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The COVID-19 outbreak marks a global public health crisis. Therefore, consideration is given to preventative measures that could contribute to reducing the risk of infection and positively influence the course of the disease. Attention is currently being paid to the use of nutraceuticals, mainly vitamin D, minerals and beta glucans. In this study, we monitor the relationship of vitamin D levels in immunodeficient patients to the risk of developing COVID-19. In a set of 71 patients, we find gradation of disease onset and progression in patients with values less than 30 ng/mL. In individuals with vitamin D levels above 40 ng/mL, we find a high level of protection, and a beneficial course of clinical manifestation stemming from the application of minerals and beta glucans. © 2023, Czech Medical Association J.E. Purkyne. All rights reserved.
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BackgroundFatigue is a difficult subject for both physicians and patients. It is barely addressed during consultations and can therefore burden patient-physician-relations. To improve communication regarding fatigue, we developed a checklist that includes suggestions for evaluating possible causes for fatigue. In this analysis, we describe our study population and report first results 3 and 6 months after using the checklist.ObjectivesThe aims of our study are to validate the use of our newly developed fatigue checklist and to demonstrate that addressing fatigue in daily clinical practice and offering possible interventions can improve fatigue.MethodsWe recruited n=110 SLE patients with fatigue from our university hospital-based lupus reference centre in Duesseldorf. Fatigue was measured using the FSS (Fatigue Severity Scale). Our checklist included signs of depression and anxiety using the PHQ-4 (Patient Health Questionnaire), BMI (body mass index), physical activity, anemia, hypothyroidism and vitamin D deficiency. For each applicable cause, we listed possible interventions for free selection by the treating physician, such as replacement therapy (vitamin D, vitamin B12, iron, folic acid, erythropoietin), physical activity programs and psychosomatic consultations that were discussed with the patients. We re-evaluated our patients after 3 (T1) and 6 months (T2).ResultsBaseline characteristics of patients are summarized in Table 1.Table 1.BMI=body mass index, TSH=thyroidea stimulating hormone, PHQ4=patient health questionnaire (cut-off >3 points), HAQ=health assessment questionnaire, IMET= Index for measuring restrictions on social participation (higher scores point towards more restrictions on social participation), FSS=fatigue severity scale (≥4 points equal severe fatigue)N = 110n (%)Mean (SD)Age (years)49.0 (12.34)Female sex99.0 (90.0)BMI (kg/m2)25.9 (5.55)Disease duration (years)19.1 (10.05)TSH (µIU/ml)1.5 (1.05)25-OH-Vitamin D (ng/ml)39.5 (15.35)Haemoglobin (g/dl)13.0 (1.64)Sports activities>4h/week6.0 (5.5)2-4h/week18.0 (16.4)1-2h/week16.0 (14.5)<1h/week28.0 (25.5)No sport42.0 (38.2)Depression (PHQ4 score)2.3 (1.63)Anxiety (PHQ4 score)2.0 (1.71)Functional status (HAQ score)0.8 (0.49)Participation (IMET score)2.8 (2.31)Fatigue (FSS score)5.3 (1.35)After 3 and 6 months, we re-evaluated 83 patients and saw a significant reduction in fatigue measured by the FSS score (T1: mean difference estimate 0.367 and p-value <0.001;T2: mean difference estimate 0.305;p-value <0.005).Figure 1.Comparing FSS-Scores from T0, T1 and T2[Figure omitted. See PDF]ConclusionThe preliminary analysis of our study shows for the first time that incorporation of a checklist procedure into the management of patients with fatigue may improve short-term outcome after 3 and 6 months of observation. The improvement of symptoms documented in our study occurred even though the suggested exercise program and psychosomatic counseling sessions were not available for use during the current observation period because of the COVID-19 pandemic. At present, the mechanisms behind the observed effect remain unclear. Our ongoing analysis will clarify whether an additional effect on fatigue will occur after all suggested interventions resulting from the use of the checklist have been executed. Finally, it will demonstrate whether the incorporation of our checklist into routine clinical practice is capable to reduce fatigue over a prolonged time period.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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Objective: The COVID-19 epidemic resulted in a global crisis of public health. Therefore, the possibility of prevention, leading to reduced infection and/or an improved disease state, is the subject of intensive attention. The novelty of this study is the direct evaluation of vitamin D levels with the risk of COVID-19 infection. Background(s): Currently, several nutraceuticals, including vitamin D, beta-glucan, and some minerals, are being studied for their role in stimulating immunity. Our study focused on the relationship between levels of vitamin D in immunodeficient patients and the risk of the development of COVID-19. Method(s): In this study, patients were supplemented with vitamin D. Result(s): In a group of 71 patients, we found that patients with vitamin D levels below 30 ng/ml had an increased risk of COVID-19 development and more severe disease progress. In patients with blood levels over 40 ng/ml, we consistently found high levels of protection against COVID-19 infection. Conclusion(s): The most important finding is that vitamin D levels above 40 ng/ml result in the reduction of risks of serious clinical manifestation of COVID-19 infection.Copyright © 2023 Richter et al.
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Background: SARS-CoV-2 vaccines offer the most effective way to reduce the risk of severe COVID-19. Recent data indicate sufficient immune response after vaccination in most patients with infammatory rheumatic diseases (IRD) on immunomodulatory treatments. Objectives: To investigate the clinical profile of SARS-CoV-2 breakthrough infections among double and triple vaccinated patients with IRD. Methods: Data from the German COVID-19-IRD registry, collected by treating rheumatologists between February 2021 and January 2022 were analysed. Patients double or triple vaccinated against COVID-19 ≥14 days prior to proven SARS-CoV-2 infection were identifed, and type of IRD, vaccine, immunomodulation, comorbidities and outcome of the infection were compared with 737 unvac-cinated IRD-patients with COVID-19. Results: In total, 271 cases of breakthrough infections were reported, 250 patients (91%) had received two doses of vaccines, 21 (9%) patients three. More than 70% of the patients received Pfzer/Biontech vaccine for the frst, second and third vaccination. The median time from second/third vaccine dose to infection was 148 days (range 14-302) days. Most of the patients were diagnosed with infamma-tory joint diseases (Table 1). Most of the patients were treated with methotrexate (Table 1). The use of Januskinase inhibitors(i) was more frequently reported in double vaccinated patients (10.4% vs 4.8%), whereas tumor necrosis (TNF)i were reported more often in triple vaccinated patients (33.3% vs. 22.8). Hospitalisation rate was higher in unvaccinated IRD-patients than in vaccinated ones, while fatality rate was similar in unvaccinated and double vaccinated patients. Although the rate of comorbidities and median age were higher in triple-vaccinated patients, infected patients showed a lower rate of hospitalisation, neither COVID-19 related complications, nor the need of oxygen treatment or death. Conclusion: In this cohort of triple-vaccinated IRD patients no fatal courses and no COVID-19 related complications were reported, although median age and rate of comorbidities were higher compared to double-vaccinated and unvacci-nated patients. These results support the general recommendations to reduce the risk of severe COVID-19 disease by administering three doses of vaccine, especially in patients with older age, presence of comorbidities, and on immuno-modulatory treatment.
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Background: At the beginning of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) disease 2019 (COVID-19) pandemic, the influence of anti-infammatory therapy on the course of SARS-CoV-2 infection in patients with infammatory rheumatic diseases (IRD) was unknown. In the meantime, several data indicate an association of severe courses of COVID-19 with the use of ritux-imab (RTX). Objectives: To gather further knowledge about SARS-CoV-2 infections in RTX-treated IRD patients, data from the German COVID-19-IRD-registry were analysed. Methods: Hospitalisation was used as a surrogate of COVID-19 severity. Baseline characteristics, disease features, medication and outcome of COVID-19 were compared in RTX-treated inpatients and outpatients. Results: In total, 3592 cases were reported in the registry, which included 130 RTX patients (3.6%) for our analysis. RTX-treated inpatients were older than RTX-treated outpatients (median age 63 y vs 56 y, p=0.007). Patients with granulomatosis with polyangiitis treated with RTX (n=32) showed a significant higher COVID-19 related hospitalisation rate (33% vs 11%, p=0.005), which was not the case for patients with rheumatoid arthritis (49% vs 50%). Cardiovascular comorbidities were reported more frequently in hospitalised RTX-treated patients (20% vs. 6%, p=0.032). More than 50% of the RTX-treated inpatients developed COVID-19 related complications, e.g. acute respiratory distress syndrome. The median time period between the last RTX treatment and SARS-CoV-2 infection was shorter in inpatients than in non-hospitalised patients (3 (range 0-17) vs. 4 months (range-29), p=0.039). The COVID-19 related mortality rate was 14% (n=19) in RTX-treated IRD patients. In RTX-treated inpatients and outpatients, there were no relevant differences with respect to the use of concomitant glucocor-ticoids or other disease modifying anti-rheumatic drugs, disease activity, median last RTX dose or median number of immunomodulatory drugs prior to RTX treatment. Conclusion: In addition to general risk factors, such as age and comorbidities, it is already known that IRD patients treated with RTX show a higher rate of severe COVID-19. In our registry, RTX-treated patients with granulomatosis with polyangiitis appear to be at even higher risk to develop severe COVID-19 compared to other IRD. Moreover, the shorter the time since the last RTX treatment, the higher seems to be the risk of developing severe COVID-19. This might be explained by a more profound B-cell depletion in the frst weeks after RTX treatment warranting further studies.
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Background: During the COVID-19 pandemic telemedicine tools rapidly and widely gained acceptance as indispensable management tools for the continuum of clinical care in rheumatic diseases. They have been adopted in position papers and guidelines for the management of rheumatic diseases in adult patients. Objectives: Evaluation of the use of video consultation as one form of tele-medicine before and during the COVID-19 pandemic and associated lockdowns among Rheumatology physicians in Germany. The survey results are expected to support the optimization and implementation of video consultation (VC) into routine clinical practice in rheumatology, providing long-term benefts for both parties, patients and their treating rheumatologists. Methods: Cross-sectional nationwide online survey among German rheumatolo-gists and rheumatologists in training. The survey was promoted by newsletters sent by means of mail and Twitter posts to members of the German Society for Rheumatology (n=1,650) and German Professional Society for Rheumatology (n=527). Results: Reported data refer to 205 participants. The majority of respondents was male (59%), older than 40 years (90%) and specialized in internal medicine/rheumatology (85%). They were divided into two groups: 'digital users' (38%) and 'digital non-users' (62%). Users employing telemedicine (TM) but never VC were defned as 'TM-users' (10%). Those using TM and VC were classifed as 'VC-users' (27%). 'Non-users' negated the use of VC and TM respectively. Knowledge on telemedicine was self-rated as 4 (median on a Likert Scale 1 (very high) to 6 (very low)) with a signifcant difference between user (VC-user 2.7±1.2, TM-user 3.2±1.1) and non-user (4.4±1.3). The Figure 1 shows a signifcant increase in the use of VC during the lockdown periods. Even between the lockdown phases, VC use was higher than in the pre-pandemic phase. Reasons for VC non-use in TM-user and non-user were administrative/technical efforts (21%), lack of technical equipment (15%), time constraints (12%), time required for individual VC sessions (12%), inadequate reimbursement (11%), lack of demand from patients (11%), data security concerns (9%), poor internet connection (8%), and lack of Scientific evaluation/evidence (5%). Based on the experience gained, physicians considered the following clinical situations to be particularly suitable for VC: follow-up visits (VC-user 79%, TM-user 62%, non-user 47%), emergency consultations (VC-user 20%, TM-user 33%, non-user 20%), and patients presenting for the frst time (VC-user 11%, TM-user 19%, non-user 8%). Conclusion: Despite the fact that the current pandemic situation, with social distancing and several lockdowns, provides an ideal environment for the implementation of new remote care forms such as VC, their use and acceptance remained below expectations. Given the reported decline in physician face-to-face consultations during the pandemic, these fndings are even more concerning. The identi-fed reasons for non-utilization should be addressed by policy makers, payers and medical societies to provide better foundations for future innovative care models.
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Background: Based on given legislation (ŞŞ 33a and 139e SGB V, Social Code Book V) the German approach to digital health applications (Digitale Gesundheitsanwendungen, DiGA) allows reimbursed prescription of approved therapeutic software products (listed in the DIGA directory https://diga.bfarm.de/de/verzeichnis) for patients since October 6th, 2020. Objectives: To evaluate the level of knowledge on DiGA among members of the German Society for Rheumatology (DGRh) after one year of DiGA under the conditions of the COVID-19 pandemic using the DiGA Toolbox of the 'health innovation hub' (hih), a think tank and sparrings partner of the German Federal Ministry of Health. Methods: Anonymous cross-sectional online survey using LimeSurvey (https://limesurvey.org). The survey was promoted by newsletters sent out to DGRh newsletter recipients and Twitter posts. Ethical approval was obtained. Results: 75 valid participants reported that they care more than 80% of their working time for patients with rheumatic diseases. Most were working in outpatient clinics (54%) and older than 40 years of age (84%). Gender distribution was balanced (50%). 70% were aware of the possibility to prescribe DiGA. Most were informed on this for the frst time via trade press (63%), and only 8% via the professional society. 46% expect information on DiGA from professional societies and the medical chambers (36%) but rarely from the manufacturer (10%) and the responsible ministry (4%). Respondents would like to be informed about DIGA via continuing education events (face-to-face 76%, online 84%), trade press (86%), and manufacturers test accounts (64%). Only 7% have already prescribed a DiGA, 46% planned to do so, and 47% did not intend DiGA prescriptions. Relevant aspects for prescription are given in Figure 1. 86% believe that using DiGA/medical apps would at least partially be feasible and understandable to their patients. 83% thought that data collected by the patients using DiGA or other digital solutions could at least partially influence health care positively. 51% appreciated to get DiGA data directly into their patient documentation system resp. clinical electronic health record (EHR) and 29% into patients' owned EHR. Conclusion: DiGA awareness was high whereas prescription rate was low. Mostly, physician-desired aspects for DiGA prescriptions were proven efficacy and efficiency for physicians and patients, risk of adverse effects and health care costs were less important. Evaluation of patients' barriers and needs are warranted. Our results will contribute to the implementation and dissemination of DIGA.
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The outbreak of COVID-19 has had severe impacts on the ability of statistical authorities to compile national accounts data in the usual way. There is a lack of usually available primary information and a need to deal with a number of new policy measures taken in the context of the COVID-19 crisis. At the same time, the new situation may be an incentive to reconsider some of the basic concepts of national accounts and the way these concepts are operationalised. The emphasis of this contribution is laid on the concepts of production and of volume measurement of production. Two examples were chosen: a) the implications of changes in the travel habits, in particular of holders of season tickets and b) the reduced number of spectators allowed in theatrical and opera performances. As shown, the methodological alternatives for dealing with these changes offered in the European legislation might lead to quite different results. The two examples reveal that similar situations are treated rather differently. The examples also indicate that the methodological alternatives pursue different concepts of production. In order to make adequate use of national accounts, empirical economists need to be well informed about the definitions and processes that lead to the data under usual conditions and in particular under exceptional circumstances such as the COVID-19 crisis.
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Background: Patients with rheumatic and musculoskeletal diseases (RMD) might have an increased risk for infection due to their immunomodulatory treatment, secondary to their disease and comorbidities. Recent studies suggest a decreased risk of severe COVID-19 in RMD-patients treated with biologics. Objectives: The aim of this study was to assess courses of RMD patients treated with TNF-inhibitors (TNF-I) included in the German COVID-19 registry. Methods: In the German physician-reported COVID-19-RMD registry, patients with an RMD and confirmed SARS-CoV-2-infection were documented (data entered between March 30, 2020 and January 30, 2021). We analysed TNF-I treated patients, their course and outcome of the infection. Data were compared to RMD-patients treated with other immunomodulatory drugs (OID) than TNF-I. Results: A total of 269 patients were treated with a TNF-I (57% female) compared to 874 patients who were treated with OID (68% female). Median age was 52 years (range: 19-87) in the TNF-I-group versus 58 years (range: 18-91) in the OID-group. Rheumatoid arthritis was the most common diagnosis (38% in TNF-I-group vs. 52% in the OID-group), followed by ankylosing spondylitis (32% vs. 6%), psoriatic arthritis (22% vs. 11%) and other RMD (9% vs. 31%). Adalimumab (35%) and etanercept (35%) were the most frequently used TNF-I (tab. 1). Glucocorticoids (GC) were used in 22% of TNF-I-treated patients and in 42% of the OID-group. Under TNF-I, stable disease was reported prior to the SARS-CoV-2-infection in 53% of the patients (OID-group: 47%), followed by low disease activity in 35% (OID: 34%), moderate disease activity in 6% (OID: 12%) and high disease activity in 4% (OID: 3%). Most frequent comorbidities were arterial hypertension (29% under TNF-I vs. 35% under OID), diabetes (8% vs. 11%) and cardiovascular diseases (7% vs. 12%). The most common reported COVID-19 symptoms were dry cough (57% vs. 55%), fever (53% vs. 61%) and fatigue (50% vs. 49%). Hospitalization due to SARSCoV infection was required in only 12% of the TNF-I-treated cases vs. in 29% in the OID-group. Oxygen treatment was necessary in 5% of the patients under TNF-I compared to 22% under OID and invasive ventilation in 2% in the TNF-Igroup compared to 6% under OID. Most notably, no fatal courses of COVID-19 were reported among the 269 RMD-patients treated with TNF-I versus 49 deaths in the 874 cases (5.6%) treated with OID. Focussing on the hospitalizated TNF-I patients, the rate of concomitant GC use (p<0.001) and higher disease activity (p=0.005) was significant higher (tab.1). Conclusion: High or moderate RMD-disease activity is an important factor associated with severity of COVID-19 including mortality. In this large cohort RMD patients treated with TNF-I show a low hospitalisation rate and no fatal course. This is reassuring for patients and treating rheumatologists to use TNF-I to control RMD disease activity. The use of glucocorticoids and high disease activity seem to counteract possible protective effects of TNF-I.
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Background: The current pandemic constitutes an entirely new situation for patients as well as physicians. The insecurity of the early phase, shutdowns, increasing infection rate and appearing SARS-CoV2 mutations have created a situation that makes live difficult especially for chronic diseases i.e. patients with rheumatic and musculoskeletal diseases (RMD) and their treating physicians. The psychosocial burden that is created by this special situation is completely unknown and is estimated to be higher in patients than in the general population. Objectives: In order to measure the impact on our patients, the German COVID19-Rheuma patient survey was set up in April 2020, during Germany's first shut down. Methods: The German COVID19-Rheuma patient survey is a patient reported longitudinal online survey where patients with RMD who registered between April and July 2020 are asked on a monthly base using an online survey on social, personal, medical factors, whether a COVID19 infection occurred, isolation measures were changed and scores regarding stress and anxiety are recorded. Between April and July 2020, 637 patients registered and completed a first survey. Up to January 2021, about 400 patients are still enrolled. Here we present an interim analysis of the first 6 months regarding patients that were enrolled in April and May during the first shut-down. This first analysis compares the situation in the first lockdown to July, a phase with very low infection numbers in Germany, and to November, the beginning of the second lockdown. Results: 150 patients (87% female) were enrolled in April/early May 2020. Mean age was 48 years (range 11-89). The majority of patients suffered from rheumatoid arthritis (51%), followed by psoriatic arthritis (17%), other spondyloarthropathies (10%) and connective tissue diseases (10%). The majority of patients received antirheumatic therapies: 32% glucocorticoids (GC), 31% cDMARDs, 21% TNF inhibitors, 7% Jak inhibitors, and 9% other biologicals. Of the patients treated with GC, 25% were on GC monotherapy. In the first lockdown, 26% of patients were working remotely and 24% were self-isolating (doubles included). Additionally, 48% were using masks that were not mandatory at that time and 41% were using disinfection in a regular manner. The rates for remote work and self-isolation did not change significantly over time while the mask use increased to 98% with the official obligation to do so. The use of disinfectants increased to 88% in November. Regarding disease activity, no change in patient global assessment could be observed over time (4.3 ± 2.5 vs. 4.0 ±2.6 and 4.0 ± 2.5). Self-reported pain was also stable over time as were sleep disturbances. While 48.2% of patients who were receiving physiotherapy paused in April, only 10 and 14% did so in July and November, respectively. 11% of the patients paused their medication in the first lockdown, whereas only 2.75% did so in July and 3.4% in November. Contact with the treating rheumatologist was maintained over time in the majority of cases. Conclusion: While in the beginning of the pandemic the insecurity was considerable and the concern that the fear for infection would lead to inadequately treated patients with RMDs, we here show for the first time that on the one hand our patients were timely in taking adequate measures to keep themselves safe (e.g. self-isolating, mask use) and adapted to the clinical situation in not pausing their medication. Altogether, in this alert cohort, the pandemic did not lead to an increase of patient-reported disease activity in the first six months.
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China 6 emission legislation was finalized in 2018 and the full implementation nationwide is postponed to 2021 due to COVID-19. It is foreseen that the post China 6 legislation will have more stringent primary and secondary emission requirements including further reduction of nitrous oxide (N2O) emissions and likely to include limits on ammonia (NH3) emissions. This study investigated the secondary emissions (i.e. N2O and NH3) of a variety of China 6 production gasoline vehicles operating under the worldwide harmonized light vehicles test cycle (WLTC) and random test standardized aggressive (RTS 95) cycle. It was found that N2O emissions were less than 5 mg/km on all these vehicles, far below the current China 6 limit (20 mg/km), however NH3 emissions varied from 2 to 48 mg/km among the production vehicles. The mechanisms of N2O and NH3 formation and their correlation with primary emissions were also investigated. Methods to reduce N2O and NH3 emissions were discussed from the perspective of catalyst system design, including substrate volume, platinum group metals (PGM), and washcoat loading. Finally, a gasoline ammonia slip catalyst (gASC) was proposed and tested on selected vehicles as an add-on device on targeting the reduction of NH3 emissions. NH3 emissions were reduced significantly reduced below 5 mg/km on the WLTC. © 2021 SAE International. All rights reserved.