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4.
Drug Safety ; JOUR:1183-1184, 45(10).
Article in English | EMBASE | ID: covidwho-2085679

ABSTRACT

Introduction: Equine hyperimmune serum (F(ab')2 fragments) has been widely used in Argentina in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as snakes (bothrops, chrotalus, elapids) and arthropods (Loxosceles, Latrodectus, Phoneutria and Tityus). These antisera were developed by the National Institute for the production of Biologicals (ANLIS-Malbran) and distributed free of charge in public hospitals in the country. Objective(s): The aims of this study (NCT04913779) is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLISMalbran) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Method(s): A randomized, double-blind controlled clinical study is carried out in 200 patients with COVID-19 requiring oxygen therapy in which the safety and efficacy of early use (72 hours from the onset of symptoms) of the research product is evaluated. The present work corresponds to a preliminary result of the safety and pharmacokinetic analysis in the first 20 patients included. Result(s): 20 initial patients (1:1 treatment: control ratio) were studied. The post-administration follow-up time was 28 days. The pharmacokinetic analysis shows that the research product presents an extracellular volume of distribution, with a median half-life of distribution was 6.3h (10-90% percentiles: 3.4-8.1 h) and half-life of elimination, 121h (10th-90th percentiles: 83-171 h). Neutralizing activity in plasma was correlated with drug concentration. Daily controls were carried out including physical examination, questioning in relation to symptoms presented, and blood extraction for routine laboratory control. No patient reported symptoms consistent with adverse reactions. Although some patients presented mild laboratory alterations (hepatogram, urea, creatinine), in all cases they were alterations that existed prior to the administration of the research product and that improved after treatment. Conclusion(s): Despite the small number of patients studied initially, and the possible masking of an adverse event due to the underlying disease (COVID-19), no significant adverse reactions were evidenced during treatment with the research product. There were no serious reactions and the pharmacokinetic characteristics appear to show a long-acting profile correlated with neutralizing activity in vitro.

5.
Ogigia-Revista Electronica De Estudios Hispanicos ; JOUR:59-78, 25.
Article in Spanish | Web of Science | ID: covidwho-2082864

ABSTRACT

Urban planning has formed a binomial with health since its origins as a discipline. The demands derived from the welfare society, environmental sustainability and the health circumstances of COVID-19 testify to the need to update this relationship. The aim of the URB_HealthS project is to study the ways of endorsing health in the contemporary city through the urban design of public space. A knowledge transfer model between the academy and the local society in the field of urban health and public space has been defined, whose theoretical structure and implementation in three European localities is presented.

6.
European psychiatry : the journal of the Association of European Psychiatrists ; 65(Suppl 1):S531-S531, 2022.
Article in English | EuropePMC | ID: covidwho-2073808

ABSTRACT

Introduction The coronavirus disease 2019 (COVID-19) pandemic has caused major sanitary crisis worldwide. Frontline healthcare workers face many difficulties, such as: direct exposure to patients with high viral load, physical exhaustion, reorganization of workspaces, face the unusually high number of deaths among patients, colleagues or relatives and ethical issues in a tense health system. Objectives Provide up-to-date information of Burnout syndrome associated with exposure of healthcare workers to the COVID-19 pandemic, after almost 20 months of the declaration of pandemic by the World Health Organization. Methods A cross-sectional study was carried out that included 84 healthcare workers from Spain in October 2021, through an anonymous, voluntary and multiple response type online survey which included questions about sociodemographic aspects and the Maslach burnout inventory Results 62% were doctors and 29% were nurses. 70% work on the front line of Covid-19. 38% report not having been able to enjoy their vacations when they wanted. 8% admit to having had suicidal ideas. Almost 52% admit low personal fulfillment, 38.6% admit a high depersonalization count, and 45% report high emotional exhaustion. Of the total sample, 17 respondents have burnout syndrome. Conclusions It is necessary create strategies to promote mental well-being in health professionals exposed to COVID-19 after 20 months of active work. Protecting and identifying health care professionals who could be at high risk for developing a mental health pathology or detecting Burnout syndrome in them should be the priority of public health post pandemic. Disclosure No significant relationships.

7.
European psychiatry : the journal of the Association of European Psychiatrists ; 64(Suppl 1):S310-S311, 2021.
Article in English | EuropePMC | ID: covidwho-2046962

ABSTRACT

Introduction SARS-CoV-2 is having an important direct impact, and also due to treatments used such as corticosteroids. Among its effects, we have focused on psychosis. Objectives The objective of this paper is to study, from following case, incidence of steroid-induced psychosis in context of COVID-19. Methods A bibliographic search was performed from different database (Pubmed, TripDatabase) about psychiatric symptoms associated with use of corticosteroids during pandemic. 64-year-old woman with no psychiatric history, who is hospitalized for pneumonia secondary to SARS-Cov2 and treated with antibiotics, bronchodilators, and corticosteroids. At 4 days she began with injury and nihilistic delusions. The corticosteroids were progressively reduced, adding 2.5 mg Risperidone, resolving after ten days. Results Corticosteroids are currently being used to treat the systemic inflammatory response associated with COVID-19, but they can produce other effects such as psychiatric symptoms (3-6%): 75% affective (mainly hypomanic symptoms);and 25% psychotic. Steroid-induced psychosis are characterized by confusion, delusions, and hallucinations, and they usually begin 3-4 days after onset, and resolve within a week. They are associated especially with oral systemic steroids and high doses: 1.3% with 40mg of prednisone, and 18% with 80mg;increased this incidence due to the greater use that is being made to treat COVID-19 and the higher doses used in severe cases (up to 120 mg). Conclusions To conclude, we need to know characteristics of these episodes in order to be able to prevent and treat them properly (minimum effective dose and less time), since they will probably occur more frequently at this time.

8.
European psychiatry : the journal of the Association of European Psychiatrists ; 64(Suppl 1):S343-S343, 2021.
Article in English | EuropePMC | ID: covidwho-2046038

ABSTRACT

Introduction Concerns have been raised about ecological momentary assessment (EMA) acceptability among patients with schizophrenia spectrum disorders (SSD), which is of major relevance during the e-Mental health-focused COVID-19 pandemic. Objectives To investigate i) the levels of adherence to a passive smartphone-based EMA tool, the Evidence-Based Behavior (eB2), among SSD patients;and ii) putative predictors of this. Methods Sample: SSD (F20-29-ICD10) outpatients, age 18-64, without financial incentives, recruited over 17/06/2019-11/03/2020 at the Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain). Those who accepted the eB2 installation -users- and those who did not -non-users- were compared in sociodemographic, clinical, premorbid adjustment, neurocognitive, psychopathological, insight and metacognitive variables by a multivariable binary logistic regression model. Results Sample (N=77): n=41 males;age: 47.69±9.76 years, n=24 users (31.2%). n=14 users (70%) had the eB2 installed at follow-up (median=14.50 weeks).Multivariable binary logistic regression model on ‘user’ as outcomeβSEWaldpOR95% CIAge-0.0750.0383.9100.0480.9280.861-0.999Education level-0.9671.2890.5630.4530.3800.030-4.755Early adolescence premorbid adjustment-0.2850.1106.6950.0100.7520.606-0.933Trail Making Test A-0.0300.0251.4880.2220.9700.924-1.018Trail Making Test B-0.0050.0100.2780.5980.9950.976-1.014Cognitive Insight0.0620.0611.0430.3071.0640.944-1.200 X2=25.296,df=6,p<0.001. Nagelkerke-R2=44.7%. Correctly classified: 76.9%, users:54.5%, non-users:88.4%. Conclusions Acceptability of a smartphone-based EMA application among SSD patients was low. Age (young) and good premorbid adjustment predicted acceptability. e-Mental Health methods need to be tailored for patients with SSD. Otherwise, these highly vulnerable individuals may be neglected by e-health-based services in the post-COVID-19 years ahead.

9.
Drug Safety ; 45(10):1183-1184, 2022.
Article in English | ProQuest Central | ID: covidwho-2045859

ABSTRACT

Introduction: Equine hyperimmune serum (F(ab')2 fragments) has been widely used in Argentina in the last 100 years with satisfactory results and an acceptable safety profile in the treatment of accidents with poisonous animals such as snakes (bothrops, chrotalus, elapids) and arthropods (Loxosceles, Latrodectus, Phoneutria and Tityus). These antisera were developed by the National Institute for the production of Biologicals (ANLIS-Malbraín) and distributed free of charge in public hospitals in the country. Objective: The aims of this study (NCT04913779) is to analyze the efficacy and safety of a passive immunotherapy strategy using hyperimmune equine serum known as Anti-SARS-CoV-2 elaborated by the National Institute for the Production of Biologicals (ANLIS-Malbraín) as an addition to the standard therapeutic approach for hospitalized patients with COVID-19, in patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Methods: A randomized, double-blind controlled clinical study is carried out in 200 patients with COVID-19 requiring oxygen therapy in which the safety and efficacy of early use (72 hours from the onset of symptoms) of the research product is evaluated. The present work corresponds to a preliminary result of the safety and pharmacokinetic analysis in the first 20 patients included. Results: 20 initial patients (1:1 treatment: control ratio) were studied. The post-administration follow-up time was 28 days. The pharmacokinetic analysis shows that the research product presents an extracellular volume of distribution, with a median half-life of distribution was 6.3h (10-90% percentiles: 3.4-8.1 h) and half-life of elimination, 121h (10th-90th percentiles: 83-171 h). Neutralizing activity in plasma was correlated with drug concentration. Daily controls were carried out including physical examination, questioning in relation to symptoms presented, and blood extraction for routine laboratory control. No patient reported symptoms consistent with adverse reactions. Although some patients presented mild laboratory alterations (hepatogram, urea, creatinine), in all cases they were alterations that existed prior to the administration of the research product and that improved after treatment. Conclusion: Despite the small number of patients studied initially, and the possible masking of an adverse event due to the underlying disease (COVID-19), no significant adverse reactions were evidenced during treatment with the research product. There were no serious reactions and the pharmacokinetic characteristics appear to show a long-acting profile correlated with neutralizing activity in vitro.

10.
15th International Conference of Technology, Learning and Teaching of Electronics, TAEE 2022 ; 2022.
Article in English | Scopus | ID: covidwho-2018990

ABSTRACT

We present a low-cost Remote Laboratory platform developed to support the practices of the Vehicle Electronics course during the COVID-19 pandemic. The platform, which emerged as an emergency solution, has become a significant teaching resource. Although the platform was designed primarily for microcontroller (or FPGA) based practices, it could be extended to Analogue Electronics practices. From a hardware perspective, low-cost devices such as a Raspberry Pi, a camera or a old PC box have been used, while the software interface has been developed using Node-RED. © 2022 IEEE.

12.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009551

ABSTRACT

Background: Despite mitigation and treatment strategies, COVID-19 continues to negatively impact patients (pts) with cancer. Identifying factors that remain consistently associated with morbidity and mortality is critical for risk identification and care delivery. Methods: Using CCC19 registry data through 12/31/2021 we report clinical outcomes (30-day case fatality rate [CFR], mechanical ventilation use (MV), intensive care unit admission (ICU), and hospitalization) in adult pts with cancer and laboratory confirmed SARS-CoV-2, stratified by patient, cancer, and treatment-related factors. Results: In this cohort of 11,417 pts (with 4% reported vaccination prior to COVID-19), 55% required hospitalization, 15% ICU, 9% MV, and 12% died. Overall outcome rates remained similar for 2020 and 2021 (Table). Hydroxychloroquine was utilized in 11% and other anti-COVID-19 drugs (remdesivir, tocilizumab, convalescent plasma, and/or steroids) in 30%. Higher CFRs were observed in older age, males, Black race, smoking (14%), comorbidities (pulmonary [17%], diabetes mellitus [16%], cardiovascular [19%], renal [21%]), ECOG performance status 2+ (31%), co-infection (25%), especially fungal (35%), and initial presentation with severe COVID-19 (48%). Pts with hematologic malignancy, active/ progressing cancer status, or receiving systemic anti-cancer therapy within 1-3 months prior to COVID-19 also had worse CFRs. CFRs were similar across anti-cancer modalities. Other outcomes (ICU, MV, hospitalization) followed similar distributions by pt characteristics. Conclusions: Unfavorable outcome rates continue to remain high over 2 years, despite fewer case reports in 2021 owing to multiple factors (e.g., pandemic dynamics, respondent fatigue, overwhelmed healthcare systems). Pts with specific socio-demographics, performance status, comorbidities, type and status of cancer, immunosuppressive therapies, and COVID-19 severity at presentation experienced worse COVID-19 severity;and these factors should be further examined through multivariable modeling. Understanding epidemiological features, patient and cancer-related factors, and impact of anti-COVID-19 interventions can help inform risk stratification and interpretation of results from clinical trials.

13.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2009530

ABSTRACT

Background: Patients with cancer have worse outcomes from COVID-19 infection. However, the specific impact of COVID-19 on patients with (HNC) is largely unknown. The COVID-19 and Cancer Consortium (CCC19) maintains an international registry (NCT04354701) aimed to investigate the clinical course and complications of COVID-19 in patients with cancer. Here, we report severity of COVID-19 and its complications among HNC patients. Methods: The CCC19 registry was queried for patients with HNC and laboratory confirmed SARS-CoV-2 infection. The co-primary outcomes were severity of COVID-19 illness on an ordinal scale (0: no complications;1: hospitalized, no oxygen (O2);2: hospitalized, required O2;3: ICU admission;4: mechanical ventilation (MV);5: death), and severity of complications (mild, moderate, serious). The outcomes were further stratified by demographics, recent treatment (systemic vs local;surgery, radiation (RT) vs systemic), treatment intent (palliative vs curative), and cancer status (remission, responding, stable, progressing). Results: From March 2020 to December 2021, 356 HNC patients were identified. Median age was 65 (interquartile range 58-74), 29% were female, 56% were white, 67% were former or current smokers, 20% had a BMI >30, 15% had an ECOG performance status >2, and 57% had >2 comorbidities. 154 (43%) had no complications, 61 (17%) were hospitalized without O2, 135 (38%) were hospitalized with O2, 50 (14%) required ICU, 32 (9%) required MV, and 74 (21%) died. 88 (25%) had mild, 59 (17%) had moderate, and 132 (37%) had serious complications. 33% of patients who received systemic therapy and 30% who received RT within 3 mo prior to COVID-19 diagnosis died. Mortality was higher in patients receiving palliative when compared to curative intent treatment (44% vs 16%). In addition, 50% of patients with actively progressing cancer, and 45% who had serious complications died. Importantly, 37 (n=12 palliative systemic therapy and n=25 local therapy) patients had a treatment delay due to COVID-19 diagnosis. Conclusions: Our study is the largest cohort to date describing COVID-19 outcomes in HNC patients and suggest a high rate of mortality even in those receiving local and curative intent treatment. Variables stratified by COVID-19 severity. Note: Ordinal levels 3 and 4 not shown due to small case numbers.

14.
Annals of the Rheumatic Diseases ; 81:1244, 2022.
Article in English | EMBASE | ID: covidwho-2009205

ABSTRACT

Background: The risk of cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA) is higher than individuals from the general population due to chronic infammation. Current CV risk screening and management strategies underestimate the actual CV risk in RA. Thus, an adequate CV risk stratifcation has special relevance in RA to identify patients at risk of CV disease. Objectives: To assess the incidence of cardiovascular events in a RA cohort after a 2 years follow-up. Methods: A cohort study was performed in which inclusion criteria were adult RA patients and matched adults in terms of age, sex and CV risk factors (controls). Population over 75 years old, patients with established CV disease and/or stage III chronic kidney disease were excluded. Controls with other infam-matory diseases, pregnant women or any malignancy were also excluded. This study was performed from July-2019 to January-2022. CV risk assessment included risk factors collection and US evaluation consisted in detection of plaques and measurement of the intima-media thickness in both right and left carotid. Results: Overall, a total of 200 cases and 111 healthy controls were enrolled in the study. Demographical and clinical variables were comparable between cases and controls and are shown in Table 1. US study revealed a higher IMT in both right and left carotid arteries with greater presence of plaques in patients than in controls (CI 95% [1.542;3.436], p<0.001). Plaques were found in both carotid arteries in the 32% of cases and 9.91% of controls. The longer duration of RA was related to a higher presence of carotid plaques (95% [1.015;1.056], p<0.001). Eight patients (4%) presented a cardiovascular event, and one of them died (0.5%). The events consisted in 2 angina pectoris, 3 transient ischemic attack, 1 acute myocardial infarction, 1 lacunar stroke and 1 cardiac arrest. Six out those 8 patients demonstrated bilateral plaque presence at baseline. Two patient caused loss of follow up due to death related to Covid-19. Not a single cardiovascular event was reported in the control group. Conclusion: Our results shows that cardiovascular events are increased in RA patients and US study may be useful in predicting an event.

15.
Annals of the Rheumatic Diseases ; 81:1286, 2022.
Article in English | EMBASE | ID: covidwho-2009174

ABSTRACT

Background: Recent published data have emerged some concerns about safety of Janus kinase (JAK) inhibitors and FDA have established prescribing restrictions. Objectives: The aim of this study was to analyze the safety profile of current approved JAK inhibitors in Europe with data from a Real World cohort. Methods: A single center observational study was performed including patients who had initiated treatment with Tofacitinib, Baricitinib or Upadacitinib from September, 2017 to January, 2022. Demographic, clinical, laboratory and safety variables were collected from baseline and at months 1, 3, 6 and every six months. Safety data was collected including any adverse event (AE) due to any cause. An AE was considered serious if it was life-threatening or result in hospitaliza-tion, disability or in death. All AE and SAE were expressed adjusted by exposure (E/100 PY). Results: A total of 194 patients were included whom baseline demographic and disease characteristics are exposed in Table 1. Drug exposure was 265.5 patient-years. Overall, 214 AE were detected being mild upper tract respiratory infection the most frequently registered (15.82 E/100PY) followed by Urinary tract Infection accounting 7.16 E/100PY. 10 Serious Infections were detected in 10 patients of which 5 were pneumonia (1.88 E/100PY), 1 cellulitis (0.38 E/100PY) and 2 COVID-19 (0.76 E/100PY). 12 herpetic infection were detected in 9 patients (4.52 E/100PY) of which 7 were caused by herpes zoster (2.64 E/100PY) and 5 by herpes simplex (1.88 E/100PY) 3 cases were mono-metameric and 4 multi-metameric. Moreover, 2 patient developed postherpetic neuralgia. A patient with RA developed Miliary Tuberculosis (0.38 E/100PY) with a negative IGRA test prior to the JAKi. A patient with RA suffered a Myocardial Infarction (0.38 E/100PY). 7 RA patients developed malignancy (2.64 E/100PY), one with oral squamous cell carcinoma, two Bowen carcinoma, one breast cancer, 2 basal cell carcinoma and a colorectal metastatic cancer. Not a single case of thromboembolic event nor Hepatitis B Virus reactivation were registered. 2 patients died, one with cancer and the other suffered a severe COVID-19 (unvaccinated). Conclusion: In this updated analysis of 194 patients treated with JAKi, the three approved JAKi showed a safety profile consistent with data from RCT. The patients under JAK therapy should be carefully evaluated on their follow-up.

16.
Annals of the Rheumatic Diseases ; 81:1699-1700, 2022.
Article in English | EMBASE | ID: covidwho-2009132

ABSTRACT

Background: SARS-CoV-2 infection is a public health problem due to its high contagiousness and mortality. Spectrum of symptoms ranges from no symptoms to interstitial pneumonia. Patients with rheumatic disease present an increased infectious risk, especially those treated with immunosuppressants or biologic therapy. Since the beginning of the pandemic, risk of contagion and development of complications in these patients has been questioned. Objectives: To describe hospitalization prevalence, seroconversion, and symptoms in patients under follow-up by the rheumatology department of a tertiary hospital. Methods: Observational, cross-sectional study conducted by phone interview including patients with different diagnosis of rhematic diseases. Data about symptoms, hospital admission, serology by ELISA (when >15 days of evolution), diagnosis and baseline treatment, from March 2020 to February 2021 were collected. Results: Eighty-six patients with different rheumatic diseases and positive COVID-19 PCR were included (82.35% women) in Table 1. Mean age was 49.30 years (16.16). The 48.71% received biological therapy, JAK inhibitors or apremi-last, with a median of 3.11 years (Q1 1,08;Q3 3,17). Secukinumab was the biological therapy most often used (24,32%), followed by Tocilizumab (13,51%). The 34,18% received DMARDs or immunosuppressors, with a median of 5.09 years (Q1 12,25;Q3 11.09). The most frequent symptoms were asthenia (72.15%), headache (66.23%) and cough (59.49%). Nine patients (11.25%) were admitted to hospital, eight of them (10%) for pneumonia. Three of them were admitted to intensive care and one died. Seroconversion occurred in 53.25%. low IgG titers were present in 2.94% and IgM persisted positive in 56.25% of this group. In 6.45% the result was indeterminate. Conclusion: Hospitalization and mortality rate obtained was low and the most frequent symptoms were mild. Seroconversion occurred in more than 50% of patients and the result of 6.45% was indeterminate. It's important to highlight that since March 2020 to May 2020 IgG positive prevalence was 25%, while since September 2021 to February 2021, this prevalence increased until 57,45%. This difference is due to a modifcation of autoantibody detection technique since summer 2020.

17.
Annals of the Rheumatic Diseases ; 81:328-329, 2022.
Article in English | EMBASE | ID: covidwho-2008991

ABSTRACT

Background: During the frst months of the Sars-CoV-2 pandemic, antimalarial drugs were the central axis of the treatment of patients with acute respiratory infection. After that, several studies reported a risk of prolongation of corrected QT interval (QTc) at the electrocardiogram (ECG). Historically, these drugs, have been the common denominator in the treatment of patients with Systemic Lupus Erythematosus (SLE). Objectives: To analyze the possible relationship between the use of antima-larial drugs ant the electrocardiographic alterations in patients diagnosed with SLE. Methods: Cross-sectional study in patients diagnosed with SLE (SLICC 2012). In all of them, we performed a 12-lead ECG at rest. We measured the QT interval: manually and automatically, ant its correction was made according to the Hodge formule (QTc). Results: 91 patients diagnosed with SLE were included in the study. Of the total of patients included in the study, 64 were in current treatment with an antimalar-ial drug, with a mean of 9.09 (5.73) years of treatment, and a mean cumulative dosage of 813.16 (436.12) gr. Of the patients on current treatment with antimalarial drugs, 4.69% had a prolonged QTc, compared to 3.7% of the patients without current treatment with these drugs. We analyzed the possible relationship between the QTc interval, the current treatment with antimalarial drugs, and the cumulated dosage of this medication. We corrected the lineal regression models by the years of disease evolution, the presence or absence of known heart disease, the women gender, and other treatments such as antiarrhythmics or beta-blockers. We found a statistically signifcant association between taking antimalarial drugs and the elongated QTc interval (p= 0,001). Nevertheless, in the multivariate analysis, we did not found a signifcant relationship between the ECG alterations and the treatment with antimalarial drugs. Conclusion: In our study, we did not observe a direct relationship between the intake of antimalarial drugs and the alteration of the corrected QT interval.

18.
Annals of the Rheumatic Diseases ; 81:535-536, 2022.
Article in English | EMBASE | ID: covidwho-2008983

ABSTRACT

Background: The need to avoid the transmission of COVID19 infection has forced to promote teleconsultations for rheumatic diseases follow-up. However, remote monitoring for rheumatic diseases which require clinical examination, as rheumatoid arthritis (RA), may affect to the evaluation of clinical activity, including the biological therapies follow-up. Due to that, count on tools as Patient Reported Outcomes (PROs) could help the remote monitoring of patients when it is not advisable their physical presence in health centers, being a great help in RA control. Objectives: We aim to assess the association among the tiredness, disability and pain perception with the clinical activity in RA patients. Methods: We performed a prospective observational study of three months of follow-up in RA patients (ACR/EULAR 2010) who are newly on biological or anti-JAK therapy. A basal visit and 1, 3 months follow-up visits were conducted. We analyzed changes during follow-up in the PROs parameters reported by patients through FACIT-fatigue and HAQ questionnaires, as well as pain VAS (0-10). Moreover we measured clinical activity through Das28, Das28-CRP, SDAI and CDAI index. Results: We included 60 patients (83.3% female), with a mean age of 55 (13) and mean disease evolution of 13 (11) years. At the basal visit, 55% of them exhibited increased levels of CRP and the 48.3% of ESR, showing moderate or high clinical activity the 83.3% of the total patients. 39 patients started anti-JAK therapy and 21 with TNF-α inhibitors. The 33.34% of patients were under monotherapy, and the 46.67% previously have been treated with biological therapy. The 77.36% of the total number of patients was on the biological therapy at 6 months of follow-up, while the 22.64% discontinued at 6 months of follow-up (9 due to inefficacy and 3 due to adverse effects). 48 patients continued the treatment in the 6 months after, and 12 patients discontinued due to ineffectiveness or drug intolerance. Clinical activity, fatigue, disability and pain perception are shown in Table 1. Using a mixed linear regression model the association among the fatigue, disability and pain perception with clinical activity was conducted, corrected by age, smoking habits, time of disease evolution, BMI, previous biological/anti-JAK therapy administration and current dose of steroids. We observed a signifcant association among clinical activity and fatigue (P<0.001), disability (P<0.001) and pain perception (P<0.001). The statistical analyses showed a signifcant association where a high fatigue is increased in cases with high pain perception (P>0.001) and high number of swollen joints (P=0.002), but not in high levels of CRP and ESR. Fatigue was higher in those cases whom discontinued treatment (P=0.044) regardless of which therapy was chosen. No effect of age, time of disease evolution, steroid dose, BMI or previous therapy and smoking habits in the PROs values was observed. Conclusion: PROs would be helpful in the disease control in those cases where a remote monitoring is needed, since HAQ or FACIT-FATIGUE index showed a signif-cant association with clinical activity index in RA. Because of its ease for shipping and handling by the health professional, PROs could be a useful tool in the disease control. Its implementation in the remote monitoring of RA patient, as has been the case of Covid19 pandemic, results in an improvement of the clinic evaluation of RA patient, due to required information to clinical management is reported, avoiding presence consultation in those situations when it is required.

19.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005660

ABSTRACT

Background: Limited information exists regarding the severity of short-term outcomes among patients with gynecologic cancer who are infected with SARS-CoV-2. Methods: Patients with gynecologic cancer and laboratory confirmed SARS-CoV-2 infection were identified from the international CCC19 registry. We estimated odds ratios (OR) from ordinal logistic regression for associations with severity of COVID-19 outcomes, defined from least to most severe as hospitalization, intensive care unit (ICU) admittance, mechanical ventilation, and 30-day mortality. Results: Of 842 patients identified, 48% had endometrial cancer, 24% had ovarian cancer, 22% had cervical cancer, and 6% had dual primary/other gynecologic cancers. The majority were from the United States (86%), most were non-Hispanic White (46%), and the median age was 62 years (IQR 52-72). The majority were diagnosed with localized disease (68%);only 18 (2%) and 15 (2%) were fully or partially vaccinated, respectively. In the 3 months prior to COVID-19, 36% had any cancer treatment, with chemotherapy the most common (23%). When diagnosed with COVID-19, most patients were in remission (50%), while 37% had active disease, including 22% with metastatic disease. Most patients presented with typical COVID-19 symptoms (76%);few had a poor ECOG performance status (PS ≥2, 14%). Outcomes included hospitalization (50%), ICU admittance (12%), mechanical ventilation (8%), and death within 30 days of testing positive for SARS-CoV-2 (10%). In unadjusted models, increasing age (OR: 1.03 1.02-1.04) and Black race (OR 1.91, 1.31-2.77) were associated with increased severity of COVID-19 outcomes. Compared to patients in remission for ≥5 years, those with progressive disease had increased severity (OR 1.88, 1.25-2.82), while those in remission for < 5 years or with stable disease had decreased severity of COVID-19 outcomes (OR 0.55, 0.39-0.76). In multivariable models that included adjustment for age, race, and cancer status, additional factors associated with increased COVID-19 outcome severity included cardiac (OR 1.57, 1.13-2.19) and renal (OR 2.00, 1.33-3.00) comorbidities, an ECOG PS ≥2 (OR 5.15, 3.21-8.27), having pneumonia or pneumonitis (OR 4.08, 2.94-5.66), venous thromboembolism (OR 4.67, 2.49-8.75), sepsis (OR 14.2, 9.05-22.1), or a co-infection within ±2 weeks of SARS-CoV-2 (OR: 4.40, 2.91-6.65);asymptomatic SARS-CoV-2 infection was associated with decreased severity of outcomes (OR: 0.25, 0.16-0.38). The overall case fatality rate was 15.7%. Conclusions: Patients with gynecologic cancer experience significant morbidity and mortality related to infection with SARS-CoV-2. Age, race, cancer status, co-morbidities, and COVID-19 complications were associated with more severe COVID-19 outcomes, along the continuum from least to most, of hospitalization, ICU admittance, mechanical ventilation, and 30-day mortality.

20.
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