Baral Pawan, Kumaran Sheela, Stapleton Fiona, Pesudovs Konrad
School of Optometry and Vision Science, Faculty of Medicine and Health, UNSW Sydney, Australia.
School of Optometry and Vision Science, Faculty of Medicine and Health, UNSW Sydney, Australia.
Ocul Surf. 2025 Jan;35:31-56. doi: 10.1016/j.jtos.2024.11.011. Epub 2024 Dec 2.
To identify and assess the quality of currently available validated patient reported outcome measures (PROMs) used to measure the quality of life (QoL) impacts of ocular surface diseases (OSDs).
A literature search was performed in the PubMed, Embase, Scopus, Cochrane Library, and Web of Science databases. Articles reporting on the development, validation, and use of PROMs specific to ocular surface diseases were included for review. The studies were classified based on the target population for which they were developed. Data on content identification, selection, psychometric properties, validity, and reliability were extracted. These data were assessed using the established quality assessment criteria for ophthalmic PROMs. A review of the contents of the PROMs was also performed.
We identified 67 studies that met the inclusion criteria. These studies used 34 unique PROMs including 16 dry eye specific PROMs, 4 contact lens specific PROMs, 1 meibomian gland dysfunction specific PROM, 1 blepharitis specific PROM, 5 Sjögren Syndrome specific PROMs, 4 generic PROMs, 1 computer vision specific PROM, 1 ocular pain specific PROM and 1 bone marrow transplant specific PROM used in ocular graft versus host disease. Testing of psychometric properties for validation was uncommon. Most of the reported data were limited to internal consistency, convergent, and known group validity. The majority (25 out of 34) of the PROMs did not involve patients for content development. Twenty-four PROMs measured symptoms only and the remaining 9 PROMs had items from other QoL domains.
This review provides a current evaluation of extant PROMs for OSD. The assessment of PROMs displayed some strengths but highlighted numerous limitations. Not involving patients for the development of PROM, limited content, inadequately reported or poor psychometric properties, and issues with multidimensionality were the main limitations. Based on this we cannot recommend a single best PROM for measuring OSD-specific QoL. This review underscores the need for the development of a higher quality PROM and suggest directions for future research.
识别并评估目前可用于测量眼表疾病（OSD）对生活质量（QoL）影响的经过验证的患者报告结局指标（PROM）的质量。
在PubMed、Embase、Scopus、Cochrane图书馆和Web of Science数据库中进行文献检索。纳入报告眼表疾病特异性PROM的开发、验证和使用的文章进行综述。这些研究根据其开发的目标人群进行分类。提取有关内容识别、选择、心理测量特性、效度和信度的数据。使用既定的眼科PROM质量评估标准对这些数据进行评估。还对PROM的内容进行了综述。
我们识别出67项符合纳入标准的研究。这些研究使用了34种独特的PROM，包括16种干眼特异性PROM、4种隐形眼镜特异性PROM、1种睑板腺功能障碍特异性PROM、1种睑缘炎特异性PROM、5种干燥综合征特异性PROM、4种通用PROM、1种计算机视觉特异性PROM、1种眼痛特异性PROM以及1种用于眼部移植物抗宿主病的骨髓移植特异性PROM。用于验证的心理测量特性测试并不常见。报告的大多数数据仅限于内部一致性、收敛性和已知组效度。大多数（34项中的25项）PROM在内容开发过程中未涉及患者。24项PROM仅测量症状，其余9项PROM包含来自其他QoL领域的项目。
本综述提供了对现有OSD的PROM的当前评估。PROM的评估显示出一些优点，但也突出了许多局限性。PROM开发未涉及患者、内容有限、心理测量特性报告不足或不佳以及多维性问题是主要局限性。基于此，我们无法推荐单一最佳的PROM来测量OSD特异性QoL。本综述强调了开发更高质量PROM的必要性，并为未来研究指明了方向。
