Liu Dan, Wu Lin, Luo Jiefeng, Li Siyu, Liu Yan, Zhang Chuan, Zeng Linan, Yu Qin, Zhang Lingli
West China School of Pharmacy, Sichuan University, Chengdu, China.
Department of Pharmacy, West China Second University Hospital, Sichuan University, Chengdu, China.
Front Pharmacol. 2022 Aug 1;13:915698. doi: 10.3389/fphar.2022.915698. eCollection 2022.
Prelabor rupture of membranes (PROM) is associated with maternal and neonatal infections. Although guidelines suggest prophylactic antibiotics for pregnant women with PROM, the optimal antibiotic regimen remains controversial. Synthesizing the data from different studies is challenging due to variations in reported outcomes. This study aimed to form the initial list of outcomes for the core outcome set (COS) that evaluates antibiotic use in PROM by identifying all existing outcomes and patients' views. Relevant studies were identified by searching PubMed, EMBASE, Cochrane Library, Chinese National Knowledge Infrastructure, Wanfang, and VIP databases. We also screened the references of the included studies as a supplementary search. We extracted basic information from the articles and the outcomes. Two reviewers independently selected the studies, extracted the data, extracted the outcomes, and grouped them into domains. Then, semi-structured interviews based on the potential factors collected by the systematic review were conducted at West China Second Hospital of Sichuan University. Pregnant women who met the diagnostic criteria for PROM were enrolled. Participants reported their concerns about the outcomes. Two researchers identified the pregnant women's concerns. A total of 90 studies were enrolled in this systematic review. The median outcomes in the included studies was 7 (1-31), and 109 different unique outcomes were identified. Pre-term PROM (PPROM) had 97 outcomes, and term PROM (TPROM) had 70 outcomes. The classification and order of the core outcome domains of PPROM and TPROM were consistent. The physiological domain was the most common for PPROM and TPROM outcomes. Furthermore, 35.1 and 57.1% outcomes were only reported once in PPROM and TPROM studies, respectively. Thirty pregnant women participated in the semi-structured interviews; 10 outcomes were extracted after normalized, and the outcomes were reported in the systematic review. However, studies rarely reported pregnant women's concerns. There was considerable inconsistency in outcomes selection and reporting in studies about antibiotics in PROM. An initial core outcomes set for antibiotics in PROM was formed.
胎膜早破（PROM）与母婴感染相关。尽管指南建议对胎膜早破的孕妇使用预防性抗生素，但最佳抗生素方案仍存在争议。由于报告结果存在差异，综合不同研究的数据具有挑战性。本研究旨在通过识别所有现有结果和患者观点，形成用于评估胎膜早破抗生素使用的核心结局集（COS）的初始结果列表。通过检索PubMed、EMBASE、Cochrane图书馆、中国知网、万方和维普数据库确定相关研究。我们还筛选了纳入研究的参考文献作为补充检索。我们从文章中提取了基本信息和结果。两名评审员独立选择研究、提取数据、提取结果并将其分组到不同领域。然后，在四川大学华西第二医院基于系统评价收集的潜在因素进行了半结构化访谈。纳入符合胎膜早破诊断标准的孕妇。参与者报告了他们对结局的关注。两名研究人员确定了孕妇的关注点。本系统评价共纳入90项研究。纳入研究的中位结果数为7（1 - 31），共识别出109个不同的独特结果。早产胎膜早破（PPROM）有97个结果，足月胎膜早破（TPROM）有70个结果。PPROM和TPROM核心结局领域的分类和顺序是一致的。生理领域是PPROM和TPROM结果中最常见的。此外，分别有35.1%和57.1%的结果在PPROM和TPROM研究中仅被报告过一次。30名孕妇参与了半结构化访谈；标准化后提取了10个结果，并在系统评价中报告了这些结果。然而，研究很少报告孕妇的关注点。关于胎膜早破抗生素的研究在结果选择和报告方面存在相当大的不一致性。形成了胎膜早破抗生素使用的初始核心结局集。
