Department of Data Science, University of Mississippi Medical Center, Jackson.
Division of Biostatistics, Department of Public Health Sciences, University of Miami, Miami, Florida.
JAMA Ophthalmol. 2021 Feb 1;139(2):191-197. doi: 10.1001/jamaophthalmol.2020.5743.
A new analytic method can evaluate factors of interest associated with graft failure after Descemet stripping automated endothelial keratoplasty (DSAEK) or more generally in any ophthalmic surgical setting with a time-to-event outcome.
To reanalyze types of intraoperative complications associated with DSAEK graft failure in the Cornea Preservation Time Study using random survival forests.
DESIGN, SETTING, AND PARTICIPANTS: This cohort study, initially conceived in April 2019, used a prediction model to conduct a post hoc secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. The study included 1090 participants, representing 1330 eyes, undergoing DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic or aphakic corneal edema (75 eyes [5.6%]). Enrollment occurred between April 16, 2012, and February 20, 2014, and follow-up ended June 5, 2017. Statistical analysis was performed from July 10, 2019, to May 29, 2020.
Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with preservation time of 7 days or less or 8 to 14 days.
Ranked variable importance for intraoperative complications among 50 donor, recipient, and eye bank variables and restricted mean survival time through 47 months (1434 days) after DSAEK were examined. Random survival forests, a nonparametric method (with less restrictive model assumptions) that is far more flexible in its ability to model nonlinear effects and interactions, was used to analyze the data.
This study included 1090 participants (663 women [60.8%]; median age, 70 years [range, 42-90 years]), representing 1330 eyes. Random survival forests ranked a DSAEK intraoperative complication as the third most predictive factor of graft failure, after surgeon and eye bank, in the final model with 5 predictors. In the first 47 months after DSAEK, the estimated mean difference in restricted mean survival time for grafts that experienced a DSAEK intraoperative complication vs those that did not was -227 days (99% CI, -352 to -70 days) based on the final RSF model.
These findings, while post hoc, support the hypothesis that random survival forests allow for an improved analytic approach for identifying factors predictive of graft failure and for obtaining adjusted graft survival estimates. Random survival forests offer the opportunity to guide the development of future population-based cohort ophthalmic surgical studies, establishing definitive factors for procedural success.
一种新的分析方法可以评估与 Descemet 剥离自动角膜内皮移植术（DSAEK）或更一般地说在任何具有时间事件结果的眼科手术环境中与移植物失败相关的感兴趣因素。
使用随机生存森林重新分析角膜保存时间研究中与 DSAEK 移植物失败相关的术中并发症类型。
设计、地点和参与者：这项队列研究最初于 2019 年 4 月构思，使用预测模型对多中心、双盲、随机临床试验中收集的数据进行事后二次分析。43 个美国临床地点的 70 名外科医生参与了该研究，供体角膜由 23 个美国眼库提供。该研究包括 1090 名参与者，代表 1330 只眼睛，接受 DSAEK 治疗 Fuchs 营养不良（1255 只眼睛[94.4%]）或假性或无晶状体角膜水肿（75 只眼睛[5.6%]）。招募发生在 2012 年 4 月 16 日至 2014 年 2 月 20 日之间，随访于 2017 年 6 月 5 日结束。统计分析于 2019 年 7 月 10 日至 2020 年 5 月 29 日进行。
Descemet 剥离自动角膜内皮移植术，供体角膜随机分配保存时间为 7 天或更短或 8 至 14 天。
在 50 个供体、受者和眼库变量中，对术中并发症的排名重要性进行了检查，并通过 DSAEK 后 47 个月（1434 天）的受限平均生存时间进行了检查。随机生存森林是一种非参数方法（具有更少的限制性模型假设），它在模拟非线性效应和交互作用方面具有更大的灵活性，用于分析数据。
这项研究包括 1090 名参与者（663 名女性[60.8%]；中位年龄为 70 岁[范围为 42-90 岁]），代表 1330 只眼睛。随机生存森林将 DSAEK 术中并发症列为继外科医生和眼库之后，预测移植物失败的第三个最重要因素，在最终包含 5 个预测因素的模型中。在 DSAEK 后最初的 47 个月内，基于最终 RSF 模型，经历 DSAEK 术中并发症的移植物与未经历的移植物的受限平均生存时间的估计平均差异为 -227 天（99%CI，-352 至-70 天）。
这些发现虽然是事后的，但支持了随机生存森林可以为识别与移植物失败相关的预测因素和获得调整后的移植物生存估计提供改进的分析方法的假设。随机生存森林为指导未来基于人群的眼科手术研究的发展提供了机会，为手术成功确立了明确的因素。
