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

作者信息

Saldanha Ian J, Lindsley Kristina, Do Diana V, Chuck Roy S, Meyerle Catherine, Jones Leslie S, Coleman Anne L, Jampel Henry D, Dickersin Kay, Virgili Gianni

机构信息

Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Byers Eye Institute, Stanford University School of Medicine, Palo Alto, California.

出版信息

JAMA Ophthalmol. 2017 Sep 1;135(9):933-940. doi: 10.1001/jamaophthalmol.2017.2583.


DOI:10.1001/jamaophthalmol.2017.2583
PMID:28772305
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5625342/
Abstract

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.

摘要

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本文引用的文献

[1]
Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery.

Cochrane Database Syst Rev. 2017-7-3

[2]
Clinical trials and systematic reviews addressing similar interventions for the same condition do not consider similar outcomes to be important: a case study in HIV/AIDS.

J Clin Epidemiol. 2017-4

[3]
Systematic review of outcome domains and instruments used in clinical trials of tinnitus treatments in adults.

Trials. 2016-6-1

[4]
Defining a Minimum Set of Standardized Patient-centered Outcome Measures for Macular Degeneration.

Am J Ophthalmol. 2016-8

[5]
Social network analysis identified central outcomes for core outcome sets using systematic reviews of HIV/AIDS.

J Clin Epidemiol. 2016-2

[6]
A Proposed Minimum Standard Set of Outcome Measures for Cataract Surgery.

JAMA Ophthalmol. 2015-11

[7]
Heterogeneity of primary outcome measures used in clinical trials of treatments for intermediate, posterior, and panuveitis.

Orphanet J Rare Dis. 2015-8-19

[8]
Consensus on Outcome Measures for Glaucoma Effectiveness Trials: Results From a Delphi and Nominal Group Technique Approaches.

J Glaucoma. 2016-6

[9]
Conclusiveness of the Cochrane Eye and Vision Group Reviews.

BMC Res Notes. 2015-6-16

[10]
Patient-reported outcomes in randomised controlled trials on age-related macular degeneration.

Br J Ophthalmol. 2015-11

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