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[大学生论坛]:4类最流行眼病

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Nicole 发表于 2017-12-31 20:36:51 | 显示全部楼层 |阅读模式

Comparison of Clinical Trial and Systematic Review Outcomes for the 4 Most Prevalent Eye Diseases

4类最流行眼病之临床试验与系统评价结果比较


Ian J. Saldanha, MBBS, MPH, PhD1; Kristina Lindsley, MS1; Diana V. Do, MD2; et al

JAMA Ophthalmol. Published online August 3, 2017. doi:10.1001/jamaophthalmol.2017.2583

Key Points
要点

Question  For the 4 most prevalent eye diseases (age-related macular degeneration, cataract, diabetic retinopathy, and glaucoma), what is the overlap between outcomes named in Cochrane reviews and outcomes reported in the trials included in the reviews?
问题 对于4类最流行的眼病(老年性黄斑变性、白内障、糖尿病性视网膜病变及青光眼),考克兰系统评价的结果与该系统评价中的试验结果有何重叠?

Findings  In this cross-sectional study, for each disease the trials included a considerably greater number of outcomes than did the reviews, ranging from 2.9 times greater (glaucoma) to 4.9 times greater (cataract). Although most review outcomes were reported in the trials, most trial outcomes were not reported in the reviews.
发现 在此项横断面研究中,每种眼病的临床试验结果远多于其系统评价结果,多出的数量范围为2.9倍(青光眼)至4.9倍(白内障)。尽管试验报告中包含大多数的系统评价结果,但大多数的实验结果并没有在系统评价中出现。

Meaning  Inconsistency in trial outcomes impedes research synthesis efforts and indicates the need for disease-specific core outcome sets in ophthalmology.
意义 临床试验结果的矛盾性会对研究综述产生阻碍,也表明眼科领域需要有针对特定疾病的核心成果集。

Abstract
摘要

Importance  Suboptimal overlap in outcomes reported in clinical trials and systematic reviews compromises efforts to compare and summarize results across these studies.
重要性 临床试验结果与系统评价结果的次优重叠弱化了比较和概括这些研究结果的效果。

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.
目的 检验针对4类最流行眼病(老年性黄斑变性 (AMD)、白内障、糖尿病性视网膜病变 (DR) 及青光眼)的临床试验与系统评价中最频繁出现的结果,以及系统评价结果与系统评价中临床试验结果的重叠部分。

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.
设计、设置及参与者 此项横断面研究检验了所有针对老年性黄斑变性、白内障、糖尿病性视网膜病变及青光眼的考克兰系统评价;这些系统评价的发表日期截至2016年7月20日;包括至少一项临床试验及系统评价中的所有试验。两位临床专家各自对每种眼病的全部结果进行分类并解决分歧。随后,对分别每种眼病的结果(结果域)进行比较。

Main Outcomes and Measures  Proportion of review outcomes also reported in trials and vice versa.
主要成果及测量 试验结果中出现系统评价结果的比例以及系统评价结果中出现试验结果的比例。

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.
结果 本项研究包含56项系统评价,其中包括414项临床试验。尽管每种眼病的每项临床试验与每项系统评价结果的中位数相同(n=5),其临床试验结果总体上多于系统评价结果,多出的数量范围为2.9倍(青光眼结果89比30)至4.9倍(老年性黄斑变性 (AMD) 结果107比22)。大多数系统评价结果,比重范围为糖尿病性视网膜病变总结果的14/19(73.7%)至白内障总结果的27/29(93.1%),在临床试验结果中也有出现。然而,临床试验结果同样出现在系统评价结果中的比例小,比重范围为老年性黄斑变性 (AMD) 总结果的19/107(17.8%)至青光眼总结果的24/89(27.0%)。只有1项结果(视敏度)在临床试验及系统评价中相应出现的数量了超过一半。

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.
结论及现实意义 尽管大多数的系统评价结果有在临床试验结果中出现,大多数的临床试验结果并没有出现在系统评价结果中。目前的分析主要针对结果域,这可能会低估结果不一致导致的问题。即使结果域有重叠的部分,结果中包含的其它因素(如,具体测量、具体度量、汇总方法及时间点)也可能有所不同。临床试验结果的矛盾性会对研究综述产生阻碍,也表明眼科领域需要有针对特定疾病的核心成果集。


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