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新冠疫情对生活质量和其他患者报告结局有何影响?手部研究队列分析。

What Is the Impact of the COVID-19 Pandemic on Quality of Life and Other Patient-reported Outcomes? An Analysis of the Hand-Wrist Study Cohort.

机构信息

A. Cohen, Department of Orthopaedic Surgery, Erasmus MC University Medical Center, Rotterdam, the Netherlands.

R. W. Selles, W. A. De Ridder, R. M. Wouters, Department of Plastic, Reconstructive and Hand Surgery, Erasmus MC University Medical Center, Rotterdam, the Netherlands.

出版信息

Clin Orthop Relat Res. 2021 Feb 1;479(2):335-345. doi: 10.1097/CORR.0000000000001514.

Abstract

BACKGROUND

The coronavirus disease 2019 (COVID-19) pandemic, and its associated lockdowns in many parts of the world, have changed our daily lives and may have a psychological impact on around the globe. However, it is unknown how this influences the patient-reported outcome measures (PROMs) of patients involved in ongoing clinical research and medical care. For both the current and potential future lockdowns, it is important to determine if PROMs collected during such a period can be interpreted with confidence.

QUESTIONS/PURPOSES: (1) Is there a difference in quality of life between patients in the COVID-19 period group (March 23, 2020 to May 4, 2020) and patients in a reference period group (from the same period in 2018 or 2019)? (2) Is there a difference in pain, hand function, anxiety, depression, and illness perception between patients in the COVID-19 period group and patients in the reference period group?

METHODS

This study was part of a large cohort study with routine outcome measures of patients with hand and wrist conditions. To answer our research questions, we analyzed two samples because not all PROMs were sent to participants at the same time points after treatment. The first sample consisted of all participants who completed PROMs on quality of life (QoL), pain, and hand function at their final follow-up time point, which was either 3, 6, or 12 months post-treatment. The second sample consisted of participants who completed PROMs 3 months post-treatment on anxiety, depression, and illness perception. Each sample consisted of two groups: a COVID-19 period group and a reference period group. We included 1613 participants in the first sample (COVID-19 period group: n = 616; reference period group: n = 997) and 535 participants in the second sample (COVID-19 period group: n = 313; reference period group: n = 222). The primary outcome was QoL, expressed in the EuroQol 5-Dimensions questionnaire (EQ-5D) index score. Secondary outcomes were the other domains on the EQ-5D, as well as pain, hand function, anxiety, depression, and illness perception.

RESULTS

We found no between-group differences in the EQ-5D index score (standardized mean difference 0.035; p = 0.98). Furthermore, there were no between-group differences in PROM scores for hand function, anxiety, or depression. There were, however, a few small differences in subdomain items regarding pain and illness perception, but we believe in aggregate that these are unlikely to make a clinically important difference in our main finding.

CONCLUSION

The COVID-19 pandemic and its associated lockdown had no influence on QoL and had little influence on secondary outcomes in participants who were part of the Hand-Wrist Study Cohort. This finding implies that PROMs data collected during this period can be used with confidence in clinical research. Our findings indicate that when a pandemic like this occurs again, we can continue to use PROMs for analysis in clinical research or routine outcome measures.

LEVEL OF EVIDENCE

Level III, therapeutic study.

摘要

背景

2019 年冠状病毒病(COVID-19)大流行及其在世界许多地区的相关封锁改变了我们的日常生活,可能对全球产生心理影响。然而,目前尚不清楚这如何影响正在进行的临床研究和医疗护理中患者报告的结果测量(PROM)。对于当前和潜在的未来封锁,重要的是要确定在此期间收集的 PROM 是否可以有信心地进行解释。

问题/目的:(1)COVID-19 期组(2020 年 3 月 23 日至 5 月 4 日)和参考期组(同年同月或 2019 年)的患者之间的生活质量是否存在差异?(2)COVID-19 期组患者与参考期组患者之间在疼痛、手部功能、焦虑、抑郁和疾病认知方面是否存在差异?

方法

本研究是一项大型队列研究的一部分,对手部和腕部疾病患者的常规结果测量进行了分析。为了回答我们的研究问题,我们分析了两个样本,因为并非所有的 PROM 都在治疗后以相同的时间点发送给参与者。第一个样本包括所有在最终随访时间点完成 PROM 的患者,这些时间点是治疗后 3、6 或 12 个月,这些 PROM 包括生活质量(QoL)、疼痛和手部功能。第二个样本包括在治疗后 3 个月完成 PROM 的焦虑、抑郁和疾病认知的患者。每个样本都包括两个组:COVID-19 期组和参考期组。第一个样本包括 1613 名参与者(COVID-19 期组:n = 616;参考期组:n = 997),第二个样本包括 535 名参与者(COVID-19 期组:n = 313;参考期组:n = 222)。主要结局是 QoL,用 EuroQol 5 维度问卷(EQ-5D)指数评分表示。次要结局是 EQ-5D 的其他领域,以及疼痛、手部功能、焦虑、抑郁和疾病认知。

结果

我们没有发现 EQ-5D 指数评分的组间差异(标准化均数差值 0.035;p = 0.98)。此外,手部功能、焦虑或抑郁的 PROM 评分也没有组间差异。然而,在疼痛和疾病认知的一些子域项目上存在一些小的差异,但我们认为总体而言,这在我们的主要发现中不太可能产生临床重要差异。

结论

COVID-19 大流行及其相关封锁对 Hand-Wrist 研究队列参与者的生活质量和次要结局几乎没有影响。这一发现意味着在此期间收集的 PROM 数据可以在临床研究中充满信心地使用。我们的研究结果表明,当再次发生此类大流行时,我们可以继续将 PROM 用于临床研究或常规结果测量的分析。

证据水平

三级,治疗性研究。

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