背景:缺铁性贫血在尼日利亚孕妇中很常见。标准治疗是口服铁剂治疗,由于副作用,这可能是次优的。静脉输注羧基麦芽糖铁(FCM)是一种基于证据的替代治疗方法,具有更有利的副作用,需要根据标准化方案施用。在这项研究中,我们根据方案评估了单剂量FCM的保真度,并确定了影响实施保真度的因素.
方法:我们在拉各斯和卡诺州的11个机构的临床试验中使用了一种混合方法方法,并采用了序贯解释性设计,尼日利亚。在实现保真度的概念框架的指导下,我们通过直接观察每个替代的FCM给药定量评估对方案的依从性,使用干预程序检查表,并按机构和州比较中位依从性。通过对来自9个有目的地选择的医疗机构的14名熟练卫生人员(SHP)进行深入访谈,进行了定性忠诚度评估。使用半结构化面试指南。我们使用Stata中的描述性和推断性统计分析了定量数据,并使用主题分析对NVivo中的转录访谈进行了分析。
结果:在11个研究地点共观察到254个FCM给药,大多数在中学(63%),其次是初级保健设施(PHCs)(30%)。总的来说,按照方案对FCM给药的依从性是中等的(63%),并因机构水平而异.在PHCs中观察到最低的粘附水平(36%)。median,依从性水平显示不同机构水平存在显著差异(p=0.001),但不同州无显著差异(p=0.889).团队合作和协议的可用性是促成高保真度的促进策略。然而,机构/后勤障碍是影响某些设施中观察到的不同保真度水平的环境因素。
结论:协作团队和对操作协议的访问在某些设施中产生了高保真度。然而,在一些PHCs中,由于上下文因素和干预复杂性,对FCM的保真度较低,从而影响交货质量。在尼日利亚,扩大FCM将需要关注员工力量,团队合作和管理协议的可用性,以优化其对妊娠期贫血的影响。
BACKGROUND: Iron deficiency anaemia is common among pregnant women in Nigeria. The standard treatment is oral iron therapy, which can be sub-optimal due to side effects. Intravenous ferric carboxymaltose (FCM) is an evidenced-based alternative treatment with a more favourable side effect profile requiring administration according to a standardized protocol. In this study, we assessed the fidelity of administering a single dose of FCM according to protocol and identified factors influencing implementation fidelity.
METHODS: We used a mixed-method approach with a sequential explanatory design nested in a clinical trial across 11 facilities in Lagos and Kano States, Nigeria. Guided by a conceptual framework of implementation fidelity, we quantitatively assessed adherence to protocol by directly observing every alternate FCM administration, using an intervention procedure checklist, and compared median adherence by facility and state. Qualitative fidelity assessment was conducted via in-depth interviews with 14 skilled health personnel (SHP) from nine purposively selected health facilities, using a semi-structured interview guide. We analyzed quantitative data using descriptive and inferential statistics in Stata and used thematic analysis to analyze the transcribed interviews in NVivo.
RESULTS: A total of 254 FCM administrations were observed across the 11 study sites, with the majority in secondary (63%), followed by primary healthcare facilities (PHCs) (30%). Overall, adherence to FCM administration as per protocol was moderate (63%) and varied depending on facility level. The lowest level of adherence was observed in PHCs (36%). Median, adherence level showed significant differences by facility level (p = 0.001) but not by state (p = 0.889). Teamwork and availability of protocols are facilitation strategies that contributed to high fidelity. However, institutional/ logistical barriers are contextual factors that influenced the varied fidelity levels observed in some facilities.
CONCLUSIONS: Collaborative teams and access to operating protocols resulted in high fidelity in some facilities. However, in some PHCs, fidelity to FCM was low due to contextual factors and intervention complexities, thereby influencing the quality of delivery. In Nigeria, scale-up of FCM will require attention to staff strength, teamwork and availability of administration protocols, in order to optimize its impact on anaemia in pregnancy.