: -5.1%, -1.6%). No relationship between stringency of pandemic responses and utilisation was observed for facility-based deliveries or family planning. CONCLUSIONS: Context-specific strategies show the ability of health systems to sustain essential health services during the pandemic. The link between pandemic responses and healthcare utilisation can inform purposeful strategies to ensure communities have access to care and provide lessons for promoting the utilisation of health services elsewhere.

The Impact of COVID-19 on Tuberculosis Program Performance in the Kingdom of Lesotho.

BACKGROUND: As tuberculosis (TB) is an airborne disease requiring multi-month therapy, systems of TB detection and care were profoundly impacted by the COVID-19 pandemic. The worsening economic situation, including income, food, and housing insecurity, impacted the social conditions in which TB-already a leading killer in resource-limited settings-thrives. This study assesses the impact of COVID-19 on TB detection and treatment in Lesotho. METHODS: We used routine program data from 78 health facilities in Lesotho. We created time series models from July 2018 to March 2021 to quantify COVID-19-related disruptions to TB program indicators: outpatient visits; presumptive, diagnosed, treated, and HIV co-infected cases; and treatment outcomes including successful (cured and completed) and unsuccessful (death and treatment outcome unknown). RESULTS: We observed a significant decline in cumulative outpatient visits (-37.4%, 95% prediction interval [PI]: -40.1%, -28.7%) and new TB cases diagnosed (-38.7%, 95%PI: -47.2%, -28.4%) during the pandemic, as well as TB-HIV co-infections (-67.0%, 95%PI: -72.6%, -60.0%). However, we observed no difference in treatment success (-2.1%, 95%PI: -17.0%, 15.8%). CONCLUSIONS: TB case detection in Lesotho fell during the COVID-19 pandemic, likely related to the uptake of overall health services. However, treatment success rates did not change, indicating a strong health system and the success of local strategies to maintain treatment programs.

Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A Mixed Methods Study.

INTRODUCTION/OBJECTIVE: Rapid global approval of coronavirus disease 2019 (COVID-19) vaccines and concurrent introduction in high-income countries and low- and middle-income countries (LMIC) highlights the importance of equitable safety surveillance of adverse events following immunization (AEFIs). We profiled AEFIs to COVID-19 vaccines, explored reporting differences between Africa and the rest of the world (RoW), and analyzed policy considerations that inform strengthening of safety surveillance in LMICs. METHODS: Using a convergent mixed-methods design we compared the rate and profile of COVID-19 vaccines' AEFIs reported to VigiBase by Africa versus the RoW, and interviewed policymakers to elicit considerations that inform the funding of safety surveillance in LMICs. RESULTS: With 87,351 out of 14,671,586 AEFIs, Africa had the second-lowest crude number and a reporting rate of 180 adverse events (AEs) per million administered doses. Serious AEs (SAEs) were 27.0%. Death accounted for about 10.0% of SAEs. Significant differences were found in reporting by gender, age group, and SAEs between Africa and the RoW. AstraZeneca and Pfizer BioNTech vaccines were associated with a high absolute number of AEFIs for Africa and RoW; Sputnik V contributed a considerably high rate of AEs per 1 million administered doses. Funding decisions for safety surveillance in LMICs were not based on explicit policies but on country priorities, perceived utility of data, and practical implementation issues. CONCLUSION: African countries reported fewer AEFIs relative to the RoW. To enhance Africa's contribution to the global knowledge on COVID-19 vaccine safety, governments must explicitly consider safety monitoring as a priority, and funding organizations need to systematically and continuously support these programs.

Breast cancer molecular diagnostics in Rwanda: a cost-minimization study of immunohistochemistry versus a novel GeneXpert® mRNA expression assay.

Objective: To compare the financial and time cost of breast cancer biomarker analysis by immunohistochemistry with that by the Xpert® STRAT4 assay. Methods: We estimated costs (personnel, location, consumables and indirect) and time involved in breast cancer diagnosis at the Butaro Cancer Centre of Excellence, Rwanda, using time-driven activity-based costing. We performed a cost-minimization analysis to compare the cost of biomarker analysis for estrogen receptor, progesterone receptor and human epidermal growth factor receptor-2 status with immunohistochemistry versus STRAT4. We performed sensitivity analyses by altering laboratory-specific parameters for the two methods. Findings: We estimated that breast cancer diagnosis in Rwanda costs 138.29 United States dollars (US$) per patient when conducting biomarker analysis by immunohistochemistry. At a realistic immunohistochemistry antibody utilization efficiency of 70%, biomarker analysis comprises 48.7% (US$ 67.33) of diagnostic costs and takes 33 min. We determined that biomarker analysis with STRAT4 yields a reduction in diagnosis cost of US$ 7.33 (10.9%; 7.33/67.33), and in pathologist and technician time of 20 min (60.6%; 20/33), per patient. Our sensitivity analysis revealed that no cost savings would be made in laboratories with antibody utilization efficiencies over 90%, or where only estrogen and/or progesterone receptor status are assessed; however, such operational efficiencies are unlikely, and more laboratories are pursuing human epidermal growth factor receptor-2 analysis as targeted therapies become increasingly available. Conclusion: Breast cancer biomarker analysis with STRAT4 has the potential to reduce the required human and capital resources in sub-Saharan African laboratories, leading to improved treatment selection and better clinical outcomes.

Breast cancer molecular diagnostics in Rwanda: a cost-minimization study of immunohistochemistry versus a novel GeneXpert® mRNA expression assay

Objective To compare the financial and time cost of breast cancer biomarker analysis by immunohistochemistry with that by the Xpert® STRAT4 assay. Methods We estimated costs (personnel, location, consumables and indirect) and time involved in breast cancer diagnosis at the Butaro Cancer Centre of Excellence, Rwanda, using time-driven activity-based costing. We performed a cost-minimization analysis to compare the cost of biomarker analysis for estrogen receptor, progesterone receptor and human epidermal growth factor receptor-2 status with immunohistochemistry versus STRAT4. We performed sensitivity analyses by altering laboratory-specific parameters for the two methods. Findings We estimated that breast cancer diagnosis in Rwanda costs 138.29 United States dollars (US$) per patient when conducting biomarker analysis by immunohistochemistry. At a realistic immunohistochemistry antibody utilization efficiency of 70%, biomarker analysis comprises 48.7% (US$ 67.33) of diagnostic costs and takes 33 min. We determined that biomarker analysis with STRAT4 yields a reduction in diagnosis cost of US$ 7.33 (10.9%; 7.33/67.33), and in pathologist and technician time of 20 min (60.6%; 20/33), per patient. Our sensitivity analysis revealed that no cost savings would be made in laboratories with antibody utilization efficiencies over 90%, or where only estrogen and/or progesterone receptor status are assessed; however, such operational efficiencies are unlikely, and more laboratories are pursuing human epidermal growth factor receptor-2 analysis as targeted therapies become increasingly available. Conclusion Breast cancer biomarker analysis with STRAT4 has the potential to reduce the required human and capital resources in subSaharan African laboratories, leading to improved treatment selection and better clinical outcomes.

Health system costs of a breast cancer early diagnosis programme in a rural district of Rwanda: a retrospective, cross-sectional economic analysis.

OBJECTIVES: This study aimed to quantify the health system cost of the first 2 years of a Breast Cancer Early Detection (BCED) programme in a rural district in Rwanda. We also aimed to estimate the cost of implementing the programme in other districts with different referral pathways and identify opportunities for enhanced cost efficiency. DESIGN: Retrospective, cross-sectional analysis using time-driven activity-based costing, based on timed patient clinical encounters, retrospective patient data and unit costs of resources abstracted from administrative and finance records. SETTING: The BCED programme focused on timely evaluation of individuals with breast symptoms. The study evaluated the health system cost of the BCED programme at seven health centres (HCs) in Burera district and Butaro Cancer Centre of Excellence (BCCOE) at Butaro District Hospital. OUTCOME MEASURES: Health system costs per patient visit and cost per cancer diagnosed were quantified. Total start-up and recurring operational costs were also estimated, as well as health system costs of different scale-up adaptations in other districts. RESULTS: One-time start-up costswere US$36 917, recurring operational costswere US$67 711 and clinical costswere US$14 824 over 2 years. Clinical breast examinations (CBE) at HCs cost US$3.27/visit. At BCCOE, CBE-only visits cost US$13.47/visit, CBE/ultrasound US$14.79/visit and CBE/ultrasound/biopsy/pathology US$147.81/visit. Overall, clinical cost per breast cancer diagnosed was US$1482. Clinicalcost drivers were personnel at HCs (55%) and biopsy/pathology supplies at BCCOE (46%). In other districts, patients experience a longer breast evaluation pathway, adding about US$14.00/patient; this could be decreased if ultrasound services were decentralised. CONCLUSION: Clinical costs associated with BCED services at HCs were modest, similar to other general outpatient services. The BCED programme's start-up and operational costs were high but could be reduced by using local trainers and virtual mentorship. In other districts, decentralising ultrasound and/or biopsies to district hospitals could reduce costs.

Childhood immunization during the COVID-19 pandemic: experiences in Haiti, Lesotho, Liberia and Malawi.

OBJECTIVE: To examine changes in vaccination of children younger than 1 year during the coronavirus disease 2019 (COVID-19) pandemic (March 2020-August 2021) in Haiti, Lesotho, Liberia and Malawi. METHODS: We used data from health management information systems on vaccination of children aged 12 months or younger in districts supported by Partners In Health. We used data from January 2016 to February 2020 and a linear model with negative binomial distribution to estimate the expected immunization counts for March 2020-August 2021 with 95% prediction intervals, assuming no pandemic. We compared these expected levels with observed values and estimated the immunization deficits or excesses during the pandemic months. FINDINGS: Baseline vaccination counts varied substantially by country, with Lesotho having the lowest count and Haiti the highest. We observed declines in vaccination administration early in the COVID-19 pandemic in Haiti, Lesotho and Liberia. Continued declines largely corresponded to high rates of COVID-19 infection and discrete stock-outs. By August 2021, vaccination levels had returned to close to or above expected levels in Haiti, Liberia and Lesotho; in Malawi levels remained below expected. CONCLUSION: Patterns of childhood immunization coverage varied by country over the course of the pandemic, with significantly lower than expected vaccination levels seen in one country during subsequent COVID-19 waves. Governments and health-care stakeholders should monitor vaccine coverage closely and consider interventions, such as community outreach, to avoid or combat the disruptions in childhood vaccination.

Disruptions in maternal health service use during the COVID-19 pandemic in 2020: experiences from 37 health facilities in low-income and middle-income countries.

The COVID-19 pandemic has heterogeneously affected use of basic health services worldwide, with disruptions in some countries beginning in the early stages of the emergency in March 2020. These disruptions have occurred on both the supply and demand sides of healthcare, and have often been related to resource shortages to provide care and lower patient turnout associated with mobility restrictions and fear of contracting COVID-19 at facilities. In this paper, we assess the impact of the COVID-19 pandemic on the use of maternal health services using a time series modelling approach developed to monitor health service use during the pandemic using routinely collected health information systems data. We focus on data from 37 non-governmental organisation-supported health facilities in Haiti, Lesotho, Liberia, Malawi, Mexico and Sierra Leone. Overall, our analyses indicate significant declines in first antenatal care visits in Haiti (18% drop) and Sierra Leone (32% drop) and facility-based deliveries in all countries except Malawi from March to December 2020. Different strategies were adopted to maintain continuity of maternal health services, including communication campaigns, continuity of community health worker services, human resource capacity building to ensure compliance with international and national guidelines for front-line health workers, adapting spaces for safe distancing and ensuring the availability of personal protective equipment. We employ a local lens, providing prepandemic context and reporting results and strategies by country, to highlight the importance of developing context-specific interventions to design effective mitigation strategies.

Childhood immunization during the COVID-19 pandemic: experiences in Haiti, Lesotho, Liberia and Malawi

Objective: To examine changes in vaccination of children younger than 1 year during the coronavirus disease 2019 (COVID-19) pandemic (March 2020-August 2021) in Haiti, Lesotho, Liberia and Malawi. Methods: We used data from health management information systems on vaccination of children aged 12 months or younger in districts supported by Partners In Health. We used data from January 2016 to February 2020 and a linear model with negative binomial distribution to estimate the expected immunization counts for March 2020-August 2021 with 95% prediction intervals, assuming no pandemic. We compared these expected levels with observed values and estimated the immunization deficits or excesses during the pandemic months. Findings: Baseline vaccination counts varied substantially by country, with Lesotho having the lowest count and Haiti the highest. We observed declines in vaccination administration early in the COVID-19 pandemic in Haiti, Lesotho and Liberia. Continued declines largely corresponded to high rates of COVID-19 infection and discrete stock-outs. By August 2021, vaccination levels had returned to close to or above expected levels in Haiti, Liberia and Lesotho; in Malawi levels remained below expected. Conclusion: Patterns of childhood immunization coverage varied by country over the course of the pandemic, with significantly lower than expected vaccination levels seen in one country during subsequent COVID-19 waves. Governments and health-care stakeholders should monitor vaccine coverage closely and consider interventions, such as community outreach, to avoid or combat the disruptions in childhood vaccination.

Syndromic surveillance using monthly aggregate health systems information data: methods with application to COVID-19 in Liberia.

BACKGROUND: Early detection of SARS-CoV-2 circulation is imperative to inform local public health response. However, it has been hindered by limited access to SARS-CoV-2 diagnostic tests and testing infrastructure. In regions with limited testing capacity, routinely collected health data might be leveraged to identify geographical locales experiencing higher than expected rates of COVID-19-associated symptoms for more specific testing activities. METHODS: We developed syndromic surveillance tools to analyse aggregated health facility data on COVID-19-related indicators in seven low- and middle-income countries (LMICs), including Liberia. We used time series models to estimate the expected monthly counts and 95% prediction intervals based on 4 years of previous data. Here, we detail and provide resources for our data preparation procedures, modelling approach and data visualisation tools with application to Liberia. RESULTS: To demonstrate the utility of these methods, we present syndromic surveillance results for acute respiratory infections (ARI) at health facilities in Liberia during the initial months of the COVID-19 pandemic (January through August 2020). For each month, we estimated the deviation between the expected and observed number of ARI cases for 325 health facilities and 15 counties to identify potential areas of SARS-CoV-2 circulation. CONCLUSIONS: Syndromic surveillance can be used to monitor health facility catchment areas for spikes in specific symptoms which may indicate SARS-CoV-2 circulation. The developed methods coupled with the existing infrastructure for routine health data systems can be leveraged to monitor a variety of indicators and other infectious diseases with epidemic potential.

Economic Evaluations of Breast Cancer Care in Low- and Middle-Income Countries: A Scoping Review.

BACKGROUND: Understanding the cost of delivering breast cancer (BC) care in low- and middle-income countries (LMICs) is critical to guide effective care delivery strategies. This scoping review summarizes the scope of literature on the costs of BC care in LMICs and characterizes the methodological approaches of these economic evaluations. MATERIALS AND METHODS: A systematic literature search was performed in five databases and gray literature up to March 2020. Studies were screened to identify original articles that included a cost outcome for BC diagnosis or treatment in an LMIC. Two independent reviewers assessed articles for eligibility. Data related to study characteristics and methodology were extracted. Study quality was assessed using the Drummond et al. checklist. RESULTS: Ninety-one articles across 38 countries were included. The majority (73%) of studies were published between 2013 and 2020. Low-income countries (2%) and countries in Sub-Saharan Africa (9%) were grossly underrepresented. The majority of studies (60%) used a health care system perspective. Time horizon was not reported in 30 studies (33%). Of the 33 studies that estimated the cost of multiple steps in the BC care pathway, the majority (73%) were of high quality, but studies varied in their inclusion of nonmedical direct and indirect costs. CONCLUSION: There has been substantial growth in the number of BC economic evaluations in LMICs in the past decade, but there remain limited data from low-income countries, especially those in Sub-Saharan Africa. BC economic evaluations should be prioritized in these countries. Use of existing frameworks for economic evaluations may help achieve comparable, transparent costing analyses. IMPLICATIONS FOR PRACTICE: There has been substantial growth in the number of breast cancer economic evaluations in low- and middle-income countries (LMICs) in the past decade, but there remain limited data from low-income countries. Breast cancer economic evaluations should be prioritized in low-income countries and in Sub-Saharan Africa. Researchers should strive to use and report a costing perspective and time horizon that captures all costs relevant to the study objective, including those such as direct nonmedical and indirect costs. Use of existing frameworks for economic evaluations in LMICs may help achieve comparable, transparent costing analyses in order to guide breast cancer control strategies.

Cost of breast cancer care in low- and middle-income countries: a scoping review protocol.

OBJECTIVE: This review will describe the scope of the literature on the cost of breast cancer care in low- and middle-income countries and summate the methodological characteristics and approaches of these economic evaluations. INTRODUCTION: In the past decade, there has been global momentum to improve capacity for breast cancer care in low- and middle-income countries, which have higher rates of breast cancer mortality compared to high-income countries. Understanding the cost of delivering breast cancer care in low- and middle-income countries is critical to guide effective cancer care delivery strategies and policy. INCLUSION CRITERIA: Studies that estimate the cost of breast cancer diagnosis and treatment in low- and middle-income countries will be included. Studies not available in English will be excluded. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review guidelines will be utilized. The search strategy has been developed in consultation with a medical librarian and will be carried out on five electronic databases from their inception (MEDLINE, Embase, Web of Science, Global Health, WHO Global Index Medicus) as well as in gray literature sources. Two independent reviewers will review all abstracts and titles in the primary screen and full-text articles in the secondary screen. A third reviewer will adjudicate conflicts. One reviewer will perform data extraction. Study demographics, design, and methodological characteristics (such as costing perspective, time horizon, and included cost categories) will be summarized in narrative and tabular formats. The methodological quality of studies will be evaluated using a validated economic evaluation tool.

The All Babies Count Initiative: Impact of a Health System Improvement Approach on Neonatal Care and Outcomes in Rwanda.

INTRODUCTION: Poor-quality care contributes to a significant portion of neonatal deaths globally. The All Babies Count (ABC) initiative was an 18-month district-wide approach designed to improve clinical and system performance across 2 rural Rwandan districts. METHODS: This pre-post intervention study measured change in maternal and newborn health (MNH) quality of care and neonatal mortality. Data from the facility and community health management information system and newly introduced indicators were extracted from facility registers. Medians and interquartile ranges were calculated for the health facility to assess changes over time, and a mixed-effects logistic regression model was created for neonatal mortality. A difference-in-differences analysis was conducted to compare the change in district neonatal mortality with the rest of rural Rwanda. RESULTS: Improvements were seen in multiple measures of facility readiness and MNH quality of care, including antenatal care coverage, preterm labor management, and postnatal care quality. District hospital case fatality decreased, with a statistically significant reduction in district neonatal mortality (odds ratio [OR]=0.54; 95% confidence interval [CI]=0.36, 0.83) and among preterm/low birth weight neonates (OR=0.47; 95% CI=0.25, 0.90). Neonatal mortality was reduced from 30.1 to 19.6 deaths/1,000 live births in the intervention districts and remained relatively stable in the rest of rural Rwanda (difference in differences -12.9). CONCLUSION: The ABC initiative contributed to improved MNH quality of care and outcomes in rural Rwanda. A combined clinical and health system improvement approach could be an effective strategy to improve quality and reduce neonatal mortality.

Health system reconstitution syndrome: an often misunderstood phenomenon in global health practice.

The beginning of the 21st century was marked by the new definition and framework of health systems strengthening (HSS). The global movement to improve access to high-quality care garnered new resources to design and implement comprehensive HSS programs. In this effort, billions of dollars flowed from novel mechanisms such as The Global Fund to Fight AIDS, Tuberculosis and Malaria; Gavi, the Vaccine Alliance; and several bilateral funders. However, poor health outcomes, particularly in low-income countries, raise questions about the effectiveness of HSS program implementation. While several evaluation projects focus on the ultimate impact of HSS programs, little is known about the short- and mid-term reactions occurring throughout the active implementation of HSS interventions. Using the well-documented WHO framework of six HSS building blocks, we describe the evolution and phases of health system reconstitution syndrome (HSRS), including: (1) quiescent phase, (2) reactive phase, (3) restorative phase and (4) stability phase. We also discuss the implications of HSRS on global health funding, implementation, policy and research. Recognizing signs of HSRS could improve the rigour of HSS program design and minimize premature decisions regarding the progress of HSS interventions.