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Table 2 Primary and secondary outcomes

From: The PRIME trial protocol: evaluating the impact of an intervention implemented in public health centres on management of malaria and health outcomes of children using a cluster-randomised design in Tororo, Uganda

Outcomes Indicator
Objective 1: Cross-sectional community surveys
Prevalence of anaemia Proportion of Hb measurements <11.0 g/dL. Anaemia will be classified according to severity: mild (Hb 8.0 – 10.9), moderate (Hb 5.0 – 7.9), severe (Hb <5.0).
Prevalence of parasitaemia Proportion of thick blood smears that are positive for asexual parasites
Prevalence of gametocytaemia Proportion of thick blood smears that are positive for gametocytes
All-cause mortality Probability of dying between birth and five years of age, expressed per 1,000 live births
Objective 2: Cohort study
Antimalarial treatment incidence density Number of antimalarial treatments given for fever/malaria over the period of follow-up
Incidence of illness episodes Episode of illness as reported by primary caregiver
Incidence of febrile episodes Episode of illness associated with fever as reported by primary caregiver
Prompt effective treatment of fever Proportion of children with fever treated within 24 hours of onset of symptoms with an ACT
Prompt effective treatment of malaria Proportion of children with malaria (confirmed by a parasitological test) treated within 24 hours of onset of symptoms with an ACT
Incidence of serious adverse events Any experience that results in death, life-threatening experience, hospitalisation, persistent or significant disability or incapacity, or specific medical or surgical intervention to prevent one of the other serious outcomes
Antibiotic treatment incidence density Number of antibiotic treatments given for fever/bacterial illnesses over the period of follow-up
Objective 3: Health facilities
Patient exit interviews
Inappropriate treatment of malaria Proportion of children under five with suspected malaria and a negative RDT result who are inappropriately given an ACT + Proportion of children under five with suspected malaria and a positive RDT result who are not prescribed an ACT
Appropriate treatment of malaria Proportion of children under five with suspected malaria and a positive RDT result who are appropriately given an ACT + Proportion of children under five with suspected malaria and a negative RDT result who are not prescribed an ACT
Inappropriate treatment of malaria Proportion of children under five with suspected malaria and a positive RDT result who are inappropriately given a non-ACT regimen
Patient satisfaction with healthcare Proportion of patients indicating they were satisfied with care provided at the health centre in exit interviews
Health facility surveillance
Patient attendance Total number of patients attending health facilities and their characteristics, including age, gender, village of residence, and diagnosis
Gaps in staffing requirements Required positions, as indicated by the MoH staffing norms policy, which are unfilled for greater than one month
Stock-outs of ACTs Days per month that AL supplied by NMS via the district is not available
Health worker knowledge questionnaire
Knowledge questionnaire scores Proportion of questions answered correctly following training in fever case management