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4种最常见的眼部疾病的临床试验和系统回顾结果的比较

Saldanha, I.J., Lindsley, K., Do, D.V., et al.

期刊名称:JAMA Ophthalmology

卷期:2017年第135卷第9期

关键词:
眼部 常见 疾病

摘要

摘要:重要性:临床试验和系统评价报告的预后中次优重叠有利于比较和总结这些研究结果。目的:旨在检查试验和4种最常见眼病(年龄相关黄斑变性[AMD],白内障,糖尿病性视网膜病变(DR)和青光眼))综述的最常见预后以及综述与试验预后中重叠部分。设计,设置和研究对象:这项横断面研究检查了所有解决AMD,白内障,DR和青光眼,且在2016720日发表的并且至少包括1项试验的Cochrane综述。对于每种疾病,由两名临床专家独立分类所有预后并解决偏差。之后分别比较每种疾病的预后。主要预后指标:报告综述预后比例。结果:本研究包括56项综述,共414项试验。虽然每项试验和每项综述的预后中位数与每种疾病相同(n = 5),但是试验所包含的预后指标数量比综述多,范围从2.9倍(青光眼8930)至4.9倍(AMD 10722)。试验中报告的预后指标从19项中有14项(73.7%)(DR)至29项中有27项(93.1%)(白内障)不等。然而,对于试验预后,综述中的比例较低,从107项预后中的19项(17.8%)(AMD)到89项预后的24项(27.0%)(青光眼)不等。在一半以上的试验和综述中,只有一项预后(视力)在一直报道。结论和意义:尽管大多数综述预后已在试验中报告,但大多数试验预后未在综述中报告。目前的分析侧重于预后领域,这可能会低估结果不一致的问题。即使重叠,其他重要元素的预后(即特定测量,特定度量,聚合方法和时间点)也可能不同。试验结果的不一致可能会阻碍研究综合,并指出对眼科疾病特异性核心预后的需求。

Importance:Suboptimal overlap in outcomes reported in clinical trials and systematic reviews compromises efforts to compare and summarize results across these studies.Objectives:To examine the most frequent outcomes used in trials and reviews of the 4 most prevalent eye diseases (age-related macular degeneration [AMD], cataract, diabetic retinopathy [DR], and glaucoma) and the overlap between outcomes in the reviews and the trials included in the reviews.Design, Setting, and Participants:This cross-sectional study examined all Cochrane reviews that addressed AMD, cataract, DR, and glaucoma; were published as of July 20, 2016; and included at least 1 trial and the trials included in the reviews. For each disease, a pair of clinical experts independently classified all outcomes and resolved discrepancies. Outcomes (outcome domains) were then compared separately for each disease.Main Outcomes and Measures:Proportion of review outcomes also reported in trials and vice versa.Results:This study included 56 reviews that comprised 414 trials. Although the median number of outcomes per trial and per review was the same (n = 5) for each disease, the trials included a greater number of outcomes overall than did the reviews, ranging from 2.9 times greater (89 vs 30 outcomes for glaucoma) to 4.9 times greater (107 vs 22 outcomes for AMD). Most review outcomes, ranging from 14 of 19 outcomes (73.7%) (for DR) to 27 of 29 outcomes (93.1%) (for cataract), were also reported in the trials. For trial outcomes, however, the proportion also named in reviews was low, ranging from 19 of 107 outcomes (17.8%) (for AMD) to 24 of 89 outcomes (27.0%) (for glaucoma). Only 1 outcome (visual acuity) was consistently reported in greater than half the trials and greater than half the reviews.Conclusions and Relevance:Although most review outcomes were reported in the trials, most trial outcomes were not reported in the reviews. The current analysis focused on outcome domains, which might underestimate the problem of inconsistent outcomes. Other important elements of an outcome (ie, specific measurement, specific metric, method of aggregation, and time points) might have differed even though the domains overlapped. Inconsistency in trial outcomes may impede research synthesis and indicates the need for disease-specific core outcome sets in ophthalmology.


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