Arun S Shet1,2,3, Merrick Zwarenstein4, Abha Rao1, Paul Jebaraj1, Karthika Arumugam1, Salla Atkins3,5, Maya Mascarenhas6, Neil Klar7, Maria Rosaria Galanti3,8. 1. Department of Hematology/Medical Oncology, St Johns Medical College and Hospital, Bangalore, India. 2. Sickle Cell Branch, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland. 3. Department of Public Health Sciences, Karolinska Institutet, Stockholm, Sweden. 4. Department of Family Medicine, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. 5. New Social Research and Faculty of Social Sciences, Tampere University, Tampere, Finland. 6. MYRADA, Bangalore, India. 7. Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada. 8. Centre for Epidemiology and Community Medicine, Stockholm Health Care District, Stockholm, Sweden.
Abstract
IMPORTANCE: Iron deficiency anemia, the largest cause of anemia worldwide, adversely affects cognitive development in children. Moreover, the imperceptible childhood anemia prevalence reduction in response to anemia control measures is associated with tremendous social and economic cost. OBJECTIVE: To evaluate the effects of community-based parental education/counseling when combined with usual treatment on children's anemia cure rate. DESIGN, SETTING, AND PARTICIPANTS: A pragmatic cluster randomized clinical trial in children aged 12 to 59 months from 55 villages from the rural Chamrajnagar district in southern India was conducted between November 2014 and July 2015; 6-month follow-up ended in January 2016. Villages were randomly assigned to either usual treatment (n = 27) or to the intervention (n = 28). Among 1144 participating children, 534 were diagnosed as having anemia (hemoglobin levels <11 g/dL and >7.9 g/dL; to convert to grams per liter, multiply by 10) and constituted the study sample in this analysis. Data were analyzed between July 2016 and September 2017. INTERVENTIONS: Iron and folic acid (IFA), 20 mg/d, 5 times daily per week, for 5 months (usual treatment) or health worker-delivered education/counseling combined with usual treatment (intervention). MAIN OUTCOMES AND MEASURES: The primary outcome was anemia cure rate defined as hemoglobin level at or greater than 11 g/dL during follow-up. RESULTS: Of the children included in the study, the mean age was 30 months, with a slightly higher ratio of boys to girls. Of 534 children with anemia (intervention n = 303; usual treatment n = 231), 517 were reassessed after 6 months (intervention n = 298; usual treatment n = 219) while 17 were lost to follow-up (intervention n = 5 and usual treatment n = 12). Anemia cure rate was higher in children in the intervention group compared with children receiving usual treatment (55.7% [n = 166 of 298] vs 41.4% [n = 90 of 219]). The risk ratio derived through multilevel logistic regression was 1.37 (95% CI, 1.04-1.70); the model-estimated risk difference was 15.1% (95% CI, 3.9-26.3). Intervention-group children demonstrated larger mean hemoglobin increments (difference, intervention vs control: 0.25 g/dL; 95% CI, 0.07-0.44 g/dL) and improved IFA adherence (61.7%; 95% CI, 56.2-67.3 vs 48.4%; 95% CI, 41.7-55.1 consumed >75% of tablets provided). Adverse events were mild (intervention: 26.8%; 95% CI, 21.8-31.9 vs usual treatment: 21%; 95% CI, 15.6-26.4). To cure 1 child with anemia, 7 mothers needed to be counseled (number needed to treat: 7; 95% CI, 4-26). CONCLUSIONS AND RELEVANCE: Parental education and counseling by a community health worker achieved perceivable gains in curing childhood anemia. Policy makers should consider this approach to enhance population level anemia control. TRIAL REGISTRATION: ISRCTN identifier: ISRCTN68413407.
IMPORTANCE: Iron deficiency anemia, the largest cause of anemia worldwide, adversely affects cognitive development in children. Moreover, the imperceptible childhood anemia prevalence reduction in response to anemia control measures is associated with tremendous social and economic cost. OBJECTIVE: To evaluate the effects of community-based parental education/counseling when combined with usual treatment on children's anemia cure rate. DESIGN, SETTING, AND PARTICIPANTS: A pragmatic cluster randomized clinical trial in children aged 12 to 59 months from 55 villages from the rural Chamrajnagar district in southern India was conducted between November 2014 and July 2015; 6-month follow-up ended in January 2016. Villages were randomly assigned to either usual treatment (n = 27) or to the intervention (n = 28). Among 1144 participating children, 534 were diagnosed as having anemia (hemoglobin levels <11 g/dL and >7.9 g/dL; to convert to grams per liter, multiply by 10) and constituted the study sample in this analysis. Data were analyzed between July 2016 and September 2017. INTERVENTIONS: Iron and folic acid (IFA), 20 mg/d, 5 times daily per week, for 5 months (usual treatment) or health worker-delivered education/counseling combined with usual treatment (intervention). MAIN OUTCOMES AND MEASURES: The primary outcome was anemia cure rate defined as hemoglobin level at or greater than 11 g/dL during follow-up. RESULTS: Of the children included in the study, the mean age was 30 months, with a slightly higher ratio of boys to girls. Of 534 children with anemia (intervention n = 303; usual treatment n = 231), 517 were reassessed after 6 months (intervention n = 298; usual treatment n = 219) while 17 were lost to follow-up (intervention n = 5 and usual treatment n = 12). Anemia cure rate was higher in children in the intervention group compared with children receiving usual treatment (55.7% [n = 166 of 298] vs 41.4% [n = 90 of 219]). The risk ratio derived through multilevel logistic regression was 1.37 (95% CI, 1.04-1.70); the model-estimated risk difference was 15.1% (95% CI, 3.9-26.3). Intervention-group children demonstrated larger mean hemoglobin increments (difference, intervention vs control: 0.25 g/dL; 95% CI, 0.07-0.44 g/dL) and improved IFA adherence (61.7%; 95% CI, 56.2-67.3 vs 48.4%; 95% CI, 41.7-55.1 consumed >75% of tablets provided). Adverse events were mild (intervention: 26.8%; 95% CI, 21.8-31.9 vs usual treatment: 21%; 95% CI, 15.6-26.4). To cure 1 child with anemia, 7 mothers needed to be counseled (number needed to treat: 7; 95% CI, 4-26). CONCLUSIONS AND RELEVANCE: Parental education and counseling by a community health worker achieved perceivable gains in curing childhood anemia. Policy makers should consider this approach to enhance population level anemia control. TRIAL REGISTRATION: ISRCTN identifier: ISRCTN68413407.