Health facility assessment of small and sick newborn care in low- and middle-income countries: systematic tool development and operationalisation with NEST360 and UNICEF.

BACKGROUND: Each year an estimated 2.3 million newborns die in the first 28 days of life. Most of these deaths are preventable, and high-quality neonatal care is fundamental for surviving and thriving. Service readiness is used to assess the capacity of hospitals to provide care, but current health facility assessment (HFA) tools do not fully evaluate inpatient small and sick newborn care (SSNC). METHODS: Health systems ingredients for SSNC were identified from international guidelines, notably World Health Organization (WHO), and other standards for SSNC. Existing global and national service readiness tools were identified and mapped against this ingredients list. A novel HFA tool was co-designed according to a priori considerations determined by policymakers from four African governments, including that the HFA be completed in one day and assess readiness across the health system. The tool was reviewed by > 150 global experts, and refined and operationalised in 64 hospitals in Kenya, Malawi, Nigeria, and Tanzania between September 2019 and March 2021. RESULTS: Eight hundred and sixty-six key health systems ingredients for service readiness for inpatient SSNC were identified and mapped against four global and eight national tools measuring SSNC service readiness. Tools revealed major content gaps particularly for devices and consumables, care guidelines, and facility infrastructure, with a mean of 13.2% (n = 866, range 2.2-34.4%) of ingredients included. Two tools covered 32.7% and 34.4% (n = 866) of ingredients and were used as inputs for the new HFA tool, which included ten modules organised by adapted WHO health system building blocks, including: infrastructure, pharmacy and laboratory, medical devices and supplies, biomedical technician workshop, human resources, information systems, leadership and governance, family-centred care, and infection prevention and control. This HFA tool can be conducted at a hospital by seven assessors in one day and has been used in 64 hospitals in Kenya, Malawi, Nigeria, and Tanzania. CONCLUSION: This HFA tool is available open-access to adapt for use to comprehensively measure service readiness for level-2 SSNC, including respiratory support. The resulting facility-level data enable comparable tracking for Every Newborn Action Plan coverage target four within and between countries, identifying facility and national-level health systems gaps for action.

Bubble CPAP and oxygen for child pneumonia care in Malawi: a CPAP IMPACT time motion study.

BACKGROUND: In some low-resource settings bubble continuous positive airway pressure (bCPAP) is increasingly used to treat children with pneumonia. However, the time required for healthcare workers (HCWs) to administer bCPAP is unknown and may have implementation implications. This study aims to compare HCW time spent administering bCPAP and low-flow nasal oxygen care at a district hospital in Malawi during CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial). METHODS: Eligible participants were 1-59 months old with WHO-defined severe pneumonia and HIV-infection, HIV-exposure, severe malnutrition, or hypoxemia and were randomized to either bCPAP or oxygen. We used time motion techniques to observe hospital care in four hour blocks during treatment initiation or follow up (maintenance). HCW mean time per patient at the bedside over the observation period was calculated by study arm. RESULTS: Overall, bCPAP required an average of 34.71 min per patient more than low-flow nasal oxygen to initiate (bCPAP, 118.18 min (standard deviation (SD) 42.73 min); oxygen, 83.47 min (SD, 20.18 min), p < 0.01). During initiation, HCWs spent, on average, 12.45 min longer per patient setting up bCPAP equipment (p < 0.01) and 11.13 min longer per patient setting up the bCPAP nasal interface (p < 0.01), compared to oxygen equipment and nasal cannula set-up. During maintenance care, HCWs spent longer on average per patient adjusting bCPAP, compared to oxygen equipment (bCPAP 4.57 min (SD, 4.78 min); oxygen, 1.52 min (SD, 2.50 min), p = 0.03). CONCLUSION: Effective bCPAP implementation in low-resource settings will likely create additional HCW burden relative to usual pneumonia care with oxygen. TRIAL REGISTRATION: Clinicaltrials.gov NCT02484183 , June 29, 2015.

Household costs among patients hospitalized with malaria: evidence from a national survey in Malawi, 2012.

BACKGROUND: With 71% of Malawians living on < $1.90 a day, high household costs associated with severe malaria are likely a major economic burden for low income families and may constitute an important barrier to care seeking. Nevertheless, few efforts have been made to examine these costs. This paper describes household costs associated with seeking and receiving inpatient care for malaria in health facilities in Malawi. METHODS: A cross-sectional survey was conducted in a representative nationwide sample of 36 health facilities providing inpatient treatment for malaria from June-August, 2012. Patients admitted at least 12 h before study team visits who had been prescribed an antimalarial after admission were eligible to provide cost information for their malaria episode, including care seeking at previous health facilities. An ingredients-based approach was used to estimate direct costs. Indirect costs were estimated using a human capital approach. Key drivers of total household costs for illness episodes resulting in malaria admission were assessed by fitting a generalized linear model, accounting for clustering at the health facility level. RESULTS: Out of 100 patients who met the eligibility criteria, 80 (80%) provided cost information for their entire illness episode to date and were included: 39% of patients were under 5 years old and 75% had sought care for the malaria episode at other facilities prior to coming to the current facility. Total household costs averaged $17.48 per patient; direct and indirect household costs averaged $7.59 and $9.90, respectively. Facility management type, household distance from the health facility, patient age, high household wealth, and duration of hospital stay were all significant drivers of overall costs. CONCLUSIONS: Although malaria treatment is supposed to be free in public health facilities, households in Malawi still incur high direct and indirect costs for malaria illness episodes that result in hospital admission. Finding ways to minimize the economic burden of inpatient malaria care is crucial to protect households from potentially catastrophic health expenditures.

Adherence to national guidelines for the diagnosis and management of severe malaria: a nationwide, cross-sectional survey in Malawi, 2012.

BACKGROUND: Severe malaria has a case fatality rate of 10-20 %; however, few studies have addressed the quality of severe malaria case management. This study evaluated the diagnostic and treatment practices of malaria patients admitted to inpatient health facilities (HF) in Malawi. METHODS: In July-August 2012, a nationwide, cross-sectional survey of severe malaria management was conducted in 36 HFs selected with equal probability from all eligible public sector HFs in Malawi. Patient records from all admissions during October 2011 and April 2012 (low and high season, respectively) were screened for an admission diagnosis of malaria or prescription of any anti-malarial. Eligible records were stratified by age (< 5 or ≥ 5 years). A maximum of eight records was randomly selected within each age and month stratum. Severe malaria was defined by admission diagnosis or documentation of at least one sign or symptom of severe malaria. Treatment with intravenous (IV) quinine or artesunate was considered correct. Patients without documentation of severe malaria were analysed as uncomplicated malaria patients; treatment with an artemisinin-based combination therapy (ACT) or oral quinine based on malaria test results was considered correct. All analyses accounted for HF level clustering and sampling weights. RESULTS: The analysis included 906 records from 35 HFs. Among these, 42 % (95 % confidence interval [CI] 35-49) had a severe malaria admission diagnosis and 50 % (95 % CI 44-57) had at least one severe malaria sign or symptom documented. Severe malaria patients defined by admission diagnosis (93, 95 % CI 86-99) were more likely to be treated correctly compared to patients defined by a severe sign (82, 95 % CI 75-89) (p < 0.0001). Among uncomplicated malaria patients, 26 % (95 % CI 18-35) were correctly treated and 53 % (95 % CI 42-64) were adequately treated with IV quinine alone or in combination with an ACT or oral quinine. CONCLUSIONS: A majority of patients diagnosed with severe malaria received the recommended IV therapy in accordance with national treatment guidelines. However, the inconsistencies between diagnosis of severe malaria and documentation of severe signs and symptoms highlight the need to improve healthcare worker recognition and documentation of severe signs and symptoms.

A neonatal ward-strengthening program improves survival for neonates treated with CPAP at district hospitals in Malawi.

From 2013-2015, a CPAP quality improvement program (QIP) was implemented to introduce and monitor CPAP usage and outcomes in the neonatal wards at all government district and central hospitals in Malawi. In 2016 the CPAP QIP was extended into healthcare facilities operated by the Christian Health Association of Malawi. Although clinical outcomes improved, ward assessments indicated that many rural sites lacked other essential equipment and a suitable space to adequately treat sick neonates, which likely limited the impact of improved respiratory care. The aim of this study was to determine if a ward-strengthening program improved outcomes for neonates treated with CPAP. To address the needs identified from ward assessments, a ward-strengthening program was implemented from 2017-2018 at rural hospitals in Malawi to improve the care of sick neonates. The ward-strengthening program included the distribution of a bundle of equipment, supplemental training, and, in some cases, health facility renovations. Survival to discharge was compared for neonates treated with CPAP at 12 rural hospitals for one year before and for one year immediately after implementation of the ward-strengthening program. In the year prior to ward strengthening, 189 neonates were treated with CPAP; in the year after, 232 neonates received CPAP. The overall rate of survival for those treated with CPAP improved from 46.6% to 57.3% after ward strengthening (p = 0.03). For the subset of neonates with admission weights between 1.00-2.49 kg diagnosed with respiratory distress syndrome, survival increased from 39.4% to 60.3% after ward strengthening (p = 0.001). A ward-strengthening program including the distribution of a bundle of equipment, supplemental training, and some health facility renovations, further improved survival among neonates treated with CPAP at district-level hospitals in Malawi.

National scale of neonatal CPAP to district hospitals in Malawi improves survival for neonates weighing between 1.0 and 1.3 kg.

OBJECTIVE: To determine whether a national quality improvement programme implementing continuous positive airway pressure (CPAP) at government hospitals in Malawi improved outcomes for neonates prioritised by an algorithm recommending early CPAP for infants weighing 1.0-1.3 kg (the 50th percentile weight at 30 weeks' gestation). DESIGN: The analysis includes neonates admitted with respiratory illness for 5.5 months before CPAP was introduced (baseline period) and for 15 months immediately after CPAP was implemented (implementation period). A follow-up data analysis was completed for neonates treated with CPAP for a further 11 months. SETTING AND PATIENTS: Neonates with admission weights of 1.0-1.3 kg before (106 neonates treated with nasal oxygen) and after implementation of CPAP (153 neonates treated with nasal oxygen, 103 neonates treated with CPAP) in the newborn wards at Malawi government district hospitals. Follow-up analysis included 87 neonates treated with CPAP. INTERVENTION: Neonatal CPAP. MAIN OUTCOME MEASURE: We assessed survival to discharge at 23 government district hospitals with no significant differences in transfer rates before and after implementation of CPAP. RESULTS: Survival improved for neonates with admission weights from 1.0 to 1.3 kg treated with CPAP (30.1%) as compared with neonates of the same weight band treated with oxygen during the baseline (17.9%) and implementation (18.3%) periods. There was no significant difference in survival for neonates treated with CPAP during the implementation and follow-up periods (30.1% vs 28.7%). CONCLUSIONS: Survival for neonates weighing 1.0-1.3 kg significantly increased with a nurse-led CPAP service in a low-resource setting and improvements were sustained during follow-up.

Capacity Building for Health Care Workers and Support Staff in Pediatric Emergency Triage Assessment and Treatment (ETAT) at Primary Health Care Level in Resource Limited Settings: Experiences from Malawi.

Primary health care facilities offer an entry point to the health care system in Malawi. Challenges experienced by these facilities include limited resources (both material and human), poor or inadequate knowledge, skills and attitudes of health care workers in emergency management, and delay in referral from primary care level to other levels of care. These contribute to poor outcomes including children dying within the first 24 hours of hospital admission. Training of health care workers and support staff in Emergency Triage Assessment and Treatment (ETAT) at primary care levels can help improve care of children with acute and severe illnesses. Health care workers and support staff in the primary care settings were trained in pediatric ETAT. The training package for health care workers was adapted from the Ministry of Health ETAT training for district and tertiary health care. Content for support staff focused on non-technical responsibility for lifesaving in emergency situations. The primary health care facilities were provided with a minimum treatment package comprising emergency equipment, supplies and drugs. Supportive supervisory visits were conducted quarterly. The training manual for health care workers was adapted from the Ministry of Health package and the support staff training manual was developed from the adapted package. Eight hundred and seventy-seven participants were trained (336 health care workers and 541 support staff). Following the training, triaging of patients improved and patients were managed as emergency, priority or non-urgent. This reduced the number of referral cases and children were stabilized before referral. Capacity building of health care workers and support staff in pediatric ETAT and the provision of a basic health center package improved practice at the primary care level. The practice was sustained through institutional mentorship and pre-service and in-service training. The practice of triage and treatment including stabilization of children with dangerous signs at the primary health care facility improves emergency care of patients, reduces the burden of patients on referral hospitals and increases the number of successful referrals.

Neonatal CPAP for Respiratory Distress Across Malawi and Mortality.

OBJECTIVES: Our aim in this observational study was to monitor continuous positive airway pressure (CPAP) usage and outcomes in newborn wards at 26 government hospitals in Malawi after the introduction of CPAP as part of a quality-improvement initiative. CPAP was implemented in 3 phases from 2013 through 2015. METHODS: Survival to discharge was analyzed for neonates treated with nasal oxygen and/or CPAP with admission weights of 1 to 2.49 kg at 24 government hospitals with transfer rates <15%. This analysis includes neonates admitted with respiratory illness for 5.5 months before (621 neonates) and 15 months immediately after CPAP implementation (1836 neonates). A follow-up data analysis was completed for neonates treated with CPAP at all hospitals during an additional 11 months (194 neonates). RESULTS: On implementation of CPAP, survival to discharge improved for all neonates admitted with respiratory distress (48.6% vs 54.5%; P = .012) and for those diagnosed with respiratory distress syndrome (39.8% vs 48.3%; P = .042). There were no significant differences in outcomes for neonates treated with CPAP during the implementation and follow-up periods. Hypothermia on admission was pervasive and associated with poor outcomes. Neonates with normal mean temperatures during CPAP treatment experienced the highest survival rates (65.7% for all neonates treated with CPAP and 60.0% for those diagnosed with respiratory distress syndrome). CONCLUSIONS: A nurse-led CPAP service can improve outcomes for neonates in respiratory distress in low-resource settings. However, the results show that real-world improvements in survival may be limited without access to comprehensive newborn care, especially for small and sick infants.

Bubble continuous positive airway pressure for children with high-risk conditions and severe pneumonia in Malawi: an open label, randomised, controlled trial.

BACKGROUND: Pneumonia is the leading cause of death among children globally. Most pneumonia deaths in low-income and middle-income countries (LMICs) occur among children with HIV infection or exposure, severe malnutrition, or hypoxaemia despite antibiotics and oxygen. Non-invasive bubble continuous positive airway pressure (bCPAP) is considered a safe ventilation modality that might improve child pneumonia survival. bCPAP outcomes for high-risk African children with severe pneumonia are unknown. Since most child pneumonia hospitalisations in Africa occur in non-tertiary district hospitals without daily physician oversight, we aimed to examine whether bCPAP improves severe pneumonia mortality in such settings. METHODS: This open-label, randomised, controlled trial was done in the general paediatric ward of Salima District Hospital, Malawi. We enrolled children aged 1-59 months old with WHO-defined severe pneumonia and either HIV infection or exposure, severe malnutrition, or an oxygen saturation of less than 90%. Children were randomly assigned 1:1 to low-flow nasal cannula oxygen or nasal bCPAP. Non-physicians administered care; the primary outcome was hospital survival. Primary analyses were by intention-to-treat and interim and adverse events analyses per protocol. This trial is registered with ClinicalTrials.gov, number NCT02484183, and is closed. FINDINGS: We screened 1712 children for eligibility between June 23, 2015, and March 21, 2018. The data safety and monitoring board stopped the trial for futility after 644 of the intended 900 participants were enrolled. 323 children were randomly assigned to oxygen and 321 to bCPAP. 35 (11%) of 323 children who received oxygen died in hospital, as did 53 (17%) of 321 who received bCPAP (relative risk 1·52; 95% CI 1·02-2·27; p=0·036). 13 oxygen and 17 bCPAP patients lacked hospital outcomes and were considered lost to follow-up. Suspected adverse events related to treatment occurred in 11 (3%) of 321 children receiving bCPAP and 1 (<1%) of 323 children receiving oxygen. Four bCPAP and one oxygen group deaths were classified as probable aspiration episodes, one bCPAP death as probable pneumothorax, and six non-death bCPAP events included skin breakdown around the nares. INTERPRETATION: bCPAP treatment in a paediatric ward without daily physician supervision did not reduce hospital mortality among high-risk Malawian children with severe pneumonia, compared with oxygen. The use of bCPAP within certain patient populations and non-intensive care settings might carry risk that was not previously recognised. bCPAP in LMICs needs further evaluation before wider implementation for child pneumonia care. FUNDING: Bill & Melinda Gates Foundation, International AIDS Society, Health Empowering Humanity.

CPAP IMPACT: a protocol for a randomised trial of bubble continuous positive airway pressure versus standard care for high-risk children with severe pneumonia using adaptive design methods.

INTRODUCTION: Pneumonia is a leading cause of mortality among children in low-resource settings. Mortality is greatest among children with high-risk conditions including HIV infection or exposure, severe malnutrition and/or severe hypoxaemia. WHO treatment recommendations include low-flow oxygen for children with severe pneumonia. Bubble continuous positive airway pressure (bCPAP) is a non-invasive support modality that provides positive end-expiratory pressure and oxygen. bCPAP is effective in the treatment of neonates in low-resource settings; its efficacy is unknown for high-risk children with severe pneumonia in low-resource settings. METHODS AND ANALYSIS: CPAP IMPACT is a randomised clinical trial comparing bCPAP to low-flow oxygen in the treatment of severe pneumonia among high-risk children 1-59 months of age. High-risk children are stratified into two subgroups: (1) HIV infection or exposure and/or severe malnutrition; (2) severe hypoxaemia. The trial is being conducted in a Malawi district hospital and will enrol 900 participants. The primary outcome is in-hospital mortality rate of children treated with standard care as compared with bCPAP. ETHICS AND DISSEMINATION: CPAP IMPACT has approval from the Institutional Review Boards of all investigators. An urgent need exists to determine whether bCPAP decreases mortality among high-risk children with severe pneumonia to inform resource utilisation in low-resource settings. TRIAL REGISTRATION NUMBER: NCT02484183; Pre-results.

Potentially Modifiable Factors Associated with Death of Infants and Children with Severe Pneumonia Routinely Managed in District Hospitals in Malawi.

OBJECTIVE: To investigate recognised co-morbidities and clinical management associated with inpatient pneumonia mortality in Malawian district hospitals. METHODS: Prospective cohort study, of patient records, carried out in Malawi between 1st October 2000 and 30th June 2003. The study included all children aged 0-59 months admitted to the paediatric wards in sixteen district hospitals throughout Malawi with severe and very severe pneumonia. We compared individual factors between those that survived (n = 14 076) and those that died (n = 1 633). RESULTS: From logistic regression analysis, predictors of death in hospital, adjusted for age, sex and severity grade included comorbid conditions of meningitis (OR =2.49, 95% CI 1.50-4.15), malnutrition (OR =2.37, 95% CI 1.94-2.88) and severe anaemia (OR =1.41, 95% CI 1.03-1.92). Requiring supplementary oxygen (OR =2.16, 95% CI 1.85-2.51) and intravenous fluids (OR =3.02, 95% CI 2.13-4.28) were associated with death while blood transfusion was no longer significant (OR =1.10, 95% CI 0.77-1.57) when the model included severe anaemia. CONCLUSIONS: This study identified a number of challenges to improve outcome for Malawian infants and children hospitalised with pneumonia. These included improved assessment of co-morbidities and more rigorous application of standard case management.