Virginia Mason Research Articles

Identification of biomarkers for COVID-19 associated secondary hemophagocytic lymphohistiocytosis.

We aimed to define and validate novel biomarkers that could identify individuals with COVID-19 associated secondary hemophagocytic lymphohistiocytosis (sHLH) and to test whether fatalities due to COVID-19 in the presence of sHLH were associated with specific defects in the immune system. In two cohorts of adult patients presenting with COVID-19 in 2020 and 2021, clinical lab values and serum proteomics were assessed. Subjects identified as having sHLH were compared to those with COVID-19 without sHLH. Eight deceased patients defined as COVID-sHLH underwent genomic sequencing in order to identify variants in immune-related genes. Two tertiary care hospitals in Seattle, Washington (Virginia Mason Medical Center and Harborview Medical Center). 186 patients with COVID-19. None. Nine percent of enrolled COVID-19 subjects met our defined criteria for sHLH. Using broad serum proteomic approaches (O-link and SomaScan), we identified three biomarkers for COVID-19 associated sHLH (soluble PD-L1, TNF-R1, and IL-18BP), supporting a role for proteins previously associated with other forms of sHLH (IL-18BP and sTNF-R1). We also identified novel biomarkers and pathways of COVID-sHLH, including sPD-L1 and the syntaxin pathway. We detected variants in several genes involved in immune responses in individuals with COVID-sHLH, including in DOCK8 and in TMPRSS15, suggesting that genetic alterations in immune-related genes may contribute to hyperinflammation and fatal outcomes in COVID-19. Biomarkers of COVID-19 associated sHLH, such as soluble PD-L1, and pathways, such as the syntaxin pathway, and variants in immune genes in these individuals, suggest critical roles for the immune response in driving sHLH in the context of COVID-19.

Abstract PO4-16-09: Enhancing Research on Inflammatory Breast Cancer through Count Me In: Assessing the Accuracy of Self-Reported Diagnoses

Abstract Background: Inflammatory breast cancer (IBC) is a rare and aggressive form of breast cancer that relies on clinical identification of specific breast changes for diagnosis, in addition to pathological confirmation of invasive breast cancer. There is a clear need to increase participation of patients with IBC in research to better understand its clinical course and optimal treatment strategy. Count Me In (CMI) is a nonprofit research initiative that enables patients across the United States and Canada to accelerate cancer research by sharing their clinical data and biospecimens. The Metastatic Breast Cancer Project (MBCProject) was the first CMI initiative and is a prospective longitudinal cohort designed to capture these data from patients with metastatic breast cancer. Methods: We reviewed available medical records of patients participating in the MBCProject and who self-reported as having IBC. Records were reviewed by a study team member to identify documentation by a provider of an IBC diagnosis. For records without a documented IBC diagnosis, the clinical symptoms were assessed using a novel quantitative IBC scoring system (Mason G et al. BCRF 2022) currently being validated. Finally, records were also assessed by a physician for final determination of an IBC diagnosis. Records were classified as “concordant” or “not concordant”. Concordant is defined as “review of medical records confirms IBC using the unifying set of specific diagnostic criteria”. We desired the rate of concordant cases to be ≥90%; if ≤ 85% it would be considered as unacceptable to rely solely on patient self-report of IBC diagnosis in future research. Results: We reviewed records of 79 patients participating in the MBCProject who self-identified as having IBC and had medical records collected. Of these, 51 (64.5%) had IBC stated in providers’ notes. Of the remaining 28 patients, 6/28 met criteria for IBC using the new IBC diagnostic criteria, 17/28 didn’t have evidence of IBC based on the records available and 6/28 we were unable to make a final determination due to lack of records at the time of initial diagnosis. In total, 57/79 (72%; 95% CI 61-82%) patients had a concordant diagnosis. Conclusion: Patient self-report registries such as CMI are invaluable for the collection of clinical information and biospecimens for research of patients with rare diseases, however, a self-reported diagnosis of IBC may not be reliable. To improve the accurate identification of IBC, optimization of the questions asked to patients on these registries is warranted. This may include additional screening questions such as specific skin findings and timing of onset of symptoms. Focusing on patients with stage III IBC may also provide a better patient population to test this strategy. Citation Format: Elizabeth Troll, Sean Ryan, Virginia (Ginny) Mason, Mariesa D. Powell, Aditi Hazra, Nikhil Wagle, Mary McGillicuddy, Sara Tolaney, Meredith Regan, Filipa Lynce. Enhancing Research on Inflammatory Breast Cancer through Count Me In: Assessing the Accuracy of Self-Reported Diagnoses [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-16-09.

Intraoperative Prophylaxis with Palonosetron for Postoperative Nausea and/or Vomiting in Adults Undergoing Cardiothoracic Surgery Under General Anesthesia: A Single-Center Retrospective Study

This study assessed the efficacy of palonosetron, alone or with dexamethasone, in reducing postoperative nausea and/or vomiting (PONV) and its impact on hospitalization duration in patients who undergo adult cardiothoracic surgery (CTS) under general anesthesia. This retrospective analysis involved 540 adult patients who underwent CTS from a single-center cohort, spanning surgeries between September 2021 and March 2023. Sensitivity, logistic, and Cox regression analyses evaluated antiemetic effects, PONV risk factors, and outcomes. At the Virginia Mason Medical Center (VMMC), Seattle, WA. Adults undergoing cardiothoracic surgery at VMMC during the specified period. Patients were categorized into the following 4 groups based on antiemetic treatment: dexamethasone, palonosetron, dexamethasone with palonosetron, and no antiemetic. Primary outcomes encompassed PONV incidence within 96 hours postoperatively. Secondary outcomes included intensive care unit stay duration and postoperative opioid use. Palonosetron recipients showed a significantly lower PONV rate of 42% (v controls at 63%). The dexamethasone and palonosetron combined group also demonstrated a lower rate of 40%. Sensitivity analysis revealed a notably lower 0- to 12-hour PONV rate for palonosetron recipients (9% v control at 28%). Logistic regression found decreased PONV risk (palonosetron odds ratio [OR]: 0.24; dexamethasone and palonosetron OR: 0.26). Cox regression identified varying PONV hazard ratios related to female sex, PONV history, and lower body mass index. This single-center retrospective study underscored palonosetron's efficacy, alone or combined with dexamethasone, in managing PONV among adult patients who undergo CTS. These findings contribute to evolving antiemetic strategies in cardiothoracic surgery, potentially impacting patient outcomes and satisfaction positively.

Effects of pancreatic enzyme replacement therapy (PERT) on overall survival (OS) in patients (pts) with advanced pancreatic ductal adenocarcinoma (APDAC) and evidence of pancreatic enzyme insufficiency (PEI): A single institution, retrospective, cohort study.

e16254 Background: Weight loss (WL)/cachexia is common in APDAC and associated with multiple adverse pt outcomes. Current NCCN guidelines recommend PERT in PDAC patients with PEI. However, little evidence exists regarding PERT use and clinical outcomes in PDAC, especially APDAC. We present here data on impact of PERT use from our institution. Methods: Study pts were identified from the Virginia Mason PDAC database (01-2010-12/2019). Eligibility criteria included: 1) No upfront resection, 2) no prior PDAC therapy, 3) FE 1 < 200 µg/g or documented evidence of PEI at diagnosis, 4) treatment at least to initial restaging event (8 wks), and 5) data regarding PERT use/dosage available. Pts were stratified by PERT/non-PERT usage. PERT use was defined by prescription for >50% of time from initial Rx to 1st restage using recommended dosing per package insert. Pts on PERT for < 50% of time during this time frame and/or prescribed less than recommended dose were excluded from analysis. Results: 505 total pts were study eligible, PERT 197(39%), non-PERT 308(61%). WL (80 vs 65%, p< 0.001) and cachexia (74 v 54%, p<0.001) were more common in PERT pts. ECOG PS 2 (4 vs 9%, p=0.02) and non-metastatic disease (51 vs 40%, p=0.02) more common in non-PERT pts. Other pt characteristics (age, sex, diabetes at dx, serum albumin, NLR, BMI distribution, % obese) were similar in both groups. OS after adjustment for PS and stage was 15.7 mo (95% CI 13.6-18.3 mo) among PERT users vs. !2.6 mo non-PERT users (95% CI 11.0 -13.7 mo, p=0.02, adjusted hazard ratio 0.81 (95% CI 0.67-0.99). Pts receiving PERT also tended to have a higher therapeutic response rate by both Ca 19.9 and CT: but without statistical significance (p=0.10, 0.09, respectively). Regarding nutrition, PERT vs. non-PERT pts at 8 weeks experienced less WL (-0.4 vs. -1.5 kg, p=0.03) and less change in BMI (-0.3 vs -1.6, p=0.02). This was true even in cachectic pts at dx (change in BMI + 0.1 vs -1.7, p=0.01). Additional analyses of impact of PERT on QOL are ongoing, including in a subset of patients who underwent serial PG-SGA scoring. Conclusions: In this pt cohort, APDAC pts prescribed PERT per recommended dosing had a statistically significant improvement in median OS vs. those not prescribed PERT. This remained true in multivariate analysis after adjustment for population imbalances. PERT use was also associated with a statistically significant reduction in weight loss and change in BMI at 8 weeks, even in those patients defined as cachectic at diagnosis. Further investigation into a) impact of PERT on quality of life, b) mechanisms producing the above observations, c) confirmatory observations in independent datasets, and d) additional therapeutic interventions designed to mitigate weight loss/cachexia in PDAC are needed.

Spillover of chalkbrood fungi to native solitary bee species from non‐native congeners

Abstract Introduced, managed bees such as mason bees (genus Osmia) can confer significant pollination benefits to agricultural systems, but a risk of introducing non‐native species into new ecosystems is the co‐introduction of pathogens along with them. Pathogen spillover to wild, native bees may then drive native bee species declines. This study examined prevalence of the chalkbrood‐causing fungal genus Ascosphaera in the nests of both non‐native and native mason bee species. We conducted large‐scale trap‐nesting and pan‐trapping efforts across the Mid‐Atlantic United States with community scientists. Using molecular methods, nests were screened for all known Ascosphaera species in which genetic sequences have been published. After finding Ascosphaera species first described in Asia, we compared their local prevalence with the local abundance of mason bees from Asia. Lastly, we compared the prevalence of co‐introduced Ascosphaera species across sites with a variety of landcover profiles. Results indicate species originally described in Japan, Ascosphaera naganensis and Ascosphaera fusiformis, are now present in native Virginia mason bees, Osmia lignaria and Osmia georgica, with high prevalence of A. naganensis found in O. georgica. We also found that the declining native mason bee O. georgica experienced higher prevalence of non‐native Ascosphaera spp. at sites with larger numbers of non‐native O. cornifrons and O. taurus, perhaps indicating greater likelihood of spillover of these Ascosphaera species with greater sources of transmission. Lastly, when the proportion of agricultural landcover surrounding bee nests was high, there was greater prevalence of non‐native Ascosphaera in O. georgica compared to more natural landcover types. Synthesis and applications. Through community science programming, we documented species of Japanese chalkbrood fungi inside native mason bee nests in North America. Native mason bees encounter non‐native fungi more frequently with increasing abundance of non‐native mason bees. Agricultural landscapes may exacerbate spillover of non‐native fungi for native mason bees. Any use of non‐native bee species in agriculture should involve monitoring native bees for pathogens in the surrounding area for detection of spillover and species declines.

Rudeness and civility in health care

Rudeness and civility in health care

Communications

Communications Alden T. Vaughan and Miles P. Grier To the Editor: The recent announcement that the 2022 Douglass Adair Memorial Award winner is "Staging the Cherokee Othello: An Imperial Economy of Indian Watching" by Miles P. Grier in the January 2016 issue of the William and Mary Quarterly prompts me to submit a minor correction. Professor Grier wonders if a book that Virginia Mason Vaughan and I coauthored, Shakespeare in America, "doubt[s] the veracity of the story" (78) regarding the Cherokee performance of 1752, the principal subject of his article. Interested readers will find the episode discussed in our book on pp. 22–23.1 Alden T. Vaughan Columbia University, emeritus Response to Letter to the Editor: I met Professors Alden and Virginia Mason Vaughan in May of 2016 when Virginia and I spoke on the same panel at "America's Shakespeare," an event sponsored by the Brown University Library and Rhode Island Historical Society. On that occasion, Alden informed me of the substance of this letter. I had written that the Vaughans' Shakespeare in America "omit[ted] the Cherokees from their discussion of the first season of professional theater offered in North America" (78) in 1752. I speculated in the article that perhaps this omission indicated that they doubted the veracity of the Virginia Gazette's report. He noted that they do discuss the incident several pages later. I was mortified, at first. How could I have made such an error? When I got my hands on a copy, I realized that I was not entirely wrong. After moving from that first season of 1752 to the 1770s, the Vaughans include an interlude without a subheading, stepping out of the chapter's chronological order to loop back and cover together all the records of Cherokees at colonial American playhouses. [End Page 428] I addressed the matter. For the revised version of the article, appearing in my book Inkface: "Othello" and White Authority in the Era of Atlantic Slavery (forthcoming from University of Virginia Press in late 2023), I moved the Vaughans' book from a footnote listing scholars who pass over the Cherokees' interruption of the 1752 performance of Othello to one containing those who give credence to the Virginia Gazette's implication that the empress of the Cherokees could not grasp the concept of playacting. That decision reflects the fact that the Vaughans eventually credit the "veracity" of the Virginia Gazette's short article on the interrupted performance. At first, though, they adopt a neutral stance: "What the Indians thought of Shakespeare's play is unrecorded, but a newspaper reported that they expressed 'great surprise' at the Harlequin pantomime afterpiece, 'as did the fighting with naked swords on the stage, which occasioned the empress to order some about her to go and prevent their killing one another.'" Here, the Vaughans decline to speculate on what motivated the surprised expressions and the command to intervene in the action. However, later they write that British Atlantic playhouses hosted "overflow audiences [who] came to ogle exotic strangers struggling to comprehend Shakespearian drama." While their choice of "exotic" suggests that the authors are ventriloquizing an imperial view that they do not share, the phrase "struggling to comprehend Shakespearian drama" transforms an inference that depends upon the reliability of the Gazette's depiction into a fact.2 The Cherokees who attended the command performance at Williamsburg in 1752 were seasoned diplomats representing a sovereign polity. Since they were not subject to the pressure to "comprehend Shakespearian drama" familiar to modern-day ticketholders or students taking a compulsory course, I decided a different question was in order. Rather than asking whether Cherokees had enough Anglo cultural competency to understand the speech and action of Othello, I asked whether the Virginia Gazette could be relied upon to "comprehend" what in Othello could have provoked chief Amouskositte's wife to disrupt the ceremonies surrounding negotiations to establish diplomatic and economic ties between her people and Virginia. I concluded that it was likely that the spectacle of a blacked-up personage's arrest at the hands of an armed white guard signaled to her that Virginia would insist on jurisdiction over Cherokees accused of crimes...

Virginia Mason Applies Quality Improvement Efforts to Morehouse School of Medicine Partnership

Virginia Mason Applies Quality Improvement Efforts to Morehouse School of Medicine Partnership

Effect of pancreatic enzyme replacement therapy (PERT) on body weight in advanced pancreatic cancer (APC).

698 Background: Malnutrition/cachexia is common in PC and is associated with multiple adverse patient (pt) outcomes. Current NCCN guidelines recommend PERT in PC pts with exocrine pancreatic insufficiency (EPI). However, little evidence exists regarding the impact of PERT on clinical outcomes in PC, especially APC. Data on impact of PERT use on change in body weight is presented here. Methods: Pts in this retrospective cohort study were identified from the Virginia Mason PC database. Eligibility requirements included: 1) no upfront resection 2) no prior PC therapy 3) pancreatic stool elastase 1< 200 µg/g stool or documented clinical evidence of EPI at diagnosis 4) treatment at least to initial restaging event (8 weeks) 5) available data regarding PERT use/dosage. Weight/BMI was assessed at baseline and after 8 weeks on therapy. Two pt groups were compared; a) pts prescribed PERT for EPI at recommended package insert dose (≥ 500KU-2500/kg/meal for ≥ 3 meals/day) for ≥ 50% treatment period and b) pts who received no PERT. Pts on PERT at lower than recommended dose and /or < 50% interval between 1st treatment and reassessment were excluded from analysis. Statistical significance was determined using the T-test for continuous variables, chi-squared for categorical variables. Results: 505 total pts were study eligible; 197 (39%) pts received PERT, 308 (61%) pts did not. Pt characteristics are shown. Despite a more adverse patient population with respect to weight loss, pts receiving PERT after 8 weeks experienced less change in weight (-0.36 kg vs -1.54 kg, P = 0.025) and change in BMI ( -0.64% vs -1.96., p= 0.026). Pts with cachexia experienced a similar outcome (-0.36% vs. -2.02 %, p= 0.026). No other pt characteristics achieved statistical significance. Conclusions: Despite a more adverse population with respect to weight loss at baseline, PERT usage prescribed per package insert guidance reduced wt loss/ change in BMI loss in APC over the 1st 8 weeks of therapy. This was also true in APC pts with cachexia. Further analysis of the impact of PERT therapy in APC with respect to treatment tolerability, and toxicity, quality of life and overall survival is warranted. [Table: see text]

Polityka wprowadzania najlepszych praktyk zarządzania (NPZ) w podmiotach leczniczych na świecie. Studium przypadku Virginia Mason Hospital w Stanach Zjednoczonych

The subject of the article is the best management practices (j. polski: NPZ) implemented in medical entities around the world. The implementation of NPZ was presented on the example of Virginia Mason Hospital in Washington State in the United States. The aim of the article is to show the advantages and benefits resulting from the implementation of NPZ in medical entities. During the considerations, answers were sought to the research questions: 1) how can NPZ be used in medical entities?; 2) how can the practice and experience of Virginia Mason Hospital be used in implementing NPZ in other healthcare entities? The article uses the system analysis method to study the United States health system and the NPZ implementation system at Virginia Mason Hospital, which required the use of a qualitative method. The comparative method was used to study differences in the implementation of NPZ. The research results were presented using a descriptive method.

Creation of standard work for the management of outpatient oral antineoplastic therapy.

369 Background: Recently, there has been a dramatic increase in the use of oral antineoplastics for the treatment of various malignancies. The development of these agents has been so rapid that the infrastructure needed for their appropriate supervision has trailed their availability. Previously at Virginia Mason, there was no standard work established for the management of patients starting these agents and consequently there were defects noted, including delays in the medications’ delivery to the patient, lack of appropriate teaching regarding potential medication toxicities and even delayed provider follow-up. The goal of this project was to create standard work around the treatment initiation and follow-up of all patients starting outpatient oral antineoplastic therapy. Methods: A multi-disciplinary team of providers, nurses, and pharmacists held a flow mapping session to identify defects and waste points in the process between the prescription being written until the first provider follow-up visit after medication delivery. The team focused on decreasing the amount of time between prescription initiation and first clinic follow up, as well as increasing the percentage of RN teaching sessions performed and documented. This involved the creation of a dedicated inbox in the Electronic Medical Record (EMR) to which pharmacy and care manager nurses had exclusive access to facilitate rapid communication between team members. The work also resulted in the creation of an antineoplastics teaching template which was used to document teaching on potential treatment toxicities. Results: Standard work was created for the outpatient oral antineoplastic administration process and teaching documentation. Using the new tools, lead time was improved by 21.7% and teaching documentation was improved by 185% at the 30-day mark. These metrics were monitored over a 3 month period, and at the end of 90 days the lead time improvement was maintained at 21.2% and teaching documentation improvement at 110% (Table). Conclusions: The rapid development of oral antineoplastic medications has required Oncology practices to develop more robust workflow infrastructure to administer these medications properly and safely. We created standard work for the proper initiation and follow-up of oral antineoplastic therapy. In doing so we identified specific defects and instances of waste and were able to improve the workflow process to address these issues, resulting in measurable quality improvements and overall better patient care.[Table: see text]

Pagetoid Dyskeratosis of the Hand With Parallel Ridge Pattern on Dermoscopy and Expression of Bcl-10 by Immunohistochemistry.

*Department of Dermatology, Oregon Health and Science Center, Portland Oregon †Department of Dermatology, Valley Medical Center, Renton Washington; and ‡Department of Pathology, Virginia Mason Medical Center, Seattle WA. Correspondence: Steven M. Ruhoy, MD, Department of Pathology, Virginia Mason Medical Center, Seattle WA (e-mail: [email protected]). The authors declare no conflicts of interest.

BUILDING A CONTROL CENTER IN THE HEART OF CARDIOLOGY

As a registered nurse since 2001, I have watched how remote monitoring has crippled cardiology device clinics, often creating inconsistencies in patient care, clinician burn-out, and liability for practitioners. Working in partnership with The Virginia Mason Heart Institute and Seven Simple Machines, we successfully implemented a new, comprehensive workflow for care of patients living with cardiovascular implantable electronic devices (CIEDs).Over the course of a year, we worked directly with Virginia Mason to uncover shortfalls in their daily work in all aspects of the device clinic. Using human-centered design, we interviewed and shadowed nurses throughout their work days.Key pain points were identified that impacted patient well-being and job satisfaction. Major deficiencies included:• Device transmissions arriving across multiple, proprietary interfaces with no ability to distinguish critical data, manage lost to follow, or track historical information• The inability to delegate tasks across staff to build clarity in roles and trust• Manual processes creating inconsistency in patient dataWe developed and deployed a control center for The Virginia Mason Heart Institute to manage all touchpoints with their patients with CIEDs. This platform, called Contatto, now provides:• A single environment providing total visibility and ease of patient management from implantation to replacement from all touch points of their device• Work queues that organize the workday for overburdened teams and speed execution on patient-critical activitiesView Large Image Figure ViewerDownload Hi-res image Download (PPT) As a registered nurse since 2001, I have watched how remote monitoring has crippled cardiology device clinics, often creating inconsistencies in patient care, clinician burn-out, and liability for practitioners. Working in partnership with The Virginia Mason Heart Institute and Seven Simple Machines, we successfully implemented a new, comprehensive workflow for care of patients living with cardiovascular implantable electronic devices (CIEDs). Over the course of a year, we worked directly with Virginia Mason to uncover shortfalls in their daily work in all aspects of the device clinic. Using human-centered design, we interviewed and shadowed nurses throughout their work days. Key pain points were identified that impacted patient well-being and job satisfaction. Major deficiencies included:• Device transmissions arriving across multiple, proprietary interfaces with no ability to distinguish critical data, manage lost to follow, or track historical information• The inability to delegate tasks across staff to build clarity in roles and trust• Manual processes creating inconsistency in patient data We developed and deployed a control center for The Virginia Mason Heart Institute to manage all touchpoints with their patients with CIEDs. This platform, called Contatto, now provides:• A single environment providing total visibility and ease of patient management from implantation to replacement from all touch points of their device• Work queues that organize the workday for overburdened teams and speed execution on patient-critical activities

NLRB Finds Satanic Claims Unprotected

Labor practitioners often marvel at the breadth of activity that the NLRB will find to be protected. However, even the NLRB acknowledges that Section 7 protections only go so far. In a recent decision from the NLRB's Division of Advice, Virginia Mason, Case No. 19‐CA‐270734, the NLRB provided a reminder that Section 7 activity is not without bounds.

Guidelines in Clinical Practice: Appraisal of Quality Metrics in the Management of Newly Diagnosed Diffuse Large B-Cell Lymphoma Based on the American Society of Hematology Practice Improvement Module

Background: The National Comprehensive Cancer Network (NCCN) has issued well-established guidelines for the management and treatment of non-Hodgkin's lymphoma (NHL), in particular for diffuse large B-cell lymphoma (DLBCL). In 2014, the American Society of Hematology established practice improvement module (ASH PIM) incorporating quality metrics in six areas: pathologic diagnosis, staging, hepatitis B testing, use of growth factors, vaccination, and fertility counseling. Currently, such practice improvement modules have allowed physicians to monitor the quality of care in their practice, and reiterating the significance of these clinical guidelines. In an appraisal of quality metrics undertaken at Virginia Mason Medical Center (VMMC), Seattle, Washington, we sought to review four of the ASH PIM metrics and several other metrics to assess adherence to treatment guidelines for Diffuse Large B-Cell Lymphoma (DLBCL) and examine the need for institutional improvement.Methods: A longitudinal cohort of all patients who were diagnosed with DLBCL and received treatment at VMMC between January 1st, 2005 to December 31st, 2016 was identified using VMMC's Tumor Registry. Utilizing the electronic medical records, each patient's chart was reviewed for these quality metrics: pathologic diagnosis, staging of lymphoma, hepatitis and HIV serology testing, echocardiogram (ECHO) prior to starting treatment, clymphoma recurrence risk categorization, chemotherapy education, use of Rituximab therapy, G-CSF use, and post-therapy CT or CT-PET scan. Parameters for pathological diagnosis included assessment of expression of CD20, germinal center vs non-germinal center phenotype based on reporting of MUM1, CD10 and BCL-6, fluorescence in-situ hybridization (FISH) and IHC studies for the presence of traslocation/overexpression of c-Myc, BCL-2 or BCL-6, and EBV assessment by EBV-encoded small RNA1 (EBER1) in-situ hybridization. Staging was evaluated based on imaging in the form of a CT or PET-CT scan prior to treatment initiation and if a bone marrow biopsy (BMB) was also obtained. Serology testing for hepatis B (HBV) and hepatitis C (HCV), and HIV was reviewed. Patients receiving anthracycline-based treatments were assessed for having undergone an ECHOcardiogram prior to initiation of treatment. Post-treatment PET-CT was noted based on the presence of an internal report or outside records.Results: A total of 179 patients were included in this analysis. The median age of this cohort was 67 years (range 24 -91 years) and 54% of these patients were male. Pre-treatment viral serologic screening was performed in 87% of patients for HBV, 78% for HCVFISH f and 92% for HIV. All the specimen were uniformly tested for expression of CD20, and the germinal center vs. non-germinal center phenotype was determined in 97% of patients. c-Myc and BCL2/BCL6 data was available in only 32% of patients. For staging, all patients had imaging (CT/PET-CT), while bone marrow was obtained in only 72% of patients. Post-treatment imaging was available in 97% of cases. Additional data analysis of treatment-related quality metrics is underway, and shall be presented at the ASH annual meeting.Conclusion: Performing regular quality assessments by employing standardized metrics provide opportunities to improve the institutional quality of care for patients with newly diagnosed DLBCL, and allows to build and ensure better adherence to evolving NCCN patient-care guidelines ASH PIM. However, performance on the metrics relying on clinical documentation may not be as high as for those relying on objective testing. Whether such quality metrics affect real-time treatment-decisons and patient outcomes needs further evaluation. DisclosuresNo relevant conflicts of interest to declare.

Editorial Comment.

No AccessJournal of UrologyAdult Urology1 May 2021Editorial CommentThis article comments on the following:Measuring Bladder Health: Development and Cognitive Evaluation of Items for a Novel Bladder Health Instrumentis a letter which has replyReply by Authors Una J. Lee Una J. LeeUna J. Lee Female Pelvic Medicine and Reconstructive Surgery, Section of Urology and Renal Transplantation, Virginia Mason Medical Center, Seattle, Washington More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001581.01AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail "Editorial Comment." The Journal of Urology, 205(5), p. 1414

Prevalence of Urinary Incontinence among a Nationally Representative Sample of Women, 2005-2016: Findings from the Urologic Diseases in America Project.

Urinary incontinence is frequently underreported and underdiagnosed in the clinical setting. We analyzed 12 years of data from a large, nationally representative sample of women in the United States to assess the prevalence, severity, and daily impact of urinary incontinence and its subtypes at the population level. We analyzed data from 15,003 women aged ≥20 years who participated in the 2005-2016 National Health and Nutrition Examination Survey. We estimated the prevalence of urinary incontinence in the prior year, overall and by subtype (stress, urgency or mixed). Among women with urinary incontinence, we additionally assessed symptom severity using the validated 4-level Incontinence Severity Index, as well as impact on daily activities. The 2005-2016 prevalence of any urinary incontinence was 53%; 16% of women had mixed urinary incontinence, 26% had stress only and 10% had urgency only. While urgency urinary incontinence and mixed urinary incontinence were highest among women aged ≥60 years, stress urinary incontinence was highest among women aged 40-59 years. NonHispanic Black women had higher prevalence of urgency urinary incontinence and lower prevalence of stress urinary incontinence compared to other racial/ethnic groups. Of women with urinary incontinence, 30% reported moderate or severe symptoms, which were more common among older than younger women. In addition, 24% of women with urinary incontinence reported that the condition affected their daily activities. Our study demonstrates a high prevalence of urinary incontinence among a nationally representative population of women in the United States, with many reporting that urinary incontinence affected their daily activities. Age and racial/ethnic trends varied by urinary incontinence subtype.

Impact of pancreatic enzyme replacement therapy (PERT) on clinical outcomes in nonresected pancreatic cancer (PC): Initial results.

400 Background: Current NCCN guidelines recommend PERT use in PC patients (pts) with symptoms of EPI. However, little evidence exists regarding clinical outcomes following PERT use in PC pts, especially those with nonresected disease. We present initial results from PERT use in this pt group regarding disease control and symptom improvement. Methods: Pts with initially nonresected PC were obtained for this study from the Virginia Mason PC Database. Eligibility criteria included:1) pathologically diagnosed nonresected adeno PC from January 2014-December 2019 ; 2) no prior PC anticancer therapy (PCRx) of any kind; 3) ≥2 PGSGA (Patient Generated Global Subjective Assessment ) forms completed with initial PGSGA reporting before 30 days following first PCRx. Pts were stratified by PERT vs non-PERT prescription as validated by the EHR. Clinicians tended to prescribe PERT based on either abnormal fecal elastase and/or clinical symptoms (e.g. diarrhea) as in the PGSGA; no formal criteria for PERT usage existed. Pts were considered to have received PERT if prescribed for the majority of time during the assessment period (i.e. > 30 days) and were analyzed based on an "intent to treat" basis without compliance validation. Results: 344 pts were identified via this method ; 207 (60%)/137 (40%) did/did not receive PERT. > 95% received Creon as PERT. Median time from 1st day PCRx to 1st reassessment was 60 days. 79% pts completed PGSGA prior to and 97% within 2 weeks of 1st day PCRx. Pt characteristics were balanced between PERT/ non PERT groups including race (90% white), age (median 68 yrs), sex (M/F 53%/47%), non-metastatic/metastatic disease 24%/76% . BMI distribution (< 18.5 3%, 18.5-25 40%, 25-30 34%, and >30 23%),and albumin distribution (<3 g/dL 6%, 3-3.4 g/dL 12% and ≥3.5 g/dL 82%). However, mean baseline PGSGA score was higher in the PERT vs non PERT group (9.9 overall, 10.9 (95% CI 10.1-11.7) vs 8.2 (95% CI 7.3 - 9.1), p< 0.01). At 1st reassessment, disease control (PR+SD) (83% overall) was greater in the PERT (87%) vs. non PERT (79%) group (p=0.04).Change from baseline PGSGA was favorable overall (Δ-5.0, 95% CI-5.7--4.3), and in all pt subsets, but with greater improvement in the PERT (Δ-6.0) vs. non PERT (Δ -3.4) group (p< 0.001) and in disease controlled (Δ-5.3) vs. non-disease controlled (Δ- 3.2) pts (p=0.033). Disease controlled vs. non-disease controlled PERT pts did not differ in their PGSGA response (Δ-6.2/-4.8, p=0.98) Conclusions: 1) PERT vs non-PERT pts were similar with respect to basic clinical or nutritional parameters (e.g. BMI, albumin) in this pt cohort. 2) Despite having more adverse baseline PGSGA scores, PERT pts were statistically superior to non PERT pts with respect to both frequency of disease control and magnitude of PGSGA response during initial Rx 3) Further investigation of the detail involving PERT usage and clinical outcomes in nonresected PC is warranted from these data.

Incidence of Skin and Respiratory Immune-Related Adverse Events Correlates With Specific Tumor Types in Patients Treated With Checkpoint Inhibitors

Checkpoint inhibitors (CPIs) increase antitumor activity by unblocking regulators of the immune response. This action can provoke a wide range of immunologic and inflammatory side effects, some of which can be fatal. Recent studies suggest that CPI-induced immune-related adverse events (irAEs) may predict survival and response. However, little is known about the mechanisms of this association. This study was undertaken to evaluate the influence of tumor diagnosis and preexisting clinical factors on the types of irAEs experienced by cancer patients treated with CPIs. The correlation between irAEs and overall survival (OS) was also assessed. All cancer patients treated with atezolizumab (ATEZO), ipilimumab (IPI), nivolumab (NIVO), or pembrolizumab (PEMBRO) at Virginia Mason Medical Center between 2011 and 2019 were evaluated. irAEs were graded according to the Common Terminology Criteria for Adverse Events (Version 5) and verified independently. Statistical analyses were performed to assess associations between irAEs, pre-treatment factors, and OS. Of the 288 patients evaluated, 59% developed irAEs of any grade, and 19% developed irAEs of grade 3 or 4. A time-dependent survival analysis demonstrated a clear association between the occurrence of irAEs and OS (P < 0.001). A 6-week landmark analysis adjusted for body mass index confirmed an association between irAEs and OS in non-Small Cell Lung Cancer (NSCLC) (P < 0.03). An association between melanoma and skin irAEs (P < 0.01) and between NSCLC and respiratory irAEs (P = 0.03) was observed, independent of CPI administered. Patients with preexisting autoimmune disease experienced a higher incidence of severe irAEs (P = 0.01), but not a higher overall incidence of irAEs (P = 0.6). A significant association between irAEs and OS was observed in this diverse patient population. No correlation was observed between preexisting comorbid conditions and the type of irAE observed. However, a correlation between skin-related irAEs and melanoma and between respiratory irAEs and NSCLC was observed, suggesting that many irAEs are driven by a specific response to the primary tumor. In patients with NSCLC, the respiratory irAEs were associated with a survival benefit.

Building a Culture of Respect for People

Summary The delivery of safe, effective, and efficient health care requires both technical ability and an enduring culture of respect within the institution. Respect for People is Virginia Mason Medical Center’s comprehensive effort to foster an organizational culture of respect. This multiyear endeavor has engaged every employee through a series of workshops and ongoing communication. As part of this effort, we sought to evolve the artifacts, norms and values, and underlying beliefs that constitute our organizational culture. Implementing and sustaining Respect for People has redefined the health care environment at Virginia Mason, to the betterment of patients and staff.