Joshuan J Barboza, Oriana Rivera-Lozada, Cesar Bonilla-Asalde, Danis Castillo-Esquivel, Nancy Calzada-Gonzales, Felipe Montecino-Rojas, Oscar Jorge-Zapata, Mahycol Bravo-Ramirez
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引用次数: 0
Abstract
Background: Substance use during pregnancy is linked to adverse neonatal and longer-term outcomes in offspring, yet evidence syntheses have primarily focused on maternal outcomes. An umbrella review is needed to consolidate and critically appraise findings from systematic reviews on how interventions to treat substance use in pregnancy affect outcomes in offspring of pregnant women and pregnant individuals.
Methods: We will conduct an umbrella review of systematic reviews (with or without meta-analysis) that include quantitative primary studies of pregnant women and pregnant individuals with substance use who receive pharmacological, psychosocial/behavioural, integrated care, or community-based interventions. Searches will cover MEDLINE (PubMed), Embase, Web of Science, Scopus, the Cochrane Database of Systematic Reviews and Epistemonikos from inception. Two independent reviewers will perform title/abstract screening, full-text screening, and data extraction at every stage; a third reviewer will arbitrate disagreements. Methodological quality of included systematic reviews will be assessed using AMSTAR 2; risk of bias of primary studies will be reported as appraised in the original systematic reviews. Overlap of primary studies will be quantified using the Corrected Covered Area (CCA), with attention to multi-arm studies and to whether overlapping primary studies actually answer the same PICO question. We will narratively synthesise findings (avoiding vote counting) and, where systematic reviews report pooled estimates, we will summarise these without conducting de novo meta-analyses of primary studies. Certainty of evidence will be reported using existing GRADE assessments, complemented by a structured umbrella-level appraisal that incorporates large effects and dose-response gradients when relevant.
Discussion: This umbrella review will clarify which interventions have the strongest evidence of benefit (or harm) for neonatal, congenital, neurodevelopmental, and behavioural/mental health outcomes in offspring, identify evidence gaps and methodological limitations, and inform clinical guidance and maternal-child health policy.
背景：怀孕期间药物使用与不良的新生儿结局和后代的长期结局有关，但证据综合主要集中在孕产妇结局上。需要进行一项总括性审查，以巩固和批判性评估系统审查中关于治疗妊娠期间药物使用的干预措施如何影响孕妇和孕妇后代结局的发现。方法：我们将对系统综述（有或没有荟萃分析）进行总括性综述，包括对孕妇和接受药理学、社会心理/行为、综合护理或社区干预的药物使用孕妇的定量初步研究。搜索将覆盖MEDLINE (PubMed), Embase, Web of Science, Scopus， Cochrane系统评论数据库和Epistemonikos。两名独立审稿人将在每个阶段进行标题/摘要筛选、全文筛选和数据提取；第三位审稿人将对分歧进行仲裁。纳入系统评价的方法学质量将使用AMSTAR 2进行评估；原始研究的偏倚风险将在原始系统评价中进行评估。将使用校正覆盖面积（CCA）对初步研究的重叠进行量化，并关注多组研究以及重叠的初步研究是否实际上回答了相同的PICO问题。我们将叙述性地综合研究结果（避免计票），并且，在系统综述报告汇总估计的情况下，我们将总结这些结果，而不对主要研究进行从头开始的荟萃分析。将使用现有的GRADE评估报告证据的确定性，并辅以结构化的伞状级别评估，在相关情况下纳入大效应和剂量反应梯度。讨论：本综述将阐明哪些干预措施对后代的新生儿、先天性、神经发育和行为/心理健康结果有最强有力的有利（或有害）证据，确定证据差距和方法局限性，并为临床指导和妇幼保健政策提供信息。系统评价注册：PROSPERO CRD420261321678。
期刊介绍：
Systematic Reviews encompasses all aspects of the design, conduct and reporting of systematic reviews. The journal publishes high quality systematic review products including systematic review protocols, systematic reviews related to a very broad definition of health, rapid reviews, updates of already completed systematic reviews, and methods research related to the science of systematic reviews, such as decision modelling. At this time Systematic Reviews does not accept reviews of in vitro studies. The journal also aims to ensure that the results of all well-conducted systematic reviews are published, regardless of their outcome.
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