Kirthi Varo, Nderitu Paul, Alam Uazman, Evans Jennifer, Nevitt Sarah, Malik Rayaz A, Jackson Timothy L
Faculty of Life Sciences and Medicine, King's College London, London, UK
Ophthalmology Research Unit, King's College Hospital NHS Foundation Trust, London, UK.
BMJ Open. 2021 Jan 7;11(1):e040997. doi: 10.1136/bmjopen-2020-040997.
There is growing evidence of a higher than expected prevalence of retinopathy in prediabetes. This paper presents the protocol of a systematic review and meta-analysis of retinopathy in prediabetes. The aim of the review is to estimate the prevalence of retinopathy in prediabetes and to summarise the current data.
This protocol is developed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines. A comprehensive electronic bibliographic search will be conducted in MEDLINE, EMBASE, Web of Science, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Google Scholar and the Cochrane Library. Eligible studies will report prevalence data for retinopathy on fundus photography in adults with prediabetes. No time restrictions will be placed on the date of publication. Screening for eligible studies and data extraction will be conducted by two reviewers independently, using predefined inclusion criteria and prepiloted data extraction forms. Disagreements between the reviewers will be resolved by discussion, and if required, a third (senior) reviewer will arbitrate.The primary outcome is the prevalence of any standard features of diabetic retinopathy (DR) on fundus photography, as per International Clinical Diabetic Retinopathy Severity Scale (ICDRSS) classification. Secondary outcomes are the prevalence of (1) any retinal microvascular abnormalities on fundus photography that are not standard features of DR as per ICDRSS classification and (2) any macular microvascular abnormalities on fundus photography, including but not limited to the presence of macular exudates, microaneurysms and haemorrhages. Risk of bias for included studies will be assessed using a validated risk of bias tool for prevalence studies. Pooled estimates for the prespecified outcomes of interest will be calculated using random effects meta-analytic techniques. Heterogeneity will be assessed using the I statistic.
Ethical approval is not required as this is a protocol for a systematic review and no primary data are to be collected. Findings will be disseminated through peer-reviewed publications and presentations at national and international meetings including Diabetes UK, European Association for the Study of Diabetes, American Diabetes Association and International Diabetes Federation conferences.
CRD42020184820.
越来越多的证据表明，糖尿病前期视网膜病变的患病率高于预期。本文介绍了一项关于糖尿病前期视网膜病变的系统评价和荟萃分析方案。该评价的目的是估计糖尿病前期视网膜病变的患病率并总结当前数据。
本方案是根据系统评价和荟萃分析方案的首选报告项目（PRISMA-P）指南制定的。将在MEDLINE、EMBASE、科学网、护理及相关健康文献累积索引（CINAHL）、谷歌学术和考克兰图书馆进行全面的电子文献检索。符合条件的研究将报告糖尿病前期成年人眼底摄影中视网膜病变的患病率数据。对发表日期不设时间限制。将由两名审阅者独立使用预先定义的纳入标准和预先试用的数据提取表对符合条件的研究进行筛选和数据提取。审阅者之间的分歧将通过讨论解决，如有需要，将由第三位（资深）审阅者进行仲裁。主要结局是根据国际临床糖尿病视网膜病变严重程度量表（ICDRSS）分类，眼底摄影中糖尿病视网膜病变（DR）任何标准特征的患病率。次要结局是（1）眼底摄影中任何不属于ICDRSS分类中DR标准特征的视网膜微血管异常的患病率，以及（2）眼底摄影中任何黄斑微血管异常的患病率，包括但不限于黄斑渗出、微动脉瘤和出血的存在。将使用经过验证的患病率研究偏倚风险工具评估纳入研究的偏倚风险。将使用随机效应荟萃分析技术计算预先指定的感兴趣结局的合并估计值。将使用I统计量评估异质性。
由于这是一项系统评价方案且不收集原始数据，因此无需伦理批准。研究结果将通过同行评审出版物以及在包括英国糖尿病协会、欧洲糖尿病研究协会、美国糖尿病协会和国际糖尿病联合会会议在内的国内和国际会议上的报告进行传播。
PROSPERO注册号：CRD42020184820。
