WorldWide Antimalarial Resistance Network (WWARN), Oxford, UK
Centre for Tropical Disease and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.
BMJ Open. 2019 Aug 22;9(8):e027503. doi: 10.1136/bmjopen-2018-027503.
Pregnant women are more vulnerable to malaria leading to adverse impact on both mothers and fetuses. However, knowledge on the efficacy and safety of antimalarials in pregnancy is limited by the paucity of randomised control trials and the lack of standardised protocols in this special subpopulation. Pooling individual patient data (IPD) for meta-analysis could address in part these limitations to summarise accurately the currently available evidence on treatment efficacy and risk factors for treatment failure.
To assess the treatment efficacy of artemisinin-based and quinine-based treatments for uncomplicated falciparum malaria in pregnancy, seven databases (Medline, Embase, Global Health, Cochrane Library, Scopus, Web of Science and Literatura Latino Americana em Ciências da Saúde) and two clinical trial registries (International Clinical Trials Registry Platform and ClinicalTrial.gov) were searched. Both interventional and observational cohort studies following up for at least 28 days will be included. IPD of the identified eligible published or unpublished studies will be sought by inviting principal investigators. Raw IPD will be shared through the web-based secure platform developed by the WorldWide Antimalarial Resistance Network using the established methodology. The primary objective is to compare the risk of PCR-corrected treatment failure among different treatments and to find the risk factors. One-stage IPD meta-analysis by Cox model with shared frailty will be conducted. A risk of bias assessment will be conducted to address the impact of unshared potential data and of the quality of individual studies. Potential limitations include difficulty in acquiring the IPD and heterogeneity of the study designs due to the lack of standard.
This IPD meta-analysis consists of secondary analyses of existing anonymous data and meets the criteria for waiver of ethics review by the Oxford Tropical Research Ethics Committee. The results of this IPD meta-analysis will be disseminated through open-access publications at peer-reviewed journals. The study results will lead to a better understanding of malaria treatment in pregnancy, which can be used for clinical decision-making and conducting further studies.
CRD42018104013.
孕妇更容易感染疟疾，这会对母婴双方造成不良影响。然而，由于随机对照试验的缺乏以及这一特殊亚人群中缺乏标准化方案，有关抗疟药物在妊娠中的疗效和安全性的知识受到限制。通过汇总个体患者数据（IPD）进行荟萃分析，可以部分解决这些限制，从而更准确地总结目前关于治疗效果和治疗失败风险因素的现有证据。
为了评估基于青蒿素和奎宁的治疗方案在治疗妊娠合并恶性疟原虫疟疾中的疗效，我们检索了七个数据库（医学文献在线数据库、Embase、全球健康、考科兰图书馆、Scopus、Web of Science 和拉丁美洲健康科学文献数据库）和两个临床试验注册处（国际临床试验注册平台和 ClinicalTrials.gov）。将纳入至少随访 28 天的干预性和观察性队列研究。将通过邀请主要研究者来寻找已发表或未发表的符合条件的研究的 IPD。将通过世界卫生组织抗疟网络开发的基于网络的安全平台共享原始 IPD，使用既定方法。主要目标是比较不同治疗方法的 PCR 校正治疗失败风险，并确定风险因素。将通过 Cox 模型共享脆弱性进行一阶 IPD 荟萃分析。将进行偏倚风险评估，以解决非共享潜在数据和单个研究质量的影响。潜在的局限性包括获取 IPD 的困难以及由于缺乏标准化导致研究设计的异质性。
这项 IPD 荟萃分析由对现有匿名数据的二次分析组成，符合牛津热带研究伦理委员会豁免伦理审查的标准。这项 IPD 荟萃分析的结果将通过同行评审期刊的开放获取出版物进行传播。该研究结果将有助于更好地了解妊娠期间的疟疾治疗，从而可用于临床决策和开展进一步的研究。
CRD42018104013。
