scholarly journals Tocilizumab improves 28-day survival in hospitalized patients with severe COVID-19: an open label, prospective study

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 ◽  
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 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.


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.


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


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.


2021 ◽  
Author(s):  
Jay Greenstein ◽  
Robert Topp ◽  
Jena Etnoyer-Slaski ◽  
Michael Staelgraeve ◽  
John McNulty ◽  
...  

BACKGROUND Adhering to prescribed medical interventions predicts the efficacy of the treatment. In the physical health clinics, not adhering to prescribed therapy can take the form of not attending a scheduled clinic visit (no-show appointment) or prematurely terminating treatment against the advice of the provider (self-discharge). A variety of interventions, including mobile phone apps have been introduced with patients to increase their adherence with attending scheduled clinic visits. Limited research has examined the impact of a mobile phone app among patients attending a chiropractic and rehabilitation clinic visits. OBJECTIVE The purpose of this study was to compare adherence with prescribed physical health treatment among patients attending a chiropractic and rehabilitation clinic who did and did not choose to adopt a phone-based app to complement their treatment. METHODS The medical records of new patients who presented for care during 2019 and 2020 at five community-based chiropractic and rehabilitation clinics were reviewed for the number of kept and no-show appointments and if the patient was provider discharged or self-discharged. During this 24-month study 36.3% of the 4,126 patients seen in the targeted clinics had downloaded the Kanvas App to their mobile phone while the remaining patients chose not to download the app (Usual Care Group). The gamification component of the Kanvas app provided the patient with a point every time they attended their visits which could be redeemed for an incentive. RESULTS During both 2019 and 2020 respectively the Kanvas App Group (50%-38%) were provider discharged at a greater rate than the Usual-Care group (47-31%). The Kanvas App Group kept a similar number of appointments compared to the Usual-Care Group in 2019 (10.20 vs. 8.68) but kept significantly more appointments than the Usual-Care Group in 2020 (11.63 vs. 7.67). During 2019 both groups exhibited a similar number of no-show appointments (1.89 vs 1.96) but in 2020 the Kanvas App Group demonstrated more no-show appointments (2.89 vs 2.14) than the Usual Care. When collapsed across years and self discharged the Kanvas App group had a greater number of kept appointments (7.79) compared to the Usual Care group (4.58). When provider discharged both groups exhibited a similar number of kept appointments (15.25 vs 13.82). The Kanvas App group (1.38) and the Usual Care group (1.34) were similar in the number of no-show appointments when provider discharged and when self-discharged the Kanvas App Group had more no-show appointments (3.37) compared to the Usual Care Group (2.44). CONCLUSIONS When patients were provider discharged, they exhibited a similar number of kept appointments and no-show appointment. When subjects were self-discharged and received the Kanvas App they exhibited 3.2 more kept appointments and .94 more no-show appointments than self-discharged Usual Care group.


2022 ◽  
Author(s):  
Maryam Zahid ◽  
Ume Sughra

BACKGROUND Malnutrition is the most common problem in congenital heart diseases patients. Health based mobile applications play an important role in planning and tracking of diet for better nutritional status OBJECTIVE To assess the effect of artificial intelligence on nutritional status of children post cardiac surgery in comparison to usual care group. To assess usefulness of diet related mobile application in comparison to usual care group. METHODS This is a two arm randomized controlled trial that was conducted at a Tertiary Care Hospital, Rawalpindi. The study duration was 6 months from February 2021 till July 2021. Sample size was calculated to be 88. Intervention group was given a diet related mobile application and usual care group was handed a pamphlet with diet instructions on discharge. RESULTS Mean weight of all participants was 15 ± 5.7 kg at the time of discharge whereas at the end of 8th week mean weight of the participants in usual care group was 16.5 ± 7.2 kg and intervention group was 17.1 ± 5 kg. Average calories consumed by usual care group was 972 ± 252 kcal and 1000.75 ± 210 kcal by intervention group after 8 weeks of discharge. Average proteins consumed by the usual care group was 34.3 ± 12.5 grams and 39± 6.4 grams by intervention group after 8 weeks of discharge. At the end of intervention preferred diet planning tool for 79% of the participants was mobile application. At 8th week 93% of the participants considered the visual cues useful, 80% think that the mobile application language was understandable, 79% of the participants think nutritional goal setting is a useful feature in mobile application and 55% of the participants think the recipes in the application were useful. CONCLUSIONS The study showed strength for the future of scalable modern technology for self-nutrition monitoring. There was slight increase in the weight and nutritional intake of both groups as interventions period was limited. CLINICALTRIAL Study was registered on clinicaltrial.gov website with trial identity number NCT04782635.


QJM ◽  
2021 ◽  
Vol 114 (Supplement_1) ◽  
Author(s):  
Mostafa K Fouad ◽  
Ashraf M Hazem ◽  
Kareem M Elnaghy

Abstract Aim of the Work to provide cumulative data about the efficacy and safety of neuro-muscular electrical stimulation (NMES) combined with usual care (UC) versus usual care alone in ICU patients with Critical Illness Myopathy (CIM). Methodology The current systematic review was done on studies published between 2009 and 2019. The total number of patients in all the included studies was 1259 patients; 652 in NMES group, and 607 in UC group. Our data were divided into two groups: NMES (652 patients), and UC (607 patients). Metaanalysis study was done on 11 studies which described and compared the 2 different techniques for treatment of CIM; with overall number of patients (N = 1259). Results Regarding 1ry outcome measures, we found 8 studies reported critical Critical illness myopathy (CIM), critical illness polyneuropathy (CIP), and the overlap, critical care setting   MRC scale for muscle strength, with total number of patients (N = 968). The random-effects model of the meta-analysis study showed non-significant difference in mean MRC scale in NMES group compared to usual care group (p &gt; 0.05). We also found 11 studies reported ICU stay with total number of patients (N = 1259). The random-effects model of the meta-analysis study showed nonsignificant difference in mean ICU stay in NMES group compared to usual care group (p &gt; 0.05). We also found only 2 studies reported SF-36 scale for quality of life, with total number of patients (N = 270). The fixed-effects model of the metaanalysis study showed highly significant decrease in mean SF-36 scale in NMES group compared to usual care group (p = 0.003). Regarding 2ry outcome measure, we found 3 studies reported CIM incidence with total number of patients (N = 394). The fixed-effects model of the meta-analysis study showed marked decrease in CIM incidence in NMES group compared to usual care group, but not reaching statistical significance (p &gt; 0.05). We also found 9 studies reported mortality rate with total number of patients (N = 1044). The fixed-effects model of the meta-analysis study showed non-significant difference in mortality rate in NMES group compared to usual care. Our systematic review and meta-analysis showed that NMES combined with usual care was not associated with significant differences in global muscle strength, ICU stay, quality of life score, CIM incidence and mortality rate in comparison with usual care alone in critically ill patients. Conclusion NMES is not superior to usual care in management of CIM. Usual care remains the mainstay of management of CIM with significant better outcomes, in addition to preventive measures as early aggressive treatment of sepsis and MOF, blood glucose control, optimizing certain drugs use, early enteral nutrition, maintaining water, electrolyte and acidbase balance.


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