Nithianandan Harrish, Kuriyan Ajay E, Venincasa Michael J, Sridhar Jayanth
Department of Ophthalmology & Visual Sciences, McGill University, Montreal, Quebec, Canada.
Retina Service, Wills Eye Hospital, Philadelphia, PA, USA.
Clin Ophthalmol. 2020 Aug 20;14:2383-2395. doi: 10.2147/OPTH.S262085. eCollection 2020.
This systematic review examined the relationship between industry funding and the presence of spin in high-impact studies evaluating intravitreal corticosteroid therapy for diabetic macular edema.
This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. MEDLINE and Embase were systematically searched from inception through July 16, 2018, for randomized controlled trials and meta-analyses investigating the treatment of patients with diabetic macular edema using intravitreal corticosteroid therapy. Only studies published in English journals with an impact factor greater than 2 as per the Clarivate Analytics 2017 Journal Citation Report were included. The authors independently assessed study quality, funding source and the presence of reporting bias using a standardized datasheet.
Title and abstract screening were completed on 7158 unique hits and full-text review yielded 44 included studies. Overall, there was correspondence between the wording of abstract conclusions and study results in 41/44 (93%) articles. Correspondence between abstract conclusions and significance of main outcome was present in 14/14 (100%) industry-funded and 27/30 (90%) nonindustry-funded studies. The odds ratio of industry funding being associated with noncorrespondence was 0.27 (95% CI: 0.01-5.61, p=0.54). The most common reason for noncorrespondence was the failure to mention rates of steroid-related intraocular pressure elevation.
The results of this systematic review indicate that biased abstract outcome reporting is rare in published randomized controlled trials and meta-analyses of intravitreal corticosteroid therapy for diabetic macular edema. Biased reporting was not associated with the presence of industry funding or a conflict of interest.
本系统评价研究了在评估玻璃体内注射皮质类固醇治疗糖尿病性黄斑水肿的高影响力研究中,行业资助与倾向性报告之间的关系。
本系统评价按照系统评价和Meta分析的首选报告项目(PRISMA)声明进行。从数据库建库至2018年7月16日,系统检索MEDLINE和Embase,查找使用玻璃体内注射皮质类固醇治疗糖尿病性黄斑水肿患者的随机对照试验和Meta分析。仅纳入发表于影响因子大于2的英文期刊(根据科睿唯安2017年期刊引证报告)的研究。作者使用标准化数据表独立评估研究质量、资助来源及报告偏倚情况。
对7158条独特记录进行了标题和摘要筛选,全文审查后纳入44项研究。总体而言,44篇文章中有41篇(93%)的摘要结论措辞与研究结果相符。在14项(100%)行业资助研究和30项(90%)非行业资助研究中,摘要结论与主要结局的显著性相符。行业资助与不相符相关的比值比为0.27(95%CI:0.01 - 5.61,p = 0.54)。不相符的最常见原因是未提及类固醇相关眼压升高的发生率。
本系统评价结果表明,在已发表的关于玻璃体内注射皮质类固醇治疗糖尿病性黄斑水肿的随机对照试验和Meta分析中,有偏倚的摘要结局报告很少见。有偏倚的报告与行业资助或利益冲突无关。