Improving possible serious bacterial infection (PSBI) management in young infants when referral is not feasible: lessons from embedded implementation research in Ethiopia and Kenya.

BACKGROUND: Sepsis is a leading cause of neonatal mortality, despite the availability of effective treatment of possible serious bacterial illness (PSBI), including when referral to a hospital is not feasible. Gaps in access and delivery worsened during COVID-19. We conducted embedded implementation research in Ethiopia and Kenya aimed at mitigating the impact of COVID-19 and addressing various implementation challenges to improve PSBI management. METHODS: The implementation research projects were implemented at the subnational level in Ethiopia and Kenya between November 2020-June 2022 (Ethiopia) and December 2020-August 2022 (Kenya). Guided by the implementation research frameworks, both projects conducted mixed formative quantitative and exploratory research from April to May 2021, followed by summative evaluations conducted between June and July 2022. Frameworks encompassed Consolidated Framework for Implementation Research (CFIR), Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM), as well as health systems framework that incorporates cascades of care and World Health Organization Health Systems Building Blocks. Results were synthesized across the projects through document review and sharing cross-project measures and strategies through a project community of practice. RESULTS: Despite differences in settings across the projects, cross-cutting facilitators included community health worker program and support, and existence of guidelines for PSBI management at primary care levels. Barriers included community attitudes towards seeking care for sick newborns, COVID-19 risks and fear, and lack of health care worker competence. Country-specific contextual barriers included supply chain issues, civil conflict (Ethiopia), and labor strikes (Kenya). Strategies chosen to mitigate barriers and support implementation and sustainability in both settings included leveraging community health workers to address resistance to care-seeking, health workers' training, COVID-19 infection prevention measures, stakeholder engagement, and advocacy to integrate PSBI management into existing programs, policies, and training. Other strategies addressing emerging project-specific barriers, included improving follow-up through a community health desk and PSBI mobile app (Kenya) and supply chain strengthening (Ethiopia). Both projects improved PSBI management coverage, increased adoption and uptake, and informed national policy changes supporting potential for sustainability. CONCLUSIONS: Pragmatic embedded implementation research effectively supports the identification of barriers and mapping to strategies designed to increase effective coverage of PSBI management when referral is not feasible during the COVID-19 pandemic. Despite differences in context, cross-cutting strategies identified could inform broader scale-up in the region, including during future health system shocks.

Neurodevelopmental outcomes following possible serious bacterial infection in early infancy in Karachi, Pakistan: a prospective cohort study.

BACKGROUND: Pakistan reports a significant burden of neonatal mortality, with infections as one of the major causes. We aim to assess the long-term impact of early infancy infections on neurodevelopmental outcomes during later childhood. METHODS: We conducted a prospective follow-up study of the cohort enrolled at the Karachi site of the Aetiology of Neonatal Infection in South Asia (ANISA) during 2019-2020. Children with a possible serious bacterial infection (based on the WHO IMCI algorithm) at early infancy were assessed for neurodevelopment at 6-9 years of age and compared with healthy controls. The Ten Questions (TQS) questionnaire, Strengths and Difficulties Questionnaire (SDQ), and Parent's Evaluation of Developmental Stage Assessment Level (PEDS: DM-AL) neurodevelopmental assessment tools, were administered and scored by the research staff who were blinded to the child's exposure status. Generalized Structural Equation Modelling (GSEM) was employed to verify relationships and associations among developmental milestones, anthropometry, and sociodemographic variables. RESULTS: A total of 398 children (241 cases and 157 controls) completed neurodevelopmental and growth assessments. Cases had a significantly higher rate of abnormal TQS scores (54.5% vs. 35.0%, p-value 0.001), greater delays in motor milestones (21.2% vs. 12.1%, p-value 0.02), lower fine motor skills (78.4 ± 1.4 vs. 83.2 ± 1.5, p-value 0.02). The receptive language skills were well-developed in both groups. According to the logistic regression model, exposure to infection during the first 59 days of life was associated with delayed TQS milestones (ß = -0.6, 95% CI -1.2,-0.04), TQS hearing domain (ß = -0.3, 95% CI: -1.2 to 0.7), PEDS: DM-AL fine motor domain (ß = -1.3, 95% CI: -4.4 to 1.7), PEDS: DM-AL receptive language development (ß = -1.1, 95% CI: -3.7 to 1.4) and child anthropometric measurements such as weight and height (ß = -0.2, 95% CI: -0.4 to 0.01 and ß = -0.2, 95% CI: -0.4 to -0.01, respectively). Early pSBI exposure was positively associated with PEDS: DM-AL self-help domain (ß = 0.6, 95% CI: -1.2 to 2.4) and SDQ-P overall score (ß = 0.02, 95% CI: -0.3 to 0.3). CONCLUSION: Children exposed to PSBI during early infancy have higher rates of abnormal development, motor delays, and lower fine motor skills during later childhood in Pakistan. Socioeconomic challenges and limited healthcare access contribute to these challenges, highlighting the need for long-term follow-ups with integrated neurodevelopment assessments.

Optimizing integration of community-based management of possible serious bacterial infection (PSBI) in young infants into primary healthcare systems in Ethiopia and Kenya: successes and challenges.

BACKGROUND: Ethiopia and Kenya have adopted the community-based integrated community case management (iCCM) of common childhood illnesses and newborn care strategy to improve access to treatment of infections in newborns and young infants since 2012 and 2018, respectively. However, the iCCM strategy implementation has not been fully integrated into the health system in both countries. This paper describes the extent of integration of iCCM program at the district/county health system level, related barriers to optimal integration and implementation of strategies. METHODS: From November 2020 to August 2021, Ethiopia and Kenya implemented the community-based treatment of possible serious bacterial infection (PSBI) when referral to a higher facility is not possible using embedded implementation research (eIR) to mitigate the impact of COVID-19 on the delivery of this life-saving intervention. Both projects conducted mixed methods research from April-May 2021 to identify barriers and facilitators and inform strategies and summative evaluations from June-July 2022 to monitor the effectiveness of implementation outcomes including integration of strategies. RESULTS: Strategies identified as needed for successful implementation and sustainability of the management of PSBI integrated at the primary care level included continued coaching and support systems for frontline health workers, technical oversight from the district/county health system, and ensuring adequate supply of commodities. As a result, support and technical oversight capacity and collaborative learning were strengthened between primary care facilities and community health workers, resulting in improved bidirectional linkages. Improvement of PSBI treatment was seen with over 85% and 81% of estimated sick young infants identified and treated in Ethiopia and Kenya, respectively. However, perceived low quality of service, lack of community trust, and shortage of supplies remained barriers impeding optimal PSBI services access and delivery. CONCLUSION: Pragmatic eIR identified shared and unique contextual challenges between and across the two countries which informed the design and implementation of strategies to optimize the integration of PSBI management into the health system during the COVID-19 pandemic. The eIR participatory design also strengthened ownership to operationalize the implementation of identified strategies needed to improve the health system's capacity for PSBI treatment.

Implementation research to increase treatment coverage of possible serious bacterial infections in young infants when a referral is not feasible: lessons learnt.

BACKGROUND: The objective was to achieve high coverage of possible serious bacterial infections (PSBI) treatment using the World Health Organization (WHO) guideline for managing it on an outpatient basis when referral to a hospital is not feasible. METHODS: We implemented this guideline in the programme settings at 10 Basic Health Units (BHU) in two rural districts of Sindh in Pakistan using implementation research. A Technical Support Unit supported the programme to operationalize guidelines, built capacity of health workers through training, monitored their clinical skills, mentored them and assured quality. The community-based health workers visited households to identify sick infants and referred them to the nearest BHU for further management. The research team collected data. RESULTS: Of 17 600 identified livebirths, 1860 young infants with any sign of PSBI sought care at BHUs and 1113 (59.8%) were brought by families. We achieved treatment coverage of 95%, assuming an estimated 10% incidence of PSBI in the first 2 months of life and that 10% of young infants came from outside the study catchment area. All 923 infants (49%; 923/1860) 7-59 days old with only fast breathing (pneumonia) treated with outpatient oral amoxicillin were cured. Hospital referral was refused by 83.4% (781/937) families who accepted outpatient treatment; 92.2% (720/781) were cured and 0.8% (6/781) died. Twelve (7.6%; 12/156) died among those treated in a hospital. CONCLUSION: It is feasible to achieve high coverage by implementing WHO PSBI management guidelines in a programmatic setting when a referral is not feasible.

Using the Implementation Research Logic Model to design and implement community-based management of possible serious bacterial infection during COVID-19 pandemic in Ethiopia.

BACKGROUND: Community-based treatment of possible serious bacterial infection (PSBI) in young infants, when referral to a hospital is not possible, can result in high treatment coverage and low case fatality. However, in Ethiopia, the coverage of PSBI treatment remains low, worsened by COVID-19. To understand the challenges of delivery of PSBI treatment and design and test adaptative strategies to mitigate the impact of COVID-19 on neonatal mortality, we did implementation research (IR) employing Implementation Research Logic Model (IRLM). In this paper, we describe IRLM application experiences in designing, implementing, and evaluating strategies to improve community-based treatment of PSBI during the COVID-19 pandemic in Ethiopia. METHODS: This IR was conducted between November 2020-April 2022 at Dembecha and Lume woredas of Amhara and Oromia regions, respectively. We employed narrative reviews, formative assessment and facilitated stakeholder engagement to develop the PSBI treatment IRLM to identify barriers, understand the conceptual linkages among determinants, choose implementation strategies, elicit mechanisms, and link to implementation outcomes. In addition, we used the IRLM to structure the capture of emerging implementation challenges and resulting strategy adaptations throughout implementation. RESULTS: This IR identified COVID-19 and multiple pre-existing contextual factors. We designed and implemented implementation strategies to address these challenges. These adaptive strategies were implemented with sufficient strength to maintain the delivery of PSBI services and improve mothers' care-seeking behavior for their sick young infants. The IRLM offers us a clear process and path to prioritize implementation challenges, choose strategies informed by mechanisms of action, and where the adaptive implementation of community-based management of PSBI would lead to high-implementation fidelity and change in mother behavior to seek care for their sick young infants. The IRLM was also an effective tool for stakeholder engagement, easily explained and used to structure discussion and decision-making during co-design meetings. CONCLUSIONS: The use of the IRLM helps us to specify the conceptual links between the implementation challenges, strategies, mechanisms of action, and outcomes to explore the complex community-based management of PSBI during complex contexts to improve high-fidelity implementation and integration of PSBI treatment in the primary healthcare delivery systems through active engagement of stakeholders.

Management of bacterial infections in young infants in Ethiopia: Facility preparedness, health workers' knowledge and quality of care.

AIM: We assessed primary care facility preparedness, health workers' knowledge and their classification and treatment of possible serious bacterial infection and local bacterial infection in young infants aged 0-59 days. METHOD: A cross-sectional survey was conducted in four regions of Ethiopia, including 169 health posts with 276 health extension workers and 155 health centres with 175 staff. Registers of 1058 sick young infants were reviewed. RESULT: Antibiotics to treat possible serious bacterial infection were available in 71% of the health centres and 38% of the health posts. Nine of ten health extension workers and eight of ten health centre staff mentioned at least one sign of possible serious bacterial infection and local bacterial infection. Among the registered cases with signs of bacterial infections, the health extension workers classified 49% as having a possible serious bacterial infection and 88% as local bacterial infection. The health centre staff classified 25% as possible serious bacterial infections and 86% as local bacterial infections. One-fourth (26%) of possible serious bacterial infection received the recommended treatment at health posts and 35% at health centres. CONCLUSION: Many health posts lacked antibiotics. The classification and treatment of possible serious bacterial infection did not follow guidelines. The lack of medicines and poor adherence compromise the quality of care.

Embedding Community-Based Newborn Care in the Ethiopian health system: lessons from a 4-year programme evaluation.

Despite remarkable gains, improving neonatal survival globally remains slow paced. Innovative service-delivery packages have been developed for community health workers (CHWs) to maximize system efficiency and increase the reach of services. However, embedding these in health systems needs structural and procedural alignment. The Community-Based Newborn Care (CBNC) programme was a response to high neonatal mortality in Ethiopia. Key aspects include simplified treatment for neonatal illness, integrated outreach services and task-shifting. Using the CHW functionality model by WHO, this study evaluates the health system response to the programme, including quality of care. A before-and-after study was conducted with three survey time points: baseline (November 2013), midline (December 2015) and follow-up (December 2017-4 years after the programme started). Data were collected at a sample of primary healthcare facilities from 101 districts across four regions. Analysis took two perspectives: (1) health system response, through supplies, infrastructure support and supervision, assessed through interviews and observations at health facilities and (2) quality of care, through CHWs' theoretical capacity to deliver services, as well as their performance, assessed through functional health literacy and direct observation of young infant case management. Results showed gains in services for young infants, with antibiotics and job aids available at over 90% of health centres. However, services at health posts remained inadequate in 2017. In terms of quality of care, only 37% of CHWs correctly diagnosed key conditions in sick young infants at midline. CHWs' functional health literacy declined by over 70% in basic aspects of case management during the study. Although the frequency of quarterly supportive supervision visits was above 80% during 2013-2017, visits lacked support for managing sick young infants. Infrastructure and resources improved over the course of the CBNC programme implementation. However, embedding and scaling up the programme lacked the systems-thinking and attention to health system building-blocks needed to optimize service delivery.

Exploration of facilitators of and barriers to the community-based service utilization for newborn possible serious bacterial infection management in Debre Libanos District, Ethiopia: descriptive qualitative study.

BACKGROUND: Globally, possible serious bacterial infection [PSBI] is a cause for about 600,000 newborn deaths per year. To decrease the burden of this infection, a community-based management newborn PSBI when referral to hospital is not possible has been on implementation. Studies showed gaps in the service utilization and this study was aimed at exploring its barriers and facilitators. METHODS: A descriptive qualitative study was conducted from March 11- April 7, 2019, in Debre Libanos District, Ethiopia. Study participants were recruited purposively. Women who gave birth within 2 months before data collection, health extension workers [HEW], health workers, religious leader, kebele chairman, and other community members were involved in the study. Five in-depth interviews, seven key informant interviews, and four focused group discussions were conducted with a total of fifty-two participants. The data were audio-recorded, transcribed verbatim and translated, and inductive thematic analysis was done using Atlas ti.7.1 software. RESULT: The availability of health workers trained on community-based newborn care [CBNC], Integrated Management of Newborn and Childhood Illness guidelines, availability of medical supplies and job aids, and performance review meetings were identified as facilitators. Communities perception that the newborn illness has no medical treatment, newborn illness is not severe and is self-resolution; the belief in healing power of traditional medicines, socio-cultural and religious beliefs, lack of awareness about service availability at the health post, poor supportive supervision or monitoring, shortage of HEW, the residency of HEWs outside the health post, a poor commitment of health workers and HEWs, and non-functionality of health developmental army were explored as barriers. CONCLUSIONS: The findings provided insight into the facilitators of and barriers to community-based service utilization for newborn PSBI management. There is a need to develop strategies to address the barriers. Therefore, health care providers should have to develop strategies, and conduct a behavioral change communication to change the perception of community members towards newborn illnesses, promote the availability of the service at the health post, and the HEWs provide the service staying at the health post.

Understanding key drivers and barriers to implementation of the WHO recommendations for the case management of childhood pneumonia and possible serious bacterial infection with amoxicillin dispersible tablets (DT) in Bangladesh: a qualitative study.

BACKGROUND: Pneumonia and possible serious bacterial infection (PSBI) are leading causes of death among under-five children. The World Health Organization (WHO) issued global recommendations for the case management of childhood pneumonia and PSBI when referral is not feasible with oral amoxicillin. However, few governments to date have incorporated child-friendly amoxicillin dispersible tablets (DT) into their national treatment guidelines and policies. We aimed to understand the key drivers to the implementation of WHO recommendations for childhood pneumonia and PSBI using amoxicillin DT in Bangladesh. METHODS: A qualitative study was conducted from October 2017 to March 2018 in two districts of Bangladesh. Interviews were completed with 67 participants consisting of government officials and key stakeholders, international development agencies, health service providers (HSPs), and caregivers of young children diagnosed and treated with amoxicillin for pneumonia or PSBI. Data were analyzed thematically. RESULTS: Policies and operational planning emerged as paramount to ensuring access to essential medicines for childhood pneumonia and PSBI. Though amoxicillin DT is included for National Newborn Health Programme and Integrated Management of Childhood Illnesses in the Operational Plan of the Directorate General of Health Services, inclusion in Community-Based Healthcare Project and Directorate General of Family Planning policies is imperative to securing national supply, access, and uptake. At the sub-national level, training on the use of amoxicillin DT as a first line intervention is lacking, resulting in inadequate management of childhood pneumonia by HSPs. Advocacy activities are needed to create community-wide demand among key stakeholders, HSPs, and caregivers not yet convinced that amoxicillin DT is the preferred formulation for the management of childhood pneumonia and PSBI. CONCLUSION: Challenges in policy and supply at the national level and HSP preparedness at the sub-national levels contribute to the slow adoption of WHO recommendations for amoxicillin DT in Bangladesh. A consultation meeting to disseminate study findings was instrumental in driving the development of recommendations by key stakeholders to address these challenges. A comprehensive and inclusive evidence-based strategy involving all divisions of the Ministry of Health and Family Welfare will be required to achieve national adoption of WHO recommendations and country-wide introduction of amoxicillin DT in Bangladesh.

Implementation research to support Bangladesh Ministry of Health and Family Welfare to implement its national guidelines for management of infections in young infants in two rural districts.

BACKGROUND: World Health Organization revised the global guidelines for management of possible serious bacterial infection (PSBI) in young infants to recommend the use of simplified antibiotic therapy in settings where access to hospital care is not possible. The Bangladesh Ministry of Health and Family Welfare (MoHFW), Government of Bangladesh (GOB) adopted these guidelines, allowing treatment at first-level facilities. During the first year of implementation, the Projahnmo Study Group and USAID/MaMoni Health Systems Strengthening (HSS) Project supported the MoHFW to operationalize the new guidelines and conducted an implementation research study in selected districts to assess challenges and identify solutions to facilitate scale-up across the country. IMPLEMENTATION SUPPORT: Projahnmo and MaMoni HSS teams supported implementation in three areas: building capacity, strengthening service delivery, and mobilizing communities. Capacity building focused on training paramedics to conduct outpatient management of PSBI cases and developing monitoring and supervision systems. The teams also filled gaps in government supply of essential drugs, equipment, and logistics. Community mobilization strategies to promote care-seeking and referrals to facilities varied across districts; in one district community, health workers made home visits while in another district, the promotion was carried out through community volunteers, village doctors, and through existing community structures. METHODS: We followed a plan-do-study-act (PDSA) cycle to identify and address implementation challenges. Three cycles-1 every 4 months-were conducted. We collected data utilizing quantitative and qualitative methods in both the community and facilities. The total sample size for this study was 13,590. DISCUSSION: This article provides implementation research design details for program managers intending to implement new guidelines on management of young infant infections. Results of this research will be reported in the forthcoming papers. Preliminary findings indicate that the management of PSBI cases at the UH&FWCs is feasible. However, MoHFW, GOB needs to address the implementation challenges before scale-up of this policy to the national level.

Risk factors for possible serious bacterial infection in a rural cohort of young infants in central India.

BACKGROUND: Possible serious bacterial infection (PBSI) is a major cause of neonatal mortality worldwide. We studied risk factors for PSBI in a large rural population in central India where facility deliveries have increased as a result of a government financial assistance program. METHODS: We studied 37,379 pregnant women and their singleton live born infants with birth weight ≥ 1.5 kg from 20 rural primary health centers around Nagpur, India, using data from the 2010-13 population-based Maternal and Newborn Health Registry supported by NICHD's Global Network for Women's and Children's Health Research. Factors associated with PSBI were identified using multivariable Poisson regression. RESULTS: Two thousand one hundred twenty-three infants (6 %) had PSBI. Risk factors for PSBI included nulliparity (RR 1.13, 95 % CI 1.03-1.23), parity > 2 (RR 1.30, 95 % CI 1.07-1.57) compared to parity 1-2, first antenatal care visit in the 2nd/3rd trimester (RR 1.46, 95 % CI 1.08-1.98) compared to 1st trimester, administration of antenatal corticosteroids (RR 2.04, 95 % CI 1.60-2.61), low birth weight (RR 3.10, 95 % CI 2.17-4.42), male sex (RR 1.20, 95 % CI 1.10-1.31) and lack of early initiation of breastfeeding (RR 3.87, 95 % CI 2.69-5.58). CONCLUSION: Infants who are low birth weight, born to mothers who present late to antenatal care or receive antenatal corticosteroids, or born to nulliparous women or those with a parity > 2, could be targeted for interventions before and after delivery to improve early recognition of signs and symptoms of PSBI and prompt referral. There also appears to be a need for a renewed focus on promoting early initiation of breastfeeding following delivery in facilities. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov ( NCT01073475 ).