Effectiveness, safety and economic viability of daycare versus usual hospital care management of severe pneumonia with or without malnutrition in children using the existing health system of Bangladesh: a cluster randomised controlled trial.

Background: We aimed to define clinical and cost-effectiveness of a Day Care Approach (DCA) alternative to Usual Care (UC, comparison group) within the Bangladesh health system to manage severe childhood pneumonia. Methods: This was a cluster randomised controlled trial in urban Dhaka and rural Bangladesh between November 1, 2015 and March 23, 2019. Children aged 2-59 months with severe pneumonia with or without malnutrition received DCA or UC. The DCA treatment settings comprised of urban primary health care clinics run by NGO under Dhaka South City Corporation and in rural Union health and family welfare centres under the Ministry of Health and Family welfare Services. The UC treatment settings were hospitals in these respective areas. Primary outcome was treatment failure (persistence of pneumonia symptoms, referral or death). We performed both intention-to-treat and per-protocol analysis for treatment failure. Registered at www.ClinicalTrials.gov, NCT02669654. Findings: In total 3211 children were enrolled, 1739 in DCA and 1472 in UC; primary outcome data were available in 1682 and 1357 in DCA and UC, respectively. Treatment failure rate was 9.6% among children in DCA (167 of 1739) and 13.5% in the UC (198 of 1472) (group difference, -3.9 percentage point; 95% confidence interval (CI), -4.8 to -1.5, p = 0.165). Treatment success within the health care systems [DCA plus referral vs. UC plus referral, 1587/1739 (91.3%) vs. 1283/1472 (87.2%), group difference 4.1 percentage point, 95% CI, 3.7 to 4.1, p = 0.160)] was better in DCA. One child each in UC of both urban and rural sites died within day 6 after admission. Average cost of treatment per child was US$94.2 (95% CI, 92.2 to 96.3) and US$184.8 (95% CI, 178.6 to 190.9) for DCA and UC, respectively. Interpretation: In our population of children with severe pneumonia with or without malnutrition, >90% were successfully treated at Day care Clinics at 50% lower cost. A modest investment to upgrade Day care facilities may provide a cost-effective, accessible alternative to hospital management. Funding: UNICEF, Botnar Foundation, UBS Optimus Foundation, and EAGLE Foundation, Switzerland.

Day clinic vs. hospital care of pneumonia and severe malnutrition in children under five: a randomised trial.

OBJECTIVES: To evaluate the clinical outcomes and costs of managing pneumonia and severe malnutrition in a day clinic (DC) management model (outpatient) vs. hospital care (inpatient). METHODS: Randomised clinical trial where children aged 2 months to 5 years with pneumonia and severe malnutrition were randomly allocated to DC or inpatient hospital care. We used block randomisation of variable length from 8 to 20 and produced computer-generated random numbers that were assigned to one of the two interventions. Successful management was defined as resolution of clinical signs of pneumonia and being discharged from the model of care (DC or hospital) without need for referral to a hospital (DC), or referral to another hospital. All the children in both DC and hospital received intramuscular ceftriaxone, daily nutrition support and micronutrients. RESULTS: Four hundred and seventy children were randomly assigned to either DC or hospital care. Successful management was achieved for 184 of 235 (78.3%) by DC alone, vs. 201 of 235 (85.5%) by hospital inpatient care [RR (95% CI) = 0.79 (0.65-0.97), P = 0.02]. During 6 months of follow-up, 30/235 (12.8%) in the DC group and 36/235 (15.3%) required readmission to hospital in the hospital care group [RR (95% CI) = 0.89 (0.67-1.18), P = 0.21]. The average overall healthcare and societal cost was 34% lower in DC (US$ 188 ± 11.7) than in hospital (US$ 285 ± 13.6) (P < 0.001), and costs for households were 33% lower. CONCLUSIONS: There was a 7% greater probability of successful management of pneumonia and severe malnutrition when inpatient hospital care rather than the outpatient day clinic care was the initial method of care. However, where timely referral mechanisms were in place, 94% of children with pneumonia and severe malnutrition were successfully managed initially in a day clinic, and costs were substantially lower than with hospital admission.

OBJECTIFS: Evaluer les résultats cliniques et les coûts de la prise en charge de la pneumonie et de la malnutrition sévère dans un modèle de prise en charge en clinique de jour (CJ) (patients ambulatoires) par rapport à des soins hospitaliers (patients hospitalisés). MÉTHODES: Essai clinique randomisé où les enfants âgés de 2 mois à 5 ans avec une pneumonie et une malnutrition sévère ont été répartis de façon aléatoire en CJ ou à des soins hospitaliers. Nous avons utilisé la randomisation par blocs de longueur variable de 8 à 20 et avons généré des nombres aléatoires par ordinateur qui ont été attribués à l'une des deux interventions. Une prise en charge réussie a été définie comme la résolution des signes cliniques de pneumonie et la sortie du modèle de soins (CJ ou hospitalisation) sans nécessiter un transfert à un hôpital (CJ), ni à un autre hôpital. Tous les enfants du bras CJ et du bras soins hospitaliers ont reçu de la ceftriaxone par voie intramusculaire, un soutien nutritionnel quotidien et des micronutriments. RÉSULTATS: 470 enfants ont été assignés aléatoirement soit à des soins en CJ ou hospitaliers. Une prise en charge réussie a été obtenue pour 184 patients sur 235 (78,3%) en CJ seule contre 201 sur 235 (85,5%) en soins hospitaliers [RR (IC95%) = 0,79 (0,65 - 0,97), p = 0,02]. Au cours des six mois de suivi, 30/235 (12,8%) du groupe CJ et 36/235 (15,3%) du groupe soins hospitaliers ont nécessité une réadmission à l'hôpital [RR (IC95%) = 0,89 (0,67 - 1,18), p = 0,21]. Le coût moyen global des soins de santé et pour la société était de 34% plus faible dans le groupe CJ (188 ± 11,7 USD) que dans le groupe soins hospitaliers (285 ± 13,6 USD) (p < 0,001) et les coûts pour les ménages étaient de 33% inférieurs. CONCLUSIONS: La probabilité d'une prise en charge réussie de la pneumonie et de la malnutrition sévère était 7% plus élevée lorsque les soins hospitaliers plutôt que les soins en CJ étaient les moyens initiaux. Cependant, là où des mécanismes de référence rapides étaient en place, 94% des enfants atteints de pneumonie et de malnutrition sévère ont été pris en charge avec succès dans une clinique de jour et les coûts étaient nettement inférieurs à ceux de soins hospitaliers.

A mixed method multi-country assessment of barriers to implementing pediatric inpatient care guidelines.

INTRODUCTION: Accelerating progress in reducing child deaths is needed in order to achieve the Sustainable Development Goal child mortality target. This will require a focus on vulnerable children-including young children, those who are undernourished or with acute illnesses requiring hospitalization. Improving adherence to inpatient guidelines may be an important strategy to reduce child mortality, including among the most vulnerable. The aim of our assessment of nine sub-Saharan African and South Asian hospitals was to determine adherence to pediatric inpatient care recommendations, in addition to capacity for and barriers to implementation of guideline-adherent care prior to commencing the Childhood Acute Illness and Nutrition (CHAIN) Cohort study. The CHAIN Cohort study aims to identify modifiable risk factors for poor inpatient and post discharge outcomes above and beyond implementation of guidelines. METHODS: Hospital infrastructure, staffing, durable equipment, and consumable supplies such as medicines and laboratory reagents, were evaluated through observation and key informant interviews. Inpatient medical records of 2-23 month old children were assessed for adherence to national and international guidelines. The records of children with severe acute malnutrition (SAM) were oversampled to reflect the CHAIN study population. Seven core adherence indicators were examined: oximetry and oxygen therapy, fluids, anemia diagnosis and transfusion, antibiotics, malaria testing and antimalarials, nutritional assessment and management, and HIV testing. RESULTS: All sites had facilities and equipment necessary to implement care consistent with World Health Organization and national guidelines. However, stockouts of essential medicines and laboratory reagents were reported to be common at some sites, even though they were mostly present during the assessment visits. Doctor and nurse to patient ratios varied widely. We reviewed the notes of 261 children with admission diagnoses of sepsis (17), malaria (47), pneumonia (70), diarrhea (106), and SAM (119); 115 had multiple diagnoses. Adherence to oxygen therapy, antimalarial, and malnutrition refeeding guidelines was >75%. Appropriate antimicrobials were prescribed for 75% of antibiotic-indicative conditions. However, 20/23 (87%) diarrhea and 20/27 (74%) malaria cases without a documented indication were prescribed antibiotics. Only 23/122 (19%) with hemoglobin levels meeting anemia criteria had recorded anemia diagnoses. HIV test results were infrequently documented even at hospitals with universal screening policies (66/173, 38%). Informants at all sites attributed inconsistent guideline implementation to inadequate staffing. CONCLUSION: Assessed hospitals had the infrastructure and equipment to implement guideline-consistent care. While fluids, appropriate antimalarials and antibiotics, and malnutrition refeeding adherence was comparable to published estimates from low- and high-resource settings, there were inconsistencies in implementation of some other recommendations. Stockouts of essential therapeutics and laboratory reagents were a noted barrier, but facility staff perceived inadequate human resources as the primary constraint to consistent guideline implementation.