Rofail Diana, Somersan-Karakaya Selin, Mylonakis Eleftherios, Choi Julia Y, Przydzial Krystian, Marquis Sarah, Zhao Yuming, Hussein Mohamed, Norton Thomas D, Podolanczuk Anna J, Geba Gregory P
Regeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA.
Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.
J Patient Rep Outcomes. 2024 Aug 9;8(1):87. doi: 10.1186/s41687-024-00737-5.
The field of long COVID research is rapidly evolving, however, tools to assess and monitor symptoms and recovery of the disease are limited. The objective of the present study was to develop a new patient-reported outcomes instrument, the Symptoms Evolution of Long COVID‑19 (SE-LC19), and establish its content validity.
The 40-item SE-LC19 instrument was developed based on patient-relevant empirical evidence from scientific literature and clinical guidelines that reported symptoms specific to long COVID. A 2-part mixed-method approach was employed. Part 1: Qualitative interviews with a purposive sample of 41 patients with confirmed long COVID were conducted for the content validation of SE-LC19. During cognitive debriefing interviews, patients were asked to describe their understanding of the instrument's instructions, specific symptoms, response options, and recall period to ensure its relevance and comprehensiveness. Five clinicians of different medical specialties who regularly treated patients with long COVID were also interviewed to obtain their clinical expert opinions on SE-LC19. Part 2: Exploratory Rasch Measurement Theory (RMT) analysis was conducted to evaluate the psychometric properties of the SE-LC19 data collected during the interviews.
Overall, patients reported that the instructions, questions, recall period, and response options for SE-LC19 were comprehensive and relevant. Minor conceptual gaps reported by patients captured nuances in the experience of some symptoms that could be considered in future studies. Some patients suggested a revision of the recall period from 24 h to 7 days to be able to capture more symptoms given the waxing and waning nature of some symptoms. Clinicians found the instrument comprehensive with minimal suggestions regarding its content. Exploratory RMT analyses provided evidence that the SE-LC19 questionnaire performed as intended.
The present mixed-methods study in patients with confirmed long COVID supports the content validity and applicability of the SE-LC19 instrument to evaluate the symptoms of patients with long COVID. Further research is warranted to explore the psychometric properties of the instrument and refine a meaningful and robust patient-relevant endpoint for use in different settings such as clinical trials and clinical practice to track the onset, severity, and recovery of long COVID.
长新冠研究领域正在迅速发展，然而，用于评估和监测该疾病症状及恢复情况的工具有限。本研究的目的是开发一种新的患者报告结局工具——长新冠-19症状演变量表（SE-LC19），并确定其内容效度。
基于科学文献和临床指南中与患者相关的经验证据开发了包含40个条目的SE-LC19量表，这些证据报告了长新冠特有的症状。采用了两部分的混合方法。第1部分：对41名确诊长新冠患者的目标样本进行定性访谈，以对SE-LC19进行内容验证。在认知反馈访谈中，要求患者描述他们对量表说明、特定症状、回答选项和回忆期的理解，以确保其相关性和全面性。还对5名经常治疗长新冠患者的不同医学专业的临床医生进行了访谈，以获取他们对SE-LC19的临床专家意见。第2部分：进行探索性拉施测量理论（RMT）分析，以评估访谈期间收集的SE-LC19数据的心理测量特性。
总体而言，患者报告称SE-LC19的说明、问题、回忆期和回答选项全面且相关。患者报告的一些小概念差距捕捉到了某些症状体验中的细微差别，可在未来研究中加以考虑。一些患者建议将回忆期从24小时改为7天，以便考虑到某些症状的波动性质而能捕捉到更多症状。临床医生发现该量表全面，对其内容的建议极少。探索性RMT分析提供了证据，表明SE-LC19问卷按预期发挥作用。
本针对确诊长新冠患者的混合方法研究支持SE-LC19量表在评估长新冠患者症状方面的内容效度和适用性。有必要进行进一步研究，以探索该量表的心理测量特性，并完善一个有意义且可靠的与患者相关的终点指标，用于临床试验和临床实践等不同场景，以跟踪长新冠的发病情况、严重程度和恢复情况。
