Abigael Cohen1, Ruud W Selles2,3, Willemijn A De Ridder2,3,4, Marloes H P Ter Stege4, J Sebastiaan Souer4, Robbert M Wouters2,3,5. 1. A. Cohen, Department of Orthopaedic Surgery, Erasmus MC University Medical Center, Rotterdam, the Netherlands. 2. 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. 3. R. W. Selles, W. A. De Ridder, R. M. Wouters, Department of Rehabilitation Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands. 4. W. A. De Ridder, M. H. P. Ter Stege, J. S. Souer, Hand and Wrist Center, Xpert Clinic, Eindhoven, the Netherlands. 5. R. M. Wouters, Center for Hand Therapy, Handtherapie Nederland, Utrecht, the Netherlands.
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.
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.
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