Search

The objective of this systematic review is to identify how reporting of micro-invasive glaucoma surgery (MIGS) procedure complications are reported in randomised controlled trials (RCTs) and the quality of this reporting compared to the CONSORT extension for harms. RCTs evaluating MIGS procedures were identified from a database of systematic reviews and from recent literature. Trials were evaluated in comparison to the CONSORT extension for harms to quantify the quality of harms reporting. Simple descriptive statistics were calculated for the CONSORT checklist. 21 trials were identified as eligible for inclusion, 14 were evaluating iStent, one Trabectome, three Hydrus, one Cypass, one Preseflo MicroShunt and one Excimer laser trabeculotomy. The average number of CONSORT for Harms checklist items fulfilled by the studies was 10 out of 16. No studies used a validated instrument to report severity of harms and only 4 had a list or definition of adverse events. An analysis of harm was conducted by 19 of 21 studies (90%). Appropriate metrics were used for reporting rates of adverse events in 19 of 21 studies but in only 4 studies was there an attempt to give these adverse events a grade of seriousness. In conclusion, most studies evaluating MIGS procedures do make an effort to acknowledge harms data, however this is not done uniformly well or in the same manner. A validated instrument to report severity and a standard list of complications for MIGS surgery would go a long way to helping this.摘要: 本系统综述的目的是发现在随机对照试验 (RCT) 中如何报告微创青光眼手术 (MIGS) 的并发症, 以及对比该报告与随机对照临床试验报告规范 (CONSORT) 损害扩展声明的质量。评估MIGS的RCT来自于最近文献及系统性综述数据库。与CONSORT损害扩展声明相比, 我们对试验进行了评估, 以量化损害报告的质量。用CONSORT检查表计算简单的描述性统计。21项临床试验符合纳入条件, 其中14项临床研究评估了iStent、一项小梁消融术、三项Hydrus微型支架、一项CyPass微型支架、一项Preseflo MicroShunt (一种青光眼引流器) 和一项准分子激光小梁切开术。本研究完成的CONSORT损害检查表的平均数量为10/16。没有研究使用经验证的工具报告损害的严重程度, 只有4项研究有不良事件的列表或定义。21项研究中的19项 (90%) 进行了损害分析。21项研究中的19项 (90%) 进行了危害分析。21项研究中有19项使用了适当的指标来报告不良事件的发生率, 但只有4项研究试图对这些不良事件的严重性进行分级。总之, 大多数评估MIGS程序的研究尽量引用了损害数据, 但这并不是以统一或相同的方式完成的。一个验证性的工具报告MIGS手术的严重程度和标准并发症的列表将会对其有长期的帮助。.