EGPS/OHTS Collaborative Analysis

描述(由申请人提供)：我们提出了一项基于迄今为止两个最大的随机试验的个体患者数据的荟萃分析，该试验评估了药物治疗在延缓或预防高眼压患者原发性开角型青光眼发病方面的效果。欧洲青光眼预防研究(EGPS)随机选择了1077名参与者，眼压治疗研究(OHTS)随机选择了1636名参与者。OHTS和EGPS在研究设计和测量方案上有相似之处，包括集中掩蔽随机化、LOP测量、角膜厚度测量、POAG的确定以及异常原因的特定归因。EGPS和OHTS参与者的基线临床特征也相似。汇集的EGPS和OHTS数据集将包括来自2,713名OH参与者的数据，这些参与者的中位数随访时间超过5年，超过245个POAG终点。汇集的样本将提供统计能力来检验假设，而这些假设可能不可能仅用一个数据集来检验。研究设计和基线参与者特征方面的相似之处表明，汇集分析将具有很高的生产力。这种合作不会干扰每项研究分析自己数据集的能力。拟议的荟萃分析的具体目标是： 1.提高已知的POAG危险因素如年龄、LOP、杯盘比和中央角膜厚度的风险系数的精确度，并评估其他可能的危险因素如性别、高血压、低血压、心脏病和糖尿病是否应包括在危险模型中。 2.根据基线协变量进行调整，以确定药物组和观察组/安慰剂组在不同LOP水平下发生POAG(危险比)的风险--即，如果接受药物治疗的患者LOP为18毫米汞与21毫米汞，预后有何差异。 3.确定一过性视野缺陷对POAG发生的预测准确性。 4.确定基线HRT指标预测POAG的准确性或随访期间这些指标的变化。 EGPS和OHTS的指导委员会、全面调查小组以及数据和安全监测委员会已经批准了合作分析。一个联合委员会将负责执行这项研究，监督分析，并编写专题介绍和出版物。

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.