Objective To describe the development and validation of a novel patient reported outcome measure for symptom burden from long covid, the symptom burden questionnaire for long covid (SBQ-LC). Design Multiphase, prospective mixed methods study. Setting Remote data collection and social media channels in the United Kingdom, 14 April to 1 August 2021. Participants 13 adults (aged ≥18 years) with self-reported long covid and 10 clinicians evaluated content validity. 274 adults with long covid field tested the draft questionnaire. Main outcome measures Published systematic reviews informed development of SBQ-LC’s conceptual framework and initial item pool. Thematic analysis of transcripts from cognitive debriefing interviews and online clinician surveys established content validity. Consensus discussions with the patient and public involvement group of the Therapies for Long COVID in non-hospitalised individuals: From symptoms, patient reported outcomes and immunology to targeted therapies (TLC Study) confirmed face validity. Rasch analysis of field test data guided item and scale refinement and provided initial evidence of the SBQ-LC’s measurement properties. Results SBQ-LC (version 1.0) is a modular instrument measuring patient reported outcomes and is composed of 17 independent scales with promising psychometric properties. Respondents rate their symptom burden during the past seven days using a dichotomous response or 4 point rating scale. Each scale provides coverage of a different symptom domain and returns a summed raw score that can be transformed to a linear (0-100) score. Higher scores represent higher symptom burden. After rating scale refinement and item reduction, all scales satisfied the Rasch model requirements for unidimensionality (principal component analysis of residuals: first residual contrast values <2.00 eigenvalue units) and item fit (outfit mean square values within 0.5 -1.5 logits). Rating scale categories were ordered with acceptable category fit statistics (outfit mean square values <2.0 logits). 14 item pairs had evidence of local dependency (residual correlation values >0.4). Across the 17 scales, person reliability ranged from 0.34 to 0.87, person separation ranged from 0.71 to 2.56, item separation ranged from 1.34 to 13.86, and internal consistency reliability (Cronbach’s alpha) ranged from 0.56 to 0.91. Conclusions SBQ-LC (version 1.0) is a comprehensive patient reported outcome instrument developed using modern psychometric methods. It measures symptoms of long covid important to people with lived experience of the condition and may be used to evaluate the impact of interventions and inform best practice in clinical management. Data for this project are not currently available for access outside the Therapies for Long COVID Study research team. The dataset may be shared when finalised, but this will require an application to the data controllers. The data may then be released to a specific research team for a specific project dependent on the independent approvals being in place.

中文翻译：

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长期新冠症状负担调查表 (SBQ-LC) 的制定和验证：Rasch 分析

目的 描述一种新型患者报告的长期新冠症状负担结果测量方法——长期新冠症状负担问卷 (SBQ-LC) 的开发和验证。设计多阶段、前瞻性混合方法研究。2021年4月14日至8月1日，在英国设置远程数据收集和社交媒体渠道。参与者由13名自我报告长期感染新冠病毒的成年人（年龄≥18岁）和10名临床医生评估内容有效性。274 名长期感染新冠病毒的成年人对问卷草案进行了测试。主要成果衡量指标 已发表的系统评价为 SBQ-LC 概念框架和初始项目库的开发提供了信息。对认知汇报访谈和在线临床医生调查的记录进行主题分析，确定了内容的有效性。与患者和公众参与非住院个体长新冠病毒治疗小组的共识讨论：从症状、患者报告的结果和免疫学到靶向治疗（TLC 研究）证实了表面有效性。现场测试数据的 Rasch 分析指导项目和量表细化，并提供 SBQ-LC 测量特性的初步证据。结果 SBQ-LC（1.0 版）是一种测量患者报告结果的模块化仪器，由 17 个具有良好心理测量特性的独立量表组成。受访者使用二分法或 4 点评分量表对过去 7 天内的症状负担进行评分。每个量表覆盖不同的症状领域，并返回一个总分，可以将其转换为线性 (0-100) 分数。分数越高代表症状负担越高。经过评级量表细化和项目缩减后，所有量表均满足 Rasch 模型对单维性（残差主成分分析：第一残差对比值 <2.00 特征值单位）和项目拟合（拟合均方值在 0.5 -1.5 logits 以内）的要求。评级量表类别按照可接受的类别拟合统计数据进行排序（拟合均方值<2.0 logits）。14 个项目对有局部依赖性的证据（剩余相关值 >0.4）。在 17 个量表中，人员可靠性范围为 0.34 至 0.87，人员分离范围为 0.71 至 2.56，项目分离范围为 1.34 至 13.86，内部一致性可靠性（Cronbach's alpha）范围为 0.56 至 0.91。结论 SBQ-LC（1.0 版）是使用现代心理测量方法开发的综合性患者报告结果工具。它测量长期新冠病毒的症状，对于有这种疾病生活经验的人来说很重要，可用于评估干预措施的影响并为临床管理的最佳实践提供信息。目前，长期新冠肺炎疗法研究团队之外无法获取该项目的数据。数据集最终确定后可以共享，但这需要向数据控制者提出申请。