PDF(Pubmed)
Abstract：
BACKGROUND: Chronic ocular surface pain (COSP) is described as a persistent, moderate-to-severe pain at the ocular surface lasting more than 3 months. Symptoms of COSP have a significant impact on patients\' vision-dependent activities of daily living (ADL) and distal health-related quality of life (HRQoL). To adequately capture patient perspectives in clinical trials, patient-reported outcome (PRO) measures must demonstrate sufficient evidence of content validity in the target population. This study aimed to explore the patient experience of living with COSP and evaluate content validity of the newly developed Chronic Ocular Pain Questionnaire (COP-Q) for use in COSP clinical trials.
METHODS: Qualitative, combined concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with 24 patients experiencing COSP symptoms in the USA. Interviews were supplemented with real-time data collection via a daily diary app task in a subset of patients (n = 15) to explore the day-to-day patient experience. Three healthcare professionals (HCPs) from the USA, Canada, and France were also interviewed to provide a clinical perspective. CE results were used to further inform development of a conceptual model and to refine PRO items/response options. CD interviews assessed relevance and understanding of the COP-Q. Interviews were conducted across multiple rounds to allow item modifications and subsequent testing.
RESULTS: Eye pain, eye itch, burning sensation, eye dryness, eye irritation, foreign body sensation, eye fatigue, and eye grittiness were the most frequently reported symptoms impacting vision-dependent ADL (e.g., reading, using digital devices, driving) and wider HRQoL (e.g., emotional wellbeing, social functioning, work). COP-Q instructions, items, and response scales were understood, and concepts were considered relevant. Feedback supported modifications to instruction/item wording and confirmed the most appropriate recall periods.
CONCLUSIONS: Findings support content validity of the COP-Q for use in COSP populations. Ongoing research to evaluate psychometric validity of the COP-Q will support future use of the instrument in clinical trial efficacy endpoints.
METHODS: Qualitative, combined concept elicitation (CE) and cognitive debriefing (CD) interviews were conducted with 24 patients experiencing COSP symptoms in the USA. Interviews were supplemented with real-time data collection via a daily diary app task in a subset of patients (n = 15) to explore the day-to-day patient experience. Three healthcare professionals (HCPs) from the USA, Canada, and France were also interviewed to provide a clinical perspective. CE results were used to further inform development of a conceptual model and to refine PRO items/response options. CD interviews assessed relevance and understanding of the COP-Q. Interviews were conducted across multiple rounds to allow item modifications and subsequent testing.
RESULTS: Eye pain, eye itch, burning sensation, eye dryness, eye irritation, foreign body sensation, eye fatigue, and eye grittiness were the most frequently reported symptoms impacting vision-dependent ADL (e.g., reading, using digital devices, driving) and wider HRQoL (e.g., emotional wellbeing, social functioning, work). COP-Q instructions, items, and response scales were understood, and concepts were considered relevant. Feedback supported modifications to instruction/item wording and confirmed the most appropriate recall periods.
CONCLUSIONS: Findings support content validity of the COP-Q for use in COSP populations. Ongoing research to evaluate psychometric validity of the COP-Q will support future use of the instrument in clinical trial efficacy endpoints.
摘要：
背景：慢性眼表疼痛（COSP）被描述为一种持续的，持续超过3个月的眼表中度至重度疼痛。COSP的症状对患者的视力依赖性日常生活活动(ADL)和远端健康相关生活质量(HRQoL)有显著影响。为了在临床试验中充分捕捉患者观点，患者报告结局(PRO)指标必须在目标人群中证明足够的内容有效性.本研究旨在探索患者生活在COSP中的体验，并评估新开发的用于COSP临床试验的慢性眼痛问卷（COP-Q）的内容有效性。
方法：定性，在美国,对24例出现COSP症状的患者进行了概念启发(CE)和认知汇报(CD)联合访谈.访谈通过每日日记应用程序任务在患者子集（n=15）中进行实时数据收集，以探索患者的日常体验。来自美国的三名医疗保健专业人员（HCP），加拿大,和法国也接受了采访，以提供临床观点。CE结果用于进一步为概念模型的开发提供信息，并完善PRO项目/响应选项。CD访谈评估了对COP-Q的相关性和理解。面试进行了多轮，以允许项目修改和后续测试。
结果：眼痛，眼睛痒,灼烧感,眼睛干燥，眼睛刺激,异物感,眼睛疲劳,眼睛沙哑是影响视觉依赖性ADL的最常见症状(例如，阅读,使用数字设备，驾驶)和更宽的HRQoL(例如，情感幸福，社会功能,工作)。COP-Q指令,items,并且理解了反应量表，和概念被认为是相关的。反馈支持对指令/项目措辞的修改，并确认了最合适的召回期。
结论：研究结果支持COP-Q用于COSP人群的内容有效性。正在进行的评估COP-Q心理测量有效性的研究将支持该仪器在临床试验疗效终点的未来使用。
方法：定性，在美国,对24例出现COSP症状的患者进行了概念启发(CE)和认知汇报(CD)联合访谈.访谈通过每日日记应用程序任务在患者子集（n=15）中进行实时数据收集，以探索患者的日常体验。来自美国的三名医疗保健专业人员（HCP），加拿大,和法国也接受了采访，以提供临床观点。CE结果用于进一步为概念模型的开发提供信息，并完善PRO项目/响应选项。CD访谈评估了对COP-Q的相关性和理解。面试进行了多轮，以允许项目修改和后续测试。
结果：眼痛，眼睛痒,灼烧感,眼睛干燥，眼睛刺激,异物感,眼睛疲劳,眼睛沙哑是影响视觉依赖性ADL的最常见症状(例如，阅读,使用数字设备，驾驶)和更宽的HRQoL(例如，情感幸福，社会功能,工作)。COP-Q指令,items,并且理解了反应量表，和概念被认为是相关的。反馈支持对指令/项目措辞的修改，并确认了最合适的召回期。
结论：研究结果支持COP-Q用于COSP人群的内容有效性。正在进行的评估COP-Q心理测量有效性的研究将支持该仪器在临床试验疗效终点的未来使用。
