After upload to the WWARN Data Repository, WWARN will standardise data sets according to the WWARN Clinical Data Management and Statistical Analysis Plan and pool into a single database of quality-assured individual patient data.
Haematocrit measurements will be converted to haemoglobin using the formula: haematocrit= 5.62+2.60*haemoglobin. Fractional fall in haemoglobin will be defined as: (haemoglobin on day 0 minus haemoglobin on day 3, 7 or last day) divided by haemoglobin on day 0. Anaemia will be defined as haemoglobin <10g/dL and severe anaemia as haemoglobin <7g/dL.
The time to haematological recovery will be assessed in a variety of subgroups. Normal haemoglobin values for each sub-group will be determined and this value will be used to calculate the fractional fall in haemoglobin before and after treatment. In particular the role of early administration of a single dose of primaquine and its effect on increasing haemolysis will be reviewed in a subset of patients with primaquine treatment.
The haematological recovery in patients treated with ACT and non-ACT treatment will be compared after controlling for known confounding factors.