University of New York State-University at Albany School of Public Health, Albany, NY, United States of America.
New York State Department of Health, Albany, NY, United States of America.
PLoS One. 2021 Sep 2;16(9):e0256934. doi: 10.1371/journal.pone.0256934. eCollection 2021.
Chronic kidney disease (CKD) patients are at an extremely high risk of silent myocardial ischemia (SMI). However, there is a dearth of evidence on the worldwide prevalence of this very lethal and yet unrecognizable complication of CKD. The proposed systematic review and meta-analysis aims to estimate the global prevalence of SMI among CKD patients.
This protocol was conceived according to the preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) statement. The systematic review will involve all observational studies and clinical trials published until April 30, 2021, and reporting on the prevalence of SMI in CKD patients. Electronic sources including MEDLINE, Embase, Web of Science, and Cochrane database of systematic reviews will be perused for potentially eligible studies, restricted to only studies published in English or French. Two investigators will independently select studies and use a pre-pilot tested form to extract data. Further, they will independently perform a qualitative assessment of the risk of bias and overall quality of the selected studies, followed by a quantitative assessment using funnel plots and Egger's tests. The heterogeneity between studies will be assessed with the Cochrane's Q statistic, and the I2 statistic will measure the percentage of variation across studies that is due to their heterogeneity rather than chance; the I2 will decide if a meta-analysis can be conducted. In case it cannot be conducted, a descriptive analysis will be performed. Otherwise, study-specific estimates will be pooled using either a fixed-effects or a random-effects model, depending on the value of the I2 statistic. Subgroup and random effects meta-regression analyses will further investigate the potential sources of heterogeneity. Finally, sensitivity analyses will be performed to measure the impact of low-quality studies on the results of the meta-analysis, and power calculations will determine the probability that we will detect a true effect if it does exist.
CRD42020211929.
The intended systematic review and meta-analysis will fill the knowledge gap on the global prevalence of silent myocardial ischemia (SMI) in CKD patients. The eligible studies will be identified through a methodic literature search followed by a rigorous screening process; we will then use robust meta-analysis tools to pool the data and provide reliable estimates of the global prevalence of SMI in CKD patients. Two major limitations could be: the predominance of clinical trials that might limit the generalizability of the findings, given that some informative patients might have been sidelined by the strict inclusion criteria of these studies; the high probability of type 1 error originating from the important number of subgroup and sensitivity analyses.
慢性肾脏病（CKD）患者发生无症状心肌缺血（SMI）的风险极高。然而，目前关于 CKD 这一极其致命但尚未被识别的并发症在全球的流行情况，证据还很缺乏。本系统评价和荟萃分析旨在估计 CKD 患者中 SMI 的全球患病率。
本方案根据系统评价和荟萃分析报告的首选报告项目（PRISMA-P）声明制定。该系统评价将包括截至 2021 年 4 月 30 日发表的所有观察性研究和临床试验，并报告 CKD 患者中 SMI 的患病率。电子资源包括 MEDLINE、Embase、Web of Science 和 Cochrane 系统评价数据库，将对可能符合条件的研究进行检索，仅限于以英文或法文发表的研究。两名研究者将独立选择研究，并使用预试验测试的表格提取数据。此外，他们将独立对所选研究进行风险偏倚的定性评估和整体质量评估，然后使用漏斗图和 Egger 检验进行定量评估。研究间的异质性将用 Cochrane's Q 统计量评估，I2 统计量将衡量研究间变异归因于其异质性而不是偶然因素的百分比；I2 将决定是否可以进行荟萃分析。如果不能进行荟萃分析，则将进行描述性分析。否则，将使用固定效应或随机效应模型汇总研究特异性估计值，具体取决于 I2 统计量的值。亚组和随机效应荟萃回归分析将进一步研究潜在的异质来源。最后，进行敏感性分析以衡量低质量研究对荟萃分析结果的影响，并进行功效计算以确定如果存在真实效果，我们检测到该效果的概率。
PROSPERO 注册号：CRD42020211929。
拟议的系统评价和荟萃分析将填补 CKD 患者无症状心肌缺血（SMI）全球患病率方面的知识空白。通过系统的文献检索和严格的筛选过程确定合格的研究；然后，我们将使用稳健的荟萃分析工具汇总数据，并提供 CKD 患者中 SMI 全球患病率的可靠估计值。两个主要的局限性可能是：临床试验的主导地位可能会限制研究结果的普遍性，因为一些有意义的患者可能因这些研究严格的纳入标准而被排除在外；由于大量的亚组和敏感性分析，存在出现 I 类错误的高概率。
