Use of patient-reported outcomes in medical product development: a report from the 2009 NEI/FDA Clinical Trial Endpoints Symposium.
作者信息
Varma Rohit, Richman Elaine A, Ferris Frederick L, Bressler Neil M
机构信息
Doheny Eye Institute, Keck School of Medicine, University of Southern California, Los Angeles, CA 90033, USA.
出版信息
Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6095-103. doi: 10.1167/iovs.10-5627.
Abstract
摘要
相似文献
1
Use of patient-reported outcomes in medical product development: a report from the 2009 NEI/FDA Clinical Trial Endpoints Symposium.患者报告结局在医疗产品研发中的应用：2009年美国国立眼科研究所/美国食品药品监督管理局临床试验终点研讨会报告
Invest Ophthalmol Vis Sci. 2010 Dec;51(12):6095-103. doi: 10.1167/iovs.10-5627.
2
Report from the NEI/FDA Ophthalmic Clinical Trial Design and Endpoints Symposium.美国国立眼科研究所/美国食品药品监督管理局眼科临床试验设计与终点研讨会报告。
Invest Ophthalmol Vis Sci. 2008 Feb;49(2):479-89. doi: 10.1167/iovs.07-1132.
3
Glaucoma research community and FDA look to the future, II: NEI/FDA Glaucoma Clinical Trial Design and Endpoints Symposium: measures of structural change and visual function.青光眼研究界与美国食品药品监督管理局展望未来，第二部分：美国国立眼科研究所/美国食品药品监督管理局青光眼临床试验设计与终点研讨会：结构变化与视觉功能的测量指标
Invest Ophthalmol Vis Sci. 2011 Oct 4;52(11):7842-51. doi: 10.1167/iovs.11-7895.
4
The glaucoma research community and FDA look to the future: a report from the NEI/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium.青光眼研究界与美国食品药品监督管理局展望未来：来自美国国立眼科研究所/美国食品药品监督管理局药品评价和研究中心青光眼临床试验设计与终点研讨会的报告
Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1497-505. doi: 10.1167/iovs.08-2843.
5
Report From the NEI/FDA Diabetic Retinopathy Clinical Trial Design and Endpoints Workshop.美国国立眼科研究所/美国食品药品监督管理局糖尿病性视网膜病变临床试验设计与终点研讨会报告
Invest Ophthalmol Vis Sci. 2016 Oct 1;57(13):5127-5142. doi: 10.1167/iovs.16-20356.
6
Report From the National Eye Institute Workshop on Neuro-Ophthalmic Disease Clinical Trial Endpoints: Optic Neuropathies.美国国立眼科研究所神经眼科疾病临床试验终点研讨会报告：视神经病变
Invest Ophthalmol Vis Sci. 2021 Nov 1;62(14):30. doi: 10.1167/iovs.62.14.30.
7
Ophthalmic Drug Discovery and Development: Regulatory Aspects of Patient Focused Drug Development in Ophthalmology.眼科药物研发：眼科以患者为中心的药物研发的监管方面
Pharm Res. 2019 Feb 21;36(4):54. doi: 10.1007/s11095-019-2577-8.
8
Measuring treatment impact: a review of patient-reported outcomes and other efficacy endpoints in approved product labels.衡量治疗效果：对已批准产品标签中患者报告的结局及其他疗效终点的综述。
Control Clin Trials. 2004 Dec;25(6):535-52. doi: 10.1016/j.cct.2004.09.003.
9
Potential of patient-reported outcomes as nonprimary endpoints in clinical trials.患者报告结局作为临床试验次要终点的潜力。
Health Qual Life Outcomes. 2013 May 15;11:83. doi: 10.1186/1477-7525-11-83.
10
FDA ovarian cancer clinical trial endpoints workshop: A Society of Gynecologic Oncology White Paper.美国食品药品监督管理局卵巢癌临床试验终点研讨会：妇科肿瘤学会白皮书
Gynecol Oncol. 2017 Oct;147(1):3-10. doi: 10.1016/j.ygyno.2017.08.012. Epub 2017 Aug 24.
引用本文的文献
1
A comparative study of the changes in the quality of life among patients with homonymous hemianopia, monocular blindness, or binocular diplopia.同向性偏盲、单眼失明或双眼复视患者生活质量变化的比较研究。
PLoS One. 2025 Aug 26;20(8):e0329433. doi: 10.1371/journal.pone.0329433. eCollection 2025.
2
CF Tummy Tracker: A Cystic Fibrosis-Specific Patient-Reported Outcome Measure for Daily Gastrointestinal Symptom Burden.囊性纤维化腹部追踪器：一种针对囊性纤维化患者报告的每日胃肠道症状负担的特定结局指标。
Mayo Clin Proc Digit Health. 2025 Mar 3;3(2):100203. doi: 10.1016/j.mcpdig.2025.100203. eCollection 2025 Jun.
3
Reduced quality of life in corneal dystrophy - a prospective case control study.角膜营养不良患者生活质量降低——一项前瞻性病例对照研究。
BMC Ophthalmol. 2025 Jun 19;25(1):341. doi: 10.1186/s12886-025-04200-x.
4
Relationship between the full-field stimulus test and self-reported visual function in patients with retinitis pigmentosa: REPEAT Study report No. 3.视网膜色素变性患者全视野刺激试验与自我报告的视觉功能之间的关系：重复研究报告第3号
Acta Ophthalmol. 2025 Jun;103(4):396-403. doi: 10.1111/aos.17427. Epub 2024 Dec 12.
5
Translation, cultural adaptation, and evaluation of the psychometric properties of the Arabic Gastroesophageal Reflux Disease Questionnaire (Ar-GerdQ).阿拉伯文胃食管反流病问卷（Ar-GerdQ）的翻译、文化调适和心理计量特性评估。
Saudi J Gastroenterol. 2024 Nov 1;30(6):369-375. doi: 10.4103/sjg.sjg_61_24. Epub 2024 Jun 28.
6
Efficacy of a Digital Diabetes Logbook for People With Type 1, Type 2, and Gestational Diabetes: Results From a Multicenter, Open-Label, Parallel-Group, Randomized Controlled Trial.数字糖尿病日志对1型、2型和妊娠期糖尿病患者的疗效：一项多中心、开放标签、平行组、随机对照试验的结果
J Diabetes Sci Technol. 2024 Mar 26:19322968241239870. doi: 10.1177/19322968241239870.
7
Daily Functionality of People with Low Vision: The Impact of Visual Acuity, Depression, and Life Orientation-A Cross-Sectional Study.低视力人群的日常功能：视力、抑郁和生活取向的影响——一项横断面研究。
Behav Neurol. 2024 Feb 26;2024:4366572. doi: 10.1155/2024/4366572. eCollection 2024.
8
Development and Validation of the Low Vision Severely Constricted Peripheral Eyesight (LV-SCOPE) Questionnaire.低视力严重受限周边视力（LV-SCOPE）问卷的制定与验证。
Am J Ophthalmol. 2023 Dec;256:70-79. doi: 10.1016/j.ajo.2023.08.014. Epub 2023 Aug 23.
9
Amblyopia and the whole child.弱视与儿童整体发展。
Prog Retin Eye Res. 2023 Mar;93:101168. doi: 10.1016/j.preteyeres.2023.101168. Epub 2023 Feb 1.
10
The NEI VFQ-25C: Calibrating Items in the National Eye Institute Visual Function Questionnaire-25 to Enable Comparison of Outcome Measures.NEI VFQ-25C：对国家眼科研究所视觉功能问卷-25 中的项目进行校准，以实现结果测量的比较。
Transl Vis Sci Technol. 2022 May 2;11(5):10. doi: 10.1167/tvst.11.5.10.
本文引用的文献
1
A comparative clinical study of the visual results between three types of multifocal lenses.三种多焦点人工晶状体的临床对比研究。
Graefes Arch Clin Exp Ophthalmol. 2010 Jan;248(1):133-40. doi: 10.1007/s00417-009-1177-4. Epub 2009 Sep 8.
2
The glaucoma research community and FDA look to the future: a report from the NEI/FDA CDER Glaucoma Clinical Trial Design and Endpoints Symposium.青光眼研究界与美国食品药品监督管理局展望未来：来自美国国立眼科研究所/美国食品药品监督管理局药品评价和研究中心青光眼临床试验设计与终点研讨会的报告
Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1497-505. doi: 10.1167/iovs.08-2843.
3
Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials.新血管性年龄相关性黄斑变性中NEI VFQ-25对视力变化的反应性：两项3期临床试验的验证研究
Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs.08-3225. Epub 2009 Feb 28.
4
Glaucoma and disability: which tasks are affected, and at what stage of disease?青光眼与残疾：哪些任务会受到影响，以及在疾病的哪个阶段受到影响？
Curr Opin Ophthalmol. 2009 Mar;20(2):92-8. doi: 10.1097/ICU.0b013e32832401a9.
5
Glaucoma and reading speed: the Salisbury Eye Evaluation project.青光眼与阅读速度：索尔兹伯里眼部评估项目
Arch Ophthalmol. 2009 Jan;127(1):82-7. doi: 10.1001/archophthalmol.2008.523.
6
Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial.雷珠单抗与光动力疗法相比，视力相关功能得到改善：一项随机临床试验。
Arch Ophthalmol. 2009 Jan;127(1):13-21. doi: 10.1001/archophthalmol.2008.562.
7
Evaluating clinical change and visual function concerns in drivers and nondrivers with glaucoma.评估青光眼患者（包括驾驶者和非驾驶者）的临床变化及视觉功能问题。
Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1718-25. doi: 10.1167/iovs.08-2575. Epub 2008 Dec 5.
8
Evaluation of topical cyclosporine for the treatment of dry eye disease.局部用环孢素治疗干眼症的评估。
Arch Ophthalmol. 2008 Aug;126(8):1046-50. doi: 10.1001/archopht.126.8.1046.
9
Quality of life in age-related macular degeneration: a review of available vision-specific psychometric tools.年龄相关性黄斑变性患者的生活质量：现有视力特异性心理测量工具综述
Qual Life Res. 2008 May;17(4):559-74. doi: 10.1007/s11136-008-9327-4.
10
Psychometric properties of the Greek version of the NEI-VFQ 25.希腊语版NEI-VFQ 25的心理测量特性。
BMC Ophthalmol. 2008 Mar 6;8:4. doi: 10.1186/1471-2415-8-4.
Zotero 插件