MRI-Ultrasound Fused Approach for Prostate Biopsy-How It Is Performed.

The use of MRI-ultrasound image fusion targeted biopsy of the prostate in the face of an elevated serum PSA is now recommended by multiple societies, and results in improved detection of clinically significant cancer and, potentially, decreased detection of indolent disease. This combines the excellent sensitivity of MRI for clinically significant prostate cancer and the real-time biopsy guidance and confirmation of ultrasound. Both transperineal and transrectal approaches can be implemented using cognitive fusion, mechanical fusion with an articulated arm and electromagnetic registration, or pure software registration. The performance has been shown comparable to in-bore MRI biopsy performance. However, a number of factors influence the performance of this technique, including the quality and interpretation of the MRI, the approach used for biopsy, and experience of the practitioner, with most studies showing comparable performance of MRI-ultrasound fusion to in-bore targeted biopsy. Future improvements including artificial intelligence promise to refine the performance of all approaches.

The Phase 3 INVIGORATE Trial of Reproxalap in Patients with Seasonal Allergic Conjunctivitis.

Purpose: There is an unmet need for new treatments for allergic conjunctivitis. Objective: To assess the activity of reproxalap, a novel reactive aldehyde species modulator, in a real-world model of seasonal allergen exposure. Methods: The INVIGORATE Trial, a prospective, quadruple-masked, vehicle-controlled, crossover, sequence-randomized Phase 3 trial, tested the efficacy of reproxalap in adults with a history of moderate to severe allergic conjunctivitis, ragweed pollen allergy, and allergen chamber-induced ocular itching and redness. Patients were randomly assigned (1:1) to receive 0.25% reproxalap ophthalmic solution or vehicle, followed by a 2-week washout period before crossing over to the other test article. The primary endpoint was ocular itching from 110 to 210 minutes after chamber entry; the key secondary endpoint was ocular redness over the chamber duration (0-4 scales for both endpoints). Results: Of the 95 randomly assigned patients, 89 completed all visits (reproxalap to vehicle: n = 46; vehicle to reproxalap: n = 43). Primary and key secondary endpoints were met: reproxalap significantly reduced ocular itching (mean [SE]: -0.50 [0.03], p < 0.001) and redness (-0.14 [0.01], p < 0.001) relative to vehicle. Responder analyses confirmed the clinical relevance of both end points. Reproxalap was safe and well tolerated. No clinically significant changes in safety assessments were observed. No serious or severe treatment-emergent adverse events (TEAEs) were reported. The most commonly reported TEAE was mild and transient installation site irritation after reproxalap versus vehicle administration. Conclusion: In this well-controlled allergen chamber trial, reproxalap was statistically superior to vehicle across typical symptoms and signs of allergic conjunctivitis. Trial Registration: NCT04207736.

A Quality Analysis of Donor Nephrectomy-Related Information on YouTube; Education or Misinformation?

INTRODUCTION: There currently remains an urgent need to increase living kidney donation to help mitigate the high demand for waitlisted kidney failure patients. Potential kidney donors can readily access social media, particularly YouTube, to gain basic knowledge about live donor nephrectomy surgical procedures. YouTube is an open-source platform where anyone can upload videos about any topic without peer review or quality control and is frequently used for disseminating health education. This study aims to assess the quality and accuracy of information regarding live donor nephrectomy on YouTube. METHODS: A YouTube search was performed using the keywords "donor nephrectomy" and "kidney transplant." A total of 57 videos were assessed for eligibility criteria. Two validated tools for evaluating health information, the DISCERN and The Patient Education Materials Assessment Tool for Audiovisual Materials tools, were used to assess YouTube video information quality, understandability, and actionability. RESULTS: A total of 53 of 57 screened videos were included in this study, with 4 videos being excluded for not being primarily in the English language. The mean (SD) DISCERN score was 23.3 (±8.3), and the mean (SD) The Patient Education Materials Assessment Tool for Audiovisual Materials Understandability and Actionability scores of 41.7% (±17.5) and 8.2% (±22.9%), respectively. Although videos were generally relevant in content to donor nephrectomy, videos lacked quality information and actionable items. CONCLUSIONS: Information on living donor nephrectomies is prevalent on YouTube. Our assessment using quality measures of selected videos illustrates substantial misinformation on living donor nephrectomies. YouTube has the potential to be a source of reliable and accurate information on living donor nephrectomies and donations.

Generic cardiology drug prices: the potential benefits of the Marc Cuban cost plus drug company model.

Introduction: Generic pharmaceuticals account for the majority of the $359 billion US pharmaceutical market, including for cardiology drugs. Amidst a lack of price transparency and administrative inefficiencies, generic drug prices are high, causing an undue burden on patients. Methods: We identified the 50 most used generic cardiology drugs by volume per the 2020 Medicare Part D spending data. We extracted cost per dose of each drug from the Marc Cuban Cost Plus Drug Company (MCCPDC) website and estimated the aggregate cost savings if MCCPDC were employed on a national scale by calculating the difference between this cost and Medicare spending. Results: Medicare spent $7.7 billion on the 50 most used generic cardiology drugs by volume in 2020 according to Medicare Part D data. Pharmacy and shipping costs accounted for a substantial portion of expenditures. Per our most conservative estimate, $1.3 billion (17% of total) savings were available on 16 of 50 drugs. A slightly less conservative estimate suggested $2.9 billion (38%) savings for 35 of 50 drugs. Discussion: There is enormous potential for cost savings in the US market for generic cardiology drugs. By encouraging increased competition, decreasing administrative costs, and advocating for our patients to compare prices between the MCCPDC and other generic pharmaceutical dispensers, we have the potential to improve access to care and corresponding outcomes for cardiology patients.

Psychological distress and health perception in patients with a previous myocardial infarction or stroke: a national cross-sectional study.

BACKGROUND: While understanding the impact of mental health on health perception improves patient-centered care, this relationship is not well-established in patients with cardiovascular disease (CVD). We examined the relationship between psychological distress and health perception in patients with a previous myocardial infarction (MI) and/or stroke. METHODS: We extracted data for patients with a previous MI and/or stroke from the 2019 National Health Interview Survey (NHIS). Health perception was self-reported. Presence and severity of anxiety and depression were estimated using the Generalized Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-8 (PHQ-8). Binary analyses of anxiety/depression, multivariable logistic regressions controlling for confounders, and univariable analyses of confounders and anxiety/depression severity were performed. RESULTS: Of 31,948 individuals for whom data on MI/stroke was available, 1235 reported a previous MI and 1203 a previous stroke. The odds of positive perceived health status were lower for individuals with anxiety/depression compared to those without anxiety/depression in both post-MI (anxiety OR 0.52, 95% CI = 0.32-0.85, P < 0.001; depression OR 0.45, 95% CI = 0.29-0.7, P < 0.001) and post-stroke groups (anxiety OR 0.61, 95% CI = 0.39-0.97, P < 0.001; depression OR 0.37, 95% CI = 0.25-0.55, P < 0.001) upon multivariable analyses. Increasing severity of anxiety/depression was also associated with worse perception of health status upon univariable analysis. CONCLUSION: Among patients with a previous acute CVD event, those with psychological distress have worse perception of their health status. Understanding the range of patient health perceptions can help physicians provide more patient-centered care and encourage patient behaviors that may improve both CVD and mental health outcomes.

Quantifying mortality burden in patients with cancer due to COVID-19 in the US: A national cross-sectional analysis.

INTRODUCTION: There is limited information on the impact of certain social factors on mortality outcomes in patients with cancer and COVID-19 on a national scale. This study aims to characterize excess mortality and analyze a subset of sociodemographic trends in COVID-19 and cancer mortality. METHODS: Patients with cancer listed on their death certificates from 2018 to 2021 and patients with COVID-19 and cancer listed on multiple cause of death certificates from the CDC Wide-Ranging Online Data for Epidemiologic Research database from March 2020 to December 2021 were included. Age-adjusted mortality rates (AAMR) per 1,000,000 population were compared across race/ethnicity groups, sex, and census regions. Crude mortality rates were compared across different age groups and regions based on urbanization status. RESULTS: Average AAMR in patients with COVID-19 and cancer was 41.7 in 2020 and 56.7 in 2021. CONCLUSIONS: Mortality rates in patients with cancer and COVID-19 were significantly higher in certain populations. Targeted interventions are necessary to improve outcomes.

The Impact of the COVID-19 Pandemic on Kidney Transplant Candidate Waitlist Status across Demographic and Geographic Groups: A National Analysis of UNOS STAR Data.

The primary goal of this retrospective study is to understand how the COVID-19 pandemic differentially impacted transplant status across race, sex, age, primary insurance, and geographic regions by examining which candidates: (i) remained on the waitlist, (ii) received transplants, or (iii) were removed from the waitlist due to severe sickness or death on a national level. Methods: The trend analysis aggregated by monthly transplant data from 1 December 2019 to 31 May 2021 (18 months) at the transplant center level. Ten variables about every transplant candidate were extracted from UNOS standard transplant analysis and research (STAR) data and analyzed. Characteristics of demographical groups were analyzed bivariately using t-test or Mann-Whitney U test for continuous variables and using Chi-sq/Fishers exact tests for categorical variables. Results: The trend analysis with the study period of 18 months included 31,336 transplants across 327 transplant centers. Patients experienced a longer waiting time when their registration centers in a county where high numbers of COVID-19 deaths were observed (SHR < 0.9999, p < 0.01). White candidates had a more significant transplant rate reduction than minority candidates (-32.19% vs. -20.15%) while minority candidates were found to have a higher waitlist removal rate than White candidates (9.23% vs. 9.45%). Compared to minority patients, White candidates' sub-distribution hazard ratio of the transplant waiting time was reduced by 55% during the pandemic period. Candidates in the Northwest United States had a more significant reduction in the transplant rate and a greater increase in the removal rate during the pandemic period. Conclusions: Based on this study, waitlist status and disposition varied significantly based on patient sociodemographic factors. During the pandemic period, minority patients, those with public insurance, older patients, and those in counties with high numbers of COVID-19 deaths experienced longer wait times. In contrast, older, White, male, Medicare, and high CPRA patients had a statistically significant higher risk of waitlist removal due to severe sickness or death. The results of this study should be considered carefully as we approach a reopening world post-COVID-19, and further studies should be conducted to elucidate the relationship between transplant candidate sociodemographic status and medical outcomes during this era.

Electronic Patient Portal Use After Kidney Transplant: A Single-Center Retrospective Study.

INTRODUCTION: Online patient portals have become a core component of patient-centered care. Limited research exists on such portal use in patients after kidney transplantation. The aim of this study was to examine preoperative, perioperative, and postoperative factors associated with post-transplantation portal use. METHODS: This cross-sectional study included all patients who underwent kidney transplantation from April 2016 to May 2019 at the University of Toledo Medical Center. Exclusion criteria included international travel for transplantation and those without available postoperative lab or follow-up records. Data were collected for 2 y post-transplantation. Univariable and multivariable linear regression was performed to determine associations with portal use. RESULTS: Two hundred and forty-seven kidney transplant recipients were included in the study; 35.6% (n = 88) used the portal versus 64.4% (n = 159) did not. Preoperative factors associated with increased use included income >$40,000 (odds ratio [OR], 2.95; P = 0.006) and cancer history (OR, 2.46; P = 0.007), whereas diabetes history had reduced use (OR, 0.51; P = 0.021). The Black race had the least use. Perioperatively, reduced use was associated with dialysis before transplant (OR, 0.25; P < 0.001) and hospital stay ≥4 d (OR, 0.49; P = 0.009). Postoperatively, associations with increased use included average eGFR >30 (P = 0.04) and hospital readmissions (n = 102), whereas those with ER (n = 138) visits had decreased use. Multivariable analysis revealed increased use with income >$40,000 (OR, 2.51; P = 0.033). CONCLUSIONS: There was no observed difference in clinical outcomes for portal users and nonusers undergoing kidney transplantation, although portal use may decrease the likelihood of ER visits. Socioeconomic status and ethnicity may play a role on who utilizes the patient portals.

Demographic and regional trends of peripheral artery disease-related mortality in the United States, 2000 to 2019.

INTRODUCTION: Peripheral artery disease (PAD) is a common progressive atherosclerotic disease associated with significant morbidity and mortality in the US; however, data regarding PAD-related mortality trends are limited. This study aims to characterize contemporary trends in mortality across sociodemographic and regional groups. METHODS: The Centers for Disease Control and Prevention Wide-Ranging OnLine Data for Epidemiologic Research (CDC WONDER) was queried for data regarding PAD-related deaths from 2000 to 2019 in the overall sample and different demographic (age, sex, race/ethnicity) and regional (state, urban-rural) subgroups. Crude and age-adjusted mortality rates (CMR and AAMR, respectively) per 100,000 people were calculated. Associated annual percentage changes (APC) were computed using Joinpoint Regression Program Version 4.9.0.0 trend analysis software. RESULTS: Between 2000 and 2019, a total of 1,959,050 PAD-related deaths occurred in the study population. Overall, AAMR decreased from 72.8 per 100,000 in 2000 to 32.35 per 100,000 in 2019 with initially decreasing APCs followed by no significant decline from 2016 to 2019. Most demographic and regional subgroups showed initial declines in AAMRs during the study period, with many groups exhibiting no change in mortality in recent years. However, men, non-Hispanic (NH) Black or African American individuals, people aged ⩾ 85 years, and rural counties were associated with the highest AAMRs of their respective subgroups. Notably, there was an increase in crude mortality rate among individuals 25-39 years of age from 2009 to 2019. CONCLUSION: Despite initial improvement, PAD-related mortality has remained stagnant in recent years. Disparities have persisted across several demographic and regional groups, requiring further investigation.

Patient-reported disruptions to cancer care during the COVID-19 pandemic: A national cross-sectional study.

BACKGROUND: The aim of this study is to evaluate the extent and associations with patient-reported disruptions to cancer treatment and cancer-related care during the COVID-19 pandemic utilizing nationally representative data. METHODS: This analysis uses data from the 2020 National Health Interview Survey (NHIS), an annual, cross-sectional survey of US adults. Adults (age >18) who reported requiring current cancer treatment or other cancer-related medical care in the second half of 2020 were included. Estimated proportions of patients with self-reported changes, delays, or cancelations to cancer treatment or other cancer care due to the COVID-19 pandemic were calculated using sampling weights and associations with sociodemographic and other health-related variables were analyzed. RESULTS: In total, 574 (sample-weighted estimate of 2,867,326) adults reported requiring cancer treatment and/or other cancer care since the start of the COVID-19 pandemic. An estimated 32.1% reported any change, delay, or cancelation. On sample-weighted univariable analysis, patients who were younger, female, had one or fewer comorbidities, and uninsured were significantly more likely to report disruptions. On sample-weighted, multivariable analysis, patients who were younger and female remained significant predictors. Nearly 90% of patients included in the study reported virtual appointment use. Patients reporting disruptions were also significantly more likely to report feelings of anxiety. CONCLUSIONS: An estimated 1/3 of patients experienced disruptions to cancer care due to the COVID-19 pandemic. Patients experiencing disruptions in care were more likely to be female or younger which may reflect risk stratification strategies in the early stages of the pandemic, and also had higher rates of anxiety. The longitudinal impact of these disruptions on outcomes merits further study.

Trends in female representation in gastroenterology fellowships in the United States.

Background: Women have historically been underrepresented in gastroenterology (GI). Currently they compose only a small percentage of practicing GI physicians in the United States. Despite the rise in women graduating medical school, the percentage of current female GI fellows has remained low in recent years. In this study, we sought to examine the trends of female representation in GI over the past 10 years, to further elucidate the disparity, and to illustrate if any major changes have occurred. The findings were compared to those for other specialties to shed light on the relationship between them. Methods: This retrospective study used data on the gender of residents obtained through the Accreditation Council for Graduate Medical Education Data Resource Books from 2009-2019. Chi-square statistical testing was used to compare representation percentages across groups. Significance was determined at the P<0.05 level, while P<0.01 was also reported. Results: Over a 10-year period from 2009-2019, an average of 33.6% of GI fellowship positions were filled by women, an increase of only 3.3% since 2009. Chi-square analysis of proportions across groups demonstrated a significantly lower percentage of female representation in GI in comparison to other specialties. Conclusions: Despite an increase in the number of women entering and graduating from medical school within the last decade, the number of female gastroenterologists remains a poor reflection of it. GI continues to have a significantly lower female representation than other specialties over the last decade.

Demographic and Regional Trends in Stroke-Related Mortality in Young Adults in the United States, 1999 to 2019.

Background Despite improvements in the management and prevention of stroke, increasing hospitalizations for stroke and stagnant mortality rates have been described in young adults. However, there is a paucity of contemporary national mortality estimates in young adults. Methods and Results Trends in mortality related to stroke in young adults (aged 25-64 years) were assessed using the Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database. Age-adjusted mortality rates per 100 000 people with associated annual percentage change were calculated. Joinpoint regression was used to assess the trends in the overall sample and different demographic (sex, race and ethnicity, and age) and geographical (state, urban-rural, and regional) subgroups. Between 1999 and 2019, a total of 566 916 stroke-related deaths occurred among young adults. After the initial decline in mortality in the overall population, age-adjusted mortality rate increased from 2013 to 2019 with an associated annual percentage change of 1.5 (95% CI, 1.1-2.0). Mortality rates were higher in men versus women and in non-Hispanic Black people versus individuals of other races and ethnicities. Non-Hispanic American Indian or Alaskan Native people had a marked increase in stroke-related mortality (annual percentage change 2010-2019: 3.3). Furthermore, rural (nonmetropolitan) counties experienced the greatest increase in mortality (annual percentage change 2012-2019: 3.1) compared with urban (metropolitan) counties. Conclusions Following the initial decline in stroke-related mortality, young adults have experienced increasing mortality rates from 2013 to 2019, with considerable differences across demographic groups and regions.

Assessing Vasectomy-Related Information on YouTube: An Analysis of the Quality, Understandability, and Actionability of Information.

This study aims to critically appraise the quality of vasectomy-related health information currently available on YouTube to better address patient information needs moving forward. A YouTube search was performed using the keyword "vasectomy." The first 100 videos were assessed, with irrelevant and duplicate videos excluded. Two independent reviewers evaluated the remaining videos using the DISCERN instrument for evaluating the quality of information and the Patient Education Materials Assessment Tool for Audiovisual materials (PEMAT-A/V) for assessing the understandability and actionability of materials. Source characteristics and markers of bias and misinformation were also collected. Seventy-eight videos were included in the study, with a mean duration of 6.6 minutes and mean of 216,672 views. The median DISCERN score was poor at 28 (IQR 22-33) out of a possible 80 with mean PEMAT-AV Understandability and Actionability scores of 67.6% (±16.7%) and 33.8% (±36.2%), respectively. A medical doctor was present in 61 (78.2%) of the videos, of which 53 (86.9%) were urologists and 38 (62.2%) promoted their personal practice or institution. False statements regarding vasectomy were made in 14 (17.9%) videos. Notably, no significant difference was noted in quality, understandability, or actionability of videos created by those with personal promotion to those without. The quality of information regarding vasectomy on YouTube is poor and reaches a wide audience. Continued appraisal and creation of YouTube videos that contain quality, understandable and actionable information by urologists is necessary to ensure patients are well-informed.

The Sun Is Still Shining: Nature of Industry Payments to Transplant Surgeons From 2014 to 2019.

Background: Established in 2013, the Open Payments Program (OPP) mandated that medical device and pharmaceutical manufacturers submit record of any financial incentive given to physicians to the Centers for Medicare and Medicaid Services, which is in turn made publicly available. This study aims to characterize these payments to transplant surgeons over the first 6 y of OPP data. Methods: The study sample included all physicians who received at least one nonresearch payment as transplant surgeons to the OPP. To capture transplant surgeons who may be listed under their pipeline specialty, the American Society of Transplant Surgeons member directory as of January 2021 was queried. Payments were analyzed temporally, geographically, and by payment type, physician, and industry payer. Results: In total, payments totaling $15 661 536 were made to 1335 transplant surgeons over the study period. The mean payment was $436.90 (SD, $1760), and the median payment was $52.94 (interquartile range, $18.29-$159.80). The top contributing companies were Intuitive Surgical, Inc.; Gilead Sciences, Inc.; and Novartis Pharmaceuticals. Only 5.3% ($827 236) was paid toward faculty or as a speaker for a nonaccredited and noncertified continuing education program and honorarium. Educational payments came in at $1 233 141 (7.9%) over the study period. $13 750 828.60 (87.8%) of the payments were for other categories (consulting fees, food and beverages, etc). Organ transplant and procurement region 7 and 8 transplant surgeons received the highest median payments during the study period. Conclusions: This study is the first to characterize the payments made to transplant surgeons since the passage of the Sunshine Act. Further studies are needed to understand and interpret the relationship between industry and transplant surgeons, as the payments may or may not translate to influence in medical decisions or use of medical devices.

Global Trends in Incidence and Burden of Urolithiasis from 1990 to 2019: An Analysis of Global Burden of Disease Study Data.

BACKGROUND: Urolithiasis is among the most common urologic diagnoses globally, with substantial burden and cost on healthcare systems worldwide. Increasing evidence links urolithiasis with an array of risk factors, including diet and lifestyle trends, noncommunicable diseases such as diabetes and obesity, and global warming. OBJECTIVE: To examine geographic, temporal, and sociodemographic patterns to better understand global disease burden of urolithiasis. DESIGN SETTING AND PARTICIPANTS: We extracted data on age-standardized incidence rate (ASIR), deaths, and disability-adjusted life years (DALYs) attributed to urolithiasis for 21 regions, including 204 countries, for 1990-2019 from the Global Burden of Disease (GBD) study. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Data were analyzed at the global, regional, and country levels, as well as stratified by the Socio-Demographic Index. The average annual percentage change (AAPC) was calculated to measure temporal trends across groups. RESULTS AND LIMITATIONS: Globally, total cases, DALYs, and deaths attributed to urolithiasis increased over the study period, while the age-standardized rates of these measures decreased. The age-standardized incidence of urolithiasis decreased from 1696.2 (95% confidence interval [CI] 1358.1-2078.1) cases per 100 000 population in 1990 to 1394.0 (95% CI, 1126.4-1688.2) cases per 100 000 population in 2019, with an AAPC of -0.7 (95% CI [-0.8, -0.6]). Of the GBD regions, Eastern Europe demonstrated a consistently higher ASIR of urolithiasis than all other regions, while the Caribbean had the highest AAPC. This study is limited by the available national and regional data, as described in the original GBD study. CONCLUSIONS: Worldwide, total cases, DALYs, and deaths attributed to urolithiasis have increased since 1990, while age-standardized rates have decreased, with demonstrated regional and sociodemographic variation. Multifaceted strategies to address urolithiasis prevention and treatment are necessary. PATIENT SUMMARY: In this study, we looked at trends in the global burden of stone disease using data from 204 countries from 1990 to 2019. We found that the overall burden has increased, but it varies by age, sociodemographic variables, and geographic region. We conclude that we need adaptable policies that suit the specific needs of the country to address this burden.

Underrepresented minority representation trends in gynecologic oncology fellowships in the United States.

OBJECTIVE: To evaluate representation trends of historically underrepresented minority (URM) groups in gynecologic oncology fellowships in the United States using a nationwide database collected by the Accreditation Council for Graduate Medical Education (ACGME). METHODS: Data on self-reported ethnicity/race of filled residency positions was collected from ACGME Database Books across three academic years from 2016 to 2019. Primary chi-square analysis compared URM representation in gynecologic oncology to obstetrics and gynecology, other surgical specialties, and other medical specialties. Secondary analysis examined representation of two URM subgroups: 1) Asian/Pacific Islander, and 2) Hispanic, Black, Native American, Other (HBNO), across specialty groups. RESULTS: A total of 528 gynecologic oncology positions, 12,559 obstetrics and gynecology positions, 52,733 other surgical positions, and 240,690 other medical positions from ACGME accredited medical specialties were included in analysis. Primary comparative analysis showed a statistically significant lower proportion (P < 0.05) of URM trainees in gynecologic oncology in comparison to each of obstetrics and gynecology, other surgical fields, and other medical fields. Secondary analysis also demonstrated a significantly lower proportion (P < 0.05) of HBNO physicians in gynecologic oncology in comparison to obstetrics and gynecology, as well as all other medical and surgical specialties. CONCLUSIONS: This study illustrates the disparities in URM representation, especially those who identify as HBNO, in gynecologic oncology fellowship training in comparison to obstetrics and gynecology as well as other medical and surgical fields. Improvements to the current recruitment and selection practices in gynecologic oncology fellowships in the United States are necessary in order to ensure a diverse and representative workforce.