ANTIPHOSPHOLIPID ANTIBODIES AND VASCULAR THROMBOSIS IN PATIENTS WITH THE MOST SEVERE FORMS OF COVID-19

BackgroundThe presence of antiphospholipid antibodies (aPL) has been observed in patients with COVID-19 (1,2), suggesting that they may be associated with deep vein thrombosis, pulmonary embolism, or stroke in severe cases (3). Antiphospholipid syndrome (APS) is a systemic autoimmune disorder and the most common form of acquired thrombophilia globally. At least one clinical criterion, vascular thrombosis (arterial, venous or microthrombosis) or pregnancy morbidity and at least one laboratory criterion- positive aPL two times at least 12 weeks apart: lupus anticoagulant (LA), anticardiolipin (aCL), anti-β2-glycoprotein 1 (anti-β2GPI) antibody, have to be met for international APS classification criteria(4). Several reports also associate anti-phosphatidylserine/prothrombin antibodies (aPS/PT) with APS.ObjectivesTo combine clinical data on arterial/venous thrombosis and pregnancy complications before and during hospitalisation with aPL laboratory findings at 4 time points (hospital admission, worsening of COVID-19, hospital discharge, and follow-up) in patients with the most severe forms of COVID-19 infection.MethodsPatients with COVID-19 pneumonia were consequetively enrolled, as they were admitted to the General hospital Pancevo. Exclusion criteria were previous diagnosis of inflammatory rheumatic disease and diagnosis of APS. Clinical data were obtained from the medical records. Laboratory results, including LA, aCL, anti-β2GPI, and aPS/PT antibodies were taken at hospital admission, worsening (defined as cytokine storm, connection of the patient to the respirator, use of the anti-IL-6 drug- Tocilizumab), at hospital discharge and at 3-months follow-up and sent to University Medical Centre Ljubljana, Slovenia for analysis. Statistics was performed by using SPSS 21.Results111 patients with COVID-19 pneumonia were recruited;7 patients died during hospitalisation (none were aPL-positive on admission and at the time of worsening), 3 due to pulmonary artery embolism. All patients were treated according to a predefined protocol which included antibiotics, corticosteroids, anticoagulation therapy and specific comorbidity drugs;patients with hypoxia were supported with oxygen. During hospitalisation, pulmonary artery thrombosis occurred in 5 patients, one was aPL-positive at all time points (was diagnosed with APS), others were negative. In addition, 9/101 patients had a history of thrombosis (5 arterial thrombosis (coronary and cerebral arteries), none of whom was aPL-positive on admission and at follow-up, and 4 venous thrombosis, one of which was aPL-positive at all time points and received an APS diagnosis). Among 9/101 patients with a history of thrombosis, 55.6% were transiently positive at the time of discharge, compared to patients without prior thrombosis, in whom 26.1% were transiently positive at the hospital release (p=0.074). Two patients had a history of pregnancy complications (both had miscarriage after 10th week of gestation), but did not have aPL positivity at any time point.ConclusionAlthough aPL was expected to be associated with vascular disease in the most severe forms of COVID-19, all patients that have died in our cohort were aPL negative. At hospital discharge, 56% of patients with a history of arterial or venous thrombosis had positive aPL that became negative at the 3-months follow-up (were transienlty positive), which should be considered when prescribing therapy after hospitalisation.References[1]Trahtemberg U, Rottapel R, Dos Santos CC, et al. Anticardiolipin and other antiphospholipid antibodies in critically ill COVID-19 positive and negative patients. Annals of the Rheumatic Diseases 2021;80:1236-1240.[2]Stelzer M, Henes J, Saur S. The Role of Antiphospholipid Antibodies in COVID-19. Curr Rheumatol Rep. 2021;23(9):72-4.[3]Xie Y, Wang X, Yang P, Zhang S. COVID-19 complicated by acute pulmonary embolism. Radiology: Cardiothoracic Imaging 2020: 2: e200067.[4]Miyakis S, Lockshin MD, Atsumi T, Branch DW, Brey RL, et al. J.Thromb.Haemost. 2006;4: 295-306.Acknowledgements:NIL.Disclosure of nterestsNone Declared.

RHEUMATOID ARTHRITIS FLARE FOLLOWING COVID-19 VACCINATION IN MALAYSIAN POPULATION AND ITS ASSOCIATED RISK FACTORS

BackgroundFlare of Rheumatoid Arthritis (RA) following COVID-19 vaccination has been reported with a low occurrence observed in those patients with disease remission. However, no local data is available in our multi-ethnic Malaysian population.ObjectivesTo evaluate the prevalence of RA flare in Malaysian patients following COVID-19 vaccination and its associated risk factors.MethodsThis was a cross-sectional study assessing RA flare based on patient-reported disease flare through self-administered questionnaires and physician-reported flare. Patient self-reported disease flare was defined as ‘a sudden worsening of rheumatology condition or arthritis within 1 month post-vaccination' while physician-reported flare was defined as ‘an increment of disease activity score 28-joint documented within 3 months post-vaccination‘ from either a scheduled or unscheduled clinic visit. A total of 186 RA patients attended the rheumatology clinic in Hospital Putrajaya from May to July 2022 who completed the primary COVID-19 vaccination under the Malaysian National Vaccination Programme were recruited. Demographic data, disease parameters including serology for rheumatoid factor (RF) and anti-citrullinated peptide antibodies (ACPA), cessation of disease modifying anti-rheumatic drugs (DMARDs) around vaccination, type of vaccines and adverse events were examined using descriptive and univariate analyses.ResultsMajority (93%) of RA patients enrolled were female with a mean age of 58 years old (standard deviation, SD 12.2) and mean disease duration was 12 years (SD 7.7). More than half were seropositive (66% RF, 63% ACPA) with 47.4% had double seropositivity (RF and ACPA positive). All patients received DMARDs with the majority (71%) were on methotrexate (MTX), 21.5% were on leflunomide, 17.7% on other DMARDs, with a small proportion (14%) of patients were receiving prednisolone. Only 4.8% of patients were on biologics or targeted synthetic disease modifying anti-rheumatic drugs. Half of the patients were in remission prior to vaccination. 62% of patients received Pfizer-BioNTech vaccine as the primary vaccine, followed by Sinovac-CoronaVac (24.6%) and Oxford-AstraZeneca (13.4%) vaccines. A booster dose had been administered to 80% of patients, of which 88.7% was Pfizer-BioNTech vaccine. MTX therapy were discontinued in 39.4% of patients (n=52) post-vaccination for a week duration. The prevalence of RA flare was only 12.9% (n=24) in which 14 were self-reported and 10 were physician-reported flares (4 severe flare, 6 mild-moderate flare). Flare rates were higher during the first and second dose of vaccination with 29.2% respectively, and only 12.5% were reported after booster vaccination. Common vaccine adverse effects were fever (16.8%), myalgia (8.6%) and arthralgia (6.4%). There were no significant differences in the occurrence of flare post-vaccination between age, gender, disease activity prior to vaccination, types of vaccine, usage of MTX and prednisolone, and discontinuation of MTX post-vaccination. Although seropositivity did not exhibit statistically significant flare rate post vaccination, sub-analysis revealed four times higher rate of flare in those who has double positivity compared to seronegative RA patients (12% vs 4%).ConclusionPrevelance of RA flare post-COVID-19 vaccination in Malaysian RA population is low. No significant associated risk factors were identified although double seropositivity appeared to have higher number of flares.References[1]Bixio, R., Bertelle, D., Masia, M., Pistillo, F., Carletto, A. and Rossini, M. (2021), Incidence of Disease Flare After BNT162b2 Coronavirus Disease 2019 Vaccination in Patients With Rheumatoid Arthritis in Remission. ACR Open Rheumatology, 3: 832-833.[2]Li X, Tong X, Yeung WWY, Kuan P, Yum SHH, Chui CSL, Lai FTT, Wan EYF, Wong CKH, Chan EWY, Lau CS, Wong ICK. Two-dose COVID-19 vaccination and possible arthritis flare among patients with rheumatoid arthritis in Hong Kong. Ann Rheum Dis. 2022 Apr;81(4):564-568.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

The Effect of Primary School Education on Preventive Behaviours during COVID-19 in Japan

Education plays a critical role in promoting preventive behaviours against the spread of pandemics. In Japan, handwashing education in primary schools was positively correlated with preventive behaviours against COVID-19 transmission for adults in 2020, during the early stages of COVID-19. The following year, the Tokyo Olympics were held in Japan, and a state of emergency was declared several times. Public perceptions of and risks associated with the pandemic changed drastically with the emergence of COVID-19 vaccines. We re-examined whether the effect of handwashing education on preventive behaviours persisted by covering a longer period of the COVID-19 pandemic than previous studies. A total of 26 surveys were conducted nearly once a month for 30 months from March 2020 (the early stage of COVID-19) to September 2022 in Japan. By corresponding with the same individuals across surveys, we comprehensively gathered data on preventive behaviours during this period. In addition, we asked about the handwashing education they had received in their primary school. We used the data to investigate how and to what degree school education is associated with pandemic-mitigating preventive behaviours. We found that handwashing education in primary school is positively associated with behaviours such as handwashing and mask wearing as a COVID-19 preventive measure but not related to staying at home. We observed a statistically significant difference in handwashing between adults who received childhood handwashing education and those who did not. This difference persisted throughout the study period. In comparison, the difference in mask wearing between the two groups was smaller but still statistically significant. Furthermore, there was no difference in staying at home between them. Childhood hygiene education has resulted in individuals engaging in handwashing and mask wearing to cope with COVID-19. Individuals can form sustainable development-related habits through childhood education.

Being a product consumer during the COVID-19 pandemic: profile of the Polish consumer in the organic dairy market

PurposeThe purpose of this paper was to determine the profile of dairy product consumers in the organic market.Design/methodology/approachThe study was based on a survey questionnaire developed by the author and administered to a total of 1,108 respondents. The statistical analysis (including descriptive statistics, the analysis of the discriminative function and the Chi2 test was performed with the use of Statistica 13.1 PL. The respondents' gender was the factor behind the differences in how they behaved.FindingsThe consumers indicated the channels they rely upon to find information on organic dairy products;in addition to trusting the opinions of their family members and experts, they also use web platforms. Further, they specified their preferred locations for buying favorite products during the pandemic: specialized organic food shops, large distribution chains and online stores.Practical implicationsThese outcomes will help in identifying target consumer segments and information channels for specific information and advertising messages. They also form an important resource for developing some potential strategies which the supply chain stakeholders could implement to promote organic consumption of dairy products.Originality/valueThis study identifies consumers' preferred dairy products;motives for purchasing organic dairy products;barriers that consumers believe exist in the market;sources of knowledge about products purchased by consumers;and consumers' preferred channels for purchasing organic dairy products. To the best of the author's knowledge, this is the first study of dairy product consumers in the organic market in Poland.

Turnover Intention Model: Self- Determination Theory Approach: Acces la Success

The purpose of this study is to examine and analyze the influence of mental workload and person-organization fit on turnover intention, using basic psychological needs frustration (BPNF) as the intervening variable in the hospital in Daerah Istimewa Yogyakarta. The sample of this study is vocational nurse in the hospital in Daerah Istimewa Yogyakarta. The sample is carried out through survey from 153 respondents, which is processed using Structural Equation Modeling (SEM) method. This study finds that mental workload does not have direct influence on turnover intention, but it is mediated (full mediation) by need for competence frustration and need for relatedness frustration. Person-organization fit has a positive influence on need for autonomy frustration. However, person-organization fit does not have an influence on turnover intention, and basic psychological needs does not mediate the relationship of these variables. This study also found that the category of mental workload is quite low, person-organization fit is low, basic psychological needs frustration is quite low, and turnover intention is low. Nurse has the extrinsic motivation of identified regulation, thus hospital leaders should bring their motivation from identified regulation to intrinsic motivation, through internalization by establishing supportive work environment, namely Islamic spiritual workplace (ISW), with basic psychological needs supporting in each of its dimension. This study is expected to be a reference for practitioners in human resource management, especially regarding human resource retention function through the implementation of ISW. ISW contributes to lower mental workload, the increase of person-organization fit, establishment of basic psychological need satisfaction, as well as the decrease of basic psychological needs frustration and turnover intention.

COVID ADVANCES CLINICAL TRIAL TRANSPARENCY

Growing public concerns about politics playing a role in vetting potential vaccines and therapies to combat the COVID-19 pandemic has prompted sponsors of leading clinical trials to make public their study protocols and statistical analysis plans. [...]AstraZeneca's timeframe for enrolling and assessing study participants was delayed by the need to address the report of a serious adverse event in its Phase III study. The disclosure of these usually confidential details on research endpoints, assessment timeframes, and study analysis plans aim to promote information sharing among vaccine developers, and also build public confidence.

Task-Technology Fit and ICT Use in Remote Work Practice During the COVID-19 Pandemic

This study examines the use of information and communications technology (ICT) in remote work practice during the COVID-19 pandemic by integrating task-technology fit theory and the post-acceptance model of IS continuance into a research framework. In addition, it operationalizes the technological characteristics of TTF (task-technology fit) with the technology acceptance model (TAM) and the diffusion of innovation (DOI) theory. The methodology to test the research model takes support from the partial least squares structural equation modeling (PLS-SEM) method using a sample of 320 employees. The results show that TAM significantly explains TTF. Furthermore, there is a positive impact of ICT use on individual and organizational performance. User satisfaction has the most significant effect on individual performance, organizational performance, and IS continuance intention. The authors provide some managerial implications for addressing the challenges of remote work related to ICT disruptions for the post-COVID-19 period.

ASSOCIATION OF URIC ACID LEVELS WITH COVID-19 SEVERITY DURING 2020 AND 2021 YEARS

BackgroundThe decrease in uric acid levels attracts more and more attention from clinicians every year [1]. In particular, a factor such as Covid-19 can cause a significant decrease in uric acid due to its increased excretion by the kidneys [2]. This retrospective study aimed to determine changes in the level of uric acid in different years, which allows us to assume the influence of different strains of Covid-19 on uric acid.ObjectivesTo analyze the relationship between uric acid levels through admission to the hospital and Covid-19 severity during 2020 and 2021 years.MethodsOur retrospective study includes 127 hospitalized patients with confirmed Covid-19 in 2021 and 63 patients in 2020 (only patients who didn't receive urate-lowering therapy). Most patients were over 45 years old (84,2% vs 90,5%), women and men almost equally. The severity of Covid-19 we determined by the type and presence of oxygen support ((1) without O2, (2) O2 by mask or nasal cannula, (3) continuous positive airway pressure, (4) positive bi-pressure in the airways or high-flow oxygen, (5) invasive ventilation). A chi-squared test and comparison of means were used.ResultsWe cannot establish the dependence of the uric acid level on the severity of the course of the Covid-19 disease, which is determined by the type of oxygen support in both 2020 and 2021. For example, in 2021, the difference between the least severe type (without O2) and the most severe (invasive ventilation) was almost the same (246.2 vs 277.12 µmol/L), as between O2 by mask or nasal cannula and positive bi-pressure in the airways or high-flow oxygen (257 vs 239.1 µmol/L). However, it was established that in 2020, higher indicators of the level of uric acid were observed for all types of oxygen support. For example, for patients who were without O2, it is higher by 72.95 µmol/L, which is statistically significant. In addition, we analyzed the dependence of the uric acid level on such indicators as the patient's age, the level of lymphocytes, C-reactive protein, and LDH at admission to the hospital. As a result of the analysis, it was found that the dependence is present for the LDH indicator (the lower the LDH, the higher the uric acid: chi-square at the level of 0.05), and for all other indicators, it was absent in 2021. In 2020, a positive relationship between CRP, LDH, and uric acid levels was also observed.ConclusionAlthough there is a trend towards lower uric acid levels in the background of Covid-19, it is not a marker of a severe disease course. The lower uric acid levels in 2021 are likely due to a feature of the strains circulating in 2021 that caused more significant renal excretion of uric acid.References[1]Hu F, Guo Y, Lin J, Zeng Y, Wang J, Li M, Cong L. Association of serum uric acid levels with COVID-19 severity. BMC Endocr Disord. 2021 May 8;21(1):97. DOI: 10.1186/s12902-021-00745-2. PMID: 33964922;PMCID: PMC8106517.[2]Dufour I, Werion A, Belkhir L, Wisniewska A, Perrot M, De Greef J, Schmit G, Yombi JC, Wittebole X, Laterre PF, Jadoul M, Gérard L, Morelle J;CUSL COVID-19 Research Group. Serum uric acid, disease severity, and outcomes in COVID-19. Crit Care. 2021 Jun 14;25(1):212. DOI: 10.1186/s13054-021-03616-3. PMID: 34127048;PMCID: PMC8201458.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

EFFICACY AND SAFETY OF DAZODALIBEP (VIB4920/HZN4920) IN SUBJECTS WITH SJÖGREN'S SYNDROME: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY

BackgroundSjögren's syndrome (SS) is a chronic, systemic autoimmune disease affecting exocrine glands, primarily the salivary and tear glands, with potentially severe manifestations in multiple organs. No approved disease-modifying therapies exist. Dazodalibep (DAZ) is a biologic antagonist of CD40L.ObjectivesThe objective of this study was to evaluate the efficacy and safety of DAZ therapy in adult SS subjects with moderate-to-high systemic disease activity (NCT04129164).MethodsWe conducted a randomized, double-blind, placebo-controlled, crossover study to evaluate DAZ therapy in adult SS subjects with moderate-to-high systemic disease activity, as defined by a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5. Eligible subjects were randomized 1:1 to receive intravenous DAZ 1500 mg or placebo (PBO) Q2W x 3 doses, then Q4W x 4 additional doses. Starting on Day 169, subjects initially randomized to DAZ received PBO Q4W x 5 doses and subjects randomized to PBO received DAZ Q4W x 5 doses and were then followed for 12 weeks. The primary endpoint was the change from Baseline in ESSDAI at Day 169. Safety assessments included the incidence of adverse (AEs), serious AEs (SAEs), and AEs of special interest (AESIs).ResultsThe 74 randomized subjects all received ≥1 dose of study medication (DAZ, N=36;PBO, N=38). The baseline demographics and disease characteristics were balanced between the two groups. The change from Baseline to Day 169 in ESSDAI score (LS mean ± SE), was -6.3 ± 0.6 in DAZ-treated subjects compared to -4.1 ± 0.6 in the PBO group, a difference of -2.2 (p = 0.0167). Compared to the PBO group, the DAZ group showed positive trends in the EULAR Sjögren's Syndrome Patient Reported Index score, and Functional Assessment of Chronic Illness Therapy-Fatigue score at Day 169. A post-hoc responder analysis of subjects achieving high levels (5 and 6 points) of improvement on ESSDAI favored DAZ (61.1% and 60.0%) over PBO (35.1% and 34.3%).The reported AEs were generally mild through Day 169 and similar in frequency between treatment groups. The most frequently reported AEs occurring in ≥5% of DAZ-treated subjects and >PBO were COVID-19, diarrhea, dizziness, ligament sprain, upper respiratory tract infection, contusion, device allergy, fatigue, hypertension, and oropharyngeal pain. Two SAEs were reported in a single DAZ-treated subject: this subject was a 59-year-old female who experienced a grade 3 SAE of COVID-19 infection and later died of unknown cause 46 days after last administration of DAZ (12 days after COVID-19 diagnosis). There was a single AESI of herpes zoster in a DAZ-treated subject.ConclusionDAZ is a potential new therapy for the treatment of systemic disease activity in patients with SS. SS subjects with moderate-to-high systemic disease receiving DAZ experienced a statistically significant reduction in disease activity relative to PBO as measured by the improvement in ESSDAI score. Except for a case of severe COVID-19 infection, DAZ therapy in SS subjects appeared to be well tolerated. Larger controlled trials of DAZ therapy for SS are warranted to further explore its safety profile and confirm its clinical efficacy.Table 1.Efficacy and Safety DataPBO N=38DAZ 1500 mg N=36EfficacyΔESSDAI, LS mean (SE) †-4.1 (0.6)-6.3 (0.6)*ΔESSPRI, LS mean (SE) †-1.12 (0.29)-1.80 (0.31)ΔFACIT-Fatigue, LS mean (SE) †5.8 (1.6)8.1 (1.6)AE Summary, n (%)≥1 AE23 (60.5)28 (77.8)≥1 related AE8 (21)10 (27.8)≥1 SAE01 (2.8)≥1 related SAE00≥1 AE leading to discontinuation00≥1 AESI01 (2.8)≥1 Death01 (2.8)Efficacy endpoints as of Day 169;† Analyzed using MMRM;Comparisons vs PBO;*p<0.05;AE summaries based on AEs that occurred through Day 169;AE, adverse event;AESI, adverse event of special interest;ESSDAI, EULAR Sjögren's Syndrome Disease Activity Index;ESSPRI, EULAR Sjögren's Syndrome Patient Reported Index;FACIT-Fatigue, Functional Assessment of Chronic Illness Therapy-Fatigue;PBO, placebo;SAE, serious adverse eventFigure 1.AcknowledgementsFunded by Horizon herapeutics. Medical writing support provided by B Lujan, PhD, an employee of Horizon Therapeutics.Disclosure of InterestsE. William St. Clair Consultant of: Horizon Therapeutics, Bristol Myers Squibb, CSL Behring, Resolve Therapeutics, Sonoma Biotherapeutics. Royalties: UpToDate, Liangwei Wang Shareholder of: Horizon Therapeutics, Employee of: Horizon Therapeutics, Ilias Alevizos Shareholder of: Horizon Therapeutics, Employee of: Horizon Therapeutics, William Rees Shareholder of: Horizon Therapeutics, Employee of: Horizon Therapeutics, Alan Baer Consultant of: Bristol Myers Squibb, Wan Fai Ng Consultant of: Novartis, GlaxoSmithKline, Abbvie, BMS, Sanofi, MedImmune, Janssen and UCB, Ghaith Noaiseh Consultant of: Novartis, Chiara Baldini Consultant of: GSK, and Sanofi.

COVID-19 VACCINE PERCEPTION AND HESITANCY AMONG PATIENTS WITH AUTOIMMUNE RHEUMATIC DISEASE (AIRD) IN MALAYSIA

BackgroundPatients with autoimmune rheumatic disease (AIRD) are at risk of severe COVID-19 infection and vaccine has been demonstrated to be able to reduce the severity of infection. Malaysia has a low flu vaccination coverage rate (approximately 3%) and hence it is important to assess the perception and hesitancy of COVID-19 vaccine especially among the vulnerable group.ObjectivesTo study the perception of COVID-19 vaccine and to determine the prevalence of vaccine hesitancy among AIRD patients in Malaysia.MethodsThis was a cross-sectional survey using online Google Forms® that was conducted among adult AIRD patients (18 years and older) from August 2021 until February 2022. Patients were recruited from the outpatient clinics as well as distribution of the survey through social medias. The survey was in English and Malay language. The survey collected data on the socio-demographic background, prior history of other vaccination after the age of 18 and COVID-19 vaccination with reasons of hesitancy, defined as being unsure or unwilling to be vaccinated. The survey also assessed the patients' perception by specifying the level of agreement to COVID-19 vaccine statements using the Likert response scale: 1-Strongly disagree;2- Disagree;3-Neither agree nor disagree;4-Agree;5-Strongly agree.ResultsA total of 162 patients participated in the survey and majority of them were females (87.7%). Our multi-racial cohort consisted of Malay (n=103, 63.5%), followed by Chinese (n=38, 23.5%), Sabahan Bumiputra (n=12, 7.4%) and Indian (n=7, 4.3%). More than half (n=107,66.6%) have not had any history of other vaccination after the age of 18. Only 16.7% (n=27) agreed/strongly agreed that COVID-19 vaccine can be given to patients with co-morbidities and 24.1 (n=39) agreed/strongly agreed that COVID-19 vaccine can be given to patients who have history of allergy to other drugs or food. At the time of the survey, vast majority of the respondents have received at least the 1st dose of Covid-19 vaccine (n=148, 91.4%). A total of 9 (5.6%) patients were hesitant to be vaccinated (6 were unsure and 3 patients were not willing to be vaccinated). The commonest reasons of being unsure or not willing to be vaccinated was worried of the vaccine's adverse effects (66.7%), worried of the blood clot complication (33,3%), worried of disease flare post-vaccine (33,3%), worried of allergic reaction (22.2%), lack of information on the safety of the vaccine in patients with AIRD from government and media (22.2%), face mask and social distancing measures were adequate (22.2%). Statistical analysis revealed that more patients who had vaccine hesitancy were from the lower socioeconomic status (income <1066 Euro/month), 88.9% vs 11.1%, p=0.03 but no association with ethnicity, education status, marital status or place of residence (urban vs rural).ConclusionCOVID-19 vaccine hesitancy is low in Malaysian patients with AIRD but patients with a low socioeconomic status are prone to have vaccine hesitancy. More education on the vaccine's efficacy and safety especially among patients with co-morbidities are warranted.Reference[1]Knowledge, acceptance and perception on COVID-19 vaccine among Malaysians: A web-based survey. Mohamed NA, Solehan HM, Mohd Rani MD, Ithnin M, Che Isahak CI (2021) Knowledge, acceptance and perception on COVID-19 vaccine among Malaysians: A web-based survey. PLOS ONE 16(8): e0256110.Acknowledgements:NIL.Disclosure of InterestsSyahrul Sazliyana Shaharir Speakers bureau: Pfizer,Novartis, Lydia Kamaruzaman: None declared, Theepa Nesam Mariamutu: None declared, Mohd Shahrir Mohamed Said: None declared, Azmawati Mohammed Nawi: None declared, Wan Syamimee Wan Ghazali: None declared, Malehah Mohd Noh: None declared.

Modeling of Physical Activity Behavioral Interventions Relying on MPC Strategy

Physical inactivity is becoming an important threat to public health in today's society. The COVID-19 pandemic has also reduced physical activity (PA) levels given all the restrictions imposed worldwide. In this work, physical activity interventions supported by mobile devices and relying on control engineering principles were proposed. The model was constructed relying on previous studies that consider a fluid analogy of Social Cognitive Theory (SCT), which is a psychological theory that describes how people acquire and maintain certain behaviors, including health-promoting behaviors, through the interplay of personal, environmental, and behavioral factors. The obtained model was validated using secondary data (collected earlier) from a real intervention with a group of male subjects in Great Britain. The present model was extended with new technology for a better understanding of behavior change interventions. This involved the use of applications, such as phone-based ecological momentary assessments, to collect behavioral data and the inclusion of simulations with logical reward conditions for reaching the behavioral threshold. A goal of 10,000 steps per day is recommended due to the significant link observed between higher daily step counts and lower mortality risk. The intervention was designed using a Model Predictive Control (MPC) algorithm configured to obtain a desired performance. The system was tested and validated using simulation scenarios that resemble different situations that may occur in a real setting.

CLINICAL SIGNIFICANCE OF SERUM FERRITIN IN PATIENTS WITH SYSTEMIC SCLEROSIS

BackgroundThe main systemic sclerosis (SSc) manifestations are skin thickening, microangiopathy and ischemic changes in tissues, fibrotic damage to the lungs, heart, kidneys, and digestive system, arthritis, and myopathy. Acute phase reactants (APR) like erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) reflect inflammation activity in various inflammatory conditions. Ferritin is a protein bound to iron;low serum ferritin indicates iron deficiency and/or anemia. Instead, high ferritin levels are associated with inflammatory and non-inflammatory conditions such as dermatomyositis, pulmonary fibrosis, lupus, systemic COVID-19, vasculitis, tissue damage, thromboembolic complications, and metastatic cancer. The possible role of ferritin in SSc as APR is unclear.ObjectivesWe aimed to assess whether ferritin levels can reflect the severity of SSc and predict the outcome.Methods241 files of SSc patients with information on serum ferritin level (ferritin over 300 mg/dL is considered elevated) who visited the Rambam Rheumatology Institute in the years 2004-2021were used for retrospective analysis. Patients' demographic, clinical, laboratory, imaging, and respiratory function data were collected from electronic hospital files. Statistics included Student's T-test, Pearson's chi-squared test, and Kaplan-Meier curve;statistical significance was determined as p<0.05.Results36 patients (FerEl-SSc) had elevated ferritin values;the rest (n=205) represented the second group (FerNor-SSc). Significant differences were seen in gender (male 44.4% - 15.6%), disease duration (4.56 - 7.7 years), modified Rodnan skin score (12.3 - 6.9), as well as in incidence of lung (65.7% - 38.7%), heart (51.4% - 21.1%), and renal (28.6% - 5.9%) involvement. Increased ferritin correlated with elevated ESR, CRP, creatinine, creatine kinase, troponin, and reduced hemoglobin, impaired pulmonary function tests and reduced left ventricular ejection fraction on echocardiography. Patients with elevated ferritin had a significant increase in mortality rates (52.8% and 35.1%) and non-significant reduction in survival.ConclusionOur study demonstrated that ferritin has a potential as a sensitive marker for SSc severity in term of skin thickening, vital organ complications, and mortality. The ferritin test is simple and inexpensive, it can add to the complex SSc assessment and contribute to treatment decision-making in complicated SSc.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

FACTORS ASSOCIATED WITH ADHERENCE TO ANTI TNF-Α THERAPY DURING THE COVID-19 PANDEMIC IN PATIENTS WITH RHEUMATOID ARTHRITIS

BackgroundRheumatoid Arthritis (RA) patients are effectively treated with anti-TNF-α therapy. However, pharmacological non-adherence limits the achievement of the therapeutic objective. This is a multifactorial behavior where factors such as the route of administration, frequency, tolerance, perception of improvement, polypharmacy and social factors are involved [1,2].ObjectivesTo explore the factors associated with non-adherence to anti TNF-α in RA patients during the COVID-19 pandemic.MethodsThis is a cohort of RA patients treated with anti TNF-α in Medicarte SAS, a Colombian center for Immune-Mediated Diseases, between January to December 2021. The program implements strategies such as pharmacotherapeutic support, informed dispensing, phone calls, text messages and home care services to increase adherence. Adherence was defined as dispensing at least 10/12 (>0.80) prescribed monthly doses for 1 year. Sociodemographic characteristics, time in the program, DAS28-CRP, HAQ and treatment were included as exposure variables. For continuous variables, median and interquartile range (IQR) were calculated. Adjusted Odds Ratio (AOR) with logistic regression were calculated, and a p-value <0.05 was considered as statistically significant.Results565 patients were included, 85.8% (n=485) were women, median age 56 years (IQR: 49-65), disease evolution time 13.7 years (IQR: 7.7-20.8), 51% (n=288) had been in the program for more than 3 years, the median time in treatment with anti TNF-α was 3 years (IQR: 1-3) and DAS-28-CRP 2.4 (IQR: 1.6-3.4). The most frequently anti TNF-α prescribed was etanercept 46.0% (n=260), followed by adalimumab 23% (n=130), subcutaneous golimumab 13.3% (n=75), certolizumab 11.0% (n=62) and intravenous golimumab 6.7% (n=38). At the admission, 18.2% (n=103) of the patients had high activity, 38.6% (n=218) mild activity, 9.2% (n=52) low activity and 34% (n=192) were in remission. At the end of follow-up, 6.4% (n=36) of patients had high activity, 18.2% (n=103) mild activity, 14.3% (n= 81) low activity and 61.1% (n= 345) were in remission. The 51.5% (n=291) did not have pharmacological adherence. The use of etanercept (AOR 0.36 CI95% 0.23- 0.58, p < 0.001) and adequate functionality measured through HAQ (AOR 0.64 CI95% 0.42- 0.97, p < 0.04) were associated with a lower risk of non-adherence. Higher DAS28-CRP at the end of follow up was associated with non-adherence (AOR 1.29 CI95% 1.12 - 1.48, p < 0.001).ConclusionDuring COVID-19 pandemic, the implementation of strategies in the home care patient program guaranteed adherence close to 50% in our cohort. Higher values of DAS28-CRP were associated with non-adherence, whilst etanercept use and a normal HAQ value were associated with a higher probability of adherence.References[1]Marengo MF, Suarez-Almazor ME. Improving treatment adherence in patients with rheumatoid arthritis: what are the options? Int J Clin Rheumtol. 2015 Oct 1;10(5):345-356.[2]Smolen JS, Gladman D, McNeil HP, Mease PJ, Sieper J, Hojnik M, et al. Predicting adherence to therapy in rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis: a large cross-sectional study. RMD Open. 2019 Jan 11;5(1):e000585.Acknowledgements:NIL.Disclosure of InterestsWilmer Gerardo Rojas Zuleta Speakers bureau: Pfizer, Jannsen Cilag, Bristol Myers Squibb, Amgen, Eli lilly, Mario Barbosa: None declared, Oscar Jair Felipe Díaz Speakers bureau: Pfizer, Jannsen Cilag, Bristol Myers Squibb, Amgen, Eli lilly, Adelis Enrique Pantoja Marquez: None declared, Jeixa Canizales: None declared, Carolina Becerra-Arias: None declared, Jorge Hernando Donado Gómez: None declared, Natalia Duque Zapata: None declared.

Stakeholders' Involvement, Organizational Learning and Social Innovation: Factors for Strengthening the Resilience of Moroccan Cooperatives in the Post-COVID-19 Era

The Moroccan cooperative sector is increasingly important, not only in the social and economic fabric of Morocco, but also in the sustainable development of the Kingdom. With the advent of COVID, the cooperative sector offers more inclusive and sustainable economic alternatives than ever before. In this context, organizational resilience is essential to preserve the sustainability of cooperatives and anticipate potential crises. This study addresses the following issue: What are the organizational factors necessary to strengthen the organizational resilience of the Moroccan cooperative in the Fez-Meknes region in times of COVID-19 crisis? The purpose of this paper was to test the hypothesized relationships between a set of latent constructs (actor involvement and mobilization, organizational learning in times of a crisis and social innovation) and the organizational resilience of cooperatives in times of a COVID-19 crisis. The methodology adopted is structural equation modeling based on the PLS-SEM method under the "SmartPLS Version 3” used on data collected through a printed questionnaire administered to 160 cooperatives in the Fez-Meknes region. The results show the significant and positive influence between the exogenous constructs on the strengthening of organizational resilience of cooperatives as an endogenous construct. The novelty of the study lies in the identification of the organizational resources needed to strengthen the organizational resilience of cooperatives in the Moroccan context. The results show that organizational resilience depends on three selected organizational factors: stakeholder involvement and mobilization, organizational learning in the times of a crisis and social innovation.

CLINICAL AND IMMUNOLOGICAL PROFILES OF PATIENTS WITH ANTI-SYNTHETASE SYNDROME: A RETROSPECTIVE COHORT STUDY FROM A TERTIARY CENTRE

BackgroundAnti-synthetase syndrome (ASS) is a rare auto-immune condition that combines autoantibodies and specifics clinical manifestations, including myositis, interstitial lung disease (ILD), polyarthritis, mechanic's hands, Raynaud's phenomenon, and unexplained fever. The hallmark of this syndrome is the presence of anti-aminoacyl-tRNA-synthetase (ARS) antibodies. Several anti-ARS antibodies have been described, anti-Jo1 being the most common, followed by anti-PL7, anti-PL12, anti-OJ, anti-EJ, anti-KS, anti-YRS, and anti-Zo. According to a recent epidemiological survey, the rising number of patients with autoimmune diseases, including idiopathic inflammatory myopathies (IIM) coincides with the COVID-19 pandemic.ObjectivesTo evaluate the clinical characteristics of ASS patients with different anti-ARS antibodies from a tertiary rheumatology center.MethodsWe conducted a retrospective, single-centered study on consecutive patients diagnosed with ASS from 1 January 2015 to 31 December 2022. Clinical and serologic data were obtained by medical records review from hospital database. Myositis-specific antibodies (MSA) and myositis-associated antibodies (MAA) were tested using commercial ELISA kits. We included all patients fulfilling Connor's criteria for ASS.ResultsSixty-one patients (44 females) with mean age 54.4 (13.8) years were included. The most frequently reported clinical manifestation was arthralgia (68.8%), followed by Raynaud's phenomenon (67.2%), ILD (65.6%), myositis (46%), mechanic's hands (44.3%), arthritis (39.3%), and fever (18.0%). The typical triad for ASS, including myositis, arthritis and ILD was present in 17 patients. Twenty-eight (45.9%) patients were PL7+, 21 (34.4%) were Jo1+, 3 (4.9%) were PL12+, and 2 (3.2%) were OJ+. Seven patients were positive for more than two anti-ARS antibodies. The most frequently found MAA was anti-Ro52 (n=23, 37.7%). Of the 61 patients included, 41 (67.2%) patients were diagnosed in the last 3 years (COVID-19 pandemic). The most frequently detected MSA in ASS patients diagnosed during COVID-19 pandemic was anti-PL7 (25/28), while anti-Jo1 was the most common MSA in ASS patients diagnosed before 2020 (p<0.05) (Fig 1).The anti-Jo1+ patients were younger, have significantly more frequent muscle involvement and significantly higher levels of CK than anti-PL7+ patients (p<0.05). The co-occurance of anti-Ro52 antibodies was more frequently observed in anti-Jo1+ patients (n=11, 52.4%) than in anti-PL7+ patients (n=6, 21.4%) (p<0.05). We did not find statistically significant differences between ASS groups regarding sex, disease duration, clinical manifestations including dermatologic lesions, Raynaud's phenomenon, arthralgia/arthritis, ILD, fever, and cancers (all p>0.05).ConclusionASS patients have heterogenous manifestations, and different types of anti-ARS antibodies are associated to distinct clinical and immunological features. The COVID-19 pandemic led to increase prevalence of ASS cases and to a remarkable shift in the anti-ARS antibodies profile, with increased frequency of anti-PL7 antibodies. Further studies are needed to investigate the link between SARS-CoV-2 infections and myositis.References[1]Witt LJ, et al. The Diagnosis and Treatment of Antisynthetase Syndrome. Clin Pulm Med. 2016 Sep;23(5):218-226.[2]Gracia-Ramos AE, et al. New Onset of Autoimmune Diseases Following COVID-19 Diagnosis. Cells. 2021 Dec 20;10(12):3592.[3]Connors GR, et al. Interstitial lung disease associated with the idiopathic inflammatory myopathies: what progress has been made in the past 35 years? Chest. 2010 Dec;138(6):1464-74.[4]García-Bravo Let al. Association of anti-SARS-COV-2 vaccine with increased incidence of myositis-related anti-RNA-synthetases auto-antibodies. J Transl Autoimmun. 2022 Jun 30;5:100160.Figure 1.ASS patients with positive anti-ARS antibodies per year (from 2015 to 2022). The green line shows the PL7+ patients;and the orange line shows the Jo1+ cases.[Figure omitted. See PDF]AcknowledgementsI have no acknowledgements to declare.Disclosure of Inter stsNone Declared.

Psychometric Performance of the Fear of COVID-19 Scale (FCV-19S) and Its Validation in Czechia

The COVID-19 pandemic has brought significant changes to people's lives, causing high levels of anxiety, distress, and fear. In response, the "Fear of COVID-19” scale (FCV-19S) was developed in 2020 to measure the severity of fears related to COVID-19. This study assessed the psychometric properties of the Czech version of the FCV-19S, which was administered to a representative sample of 1372 participants, and confirmatory factor analysis (CFA) was conducted. The sample reflects the structure of a theoretical population aged 15–74 years and is composed of 50% males and 50% females. Moreover, univariate statistics were calculated, internal consistency was tested, and uni-dimensionality based on principal component analysis was performed. In addition, univariate statistical analyses were performed, internal consistency was tested, and univariate consistency was also assessed using principal component analysis. CFA indicated that the scale demonstrated very good standard indices;FCV-19S showed a high level of internal consistency, and it adequately differentiated the levels of fear among diverse subpopulations. The findings suggest that the Czech version of the FCV-19S is a valid and reliable instrument that has robust psychometric properties and can, therefore, be recommended for use in research. The availability of the Czech version of the FCV-19S will contribute to assessments of the impact of the COVID-19 pandemic on the Czech population, providing valuable information in guiding interventions aimed at reducing the negative psychological impacts of the pandemic.

IMPACT OF THE COVID-19 PANDEMIC ON ADHERENCE TO DISEASE MODIFYING DRUGS AMONG PATIENTS WITH RHEUMATIC DISEASES: A POPULATION-BASED, INTERRUPTED TIME SERIES ANALYSIS

BackgroundAlthough studies have quantified adherence to medications among patients with rheumatic diseases (RD) during the COVID-19, lack of direct pre-pandemic comparison precludes understanding of impact of the pandemic.ObjectivesOur objective was to evaluate the effect of the COVID-19 pandemic on adherence to disease modifying drugs (DMARDs) including conventional synthetic (csDMARDs) and targeted synthetic (tsDMARDs).MethodsWe linked population-based health data on all physician visits, hospital admissions, and all dispensed medications, regardless of payer in British Columbia from 01/01/1996 to 3/31/2021. We identified prescriptions for csDMARDs (including methotrexate, hydroxychloroquine) and tsDMARDs, namely anti-TNFs (including infliximab, etanercept, adalimumab) and rituximab using drug identification numbers among indicated individuals with RD. We defined March 11, 2020, as the ‘index date' which corresponded to the date that mitigation measures for the COVID-19 pandemic were first introduced. We assessed adherence as proportion days covered (PDC), calculated monthly in the 12 months before and 12 months after the index date. We used interrupted time-series models, namely segmented regression to estimate changes and trends in adherence before and after the index date.ResultsOur analysis showed that the mean PDCs for all included DMARDs stayed relatively steady in the 12 months before and after mitigation measures were introduced (see Table 1). Adherence was highest among anti-TNFs, methotrexate, and azathioprine. Anti-TNFs were on a downward trajectory 12 months prior to the index date. Interrupted time-series modeling demonstrated statistically significant differences in the trends in PDCs post- vs. pre-mitigation measures for all anti-TNFS (slope [∂]: 1.38, standard error [SE]: 0.23), infliximab (∂: 1.35, SE: 0.23), adalimumab (∂: 0.82, SE: 0.25), and etanercept (∂: 1.07, SE: 0.25) (see Figure 1a). Conversely, the csDMARDs were on a flatter trajectory, and methotrexate (∂: -0.53, SE: 0.16), leflunomide (∂: 0.43, SE: 0.08), mycophenolate (∂: -1.26, SE: 0.48), cyclophosphamide (∂: 0.29, SE: 0.05), minocycline (∂: 0.04, SE: 0.02), chloroquine (∂: 0.02, SE: 0.00) showed statistically significant changes in estimated PDC trajectory after mitigation measures were introduced (see Figure 1b).ConclusionThis population-based study demonstrates that messaging and pandemic mitigation measures did not affect adherence to DMARDs.Table 1.Mean PDC 1 year before and after mitigation measures for the COVID-19 pandemic were introduced.MedicationMean PDC (%) 12 months before index dateMean PDC (%) 12 months after index datecsDMARDsmethotrexate28.926.8azathioprine21.819.5sulfasalazine16.214.9leflunomide14.313.0cyclosporine13.711.5hydroxychloroquine10.59.6mycophenolate4.52.9antimalarials4.43.9penicillamine3.53.4cyclophosphamide1.50.7chlorambucil1.20.4minocycline1.10.9gold0.50.2chloroquine0.10.0tsDMARDsanti-TNFs52.149.2infliximab41.838.3adalimumab40.336.8etanercept31.828.9rituximab3.42.9REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.

A Three-Stage Hybrid SEM-BN-ANN Approach for Analyzing Airport Service Quality

The novel coronavirus (COVID-19) outbreak has impacted the aviation industry worldwide. Several restrictions and regulations have been implemented to prevent the virus's spread and maintain airport operations. To recover the trustworthiness of air travelers in the new normality, improving airport service quality (ASQ) is necessary, ultimately increasing passenger satisfaction in airports. This research focuses on the relationship between passenger satisfaction and the ASQ dimensions of airports in Thailand. A three-stage analysis model was conducted by integrating structural equation modeling, Bayesian networks, and artificial neural networks to identify critical ASQ dimensions that highly impact overall satisfaction. The findings reveal that airport facilities, wayfinding, and security are three dominant dimensions influencing overall passenger satisfaction. This insight could help airport managers and operators recover passenger satisfaction, increase trustworthiness, and maintain the efficiency of the airports in not only this severe crisis but also in the new normality.

Environmental Sustainability and Territorial Competitiveness: A Comparison between Italian Provinces

The emergence of globalisation and the removal of obstacles between markets have heightened rivalry between territorial areas. To have a competitive advantage, the regions have to be unique. As one of the tactics used to boost their reputation on a territorial level, territories are progressively adopting environmental policies for sustainable and shared prosperity. Indeed, effective management of urban growth depends heavily on sustainable development. In this regard, the literature occasionally refers to the "green branding” of cities, a strategy that makes use of environmental aspects to boost the allure of metropolitan environments. There is currently little consensus in the literature on the measuring of environmental performance, and no statistical study has been done to confirm the efficacy of these measures in terms of territorial competitiveness. Therefore, it is important to determine whether there is a relationship between a territory's level of sustainability and competitiveness in Italy. According to the statistical analysis of the Italian provinces, the Northeast, Northwest, Centre, and Islands are the four geographical regions with the highest average scores. This unquestionably indicates a basic comprehension and supports the notion that there is a relationship between the two variables. However, it also serves as a warning about how geographical disparities in Italy represent a major issue affecting the most diverse sectors. In addition, the COVID-19 pandemic problem has drastically altered consumer demands and goals, leading consumers to seek out more sustainable travel and cities that are designed with citizens' requirements in mind. It will therefore become more and more important to research how public and private administrators, as well as policy makers, react to these changes.

The Role of Information Sources on Tourist Behavior Post-Earthquake Disaster in Indonesia: A Stimulus–Organism–Response (SOR) Approach

The earthquake disaster has an impact on tourist visit intention. This study aims to investigate tourist behavior in the post-earthquake disaster linkage between information sources (word of mouth and electronic word of mouth) and risk perception toward tourists' visit intentions to a destination in Indonesia. This study applies the SOR theory to predict tourists' behavior in the destination aftermath. The Partial Least Squares Structural Equation Model was used to examine the hypothesis of the study. The result found that information sources (electronic word of mouth and word of mouth) significantly influenced visit intention in the time of post-earthquake disaster. The risk perception has not significantly influenced visit intention in post-earthquake disasters. The discussion and conclusion of the study are discussed herein. Overall, the findings of the study may contribute to the theory by adding information sources to predict tourist behavior post-earthquake disaster and also gives a practical contribution to the tourism sector, stakeholders, tourism marketers, and policymakers in Indonesia to enhance the marketing strategy by considering destination promotion through word of mouth (offline) and electronic word of mouth (online) and its mechanism on tourists' travel decision in the time of aftermath.