Clinical Trial Services, CVS Health, Woonsocket, RI, USA.
Pfizer Inc, Health Economics and Outcomes Research, New York, NY, USA.
Health Qual Life Outcomes. 2023 Sep 8;21(1):103. doi: 10.1186/s12955-023-02187-x.
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.
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.
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.
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).
在 COVID-19 之前评估健康相关生活质量（HRQoL）至关重要，但目前尚无证据表明使用 EuroQol 5 维度，5 水平版（EQ-5D-5L）回溯性应用于 COVID-19 研究。
在美国 CVS 健康测试点招募 SARS-CoV-2 有症状的患者，招募时间为 2022 年 1 月 31 日至 4 月 30 日。同意的参与者两次完成 EQ-5D-5L 问卷：一个修改版本，其中所有问题都是过去式，以回溯性评估 COVID-19 之前的基线 QoL；另一个是标准版本，用于评估当前的 HRQoL。采用邓肯新多重范围检验进行方差分析后，对每个 5 个域的问题水平的 EQ 视觉模拟量表（EQ VAS）均值进行两两比较。应用线性混合模型检查 COVID-19 前后 EQ VAS 和效用指数（UI）之间的关系是否一致。采用匹配调整间接比较，将 COVID-19 前的 UI 和 EQ VAS 评分与美国人群进行比较。最后，使用 Cohen's d 量化两组间均值差异的大小。
在 676 名参与者中，10.2%的人年龄在 65 岁或以上，73.2%为女性，71.9%为白人。4.7%的参与者报告有糖尿病，11.2%的参与者有高血压。UI-回溯收集指标交互项的估计系数（0=标准前瞻性收集，1=COVID-19 前回溯收集）为-4.2（SE：3.2），P=0.197，表明回溯收集不会显著改变 EQ VAS 和 UI 之间的关系。在调整年龄、性别、糖尿病、高血压和移动能力问题的比例后，COVID-19 前基线 EQ VAS 和 UI 的预测均值分别为 84.6 和 0.866。与观察到的数值（87.4 和 0.924）相比，这两个均值都接近公布的美国人群正常值（80.4 和 0.851）。在调整年龄、性别、糖尿病和高血压后，UI 和 EQ VAS 之间 COVID-19 前后的计算 ES 分别为 0.15 和 0.39。如果不回溯收集 EQ-5D-5L，使用美国人群的正常值可能会低估 COVID-19 对 HRQoL 的影响。
在群体水平上，回溯性收集的 COVID-19 前 EQ-5D-5L 是足够的，并能够直接评估 COVID-19 对 HRQoL 的影响。（ClinicalTrials.gov NCT05160636）。
