Fung Anne E, Palanki Ram, Bakri Sophie J, Depperschmidt Eric, Gibson Andrea
Pacific Eye Associates, California Pacific Medical Center, San Francisco, California 94115, USA.
Ophthalmology. 2009 Feb;116(2):286-96. doi: 10.1016/j.ophtha.2008.09.014. Epub 2008 Dec 16.
To evaluate the quality of reporting in the neovascular age-related macular degeneration (nvAMD) literature by applying the Consolidated Standards for Reporting Trials (CONSORT) and Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement writing standards.
CONSORT and STROBE impact analysis; literature review.
Phase III randomized controlled trials (RCTs) of verteporfin photodynamic therapy, pegaptanib, and ranibizumab, and interventional case studies of bevacizumab for nvAMD.
A literature search identified eligible articles published before October 31, 2007. We assessed the report quality of Phase III RCTs using the CONSORT statement and case series publications using the STROBE statement, both with indicators relevant to nvAMD.
Presence or absence of CONSORT or STROBE statement indicators.
Seven publications of Phase III RCTs and 29 publications on bevacizumab interventional case studies for nvAMD met our inclusion criteria. Of 37 possible CONSORT writing guideline items, the mean report quality for RCTs was 30.6 (83%), with a range from 23 to 35 (65%-95%). Of 35 possible STROBE writing guideline items, the mean report quality grade for intravitreal bevacizumab case series was 23 (70%), with a range from 16 to 31 (46%-94%). Among the bevacizumab studies, more than 90% reported scientific background, drug dose and administration, baseline characteristics, unadjusted results, and adverse events. Fewer than 20% reported study size calculations, handling of missing data, or a discussion of bias.
Since the adoption of the CONSORT standards by Ophthalmology and other journals in 1996, the reporting quality for RCTs has further improved among this cohort of nvAMD articles. On the other hand, no reporting standards for case series have existed until the recent publication of the STROBE statement. In this first application of the STROBE standards to ophthalmology, we found that the small interventional studies in our series had an average reporting score lower than the RCTs, but also that some individual scores were higher than the RCTs. This outcome demonstrates that good, useful articles can be written about small studies. Although not a direct measure of the quality of a study, good reporting allows a reader to assess the validity and applicability of the study's findings.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
通过应用《试验报告统一标准》（CONSORT）和《加强流行病学观察性研究报告规范》（STROBE）声明写作标准，评估新生血管性年龄相关性黄斑变性（nvAMD）文献的报告质量。
CONSORT和STROBE影响分析；文献综述。
维替泊芬光动力疗法、培加他汀和兰尼单抗的III期随机对照试验（RCT），以及贝伐单抗治疗nvAMD的介入性病例研究。
文献检索确定了2007年10月31日前发表的符合条件的文章。我们使用CONSORT声明评估III期RCT的报告质量，使用STROBE声明评估病例系列出版物的报告质量，两者均采用与nvAMD相关的指标。
CONSORT或STROBE声明指标的有无。
7篇III期RCT出版物和29篇关于贝伐单抗治疗nvAMD的介入性病例研究出版物符合我们的纳入标准。在37项可能的CONSORT写作指南项目中，RCT的平均报告质量为30.6（83%），范围为23至35（65%-95%）。在35项可能的STROBE写作指南项目中，玻璃体内注射贝伐单抗病例系列的平均报告质量等级为23（70%），范围为16至31（46%-94%）。在贝伐单抗研究中，超过90%的研究报告了科学背景、药物剂量和给药方式、基线特征、未调整结果和不良事件。报告研究规模计算、缺失数据处理或偏倚讨论的研究不到20%。
自1996年眼科学和其他期刊采用CONSORT标准以来，在这组nvAMD文章中，RCT的报告质量有了进一步提高。另一方面，在STROBE声明最近发表之前，病例系列没有报告标准。在STROBE标准首次应用于眼科学时，我们发现我们系列中的小型介入性研究的平均报告得分低于RCT，但也有一些个体得分高于RCT。这一结果表明，可以写出关于小型研究的优秀、有用的文章。虽然不是对研究质量的直接衡量，但良好的报告能让读者评估研究结果的有效性和适用性。
专有或商业披露可在参考文献之后找到。
