Impact of a pharmaceutical care service for patients with rheumatoid arthritis using a customised mobile device (the PROUD trial): study protocol for a randomised controlled trial.

INTRODUCTION: Rheumatoid arthritis (RA) generally requires lifelong treatment; however, its medication complexity might affect non-adherence. Pharmacist-led telehealth services were as effective as face-to-face services and reduced potential side effects in outpatients with chronic diseases. This study aims to analyse the effect of a telepharmacy service with a customised mobile device in comparison with the usual pharmacist service on the humanistic and clinical outcomes in patients with RA. METHODS AND ANALYSIS: The study is designed as a prospective, randomised, open-label, and controlled trial to compare the humanistic and clinical outcomes of the pharmaceutical care service with monthly telecommunications and a customised mobile application (telepharmacy care group) against the usual service by community pharmacists (usual care group) in 256 patients with RA and prescribed at least one of the disease-modifying antirheumatic drugs. Participants will be recruited from a tertiary hospital in Republic of Korea with written informed consent. The primary outcome will be the changes in health-related quality of life as measured by the Korean version of the EuroQoL's five-dimensional questionnaire at 6 months compared with baseline. The secondary outcomes will be the changes in the following: scores of the Korean version of the Compliance Questionnaire-Rheumatology and medication knowledge at 3 and 6 months compared with baseline; scores of the Korean version of the Pharmacy Service Questionnaire at 6 months compared with baseline; clinical parameters such as erythrocyte sedimentation rate, C reactive protein level, and pain score at 3 and 6 months compared with baseline; frequency of acute care utilisation over 6 months. Analysis will be carried out with intent-to-treat and per-protocol principles. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Institutional Review Board (IRB) of Daegu Catholic University Medical Center (IRB no. CR-21-082-L, 14 July 2021). The study findings will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: KCT0006508.

Baseline use of hydroxychloroquine or immunosuppressive drugs and the risk of coronavirus disease 2019.

BACKGROUND/AIMS: The preventive role of hydroxychloroquine (HCQ) on coronavirus disease 2019 (COVID-19) remains unclear. The aim of this study was to examine the effects of HCQ and other immunosuppressive drugs on the incidence of COVID-19. METHODS: The data were collected from the South Korea National Health Insurance Sharing-COVID-19 database. All individuals who underwent nasopharyngeal and oropharyngeal swab tests for COVID-19 from January 2020 to May 2020 are included. The association between COVID-19 risk and HCQ use was examined in a propensity score-matched population. Factors associated with COVID-19 were identified using multiple logistic regression analysis. RESULTS: Total 8,070 patients with COVID-19 and 121,050 negative controls were included from the database. Among all participants, 381 were HCQ users. In a propensity score-matched population, the incidence of COVID-19 was 7.1% in HCQ users and 6.8% in non-users. The odds ratio (OR) for HCQ use was 1.05 with a 95% confidence interval (CI) of 0.58 to 1.89. Among the subpopulation of patients with rheumatoid arthritis (RA), 33 were diagnosed with COVID-19 and 478 were not. Use of HCQ, glucocorticoids, or other immunosuppressive drugs was not associated with COVID-19 risk, whereas abatacept use was. Chronic lung disease was an independent risk factor for COVID-19 diagnosis in patients with RA (adjusted OR, 6.07; 95% CI, 1.10 to 33.59). CONCLUSION: The risk of COVID-19 did not differ between HCQ users and non-users. Glucocorticoids, conventional disease-modifying antirheumatic drugs (DMARDs), and biological DMARDs other than abatacept did not increase the risk of COVID-19.

Prognostic Implication of Baseline Sarcopenia for Length of Hospital Stay and Survival in Patients With Coronavirus Disease 2019.

BACKGROUND: The impact of sarcopenia on clinical outcomes of coronavirus disease 2019 (COVID-19) is not clearly determined yet. We aimed to investigate the association between baseline sarcopenia and clinical outcomes in patients with COVID-19. METHODS: All hospitalized adult patients with COVID-19 who had baseline chest computed tomography (CT) scans at a Korean university hospital from February 2020 to May 2020 were included. The main outcome was time from hospital admission to discharge. Death was considered as a competing risk for discharge. Baseline skeletal muscle cross-sectional area at the level of the 12th thoracic vertebra was measured from chest CT scans. The lowest quartile of skeletal muscle index (skeletal muscle cross-sectional area divided by height-squared) was defined as sarcopenia. RESULTS: Of 121 patients (median age, 62 years; 44 men; 29 sarcopenic), 7 patients died and 86 patients were discharged during the 60-day follow-up. Patients with sarcopenia showed a longer time to discharge (median, 55 vs 28 days; p < .001) and a higher incidence of death (17.2% vs 2.2%; p = .004) than those without sarcopenia. Baseline sarcopenia was an independent predictor of delayed hospital discharge (adjusted hazard ratio [aHR], 0.47; 95% confidence interval [95% CI], 0.23-0.96), but was not independently associated with mortality in patients with COVID-19 (aHR, 3.80; 95% CI, 0.48-30.26). The association between baseline sarcopenia and delayed hospital discharge was consistent in subgroups stratified by age, sex, comorbidities, and severity of COVID-19. CONCLUSIONS: Baseline sarcopenia was independently associated with a prolonged hospital stay in patients with COVID-19. Sarcopenia could be a prognostic marker in COVID-19.