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Background Most states have recently passed laws requiring prescribers to use prescription drug monitoring programs (PDMPs) before prescribing opioid medications. The impact of these mandates on discontinuing chronic opioid therapy among Veterans managed in the Veterans Health Administration (VA) is unknown. We assess the association between the earliest of these laws and discontinuation of chronic opioid therapy in Veterans receiving VA health care. Methods We conducted a comparative interrupted time-series study in the 5 states mandating PDMP use before August 2013 (Ohio, West Virginia, Kentucky, New Mexico, and Tennessee), adjusting for trends in the 17 neighboring control states without such mandates. We modeled 25 months of prescribing for each state centered on the month the mandate became effective. We included Veterans prescribed long-term outpatient opioid therapy (305 of the preceding 365 d). Our outcomes were discontinuation of chronic opioid therapy (primary outcome) and the average daily quantity of opioids per Veteran over the following 6 months (secondary outcome). Results We included 250 monthly cohorts with 225,665 unique Veterans and 3.4 million Veteran-months. Baseline discontinuation rates before the PDMP mandates were 0.4%-2.7% per month. Kentucky saw a discontinuation increase of 1 absolute percentage point following its PDMP mandate which decreased over time. The other 4 states had no significant association between their mandates and change in opioid discontinuation. There was no evidence of decreasing opioid quantities following PDMP mandates. Conclusion We did not find consistent evidence that state laws mandating provider PDMP use were associated with the discontinuation of chronic opioid therapy within the VA for the time period studied.

BACKGROUND Depression is common after a diagnosis of prostate cancer and may contribute to poor outcomes, particularly among African Americans. The authors assessed the incidence and management of depression and its impact on overall mortality among African American and White veterans with localized prostate cancer. METHODS The authors used the Veterans Health Administration Corporate Data Warehouse to identify 40,412 African American and non-Hispanic White men diagnosed with localized prostate cancer from 2001 to 2013. Patients were followed through 2019. Multivariable logistic regression was used to measure associations between race and incident depression, which were ascertained from administrative and depression screening data. Cox proportional hazards models were used to measure associations between incident depression and all-cause mortality, with race-by-depression interactions used to assess disparities. RESULTS Overall, 10,013 veterans (24.5%) were diagnosed with depression after a diagnosis of prostate cancer. Incident depression was associated with higher all-cause mortality (adjusted hazard ratio [aHR], 1.27; 95% confidence interval [CI], 1.23-1.32). African American veterans were more likely than White veterans to be diagnosed with depression (29.3% vs 23.2%; adjusted odds ratio [aOR], 1.15; 95% CI, 1.09-1.21). Among those with depression, African Americans were less likely to be prescribed an antidepressant (30.4% vs 31.7%; aOR, 0.85; 95% CI, 0.77-0.93). The hazard of all-cause mortality associated with depression was greater for African American veterans than White veterans (aHR, 1.32 [95% CI, 1.26-1.38] vs 1.15 [95% CI, 1.07-1.24]; race-by-depression interaction P < .001). CONCLUSIONS Incident depression is common among prostate cancer survivors and is associated with higher mortality, particularly among African American men. Patient-centered strategies to manage incident depression may be critical to reducing disparities in prostate cancer outcomes.

Objective: To identify sociodemographic profiles of patients prescribed high-dose opioids . Design: Cross-sectional cohort study. Setting/Patients: Veterans dually-enrolled in Veterans Health Administration and Medicare Part D, with ≥ 1 opioid prescription in 2012. Main Outcome Measures: We identified five patient-level demographic characteristics and 12 community variables reflective of region, socioeconomic deprivation, safety, and internet connectivity. Our outcome was the proportion of veterans receiving >120 morphine milligram equivalents (MME) for ≥ 90 consecutive days, a Pharmacy Quality Alliance measure of chronic high-dose opioid prescribing. We used classification and regression tree (CART) methods to identify risk of chronic high-dose opioid prescribing for sociodemographic subgroups. Results: Overall, 17,271 (3.3 percent) of 525,716 dually enrolled veterans were prescribed chronic high-dose opioids. CART analyses identified 35 subgroups using four sociodemographic and five community-level measures, with high-dose opioid prescribing ranging from 0.28 percent to 12.1 percent. The subgroup (n = 16,302) with highest frequency of the outcome included veterans who were with disability, age 18-64 years, white or other race, and lived in the Western Census region. The subgroup (n = 14,835) with the lowest frequency of the outcome included veterans who were without disability, did not receive Medicare Part D Low Income Subsidy, were >85 years old, and lived in communities within the second and sixth to tenth deciles of community public assistance. Conclusions: Using CART analyses with sociodemographic and community-level variables only, we identified subgroups of veterans with a 43-fold difference in chronic high-dose opioid prescriptions. Interactions among disability, age, race/ ethnicity, and region should be considered when identifying high-risk subgroups in large populations.

Research is limited about whether and to what extent registered sex offenders (RSOs) face an increased risk of housing instability. The intersection of RSO and housing instability is particularly salient for veterans as there are disproportionately higher rates of veterans among both RSOs and homeless populations. This study assessed the relationship between RSO status and risk of housing instability and homelessness among military veterans. We matched a list of 373,774 RSOs obtained from publicly available sex offender registries in 19 states with a cohort of 5.9 million veterans who responded to a brief screening for housing instability administered throughout the Veterans Health Administration between 2012 and 2016. Logistic regression estimated adjusted odds of any housing instability and homelessness among veterans identified as RSOs. Veterans identified as RSOs had 1.81 (95% confidence interval [CI] 1.46–2.25) and 2.97 (95% CI 1.67–5.17) times greater odds of reporting any housing instability and homelessness, respectively, than non-RSOs. Findings represent some of the strongest evidence to date for the high risk of housing instability and homelessness among RSOs, suggesting a clear gap in policy and programmatic responses to their unique housing needs. Evidence-based alternative approaches to residence restriction laws may reduce recidivism and protect public safety.

To examine the relationship between Veterans’ housing instability and mortality by homicide, suicide, and unintentional injury, this retrospective study examined administrative data from Veterans H...

Background Few studies have assessed prescription opioid supply preceding death in individuals dying from unintentional prescription opioid overdoses, or described the characteristics of these individuals, particularly among Veterans. Objectives To describe the history of prescription opioid supply preceding prescription opioid overdose death among Veterans. Methods In a national cohort of Veterans who filled ≥1 opioid prescriptions from the Veterans Health Administration (VA) or Medicare Part D during 2008–2013, we identified deaths from unintentional or undetermined-intent prescription opioid overdoses in 2012–2013. We captured opioid prescriptions using both linked VA and Part D data, and VA data only. Results Among 1181 decedents, 643 (54.4%) had prescription opioid supply on the day of death, and 735 (62.2%) within 30 days based on linked data, compared to 40.1% and 46.7%, respectively, using VA data alone. Decedents with prescription opioid supply were significantly older and less likely to have alcohol or illicit drugs as co-occurring substances involved in the overdose. Using linked data, 241 (20.4%) decedents lacked prescription opioid supply within a year of death. Conclusions Many VA patients who die from prescription opioid overdose receive opioid prescriptions outside VA or not at all. It is important to supplement VA with non-VA data to more accurately measure prescription opioid exposure and improve opioid medication safety.

Key Points Question Are cardiovascular risk factors assessed and appropriately managed in patients with prostate cancer initiating androgen deprivation therapy? Findings In this cross-sectional analysis of 90 494 US veterans with prostate cancer, 68.1% received comprehensive cardiovascular risk factor assessment and 54.1% had uncontrolled risk factors; of these, 29.6% were not receiving risk-reducing medication. Patients with known atherosclerotic cardiovascular disease had improved cardiovascular risk factor assessment, control, and treatment; however, androgen deprivation therapy initiation was not associated with meaningful differences in these outcomes. Meaning In this study, veterans with prostate cancer, including those initiating androgen deprivation therapy, appeared to have a high burden of underassessed and undertreated cardiovascular risk factors., Importance Cardiovascular disease is a leading cause of mortality in patients with prostate cancer, and androgen deprivation therapy (ADT) may worsen cardiovascular risk. Adherence to guideline-recommended assessment and management of cardiovascular risk factors (CVRFs) in patients initiating ADT is unknown. Objective To describe CVRF assessment and management in men with prostate cancer initiating ADT and overall. Design, Setting, and Participants A cross-sectional analysis of 90 494 men treated within the US Veterans Health Administration diagnosed with prostate cancer between January 1, 2010, and December 31, 2017, was conducted. Participants included men with a history of atherosclerotic cardiovascular disease (ASCVD), and treatment with ADT within 1 year of diagnosis. Data analysis was conducted from September 10, 2019, to July 1, 2020. Main Outcomes and Measures Rates of comprehensive CVRF assessment, uncontrolled CVRFs, and untreated CVRFs. Comprehensive CVRF assessment was defined as recorded measures for blood pressure, cholesterol, and glucose levels; CVRF control as blood pressure lower than 140/90 mm Hg, low-density lipoprotein cholesterol 130 mg/dL, and hemoglobin A1c less than 7%; and CVRF treatment as receipt of cardiac risk–reducing medications. Multivariable risk difference regression assessed the association between ASCVD and initiation of ADT and these outcomes. Results Of 90 494 veterans, median age was 66 years (interquartile range, 62-70 years); and 22 700 men (25.1%) received ADT. Overall, 68.1% (95% CI, 67.8%-68.3%) of the men received comprehensive CVRF assessment; 54.1% (95% CI. 53.7%-54.4%) of those assessed had uncontrolled CVRFs, and 29.6% (95% CI, 29.2%-30.0%) of those with uncontrolled CVRFs were not receiving corresponding cardiac risk–reducing medication. Compared with the reference group of patients without ASCVD not receiving ADT, patients with ASCVD not receiving ADT had a 10.4% (95% CI, 9.5%-11.3%) higher probability of comprehensive CVRF assessment, 4.0% (95% CI, 2.9%-5.1%) lower risk of uncontrolled CVRFs, and 22.2% (95% CI, 21.1%-23.3%) lower risk of untreated CVRFs. Similar differences were observed in patients with ASCVD receiving ADT. In contrast, patients without ASCVD receiving ADT had only a 3.0% (95% CI, 2.1%-3.9%) higher probability of comprehensive CVRF assessment, 2.6% (95% CI, 1.6%-3.5%) higher risk of uncontrolled CVRFs, and 5.4% (95% CI, 4.2%-6.6%) lower risk of untreated CVRFs. Conclusions and Relevance These findings suggest that veterans with prostate cancer had a high rate of underassessed and undertreated CVRFs, and ADT initiation was not associated with substantial improvements in CVRF assessment or management. These findings highlight gaps in care and the need for interventions to improve CVRF mitigation in this population., This cross-sectional study examines the assessment and management of cardiovascular risk factors among men initiating androgen deprivation therapy for prostate cancer.

Objective To evaluate the effect of dual use of VA/Medicare Part D drug benefits on antihypertensive medication supply in older Veterans with dementia. Data sources/study setting National, linked 2007-2010 Veterans Affairs (VA) and Medicare utilization and prescription records for 50,763 dementia patients with hypertension. Study design We used inverse probability of treatment (IPT)-weighted multinomial logistic regression to examine the association of dual prescription use with undersupply and oversupply of antihypertensives. Data collection/extraction methods Veterans Affairs and Part D prescription records were used to classify patients as VA-only, Part D-only, or dual VA/Part D users of antihypertensives and summarize their antihypertensive medication supply in 2010: (1) appropriate supply of all prescribed antihypertensive classes, (2) undersupply of ≥1 class with no oversupply of another class, (3) oversupply of ≥1 class with no undersupply, or (4) both undersupply and oversupply. Principal findings Dual prescription users were more likely than VA-only users to have undersupply only (aOR = 1.28; 95 percent CI = 1.18-1.39), oversupply only (aOR = 2.38; 95 percent CI = 2.15-2.64), and concurrent under- and oversupply (aOR = 2.89; 95 percent CI = 2.53-3.29), versus appropriate supply of all classes. Conclusions Obtaining antihypertensives through both VA and Part D was associated with increased antihypertensive under- and oversupply. Efforts to understand how best to coordinate dual-system prescription use are critically needed.

BACKGROUND Homeless patients describe poor experiences with primary care. In 2012, the Veterans Health Administration (VHA) implemented homeless-tailored primary care teams (Homeless Patient Aligned Care Team, HPACTs) that could improve the primary care experience for homeless patients. OBJECTIVE To assess differences in primary care experiences between homeless and nonhomeless Veterans receiving care in VHA facilities that had HPACTs available (HPACT facilities) and in VHA facilities lacking HPACTs (non-HPACT facilities). RESEARCH DESIGN We used multivariable multinomial regressions to estimate homeless versus nonhomeless patient differences in primary care experiences (categorized as negative/moderate/positive) reported on a national VHA survey. We compared the homeless versus nonhomeless risk differences (RDs) in reporting negative or positive experiences in 25 HPACT facilities versus 485 non-HPACT facilities. SUBJECTS Survey respondents from non-HPACT facilities (homeless: n=10,148; nonhomeless: n=309,779) and HPACT facilities (homeless: n=2022; nonhomeless: n=20,941). MEASURES Negative and positive experiences with access, communication, office staff, provider rating, comprehensiveness, coordination, shared decision-making, and self-management support. RESULTS In non-HPACT facilities, homeless patients reported more negative and fewer positive experiences than nonhomeless patients. However, these patterns of homeless versus nonhomeless differences were reversed in HPACT facilities for the domains of communication (positive experience RDs in non-HPACT versus HPACT facilities=-2.0 and 2.0, respectively); comprehensiveness (negative RDs=2.1 and -2.3), shared decision-making (negative RDs=1.2 and -1.8), and self-management support (negative RDs=0.1 and -4.5; positive RDs=0.5 and 8.0). CONCLUSIONS VHA facilities with HPACT programs appear to offer a better primary care experience for homeless versus nonhomeless Veterans, reversing the pattern of relatively poor primary care experiences often associated with homelessness.

BACKGROUND: Managing depression in primary care settings has increased with the rise of integrated models of care, such as patient-centered medical homes (PCMHs). The relationship between patient experience in PCMH settings and receipt of depression treatment is unknown. OBJECTIVE: In a large sample of Veterans diagnosed with depression, we examined whether positive PCMH experiences predicted subsequent initiation or continuation of treatment for depression. DESIGN AND PARTICIPANTS: We conducted a lagged cross-sectional study of depression treatment among Veterans with depression diagnoses (n = 27,362) in the years before (Y1) and after (Y2) they completed the Veterans Health Administration’s national 2013 PCMH Survey of Healthcare Experiences of Patients. MAIN MEASURES: We assessed patient experiences in four domains, each categorized as positive/moderate/negative. Depression treatment, determined from administrative records, was defined annually as 90 days of antidepressant medications or six psychotherapy visits. Multivariable logistic regressions measured associations between PCMH experiences and receipt of depression treatment in Y2, accounting for treatment in Y1. KEY RESULTS: Among those who did not receive depression treatment in Y1 (n = 4613), positive experiences in three domains (comprehensiveness, shared decision-making, self-management support) predicted greater initiation of treatment in Y2. Among those who received depression treatment in Y1 (n = 22,749), positive or moderate experiences in four domains (comprehensiveness, care coordination, medication decision-making, self-management support) predicted greater continuation of treatment in Y2. CONCLUSIONS: In a national PCMH setting, patient experiences with integrated care, including care coordination, comprehensiveness, involvement in shared decision-making, and self-management support predicted patients’ subsequent initiation and continuation of depression treatment over time—a relationship that could affect physical and mental health outcomes. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11606-018-4522-7) contains supplementary material, which is available to authorized users.

Objective Transgender individuals are vulnerable to negative health risks and outcomes, but research remains limited because data sources, such as electronic medical records (EMRs), lack standardized collection of gender identity information. Most EMR do not include the gold standard of self-identified gender identity, but International Classification of Diseases (ICDs) includes diagnostic codes indicating transgender-related clinical services. However, it is unclear if these codes can indicate transgender status. The objective of this study was to determine the extent to which patients’ clinician notes in EMR contained transgender-related terms that could corroborate ICD-coded transgender identity. Methods Data are from the US Department of Veterans Affairs Corporate Data Warehouse. Transgender patients were defined by the presence of ICD9 and ICD10 codes associated with transgender-related clinical services, and a 3:1 comparison group of nontransgender patients was drawn. Patients’ clinician text notes were extracted and searched for transgender-related words and phrases. Results Among 7560 patients defined as transgender based on ICD codes, the search algorithm identified 6753 (89.3%) with transgender-related terms. Among 22 072 patients defined as nontransgender without ICD codes, 246 (1.1%) had transgender-related terms; after review, 11 patients were identified as transgender, suggesting a 0.05% false negative rate. Conclusions Using ICD-defined transgender status can facilitate health services research when self-identified gender identity data are not available in EMR.

Background We evaluated the effectiveness of targeted antimicrobial prophylaxis in transrectal ultrasound guided prostate biopsy (TRUSP). Methods A prospective, non-randomized cohort study was conducted. Rectal swab cultures plated on non-selective blood agar and on selective MacConkey agar supplemented with ciprofloxacin identified ciprofloxacin-susceptible and –resistant gram-negative bacteria (CS-GNB and CR-GNB). Patients with CS-GNB received ciprofloxacin while those with CR-GNB received directed prophylaxis. Infectious complications were defined clinically and microbiologically within 30 days after TRUSP. Data were derived at 7 and 30 days post procedure by questionnaires and electronic medical records. We hypothesized that there would be no difference in the infectious outcomes among the CS and CR groups. Results From November 1, 2012 to March 31, 2015, 510 men completed the study; 430 (84.3%) had CS-GNB and 80 (15.7%) had CR-GNB. 484 (94.9%) completed the study per protocol, while 26 (5.1%) had an intention-to-treat (ITT) analysis. Of the 484, 475 (98.1%) had no infections, nine (1.9%) had infections, six of which (1.2%) were culture-proven (CP). The nine infections were as follows: five (1.0%) uncomplicated UTIs, one (0.2%) complicated UTI, and three (0.6%) urosepsis. One case of uncomplicated UTI and two cases of urosepsis were not CP, but were diagnosed clinically. ITT outcomes were similar. The infection rates were not statistically different between the CS-and CR-GNB patients (p-value = 0.314; 95% CI 0.8–3.3). The four patients with complicated UTIs or sepsis were hospitalized for a mean of 2.6 days and discharged without sequelae. Of the nine infections, three were antimicrobial prophylaxis failures (two ciprofloxacin and one amikacin); three were likely due to failure of the collection or processing of the rectal swab or increasing bacterial resistance between the time of swab collection and biopsy, and three developed clinical infections with no isolate recovered. Conclusions Targeted antimicrobial prophylaxis follows the principles of antimicrobial stewardship and achieved a low rate of infectious complications with limited morbidity and no sequelae. This individualized method of prophylaxis may be widely applied. Further studies are needed to explore reasons for targeted prophylaxis failure and to determine comparative efficacy of non-ciprofloxacin-containing targeted prophylaxis regimens. Trial registration ClinicalTrials.gov. NCT01659866. Registered 9 July 2012. First patient enrolled 1 November 2012. Electronic supplementary material The online version of this article (doi:10.1186/s12879-017-2470-1) contains supplementary material, which is available to authorized users.

This observational study evaluates the association of dual prescribing for Veterans Affairs and Medicare Part D benefits with unsafe prescription exposure in a national cohort of older veterans.

BACKGROUND: There is systemic undercoding of medical comorbidities within administrative claims in the Department of Veterans Affairs (VA). This leads to bias when applying claims-based risk adjustment indices to compare outcomes between VA and non-VA settings. Our objective was to compare the accuracy of a medication-based risk adjustment index (RxRisk-VM) to diagnostic claims-based indices for predicting mortality. METHODS: We modified the RxRisk-V index (RxRisk-VM) by incorporating VA and Medicare pharmacy and durable medical equipment claims in Veterans dually-enrolled in VA and Medicare in 2012. Using the concordance (C) statistic, we compared its accuracy in predicting 1 and 3-year all-cause mortality to the following models: demographics only, demographics plus prescription count, or demographics plus a diagnostic claims-based risk index (e.g., Charlson, Elixhauser, or Gagne). We also compared models containing demographics, RxRisk-VM, and a claims-based index. RESULTS: In our cohort of 271,184 dually-enrolled Veterans (mean age=70.5 years, 96.1% male, 81.7% non-Hispanic white), RxRisk-VM (C=0.773) exhibited greater accuracy in predicting 1-year mortality than demographics only (C=0.716) or prescription counts (C=0.744), but was less accurate than the Charlson (C=0.794), Elixhauser (C=0.80), or Gagne (C=0.810) indices (all P

Importance More conservative prescribing has the potential to reduce adverse drug events and patient harm and cost; however, no method exists defining the extent to which individual clinicians prescribe conservatively. One potential domain is prescribing a more limited number of drugs. Personal formularies-defined as the number and mix of unique, newly initiated drugs prescribed by a physician-may enable comparisons among clinicians, practices, and institutions. Objectives To develop a method of defining primary care physicians' personal formularies and examine how they differ among primary care physicians at 4 institutions; evaluate associations between personal formularies and patient, physician, and practice site characteristics; and empirically derive and examine the variability of the top 200 core drugs prescribed at the 4 sites. Design, setting, and participants This retrospective cohort study was conducted at 4 US health care systems among 4655 internal and family medicine physicians and 4 930 707 patients who had at least 1 visit to these physicians between January 1, 2017, and December 31, 2018. Exposures Personal formulary size was defined as the number of unique, newly initiated drugs. Main outcomes and measures Personal formulary size and drugs used, physician and patient characteristics, core drugs, and analysis of selected drug classes. Results The study population included 4655 primary care physicians (2274 women [48.9%]; mean [SD] age, 48.5 [4.4] years) and 4 930 707 patients (16.5% women; mean [SD] age, 51.9 [8.3] years). There were 41 378 903 outpatient prescriptions written, of which 9 496 766 (23.0%) were new starts. Institution median personal formulary size ranged from 150 (interquartile range, 82.0-212.0) to 296 (interquartile range, 230.0-347.0) drugs. In multivariable modeling, personal formulary size was significantly associated with panel size (total number of unique patients with face-to-face encounters during the study period; 1.2 medications per 100 patients), physician's total number of encounters (5.7 drugs per 10% increase), and physician's sex (-6.2 drugs per 100 patients for female physicians). There were 1527 unique, newly prescribed drugs across the 4 sites. Fewer than half the drugs (626 [41.0%]) were used at every site. Physicians' prescribing of drugs from a pooled core list varied from 0% to 100% of their prescriptions. Conclusions and relevance Personal formularies, measured at the level of individual physicians and institutions, reveal variability in size and mix of drugs. Similarly, defining a list of commonly prescribed core drugs in primary care revealed interphysician and interinstitutional differences. Personal formularies and core medication lists enable comparisons and may identify outliers and opportunities for safer and more appropriate prescribing.

BACKGROUND Patient-Centered Medical Homes (PCMH) may be effective in managing care for racial/ethnic minorities with mental health and/or substance use disorders (MHSUDs). How such patients experience care in PCMH settings is relatively unknown.

201 Background: Depressive disorder is a common cause of morbidity among men with prostate cancer (PC) and may contribute to known racial disparities in PC outcomes. We estimated the incidence, management, and impact of depressive disorder (depression) on overall mortality among African American (AA) and non-Hispanic White (W) Veterans with localized PC. Methods: In this retrospective cohort study, we used linked administrative, survey, and electronic health record data from the Veterans Health Administration (VA) Corporate Data Warehouse to identify AA and W Veterans with no preexisting depression who were diagnosed with localized PC between January 1, 2004 and December 31, 2013. Patients were followed through December 31, 2019. The primary outcomes were incident depression (defined from diagnosis codes and PHQ-2 and -9 screenings between six months to five years after PC diagnosis), receipt of anti-depressant therapy, and all-cause mortality. We used logistic and Cox regression models, adjusted for sociodemographic factors, PSA, Gleason score, and prostate cancer treatment, to estimate associations with all outcomes, using race-by-depression and race-by-treatment interaction terms to investigate racial disparities. Results: Among 32,194 Veterans diagnosed with localized prostate cancer (median age 67 years [interquartile range [IQR] 62 to 73 years], median follow-up 9.9 years [IQR 8.0 to 12.1 years]), 8,177 (25.4%) were AA. Overall, 8,285 (25.7%) Veterans were diagnosed with depression after PC diagnosis, and 2,525 (30.5%) of depressed Veterans received an antidepressant. Compared to Veterans without depression, Veterans with incident depression had higher all-cause mortality (adjusted hazard ratio [aHR] 1.30 [95% CI 1.25-1.35]). Race moderated all outcomes: AAs were more likely than Ws to be diagnosed with depression. However, among those with depression, AAs were less likely than Ws to receive an antidepressant. Interaction analyses showed that the HR of all-cause mortality associated with depression among AAs was significantly greater than that of Ws. Antidepressant receipt was not associated with improved mortality (aHR 1.05 [95% CI 0.97-1.13]); this finding was not moderated by race. Conclusions: Depression was common among men with prostate cancer within a large equal-access health care system, and African American men had more adverse depression-related outcomes than White men. Identifying and managing incident depression should be a key target of efforts to improve prostate cancer outcomes and disparities. [Table: see text]

202 Background: Known racial disparities in prostate cancer outcomes between African-American (AA) and non-Hispanic White (W) men may be ameliorated in the Veterans Health Administration (VA), a large national equal-access health system. We examined factors contributing to racial disparities in mortality among men with high-risk localized prostate cancer diagnosed in the VA. Methods: In this retrospective cohort study, we used linked administrative, survey, and electronic health record data from the Veterans Health Administration (VA) Corporate Data Warehouse to identify AA and W Veterans who were diagnosed with high-risk localized PC, as defined by D’Amico criteria, between January 1, 2004 and December 31, 2013. Patients were followed through December 31, 2019. The primary outcome was all-cause mortality. We used hierarchical Cox regression models, sequentially adjusting for covariates related to social determinants of health (e.g. travel time, marital status), clinical factors at diagnosis (e.g. PSA, Gleason, comorbidity), diagnosing facility, and prostate cancer treatment and adherence to American Cancer Society survivorship care guidelines. Results: Among 21,338 Veterans receiving continuous VA-based care (median age at diagnosis 66 years [interquartile range [IQR] 61-74]), 7,472 (28.7%) were AA, 9,404 (44.1%) died, and median follow-up was 8.4 years (IQR 6.1-11.1). After adjusting for all covariates, AA Veterans (adjusted hazard ratio [aHR] 0.84, 95% confidence interval [CI] 0.83-0.91) had improved overall survival compared to W Veterans. This association persisted in all hierarchical regressions (see Table), was present in all pre-specified subgroups, and was strongest among Veterans living in rural domiciles (aHR 0.70, 95% CI 0.64-0.77). Conclusions: AA Veterans with high-risk localized prostate cancer had improved long-term survival compared to W Veterans, which stands in contrast to prior studies among non-Veterans. Equal access to care may improve racial disparities in prostate cancer, although future studies should clarify mechanisms of improved survival for AA Veterans with prostate cancer in order to provide insights for ameliorating outcome disparities in non-Veterans with prostate cancer. [Table: see text]

Key Points Question Are there racial differences in receipt and duration of conservative management (ie, active surveillance or watchful waiting) among veterans with low-risk and intermediate-risk prostate cancer? Findings In this cohort study of 51 543 veterans with low-risk and intermediate-risk prostate cancer, African American veterans were less likely than White veterans to receive conservative management, and African American patients who received conservative management were more likely to receive definitive therapy within 5 years of diagnosis. Meaning The findings of this study suggest that conservative management for low-risk and intermediate-risk prostate cancer may be less durable for African American veterans compared with White veterans., This cohort study examines the association of African American race with the receipt and duration of conservative management (ie, active surveillance or watchful waiting) in the Veterans Health Administration from 2004 to 2018., Importance Conservative management (ie, active surveillance or watchful waiting) is a guideline-based strategy for men with low-risk and intermediate-risk prostate cancer. However, use of conservative management is controversial for African American patients, who have worse prostate cancer outcomes compared with White patients. Objective To examine the association of African American race with the receipt and duration of conservative management in the Veterans Health Administration (VA), a large equal-access health system. Design, Setting, and Participants This cohort study used data from the VA Corporate Data Warehouse for 51 543 African American and non-Hispanic White veterans diagnosed with low-risk and intermediate-risk localized node-negative prostate cancer between January 1, 2004, and December 31, 2013. Men who did not receive continuous VA care were excluded. Data were analyzed from February 1 to June 30, 2020. Exposures All patients received either definitive therapy (ie, prostatectomy, radiation, androgen deprivation therapy) or conservative management (ie, active surveillance or watchful waiting). Main Outcomes and Measures Receipt of conservative management and (for patients receiving conservative management) time from diagnosis to definitive therapy. Results The median (interquartile range) age of the 51 543 veterans in our cohort was 65 (61-70) years, and 14 830 veterans (28.8%) were African American individuals. Compared with White veterans, African American veterans were more likely to have intermediate-risk disease (18 988 [51.7%] vs 8526 [57.5%]), 3 or more comorbidities (15 438 [42.1%] vs 7614 [51.3%]), and high disability-related or income-related needs (9078 [24.7%] vs 4614 [31.1%]). Overall, 20 606 veterans (40.0%) received conservative management. African American veterans with low-risk disease (adjusted relative risk, 0.95; 95% CI, 0.92-0.98; P

Background In 2012, select Veterans Health Administration (VHA) facilities implemented a homeless-tailored medical home model, called Homeless Patient Aligned Care Teams (H-PACT), to improve care processes and outcomes for homeless Veterans. Objective The main aim of this study was to determine whether H-PACT offers a better patient experience than standard VHA primary care. Research design We used multivariable logistic regressions to estimate differences in the probability of reporting positive primary care experiences on a national survey. Subjects Homeless-experienced survey respondents enrolled in H-PACT (n=251) or standard primary care in facilities with H-PACT available (n=1527) and facilities without H-PACT (n=10,079). Measures Patient experiences in 8 domains from the Consumer Assessment of Healthcare Provider and Systems surveys. Domain scores were categorized as positive versus nonpositive. Results H-PACT patients were less likely than standard primary care patients to be female, have 4-year college degrees, or to have served in recent military conflicts; they received more primary care visits and social services. H-PACT patients were more likely than standard primary care patients in the same facilities to report positive experiences with access [adjusted risk difference (RD)=17.4], communication (RD=13.9), office staff (RD=13.1), provider ratings (RD=11.0), and comprehensiveness (RD=9.3). Standard primary care patients in facilities with H-PACT available were more likely than those from facilities without H-PACT to report positive experiences with communication (RD=4.7) and self-management support (RD=4.6). Conclusions Patient-centered medical homes designed to address the social determinants of health offer a better care experience for homeless patients, when compared with standard primary care approaches. The lessons learned from H-PACT can be applied throughout VHA and to other health care settings.

Background Overlapping use of opioids and benzodiazepines is associated with increased risk for overdose. Veterans receiving medications concurrently from the U.S. Department of Veterans Affairs (VA) and Medicare may be at higher risk for such overlap. Objective To assess the association between dual use of VA and Medicare drug benefits and receipt of overlapping opioid and benzodiazepine prescriptions. Design Cross-sectional. Setting VA and Medicare. Participants All veterans enrolled in VA and Medicare Part D who filled at least 2 opioid prescriptions in 2013 (n = 368 891). Measurements Outcomes were the proportion of patients with a Pharmacy Quality Alliance (PQA) measure of opioid-benzodiazepine overlap (≥2 filled prescriptions for benzodiazepines with ≥30 days of overlap with opioids) and the proportion of patients with high-dose opioid-benzodiazepine overlap (≥30 days of overlap with a daily opioid dose >120 morphine milligram equivalents). Augmented inverse probability weighting regression was used to compare these measures by prescription drug source: VA only, Medicare only, or VA and Medicare (dual use). Results Of 368 891 eligible veterans, 18.3% received prescriptions from the VA only, 30.3% from Medicare only, and 51.4% from both VA and Medicare. The proportion with PQA opioid-benzodiazepine overlap was larger for the dual-use group than the VA-only group (23.1% vs. 17.3%; adjusted risk ratio [aRR], 1.27 [95% CI, 1.24 to 1.30]) and Medicare-only group (23.1% vs. 16.5%; aRR, 1.12 [CI, 1.10 to 1.14]). The proportion with high-dose overlap was also larger for the dual-use group than the VA-only group (4.7% vs. 2.3%; aRR, 2.23 [CI, 2.10 to 2.36]) and Medicare-only group (4.7% vs. 2.9%; aRR, 1.06 [CI, 1.02 to 1.11]). Limitation Data are from 2013 and cannot capture medications purchased without insurance; unmeasured confounding may remain in this cross-sectional study. Conclusion Among a national cohort of veterans dually enrolled in VA and Medicare, receiving prescriptions from both sources was associated with greater risk for receiving potentially unsafe overlapping prescriptions for opioids and benzodiazepines. Primary Funding Source U.S. Department of Veterans Affairs.

Background Obtaining prescription medications from multiple health systems may complicate coordination of care. Older Veterans who obtain medications concurrently through Veterans Affairs (VA) benefits and Medicare Part D benefits (dual users) are at higher risk of unintended negative outcomes. Objective: To explore characteristics predicting dual drug benefit use from both VA and Medicare Part D in a national sample of older Veterans with dementia. Methods Administrative data were obtained from the VA and Medicare for a national sample of 110,828 Veterans with dementia ages 68 and older in 2010. Veterans were classified into three drug benefit user groups based on the source of all prescription medications they obtained in 2010: VA-only, Part D-only, and Dual Use. Multinomial logistic regression was used to examine predictors of drug benefit user group. The source of prescriptions was described for each of the ten most frequently used drug classes and opioids. Results Fifty-six percent of Veterans received all of their prescription medications from VA-only, 28% from Part D-only, and 16% from both VA and Part D. Veterans who were eligible for Medicaid or who had a priority group score conferring less generous drug benefits within the VA were more likely to be Part D-only or dual users. Nearly one fourth of Veterans taking opioids concurrently received opioid prescriptions from dual sources (24.7%). Conclusions Medicaid eligibility and Veteran priority group status, which largely decrease copayments for drugs obtained outside versus within the VA, respectively, were the main factors predicting drug user benefit group. Policies to encourage single-system prescribing and enhance communication across health systems are crucial to preventing negative health outcomes related to care fragmentation.

Objective To design and implement a tool that creates a secure, privacy preserving linkage of electronic health record (EHR) data across multiple sites in a large metropolitan area in the United States (Chicago, IL), for use in clinical research. Methods The authors developed and distributed a software application that performs standardized data cleaning, preprocessing, and hashing of patient identifiers to remove all protected health information. The application creates seeded hash code combinations of patient identifiers using a Health Insurance Portability and Accountability Act compliant SHA-512 algorithm that minimizes re-identification risk. The authors subsequently linked individual records using a central honest broker with an algorithm that assigns weights to hash combinations in order to generate high specificity matches. Results The software application successfully linked and de-duplicated 7 million records across 6 institutions, resulting in a cohort of 5 million unique records. Using a manually reconciled set of 11 292 patients as a gold standard, the software achieved a sensitivity of 96% and a specificity of 100%, with a majority of the missed matches accounted for by patients with both a missing social security number and last name change. Using 3 disease examples, it is demonstrated that the software can reduce duplication of patient records across sites by as much as 28%. Conclusions Software that standardizes the assignment of a unique seeded hash identifier merged through an agreed upon third-party honest broker can enable large-scale secure linkage of EHR data for epidemiologic and public health research. The software algorithm can improve future epidemiologic research by providing more comprehensive data given that patients may make use of multiple healthcare systems.

Objectives. To estimate the prevalence and consequences of receiving prescription opioids from both the Department of Veterans Affairs (VA) and Medicare Part D. Methods. Among US veterans enrolled in both VA and Part D filling 1 or more opioid prescriptions in 2012 (n = 539 473), we calculated 3 opioid safety measures using morphine milligram equivalents (MME): (1) proportion receiving greater than 100 MME for 1 or more days, (2) mean days receiving greater than 100 MME, and (3) proportion receiving greater than 120 MME for 90 consecutive days. We compared these measures by opioid source. Results. Overall, 135 643 (25.1%) veterans received opioids from VA only, 332 630 (61.7%) from Part D only, and 71 200 (13.2%) from both. The dual-use group was more likely than the VA-only group to receive greater than 100 MME for 1 or more days (34.3% vs 10.9%; adjusted risk ratio [ARR] = 3.0; 95% confidence interval [CI] = 2.9, 3.1), have more days with greater than 100 MME (42.5 vs 16.9 days; adjusted difference = 16.4 days; 95% CI = 15.7, 17.2), and to receive greater than 120 MME for 90 consecutive days (7.8% vs 3.1%; ARR = 2.2; 95% CI = 2.1, 2.3). Conclusions. Among veterans dually enrolled in VA and Medicare Part D, dual use of opioids was associated with more than 2 to 3 times the risk of high-dose opioid exposure.

Persons who are homeless, particularly those with mental health and/or substance use disorders (MHSUDs), often do not access or receive continuous primary care services. In addition, negative experiences with primary care might contribute to homeless persons' avoidance and early termination of MHSUD treatment. The patient-centered medical home (PCMH) model aims to address care fragmentation and improve patient experiences. How homeless persons with MHSUDs experience care within PCMHs is unknown. This study compared the primary care experiences of homeless and nonhomeless veterans with MHSUDs receiving care in the Veterans Health Administration's medical home environment, called Patient Aligned Care Teams. The sample included VHA outpatients who responded to the national 2013 PCMH-Survey of Health Care Experiences of Patients (PCMH-SHEP) and had a past-year MSHUD diagnosis. Veterans with evidence of homelessness (henceforth "homeless") were identified through VHA administrative records. PCMH-SHEP survey respondents included 67,666 veterans with MHSUDs (9.2% homeless). Compared with their nonhomeless counterparts, homeless veterans were younger, more likely to be non-Hispanic Black and nonmarried, had less education, and were more likely to live in urban areas. Homeless veterans had elevated rates of most MHSUDs assessed, indicating significant co-occurrence. After controlling for these differences, homeless veterans reported more negative and fewer positive experiences with communication; more negative provider ratings; and more negative experiences with comprehensiveness, care coordination, medication decision-making, and self-management support than nonhomeless veterans. Homeless persons with MHSUDs may need specific services that mitigate negative care experiences and encourage their continuation in longitudinal primary care services. (PsycINFO Database Record

ImportanceCase reports describe persistent erectile dysfunction (PED) associated with exposure to 5α-reductase inhibitors (5α-RIs). Clinical trial reports and the manufacturers’ full prescribing information (FPI) for finasteride and dutasteride state that risk of sexual adverse effects is not increased by longer duration of 5α-RI exposure and that sexual adverse effects of 5α-RIs resolve in men who discontinue exposure.ObjectiveOur chief objective was to assess whether longer duration of 5α-RI exposure increases risk of PED, independent of age and other known risk factors. Men with shorter 5α-RI exposure served as a comparison control group for those with longer exposure.DesignWe used a single-group study design and classification tree analysis (CTA) to model PED (lasting ≥90 days after stopping 5α-RI). Covariates included subject attributes, diseases, and drug exposures associated with sexual dysfunction.SettingOur data source was the electronic medical record data repository for Northwestern Medicine.SubjectsThe analysis cohorts comprised all men exposed to finasteride or dutasteride or combination products containing one of these drugs, and the subgroup of men 16–42 years old and exposed to finasteride ≤1.25 mg/day.Main outcome and measuresOur main outcome measure was diagnosis of PED beginning after first 5α-RI exposure, continuing for at least 90 days after stopping 5α-RI, and with contemporaneous treatment with a phosphodiesterase-5 inhibitor (PDE5I). Other outcome measures were erectile dysfunction (ED) and low libido. PED was determined by manual review of medical narratives for all subjects with ED. Risk of an adverse effect was expressed as number needed to harm (NNH).ResultsAmong men with 5α-RI exposure, 167 of 11,909 (1.4%) developed PED (persistence median 1,348 days after stopping 5α-RI, interquartile range (IQR) 631.5–2320.5 days); the multivariable model predicting PED had four variables: prostate disease, duration of 5α-RI exposure, age, and nonsteroidal anti-inflammatory drug (NSAID) use. Of 530 men with new ED, 167 (31.5%) had new PED. Men without prostate disease who combined NSAID use with >208.5 days of 5α-RI exposure had 4.8-fold higher risk of PED than men with shorter exposure (NNH 59.8, allp< 0.002). Among men 16–42 years old and exposed to finasteride ≤1.25 mg/day, 34 of 4,284 (0.8%) developed PED (persistence median 1,534 days, IQR 651–2,351 days); the multivariable model predicting PED had one variable: duration of 5α-RI exposure. Of 103 young men with new ED, 34 (33%) had new PED. Young men with >205 days of finasteride exposure had 4.9-fold higher risk of PED (NNH 108.2,p< 0.004) than men with shorter exposure.Conclusion and relevanceRisk of PED was higher in men with longer exposure to 5α-RIs. Among young men, longer exposure to finasteride posed a greater risk of PED than all other assessed risk factors.

Bladder and ureteral injury are serious iatrogenic complications during abdominal and pelvic surgery but are poorly investigated in the general surgery literature. The objective of this study was to examine rates, trends, and patient and surgical characteristics present in lower urinary tract injuries during gastrointestinal surgery using the Nationwide Inpatient Sample (NIS) database. The NIS database was queried from 2002 to 2010 for gastrointestinal surgery procedures including small/large bowel, rectal surgery, and procedures involving a combination of the two. These were crossreferenced with bladder and ureteral injury using International Classification of Diseases, 9th Revision, Clinical Modification codes. Multivariate regression analysis was used to calculate odds ratios for hypothesized risk factors. From 2002 to 2010, total average rates of bladder injury and ureteral injury were 0.15 and 0.06 per cent, respectively. Small/large bowel procedures had lower annual rates of ureteral (0.05 to 0.07%) and bladder (0.12 to 0.14%) injuries compared with ureteral (0.11 to 0.25%) and bladder (0.27 to 0.41%) injuries in rectal procedures. Presence of metastatic disease was associated with the greatest risk for bladder (odds ratio, 2.0; 95% confidence interval, 1.8 to 2.2) and ureteral (2.2; 1.9 to 2.5) injury in small/large bowel surgery, and for bladder (3.1; 2.5 to 3.9) and ureteral (4.0; 3.2 to 5.0) injury in combination procedures. Injury rates were significantly greater in open surgeries compared with laparoscopic procedures for both bladder injury (0.78 vs 0.26%, P < 0.0001) and ureteral injury (0.34 vs 0.06%, P < 0.0001). The incidence of genitourinary (GU) injury in gastrointestinal surgery is rare, less than 1.0 per cent, and is less than the incidence of GU injury reported in gynecologic surgery. This risk is increased by operations on the rectum and the presence of malignancy.

A penile prosthesis infection (PPI) is either treated with explantation of the prosthesis with a possible delayed reimplantation or a salvage procedure with an immediate reimplantation of the prosthesis.We used a large, all-payer national database to investigate the use of the salvage procedure in the setting of PPI.The study used years 2000-2009 of the Nationwide Inpatient Sample to identify PPIs treated with immediate salvage or explantation alone. Admissions were then stratified by various parameters to compare differences in the salvage rates.Salvage Rate of Penile Prosthesis infection.A total of 1,557 patients were treated with an explantation only (82.7%) or salvage (17.3%) for PPI, a proportion that remained stable over the study period. The patients treated with salvage were younger (60.4 vs. 65.1 years), more likely to be discharged home (87.3% vs. 61.9%), and were less likely to have a severe presentation (7.2% vs. 31.6%) than those who were explanted only (P 0.001). These factors were confirmed on multivariate regression analysis. The regression also revealed that treatment at rural hospitals had lower odds of salvage than treatment at urban teaching hospitals. Race, comorbid diabetes, and insurance status did not independently affect the salvage rate. There was no significant difference in total hospital charges between groups.Salvage rates have remained low over the past decade. Our study elucidated several factors decreasing the chances of salvage after PPI including age, severity of presentation, and hospital setting.

Background More than half of enrollees in the U.S. Department of Veterans Affairs (VA) are also covered by Medicare and can choose to receive their prescriptions from VA or from Medicare-participating providers. Such dual-system care may lead to unsafe opioid use if providers in these 2 systems do not coordinate care or if prescription use is not tracked between systems. Objective To evaluate the association between dual-system opioid prescribing and death from prescription opioid overdose. Design Nested case-control study. Setting VA and Medicare Part D. Participants Case and control patients were identified from all veterans enrolled in both VA and Part D who filled at least 1 opioid prescription from either system. The 215 case patients who died of a prescription opioid overdose in 2012 or 2013 were matched (up to 1:4) with 833 living control patients on the basis of date of death (that is, index date), using age, sex, race/ethnicity, disability, enrollment in Medicaid or low-income subsidies, managed care enrollment, region and rurality of residence, and a medication-based measure of comorbid conditions. Measurements The exposure was the source of opioid prescriptions within 6 months of the index date, categorized as VA only, Part D only, or VA and Part D (that is, dual use). The outcome was unintentional or undetermined-intent death from prescription opioid overdose, identified from the National Death Index. The association between this outcome and source of opioid prescriptions was estimated using conditional logistic regression with adjustment for age, marital status, prescription drug monitoring programs, and use of other medications. Results Among case patients, the mean age was 57.3 years (SD, 9.1), 194 (90%) were male, and 181 (84%) were non-Hispanic white. Overall, 60 case patients (28%) and 117 control patients (14%) received dual opioid prescriptions. Dual users had significantly higher odds of death from prescription opioid overdose than those who received opioids from VA only (odds ratio [OR], 3.53 [95% CI, 2.17 to 5.75]; P < 0.001) or Part D only (OR, 1.83 [CI, 1.20 to 2.77]; P = 0.005). Limitation Data are from 2012 to 2013 and cannot capture prescriptions obtained outside the VA or Medicare Part D systems. Conclusion Among veterans enrolled in VA and Part D, dual use of opioid prescriptions was independently associated with death from prescription opioid overdose. This risk factor for fatal overdose among veterans underscores the importance of care coordination across health care systems to improve opioid prescribing safety. Primary Funding Source U.S. Department of Veterans Affairs.

We determined whether including a care coordination system to manage the referral process for hematuria would lead to improved quality of care.Inflection Navigator, a protocol based, electronic medical record enabled care coordination system, was developed to support primary care physicians evaluating newly discovered hematuria. We studied the system for patients referred for microscopic and gross hematuria from May 2009 to May 2010. We compared outcomes in these 106 patients and in 105 referred to our urology department for hematuria during the same period who did not use the system.Patients in the care coordination group completed the evaluation in a significantly shorter time with more than a 1-month difference in time between referral and the completion of the imaging and cystoscopy components of the assessment (mean 40.9 vs 74.1 days, p0.05). This system potentially lowered health care costs by decreasing the mean ± SD number of urology visits needed to complete an evaluation from 2.1 ± 1.5 in the standard referral group to 1.6 ± 1.4 in the care coordination group (p0.05).A protocol based care coordination system for hematuria decreased the time needed to complete an evaluation and decreased the number of overall visits required to make a final diagnosis. Thus, the Inflection Navigator system is an example of an electronic medical record enabled process innovation that can improve the efficiency of care while potentially lowering health care costs.

Background. We developed and assessed the impact of a patient registry and electronic admission notification system relating to regional antimicrobial resistance (AMR) on regional AMR infection rates over time. We conducted an observational cohort study of all patients identified as infected or colonized with methicillin-resistant Staphylococcus aureus (MRSA) and/or vancomycin-resistant enterococci (VRE) on at least 1 occasion by any of 5 healthcare systems between 2003 and 2010. The 5 healthcare systems included 17 hospitals and associated clinics in the Indianapolis, Indiana, region. Methods. We developed and standardized a registry of MRSA and VRE patients and created Web forms that infection preventionists (IPs) used to maintain the lists. We sent e-mail alerts to IPs whenever a patient previously infected or colonized with MRSA or VRE registered for admission to a study hospital from June 2007 through June 2010. Results. Over a 3-year period, we delivered 12 748 e-mail alerts on 6270 unique patients to 24 IPs covering 17 hospitals. One in 5 (22%–23%) of all admission alerts was based on data from a healthcare system that was different from the admitting hospital; a few hospitals accounted for most of this crossover among facilities and systems. Conclusions. Regional patient registries identify an important patient cohort with relevant prior antibioticresistant infection data from different healthcare institutions. Regional registries can identify trends and interinstitutional movement not otherwise apparent from single institution data. Importantly, electronic alerts can notify of the need to isolate early and to institute other measures to prevent transmission.

Background. The individual concerns of non-Hodgkin’s lymphoma (NHL) patients require identification and assessment during clinical research proposing to measure patients’ outcomes. The FACT-Lym was developed as part of the FACIT measurement system to address health-related quality-of-life (HRQL) issues for NHL patients. Patients and Methods. Items for the FACT lymphoma subscale (LymS) were generated from healthcare provider interviews, published literature, and content validity patient interviews. The FACT-Lym was validated on a sample of 84 NHL patients, with additional measures at baseline (T1), 3–7 days (T2), and 8–12 weeks (T3). Results. Item correlations, expert relevance ratings, and patient input on content shortened the initial 22-item LymS to 15 items. The validation sample included 56% female, 76.2% white, 60% indolent disease, and 85% receiving treatment. Internal consistency coefficients for the 15-item LymS (.79, .85, and .84 T1–T3) and test-retest stability (.84) indicated good reliability. Correlations between LymS and SF-36 physical (r=.62) and mental (r=.48) summary scores reflect concurrent validity. Responsiveness to ECOG performance status and treatment status exceeded established FACT subscale scores. The FACT-LymS differentiated patients’ retrospective ratings of change in each of the three groups (better; unchanged; worse), P<0.001. Conclusions. These results support the validity of the FACT-Lym and suggest it will be a useful targeted endpoint in NHL clinical research.

Laparoscopic and especially robot-assisted minimally invasive prostatectomy (MIP) has increased in popularity over the past decade. We analyzed how the increasing prevalence of MIP has affected the outcomes of MIP and open radical prostatectomy (RRP).In the Nationwide Inpatient Sample, 23,473 patients undergoing MIP and 118,266 undergoing RRP between 2002 and 2008 are reported. We analyzed length of stay (LOS), hospital charges (THC), complication rates (CR), and socioeconomic characteristics. We used the American College of Surgeons National Surgical Quality Improvement Program (NSQIP) to identify complication rates (RRP n=666, and MIP n=2205).The proportion of MIP increased from 1.4% in 2002 to 29.5% in 2008. Mean LOS decreased for MIP (2.4 days in 2002, 1.6 days in 2008) and RRP (3.1 days in 2002, 2.1 days in 2008). Mean THC for MIP decreased ($46k in 2002, $34k in 2008) and increased for RRP ($18k in 2002, $32k in 2008). After 2005, overall CRs of MIP were lower than for RRP. High-volume centers reported lower CRs for both procedures. MIP was associated with fewer transfusions and wound complications. Men living in ZIP codes with the top quartile of yearly mean household income were more likely to undergo MIP than RRP (P0.001). Although there were more white patients receiving MIP and black or Hispanic patients more frequently underwent RRP, there was no statistically significant difference.Increasing use of MIP led to decreased hospital stay for all patients, increase charges for RRP, and decreased CRs for both MIP and RRP. In recent years, MIP was associated with fewer complications. Charges for RRP have increased over time to approach those for MIP, and patients with increased socio-economic status were more likely to undergo MIP.

Background: Buprenorphine is a key tool in the management of opioid use disorder, but there are growing concerns about abuse, diversion, and safety. These concerns are amplified for the Department of Veterans Affairs (VA), whose patients may receive care concurrently from multiple prescribers within and outside VA. To illustrate the extent of this challenge, we examined overlapping prescriptions for buprenorphine, opioids, and benzodiazepines among veterans dually enrolled in VA and Medicare Part D. Methods: We constructed a cohort of all veterans dually enrolled in VA and Part D who filled an opioid prescription in 2012. We identified patients who received tablet or film buprenorphine products from either source. We calculated the proportion of buprenorphine recipients with any overlapping prescription (based on days supply) for a nonbuprenorphine opioid or benzodiazepine, focusing on veterans who received overlapping prescriptions from a different system than their buprenorphine prescription (Part D buprenorphine recipients receiving overlapping opioids or benzodiazepines from VA and vice versa). Results: There were 1790 dually enrolled veterans with buprenorphine prescriptions, including 760 (43%) from VA and 1091 (61%) from Part D (61 veterans with buprenorphine from both systems were included in each group). Among VA buprenorphine recipients, 199 (26%) received an overlapping opioid prescription and 11 (1%) received an overlapping benzodiazepine prescription from Part D. Among Part D buprenorphine recipients, 208 (19%) received an overlapping opioid prescription and 178 (16%) received an overlapping benzodiazepine prescription from VA. Among VA and Part D buprenorphine recipients with cross-system opioid overlap, 25% (49/199) and 35% (72/208), respectively, had >90 days of overlap. Conclusions: Many buprenorphine recipients receive overlapping prescriptions for opioids and benzodiazepines from a different health care system than the one in which their buprenorphine was filled. These findings highlight a previously undocumented safety risk for veterans dually enrolled in VA and Medicare.

We evaluated targeted antimicrobial prophylaxis in men undergoing transrectal ultrasound guided prostate biopsy based on rectal swab culture results.From July 2010 to March 2011 we studied differences in infectious complications in men who received targeted vs standard empirical ciprofloxacin prophylaxis before transrectal ultrasound guided prostate biopsy. Targeted prophylaxis used rectal swab cultures plated on selective media containing ciprofloxacin to identify fluoroquinolone resistant bacteria. Patients with fluoroquinolone susceptible organisms received ciprofloxacin while those with fluoroquinolone resistant organisms received directed antimicrobial prophylaxis. We identified men with infectious complications within 30 days after transrectal ultrasound guided prostate biopsy using the electronic medical record.A total of 457 men underwent transrectal ultrasound guided prostate biopsy, and of these men 112 (24.5%) had rectal swab obtained while 345 (75.5%) did not. Among those who received targeted prophylaxis 22 (19.6%) men had fluoroquinolone resistant organisms. There were no infectious complications in the 112 men who received targeted antimicrobial prophylaxis, while there were 9 cases (including 1 of sepsis) among the 345 on empirical therapy (p=0.12). Fluoroquinolone resistant organisms caused 7 of these infections. The total cost of managing infectious complications in patients in the empirical group was $13,219. The calculated cost of targeted vs empirical prophylaxis per 100 men undergoing transrectal ultrasound guided prostate biopsy was $1,346 vs $5,598, respectively. Cost-effectiveness analysis revealed that targeted prophylaxis yielded a cost savings of $4,499 per post-transrectal ultrasound guided prostate biopsy infectious complication averted. Per estimation, 38 men would need to undergo rectal swab before transrectal ultrasound guided prostate biopsy to prevent 1 infectious complication.Targeted antimicrobial prophylaxis was associated with a notable decrease in the incidence of infectious complications after transrectal ultrasound guided prostate biopsy caused by fluoroquinolone resistant organisms as well as a decrease in the overall cost of care.

Study Type – Prognosis (individual cohort) Level of Evidence 2b What's known on the subject? and What does the study add? Ductal prostate cancer is a rare histological variant of prostate cancer. The incidence, natural history and outcomes of patients with ductal have not been described. We demonstrate that ductal prostate cancers often present with advanced stage and a high percentage of men die from their disease. OBJECTIVE • To use the national Surveillance, Epidemiology, and End Results (SEER) cancer registry to describe the natural history, national incidence and treatment patterns for ductal prostate cancer (PCa) over the last 20 years, as the available literature on ductal PCa is limited to small case series because of few patient numbers. PATIENTS AND METHODS • From the SEER registry, 693 men with ductal PCa were identified from 1970. • The demographics, clinical features and cause of death data were collected from men with ductal and acinar histological types. RESULTS • The incidence of ductal PCa has increased over each decade, but the overall percentage of ductal relative to acinar PCa has remained stable. • Men with ductal PCa were more likely to present with advanced disease (30% T3 with ductal PCa, compared with 7% with acinar PCa). • Men with ductal PCa underwent similar rates of radical surgery, lower rates of radiotherapy but a higher frequency of outlet (transurethral resection) procedures. • Men with ductal PCa had a significantly greater rate of death from PCa (12% vs 4%) than men with acinar PCa. • Comparing PCa-specific mortality, men with ductal PCa had similar rates of death to men with Gleason 4 + 4 grade acinar PCa. CONCLUSIONS • Despite a stable incidence, ductal PCa remains an aggressive PCa usually presenting with advanced clinical stage and resulting in a high rate of PCa-specific mortality similar to Gleason 4 + 4 acinar PCa. • Patients would probably benefit from combined modalities including radical surgery, radiotherapy and palliative outlet procedures.

Radiofrequency ablation (RFA)-assisted laparoscopic partial nephrectomy (LPN) may allow for improved hemostasis without need for renal hilar vessel clamping and elimination of warm ischemia to the kidney. We compare outcomes in patients undergoing radiofrequency ablation-assisted robotic clampless partial nephrectomy (RF-RCPN) and LPN.Thirty-six patients and 42 patients underwent LPN and RF-RCPN, respectively. In the RF-RCPN group, the Habib 4x RFA device was used to coagulate a margin of normal parenchyma around the renal mass to allow excision of the mass within a bloodless plane. Unlike in the LPN group, renal hilar vascular occlusion was not performed in the RF-RCPN group.Tumors treated in the RF-RCPN group tended to be larger (2.8 vs. 2.0 cm) and more often endophytic (52.6% vs. 16.1%). Collecting system reconstruction occurred more often in the RF-RCPN group (78.6% vs. 30.6%). Operative duration was longer in the RF-RCPN group (373 vs. 250 minutes), but this included time for cystoscopy, ureteral stenting, and repositioning of the patient. Blood loss, transfusion rates, renal function, and complication rates did not differ between the two groups. No patients required renal hilar vessel clamping or nephrectomy to control bleeding in the RF-RCPN group.The use of RFA-assistance during robotic partial nephrectomy allows excision of renal tumors without hilar vascular clamping, thus eliminating renal warm ischemia. Larger and more centrally located tumors were excised with RF-RCPN. No differences in blood loss, complication rate, postoperative bleeding, renal function, or recurrence rate were noted compared with LPN.

Study Type – Therapy (case series) Level of Evidence 4 OBJECTIVES To present our operative and postoperative functional outcomes of sutured compared with endovascular staple ligation of the dorsal venous complex (DVC) during robot-assisted laparoscopic radical prostatectomy (RALP). Ligation of the DVC during RALP with an endovascular stapler has purported advantages of decreased apical positive surgical margin (PSM) rate, blood loss, and operative time when compared with suture ligation. PATIENTS AND METHODS In all, 162 patients who underwent RALP between October 2005 and April 2008 by one surgeon (R.B.N.) were assessed. We retrospectively analysed two different treatment groups: group 1 underwent DVC ligation with a single suture, while group 2 underwent endovascular staple ligation. RESULTS Of the 162 patients evaluated, 67 had suture ligation (group 1) and 95 had staple ligation (group 2) of the DVC. Baseline patient characteristics (age, body mass index, biopsy Gleason score, clinical stage) and tumour characteristics (specimen weight, tumour volume, pathological Gleason score and stage) did not differ between the groups. Estimated blood loss (494 mL vs 288 mL), time to dissect out, ligate and transect the DVC (30 min vs 24 min), apical PSM rate (13.4% vs 2.1%) differed significantly between groups 1 and 2 respectively, favouring staple ligation of the DVC. At 6 months follow-up, there was no difference between the groups for PSA recurrence (3.7% vs 0%), complete continence (63.4% vs 55.7%) and Sexual Health Inventory for Men score (8.4 vs 8.6). CONCLUSIONS In the present study, staple ligation of the DVC during RALP resulted in improved apical PSM rates, faster operative times and less blood loss.

This study describes barriers perceived by nurses to the implementation of research findings in a community hospital. The BARRIERS to Research Utilization Scale was distributed to 1100 registered nurses. Items related to characteristics of the organization, including lack of time and practice authority, were perceived as the greatest barriers. Results of this study are useful for determining strategies to facilitate clinical nursing research and integrate research findings in the practice setting.

There are several advantages to including comprehensive health-related quality of life (HRQL) in symptom trials in oncology. The most obvious is to test the hypothesis that HRQL will be improved in addition to the symptom benefit. We should not "require," however, that a successful symptom intervention also improve other dimensions of HRQL. On the other hand, we should expect that it will not make other dimensions worse through side effects or exacerbation of disease, even if it improves the symptom. HRQL assessment in the trial helps evaluate the competing risks of any therapy. Furthermore, assessment of HRQL is now accomplished with very brief assessment (usually 30 questions or less), and the knowledge gained is valuable. With HRQL, one can compare cancer patients with those with other conditions and can determine the contribution of symptoms and side effects to the more broadly defined HRQL. Examples using the Functional Assessment of Cancer Therapy measurement system will demonstrate how HRQL assessment has contributed to our understanding of common cancer symptoms and their place in the conceptualization of HRQL. The prevalence of clinically significant symptoms is greatest in poor performance status (PS) patients compared with patients with good PS. Symptom improvement trials specifically designed for these patients should be encouraged, particularly with interventions that can provide symptomatic relief and improve multidimensional HRQL.

Importance Two meta-analyses conclude that finasteride treatment of androgenic alopecia (AGA) is safe but do not assess quality of safety reporting. Objective To assess safety reporting for clinical trial reports of finasteride for AGA. Data Sources MEDLINE, ClinicalTrials.gov, and a clinical data repository for an academic medical center. Study Selection Published clinical trial reports for finasteride treatment of AGA. Data Extraction and Synthesis For each trial, we assessed quality of adverse event reporting, extracted the number and type of adverse events in treatment and placebo groups, and assessed duration of safety evaluation and adequacy of blinding. Two observers independently extracted the data; differences were resolved by consensus. We assessed generalizability in a large cohort of men prescribed finasteride, 1.25 mg/d or less, by assessing for eligibility in the finasteride-AGA pivotal trials. Main Outcomes and Measures Quality was assessed as adequate, partially adequate, inadequate, or no events reported. We used funnel plots of the hazard ratio to assess bias. Results Of 34 clinical trials, none had adequate safety reporting, 19 were partially adequate, 12 were inadequate, and 3 reported no adverse events. Funnel plots were asymmetric with a bias toward lower odds ratio for sexual adverse effects, suggesting systematic underdetection. No reports assessed adequacy of blinding, 18 (53%) disclosed conflicts of interest, and 19 (56%) received funding from the manufacturer. Duration of drug safety evaluation was 1 year or less for 26 of 34 trials (76%). Of 5704 men in the clinical data repository who were treated for AGA with finasteride, 1.25 mg/d or less, for AGA, only 31% met inclusion criteria for the pivotal trials referenced in the manufacturer’s full prescribing information and 33% took finasteride for more than 1 year. Conclusions and Relevance Available toxicity information from clinical trials of finasteride in men with AGA is very limited, is of poor quality, and seems to be systematically biased. In a cohort of men prescribed finasteride for routine treatment of AGA, most would have been excluded from the pivotal studies that supported US Food and Drug Administration approval for AGA. Published reports of clinical trials provide insufficient information to establish the safety profile for finasteride in the treatment of AGA.

Background Cognitive deficits have been reported to occur in a significant proportion of patients undergoing coronary artery bypass grafting (CABG), but the extent to which these deficits were preexistent or related to the natural history of cognitive decline in this patient population remains poorly defined. Methods After excluding patients with conditions known to cause brain dysfunction (eg, hepatic dysfunction, stroke), a group of patients referred for percutaneous coronary intervention (PCI) or CABG (n = 82) was compared with an age- and education-matched control group that did not have clinical evidence of coronary artery disease (n = 41). These subjects underwent a battery of neurocognitive and emotional testing. Results Test score means for 5 of 14 different measures were significantly greater (impaired) in cardiac compared with control group subjects. Of cardiac subjects, 20% demonstrated clinical impairment (test result ≥ 1 SD worse than mean for normative standards) in 6 of 14 tests, compared with 10% of the controls. By clinical standards, 46% of cardiac subjects would be considered to be impaired (score 1 SD or more below the control group mean) on 3 or more neuropsychologic measures, compared with 29% of the controls. By this (control group mean) standard, cardiac subjects demonstrated impaired scores on 3.06 ± 2.6 tests compared with impairment in 2.0 ± 2.35 tests for the control group ( p = 0.01). Conclusions Even excluding patients at high risk for brain dysfunction, cognitive impairment is found in patients with coronary artery disease before interventional therapy. Baseline impairment must be considered when evaluating outcomes after intervention.

Chronic pelvic pain syndrome (CPPS) is the most common form of prostatitis, accounting for 90-95% of all diagnoses. It is a complex multi-symptom syndrome with unknown etiology and limited effective treatments. Previous investigations highlight roles for inflammatory mediators in disease progression by correlating levels of cytokines and chemokines with patient reported symptom scores. It is hypothesized that alteration of adaptive immune mechanisms results in autoimmunity and subsequent development of pain. Mouse models of CPPS have been developed to delineate these immune mechanisms driving pain in humans. Using the experimental autoimmune prostatitis (EAP) in C57BL/6 mice model of CPPS we examined the role of CD4+T-cell subsets in the development and maintenance of prostate pain, by tactile allodynia behavioral testing and flow cytometry. In tandem with increased CD4+IL17A+ T-cells upon EAP induction, prophylactic treatment with an anti-IL17 antibody one-day prior to EAP induction prevented the onset of pelvic pain. Therapeutic blockade of IL17 did not reverse pain symptoms indicating that IL17 is essential for development but not maintenance of chronic pain in EAP. Furthermore we identified a cytokine, IL7, to be associated with increased symptom severity in CPPS patients and is increased in patient prostatic secretions and the prostates of EAP mice. IL7 is fundamental to development of IL17 producing cells and plays a role in maturation of auto-reactive T-cells, it is also associated with autoimmune disorders including multiple sclerosis and type-1 diabetes. More recently a growing body of research has pointed to IL17's role in development of neuropathic and chronic pain. This report presents novel data on the role of CD4+IL17+ T-cells in development and maintenance of pain in EAP and CPPS.

OBJECTIVE To compare perioperative glycemic and long-term surgical outcomes in patients undergoing cardiac surgery before and after the recommended 2009 changes in inpatient glycemic targets. RESEARCH DESIGN AND METHODS We performed a retrospective review of patients who underwent cardiac surgery between 4 September 2007 and 30 April 2011. Comparison was made of blood glucose (BG) outcomes 3 days after surgery, and 30-day cardiac outcomes before and after a change in insulin protocol that took place on 1 September 2009, which consisted of raising the glycemic targets during intravenous insulin infusions from 80–110 mg/dL (80–110 group) to 110–140 mg/dL (110–140 group). RESULTS When compared with the 80–110 group (n = 667), the 110–140 group (n = 658) had higher mean postoperative BG levels during the intravenous insulin infusion (141 ± 15 vs. 121 ± 15 mg/dL, P < 0.001) and the subcutaneous insulin period (134 ± 24 vs. 130 ± 23 mg/dL, P < 0.001), and for 3 days postoperatively (141 ± 17 vs. 127 ± 15 mg/dL, P < 0.001). Fewer patients in the 110–140 mg/dL group experienced moderate hypoglycemia (BG CONCLUSIONS The higher glycemic target of 110–140 mg/dL resulted in similar mean glucose values, with significantly less hypoglycemia and no significant differences in mortality/morbidity compared with the more strict target of 80–110 mg/dL.

We sought to examine a large nationwide (United States) sample of emergency department (ED) visits to determine data related to utilization and costs of care for urolithiasis in this setting.Nationwide Emergency Department Sample was analyzed from 2006 to 2009. All patients presenting to the ED with a diagnosis of upper tract urolithiasis were analyzed. Admission rates and total cost were compared by region, hospital type, and payer type. Numbers are weighted estimates that are designed to approximate the total national rate.An average of 1.2 million patients per year were identified with the diagnosis of urolithiasis out of 120 million visits to the ED annually. Overall average rate of admission was 19.21%. Admission rates were highest in the Northeast (24.88%), among teaching hospitals (22.27%), and among Medicare patients (42.04%). The lowest admission rates were noted for self-pay patients (9.76%) and nonmetropolitan hospitals (13.49%). The smallest increases in costs over time were noted in the Northeast. Total costs were least in nonmetropolitan hospitals; however, more patients were transferred to other hospitals. When assessing hospital ownership status, private for-profit hospitals had similar admission rates compared with private not-for-profit hospitals (16.6% vs 15.9%); however, costs were 64% and 48% higher for ED and inpatient admission costs, respectively.Presentation of urolithiasis to the ED is common, and is associated with significant costs to the medical system, which are increasing over time. Costs and rates of admission differ by region, payer type, and hospital type, which may allow us to identify the causes for cost discrepancies and areas to improve efficiency of care delivery.

Objective To determine the temporal relationship between vasectomy, varicocele, and hypogonadism diagnosis. Many young men undergo their first thorough genitourinary examination in their adult lives at the time of vasectomy consultation, providing a unique opportunity for diagnosis of asymptomatic varicoceles. Varicoceles have recently been implicated as a possible reversible contributor to hypogonadism. Hypogonadism may be associated with significant adverse effect, including decreased libido, impaired cognitive function, and increased cardiovascular events. Early diagnosis and treatment of hypogonadism may prevent these adverse sequelae. Methods Data were collected from the Truven Health Analytics MarketScan database, a large outpatient claims database. We reviewed records between 2003 and 2010 for male patients between the ages of 25 and 50 years with International Classification of Diseases , Ninth Revision codes for hypogonadism, vasectomy, and varicocele, and queried dates of first claim. Results A total of 15,679 men undergoing vasectomies were matched with 156,790 men with nonvasectomy claims in the same year. Vasectomy patients were diagnosed with varicocele at an earlier age (40.9 vs 42.5 years; P = .009). We identified 224,817 men between the ages of 25 and 50 years with a claim of hypogonadism, of which 5883 (2.6%) also had a claim of varicocele. Men with hypogonadism alone were older at presentation compared with men with an accompanying varicocele (41.3 [standard deviation ± 6.5] vs 34.9 [standard deviation ± 6.1]; P Conclusion Men undergoing vasectomies are diagnosed with varicoceles at a younger age than age-matched controls. Men with varicoceles present with hypogonadism earlier than men without varicoceles. Earlier diagnosis of varicocele at the time of vasectomy allows for earlier detection of hypogonadism.

Introduction The epidemiology of priapism is not well characterized. A small number of studies based on inpatient data or small population samples have estimated the incidence to range from 0.34 to 1.5 cases per 100,000 males. Aim To estimate the current epidemiology and impact on resource utilization of priapism in the United States (US). Main Outcome Measures Rate of emergency department encounters for priapism in the US. Methods Emergency department (ED) visits for priapism were analyzed using discharge data from the Nationwide Emergency Department Sample (NEDS), Healthcare Cost and Utilization Project (HCUP). Priapism encounters were identified by ICD9 code. Priapism encounters were analyzed for patient and hospital characteristics, associated diagnoses, and hospital charge. Established weighting in the sample was used to calculate nationwide estimates. Results A total of 8,738 ED encounters for priapism were identified between 2006 and 2009 in the NEDS. This translated to an estimated 39,964 encounters out of a total of 496,195,793 ED visits, or 8.05 per 100,000 ED visits (95% confidence interval [CI] 7.59–8.51). 21.1% of patients had a concurrent diagnosis of sickle cell disease (SCD). 72.1% of all patients were discharged home from the ED, while only 49.6% of patients with SCD were discharged home. A concurrent diagnosis of SCD was associated with an odds ratio (OR) of 3.84 (95% CI 3.65–4.05) for admission to the hospital when controlling for age, region, hospital and payer type. The mean hospital charge was $1,778 per encounter if discharged home and $41,909 per encounter if admitted. The estimated mean total annual charge for priapism was $123,860,432 with 86.8% of charges attributed to inpatient admissions. Conclusions Our estimate of the rate of ED visits for priapism was significantly higher than prior estimates with a SCD concurrence rate lower than previously estimated. Stein DM, Flum AS, Cashy J, Zhao LC, and McVary KT. Nationwide emergency department visits for priapism in the United States. J Sex Med 2013;10:2418–2422.

Testosterone replacement therapy is commonly used to treat men with hypogonadism. However, there has been caution in using testosterone replacement therapy in men with moderate to severe lower urinary tract symptoms for fear of worsening the symptoms. In this study we examine the effect of testosterone replacement therapy on lower urinary tract symptoms in hypogonadal men.We retrospectively reviewed our outpatient database and identified patients with a diagnosis of hypogonadism who received testosterone replacement therapy from 2002 to 2012. Lower urinary tract symptoms were assessed using the AUASI (American Urological Association symptom index) before and after testosterone replacement therapy. Testosterone and prostate specific antigen were also continuously measured, and all patients were closely monitored for side effects of testosterone replacement therapy. Patients who had progression of lower urinary tract symptoms to the point of requiring surgery were included in the study.We identified 120 hypogonadal men who received testosterone replacement therapy, the majority of whom had topical therapy or a combination of topical and pellet based therapy (57.5% and 20.8%, respectively). Mean baseline AUASI (±SD) was 10.8 (±7.8) and mean duration of testosterone replacement therapy was 692 days (±773). Mean change in AUASI was -1.07 (±6.06). Mean baseline prostate specific antigen was 1.6 ng/dl (±1.9) and mean change in prostate specific antigen was 0.44 (±2.2). Of the patients 8.1% had a baseline prostate specific antigen greater than 4.0 ng/dl, and these patients had greater improvement in AUASI than those with a baseline prostate specific antigen less than 4.0 ng/dl (-1.9 vs -1.0, p not significant). Overall 45.8% of patients had a less than 3-point change in AUASI in either direction. Of the 120 patients 38 (31.7%) had improvement in AUASI 3 or more points while 27 (22.5%) had worsening of AUASI 3 or more points. Patients with an improved AUASI had a mean prostate specific antigen change of 0.3 (±3.4), while those who had worsening of AUASI had a mean prostate specific antigen change of 0.7 (±2.2) (p not significant). Approximately 9 of 120 (7.5%) of these men initiated new medications for lower urinary tract symptoms during the course of the study. There was no significant change in AUASI compared to patients without any use of lower urinary tract symptoms medications. In addition, 4 (3.3%) patients had progression of lower urinary tract symptoms and required transurethral resection of the prostate.We demonstrate that initiating testosterone replacement therapy in hypogonadal men involves a low risk of worsening lower urinary tract symptoms. In fact, many men experience symptom improvement while changes in prostate specific antigen appear minor. Future research should focus on larger patient population studies to further examine this relationship.