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Patient-Reported Outcomes Positively Affected by Vaccine Availability During COVID-19 Pandemic

“The COVID-19 pandemic causes concern among patients with ARD due to increased risk of infection and heightened isolation from social distancing,” investigators explained.

According to an ArthritisPower analysis, patients with autoimmune and rheumatic disease (ARD) reported improvements in mental, social, and physical health scores during the summer of 2021, which were consistent with the availability of COVID-19 vaccinations. However, as the US faced new variants of the virus, mental and social health scores worsened by December.

“The COVID-19 pandemic causes concern among patients with ARD due to increased risk of infection and heightened isolation from social distancing,” investigators explained.

To examine how mean patient-reported outcome (PRO) scores for mental, social, and physical health fluctuated after COVID-19 vaccine availability in the United States, ArthritisPower reported on an analysis, conducted between January 2020 and April 2021, in which participants enrolled in the registry completed a variety of Patient-Reported Outcomes Measurement Information System (PROMIS) measures. These included physical health (physical function, pain interference, fatigue, and sleep disturbance), mental health (anger, depression, and anxiety), and social health (emotional support and social isolation). Separately, a follow-up analysis was performed between May and December 2021. Only patients recruited in the initial analysis were eligible to participate in the follow-up.

A null hypothesis was defined as no change in monthly average scores across the 23-month pandemic period. An analysis of means was used to compare monthly assessment mean scores with overall mean scores for each measure during this time. Patients with <2 assessment time points and osteoarthritis without ARD were excluded.

A total of 49,940 PRO scores were collected from 2266 participants during the study period, with 8393 scores were contributed during the follow-up period (mean number of observations per patient was 5.6). The majority of patients were female (87.6%), White (86.7%), and had a mean age of 52.1 (12.7) years. Nearly half (49.9%, n=1131) of participants were diagnosed with rheumatoid arthritis (RA).

The most commonly reported PRO measures, with >11,000 results, were fatigue, sleep disturbance, pain interference, and physical function. While mental and social health assessment scores initially improved, they worsened during the last 8 months of 2021. Overall scores were anger 61.5 (12.8), social isolation 61.9 (10.5), and anxiety 62.4 (12.5). Between July and August, social isolation decreased by 1 standard deviation (SD). Additionally, anger declined by > ½ SD (53.3 [19.4]) in August and anxiety declined by ½ SD (57.7 [11.3]) in September. However, in December, anger rose by > ½ SD (68.6 [5.0]). While pain interference (mean: 63.3 [7.8]), fatigue (62.6 [9.5]), and sleep disturbance (58.1 [9.0]) scores were significantly lower in May, June, July, and August compared with the assessment mean, none decreased by > ½ SD.

The study, “Changes in Patient-Reported Outcome Scores During COVID-19 Pandemic: Data from the ArthritisPower Registry,” was presented at the Annual European Congress of Rheumatology (EULAR 2022).