Indian Council of Medical Research (ICMR)-Rajendra Memorial Research Institute of Medical Sciences (RMRIMS), Patna, India.
Infectious Diseases Data Observatory (IDDO), University of Oxford, Oxford, UK
BMJ Open. 2023 Oct 28;13(10):e074679. doi: 10.1136/bmjopen-2023-074679.
Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. There is an observed variation in the efficacy of the current first-line therapies across different regions. Such heterogeneity could be a function of host, parasite and drug factors. An individual participant data meta-analysis (IPD-MA) is planned to explore the determinants of treatment outcomes.
The Infectious Diseases Data Observatory (IDDO) VL living systematic review (IDDO VL LSR) library is an open-access resource of all published therapeutic studies in VL since 1980. For this current review, the search includes all clinical trials published between 1 January 1980 and 2 May 2021. Studies indexed in the IDDO VL LSR library were screened for eligibility for inclusion in this IPD-MA. Corresponding authors and principal investigators of the studies meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Authors agreeing to participate in this collaborative research were requested to share the IPD using the IDDO VL data platform. The IDDO VL data platform currently holds data sets from clinical trials standardised to a common data format and provides a unique opportunity to identify host, parasite and drug determinants of treatment outcomes. Multivariable regression models will be constructed to identify determinants of therapeutic outcomes using generalised linear mixed-effects models accounting for within-study site clustering.
This IPD-MA meets the criteria for waiver of ethical review as defined by the Oxford Tropical Research Ethics Committee (OxTREC) granted to IDDO, as the research consists of secondary analysis of existing anonymised data (Exempt granted on 29 March 2023, OxTREC REF: IDDO) Ethics approval was granted by the ICMR-Rajendra Memorial Research Institute of Medical Sciences ethics committee (Letter no: RMRI/EC/30/2022) on 04-07-2022. The results of this IPD-MA will be disseminated at conferences, IDDO website and any peer-reviewed publications. All publications will be open source. Findings of this research will be critically important for the control programmes at regional/global levels, policy makers and groups developing new VL treatments.
CRD42021284622.
内脏利什曼病（VL）是一种寄生虫病，每年估计有 30000 例新发病例。目前的一线治疗方法在不同地区的疗效存在观察到的差异。这种异质性可能是宿主、寄生虫和药物因素的函数。计划进行一项个体参与者数据荟萃分析（IPD-MA），以探讨治疗结果的决定因素。
传染病数据观测站（IDDO）VL 系统评价库是一个自 1980 年以来发表的所有 VL 治疗研究的开放获取资源。在本次审查中，检索包括 1980 年 1 月 1 日至 2021 年 5 月 2 日期间发表的所有临床试验。IDDO VL 系统评价库中索引的研究将筛选出符合纳入本 IPD-MA 的研究。邀请符合纳入标准的研究的通讯作者和主要研究者参与合作 IPD-MA。同意参与这项合作研究的作者被要求使用 IDDO VL 数据平台共享 IPD。IDDO VL 数据平台目前拥有以通用数据格式标准化的临床试验数据集，为确定治疗结果的宿主、寄生虫和药物决定因素提供了独特的机会。将使用考虑到研究内站点聚类的广义线性混合效应模型构建多变量回归模型，以确定治疗结果的决定因素。
本 IPD-MA 符合牛津热带研究伦理委员会（OxTREC）授予 IDDO 的豁免伦理审查标准，因为该研究由现有匿名数据的二次分析组成（2023 年 3 月 29 日授予豁免，OxTREC REF：IDDO）。ICMR-Rajendra Memorial 医学科学研究伦理委员会于 2022 年 7 月 4 日批准了该研究的伦理（信笺号：RMRI/EC/30/2022）。该 IPD-MA 的结果将在会议、IDDO 网站和任何同行评审出版物上公布。所有出版物都将开源。这项研究的结果对于区域/全球层面的控制项目、政策制定者和开发新 VL 治疗方法的团体来说将是至关重要的。
PROSPERO 注册：CRD42021284622。
