Integrated Sustainable childhood Pneumonia and Infectious disease Reduction in Nigeria (INSPIRING) through whole system strengthening in Jigawa, Nigeria: study protocol for a cluster randomised controlled trial.
Integrated Sustainable childhood Pneumonia and Infectious disease Reduction in Nigeria (INSPIRING) through whole system strengthening in Jigawa, Nigeria: study protocol for a cluster randomised controlled trial.
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DOI：
10.1186/s13063-021-05859-5
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发表时间：
2022-01-31
期刊：
影响因子：
2.5
通讯作者：
INSPIRING Project Consortium
中科院分区：
文献类型：
--
作者：
King C;Burgess RA;Bakare AA;Shittu F;Salako J;Bakare D;Uchendu OC;Iuliano A;Isah A;Adams O;Haruna I;Magama A;Ahmed T;Ahmar S;Cassar C;Valentine P;Olowookere TF;MacCalla M;Graham HR;McCollum ED;Falade AG;Colbourn T;INSPIRING Project Consortium
儿童死亡率仍然高得令人无法接受，北方尼日利亚报告的死亡率在全球范围内属于最高之列（例如，吉川州的活产率为192/1 000）。关键的保护和预防干预措施，如疫苗接种和使用清洁烹饪燃料的覆盖率很低。此外，知识、寻求护理和卫生系统因素也很差。因此，需要采取全系统办法，以持续降低儿童死亡率。这是一项整群随机对照试验，综合了过程和经济评价，于2021年1月至2022年9月进行。试验将在尼日利亚吉川州基亚瓦地方政府区进行，估计人口为23万。集群被定义为初级政府卫生设施集水区（n = 33）。33个集群将在公开仪式上随机分配（1：1），32个集群将纳入影响评估。该试验将评估一个适合当地的“整体系统加强”一揽子计划，其中包括三种基于证据的方法：社区男性和女性团体，伙伴关系定义的质量记分卡和医疗保健工作者培训，指导和提供基本的必要设备和商品。主要结局是7天至59个月儿童的死亡率。将使用队列设计前瞻性记录死亡率，并通过基线和终点横断面调查测量次要结局。假设如下，我们将具有30%的最小可检测效应量：（a）每1000例活产100例的基线死亡率，（B）4480种化合物，每种化合物3个合格儿童，（c）80%功效，（d）5%显著性，（e）群内相关性为0.007，（f）群大小的方差系数为0.74。分析将通过意向治疗，比较干预和对照组，调整化合物和试验组。这项研究将提供强有力的证据，证明以社区为基础的参与性学习和行动的效力和成本效益，以及综合保健系统的加强和问责机制，以降低儿童死亡率。人种学过程评估将有助于充分了解干预措施在这一背景下如何发挥作用。然而，由于缺乏及时可靠的死亡率数据以及COVID-19疫情的不确定影响，我们在计算样本量时遇到了一个关键挑战。ISRCTN 39213655。于2019年12月11日注册在线版本包含补充材料，可通过10.1186/s13063-021-05859-5获得。
Child mortality remains unacceptably high, with Northern Nigeria reporting some of the highest rates globally (e.g. 192/1000 live births in Jigawa State). Coverage of key protect and prevent interventions, such as vaccination and clean cooking fuel use, is low. Additionally, knowledge, care-seeking and health system factors are poor. Therefore, a whole systems approach is needed for sustainable reductions in child mortality. This is a cluster randomised controlled trial, with integrated process and economic evaluations, conducted from January 2021 to September 2022. The trial will be conducted in Kiyawa Local Government Area, Jigawa State, Nigeria, with an estimated population of 230,000. Clusters are defined as primary government health facility catchment areas (n = 33). The 33 clusters will be randomly allocated (1:1) in a public ceremony, and 32 clusters included in the impact evaluation. The trial will evaluate a locally adapted ‘whole systems strengthening’ package of three evidence-based methods: community men’s and women’s groups, Partnership Defined Quality Scorecard and healthcare worker training, mentorship and provision of basic essential equipment and commodities. The primary outcome is mortality of children aged 7 days to 59 months. Mortality will be recorded prospectively using a cohort design, and secondary outcomes measured through baseline and endline cross-sectional surveys. Assuming the following, we will have a minimum detectable effect size of 30%: (a) baseline mortality of 100 per 1000 livebirths, (b) 4480 compounds with 3 eligible children per compound, (c) 80% power, (d) 5% significance, (e) intra-cluster correlation of 0.007 and (f) coefficient of variance of cluster size of 0.74. Analysis will be by intention-to-treat, comparing intervention and control clusters, adjusting for compound and trial clustering. This study will provide robust evidence of the effectiveness and cost-effectiveness of community-based participatory learning and action, with integrated health system strengthening and accountability mechanisms, to reduce child mortality. The ethnographic process evaluation will allow for a rich understanding of how the intervention works in this context. However, we encountered a key challenge in calculating the sample size, given the lack of timely and reliable mortality data and the uncertain impacts of the COVID-19 pandemic. ISRCTN 39213655. Registered on 11 December 2019 The online version contains supplementary material available at 10.1186/s13063-021-05859-5.
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DOI：
10.1136/bmj.h1258
发表时间：
2015-03-19
期刊：
BMJ (Clinical research ed.)
影响因子：
--
作者：
Moore GF;Audrey S;Barker M;Bond L;Bonell C;Hardeman W;Moore L;O'Cathain A;Tinati T;Wight D;Baird J
通讯作者：
Baird J
影响因子：
3.7
作者：
Liu, Li;Kalter, Henry D.;Black, Robert E.
通讯作者：
Black, Robert E.
影响因子：
4.8
作者：
Hemming, Karla;Marsh, Jen
通讯作者：
Marsh, Jen
影响因子：
3.1
作者：
King, Carina;Iuliano, Agnese;Falade, Adegoke G.
通讯作者：
Falade, Adegoke G.
影响因子：
168.9
作者：
Liu, Li;Oza, Shefali;Hogan, Dan;Chu, Yue;Perin, Jamie;Zhu, Jun;Lawn, Joy E.;Cousens, Simon;Mathers, Colin;Black, Robert E.
通讯作者：
Black, Robert E.