PDF(Pubmed)
Abstract：
BACKGROUND: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
背景：长期的COVID研究领域正在迅速发展，然而,评估和监测症状和疾病恢复的工具是有限的。本研究的目的是开发一种新的患者报告结果工具，长型COVID-19（SE-LC19）的症状演变，并确立其内容的有效性。
方法：40项SE-LC19仪器是根据科学文献和临床指南中与患者相关的经验证据开发的，这些证据报告了长COVID特有的症状。采用两部分混合方法。第一部分：对41例确诊为长COVID患者的目的样本进行定性访谈，以验证SE-LC19的含量。在认知汇报访谈中，患者被要求描述他们对仪器说明书的理解，具体症状,响应选项,和召回期以确保其相关性和全面性。还采访了五名不同医学专业的临床医生，他们定期治疗长期COVID患者，以获得他们对SE-LC19的临床专家意见。第2部分：进行了探索性Rasch测量理论（RMT）分析，以评估在访谈中收集的SE-LC19数据的心理测量特性。
结果：总体而言，患者报告说，说明，问题,召回期,SE-LC19的反应选项是全面和相关的。患者报告的微小概念差距在某些症状的经历中发现了细微差别，可以在未来的研究中考虑。一些患者建议将召回期从24小时修改为7天，以便能够捕获更多的症状，因为某些症状的起伏和减弱。临床医生发现该仪器全面，对其内容的建议很少。探索性RMT分析提供了SE-LC19问卷按预期执行的证据。
结论：目前在确诊为长COVID患者中进行的混合方法研究支持SE-LC19仪器评估长COVID患者症状的内容有效性和适用性。有必要进行进一步的研究，以探索仪器的心理测量特性，并完善有意义且稳健的患者相关终点，以用于不同的环境，例如临床试验和临床实践，以跟踪发作。严重程度,和长COVID的恢复。
方法：40项SE-LC19仪器是根据科学文献和临床指南中与患者相关的经验证据开发的，这些证据报告了长COVID特有的症状。采用两部分混合方法。第一部分：对41例确诊为长COVID患者的目的样本进行定性访谈，以验证SE-LC19的含量。在认知汇报访谈中，患者被要求描述他们对仪器说明书的理解，具体症状,响应选项,和召回期以确保其相关性和全面性。还采访了五名不同医学专业的临床医生，他们定期治疗长期COVID患者，以获得他们对SE-LC19的临床专家意见。第2部分：进行了探索性Rasch测量理论（RMT）分析，以评估在访谈中收集的SE-LC19数据的心理测量特性。
结果：总体而言，患者报告说，说明，问题,召回期,SE-LC19的反应选项是全面和相关的。患者报告的微小概念差距在某些症状的经历中发现了细微差别，可以在未来的研究中考虑。一些患者建议将召回期从24小时修改为7天，以便能够捕获更多的症状，因为某些症状的起伏和减弱。临床医生发现该仪器全面，对其内容的建议很少。探索性RMT分析提供了SE-LC19问卷按预期执行的证据。
结论：目前在确诊为长COVID患者中进行的混合方法研究支持SE-LC19仪器评估长COVID患者症状的内容有效性和适用性。有必要进行进一步的研究，以探索仪器的心理测量特性，并完善有意义且稳健的患者相关终点，以用于不同的环境，例如临床试验和临床实践，以跟踪发作。严重程度,和长COVID的恢复。
