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资金来源对玻璃体内黄斑牵引和黄斑裂孔的奥克纤溶酶治疗研究中“倾向性报告”的影响。

Effect of Funding Source on "Spin" in Studies of Ocriplasmin Therapy for Vitreomacular Traction and Macular Hole.

作者信息

Hubschman Sasha, Venincasa Michael J, Kuriyan Ajay E, Sridhar Jayanth

机构信息

Department of Ophthalmology, Bascom Palmer Eye Institute, Miller School of Medicine, University of Miami, Miami, FL, USA.

Department of Ophthalmology, Flaum Eye Institute, University of Rochester Medical Center, Rochester, NY, USA.

出版信息

Clin Ophthalmol. 2020 Jan 13;14:81-88. doi: 10.2147/OPTH.S233816. eCollection 2020.

Abstract

PURPOSE

To examine the relationship between industry funding and "spin" in randomized controlled trials (RCTs) and meta-analyses investigating use of ocriplasmin for patients with vitreomacular traction (VMT) and macular hole (MH).

METHODS

In this study, we examined all PubMed and Ovid MEDLINE RCTs and meta-analyses published in journals with impact factor ≥2 investigating effectiveness of ocriplasmin use for VMT and MH. The main outcome measure was correspondence between the studies' main statistical outcome and their abstract conclusion wording. Each article was reviewed by three independent observers and was evaluated for source of funding, industry co-authorship, study methodology, statistical significance of main outcome measure, correspondence between results of main outcome measure and abstract conclusion, and journal impact factor. Funding was determined by public disclosure. Discrepancies were resolved by consensus.

RESULTS

Twelve studies met inclusion criteria, of which 11 were industry funded and 1 was non-industry funded; 11 (91.67%) showed correspondence between outcome and abstract conclusion, without difference between industry-funded and non-industry funded publications or between publications in journals with high impact factor (≥3) versus low impact factor (≥2 and <3).

CONCLUSION

In RCTs and meta-analyses of ocriplasmin for VMT and MH, our results suggest that neither industry funding nor journal impact factor affected the rate of "spin" in study conclusions. This study helps physicians understand what challenges they face when learning about a newer, less-established drug.

摘要

目的

探讨在随机对照试验(RCT)以及关于玻璃体内黄斑牵引(VMT)和黄斑裂孔(MH)患者使用奥克纤溶酶的荟萃分析中,行业资助与“倾向性”之间的关系。

方法

在本研究中,我们检索了发表于影响因子≥2的期刊上的所有PubMed和Ovid MEDLINE数据库中的RCT以及荟萃分析,这些研究探讨了奥克纤溶酶用于VMT和MH的有效性。主要结局指标是研究的主要统计结果与其摘要结论措辞之间的一致性。每篇文章由三位独立观察者进行审阅,并评估其资金来源、行业共同作者身份、研究方法、主要结局指标的统计学显著性、主要结局指标结果与摘要结论之间的一致性以及期刊影响因子。资金来源通过公开披露确定。分歧通过协商解决。

结果

12项研究符合纳入标准,其中11项由行业资助,1项由非行业资助;11项(91.67%)的结局与摘要结论一致,行业资助和非行业资助的出版物之间,以及高影响因子(≥3)与低影响因子(≥2且<3)期刊上的出版物之间均无差异。

结论

在关于奥克纤溶酶用于VMT和MH的RCT和荟萃分析中,我们的结果表明,行业资助和期刊影响因子均未影响研究结论中的“倾向性”发生率。本研究有助于医生了解在了解一种较新的、尚未广泛应用的药物时所面临的挑战。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a970/6968818/02e6be4212a1/OPTH-14-81-g0001.jpg

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