Your browser doesn't support javascript.
Show: 20 | 50 | 100
Results 1 - 20 de 108
Filter
1.
BMC Infect Dis ; 22(1):739, 2022.
Article in English | PubMed | ID: covidwho-2038668

ABSTRACT

BACKGROUND: Healthcare-associated infection (HAI) is a common and largely preventable cause of morbidity and mortality. The COVID-19 pandemic has presented unprecedented challenges to health systems. We conducted a national survey to ascertain hospital characteristics and the use of HAI prevention measures in Israel. METHODS: We e-mailed surveys to infection prevention and control (IPC) leads of acute care hospitals in Israel. The survey included questions about the use of practices to prevent catheter-associated urinary tract infection (CAUTI), central line-associated bloodstream infection (CLABSI), ventilator-associated pneumonia (VAP), and Clostridioides difficile infection (CDI). The survey also assessed COVID-19 impact and healthcare worker well-being. RESULTS: IPC leads from 15 of 24 invited hospitals (63%) completed the survey. Only one-third of respondents reported strong support for IPC from hospital leadership. Although several prevention practices were used by all hospitals (e.g., maximum sterile barrier precautions for CLABSI and real-time assessment of environmental cleaning for CDI), use of other practices was suboptimal-particularly for CAUTI and VAP. COVID-19 had a profound impact on Israeli hospitals, with all hospitals reporting opening of new units to care for COVID patients and most reporting moderate to extreme financial hardship. All hospitals reported highly successful plans to vaccinate all staff and felt confident that the vaccine is safe and effective. CONCLUSION: We provide a status report of the IPC characteristics and practices Israeli hospitals are currently using to prevent HAIs during the COVID-19 era. While many globally accepted IPC practices are widely implemented, opportunities to increase the use of certain IPC practices in Israeli hospitals exist.

2.
Am J Infect Control ; 2022 Aug 07.
Article in English | MEDLINE | ID: covidwho-2035672

ABSTRACT

In the midst of the COVID - 19 pandemic, a multidisciplinary team implemented evidence-based strategies to eliminate catheter associated urinary tract infections (CAUTI), as defined by the National Healthcare Safety Network (NHSN) surveillance definition for those units included in the NHSN standardized infection ratio (SIR). The team evaluated indwelling urinary catheters daily for indication, implemented a urinary catheter order set, established a urinary catheter insertion checklist, and promoted use of external urinary diversion devices. The facility NHSN SIR for CAUTI was 0.37 in 2019, 0.23 in 2020, and 0.00 in 2021. A collaborative approach decreasing hospital acquired infections may be effective even in a climate of increased acuity, increased length of stay, and staffing challenges.

3.
Anales de la Real Academia Nacional de Farmacia ; 88(2):123-130, 2022.
Article in English | EMBASE | ID: covidwho-2033626

ABSTRACT

Objetive: Description of the different isolated microorganisms and their prevalence in infections associated with health care, in addition to determining their patterns of resistance to antibiotics in patients admitted with a confirmed or suspected diagnosis of COVID-19 in the Intensive Care Unit, during a third-level medical center with hospital reconversion. Method: Patient demographic data was obtained from the clinical record, with defined criteria. Antibiotic resistance patterns were evaluated as well as the identification of isolated bacteria in cultures of expectoration, pleural fluid, catheter tips. For bacterial identification and resistance mechanisms, automated equipment and phenotypic tests were used, following the CLSI (Clinical & Laboratory Standards Institute) criteria. Results: A total of 100 patients with bacterial infection added to the main COVID-19 picture were obtained, representing pneumonia, urinary tract infection, catheter infections and bacteremia. A total of 100 strains were isolated, of which 84 are Extremely Drug Resistant, 12 Multidrug Resistant and only 4 variable sensitivity. The bacteria with the highest prevalence is Staphylococcus aureus with, followed by Pseudonomas aeruginosa and Stenotrophomonas maltophilia. 100% of the patients admitted to the ICU (Intensive Care Unit) had death. Conclusion: The increase in resistance to antibiotics in the COVID-19 pandemic has set off alarms due to the complication that this brings, and the improper use of drugs as prophylaxis or attempted treatment only generates selective pressure that leads to an increase in resistance as observed in the isolated strains in this study, where the vast majority present enzymes as well as other resistance mechanisms that confer them to be XDR (Extremely Drug Resistant).

4.
Flora ; 27(2):317-323, 2022.
Article in Turkish | EMBASE | ID: covidwho-2033380

ABSTRACT

Introduction: Although there is limited data on the frequency of nosocomial infections in patients followed up in the intensive care unit due to COVID-19, the rate of empirical antibiotic use in these patients is quite high. In our study, it was planned to determine the frequency of nosocomial infections in patients hospitalized in intensive care units due to COVID-19, the pathogens isolated in nosocomial infections, and to investigate the characteristics of these infections. Materials and Methods: Our study is a retrospective study in which the records of 590 adult patients hospitalized in the COVID-19 intensive care unit and followed prospectively between April 1, 2020 and December 31, 2021 were examined. Results: In our study, nosocomial infection developed in 7.28% of patients hospitalized in the intensive care unit due to COVID-19, and mortality was 93% in patients who developed nosocomial infections. Of these infections, 67.44% were lower respiratory tract infections, 25.58% were bloodstream infections, and 6.97% were urinary tract infections. While the median number of toatl hospital stay was 20 days, the median time since admission to infection was 12 days. Infections often developed with a single microorganism, and the most frequently isolated microorganisms are A. baumannii and K. pneumoniae. Conclusion: Nosocomial infections that develop in patients followed in the intensive care unit due to COVID-19, are seen in approximately 7% of patients, but are mortal. In this patient group, regular microbiological follow-up and implementation of strict infection control measures especially for the prevention of ventilator-associated pneumonia;It is recommended to review the antibiotics frequently used in the follow-up and treatment of COVID-19 and to be selective in the decision to start empirical antibiotics in order to prevent the development of antimicrobial resistance.

5.
HemaSphere ; 6:770-771, 2022.
Article in English | EMBASE | ID: covidwho-2032093

ABSTRACT

Background: CDK8 and its paralog CDK19 have central roles in maintenance of cancer cell viability and undifferentiated state for a variety of tumor types. (Dannappel et al. 2019;Rzymski et al. 2015;Philip et al. 2018). RVU120 (SEL120), a novel CDK8/CDK19 kinase inhibitor with significant efficacy in preclinical AML models, has shown clinical efficacy in a currently ongoing phase Ib trial in patients with relapsed/refractory (R/R) AML or HR-MDS (NCT04021368). This paper provides update with new available data on disease evaluation from ongoing patients and further enrolment into next cohort level 85 mg. Aims: The primary objective of the study is to determine preliminary safety profile, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) and the recommended phase 2 dose of RVU120 as a single agent. Secondary objectives include PK, antileukemic activity and exploratory PD characterization. Methods: The study comprises at least 7 dose escalating cohorts. The first 3 cohorts followed an accelerated scheme, 1 patient enrolled/cohort from 10 to 50 mg dose levels, from cohort 4 (75 mg) to 7 (100 mg) doses onwards a 3+3 design is followed. Data from each cohort is evaluated by a data review committee (DRC). RVU120 is administered orally every other day, for a total of 7 doses, in a 3-week treatment cycle until disease progression/unacceptable toxicity. Adverse events are graded according to NCI-CTCAE v.5.0. DLTs are assessed at completion of C1. Disease evaluation is performed according to Dohner 2017 and Cheson 2006 response criteria for AML and MDS respectively. PK parameters are calculated by non-compartmental analysis. Pharmacodynamic (PD) activity is assessed by flow cytometry measure of pSTAT5 Ser725 levels, that are highly dependent on the activity of CDK8 and CDK19 in AML/MDS cells. Results: At data cut off of 23rd Feb22, 13 pts have been enrolled, median age 73 years and median 2 previous lines of therapy, ECOG PS 2 in 4 pts, 1 in 7, 0 in 2. No DLTs were observed, all 14 Serious Adverse Events, including 1 COVID19 death and 1 pancreatitis, were not related to study drug (G1 fever, G2 Upper Respiratory Infection, G3: pseudomonas sepsis;urinary tract infection;febrile neutropenia;lung infection, pain, hemoptysis, pleural effusion, G5 pneumonitis, death NOS, pancreatitis). Cohort 1 pt, 10 mg dose level, and cohort 2 pt, 25 mg, showed stable (SD) and progressive disease (PD) respectively at the end of C1. Cohort 3 pt, an 81 YO male HR-MDS, escalated from 50 to 75 mg dose from C7, is SD at C24D13 with Erythroid Hematological Improvement on C5, C7, C10, C18. Cohort 4, 75 mg dose pt, a 62 YO male with AML DNMT3A pos, relapsing after Ven/Dec, achieved CRi at the end of C1 and CR in C7, and progressed at the end of C8. Two out of the remaining 4 pts treated at 75 mg reached SD (1 still ongoing at C3D15 and another died on C3D20 while on SD), 1 pt died of COVID-19 pneumonitis on C1D18, 1 pt with AML secondary to MPN was SD at C2 and progressed on C4. Two pt were treated at 110 mg (cohort 5), 1 not evaluable died for pancreatitis and 1 was SD at the end of C1. 2 pt entered cohort 6, 85 mg, and will be evaluable at the end of March 2022. Summary/Conclusion: Preliminary results from the first 6 cohorts have shown a favorable safety and a predictable PK profile of RVU120. Meaningful PD activity and clinical efficacy were observed at 50 and 75 mg doses. Enrollment is currently ongoing at 85 mg cohort.

6.
Gynecologic Oncology ; 166:S7, 2022.
Article in English | EMBASE | ID: covidwho-2031752

ABSTRACT

Objectives: To evaluate the surgical volume, surgical outcomes, and the evolving role of gynecologic oncologists in peripartum hysterectomies (PPH). Methods: We conducted an IRB-approved retrospective chart review of PPH cases performed at our institution from June 1, 2014, to June 30, 2021. Clinical-pathologic information was ed into a REDCap database. All analyses were conducted using STATA 17. Results: A total of 109 cases were performed over the 7-year period. Gynecologic oncologists (GYO) involvement in the cases increased from 33% in 2014 to 80% in 2021. The mean age was 36 (range: 23-47) years. Most patients were White (81/109, 74.3%), and the median BMI was 30.7 (range: 21-57) kg/m2. Surgical indications included placenta accreta syndrome (PAS) in 84 (77%) cases, uterine atony in ten (9.2%), uterine rupture in three (2.8%), malignancy in five (4.6%), and hemorrhage other than atony in seven cases (6.4%). Intraoperative complications included bladder injury (or intentional dissection) in eight (7.3%), ureter injury in four (3.7%), vascular injury in three (2.8%), and femoral pseudoaneurysm in one (0.9%) of the cases. Postoperative complications included urinary tract infection in 11 (10.1%), nerve injury in one (0.9%), surgical site infection in 13 (11.2%), and venous thromboembolism in five (4.6%) cases. Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) usage started in 2019 with one case followed by six cases in 2020 (31.6%) and 3/16 cases in the first half of 2020 (15.8%). A higher REBOA usage in 2020 corresponded with blood products shortages during the COVID crisis.[Formula presented] Conclusions: Overall volume and complexity of peripartum hysterectomy are increasing. This trend is likely driven by an increased incidence of placenta accreta syndrome cases. Gynecologic oncologists are increasingly delegated as primary surgeons in many institutions. Fellowship training programs should strongly consider training in peripartum hysterectomy for trainees.

7.
IDCases ; 30, 2022.
Article in English | EMBASE | ID: covidwho-2031315

ABSTRACT

Brevibacterium species are to be opportunistic pathogens. Although rare, several case reports have mentioned infections ranging from cutaneous infections to bacteremia. Here, we present a case report describing a 64-year-old male pancreatic cancer patient diagnosed with B. luteolum bacteremia.

8.
BMC Pediatr ; 22(1):550, 2022.
Article in English | PubMed | ID: covidwho-2029697

ABSTRACT

BACKGROUND: The first Covid-19 pandemic affected the epidemiology of several diseases. A general reduction in the emergency department (ED) accesses was observed during this period, both in adult and pediatric contexts. METHODS: This retrospective study was conducted on the behalf of the Italian Society of Pediatric Nephrology (SINePe) in 17 Italian pediatric EDs in March and April 2020, comparing them with data from the same periods in 2018 and 2019. The total number of pediatric (age 0-18 years) ED visits, the number of febrile urinary tract infection (UTI) diagnoses, and clinical and laboratory parameters were retrospectively collected. RESULTS: The total number of febrile UTI diagnoses was 339 (73 in 2020, 140 in 2019, and 126 in 2018). During the first Covid-19 pandemic, the total number of ED visits decreased by 75.1%, the total number of febrile UTI diagnoses by 45.1%, with an increase in the UTI diagnosis rate (+ 121.7%). The data collected revealed an increased rate of patients with two or more days of fever before admission (p = 0.02), a significant increase in hospitalization rate (+ 17.5%, p = 0.008) and also in values of C reactive protein (CRP) (p = 0.006). In 2020, intravenous antibiotics use was significantly higher than in 2018 and 2019 (+ 15%, p = 0.025). Urine cultures showed higher Pseudomonas aeruginosa and Enterococcus faecalis percentages and lower rates of Escherichia coli (p = 0.02). CONCLUSIONS: The first wave of the Covid-19 pandemic had an essential impact on managing febrile UTIs in the ED, causing an absolute reduction of cases referring to the ED but with higher clinical severity. Children with febrile UTI were more severely ill than the previous two years, probably due to delayed access caused by the fear of potential hospital-acquired Sars-Cov-2 infection. The possible increase in consequent kidney scarring in this population should be considered.

9.
Female Pelvic Medicine and Reconstructive Surgery ; 28(6):S266-S267, 2022.
Article in English | EMBASE | ID: covidwho-2008709

ABSTRACT

Introduction: With the strain placed on the medical system by the ongoing surges of the Covid-19 pandemic, inpatient surgery is often suspended, and same day discharge rates are increasing. Sacrospinous ligament fixation (SSLF) is an apical suspension procedure performed retroperitoneally;retroperitoneal hemorrhage and nerve injury are potential severe complications. Given these risks, providers vary in their preference for same day discharge vs. routine overnight admission after this procedure. Objective: To establish the safety of outpatient SSLF and evaluate the frequency of complications identified during the hospital stay. Methods: This is a retrospective cohort study of women who underwent SSLF by Urogynecologists at our large, academic institution between March 2018 and October 2021. Patients were identified from the Gynecologic Enhanced Recovery Surgical database, which includes all surgical patients in the department of OBGYN. The data was collected from the electronic medical record (EMR) to track compliance and outcomes in real time for quality improvement purposes during implementation of our enhanced recovery protocol. Institutional IRB approval was obtained. Descriptive statistics were performed. Student's t-test and two-sample tests-of-proportions were used, with a p-value <0.05 denoting statistical significance. Results: A total of 165 patients underwent SSLF;23 were outpatient, and 142 were admitted for at least one night. Over 90% of patients in both groups identified as white, non-Hispanic, and English-speaking. The mean BMI for both groups was 28.8 kg/m2. The outpatient group was younger (57.9 years compared to 64.7 years;P = 0.0051);outpatients were more likely to have commercial insurance (P = 0.0143) and inpatients to have Medicare (P = 0.0282). Almost double the proportion of those in the inpatient group had anxiety and depression, but this did not achieve statistical significance. Outpatients were more likely to be never smokers (P = 0.0175) and use narcotics preoperatively (P = 0.0385). They had a lower mean ASA score (P = 0.0067), Charleston Comorbidity Index score (P = 0.0452), total length of surgery (P < 0.001), total length of anesthesia (P < 0.001), and estimated blood loss (P = 0.0142). Those who went home the same day were more likely to have been the first case (P = 0.0123), and same-day discharge rates increased significantly after the onset of the Covid-19 pandemic (P = 0.0039). Both complications that required operative intervention were identified in the post-anesthesia care unit on the day of surgery. Notably, 30-day post-operative complications were proportionally lower in the outpatient group, but this did not achieve significance. Most of the complications were urinary tract infections, including the sole complication identified in the outpatient group. Conclusions: With the ongoing Covid-19 pandemic and rapidly evolving practice patterns, it is important to establish the safety of outpatient surgery. Our study demonstrates that outpatient SSLF is safe for appropriately selected patients after routine post-operative monitoring including serial vital signs and assessment of neuropathic pain. Severe complications requiring reoperation can often be identified immediately after surgery. Thirty-day post-operative complication rates did not significantly differ between patients undergoing outpatient versus inpatient SSLF.

10.
Female Pelvic Medicine and Reconstructive Surgery ; 28(6):S279, 2022.
Article in English | EMBASE | ID: covidwho-2008704

ABSTRACT

Introduction: While an estimated 50% of adult women experience urinary incontinence (UI), the majority will never receive treatment. Most studies of incontinence care delivery have been limited to administrative (billing) data following treatment. Much less is known about earlier steps in evaluation, including primary care intentions to refer to specialty care. Objective: To better understand the gaps and barriers to receiving care, we examined referral patterns from primary care providers for patients with new diagnoses of urinary incontinence between 2018-2020 and the extent to which such referrals changed during the COVID-19 pandemic. Methods: Electronic health records (EHR) from 24 primary care practices within a single academic medical system were queried to identify a cohort of adult (18 - 90-year-old) female patients first diagnosed with urinary incontinence during primary care (family or general internal medicine) outpatient visits between January 2018 and December 2020. Demographics were determined from appropriate EHR fields, and diagnoses pulled from problem lists, past medical histories, and office visit diagnosis fields. EHR referral fields were utilized to ascertain referral dates, types, and associated diagnoses. Electronic prescription fields were used to record treatment information including medication class, name, and prescription dates. Subjects were excluded if there was EHR evidence of urinary tract infection at diagnosis, UI in the prior year based on diagnosis or medication usage (anticholinergic, B3 agonists), or presence of conditions for which incontinence management might differ substantially in the prior year (pregnancy, spinal cord injury). Referrals to specialty physicians (urology/urogynecology) and pelvic floor physical therapy (PFPT) were examined for the year after UI diagnosis. Logistic regression was then used to assess for associations between referrals and patient demographics, comorbidity, and diagnosis dates (pre-vs during-COVID-19). Results: The study identified 514 women with a newly diagnosed urinary incontinence diagnosis (Table 1). In the year following UI diagnosis, 31.91% were referred to specialty care for management -29.0% to urology/urogynecology and 3.5% to pelvic floor physical therapists. Women diagnosed with UI during the COVID-19 pandemic, starting January 2020, were less likely to be referred with an odds ratio of 0.29 (95% CI 0.19, 0.45) compared to those diagnosed before (Table 2). There was no association of referrals with patient age, race, or number of comorbidities (Elixhauser Comorbidity Index), but confidence intervals were wide. Patterns were similar for models that examined specialty physician or PFPT referral separately. Conclusions: Less than 1 in 3 women were referred to specialty care for UI by their primary care provider with less than 1 in 25 referred to PFPT. There was a significant decrease in likelihood of referrals during 2020 suggesting that the COVID-19 pandemic interfered with UI patients receiving quality care. Future studies aiming to improve incontinence care should examine other aspects of nonsurgical UI care delivery, including barriers to behavioral self-management, medication use, and completion of specialty referrals.

11.
Female Pelvic Medicine and Reconstructive Surgery ; 28(6):S61-S62, 2022.
Article in English | EMBASE | ID: covidwho-2008702

ABSTRACT

Introduction: Enhanced recovery after surgery (ERAS) protocols have decreased hospital length of stay (LOS) and increased the rate of same-day discharge in patients undergoing minimally invasive surgery, including in female pelvic medicine and reconstructive surgery (FPMRS). In October of 2019, our hospital implemented an ERAS protocol;however, the onset of the COVID-19 epidemic accelerated the need to adopt a same day discharge policy. Given the rapid implementation of this policy, it was important to determine its effect on FPMRS surgical outcomes in a public teaching hospital serving predominantly uninsured and underinsured patients. Objective: The primary objective of this study was to evaluate perioperative management and postoperative outcomes for FPMRS patients after implementation of an ERAS protocol in a public teaching hospital. Methods: A single-center review was performed of FPMRS patients undergoing surgery prior to introduction of the ERAS protocol from January 2019 to June 2019 compared to those undergoing surgery after its implementation from January 2021 to June 2021. Demographic and surgical details were collected for all patients. A retrospective analysis was performed comparing outcomes, including percentage of outpatient surgery, emergency department visits within 30 days of surgery, and opioid use pre- and post-ERAS implementation Results: 29 patients were included in the pre-implementation group and 19 patients were included in the post-ERAS implementation group. Procedure types and patient demographics are seen in table 1. Ninety-three percent of patients self-described as Hispanic/Latino ethnicity. The percentage of outpatient surgeries increased from 17% to 90% (p < 0.01). Preoperative acetaminophen use increased from 3% to 74% of patients (p < 0.01), while mean perioperative morphine milligram equivalents decreased from 57 mg to 42 mg (p < 0.01). Mean opioid pills prescribed was not different after implementation of ERAS. Thirty-day emergency department (ED) returns increased from 0% to 11% (P = 0.15). These two ED returns included one visit for a urinary tract infection and the other for nephrolithiasis. Conclusions: ERAS implementation for FPMRS patients at a public hospital led to a significant decrease in LOS, inpatient admission, and perioperative morphine milligram equivalents used without a significant increase in 30-day ED returns. While the COVID-19 epidemic resulted in an accelerated adoption of ERAS protocol, it was found to be safe and effective in our underserved FPMRS patient population.

12.
Female Pelvic Medicine and Reconstructive Surgery ; 28(6):S33-S34, 2022.
Article in English | EMBASE | ID: covidwho-2008694

ABSTRACT

Introduction: Postmenopausal women with recurrent urinary tract infections (RUTI) are repeatedly exposed to antibiotics and therefore at risk for colonization by multi-drug resistant organisms. Methenamine hippurate (MH) is FDAapproved for the prevention of RUTI;however, the mechanism of action of MH or, more specifically, the role of MH in the alteration of the urobiome is not known. Since preliminary data has shown that MH may be effective against some bacteria (e.g., Escherichia coli), but not others (e.g., Enterococcus faecalis), we hypothesize that resident bladder microbiota will be altered by administration of MH. Objective: Our objective is to determine the longitudinal effect of MH on the urobiome of postmenopausal women with RUTI. Methods: A longitudinal study with a convenient sample of 10 postmenopausal women with a clinical history of RUTI was conducted (Figure 1). UDI6 questionnaires, voided urine, catheterized urine, and peri-urethral swabs were obtained at baseline and three months after daily MH use. Expanded quantitative urine culture (EQUC) was performed on these specimens. In addition, during the 3-month timeframe, four self-collection windows were completed (windows A-D): (A) prior to initiating MH (baseline urobiome), (B) one week after starting MH, (C) two weeks before the 3-month follow-up, and (D) one week before the 3-month follow-up. Voided urine and peri-urethral swabs were collected daily for one week during windows A-D to determine how the urobiome changed. Sequencing of samples from these collection windows is pending. Results: Ten participants enrolled;however, three participants were not able to complete the study due to allergic reaction, improper handling of samples, and COVID infection. Six participants have completed the study;microbiological studies for one participant are still in process. There were no episodes of acute cystitis for any participant during the length of the study. UDI6 results suggested a trend towards a decrease in frequency, leakage with urgency, and abdominal pain;however, none of these were statistically significant (Table 1). Of the six remaining participants, the average baseline urine pH was 5.8 ± 0.8. For the completed participants, an initial microbiological comparison of EQUC results at baseline and 3-month visits show differences in sample diversity. Specifically, the number of species detected (richness) in catheterized urine increased for all but one participant (Figures 2A and 2B) though there was little or no changes in overall diversity (Shannon Index, Figure 2B) or evenness (Pielou's Index, Figure 2C) for any sample type. Exposure to MH did not result in the loss of uropathogenic species present in catheterized urine at baseline;instead, additional uropathogenic and commensal microbiota were detected at the 3-month visit. Conclusions: UDI6 trended towards symptom improvement in frequency, urge incontinence, and pain, consistent with RUTI prevention and symptoms control. Microbiological results suggest that MH increases the richness of the bladder urobiome. This consistent trend suggests MH may reduce RUTI events by altering the urobiome community richness instead of eliminating uropathogenic microbiota from the bladder. Further studies are needed to understand the interaction between MH and a host that is susceptible to uropathogen overgrowth (Table Presented).

13.
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.

14.
Annals of the Rheumatic Diseases ; 81:1282, 2022.
Article in English | EMBASE | ID: covidwho-2009099

ABSTRACT

Background: Multimorbidity in patients with rheumatoid arthritis (RA) has been described as the coexistence of two or more chronic diseases and is the most common cause of death in this population. Objectives: To describe the prevalence of multimorbidity and mortality trends in a well-characterized cohort of patients with RA. Methods: A retrospective cohort study of patients with RA (1987 ACR criteria) was conducted. Each patient was evaluated and followed by a rheuma-tologist in a single outpatient private center in Bogotá, Colombia, from 2014 to 2021. Categorical variables were expressed in frequency and percentage and quantitative variables in mean and standard deviation or median with interquartile range, depending on the distribution of the data. Statistical package: SPSS 25. Results: A total of 783 patients were included. 11% of patients with RA present multimorbidity. Baseline characteristics were as follows: female gender 81.6%, mean age 51.8±11 years, mean disease duration 8 (IQR 3-15) years, RF positive 80.1%, ACPA positive 58.2%, and erosions 24.9%. Most patients have received glucocorticoids (89.8%), and conventional synthetic DMARDs (97.8%), being prednisone and methotrexate the most frequently prescribed. Hypertension was prevalent in 27.7%, osteoporosis 19.3%, malignancies in 5.5% and principal infection was urinary infection 14.3%. Polyautoimmunity was present in 5.7% most frequently Autoimmune thyroid diseases 10.6% and Sjögren syndrome 9%. After a median of 73 months of follow-up, the mortality rate was 1% of the entire cohort, being cardiovascular disease and COVID-19 infection the main causes. Conclusion: Patients with RA have an important multimorbidity burden and this increased risk of adverse outcomes and mortality.

15.
Annals of the Rheumatic Diseases ; 81:1861, 2022.
Article in English | EMBASE | ID: covidwho-2009050

ABSTRACT

Background: A 50 years old woman, a medical doctor, came to our department with symmetrical proximal muscular weakness, several months after Covid-19 infection and three weeks after a second dose of Covid-19 mRNA vaccine. The patient had no prior or family history of autoimmune diseases and take no medicines. In the past she undergone an operation for double-kidney with frequent urinary infections. Objective fndings have shown symmetrical proximal muscular weakness and classic sings of dermatomyositis-Gottron's papules, shawl and holster signs, periungual vasculitis. Objectives: We present a case of a 50 old woman with clinical and laboratory proven dermatomyositis, starting three weeks after a second dose of a Covid1-19 mRNA vaccine without other reasons. Methods: The laboratory tests showed elevated CPK, lactate dehydroge-nase, aspartate aminotransferase and alanine aminotransferase, high ANA-1:1280 and myositis specifc autoantibodies-anti-NXP2 and anti-Mi-2-beta. The electromyography showed myopathic changes and the muscle MRI-symmetrical edema of mm.obturator and mm.adductor brevis. We exclude diseases that may mimic infammatory myopathies. We made a cancer screening-whole body MRI, colonoscopy, gastroscopy, mammography and gynecological exam, immunoblot for detection of paraneoplastic syndrome-associated neuronal antibodies, with no detection of cancer. Muscle biopsy of m.vastus lateralis showed attenuating muscle infammation with advancing muscle atrophy and fbrosis. Results: The diagnose dermatomyositis was made according Bohan and Peter criteria and we start a high dose (1mg/kg/day) glucocorticoid therapy with good initial clinical and laboratory effect. Two months after starting a therapy muscle weakness worsened together with difficulty of swallowing. We excluded steroid myopathy after second EMG and lack of improvement when tapering the GS dose. Methotrexate 20 mg/weekly was added as a steroid sparing drug with good response, but was stopped because fare of pyelonephritis. Accordning to the opinion of dermatologist hydroxychloroquine was started for a couple of weeks, because of active skin manifestations. Muscle weakness worsened on the background of treatment, which was stopped. We started a therapy with intravenous immunoglobulins and considered therapy with cyclophosphamide or azathio-prine after urinary infection. Because the patient was infected for a second time with covid-19, although vaccine, we continued only with glucocorticoids and anti-osteoporotic therapy. Conclusion: The etiology and pathogenesis of infammatory myopathies are not fully clarifed so far. We speculate that the infection with Covid-19 as well as mRNA vaccine trigger infammatory myopathy and compromise the patient's immunity for poor treatment response with glucocorticoids and immunosuppres-sives. On the other hand advanced muscle atrophy and fbrosis within a short period show that suspected triggering factors could be a reason for difficult to treat such type of dermatomyiositis.

16.
Annals of the Rheumatic Diseases ; 81:1420-1421, 2022.
Article in English | EMBASE | ID: covidwho-2008992

ABSTRACT

Background: Giant Cell Arteritis (GCA) is a systemic vasculitis involving large and medium-sized blood vessels. Treatment is with high dose glucocorticoids. Steroid-sparing agents and Tocilizumab (TCZ) are used for refractory or relapsing cases. NHS England requires all GCA patients to be discussed in a regional multidisciplinary team meeting (MDT) prior to commencing TCZ. TCZ has only been permitted for a maximum of one year;this time limitation was extended during the Covid-19 pandemic (1). The monthly virtual Bristol and Bath regional MDT started in November 2018. Objectives: We aimed to review: 1) Baseline data on all patients referred to the Bristol and Bath TCZ for GCA MDT, including demographics, clinical presentation and previous steroid-sparing agents used and 2) 12 month follow up data including number of completions, adverse effects, and fares on treatment. Methods: The TCZ MDT referral proforma, adapted from the NHS England Blueteq approval form, was reviewed for all patients referred. 12 month follow up data was obtained from clinic letters. Results: Baseline data Thirty-eight cases were referred between November 2018 and September 2021. Of these, 31 were approved for TCZ usage;100% fulflled the criteria for either refractory (n=11) or relapsing (n=20) disease. Mean age was 74 years and 74.2% were female. Average disease duration was 161.5 days for the refractory and 827.3 days for the relapsing group. 77.4% had cranial GCA, 48.4% had large vessel involvement, 45.2% had visual symptoms and 25.8% had ischaemic visual loss. The positive investigations were PET-CT (48.4%), temporal artery ultrasound (41.9%) and temporal artery biopsy (32.3%). 64.5% had trialled a steroid-sparing agent at time of referral (61.3 % metho-trexate, 9.7% azathioprine, 6.5% lefunomide), 35.5% had received intravenous methylprednisolone and 58% were receiving greater than 40mg prednisolone at the time of referral. Glucocorticoid adverse effects of osteoporosis, weight gain, cataracts and hypertension were each seen in 19.4%;whilst diabetes, neuropsychiatric symptoms and sleep disturbance were each reported in 16.1%. Those with ocular involvement tended to be referred earlier than those without (478.2 days vs 648.1 days), were referred on higher doses of glucocorticoids (71.4% vs 47.1% on ≥ 40mg) and had less steroid-sparing agents prior to referral. Follow up data In December 2021, a follow-up audit revealed 14/31 patients had completed at least 12 months of tocilizumab;5 of these had had an extension under Covid-19 exceptional guidance (mean duration of 5.2 months). Of the remaining 17: 3 patients had stopped early (1 death, 1 moved away, 1 due to adverse effects of headache and gastro-intestinal side effects), 4 had not started tocilizumab and 10 had not completed 12 months of treatment at that point. Adverse events in the 14 patients at 12 months included: liver abnormalities (2/14;14.3%), neutropenia (2/14;14.3%), thrombocytopaenia (1/14;7.1%), soft tissue infections (3/14;21.4%), urinary tract infection (1/14;7.1%) and lipid derangement (4/14 28.6%). One case of GCA relapse occurred on TCZ (mild headache and raised infammatory markers settled on small increase in prednisolone). After 12 months, mean prednisolone dose was 3mg (range 0-15mg). Conclusion: All patients approved for Tocilizumab in the GCA MDT fulflled NHS England criteria for either relapsing or refractory disease. The majority of cases had cranial disease, but almost half had either ocular or large vessel involvement, refecting a severe spectrum of disease. Cases showed a high burden of glucocorticoid toxicity. Follow up data suggests that TCZ was effective in allowing glucocorticoid weaning and disease control, but with some adverse effects. Future work to follow up patients after stopping Tocilizumab would be informative, as the twelve month limitation on treatment is likely to be re-instated.

17.
Indian Journal of Critical Care Medicine ; 26:S25, 2022.
Article in English | EMBASE | ID: covidwho-2006331

ABSTRACT

Aim and background: SARS-CoV-2 pandemic questioned many basic concepts in medicine. COVID-19 affects many organ systems despite the lung being the primary affected organ. ARDS management is challenging and a new complication during the management adds to the burden. Macklin described a pathophysiological process by which air escaped through the ruptured alveolar basement membrane causing pneumomediastinum. The occurrence of air leak syndromes (ALS) in COVID-19 made us investigate the disease and its association with the complication. Objective: To observe the clinicopathological profile of patients who developed air leak syndrome during the second wave of the pandemic. Materials and methods: A retrospective analysis was conducted on SARSCoV- 2 patients admitted to ICU due to ARDS. The study included patients admitted from March to June 2021 with rTPCR positive test for SARS-CoV-2 illness and diagnosed to have ARDS as defined by the Berlin criteria. We analyzed 195 cases admitted in the ICU who met the above criteria and received protocolised care as per national and institutional guidelines. Cases who received ventilatory support either as HFNO (high flow nasal oxygenation), NIV (noninvasive ventilation), or invasive mechanical ventilation as per ARDS NET protocol and developed ALS were included. Demographic and clinical profiles of patients and laboratory parameters like acute phase reactants, haemogram, and serum creatinine were analysed. Results: 5.6% of patients were diagnosed to have air leak syndrome, which includes subcutaneous emphysema, pneumomediastinum, pneumopericardium, and pneumothorax. 81% of the cases were men. The average age was 44.8 years. 90% of the patients had no pre-existing lung pathology or respiratory comorbidity. 81.8% did not have a documented history of smoking. 63.33% of patients had other preexisting co-morbidities. 27.2% of patients had more than one comorbidity with diabetes mellitus being the most common. The average time to develop air leak syndrome was 6 days. 81% of the patients received mechanical ventilation, 2 patients were only on HFNO. 90% of the patients were prone in view of severe ARDS. From air leak syndromes mentioned above, 72.2% developed pneumothorax, 63.3% of the patients developed subcutaneous emphysema, 54.5% of the patients developed pneumomediastinum, and 9% developed pneumopericardium. 1 patient (9%) developed the complete spectrum of ALS. 63% of the patients developed 2 or more entities of the air leak, i.e., subcutaneous emphysema, pneumomediastinum, pneumopericardium, and pneumothorax. Acute phase reactants were elevated in all patients who developed ALS. There was neutrophil predominance in the haemogram. Only one patient developed AKI. Another compelling finding was the development of secondary infection, the majority was respiratory tract infections (81%) followed by urinary tract infections. Candiduria was observed in 36.6% of patients. The average duration of stay was 21.6 days. The mortality rate was 63%. 4 patients were discharged who had an average time to resolution of 8 days. Conclusion: COVID-19 is majorly a self-limiting disease. Secondary bacterial infection and poor oxygenation was major finding in our study. Development of ALS in a previously normal lung with no preexisting lung pathology points towards the need to conclude ALS and viral pneumonias.

18.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005657

ABSTRACT

Background: Combined-modality treatments are bladder-preserving alternatives for patients (pts) who are not candidates for radical cystectomy by medical reasons, refusal, or patientś choice. Immune therapies seem to potentiate tumor-specific immune response induced by radiotherapy (RT). Combination of RT with anti-PD-1/PD-L1 therapy appears safe and there are signs of promising activity. The aim of this study is to assess the efficacy and safety of atezolizumab (ATZ) concurrent with external beam radiotherapy (EBRT) for the treatment of muscle-invasive bladder cancer (MIBC) with bladder preservation intent. Here we present an interim analysis. Methods: This is an open, multicenter, and phase II trial, sponsored by SOGUG, in pts with confirmed diagnosis of MIBC in clinical stages cT2-T4a N0 M0 who are not candidates for radical cystectomy. Treatment consists of 6 doses of ATZ 1200 mg IV every 3 weeks, starting on day 1 of EBRT, and 60 Gy of RT in 30 fractions over 6 weeks at 2 Gy/day. The primary endpoint of the study is pathological complete response (pCR) defined as a response of grade 5 according to Miller and Payne criteria, 1 to 2 months after the last dose of ATZ. A planned interim analysis has been performed (data cut-off date: November 2021) on the primary endpoint to avoid exposure to ineffective treatment according to the minimax two-stages Simon's design (stopping rule: 9 out of the first 13 evaluable pts should achieve pCR). Incidence of adverse events (AE) and serious AE (SAE) has been also secondarily assessed. Results: From September 2019 to November 2021, 39 pts were screened, of whom 13 were excluded due to non-compliance with eligibility criteria. Thus, the evaluable population consisted of 26 pts. The safety analysis was performed in 22 pts who had received at least one dose of ATZ. 14 pts were assessed pathologically and, thus, included in interim efficacy analysis (median age: 78.6 years;clinical stage: 71.4% T2a, 14.3% T2b, 7.1% T3a, 7.1% T3b). All 14 pts had achieved pCR at the cut-off date. 20/22 (91%) pts experienced at least one AE, with asthenia (11 pts), diarrhea (9 pts), and urinary tract infection (4 pts) being the most common. 9 SAEs were reported in 7 (32%) pts (bacteriemia, COVID-19 infection, depressed LVEF, unknown origin fever, hepatic toxicity, kidney failure, rectorrhagia, respiratory infection, and urinary sepsis). 6 (27%) pts suffered AEs leading to treatment discontinuation. No AEs leading to death occurred. 17 pts with available data on survival were alive at the cut-off date. Conclusions: Interim results suggest that ATZ combined with EBRT is a feasible and effective treatment in terms of pCR, with a manageable safety profile. The final results from this trial will provide information about its effects on clinical outcome, including survival and updated safety findings.

19.
Indian Journal of Radiology and Imaging ; 2022.
Article in English | EMBASE | ID: covidwho-2004819

ABSTRACT

We present the case of a 60-year-old diabetic female who was diagnosed with coronavirus disease 2019 (COVID-19) pneumonitis. After her recovery during follow-up, she presented with recurrent hematuria, burning of micturition and, occasional lower abdominal discomfort, with unsatisfactory response to oral antibiotics. On imaging evaluation, there was mild right hydronephrosis and hydroureter with urothelial thickening involving the right lower ureter and a filling defect in the urinary bladder close to the vesicoureteric junction seen on excretory phase images. Cystoscopy revealed a whitish friable mass-like lesion that was retrieved, histopathology of which revealed fungal elements, and Rhizopus was isolated in culture. Thus, the diagnosis of urinary bladder fungal ball due to mucormycosis infection of the urinary tract was reached. The patient was asymptomatic after 10 weeks of antifungal treatment. The treating physicians, urologist, and radiologists need to have a high index of suspicion of urinary mucormycosis in patients with COVID-19 pneumonia.

20.
Clinical Nutrition ESPEN ; 48:481-482, 2022.
Article in English | EMBASE | ID: covidwho-2003942

ABSTRACT

Background: In the UK, 38% of people residing in care homes are estimated to be at high risk of malnutrition1 and it is known now that nutritional status can further be negatively affected by COVID-19 not only directly through medical complications but also social factors such as social isolation, staffing issues, increased anxiety and low mood2. Our aim is to evaluate the clinical and cost effectiveness of direct dietetic input (Rapid Access Dietetic Service) to care homes during the COVID-19 pandemic. Methods: During the first wave of the Covid-19 pandemic, a rapid access service to support care homes was set up, accepting referrals directly from the care home staff and offering a remote dietetic assessment within 1 week of referral. Patients at high risk of malnutrition / on ONS were followed up as part of a 12-week care pathway. The 12-week pathway consisted of initial and last telephone/video consultation by the dietitian and monthly telephone follow ups in between by the dietetic assistant. Care home staff were provided remote training on ‘Food First’ malnutrition management and ONS prescribing. Outcomes audited were MUST, clinical outcomes (number of falls, pressure sores, chest and UTI infections, hospital admissions, A&E attendance in the last 3 months) pre and after 12-week pathway. Cost benefit analyses were performed on both clinical outcomes and ONS changes. Service evaluation was done by requesting GP / care staff and community dietitians’ feedback. Results: 54 patients were referred by the care homes staff/GP, 24 of those because of medium/high risk of malnutrition, 30 referred for ONS review. Out of the patients who were medium/high risk (n = 24) and were onboarded onto the 12-week care pathway, the number of patients with MUST of 0 (low risk) increased 8-fold, patients with MUST of 1 (medium risk) increased 2.3 times and patients with MUST of 2 or above (high risk) declined by half after the 12-week care pathway. Cost benefit analysis on clinical outcomes showed combined estimated cost savings of £26,061 (Table 1). Out of the patients on ONS, 11 prescriptions were changed, 5 were stopped, 13 were continued resulting in a total ONS annualised savings of £12,753 / £425 per patient. The service was evaluated by the community dietitians, care staff and GPs and positive feedback was provided. [Formula presented] Discussion: Despite being an existing service, significant adaptations were made in order to continue providing care throughout the COVID-19 pandemic. All interactions and engagement with GPs and care home staff were conducted remotely in place of the usual in-person service. Despite this change, marked improvements in patient malnutrition status were seen during the 12-week care pathway. Cost benefit analysis show a combined annualised cost saving of £38,814 during the 6-month intervention from the ONS changes and clinical outcomes. This equates to an annualised cost saving of £77,628 and £718.7 per person referred. The service was highly valued by the care home staff, GPs and community dietitians as evidenced by the positive feedback received. Limitations include other possible factors may have influenced the results e.g. medications/other HCP involvement. Annualized savings for ONS changes and clinical outcomes were estimated based on savings achieved in the 6 months over the service was running. The cost of dietitian was not included as a pre-existing service was altered during the pandemic months prioritizing care homes. Conclusion: The new rapid access service for care homes resulted in residents being seen quickly and appropriately treated for malnutrition where identified. The service also resulted in significant cost savings for ONS prescriptions and avoidance of healthcare costs associated with malnutrition. Continuation of this new service model should be considered to reduce the incidence of malnutrition and effectively manage those identified as malnourished. References 1. Nutrition Screening Survey in care Homes in the UK: A report based on the amalgamated data from the four Nutrition Screening Week surveys undertaken by BAPEN in 2007, 2008, 2010 and 2011 C A Russell and M Elia on behalf of BAPEN and collaborators 2. Azzolino D, Saporiti E, Proietti M, Cesari M. Nutritional considerations in frail older patients with COVID-19. The journal of nutrition, health & aging. 2020 Jul;24:696-8. 3. National Schedule of Reference Costs 2017/2018 4. Dealey C, Posnett J, Walker A. The cost of pressure ulcers in the United Kingdom. J Wound Care. 2012 Jun;21(6):261-2, 264, 266. 5. British National Formulary – National Institute for Health and Care Excellence -

SELECTION OF CITATIONS
SEARCH DETAIL