A digital health algorithm to guide antibiotic prescription in pediatric outpatient care: a cluster randomized controlled trial.

Excessive antibiotic use and antimicrobial resistance are major global public health threats. We developed ePOCT+, a digital clinical decision support algorithm in combination with C-reactive protein test, hemoglobin test, pulse oximeter and mentorship, to guide health-care providers in managing acutely sick children under 15 years old. To evaluate the impact of ePOCT+ compared to usual care, we conducted a cluster randomized controlled trial in Tanzanian primary care facilities. Over 11 months, 23,593 consultations were included from 20 ePOCT+ health facilities and 20,713 from 20 usual care facilities. The use of ePOCT+ in intervention facilities resulted in a reduction in the coprimary outcome of antibiotic prescription compared to usual care (23.2% versus 70.1%, adjusted difference -46.4%, 95% confidence interval (CI) -57.6 to -35.2). The coprimary outcome of day 7 clinical failure was noninferior in ePOCT+ facilities compared to usual care facilities (adjusted relative risk 0.97, 95% CI 0.85 to 1.10). There was no difference in the secondary safety outcomes of death and nonreferred secondary hospitalizations by day 7. Using ePOCT+ could help address the urgent problem of antimicrobial resistance by safely reducing antibiotic prescribing. Clinicaltrials.gov Identifier: NCT05144763.

Effect of a home-based health, nutrition and responsive stimulation intervention and conditional cash transfers on child development and growth: a cluster-randomised controlled trial in Tanzania.

INTRODUCTION: Evidence on the effects of community health worker (CHW) interventions and conditional cash transfers (CCTs) on child growth and development in sub-Saharan Africa remains sparse. METHODS: We conducted a single-blind, cluster-randomised controlled trial of an integrated home-visiting health, nutrition and responsive stimulation intervention alone and in combination with CCTs to promote antenatal and child clinic attendance from 2017 to 2019 in rural Morogoro Region, Tanzania. Pregnant women and caregivers with a child <1 year of age were enrolled. Twelve villages were randomised to either (1) CHW (n=200 participants), (2) CHW+CCT (n=200) or (3) control (n=193). An intention-to-treat analysis was conducted for the primary trial outcomes of child cognitive, language and motor development assessed with the Bayley Scales of Infant and Toddler Development and child length/height-for-age z-scores (HAZ) at 18 months of follow-up. RESULTS: The CHW and CHW+CCT interventions had beneficial effects on child cognitive development as compared with control (standardised mean difference (SMD): 0.15, 95% CI 0.05 to 0.24, and SMD: 0.18, 95% CI 0.07 to 0.28, respectively). The CHW+CCT intervention also had positive effects on language (SMD: 0.08, 95% CI 0.01 to 0.15) and motor (SMD: 0.16, 95% CI 0.03 to 0.28) development. Both CHW and CHW+CCT interventions had no effect on HAZ in the primary analysis; however, there were statistically significant positive effects in multivariable analyses. The CHW+CCT group (mean difference: 3.0 visits, 95% CI 2.1 to 4.0) and the CHW group (mean difference: 1.5 visits, 95% CI 0.6 to 2.5) attended greater number of child health and growth monitoring clinic visits as compared to the control group. CONCLUSION: Integrated CHW home-visiting interventions can improve child cognitive development and may have positive effects on linear growth. Combining CHW with CCT may provide additional benefits on clinic visit attendance and selected child development outcomes. TRIAL REGISTRATION NUMBER: ISRCTN10323949.

Effect of a community health worker delivered health, nutrition and responsive stimulation package and conditional cash transfers on child development and growth in rural Tanzania: protocol for a cluster-randomized trial.

BACKGROUND: Child health, nutrition, and responsive stimulation interventions have been developed to improve child survival, growth and development outcomes in low- and middle-income countries. Nevertheless, research on integrated implementation approaches to deliver and promote uptake of these interventions is needed, particularly in sub-Saharan Africa. METHODS/DESIGN: We will conduct a cluster-randomized controlled trial of a supply-side community health worker (CHW) delivered child health, nutrition, and responsive stimulation intervention alone and in combination with a demand-side conditional cash transfer (CCT) intervention to promote antenatal care and child growth monitoring attendance in rural Morogoro region, Tanzania. Twelve village clusters will be randomly assigned to one of the three trial arms: (1) CHW, (2) CHW + CCT, or (3) Control. Mothers (or another primary caregiver) residing in study villages are eligible for trial enrollment if they are currently pregnant or have a child < 1 year of age at the time of enrollment. For the duration of the trial, CHWs will visit households once every 4-6 weeks to deliver the intervention package and CCTs will be provided for documented antenatal care and routine child health and growth monitoring clinic visits. Participants will be followed-up at 9 months (midline) and 18 months (endline) post-randomization. The primary outcomes of the trial are child development assessed by the Bayley Scales of Infant and Toddler Development (BSID-III) and child height-for-age z-score. Secondary outcomes include a range of maternal, child and household outcomes. DISCUSSION: This trial will provide evidence on the effect of CHWs and conditional cash transfers on child growth and development. The results of the trial may be generalizable to similar settings in sub-Saharan Africa. TRIAL REGISTRATION: ISRCTN10323949 , Retrospectively registered on October 3, 2017.

Development and validation of an early childhood development scale for use in low-resourced settings.

BACKGROUND: Low-cost, cross-culturally comparable measures of the motor, cognitive, and socioemotional skills of children under 3 years remain scarce. In the present paper, we aim to develop a new caregiver-reported early childhood development (ECD) scale designed to be implemented as part of household surveys in low-resourced settings. METHODS: We evaluate the acceptability, test-retest reliability, internal consistency, and discriminant validity of the new ECD items, subscales, and full scale in a sample of 2481 18- to 36-month-old children from peri-urban and rural Tanzania. We also compare total and subscale scores with performance on the Bayley Scales of Infant Development (BSID-III) in a subsample of 1036 children. Qualitative interviews from 10 mothers and 10 field workers are used to inform quantitative data. RESULTS: Adequate levels of acceptability and internal consistency were found for the new scale and its motor, cognitive, and socioemotional subscales. Correlations between the new scale and the BSID-III were high (r > .50) for the motor and cognitive subscales, but low (r < .20) for the socioemotional subscale. The new scale discriminated between children's skills based on age, stunting status, caregiver-reported disability, and adult stimulation. Test-retest reliability scores were variable among a subset of items tested. CONCLUSIONS: Results of this study provide empirical support from a low-income country setting for the acceptability, reliability, and validity of a new caregiver-reported ECD scale. Additional research is needed to test these and other caregiver reported items in children in the full 0 to 3 year range across multiple cultural and linguistic settings.