Evaluating patient-reported outcome measures (PROMs) for future clinical trials in adult patients with optic neuritis.
Journal
Eye (London, England)
ISSN: 1476-5454
Titre abrégé: Eye (Lond)
Pays: England
ID NLM: 8703986
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
received:
31
08
2022
accepted:
28
02
2023
revised:
09
01
2023
medline:
12
10
2023
pubmed:
19
3
2023
entrez:
18
3
2023
Statut:
ppublish
Résumé
To search for and critically appraise the psychometric quality of patient-reported outcome measures (PROMs) developed or validated in optic neuritis, in order to support high-quality research and care. We systematically searched MEDLINE(Ovid), Embase(Ovid), PsycINFO(Ovid) and CINAHLPlus(EBSCO), and additional grey literature to November 2021, to identify PROM development or validation studies applicable to optic neuritis associated with any systemic or neurologic disease in adults. We included instruments developed using classic test theory or Rasch analysis approaches. We used established quality criteria to assess content development, validity, reliability, and responsiveness, grading multiple domains from A (high quality) to C (low quality). From 3142 screened abstracts we identified five PROM instruments potentially applicable to optic neuritis: three differing versions of the National Eye Institute (NEI)-Visual Function Questionnaire (VFQ): the 51-item VFQ; the 25-item VFQ and a 10-item neuro-ophthalmology supplement; and the Impact of Visual Impairment Scale (IVIS), a constituent of the Multiple Sclerosis Quality of Life Inventory (MSQLI) handbook, derived from the Functional Assessment of Multiple Sclerosis (FAMS). Psychometric appraisal revealed the NEI-VFQ-51 and 10-item neuro module had some relevant content development but weak psychometric development, and the FAMS had stronger psychometric development using Rasch Analysis, but was only somewhat relevant to optic neuritis. We identified no content or psychometric development for IVIS. There is unmet need for a PROM with strong content and psychometric development applicable to optic neuritis for use in virtual care pathways and clinical trials to support drug marketing authorisation. 摘要: 目的: 寻找并严格评估在视神经炎中开发或验证的患者报告结局测量 (PROMs) 的心理测量质量, 以支持高质量的研究和临床诊疗。方法: 我们系统地检索了MEDLINE(Ovid)、Embase(Ovid)、PsycINFO(Ovid)和CINAHLPlus(EBSCO), 以及截至2021年11月的其他文献, 以确定适用于与任何系统性或神经性疾病相关的成人视神经炎的PROM开发或验证的研究。我们将经典测试理论或Rasch分析方法开发的工具用于研究。我们使用既定的质量标准来评估内容开发、有效性、可靠性和响应性, 将多个领域从A (高质量) 到C (低质量) 分级。结果: 从3142份筛选的摘要中, 确定了五种可能适用于视神经炎的PROM工具: 国家眼科研究所 (NEI) 视觉功能问卷 (VFQ) 的三个不同版本: 51-item VFQ;25-item VFQ和10-item神经眼科补充问卷;以及视觉障碍影响量表 (IVIS), 这是多发性硬化症生活质量清单 (MSQLI) 手册的组成部分, 来源于多发性硬化症功能评估 (FAMS) 。心理测量评估显示, NEI-VFQ-51和10 item神经模块有些相关的内容, 但心理测量发展较慢, 而FAMS使用Rasch分析法有较快的心理测量开发, 但只与视神经炎有一定的关联。我们没有发现IVIS的内容或心理测量开发。结论: 目前对适用于视神经炎且具有强大内容和心理测量开发的PROM的虚拟诊疗路径和临床试验尚不多, 不足以支持药物上市授权。.
Autres résumés
Type: Publisher
(chi)
摘要: 目的: 寻找并严格评估在视神经炎中开发或验证的患者报告结局测量 (PROMs) 的心理测量质量, 以支持高质量的研究和临床诊疗。方法: 我们系统地检索了MEDLINE(Ovid)、Embase(Ovid)、PsycINFO(Ovid)和CINAHLPlus(EBSCO), 以及截至2021年11月的其他文献, 以确定适用于与任何系统性或神经性疾病相关的成人视神经炎的PROM开发或验证的研究。我们将经典测试理论或Rasch分析方法开发的工具用于研究。我们使用既定的质量标准来评估内容开发、有效性、可靠性和响应性, 将多个领域从A (高质量) 到C (低质量) 分级。结果: 从3142份筛选的摘要中, 确定了五种可能适用于视神经炎的PROM工具: 国家眼科研究所 (NEI) 视觉功能问卷 (VFQ) 的三个不同版本: 51-item VFQ;25-item VFQ和10-item神经眼科补充问卷;以及视觉障碍影响量表 (IVIS), 这是多发性硬化症生活质量清单 (MSQLI) 手册的组成部分, 来源于多发性硬化症功能评估 (FAMS) 。心理测量评估显示, NEI-VFQ-51和10 item神经模块有些相关的内容, 但心理测量发展较慢, 而FAMS使用Rasch分析法有较快的心理测量开发, 但只与视神经炎有一定的关联。我们没有发现IVIS的内容或心理测量开发。结论: 目前对适用于视神经炎且具有强大内容和心理测量开发的PROM的虚拟诊疗路径和临床试验尚不多, 不足以支持药物上市授权。.
Identifiants
pubmed: 36932161
doi: 10.1038/s41433-023-02478-z
pii: 10.1038/s41433-023-02478-z
pmc: PMC10022552
doi:
Types de publication
Systematic Review
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
3097-3107Informations de copyright
© 2023. The Author(s).
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