Gadapani Pathak Barsha, Nisar Yasir Bin, Madhur Tarun, Garg Naveen, Qazi Shamim, Mazumder Sarmila
Society for Applied Studies, New Delhi, India.
Faculty of Medicine, University of Bergen, Bergen, Norway.
BMJ Open. 2025 Jul 7;15(7):e093705. doi: 10.1136/bmjopen-2024-093705.
The National Family Health Survey-5 has reported an under-five mortality rate of 41.9 per 1000 live births in India. Pneumonia, one of the leading causes of under-five mortality, contributes substantially to this figure. The Indian government has made efforts through multiple national programmes, but pneumonia-specific mortality remains high. The Government of India revised their Childhood Pneumonia Management Guidelines in 2019 to improve under-five pneumonia prevention and management. This implementation study aims to achieve a high population-based coverage of pneumonia treatment for under 5 yearold children in the Palwal district of India.
This implementation study uses a quasi-experimental pre-post design and a mixed-methods approach, conducted in three phases: (i) formative research, (ii) model optimisation through iterative testing in a learning block and (iii) scale-up and concurrent evaluation. The study is set in Palwal district, Haryana, and the primary catchment/study area will be the Health and Wellness Centres, the most accessible public health facilities for the community. Approximately 4167 households will be surveyed to capture ~2400 under-five children, among whom about 120 pneumonia cases (based on an estimated 5% prevalence) will be included in the analysis of treatment coverage and outcomes. Quantitative data will be analysed using descriptive statistics and generalised linear models, while qualitative data from focus group discussions and in-depth interviews will be thematically analysed using NVivo software.
Ethical approval was granted by the ethical committees of the Society for Applied Studies (ERC/IR Pneumonia/2021), the Regional Ethics Committee of Western Norway (2022/531608) and the WHO(ERC.0003652). Additionally, this study has obtained the Government of Haryana state (Memo no. HSHRC/2022/505) and Health Ministry steering committee (approval date: 19 Dec 2022, proposal id 2022-17596) approvals. Informed consent will be obtained from all participants, including caregivers and healthcare workers, prior to data collection. Dissemination meetings in the study country will share results with stakeholders, including Ministry of Health officials, health managers, families of under-five children, community leaders and academia, to discuss national health programme implications. Results will also be shared regionally and globally, with publications and presentations encouraged in national and international forums.
Clinical Trials Registry - India, CTRI/2021/03/031622.
《国家家庭健康调查-5》报告称,印度每1000例活产中5岁以下儿童的死亡率为41.9。肺炎是5岁以下儿童死亡的主要原因之一,这一数字中很大一部分是由肺炎导致的。印度政府通过多项国家计划做出了努力,但特定肺炎的死亡率仍然很高。印度政府于2019年修订了《儿童肺炎管理指南》,以改善5岁以下儿童肺炎的预防和管理。本实施研究旨在使印度帕尔瓦尔地区5岁以下儿童的肺炎治疗在人群中获得高覆盖率。
本实施研究采用准实验前后设计和混合方法,分三个阶段进行:(i)形成性研究,(ii)通过在学习模块中进行迭代测试进行模型优化,以及(iii)扩大规模和同步评估。该研究在哈里亚纳邦的帕尔瓦尔地区进行,主要集水区/研究区域将是健康与 wellness 中心,这是社区最容易到达的公共卫生设施。将对约4167户家庭进行调查,以涵盖约2400名5岁以下儿童,其中约120例肺炎病例(基于估计的5%患病率)将纳入治疗覆盖率和结果分析。定量数据将使用描述性统计和广义线性模型进行分析,而来自焦点小组讨论和深入访谈的定性数据将使用NVivo软件进行主题分析。
应用研究协会伦理委员会(ERC/IR Pneumonia/2021)、挪威西部区域伦理委员会(2022/531608)和世界卫生组织(ERC.0003652)已批准伦理许可。此外,本研究已获得哈里亚纳邦政府(备忘录编号HSHRC/2022/505)和卫生部指导委员会(批准日期:2022年12月19日,提案编号2022-17596)的批准。在数据收集之前,将从所有参与者,包括照顾者和医护人员那里获得知情同意。研究所在国家的传播会议将与利益相关者分享结果,包括卫生部官员、卫生管理人员、5岁以下儿童的家庭、社区领袖和学术界,以讨论对国家卫生计划的影响。结果还将在区域和全球范围内分享,鼓励在国家和国际论坛上发表论文和进行展示。
印度临床试验注册中心,CTRI/2021/03/031622。