TY - JOUR
T1 - Universal versus conditional three-day follow up visit for children with uncomplicated fever at the community level
T2 - Design of a cluster-randomized, community-based, non-inferiority trial in Tanganyika, Democratic Republic of Congo
AU - van Boetzelaer, Elburg
AU - Ho, Lara S.
AU - Gutman, Julie R.
AU - Steinhardt, Laura C.
AU - Wittcoff, Alison
AU - Barbera, Yolanda
AU - Ngoy, Pascal
AU - Harvey, Steven A.
AU - Mullany, Luke C.
N1 - Funding Information:
This study was funded by the United States Agency for International Development under Translating Research into Action, Cooperative Agreement No. GHS-A-00-09-00015-00.
Publisher Copyright:
© 2017 The Author(s).
PY - 2017/1/26
Y1 - 2017/1/26
N2 - Background: The current recommendation within integrated Community Case Management guidelines that all children presenting with uncomplicated fever and no danger signs be followed up after three days may not be necessary. Such fevers often resolve rapidly (usually within 48-96 h), and previous studies suggest that expectant home care for uncomplicated fever can be safely recommended. We aim to determine the non-inferiority of a conditional versus a universal follow-up visit for these children. Methods: We are conducting a cluster-randomized, community-based, non-inferiority trial enrolling ~4300 children (ages 2-59 months) presenting to community health workers (CHWs) with uncomplicated fever in Tanganyika Province, Democratic Republic of the Congo. Clusters (n = 28) of CHWs are randomized to advise caretakers of such children to either 1) return for a follow-up visit on Day 3 following the initial consultation (Day 1), regardless of illness resolution (as per current guidelines) or 2) return for a follow-up visit on Day 3 only if the child's signs have not resolved. Enrolled children are followed up at Day 7 for a repeat assessment and recording of the primary outcome of the study, "failure", which is defined as having fever, diarrhea, pneumonia or decline of health status (e.g. hospitalization, presenting danger signs, or death). Discussion: The results of this trial will be interpreted in conjunction with a similarly designed trial currently ongoing in Ethiopia. If a follow-up visit conditional on continued illness is shown to be non-inferior to current guidelines stipulating universal follow-up, appropriate updating of such guidelines could reduce time and human resource pressures on both providers and caregivers throughout communities of sub-Saharan Africa and South Asia. Trial registration: This trial was registered at ClinicalTrials.gov
AB - Background: The current recommendation within integrated Community Case Management guidelines that all children presenting with uncomplicated fever and no danger signs be followed up after three days may not be necessary. Such fevers often resolve rapidly (usually within 48-96 h), and previous studies suggest that expectant home care for uncomplicated fever can be safely recommended. We aim to determine the non-inferiority of a conditional versus a universal follow-up visit for these children. Methods: We are conducting a cluster-randomized, community-based, non-inferiority trial enrolling ~4300 children (ages 2-59 months) presenting to community health workers (CHWs) with uncomplicated fever in Tanganyika Province, Democratic Republic of the Congo. Clusters (n = 28) of CHWs are randomized to advise caretakers of such children to either 1) return for a follow-up visit on Day 3 following the initial consultation (Day 1), regardless of illness resolution (as per current guidelines) or 2) return for a follow-up visit on Day 3 only if the child's signs have not resolved. Enrolled children are followed up at Day 7 for a repeat assessment and recording of the primary outcome of the study, "failure", which is defined as having fever, diarrhea, pneumonia or decline of health status (e.g. hospitalization, presenting danger signs, or death). Discussion: The results of this trial will be interpreted in conjunction with a similarly designed trial currently ongoing in Ethiopia. If a follow-up visit conditional on continued illness is shown to be non-inferior to current guidelines stipulating universal follow-up, appropriate updating of such guidelines could reduce time and human resource pressures on both providers and caregivers throughout communities of sub-Saharan Africa and South Asia. Trial registration: This trial was registered at ClinicalTrials.gov
KW - Cluster randomized trial
KW - Community health worker
KW - Democratic Republic of the Congo
KW - Integrated community case management
KW - Non-inferiority
KW - Pediatrics
KW - Uncomplicated fever
UR - http://www.scopus.com/inward/record.url?scp=85010447503&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85010447503&partnerID=8YFLogxK
U2 - 10.1186/s12887-017-0792-1
DO - 10.1186/s12887-017-0792-1
M3 - Article
C2 - 28122542
AN - SCOPUS:85010447503
SN - 1471-2431
VL - 17
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 36
ER -