Browsing by Subject "Republic of Korea"

Now showing 1 - 6 of 6
  • Thumbnail Image
    ItemOpen Access
    Efficacy of interferon beta-1a plus remdesivir compared with remdesivir alone in hospitalised adults with COVID-19: a double-bind, randomised, placebo-controlled, phase 3 trial.
    (The Lancet. Respiratory medicine, 2021-12) Kalil, Andre C; Mehta, Aneesh K; Patterson, Thomas F; Erdmann, Nathaniel; Gomez, Carlos A; Jain, Mamta K; Wolfe, Cameron R; Ruiz-Palacios, Guillermo M; Kline, Susan; Regalado Pineda, Justino; Luetkemeyer, Anne F; Harkins, Michelle S; Jackson, Patrick EH; Iovine, Nicole M; Tapson, Victor F; Oh, Myoung-Don; Whitaker, Jennifer A; Mularski, Richard A; Paules, Catharine I; Ince, Dilek; Takasaki, Jin; Sweeney, Daniel A; Sandkovsky, Uriel; Wyles, David L; Hohmann, Elizabeth; Grimes, Kevin A; Grossberg, Robert; Laguio-Vila, Maryrose; Lambert, Allison A; Lopez de Castilla, Diego; Kim, EuSuk; Larson, LuAnn; Wan, Claire R; Traenkner, Jessica J; Ponce, Philip O; Patterson, Jan E; Goepfert, Paul A; Sofarelli, Theresa A; Mocherla, Satish; Ko, Emily R; Ponce de Leon, Alfredo; Doernberg, Sarah B; Atmar, Robert L; Maves, Ryan C; Dangond, Fernando; Ferreira, Jennifer; Green, Michelle; Makowski, Mat; Bonnett, Tyler; Beresnev, Tatiana; Ghazaryan, Varduhi; Dempsey, Walla; Nayak, Seema U; Dodd, Lori; Tomashek, Kay M; Beigel, John H; ACTT-3 study group members

    Background

    Functional impairment of interferon, a natural antiviral component of the immune system, is associated with the pathogenesis and severity of COVID-19. We aimed to compare the efficacy of interferon beta-1a in combination with remdesivir compared with remdesivir alone in hospitalised patients with COVID-19.

    Methods

    We did a double-blind, randomised, placebo-controlled trial at 63 hospitals across five countries (Japan, Mexico, Singapore, South Korea, and the USA). Eligible patients were hospitalised adults (aged ≥18 years) with SARS-CoV-2 infection, as confirmed by a positive RT-PCR test, and who met one of the following criteria suggestive of lower respiratory tract infection: the presence of radiographic infiltrates on imaging, a peripheral oxygen saturation on room air of 94% or less, or requiring supplemental oxygen. Patients were excluded if they had either an alanine aminotransferase or an aspartate aminotransferase concentration more than five times the upper limit of normal; had impaired renal function; were allergic to the study product; were pregnant or breast feeding; were already on mechanical ventilation; or were anticipating discharge from the hospital or transfer to another hospital within 72 h of enrolment. Patients were randomly assigned (1:1) to receive intravenous remdesivir as a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose administered daily for up to 9 days and up to four doses of either 44 μg interferon beta-1a (interferon beta-1a group plus remdesivir group) or placebo (placebo plus remdesivir group) administered subcutaneously every other day. Randomisation was stratified by study site and disease severity at enrolment. Patients, investigators, and site staff were masked to interferon beta-1a and placebo treatment; remdesivir treatment was given to all patients without masking. The primary outcome was time to recovery, defined as the first day that a patient attained a category 1, 2, or 3 score on the eight-category ordinal scale within 28 days, assessed in the modified intention-to-treat population, defined as all randomised patients who were classified according to actual clinical severity. Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04492475.

    Findings

    Between Aug 5, 2020, and Nov 11, 2020, 969 patients were enrolled and randomly assigned to the interferon beta-1a plus remdesivir group (n=487) or to the placebo plus remdesivir group (n=482). The mean duration of symptoms before enrolment was 8·7 days (SD 4·4) in the interferon beta-1a plus remdesivir group and 8·5 days (SD 4·3) days in the placebo plus remdesivir group. Patients in both groups had a time to recovery of 5 days (95% CI not estimable) (rate ratio of interferon beta-1a plus remdesivir group vs placebo plus remdesivir 0·99 [95% CI 0·87-1·13]; p=0·88). The Kaplan-Meier estimate of mortality at 28 days was 5% (95% CI 3-7%) in the interferon beta-1a plus remdesivir group and 3% (2-6%) in the placebo plus remdesivir group (hazard ratio 1·33 [95% CI 0·69-2·55]; p=0·39). Patients who did not require high-flow oxygen at baseline were more likely to have at least one related adverse event in the interferon beta-1a plus remdesivir group (33 [7%] of 442 patients) than in the placebo plus remdesivir group (15 [3%] of 435). In patients who required high-flow oxygen at baseline, 24 (69%) of 35 had an adverse event and 21 (60%) had a serious adverse event in the interferon beta-1a plus remdesivir group compared with 13 (39%) of 33 who had an adverse event and eight (24%) who had a serious adverse event in the placebo plus remdesivir group.

    Interpretation

    Interferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo.

    Funding

    The National Institute of Allergy and Infectious Diseases (USA).
  • Thumbnail Image
    ItemOpen Access
    Factors associated with eating performance in older adults with dementia in long-term care facilities: a cross-sectional study
    (BMC Geriatrics, 2021-12) Jung, Dukyoo; De Gagne, Jennie C; Lee, Hyesoon; Lee, Minkyung
    Background: The purpose of this study was to investigate factors influencing eating performance in older adults with dementia (OAWDs) in long-term care (LTC) facilities. Methods: This cross-sectional study examined risk factors for compromised eating performance by comparing both independent and dependent older adults with dementia. The study participants were 117 OAWDs in LTC facilities in South Korea. Measurements included (a) general characteristics, (b) activities of daily living (ADL) including eating performance, (c) cognitive function, (d) physical capability, (e) grip strength, (f) Behavioral Psychological Symptoms of Dementia (BPSD), and (g) depression. Data were analyzed by the percentage, mean and standard deviation, Chi-square test, t-test, and logistic regression. Results: The eating independent group had more comorbidities than the dependent group (t = 2.793, p < .006); had significantly higher cognition (t = 4.108, p < .001) and physical capability (t = 5.258, p < .001); and had stronger grip strength (t = 2.887, p = .005). Comorbidities and physical capability were determinants for independent eating performance (Odds Ratio [OR] = 1.969, p = .014; OR = 1.324, p < .001). Conclusions: It is suggested that maintaining physical capability should be encouraged to support independent eating performance by OAWDs in LTC facilities. The results of this study could serve as a basis for developing function-focused care to maintain the residual eating performance of OAWDs in Korean LTC facilities. This is a subject area that has not been fully explored.
  • Thumbnail Image
    ItemOpen Access
    Lifetime cost-effectiveness analysis of ticagrelor in patients with acute coronary syndromes based on the PLATO trial: a Singapore healthcare perspective.
    (Singapore medical journal, 2013-03) Chin, Chee Tang; Mellstrom, Carl; Chua, Terrance Siang Jin; Matchar, David Bruce

    Introduction

    Ticagrelor is a novel antiplatelet drug developed to reduce atherothrombosis. The PLATO trial compared ticagrelor and aspirin to clopidogrel and aspirin in patients with acute coronary syndromes (ACS). Ticagrelor was found to be superior in the primary composite endpoint of cardiovascular death, myocardial infarction or stroke, without increasing major bleeding events. The current study estimates the lifetime cost-effectiveness of ticagrelor relative to generic clopidogrel from a Singapore public healthcare perspective.

    Methods

    This study used a two-part cost-effectiveness model. The first part was a 12-month decision tree (using PLATO trial data) to estimate the rates of major cardiovascular events, healthcare costs and health-related quality of life. The second part was a Markov model estimating lifetime quality-adjusted survival and costs conditional on events during the initial 12 months. Daily drug costs applied were SGD 1.05 (generic clopidogrel) and SGD 6.00 (ticagrelor). Cost per quality-adjusted life years (QALY) was estimated from a Singapore public healthcare perspective using life tables and short-term costs from Singapore, and long-term costs from South Korea. Deterministic and probabilistic sensitivity analyses were performed.

    Results

    Ticagrelor was associated with a lifetime QALY gain of 0.13, primarily driven by lower mortality. The resulting incremental cost per QALY gained was SGD 10,136.00. Probabilistic sensitivity analysis indicated that ticagrelor had a > 99% probability of being cost-effective, given the lower recommended WHO willingness-to-pay threshold of one GDP/capita per QALY.

    Conclusion

    Based on PLATO trial data, one-year treatment with ticagrelor versus generic clopidogrel in patients with ACS, relative to WHO reference standards, is cost-effective from a Singapore public healthcare perspective.
  • Thumbnail Image
    ItemOpen Access
    Nursing faculty experiences with student incivility in South Korea: a qualitative study.
    (BMC medical education, 2022-02) Hyun, Myung Sun; Kang, Hee Sun; De Gagne, Jennie C; Park, Jeonghwa

    Background

    Student academic incivility is a serious problem in nursing education because it negatively influences the learning process, wellbeing of faculty members, and faculty-student relationships. The aim of this study was to explore nursing faculty experiences related to student incivility in nursing education.

    Methods

    We used an exploratory qualitative methodology and conducted in-depth interviews with 14 nursing faculty members working at 11 nursing universities in South Korea. A qualitative content analysis was carried out.

    Results

    The six themes that emerged from the faculty experiences were nursing student indifference to teachers' expectations; ignoring behavioral standards in school life; differing responses to uncivil student behavior; self-reflection as a nursing educator; negative impact on faculty in a nursing education context; and awareness of civility in a nursing education context.

    Conclusion

    Dealing with student academic incivility in nursing education is one of the most challenging tasks for faculty members, and it should be managed to provide a comfortable learning environment. The present study delineated the uncivil behavior experienced by the faculty and their negative effects in the educational context and suggested alternatives to manage student incivility and foster a positive educational environment through the eyes of the faculty. The findings of this study suggest an evidence-based direction for fostering a culture of civility in nursing schools.
  • Thumbnail Image
    ItemOpen Access
    Social networks, health-promoting behaviors, and health-related quality of life in older adults with and without arthritis.
    (PloS one, 2019-01) Hong, Minjoo; Shin, Hyewon; De Gagne, Jennie C
    The purpose of this secondary analysis study was to compare social networks, health-promoting behaviors, and health-related quality of life of South Korean adults, aged 65 years or older, with and without arthritis, and to identify factors that are related to health-related quality of life. The sample consisted of 103 adults with arthritis and 123 adults without arthritis. Data were analyzed using a two-way analysis of variance, χ2-test, Pearson's correlation, and multiple regression analysis. All variables except age and religion showed statistically significant differences between older adults with and without arthritis. The group with arthritis reported lower scores on social networks, health-promoting behaviors, and health-related quality of life compared to the healthy group without arthritis. Analyzed using multiple regression, 43.8% of the older adults with arthritis had the factors related to health-related quality of life (F = 40.71, p < .001) including exercise (β = .43, p < .001) and living with someone (β = .32, p = .001). In the group of older adults without arthritis, 26.2% had the factors related to health-related quality of life (F = 15.44, p < .001) including exercise (β = .31, p = .001), social gatherings, and employment status. Exercise was one of the factors that showed the strongest relationship to health-related quality of life. The provision of resources that can enable an individual to engage in physical activities is warranted.
  • Thumbnail Image
    ItemOpen Access
    The impact of the CONSORT statement on reporting of randomized clinical trials in psychiatry.
    (Contemporary clinical trials, 2009-03) Han, Changsu; Kwak, Kyung-phil; Marks, David M; Pae, Chi-Un; Wu, Li-Tzy; Bhatia, Kamal S; Masand, Prakash S; Patkar, Ashwin A
    To determine whether the CONSORT recommendations influenced the quality of reporting of randomized controlled trials (RCTs) in the field of psychiatry, we evaluated the quality of clinical trial reports before and after the introduction of CONSORT statement. We selected seven high impact journals and retrieved the randomized, clinical trials in the field of psychiatry during the period of 1992-1996 (pre-CONSORT) and 2002-2007 (post-CONSORT). Among the total 5201 articles screened, 736 were identified and entered in our database. After critical review of the publications, 442 articles met the inclusion and exclusion criteria. The CONSORT Index (sum of 22 items of the checklist) during the post-CONSORT period was significantly higher than that during the pre-CONSORT period. However, over 40% of post-CONSORT studies did not adhere to CONSORT statement for reporting the process of randomization, and details of the process for obtaining informed consent were still insufficient. Furthermore, adherence to the CONSORT guidelines of reporting how blinding was accomplished and evaluated actually decreased after publication of the CONSORT statement. Although the overall quality of reporting on psychiatric RCTs generally improved after publication of the CONSORT statement, reporting the details of randomization, blinding, and obtaining informed consent remain insufficient.