The Tools for Integrated Management of Childhood Illness (TIMCI) study protocol: a multi-country mixed-method evaluation of pulse oximetry and clinical decision support algorithms.

Effective and sustainable strategies are needed to address the burden of preventable deaths among children under-five in resource-constrained settings. The Tools for Integrated Management of Childhood Illness (TIMCI) project aims to support healthcare providers to identify and manage severe illness, whilst promoting resource stewardship, by introducing pulse oximetry and clinical decision support algorithms (CDSAs) to primary care facilities in India, Kenya, Senegal and Tanzania. Health impact is assessed through: a pragmatic parallel group, superiority cluster randomised controlled trial (RCT), with primary care facilities randomly allocated (1:1) in India to pulse oximetry or control, and (1:1:1) in Tanzania to pulse oximetry plus CDSA, pulse oximetry, or control; and through a quasi-experimental pre-post study in Kenya and Senegal. Devices are implemented with guidance and training, mentorship, and community engagement. Sociodemographic and clinical data are collected from caregivers and records of enrolled sick children aged 0-59 months at study facilities, with phone follow-up on Day 7 (and Day 28 in the RCT). The primary outcomes assessed for the RCT are severe complications (mortality and secondary hospitalisations) by Day 7 and primary hospitalisations (within 24 hours and with referral); and, for the pre-post study, referrals and antibiotic. Secondary outcomes on other aspects of health status, hypoxaemia, referral, follow-up and antimicrobial prescription are also evaluated. In all countries, embedded mixed-method studies further evaluate the effects of the intervention on care and care processes, implementation, cost and cost-effectiveness. Pilot and baseline studies started mid-2021, RCT and post-intervention mid-2022, with anticipated completion mid-2023 and first results late-2023. Study approval has been granted by all relevant institutional review boards, national and WHO ethical review committees. Findings will be shared with communities, healthcare providers, Ministries of Health and other local, national and international stakeholders to facilitate evidence-based decision-making on scale-up.Study registration: NCT04910750 and NCT05065320.

Pulse oximetry and clinical decision support algorithms show potential for supporting healthcare providers to identify and manage severe illness among children under-five attending primary care in resource-constrained settings, whilst promoting resource stewardship but scale-up has been hampered by evidence gaps.This study design article describes the largest scale evaluation of these interventions to date, the results of which will inform country- and global-level policy and planning .

User-Centered Design: Developing the RELI Delivery System - a Low-Cost, Non-Electric, Pneumatic Infusion Pump.

PURPOSE: Infusion pumps are the preferred method for intravenous delivery of drugs and fluids, and an essential tool in health facilities. Their high cost, complexity and reliance on electricity pose serious challenges to wide-spread use, availability and access in low- and middle-income countries. PATH developed the RELI Delivery System (RELI), a low cost, non-electric infusion pump to address these challenges. Input collected from fifty-nine newborn and maternal care providers and from seven national level decision makers in Uganda was used to guide product development, further informing product design requirements, and optimal design features to best serve their needs. METHODS: A formative evaluation following a mixed methods approach including focus group discussions (FGDs), stakeholder interviews, and observations was used to collect data from end users. RESULTS: Stakeholders provided critical input on the RELI prototype design features, safety criteria, and contexts of use of infusion pumps, as well as recommendations for design refinements. Infusion systems are greatly needed but not readily available and their use is limited to well-resourced higher level facilities, even though the need is high in non-tertiary care hospital where patient volume is high, resources are scarce, power is inconsistent, and facilities are understaffed and overcrowded. Users expressed a need for an affordable and simple device with an intuitive user interface, clear instructions for use, and basic safety features. CONCLUSION: The study provided important guidance for further design refinements based on input from respondents and confirmed the need for robust, affordable, infusion pumps that meet the requirements for use in low-resource settings.