Veterans Health Administration Databases Research Articles

US Veterans Administration Autosomal Dominant Polycystic Kidney Disease Cohort: Demographic, Comorbidity, and Key Laboratory Data Characteristics.

We used the largest integrated US health care system, the Veterans Health Administration (VHA), to establish a robust resource for demographic, longitudinal outcome, and predictive modeling studies in autosomal dominant polycystic kidney disease (ADPKD). We built the ADPKD cohort by extracting the relevant electronic health record (EHR) data from nationwide VHA database (years 1999-2020). We identified 12,217 patients diagnosed with ADPKD. By the end of the 20-year study period, 5,342 ADPKD patients were deceased, 1,583 were alive but reached end-stage kidney disease (ESKD), and 4,827 remained alive without ESKD. Most demographic characteristics of this ADPKD cohort resemble the total U.S. veteran population. For example, 94% were males, 45% age 65 years or older, 85% non-Hispanic, 66% white; however, 19% were Black/African Americans (vs. 12% in the general veteran population; a relevant enrichment after considering age and sex distributions between races). The comorbidities overrepresented in the ADPKD cohort include hypertension (89% vs. 50%), diabetes (32% vs. 22%), depression (40% vs. 10%), chronic obstructive pulmonary disease (30% vs 6%), and congestive heart failure (21% vs 1%). In contrast, obesity was under-represented in veterans with ADPKD (30% vs 41%). We established a large EMR-based cohort of ADPKD veterans. Here we provide initial analysis of its demographic, comorbidity and key laboratory data.

Perinatal mental health and pregnancy-associated mortality: opportunities for change.

Perinatal mental health conditions have been associated with adverse pregnancy outcomes, including maternal death. This quality improvement project analyzed pregnancy-associated death among veterans with mental health conditions in order to identify opportunities to improve healthcare and reduce maternal deaths. Pregnancy-associated deaths among veterans using Veterans Health Administration (VHA) maternity care benefits between fiscal year 2011 and 2020 were identified from national VHA databases. Deaths among individuals with active mental health conditions underwent individual chart review using a standardized abstraction template adapted from the Centers for Disease Control and Prevention (CDC). Thirty-two pregnancy-associated deaths were identified among 39,720 paid deliveries with 81% (n = 26) occurring among individuals with an active perinatal mental health condition. In the perinatal mental health cohort, most deaths (n = 16, 62%) occurred in the late postpartum period and 42% (n = 11) were due to suicide, homicide, or overdose. Opportunities to improve care included addressing (1) racial disparities, (2) mental health effects of perinatal loss, (3) late postpartum vulnerability, (4) lack of psychotropic medication continuity, (5) mental health conditions in intimate partners, (6) child custody loss, (7) lack of patient education or stigmatizing patient education, and (8) missed opportunities for addressing reproductive health concerns in mental health contexts. Pregnancy-associated deaths related to active perinatal mental health conditions can be reduced. Mental healthcare clinicians, clinical teams, and healthcare systems have opportunities to improve care for individuals with perinatal mental health conditions.

Improving the Maternity Care Safety Net: Establishing Maternal Mortality Surveillance for Non-Obstetric Providers and Institutions.

The siloed nature of maternity care has been noted as a system-level factor negatively impacting maternal outcomes. Veterans Health Administration (VA) provides multi-specialty healthcare before, during, and after pregnancy but purchases obstetric care from community providers. VA providers may be unaware of perinatal complications, while community-based maternity care providers may be unaware of upstream factors affecting the pregnancy. To optimize maternal outcomes, the VA has initiated a system-level surveillance and review process designed to improve non-obstetric care for veterans experiencing a pregnancy. This quality improvement project aimed to describe the VA-based maternal mortality review process and to report maternal mortality (pregnancy-related death up to 42 days postpartum) and pregnancy-associated mortality (death from any cause up to 1 year postpartum) among veterans who use VA maternity care benefits. Pregnancies and pregnancy-associated deaths between fiscal year (FY) 2011-2020 were identified from national VA databases. All deaths underwent individual chart review and abstraction that focused on multi-specialty care received at the VA in the year prior to pregnancy until the time of death. Thirty-two pregnancy-associated deaths were confirmed among 39,720 pregnancies (PAMR = 80.6 per 100,000 live births). Fifty percent of deaths occurred among individuals who had experienced adverse social determinants of health. Mental health conditions affected 81%. Half (n = 16, 50%) of all deaths occurred in the late postpartum period (43-365 days postpartum) after maternity care had ended. More than half of these late postpartum deaths (n = 9, 56.2%) were related to suicide, homicide, or overdose. Integration of care delivered during the perinatal period (pregnancy through postpartum) from primary, mental health, emergency, and specialty care providers may be enhanced through a system-based approach to pregnancy-associated death surveillance and review. This quality improvement project has implications for all healthcare settings where coordination between obstetric and non-obstetric providers is needed.

Mortality among US veterans with a physician-documented diagnosis of pyruvate kinase deficiency

ABSTRACT Real-world studies of pyruvate kinase (PK) deficiency and estimates of mortality are lacking. This retrospective observational study aimed to identify patients with PK deficiency and compare their overall survival (OS) to that of a matched cohort without PK deficiency. Patients with ≥1 diagnosis code related to PK deficiency were selected from the US Veterans Health Administration (VHA) database (01/1995–07/2019); patients with a physician-documented diagnosis were included (PK deficiency cohort; index: date of first diagnosis code related to PK deficiency). Patients in the PK deficiency cohort were matched 1:5 to patients from the general VHA population (non-PK deficiency cohort; index: random visit date during match’s index year). OS from index was compared between the two cohorts. Eighteen patients in the PK deficiency cohort were matched to 90 individuals in the non-PK deficiency cohort (both cohorts: mean age 57 years, 94% males; median follow-up 6.0 and 8.0 years, respectively). At follow-up, patients in the non-PK deficiency cohort had significantly longer OS than the PK deficiency cohort (median OS: 17.1 vs. 10.9 years; hazard ratio: 2.3; p = 0.0306). During their first-year post-index, 75% and 40% of the PK deficiency cohort had laboratory-confirmed anemia and iron overload, respectively. Among patients who died, cause of death was highly heterogeneous. These results highlight the increased risk of mortality and substantial clinical burden among patients with PK deficiency. While the intrinsic characteristics of the VHA database may limit the generalizability of the results, this is the first real-world study to characterize mortality in patients with PK deficiency.

Insights from a Veterans Health Administration Database Analysis: Immune-Related Adverse Effects of Immunotherapy in Relapsed/Refractory Classical Hodgkin Lymphoma

Introduction: Despite the high success rates in treating Classical Hodgkin lymphoma (cHL), a specific group of patients still experience relapsed or refractory (R/R) disease, affecting approximately 10-20% of cases. The use of immunotherapy with checkpoint inhibitors (CPIs) has emerged as a promising approach, demonstrating impressive efficacy in R/R cHL patients [2,3]. However, there is a lack of real-world evidence regarding the immune-related adverse effects (irAEs) associated with immunotherapy in this relatively rare patient population. To address this gap, this study leverages the Veterans Health Administration (VHA) database to investigate irAEs, providing valuable insights to optimize treatment decisions. Methods: A retrospective analysis was conducted on Hodgkin lymphoma patients who received immunotherapy from the VHA Corporate Data Warehouse from 2014-2022. Patients came from all 18 Veterans Integrated Service Networks, spanning all 50 states and US territories. Data was collected to determine the baseline characteristics, disease factors, detailed AE occurrence as well as outcomes in this cohort. Results: The analysis included 68 cHL patients who received immunotherapy. The cohort had a mean age of 62.2 years (SD=15.9) and a median age of 66 years (IQR 54-72). The majority of the patients were male (97%) and White (80%) and only 6% of patients had a history of autoimmune disease. The distribution of patients across stages was as follows: Stage 1 (5%), Stage 2 (15%), Stage 3 (40%), and Stage 4 (40%). Additionally, 20% of patients underwent autologous stem cell transplantation (ASCT), with 10% receiving immunotherapy before transplantation and the remaining 10% receiving it post-transplant. In our cohort, 31% had documented adverse effects related to immunotherapy. The most common adverse events observed were hematological/cytopenias (8%), dermatologic/rash (6%), endocrine-related (6%), pneumonitis (5%), hepatitis (2%), myocarditis (2%), and other adverse events (8%). Discontinuation of therapy due to irAEs occurred in 12% of patients. These findings align with prior literature, which has consistently reported thyroid gland dysfunction (such as hypothyroidism and thyroiditis) and rash as the most frequently observed immune-related adverse events [2]. The most common management of irAEs were holding therapy followed by use of corticosteroids. Kaplan-Meier survival analysis revealed a median overall survival of 55.4 months (IQR=37.2-59.2), with a median follow-up time of 36.4 months (IQR=21.6 -58.6). Conclusion: This study, utilizing the VA database, provides a distinctive and valuable perspective on irAEs associated with immunotherapy in cHL patients. By leveraging a comprehensive database on a large scale, this study significantly enhances our comprehension of immunotherapy in the context of cHL, thereby offering crucial guidance for treatment decisions concerning relapsed/refractory Hodgkin lymphoma patients. The findings of this study strongly indicate the sustained benefits of immune checkpoint inhibitors (ICI) in this population, emphasizing the importance of close patient monitoring to detect and manage immune-related adverse events at an early stage, thereby preventing life-threatening complications.

Racial Differences in the Association of Glucagon-like Peptide 1 Agonist Use and the Progression of Monoclonal Gammopathy of Undetermined Significance to Multiple Myeloma in US Veterans with Diabetes Mellitus

Background: Glucagon-like peptide 1 (GLP-1) agonists are antidiabetic medications that exert cardiac and renal benefits in addition to their well-established antihyperglycemic effects. A prior analysis has shown that GLP-1 agonist use is associated with a 65% reduction in the risk of progression from monoclonal gammopathy of undetermined significance (MGUS) to multiple myeloma (MM) in US Veterans with diabetes mellitus (DM). However, it is unknown whether there are racial differences to this effect of GLP-1 agonists. We aimed to assess the racial differences in the association between GLP-1 agonist use and the progression risk in diabetic patients with MGUS. Methods: Patients diagnosed with MGUS in the Veterans Health Administration (VHA) database from 10/1/99-12/31/21 were identified using ICD codes. A natural language processing algorithm was used to confirm MGUS diagnosis and progression to smoldering MM or MM. Patients diagnosed with MGUS before DM and those who experienced progression within 1 year of MGUS diagnosis or within 2 years of DM diagnosis were excluded. For each race, we performed 1:2 matching for patients with and without GLP-1 agonist use based on follow-up time. The outcome was progression to smoldering MM or MM. Cumulative incidence functions stratified by GLP-1 agonist use (ever vs. never use) were plotted and a Gray's test was performed to detect the difference between the functions. The association between time-varying GLP-1 agonist use and MGUS progression was estimated using a multivariable Fine-Gray subdistribution hazard model with death as a competing event. Results: Our NLP algorithm confirmed 20,832 patients with DM and MGUS. After applying our inclusion and exclusion criteria, we had 9,294 white patients and 4,981 black patients, of which 909 and 403, respectively, were GLP-1 agonist users. After matching, our analytic cohort included 2,718 white patients (33.3% with GLP-1 agonist use) and 1,191 black patients (33.3% with GLP-1 agonist use). GLP-1 agonist use was associated with a dramatically significant reduction in progression rate in white patients (aHR 0.25; 95% CI 0.09-0.68), while the association was not shown in black patients (aHR 1.01; 95% CI 0.36-2.90). Conclusion: For patients with MGUS and DM, GLP-1 agonist use is associated with a 75% reduction in progression risk in white patients and no significant reduction in black patients. This highlights a racial disparity in the potential role of GLP-1 agonist for chemoprevention in the management of MGUS.

Association of Transgender or Gender Non-Binary Identity on Disease Characteristics and Survival Outcomes in Prostate Cancer.

While it is becoming increasingly common for people to identify as transgender or gender-non-binary, our understanding of the influence of gender identity on disease severity of hormone-sensitive malignancies, including prostate cancer (PC) is limited. The goal of this study is to compare the aggressiveness of disease and survival outcomes between transgender or gender non-binary (TG) and cis-gender (CG) patients with PC. The cohort included patients diagnosed with PC between 1999 and 2022 within the Veterans Health Administration (VHA) Database. TG patients were identified with an ICD 9 or 10 diagnosis code that occurred prior to PC diagnosis. Treatment information and baseline disease characteristics were ascertained through the VHA electronic health records. Multivariable logistic regressions were performed to estimate the association between TG status and presenting with Gleason > = 8, PSA > 20 ng/mL, and metastatic disease at diagnosis. Covariates in these models included age at diagnosis, race, ethnicity, marital status, and smoking status. Metastases were identified through natural language processing from cancer or radiology documents. Time to metastases was defined as the time from PC diagnosis to metastases, with other causes of death considered as competing risks. The association between TG identity status and metastatic disease was calculated with a Cox regression model. The difference in overall survival was assessed with the Kaplan-Meier method and log-rank test. The final cohort was composed of 282,264 individuals, 219 (0.08%) of which were identified as TG. TG patients have similar odds of presenting with presenting with Gleason Score ≥8 (Odds Ratio (OR) 1.18, p = 0.31), PSA >20 ng/mL (OR 0.78, p = 0.59), and metastasis at diagnosis (OR 0.47, p = 0.29). There were 34,918 patients who develop metastatic disease at any time, 24 of which were TG. The 10-year cumulative incidence of metastases for TG and CG individuals was 11.5% (95% Confidence Interval (CI): 6.6-16.1%) and 13.9% (CI: 13.7-14.0%), respectively. There was no significant difference between TG status and risk of developing metastases (Hazard Ratio (HR) 0.93, p = 0.71). The 10-year overall survival for TG and CG was 73.4% (CI: 66.5-80.9%) and 65.0% (CI: 64.8-65.2%), respectively. There was no significant difference between TG status and overall survival (Hazard Ratio (HR) 0.83, p = 0.13). TG individuals do not appear to have a difference in disease characteristics at diagnosis or survival compared to CG individuals. Future research should be done to determine the effect of gender affirming treatment on these outcomes. Furthermore, it is unclear if diagnosis codes are accurately identifying TG individuals.

Associations Between Intraductal Prostate Cancer and Metastases Following Radical Prostatectomy in Men With Prostate Cancer in the Veterans Affairs Database.

Intraductal carcinoma of the prostate (IDC-P) is a relatively unstudied feature present in some prostate cancer (PC) diagnoses with several studies suggesting associations with higher Gleason scores (GS) and earlier time to biochemical recurrence (BCR) after definitive treatment. We looked to identify cases of IDC-P in the Veterans Health Administration (VHA) database and measure associations between IDC-P and pathological stage, BCR, and metastases. Patients in the VHA database diagnosed with PC from 2000 to 2017, treated with radical prostatectomy (RP) at the VHA were included in the cohort. BCR was defined as post-RP PSA >0.2 or administration of androgen deprivation therapy (ADT). Time to event was defined as time from RP to event or censor. Differences in cumulative incidences were assessed through Gray's test. Associations with IDC-P and pathologic features at RP, BCR and metastases were assessed through multivariable logistic and Cox regression models. Of 13,913 patients meeting inclusion criteria, 45 patients had IDC-P. Median follow up was 8.8 years from RP. Multivariable logistic regressions showed patients with IDC-P were more likely to have GS ≥8 (Odds Ratio (OR) 1.14, P=.009) and higher T stages (T3 or 4 vs. T1 or 2 OR 1.14, P < .001). In total, 4,318 patients experienced a BCR, and 1,252 patients developed metastases of whom 26 and 12, respectively, had IDC-P. On multivariable regression IDC-P was associated with higher risk of BCR (IDC-P Hazard Ratio (HR) 1.71, P=.006) and metastases (HR 2.84, P < .001). Cumulative incidence of metastases at 4 years for IDC-P and non-IDC-P were 15.9% and 5.5% (P < .001) respectively. In this analysis, IDC-P was associated with higher Gleason score at RP, shorter time to BCR, and higher rates of metastases. Further studies are warranted to investigate the molecular underpinnings of IDC-P to better guide treatment strategies for this aggressive disease entity.

Evaluating the Association of Montelukast Use on Neuropsychiatry-Related Healthcare Utilization and Depression in COVID-19-Hospitalized Veterans: A Nationwide VA Observational Cohort Study.

Montelukast's new boxed warning for neuropsychiatric events questions its use in the setting of coronavirus disease 2019 (COVID-19) due to increased risk for new-onset psychiatric diagnoses. We aim to evaluate the impact of using montelukast in patients hospitalized with COVID-19 on neuropsychiatry-related healthcare utilization and depression. This retrospective nationwide observational cohort study using the Veterans Health Administration database included patients from January 1, 2020, through July 1, 2021. The treatment cohorts consisted of patients with and without montelukast use prior to COVID-19 hospitalization and matched using propensity score (PS) to two control cohorts: patients with COVID-19-related hospitalization without prior montelukast use and patients with prior montelukast use who were hospitalized for reasons other than COVID-19. The primary outcome of psychiatric hospitalizations at 90days and 180days and mental health visits at 180 days were compared using Poisson or negative binomial regression. Secondary outcomes of new-onset depression and new use of antidepressants were analyzed using multivariable logistic regression. After PS matching, a total of 415 patients were included in COVID-19 with and without montelukast matched cohort and 409 patients in montelukast with and without COVID-19-related hospitalization matched cohorts. For the primary outcomes, inpatient psychiatric hospitalization at 90days [incidence rate ratio (IRR) 95% CI 1.79 (1.36-2.36)] and 180 days [IRR 95% CI 1.79 (1.32-2.25)] and mental health visits at 180 days [IRR 95% CI 1.72 (1.45-2.03)] were significantly higher in the montelukast with COVID-19 hospitalization group compared with those hospitalized without COVID-19. No difference in primary outcomes were noted in patients hospitalized with COVID-19 with and without use of montelukast. No significant difference was found in the secondary outcomes between either comparator group. Patients with prior montelukast use who were hospitalized with COVID-19 appeared to have increased rate of neuropsychiatry-related healthcare utilization.

Long-term opioid therapy trajectories and overdose in patients with and without cancer

ObjectivePain is experienced by most patients with cancer and opioids are a cornerstone of management. Our objectives were (1) to identify patterns or trajectories of long-term opioid therapy (LTOT) and...

Risk of Parkinson Disease Among Service Members at Marine Corps Base Camp Lejeune

An increased risk of Parkinson disease (PD) has been associated with exposure to the solvent trichloroethylene (TCE), but data are limited. Millions of people in the US and worldwide are exposed to TCE in air, food, and water. To test whether the risk of PD is higher in veterans who served at Marine Corps Base Camp Lejeune, whose water supply was contaminated with TCE and other volatile organic compounds (VOCs), compared with veterans who did not serve on that base. This population-based cohort study examined the risk for PD among all Marines and Navy personnel who resided at Camp Lejeune, North Carolina (contaminated water) (n = 172 128), or Camp Pendleton, California (uncontaminated water) (n = 168 361), for at least 3 months between 1975 and 1985, with follow-up from January 1, 1997, until February 17, 2021. Veterans Health Administration and Medicare databases were searched for International Classification of Diseases diagnostic codes for PD or other forms of parkinsonism and related medications and for diagnostic codes indicative of prodromal disease. Parkinson disease diagnoses were confirmed by medical record review. Water supplies at Camp Lejeune were contaminated with several VOCs. Levels were highest for TCE, with monthly median values greater than 70-fold the permissible amount. Risk of PD in former residents of Camp Lejeune relative to residents of Camp Pendleton. In those without PD or another form of parkinsonism, the risk of being diagnosed with features of prodromal PD were assessed individually and cumulatively using likelihood ratio tests. Health data were available for 158 122 veterans (46.4%). Demographic characteristics were similar between Camp Lejeune (5.3% women, 94.7% men; mean [SD] attained age of 59.64 [4.43] years; 29.7% Black, 6.0% Hispanic, 67.6% White; and 2.7% other race and ethnicity) and Camp Pendleton (3.8% women, 96.2% men; mean [SD] age, 59.80 [4.62] years; 23.4% Black, 9.4% Hispanic, 71.1% White, and 5.5% other race and ethnicity). A total of 430 veterans had PD, with 279 from Camp Lejeune (prevalence, 0.33%) and 151 from Camp Pendleton (prevalence, 0.21%). In multivariable models, Camp Lejeune veterans had a 70% higher risk of PD (odds ratio, 1.70; 95% CI, 1.39-2.07; P < .001). No excess risk was found for other forms of neurodegenerative parkinsonism. Camp Lejeune veterans also had a significantly increased risk of prodromal PD diagnoses, including tremor, anxiety, and erectile dysfunction, and higher cumulative prodromal risk scores. The study's findings suggest that the risk of PD is higher in persons exposed to TCE and other VOCs in water 4 decades ago. Millions worldwide have been and continue to be exposed to this ubiquitous environmental contaminant.

Anti-HIV Drugs Reduce Risk of Prediabetes and Progression to Type 2 Diabetes in HIV-Infected Patients.

The aim of this study was to investigate whether the use of nucleoside reverse transcriptase inhibitors (NRTIs) impacts the incidence of prediabetes or type 2 diabetes mellitus (T2DM) or the progression from prediabetes to T2DM in people living with HIV (PLWH). We conducted a retrospective cohort study using the U.S. Veterans Health Administration database among adult patients with an HIV diagnosis from the year 2000 until 2021 to determine the incidence of prediabetes and further progression to T2DM among NRTI exposed and unexposed patients. A multistate model was used to evaluate progression from normoglycemia to prediabetes and then to T2DM, and covariate adjustment with the Cox proportional hazards model was used to estimate the hazard ratios. Among 32,240 veterans diagnosed with HIV, prediabetes and T2DM were observed among 20.2% and 20.7% of patients, respectively. Among those diagnosed with prediabetes, 31.8% progressed to T2DM. Patients exposed to NRTIs at any time (86.6%), had a reduced risk of prediabetes [HR 0.50 (0.47-0.53 95% CI)] and among prediabetics, a lower risk of progression to T2DM [HR 0.73 (0.63-0.85 95% CI)] when compared to patients who never used NRTIs. In summary, NRTIs may reduce the risk of developing prediabetes and the progression from prediabetes to T2DM in PLWH.

PD16-12 REAL-WORLD OUTCOMES AMONG MEN WITH NONMETASTATIC CASTRATION-SENSITIVE BIOCHEMICAL RECURRENCE AFTER DEFINITIVE THERAPY WITH SHORT PSA DOUBLING TIME RECEIVING EARLY SECONDARY TREATMENT

You have accessJournal of UrologyCME1 Apr 2023PD16-12 REAL-WORLD OUTCOMES AMONG MEN WITH NONMETASTATIC CASTRATION-SENSITIVE BIOCHEMICAL RECURRENCE AFTER DEFINITIVE THERAPY WITH SHORT PSA DOUBLING TIME RECEIVING EARLY SECONDARY TREATMENT Stephen J Freedland, Wei Gao, Angela Lax, Hongbo Yang, Krishnan Ramaswamy, David Russell, Agnes Hong, and Jasmine Ivanova Stephen J FreedlandStephen J Freedland More articles by this author , Wei GaoWei Gao More articles by this author , Angela LaxAngela Lax More articles by this author , Hongbo YangHongbo Yang More articles by this author , Krishnan RamaswamyKrishnan Ramaswamy More articles by this author , David RussellDavid Russell More articles by this author , Agnes HongAgnes Hong More articles by this author , and Jasmine IvanovaJasmine Ivanova More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003271.12AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: There is no consensus on treatment (tx) for men with nonmetastatic castration-sensitive prostate cancer (nmCSPC) with biochemical recurrence (BCR) after definitive tx (radical prostatectomy or radiotherapy). We assessed outcomes in men with nmCSPC and short prostate-specific antigen doubling time (PSADT) following BCR after definitive tx. METHODS: We reviewed the Veterans Health Administration (VHA) database between January 1, 2006 and June 22, 2020 for men with nmCSPC and BCR (index date) after definitive tx. Men were required to have PSADT ≤15 months after index date and were categorized into rapid (≤9 months) and less rapid (>9 but ≤15 months) PSADT. Outcomes included time to first antineoplastic tx after BCR and metastasis-free survival (MFS; time to metastasis or death). Cox proportional models compared the rapid and less rapid PSADT cohorts. Adjusted models controlled for baseline demographic and clinical characteristics. RESULTS: 753 men with nmCSPC were included in the analysis (rapid, n=485; less rapid, n=268). The rapid PSADT men were younger, more likely to be White, and had shorter median time from definitive tx to index (Table 1). Versus less rapid PSADT, rapid PSADT men had shorter median time to first antineoplastic tx (11.3 vs. 29.3 months), and MFS (94.1 vs. not reached) after BCR. CONCLUSIONS: Most rapid PSADT men underwent secondary tx within 1 year of BCR compared with less rapid PSADT men (53.2% vs 16.2%), whereas most less rapid PSADT men remained tx free for >2 years. Importantly, median MFS in men with rapid PSADT was 94.1 months, closely approximating the Pound data from Hopkins, wherein median time to metastases after BCR was 96 months (8 years). However, the Pound data included all BCR patients, not just those with rapid PSADT. Also, in the Pound data, no patients received early hormonal tx, whereas most VHA patients received secondary tx within 1 year of BCR. While circumstantial, the fact that rapid PSADT VHA patients heavily treated with secondary tx had similar outcomes to all BCR patients in the Pound series where none received aggressive secondary tx suggests the potential benefit of aggressive early tx of men with rapid PSADT after BCR. Source of Funding: Pfizer © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e493 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Stephen J Freedland More articles by this author Wei Gao More articles by this author Angela Lax More articles by this author Hongbo Yang More articles by this author Krishnan Ramaswamy More articles by this author David Russell More articles by this author Agnes Hong More articles by this author Jasmine Ivanova More articles by this author Expand All Advertisement PDF downloadLoading ...

Association of exposure of Camp Lejeune contaminated water and prostate cancer outcomes.

265 Background: There is evidence that exposure to contaminated water while serving at Camp Lejeune is associated with the development of genitourinary cancers including kidney and bladder; however, there is a lack of literature regarding prostate cancer (PC). We investigated disease severity at diagnosis, overall survival, and cumulative incidence of metastases for PC patients within the Veterans Health Administration (VHA) who served at Camp Lejeune. Methods: The cohort included men diagnosed with PC between 1999 and 2022 within the VHA Database. Patients who were housed at or had one or more Military Service Episodes between August 1, 1953 and December 31, 1987 at Camp Lejeune were considered to have exposure. Camp Lejeune exposure status and baseline characteristics were ascertained through the VHA electronic health records. Logistic regressions were used to analyze associations between Camp Lejeune exposure and adverse diagnostic characteristics, adjusted for demographic covariates. The outcome of metastases was identified through natural language processing from cancer or radiology documents. Time to metastases was defined as the time from PC diagnosis to metastases, with other causes of death considered as competing risks. The hazard ratio for the association between Camp Lejeune exposure and metastatic disease was calculated with a Cox regression model, controlling for covariates. The difference in overall survival was assessed with the Kaplan-Meier method and log-rank test. Results: The cohort included 6,918 men with PC, 1,635 (23.6%) of which had Camp Lejeune exposure and 5,283 (76.4%) without. Median age at diagnosis was 65 years. Logistic regression models indicated patients with Camp Lejeune exposure have similar odds of having Gleason Score ≥8 at diagnosis (odds ratio (OR) 0.97, p=0.62) and metastasis at diagnosis (OR 1.00, p=0.997), and slightly lower odds of PSA &gt;20 ng/mL at diagnosis (OR 0.78, p=0.02).There were 803 patients with metastatic disease, 159 of which had Camp Lejeune exposure in comparison to the 644 that did not. The 10-year cumulative incidence of metastases for those with Camp Lejeune exposure was 11.9% (CI: 9.9-13.9%), while for those without exposure it was 14.0% (CI: 12.8-15.1%). The Cox proportional hazards model indicated that those with Camp Lejeune exposure had a similar risk of developing metastases (hazard tatio (HR) 0.93, p=0.43) compared to those without exposure. The 10-year overall survival was similar for those with Camp Lejeune exposure (83.3% [CI: 80.7-85.9%]) compared to those without exposure (82.5% [CI: 81.1-83.9%]) (p=0.2). Conclusions: In contrast to kidney and bladder cancers, Camp Lejeune exposure is not associated with worse outcomes for PC. Further research should be conducted to test whether Camp Lejeune exposure affects the risk of developing PC. However, these data do not support Camp Lejeune exposure playing a large role in PC outcomes.

Iodinated Contrast Administration and Risks of Thyroid Dysfunction: A Retrospective Cohort Analysis of the U.S. Veterans Health Administration System.

Background: Iodine-induced thyroid dysfunction is a potential risk among susceptible individuals. Iodinated contrast media is a common source of an acute iodine load used in the health care setting and is frequently required for diagnostic computed tomography scans, coronary angiograms, and other radiologic studies. However, the epidemiologic risks of iodine-thyroid dysfunction have not been fully established in the United States. Methods: This population-based retrospective cohort study used the U.S. Veterans Health Administration database between 1998 and 2021 and included adults aged ≥18 years with a serum thyrotropin (TSH) measurement. Multivariable logistic regression was used to ascertain the risk of incident thyroid dysfunction (defined by repeated measurements of serum thyroid function) following iodine exposure, adjusting for age, sex, race/ethnicity, baseline serum TSH concentration, and duration between baseline and follow-up TSH concentration. Results: The cohort was composed of N = 4,253,119 veterans (mean ± SD = 63.5 ± 14.3 years; 92.9% men; 65.6% non-Hispanic Whites) with 8,729,155 corresponding pairs of serum TSH measurements, from which there were 499,897 TSH pairs with intervening iodine exposure. Thyroid dysfunction occurred in 4.8% of those pairs who had received iodine contrast and 3.6% of those without iodine exposure. Iodinated exposure was associated with an increased risk of thyroid dysfunction (odds ratio [OR] = 1.39, 95% confidence intervals [CI] = 1.37-1.41, p < 0.001) and consistent for all types of serum thyroid dysfunction (overt or subclinical hypo-/hyperthyroidism). Men were at higher risk for the development of thyroid dysfunction than women (men: OR = 1.42, 95% CI = 1.40-1.44; women: OR = 1.16, 95% CI = 1.11-1.21; p-for-interaction <0.001). Conclusions: In this largest analysis of U.S. adults to date, iodine exposure was associated with only clinically small absolute increased risks of thyroid dysfunction, particularly in men. These findings suggest that screening of thyroid function following iodinated contrast administration should be targeted to high-risk individuals.

Trends in overall mortality among US veterans with primary myelofibrosis

BackgroundPrimary myelofibrosis [PMF] is a myeloproliferative neoplasm associated with reduced overall survival (OS). Management strategies for PMF have evolved over the last two decades, including approval of ruxolitinib as the first Janus kinase 1 (JAK1)/JAK2 inhibitor for patients with intermediate or high-risk myelofibrosis. This study assessed changes in mortality before and after ruxolitinib approval, independent of ruxolitinib treatment.MethodsThis retrospective study investigated mortality trends among US veterans with PMF in 2 time periods, pre-ruxolitinib approval (01/01/2007–12/31/2010) and post-ruxolitinib approval (01/01/2015–09/30/2018). Deidentified patient-level data were extracted from US Veterans Health Administration (VHA) databases using PMF diagnosis codes; index was the first PMF diagnosis date. The analysis included adults with ≥2 PMF claims during the analysis periods who were continuously enrolled in the VHA plan 1 calendar year prior to and 6 months post-index and had ≥1 available International Prognostic Scoring System (IPSS) risk factor (available factors were age > 65, hemoglobin < 10 g/dL, and white blood cell count > 25 × 109/L; each counted as one point). Patients with ≥1 MF diagnosis for 12 months before the index period were excluded. Ruxolitinib treatment was not a requirement to be included in the post-ruxolitinib approval cohort. Mortality rates and OS were estimated using the Kaplan-Meier approach; all-cause mortality hazard ratio was estimated using univariate Cox regression.ResultsThe pre- and post-ruxolitinib approval cohorts included 193 and 974 patients, respectively, of which 80 and 197 had ≥2 IPSS risk factors. Ruxolitinib use in the post-ruxolitinib cohort was 8.5% (83/974). At end of follow-up, median (95% CI) OS was significantly shorter in the pre-ruxolitinib cohort (1.7 [1.2–2.6] years vs not reached [3.4–not reached]; P < 0.001). Overall mortality rates for the pre- versus post-ruxolitinib approval cohorts were 79.8% versus 47.3%, respectively, and overall risk of death was 53% lower in the post-ruxolitinib period (hazard ratio, 0.47; 95% CI, 0.37–0.58; P < 0.001). Mortality rates were lower among patients with < 2 vs ≥2 IPSS risk factors.ConclusionsAlthough veterans with PMF have high overall mortality rates, and results in this population might not be generalizable to the overall population, there was a significant lowering of mortality rate in the post-ruxolitinib period.

Comparative effectiveness of metformin versus sulfonylureas on kidney function decline or death among patients with reduced kidney function: a retrospective cohort study.

Diabetes often causes kidney disease. In this study, we sought to evaluate if metformin use was associated with death or kidney events in patients with diabetes and concurrent reduced kidney function. We used data from the Veterans Health Administration, Medicare and National Death Index databases to assemble a national retrospective cohort of veterans who were using metformin or sulfonylureas from 2001 through 2016 and who began follow-up at an estimated glomerular filtration rate (eGFR) of less than 60 mL/min/1.73 m2. The primary composite outcome was a kidney event (i.e., 40% decline in eGFR or end-stage renal disease) or death. The secondary outcome was a kidney event (eGFR decline or end-stage renal disease). We weighted the cohort using propensity scores and used Cox proportional models to estimate the cause-specific hazard of outcomes and of treatment nonpersistence as a competing risk. We stratified follow-up into 2 periods, namely the first 360 days from the start of follow-up, and 361 days and beyond. In the first 360 days, the propensity score-weighted cohort included 24 883 patients who used metformin and 24 998 who used sulfonylureas. There were 33.5 (95% confidence interval [CI] 30.9-36.3) and 43.0 (95% CI 40.1-46.0) deaths or kidney events per 1000 person-years for patients who used metformin or sulfonylureas, respectively (hazard ratio [HR] 0.78, 95% CI 0.71-0.85). For the secondary outcome of kidney events, the HR was 0.94 (95% CI 0.67-1.33). In the second period from 361 days onward, the primary outcome event rate was 26.5 (95% CI 24.7-28.5) per 1000 person-years for those who used metformin, compared with 36.3 (95% CI 34.2-38.6) per 1000 person-years for those who used sulfonylureas (HR 0.73, 95% CI 0.67-0.79). Results were consistent for kidney events alone (HR 0.73, 95% CI 0.59-0.91). Metformin use for 361 days or longer after reaching an eGFR of less than 60 mL/min/1.73 m2 was associated with decreased likelihood of kidney events or death in patients with diabetes, compared with use of sulfonylureas. Metformin provided end-organ protection, in addition to glucose control.

736. Impact of COVID-19 on Mortality Associated with Pseudomonas aeruginosa Bloodstream Infection in the Veterans Health Administration System

Abstract Background Pseudomonas aeruginosa bloodstream infection (PA-BSI) is associated with high mortality. The extent to which the COVID-19 pandemic has introduced challenges to diagnosis and treatment of this infection is unknown. In this study, we examined the direct and indirect effects of COVID-19 on PA-BSI associated mortality in the Veterans Health Administration (VHA) population. Methods We identified patients within the VHA database with PA-BSI identified between January 1, 2009 and December 31, 2019 (pre-COVID) and January 1, 2020 to December 31, 2021 (COVID). Extracted data included age, race, ethnicity, Charlson Comorbidity Index (CCI), susceptibility testing, treatment, and COVID-19 infection. Antimicrobial resistance was characterized as pan-susceptible, any unclassified resistance, multi-drug resistant (MDR), difficult to treat resistant (DTR), and extremely or pan-drug resistant (XDR/PDR). Active therapy was defined as an effective antibiotic initiated within 48 hours of blood culture collection. We used logistic regression to assess the impact of each factor on 30-day mortality. Results We identified 7,578 patients with PA-BSI and known 30-day mortality status, which was 24% overall (Table 1). Age and CCI were higher during COVID, while effective treatment and resistance improved (Table 2). In the multivariate analysis, concomitant COVID infection tripled the odds of mortality (odds ratio [OR] 3.00, 95% confidence interval [CI] 1.40–6.37) (Figure 1). However, the COVID period itself was not associated with higher mortality. Effective treatment was associated with 19% lower odds of mortality (OR 0.81, 95% CI 0.66–1.01), while DTR and XDR/PDR nearly doubled mortality (OR 1.75, 95% CI 1.23–2.47 and OR 2.06, 95% CI 1.25–3.34, respectively). Conclusion We observed higher odds of mortality in patients with PA-BSI and COVID-19 coinfection, supporting the hypothesis that COVID-19 directly impacts PA-BSI outcomes. Annual PA-BSI incidence and associated 30-day mortality, however, were similar during the COVID period. Favorable resistance trends, effective treatment, and a low rate of PA-BSI and COVID-19 coinfection may explain these findings, despite increased age and comorbidities in this vulnerable population. Disclosures Federico Perez, MD, MS, Accelerate: Grant/Research Support|Merck: Grant/Research Support|Pfizer: Grant/Research Support Robert A. Bonomo, MD, Merck: Grant/Research Support|Pfizer: Honoraria|VenatoRx: Grant/Research Support|Wockhardt: Grant/Research Support.

411. Characterization of Antibiotic Prophylaxis Prior to Trans Rectal Ultrasound Guided Prostate Needle Biopsy (TRUS PNB): A 5-Year Nationwide Study among Patients in the United States Veterans Health Administration

Abstract Background Prophylactic antibiotics are used prior to TRUS PNB to reduce risk for infectious complications such as UTI, prostatitis, epididymitis, orchitis, bacteremia and sepsis. Fluoroquinolones have been commonly used for prophylaxis, however, the incidence of post TRUS PNB infections caused by fluoroquinolone resistant Escherichia coli has increased. The purpose of this study was to characterize the prophylaxis agents used nationwide in the Veterans Health Administration (VHA) prior to TRUS PNB. Methods We conducted a review of records of all patients undergoing TRUS PNB in the VHA database from January 1st, 2013 to December 31st, 2018. We collected data about outpatient oral prophylaxis antibiotics, inpatient injectable antibiotics and microbiology results from rectal swabs and urine cultures performed within 90 days prior to the procedure. Results Of 153,055 patients undergoing prostate biopsy between January 1st, 2013 and December 31st, 2018, 27.6% (n=42,319) had urine cultures and 3.9% (n=5,294) had rectal swab cultures done within the 90-day window prior to the procedure. Among these who had urine and rectal swabs culture, 3.0% (n=1,292) and 20.1% (n=1,062) were positive for E. coli, respectively; 40.2% of E. coli isolates recovered from urine and 89.6% recovered from rectal swabs were resistant to fluoroquinolones. Table 1 shows the frequencies and percentages of oral prophylactic agents administered within the 90 days prior to the procedure and injectable antibiotics administered on the day of the procedure. Frequency and percentage of oral prophylactic agents administered within the 90 days prior to the procedure and injectable antibiotics administered on the day of the procedure Frequency and percentage of oral prophylactic agents administered within the 90 days prior to the procedure and injectable antibiotics administered on the day of the procedure Conclusion Despite the high rate of recovery of fluoroquinolone-resistant E. coli in pre-procedure urine and rectal swabs, oral fluoroquinolones remained the most frequently used prophylactic agents prior to TRUS PNB. This inadequate prophylactic coverage may increase the risk of infectious complications following prostate biopsy. Disclosures Elie Saade, MD, MPH, FIDSA, Janssen: Advisor/Consultant.

Risk of Prostate Cancer in US Veterans With Rheumatoid Arthritis.

Patients with rheumatoid arthritis (RA) have an increased risk of select cancers, including lymphoma and lung cancer. Whether RA influences prostate cancer risk is uncertain. We aimed to determine the risk of prostate cancer in patients with RA compared to patients without RA in the Veterans Health Administration (VA). We performed a matched (up to 1:5) cohort study of male patients with and without RA in the VA from 2000 to 2018. RA status, as well as covariates, were obtained from national VA databases. Prostate cancer was identified through linked VA cancer databases and the National Death Index. Multivariable Cox models compared prostate cancer risk between patients with RA and patients without RA, including models that accounted for retention in the VA system. We included 56,514 veterans with RA and 227,284 veterans without RA. During 2,337,104 patient-years of follow-up, 6,550 prostate cancers occurred. Prostate cancer incidence (per 1,000 patient-years) was 3.50 (95% confidence interval [95% CI] 3.32-3.69) in patients with RA and 2.66 (95% CI 2.58-2.73) in patients without RA. After accounting for confounders and censoring for attrition of VA health care, RA was modestly associated with a higher prostate cancer risk (adjusted HR [HRadj ] 1.12 [95% CI 1.04-1.20]). There was no association between RA and prostate cancer mortality (HRadj 0.92 [95% CI 0.73-1.16]). RA was associated with a modestly increased risk of prostate cancer, but not prostate cancer mortality, after accounting for relevant confounders and several potential sources of bias. However, even minimal unmeasured confounding could explain these findings.