Shet Arun S, Zwarenstein Merrick, Rao Abha, Jebaraj Paul, Arumugam Karthika, Atkins Salla, Mascarenhas Maya, Klar Neil, Galanti Maria Rosaria
Department of Hematology/Medical Oncology, St Johns Medical College and Hospital, Bangalore, India.
Sickle Cell Branch, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland.
JAMA Pediatr. 2019 Sep 1;173(9):826-834. doi: 10.1001/jamapediatrics.2019.2087.
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.
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.
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).
The primary outcome was anemia cure rate defined as hemoglobin level at or greater than 11 g/dL during follow-up.
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).
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.
ISRCTN identifier: ISRCTN68413407.
缺铁性贫血是全球范围内贫血的最主要原因，对儿童认知发育有不利影响。此外，针对贫血控制措施，儿童贫血患病率的降低难以察觉，这与巨大的社会和经济成本相关。
评估基于社区的家长教育/咨询与常规治疗相结合对儿童贫血治愈率的影响。
设计、地点和参与者：2014年11月至2015年7月在印度南部农村钱德拉吉讷格尔地区55个村庄开展了一项针对12至59个月儿童的实用整群随机临床试验；6个月的随访于2016年1月结束。村庄被随机分配至常规治疗组（n = 27）或干预组（n = 28）。在1144名参与研究的儿童中，534名被诊断为贫血（血红蛋白水平<11 g/dL且>7.9 g/dL；换算为克/升需乘以10），并构成了本分析中的研究样本。2016年7月至2017年9月进行数据分析。
铁剂和叶酸（IFA），20毫克/天，每周5次，持续5个月（常规治疗），或由卫生工作者提供教育/咨询并结合常规治疗（干预措施）。
主要结局为贫血治愈率，定义为随访期间血红蛋白水平达到或高于11 g/dL。
纳入研究的儿童平均年龄为30个月，男孩与女孩的比例略高。在534名贫血儿童中（干预组n = 303；常规治疗组n = 231），6个月后对517名儿童进行了重新评估（干预组n = 298；常规治疗组n = 219），17名儿童失访（干预组5名，常规治疗组12名）。干预组儿童的贫血治愈率高于接受常规治疗的儿童（55.7% [298名中的166名] 对41.4% [219名中的90名]）。通过多水平逻辑回归得出的风险比为1.37（95% CI，1.04 - 1.70）；模型估计的风险差为15.1%（95% CI，3.9 - 26.3）。干预组儿童的平均血红蛋白增量更大（差异，干预组对对照组：0.25 g/dL；95% CI，0.07 - 0.44 g/dL），并且铁剂和叶酸的依从性提高（61.7%；95% CI，56.2 - 67.3对48.4%；95% CI，41.7 - 55.1，服用了提供片剂的>75%）。不良事件较轻（干预组：26.8%；95% CI，21.8 - 31.9对常规治疗组：21%；95% CI，15.6 - 26.4）。为治愈1名贫血儿童，需要对7名母亲进行咨询（治疗所需人数：7；95% CI，4 - 26）。
社区卫生工作者进行的家长教育和咨询在治愈儿童贫血方面取得了显著成效。政策制定者应考虑采用这种方法来加强人群层面的贫血控制。
ISRCTN标识符：ISRCTN68413407。
