{"title":"Development and validation of a simple 11-item long COVID burden index (LCBI).","authors":"Gen Yamada, Takahiro Itaya, Noriko Iwamoto, Yoshie Yamada, Yusuke Ogawa, Michiyo Suzuki, Shinichiro Morioka, Kentaro Tochitani, Daisuke Miyamori, Jun Miyashita, Norio Ohmagari, Yosuke Yamamoto","doi":"10.1016/j.jiac.2025.102809","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Existing patient-reported outcome measures for long COVID are comprehensive; however, they are time-consuming and burdensome for some patients in daily practice.</p><p><strong>Objectives: </strong>This study aimed to develop and validate a simple patient-reported outcome measure to assess the burden associated with frequently occurring symptoms in patients with long COVID.</p><p><strong>Methods: </strong>Following an extensive literature review, a questionnaire consisting of 11 items was developed based on the modified Delphi method with an expert panel. Its face validity was assessed in three individuals with COVID-19 history. The study subjects were Japanese residents who responded to the online QoLCoVE (Quality of Life in the COVID-19 Era) study between March 8 and April 1, 2024. The known-groups and concurrent validity were assessed after exploratory factor analysis. The internal consistency was evaluated using Cronbach's alpha.</p><p><strong>Results: </strong>A total of 1014 participants were included in the analysis, all at least two months after their last COVID-19 infection. The factor analysis results showed unidimensionality. Internal consistency reliability assessed using Cronbach's alpha was 0.89. For known-groups validity, the total score decreased with time since the acute COVID-19 infection, as well as with more frequent vaccinations, and increased with an increasing previous history of COVID-19. A dose-dependent relationship was observed between EQ-5D-5L and the scale's total score, categorized according to quartiles.</p><p><strong>Conclusion: </strong>We successfully developed the Long COVID Burden Index, a simple 11-item scale to easily quantify symptoms frequently experienced by patients with long COVID, which may interfere with their daily lives.</p>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":" ","pages":"102809"},"PeriodicalIF":1.5000,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Infection and Chemotherapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.jiac.2025.102809","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Existing patient-reported outcome measures for long COVID are comprehensive; however, they are time-consuming and burdensome for some patients in daily practice.
Objectives: This study aimed to develop and validate a simple patient-reported outcome measure to assess the burden associated with frequently occurring symptoms in patients with long COVID.
Methods: Following an extensive literature review, a questionnaire consisting of 11 items was developed based on the modified Delphi method with an expert panel. Its face validity was assessed in three individuals with COVID-19 history. The study subjects were Japanese residents who responded to the online QoLCoVE (Quality of Life in the COVID-19 Era) study between March 8 and April 1, 2024. The known-groups and concurrent validity were assessed after exploratory factor analysis. The internal consistency was evaluated using Cronbach's alpha.
Results: A total of 1014 participants were included in the analysis, all at least two months after their last COVID-19 infection. The factor analysis results showed unidimensionality. Internal consistency reliability assessed using Cronbach's alpha was 0.89. For known-groups validity, the total score decreased with time since the acute COVID-19 infection, as well as with more frequent vaccinations, and increased with an increasing previous history of COVID-19. A dose-dependent relationship was observed between EQ-5D-5L and the scale's total score, categorized according to quartiles.
Conclusion: We successfully developed the Long COVID Burden Index, a simple 11-item scale to easily quantify symptoms frequently experienced by patients with long COVID, which may interfere with their daily lives.
期刊介绍：
The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.
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