Number Of Patient-days Research Articles

Bimekizumab cumulative clinical benefit in patients with moderate to severe hidradenitis suppurativa through 1 year of the BE HEARD I&II phase 3 trials

Introduction: Hidradenitis suppurativa (HS) is a chronic, inflammatory skin disease which significantly impacts health-related quality of life.1 Bimekizumab (BKZ) is a humanized IgG1 monoclonal antibody that selectively inhibits interleukin (IL)-17F in addition to IL-17A.2 ere, the cumulative benefit of BKZ treatment on HS clinical response (HiSCR) through 16 and 48 weeks (wks) is reported using area under the curve (AUC) analyses.Procedure/study: Pooled data from BE HEARD I&II included an initial (Wks0–16) and maintenance treatment period (Wks16–48).3 Randomization: 2:2:2:1 (initial/maintenance) BKZ 320mg every 2 wks (Q2W)/Q2W, BKZ Q2W/Q4W, BKZ Q4W/Q4W, or placebo (PBO)/BKZ Q2W. HiSCR50/75/90 response was achieved at a given visit if there was ≥50/75/90% reduction in the total abscess/inflammatory nodule count with no increase from baseline in abscess or draining tunnel count. Cumulative clinical benefit estimation: total AUC through Wk48 for HiSCR50/75/90 achievers. Calculation of estimated number of days patients achieved each response: proportion of total possible AUC for each outcome multiplied by total number of days in the period (Wks0–16: 112 days, Wks0–48: 336). Data are reported as observed case, where N represents number of patients with a non-missing lesion count assessment in the given week, and percentages are calculated accordingly (i.e. where data recorded after an intercurrent event are included).Results: Overall, 1,014 patients were randomized to BKZ Q2W/Q2W (N=288), BKZ Q2W/Q4W (N=292), BKZ Q4W/Q4W (N=288) and PBO/BKZ Q2W (N=146). Through 16wks, the total number of days patients achieved HiSCR50 was almost double in BKZ Q2W/Q2W (47 days), BKZ Q2W/Q4W (49), and BKZ Q4W/Q4W (47) groups vs PBO (27). To Wk16, the total number of days patients achieved HiSCR75/90 was at least double in the BKZ groups vs PBO. To Wk48, total number of days with HiSCR50 achievement: BKZ Q2W/Q2W, 211; BKZ Q2W/Q4W, 212; BKZ Q4W/Q4W, 206 vs PBO/BKZ Q2W, 178. Comparable results were observed for HiSCR75/90 at Wk48, with BKZ groups maintaining higher responses vs PBO. Conclusion: High levels of cumulative clinical benefit were observed for patients on BKZ through Wk16; benefits increased substantially through Wk48. The cumulative benefit of BKZ through 48wks was evident for patients receiving continuous BKZ and PBO switchers. The total number of days of clinical outcome achievement remained higher in those on continuous BKZ vs PBO switchers. These results demonstrate the rapid, high-level and durable responses that can be obtained with BKZ.

Integrating diabetes care into an oncology practice: A patient-centric model of care delivery at a safety-net health system.

2 Background: Oncologic treatments can disrupt glycemic control in people with diabetes and induce dysglycemia in individuals without diabetes through the use of steroids and/or targeted therapies. Severe hyperglycemia can result in delay/interruption of oncologic care and emergency department (ED) utilization. Here we report on an integrated model of diabetes care at a safety-net system, where patients commonly use the ED for their care. Methods: Parkland Health is an academic-affiliated safety-net system, primarily providing care for the un-/under-insured patients in Dallas County. An advanced nurse practitioner specializing in diabetes care (DM-ANP), supervised by an endocrinologist, was embedded in oncology clinics. Patients were referred to the DM-ANP by their oncology provider, or through an automated process if they had a recent hemoglobin A1c >8.0% or a random blood sugar > 250mg/dL. Patient education was provided by a trained nurse educator. Nutrition consult was available through an oncology dietitian. An acute hyperglycemia management protocol was developed to manage patients in the infusion center and prevent unnecessary ED visits. Results: Between March 2021 and March of 2024, the DM-ANP provided 4,276 visits to 797 distinct patients (average, 1425 visits per year). Breast cancer was the most common malignancy among patients seen in the integrated clinic. DM-ANP visits were coupled with oncology visits (clinic or infusion) or via telehealth, thereby increasing access and decreasing number of days patients had to come to clinic to receive care. Telehealth visit rate was highest in 2021 (27.5%) reflecting the impact of the pandemic, and subsequently dropped to 10.1% in 2023. Patients who were seen by the DM-ANP had an overall lower number of ED visits. Comparing prior vs post establishing care with the DM-ANP, the total number of ED visits by patients with diabetes significantly reduced in 2021-2022 (2021: 970 vs. 241, p <0.01; 2022: 796 vs. 501, p<0.01) before equilibrating in 2023-2024; (2023: 426 vs. 468, p=0.24). On average, patients had 1.2 less ED visits after receiving care from the DM-ANP. Since in-person visits were coupled with other oncology visits, the no-show rate for DM-ANP mirrored the rates for oncology clinics/infusion visits. Conclusions: Integrating diabetes/glycemic management into our oncology practice provided a patient-centric model of care delivery, improved visit adherence compared to an off-site model, reduced the time-toxicity by having fewer clinic visit days. Future directions include comparing oncologic outcomes in patients who had DM-ANP management to those who were managed by primary care.

Impact of the COVID-19 Pandemic on Inpatient Antibiotic and Antifungal Drug Prescribing Volumes in Germany.

Previous studies found that the coronavirus disease 2019 (COVID-19) pandemic had a variable impact on the consumption of antimicrobial drugs in human medicine, with trends in several European countries differing between community and inpatient prescribing. This study analysed changes in the volumes and use density of antibacterial and antifungal drugs dispensed in acute care hospitals in Germany between 2019 and 2022. Surveillance data for the four years available from 279 hospitals were expressed as the total volumes of daily doses or as use density (daily doses per 100 patient/occupied bed days) per year and analysed descriptively, using recommended hospital-adapted daily dose definitions (RDDs) and (as sensitivity analysis) WHO/ATC-defined daily dose definitions (DDD). Hospitals were stratified according to size (number of beds), university affiliation, and location (East, West, South). There were significant decreases in both the total number of patient days and antibacterial drug volumes in 2020 through 2022 compared with 2019. The relative changes between 2019 and 2020, 2021, and 2022 were -12.8%, -13.5%, and -13.3% for patient days, and -9.7%, -11.0%, and -10.1% for antibacterial RDDs, respectively. Broad-spectrum betalactams, notably piperacillin-tazobactam and carbapenems, increased in volume, unlike most other drug classes. The resulting antibacterial drug use density was slightly but significantly increased, with pooled means (and medians) of 43.3 (40.0) RDD/100 in 2019 compared to 44.8 (41.7), 44.5 (40.80), and 44.9 (41.7) RDD/100 in the years 2020 through 2022, respectively. Antifungal drug volumes and use density increased after 2019 and peaked in 2021 (the difference between 2019 and 2021 for total volumes was +6.4%, and that for pooled mean use density values was +22.9%, respectively). These trends were similar in the different hospital strata and comparable when DDDs instead of RDDs were used. Similar to what has been observed in a majority of European countries, the total volume of antibacterial drug use in German acute care hospitals decreased with the pandemic, without a rebound phenomenon in 2022. In association with restricted hospital capacities and presumably more immunocompromised general medicine patients, however, inpatient prescribing of (primarily broad-spectrum) antibacterials and of antifungal drugs increased.

Epidemiology of candidemia during COVID-19 pandemic era in a teaching hospital: A non-concurrent cohort study.

During the COVID-19 pandemic, an increase in the incidence of bloodstream infections caused by fungi of the Candida genus, also known as candidemia, was observed in patients with SARS-CoV-2 infection. This study aimed to assess the incidence of candidemia, the factors related to COVID-19-associated candidemia (CAC), and prognostic factors. A non-concurrent cohort of 87 cases of patients aged over 18 years with candidemia between March 2020 and February 2022 was evaluated. Incidence density (ID) was calculated by the number of patient-days during the period. All causes of mortality within 30 days of observation were considered. Logistic regression and Cox proportional hazards regression were used, respectively, to determine factors associated with CAC and prognostic factors. Values <0.05 were considered significant. The ID of CAC was eight times higher than candidemia in patients without COVID-19 [2.40 per 1000 person-days vs. 0.27 per 1000 person-days; P<.01]. The corticosteroid therapy was as an independent factor associated with CAC [OR=15.98 (3.64-70.03), P<.01], while abdominal surgery was associated with candidemia in patients without COVID-19 [OR=0.09 (0.01-0.88), P=.04]. Both patients with and without COVID-19 had a high 30 days-mortality rate (80.8% vs. 73.8%, respectively; P=.59). Liver disease [HR=3.36 (1.22-9.27); P=.02] and the Charlson score [HR=1.17 (1.01-1.34); P=.03] were independent factors of death, while the use of antifungals [HR=0.15 (0.07-0.33); P<.01] and removal of the central venous catheter [HR=0.26 (0.12-0.56); P<.01] independently reduced the risk of death. These findings highlight the high incidence of candidemia in COVID-19 patients and its elevated mortality.

Impact of pandemic and socioeconomic influences on decision-making for emergency ostomy procedures: Key factors affecting hospital visit decisions.

Emergency surgeries are linked with increased morbidity and reduced life expectancy, often associated with low socioeconomic status, limited access to healthcare, and delayed hospital admissions. While the influence of socioeconomic status on elective surgery outcomes is well-established, its impact on emergency surgeries, including ostomy creation and closure, is less clear. This study aimed to explore how the pandemic and socioeconomic status affect emergency ostomy procedures, seeking to determine which has a greater effect. It emphasizes the importance of considering socioeconomic factors in patient care pathways for ostomy procedures. A total of 542 patients who underwent emergency ostomy formation between 2016 and 2022 were retrospectively analyzed and divided into pre-pandemic and pandemic periods. The pre-pandemic and pandemic periods were compared between themselves and against each other. Demographic data (age and sex), comorbidities, socioeconomic status, etiology of the primary disease, type of surgery, stoma type, length of hospital stay, ostomy closure time, and postoperative complications were retrospectively analyzed for all patients. In total, 290 (53%) patients underwent surgery during the pandemic period, whereas 252 (47%) underwent surgery during the pre-pandemic period. Emergency surgery was performed for malignancy in 366 (67%) patients. The number of days patients underwent ostomy closure was significantly higher in the low-income group (P = .038, 95% CI: 293,2, 386-945). The risk of failure of stoma closure was 3-fold (95% CI: 1.8-5.2) in patients with metastasis. The risk of mortality was 12.4-fold (95% CI: 6.5-23.7) when there was failure of stoma closure. When compared to pandemic period, the mortality risk was 6.3-fold (95% CI: 3.9-10.2) in pre-pandemic period. Pandemic patients had a shorter hospital stay than before the pandemic (P = .044). A high socioeconomic status was significantly associated with early hospital admission for ostomy closure, and lower probability of mortality. More metastases and perforations were observed during the pandemic period and mortality was increased during pandemic and in patients without ostomy closure. The socioeconomic status lost its effect in cases of emergency ostomy creation and had no impact on length of hospital stay in either the pre-pandemic or pandemic period.

Real world tebentafusp-tebn experience at a tertiary care referral center.

e21526 Background: Tebentafusp-tebn is an FDA approved therapy specifically for patients with metastatic uveal melanoma (MUM). The major challenge of this treatment is the weekly infusion schedule and potentially significant toxicity during the dose escalation and induction phase (Cycle 1). To overcome this challenge, we developed a treatment model consisting of an induction phase at a tertiary center of MUM and subsequent treatments at a local cancer center. Methods: This retrospective cohort study included patients who received Cycle 1 at our institution since FDA approval. Patients who received initial induction doses at other health systems were excluded. Data was collected by chart review. Cytokine release syndrome (CRS) was graded by ASTCT consensus guidelines. Results: From 3/14/2022-11/7/23, 26 patients received at least one dose of tebentafusp-tebn at our institution. 14/26 were female and median age was 69 (range 51-80). 24/26 patients had metastatic disease to the liver, followed by bone (6/26), lung (3/26), and others (5/26). Patients underwent a median of 2 (range 0-5) lines of therapy prior to tebentafusp-tebn initiation. Major side effects during Cycle 1 included CRS (22/26), rash/itching (24/26), and nausea (3/26). One patient developed grade 4 liver enzyme elevations. Of the patients who developed CRS, 77.3% (17/22) were grade 1, 13.7% (3/22) were grade 2, and 9.1% (2/22) were grade 3. 5/26 (19.2%) patients required at least one dose of steroid for management of CRS. The median number of hospitalizations for Cycle 1 was 3 (range 3-6). After Cycle 1, 21/26 (80.8%) patients were successfully transitioned to local health systems to continue outpatient weekly tebentafusp-tebn infusions, including 2 patients who went were able to continue of therapy in their home countries. 1 patient is in the process of transferring, 1 patient discontinued after dose escalation due to disease progression, and 3 patients decided to continue treatment at our institution. 19 patients who were transitioned to their local cancer centers in the US traveled a median of 107 miles (range 30-298 miles) for Cycle 1 at our institution, and a median of 23 miles (range 4-58 miles) after transition to local health systems. The median number of days patients received therapy was 203 days (range 22-610 days). Median time to progression was 12.6 weeks (range 5.8-65.6). 6/26 (23.1%) patients have received additional therapy upon progression while continuing tebentafusp-tebn. 12/26 patients are currently receiving therapy and 2 patients were lost to follow up after transferring to a local site. At time of review 19/26 patients were alive. Conclusions: This hybrid model of treatment (Cycle 1 at a tertiary center followed by continuation at a local cancer center) made weekly tebentafusp-tebn treatment safe and feasible for patients with MUM. Our single center experience demonstrates side effects and outcomes similar to what has been reported in the clinical trial.

Acute Gastrointestinal Injury in Critically Ill Patients in a South Indian Intensive Care Unit: A Prospective, Observational, Preliminary Study.

Introduction The acute gastrointestinal injury (AGI) score was proposed by the Working Group on Abdominal Problems of the European Society of Intensive Care Medicine (ESICM) as a tool to define and grade gut dysfunction. There have not been any studies in India to validate this tool. The objectiveof this preliminary study was primarily to study the frequency of AGI in the first week of ICU stay in critically ill patients in ourintensive care unit (ICU). We also sought to determine the risk factors predisposing to the development of AGIand to determine the prognostic implication of gastrointestinal (GI) injury in critically ill patients. Materials and methods A prospective, observational, preliminary, single-center study was conducted on critically ill patients (APACHE II > 8) who were on enteral tube feeds and admitted to a mixed ICU of a tertiary care hospital. Anthropometric data, admission diagnosis, APACHE II score, and comorbidities were recorded. Data of daily heart rate, mean arterial pressure, dose of vasopressors, intra-abdominal pressure, fluid balance, feeding intolerance, mechanical ventilation, and laboratory tests were noted for the first seven days of ICUstay or till ICU discharge, whichever was earlier. The occurrence of AGIscore (1-4) during the first seven days of critical illness was the primary outcome of interest. Patient outcome at 28 days was recorded and the impact of the occurrence of AGI on patient outcome was analyzed using the Chi-square test. The patient characteristics associated with AGI were characterized as risk factors and analyzed using a multivariate model. Results Data were collected from 33 patients over 201 patient days. The frequency of acute GI dysfunction in the first seven days of ICU stay in our group of patients was 45.45% (15/33). APACHE II, fluid balance, creatinine, and lactate were identified as possible predictors ofGI injury based on existing literature. These four variables were entered into an ordinal logistic regression model to assess their ability to predict the occurrence ofGI Injury. When fitted into a predictive model, only fluid balance and creatinine were predictive of the final model (p-value < 0.05). A greater fluid balance was predictive in the final model of the development ofGI injury;however,it showed negligible clinical significance (OR: 1.00033, 95% CI: 1.000051-1.00061). Lower creatinine levels were predictive in the final model of the development of AGI Injury,as demonstrated by the negative coefficient. Creatinine also had a greater clinical significance (OR: 0.63, 95% CI: 0.44-0.90) in the development ofAGI. The impact of the AGI scores on mortality was analyzed. The number of patient days with higher AGI scores was significantly associated with increased mortality at 28 days (p-value < 0.001). Conclusion The study showed that nearly half of the critically ill patients included in the study developed acute GI dysfunction.We could not identify any predictors ofGI injury based on our results. The result suggested an association between the severity of GI dysfunction and mortality at 28 days.

An economic evaluation of chronic obstructive pulmonary disease clinical pathway in Saskatchewan, Canada: Data-driven techniques to identify cost-effectiveness among patient subgroups.

Saskatchewan has implemented care pathways for several common health conditions. To date, there has not been any cost-effectiveness evaluation of care pathways in the province. The objective of this study was to evaluate the real-world cost-effectiveness of a chronic obstructive pulmonary disease (COPD) care pathway program in Saskatchewan. Using patient-level administrative health data, we identified adults (35+ years) with COPD diagnosis recruited into the care pathway program in Regina between April 1, 2018, and March 31, 2019 (N = 759). The control group comprised adults (35+ years) with COPD who lived in Saskatoon during the same period (N = 759). The control group was matched to the intervention group using propensity scores. Costs were calculated at the patient level. The outcome measure was the number of days patients remained without experiencing COPD exacerbation within 1-year follow-up. Both manual and data-driven policy learning approaches were used to assess heterogeneity in the cost-effectiveness by patient demographic and disease characteristics. Bootstrapping was used to quantify uncertainty in the results. In the overall sample, the estimates indicate that the COPD care pathway was not cost-effective using the willingness to pay (WTP) threshold values in the range of $1,000 and $5,000/exacerbation day averted. The manual subgroup analyses show the COPD care pathway was dominant among patients with comorbidities and among patients aged 65 years or younger at the WTP threshold of $2000/exacerbation day averted. Although similar profiles as those identified in the manual subgroup analyses were confirmed, the data-driven policy learning approach suggests more nuanced demographic and disease profiles that the care pathway would be most appropriate for. Both manual subgroup analysis and data-driven policy learning approach showed that the COPD care pathway consistently produced cost savings and better health outcomes among patients with comorbidities or among those relatively younger. The care pathway was not cost-effective in the entire sample.

Evaluation of mental health services delivered before and after the introduction of pilot Mental Health Centers in Poland using monitoring indicators.

The study assessed the performance of Mental Health Centres compared to previous non-integrated mental health facilities. The study used National Health Fund (NHF) data of individuals over 18 years treated in 27 centres (January 2017 - February 2020). Performance indicators from 19 months before (N = 124,497) and after the introduction of Mental Health Centres (N = 182,789) were compared for outpatient care, community treatment teams, inpatient wards and day wards. The total number of patients who received mental health care increased, compared to before the establishment of those Centres; whereas the number of hospitalisations decreased by 6% and the number of patient days per person decreased by 9%. Day care saw a 14% increase in admissions following the introduction of Mental Health Centres, with a 5% decrease in patient days per person. The proportion of patients in community care increased by 86%, in outpatient care by 62% and in day care by 14%. The number of first-time patients after the introduction of Mental Health Centres increased and the number of follow-up patients decreased. For all groups of mental disorders, the priority indicator in inpatient care decreased, while increasing in outpatient and community care for most groups of disorders. The results confirmed the effectiveness of the National Mental Health Protection Programme project in relation to the availability and reduction of inpatient treatment through Mental Health Centres. The methodology used in this study can be used for assessing the effectiveness of Mental Health Centre activities in subsequent stages of the pilot.

Delayed discharges at a tertiary rehabilitation centre in Saudi Arabia: contributing factors and cost impact.

There are various challenges in discharging hospitalized patients with disabilities. Discharge process for individuals with disabilities is multifactorial and can vary from one health system to another. The current study is aimed to explore the factors contributing to delayed discharges and to determine the number of exceeded bed days and subsequent cost impact at a government rehabilitation facility in Saudi Arabia. This retrospective cohort study was conducted at the Rehabilitation Hospital of King Fahad Medical City, Riyadh. All the 2285 discharges from inpatient rehabilitation from August 2011 to March 2017 were included in the study. Patients with delayed discharge were identified. Information about the diagnosis and reasons for delayed discharge was obtained from the rehabilitation hospital bed utilization data. The cost impact was calculated based on the number of days patients stayed beyond the estimated length of stay for each diagnosis. Of the 2285 discharges, 531 (23.3%) were delayed. The most common clinical conditions of patients with delayed discharge included spinal cord injury (n = 168, 31.6%) and traumatic brain injury (n = 145, 27.3%). The factors that led to delayed discharges were medical complications (n = 352, 66.7%), organizational factors (n = 83, 15.7%), family factors (n = 46, 8.7%), and external factors (n = 46, 8.7%). A total of 21 817 hospital bed days were exceeded, with an approximate estimated cost of 80 million Saudi Arabian Riyals. Early rehabilitation and enhancement of the discharge process may significantly decrease delayed discharge rates. Strategies need to be adapted to identify patients at risk of delayed discharge based on the factors highlighted in this study. Development of long-term care capacity, community services, and optimizing family and social support can promote timely discharge.

Association between Neutropenic Index for Venetoclax Exposure (NIVE) and Survival Outcomes Among AML Patients Highlighting Racial Disparities

Background Venetoclax (Ven) is a potent Bcl-2 inhibitor, approved by FDA for use in combination with hypomethylating agents (HMAs) or low dose cytarabine (LDAC) for newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities based on VIALE trial. The combination regimen often results in severe neutropenia. Febrile neutropenia is one of the most common treatment-associated complications in the management of AML, increasing risk of hospitalization and death. Severe neutropenia is defined as absolute neutrophil count (ANC) &amp;lt;500/uL and often leads to clinicians holding treatment. There have been some studies about racial disparities in genetics and survival outcomes amongst AML patients, however there are limited studies regarding severe neutropenia and its implication between different races. There is also no prediction tool for infection-related death (IRD), overall survival (OS) and event-free survival (EFS) that is helpful in dosing Ven for AML thus far. Method We queried Northwell Health Cancer Institute's electronic health records to identify all patients with AML who received at least one cycle of Ven and HMA between January 2019 and December 2022. We retrospectively analyzed 76 patients who had received at least 3 cycles of Ven with HMA. Data on neutropenic duration was collected by counting the number of days patients had an ANC&amp;lt;500/uL starting from cycle 3 until data censor date, change of treatment, relapse, or transplant. OS was calculated as the time between date of definitive diagnosis to death or date of last contact and EFS was calculated as the time between date of diagnosis to events such as stopping Ven due to intolerability, relapse or transplant. We calculated Neutropenic Index for Ven Exposure (NIVE) by dividing the total number of days of severe neutropenia by total number of days on Ven and multiplying by 100 days. Statistical analysis was done by using Stata. Findings The study cohort consists of 63.1% White, 15.7%, African-American (AA), 7.8% Asians, 2.6% mixed race and 10.5% unknown. While 14% of the patients died of infection, 28.6% of those who died of infection were AA.Among AA, 55% had complex karyotype. Risk of death due to infection was 2.36 times higher in AA compared to non-AA (p= 0.08). We also found that the median OS for non-AA was 20.5 months vs 11.2 months for AA population (p= 0.66) and EFS was 11.6 months for non-AA vs 6.8 months for AA patients (p= 0.25) (Fig.1). On subgroup analysis, the median of NIVE was 77 in patients who received Ven in the frontline setting vs 109 days in relapsed/refractory setting (p= 0.21).The median NIVE for patients who received Azacytidine+Ven was 61.6 vs 94 days for Decitabine+Ven group (p= 0.12). On univariate analysis, high NIVE is associated with lower EFS (p= 0.04) and shows a trend towards decrease in overall survival (p= 0.09) (Fig.2). On Mann-Whitney test, NIVE is higher in AA population (p= 0.04), with median NIVE of 157 days in AA patients vs 82 days in non-AA patients. On multivariate regression analysis including age, sex, ELN risk stratification and age at diagnosis, median NIVE is also higher in AA compared to non-AA patients(p= 0.002) . NIVE is also found to be higher in the patient cohort that died of infections over other causes (p= 0.02). On subgroup analysis, patients with NIVE &amp;gt; 60 were found to have a significantly lower median OS than the NIVE ≤ 60 group (p= 0.04). Discussion s Our findings suggest that AA patients have significantly lower EFS and higher risk of infection-related death (IRD) compared to non-AA group. This highlights the need for further studies to identify the cause of disparities in IRD and outcomes among AA patients which needs explanation beyond socioeconomic factors and access to treatment. Our study shows disparities in median NIVE between AA vs non-AA patients. Larger studies are needed to clarify if AA patients are more susceptible to severe neutropenia while on Ven. Racial consideration may be important in deciding the optimum dose of Ven and interval between cycles. The positive association of NIVE with relapsed/refractory group &amp; Decitabine+Ven group compared to frontline &amp; Azacytidine+Ven group respectively suggests that the former group may benefit from adjustments in Ven dosing or total drug exposure per cycle. NIVE may be a novel prediction tool for IRD, EFS and possibly OS for AML patients on Ven which may help with patient management.

High Proportion of Mucosal Barrier Injury- Laboratory Confirmed Bloodstream Infection Among Paediatric Oncology Patients in a Cancer Centre in Eastern India

Abstract Introduction Blood stream Infections (BSI) is associated with increased morbidity, mortality, health care costs and healthcare resource utilization. The 2022 version of CDC/NHSN criteria for mucosal barrier injury-associated laboratory-confirmed bloodstream infection (MBI-LCBI-1) included isolation of any intestinal organism from blood culture in a patient with absolute neutrophil count &amp;lt;500/mm3. Children with malignancy have a high risk for infections due to neutropenia, immunosuppressive therapy, individual immune and nutritional status, chemotherapy infusion, radiotherapy, impaired mucosal barrier, and presence of different types of indwelling catheters. CLABSI is defined as an LCBI where an eligible BSI organism is identified, and an eligible central line is present on the LCBI date of event or the day before. Device Utilisation Ratio (DUR) is a ratio comparing the number of device days to the number of patient days for the included time period. Methods A retrospective analysis of all BSI-s in the paediatric unit of a tertiary oncology hospital in a low-middle income country (LMIC) for 43 months (April 2019-October 2022) was performed. The primary objective was to assess the burden of MBI-LCBI-1 in children with cancer. The secondary objective was to assess the CLABSI rate and compare it to the DUR. MBI-LCBI-1, CLABSI and DUR were determined using the standard CDC/NHSN criteria. The adapted CDC/NHSN bloodstream infection case report form included microbiological (type of pathogen) and clinical (signs, symptoms, and underlying conditions such as neutropenia) information. Neutropenia (absolute neutrophil count &amp;lt;500 cells/mm3) was the underlying condition in the MBI-LCBI cases. Blood cultures were done using BACT-ALERT system and antibiotic susceptibility testing performed using VITEK2 system (Biomerieux). Results A total of 47 positive blood cultures were obtained from 46 patients during the study period. Thirty-three cases of MBI-LCBI-1 (33/47= 70%) from 28 patients (median age 14 years; range 4-20 years) and 3 cases of CLABSI (3/47= 6.3%) from 3 patients (median age 7 years; range 3-9 years) were detected giving a CLABSI rate of 0.60 per 1000 central line days. Total Patient days and central line days was 15,002 and 14,764 respectively. The device utilization ratio of central line was 0.98. There were 48 isolates from 47 cases of BSI. Forty-three (90%) were Gram negative bacilli (GNB), 2 (4%) Gram positive cocci (GPC) and 3 (6%) Candida species. Klebsiella pneumoniae (28%) was the commonest GNB. Amongst the multi-drug resistant organisms (MDRO) associated with MBI-LCBI-1, carbapenem-resistant enterobacterales (CRE) was detected in 14/43 (32.5%), carbapenem-resistant Acinetobacter baumanii complex (CRAb) in 1/43 (2.3%), carbapenem-resistant Pseudomonas aeruginosa (CRPseu) in 2/43 (4.7%). Candida auris was detected in 1/3 Candida isolates. Six out of 46 patients with BSI died within 30 days of BSI (all-cause mortality). Four of these patients had CRE, 1 had CRAb and 1 had Candida auris. There were no isolates of Methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin resistant enterococci (VRE). Conclusion All patients who died had MDRO isolates. Strict adherence to standard and contact precautions, with high level of awareness is necessary for lowering the incidence of BSI. Low incidence of CLABSI is a good indicator of good infection control practices.

802 Are Patients with Malignant Melanoma Operated on Within National Cancer Waiting Time Standards?

Abstract Aim This audit evaluated the performance of the local melanoma referral pathway against national cancer wait times, to identify limiting factors and find solutions to deliver service in a safe and streamlined manner. Method Patients with malignant melanoma referred to general surgeons between March and June 2022 were identified retrospectively. Patients with other skin cancers, concurrent malignancy, metastatic melanoma, or those declining surgery were excluded. The date of each step of the referral pathway was noted for each patient using Microsoft Excel, and the difference between the dates was calculated. The percentage of compliance with the 31-day and 62-day wait was compared against the national operational standard. Results During the audit period, 59 patients with malignant melanoma were referred to the general surgeons, 22 of these were excluded for the aforementioned reasons. Of the remaining 37 patients, 65% were male and the average age was 66 years old. 83% of patients received their first treatment from diagnosis within 31 days, falling short of the 96% target. Only 60% of patients received surgery within the following 31 days. On average it took 56.8 days from diagnosis to surgical treatment, with wait time to operation varying from 15 days to 101 days. Conclusions Overall, the average time to surgery for patients with malignant melanoma was less than the target 62 days, however there was notable variation in the number of days patients waited for their operation. Further detailed analysis of cases with long wait times is required to reduce the risk of delaying vital cancer treatment.

Safety and efficacy of tumor treating fields (TTFields) prior and concomitant to radiotherapy in patients with newly diagnosed glioblastoma: Results from PriCoTTF.

2050 Background: Tumor Treating Fields (TTFields) therapy is a locoregional, antimitotic cancer modality that utilizes electric fields delivered noninvasively to the tumor region using arrays. Preclinical findings have demonstrated that TTFields have an enhanced inhibitory effect on glioblastoma (GBM) cell proliferation when used concomitantly with radiotherapy (RT). These results provided the rationale for the phase 1/2 PriCoTTF study that investigated the safety and efficacy of TTFields therapy initiated prior and concomitant to radio-chemotherapy in adult patients with newly diagnosed (nd)GBM. Methods: TTFields therapy was initiated following surgery and continued concomitant with radio-chemotherapy and adjuvant chemotherapy for a total of approximately 9 months. TTFields rechallenge was permitted upon GBM recurrence. RT was conducted with arrays placed on the patients’ scalp. The primary endpoint was safety and tolerability gauged by a series of pre-selected treatment-limiting toxicities (TLTs). Results: The baseline characteristics of 33 patients enrolled to date were typical for GBM, except for a small proportion of patients with gross total resection (22.5%). The frequency of adverse events (AEs) grade ≥ 3 was comparable to other studies in GBM. Of note, grade ≥ 3 skin AEs only occurred in 2 patients (6%) and no patients developed a TLT. The median duration of TTFields therapy was 8.4 months. Median overall survival (OS) was not reached (48% of events had occurred), which precluded conclusions regarding efficacy. However, notably, multivariable Cox regression found that OS was independently associated with the number of days patients achieved &gt; 23 h TTFields therapy (HR 0.96, 95% CI 0.93–0.99, P = 0.008). Conclusions: The PriCoTTF study met its primary endpoint by finding that TTFields therapy concomitant with RT was well tolerated in patients with ndGBM. This included that high-grade skin toxicities were rare. Longer follow up is needed to estimate the efficacy of TTFields therapy in this setting, and will need to consider the relatively low overall duration of TTFields therapy and proportion of patients who received GTR.

Patient-reported ability to walk 4m and to wash: New clinical endpoints and predictors of survival in patients with pre-terminal cancer.

Maintaining the ability to perform self-care is a critical goal in patients with cancer. We assessed whether the patient-reported ability to walk 4m and wash oneself predict survival in patients with pre-terminal cancer. We performed a prospective observational study on 169 consecutive hospitalized patients with cancer (52% female, 64±12years) and an estimated 1-12months prognosis at an academic, inpatient palliative care unit. Patients answered functional questions for 'today', 'last week', and 'last month', performed patient-reported outcomes (PROs), and physical function assessments. Ninety-two (54%) patients reported the ability to independently walk 4m and 100 (59%) to wash 'today'. The median number of days patients reported the ability to walk 4m and wash were 6 (IQR 0-7) and 7 (0-7) days ('last week'); and 27 (5-30) and 26 (10-30) days ('last month'). In the last week, 32% of patients were unable to walk 4m on every day and 10% could walk on 1-3days; 30% were unable to wash on every day and 10% could wash on 1-3days. In the last months, 14% of patients were unable to walk 4m on every day and 10% could only walk on 1-10days; 12% were unable to wash on every day and 11% could wash on 1-10days. In patients who could walk 'today' average 4m gait speed was 0.78±0.28m/s. Patients who reported impaired walking and washing experienced more symptoms (dyspnoea, exertion, and oedema) and decreased physical function (higher Eastern Cooperative Oncology Group Performance Status, and lower Karnofsky Performance Status and hand-grip strength [unable vs. able to walk 'today': 205±87 vs. 252±78 Newton, P=0.001; unable vs. able to wash 'today': 204±86 vs. 250±80 Newton, P=0.001]). During the 27months of observation, 152 (90%) patients died (median survival 46days). In multivariable Cox proportional hazards regression analyses, all tested parameters were independent predictors of survival: walking 4m 'today' (HR 0.63, P=0.015), 'last week' (per 1day: HR 0.93, P=0.011), 'last month' (per 1day: HR 0.98, P=0.012), 4m gait speed (per 1m/s: HR 0.45, P=0.002), and washing 'today' (HR 0.67, P=0.024), 'last week (per 1 day HR 0.94, p=0.019), and 'last month' (per 1day HR 0.99, P=0.040). Patients unable to walk and wash experienced the shortest survival and most reduced functional status. In patients with pre-terminal cancer, the self-reported ability to walk 4m and wash were independent predictors of survival and associated with decreased functional status.

Characteristics and outcomes of COVID-19 patients during the BA.5 omicron wave in Tehran, Iran: a prospective observational study

BackgroundOmicron (B.1.1.529) is the fifth variant of concern of SARS-CoV-2, which has several subvariants. Clinical features of BA.1 and BA.2 infections have been described in the literature, but we have limited information about the clinical profile of BA.5, which caused the seventh wave in Iran.MethodsA prospective observational study was conducted on the BA.5 confirmed patients referred to Imam Khomeini Hospital Complex, Tehran, Iran, from 11th to 31st August 2022. The patients were divided into the two groups of outpatients and hospitalized patients, and their clinical, radiological, and laboratory data and outcomes were recorded and analyzed.ResultsWe included 193 patients with confirmed BA.5 infection, of whom 48 patients (24·8%) were hospitalized. The mean age of the patients was 45·3 ± 16·5 years, and 113 patients (58·5%) were female. The mean number of days patients had symptoms was 6·8 ± 2·4 days. The most common symptoms were weakness (69·9%), sore throat (67·4%), myalgia (66·3%), hoarseness (63·7%), headache (55·4%), fatigue (54·9%), and dry cough (50·3%). Fever and dyspnea were significantly more observed in the hospitalized patients (p < 0·0001). The COVID-19 vaccination rate was significantly lower in hospitalized patients than in outpatients (35/48–72·9% vs. 140/145 − 96·6%, p < 0·0001). The most common underlying diseases were hypertension (16·1%), diabetes mellitus (9·8%), and cardiovascular diseases (9·8%), all of which were significantly more common in hospitalized patients. Lung opacities were observed in 81·2% of hospitalized patients. By the end of our study, 1·5% of patients died despite receiving critical care services.ConclusionsOur findings suggested that BA.5 symptoms are more non-respiratory and usually improve within 7 days. Although the proportion of hospitalized patients is still significant, very few patients require intensive care. COVID-19 vaccination is effective in reducing the hospitalization rate.Trial registrationNot applicable. This study is not a clinical trial.

Compliance challenges in a longitudinal COVID-19 cohort using wearables for continuous monitoring.

Wearables to Investigate the Long Term Cardiovascular and Behavioral Impacts of COVID-19 (WEAICOR) study is a prospective observational study using continuous monitoring to detect and analyze biometrics. Compliance to wearables was a major challenge when conducting the study and was crucial for the results. The aim of this study is to evaluate patients' compliance to wearable wristbands and determinants of compliance in a prospective COVID-19 cohort. Biostrap wearable device was used to monitor participants' biometric data. Compliance was calculated by dividing the total number of days in which transmissions were sent by the total number of days in the study. Univariate correlation was performed between compliance, days in the study and age, BMI, sex, symptom severity, and number of complications/comorbidites as independent variables. Also, multivariate linear regression was then performed with days in the study as a dependent variable to assess the power of different parameters in determining days in the study. On hundred twenty-two patients were included in the study. Patients were on average 43 years old and 32% were female. Age was found to be correlated with compliance (r=0.23, P=0.01). In addition, age (r=0.30, P=0.001), BMI (r=0.19, P=0.03) and severity of symptoms (r=0.19, P=0.03) were found to be correlated with days spent in the study. On multivariate analysis with days spent in the study as a dependent variable, only increased age was a significant determinant of compliance with wearables (adjusted R2 = 0.1, β = 1.6, P= 0.01). Compliance is a major obstacle in remote monitoring studies and the reasons for a lack thereof are multifactorial. Patient factors such as age, in addition to environmental factors can affect compliance to wearables.

No Advantage for Early Active Mobilization During Mechanical Ventilation

According to this study: Among adults undergoing mechanical ventilation in the ICU, early active mobilization didn't increase the number of days patients were alive and out of the hospital compared with usual care.Adverse events were more common among people who had early mobilization interventions.

Days at home in the last three months of life: patterns-of-care analysis in patients with non-small cell lung cancer.

To calculate the number of days patients with terminal non-small cell lung cancer (NSCLC) spent at home in the last 3 months of life, and to identify factors that predict a lower proportion of days at home. Retrospective study of 434 deceased patients with NSCLC. The number of days spent in a hospital or nursing home was identified from electronic health records. Most patients received primary chemotherapy. Only 45% received palliative care provided by a dedicated palliative care team (PCT). In the last 3 months of life, only 39 patients (9%) were not hospitalized. The median number of days spent in hospital was 17, range 0-61. Hospital death occurred in 48%. Admission to a nursing home was recorded in 45%. Overall, the patients spent a median of 64 days at home. Both, older patients and females spent fewer days at home. Family network and aspects of palliative care, possibly reflecting the symptom duration or burden, also impacted days at home. Long-lasting need for PCT support (not just the final 3 months) and earlier necessity for opioid analgesics were predictive for a reduced number of days at home. However, modifiable factors such as sex were identified too.

Evaluation of open reduction and internal fixation with closed reduction and external fixation in distal radial fracture

&lt;p&gt;&lt;strong&gt;Background:&lt;/strong&gt; Radial fracture frequently occurs in osteoporotic disorders, or in low-energy injuries. It is most frequent fracture of the upper extremity. Open reduction or closed reduction is done but there is debate between the two about its efficacies. Aims and objectives were to find out the efficacy and safety of open reduction and internal fixation (ORIF) with that of closed reduction and external fixation (CREF) among patients with distal radial fracture of all ages.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods:&lt;/strong&gt; This prospective study was conducted with patients of distal radial fracture. They underwent interventions, namely, ORIF (Open reduction group) or CREF (Closed reduction group). DASH score was measured before the intervention and during several follow ups at 4&lt;sup&gt;th&lt;/sup&gt; week to 15&lt;sup&gt;th&lt;/sup&gt; week. DASH score was statistically analyzed between the two groups. Additionally, the complications of the patients in each group were evaluated and sick leaves of the patients was recorded to assess their quality of life.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results:&lt;/strong&gt; The study has found that the number of days taking patients took sick leave from field work is significantly more in "closed reduction" group as compared to "open reduction" group (p&amp;lt;0.05). The number of days patients took sick leave is significantly higher in “closed reduction” group as compared to “open reduction” group (p&amp;lt;0.05).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions:&lt;/strong&gt; The study has concluded that the disability of the patients who received ORIF decreased significantly as compared to those who received external fixation and the patients who received open reduction significantly improved from the fracture.&lt;/p&gt;