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A recent study that evaluated the risk of facing a malpractice claim by physician specialty found that orthopedic surgeons were at a significantly greater risk of being sued than other medical specialists. To date, no studies have characterized trends in orthopedic surgery malpractice claims. The Westlaw legal database was used to locate state and federal jury verdicts and settlements related to medical malpractice and orthopedic surgery from 2010 to 2016. Eighty-one cases were analyzed. The mean age of the affected patients and/or plaintiffs was 53.4 years. Spine surgery (21 cases; 25.9%), knee surgery (17 cases; 21.0%), and hip surgery (11 cases; 13.6%) were litigated most often. Procedural error (71 cases; 87.7%) and negligence (58 cases; 71.6%) were the 2 most commonly cited reasons for litigation. The jury found in favor of the defendant in most (50 cases; 61.7%) of the cases. The mean plaintiff (17 cases; 21.0%) verdict payout was $3,015,872, and the mean settlement (13 cases; 16.0%) value was $1,570,833. Unnecessary surgery (odds ratio [OR], 12.29; 95% confidence interval [CI], 1.91-108.46; P=.040) and surgery resulting in death (OR, 26.26; 95% CI, 2.55-497.42; P=.040) were significant predictors of a verdict in favor of the plaintiff. Patient death (OR, 0.05; 95% CI, 0.01-0.38; P=.021) and male patient sex (OR, 0.26; 95% CI, 0.09-0.71; P=.033) were significant negative predictors of a verdict in favor of the defendant. The jury found in favor of the defendant orthopedic surgeon in most cases. Procedural error and/or negligence were cited most commonly by the plaintiffs as the bases for the claims. Verdicts in favor of the plaintiffs resulted in payouts nearly double those of settlements. [Orthopedics. 2018; 41(5):e615-e620.]. [ABSTRACT FROM AUTHOR]

A biography of Massachusetts Congregational clergyman Daniel Breck is presented. He was born on July 28, 1743. He served as a chaplain in a Massachusetts military regiment during the Revolutionary War. He was ordained as a pastor of the Congregational Church in Topsfield, Massachusetts, in 1779. He was dismissed by the church in 1788. He relocated to Marietta, Ohio, and presided over the first religious service there. He died on August 12, 1845.

The article discusses the history surrounding 18th century maps of the Marietta, Ohio region created just before European and American settlement, which represented elements of Native American culture. Particular is given to a manuscript map compiled by the surveyor and geographer Thomas Hutchins, including the map's representation of Native American mounds. An overview of Americans' movement westward, including an alleged increase of westward settlers following the Paris, France Treaty of 1783 that ended the French and Indian War, is provided.

In the United States, over 17 million people are diagnosed with type 1 diabetes mellitus (DM) with its inherent morbidity of delayed bone healing and nonunion. Recent studies demonstrate the utility of pulsed low-intensity ultrasound (LIPUS) to facilitate fracture healing. The current study evaluated the effects of daily application of LIPUS on mid-diaphyseal femoral fracture growth factor expression, cartilage formation, and neovascularization in DM and non-DM BB Wistar rats. Polymerase chain reaction (PCR) and ELISA assays were used to measure and quantify growth factor expression. Histomorphometry assessed cartilage formation while immunohistochemical staining for PECAM evaluated neovascularization at the fracture site. In accordance with previous studies, LIPUS was shown to increase growth factor expression and cartilage formation. Our study also demonstrated an increase in fracture callus neovascularization with the addition of LIPUS. The DM group showed impaired growth factor expression, cartilage formation, and neovascularization. However, the addition of LIPUS significantly increased all parameters so that the DM group resembled that of the non-DM group. These findings suggest a potential role of LIPUS as an adjunct for DM fracture treatment. © 2010 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 29:181-188, 2011 [ABSTRACT FROM AUTHOR]

Although the elderly in this country are often thought of as isolated And forgotten by family and friends, the study reported here found that this image differs significantly from reality in most cases. After exploring the personal relationship between older people and those they designate as responsible lot them in the event of a crisis, the authors discuss the various aspects of the support systems on which most elderly people rely. [ABSTRACT FROM AUTHOR]

The article focuses on Ebenezer Smith Platt, a young British colonial, confined in London's infamous Newgate prison during 1777. On February 17, John Wilkes, the controversial politician, pamphleteer, and propagandist, rose to address the British House of Commons to illustrate the oppressive, unwarrantable and alienating effects of the proposed act on Americans by citing the case of Platt. Platt, whom Wilkes identified as an American merchant from Georgia, accused of treason, had allegedly been denied his basic judicial right to habeas corpus, and Wilkes intimated that the notoriety of this case was influencing the American commissioners in Paris to seek a French alliance. Ebenezer Smith Platt was possessed of a prominent family lineage--one that reached back to New England's first Puritan settlements. The travels of Ebenezer began during his Long Island boyhood. By the late 17605 Jonas Platt had taken his family to New York City, leaving his elderly father and half-brother Jeremiah to administer the family's extensive Suffolk County landholdings.

An essay is presented which outlines a theory of state power. The essay has the aim of showing how the power of the states has drawn from two sources, each of which claims a democratic genealogy. These two sources are reason of state and the other is welfare. The essay is directed mainly at the American context although several references are made to the history of European states and to recent socialist debates about the welfare state.

This article suggests that the conception of a birthright, a depicted in the Biblical story of Esau and Jacob, provides a more powerful way of understanding present U.S. political condition than does social contract theory. It also contends that the social contract theory only tend to exacerbate the present political problems rather than solve them. It explains that Americans, like Esau, have an inherited birthright, which gives them a unique collective identity. And like Esau, their birthright is not being extracted from them by force. Rather it is being negotiated or contracted away. In contracting their birthright Americans have reduced it to a negotiable commodity. This birthright is an entitledment that Americans exchange for something less to become political.

Ways in which behavioral scientists can combine their professional interests with work concerning civil liberties are explored along with a brief statement about each article included in the issue. The overview highlights certain themes that recur in the separate articles: (a) the absence of a solid consensus in the United States to support specific applications of the Bill of Rights despite increased willingness to support the liberties of some dissenters, (b) the relation of education to civil liberties attitudes, (c) the interrelationships of personality and political attitudes, (d) child and adult (work) socialization influences, and (e) the influence of face-to-face social interactions. [ABSTRACT FROM AUTHOR]

Presents remarks of government guests on Section of Taxation in Honolulu, Hawaii. Advantage of data processing system on tax administration purposes; Proposals on the availability of information under the Information Act; Amendments of mortgage guaranty insurance.

Comments on the administration and control of tax collection in the United States. Changes in the laws of the tax system; Significance of the revenue system; Emphasis on courtesy and service to taxpayers.

Background: Despite the rise in gender-affirming care, our understanding of prostate cancer (PCa) in transgender women (TGW) remains in its infancy. Health disparities and lack of PCa awareness and screening are possible barriers to providing quality care for this population. In addition, the implication of hormonal manipulation for the aggressiveness of PCa in TGW is yet to be determined. Here, this study sought to compare oncological characteristics and survival outcomes between transgender and cisgender (CG) patients with PCa via two national data sets., Methods: The Veterans Affairs Informatics and Computing Infrastructure database (1999-2020) and the Surveillance, Epidemiology, and End Results-Medicare database (2010-2017) were reviewed. Demographic and clinical details were analyzed. Logistic regression analysis was performed on propensity score-matched groups to identify predictors of high-risk disease and metastasis in patients with PCa. Groups were matched 5:1 (CG:TGW) on the basis of age, race, year of diagnosis, and Charlson Comorbidity Index score. Primary outcomes included metastatic presentation, high-risk localized disease, overall survival (OS), and prostate cancer-specific mortality (PCSM)., Results: A total of 1194 patients were included (199 TGW; 995 CG). Associations between transgender identity and metastatic presentation (odds ratio [OR], 0.38; p = .2), high-risk localized disease (OR, 1.19; p = .50), or PCSM (hazard ratio [HR], 0.65; p = .3) were not detected. Transgender identity was associated with improved OS (HR, 0.67; p = .014)., Conclusions: PCa-specific outcomes seem comparable between TGW and CG men, although the study was underpowered to detect modest differences. Further investigation into the incidence and outcomes of PCa in TGW is warranted., (© 2024 American Cancer Society.)

In the early 20th century, neurology training included more experience in psychiatry, and psychiatry training included more training in neurology than what is currently required. After World War I, the increased need for differential diagnosis of what might now be called functional neurological disorders resulted in the military encouraging combined residency training in neurology and psychiatry and the promulgation of the term "neuropsychiatry" for this specialty. Thirty-six percent of physicians certified by the American Board of Psychiatry and Neurology in its first decade (1935-1945) held certification in both neurology and psychiatry. However, the term neuropsychiatry gradually became used interchangeably with general psychiatry-to distinguish it from psychoanalysis-and lost its specificity. It is widely held that the popularity of psychoanalysis resulted in psychiatrists perceiving less need for neurological knowledge, and inclusion of neurology content in psychiatry training decreased. Dual residency training programs in neurology and psychiatry began to increase in popularity again in the 1980s as advances in neuroscience, neuroimaging, and pharmacology, paired with the growth of behavioral neurology, laid the foundation for meaningful practice of neuropsychiatry. The author surveyed 207 physicians who graduated from both a neurology and psychiatry residency and 18 current trainees in combined neuropsychiatry residency programs to collect information on their current practice, academic activity, and opinions about their training. The response rate was 64%. Respondents' attitudes toward the value of their dual neurology and psychiatry training were overwhelmingly positive. Reasons for the lack of growth of combined residency programs in neurology and psychiatry are examined., Competing Interests: Dr. Benjamin is a partner in and author for Brain Educators, LLC, publisher of neuropsychiatry educational materials, and he receives a stipend as a psychiatry director of the American Board of Psychiatry and Neurology.

Engagement in services is a core element to successful outcomes for service users and programs. In coordinated specialty care (CSC) programs, designed for individuals experiencing first-episode psychosis, engagement has only been measured programmatically and not by service component. This qualitative study sought to explore provider perspectives on service user engagement in service components of CSC. Semistructured interviews were conducted with 20 service providers from five community-based early intervention programs for psychosis in the United States. Interviews were recorded and transcribed verbatim, and thematic analysis was used to analyze the data collected. Provider participants described barriers and facilitators that contribute to disengagement or engagement in four service components within early intervention programs: individual psychotherapy, family education and support, medication management, and vocational services. Barriers identified included substance use, stigma, trauma, and external pressures. Identified barriers to engagement in CSC were both unique to individual components and cut across them. By better understanding the complexity of barriers and their intersections within and across CSC components, there can be more effective policy and program development to reduce disengagement and hopefully increase positive outcomes for service users. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Aim: The purpose of this article was to examine whether psychological flourishing, a multi-dimensional construct of well-being, has the potential to play a preventative role in suicidal and nonsuicidal thoughts and actions., Methods: This two-part study utilized cross-sectional survey data from college students across the United States, assessing levels of psychological distress, loneliness, and psychological flourishing. Frequencies of suicidal ideation, intent, previous suicidal attempts, and nonsuicidal self-injury (NSSI) were also assessed. Data collected in 2019 were used for Study 1 ( n  = 38,679) and data collected in 2020 were used for Study 2 ( n  = 50,307)., Results: Psychological flourishing is significantly inversely related to suicide and NSSI risk when controlling for loneliness and psychological distress. There were two-way interactions between flourishing and distress, whereby under conditions of high distress, the inverse effect of flourishing on suicidal ideation, intent, and attempts and NSSI was more pronounced. These results were consistent across both studies. Subgroup analyses revealed similar results regardless of participants' race, sexual orientation, and gender identity., Conclusion: Inverse associations between flourishing and self-injurious thoughts and behaviors suggest that flourishing may buffer risk of suicide and NSSI, and these findings may have important implications for developing evidence-based therapeutic interventions. Additional research, including longitudinal and clinical work, is warranted.

Background: Cisgender women account for 1 in 5 new HIV infections in the United States, yet remain under-engaged in HIV prevention. Women experiencing violence face risk for HIV due to biological and behavioral mechanisms, and barriers to prevention, such as challenges to Pre-Exposure Prophylaxis for HIV Prevention (PrEP) adherence. In this analysis, we aim to characterize intimate partner violence (IPV) among cisgender heterosexual women enrolled in a PrEP demonstration project and assess the associations with PrEP adherence., Methods: Adherence Enhancement Guided by Individualized Texting and Drug Levels (AEGiS) was a 48-week single-arm open-label study of PrEP adherence in HIV-negative cisgender women in Southern California (N = 130) offered daily tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). From 6/2016 to 10/2018, women completed a survey reporting HIV risk behavior and experiences of any IPV (past 90-days) and IPV sub-types (past-year, lifetime) and biological testing for HIV/STIs at baseline, and concentrations of tenofovir-diphosphate (TFV-DP) in dried blood spots at weeks 4, 12, 24, 36, and 48. Outcomes were TFV-DP concentrations consistent with ≥ 4 or ≥ 6 doses/week at one or multiple visits. Multivariable logistic regression models were conducted to examine associations., Results: Past-90-day IPV was reported by 34.4% of participants, and past-year and lifetime subtypes reported by 11.5-41.5%, and 21.5-52.3%, respectively. Women who engaged in sex work and Black women were significantly more likely to report IPV than others. Lifetime physical IPV was negatively associated with adherence at ≥ 4 doses/week at ≥ 3 of 5 visits, while other relationships with any IPV and IPV sub-types were variable., Conclusion: IPV is an indication for PrEP and important indicator of HIV risk; our findings suggest that physical IPV may also negatively impact long-term PrEP adherence., Clinical Trials Registration: NCT02584140 (ClinicalTrials.gov), registered 15/10/2015., (© 2024. The Author(s).)

Background: Transfusion of blood products is a common practice in anesthesiology. Inadequate transfusion medicine knowledge may lead to inappropriate transfusion practices and patient risk. Using a validated assessment tool modified for anesthesiology, we conducted a survey of anesthesiology residents in the United States to assess transfusion medicine knowledge., Methods: A validated transfusion medicine examination and accompanying survey were forwarded by program directors to residents for anonymous completion on May 5 and closed on June 30, 2021. The outcome of interest was the mean examination score. Secondary areas of interest were performance by year of training and previous educational experience in transfusion reported by the trainees. Rasch analysis was performed on the examination quality and individual question performance. Kruskal-Wallis H tests were used to identify differences between mean scores. Post hoc comparisons were used to assess specific pairwise differences between mean test scores by survey variable., Results: Four hundred twenty-three anesthesiology residents in 37 programs completed the examination. The mean score was 45.5% ± 12.6%. There was a significant difference in mean cumulative examination scores between different resident training levels ( P < 0.001). There was a significant difference in scores between clinical anesthesia (CA)-1 and CA-2 residents ( P = 0.011) and CA-1 and CA-3 residents ( P = 0.012). No significant difference in examination scores was observed between CA-2 and CA-3 residents ( P = 0.95). All these subgroups scored below 50% on the examination. Significant differences between the residency training programs and cumulative scores were identified ( P < 0.001)., Conclusions: This examination highlights gaps in transfusion medicine knowledge within US anesthesiology residents. Targeted education may improve knowledge in this area and patient care., Competing Interests: Conflicts of Interest: See Disclosures at the end of the article., (Copyright © 2020 International Anesthesia Research Society.)

Black and Latinx transgender women in the United States (U.S.) are at disproportionately high risk for HIV. Although HIV pre-exposure prophylaxis (PrEP) reduces the risk of HIV infection, uptake and persistence (i.e., ability to continue taking PrEP over time) can be a challenge for Black and Latinx transgender women due to myriad social and structural forces. In this qualitative study, we present unique data on the facilitators of PrEP persistence from Black and Latinx transgender women who initiated PrEP and exhibited varying levels of persistence during a demonstration project in Southern California. PrEP persistence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels on dried blood spot (DBS) samples collected at weeks 12 and 48. Informed by the socioecological framework, we conducted and analyzed interviews using qualitative content analysis to determine themes on the facilitators of PrEP persistence. Individual-level facilitators included the use of reminders, having high individual-level HIV risk perception, feeling empowered to take PrEP, and reporting having improved peace of mind and mental health because of taking PrEP. Interpersonal/Community-level facilitators included feeling motivation to prevent HIV in the community, motivation to prevent HIV in the context of sex work, and having high community-level risk perception. Structural-level facilitators included having positive experiences in affirming healthcare settings and having PrEP visits combined with other gender-related healthcare visits. Interventions aiming to increase PrEP uptake and persistence among Black and Latinx transgender women in the U.S. should harness the multiple levels of support exhibited by those who were able to start and persist on PrEP in the face of the myriad social and structural barriers.

Objective: Our study examined officers' attitudes and perceptions of adolescents in general (and challenges in policing adolescents) and the degree to which community variables affect those perceptions., Hypotheses: Our examinations of officers' descriptions of adolescents and challenges in policing adolescents were exploratory. We hypothesized that community characteristics would significantly influence officers' perceptions of adolescents, such that working in more impoverished, higher crime, and more proportionally Black communities would be associated with more negative perceptions of adolescents., Method: Data were obtained from 1,112 active law enforcement officers representing 30 police agencies/departments across the United States. Participating officers completed a survey about adolescents and challenges in policing adolescents. Publicly available data sets were used to measure select community and police agency/departmental characteristics. We examined qualitative data using an inductive methodological approach., Results: Police officers' descriptions of adolescents were significantly more negative than positive. Negativity was observed in the relative frequency of negative versus positive comments about adolescents as well as the use of inherently problematic descriptors. Police officers working in more impoverished, higher crime, and more proportionally Black communities displayed significantly more problematic attitudes and significantly fewer positive attitudes compared with those in less proportionally Black communities. The findings related to race were partially-but not completely-explained by other community variables., Conclusions: Officers' negative descriptors, their occasional use of inherently problematic terms, and the intensification of those tendencies when working in communities with more poverty, higher crime, and a larger proportion of Black residents suggest an urgent need for intervention to help officers better understand youth. Training that would help police officers better understand youth, recognize developmental influences, and see each youth individually rather than as a representative of a group could help officers interact more supportively with youth, be less likely to inadvertently create confrontation, and more effectively de-escalate situations involving distressed or activated youth. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Background: Non-small cell lung cancer (NSCLC) continues to be a major cause of cancer deaths. Previous investigation has suggested that metformin use can contribute to improved outcomes in NSCLC patients. However, this association is not uniform in all analyzed cohorts, implying that patient characteristics might lead to disparate results. Identification of patient characteristics that affect the association of metformin use with clinical benefit might clarify the drug's effect on lung cancer outcomes and lead to more rational design of clinical trials of metformin's utility as an intervention. In this study, we examined the association of metformin use with long-term mortality benefit in patients with NSCLC and the possible modulation of this benefit by body mass index (BMI) and smoking status, controlling for other clinical covariates., Methods: This was a retrospective cohort study in which we analyzed data from the Veterans Affairs (VA) Tumor Registry in the United States. Data from all patients with stage I NSCLC from 2000 to 2016 were extracted from a national database, the Corporate Data Warehouse that captures data from all patients, primarily male, who underwent treatment through the VA health system in the United States. Metformin use was measured according to metformin prescriptions dispensed to patients in the VA health system. The association of metformin use with overall survival (OS) after diagnosis of stage I NSCLC was examined. Patients were further stratified according to BMI and smoking status (previous vs current) to examine the association of metformin use with OS across these strata., Results: Metformin use was associated with improved survival in patients with stage I NSCLC (average hazard ratio, 0.82; P < .001). An interaction between the effect of metformin use and BMI on OS was observed (χ 2  = 3268.42; P < .001) with a greater benefit of metformin use observed in patients as BMI increased. Similarly, an interaction between smoking status and metformin use on OS was also observed (χ 2  = 2997.05; P < .001) with a greater benefit of metformin use observed in previous smokers compared with current smokers., Conclusions: In this large retrospective study, we showed that a survival benefit is enjoyed by users of metformin in a robust stage I NSCLC patient population treated in the VA health system. Metformin use was associated with an 18% improved OS. This association was stronger in patients with a higher BMI and in previous smokers. These observations deserve further mechanistic study and can help rational design of clinical trials with metformin in patients with lung cancer., (Copyright © 2022 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.)

This study examined associations between physical activity frequency and self-efficacy for exercise (SEE) among Marshallese adults in the United States. Data were collected from overweight and obese Marshallese participants (N = 378) enrolled in a Diabetes Prevention Program trial. Logistic and ordinal logistic regressions were employed to examine associations between physical activity and SEE, adjusting for covariates. SEE was significantly associated with engaging in sufficient total physical activity [odds ratio (OR) = 1.70], moderate physical activity (OR = 2.23), and vigorous physical activity (OR = 2.13). Unemployment was associated with less frequent moderate physical activity (OR = 0.59). Younger age (OR = 0.98), being male (OR = 2.67), and reporting excellent health (OR = 3.14) or good health (OR = 2.06) were associated with more frequent vigorous physical activity. Physical activity is a modifiable lifestyle behavior associated with many chronic disease disparities faced by the Marshallese community, and the study results will be useful for practitioners and researchers working to address these disparities., (© 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Donald A.B. Lindberg M.D., Director of the U.S. National Library of Medicine (NLM) from August 1984-March 2015, had a remarkable vision for NLM's scope, goals, and function. This vision resulted in many external partnerships and initiatives with the publishing industry, commercial and non-profit, journal editors, and professional organizations. These partnerships ranged from ongoing collaboration and dialogue, such as the NLM Publisher's Committee and the International Committee of Medical Journal Editors (ICMJE). to the more practical, such as the creation of HINARI and the Emergency Access Initiative (EAI). Dr. Lindberg fostered partnerships outside the NLM to expand the use and reach of Library resources, including MEDLINE and ClinicalTrials.gov to support innovations in the processes that build them, and improve the quality of biomedical journals. Dr. Lindberg also encouraged the use of technology to enhance medical information and supported the early development of fully interactive publications. Attitudes that contained a measure of skepticism and distrust faded as collaborators came to have a better understanding of both NLM and their partners. This chapter discusses these relationships and accomplishments that NLM achieved working with publishers and other creators and disseminators of medical information under Dr. Lindberg's leadership.

Little information is known about the cisgender women who seek and initiate pre-exposure prophylaxis (PrEP) for HIV prevention in the United States. Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week single-arm open-label demonstration study of daily oral tenofovir disoproxil fumaratel emtricitabine (TDF/FTC) in cisgender women ≥ 18 years old at risk for HIV. Participants were surveyed at screening and enrollment about sociodemographics, HIV risk perception and behaviors, and PrEP perspectives and aggregated into three risk groups according to HIV sexual risk behavior: being in a serodiscordant partnership (SD), engaging in sex work (SW), and having partners with unknown HIV status at risk for HIV (UP). One hundred sixty-seven women presented for screening with n  = 31 screen failures. Of the 162 women completing enrollment, mean age was 40 (standard deviation 11), with 41% non-Hispanic Black, 22% non-Hispanic White, and 19% Latina. Compared with those who screened ineligible, enrolled participants were more likely to have heard of PrEP, had higher HIV risk perception, and reported higher perceived PrEP efficacy. Sixty-four women (47%) were categorized as SD, 21 (15%) as SW, and 51 (38%) as UP. The SW were more likely to report higher levels of drinking and drug use ( p  = 0.002) and history of intimate partner violence in the past year ( p  < 0.001) compared with SD and UP. Among cisgender women enrolled, there were significant differences between the three risk groups by demographics, HIV risk behavior, and PrEP perspectives, suggesting that interventions to successfully implement PrEP in US women may need to be tailored by HIV risk group. Clinical Trial Registration number: NCT02584140.

Mobile phones are among the most highly touched personal objects. As part of a broader study on the contribution of fomites to influenza transmission, between 2017 and 2019, we swabbed mobile phones from 138 patients with influenza in 2 locations. Influenza viral RNA detection rates were 23% (23 of 99 phones) and 36% (14 of 39) in Hong Kong and Maryland, respectively. In Hong Kong, infectious influenza virus was recovered from 3 of 23 mobile phones which had influenza viral RNA detected. Mobile phone influenza contamination was positively associated with upper respiratory tract viral load and negatively associated with age. Cleaning personal objects of patients with influenza should be recommended, and individuals should avoid sharing objects with these patients., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Daily oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) is effective for reducing human immunodeficiency virus (HIV) acquisition among cisgender women. We report results from the first US observational open-label demonstration project of pre-exposure prophylaxis (PrEP) among at-risk cisgender women., Methods: Adherence Enhancement Guided by Individualized Texting and Drug Levels was a 48-week, single-arm, open-label demonstration study of daily oral TDF/FTC in cisgender women ≥18 years old at risk for HIV. Adherence was supported using 2-way text messaging and titrated adherence counseling based on rapid-turnaround tenofovir diphosphate concentrations from dried blood spots. Study visits occurred at baseline, weeks 4 and 12, and quarterly through week 48. Outcomes included TDF/FTC adherence, retention, and persistence., Results: From June 2016 to October 2018, 136 cisgender women enrolled (mean age, 40 years (standard deviation, 11); 38% non-Hispanic Black and 19% Latina). At 48 weeks, 84 (62%) participants were retained and 62 (46%) remained on PrEP. More than one-third (12/31) of those on study but off PrEP throughout the study discontinued TDF/FTC because of side effects, and 1 adverse event led to study discontinuation. Of 120 participants with drug concentrations measured, 67 (56%) had at least 1 concentration consistent with 6 doses/week; 22 (18%) had consistent ≥6 doses/week across all study visits attended. There were no incident HIV infections and 4 incident bacterial sexually transmitted infections., Conclusion: Adequate PrEP adherence for protective drug concentrations was not achieved for most study participants. More work needs to be done to fully explicate the reasons for nonadherence and low retention in cisgender women., (© The Author(s) 2021. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: In 2017, the American Society of Breast Surgeons (ASBrS) published expert panel recommendations for patients at risk for breast cancer-related lymphedema (BCRL) and those affected by BCRL. This study sought to determine BCRL practice patterns., Methods: A survey was sent to 2975 ASBrS members. Questions evaluated members' clinical practice type, practice duration, and familiarity with BCRL recommendations. Descriptive statistics, the chi-square test, and Fisher's exact test were used., Results: Of the ASBrS members surveyed, 390 (13.1%) responded. Most of the breast surgeons (58.5%, 228/390) indicated unfamiliarity with recommendations. Nearly all respondents (98.7%, 385/390) educate at-risk patients. Most (60.2%, 234/389) instruct patients to avoid venipuncture, injection or blood pressure measurements in the at-risk arm, and 35.6% (138/388) recommend prophylactic compression sleeve use during air travel. Nearly all (97.7%, 380/389) encourage those at-risk to exercise, including resistance exercise (86.2%, 331/384). Most do not perform axillary reverse mapping (ARM) (67.9%, 264/389) or a lymphatic preventive healing approach (LYMPHA) (84.9%, 331/390). Most (76.1%, 296/389) screen at-risk patients for BCRL. The most frequently used screening tools include self-reported symptoms (81%, 255/315), circumferential tape measure (54%, 170/315) and bioimpedance spectroscopy (27.3%, 86/315). After a BCRL diagnosis, most (90%, 351/390) refer management to a lymphedema-certified physical therapist. For affected patients, nearly all encourage exercise (98.7%, 384/389). Many (49%, 191/390) refer affected patients for consideration of lymphovenous bypass or lymph node transfer., Conclusion: Most respondents were unfamiliar with the ASBrS expert panel recommendations for patients at risk for BCRL and those affected by BCRL. Opportunities exist to increase awareness of best practices and to acquire ARM and LYMPHA technical expertise., (© 2021. Society of Surgical Oncology.)

Pacific Islanders are the second fastest-growing population in the United States; however, Pacific Islanders, and Marshallese specifically, are underrepresented in health research. A community-based participatory research (CBPR) approach was used to engage Marshallese stakeholders and build an academic-community research collaborative to conduct health disparities research. Our CBPR partnership pilot tested a multicomponent consent process that provides participants the option to control the use of their data. Consent forms used concise plain language to describe study information, including participant requirements, risks, and personal health information protections, and were available in both English and Marshallese. This study demonstrates that when provided a multicomponent consent, the vast majority of consenting study participants (89.6%) agreed to all additional options, and only five (10.4%) provided consent for some but not all options. Our description of the development and implementation of a multicomponent consent using a CBPR approach adds a specific example of community engagement and may be informative for other indigenous populations.

Black and Hispanic/Latinx transgender women in the United States (U.S.) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) reduces risk of HIV infection but PrEP uptake remains low among Black and Hispanic/Latinx transgender women. Between July 2018 and August 2019, we conducted individual interviews with 30 Black and Hispanic/Latinx transgender women who were prescribed PrEP through a PrEP demonstration project and 10 healthcare providers who provide PrEP services to transgender women in Los Angeles and San Diego, California. The interviews assessed general attitudes, experiences, and beliefs about PrEP as well as individual-, interpersonal-, community-, and structural-level barriers to PrEP uptake and adherence. PrEP adherence was assessed by collecting quantitative intracellular tenofovir-diphosphate (TFV-DP) levels in retrospect on batched, banked dried blood spot (DBS) samples. We utilized qualitative content analysis to identify themes from the interviews. Findings indicated the presence of individual-level barriers including cost concerns, mental health issues, substance use, and concerns about PrEP side effects including hormone interaction. Interpersonal-level barriers included the influence of intimate/romantic partners and the impact of patient-provider communication. Community-level barriers consisted of experiencing stigma and negative community opinions about PrEP use as well as having negative experiences in healthcare settings. Structural-level barriers included unreliable transportation, employment, and housing insecurity. Interventions aiming to increase PrEP uptake and adherence among Black and Hispanic/Latinx transgender women in the U.S. should employ a multilevel approach to addressing the needs of transgender women, especially the structural barriers that have greatly limited the use of PrEP.

While HIV infections among men who have sex men (MSM) have started to decline in the United States, Black MSM continue to experience disproportionate rates of HIV infection. The purpose of this secondary analysis is to examine risk perception and its influence on PrEP adherence among Black MSM from HPTN 073. Risk perception was measured using the adapted Perceived Vulnerability to HIV Scale. The associations between risk perception and PrEP adherence were tested using generalized estimation equation model for time-variant repeated measures. Risk perception was not significantly associated with PrEP adherence. These findings suggest an there was no risk compensation among PrEP users, and inconsistency in perceived risk for HIV. Future studies should investigate the rationale for long term adherence to PrEP among Black MSM.

Background: COVID-19 has disproportionately affected older adults and certain racial and ethnic groups in the United States. Data quantifying the disease burden, as well as describing clinical outcomes during hospitalization among these groups, are needed., Objective: We aimed to describe interim COVID-19 hospitalization rates and severe clinical outcomes by age group and race and ethnicity among US veterans by using a multisite surveillance network., Methods: We implemented a multisite COVID-19 surveillance platform in 5 Veterans Affairs Medical Centers located in Atlanta, Bronx, Houston, Palo Alto, and Los Angeles, collectively serving more than 396,000 patients annually. From February 27 to July 17, 2020, we actively identified inpatient cases with COVID-19 by screening admitted patients and reviewing their laboratory test results. We then manually abstracted the patients' medical charts for demographics, underlying medical conditions, and clinical outcomes. Furthermore, we calculated hospitalization incidence and incidence rate ratios, as well as relative risk for invasive mechanical ventilation, intensive care unit admission, and case fatality rate after adjusting for age, race and ethnicity, and underlying medical conditions., Results: We identified 621 laboratory-confirmed, hospitalized COVID-19 cases. The median age of the patients was 70 years, with 65.7% (408/621) aged ≥65 years and 94% (584/621) male. Most COVID-19 diagnoses were among non-Hispanic Black (325/621, 52.3%) veterans, followed by non-Hispanic White (153/621, 24.6%) and Hispanic or Latino (112/621, 18%) veterans. Hospitalization rates were the highest among veterans who were ≥85 years old, Hispanic or Latino, and non-Hispanic Black (430, 317, and 298 per 100,000, respectively). Veterans aged ≥85 years had a 14-fold increased rate of hospitalization compared with those aged 18-29 years (95% CI: 5.7-34.6), whereas Hispanic or Latino and Black veterans had a 4.6- and 4.2-fold increased rate of hospitalization, respectively, compared with non-Hispanic White veterans (95% CI: 3.6-5.9). Overall, 11.6% (72/621) of the patients required invasive mechanical ventilation, 26.6% (165/621) were admitted to the intensive care unit, and 16.9% (105/621) died in the hospital. The adjusted relative risk for invasive mechanical ventilation and admission to the intensive care unit did not differ by age group or race and ethnicity, but veterans aged ≥65 years had a 4.5-fold increased risk of death while hospitalized with COVID-19 compared with those aged <65 years (95% CI: 2.4-8.6)., Conclusions: COVID-19 surveillance at the 5 Veterans Affairs Medical Centers across the United States demonstrated higher hospitalization rates and severe outcomes among older veterans, as well as higher hospitalization rates among Hispanic or Latino and non-Hispanic Black veterans than among non-Hispanic White veterans. These findings highlight the need for targeted prevention and timely treatment for veterans, with special attention to older aged, Hispanic or Latino, and non-Hispanic Black veterans., (©Cristina V Cardemil, Rebecca Dahl, Mila M Prill, Jordan Cates, Sheldon Brown, Adrienne Perea, Vincent Marconi, LaSara Bell, Maria C Rodriguez-Barradas, Gilberto Rivera-Dominguez, David Beenhouwer, Aleksandra Poteshkina, Mark Holodniy, Cynthia Lucero-Obusan, Neha Balachandran, Aron J Hall, Lindsay Kim, Gayle Langley. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 22.01.2021.)

Interest continues to grow regarding the role of serologic assays for the detection of prior infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) status to many SARS-CoV-2 serologic assays. In this document, expert recommendations from clinical microbiologist members of the American Society for Microbiology (ASM) concerning detailed verification strategies for SARS-CoV-2 serologic assays with FDA EUA are provided, as are insights into assay limitations and reporting considerations for laboratories. Assessments concerning single-antibody and multiantibody isotype detection assays, which may provide either differentiated or nondifferentiated (i.e., total antibody) antibody class results, are addressed. Additional considerations prior to assay implementation are also discussed, including biosafety, quality control, and proficiency testing strategies. As the landscape of SARS-CoV-2 serologic testing is rapidly changing, this document provides updated guidance for laboratorians on application of these assays., (Copyright © 2020 American Society for Microbiology.)

Objectives: Our study aimed to assess whether elective posterior lumbar fusions (PLFs) performed in states with Certificate-of-Need (CON) laws versus states without CON laws had lower utilization rates, lower costs, and better quality of care., Methods: The 2005-2014 100% Medicare Standard Analytical File was queried to identify patients undergoing elective 1- to 3-level PLF. Differences in per-capita utilization, 90-day reimbursements, and proportion of high-volume between CON and No-CON states were reported. Multivariate analyses were used to analyze 90-day complications and readmissions., Results: A total of 188,687 patients underwent an elective 1- to 3-level PLF in a CON state and 167,642 patients in a No-CON state during 2005-2014. The average per capita utilization of PLFs was lower in CON states as compared with No-CON states (14.5 vs. 15.4 per 10,000 population; P < 0.001). Average 90-day reimbursements between CON and No-CON states differed by a small amount ($22,115 vs. $21,802). CON states had a higher proportion of high-volume facilities (CON vs. No CON-40.9% vs. 29.9%; P < 0.05) and lower proportion of low-volume facilities (CON vs. No-CON-37.2% vs. 45.0%; P < 0.05). PLFs performed in CON states had slightly lower odds of 90-day complications (odds ratio 0.97 [95% confidence interval 0.96-0.99]; P < 0.001) and readmissions (odds ratio 0.95 [95% confidence interval 0.93-0.97]; P < 0.001)., Conclusions: The presence of CON laws was associated with lower utilization of elective 1- to 3-level PLFs and a greater number of high-volume facilities. However, their effect on quality of care, via reduction of 90-day readmissions and 90-day complications, is minimally significant., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background Context: Despite the increasing national incidence, osteoporosis and its associated comanagement, often remain an overlooked issue in the orthopedic world. Screening and associated management of osteoporosis is often only considered by providers when patients present with multiple fragility fractures. Current evidence with regard to the trends in screening and medical comanagement/antiosteoporotic therapy of osteoporotic vertebral compression fractures (VCFs) remains limited., Purpose: To understand trends, costs, and clinical impact associated the utilization of antiosteoporotic medication and screening with the 1 year following occurrences of sentinel/primary osteoporotic VCFs., Study Design/setting: Retrospective review of 2008-2015Q3 Humana Administrative Claims (HAC) database., Patient Sample: The 2008-2015Q3 HAC database was queried using International Classification of Diseases 9th Edition (ICD-9) diagnosis codes 805.2 and 805.4 to identify patients with primary closed osteoporotic thoracolumbar VCFs. Patients with a concurrent diagnosis of trauma and/or malignancy were excluded. Patients experiencing a fragility fracture of the hip, distal radius or proximal humerus, and/or those already on osteoporotic medications within the year before the VCF were excluded to prevent an overlap in the screening and/or antiresorptive medication rates. Finally, only those patients who had complete 2-year follow-up data were analyzed., Outcome Measures: To understand trends over time in the utilization of medication for osteoporosis and screening within 1 year following sentinel VCFs. The study also aimed to report per-prescription and per-patient average costs associated with different antiosteoporotic medications. As secondary objectives, we also assessed (1) risk factors associated with not receiving antiosteoporotic medication within the year following sentinel VCFs and (2) differences in rates of experiencing a secondary fragility fracture of vertebrae, hip, distal radius, and proximal humerus between patients who received medication following the sentinel VCF versus those who did not receive any medication., Results: A total of 6,464 primary osteoporotic VCFs were retrieved from the database. A majority of the VCFs were seen in females (N=5,199; 80.4%). Only 28.8% (N=1,860) patients received some form of medication for osteoporosis medication in the year following the VCF. Over a 6-year interval, treatment with medication for osteoporosis declined from 38% in 2008 to 24% in 2014. The average cost of antiosteoporotic treatment per patient was $1,511. The most commonly prescribed treatment and associated average cost/patient was alendronate sodium (N=1,239; 66.6% to $120/patient). The most costly prescribed treatment was Forteo (N=177; 2.7%) with an average cost/patient of $12,074 and cost/injection being $2,373. Only 36.7% (N=2,371) received a dual-energy X-ray absorptiometry/bone density scan in the year following the VCF with an average cost/patient of $76. Risk factors associated with no prescription of medication for osteoporosis within 1 year of VCF were male gender (odds ratio [OR] 1.17 [95% confidence interval {CI} 1.01-1.35]; p=.027), history of cerebrovascular accident/stroke (OR 1.56 [95% CI 1.08-2.32]; p=.022), history of diabetes mellitus (OR 1.28 [95% CI 1.04-1.58]; p=.023). Of note, patients in the West versus Midwest (OR 1.26 [95% CI 1.04-1.51]; p=.016) and commercial insurance beneficiaries (OR 1.95 [95% CI 1.08-3.52]; p=.027) were more likely to receive antiosteoporotic medication. Patients who were placed on antiosteoporotic medication were significantly less likely to suffer a second fragility fracture compared with patients that did not receive medication (OR 0.27 [95% CI 0.24-0.31]; p=.033)., Conclusions: The proportion of patients starting antiosteoporotic medication within a year after a VCF remains low (28.8%). Furthermore, a declining trend of antiosteoporotic medication prescription was noted over time. Providers who care for patients with sentinel VCFs need to be more diligent in their efforts to diagnose and treat the underlying osteoporosis to reduce the burden of future fragility fractures., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Background: Clostridium difficile infection (CDI) is a reportable hospital metric associated with significant healthcare expenditures. The epidemiology of CDI is pivotal to the implementation of preventative measures., Objective: To portray temporal CDI trends in Veterans Health Administration (VA) hospitals., Design: A retrospective analysis of veterans who had stool testing for C. difficile., Setting: VA acute-care hospitals within the continental United States., Methods: Data were mined from the VA's Corporate Data Warehouse. CDI is reported per 10,000 patient days., Results: From 2006 to 2016, 472,346 patients had C. difficile testing. Overall, decreases in incidence of total CDI (16.81 to 13.66) and hospital-onset healthcare facility-associated (HO-HCFA) CDI (10.87 to 6.41) were observed. Temporal increases in the incidence of total and HO-HCFA CDI were associated with the increased use of molecular testing (P < .0001). Decreased use of fluoroquinolones (P < .0001), clindamycin (P = .0006), and third-generation cephalosporins (P = .0002) correlated with decreased rates of CDI, but VA mandatory reporting did not influence CDI rates (P = .24). The overall crude 30-day mortality of patients with CDI decreased from 2.17 deaths per 10,000 patient days in 2006 to 1.41 in 2016. The frequency of International Classification of Disease, Ninth/Tenth Revision (ICD-9/10) discharge diagnosis for CDI was 73.3%., Conclusion: Molecular testing was associated with increased incidence of CDI. Controlling CDI is likely multifactorial. Although the VA initiative to report cases of hospital-acquired CDI was not significant in our model, the advent of stewardship programs throughout the VA and reductions in the use of third-generation cephalosporins, fluoroquinolones, and clindamycin were significantly associated with reduced rates of CDI.

Accurate HIV risk assessment among men who have sex with men (MSM) is important to help providers assess risk, and target HIV prevention interventions. We sought to develop an evidence-based HIV risk assessment tool for US MSM that is inclusive of Black MSM. Data from four large longitudinal cohorts of MSM were used to develop (EXPLORE), and validate (VAX004, HPTN061, and HVTN505). These data included visits in which participants self-reported HIV risk behavior and underwent HIV testing. We developed a pooled logistic model for incident HIV infection based on self-reported risk behaviors during the 6 months before each study visit. A total of 4069 MSM were used for the development cohort, and 8047 MSM in the three validation cohorts through 2013. The final model includes age (< 35, ≥ 35); Black race and Latino ethnicity; numbers of HIV-negative anal sex partners; number of insertive or receptive anal intercourse episodes; having 1 HIV-negative partner only; self-reported substance use; and bacterial sexually transmitted infection diagnosis. The model showed good discrimination in internal validation (C-statistic = 79.5). The external validation cohorts also showed good discrimination, with C-statistics of 73.1, 71.0, 71.9 in VAX004, HPTN061, and HVTN505 respectively, and acceptable calibration. We developed and validated an HIV risk assessment tool for MSM, which showed good predictive ability, including among the largest cohort of HIV-uninfected Black MSM in the US. This tool is available online (mysexpro.org) and can be used by providers to support targeting of HIV prevention interventions such as pre-exposure prophylaxis for MSM.

Background Context: The current Bundled Payment for Care Improvement model relies on the use of "Diagnosis Related Groups" (DRGs) to risk-adjust reimbursements associated with a 90-day episode of care. Three distinct DRG groups exist for defining payments associated with cervical fusions: (1) DRG-471 (cervical fusions with major comorbidity/complications), (2) DRG-472 (with comorbidity/complications), and (3) DRG-473 (without major comorbidity/complications). However, this DRG system may not be entirely suitable in controlling the large amounts of cost variation seen among cervical fusions. For instance, these DRGs do not account for area/location of surgery (upper cervical vs. lower cervical), type of surgery (primary vs. revision), surgical approach (anterior vs. posterior), extent of fusion (1-3 level vs. >3 level), and cause/indication of surgery (fracture vs. degenerative pathology)., Purpose: To understand factors responsible for cost variation in a 90-day episode of care following cervical fusions., Study Design: Retrospective study of a 5% national sample of Medicare claims from 2008 to 2014 5% Standard Analytical Files (SAF5)., Outcome Measures: To calculate the independent marginal cost impact of various patient-level, geographic-level, and procedure-level characteristics on 90-day reimbursements for patients undergoing cervical fusions under DRG-471, DRG-472, and DRG-473., Methods: The 2008 to 2014 Medicare SAF5 was queried using DRG codes 471, 472, and 473 to identify patients receiving a cervical fusion. Patients undergoing noncervical fusions (thoracolumbar), surgery for deformity/malignancy, and/or combined anterior-posterior fusions were excluded. Patients with missing data and/or those who died within 90 days of the postoperative follow-up period were excluded. Multivariate linear regression modeling was performed to assess the independent marginal cost impact of DRG, gender, age, state, procedure-level factors (including cause/indication of surgery), and comorbidities on total 90-day reimbursement., Results: Following application of inclusion/exclusion criteria, a total of 12,419 cervical fusions were included. The average 90-day reimbursement for each DRG group was as follows: (1) DRG-471=$54,314±$32,643, (2) DRG-472=$28,535±$17,271, and (3) DRG-473=$18,492±$10,706. The risk-adjusted 90-day reimbursement of a nongeriatric (age <65) female, with no major comorbidities, undergoing a primary 1- to 3-level anterior cervical fusion for degenerative cervical spine disease was $14,924±$753. Male gender (+$922) and age 70 to 84 (+$1,007 to +$2,431) was associated with significant marginal increases in 90-day reimbursements. Undergoing upper cervical surgery (-$1,678) had a negative marginal cost impact. Among other procedure-level factors, posterior approach (+$3,164), >3 level fusion (+$2,561), interbody (+$667), use of intra-operative neuromonitoring (+$1,018), concurrent decompression/laminectomy (+$1,657), and undergoing fusion for cervical fracture (+$3,530) were associated higher 90-day reimbursements. Severe individual comorbidities were associated with higher 90-day reimbursements, with malnutrition (+$15,536), CVA/stroke (+$6,982), drug abuse/dependence (+$5,059), hypercoagulopathy (+$5,436), and chronic kidney disease (+$4,925) having the highest marginal cost impacts. Significant state-level variation was noted, with Maryland (+$8,790), Alaska (+$6,410), Massachusetts (+$6,389), California (+$5,603), and New Mexico (+$5,530) having the highest reimbursements and Puerto Rico (-$7,492) and Iowa (-$3,393) having the lowest reimbursements, as compared with Michigan., Conclusions: The current cervical fusion bundled payment model fails to employ a robust risk adjustment of prices resulting in the large amount of cost variation seen within 90-day reimbursements. Under the proposed DRG-based risk adjustment model, providers would be reimbursed the same amount for cervical fusions regardless of the surgical approach (posterior vs. anterior), the extent of fusion, use of adjunct procedures (decompressions), and cause/indication of surgery (fracture vs. degenerative pathology), despite each of these factors having different resource utilization and associated reimbursements. Our findings suggest that defining payments based on DRG codes only is an imperfect way of employing bundled payments for spinal fusions and will only end up creating major financial disincentives and barriers to access of care in the healthcare system., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Evidence indicating Prostatic Urethral Lift (PUL) delivers significant improvement in symptomatic BPH with low morbidity is based on subjects with lateral lobe (LL) enlargement only. MedLift was an FDA IDE extension of the L.I.F.T. randomized study designed to examine safety and efficacy of PUL for treatment of obstructive middle lobes (OML). Inclusion criteria for this non-randomized cohort were identical to the L.I.F.T. randomized study, except for requiring an OML: ≥ 50 years of age, IPSS ≥ 13, and Qmax ≤ 12 ml/s. Primary endpoint analysis quantified improvement in IPSS over baseline and rate of post-procedure serious complications. Quantification of symptom relief, quality of life, flow rate, and sexual function occurred through 12 months. Outcomes were compared to historical L.I.F.T LL results and were combined to demonstrate the full effectiveness of PUL. Of the 71 screened subjects, 45 were enrolled. At 1, 3, 6, and 12 months, mean IPSS improved from baseline at least 13.5 points (p < 0.0001). Quality of life and BPHII were similarly improved (>60% and >70%, respectively at 3, 6, and 12 months, p < 0.0001). Mean Qmax improvement ranged from 90 to 129% (p < 0.0001). At 1 month, 86% (CI 73-94%) reported ≥70 on the Quality of Recovery scale, 80% (CI 66-89%) reported being "much" or "very much better," and 89% (CI 76-95%) would recommend the procedure. Compared to LL subjects, OML subjects' symptoms improved at least as much at every time point (OML range 13.5-15.9, LL range 9.9-11.1, p ≤ 0.01). On combining OML with LL data, >70% (range CI 63-81%) of subjects demonstrated ≥ 8 point improvement in IPSS through 12 months. Analysis of the combined dataset indicates ≥ 40% (CI 30-51%) of sexually active men improved the minimal clinically important difference in erectile function through 12 months. Prostates, including those with middle lobe obstruction, can be treated with the PUL procedure safely and effectively.