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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.
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BackgroundPsoriasis (PsO) and psoriatic arthritis (PsA) can greatly impact quality of life and result in substantial personal and societal costs. Complete and up to date data on the prevalence and incidence of these conditions and whether these change over time and vary by age is important for healthcare service planning so that specialist care and funding can be appropriately allocated.ObjectivesTo determine the prevalence and incidence of PsO and PsA in males and females from 2009-2019 across all age groups in England.MethodsWe used Clinical Practice Research Datalink AURUM, a primary care electronic health record database, including 20% of the English population. The codes used to identify patients with PsO and PsA were selected by rheumatologists and dermatologists and cross-checked with published code lists from other studies to ensure inclusion of all relevant codes. All included patients must have data for at least 1 year before their diagnosis. The annual incidence and point prevalence were calculated from 2009-2019 and stratified by age/sex. The study period ended in 2019 to avoid COVID-19 pandemic affecting results.ResultsThe prevalence of PsO and PsA in males and females increased annually, peaking in 2019 (PsO males 2.41% [95% confidence interval (CI) 2.40, 2.42];PsO females 2.60% [95% CI 2.59-2.61];PsA males 0.20% [95% CI 0.20-0.20];PsA females 0.21% [95% CI 0.21- 0.22]), as illustrated in Table 1. In 2019, the prevalence of PsO and PsA was highest in the over 65 years age group;PsO 4.25% [95% CI 4.22-4.28] and PsA 0.38% [95% CI 0.37-0.38]. The annual incidence (per 100,000 person years) of PsO has gradually decreased in males (from 168 (164-171) in 2009 to 148 (145-151) in 2019) but in females it has been stable with a slight annual decrease (from 180 (177-184) in 2009 to 173 (170-176) in 2019). The annual incidence for PsA has increased in both males and females (13 (12-14) in 2009 and 15 (14-16) in 2019 for males and 12 (11-13) in 2009 and 18 (17-19) in 2019 for females).ConclusionThe increasing prevalence of PsO and PsA highlights the importance of organising healthcare services to meet this need, particularly in the elderly population.ReferencesNIL.Table 1.Prevalence of PsO and PsA from 2009-2019 in EnglandYear20092010201120122013201420152016201720182019Population (n)1073383110910802110318501118036711343299112249341137842211657996119336261223432512420998PsO (n)216841229106239819250667259988268032276804286499295712304568311104PsO prevalence (%, 95%CI)-Male1.98 (1.96-1.99)2.06 (2.05- 2.07)2.13 (2.12-2.14)2.19 (2.18-2.20)2.24 (2.23- 2.25)2.33 (2.32- 2.34)2.37 (2.36- 2.38)2.39 (2.38- 2.40)2.40 (2.39- 2.41)2.40 (2.39- 2.42)2.41 (2.40- 2.42)-Female2.07 (2.05- 2.08)2.14 (2.13- 2.16)2.22 (2.21- 2.23)2.29 (2.28- 2.31)2.35 (2.33- 2.36)2.45 (2.43- 2.46)2.50 (2.49- 2.51)2.53 (2.52- 2.54)2.56 (2.54- 2.57)2.58 (2.56- 2.59)2.60 (2.59- 2.61)PsO incidence (100,000 person years)-Male168 (164-171)158 (155- 162)161 (158-165)153 (150-157)161 (157- 164)156 (153- 159)155 (152- 159)154 (151- 157)153 (150-156)150 (147-153)148 (145-151)-Female180 (177-184)176 (172-179)181 (177-184)171 (167-174)175 (171-178)176 (172-180)179 (176-183)178 (174-181)177 (174-181)174 (170-177)173 (170-176)PsA (n)1444515443164681752218545196182072021994232572451425683PsA prevalence (%, 95%CI)-Male0.14 (0.14- 0.14)0.15 (0.14- 0.15)0.15 (0.15- 0.16)0.16 (0.16- 0.16)0.17 (0.16- 0.17)0.18 (0.17- 0.18)0.18 (0.18- 0.19)0.19 (0.18- 0.19)0.19 (0.19- 0.20)0.20 (0.19- 0.20)0.20 (0.20- 0.20)-Female0.13 (0.13- 0.13)0.14 (0.13- 0.14)0.15 (0.14- 0.15)0.15 (0.15- 0.16)0.16 (0.16- 0.16)0.17 (0.17- 0.18)0.18 (0.18- 0.18)0.19 (0.19- 0.19)0.20 (0.19- 0.20)0.20 (0.20- 0.21)0.21 (0.21- 0.22)PsA incidence (100,000 person years)-Male13 (12- 14)12 (11- 13)13 (12- 14)12 (11- 13)13 (12-14)14 (13- 15)14 (13- 15)14 (13-15)1514-16)14(13- 15)15 (14-16)-Female12 (11- 13)13 (12- 14)13 (12- 14)14 (13-15)14 (13-15)15 (14-16)17 (16- 18)16 (15- 17)17 (16- 18)18 (17-19)18 (17-19)Acknowledgements:NIL.Disclosure of InterestsArani Vivekanantham: None declared, Edward Burn: None dec ared, Marta Pineda-Moncusí: None declared, Sara Khalid Grant/research support from: SK has received research grant funding from the UKRI and Alan Turing Institute outside this work. SK's research group has received grant support from Amgen and UCB Biopharma., Daniel Prieto-Alhambra Grant/research support from: DPA's department has received grant/s from Amgen, Chiesi-Taylor, Lilly, Janssen, Novartis, and UCB Biopharma. His research group has received consultancy fees from Astra Zeneca and UCB Biopharma. Amgen, Astellas, Janssen, Synapse Management Partners and UCB Biopharma have funded or supported training programmes organised by DPA's department., Laura Coates Speakers bureau: LC has been paid as a speaker for AbbVie, Amgen, Biogen, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Medac, Novartis, Pfizer and UCB., Consultant of: LC has worked as a paid consultant for AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Gilead, Galapagos, Janssen, Novartis, Pfizer and UCB., Grant/research support from: LC has received grants/research support from AbbVie, Amgen, Celgene, Eli Lilly, Novartis and Pfizer.
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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.
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BackgroundThe workload at rheumatology clinics have been growing relentlessly and an audit on new.referrals helps to identify referral behaviour of primary care doctors and improvement can be done by providing further training.ObjectivesTo audit on new referral cases to rheumatology clinic from 2020-2022 and to identify new cases with misdiagnosis for future training purpose.MethodsThis was a retrospective study. The medical records of all new referral to rheumatology clinic Hospital Sultan Ismail and Hospital Pakar Sultanah Fatimah from 1st January 2020 to 31th November 2022 were reviewed. The referral diagnosis and final diagnosis were identified and analysed.ResultsThere were total of 927 new cases referral throughout the 35 months during Covid-19pandemic. Majority of them were diagnosed to have rheumatoid arthritis (217/927)followed by systemic lupus erythematosus (190/927), psoriatic arthritis (147/927),gout (62/927), osteoarthritis (58/927), systemic sclerosis (25/927), ankylosing spondylitis (25/927), soft tissue rheumatism (24/927), Sjogren syndrome (24/927),mixed connective tissue disease (14/927), vasculitis (11/927), fibromyalgia (10/927),polymyositis (7/927) and miscellaneous (39/927).45 out of the new cases were diagnosed as unlikely rheumatic diseases. There were 29pending cases awaiting final diagnosis.212 of the referrals were identified as misdiagnosis with the highest as nodal osteoarthritis.(55/212) followed by unlikely rheumatic disease (43/212), soft tissue rheumatism (24/212),psoriatic arthritis (20/212), Sjogren syndrome (14/212), gout (8/212), rheumatoid arthritis (7/212), fibromyalgia (6/212), systemic lupus erythematosus (5/212), ankylosing spondylitis (4/212), mixed connective tissue disease (3/212), systemic sclerosis (2/212), polymyositis (2/212) and others (19/212): diffuse idiopathic skeletal hyperostosis, hypermobility syndrome, RS3PE syndrome, idiopathic uveitis, graft versus host disease, juvenile idiopathic arthritis, antiphospholipid syndrome, hypothyroidism, post streptococcal arthritis, prolapsed intervertebral disc, cerebrovascular disease, traumatic sternoclavicular joint subluxation, ledderhose disease, paraspinal muscle spasm and viral myalgia).ConclusionNodal osteoarthritis and soft tissue rheumatism can be great mimicker for inflammatory.arthritis and if wrongly diagnosed will lead to unnecessary anxiety or wrong treatment. More training is needed to improve clinical skills amongst primary care doctors.ReferencesNA.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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COVID-19 pandemic brought up issues with healthcare costs, national economic development and welfare of the society in forefront. Nations across the globe followed different approaches to deal with COVID-19, such as zero tolerance, herd immunity, containment to build treatment capability. National healthcare became a contentious sociopolitical issue involving healthcare costs, technologies and societal health. In the United States even during the COVID-19 pandemic, the government approach was pursuing a sustainable improvement in patient care through adoption of medical and information technologies. The national healthcare policies are framed around technological interventions with the assumption that deployment of technologies could keep healthcare costs under control and at the same time improve health outcomes. However, evidences show that the healthcare costs are in the rise even with impressive progress in technological deployment. This article highlights some of the recent trends in healthcare costs, technological preparedness, medical technology developments in managing COVID-19 pandemic. The US government mandated electronic health record (EHR) systems implementation and assess its impact on healthcare costs and health outcomes. This article emphasizes the need for understanding the interconnectedness of costs, technology and societal health.
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BackgroundBelimumab (BLM) is a monoclonal antibody that inhibits B-lymphocyte stimulating factor (BlyS) approved as a specific treatment for systemic lupus erythematosus (SLE) in 2011. We present the experience with BLM in a Spanish cohort with more than 460 patients.ObjectivesTo describe demographic characteristics, efficacy and safety of BLM in patients with SLE in Spanish population since its approval.MethodsDescriptive, retrospective, multicenter study in patients diagnosed with SLE according to EULAR/ACR 2019, SLICC and/or ACR 1997 diagnostic criteria. Data regarding SLE patients treated with BLM were collected from medical records (2011-2022). Demographic features, efficacy, laboratory variables, SLEDAI, renal involvement, steroid dose, administration routes and safety were assessed. To see whether a trend in BLM prescription had changed or not over time, two periods of time were analyzed: 2011-2016 (period1) and 2017-2022 (period2).ResultsBaseline characteristics of patients are summarized in Table 1.A total of 462 patients (36 hospitals) were included, 50.9% were on intravenous (IV), 34% on subcutaneous (SC) and 15.1% switched from IV to SC route. The median number of pre-BLM csDMARD use was 2.0 (2.0-3.0), being hydroxychloroquine (HCQ) the most frequently used (94.5%). Fifty-two patients were treated with IV cyclophosphamide with a median of 6 bolus received. At the time of BLM start, 443 patients were on prednisone with a median dose of 6.2 mg (5.0-10.0). Significant decreases in prednisone dose, SLEDAI and anti-DNA antibodies were observed from baseline until the last visit, whereas complement C3 and C4 values raised (Figure 1). A total of 118 patients (27.4%) had renal involvement with a median proteinuria of 1.0 g/day (0.5-2.4). Renal biopsy was done in 102 out of 118 patients, being class IV (33%), class III (21%) and class V (16%) the most frequently reported. After BLM, 73.3% of these patients improved (median proteinuria of 0.2 g/day (0.1-0.7).In period1, 100 patients started BLM compared to 362 in period2. The median time from SLE diagnosis to BLM begin was 7.1 (4.0-13.7) and 6.2 (2.1 -14.4) years in period1 and period2, respectively (p=0.454). We found a trend to use more csDMARD before BLM treatment in period1: 2.5 (2-3) vs. 2 (2-3) (p=0.088).A total of 143 (30.5%) patients discontinued treatment mostly due to inefficacy (55.9%) and infections (11.9%). In fact, 116 patients developed infections, mostly mild;2 patients died, 16 had COVID-19 and 4 patients developed tumors requiring discontinuation of the drug.ConclusionIn our cohort of SLE patients in a real-world setting, BLM has been effective, safe and seems to be a good choice to treat renal involvement.References[1]Navarra SV, Guzmán RM, Gallacher AE, et al. Lancet. 2011;377(9767):721-31.[2]Stohl W, Hiepe;rt al. Arthritis Rheum. 2012;64(7):2328-37.[3]Furie R, Rovin BH, Houssiau F, et al. N Engl J Med. 2020;383(12):1117-1128.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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BackgroundPatients with autoimmune inflammatory rheumatic diseases are at higher risk for coronavirus disease (COVID)-19 hospitalization and worse clinical outcomes compared with the general population. However, data on the association between COVID-19 outcomes and gout, or gout-related medications are still lacking.ObjectivesWe aimed to compare COVID-19 related clinical outcomes in gout vs. non-gout patients.MethodsWe conducted a retrospective cohort study using the electronic health record-based databases of Seoul National University hospital (SNUH) from January 2021 to April 2022 mapped to a common data model. Patients with gout and without gout were matched using a large-scale propensity score (PS) algorithm. The clinical outcomes of interest were COVID-19 infection, severe COVID-19 outcomes defined as the use of mechanical ventilation, tracheostomy or extracorporeal membrane oxygenation, and death within 30 days of COVID-19 diagnosis. The hazard ratio (HR) for gout vs. non-gout patients derived by Cox proportional hazard models were estimated utilizing a 1:5 PS-matched cohort.Results2,683 patients with gout and 417,035 patients without gout were identified among the patients who visited SNUH. After 1:5 PS matching, 1,363 gout patients and 4,030 non-gout patients remained for the analysis. The risk of COVID-19 infection was not significantly different between patients with gout and those without gout (HR 1.07 [95% CI 0.59-1.84]). Within the first month after the COVID-19 diagnosis, there was also no significant difference in the risk of hospitalization (HR 0.57 [95% CI 0.03-3.90], severe COVID-19 outcomes (HR 2.90 [95% CI 0.54-13.71]), or death (HR 1.35 [95% CI 0.06-16.24]).ConclusionPatients with gout did not have an increased risk of COVID-19 infection or worse clinical outcomes. Updates of temporal trends of COVID-19 outcomes in gout patients are yet warranted as new SARS-CoV-2 variants emerge.References[1]Shin YH, et al. Autoimmune inflammatory rheumatic diseases and COVID-19 outcomes in South Korea: a nationwide cohort study. Lancet Rheumatol. 2021 Oct;3(10):e698-e706.[2]Topless RK, et al. Gout and the risk of COVID-19 diagnosis and death in the UK Biobank: a population-based study. Lancet Rheumatol. 2022 Apr;4(4):e274-e281.[3]Xie D, et al. Gout and Excess Risk of Severe SARS-CoV-2 Infection Among Vaccinated Individuals: A General Population Study. Arthritis Rheumatol.2023 Jan;75(1):122-132.Table 1.Clinical outcomes of COVID-19 infection in patients with goutOutcomesUnmatched populationPopulation with PS stratification using 10 strata1:5 PS matched populationHazard ratio (95% CI)p-valueHazard ratio (95% CI)p-valueHazard ratio (95% CI)p-valueCOVID-19 infection1.68 (1.03-2.57)0.031.20 (0.72-1.87)0.461.07 (0.59-1.84)0.82Hospitalization due to COVID-191.92 (0.32-6.05)0.391.63 (0.26-5.77)0.540.57 (0.03-3.90)0.66Severe COVID-19 infection4.72 (1.44-11.28)<0.014.22 (1.17-12.21)0.022.90 (0.54-13.71)0.20Death due to COVID-191.15 (0.07-5.18)0.900.77 (0.04-3.81)0.821.35 (0.06-16.24)0.84Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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Objectives Human leukocyte antigens (HLA) are highly diverse transmembrane proteins that present viral peptides to T cells and launch pathogen-specific immune responses. We aim to investigate the correlation between HLA evolutionary divergence (HED), a surrogate for the capacity to present different peptides, and the outcomes of SARS-CoV-2 infection in a cohort from the St. Louis Metropolitan area. Methods We enrolled adult patients with SARS-CoV-2 infection confirmed by RT-PCR who were hospitalized at two tertiary hospitals in St. Louis between March and July 2020. Genomic DNA was extracted from peripheral blood and genotyped by next-generation sequencing (NGS). HLA alleles were assigned based on key-exon sequences (G group) and limited to the 2-field resolution. HED was calculated by Grantham distance, which considers the difference in composition, polarity, and molecular volume between each pair of amino acids from maternal and paternal HLA. The HED score was obtained for HLA class I (HLA-A, -B, and -C) genotypes using the HLAdivR package in R. Clinical data were collected retrospectively from electronic medical records. A poor outcome was defined as an admission to the intensive care unit (ICU), a need for mechanical ventilation, or death. A favorable outcome was defined as the absence of the above poor outcomes. Results A total of 234 patients were enrolled in this study, 96 being females (41%). The median age and BMI were 66 years old and 28.30 kg/m2, respectively. African Americans comprised 71.4% of the cohort. Only 19 patients (8.1%) presented with no comorbidity;the rest had one or more comorbidities, with cardiovascular diseases being the most common. A total of 137 (58.5%) patients had poor outcomes from SARS-CoV-2 infection, while 97 (41.5%) patients had a favorable outcome. We detected a significant association between higher HLA-B HED and favorable outcomes, with each 1-point increase in HLA-B HED associated with 8% increased probability for the composite endpoint (OR 1.08, 95% CI=1.01-1.16, P = 0.04). The HED scores calculated for HLA-A or HLA-C were not significantly different between patients with favorable or poor outcomes. In a multivariate logistic regression analysis, increased HLA-B HED score, younger age, and no comorbidity were independently associated with favorable outcomes (P = 0.02, P = 0.01, and P = 0.05, respectively). Conclusion Our study shows a significant correlation between lower HLA-B HED scores and poor outcomes after SARS-CoV-2 infection. This finding suggests that maximizing the presentation of diverse SARS-CoV-2 peptides by HLA-B alleles may improve the clearance of SARS-CoV-2. Further studies are warranted to understand the functional and mechanistic implications of this finding.
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The deadly complication Scientists failed to find evidence that COVID-19 causes a "cytokine storm” leading to death in patients with COVID-19 but they did find that secondary bacterial pneumonia that does not resolve was a key driver of death in patients with COVID-19 and may have exceeded death rates from the viral infection itself. The approach grouped similar ICU patient-days into clinical states based on electronic health record data and allowed the scientists to discover how complications such as bacterial pneumonia impacted the course of illness. For more on complications in COVID19 see J Clin Investig 2023;published online April 27. https://doi.org/10.1172/JCI170682 For more on efficacious monoclonal antibodies see Ann Intern Med 2023;published online April 18. https://doi.org/10.7326/M22-3428 For more on targets for herpes virus see Sci Adv 2023;9: eadf3977 For more on an RSV vaccine in pregnancy see N Engl J Med 2023;388: 1451–64 For more on Pillar[5]arene see Nat Commun 2023;14: 2141 For more on doxycycline for STIs see N Engl J Med 2023;388: 1296–306 For more on immunity in tuberculosis see Nat Immunol 2023;24: 753–54
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BackgroundD-dimer and fibrinogen elevation has been observed in severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) infection which is associated with higher incidence of venous thromboembolism (VTE) and higher mortality rates. [1-3]. Autoimmune Rheumatic Diseases (ARDs) are associated with higher rates of VTE compared to general population [4]. Whether patients with ARDs infected with SARS-CoV2 have similar D-dimer and fibrinogen trends compared to patients without ARDs is unknown.ObjectivesCompare D-dimer and fibrinogen levels in patients with ARDs infected with SARS-CoV2 to patients without ARDs.MethodsPatients with ARDs infected with SARS-CoV2 were identified retrospectively from the electronic medical records (EMR) of Hamad Medical Corporation and matched (age and sex) to controls (1:3). D-dimer and fibrinogen levels were extracted electronically from EMR and stratified into six-time intervals defined in table 1. Day 0 was defined as the date of positive nasopharyngeal polymerase chain reaction swab test. 2 Independent Samples test (Mann-Whitney U) was used to compare the median (25th - 75th interquartile range [IQR]) level of D-dimer and fibrinogen between both study groups at the defined intervals.ResultsThe study included 203 cases and 551 controls with a mean (SD) age of 45.3 (11.7) and 44 (12.5) years, females were (122 [60.1%] vs. 297 [53.9%], p = 0.129), respectively.Distribution of ARDs was rheumatoid arthritis 86 (42.4%), spondyloarthropathy 33 (16.1%) and systemic lupus erythematosus 31 (15.7%) cases. 67% were on conventional synthetic disease modifying anti-rheumatic drugs (Cs-DMARDs), 15.8% on biological DMARDs and 4.9% on rituximab. About 83% of the ARDs group were in remission or low disease activity and 13% were in moderate or high disease activity.The median (25th - 75th IQR) level of D-dimer and fibrinogen were comparable between study groups in all defined intervals with insignificant p values except at interval 4, fibrinogen was significantly higher in the cases, p 0.006. Table 1ConclusionThere was no significant difference in the trend of D-dimer and fibrinogen levels during SARS-CoV2 infection between patients with ARDs and those without ARDs. Additional studies are needed to quantify the actual risk of VTE in patients with ARDs during SARS-CoV2 in correlation with serum markers of VTE.References[1]Eljilany I, Elzouki AN. D-Dimer, Fibrinogen, and IL-6 in COVID-19 Patients with Suspected Venous Thromboembolism: A Narrative Review. Vasc Health Risk Manag. 2020;16:455-62.[2]Li JY, Wang HF, Yin P, Li D, Wang DL, Peng P, et al. Clinical characteristics and risk factors for symptomatic venous thromboembolism in hospitalized COVID-19 patients: A multicenter retrospective study. J Thromb Haemost. 2021;19(4):1038-48.[3]Zhan H, Chen H, Liu C, Cheng L, Yan S, Li H, et al. Diagnostic Value of D-Dimer in COVID-19: A Meta-Analysis and Meta-Regression. Clin Appl Thromb Hemost. 2021;27:10760296211010976.[4]Lee JJ, Pope JE. A meta-analysis of the risk of venous thromboembolism in inflammatory rheumatic diseases. Arthritis Res Ther. 2014;16(5):435.Table 1.Differences in D-dimer and fibrinogen during SARS-CoV2 infection between patients with ARDs and those without at the defined intervals.Case N = 203Control N = 551P valueMedian (25th - 75th IQR), D-dimer (mg/L)(0 to < 3 days)0.56 (0.34 – 1.31)0.86 (0.54 – 1.41)0.096(≤ 3 to < 6 days)0.67 (0.35 – 2.58)1.11 (0.44 – 1.11)0.340(≤ 6 to < 9 days)0.81 (0.33 – 5.12)1.12 (0.56 – 3.28)0.299(≤ 9 to 12 days)0.94 (0.72 – 5.44)5.20 (1.0 – 15.05)0.058(≤ 12 to < 15 days)2.88 (0.72 – 5.53)4.96 (0.57 – 9.98)0.681(≤ 15 to 18 days)1.81 (0.89 – 2.55)5.56 (2.60 – 15.1)0.086Median (25th – 75th IQR), fibrinogen (mg/L)(0 to < 3 days)6.53 (2.0 - 6.53)5.65 (3.75 – 7.17)1.000(≤ 3 to < 6 days)6.25 (3.72 – 8.3)4.6 (4.1 – 5.6)0.385(≤ 6 to < 9 days)3.53 (3.29 – 4.62)3.4 (3.2 – 3.92)0.328(≤ 9 to 12 days)4.3 (2.82 – 4.78)2.2 (1.65 – 3.05)0.006(≤ 12 to < 15 days)4.4 (2.37 – 5.13)3.1 (1.7 – 4.45)0.170(≤ 15 to 18 days)3.6 ( – 5.7)3.7 (2.0 – 4.88)0.524Acknowledgements:NIL.Disclosure of InterestsNone Declared.
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During the height of the COVID-19 pandemic, this core aspect of a CRA's role was altered greatly, with many sites unable to continue research and/or unable to accommodate visitors, therefore forcing a change in the method of monitoring source documentation and challenging their relationship with site staff. Protocol mandated procedures and methods of data collection, though seemingly straight forward, have met challenges at sites when faced with hospital visitor restrictions, government travel restrictions, the risk of COVID-19 associated with visiting hospital, vulnerable patients, redeployed staff, limited time... the list goes on! Remote monitoring without SDV, though challenging, has still been found to be valuable in highlighting and resolving issues, maintaining good working relationships with the sites, ensuring data is entered, training site staff, and ensuring the ongoing success of the study.
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Background and Purpose: according to the studies that have been conducted so far, the corona virus has more severe clinical consequences in diabetic patients than in non-diabetic cases;Therefore, the present study was conducted with the aim of investigating the severity of the disease and mortality in patients infected with the Coronavirus between these 2 groups. Materials and Methods: In this cross-sectional-analytical study, the clinical records of 185 hospitalized patients with a positive laboratory diagnosis of Covid-19 were reviewed from February 14 to February 26, 2020. The patients were divided into 2 non-diabetic (95 people) and diabetic (90 people) groups, and their clinical symptoms and blood biochemical parameters were compared. Results: Based on the results, most of the patients were male and compared to non-diabetic patients, the diabetic group was significantly older (P=0.01). In this study, the disturbance in paraclinical factors such as d-dimer, BUN, VBG and lymphopenia in diabetic patients was significantly higher than in the control group, which indicates the need for more care in diabetic patients. Conclusion: it is suggested to follow health protocols for people with land diseases, be more careful., therefore, more extensive research with larger sample sizes is needed to achieve more accurate results. [ FROM AUTHOR] Copyright of Journal of Pharmaceutical Negative Results is the property of ResearchTrentz and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)
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Background and ImportanceIn recent years not just the novel therapeutic approaches, but the Coronavirus pandemic has also affected the therapy management of patients with rheumatoid arthritis. Beside these changes, the immunisation against COVID-19 has also been an issue and raised several questions from clinicians to patients.Aim and ObjectivesTherefore, our aim was to find out the possible changes that patients were experiencing and the potential factors influencing their therapy.Material and MethodsData was collected through structured personal interviews with a 33-item questionnaire licensed by the Regional Research Ethics Committee of the University of Pécs and review of the medical records from January until September in 2022. We used the data available in the ambulatory medical records and the itemised reporting interface of the National Health Insurance Fund. Drug interactions were analysed using UpToDate Lexicomp database.Results35 female patients (average age: 63.53 years ± 13.82) and 23 male patients (average age: 53.54 ± 12.96) received biological or targeted therapy for an average of 7.17 years ( ± 4.12), while the average patient activity index DAS28 was 3.15 ( ± 1.17) and BASDAI was 5.29 ( ± 5.52). 87.93% (51/58) of the patients have used non-medication health products, mainly vitamin C or D. 34.48% of the patients were confirmed with coronavirus infection during the pandemic, while the vaccination rate was 87.89%. 83.45% of the patients received at least one mRNA vaccine. In our patient group, the influenza vaccination rate was 36.21%, while only 5.21% of the patients had been vaccinated against Pneumococcus in six months previous to our survey. The total number of serious (category X and D) interactions were 216, in 135 cases a vaccine and in 58 cases a monoclonal antibody or targeted therapy was included as interacting pair.Conclusion and RelevanceDespite the growing number of new therapeutic approaches and vaccines, the screening methods for analysing potential drug interaction are lacking behind and the Summary of Product Characteristics are not suitable for comprehensive evaluations. The inclusion of these therapies and the optimisation in vaccination status in the medication review process and the understanding of immunological mechanism potentially influencing the therapy of patients is warranted.References and/or AcknowledgementsConflict of InterestNo conflict of interest
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The impact of the 2019 coronavirus disease (COVID-19) pandemic is still being revealed, and little is known about the effect of COVID-19-induced outpatient and inpatient losses on hospital operations in many counties. Hence, we aimed to explore whether hospitals adopted profit compensation activities after the 2020 first-wave outbreak of COVID-19 in China. A total of 2,616,589 hospitalization records from 2018, 2019, and 2020 were extracted from 36 tertiary hospitals in a western province in China; we applied a difference-in-differences event study design to estimate the dynamic effect of COVID-19 on hospitalized patients' total expenses before and after the last confirmed case. We found that average total expenses for each patient increased by 8.7% to 16.7% in the first 25 weeks after the city reopened and hospital admissions returned to normal. Our findings emphasize that the increase in total inpatient expenses was mainly covered by claiming expenses from health insurance and was largely driven by an increase in the expenses for laboratory tests and medical consumables. Our study documents that there were profit compensation activities in hospitals after the 2020 first-wave outbreak of COVID-19 in China, which was driven by the loss of hospitalization admissions during this wave outbreak.
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Introduction: Electronic medical records (EMRs) maintained in primary care in the UK and collected and stored in EMR databases offer a world-leading resource for observational clinical research. We aimed to profile one such database: the Optimum Patient Care Research Database (OPCRD). Methods and Participants: The OPCRD, incepted in 2010, is a growing primary care EMR database collecting data from 992 general practices within the UK. It covers over 16.6 million patients across all four countries within the UK, and is broadly representative of the UK population in terms of age, sex, ethnicity and socio-economic status. Patients have a mean duration of 11.7 years' follow-up (SD 17.50), with a majority having key summary data from birth to last data entry. Data for the OPCRD are collected incrementally monthly and extracted from all of the major clinical software systems used within the UK and across all four coding systems (Read version 2, Read CTV3, SNOMED DM+D and SNOMED CT codes). Via quality-improvement programmes provided to GP surgeries, the OPCRD also includes patient-reported outcomes from a range of disease-specific validated questionnaires, with over 66,000 patient responses on asthma, COPD, and COVID-19. Further, bespoke data collection is possible by working with GPs to collect new research via patient-reported questionnaires. Findings to Date: The OPCRD has contributed to over 96 peer-reviewed research publications since its inception encompassing a broad range of medical conditions, including COVID-19. Conclusion: The OPCRD represents a unique resource with great potential to support epidemiological research, from retrospective observational studies through to embedded cluster-randomised trials. Advantages of the OPCRD over other EMR databases are its large size, UK-wide geographical coverage, the availability of up-to-date patient data from all major GP software systems, and the unique collection of patient-reported information on respiratory health.
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In recent years, the trend of deploying digital systems in numerous industries has hiked. The health sector has observed an extensive adoption of digital systems and services that generate significant medical records. Electronic health records contain valuable information for prospective and retrospective analysis that is often not entirely exploited because of the complicated dense information storage. The crude purpose of condensing health records is to select the information that holds most characteristics of the original documents based on a reported disease. These summaries may boost diagnosis and save a doctor's time during a saturated workload situation like the COVID-19 pandemic. In this paper, we are applying a multi-head attention-based mechanism to perform extractive summarization of meaningful phrases on clinical notes. Our method finds major sentences for a summary by correlating tokens, segments, and positional embeddings of sentences in a clinical note. The model outputs attention scores that are statistically transformed to extract critical phrases for visualization on the heat-mapping tool and for human use.
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Technological advancements and the COVID-19 pandemic have catapulted process virtualization across many industries, including healthcare, where telehealth has enabled significant digital transformation of care delivery. Although telehealth has been proposed as a potential solution to improve access to care and restrain runaway healthcare costs, it can increase spending if telehealth use leads to new types of resource utilization. Drawing on the lens of process virtualization theory, we study the impact of telehealth on healthcare utilization by examining visit-level patient data of telehealth use in facilitating e-visits with healthcare providers. On average, a telehealth visit reduces the number of future outpatient visits by 13.6% (or 0.15 visits), equal to a reduction of $239 in total cost within 30 days after the visit. Our results suggest that the benefits of telehealth use are observed primarily among diseases with high virtualization potential. Specifically, patients with mental health, skin, metabolic, and musculoskeletal diseases exhibit a significant reduction of 0.21 outpatient visits per quarter (an equivalent cost reduction of $179) when they are treated via telehealth, suggesting a substitution effect with respect to traditional clinic visits. Our research identifies the boundary conditions that determine the nuanced impact of telehealth on care utilization and shows that its effectiveness depends on the process virtualization potential of different diseases. Our findings have several practical and theoretical implications for fostering telehealth use in a value-based healthcare environment, especially for diseases with high virtualization potential where telehealth use should be promoted to bend the cost curve.
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COVID-19 is currently a major global public health challenge. In the battle against the outbreak of COVID-19, how to manage and share the COVID-19 Electric Medical Records (CEMRs) safely and effectively in the world, prevent malicious users from tampering with CEMRs, and protect the privacy of patients are very worthy of attention. In particular, the semi-trusted medical cloud platform has become the primary means of hospital medical data management and information services. Security and privacy issues in the medical cloud platform are more prominent and should be addressed with priority. To address these issues, on the basis of ciphertext policy attribute-based encryption, we propose a blockchain-empowered security and privacy protection scheme with traceable and direct revocation for COVID-19 medical records. In this scheme, we perform the blockchain for uniform identity authentication and all public keys, revocation lists, etc are stored on a blockchain. The system manager server is responsible for generating the system parameters and publishes the private keys for the COVID-19 medical practitioners and users. The cloud service provider (CSP) stores the CEMRs and generates the intermediate decryption parameters using policy matching. The user can calculate the decryption key if the user has private keys and intermediate decrypt parameters. Only when attributes are satisfied access policy and the user's identity is out of the revocation list, the user can get the intermediate parameters by CSP. The malicious users may track according to the tracking list and can be directly revoked. The security analysis demonstrates that the proposed scheme is indicated to be safe under the Decision Bilinear Diffie-Hellman (DBDH) assumption and can resist many attacks. The simulation experiment demonstrates that the communication and storage overhead is less than other schemes in the public-private key generation, CEMRs encryption, and decryption stages. Besides, we also verify that the proposed scheme works well in the blockchain in terms of both throughput and delay.
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OBJECTIVES/GOALS: Missed appointments (MAs) negatively impact the health outcomes of adults living with type 2 diabetes mellitus (T2DM), causing disruptions in clinic operation and added financial cost to healthcare providers and systems. This study aimed to identify risk factors for MAs in both in-person and telehealth settings among adults living with T2DM. METHODS/STUDY POPULATION: Using a sequential multi-method design guided by the modified Quality-Caring Model, the quantitative phase of this study used electronic health records (EHR) data in Calendar Years 2019 and 2020 with 7,276 encounters made by 2,235 patients with T2DM from four diabetes clinics within a tertiary academic medical center in Baltimore, MD. Multivariable random effect logistic regression were used to examine the association between MAs and included predictors (i.e., patient characteristics [e.g., age, race, health status], health provider factors [e.g., types of provider], and health system factors [e.g., scheduling lag]). Based on the results of the quantitative phase, a purposive sample of 23 adults with T2DM and 10 providers were then interviewed individually via phone or zoom. RESULTS/ANTICIPATED RESULTS: The EHR data found that the following variables decreased the odds of MAs: having an activated patient portal account, patients with age over 46 or with white race. Telehealth was associated with 50% decreased odds of MAs during COVID (after 3/23/2020). On the other hand, longer scheduling lag increased the odds of MAs. Qualitative interviews revealed that MAs were often related to social needs, such as lack of/limited health-related transportation and its associated financial burden. Telehealth helped break these barriers for some adults with T2DM, but technical challenges in telehealth persisted for those with low digital health literacy and people who did not have a digital device and/or with unstable internet connection. Providers worried that these challenges might undermine the quality of diabetes care. DISCUSSION/SIGNIFICANCE: Disparities in MAs by age and race were noted, which might reflect the impact of unmeasured social needs in EHR. Perceived convenient telehealth may reduce MAs in T2DM care. However, the persistent technical challenges of telehealth should be addressed to optimize the quality of diabetes care and to promote care continuity for underserved populations.
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OBJECTIVES/GOALS: Evaluate the impact of COVID-19 on oral clefts services including surgical and dental treatments in Puerto Rico. METHODS/STUDY POPULATION: This Observational retrospective cohort study will consider patients 0-21 y/o with CL/P that visited the UPR school of Dental Medicine, Pediatric University Hospital Dr. Antonio Ortiz and ongoing case-control research project Face-Genes. Records to be used are classified as follow: Pandemic (March 15, 2020 to March 15 2022) Pre-pandemic (March 15, 2015 to March 15, 2017) Power analysis (power=0.80 alpha=0.05) will be calculated. Unavailable and incomplete medical records and those that did not attended study clinic during study period will be excluded. Data extraction instrument will be based on previous published study. Descriptive statistics, Chi-square, Odds Ratios at 95% confidence intervals and multiple logistic regression will be estimated. RESULTS/ANTICIPATED RESULTS: We hypothesize that surgical and dental services in Puerto Rico will be adversely impacted because of COVID-19 pandemic. DISCUSSION/SIGNIFICANCE: CL/P are common congenital diseases that require early interdisciplinary attention. Lack of timely care as well as surgery and treatment delays, could be associated with poorer prognosis, increased morbidity and mortality. If there is high risk of dh services during emergency situations, our findings will help to allocate the available resources