PDF(Pubmed)
Abstract：
Visceral leishmaniasis (VL) is a parasitic disease with an estimated 30 000 new cases occurring annually. Despite anaemia being a common haematological manifestation of VL, the evolution of different haematological characteristics following treatment remains poorly understood. An individual participant data meta-analysis (IPD-MA) is planned to characterise the haematological dynamics in patients with VL.
The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.
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 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.
CRD42021284622.
The Infectious Diseases Data Observatory (IDDO) VL data platform is a global repository of IPD from therapeutic studies identified through a systematic search of published literature (PROSPERO registration: CRD42021284622). The platform currently holds datasets from clinical trials standardised to a common data format. Corresponding authors and principal investigators of the studies indexed in the IDDO VL data platform meeting the eligibility criteria for inclusion were invited to be part of the collaborative IPD-MA. Mixed-effects multivariable regression models will be constructed to identify determinants of haematological parameters by taking clustering within study sites into account.
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 4 July 2022. The results of this analysis will be disseminated at conferences, the IDDO website and peer-reviewed publications in open-access journals. The findings of this research will be critically important for control programmes at regional and global levels, policymakers and groups developing new VL treatments.
CRD42021284622.
摘要：
背景：内脏利什曼病（VL）是一种寄生虫病，每年估计发生30000例新病例。尽管贫血是VL的常见血液学表现，治疗后不同血液学特征的演变仍知之甚少.计划进行个体参与者数据荟萃分析（IPD-MA），以表征VL患者的血液学动力学。
方法：传染病数据观察站（IDDO）VL数据平台是通过系统检索已发表文献（PROSPERO注册：CRD42021284622）确定的治疗性研究中的IPD的全球存储库。该平台目前将临床试验的数据集标准化为通用数据格式。IDDOVL数据平台中符合纳入资格标准的研究的相应作者和主要研究者被邀请成为IPD-MA协作的一部分。将构建混合效应多变量回归模型，以通过考虑研究地点内的聚类来识别血液学参数的决定因素。
背景：本IPD-MA符合牛津热带研究伦理委员会（OxTREC）授予IDDO的伦理审查豁免标准，因为该研究包括对现有匿名数据的二次分析（2023年3月29日获得豁免，OxTRECREF：IDDO）。伦理批准由ICMR-Rajendra纪念医学科学研究所伦理委员会批准(信号：RMRI/EC/30/2022），2022年7月4日。这项分析的结果将在会议上传播，IDDO网站和开放获取期刊上的同行评审出版物。这项研究的结果对于区域和全球一级的控制方案至关重要，政策制定者和团体开发新的VL治疗。
■CRD42021284622。
方法：传染病数据观察站（IDDO）VL数据平台是通过系统检索已发表文献（PROSPERO注册：CRD42021284622）确定的治疗性研究中的IPD的全球存储库。该平台目前将临床试验的数据集标准化为通用数据格式。IDDOVL数据平台中符合纳入资格标准的研究的相应作者和主要研究者被邀请成为IPD-MA协作的一部分。将构建混合效应多变量回归模型，以通过考虑研究地点内的聚类来识别血液学参数的决定因素。
背景：本IPD-MA符合牛津热带研究伦理委员会（OxTREC）授予IDDO的伦理审查豁免标准，因为该研究包括对现有匿名数据的二次分析（2023年3月29日获得豁免，OxTRECREF：IDDO）。伦理批准由ICMR-Rajendra纪念医学科学研究所伦理委员会批准(信号：RMRI/EC/30/2022），2022年7月4日。这项分析的结果将在会议上传播，IDDO网站和开放获取期刊上的同行评审出版物。这项研究的结果对于区域和全球一级的控制方案至关重要，政策制定者和团体开发新的VL治疗。
■CRD42021284622。
