背景:急性感染性结膜炎是最常见的由病毒或细菌引起的疾病。临床结果评估已用于评估细菌性和病毒性结膜炎的体征和症状,但尚未评估内容的有效性。我们旨在开发内容有效的患者(PRO)和观察者报告的结果(ObsRO)工具,以评估成人和儿科患者与病毒性或细菌性结膜炎相关的眼部不适症状。
方法:草案项目是根据先前对2001年至2015年已发表研究的综述而制定的。招募过去6个月内诊断为病毒性或细菌性结膜炎的患者和护理人员。带有开放式问题的概念启发探索了体征和症状,随后进行认知访谈,以评估项目草案的清晰度和相关性。年龄≥8岁的患者接受了PRO采访;1-10岁儿童的父母/看护人接受了ObsRO采访。面试分三轮进行,以允许更改。使用饱和度网格记录概念饱和度。认知访谈数据进行了迭代分析,重点是清晰度,工具内容的相关性和不一致解释。
结果:总体而言,23名患者或父母/照顾者参与(第1轮,n=10;第2轮,n=6;第3轮,n=7)。第16次访谈达到了数据饱和。最常见的自发报告的体征/症状是:出院,红色/粉红色的眼睛,瘙痒,肿胀/浮肿,水汪汪的眼睛,疼痛,燃烧和异物感。瘙痒,疼痛/灼热/刺痛和异物感是最常见的三大最令人困扰的症状。访谈结果表明,关于疼痛的项目,PRO的瘙痒和异物感以及ObsRO的疼痛或不适与患者结膜炎的经历有关,并且清晰易懂。
结论:发现PRO和ObsRO项目清晰,在评估成人和儿科患者的关键病毒性和细菌性结膜炎症状时相关和适当。
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.