Greater Percentage Of Patients Research Articles

Prostate-specific antigen (PSA) response among patients with metastatic castration-sensitive prostate cancer (mCSPC) initiated on apalutamide (APA) or abiraterone acetate (ABI) in real-world urology practices.

53 Background: Recently approved oral therapies APA and ABI (plus prednisone) are effective mCSPC treatments. Prior real-world evidence showed that, relative to ABI, patients who initiated APA had significantly higher rates of PSA decline ≥90% (PSA90), which has been associated with longer overall survival. The objective of this study was to compare PSA90 response among an enhanced cohort of patients with mCSPC initiated on APA or ABI. Methods: Electronic medical records from PPS Analytics including data from US community urology practices were linked with administrative claims from the Komodo Health Solutions Research Database. Androgen receptor signaling inhibitor (ARSI)-naïve patients with mCSPC with ≥12 months of pre-index clinical activity were selected into the APA or ABI cohort based on their first paid claim/dispensation on or after 17 Sep 2019 (index date). Patients were followed to earliest of index ARSI discontinuation or switch, radiopharmaceutical use, end of insurance or clinical activity, or end of data availability (30 Sep 2022). Inverse probability treatment weighting (IPTW) was used to reduce potential pre-index confounding, controlling for age, race, region, insurance payer, index year, time from metastasis to index date, time from first prostate cancer (PC) diagnosis to index date, metastasis locations, de novo PC, use of androgen deprivation therapy, first-generation antiandrogens or chemotherapy, most recent PSA and testosterone levels, and most recent Gleason score. PSA90 was defined as the earliest attainment of ≥90% decline in PSA relative to pre-index (most recent value within 13 weeks). The proportion of patients achieving PSA90 was compared using a weighted Kaplan-Meier analysis and the time-to-PSA90 response was compared using a weighted Cox proportional hazards model. Results: A total of 917 APA and 632 ABI patients were identified. Patient characteristics were balanced with IPTW (Table). By 6 months post-index, 80.9% of APA and 72.8% of ABI patients had a PSA measurement. By 6 months, significantly more APA patients attained a PSA90 response, as compared to ABI patients (P < 0.001; Table). Median time-to-PSA90 was 3.5 months for APA patients and 8.8 months for ABI patients. Conclusions: This real-world study supports previous findings that a greater percentage of patients with mCSPC in the US initiating APA achieved deep PSA response compared to those initiating ABI. [Table: see text]

Real-world comparison of prostate-specific antigen (PSA) response in patients with metastatic castration-sensitive prostate cancer (mCSPC) treated with apalutamide (APA) or enzalutamide (ENZ).

51 Background: APA and ENZ, two androgen receptor synthesis inhibitors (ARSIs), used in combination with androgen deprivation therapy (ADT) are among the recommended treatments for patients with mCSPC. Deep PSA response, evaluated as ≥90% PSA decline (PSA90), is an important outcome after ARSI initiation, with early, deep response associated with longer survival. The primary objective of this study was to compare PSA90 response in ARSI-naïve patients with mCSPC by 6 months after initiating APA or ENZ in real-world clinical practice. Methods: Linked electronic medical record (EMR) data of US community urology practices in the from PPS Analytics and administrative health data from Komodo Health Solutions Research Database were evaluated. Patients with mCSPC were selected into two cohorts, based on the index date, defined as the first paid pharmacy claim or in-office dispensation for APA or ENZ on or after 16 Dec 2019. Patients were required to have ≥12 months of pre-index EMR clinical activity. Pre-index characteristics (i.e., age, race, geographic region, payer type, index year, time from metastasis, time from first prostate cancer [PC] diagnosis, de novo PC, ADT use, first-generation antiandrogen use, chemotherapy use, metastasis locations, most recent PSA level, testosterone level, and Gleason score) were balanced between cohorts with inverse-probability treatment weighting (IPTW). Patients were followed from index date until the earliest of index ARSI discontinuation or switch, radiopharmaceutical initiation, end of open administrative claim or EMR clinical activity, or end of data availability (30 Sep 2022). PSA90 was defined as the earliest ≥90% decline in PSA relative to most recent pre-index PSA. The proportion of patients achieving PSA90 was compared using a weighted Kaplan-Meier analysis and the time-to-PSA90 response was compared using a weighted Cox proportional hazards model. Results: In total 860 APA and 869 ENZ patients were identified. Patient pre-index characteristics were balanced with IPTW (Table). By 6 months post-index, 80.3% of APA and 75.0% of ENZ patients had ≥1 PSA test result. By 6 months, significantly more APA patients attained a PSA90 response, as compared to ENZ patients (p=0.005; Table). The median time to PSA90 response was 3.5 months for APA and 4.9 months for ENZ. Conclusions: This US real-world study of patients with mCSPC demonstrated that treatment with APA produces a deep, early PSA response by 6 months in a greater percentage of patients than treatment with ENZ. [Table: see text]

Endovenous laser treatment vs conventional surgery for great saphenous vein varicosities: A propensity score matching analysis.

Varicosis is a common venous condition, which is typically treated surgically. However, selection of the optimal surgical approach can be challenging. Previous studies comparing endovenous laser treatment (EVLT) and conventional surgery were retrospective and observational in nature and the results may therefore have been influenced by selection bias and the presence of other confounding factors. In this study, we used propensity score matching to reduce selection bias when comparing EVLT and conventional surgery for the treatment of varicose great saphenous veins. To compare the perioperative and postoperative outcomes of EVLT and conventional surgery in patients with great saphenous vein varicosis. We retrospectively reviewed the records of 1063 patients treated for primary varicosis of the great saphenous vein at the Second Affiliated Hospital of Xuzhou Medical University between January 2009 and December 2019. Among them, 56 patients were excluded owing to additional small saphenous varicose vein involvement, 81 owing to recurring varicose veins, 83 owing to complicated varicose veins (CEAP clinical classification C5-C6), and 6 owing to perioperative phlebitis. Finally, 772 patients were enrolled in this study. Standard demographic and clinicopathological data were collected from the medical records of the patients. For propensity score matching, 522 patients (261 who underwent EVLT and 261 who underwent conventional surgery) were randomly matched 1:1 by age, sex, onset time, smoking status, presence of diabetes, family history, stress therapy, C class, and the affected leg. Of the 772 patients included in the study, 467 underwent EVLT and 305 underwent conventional surgery. There were significant differences in age, onset time, smoking and diabetes status, and family history between the two groups. Following propensity score matching, no significant differences in patients' characteristics remained between the two groups. ELVT was associated with a shorter operation time and hospital stay than conventional surgery, both before and after propensity score matching. There were no differences in complications between the two groups after propensity score matching. Patients who underwent EVLT had a higher recurrence rate during the two-year follow-up period than those who underwent conventional surgery (33.33% vs 21.46%, χ2 = 11.506, P = 0.001), and a greater percentage of patients who underwent EVLT experienced pain one week after the procedure (39.85% vs 19.54%, P = 0.000). EVLT may not always be the best option for the treatment of great saphenous vein varicosis.

Higher prevalence of benign tumors in men with testicular tumors and history of treated cryptorchidism

ObjectivesTo identify if surgically treated cryptorchidism correlated with testicular tumor pathology at presentation. Materials and methodsAn institutional database of patients treated for testicular cancer between 2003 and 2020 was reviewed. Inclusion criteria included orchiectomy patients. Exclusion criteria included unknown cryptorchidism history or pathology or laterality of orchiectomy. Data collection included demographics, surgical history, and tumor marker status. ResultsA total of 435 patients were included. Thirty-three of these patients had a history of UDT. There was no statistical difference in age at orchiectomy, laterality of orchiectomy, or lymphovascular invasion with regard to UDT history. There was a statistical difference in tumor pathology after orchiectomy, P = 0.03. On secondary analysis, benign pathology was significantly more common in patients with a history of UDT (15.2%) than without (4.7%), P = 0.01. Mixed GCT was also found at a significantly lower rate in patients with a history of UDT (18.2%) compared to those with no history of UDT (37.3%), P = 0.03. There were no statistically significant differences in other pathology. ConclusionPrevious studies have shown that there is a greater rate of seminoma in patients with testicular cancer in an undescended testis. This study shows that in patients with a history of UDT compared to those without a history of UDT, there is a greater percentage of patients with benign testicular masses after orchiectomy. Guideline based practices including monthly self-examination and testis-sparing surgery for appropriate patients may reduce rates of radical orchiectomy for benign tumors.

No Increased Risk of Cerebrovascular Accident With Beach-Chair Versus Lateral Positioning for Shoulder Arthroscopy

To assess the incidence of adverse cerebrovascular events following shoulder arthroscopy in the beach-chair position when compared with the lateral position. Records of 5 shoulder surgeons were searched using Current Procedural Technology codes to identify patients who underwent arthroscopic shoulder surgery in both the beach-chair and lateral positions between 2015 and 2020. Using both Current Procedural Technology codes for cerebrovascular accident (CVA) imaging as well as the International Classification of Diseases, Tenth Revision, codes for CVA and late neurologic sequela, patient charts were analyzed in the 30-day postoperative period. The anesthesiology record also was queried for data regarding the blood pressure management intraoperatively, recording mean arterial pressures (MAPs), and vasopressor administration. Patient demographics, comorbidities, and complications were compared between the 2 cohorts using the Student 2-tailed t-test for continuous variables and χ2 analysis for categorical variables. Significance was set at P < .05. There were 711 patients included in the analysis, with 471 in the beach-chair cohort and 240 in the lateral cohort. Baseline demographics were similar between groups, except for age and American Society of Anesthesiologists physical status classification, with the lateral group being significantly younger (P < .001) and lower American Society of Anesthesiologists physical status classification (P= .001) than the beach-chair group. Mean body mass index, history of CVA, transient ischemic attack, hypertension, and peripheral vascular disease were not significantly different. There were no documented CVAs in either cohort. There was no significant difference in the number of postoperative radiologic scans to evaluate for CVA (P= .77) or neurologic sequelae (P= .48) between groups. The beach-chair cohort had fewer instances of MAP <65 mm Hg, greater mean minimum MAP, but a greater percentage of patients who received blood pressure support. There were no significant differences identified in the incidence of CVA between patients undergoing arthroscopic shoulder surgery in the beach-chair and lateral positions. Level III, retrospective cohort study.

Access to Medications for Opioid Use Disorder During COVID-19: Retrospective Study of Commercially Insured Patients from 2019–2022

This study assesses disparities in medications for opioid use disorder in adults with opioid use disorder and examines the associations between state-level COVID-19 lockdown and telehealth policies and medications for opioid use disorder utilization rates during the COVID-19 pandemic. This retrospective cohort study of 396,872 adults with opioid use disorder analyzed monthly medications for opioid use disorder utilization rates between January 2019 and June 2022 using data from Clinformatics Data Mart Database. Primary outcome measure was monthly medications for opioid use disorder utilization rates. Variables of interest were patients' demographics and state-level characteristics (telehealth policies for controlled substance prescribing, COVID-19 lockdown policy, and registered buprenorphine providers/100,000). In multivariable analyses, time trend was grouped into four time periods: before COVID-19, early COVID-19, early vaccine, and Omicron-related COVID-19 surge and thereafter. Medications for opioid use disorder rates increased from a 1.2% change in slope monthly on a log scale to 2% monthly from February 2021 to October 2021, after which the utilization rate increased to a lesser degree. Women had 28% lower odds of receiving medications for opioid use disorder than men; Hispanic, Black, and Asian patients had 40%, 34%, and 32% lower odds of receiving medications for opioid use disorder than White patients, respectively. These sex and racial disparities persisted throughout the pandemic. Regional medications for opioid use disorder rate differences, mediated by buprenorphine providers/100,000 state population, decreased during the pandemic. States with telehealth policies for controlled substance prescribing had greater percentages of patients on medications for opioid use disorder (11.7%) than states without such policies (10.4%). Monthly medications for opioid use disorder rates increased during the pandemic, with higher rates in men, White individuals, and residents of the Northeast region. States with policies permitting telehealth prescribing of controlled substances also had higher medications for opioid use disorder rates, supporting a future expansion of medications for opioid use disorder-related telehealth to improve access to care.

A comparison of general anesthesia versus monitored anesthesia care during catheter ablation for ventricular tachycardia

Abstract Background Catheter ablation of ventricular tachycardia (VT) may be performed under general anesthesia (GA) or monitored anesthesia care (MAC). There is a paucity of data studying these two sedation strategies with respect to intraprocedural characteristics, and outcomes of VT ablation. Purpose The purpose of this study was to assess the effects of anesthesia techniques on VT inducibility and outcomes. Methods A single-center, retrospective study of patients undergoing catheter ablation for scar-related VT, from 2016-2022, was conducted. Data collected included demographics, comorbidities, medications, relevant laboratory abnormalities, electrocardiograms, echocardiograms, detailed procedural characteristics, and outcomes. Results One hundred sixty-eight patients who underwent a total of 200 VT ablation procedures were included. The patients undergoing GA had a greater burden of comorbidities including congestive heart failure (77.2% vs. 60.9%), hypertension (66.9% vs. 60.0%), atrial arrhythmias (50.7% vs. 43.8%), diabetes mellitus (21.3% vs. 9.4%), chronic kidney disease (44.1% vs. 31.3%), prior stroke (11.8% vs. 10.9%), myocardial infarction (31.6% vs. 29.7%), pre-existing implantable cardioverter-defibrillator (86.8% vs. 71.9%) and had a higher median number of antiarrhythmic drugs at baseline (2 vs. 1) [Figure 1]. There was a greater percentage of patients with non-ischemic cardiomyopathy (58.1% vs. 51.6%) in the GA cohort. The mean left ventricular ejection fraction was not different among the two groups (39.3 ± 13.9 vs. 42.5 ± 15.3). The GA group had more hemodynamic instability at baseline (p &amp;lt; 0.01), and during VT induction (p &amp;lt; 0.01). There was no significant difference in the number of VT induced, or tachycardia cycle length, in each group. Despite higher radiofrequency energy delivery time in the GA group as compared to the MAC group, the GA group had higher VT inducibility post-procedure and were more likely to be discharged on antiarrhythmic drugs. Even though the recurrence of VT was higher in the GA group compared to the MAC group (41.9% vs. 31.3%), the VT-free survival curves were not significantly different by Kaplan-Meier analysis (p=0.19) [Figure 2]. In a multivariate regression analysis, the sedation strategy was not an independent predictor of VT recurrence (p=NS). However, baseline hemodynamic instability was an independent predictor of VT recurrence after accounting for all intraprocedural characteristics (p=0.008). Conclusion Patients undergoing VT ablation under GA have more comorbidities and tend to be on more antiarrhythmic drugs. The GA group had more hemodynamic instability during the procedure and had greater overall VT recurrence, however, not significant in a time-based analysis. The greater overall recurrence in the GA group could be because they represent a sicker population, or the hemodynamics during the procedure preclude adequate ablation of the VT circuit elements.Figure 1Figure 2

Real world data on adopting guideline directed medical therapy post 2021 ESC HF guidelines and effect on renal function

Abstract Introduction This single-centre cohort study aims to compare the use of guideline-directed medical therapies (GDMT) before and after the 2021 ESC HF guidelines and the effect on renal function. There has been good adoption of these guidelines worldwide following the publication in 2021. We know HF patients will have less decline in renal function when GDMT is better optimised. This study aims to compare renal function on admission (adm) and discharge (dc) following acute heart failure admission. Methods Our database is composed of 460 patients with AHF admitted to our HF unit from 01/08/2020 till 31/07/2022inclusive. We divided this group into two; Group A was composed of 187 patients from August 2020 to Aug 2021(pre-ESC guidelines) and Group B included 273 patients from August 2021 to Aug 2022 (post-ESC guidelines). We compared the number of patients initiated on the 4 pillars of HF medication on admission and discharge. Both groups were analysed based on their ejection fraction (HFrEF, HFmrEF and HFpEF). Baseline parameters were were similar between the two groups. We analyzed eGFR (mL/min) on admission (adm), eGFR on discharge (dc), K+ (mmol/l) on dc and the 8 medications for HFrEF and HFmrEF. We also reviewed three medications for HFpEF. Results Group A (Aug 2020-Aug 2021): HFrEF patients had an average eGFR of 52.4 on adm and 47,0 at dc, average K+ was 4.34 on dc. HFmrEF subgroup had an average eGFR of 48.8 on adm and 45.4 at dc, average K+ was 4.23 on dc. HFpEF subgroup had an average eGFR of 51.2 on adm and 44.2 at dc, average K+ was 4.24 on dc. Group B (Aug 2021-Aug 2022): HFrEF patients had an average eGFR of 53.5 on adm and 50.7 dc, average K+ was 4.38 on dc. HFmrEF subgroup had an average eGFR of 49.4 on adm and 47.0 at dc, average K+ was 4.34 on dc. HFpEF subgroup had an average eGFR of 45.9 on adm and 41.7 at dc, average K+ was 4.35 on dc. Group A and B comparison (Table1): In Group A, HFrEF patients had a drop of eGFR of 5.4 between adm and dc. However, HFrEF patients in Group B, where they had their GDMT optimized, had an eGFR drop of only 2.8 (less by 2.6). In Group A, HFmrEF patients had an eGFR drop of 3.4 in comparison to HFmrEF patients in Group B where eGFR dropped by 2.4 (less by 1.0). In Group A, HFpEF subgroup had an eGFR drop of 7.0 versus Group B HFpEF where eGFR dropped by 4.2 only (less by 2.8). Despite better GDMT in group B, K+ was comparable to group A. Conclusions Patients with AHF managed in the HF Unit have better optimization of GDMT post 2021 HF ESC guidelines. In Group B, all patient subgroups (HFrEF; HFmrEF and HFpEF) in the year following publication of the ESC HF guidelines had a reduced decline in eGFR i.e. less worsening of renal function despite higher dose and a greater percentage of patients on the 4 pillars of GDMT. This study demonstrates that renal function of patients admitted with AHF is better preserved with optimization of GMDT during their admission.MEDICATIONS (GDMT)RENAL FUNCTION

Erythrocyte membrane fluidity: A novel biomarker of residual cardiovascular risk in type 2 diabetes.

Improving the composition of circulating fatty acids (FA) leads to a reduction in cardiovascular diseases (CVD) in high-risk individuals. The membrane fluidity of red blood cells (RBC), which reflects circulating FA status, may be a valid biomarker of cardiovascular (CV) risk in type 2 diabetes (T2D). Red blood cell membrane fluidity, quantified as general polarization (GP), was assessed in 234 subjects with T2D, 86 with prior major CVD. Based on GP distribution, a cut-off of .445 was used to divide the study cohort into two groups: the first with higher GP, called GEL, and the second, defined as lower GP (LGP). Lipidomic analysis was performed to evaluate FA composition of RBC membranes. Although with comparable CV risk factors, the LGP group had a greater percentage of patients with major CVD than the GEL group (40% vs 24%, respectively, p < .05). Moreover, in a logistic regression analysis, a lower GP value was independently associated with the presence of macrovascular complications. Lipidomic analysis showed a clear shift of LGP membranes towards a pro-inflammatory condition due to higher content of arachidonic acid and increased omega 6/omega 3 index. Increased membrane fluidity is associated with a higher CV risk in subjects with T2D. If confirmed in prospective studies, membrane fluidity could be a new biomarker for residual CV risk assessment in T2D.

Quality-of-Life Outcomes for Patients Taking Opioids and Psychotropic Medications Before Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy.

The impact of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) on quality of life (QoL) for patients taking opioids and psychotropic medications preoperatively is unclear. This study retrospectively reviewed a CRS-HIPEC single-center prospectively maintained database for 2012-2016. Demographics and clinical data on opioids/psychotropic medication use were collected via chart review. The study collected QoL outcomes at baseline, then 3, 6, and 12 months postoperatively via the Center for Epidemiologic Studies Depression Scale (CES-D), Brief Pain Inventory, Functional Assessment of Cancer Therapy, and 36-Item Short-Form Health Survey. Differences in QoL between the groups were calculated using repeated measures analysis of variance regression. Descriptive statistics and Kaplan-Meier analyses were performed. Of 388 patients, 44.8% were taking opioids/psychotropic medications preoperatively. At baseline, those taking opioids/psychotropic medications preoperatively versus those not taking these medications had significantly worse QoL. By 1 year postoperatively, the QoL measures did not differ significantly except for emotional functioning (e.g., no medications vs. opioids/psychotropic medications: CES-D, 5.6 vs. 10.1). Median survival did not differ significantly (opioids/psychotropic medications vs. no medications: 52.3 vs. 60.6 months; p = 0.66). At 1 year after surgery, a greater percentage of patients were taking opioids, psychotropic medications, or both than at baseline (63.2% vs. 44.8%; p < 0.001). Despite worse baseline QoL, patients who took opioids/psychotropic medications had QoL scores 1 year postoperatively similar to the scores of those who did not except in the emotional domains. These data point to the potential utility of a timed psychosocial intervention to enhance emotional adaptation and further support the role of CRS-HIPEC in improving QoL.

Phase 3 Trial of Nemolizumab in Patients with Prurigo Nodularis

BackgroundPrurigo nodularis is a chronic, debilitating, and severely pruritic neuroimmunologic skin disease. Nemolizumab, an interleukin-31 receptor alpha antagonist, down-regulates key pathways in the pathogenesis of prurigo nodularis.MethodsIn this phase 3, double-blind, multicenter, randomized trial, we assigned adults with moderate-to-severe prurigo nodularis to receive an initial 60-mg dose of nemolizumab followed by subcutaneous injections of 30 mg or 60 mg (depending on baseline weight) every 4 weeks for 16 weeks or matching placebo. The primary end points were an itch response (a reduction of ≥4 points on the Peak Pruritus Numerical Rating Scale [PP-NRS; scores range from 0 to 10, with higher scores indicating more severe itch]) and an Investigator’s Global Assessment (IGA) response (a score of 0 [clear] or 1 [almost clear] on the IGA [scores range from 0 to 4] and a reduction from baseline to week 16 of ≥2 points). There were five key secondary end points.ResultsA total of 274 patients underwent randomization; 183 were assigned to the nemolizumab group, and 91 to the placebo group. Treatment efficacy was shown with respect to both primary end points at week 16; a greater percentage of patients in the nemolizumab group than in the placebo group had an itch response (56.3% vs. 20.9%; strata-adjusted difference, 37.4 percentage points; 95% confidence interval [CI], 26.3 to 48.5), and a greater percentage in the nemolizumab group had an IGA response (37.7% vs. 11.0%; strata-adjusted difference, 28.5 percentage points; 95% CI, 18.8 to 38.2) (P<0.001 for both comparisons). Benefits were observed for the five key secondary end points: itch response at week 4 (41.0% vs. 7.7%), PP-NRS score of less than 2 at week 4 (19.7% vs. 2.2%) and week 16 (35.0% vs. 7.7%), and an improvement of 4 or more points on the sleep disturbance numerical rating scale (range, 0 [no sleep loss] to 10 [unable to sleep at all]) at week 4 (37.2% vs. 9.9%) and week 16 (51.9% vs. 20.9%) (P<0.001 for all comparisons). The most common individual adverse events were headache (6.6% vs. 4.4%) and atopic dermatitis (5.5% vs. 0%).ConclusionsNemolizumab monotherapy significantly reduced the signs and symptoms of prurigo nodularis. (Funded by Galderma; ClinicalTrials.gov number, NCT04501679; EudraCT number, 2019-004789-17.)

Prognostic Value of Pulmonary Artery Oxygen Saturation in Pulmonary Embolism Requiring Endovascular Intervention

This retrospective study evaluates the prognostic value of pulmonary artery oxygen saturation (PA O2) among patients who undergo mechanical intervention for pulmonary embolism (PE). Patients who died within 90 days had less PA O2, and a greater percentage of patients with a PA O2 of <50 died within 90 days of intervention. Regression analysis revealed an association of PA O2 with mortality that held true despite accounting for Pulmonary Embolism Severity Index (PESI) score and type of endovascular intervention. Receiver operator curve testing revealed PA O2 <50% to be inferior to PESI score but superior to Bova score in predicting mortality after mechanical PE intervention, with the combination of PA O2 <50% and PESI outperforming PESI and PA O2 in predicting mortality. Our pilot evaluation suggests preintervention PA O2 <50% to be associated with increased risk of all-cause mortality and may help identify patients at greatest risk of deterioration.

The Geriatric Patient One Year After Trauma: Palliative Performance Scale Predicts Functional Outcomes

IntroductionFrailty in trauma has been found to predict poor outcomes after injury including additional in-hospital complications, mortality, and discharge to dependent care. These gross outcome measures are insufficient when discussing long-term recovery as they do not address what is important to patients including functional status and quality of life. The purpose of this study is to determine if the Palliative Performance Scale (PPS) predicts mortality and functional status one year after trauma in geriatric patients. Material and MethodsProspective observational study of trauma survivors, age ≥55 years. Patients were stratified by pre-injury PPS high (>70) or low (≤70). Outcomes were functional status at 1 year measured by Glasgow Outcome Scale Extended (GOSE), Euroqol-5D and SF-36. Adjusted relative risks (aRR) were obtained using modified Poisson regression. ResultsFollow-up was achieved on 215/301 patients. Mortality was 30% in low PPS group vs 8% in the high PPS group (P<0.001). A greater percentage of patients in the high group had a good functional outcome at one year compared to patients in the low group (78% vs 30% p<0.001). The high PPS patients were more likely to have improvement of GOSE at 1 year from discharge compared to low group (66% vs 27% P<0.001). Low PPS independently predicted poor functional outcome (aRR, 2.64; 95% confidence interval, 1.79-3.89) and death at 1 year (aRR, 3.64; 95% confidence interval 1.68-7.92). An increased percentage of low PPS patients reported difficulty with mobility (91% vs 46% p<0.0001) and usual activities (82% vs 56% p=0.002). Both groups reported pain (65%) and anxiety/depression (47%). ConclusionLow pre-Injury PPS predicts mortality and poor functional outcomes one year after trauma. Low PPS patients were more likely to decline, rather than improve. Regardless of PPS, most patients have persistent pain, anxiety, and limitations in performing daily activities.

Quality Improvement (QI) Framework to Examine Health Care Disparities in Behavioral Emergency Management in the Inpatient Medical Setting: A Consultation-Liaison (CL) Psychiatry Health Equity Project.

De-escalation of behavioral emergencies in the inpatient medical setting may involve restrictive clinical interventions that directly challenge patient autonomy. We describe a quality improvement framework used to examine associations between patient characteristics and behavioral emergency de-escalation strategies. This project may inform other Consultation-Liaison Psychiatry teams seeking to promote equity in care. We examined behavioral emergency response team (BERT) management at an urban, tertiary-care medical center in the United States over a 3-year period. BERT data from an existing dataset were combined with demographic information from the hospital's electronic medical record. Race and ethnic identities were categorized as Black, Hispanic, Asian, White, and unknown. BERT events were coded based on the most restrictive intervention utilized per unique patient. Cross-tabulations and adjusted odds ratios from multivariate logistic regression were used to identify quality improvement targets in this exploratory project. The sample included N= 902 patients and 1532 BERT events. The most frequent intervention reached was verbal de-escalation (n= 419 patients, 46.45%) and the least frequent was 4-point restraints (n= 29 patients, 3.2%). Half of BERT activations for Asian and a third for Hispanic patients required interpreter services. Anxiety and cognitive disorders and 2 BERT interventions, verbal de-escalation, and intramuscular/intravenous/ medications, were significantly associated with race/ethnic category. The most restrictive intervention for BERTs involving Black and Asian patients were verbal de-escalation (60.1%) and intramuscular/intravenous(53.7%), respectively. These proportions were higher compared with other race/ethnic groups. There was a greater percentage of patients from the unknown (6.3%) and Black (5.9%) race/ethnic groups placed in 4-point restraints compared with other groups (3.2%) that did not reach statistical significance. A logistic regression model predicting 4-point restraints indicated that younger age, multiple BERTs, and violent behavior as a reason for BERT activation, but not race/ethnic group, resulted in significantly higher odds. This project illustrates that a quality improvement framework utilizing existing clinical data can be used to engage in organizational introspection and identify potential areas of bias in BERT management. Our findings suggest opportunities for further exploration, enhanced education, and programmatic improvements regarding BERT intervention; 4-point restraints; interpreter services; and the influence of race on perception of psychopathology.

The long weight: association between distressed communities index and long-term weight outcomes following bariatric surgery

BackgroundSocioeconomic status (SES) is multifactorial, and its effect on post-bariatric weight recurrence is unclear. Distressed Community Index (DCI) is a composite SES score measuring community economic well-being. This study aims to evaluate the effect of DCI on long-term post-bariatric weight outcomes.MethodsRetrospective analysis of patients undergoing primary laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy between 2015 and 2020 was performed. All weights in the electronic medical record (EMR), including non-bariatric visits, were captured. Patients were stratified into low tier (LT) and high tier (HT) DCI groups.ResultsOf 583 patients, 431 (73.9%) were HT and 152 (26.1%) were LT. Average bariatric follow up was 1.78 ± 1.6 years and average postoperative weight in the EMR was 3.96 ± 2.26 years. Rates of bariatric follow up within the last year were similar (13.8% LT vs 16.2% HT, p = 0.47). LT had higher percent total body weight loss (%TWL; 26% LT vs 23% HT, p < 0.01) and percent excess weight loss (%EWL; 62% vs 57%, p = 0.04) at 1 year on univariate analysis. On multivariate linear regression adjusting for baseline characteristics and surgery type, there were no differences in %EWL between groups at 1 year (p = 0.22), ≥ 3 years (p = 0.53) or ≥ 5 years (p = 0.34) postop. While on univariate analysis LT only trended towards greater percentage of patients with > 15% increase from their 1-year weight (33.3% LT vs 21.0% HT, p = 0.06), on multivariate analysis this difference was significant (OR 2.0, LT 95%CI 1.41–2.84). There were no differences in the percentage of patients with > 15% decrease in %EWL from 1 to 3 + years postop between groups (OR 0.98, LT 95% CI 0.72–1.35).ConclusionsWhile low tier patients had similar weight loss at 1 year, they were twice as likely to have weight recurrence at ≥ 3 years. Further studies are needed to identify factors contributing to greater weight recurrence among this population.

Demographic and socioeconomic factors in poorly differentiated Sertoli-Leydig cell tumors: A National Cancer Database analysis.

e17568 Background: Poorly differentiated Sertoli-Leydig cell tumor (PD-SLCT) is a rare and aggressive type of ovarian cancer. This cancer has a 5-year cancer-specific survival rate of 43.9% with a chance of early relapse of approximately 2-3 years following initial diagnosis. Given the rarity of the cancer, potential risk factors could offer providers and patients more information about the epidemiology. The National Cancer Database (NCDB) was analyzed to study the demographic factors in patients diagnosed with PD-SLCT. Methods: Cases of PD-SLCT (N = 405) in the NCDB from 2004 – 2020 were determined via histology (ICD-O-3 code = 8631). A retrospective cohort analysis using demographic factors such as race, age, sex, insurance status, urban/rural, facility type, and Charleson-Deyo score were analyzed by descriptive statistics and incidence trends were interpreted in regression analysis. Results: A total of 405 patients with a diagnosis of PD-SLCT were identified in the database with a steady incidence of patients diagnosed per year (mean = 23.8 per year, R2 = 0.1). The average age of diagnosis was 41.7 years (SD = 20.1, range = 8 – 90 years). The majority of patients were non-Hispanic (82.5%) and White (69.4 %). More patients were in the top quartile of income earners (30.8.%) and were privately insured (56.8%) relative to those who were uninsured or insured by Medicare/Medicaid (43.2%). A greater percentage of patients with PD-SLCT were treated at a non-academic program (54.0%) compared to an academic/research program (46.0%). More patients lived in metropolitan counties with a population greater than 1 million (59.8%) versus less populated metropolitan communities or urban communities (40.2%). Most individuals (84.2%) had Charlson-Deyo comorbidity scores of 0. Conclusions: This novel study of the NCDB addresses a significant knowledge gap on patients with PD-SLCT, as it provides demographic insight into this rare type of tumor and the patients who are diagnosed with it. Most PD-SLCT patients tend to be in the premenopausal age, as previously described in literature. Most patients are White and non-Hispanic. This is the first time the socioeconomic factors of PD-SLCT patients have been described in the literature: patients are more likely to be in the top income quartile, live in densely populated metropolitan areas, and be treated in a non-academic program. Further research is needed to better understand the impact of these factors on the diagnosis of, treatments utilized, and overall survival of patients with PD-SLCT to ensure that all patients receive the best possible care, regardless of their background.

Comparison of real-world outcomes over time in a large population-based cohort of patients with metastatic breast cancer.

e13112 Background: The treatment of metastatic breast cancer (MBC) has evolved over the past two decades, with a number of new therapeutics being introduced. Real-world evidence is needed to evaluate whether these new therapeutics have made an impact on population survival, as improvements in survival seen within clinical trials do not necessarily translate into the real world. The purpose of this study was to investigate whether survival for each subtype of MBC has improved in patients diagnosed with MBC between 2003 and 2017. In addition, for the HER2+ subtype, we aimed to characterize and correlate changes in the use of anti-HER2 therapeutics with any observed real-world survival changes. Methods: The study included residents of British Columbia, Canada who were diagnosed with de novo or recurrent MBC during one of the following four time periods: 2003 to 2005, 2007 to 2009, 2011 to 2013, and 2014 to 2017. Patients were included whether or not they received any systemic therapies for MBC. Patient, disease, and treatment characteristics were obtained through medical records and the Breast Cancer Outcomes Unit database. Survival estimates were calculated using the Kaplan-Meier method. Univariable analyses were performed using the log-rank test, and multivariable analyses (MVA) were performed using the Cox proportional hazards model. Results: 5,924 patients were diagnosed with MBC during one of the four time periods. 3,756 (63%) had hormone receptor positive (HR+) subtype, 1,145 (19%) had HER2+ subtype, 770 (13%) had triple negative (TN) subtype, and 253 (4%) had unknown subtype. For the HR+ subtype, overall survival (OS) was similar for cohorts 1 to 3 (median survivals: 751 days, 704 days, and 702 days). However, OS was longer for cohort 4 (median survival: 855 days) compared to cohort 3 ( p &lt; 0.001). For the HER2+ subtype, OS was similar for cohorts 1 to 3 (median survivals: 594 days, 511 days, and 592 days). However, OS was longer for cohort 4 (median survival: 791 days) compared to cohort 3 ( p = 0.03). For the TN subtype, there was no significant change in OS for the four cohorts (median survivals: 234 days, 236 days, 274 days, and 255 days). On MVA, younger age, non-TN subtype, time cohort 4, de novo presentation, and disease-free interval of &gt; 12 months were associated with improved OS. For the HER2+ subtype, a greater percentage of patients in the later cohorts were treated with pertuzumab ( p &lt; 0.001) and trastuzumab emtansine (T-DM1) ( p &lt; 0.001), with 12.4% and 36.3% respectively receiving these drugs in cohort 3 compared to 80.9% and 52.5% respectively in cohort 4. Conclusions: Patients diagnosed with MBC of the HR+ or HER2+ subtypes in the 2014 to 2017 time period had improved real-world outcomes compared to those diagnosed in earlier time periods. Improvements in real-world outcomes were likely associated with new therapeutic agents with demonstrated OS benefit in trial settings.

Diffuse large B-cell lymphoma in HHV8+ multicentric castleman disease: A national analysis of demographic features.

e19535 Background: Diffuse large B-cell lymphoma (DLBCL) in human herpesvirus 8 associated (HHV8+) multicentric Castleman disease (MCD) is a rare type of DLBCL. DLBCL, the most common non-Hodgkin lymphoma, is a cancer arising in the lymphatics. HHV8+ MCD is a lymphoproliferative disorder usually occurring in HIV patients. Patients who develop DLBCL in this setting typically die within a year. Prior National Cancer Database (NCDB) studies have assessed survival and demographics in the broader category of CD20- LBCLs, but have not specifically examined the socioeconomic and demographics associated with DLBCL in HHV8+ MCD. Methods: A retrospective analysis of NCDB data from 2010 – 2020 included patients diagnosed with DLBCL in HHV8+ MCD (N = 237). Demographic factors such as sex, race, Hispanic ethnicity, income status, insurance status, Charlson-Deyo score, facility type/location, and metastasis at diagnosis were evaluated with descriptive statistics. Primary site was also examined. Incidence trends were assessed via regression analysis. Results: A total of 237 patients with DLBCL in HHV8+ MCD were identified in the database, with an average incidence of 21.5 cases per year (R2 = 0.236, SD = 5.7, range = 9 – 29). 74.7% were male and the average age of diagnosis was 53.8 years (SD = 18.62, range = 3 – 90). 40 different primary sites were identified, with the most common being lymph nodes of multiple regions (32.9%). Extranodal primary sites were rare but documented. Charlson-Deyo comorbidity scores varied: Score 0 = 61.6%, Score 1 = 8.4%, Score 2 = 4.2%, Score ≥ 3 = 25.7%. Incidence for race was highest among Whites (69.2%), followed by Blacks (25.3%), then Asians (3.4%). 8.4% of patients were of Hispanic ethnicity. A greater percentage of patients were in the top income quartile (33.8%), compared to the second (19.7%), third (23.9%), and fourth (22.5%). Most patients were either insured privately or by Medicare (73.9%), whereas 8.9% were uninsured. Most were treated at academic facilities (54.7%), and many were treated at facilities in the Eastern United States (47.5%). 19.1% of patients had metastases at diagnosis, most often in distant lymph nodes (6.1%). Conclusions: This study provides insight into the demographics of patients diagnosed with DLBCL in HHV8+ MCD. This cancer showed a nearly 3-fold male preponderance and primarily affected Whites, mirroring existing trends in DLBCL overall. About one fifth of patients presented with metastasis at diagnosis. Interestingly, patient Charlson-Deyo scores displayed a bimodal distribution, with 87.3% of patients having a Score of either 0 or ≥3. The top income quartile was most affected, but patients were more evenly distributed among the bottom three. Further investigation is needed to better define the role of demographics in shaping diagnostic, therapeutic, and outcome discrepancies in those with DLBCL in HHV8+ MCD.

0533 Healthcare Utilization by Patients with Obstructive Sleep Apnea and Excessive Daytime Sleepiness After Airway Therapy in the UK

Abstract Introduction Obstructive Sleep Apnea (OSA) is a chronic condition characterized by repetitive episodes of upper airway collapse during sleep. Despite standard treatment with continuous positive airway pressure (CPAP), some patients continue to experience residual excessive daytime sleepiness (rEDS). Pharmacotherapy use for rEDS is low in Europe and some wake-promoting agents are no longer allowed as treatments by the European Medicines Agency. The objective of this study was to characterize the patient demographics, comorbidities, medications, and healthcare resource utilization (HCRU) in a population of OSA patients with and without rEDS after CPAP initiation. Methods The retrospective observational cohort study used the Clinical Practice Research Datalink (CPRD) AURUM, a primary care database, linked at the patient level to the Hospital Episode Statistics (HES) database, which covers secondary care for all of England. The population included 10,746 adult OSA patients with a first record of CPAP treatment during the eligibility period (Jan 1, 2009-Mar 21, 2018). rEDS patients were identified 6 months after initiating CPAP treatment. Results Among all eligible OSA patients in the AURUM database, 596 (5.6%) had rEDS; 80.5% of rEDS patients were identified using recorded diagnosis code of daytime fatigue, and 21.7% using ESS score ≥11 (13 patients had both measures). A greater percentage of patients had a history of psychiatric (21.5%; p&amp;lt; 0.0001), gastrointestinal (7.7%; p&amp;lt; 0.0001), and neurodegenerative (13.6%; p=0.003) disorders in the rEDS group, compared with the non-rEDS group, while the prevalence of obesity, cardiovascular, and sleep disorders did not significantly differ between groups. Across all patients, rates of prescription for stimulants or modafinil were low during the 12 months prior to CPAP initiation. Patients with rEDS had significantly higher HCRU compared to non-rEDS patients in the first and second years after CPAP initiation. Conclusion Despite low rates of rEDS identified in this study, the clinical needs of patients with rEDS are significant, as evidenced by the volume of HCRU, low use of pharmacotherapy, and high comorbidity rates, highlighting the need to improve patient care in rEDS. Support (if any) Axsome Therapeutics and Jazz Pharmaceuticals

Time Trends of Environmental and Socioeconomic Risk Factors in Patients with Inflammatory Bowel Disease over 40 Years: A Population-Based Inception Cohort 1977-2020.

Data from population-based studies investigating trends in environmental factors associated with inflammatory bowel disease (IBD) is lacking. We aimed to assess long-term time trends of environmental and socioeconomic factors in IBD patients from a well-defined population-based cohort from Veszprem, Hungary. Patients were included between 1 January 1977, and 31 December 2020. Trends of environmental and socioeconomic factors were evaluated in three periods based on the decade of diagnosis, representing different therapeutic eras: cohort-A,1977-1995; cohort-B,1996-2008 (immunomodulator era); and cohort-C, 2009-2020 (biological era). A total of 2240 incident patients with IBD were included (ulcerative colitis (UC) 61.2%, male 51.2%, median age at diagnosis: 35 years (IQR 29-49)). Rates of active smoking significantly decreased over time in Crohn's disease (CD): 60.2%, 49.9%, and 38.6% in cohorts A/B/C (p < 0.001). In UC, the rates were low and stable: 15.4%, 15.4%, and 14.5% in cohorts A/B/C (p = 0.981). Oral contraceptive use was more common in CD compared to UC (25.0% vs. 11.6%, p < 0.001). In UC, prevalence of appendectomy before diagnosis decreased over time: 6.4%, 5.5%, and 2.3% in cohorts A/B/C (p = 0.013). No significant changes were found in the socio-geographic characteristics of the IBD population (urban living: UC, 59.8%/64.8%/ 62.5% (p = 0.309) and CD, 62.5%/ 62.0%/ 59.0% (p = 0.636), in cohorts A/B/C). A greater percentage of patients had completed secondary school as the highest education level in later cohorts in both UC (42.9%/50.2%/51.6%, p < 0.001) and CD (49.2%/51.7%/59.5%, p = 0.002). A higher percentage of skilled workers (34.4%/36.2%/38.9%, p = 0.027) was found in UC, but not in CD (p = 0.454). The association between trends of known environmental factors and IBD is complex. Smoking has become less prevalent in CD, but no other major changes occurred in socioeconomic factors over the last four decades that could explain the sharp increase in IBD incidence.