Overall Proportion Of Patients Research Articles

Antibiotic Overuse in Pediatric Patients Hospitalized with RSV, COVID-19, and Influenza

Abstract Background Children hospitalized with viral respiratory tract infections (RTIs) are often treated with antibiotics due to concern for bacterial co-infection, although most do not have concurrent bacterial infections. This practice leads to unnecessary antibiotic treatment, which can lead to development of resistant bacteria and adverse events. The extent of antibiotic overuse in hospitalized children with community-onset viral RTI has not been well-quantified in recent years and may have worsened during the COVID-19 pandemic. The objectives of this study were to quantify and compare the extent of antibiotic overtreatment and to determine predictors of antibiotic use post-COVID-19 pandemic in children hospitalized with RSV, COVID-19, and influenza. Methods We performed a single center retrospective study evaluating percentages of antibiotic use and bacterial co-infection among children and adolescents aged <19 years old, hospitalized with respiratory syncytial virus (RSV), influenza, or SARS-CoV-2 between April 2020 and May 2023. Bacterial infection was defined as growth of bacteria from any specimen source, including blood, urine, pleural fluid, cerebrospinal fluid, and respiratory secretions, excluding common contaminants like coagulase-negative Staphylococci. Predictors of antibiotic treatment were determined using multivariable logistic regression. Results During the study period 1,718 patients were included (1022 with RSV, 188 with influenza, 535 with COVID-19). RSV patients were younger and more likely to be in the ICU than influenza or COVID-19 patients. The overall proportion of patients with culture-confirmed bacterial co-infection was low at 8% and did not differ greatly by virus type (8% for influenza, 6.9% for RSV, 10.3% for COVID-19, p=0.03). The proportion of children receiving antibiotics was higher for influenza than for other viruses (60.6% for influenza, 41.2% for RSV, and 48.6% for COVID-19, p < 0.001). Among patients with the lowest severity of illness (with normal inflammatory markers [PCT <0.5 ug/mL or CRP <50 mg/L] and not admitted to the ICU), 7.3% had a culture-confirmed bacterial infection while 48.1% received antibiotics. Independent predictors for receiving antibiotics were elevated inflammatory markers (C-reactive protein or procalcitonin), having >3 comorbidities, mechanical ventilation, and influenza diagnosis. Conclusion In children hospitalized with community-onset viral RTIs, antibiotic treatment is substantially higher than the burden of culture-confirmed bacterial infection, suggesting antibiotic overuse. Antibiotic use was greater for patients with influenza than for those with RSV or COVID-19. Antibiotic overuse was estimated to occur in over 40% of patients with low severity of illness. Stewardship programs can use this data to design interventions to promote more judicious antibiotic use. Figure 1. Rates of bacterial co-infection and antibiotic utilization among patients hospitalized with influenza, RSV, and COVID. Blue, percentage of patients who had a culture-confirmed bacterial infection; orange, percentage of patients who received any antibiotics; green, percentage of patients who received >3 days of antibiotics.

Development and validation of a risk prediction model for acute care use among patients with advanced cancer on clinical trials.

277 Background: Patients with advanced cancer on clinical trials are at high risk for unplanned Emergency Room visits (ER_visits) and hospital stays (HS). Identifying patients at highest risk could inform personalized intervention strategies. Methods: The data were from the SWOG Cancer Research Network. Medicare claims data were linked to data from advanced cancer clinical trials. The occurrence of any HS or ER visit within 1 year after enrollment was the primary endpoint. Patients must have had 6 months of continuous Medicare claims prior to registration to determine comorbid conditions prior to treatment, and 12 months of claims after registration (or until death) to detect outcomes. We examined 23 sociodemographic (age, sex, race, ethnicity, insurance status), geographic (rural or urban, area-level deprivation), clinical (disease severity, performance status), treatment (line of therapy, therapy type), and individual comorbidity factors to establish a predictive risk model. Model derivation was conducted in a 60% random sample and tested in the remaining 40%. Best subset selection with logistic regression was used with iterative application of 3-, 4-, and 5-fold cross validation repeated 10 times. Results: Among N=1397 total patients from 6 trials (lung, 3; prostate, 2; pancreas, 1), 33.9% were 75+ years, 20.3% were female, and 8.2% were Black. The overall proportion of patients with ≥1 HS/ER visit was 68.8%. In the training set (n=839), a best 5-variable risk was identified with adverse risk factors including cancer type (prostate vs other), performance status (PS; 0 vs. >=1), coronary artery disease (CAD; yes vs. no), hypertension (yes vs. no), and liver disease (yes vs. no). As cancer type was a study-level variable, we derived a risk model using PS, CAD, hypertension, and liver disease and adjusted for cancer type. There were no differences in adverse risk between those in with and without prostate cancer (interaction p-value=.44), justifying combining across cancer types. In the training set, patients with ≥2 risk factors (high risk; n=303, 36.1%) vs. 0/1 risk factor (low risk; n=536, 63.9%) had nearly a 3-fold increased odds of experiencing HS/ER visit (82.2% vs. 59.1%, OR=2.85, 95% CI, 2.01-4.03, p<.001). Results were successfully validated in the test set (OR=1.93, p=.002). In all patients, those in the highest risk quartile (3/4 factors) vs the lowest risk (0 factors) had nearly a fourfold increased odds of HS/ER visits (OR=3.92, 95% CI, 2.25-6.83, p<.001). Conclusions: Rates of HS_ER visits were high within the first year after enrolling on a trial for advanced cancer. We derived and validated a risk model that delineated strong differences in risk. With expansion of eligibility to include patients with more comorbid conditions, personalized interventions aimed at preventing acute care use could decrease the cost and improve the quality of cancer care.

Prehospital Post-Resuscitation Vital Sign Phenotypes are Associated with Outcomes Following Out-of-Hospital Cardiac Arrest

Objectives The use of machine learning to identify patient ‘clusters’ using post-return of spontaneous circulation (ROSC) vital signs may facilitate the identification of patient subgroups at high risk of rearrest and mortality. Our objective was to use k-means clustering to identify post-ROSC vital sign clusters and determine whether these clusters were associated with rearrest and mortality. Methods The ESO Data Collaborative 2018–2022 datasets were used for this study. We included adult, non-traumatic OHCA patients with >2 post-ROSC vital sign sets. Patients were excluded if they had an EMS-witnessed OHCA or were encountered during an interfacility transfer. Unsupervised (k-means) clustering was performed using minimum, maximum, and delta (last minus first) systolic blood pressure (BP), heart rate, SpO2, shock index, and pulse pressure. The assessed outcomes were mortality and rearrest. To explore the association between rearrest, mortality, and cluster, multivariable logistic regression modeling was used. Results Within our cohort of 12,320 patients, five clusters were identified. Patients in cluster 1 were hypertensive, patients in cluster 2 were normotensive, patients in cluster 3 were hypotensive and tachycardic (n = 2164; 17.6%), patients in cluster 4 were hypoxemic and exhibited increasing systolic BP, and patients in cluster 5 were severely hypoxemic and exhibited a declining systolic BP. The overall proportion of patients who experienced mortality stratified by cluster was 63.4% (c1), 68.1% (c2), 78.8% (c3), 84.8% (c4), and 86.6% (c5). In comparison to the cluster with the lowest mortality (c1), each other cluster was associated with greater odds of mortality and rearrest. Conclusions Unsupervised k-means clustering yielded 5 post-ROSC vital sign clusters that were associated with rearrest and mortality.

Impact of C-reactive protein point-of-care testing on antibiotic prescriptions for children and adults with suspected respiratory tract infections in primary care: a French patient-level randomized controlled superiority trial

ObjectivesThe value of C-reactive protein point-of-care testing (CRP POCT) to guide antibiotic prescriptions in adults has previously been emphasized. The aim of this study was to assess the impact of CRP POCT on antibiotic prescriptions by general practitioners (GPs) for suspected lower respiratory tract infections in children ≥3 years old and in adults. MethodsThis was an open-label randomized trial (NCT03540706) conducted in 26 GPs in France between October 2019 and March 2023. Of the 404 participating patients, 207 (51.2%) were randomized to the CRP POCT group and 197 (48.8%) to the control group (i.e. no CRP POCT). During consultations, GPs measured CRP levels in patients randomized to the CRP POCT group. The primary endpoint was the proportion of patients in each group who were prescribed antibiotics by their GP during the consultation. Z-tests were used for comparisons. ResultsThe overall proportion of patients treated with antibiotics was similar in the CRP POCT (n = 89/207, 43% CI: 36.2, 50.0) and in the control group (n = 94/197, 47.7% CI: 40.6, 54.9), difference: −4.7 CI: −14.4, 5.0; p 0.3. Overall, 75% of the GPs followed CRP-based antibiotic prescription recommendations in the CRP POCT group. DiscussionCRP POCT did not reduce antibiotic prescriptions in this trial.

Results of surgical treatment of patients with acute destructive diverticulitis of the colon using minimally invasive technologies

Among the diseases of the colon, diverticular disease occupies one of the leading positions, the frequency of which is currently 1.2 cases per 1000 people. Complications in this condition develop in 5% of cases and account for 3-5% of all patients with acute abdominal diseases. Surgical intervention is required in 15% to 30% of such patients. The mortality rate after surgical treatment of acute complications of the diverticular disease remains high, ranging from 7% to 25%. The purpose of our study was to compare the outcomes in the treatment of patients with acute destructive diverticulitis of the colon using traditional surgical treatment versus minimally invasive technologies. In the study, 114 patients diagnosed with acute destructive diverticulitis were examined. Group I consisted of 56 patients who underwent initial surgical interventions employing minimally invasive methods like laparoscopy, laparoscopic-assisted techniques, or percutaneous drainage guided by ultrasound. Group II comprised 58 patients who underwent the first surgical intervention through laparotomy access. The data of our study show that the overall proportion of patients with complications was higher in Group II – 20 (34.5%) compared to 6 (10.1%) in Group I (p=0.005). The application of diverse surgical methods did not notably impact the mortality rate, with 6 (10.3%) fatalities in Group II compared to 2 (3.6%) in Group I (p=0.2). Stoma creation was more frequent in Group II, in 40 (67%) patients, whereas in Group I, the occurrence of stomas was lower, in 15 (25.9%) cases. The average period to stoma closure was 5 months in Group II and 2 months in Group I. There was observed a decrease in the time of urgent surgery from 143±13.5 minutes in Group II to 65.7±15.2 minutes in Group I (p<0.01) and the duration of the first hospitalization from 14.2±1.8 days to 5.6±0.7 days, accordingly (p<0.01). When dealing with primary anastomosis or severe peritonitis, utilizing a laparoscope for dynamic laparoscopy allows for real-time monitoring of the abdominal cavity and early identification of complications, eliminating the need for scheduled laparostomy. The research data demonstrate that, while not affecting mortality, minimally invasive methods have several significant advantages, including a reduction in the number of complications, a decrease in the proportion of patients with stomas, a reduction in the time to reconstructive surgery, and a decrease in the duration of urgent surgery and the length of hospitalization.

LMIC-08. NEUROSURGERY UTILIZATION RATE FOR PEDIATRIC LOW-GRADE GLIOMA: A SIMULATION-BASED ANALYSIS

Abstract BACKGROUND The outcomes of pediatric low-grade glioma (pLGG) are markedly influenced by accessibility to neurosurgical services. Even when clinically recommended, neurosurgical interventions might not be feasible when there is scarcity in qualified medical professionals and preparedness of medical facilities, which is the case in many low- and middle-income countries (LMICs). To aid cancer control planning efforts and guide policy makers and clinicians to prioritize allocation of resources, accurate neurosurgical utilization rate (NUR) estimations are crucial. This study developed a model to estimate the NUR, to facilitate the approximation of neurosurgery needs for pLGG. METHODS A decision tree model was developed to assess the NUR in HICs and LMICs. Patients were classified into five groups based on the anatomic site of the tumor. For each type of cancer, patients had three surgical options, gross total resection, subtotal resection, and biopsy. Anatomic distribution and likelihood to perform surgical resection were retrieved from the literature for both HICs and LMICs. RESULTS Findings showed discrepancy in the anatomic distribution of pLGG in HICs and LMICs. Proportion of patients with cerebral hemisphere, cerebellum, OPHG/diencephalon, brainstem, and spine tumors and their likelihood to undergo surgical intervention were 34% | 28%, 32% | 27%, 17% | 4%, 12% | 3% and 5% | 4% in HICs, and 26% | 22%, 39% | 32%, 26% | 5%, 6% | 2% and 3% | 2% in LMICs, respectively. Overall, NUR in pLGG patients was 66% in HICs and 63% in LMICs. CONCLUSION Despite the limited resources in LMICs, the overall proportion of patients recommended to undergo a surgical intervention is comparable to HICs. For this need to be met, long-term planning need to take place at the policymaking level. It is possible to estimate the NUR for all pediatric CNS tumors following the same approach to more comprehensively estimate the neurosurgical needs of this patient population globally.

Risk factors for subsequent fractures in hip fracture patients: a nested case-control study

BackgroundThe risk factors for subsequent fractures following an initial hip fracture are not entirely understood. This study examined the clinical characteristics of hip fracture patients to identify potential risk factors associated with a higher risk of experiencing subsequent fractures.MethodsWe conducted a nested case-control study using data from the Chinese PLA General Hospital Hip Fracture Cohort between January 2008 and March 2022. The cases were individuals who experienced subsequent fractures following an initial hip fracture. Each case was matched with up to 2 controls who did not develop subsequent fractures. Important clinical factors were compared across groups, including traditional fracture risk factors and potential risk factors (e.g., comorbidities, falls risk, physical impairment, calcium or vitamin D use, and anti-osteoporosis medications). Conditional logistic regression analyses were used to evaluate the impact of these clinical features as potential risk factors for subsequent fractures.ResultsA total of 96 individuals who suffered from subsequent fractures were matched with 176 controls. The median time between the initial hip fracture and the subsequent fracture was 2.1 years. The overall proportion of patients receiving anti-osteoporosis treatment after initial hip fracture was 25.7%. In the multivariable regression analysis, living in a care facility (OR = 3.78, 95%CI: 1.53–9.34), longer hospital stays (OR = 1.05, 95%CI: 1.00–1.11), and falls after discharge (OR = 7.58, 95%CI: 3.37–17.04) were associated with higher odds of subsequent fractures.ConclusionsThis study showed that living in a care facility, longer hospital stays, and falls after discharge may be independent risk factors for repeat fractures following an initial hip fracture. These findings could be used to identify and manage patients at high risk of subsequent fractures.

Retrospective Cross-Sectional Epidemiological Study of Human Papillomavirus-Associated Precancers and Anogenital Warts in Patients Attending Specialized Clinics in Russian Federation

Background. In Russia, there are no country level registries on HPV-associated pre-cancers (cervical intraepithelial neoplasia, CIN; vulvar intraepithelial neoplasia, VIN; vaginal intraepithelial neoplasia, VaIN; anal intraepithelial neoplasia, AIN; penile intraepithelial neoplasia PIN) and anogenital warts (AWs) and no national-level cervical cancer screening program. Aims — the aim of this study was to assess the proportion of patients with CIN, VIN, VaIN, AIN, PIN and AWs diagnosis in the clinical settings in Russia. Methods. This study was a non-interventional retrospective multi-center chart-review study in 28 investigational sites representing 21 Federal subjects of 6 Federal Districts of Russia. Medical charts of adult men and women visited gynecology, sexual health, dermatovenerology or urology services between 1 Jan 2000 — 31 Dec 2019 were reviewed. Data were abstracted, using a standardized approach, on patient demographic characteristics, presence or absence of pre-cancers and AWs diagnoses, method of diagnosing pre-cancer and HPV infection, and grade of neoplasia. Results. A total of 11 520 patients (1732 male and 9788 female) were included in the analysis. The overall proportion of patients with HPV-associated precancers and AWs was 10.8%. By service type, cases of HPV-associated conditions were revealed most often in dermatological departments (14.5%) and gynecological hospitals (13.8%). CIN detection rate in Russian clinical settings increased over the 20-years from 3.2 to 11.1% and was higher in gynecological in-patient departments compared to out-patient departments (12.5 and 5.2% respectively). The number of non-cervical precancers (VIN, VaIN, AIN, PIN) cases were very low (the detection rate was less than 1%). The frequency of HPV type 16 and 18 detection increased from 0.6 to 4.8%, and from 0.2 to 1.9%, respectively, for the 20-years period. Conclusions. Our study suggested high level of HPV-related pre-cancer and AW disease burden as well as presence of high-risk HPV types. Preventive strategy through effective national HPV immunization program would be beneficial to reduce HPV-related disease burden in Russia.

Contrast-enhanced transcranial Doppler for the detection of right-to-left shunt: A new provocation method with a syringe-modified Valsalva maneuver.

Contrast-enhanced transcranial Doppler (cTCD) study has been established as one of the most common investigations for detecting right-to-left shunt (RLS). Although the conventional Valsalva maneuver (c-VM) has been used to increase the sensitivity of cTCD for RLS, efforts are still needed to improve the detection rate further. We proposed a new provocation method with a syringe-modified Valsalva maneuver (sm-VM) during cTCD and compared the efficacy of this strategy with cTCD measured at resting and with the provocation of c-VM. Consecutive patients with suspicion of RLS who underwent cTCD in our institution between September 27, 2021, and April 1, 2022, were included in this study. Examination of cTCD was performed separately at the resting state and provoked with c-VM and sm-VM. The overall proportion of patients with RLS and their distribution with different RLS grades were compared. A total of 389 patients (mean age: 49.37 years, male: 52.2%) were included in this study. The positive rate for RLS was significantly higher for cTCD detected with sm-VM than those detected at resting state and with c-VM (46.8% vs. 21.6% and 34.2%, all p<.05). Besides, cTCD detected with sm-VM was also associated with a higher proportion of patients with grade III RLS than those detected at resting state and with c-VM (11.3% vs. 1.8% and 0%, all p<.05). Compared to cTCD detected at resting state and with c-VM, cTCD with sm-VM could further increase the positive detection rate of RLS.

Utilization of genetic and genomic data and correlation to outcomes of treatment with PARP inhibitors in advanced or metastatic castrate-resistant prostate cancer.

e17034 Background: Prostate cancer is the second-leading cause of cancer death in men in the United States, with aggressive forms associated with mutations in homologous recombination repair (HRRm) genes. PARP inhibitors (PARPi) (olaparib, rucaparib, niraparib, and talazoparib) are FDA approved for treatment of HRRm metastatic castration-resistant prostate cancer (mCRPC). Previous data have shown PARPi has the greatest benefit in patients with HRRm, but the responses in HRR genes other than BRCA1/2 and ATM are less robust based on available data. Methods: This retrospective study utilized the electronic health record to identify adult patients diagnosed with prostate cancer and treated at Avera Cancer Institute from 1/1/2018 to 12/31/2022 who received somatic (tumor and/or ctDNA) and/or germline genetic testing. Testing results were reviewed for pathogenic HRRm (BRCA1, BRCA2, ATM, ATR, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C) and treatment histories were reviewed to identify PARPi use. Data about PARPi received, duration, and biochemical response (decline in PSA during therapy) were collected. Results: 191 patients were included in the final analysis. Of these, 88 (46%) patients had germline only testing, 31 (16%) had somatic only testing, and 72 (38%) had both germline and somatic testing completed. 45 patients had HRRm of which 22 were somatic and 33 were germline. The average patient age at time of testing was 70 years. Thirteen of the patients in this cohort received treatment with a PARPi . Twelve of these patients received treatment with olaparib monotherapy, and one patient received olaparib in combination with abiraterone. Average progression free survival was 26 months (range 5-92 months) and the median PFS was 11 months. Four patients were biochemical non-responders, with an average PFS of 8 months, compared to 33 months for the 9 biochemical responders (p=0.04). Gene alterations present in non-responders included germline BRCA1 (n=1), germline CHEK2 (n=2), and somatic ATM (n=1). Germline alterations present in responders included BRCA2 (n=7) and PALB2 (n=2). In patients who received PARPi therapy, the average age of testing was 73 years. Conclusions: The patients found to have HRRm that were treated with a PARPi showed similar responses to previously described data in that the BRCA2 mutated group showed best response, followed by PALB2 mutated tumors. The overall proportion of patients with HRRm that were ultimately treated with PARPi was smaller than expected warranting further investigation. New FDA approvals of PARPi combined with next generation hormonal agents in the first line mCRPC setting are expected to increase utilization of PARPi. Additional outcomes data for individual HRR genes are needed to improve patient selection, outcomes, and reduce unnecessary toxicity due to PARPi therapy.

Risk prediction model for acute care use among patients with advanced cancer on clinical trials.

11074 Background: Reducing acute care use is an important strategy for improving value. Patients with advanced cancer are at high risk for unplanned Emergency Room visits (ER_visit) and hospital stays (HS). Identifying patients at highest risk could inform personalized risk-based intervention strategies and resource allocation. Methods: The data were from the SWOG Cancer Research Network. We linked data from trials in advanced cancer to Medicare claims data. The primary endpoint was the occurrence of any HS or ER_visit within 1 year after enrollment. Patients were required to have had continuous Medicare parts A and B claims from registration to 12 months after registration or death to detect all utilization outcomes. We examined sociodemographic (age, sex, race, ethnicity, insurance status), geographic (rural or urban, area-level deprivation), clinical (prognostic risk, performance status), treatment characteristics (line of therapy, therapy type), and individual comorbidity factors to establish a predictive risk model. Twenty-six factors were evaluated. A training/test approach was used. First, a 60% random sample training set of patients was generated. Best subset selection was used to identify candidate variables that minimized mean squared error using 5-fold cross validation repeated 10 times. Candidate variables were examined in multivariable logistic regression, with factors with p&lt;.05 retained. A risk model was built by summing adverse factors and creating high vs low- risk groups by splitting at the median and into quartiles. The derived model is reported. Results: Among N=1397 total patients from 6 trials (lung, 3; prostate, 2; pancreas, 1), 839 (60%) comprised the training set. In these, 32.9% were 75+ years, 21.3% were female, and 7.7% were Black. The overall proportion of patients with &gt;1 hospitalization/ER visit was 67.5%. In the training set, adverse risk factors were first line treatment (vs. subsequent), high (vs. low) prognostic risk, coronary artery disease (yes vs. no), hypertension (yes vs. no), and liver disease (yes vs. no). Patients with &gt;2 factors (high risk; n=487, 58.0%) vs. 0/1 risk factor (low risk; n=352, 42.0%), were more likely to experience hospitalization/ER visit (80.3% vs. 49.7%, p&lt;.001), corresponding to a &gt;4-fold increase in risk (OR=4.12, 95% CI, 3.03-5.59, p&lt;.001). Quartile-level proportions were 38.8%, 55.4%, 76.8%, and 84.0%, respectively, with an eightfold increased risk for those in the highest vs. lowest quartiles (Q4 vs. Q1, OR=8.25, 95% CI, 4.98-13.65, p&lt;.001). Validation of the derived risk model in an independent set of 558 patients (40%) is planned. Conclusions: A limited set of 5 comorbid conditions, clinical and treatment variables predicted a 4-fold increased risk of HS and ER_visits in cancer patients with advanced disease. Personalized targeted interventions aimed at preventing acute care use could decrease the cost and improve the quality of cancer care.

Inhaled corticosteroid treatment and pneumonia in patients with chronic obstructive pulmonary disease – nationwide development from 1998 to 2018

ABSTRACT Background A decreasing use of inhaled corticosteroids (ICS) in patients with a hospital-registered diagnosis of chronic obstructive pulmonary disease (COPD) has recently been documented in Denmark. ICS treatment is not recommended in patients with high pneumonia risk, and we aimed to assess the development of ICS treatment in relation to pneumonia occurrence. Methods Annual nationwide register-based cross-sectional studies from 1998 to 2018 including all patients ≥40 years of age with a hospital-registered ICD-10 diagnosis of COPD on the 31st of December each year. We calculated the annual proportion of patients with at least one outpatient pneumonia (redeemed prescription of relevant antibiotics) or pneumonia hospitalization (hospitalization or ER visit), and stratified by ICS dose (No ICS, low dose, medium dose, or high dose). Results The study population increased from 35,656 patients in 1998 to 99,057 patients in 2018. The annual proportion of patients experiencing a pneumonia decreased from 69.4% to 55.2%. The proportion of patients with at least one outpatient pneumonia, but no hospitalization, decreased (59.2% to 46.2%). The overall proportion of patients with at least one pneumonia hospitalization remained unchanged (10.2% to 9.0%), but this proportion increased in patients in high dose ICS (9.9% to 14.6%). The overall proportion of patients in high dose treatment decreased (12.7% to 5.7%), but not in patients with pneumonia hospitalization (16.5% to 15.1). Conclusions Our study demonstrates a nationwide decrease from 1998 to 2018 in the proportion of patients who redeemed a prescription for antibiotics used mainly for respiratory tract infections, which may reflect a decrease in the number of outpatient pneumonias. This decrease was largely caused by an increase in the number of patients without pneumonia. No differences over time were seen regarding hospitalization-requiring pneumonia. High dose ICS treatment was unchanged in patients with hospitalization-requiring pneumonia.

E066 Baseline characteristics of patients initiating ixekizumab, secukinumab or a tumour necrosis factor inhibitor by country in the 24-month Prospective Psoriatic Arthritis Observational Study of Persistence of Treatment - PRO-SPIRIT

Abstract Background/Aims The Psoriatic Arthritis Observational Study of Persistence of Treatment (PRO-SPIRIT) is the first large-sample, multinational, prospective, observational study to provide real-world evidence for ixekizumab (IXE) in patients with psoriatic arthritis (PsA) who start a new biologic/targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD), with a primary end point of persistence at 24 months. Aims: To describe baseline characteristics of PRO-SPIRIT patients initiating or switching to IXE, secukinumab (SEC) or a tumour necrosis factor inhibitor (TNFi) in Canada (CA), France (FR), Germany (DE), Italy (IT), Spain (ES) and the United Kingdom (UK). Methods PRO-SPIRIT enrolled adults diagnosed with PsA (≥6 months) between December 2019 and June 2022 to be initiated or switched to a new b/tsDMARD, locally approved for the management of PsA. Baseline characteristics, including patient demographics, therapy and disease activity measures, are described here by country for patients initiating IXE, SEC (both IL-17A inhibitors) or a TNFi (adalimumab, etanercept, infliximab or biosimilar) only. Results This analysis included 943 patients (Table 1). The overall proportion of patients with BMI ≥30 mg/kg2 was highest in CA (67.2%) and lowest in IT (24.5%); across countries, higher proportions of patients initiating an IL-17A vs a TNFi had BMI ≥30 mg/kg2 (except IXE groups in IT, ES and UK). Higher proportions of patients initiating an IL-17A vs a TNFi were diagnosed with PsA ≥3 years before baseline (except SEC groups in DE and ES). The highest proportions of b/tsDMARD-naïve patients were observed in the TNFi groups in all countries (range 46.2% [CA] to 81.9% [UK]). Patients in the IL-17A groups were more likely to be on monotherapy than patients in the TNFi groups (except in FR). There were no clear trends in baseline disease activity for patients initiating IL-17As or TNFis, although country-specific differences were observed. Conclusion The PRO-SPIRIT baseline characteristics described offer important insights into country-specific patient demographics and treatment patterns when initiating or switching to a new b/tsDMARD in a real-world setting. Between-country variations observed in PRO-SPIRIT baseline characteristics may be due to differences in healthcare systems and/or the evolution of treatment options for patients with PsA in each country. Disclosure N. Gullick: Consultancies; AbbVie,Novartis, UCB. Honoraria; AbbVie, Eli Lilly, Janssen, Novartis, UCB. Grants/research support; AbbVie, Astra Zeneca, Eli Lilly, Novartis. M. Sheesh: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. C. Laedermann: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. M. Ngantcha: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. B. Gittens: Corporate appointments; Eli Lilly and Company. K. Ng: Corporate appointments; Eli Lilly and Company. Shareholder/stock ownership; Eli Lilly and Company. W. Tillett: Consultancies; Abbvie, Amgen, Eli Lilly and Company, GSK, Janssen, Novartis, Ono Pharma, Pfizer, UCB. Member of speakers’ bureau; AbbVie, Amgen, Eli Lilly and Company, GSK, Janssen, Novartis, Pfizer, UCB. Grants/research support; Janssen, UCB, Pfizer, Eli Lilly and Company. J. Morel: Consultancies; Pfizer, AbbVie, Boerhinger Ingelheim, Galapagos, GSK. Member of speakers’ bureau; Biogen, Amgen, Bristol Myers Squib, Eli Lilly and Company, Novartis, Sanofi, MSD, Mylan, Fresenius Kabi, Roche, Union Chimique Belge, Janssen, Medac, Nordic Pharma. Grants/research support; Fresenius Kabi. E. Lubrano: Member of speakers’ bureau; Abbvie, Janssen Cilag, Lilly, UCB, Pfizer, Novartis. R. Alten: Consultancies; AbbVie, BMS, Celltrion, Galapagos, Eli Lilly and Company, Novartis, Pfizer, Roche, UC. Member of speakers’ bureau; AbbVie, BMS, Celltrion, Galapagos, Eli Lilly and Company, Novartis, Pfizer, Roche, UCB. L. Kristensen: Consultancies; Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. Member of speakers’ bureau; Pfizer, AbbVie, Amgen, UCB, Gilead, Biogen, BMS, MSD, Novartis, Eli Lilly and Company, Janssen. Grants/research support; Pfizer, Abb- Vie, UCB, Gilead, Biogen, Novartis, Eli Lilly and Company, Janssen. V. Chandran: Consultancies; AbbVie, Eli Lilly, Novartis, Amgen, Janssen. Grants/research support; AbbVie. A. Martinez-Ferrer: Grants/research support; Eli Lilly and Company. B. Kirkham: Consultancies; Abbvie, Eli Lilly and Company, Galapagos, Novartis. Member of speakers’ bureau; Abbvie, Eli Lilly and Company, Galapagos, Janssen, Novartis, Pfizer, UCB. Grants/research support; Eli Lilly and Company, Novartis.

Nonsteroidal anti-inflammatory drug “allergy” labeling is associated with increased postpartum opioid utilization

Current guidelines recommend a stepwise approach to postpartum pain management, beginning with acetaminophen and nonsteroidal anti-inflammatory drugs (NSAIDs), with opioids added only if needed. Report of a prior NSAID-induced adverse drug reaction (ADR) may preclude use of first-line analgesics, despite evidence that many patients with this allergy label may safely tolerate NSAIDs. We assessed the association between reported NSAID ADRs and postpartum opioid utilization. We performed a retrospective cohort study of birthing people who delivered within an integrated health system (January 1, 2017, to December 31, 2020). Study outcomes were postpartum inpatient opioid administrations and opioid prescriptions at discharge. Statistical analysis was performed on a propensity score-matched sample, which was generated with the goal of matching to the covariate distributions from individuals with NSAID ADRs. Of 38,927 eligible participants, there were 883 (2.3%) with an NSAID ADR. Among individuals with reported NSAID ADRs, 49.5% received inpatient opioids in the postpartum period, compared to 34.5% of those with no NSAID ADRs (difference= 15.0%, 95% confidence interval 11.4-18.6%). For patients who received postpartum inpatient opioids, those with NSAID ADRs received a higher total cumulative dose between delivery and hospital discharge (median 30.0 vs 22.5 morphine milligram equivalents [MME] for vaginal deliveries; median 104.4 vs 75.0 MME for cesarean deliveries). The overall proportion of patients receiving an opioid prescription at the time of hospital discharge was higher for patients with NSAID ADRs compared to patients with no NSAID ADRs (39.3% vs 27.2%; difference= 12.1%, 95% confidence interval 8.6-15.6%). Patients with reported NSAID ADRs had higher postpartum inpatient opioid utilization and more frequently received opioid prescriptions at hospital discharge compared tothose without NSAID ADRs, regardless of mode of delivery.

Treatment Outcomes for Adults with Mixed Phenotypic Acute Leukemia: A Large Single-Center Retrospective Study

Introduction: Mixed phenotype acute leukemia (MPAL) is a rare subtype of acute leukemia characterized by differentiation along more than one lineage. In the absence of eosinophilia and/or stereotypical tyrosine kinase gene fusions, there is no established optimal therapy for adults with MPAL. Typical treatments include acute myeloid leukemia (AML)-type, acute lymphoblastic leukemia (ALL)-type or hybrid-type therapy approaches. We conducted a retrospective comparison of different induction chemotherapy strategies at our institution to help clarify the optimal initial chemotherapy for patients with MPAL. Methods: Patients evaluated at the University of Washington/Fred Hutchinson Cancer Center diagnosed with MPAL from 1/2005 to 9/2022 were identified through our IRB-approved institutional repository. MPAL diagnosis was confirmed by independent pathology review (AE and XC). Lineage assignment used the 2022 World Health Organization criteria based on initial diagnostic immunophenotype or genetic features. Treatment was classified as either AML-type (anthracycline + cytarabine with or without purine analogs, e.g. 7+3, CLAG-M or FLAG-IDA), ALL-type (anthracycline + cyclophosphamide + steroid + vincristine, e.g. hyperCVAD, or CALGB 10403) or hybrid-type regimens (most often CLAG-M + vincristine + dexamethasone). Log-rank survival and Cox proportional hazards were used to compare survival. Results: We identified a total of 49 patients with MPAL who received induction chemotherapy at our institution. These included 14 patients (28.6%) treated with ALL-type therapies, 9 patients (18.4%) treated with AML-type therapies and 26 patients (53.1%) treated with hybrid-type therapies. The proportions of B/myeloid, T/myeloid and rare B/T phenotypes were similar among the 3 treatment groups, though patients treated with ALL-type regimens were significantly younger (Table 1). The overall proportion of patients who achieved complete remission (CR) was high (67%) with a non-statistically significant trend for non-AML-type treatments (ALL-type = 10/14, 71.4%; AML-type = 5/9, 55.6%; hybrid-type = 21/26, 80.8%; p = 0.22). Overall, patients had similar survival regardless of induction therapy type with 43.8% of patients treated with ALL-type therapy, 50.0% of patients treated with AML-type therapy, and 39.0% of patients treated with hybrid-type therapy alive 48 months post-induction treatment (p=0.68) (Figure 1). Compared to patients treated with ALL-type therapy, the Cox proportional hazard for death among patients treated with AML-type therapy was 1.5 (95% CI 0.4 - 5.3, p = 0.5) and for those who received hybrid-type therapy was 1.5 (95% CI 0.6 - 39, p = 0.4). Among 36 patients who achieved complete response after induction chemotherapy, there was a trend toward longer survival among patients who were found to be measurable residual disease (MRD) negative by flow cytometry compared to MRD+ with 63.1% in the MRD- group alive at 48 months compared to 33.3% in the MRD+ group (p = 0.07). Compared to the MRD- group, the MRD+ Cox proportion hazard ratio for survival was 2.6 (95% CI 0.9 - 7.9, p = 0.07). The proportion of patients subsequently transplanted was similar in each treatment group (28 patients total; Table 1). Patients who received HSCT lived longer. In a landmark analysis of patients who survived a minimum of 100 days following initiation of induction therapy, 57.8% of HSCT recipients were still alive at 48 months compared to 20.2% of patients who did not undergo HSCT (p = 0.001). Compared to patients who did not receive a HSCT, the Cox proportion hazard ratio for survival for those receiving HSCT was 0.25 (95% CI 0.1 - 0.61, p &amp;lt; 0.003). Conclusion: Although our data showed a non-statistically significant trend toward a higher CR rate with ALL-type regimens for patients with MPAL regardless of immunophenotype, it failed to show a survival benefit at 48 months based on choice of ALL-, AML- or hybrid-type induction regimens. Despite being one of the largest cohorts reported of patients with MPAL, this study was limited by sample size and its retrospective nature. Clinical trials are needed to better determine optimal induction regimens. A survival benefit was seen for patients receiving HSCT consolidation; therefore, HSCT should be encouraged for all eligible patients with MPAL.

Low Socioeconomic Status Confers Poorer Real-World Overall Survival for Patients with Acute Myeloid Leukemia Treated in the Modern Era

Introduction: There has been considerable growth in the treatment armamentarium of acute myeloid leukemia (AML) in the last decade. However, there is a lack of recent real-world evidence examining trends in survival amidst this rapidly changing treatment landscape. Further, prior literature has demonstrated significant heterogeneity in outcomes across different demographic groups, with scant data to understand how newer therapies have impacted survival outcomes across demographic groups in a real-world setting. The objective of this study is to describe recent trends in overall survival (rwOS) among patients with AML and to examine associations between race, ethnicity, and socioeconomic status (SES) with rwOS over time. Methods: We conducted a retrospective cohort study with data from the nationwide Flatiron health (FH) electronic health record-derived de-identified database, which is comprised of predominantly community oncology-based sites. We included patients with ≥2 visits in the FH network with a confirmed diagnosis of AML between Jan 1, 2014 and Dec 31, 2022, with potential follow-up through May 31, 2023. Our exposures included year of diagnosis in 3-year periods (2014-2016, 2017-2019, 2020-2022), race, ethnicity, and area-level SES, as measured using the Yost Index at census block group level. Patient characteristics and treatment patterns were described overall and by time periods of AML diagnosis. The Kaplan-Meier method was used to estimate median rwOS and 95% confidence intervals (CIs) from the time of initial AML diagnosis; overall and stratified by time period of AML diagnosis. Cox proportional hazards models were used to estimate unadjusted and minimally-adjusted (for age and sex) hazard ratios (HR) and 95% CIs for associations between race, ethnicity, and SES (modeled separately) with rwOS overall and by year of AML diagnosis.. Results: A total of 10,062 patients were included in the analysis. The median (IQR) age at diagnosis was 70 years (58, 78) and 57% of patients were male. Three-fourths of the study population was White, and 70% of the cohort received care at the community oncology clinic. We identified more patients ≥75 years at diagnosis in 2020-2022 versus 2014-2016 (38% vs 31%) and an overall decrease in patients who underwent hematopoietic stem cell transplant (15% vs 21%). Although the overall proportion of patients receiving any first-line treatment was similar across time periods, fewer patients received induction chemotherapy-based regimens (29%) compared to less intensive therapies (e.g., venetoclax + hypomethylating agent; 34%) in later years. There were 6,132 deaths and an overall median rwOS was 14.2 months (95% CI 13.7-14.7). Age and sex-adjusted Cox models indicated no evidence of decreased risk of death for diagnoses in 2020-2022 (HR 0.98, 95% CI 0.92-1.05) or 2017-2019 (HR 0.95, 95% CI 0.90, 1.02) compared to diagnoses in 2014-2016. Adjusted Cox models showed no statistically significant associations between race or ethnicity with survival overall and across strata of AML diagnosis time periods. Consistent associations between the lowest SES and increased risk of overall mortality among patients with AML were observed across all time periods. Patients residing in areas in the lowest quintile of SES had increased risks of death across all three time periods (2014-2016: HR 1.18, 95% CI 1.00-1.38; 2017-2019: HR 1.28, 95% CI 1.09-1.50; 2020-2022: HR 1.21, 95% CI 1.02-1.43). Conclusion: Results of this real-world study indicate that persons with AML who are in the lowest SES group are associated with increased mortality risk, and this association persists across recent time periods. Race and ethnicity were not associated with survival in this study, although sample size was limited for some groups. Despite introduction of new therapeutic options and an increased utilization of less intensive therapies, we did not observe an increase in the overall proportion of patients with AML receiving first-line treatment. Additionally, we observed no improvement in survival outcomes across these time periods in a predominantly community-based setting. Our study adds to the growing evidence on the complex health inequities in AML and supports the persistent need for tolerable and accessible therapy to improve OS in AML. Future strategies and policies are urgently needed to offset the adverse effects of low SES to further improve outcomes for all patients with AML.

Brentuximab Vedotin Plus Bendamustine in Patients with Relapsed or Refractory Classical Hodgkin Lymphoma: A Meta-Analysis

Introduction The prognosis for relapsed or refractory Classical Hodgkin Lymphoma (R/R cHL) remains poor, necessitating the development of advanced therapeutic strategies. Brentuximab Vedotin (Bv), a CD30-targeting antibody-drug conjugate, and Bendamustine (B), an alkylating agent, show potential for R/R cHL treatment, yet their individual efficacies have proven only moderate. The putative synergy of the BvB combination on R/R cHL remains largely uncharted, due to restricted sample sizes of existing studies. To address this gap, this meta-analysis is designed to assess response rates and survival outcomes in 527 R/R cHL patients who received the BvB combination as a salvage regimen to enable a curative stem cell transplant. Methods This meta-analysis included patient-level data on adult and pediatric patients with R/R cHL. Individual patient data (IPD) for time-to-event analysis were obtained using the IPDfromKM method. This statistical approach involves reconstructing IPD from the pooled Kaplan-Meier survival curves, allowing for a more comprehensive analysis of patient survival outcomes, including overall survival (OS) and progression-free survival (PFS). Parallel meta-analyses of aggregated data were conducted to determine the overall proportion of patients achieving complete response (CR) and partial response (PR) rates. All statistical analyses were performed using STATA software, version 17. A comprehensive search of clinical trials and real-world data (RWD) was conducted in PubMed and Scopus, including published data until May 2023. Results Four clinical trials and 10 observational studies of real-world clinical data were included in this meta-analysis with a total of 527 R/R cHL patients who received the BvB combination therapy. The overall CR and PR rates were 67% (95% CI [63% - 71%]) and 14% (95% CI [11% - 17%]), respectively. The results of CR and PR did not differ significantly between clinical trials and the RWD. BvB response rate was dependent on frontline disease status. The CR rate was higher in relapsed patients (86%, 95% CI [79% - 92%]) than in primary refractory patients (57%, 95% CI [49% - 66%]). After a median of follow-up of 22 months (12 - 42), the OS was 85.4% (95% CI [81.3% - 88.6%]) at 1 year and 77.1% (95% CI [72.35 - 81.1%]) at 3 years. The PFS at 1- and 3-years was 68.0% (95 % CI [63.5% - 72.4%]) and 53.2% (95% CI [48.1% - 58.0%]), respectively. Among relapsed patients, the 3-year PFS rate was higher at 48.9% (95% CI [33.7% - 62.4%]) compared to primary refractory patients at 29.8% (95% CI [18.6% - 41.8%]); however, the difference did not reach statistical significance (hazard ratio [HR] = 1.59, 95% CI [0.95 - 2.65], p=0.07). Patients ineligible for ASCT had significantly lower 1-year PFS (41.3% [95% CI: 27.1%-55.4%]) and OS (47.6% [95% CI: 25.7% - 66.7%]) compared to those who underwent ASCT after BvB (PFS: 80.2% [95% CI: 69.2%-87.6%]; OS: 93.8% [95% CI: 84.3% - 97.6%]). Interestingly, the OS was significantly lower in the clinical trials data compared to the RWD (HR= 0.63, 95% CI [0.41 - 0.97], p=0.03). Conclusions The BvB regimen demonstrates a notably high clinical response rate and favorable survival outcomes, emphasizing its potential as a valuable rescue therapy, enabling curative stem cell transplantation in patients with R/R cHL.

Ventriculostomy-Related Infections: Reduced Incidence by Terminating Cerebrospinal Fluid Screening

The external ventricular drain (EVD) is an important instrument in managing patients in neurointensive care (NICU). A frequent and sometimes severe complication is ventriculostomy-related infection (VRI). This study aimed to evaluate the effects of biweekly VRI screening by CSF sampling on the clinical course and rate of VRI. Patients with implanted EVDs were retrospectively identified and a cohort screened twice per week was compared with a cohort sampled only on clinical indication. VRI was defined either as a suspected case or a culture-confirmed case. Length of stay in the NICU and CSF shunt dependency were used as outcome parameters. A total of 562 patients were included. The overall proportion of patients treated for VRI was 22% and was not affected by screening (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.57-1.54). Screening was associated with a higher proportion of patients with culture-confirmed VRI (OR, 2.86; 95% CI, 1.36-6.73). The main risk factor for VRI was the number of days with EVD. Positive bacterial culture was associated with both a longer time in the NICU (β= 3.6; P < 0.01) and higher risk for shunt surgery (OR, 1.95; 95% CI, 1.04-3.64). Screening was associated with a higher number of culture-confirmed VRI cases. In addition, screening did not detect VRI at an earlier stage and was not associated with a reduction in the rate of permanent hydrocephalus. No clinical benefit of screening was found. Frequent CSF sampling might contribute to infection. Based on these findings, CSF screening for VRI cannot be recommended.

IRON NOF trial: IV iron for anaemic patients with femoral fracture

BackgroundPreoperative anaemia is associated with increased use of blood transfusions, a greater risk of postoperative complications, and patient morbidity. The IRON NOF trial aimed to investigate whether the administration of i.v. iron in anaemic patients during hip fracture surgery reduced the need for blood transfusion and improved patient outcomes. MethodsThis phase III double-blind, randomised, placebo-controlled trial included patients >60 yr old with preoperative anaemia undergoing surgery for femoral neck or subtrochanteric fracture across seven Australian Hospitals. Patients were randomly allocated on a 1:1 basis to receive either i.v. iron carboxymaltose 1000 mg or placebo (saline) at operation. The primary endpoint was blood transfusion use, with secondary endpoints of haemoglobin concentration at 6 weeks, length of hospital stay, rehabilitation duration to discharge, and 6-month mortality. Subgroup analysis compared outcomes in patients <80 yr old and patients >80 yr old. All analyses were performed by intention-to-treat. This trial was terminated early because of jurisdictional changes of more restrictive transfusion practices and changes in consent requirements. ResultsParticipants (n=143) were recruited between February 2013 and May 2017. There was no difference observed in the incidence of blood transfusion between the treatment group (18/70) (26%) compared with the placebo group (27/73) (37%) (odds ratio for transfusion if receiving placebo: 1.70; 95% confidence interval [CI] 0.83–3.47; P=0.15) and there was no overall difference in the median number of blood units transfused between groups (odds ratio 1.52; 95% CI 0.77–3.00; P=0.22). Patients receiving i.v. iron had a higher haemoglobin 6 weeks after intervention compared with the placebo group (Hb 116 g L−1vs 108 g L−1; P=0.01). No difference was observed in length of hospital stay, rehabilitation duration to discharge, or 6-month mortality. However, in younger patients without major bleeding, the use of placebo compared with i.v. iron was associated with an increased number of units of blood transfused (placebo transfusion incidence rate ratio 3.88; 95% CI 1.16–13.0; P=0.03). ConclusionsIn anaemic patients undergoing surgery for hip fracture, i.v. iron did not reduce the overall proportion of patients receiving blood transfusion. The use of i.v. iron may reduce the amount of blood transfused in younger patients. The use of i.v. iron is associated with increased haemoglobin concentrations 6 weeks after the operation. Clinical trial registrationACTRN12612000448842.

Evaluating rates of chiropractic use and utilization by patient sex within the United States Veterans Health Administration: a serial cross-sectional analysis

BackgroundWithin the United States Veterans Health Administration (VHA), the number of patients using healthcare services has increased over the past several decades. Females make up a small proportion of overall patients within the VHA; however, this proportion is growing rapidly. Previous studies have described rates of VHA chiropractic use; however, no prior study assessed differences in use or utilization rates between male and female veterans. The purpose of this study was to assess rates of use and utilization of chiropractic care by sex among VHA patients receiving care at VHA facilities with on-station chiropractic clinics.MethodsA serial cross-sectional analysis of VHA national electronic health record data was conducted in Fall 2021 for fiscal year (FY) 2005–2021. The cohort population was defined as VHA facilities with on-station chiropractic clinics, and facilities were admitted to the cohort after the first FY with a minimum of 500 on-station chiropractic visits. Variables extracted included counts of unique users of any VHA on-station facility outpatient services, unique users of VHA on-station facility chiropractic services, number of chiropractic visits, and sex. To calculate use, we determined the proportion of patients of each sex who received chiropractic services to the total patients of the same sex receiving any outpatient care within each facility. To calculate utilization, we determined the number of chiropractic care visits per patient per fiscal year. A linear mixed effects model was applied to examine the difference in chiropractic care utilization by sex.ResultsThe percentage of female VHA on-station chiropractic patients increased from 11.7 to 17.7% from FY2005–FY2021. Among VHA facilities with on-station chiropractic care, the percentage of female VHA healthcare users who used chiropractic care (mean = 2.3%) was greater than the percentage of male VHA healthcare users who used chiropractic care (mean = 1.1%). Rates of chiropractic utilization by sex among VHA facilities with on-station chiropractic clinics were slightly higher for females (median = 4.3 visits per year, mean = 4.9) compared to males (median = 4.1 visits per year, mean = 4.6).ConclusionWe report higher use and utilization of VHA chiropractic care by females compared with males, yet for both sexes rates were lower than in the private US healthcare system. This highlights the need for further assessment of the determinants and outcomes of VHA chiropractic care.