دورية أكاديمية
The symptoms evolution of long COVID‑19 (SE-LC19): a new patient-reported content valid instrument.
| العنوان: | The symptoms evolution of long COVID‑19 (SE-LC19): a new patient-reported content valid instrument. |
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| المؤلفون: | Rofail D; Regeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA. diana.rofail@regeneron.com., Somersan-Karakaya S; Regeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA., Mylonakis E; Infectious Diseases Division, Warren Alpert Medical School of Brown University, Providence, RI, USA.; Department of Medicine, Houston Methodist Hospital, Houston, TX, USA., Choi JY; Modus Outcomes, Cambridge, MA, USA., Przydzial K; Modus Outcomes, Cambridge, MA, USA., Marquis S; Modus Outcomes, Cambridge, MA, USA., Zhao Y; Regeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA., Hussein M; Regeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA., Norton TD; Regeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA., Podolanczuk AJ; Weill Cornell Medical College, New York, NY, USA., Geba GP; Regeneron Pharmaceuticals, Inc., 1 Rockwood Road, Sleepy Hollow, NY, 10591, USA. |
| المصدر: | Journal of patient-reported outcomes [J Patient Rep Outcomes] 2024 Aug 09; Vol. 8 (1), pp. 87. Date of Electronic Publication: 2024 Aug 09. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer International Publishing Country of Publication: Germany NLM ID: 101722688 Publication Model: Electronic Cited Medium: Internet ISSN: 2509-8020 (Electronic) Linking ISSN: 25098020 NLM ISO Abbreviation: J Patient Rep Outcomes Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: [Heidelberg] : Springer International Publishing, [2017]- |
| مواضيع طبية MeSH: | COVID-19*/psychology , Patient Reported Outcome Measures* , Psychometrics*/methods , Psychometrics*/instrumentation , Post-Acute COVID-19 Syndrome* , SARS-CoV-2*, Humans ; Female ; Male ; Middle Aged ; Aged ; Adult ; Reproducibility of Results ; Surveys and Questionnaires |
| مستخلص: | 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. Conclusion: 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. (© 2024. The Author(s).) |
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| معلومات مُعتمدة: | N/A Regeneron Pharmaceuticals; HHSO100201700020C Department of Health and Human Services, Office of the Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority |
| فهرسة مساهمة: | Keywords: Long COVID; Long haulers; Long-haul COVID; Patient-reported outcome measures; Patient-reported outcomes; Post-COVID conditions; Qualitative; Questionnaire; Symptoms |
| تواريخ الأحداث: | Date Created: 20240808 Date Completed: 20240808 Latest Revision: 20240811 |
| رمز التحديث: | 20240812 |
| مُعرف محوري في PubMed: | PMC11310370 |
| DOI: | 10.1186/s41687-024-00737-5 |
| PMID: | 39117891 |
| قاعدة البيانات: | MEDLINE |
Find this article in full text from Springer Verlag. 
Full Text Finder | تدمد: | 2509-8020 |
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| DOI: | 10.1186/s41687-024-00737-5 |