Botucatu Medical School, Postgraduation Program in Tocogynecology, Sao Paulo State University Julio de Mesquita Filho, Sao Paulo, Brazil
Department of Gynecology and Obstetrics, Botucatu Medical School, Sao Paulo State University Julio de Mesquita Filho, Sao Paulo, Brazil.
BMJ Open. 2022 Feb 24;12(2):e059484. doi: 10.1136/bmjopen-2021-059484.
Current evidence remains insufficient to strongly demonstrate the benefits of consolidation chemotherapy to all women with low-risk gestational trophoblastic neoplasia (GTN). This protocol outlines a systematic review to investigate whether consolidation chemotherapy is necessary for all patients with postmolar low-risk GTN after human chorionic gonadotropin normalisation with first-line single-agent chemotherapy.
A search string will be used to search the PubMed (MEDLINE), EMBASE, Web of Sciences, Scopus, LILACS and Cochrane Central Register of Controlled Trials databases. Articles will be screened at the title and abstract level, and then at the full article level by two independent reviewers using inclusion/exclusion criteria. Randomised and non-randomised study designs will be included, while case studies, commentaries, editorials, review articles, animal studies, basic science studies and cross-sectional studies, as well as studies not reporting relapse/recurrence rates and/or whether consolidation chemotherapy was delivered will be excluded. There will be no restrictions on date of publication, geographical location, study setting, or language of publication. The primary outcome is rate of recurrence/relapse. The assessments of randomised controlled trials will be performed using the risk of bias tool from the Cochrane Collaboration. Non-randomised studies will be assessed using the Newcastle-Ottawa scale. The quality of evidence will be assessed using the Grading quality of evidence and strength of recommendations (Grades of Recommendations, Assessment, Development and Evaluation) guidelines.
No formal ethical approval is required as all data collected will be secondary data and analysed anonymously. Results will be disseminated through a peer-reviewed publication and at scientific events.
CRD42020164822.
目前的证据仍然不足以有力地证明巩固化疗对所有低风险妊娠滋养细胞肿瘤（GTN）女性的益处。本方案概述了一项系统评价，旨在研究在人绒毛膜促性腺激素（hCG）正常化后，一线单药化疗后，所有低风险 postmolar GTN 患者是否需要巩固化疗。
将使用搜索字符串搜索 PubMed（MEDLINE）、EMBASE、Web of Sciences、Scopus、LILACS 和 Cochrane 中央对照试验注册库。文章将在标题和摘要层面进行筛选，然后由两名独立评审员根据纳入/排除标准在全文层面进行筛选。将纳入随机和非随机研究设计，而排除病例研究、评论、社论、综述文章、动物研究、基础科学研究和横断面研究，以及未报告复发/复发率和/或是否给予巩固化疗的研究。出版日期、地理位置、研究环境或语言均不受限制。主要结局是复发/复发率。将使用 Cochrane 协作组织的偏倚风险工具评估随机对照试验的评估。将使用纽卡斯尔-渥太华量表评估非随机研究。将使用 Grades of Recommendations, Assessment, Development and Evaluation 指南评估证据质量和推荐强度。
由于所有收集的数据都是二手数据且匿名分析，因此不需要正式的伦理批准。结果将通过同行评审出版物和科学活动进行传播。
PROSPERO 注册号：CRD42020164822。
