scholarly journals Tocilizumab in Hospitalized Patients with Severe COVID-19: An Open Label, Prospective Study

Author(s):  
Theodoros Karampitsakos ◽  
Elli Malakounidou ◽  
Ourania Papaioannou ◽  
Vasilina Dimakopoulou ◽  
Eirini Zarkadi ◽  
...  

Abstract Background: Data on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched.Methods: In this open label, prospective study, we evaluated clinical outcomes in consecutive patients with COVID-19 and PaO2/FiO2<200 receiving tocilizumab plus usual care versus usual care alone. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO2/FiO2 at day 5 and change in WHO progression scale at day 10.Findings: Overall, 114 patients were included in the analysis (tocilizumab plus usual care: 56, usual care: 58). Allocation to usual care was associated with significant increase in 28-day mortality compared to tocilizumab plus usual care [Cox proportional-hazards model: HR: 3.34, (95%CI: 1.21 to 9.30), (p=0.02)]. There was not a statistically significant difference with regards to hospital discharge over the 28-day period for patients receiving tocilizumab compared to usual care [11.0 days (95%CI: 9.0 to 16.0) vs 14.0 days (95%CI: 10.0 to 24.0), HR: 1.32 (95%CI: 0.84 to 2.08), p=0.21]. ΔPaO2/FiO2 at day 5 was significantly higher in the tocilizumab group compared to the usual care group [42.0 (95%CI: 23.0 to 84.7) vs 15.8 (95%CI: -19.4 to 50.3), p=0.03]. ΔWHO scale at day 10 was significantly lower in the tocilizumab group compared to the usual care group (-0.5±2.1 vs 0.6±2.6, p=0.005). Conclusion: This is the first study administrating tocilizumab in patients with COVID-19 based on PaO2/FiO2. Tocilizumab improved survival and other clinical outcomes in hospitalized patients with COVID-19 and PaO2/FiO2<200 irrespective of systemic inflammatory markers levels.

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Theodoros Karampitsakos ◽  
Elli Malakounidou ◽  
Ourania Papaioannou ◽  
Vasilina Dimakopoulou ◽  
Eirini Zarkadi ◽  
...  

Abstract Background Data on the safety and efficacy profile of tocilizumab in patients with severe COVID-19 needs to be enriched. Methods In this open label, prospective study, we evaluated clinical outcomes in consecutive patients with COVID-19 and PaO2/FiO2 < 200 receiving tocilizumab plus usual care versus usual care alone. Tocilizumab was administered at the time point that PaO2/FiO2 < 200 was observed. The primary outcome was 28-day mortality. Secondary outcomes included time to discharge, change in PaO2/FiO2 at day 5 and change in WHO progression scale at day 10. Findings Overall, 114 patients were included in the analysis (tocilizumab plus usual care: 56, usual care: 58). Allocation to usual care was associated with significant increase in 28-day mortality compared to tocilizumab plus usual care [Cox proportional-hazards model: HR: 3.34, (95% CI: 1.21–9.30), (p = 0.02)]. There was not a statistically significant difference with regards to hospital discharge over the 28 day period for patients receiving tocilizumab compared to usual care [11.0 days (95% CI: 9.0 to 16.0) vs 14.0 days (95% CI: 10.0–24.0), HR: 1.32 (95% CI: 0.84–2.08), p = 0.21]. ΔPaO2/FiO2 at day 5 was significantly higher in the tocilizumab group compared to the usual care group [42.0 (95% CI: 23.0–84.7) vs 15.8 (95% CI: − 19.4–50.3), p = 0.03]. ΔWHO scale at day 10 was significantly lower in the tocilizumab group compared to the usual care group (-0.5 ± 2.1 vs 0.6 ± 2.6, p = 0.005). Conclusion Administration of tocilizumab, at the time point that PaO2/FiO2 < 200 was observed, improved survival and other clinical outcomes in hospitalized patients with severe COVID-19 irrespective of systemic inflammatory markers levels.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Chiaki Ura ◽  
Tsuyoshi Okamura ◽  
Sachiko Yamazaki ◽  
Masaya Shimmei ◽  
Keisuke Torishima ◽  
...  

Abstract Background Green care farms, which offer care for people with dementia in a farm setting, have been emerging in the Netherlands. The aim of this study was to 1) implement green care farms which use rice farming in Japan, 2) explore the positive experiences of rice farming care, and 3) compare the effect of rice farming care to that of usual care on well-being and cognitive ability. Methods We developed a new method of green care farm in Japan which uses rice farming, a farming that is practiced all over East Asia. The participants were 15 people with dementia (mean age = 75.6 ± 9.8 years) who participated in a one-hour rice farming care program once a week for 25 weeks. We also collected qualitative data on the positive experiences of study participants after the program. As a reference data, we also collected the corresponding data of the usual care group which included 14 people with dementia (mean age = 79.9 ± 5.8 years) who were attending the near-by day-care. Results The mean participation rate on the rice farming care group was 72.1%. After the intervention, participants reported experiencing enjoyment and connection during the program. It also changed the staff’s view on dementia. The green care farm group showed a significant improvement in well-being but no significant difference in cognitive function compared to the usual care group. Conclusions Green care farms by using rice farming is promising care method which is evidence-based, empowerment-oriented, strengths-based, community-based dementia service, which also delivers meaningful experience for the people with dementia in East Asia. Trial registration UMIN, UMIN000025020, Registered 1 April 2017.


Circulation ◽  
2014 ◽  
Vol 130 (suppl_2) ◽  
Author(s):  
Tomonori Akasaka ◽  
Seiji Hokimoto ◽  
Noriaki Tabata ◽  
Kenji Sakamoto ◽  
Kenichi Tsujita ◽  
...  

Background: Based on 2011 ACCF/AHA/SCAI PCI guideline, it is recommended that PCI should be performed at hospital with onsite cardiac surgery. But, recent data suggests that there is no significant difference in clinical outcomes following primary or elective PCI between hospitals with and without onsite cardiac surgery. The proportion of PCI centers without onsite cardiac surgery comprises approximately more than half of all PCI centers in Japan. We examined the impact of with or without onsite cardiac surgery on clinical outcomes following PCI to ACS. Methods: From Aug 2008 to March 2011, subjects (n=2288) were enrolled from the Kumamoto Intervention Conference Study (KICS), which is a multicenter registry, and enrolling consecutive patients undergoing PCI in 15 centers in Japan. Patients were assigned to two groups treated in hospitals with (n=1954) or without (n=334) onsite cardiac surgery. Clinical events were followed up for 12 months. Primary endpoint was in-hospital death, cardiovascular death, myocardial infarction, and stroke. And we monitored other events those were non-cardiovascular deaths, bleeding complications, revascularizations, and emergent CABG. Results: There was no overall significant difference in primary endpoint between hospitals with and without onsite cardiac surgery (9.6%vs9.5%; P=0.737). There was also no significant difference when events in primary endpoint were considered separately. In other events, only revascularization was more frequently seen in hospitals with onsite cardiac surgery (22.1%vs12.9%; P<0.001). Kaplan-Meier analysis for primary endpoint showed that there was no significant difference between two groups (Log Rank P=0.943). By cox proportional hazards model analysis for primary endpoint, without onsite cardiac surgery was not a predictive factor for primary endpoint (HR 0.969, 95%CI 0.704-1.333; P=0.845). We performed propensity score matching analysis to correct for the disparate patient numbers between two groups, and there was also no significant difference for primary endpoint (6.9% vs 8.0%; P=0.544). Conclusions: There is no significant difference in clinical outcomes following PCI for ACS between hospitals with and without onsite cardiac surgery backup in Japan.


2021 ◽  
Author(s):  
◽  
Peter W Horby ◽  
Lise Estcourt ◽  
Leon Peto ◽  
Jonathan R Emberson ◽  
...  

ABSTRACTBackgroundTreatment of COVID-19 patients with plasma containing anti-SARS-CoV-2 antibodies may have a beneficial effect on clinical outcomes. We aimed to evaluate the safety and efficacy of convalescent plasma in patients admitted to hospital with COVID-19.MethodsIn this randomised, controlled, open-label, platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]) several possible treatments are being compared with usual care in patients hospitalised with COVID-19 in the UK. Eligible and consenting patients were randomly allocated to receive either usual care plus high titre convalescent plasma or usual care alone. The primary outcome was 28-day mortality.FindingsBetween 28 May 2020 and 15 January 2021, 5795 patients were randomly allocated to receive convalescent plasma and 5763 to usual care alone. There was no significant difference in 28-day mortality between the two groups: 1398 (24%) of 5795 patients allocated convalescent plasma and 1408 (24%) of 5763 patients allocated usual care died within 28 days (rate ratio [RR] 1·00; 95% confidence interval [CI] 0·93 to 1·07; p=0·93). The 28-day mortality rate ratio was similar in all prespecified subgroups of patients, including in those patients without detectable SARS-CoV-2 antibodies at randomisation. Allocation to convalescent plasma had no significant effect on the proportion of patients discharged from hospital within 28 days (66% vs. 67%; rate ratio 0·98; 95% CI 0·94-1·03, p=0·50). Among those not on invasive mechanical ventilation at baseline, there was no significant difference in the proportion meeting the composite endpoint of progression to invasive mechanical ventilation or death (28% vs. 29%; rate ratio 0·99; 95% CI 0·93-1·05, p=0·79).InterpretationAmong patients hospitalised with COVID-19, high-titre convalescent plasma did not improve survival or other prespecified clinical outcomes.FundingUK Research and Innovation (Medical Research Council) and National Institute of Health Research (Grant refs: MC_PC_19056; COV19-RECPLA).


2020 ◽  
Author(s):  
Chiaki Ura ◽  
Tsuyoshi Okamura ◽  
Sachiko Yamazaki ◽  
Masaya Shimmei ◽  
Keisuke Torishima ◽  
...  

Abstract BackgroundGreen care farms, which offer care for people with dementia in a farm setting, have been emerging in the Netherlands. The aim of this study was to 1) implement green care farms which use rice farming in Japan, 2) explore the positive experiences of rice farming care, and 3) compare the effect of rice farming care to that of usual care on well-being and cognitive ability. MethodsWe developed a new method of green care farm in Japan which uses rice farming, a farming that is practiced all over East Asia. The participants were 15 people with dementia (mean age = 75.6±9.8 years) who participated in a one-hour rice farming care program once a week for 25 weeks. We also collected qualitative data on the positive experiences of study participants after the program. As a reference data, we also collected the corresponding data of the usual care group which included 14 people with dementia (mean age = 79.9±5.8 years) who were attending the near-by day-care.ResultsThe mean participation rate on the rice farming care group was 72.1%. After the intervention, participants reported experiencing enjoyment and connection during the program. It also changed the staff’s view on dementia. The green care farm group showed a significant improvement in well-being but no significant difference in cognitive function compared to the usual care group. ConclusionsGreen care farms by using rice farming is promising care method which is evidence-based, empowerment-oriented, strengths-based, community-based dementia service, which also delivers meaningful experience for the people with dementia in East Asia.


2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
Aya Ozaki ◽  
Cynthia JACKEVICIUS ◽  
Alice Chong ◽  
Maria Koh ◽  
Maneesh Sud ◽  
...  

Background: Ticagrelor is a P2Y12 inhibitor with better cardiovascular outcomes than clopidogrel in clinical trials for acute coronary syndromes. However, the adoption of ticagrelor into clinical practice has been understudied. Therefore, we evaluated: 1) temporal trends in ticagrelor use, 2) factors associated with its use, and 3) hospital variation in its adoption and clinical outcomes. Methods: We conducted a population-based cohort study using administrative claims data in Ontario, Canada between 4/2014 and 3/2018. We identified individuals >65 years of age who were admitted for myocardial infarction (MI) or unstable angina (UA) and filled a prescription for ticagrelor or clopidogrel at or within 7 days of discharge. We categorized hospitals into quartiles based on ticagrelor utilization rates. The primary composite outcome was 1-year death or hospitalization for MI/UA, and 1-year bleeding hospitalization was a secondary outcome. Outcomes were evaluated using a Cox proportional hazards model to compare high vs. low utilization groups. Further, we quantified the between-hospital variability of ticagrelor utilization using multi-level logistic regression analysis, expressed as median odds ratios (MOR). Results: Among 23 962 patients in our cohort, 42.5% were prescribed ticagrelor ≤7 days post-hospital discharge. Ticagrelor utilization increased from 32.6% in 2014 to 51.8% in 2017. Hospitals at the lowest quartile of ticagrelor utilization (<8.8%) had a higher hazard of the primary outcome (adjusted hazard ratio: 1.27 95%CI: 1.11-1.46, p<0.001) compared with high ticagrelor utilization hospitals (>40%). No significant difference in bleeding hospitalization across hospital quartiles was observed. Some factors associated with higher ticagrelor use were cardiologist as most responsible physician during index hospitalization and urban hospital. After adjusting for patient-, prescriber- and hospital-level characteristics, substantial variation remained between hospitals in the likelihood of patients receiving ticagrelor at discharge (MOR: 2.54). Conclusion: Increasing trends of ticagrelor utilization were observed. Ticagrelor utilization rates varied across hospitals, and hospitals with higher ticagrelor adoption were associated with better clinical outcomes.


2018 ◽  
Vol 2018 ◽  
pp. 1-6 ◽  
Author(s):  
Natthaporn Sudas Na Ayutthaya ◽  
Itsarawan Sakunrak ◽  
Teerapon Dhippayom

Objective. To evaluate the impact of telephone follow-up service on clinical outcomes in patients on warfarin when discharged from hospital. Methods. This randomized controlled trial was conducted at a general hospital in Thailand. Patients aged ≥20 years who were prescribed warfarin when discharged were eligible to participate in this study. They were randomly allocated, using a computer generated random number, to receive either telephone follow-up intervention or usual care. Participants in the intervention group received telephone follow-up by hospital pharmacists for three months. During each telephone call, pharmacists performed medicine use reviews and addressed any problems identified. Key Findings. A total of 50 patients participated in this study. The proportion of international normalized ratio (INR) values in the target range for the telephone follow-up group (36/79, 45.6%) was higher than that in the usual care group (19/79, 24.1%), p=0.005. The mean time in the therapeutic range (TTR) in the telephone follow-up group was also higher than that in the usual care group (49.8±34.3 versus 28.0±27.5, p=0.017). All patients in the usual care group experienced one or more out-of-range INR values (25/25, 100%) compared to 21 out of 25 (84%) in the telephone follow-up group, p=0.037. There was no difference between the two groups in the incidence of complications or adverse events associated with warfarin. Conclusions. The telephone follow-up service in recently discharged patients helps them achieve and maintain their INR target. This anticoagulant supportive service should be promoted to patients receiving warfarin therapy after discharge. This trial is registered with TCTR20180614006 (Thai Clinical Trials Registry).


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 855.1-855
Author(s):  
E. Van Delft ◽  
K. H. Han ◽  
J. Hazes ◽  
D. Lopes Barreto ◽  
A. Weel

Background:Western countries experience an increasing demand for care, particularly for inflammatory arthritis (IA), while the healthcare budget decreases1. The innovative value-based primary care strategy2includes integrated care networks, where primary and secondary care bundle their expertise to improve patient value by providing the right care at the right place.General practitioners (GPs) have difficulties recognising IA, leading up to only 20% IA diagnoses of all newly referred arthralgia patients. However, since IA needs to be treated as early as possible to overcome progression, it is worthwhile to analyse whether integrated care networks have an impact on patient outcomes and cost-effectiveness. Triage by a rheumatologist in a primary care setting is one of the most promising integrated care networks for efficient referrals3.Objectives:To assess the effect of triage by a rheumatologist in a primary care setting in patients suspect for inflammatory arthritis.Methods:The present study follows a cluster randomized controlled trial design. The intervention, triage by a rheumatologist in a local primary care centre, will be compared to usual care. Usual care means that patients are referred to a rheumatology outpatient clinic based on the opinion of the general practitioner.The primary outcome is the frequency of IA diagnoses assessed by a rheumatologist. Patient reported outcome measures (PROMs (EQ-5D)) and costs (work productivity (iPCQ) and healthcare utilization (iMCQ)) were determined at baseline, after three, six and twelve months. The target was to include 267 patients for each study group (power level 0.8). Since this study is still ongoing we can only show first results on the efficiency of referrals.Results:In the period between February 2017 and December 2019 a total of 543 participants were included; 275 in the usual care group and 268 in the triage group. Mean age (51.3 ± 14.6 years) and percentage of men (23.6%) were comparable between groups (page=0.139; psex=0.330).The preliminary data show that the number of referred patients in the triage group is n=28 (10.5%) (Fig. 1). 32 patients (11.9%) were not referred directly but advice was given for additional diagnostics. Since all patients in the usual care group were referred there is a decrease of at least 77.6% in referrals when rheumatologists are participating in the integrated practice units.Preliminary data on diagnosis are available for all referred patients in the triage group and for n=137 (49.8%) in the usual care group at this point. In the triage group n=18 (64.2%) of referred patients were diagnosed with IA (6.7% of the total study population). In the usual care group this was n=52 (38.0%) of the patients yet diagnosed.Conclusion:These preliminary results of an integrated care network are promising. Approximately three-quarters of all patients can be withheld from expensive outpatient care. PROMs data and cost-effectiveness analysis will give clear answers in order to provide evidence whether this integrated care network can be implemented as a standard of care.References:[1] Rijksoverheid. (2018). Bestuurlijk akkoord medisch-specialistische zorg 2019 t/m 2022.https://www.rijksoverheid.nl/.[2] Porter ME, Pabo EA, Lee TH. (2013). Redesigning Primary Care: a strategic vision to improve value by organizing around patients’ needs. Health affairs, 32(3);516-525[3] Akbari A, et al. (2008). Interventions to improve outpatient referrals from primary care to secondary care. Cochrane Database Syst Rev, 4,CD005471.Disclosure of Interests:None declared


Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 105
Author(s):  
Jatapat Hemapanpairoa ◽  
Dhitiwat Changpradub ◽  
Sudaluck Thunyaharn ◽  
Wichai Santimaleeworagun

The prevalence of enterococcal infection, especially E. faecium, is increasing, and the issue of the impact of vancomycin resistance on clinical outcomes is controversial. This study aimed to investigate the clinical outcomes of infection caused by E. faecium and determine the risk factors associated with mortality. This retrospective study was performed at the Phramongkutklao Hospital during the period from 2014 to 2018. One hundred and forty-five patients with E. faecium infections were enrolled. The 30-day and 90-day mortality rates of patients infected with vancomycin resistant (VR)-E. faecium vs. vancomycin susceptible (VS)-E. faecium were 57.7% vs. 38.7% and 69.2% vs. 47.1%, respectively. The median length of hospitalization was significantly longer in patients with VR-E. faecium infection. In logistic regression analysis, VR-E. faecium, Sequential Organ Failure Assessment (SOFA) scores, and bone and joint infections were significant risk factors associated with both 30-day and 90-day mortality. Moreover, Cox proportional hazards model showed that VR-E. faecium infection (HR 1.91; 95%CI 1.09–3.37), SOFA scores of 6–9 points (HR 2.69; 95%CI 1.15–6.29), SOFA scores ≥ 10 points (HR 3.71; 95%CI 1.70–8.13), and bone and joint infections (HR 0.08; 95%CI 0.01–0.62) were significant risk factors for mortality. In conclusion, the present study confirmed the impact of VR-E. faecium infection on mortality and hospitalization duration. Thus, the appropriate antibiotic regimen for VR-E. faecium infection, especially for severely ill patients, is an effective strategy for improving treatment outcomes.


2021 ◽  
Vol 10 (4) ◽  
pp. 618
Author(s):  
Hiroyuki Ohbe ◽  
Kensuke Nakamura ◽  
Kazuaki Uda ◽  
Hiroki Matsui ◽  
Hideo Yasunaga

It is unclear when to begin rehabilitation after coronary artery bypass grafting (CABG) in the intensive care unit (ICU). Using the Japanese Diagnosis Procedure Combination inpatient database from 2010 to 2018, we identified adult patients who underwent a CABG and who were admitted to the ICU for ≥3 consecutive days from the date of their CABG. Patients who started any rehabilitation program prescribed by physicians or therapists within 3 days of CABG were defined as the early rehabilitation group, and the remaining patients were defined as the usual care group. We identified 30,568 eligible patients, with 13,150 (43%) patients in the early rehabilitation group. An inverse probability of treatment weighting analyses showed that the Barthel Index score at discharge in the early rehabilitation group was significantly higher than that in the usual care group (difference: 3.2; 95% confidence interval: 1.5–4.8). The early rehabilitation group had significantly lower in-hospital mortality, total hospitalization costs, length of ICU stay, and hospital stay vs. the usual care group. Our results suggested that early rehabilitation by physicians or therapists beginning within 3 days of CABG was safe, as suggested by the low mortality and improved physical function in patients who underwent CABG.


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