Davuluri Swetha, Yannuzzi Nicolas A, Kloosterboer Amy, Kuriyan Ajay E, Sridhar Jayanth
Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, FL, USA.
Department of Retina Service, Mid-Atlantic Retina, Wills Eye Hospital, Thomas Jefferson University, Philadelphia, PA, USA.
Clin Ophthalmol. 2021 Sep 17;15:3849-3857. doi: 10.2147/OPTH.S324231. eCollection 2021.
To evaluate the accuracy, quality, and readability of online information regarding the Food and Drug Administration (FDA) approved ocular gene therapy voretigene neparvovec (Luxturna, Spark Therapeutics, Philadelphia, PA, USA).
Ten online resources about voretigene neparvovec were assessed in this cross-sectional study. A novel 25-question assessment was created to evaluate the information most relevant to patients. Each article was assessed by independent graders using the assessment and the DISCERN instrument. An online readability tool, Readable, was used to assess readability. Accountability was evaluated using the Journal of the American Medical Association (JAMA) benchmarks.
The average questionnaire score for all the articles was 33.93 (SD 11.21, CI 95% ±6.95) out of 100 possible points with significant variation in the content accuracy and quality between the articles (P=0.017). EyeWiki achieved the highest score and MedicineNet the lowest. The mean reading grade for all articles was 12.88 (SD 1.93, CI 95% ±1.19) with significant variation between articles (P=0.001). Wikipedia was the most readable, and the FDA website was the least. None of the articles achieved all four JAMA benchmarks, and only one of the ten articles, EyeWiki, achieved three of the four JAMA benchmarks.
The information available online regarding this FDA-approved ocular gene therapy is generally of low quality, above the average reading level of the general population, and varies significantly between sources. The articles provide incomplete information that is not entirely accurate or easy to read, and as a result, the material would not support patients adequately in their medical decisions and questions about this new therapeutic option.
评估关于美国食品药品监督管理局（FDA）批准的眼部基因疗法——voretigene neparvovec（商品名Luxturna，由美国宾夕法尼亚州费城的Spark Therapeutics公司生产）的在线信息的准确性、质量和可读性。
在这项横断面研究中，对10个关于voretigene neparvovec的在线资源进行了评估。创建了一个包含25个问题的新颖评估工具，以评估与患者最相关的信息。由独立评分者使用该评估工具和DISCERN工具对每篇文章进行评估。使用在线可读性工具Readable评估可读性。根据美国医学会杂志（JAMA）的标准评估信息的可靠性。
所有文章的平均问卷得分为33.93（标准差11.21，95%置信区间±6.95）（满分100分），文章之间的内容准确性和质量存在显著差异（P = 0.017）。EyeWiki得分最高，MedicineNet得分最低。所有文章的平均阅读难度等级为12.88（标准差1.93，95%置信区间±1.19），文章之间存在显著差异（P = 0.001）。维基百科的可读性最强，FDA网站的可读性最差。没有一篇文章达到JAMA的全部四项标准，十篇文章中只有一篇，即EyeWiki，达到了JAMA四项标准中的三项。
关于这种FDA批准的眼部基因疗法的在线信息总体质量较低，高于普通人群的平均阅读水平，并且不同来源之间差异显著。这些文章提供的信息不完整，不完全准确且不易阅读，因此，这些材料无法充分支持患者就这种新的治疗选择做出医疗决策和解答相关问题。
