Development and validation of a measurement instrument to assess health-related quality of life (HRQoL) in Long COVID-19 (QoLCOVI)

由冠状病毒SARS-CoV-2引起的冠状病毒病（COVID- 19）越来越多地与感染后持续超过12周的长期症状相关。在这种被称为长期COVID的长期疾病中，即使是轻微的疾病进展也会导致严重的影响，例如几步后呼吸急促或味觉和嗅觉丧失。接受重症监护的患者出现更频繁和更严重的长期COVID症状的风险似乎增加了。很明显，长期COVID-19可能会影响健康相关生活质量（HRQoL）的身体、情感、社交和认知组成部分。然而，迄今为止，尚未开发和验证一种工具，从受长期COVID影响的个人的角度系统地捕捉这些影响。本项目的总体目标是开发和验证长期COVID-19特异性患者报告结局指标（PROM），以评估长期COVID-19患者的HRQoL。本项目的具体目的是：1）识别患有Long COVID-19症状的患者的HRQoL问题，为生成Long COVID-19中HRQoL问题的概念框架提供信息，2）生成一组草案项目，3）评估这些草案项目的内容有效性，4）使用经典测试理论（CTT）系统地减少项目并完善草案PROM，项目反应理论（IRT）和Rasch分析，5）验证最终PROM的内容，6）评估新PROM的心理测量学特性，包括可解释性和可行性方面的评估。在对最近的COVID-19长期文献进行系统综述后，将使用患者和专家访谈以及焦点小组的定性研究来得出概念模型（任务1）。随后将根据患者输入生成项目池（任务2）。在对初始项目集进行内容验证（任务3）之后，将提供第一个原型PROM。这一原型将用于第一次定量研究，目的是减少项目数量，并确定最合适的项目和基本因素结构。将评估应对方案的适当性（任务4）。将通过患者访谈（任务5）确认最终一组项目的内容有效性和回忆期的适用性、说明和回答选项的措辞。最终的PROM将在第二次定量研究中进行心理测量验证，以确定其测量特性以及这种新PROM的可解释性和可行性（任务6）。该项目将创建一个简短的高质量PROM，该PROM将针对长期COVID-19特定HRQoL方面进行定制，用于未来的流行病学研究和临床试验以及临床实践。

Coronavirus Disease (COVID) - 19 caused by coronavirus SARS-CoV-2 is increasingly associated with long-lasting symptoms persisting more than 12 weeks after infection. In this long-term symptomatology, known as Long COVID, even a mild progression of the disease can lead to serious impacts such as shortness of breath after a few steps or the loss of sense of taste and smell. Patients admitted to intensive care seem to be at increased risk of developing more frequent and more severe Long COVID symptoms. It is evident that Long COVID-19 likely affects the physical, emotional, social and cognitive components of health-related quality of life (HRQoL). However, an instrument systematically capturing these impacts from the perspective of individuals affected by Long COVID has not been developed and validated so far. The overall aim of this project is to develop and validate a Long COVID-19-specific patient-reported outcome measure (PROM) to assess HRQoL in Long COVID-19 patients. The specific aims of this project are 1) to identify HRQoL issues in patients suffering from Long COVID-19 symptoms that inform the generation of a conceptual framework about HRQoL issues in Long COVID-19, 2) to generate a set of draft items, 3) to assess the content validity of those draft items, 4) to systematically reduce items and refine the draft PROM using classical test theory (CTT), item response theory (IRT) and Rasch analysis, 5) to validate the content of the final PROM, 6) to assess the psychometric properties of the new PROM including the assessment of aspects on interpretability and feasibility.The Wilson and Cleary model of HRQoL will be used to guide the proposed development. After a systematic review of recent Long COVID-19 literature, qualitative research with patient and expert interviews and focus groups will be used to elicit a conceptual model (task 1). This will be followed by the generation of a pool of items based on patient input (task 2). After the content validation of the initial set of items (task 3), a first prototype PROM will be available. This prototype will be used in a first quantitative study that aims to reduce the number of items and to identify the most suitable items and the underlying factor structure. The appropriateness of the response options will be assessed (task 4). Content validity of the final set of items and the suitability of the recall period, the instructions and the wording of the response options will be confirmed using patient interviews (task 5). The final PROM will be psychometrically validated in a second quantitative study in order to determine its measurement properties as well as aspects of interpretability and feasibility of this new PROM (task 6). This project will create a brief high-quality PROM that will be tailored to Long COVID-19-specific HRQoL aspects for use in future epidemiological research and clinical trials, as well as clinical practice.