Mathew David J, McKay Bryon R, Basilious Alfred, Belkin Avner, Trope Graham E, Buys Yvonne M
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.
Department of Ophthalmology and Vision Sciences, University of Toronto, Toronto, Canada.
Ophthalmol Glaucoma. 2019 Mar-Apr;2(2):78-85. doi: 10.1016/j.ogla.2019.01.007. Epub 2019 Jan 28.
To determine how well microinvasive glaucoma surgical (MIGS) trials conform to the World Glaucoma Association (WGA) guidelines. Lack of well-designed MIGS studies hinders meaningful evaluation of these technologies.
Cross-sectional literature survey.
Using a predefined search strategy, the following databases were searched for comparative trials involving MIGS in the English peer-reviewed literature from January 1, 2000, through June 21, 2018: Medline, EMBASE, BIOSIS, Cochrane, and Web of Science. From the WGA guidelines, 53 outcomes were selected for evaluation: methodology (n = 31), definition of success (n = 7), ethics (n = 10), postoperative complications (n = 1), economic evaluation (n = 1), and statistical reporting (n = 3). Each article was assessed by 2 reviewers; differences were resolved by consensus.
Twenty-five eligible publications were identified: 10 randomized controlled trials (RCTs) and 15 nonrandomized comparative trials (non-RCTs). The mean follow-up was 19.9±11.6 months (range, 6-48 months). The mean number of outcomes adhering to the WGA guidelines of the 53 evaluated was 24.2±6.1 (45.6% compliance): 28.0±6.2 (52.8%) and 21.6±4.7 (40.8%) for RCTs and non-RCTs, respectively (P = 0.01). Mean percent compliance for each subsection were: methodology, 48.8%; definition of success, 21.1%; ethics, 55.6%; postoperative complications, 88%; economic evaluation, 0%; and statistical reporting, 37.3%. In 16 studies (64%), at least 1 author reported an association with the industry. Thirty-two percent of studies reported an author being a shareholder. Twenty-four percent of studies had an industry employee author. The primary intraocular pressure (IOP) end point was defined as both an upper limit and percentage reduction in only 4 studies (16%; 1 RCT, 3 non-RCTs). An IOP-based survival curve was provided in 7 studies (28%; none of the RCTs). Two studies (8%) included an IOP scatterplot. Twelve studies (48%) reported 95% confidence intervals. Only 4 studies (16%) used the mean of 3 diurnal IOP readings as the baseline IOP.
Published comparative MIGS trials show low adherence (45.6%) to the WGA guidelines. Development of standardized methodology and outcomes could enhance interpretation and transparency of study results and facilitate comparisons between trials. Authors and journals should be encouraged to follow the WGA guidelines.
确定微创青光眼手术（MIGS）试验符合世界青光眼协会（WGA）指南的程度。缺乏精心设计的MIGS研究阻碍了对这些技术进行有意义的评估。
横断面文献调查。
采用预定义的检索策略，在以下数据库中检索2000年1月1日至2018年6月21日期间英文同行评审文献中涉及MIGS的比较试验：医学文献数据库（Medline）、荷兰医学文摘数据库（EMBASE）、生物学文摘数据库（BIOSIS）、考科蓝图书馆（Cochrane）和科学引文索引数据库（Web of Science）。从WGA指南中选择53项结果进行评估：方法学（n = 31）、成功的定义（n = 7）、伦理学（n = 10）、术后并发症（n = 1）、经济评估（n = 1）和统计报告（n = 3）。每篇文章由2名评审员评估；分歧通过共识解决。
确定了25篇符合条件的出版物：10项随机对照试验（RCT）和15项非随机对照试验（非RCT）。平均随访时间为19.9±11.6个月（范围6 - 48个月）。在评估的53项结果中，符合WGA指南的平均结果数量为24.2±6.1（符合率45.6%）：RCT和非RCT分别为28.0±6.2（52.8%）和21.6±4.7（40.8%）（P = 0.01）。每个子部分的平均符合百分比为：方法学，48.8%；成功的定义，21.1%；伦理学，55.6%；术后并发症（88%）；经济评估，0%；统计报告，37.3%。在16项研究（64%）中，至少有1位作者报告与行业有关联。32%的研究报告有作者为股东。24%的研究有行业雇员作者。仅在4项研究（16%；1项RCT，3项非RCT）中将主要眼压（IOP）终点定义为上限和降低百分比。7项研究（28%）提供了基于IOP的生存曲线（RCT中均无）。2项研究（8%）纳入了IOP散点图。12项研究（48%）报告了95%置信区间。仅4项研究（16%）将3次日间IOP读数的平均值用作基线IOP。
已发表的MIGS比较试验对WGA指南的遵循率较低（45.6%）。制定标准化的方法和结果可提高研究结果的解释性和透明度，并便于试验间的比较。应鼓励作者和期刊遵循WGA指南。
