Clinical Epidemiology, Hyogo College of Medicine, Nishinomiya, Japan
Department of Data Science, The Institute of Statistical Mathematic, Tachikawa, Japan.
BMJ Open. 2019 Aug 21;9(8):e026924. doi: 10.1136/bmjopen-2018-026924.
Adverse events following the injection (AEFIs) of human papillomavirus vaccine (HPVv) among female adolescents are still a major public health concern.
According to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension statement for systematic reviews incorporating network meta-analyses, all prospective randomised trials will be included. The primary outcome for adverse events is topical pain during the observation period.We will mainly search 17 electronic databases from January 2000 through September 2019 with suitable Medical Subject Headings and text words for PubMed. Two reviewers will independently check the reports at the title/abstract level and identify potentially applicable studies. Then we will obtain their full texts and decide whether to include them based on the same eligible criteria.We will compare HPVv with placebo, HPVv with adjuvant and HPVv with other vaccines. Interstudy heterogeneity, publication biases or small study effects will be evaluated using conventional meta-analysis methods. The consistency of the network will be checked using tests for local and global inconsistency and the side-splitting method. To address the heterogeneity of treatment effects among the studies, we will use the multivariable random effect model.
This pairwise or network meta-analysis does not require ethics approval. The data used here are not individual nor private. We will be able to determine which component of the vaccine induces adverse events, especially topical pain. This systematic review with network meta-analysis will provide valid answers regarding AEFIs for HPVv.
CRD42018109265.
人乳头瘤病毒疫苗（HPVv）接种后不良反应（AEFIs）仍然是一个主要的公共卫生关注点。
根据纳入网络荟萃分析的系统评价首选报告项目扩展声明，所有前瞻性随机试验都将被纳入。主要的不良反应结局是观察期间的局部疼痛。我们将主要在 2000 年 1 月至 2019 年 9 月期间通过 17 个电子数据库进行检索，包括适当的医学主题词和 PubMed 文本词。两名审查员将独立检查标题/摘要级别的报告，并识别潜在适用的研究。然后，我们将获取它们的全文，并根据相同的合格标准决定是否纳入。我们将比较 HPVv 与安慰剂、HPVv 与佐剂和 HPVv 与其他疫苗。使用传统的荟萃分析方法评估研究间异质性、发表偏倚或小样本效应。使用局部和全局不一致性检验和侧部分割法检查网络的一致性。为了解决研究间治疗效果的异质性，我们将使用多变量随机效应模型。
这项两两或网络荟萃分析不需要伦理批准。这里使用的数据不是个体的也不是私人的。我们将能够确定哪种疫苗成分会引起不良反应，特别是局部疼痛。这项针对 HPVv 接种后不良反应的系统评价与网络荟萃分析将为其提供有效的答案。
CRD42018109265。
