The Consortium on Newborn Screening in Africa for sickle cell disease: study rationale and methodology.
The Consortium on Newborn Screening in Africa for sickle cell disease: study rationale and methodology.
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非洲新生儿筛查联盟的镰状细胞疾病：研究理由和方法论。
DOI：
10.1182/bloodadvances.2022007698
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发表时间：
2022-12-27
期刊：
影响因子：
7.5
通讯作者：
Novelli EM
中科院分区：
文献类型：
--
作者：
Green NS;Zapfel A;Nnodu OE;Franklin P;Tubman VN;Chirande L;Kiyaga C;Chunda-Liyoka C;Awuonda B;Ohene-Frempong K;Inusa BPD;Ware RE;Odame I;Ambrose EE;Dogara LG;Oron AP;Willett C;Thompson AA;Berliner N;Coetzer TL;Novelli EM
由美国血液学学会领导的撒哈拉以南7国联盟（CONSA）开展新生儿SCD筛查和早期临床干预的实施研究。主要目标是确定SCD出生发生率和早期标准化护理预防U5M的有效性。镰状细胞病（SCD）是撒哈拉以南非洲地区的一种常见疾病，与5岁以下儿童高死亡率（U5M）有关。美国血液学学会（American Society of Hematology）建立了非洲新生儿SCD筛查联盟（CONSA），这是一个由7个国家组成的站点网络，旨在对撒哈拉以南非洲的SCD儿童实施标准化的新生儿血红蛋白病筛查和早期干预。CONSA的总体假设是，与该地区的历史估计相比，早期婴儿SCD筛查和进入标准化、持续护理将减少U5M。试验的主要目的是确定以人群为基础的SCD出生发生率和早期标准化护理在每个国家预防早期死亡的有效性。次要目标是在CONSA合作伙伴的临床网络中建立SCD的普遍筛查和早期干预措施，并评估试验实施情况。结果将从使用共享患者登记处收集的数据进行评估。标准化的试验程序将在7个非洲国家的指定出生人口中实施，这些国家的项目符合资格标准。治疗方案包括提供抗菌和抗疟疾预防以及针对SCD儿童常见感染的标准儿童疫苗接种。在每个联盟合作伙伴定义的集水区内筛查阳性并确认SCD的婴儿将被纳入临床干预方案，并定期随访至5岁。这些早期干预措施的有效性，以及文化上适当的家庭教育和咨询，将通过比较入组队列的U5M与预估的计划数据来评估。在这里，我们描述了该试验计划的方法。
American Society of Hematology–led 7-country sub-Saharan consortium (CONSA) for implementation research on newborn SCD screening and early clinical intervention. The primary objectives are to determine SCD birth incidence and effectiveness of early standardized care for preventing U5M. Sickle cell disease (SCD) is a common condition within sub-Saharan Africa and associated with high under-5 mortality (U5M). The American Society of Hematology instituted the Consortium on Newborn Screening in Africa (CONSA) for SCD, a 7-country network of sites to implement standardized newborn hemoglobinopathy screening and early intervention for children with SCD in sub-Saharan Africa. CONSA’s overall hypothesis is that early infant SCD screening and entry into standardized, continuous care will reduce U5M compared with historical estimates in the region. Primary trial objectives are to determine the population-based birth incidence of SCD and effectiveness of early standardized care for preventing early mortality consortium-wide at each country’s site(s). Secondary objectives are to establish universal screening and early interventions for SCD within clinical networks of CONSA partners and assess trial implementation. Outcomes will be evaluated from data collected using a shared patient registry. Standardized trial procedures will be implemented among designated birth populations in 7 African countries whose programs met eligibility criteria. Treatment protocol includes administering antibacterial and antimalarial prophylaxis and standard childhood vaccinations against infections commonly affecting children with SCD. Infants with a positive screen and confirmation of SCD within the catchment areas defined by each consortium partner will be enrolled in the clinical intervention protocol and followed regularly until age of 5 years. Effectiveness of these early interventions, along with culturally appropriate family education and counseling, will be evaluated by comparing U5M in the enrolled cohort to estimated preprogram data. Here, we describe the methodology planned for this trial.
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