Objectives of the Study and End Points
±2, acute febrile illness, disability
ADVERSE EVENTS, SECONDARY, ADVERSE EVENT, EVENT
The primary objectives of this study were to assess the impact of the package on clinical outcomes and antibiotic prescriptions compared with standard care for children and adolescents who present with nonsevere acute febrile illness at outpatient clinics. We calculated the proportion of patients with favorable clinical outcomes at day 7 and a prescription of any antibiotic at day 0 and compared between arms. The clinical outcome was defined as favorable if the participant was alive and well (defined as the resolution of symptoms at day 7 ±2 days with which the participant presented at day 0). The clinical outcome was unfavorable if there was persistence or worsening of symptoms present at day 0 or the development of serious adverse events.The secondary study objectives were to assess adherence to the new diagnostic algorithm by healthcare workers, adherence to the prescriptions by patients and caregivers, and the safety of these practices. We calculated the proportion of healthcare worker actions that adhered to the algorithm, the proportion of patients who adhered to the prescription (or not) of an antibiotic, and the rates of adverse and serious adverse events per arm.Adherence was defined as adhering to the dosage, frequency, and duration of prescribed medications including antibiotics. For participants not prescribed medications, adherence involved not buying any medications on their own, especially antibiotics, within the study period. Adherence was confirmed by pill count (≥90%) by the study pharmacist and qualitative in-depth interviews for participants who visited the clinic on day 7. The study team conducted in-depth interviews by phone for participants who could not come in for an in-person interview.An adverse event was defined as any adverse medical occurrence (any unfavorable sign or symptom or worsening/persistent sign or symptom). A serious adverse event was defined as an adverse event that was either fatal or life-threatening, required hospitalization, or resulted in persistent or significant disability or as an important medical event that required intervention to prevent any of the aforementioned outcomes.