Department of Medicine (RDH), University of California, Los Angeles, California, USA; The RAND Corporation (RDH), Santa Monica, California, USA.
US Food and Drug Administration (MET and ME), Center for Devices and Radiologic Health, Silver Spring, Maryland, USA.
Am J Ophthalmol. 2024 Oct;266:313-320. doi: 10.1016/j.ajo.2024.05.031. Epub 2024 Jun 15.
To develop a patient-reported outcome measure to assess the impact of glaucoma and treatment, including minimally invasive glaucoma surgery (MIGS).
Observational study before and after concomitant cataract and Food and Drug Administration-approved implantable MIGS device surgery.
Survey administration was on a computer, iPad, or similar device.
184 adults completed the baseline survey, 124 a survey 3 months after surgery, and 106 the 1-month test-retest reliability survey. The age range was 37 to 89 (average age = 72). Most were female (57%), non-Hispanic White (81%), and had a college degree (56%).
The Glaucoma Outcomes Survey (GOS) assesses functional limitations (27 items), vision-related symptoms (7 items), psychosocial issues (7 items), and satisfaction with microinvasive glaucoma surgery (1 item). These multiple-item scales were scored on a 0 to 100 range, with a higher score indicating worse health.
Internal consistency reliability estimates ranged from 0.75 to 0.93, and 1-month test-retest intraclass correlations ranged from 0.83 to 0.92 for the GOS scales. Product-moment correlations among the scales ranged from 0.56 to 0.60. Improvement in visual acuity in the study eye from baseline to the 3-month follow-up was significantly related to improvements in GOS functional limitations (r = 0.18, P = .0485), vision-related symptoms (r = 0.19, P = .0386), and psychosocial concerns (r = 0.18, P = .0503). Responders to treatment ranged from 17% for vision-related symptoms to 48% for functional limitations.
This study supports using the GOS for ophthalmic procedures such as MIGS. Further evaluation of the GOS in different patient subgroups and clinical settings is needed.
开发一种患者报告的结局测量工具,以评估青光眼及其治疗(包括微创青光眼手术[MIGS])的影响。
在同时进行白内障和经食品和药物管理局批准的可植入 MIGS 装置手术后进行前瞻性观察研究。
调查管理在计算机、iPad 或类似设备上进行。
184 名成年人完成了基线调查,124 名在手术后 3 个月进行了调查,106 名在 1 个月的重测信度调查中完成了调查。年龄范围为 37 岁至 89 岁(平均年龄=72 岁)。大多数患者为女性(57%)、非西班牙裔白人(81%)和拥有大学学历(56%)。
青光眼结局调查(GOS)评估功能障碍(27 项)、视力相关症状(7 项)、心理社会问题(7 项)和对微创青光眼手术的满意度(1 项)。这些多项目量表的评分范围为 0 至 100,分数越高表示健康状况越差。
GOS 量表的内部一致性信度估计值范围为 0.75 至 0.93,1 个月的重测信度的组内相关系数范围为 0.83 至 0.92。量表之间的皮尔逊积矩相关系数范围为 0.56 至 0.60。从基线到 3 个月随访时研究眼视力的改善与 GOS 功能障碍(r=0.18,P=0.0485)、视力相关症状(r=0.19,P=0.0386)和心理社会问题(r=0.18,P=0.0503)的改善显著相关。对治疗有反应的患者比例范围为 17%的视力相关症状到 48%的功能障碍。
本研究支持将 GOS 用于 MIGS 等眼科手术。需要进一步评估 GOS 在不同患者亚组和临床环境中的应用。