Additional Patient Characteristics Research Articles

O89 POOLED, LONG-TERM ANALYSIS OF THE GLOBAL SYMPLICITY CLINICAL TRIAL PROGRAM OF RADIOFREQUENCY RENAL DENERVATION FOR THE TREATMENT OF UNCONTROLLED HYPERTENSION

Background/Objective: The Global Symplicity Clinical program is the largest investigation of radiofrequency renal denervation (RDN) to treat uncontrolled hypertension (HTN) to date. Over 4,000 patients enrolled into Spyral First-in-Man, Global SYMPLICITY Registry DEFINE, and multiple randomized, controlled and sham controlled trials including HTN-Japan, Symplicity HTN-3, SPYRAL HTN-OFF and -ON MED studies. We leveraged the entire Symplicity Global Clinical program dataset to develop a multivariate, patient-level, mixed model assessing (1) long-term BP reductions after RDN, and (2) whether specific patient characteristics correlate with future BP reductions after the procedure. Methods: Repeated BP measurements from each patient in the Global Symplicity Clinical program were analyzed using linear mixed models fitted with 24-h ambulatory systolic (S)BP and office SBP as outcome variables. Baseline SBP, baseline number of antihypertensive (AH) medications, and AH medications over time were included as fixed effects. Additional patient characteristics were included as potential significant fixed effects. To account for multiple BP measurements per patient and multiple studies, nested random effects were included using an auto-regressive correlation structure. Results: Data from 4156 patients treated with either the first-generation Symplicity Flex or the next-generation Symplicity Spyral catheter. Estimated, office and 24-h ambulatory SBP changes through 36 months, after adjusting for AH medication effects, were biphasic with a steep reduction after RDN through the first 6 months (Figure), followed by a steady reduction in SBP afterward through 36 months. Higher baseline SBP was correlated with greater BP reductions. AF history (-3.7 mmHg compared to no AF, p=0.0048) and increasing eGFR at baseline (-0.039 mmHg for every 1 ml/min increase in baseline eGFR, p=0.040) significantly correlated with lower 24-h ambulatory SBP. Conclusion: This is the most comprehensive analysis of radiofrequency RDN to date. Higher baseline SBP was strongly correlated with greater BP reductions. The results demonstrate the durability of RDN as an adjunctive therapy to treat HTN. Prospective studies need to validate whether certain patient characteristics are associated with improved response to RDN.

Patient Characteristics Associated with Time to Next Treatment in Patients with Ovarian Cancer Treated with Niraparib: The PRED1CT Real-World Study.

Niraparib first-line maintenance (1LM) therapy has demonstrated clinical benefit for patients with ovarian cancer (OC) in clinical trial and real-world settings, but data on factors associated with real-world patient outcomes remain limited. This analysis identified patient characteristics associated with time to next treatment (TTNT), a proxy for real-world progression-free survival, in patients with OC treated with 1LM niraparib monotherapy. This retrospective observational study used a USA nationwide electronic health record-derived deidentified database and included adult patients diagnosed with OC who initiated 1LM niraparib monotherapy after first-line platinum-based chemotherapy. Patients were followed until the earliest occurrence of last clinical activity, death, or end of study period. TTNT was measured from 1LM niraparib initiation to the start of second-line treatment or death. Cox proportional hazards models assessed univariable and multivariable associations between baseline characteristics and TTNT. Of 7872 patients diagnosed with OC, 526 met the eligibility criteria and were included in this analysis. Median (IQR) duration of follow-up was 14.1 (7.4-23.6) months. In univariable analyses, age, BRCA/homologous recombination deficiency (HRD) status, socioeconomic status, stage at initial diagnosis, cytoreductive surgery type, and residual disease status were significantly associated with observed TTNT and were introduced into the multivariable model with other clinically relevant variables. In the multivariable analysis, BRCA/HRD status, cytoreductive surgery type, and residual disease status were significantly associated with observed TTNT after covariate adjustment. Conversely, age, Eastern Cooperative Oncology Group performance status, disease stage, niraparib starting dose status, and first-line bevacizumab use were not associated with observed TTNT. This real-world, retrospective, observational analysis offers valuable insights on prognostic factors associated with TTNT in patients with OC treated with 1LM niraparib monotherapy after first-line platinum-based chemotherapy. Future studies are needed to examine how additional patient characteristics associated with clinical outcomes may guide treatment decisions and improve outcomes.

POOLED, LONG-TERM ANALYSIS OF THE GLOBAL SYMPLICITY CLINICAL TRIAL PROGRAM OF RADIOFREQUENCY RENAL DENERVATION FOR THE TREATMENT OF UNCONTROLLED HYPERTENSION

Objective: The Global Symplicity Clinical program is the largest investigation of radiofrequency renal denervation (RDN) to treat uncontrolled hypertension (HTN) to date. Collectively, over 4,000 patients enrolled into Spyral First-in-Man, the Global SYMPLICITY Registry (GSR) DEFINE, and multiple randomized controlled and sham controlled trials including HTN-Japan, Symplicity HTN-3, and the SPYRAL HTN-OFF and ON MED studies. We leveraged the entire Symplicity Global Clinical program patient dataset to develop a multivariate, patient-level, mixed model assessing (1) long-term BP reductions after RDN, and (2) whether specific patient characteristics correlate with future BP reductions after the procedure. Design and method: Repeated BP measurements from each patient in the Global Symplicity Clinical program were analyzed using linear mixed models fitted with 24-h ambulatory systolic (S)BP and office SBP as outcome variables. Baseline SBP, baseline number of antihypertensive (AH) medications, and AH medications over time were included as fixed effects. Additional patient characteristics were included as potential significant fixed effects. To account for multiple BP measurements per patient and multiple studies, nested random effects were included using an auto-regressive correlation structure. Results: The mixed model included data from 4156 patients treated with either the first-generation Symplicity Flex or the next-generation Symplicity Spyral catheter. Estimated, office and 24-h ambulatory SBP changes through 36 months, after adjusting for AH medication effects, were biphasic with a steep reduction after RDN through the first 6 months (Figure), followed by a steady reduction in SBP afterward through 36 months. Higher baseline SBP was correlated with greater BP reductions. History of AF (-3.7 mmHg compared to no AF, p=0.0048) and increasing eGFR at baseline (-0.039 mmHg for every 1 ml/min increase in baseline eGFR, p=0.040) significantly correlated with lower 24-h ambulatory SBP. Conclusions: This is the most comprehensive analysis of radiofrequency RDN to date. Higher baseline SBP was strongly correlated with greater BP reductions. The results demonstrate the durability of RDN as an adjunctive therapy to treat HTN patients. Prospective studies need to validate whether certain patient characteristics are associated with improved response to RDN.

Clinical Outcomes and Treatment Patterns in Adults With FLT3-ITDmut+ Acute Myeloid Leukemia Undergoing Allogeneic Hemopoietic Cell Transplantation in the United States and Canada

Allogeneic hematopoietic cell transplantation (alloHCT) is used to treat patients with acute myeloid leukemia (AML) with internal tandem duplication of the FMS-like tyrosine kinase 3 gene (FLT3-ITDmut+). However, the effect of different characteristics on outcomes after transplant is not fully understood. The aim of this study was to determine the impact of patient, disease, and transplant characteristics on clinical outcomes and trends in maintenance therapy for patients with FLT3-ITDmut+ AML who underwent their first alloHCT. This was an observational cohort study of adults ≥18 years who were recipients of human leukocyte antigen identical sibling, haploidentical, 8/8 or 7/8 unrelated, or cord blood donor alloHCT in the United States and Canada between 2014 and 2019. Patient, disease, and transplant characteristics were collected from Center for International Blood & Marrow Transplant Research between 2014 and 2022. Patients enrolled in the MORPHO clinical trial (NCT02997202) were excluded. Clinical outcomes were measured from the time of alloHCT by disease status: first complete remission (CR1), second or greater complete remission (≥CR2), or relapsed/refractory (R/R). The primary endpoints of this study were overall survival (OS) and leukemia-free survival (LFS). Key secondary endpoints included relapse after alloHCT, nonrelapse mortality (NRM), time from diagnosis to complete remission, time from complete remission to alloHCT, and maintenance therapy before and after alloHCT. Univariate analyses were conducted with Gray's test and log-rank test, while multivariable analyses were conducted using Cox proportional hazards models. A total of 3147 eligible patients (CR1, n = 2389; ≥CR2, n = 340; R/R, n = 418) were included. Most patient, disease, and transplant characteristics were similar between different disease statuses. In univariate analyses, disease status of CR1 compared with ≥CR2 or R/R was significantly (P < .001) associated with improved OS and LFS, and decreased probability of relapse; NRM likely differed across cohorts after alloHCT (P = .003). In multivariable analyses, patients with a disease status of ≥CR2 and R/R compared with CR1 had significantly shorter OS (hazard ratio [HR] 95% confidence interval [CI], 1.43 [1.19 to 1.72], P = .0001, and 2.14 [1.88 to 2.44], P < .0001, respectively). Patients with a disease status of CR1 at ≤2.6 months had better LFS compared with ≥CR2 and R/R (HR [95% CI], 2.03 [1.56 to 2.63], P < .0001 and 3.98 [3.07 to 5.17], P < .0001, respectively). Patients with a ≥CR2 or R/R disease status at ≤2.6 months had an increased likelihood of relapse compared with CR1 (HR [95% CI], 2.46 [1.82 to 3.33], P < .0001 and 4.68 [3.46 to 6.34], P < .0001, respectively). Disease status was not significantly associated with NRM. We also identified several additional patient, disease, and transplant characteristics that may have been associated with inferior OS and/or LFS and greater relapse and/or NRM. Maintenance therapy usage after alloHCT increased from 2014 to 2019 primarily due to increased FLT3 inhibitor use. In this largest study to date of patients from the United States and Canada with FLT3-ITDmut+ AML, disease status of CR1 at the time of alloHCT was associated with better clinical outcomes. Additional factors were identified that may also impact clinical outcomes, and in total, have the potential to inform clinical decision-making.

Female Sex and Mortality in Patients with Staphylococcus aureus Bacteremia

Staphylococcus aureus is the leading cause of death due to bacterial bloodstream infection. Female sex has been identified as a risk factor for mortality in S aureus bacteremia (SAB) in some studies, but not in others. To determine whether female sex is associated with increased mortality risk in SAB. MEDLINE, Embase, and Web of Science were searched from inception to April 26, 2023. Included studies met the following criteria: (1) randomized or observational studies evaluating adults with SAB, (2) included 200 or more patients, (3) reported mortality at or before 90 days following SAB, and (4) reported mortality stratified by sex. Studies on specific subpopulations (eg, dialysis, intensive care units, cancer patients) and studies that included patients with bacteremia by various microorganisms that did not report SAB-specific data were excluded. Data extraction and quality assessment were performed by 1 reviewer and verified by a second reviewer. Risk of bias and quality were assessed with the Newcastle-Ottawa Quality Assessment Scale. Mortality data were combined as odds ratios (ORs). Mortality at or before 90-day following SAB, stratified by sex. From 5339 studies retrieved, 89 were included (132 582 patients; 50 258 female [37.9%], 82 324 male [62.1%]). Unadjusted mortality data were available from 81 studies (109 828 patients) and showed increased mortality in female patients compared with male patients (pooled OR, 1.12; 95% CI, 1.06-1.18). Adjusted mortality data accounting for additional patient characteristics and treatment variables were available from 32 studies (95 469 patients) and revealed a similarly increased mortality risk in female relative to male patients (pooled adjusted OR, 1.18; 95% CI, 1.11-1.27). No evidence of publication bias was encountered. In this systematic review and meta-analysis, female patients with SAB had higher mortality risk than males in both unadjusted and adjusted analyses. Further research is needed to study the potential underlying mechanisms.

WORKING TOGETHER TO PROVIDE GERIATRIC CARE: INTERDISCIPLINARY TEAM CREATION AND EVALUATION IN CANADA

Abstract Prince Edward Island is Canada’s smallest province (pop. 160,000) and has one of the oldest populations in Canada. While there is a robust and growing geriatrics program through provincial healthcare, it consists exclusively of medical providers (i.e., geriatricians and nurse practitioners). An opportunity for formal interprofessional collaboration presented itself when the University of Prince Edward Island began a Doctor of Psychology (PsyD) program in 2019. Soon thereafter, we established an interdisciplinary team between the PsyD and the provincial geriatrics programs. The goals of the team included: 1) enhancing care for older adults on the island, 2) providing training for PsyD students, and 3) increasing interprofessional collaboration and learning. In an evaluation of the first year of the collaboration, we collected data on the types of referrals and characteristics of the patients referred (e.g., number of medications), and asked all providers on the team (N=4 geriatricians, N=9 nurse practitioners, and N=4 psychology student clinicians) to answer open ended questions on the highlights and challenges of establishing the team, the organization of formal team meetings, and provision of patient care. Of the 74 patients seen by psychology, reasons included cognitive or psychodiagnostic assessment (N=22, 30%), psychotherapy (N=20, 27%), caregiver support (N= 25, 34%), or multiple services (i.e., both assessment and intervention; n=7, 10%). Additional patient characteristics will be shared, as well as themes from provider survey responses. Our program has implications for other areas in rural North America, particularly training opportunities built into our team functioning.

Assessment of Incidence of Distress and Utilization of Supportive Care Services in Multiple Myeloma Patients, a Retrospective Single Center Experience

Introduction: Multiple myeloma (MM) is the second most common hematological malignancy. Current literature represents substantial underutilization of guideline-recommended supportive services (SS) in MM patients. Earlier studies have shown that most patients with MM have focal osseous lesions leading to skeletal-related events, fractures, pain, and debility. These events may negatively affect the treatment course and result in poor quality of life. Recent NCCN and ASCO guidelines recommend utilization of SS in all patients by early integration of cancer care for symptom control while being treated for primary malignancy. We evaluated the level of distress in patients (pts), SS utilization, ED visits, and hospitalization in pts with MM. Methods: We included adult patients (≥18 years) with newly diagnosed or relapsed/refractory MM at Levine Cancer Institute who had completed an electronic distress survey (EDS) within three months of diagnosis or relapse. Amyloidosis and plasma cell leukemia diagnoses were excluded. The EDS includes questions related to sociodemographic, patient-reported outcomes (PROs): distress level, physical symptoms (scale 0 - 10), screening for depression (PHQ-2, scale 0 - 6), anxiety (GAD-2, scale 0 - 6),Utilization of at least one SS (social work, palliative medicine, psych-oncology, cancer rehab, integrative medicine, and nutrition) within 6 months of EDS and emergency department visits/hospitalizations within 1 year of EDS were collected, retrospectively, from the electronic medical record. The PROs were summarized overall and compared among three distress groups [Distress score (DS) &amp;lt;4, 4-6, ≥7] with Wilcoxon rank sum tests for the EDS symptom scores and Fisher's exact tests for other categorical endpoints. Results: 541 MM pts were identified with an EDS within 3 months of diagnosis or relapse (assessment date range: January 2017 - May 2022), with 71.5% of those occurring near diagnosis, and 28.5% occurring around relapse. The mean age was 64.9 years, 58.6% were male, and additional patient characteristics are presented in Table 1. There were 33.8% (n=183) pts with DS&amp;lt;4, 30.9% (167) with DS 4-6, and 35.3% (191) with DS of ≥7. The highest scoring EDS symptoms were pain (mean score 4.7), fatigue (5.1) and sleep disturbance (3.6). Broadly, patients with higher distress scores had higher symptom scores (p&amp;lt;0.05 for all symptoms). There were 77.6% (420) pts with anxiety GAD-2 score of 0-2, 12.9% (70) pts with a score of 3-4 and 9.4% (51) pts with a score of 5-6. Similarly, for depression, 76.9% (416) pts reported a PHQ-2 score of 0-2, 15% (81) with a score of 3-4, and 8.1% (44) with a score of 5-6. For anxiety and depression, patients with higher DS had higher depression and anxiety screening scores (p &amp;lt;0.001), as shown in Table 2. 64.3% (348) pts utilized at least one SS within six months of their initial EDS assessment. The rate of utilization of at least one SS increased with DS (49.2% in DS &amp;lt;4, 67.1% in DS 4-6, and 76.7% in DS ≥7; p value&amp;lt;0.001). Numerically, more patients with high distress had at least one ED visit within a year of EDS (25.7% DS &amp;lt;4, 33.5% DS 4-6, 36.1% DS ≥7, p = 0.08). There was no significant difference in hospitalization within 1 year between the DS groups. There were 147 (36.8%) pts with high-risk cytogenetics, of which 43.5% had a distress score of ≥7. The rate of utilization of SS, ED visits, and hospitalizations was numerically higher in pts with newly diagnosed MM (68.5%, 34.4%, 63.1%, respectively), as compared to pts with RRMM (64.3%, 25.3%, 48.7%). Conclusion: The disease-specific symptoms predict clinically significant DS &amp;gt;4 on EDS. There were about 20% of pts with screening score &amp;gt;2 for anxiety (GAD-2) &amp; depression (PHQ-2) that may warrant further exploration regarding the detail and nature of symptoms related to the diagnosis. There was a higher rate of utilization of SS and ED visits in pts with higher DS. Given these findings, there is a need to identify the optimal healthcare pathways for better utilization &amp; incorporation of these EDS and PROs in the clinical care of distressed patients. Our study indicates that more work is needed to align needs with resources in order to optimize quality of life and disease outcomes for our pts.

Direct-to-Consumer Teledermatology in Germany: A Retrospective Analysis of 1,999 Teleconsultations Suggests Positive Impact on Patient Care.

Background: There is a high demand for dermatological care in Germany. As use of teledermatology has increased significantly, this study aimed to investigate the impact of teledermatology on patient care. Methods: This retrospective cross-sectional study used data from a direct-to-consumer teledermatology platform using store-and-forward technology available in Germany between July 2021 and April 2022. Additional patient characteristics were collected using a voluntary follow-up questionnaire, 28 days after teleconsultation. Results: Data of 1,999 enrolled patients were evaluated. Patients had a mean age of 36 years, and 61.2% (1,223/1,999) lived in a rural residence. The most common diagnoses included eczema (36.0%, 701/1,946), fungal diseases (15.4%, 299/1,946), and acne (12.5%, 243/1,946). The follow-up questionnaire was answered by 166 patients (8.3%, 166/1,999). In total, 42.8% (71/166) of patients had undergone no previous medical consultation. The most frequent reason for using teledermatology was the waiting time for a dermatology outpatient appointment (62.0%, 103/166). A total of 62.0% (103/166) participants rated the treatment success as good or very good, while 86.1% (143/166) rated the quality of telemedical care as equal or better to that of an outpatient visit. Conclusion: This study showed that patients often use teledermatology because of functional barriers (waiting times). In this cohort, the diagnoses strongly corresponded to reasons for outpatient presentation. Most patients rated the quality of teledermatology service as at least equivalent to that of outpatient physician visits and reported treatment success. Thus, teledermatology can relieve the burden of outpatient care while providing high benefits from the patient's perspective.

Re-Dosing del Nido cardioplegia in adult cardiac surgery: Perfusion characteristics and outcomes--Is there an optimal redosing strategy?

del Nido cardioplegia is utilized for myocardial protection in adult patients undergoing cardiac surgery; however, no standardized re-dosing protocol exists. We describe perfusion characteristics and clinical outcomes in adult cardiac surgery patients who were re-dosed with del Nido cardioplegia. Chart review was performed for adult patients undergoing cardiac surgery (specific inclusion/exclusion criteria below) who received exactly two doses of del Nido cardioplegia from 2012 to 2019; n = 542 patients. The main outcome was a composite endpoint comprised of operative mortality, myocardial infarction, post-operative cardiac support device (CSD), and postoperative decrease in ejection fraction (EF), which was analyzed via multivariable logistic regression (MVLR). A secondary analysis evaluated postoperative vasoactive-inotropic scores (VIS) via gamma log link regression (GLLR) as a more physiologic indication of myocardial recovery. MVLR demonstrated that increased total cardiopulmonary bypass (CPB) time was associated with a positive composite outcome (p < .001), whereas time between doses (p = .237) and the volume of each dose was not (p = .626). GLLR also demonstrated that prolonged CBP, decreased EF, congestive heart failure at time of surgery, and low hematocrit at the start of the surgery were all associated with higher VIS. In this retrospective study, variations in re-dosing strategy for del Nido cardioplegia do not affect postoperative outcomes and increased CPB time is associated with increased operative mortality, myocardial infarction, need for post-operative CSDs, and reduced postoperative EF, and increased VIS, irrespective of the re-dosing strategy. Further studies are warranted to to identify additional patient and operative characteristics that predispose to complications.

Abstract 48: Identifying Temporal Patterns in Healthcare Service-Use Trajectories of Long-Term Breast Cancer Survivors

Abstract Purpose: Advances in the population screening programs and treatment efficacy, as well as, the rapidly aging global population, have led to a gradual increase of the number of long-term breast cancer survivors (BCS) in the past years. With the estimation for their survival rate to continue rising, it has become evident by the clinical and scientific community that BCS should be efficiently monitored in order to obtain a better understanding of their needs and subsequently, improve their medical care, further increase their survivorship and optimize the associated healthcare costs. Methods: A novel data-mining methodology is proposed for the temporal analysis of healthcare service-use trajectories of long-term BCS. Specifically, an unsupervised clustering technique, based on Dynamic Time Warping, is applied on the extracted trajectories of a large longitudinal cohort (SURBCAN) of BCS and non-breast cancer (BC) women, with data on their contacts to all healthcare services. Introducing the time dimension permits the identification of complex time-dependent patterns (clusters) of the services that these women have used throughout the course of a five-year monitoring period. A comparison of the identified time patterns and the respective patient characteristics is also performed between the BCS (case) and non-BC (control) group. Results: More than two hundred clusters representing temporal patterns of healthcare service use, were extracted for both the case and control group. It was found that the BCS group made a more complex and intense use of certain healthcare services, such as, radiology, outpatient care and hospital admission, than the control group. Furthermore, the corresponding mortality rates were significantly higher and a larger number of comorbidities (varying between different clusters) were registered at the beginning of the monitoring period in BCS. Additional patient characteristics and time information for certain paths of the extracted service-use network were reported and analyzed. Conclusion: A flexible data-mining methodology was applied on a longitudinal cohort of long-term BCS for the identification of temporal patterns of healthcare service use, in an attempt to gain more insight into their needs, better predict their evolution, and subsequently, improve their received attention and eventually optimize the associated healthcare costs. Citation Format: Alexia Giannoula, Mercè Comas, José Martín Solorzano Gonzalez, Ferrán Sanz, Xavier Castells, Maria Sala. Identifying Temporal Patterns in Healthcare Service-Use Trajectories of Long-Term Breast Cancer Survivors [abstract]. In: Proceedings of the 11th Annual Symposium on Global Cancer Research; Closing the Research-to-Implementation Gap; 2023 Apr 4-6. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(6_Suppl):Abstract nr 48.

Interdisciplinary feeding clinic during the coronavirus disease 2019 pandemic: Implementing telehealth and social determinants of health screening.

Interdisciplinary feeding clinic during the coronavirus disease 2019 pandemic: Implementing telehealth and social determinants of health screening.

Short- and long-term real-world survival for metastatic bile duct cancer, 2000 to 2018.

523 Background: Real-world survival outcomes in metastatic biliary tract cancer (BTC) are largely unknown. Quoted numbers are often based on reports of clinical trials and hospital registry data and may not be representative of patients treated in the real world. Furthermore, the impact of more widespread adoption of standard combination chemotherapy since 2010 on survival is unclear. We performed a population-based survival analysis of patients who presented with metastatic BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer. Methods: Utilizing the Surveillance, Epidemiology, and End Results (SEER) database, we collected data for patients diagnosed with metastatic BTC from 2000 to 2018 and stratified by overall survival (OS) of ≤ 3 months (short-term survivors) or ≥ 12 months (long-term survivors), before and after 2010. Additional patient and tumor characteristics, including anatomic location, prior surgical intervention, age, sex, race, and marital status were retrieved. Survival was analyzed using the Kaplan-Meier method. Multivariate cox regression models assessing effects of patient and tumor characteristics between short-term and long-term survivors were employed. Results: Of the 13,287 cases retrieved, 57% were female. Median age was 68 years (range 10-100). Prognosis correlated with anatomic location, marital status, and period of diagnosis. 41% of patients were short term survivors and only 20% were long term survivors. Median OS was 4.5 months for the entire cohort. Median OS only improved marginally from 3.5 months pre-2010 to 4.5 months post-2010 ( p&lt;0.001). Long-term survivors tended to be younger, with a median age at diagnosis of 64 years vs 72 years ( p&lt;0.001). Within the long-term survivor cohort, intrahepatic disease was significantly associated with improved outcomes (HR 0.81, 95% CI 0.73 – 0.90, p= 0.001). Conclusions: The real-world prognosis of metastatic BTC is remarkably poorer than described in clinical trials as a large proportion of patients survive less than three months. Over the last decade, the improvement in survival has been minimal.

SPLIT-DOSE BOWEL PREPARATION IS SUPERIOR TO STRAIGHT-DOSE IN HOSPITALIZED PATIENTS UNDERGOING INPATIENT COLONOSCOPY.

There is a two-fold higher rate of failed colonoscopy secondary to inadequate bowel preparation among hospitalized versus ambulatory patients. Split-dose bowel preparation is widely used in the outpatient setting but has not been generally adapted for use among the inpatient population. The aim of this study is to evaluate the effectiveness of split versus single dose polyethylene glycol bowel (PEG) preparation for inpatient colonoscopies and determine additional procedural and patient characteristics that drive inpatient colonoscopy quality. A retrospective cohort study was performed on 189 patients who underwent inpatient colonoscopy and received 4 liters PEG as either split- or straight-dose during a 6-month period in 2017 at an academic medical center. Bowel preparation quality was assessed using Boston Bowel Preparation Score (BBPS), Aronchick Score, and reported adequacy of preparation. Bowel preparation was reported as adequate in 89% of the split-dose group versus 66% in the straight-dose group (P=0.0003). Inadequate bowel preparations were documented in 34.2% of the single-dose group and 10.7% of the split-dose group (P<0.001). Only 40% of patients received split-dose PEG. Mean BBPS was significantly lower in the straight-dose group (Total: 6.32 vs 7.73, P<0.001). Split-dose bowel preparation is superior to straight-dose preparation across reportable quality metrics for non-screening colonoscopies and was readily performed in the inpatient setting. Interventions should be targeted at shifting the culture of gastroenterologist prescribing practices towards use of split-dose bowel preparation for inpatient colonoscopy.

S1187 Clinical and Economic Burden of Patients With HRS-AKI Treated With Current Standard of Care: Retrospective Analysis of Real World Data

Introduction: Hepatorenal syndrome-acute kidney injury (HRS-AKI) is a serious complication in cirrhotic patients, leading to significant morbidity and mortality. The purpose of this study was to evaluate clinical characteristics and treatment (Tx) response of HRS-AKI patients receiving currently available standard of care (SOC) treatment. Methods: Cerner Real World Data (from 113 U.S. health systems) was used to identify adult HRS-AKI (ICD-10, K76.7) patients hospitalized between 2016 and 2020. Patients with baseline serum creatinine (SCr) >1.5mg/dL treated with midodrine (MID), octreotide (OCT), or norepinephrine (NOR) were included. Tx response was assessed based on baseline SCr and post-Tx SCr readings (Day 14 or Tx discontinuation, whichever came first). Complete response was achieved if post-Tx SCr improved to ≤1.5 mg/dL; partial if decreased by ≥30% but remained >1.5 mg/dL; and no response if decreased by < 30%. Tx response by AKI stage using KDIGO guidelines and several comorbidities during hospitalization were also evaluated, including mechanical ventilation (MV), respiratory failure (RF), and fluid overload. Results: A total of 3,918 patients with HRS-AKI (64.5% male, mean age: 59.4±12.7 years) were identified. Most common precipitant included diuretic treatment (79.2%), paracentesis (55.7%), and gastrointestinal bleeding (29.7%). Majority of patients received MID or OCT (n=2,013, 51.4%) or MID+OCT without NOR (n=1,168, 29.8%) and 982 (25.1%) received NOR, regardless of other vasopressors. During hospitalization, 658 (16.8%) patients received MV, of whom 454 (11.6%) had RF. Additionally, 363 patients had RF without MV. Other common comorbid conditions included fluid overload (20.6%), pleural effusion (14.1%), and abdominal pain (9.6%). Complete response was observed in 683 patients overall (17.4%) and patients with AKI stage 1 or 2 (n=2,302) had a higher rate of complete response (13.0% vs 7.6%) and partial response (11.0% vs 8.0%) than patients with AKI stage 3. Additional patient and clinical characteristics are shown in Table. Conclusion: At least one in six HRS-AKI patients required mechanical ventilation, had RF and/or fluid overload during hospitalization. Current SOC for HRS-AKI was ineffective. The results also suggest an inverse relationship between KDIGO-staged AKI and rate of complete response, indicating a benefit for earlier diagnosis and treatment initiation. Table 1. - Additional Patient and Clinical Characteristics Characteristic N=3,918 Patient Demographics Age, years, mean ± SD 59.4 ± 12.7 Male, n (%) 2,528 (64.5) Ethnicity, n (%) White or Caucasian 3,243 (68.2) Black or African American 325 (6.8) Other 1,036 (21.8) Unknown 151 (3.2) Clinical Characteristics Baseline SCr*, mg/dL, mean ± SD 3.0 ± 1.7 Selected treatments, n (%) Midodrine or Octreotide without norepinephrine 2,013 (51.4) Midodrine and Octreotide without norepinephrine 1,168 (29.8) Norepinephrine (regardless of any other vasopressor) 982 (25.1) Etiology of liver disease*, n (%) Alcoholic cirrhosis/hepatitis 1,779 (45.4) Viral hepatitis 560 (14.3) NASH/NAFLD 1,728 (44.1) Precipitants of HRS-AKI*, n (%) Diuretic treatment 3,104 (79.2) Paracentesis 2,183 (55.7) Gastrointestinal bleeding 1,163 (29.7) Other infections 1,101 (28.1) Spontaneous bacterial peritonitis 690 (17.6) Hepatocellular carcinoma 374 (9.5) Use of mechanical ventilation and rate of respiratory failure, n (%) Mechanical ventilation 658 (16.8) Respiratory failure 454 (11.6) No respiratory failure 204 (5.2) No mechanical ventilation 3,260 (83.2) Respiratory failure 363 (9.3) No respiratory failure 2,897 (73.9) Response type by KDIGO-staged AKI No AKI, n (%) 1,103 (28.2) Complete response, n (% of no AKI) 345 (31.3) Partial response, n (% of no AKI) 146 (13.2) No response, n (% of no AKI) 612 (55.5) Stage 1 or 2 AKI, n (%) 2,302 (58.8) Complete response, n (% of Stage 1 or 2 AKI) 299 (13.0) Partial response, n (% of Stage 1 or 2 AKI) 244 (10.6) No response, n (% of Stage 1 or 2 AKI) 1,759 (76.4) Stage 3 AKI, n (%) 513 (13.1) Complete response, n (% of Stage 3 AKI) 39 (7.6) Partial response, n (% of Stage 3 AKI) 41 (8.0) No response, n (% of Stage 3 AKI) 433 (84.4) Comorbid conditions during hospitalization, n (%) Sepsis 846 (21.6) Respiratory failure 817 (20.9) Fluid overload 807 (20.6) Pleural effusion 553 (14.1) Abdominal pain 354 (9.0) Diarrhea 199 (5.1) Bradycardia 123 (3.1) Dyspnea 89 (2.3) Nausea 54 (1.4) *not mutually exclusive. Abbreviations: AKI, acute kidney injury; HRS, hepatorenal syndrome; KDIGO, Kidney Disease Improving Global Outcomes; NAFLD, non-alcoholic fatty liver disease; NASH, non-alcoholic steatohepatitis; SCr, serum creatinine; SD, standard deviation.

Modified DIVA Score: An Improved Clinical Predictive Tool for Detecting Difficult Access in Children.

This study aims to validate the DIVA (Difficult Intravenous Access) score in our population and to identify any additional patient characteristics that may be associated with difficult access in children. This was a cross-sectional study in an urban quaternary pediatric emergency department with patients younger than 21 years and Emergency Severity Index ≥2 who require intravenous (IV) access for their management. In addition to patient characteristics comprising the DIVA score, data were collected on patient "history of difficult access," hydration status, skin shade, history of sickle cell disease or diabetes, technology dependence, and body mass index. The number of IV cannulation attempts and total time taken were recorded for each patient. "Difficult access" was defined as ≥2 or more attempts or time >30 minutes to achieve successful IV cannulation. A convenience sample of 300 pediatric patients was enrolled. The DIVA score had a sensitivity of 51% (95% confidence interval [CI], 40.8%-61.14%) and a specificity of 82.99% (95% CI, 76.95%-87.99%) for predicting "difficult access" in our population. Among all patient characteristics examined in this study, only "history of difficult access" improved the identification of "difficult access" patients. The "history of difficult access" variable had a sensitivity of 61% (95% CI, 50.7%-70.6%) and a specificity of 75.7% (95% 95% CI, 69.12%-81.62%) in predicting "difficult access." With the addition of "history of difficult access" to the original DIVA score, we developed a "modified DIVA score (m-DIVA)." The m-DIVA score had a sensitivity of 78% (95% CI, 68.6%-85.6%) and specificity of 67% (95% CI, 59.9%-73.58%), representing a 52.9% improvement in correctly identifying "difficult access" patients over the original DIVA score. The m-DIVA score, which incorporates prior history, increases the screening test's sensitivity in identifying "difficult access" patients and should be further investigated as clinical tool.

Factors affecting MRI scanner efficiency in an academic center.

To determine which patient characteristics influence MRI scan time and how. A database search of outpatient MRI liver examinations on 1.5T and 3T scanners from 1/1/2019 to 4/4/2019 was performed using an in-house developed software tool. Mean and median scan times were calculated. Patients who had difficulty following breathing instructions or completing breath-hold sequences were identified. Twenty-one additional patient characteristics were obtained from an Electronic Medical Record (EMR) search. Scan times were significantly increased for patients with breath-holding issues during the exam (N = 43, median = 23.98min) versus not (N = 179, median = 17.5min, p < 0.001). Among patients who had difficulty following breathing instructions/completing breath-hold sequences, a significant number were non-native English speakers (23/43, 53%) compared to those whose first language was English (48/179, 27%, p < 0.001). Breath-holding issues were also significantly more frequent for patients requiring a translator during the exam (15/43, 35%) versus those who did not (24/179, 13%, p < 0.001). No other patient characteristics showed a significance difference between those with breathing issues and those without. Patient characteristics that caused a significant number of scan times to be one standard deviation or more above the median were as follows: Breath-holding issues during exam (21/43 ≥ one SD above, 51%, versus 22/189 < one SD above, 12%, p < 0.001); and first language not English (16/71 ≥ one SD above, 23%, versus 55/189 < one SD above, 29%, p = 0.03). The ability to follow breathing instructions and complete breath-hold sequences had a significant impact on patient scan time. Patients who were not native English speakers had more frequent breathing issues during scans and significantly longer scans times compared native English speakers.

Risk Factors Associated With Mortality and Neurologic Disability After Intracerebral Hemorrhage in a Racially and Ethnically Diverse Cohort

Intracerebral hemorrhage (ICH) is the most severe subtype of stroke. Its mortality rate is high, and most survivors experience significant disability. To assess primary patient risk factors associated with mortality and neurologic disability 3 months after ICH in a large, racially and ethnically balanced cohort. This cohort study included participants from the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study, which prospectively recruited 1000 non-Hispanic White, 1000 non-Hispanic Black, and 1000 Hispanic patients with spontaneous ICH to study the epidemiological characteristics and genomics associated with ICH. Participants included those with uniform data collection and phenotype definitions, centralized neuroimaging review, and telephone follow-up at 3 months. Analyses were completed in November 2021. Patient demographic and clinical characteristics as well as hospital event and imaging variables were examined, with characteristics meeting P < .20 considered candidates for a multivariate model. Elements included in the ICH score were specifically analyzed. Individual characteristics were screened for association with 3-month outcome of neurologic disability or mortality, as assessed by a modified Rankin Scale (mRS) score of 4 or greater vs 3 or less under a logistic regression model. A total of 25 characteristics were tested in the final model, which minimized the Akaike information criterion. Analyses were repeated removing individuals who had withdrawal of care. A total of 2568 patients (mean [SD] age, 62.4 [14.7] years; 1069 [41.6%] women and 1499 [58.4%] men) had a 3-month outcome determination available, including death. The final logistic model had a significantly higher area under the receiver operating characteristics curve (C = 0.88) compared with ICH score alone (C = 0.76; P < .001). Among characteristics associated with neurologic disability and mortality were larger log ICH volume (OR, 2.74; 95% CI, 2.36-3.19; P < .001), older age (OR per 1-year increase, 1.04; 95% CI, 1.02-1.05; P < .001), pre-ICH mRS score (OR, 1.62; 95% CI, 1.41-1.87; P < .001), lobar location (OR, 0.22; 95% CI, 0.16-0.30; P < .001), and presence of infection (OR, 1.85; 95% CI, 1.42-2.41; P < .001). The findings of this cohort study validate ICH score elements and suggest additional baseline and interim patient characteristics were associated with variation in 3-month outcome.

Early Rooming Triage: Accuracy and Demographic Factors Associated with Clinical Acuity.

IntroductionEarly rooming triage increases patient throughput and satisfaction by rapidly assigning patients to a definitive care area, without using vital signs or detailed chart review. Despite these operational benefits, the clinical accuracy of early rooming triage is not well known. We sought to measure the accuracy of early rooming triage and uncover additional patient characteristics that can assist triage.MethodsWe conducted a single-center, retrospective population study of walk-in emergency department (ED) patients presenting to the ED via an early rooming triage system, examining triage accuracy and demographic factor correlation with higher acuity ED outcomes.ResultsAmong all patients included from the three-year study period (N = 238,457), early rooming triage was highly sensitive (0.89) and less specific (0.61) for predicting which patients would have a severe outcome in the ED. Patients triaged to the lowest acuity area of the ED experienced severe outcomes in 4.39% of cases, while patients triaged to the highest acuity area of the ED experienced severe outcomes in 65.9% of cases. An age of greater than 43 years (odds ratio [OR] 3.48, 95% confidence interval: 3.40, 3.57) or patient’s home address farther from the ED ([OR] 2.23 to 3.08) were highly correlated with severe outcomes. Multivariable models incorporating triage team judgment were robust for predicting severe outcomes at triage, with an area under the receiver operating characteristic of 0.82.ConclusionEarly rooming workflows are appropriately sensitive for ED triage. Consideration of demographic factors, automated or otherwise, can augment ED processes to provide optimal triage.

Abstract P1-18-29: Male patients with hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) receiving palbociclib in the real-world: patient characteristics, treatment patterns, and outcomes from the POLARIS study

Abstract Background: Although male breast cancer accounts for &amp;lt;1% of all breast cancer diagnoses, its incidence is increasing. Palbociclib in combination with an aromatase inhibitor or fulvestrant is indicated for treating HR+/HER2- ABC in men. Adding to a previous analysis describing real-world patient characteristics and treatment patterns in men with HR+/HER2- ABC, this analysis describes additional patient characteristics, study site characteristics, and preliminary tumor response data in male patients enrolled in the POLARIS study. Methods: POLARIS is a prospective, noninterventional real-world study of patients with HR+/HER2- ABC who received palbociclib as deemed appropriate by a physician; the targeted enrollment is 1500 patients from approximately 110 US and Canadian sites. Patient and study site data were collected from the treating physicians’ routine clinical assessments (eg, patient medical charts, surveys, site questionnaires). Real-world tumor response was determined based on the treating physicians’ assessments of imaging results and clinical progression. Results: As of December 17, 2020, 15 men were enrolled across 12 US sites; most were community-based sites (75%; Table 1) and most physicians (58.3%) had been treating patients with ABC for 11-20 years. The median age of patients was 66 years, 46.7% of patients had visceral disease, and 41.7% had bone-only disease. Seven patients received palbociclib plus an aromatase inhibitor, 7 patients received palbociclib plus fulvestrant, and 1 patient received palbociclib plus tamoxifen. Two patients initiated palbociclib treatment at 100 mg due to comorbidities. Five patients had ≥1 comorbidity (ie, anemia, neutropenia, cellulitis, myocardial infarction, hypertension, neoplasm, or cerebrovascular disorder). All patients received ≥1 concomitant medications (Table 2). Medications commonly received included antihyperglycemics (53.3%), antidepressants (46.7%), opioids (40.0%), antihyperlipidemics (26.7%), and antithrombotics (26.7%). Among all 15 patients, 1 had a best tumor response of complete response (CR) and 4 patients had a partial response (PR), as reported by the physician. Among patients who received palbociclib in the first-line setting (n=9), 1 had a CR and 3 had a PR, as reported by the physician. Conclusions: These findings add to the current knowledge of the male patient population enrolled in the POLARIS study and provide preliminary information on clinical outcomes. This population represents a real-world patient cohort with a heavy disease burden. Although longer follow-up of this patient cohort is warranted, these results continue to support palbociclib as a treatment for men with HR+/HER2- ABC. Pfizer (NCT03280303). Table 1.US Study Site CharacteristicsSite characteristicSites (N=12), n (%)Geographic locationSouth8 (66.7)Midwest3 (25.0)West1 (8.3)Site categoryCommunity9 (75.0)Academic1 (8.3)Other2 (16.7)Number of treating physicians at the practice*Median (range)12 (3-30)Distribution1-104 (33.3)11-205 (41.7)21-302 (16.7)Not reported1 (8.3)Number of breast cancer cases treated annually†Median (range)350 (50, 3000)Distribution50-1502 (16.7)&amp;gt;1508 (66.7)Not reported2 (16.7)Number of HR+/HER2- A/MBC cases treated annually†Median (range)100 (20, 600)Distribution&amp;lt;503 (25.0)50-1503 (25.0)&amp;gt;1504 (33.3)Missing2 (16.7)Use of clinical pathwaysYes7 (58.3)No5 (41.7)A/MBC=advanced/metastatic breast cancer. *Data missing for 1 site; †data missing for 2 sites. Table 2.Documented Concomitant Medications Received in &amp;gt;10% of Patients*MedicationPatients (N=15), n (%)Antihyperglycemics8 (53.3)Metformin4 (26.7)Glimepiride2 (13.3)Antidepressants7 (46.7)Anxiolytics7 (46.7)Alprazolam4 (26.7)Buspirone2 (13.3)Vitamin A and D, including combinations6 (40.0)Cholecalciferol6 (40.0)Opioids6 (40.0)Procet2 (13.3)Calcium3 (20.0)Other analgesics and antipyretics6 (40.0)Paracetamol3 (20.0)Antiemetics and antinauseants5 (33.3)Prochlorperazine3 (20.0)Ondansetron2 (13.3)Antihyperlipidemics4 (26.7)Atorvastatin2 (13.3)Antithrombotics4 (26.7)Rivaroxaban2 (13.3)Peptic ulcer and GORD medications4 (26.7)Pantoprazole2 (13.3)Thyroid medications3 (20.0)Levothyroxine3 (20.0)Angiotensin II receptor blockers3 (20.0)Losartan3 (20.0)ACE inhibitors2 (13.3)Lisinopril2 (13.3)Low-ceiling diuretics, thiazides2 (13.3)Hydrochlorothiazide2 (13.3)High-ceiling diuretics2 (13.3)Furosemide2 (13.3)Vitamin B12 and folic acid2 (13.3)Cyanocobalamin2 (13.3)Hypnotics and sedatives2 (13.3)Zolpidem2 (13.3)ACE=angiotensin-converting enzyme; GORD=gastro-oesophageal reflux disease.*Specific medications received by &amp;gt;10% of patients; information is entered voluntarily and is subject to missing data. This list is not exhaustive. Citation Format: Joanne Blum, Caroline DiCristo, David Gordon, Meghan Karuturi, David Oubre, Erin Jepsen, Juan Cuevas, Shailendra Lakhanpal, Zhe Zhang, Yao Wang, Debu Tripathy. Male patients with hormone receptor positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) receiving palbociclib in the real-world: patient characteristics, treatment patterns, and outcomes from the POLARIS study [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P1-18-29.

Regional anesthesia reduces inpatient and outpatient perioperative opioid demand in periarticular elbow surgery

Regional anesthesia (RA) can be used to manage perioperative pain in the treatment of periarticular elbow fracture fixation. However, the opioid-sparing benefit is not well-characterized. The hypothesis of this study was that RA had reduced inpatient opioid consumption and outpatient opioid demand in patients who had undergone periarticular elbow fracture surgery. This study retrospectively reviews inpatient opioid consumption and outpatient opioid demand in all patients aged ≥18 years at a single Level I trauma center undergoing fixation of periarticular elbow (distal humerus and proximal forearm) fracture surgery (n=418 patients). In addition to RA vs. no RA, additional patient and operative characteristics were recorded. Unadjusted and adjusted models were constructed to evaluate the impact of RA and other factors on inpatient opioid consumption and outpatient opioid demand. Adjusted models demonstrated decreases in inpatient opioid consumption postoperation in patients with RA (13.7 estimated oxycodone 5-mg equivalents or OEs without RA vs. 10.4 OEs with RA from 0 to 24 hours postoperation, P = .003; 12.3 vs. 9.2 OEs from 24 to 48 hours postoperation, P = .045). Estimated cumulative outpatient opioid demand differed significantly in patients with RA (166.1 vs. 132.1 OEs to 6 weeks, P = .002; and 181 vs. 138.6 OEs to 90 days, P < .001). In proximal forearm and distal humerus fracture surgery, RA was associated with decreased inpatient and outpatient opioid demand after adjusting for baseline patient and treatment characteristics. These results encourage utilization of perioperative RA to reduce opioid use.