Table 1. Indicators of system performance in child TB case contact management.
Parameter | Indicator | Specific Study Details/Design |
Screening and diagnosis | Number of child contacts of TB cases and their basic characteristics | Routinely record details of all cases and their household contacts |
Proportion of children who attend for screening in community and at the clinic | Cohort study of consecutive household contacts (n = 500)a | |
Proportion of children diagnosed with or without TB that are misclassified | Review of all case notes over the previous 6 months | |
Proportion of children who require clinical follow up to clarify diagnosis | Review of all case notes over the previous 6 months | |
Proportion of those who require follow-up that complete it to a diagnostic decision | Review of all case notes over the previous 6 months | |
Medication | Availability and consistency of medicine supply | Annual survey of supply outlets |
Current quality | Annual analysis of drug quality in random samples | |
Current cost | Annual review of cost | |
Adherence/acceptability | Proportion of adherent children | Cohort of consecutively treated children (n = 500)b |
Proportion of temporary default children | Cohort of consecutively treated children (n = 500)b | |
Proportion of permanent default children | Cohort of consecutively treated children (n = 1,000)b | |
Patient/parent acceptability | Qualitative survey of caregivers (n = 30-50) | |
Clinician and staff acceptability | Qualitative survey of staff from various disciplines (n = 30–50) | |
Treatment outcome | Number of children (<5 years) on preventive treatment who develop TB | Cohort of consecutively treated children, 1 year follow-up (n = 2,000)c |
Proportion with side effects of preventive treatment | Cohort of consecutively treated children (n = 200)d | |
Proportion stopping treatment because of side effects of medication | Cohort of consecutively treated children (n = 200)d | |
Cost | Cost to clinic | Survey of key staff (n = 10) |
Direct and indirect costs to child and caregiver | Survey of primary caregivers (n = 50) |
Index cases interviewed at diagnosis to identify case, contact, and household factors associated with non-attendance. A study of 500 contacts is advised, assuming non-attendance of at least 20%.
Cohort study of 500 enables evaluation of risk factors for non-adherence (taking <80% of doses) and temporary defaulting (not taking medicine for at least one week), assuming at least 20% non-adherence; enlarged to 1,000 assuming permanent default rate is at least 10%.
n = 2,000 is estimated to identify “secondary cases” on the basis of 60%–90% efficacy of preventive therapy, an assumption of >80% adherence and a natural progression off treatment of up to 20% over one year [2].
Cohort of 200 is based on an expected incidence of symptomatic hepatotoxicity due to IPT of <10% over a treatment course in children [25].