Shire, a Takeda company, 300 Shire Way, Lexington, MA, 02421, USA.
ICON PLC, Gaithersburg, MD, 20878, USA.
Health Qual Life Outcomes. 2019 Oct 30;17(1):163. doi: 10.1186/s12955-019-1223-9.
Acute infectious conjunctivitis is a common condition most frequently caused by viruses or bacteria. Clinical outcome assessments have been used to assess signs and symptoms of bacterial and viral conjunctivitis, but have not been evaluated for content validity. We aimed to develop content-valid patient- (PRO) and observer-reported outcome (ObsRO) instruments to assess symptoms of ocular discomfort associated with viral or bacterial conjunctivitis in adult and pediatric patients.
Draft items were developed from a previous review of published studies from 2001 to 2015. Patients and caregivers of patients with a diagnosis of viral or bacterial conjunctivitis within the past 6 months were recruited. Concept elicitation with open-ended questions explored signs and symptoms, followed by cognitive interviewing to assess clarity and relevance of the draft items. Patients aged ≥8 years were interviewed for the PRO; parents/caregivers of children aged 1-10 years were interviewed for the ObsRO. Interviews were conducted in three rounds to allow changes. Concept saturation was documented using a saturation grid. Cognitive interview data were analyzed iteratively and focused on clarity, relevance and inconsistent interpretation of the instrument's content.
Overall, 23 patients or parents/caregivers participated (round 1, n = 10; round 2, n = 6; round 3, n = 7). Data saturation was reached by the 16th interview. The most frequent spontaneously reported signs/symptoms were: discharge, red/pink eyes, itchiness, swelling/puffiness, watery eyes, pain, burning and foreign body sensation. Itching, pain/burning/stinging and foreign body sensation were most commonly reported as the top three most bothersome symptoms. Interview results indicated that items on pain, itching and foreign body sensation for the PRO and pain or discomfort for the ObsRO were relevant to the patients' experience of conjunctivitis and were clear and easy to understand.
PRO and ObsRO items were found to be clear, relevant and appropriate in assessing key viral and bacterial conjunctivitis symptoms in adult and pediatric patients.
急性传染性结膜炎是一种常见病症，通常由病毒或细菌引起。临床结局评估被用于评估细菌性和病毒性结膜炎的体征和症状，但尚未进行内容效度评估。我们旨在开发针对病毒性或细菌性结膜炎患者（PRO）和观察者报告结局（ObsRO）的内容有效的评估工具，以评估与成人和儿童患者眼部不适相关的症状。
从 2001 年至 2015 年发表的研究中进行了文献回顾，以制定草案项目。招募了过去 6 个月内被诊断患有病毒性或细菌性结膜炎的患者和患者的照顾者。通过开放式问题进行概念提取，以探索体征和症状，然后进行认知访谈，以评估草案项目的清晰度和相关性。年龄≥8 岁的患者接受 PRO 访谈；年龄 1-10 岁的儿童的父母/照顾者接受 ObsRO 访谈。访谈分三轮进行，允许进行更改。使用饱和度网格记录概念饱和度。对认知访谈数据进行迭代分析，重点关注工具内容的清晰度、相关性和不一致的解释。
共有 23 名患者或父母/照顾者参与了研究（第一轮，n=10；第二轮，n=6；第三轮，n=7）。第 16 次访谈时达到数据饱和度。最常自发报告的体征/症状是：分泌物、眼红/粉红、瘙痒、肿胀/浮肿、泪眼、疼痛、灼热和异物感。瘙痒、疼痛/灼热/刺痛和异物感是最常报告的三个最困扰的症状。访谈结果表明，PRO 中的疼痛、瘙痒和异物感以及 ObsRO 中的疼痛或不适项目与患者的结膜炎体验相关，且清晰易懂。
PRO 和 ObsRO 项目在评估成人和儿童患者的病毒性和细菌性结膜炎的关键症状时，被认为是清晰、相关和适当的。
