| Autor: |
Beynon F; Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Faculty of Science, University of Basel, Basel, Switzerland., Langet H; Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Faculty of Science, University of Basel, Basel, Switzerland., Bohle LF; Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Faculty of Science, University of Basel, Basel, Switzerland., Awasthi S; Department of Paediatrics, King George's Medical University, Lucknow, India., Ndiaye O; Faculté de médecine, Université Cheikh Anta Diop, Dakar, Senegal., Machoki M'Imunya J; College of Health Sciences, University of Nairobi, Nairobi, Kenya., Masanja H; Directorate, Ifakara Health Institute, Dar es Salaam, Tanzania., Horton S; School of Public Health and Health Systems, University of Waterloo, Waterloo, Canada., Ba M; PATH., Cicconi S; Faculty of Science, University of Basel, Basel, Switzerland.; Department of Medicine, Swiss Tropical and Public Health Institute, Allschwil, Switzerland., Emmanuel-Fabula M; PATH., Faye PM; Faculté de médecine, Université Cheikh Anta Diop, Dakar, Senegal., Glass TR; Faculty of Science, University of Basel, Basel, Switzerland.; Department of Medicine, Swiss Tropical and Public Health Institute, Allschwil, Switzerland., Keitel K; Department of Medicine, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Division of Pediatric Emergency Medicine, Department of Pediatrics,Inselspital, University of Bern, Bern, Switzerland., Kumar D; Department of Paediatrics, King George's Medical University, Lucknow, India., Kumar G; Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Faculty of Science, University of Basel, Basel, Switzerland., Levine GA; Faculty of Science, University of Basel, Basel, Switzerland.; Department of Medicine, Swiss Tropical and Public Health Institute, Allschwil, Switzerland., Matata L; Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Faculty of Science, University of Basel, Basel, Switzerland.; Health Systems, Impact Evaluation and Policy, Ifakara Health Institute, Dar es Salaam, Tanzania., Mhalu G; Health Systems, Impact Evaluation and Policy, Ifakara Health Institute, Dar es Salaam, Tanzania., Miheso A; PATH., Mjungu D; PATH., Njiri F; College of Health Sciences, University of Nairobi, Nairobi, Kenya., Reus E; Faculty of Science, University of Basel, Basel, Switzerland.; Department of Medicine, Swiss Tropical and Public Health Institute, Allschwil, Switzerland., Ruffo M; PATH., Schär F; Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Faculty of Science, University of Basel, Basel, Switzerland., Sharma K; PATH., Storey HL; PATH., Masanja I; Health Systems, Impact Evaluation and Policy, Ifakara Health Institute, Dar es Salaam, Tanzania., Wyss K; Swiss Centre for International Health, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Faculty of Science, University of Basel, Basel, Switzerland., D'Acremont V; Department of Medicine, Swiss Tropical and Public Health Institute, Allschwil, Switzerland.; Digital Global Health Department, Centre for Primary Care and PublicHealth (Unisanté), University of Lausanne, Lausanne, Switzerland. |
| Abstrakt: |
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. |
