EGPS/OHTS Collaborative Analysis

描述（由申请人提供）：我们提出了一项荟萃分析，该分析基于迄今为止两项最大的随机试验的个体患者数据，这些试验评价了药物治疗在延迟或预防高眼压患者原发性开角型青光眼发作方面的疗效。欧洲青光眼预防研究（EGPS）随机分配了1,077名参与者，高眼压治疗研究（OHTS）随机分配了1,636名参与者。 OHTS和EGPS在研究设计和测量方案方面具有相似性，包括集中盲法随机化、IOP测量、角膜厚度测量、POAG的确定和异常的原因特异性归因。 EGPS和OHTS参与者的基线临床特征也相似。 汇总的EGPS和OHTS数据集将包括来自2，713名OH参与者的数据，中位随访时间超过5年，POAG终点超过245个。 合并样本将提供统计功效，以检验单独使用一个数据集可能无法实现的假设。 研究设计和基线受试者特征的相似性表明，汇总分析将是高效的。 这种合作不会干扰每个研究分析自己数据集的能力。 拟定荟萃分析的具体目的是： 1.提高已知的POAG风险因素（例如年龄、IOP、杯/盘比和中央角膜厚度）的风险系数的精确度，并评估其他推定的风险因素（例如性别、高血压、低血压、心脏病和糖尿病）是否应包括在风险模型中。 2.确定药物组和观察组/安慰剂组在随访期间不同lOP水平下发生POAG的风险（风险比），调整基线协变量-即，如果一个病人在药物治疗中达到18和21 mm Hg的IOP，那么预后有什么不同。 3.确定POAG随访期间一过性视野缺损的预测准确性。 4.确定基线HRT指标或随访期间这些指标变化对POAG发展的预测准确性。 EGPS和OHTS的指导委员会、全面调查组以及数据和安全性监测委员会已批准了合作分析。 一个联合委员会将负责执行这项研究，监督分析工作，并编写报告和出版物。

DESCRIPTION (provided by applicant): We propose a meta-analysis based on individual patient data from the two largest randomized trials to date that evaluate the efficacy of medical treatment in delaying or preventing the onset of primary open angle glaucoma in ocular hypertensive individuals. The European Glaucoma Prevention Study (EGPS) randomized 1,077 participants and the Ocular Hypertension Treatment Study (OHTS) randomized 1,636 participants. OHTS and EGPS share similarities in study design and measurement protocols including centralized masked randomization, lOP measurement, corneal thickness measurement, ascertainment of POAG, and cause-specific attribution of abnormality. Baseline clinical characteristics of the EGPS and OHTS participants are also similar. The pooled EGPS and OHTS datasets will include data from 2,713 OH participants with a median follow-up of more than 5 years and over 245 POAG endpoints. The pooled sample will provide statistical power to test hypotheses that might not be possible with one dataset alone. Similarities in study design and baseline participant characteristics suggest that pooled analyses will be highly productive. This collaboration will not interfere with each study's ability to analyze its own dataset. The Specific Aims of the proposed meta-analyses are: 1. To improve the precision of risk coefficients for known risk factors for developing POAG such as age, lOP, cup/disc ratio and central corneal thickness and to assess whether other putative risk factors such as gender, high blood pressure, low blood pressure, heart disease and diabetes should be included in the risk model. 2. To determine the risk of developing POAG (hazard ratio) at different levels of lOP over follow-up in both the medication and observation/placebo groups adjusting for baseline covariates - i.e., what is the difference in prognosis if a patient on medication achieves an lOP of 18 versus 21 mm Hg. 3. To determine the predictive accuracy of transient visual field defects during follow-up for developing POAG. 4. To determine the predictive accuracy of baseline HRT indices or changes in these indices during follow-up for developing POAG. The Steering Committees, Full Investigative Groups and Data and Safety Monitoring Committees of the EGPS and OHTS have approved the collaborative analyses. A Joint Committee will be responsible for implementing the study, overseeing the analyses and preparing presentations and publications.