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Assessment of retrospective collection of EQ-5D-5L in a US COVID-19 population.
Sun, Xiaowu; Di Fusco, Manuela; Puzniak, Laura; Coetzer, Henriette; Zamparo, Joann M; Tabak, Ying P; Cappelleri, Joseph C.
Afiliação
  • Sun X; Clinical Trial Services, CVS Health, Woonsocket, RI, USA. xiaowu.sun@cvshealth.com.
  • Di Fusco M; Pfizer Inc, Health Economics and Outcomes Research, New York, NY, USA.
  • Puzniak L; Pfizer Inc, MDSCA Vaccines, Collegeville, PA, USA.
  • Coetzer H; Clinical Trial Services, CVS Health, Woonsocket, RI, USA.
  • Zamparo JM; Pfizer Inc, Groton, CT, USA.
  • Tabak YP; Clinical Trial Services, CVS Health, Woonsocket, RI, USA.
  • Cappelleri JC; Pfizer Inc, Statistical Research and Data Science Center, Groton, CT, USA.
Health Qual Life Outcomes ; 21(1): 103, 2023 Sep 08.
Article em En | MEDLINE | ID: mdl-37679771
BACKGROUND: It is imperative to evaluate health related quality of life (HRQoL) pre-COVID-19, but there is currently no evidence of the retrospective application of the EuroQol 5-Dimension, 5 level version (EQ-5D-5L) for COVID-19 studies. METHODS: Symptomatic patients with SARS-CoV-2 at CVS Health US test sites were recruited between 01/31/2022-04/30/2022. Consented participants completed the EQ-5D-5L questionnaire twice: a modified version where all the questions were past tense to retrospectively assess pre-COVID-19 baseline QoL, and the standard version in present tense to assess current HRQoL. Duncan's new multiple range test was adopted for post analysis of variance pairwise comparisons of EQ visual analog scale (EQ VAS) means between problem levels for each of 5 domains. A linear mixed model was applied to check whether the relationship between EQ VAS and utility index (UI) was consistent pre-COVID-19 and during COVID-19. Matching-adjusted indirect comparison was used to compare pre-COVID-19 UI and EQ VAS scores with those of the US population. Lastly, Cohen's d was used to quantify the magnitude of difference in means between two groups. RESULTS: Of 676 participants, 10.2% were age 65 or more years old, 73.2% female and 71.9% white. Diabetes was reported by 4.7% participants and hypertension by 11.2%. The estimated coefficient for the interaction of UI-by-retrospective collection indicator (0 = standard prospective collection, 1 = retrospective for pre-COVID-19), -4.2 (SE: 3.2), P = 0.197, indicates that retrospective collection does not significantly alter the relationship between EQ VAS and UI. After adjusting for age, gender, diabetes, hypertension, and percent of mobility problems, the predicted means of pre-COVID-19 baseline EQ VAS and UI were 84.6 and 0.866, respectively. Both means were close to published US population norms (80.4 and 0.851) compared to those observed (87.4 and 0.924). After adjusting for age, gender, diabetes, and hypertension, the calculated ES between pre-COVID-19 and COVID-19 for UI and EQ VAS were 0.15 and 0.39, respectively. Without retrospectively collected EQ-5D-5L, using US population norms tended to underestimate the impact of COVID-19 on HRQoL. CONCLUSION: At a group level the retrospectively collected pre-COVID-19 EQ-5D-5L is adequate and makes it possible to directly evaluate the impact of COVID-19 on HRQoL. ( ClinicalTrials.gov NCT05160636).
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: COVID-19 / Hipertensão Tipo de estudo: Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Child / Female / Humans / Male Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: COVID-19 / Hipertensão Tipo de estudo: Observational_studies / Prognostic_studies / Risk_factors_studies Limite: Aged / Child / Female / Humans / Male Idioma: En Ano de publicação: 2023 Tipo de documento: Article