School of Medicine, University of Missouri, Columbia, Missouri, USA.
Department of Gastroenterology, Central South University Third Xiangya Hospital, Changsha, China.
BMJ Open. 2022 Jun 13;12(6):e059785. doi: 10.1136/bmjopen-2021-059785.
Patients with inflammatory bowel disease (IBD) might be at an increased risk for the development of cardiovascular disease (CVD). The present protocol is developed to review and analyse published data to determine if patients with IBD have an increased CVD burden.
We will conduct a systematic review of all observational studies that examine endothelial function, arterial stiffness and carotid intima-media thickness in patients with IBD. Study selection will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, and study quality will be assessed using the Newcastle-Ottawa Scale. If sufficient data are available, a meta-analysis will be conducted. The overall effect sizes will be estimated using both fixed effects models and random effects models. Statistical heterogeneity will be calculated using Higgin's (I) tests. Subgroup analyses, conditional number of studies retrieved and their sample size, will be stratified according to participant disease category or gender or disease activity.
Formal ethics approval is not required as individual data will not be collected. The results will be disseminated through peer-reviewed publications, conference presentations and scientific news releases.
CRD42021274093.
炎症性肠病(IBD)患者发生心血管疾病(CVD)的风险可能会增加。本方案旨在回顾和分析已发表的数据,以确定 IBD 患者是否存在 CVD 负担增加的情况。
我们将对所有观察性研究进行系统评价,这些研究检查了 IBD 患者的内皮功能、动脉僵硬和颈动脉内膜中层厚度。研究选择将遵循系统评价和荟萃分析的 Preferred Reporting Items 指南,并使用 Newcastle-Ottawa 量表评估研究质量。如果有足够的数据,将进行荟萃分析。使用固定效应模型和随机效应模型估计总体效应大小。使用 Higgin's(I)检验计算统计异质性。根据参与者的疾病类别或性别或疾病活动度进行亚组分析、检索的研究数量及其样本量分层。
由于不收集个人数据,因此不需要正式的伦理批准。研究结果将通过同行评审的出版物、会议演讲和科学新闻发布进行传播。
PROSPERO 注册号:CRD42021274093。