Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in Ethiopia: A cluster-randomised non-inferiority trial.

BACKGROUND: With declining malaria prevalence and improved use of malaria diagnostic tests, an increasing proportion of children seen by community health workers (CHWs) have unclassified fever. Current community management guidelines by WHO advise that children seen with non-severe unclassified fever (on day 1) should return to CHWs on day 3 for reassessment. We compared the safety of conditional follow-up reassessment only in cases where symptoms do not resolve with universal follow-up on day 3. METHODS AND FINDINGS: We undertook a 2-arm cluster-randomised controlled non-inferiority trial among children aged 2-59 months presenting with fever and without malaria, pneumonia, diarrhoea, or danger signs to 284 CHWs affiliated with 25 health centres (clusters) in Southern Nations, Nationalities, and Peoples' Region, Ethiopia. The primary outcome was treatment failure (persistent fever, development of danger signs, hospital admission, death, malaria, pneumonia, or diarrhoea) at 1 week (day 8) of follow-up. Non-inferiority was defined as a 4% or smaller difference in the proportion of treatment failures with conditional follow-up compared to universal follow-up. Secondary outcomes included the percentage of children brought for reassessment, antimicrobial prescription, and severe adverse events (hospitalisations and deaths) after 4 weeks (day 29). From December 1, 2015, to November 30, 2016, we enrolled 4,595 children, of whom 3,946 (1,953 universal follow-up arm; 1,993 conditional follow-up arm) adhered to the CHW's follow-up advice and also completed a day 8 study visit within ±1 days. Overall, 2.7% had treatment failure on day 8: 0.8% (16/1,993) in the conditional follow-up arm and 4.6% (90/1,953) in the universal follow-up arm (risk difference of treatment failure -3.81%, 95% CI -∞, 0.65%), meeting the prespecified criterion for non-inferiority. There were no deaths recorded by day 29. In the universal follow-up arm, 94.6% of caregivers reported returning for reassessment on day 3, in contrast to 7.5% in the conditional follow-up arm (risk ratio 22.0, 95% CI 17.9, 27.2, p < 0.001). Few children sought care from another provider after their initial visit to the CHW: 3.0% (59/1,993) in the conditional follow-up arm and 1.1% (22/1,953) in the universal follow-up arm, on average 3.2 and 3.4 days later, respectively, with no significant difference between arms (risk difference 1.79%, 95% CI -1.23%, 4.82%, p = 0.244). The mean travel time to another provider was 2.2 hours (95% CI 0.01, 5.3) in the conditional follow-up arm and 2.6 hours (95% CI 0.02, 4.5) in the universal follow-up arm (p = 0.82); the mean cost for seeking care after visiting the CHW was 26.5 birr (95% CI 7.8, 45.2) and 22.8 birr (95% CI 15.6, 30.0), respectively (p = 0.69). Though this study was an important step to evaluate the safety of conditional follow-up, the high adherence seen may have resulted from knowledge of the 1-week follow-up visit and may therefore not transfer to routine practice; hence, in an implementation setting it is crucial that CHWs are well trained in counselling skills to advise caregivers on when to come back for follow-up. CONCLUSIONS: Conditional follow-up of children with non-severe unclassified fever in a low malaria endemic setting in Ethiopia was non-inferior to universal follow-up through day 8. Allowing CHWs to advise caregivers to bring children back only in case of continued symptoms might be a more efficient use of resources in similar settings. TRIAL REGISTRATION: www.clinicaltrials.gov, identifier NCT02926625.

'I also take part in caring for the sick child': a qualitative study on fathers' roles and responsibilities in seeking care for children in Southwest Ethiopia.

OBJECTIVES: Fathers play an important role in household decision-making processes and child health development. Nevertheless, they are under-represented in child health research, especially in low-income settings. Little is known about what roles fathers play in the care-seeking processes or how they interact with the health system when their child is sick. This study aimed to understand Ethiopian fathers' roles and responsibilities in caring for their children when they are or become ill. DESIGN: Qualitative study using semistructured interviews with fathers. SETTING: This study was conducted in three rural districts of the Southern Nations, Nationalities and People's Region of Ethiopia. PARTICIPANTS: Twenty-four fathers who had at least one child between 2 and 59 months who visited a health extension worker with fever. RESULTS: The overarching theme of this study was 'changing perceptions of paternal responsibilities during children's ill health'. It constituted three subthemes, namely, 'fathers' burden of earning money for care', 'fatherhood entails advocating children's healthcare needs' and 'investing in children's health can benefit the family in the future'. Fathers described that they were the ones mainly responsible for the financial arrangement of care and that this financial responsibility can involve stress when resources are scarce. Fathers knew what health services were available and accessible to them and were involved in different ways in the care seeking of the child. Changes in the importance ascribed to child health were expressed by fathers who described being more alert to children's ill-health. CONCLUSION: Fathers play various roles in the care-seeking process during children's illness episodes. This included, for instance, arranging resources to seek care, (co)-deciding where to seek care as well as accompanying the child to the health facility. The inability to organise necessary resources for care can lead to involuntary delays in care seeking for the child. This demonstrates the importance of including fathers in future interventions on maternal and child health.

Management and Follow-up Practices of Children with Unclassified Fever in Rural Ethiopia: Experiences of Health Extension Workers and Caregivers.

Different health-care management guidelines by the World Health Organization exist to help health workers in resource-limited settings treat patients. However, for children with unclassified fever and no danger signs, management guidelines are less clear and follow-up recommendations differ. Both a "universal follow-up" for all children, irrespective of health status, and a "conditional follow-up" only for children whose fever persists are recommended in different guidelines. It is unclear how feasible and acceptable these two different follow-up guidelines are among community health workers and caregivers of the sick child. This qualitative study was conducted in Ethiopia and was nested within a cluster-randomized controlled trial (cRCT). It aimed to determine health extension workers' (HEWs') and caregivers' experiences of the management of febrile children and their perceptions of universal versus conditional follow-up recommendations. Seventeen HEWs and 20 caregivers were interviewed. The interviews revealed that HEWs' understanding of how to handle an unclassified fever diagnosis increased with the implementation of the cRCT in both study arms (universal versus conditional follow-up). This enabled HEWs to withhold medicines from children with this condition and avoid referral to health centers. Both follow-up recommendations had perceived advantages, while the universal follow-up provided an opportunity to see the child's health progress, the conditional follow-up advice allowed saving time and costs. The findings suggest that improved awareness of the unclassified fever condition can make HEWs feel more comfortable in managing these febrile children themselves and omitting unnecessary medication. Future community-level management guidelines should provide clearer instructions on managing fever where no malaria, pneumonia, diarrhea, or danger signs are present.