The vast majority of children with sickle cell anemia (SCA) live in Africa, where evidence-based guidelines for primary stroke prevention are lacking. In Kano, Nigeria, we conducted a feasibility trial to determine the acceptability of hydroxyurea therapy for primary stroke prevention in children with abnormal transcranial Doppler (TCD) measurements. Children with SCA and abnormal non-imaging TCD measurements (≥ 200 cm/s) received moderate fixed-dose hydroxyurea therapy (~20 mg/kg/day). A comparison group of children with TCD measurements < 200 cm/s was followed prospectively. Approximately 90% (337 of 375) of families agreed to be screened, while 92% (25 of 27) of those with abnormal TCD measurements, on two separate occasions, enrolled in the trial. No participant elected to withdraw from the trial. The average mean corpuscular volume increased from 85 fL at baseline to 101.3 fL at 24 months, demonstrating adherence to hydroxyurea. The comparison group consisted of 210 children, of which four developed abnormal TCD measurements, and were started on hydroxyurea. None of the monthly research visits were missed (n = total 603 visits). Two and ten deaths occurred in the treatment and comparison groups, with mortality rates of 2.69 and 1.81 per 100 patient-years, respectively (p = 0.67). Our results provide strong evidence, for high family recruitment, retention, and adherence rates, to undertake the first randomized controlled trial with hydroxyurea therapy for primary stroke prevention in children with SCA living in Africa.
We wish to formally correct the above-referenced article and omit mention utilization of the Morisky medication adherence scale. The Morisky medication adherence scale was used to access study participants adherence on a monthly basis by parental recall. We did not realize that the questions were protected by copyright and required permission for utilization. For the duration of the study, the adherence tool is used as a secondary measurement of adherence, while the primary indicator included change in mean cell volume. The removal of the Morisky scale adherence data does not affect the primary outcomes of the study and does not alter the evidence of adherence, because increase in MCV was the primary measure of adherence.All the authors of the manuscript have been informed of the changes and have agreed to the publication of an erratum. We apologize for any inconvenience that this error might have caused.
Background
Developing countries bear the burden of childhood stunting but lack resources for cohort studies to develop preventive strategies. To enable future prospective studies, we designed and tested the Child Electronic Growth Monitoring System (CEGROMS) using a readily available electronic data capture platform, the Research Electronic Data Capture (REDCap).
Objectives
To demonstrate the feasibility of using CEGROMS for data collection for a pilot study for the Kaduna Infant Development (KID) Birth Cohort Study in Nigeria.
Methods
CEGROMS consists of the data capture form for growth monitoring, a central cloud server, electronic tablets, and desktop computer. We implemented the pilot study in 2017‐2019 at the Barau Dikko Teaching Hospital, Kaduna, Nigeria. Odds ratios (OR) and 95% confidence intervals (CI) were calculated for completeness of baseline data (relative to individuals with incomplete data) and completion of follow‐up at different time points (relative to individuals with no follow‐up visit) by the participant characteristics. Complete data were defined as date of birth, sex, and birthweight recorded at recruitment.
Results
Among 3152 infant records in CEGROMS, 2789 (88.5%) had complete data. Of these, 1905 (68.3%) had at least one follow‐up visit. The main determinants of data completeness were health facility delivery (OR 19.17, 95% CI 13.65, 26.92) and tertiary education (OR 3.54, 95% CI 2.69, 4.67). Follow‐up was greater for women with tertiary education (OR 1.33, 95% CI 1.06, 1.51 for at least one visit). Maternal education is associated with completeness and follow‐up (following adjustments for parity and employment).
Conclusions
The CEGROMS electronic data collection system enables complete and consistent data collection. The data will enable design of strategies to improve follow‐up in the future implementation of the birth cohort study.
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