Renal & Urology News - Sept-Oct 2019 Edition

SE P T E MBE R /O C T OBE R 2019

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VOL UME 18, IS SUE NUMBER 5

Bone Complications Common in CRPC Study finds a 40% cumulative incidence rate

BY JOHN SCHIESZER MEN WITH PROSTATE cancer have a 40% cumulative incidence of first skeletal-related events (SREs) following development of castration-resistant disease, according to investigators who report that they have conducted the first large observational study to estimate SRE rates in this patient population.

The study, led by Alison Tse Kawai, ScD, of RTI Health Solutions in Waltham, Massachusetts, included 2234 men with castration-­resistant prostate cancer (CRPC) in the ­Sur­veil­lance, Epidemiology, and End Results-

Medicare database. The study population had a mean follow-up period of 10.6 months, during which 896 men (40%) experienced first SREs, with 74% of SREs occurring within 12 months after cohort entry. First SREs occurred more commonly among whites than blacks.

Use of a bone-targeted agent (BTA) was associated with a decreased incidence of first SREs, which included fractures, bone surgery, radiation therapy to bone, or spinal cord compression.

The SRE incidence rate before any BTA use was 4.16 per 100 personmonths. The rate declined to 3.60 per

RP Caseload Predicts Survival MEN WHO UNDERGO radical prostatectomy (RP) for localized prostate cancer (PCa) live longer after surgery if they have the procedure at facilities with a high annual PCa caseload, both in terms of overall encounters and the number of RPs performed, according to a new study.

Facility caseload as measured by all PCa encounters, however, is a better

Men live longer when the surgery is done at high-volume facilities, a recent study finds.

predictor of survival than the number of RPs performed, investigators reported in Cancer.

Using the National Cancer Database, a team led by Sarmad Sadeghi, MD, PhD, of the Norris Comprehensive Cancer Center at the University of Southern California in Los Angeles, examined survival outcomes among 488,389 men who underwent RP in the United States as they relate to facility annual caseload (FAC) for all PCa encounters and facility annual surgical caseload (FASC) for RP cases.

The investigators classified facilities into 4 volume groups (VGs) based on caseload: less than 50th percentile (VG1); 50th to 74th percentile (VG2); continued on page 7

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ADT DURATION AND SREs In a study of men with metastatic castration-resistant prostate cancer, the incidence rate of first skeletal-related events (SREs) per 100 person-months decreased with increasing duration of androgen deprivation therapy (ADT) prior to study entry.

5 4

4.85% 4.10%

3

3.32%

3.20%

3.11%

>2 – 3 years

>3 – 5 years

>5 years

2 1 0

0 –1 year

>1 – 2 years

Duration of ADT Source: Kawai AT, Martinez D, Saltus CW, et al. Incidence of skeletal-related events in patients with castration-resistant prostate cancer: An observational retrospective cohort study in the US. Prostate Cancer. 2019;2019:5971615.

100 person-months after any BTA use.

“A decrease in incidence of SREs after starting BTA is suggested, but the magnitude of the effect may be confounded by indication and other factors such as age and prior SRE,” the authors wrote in Prostate Cancer.

Marital Status Affects mRCC Therapy Odds

BY JODY A. CHARNOW UNMARRIED PATIENTS are less likely to undergo treatment for metastatic renal cell carcinoma (mRCC) compared with their married counterparts, according to a new study.

Among men, but not women, unmarried status, compared with being married, is associated with an increased risk of cancer-specific mortality (CSM).

Investigators led by Giuseppe Rosiello, MD, of IRCCS San Raffaele Scientific Institute in Milan, Italy, examined rates of cytoreductive nephrectomy, metastasectomy, and systemic therapy use according to marital status among 6975 patients with clear cell mRCC (2169 women and 4806 men) within the Surveillance, Epidemiology, and End Results database. Of these, 1018 women (46.9%) and 1450 men (30.2%) were unmarried.

Compared with married men, unmarried men had significant 46%, 30%, and 39% lower odds of receiving continued on page 7

The study included men aged 65 years and older (mean age 76.6 years) ­diagnosed from 2000 to 2011. Inclusion criteria included absence of a prior malignancy (other than non-melanoma skin cancer) and intervention with continued on page 7

IN THIS ISSUE 4

Nivolumab offers long-term survival in advanced mRCC

8 Certain urinary bacteria may indicate bladder cancer

13 Metastasis site in advanced PCa predicts death risk

14

Docetaxel after PCa radiation therapy not beneficial

16

Statin use may attenuate prostate growth

18 Patients’ time on mRCC drugs found to predict survival 18 Post-RP complications more likely in patients with CKD Study links erectile dysfunction in pro football players to concussions PAGE 11

2 Renal & Urology News

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Low Muscle Strength Is An Ominous Sign in KTRs LOW MUSCLE STRENGTH is common among kidney transplant recipients (KTRs), and it is independently associated with poor outcomes, according to investigators.

In a prospective longitudinal study that enrolled 128 KTRs at least 1 year after transplantation, Winnie Chan, PhD,

University Hospitals Birmingham NHS Foundations Trust in the United Kingdom, and collaborators found that 82 patients (64%) had low muscle strength, and this was significantly associated with a nearly 2.5-fold increased risk of a composite end point of mortality and hospitalization compared with

normal muscle strength after adjusting for multiple potential confounders. Low muscle strength also was significantly associated w ith d iminished physical- and mental-related quality of life (QoL). The study found no significant association between the composite outcome and low muscle mass,

s­arcopenia, and obesity. Low muscle mass and sarcopenia, but not obesity, were significantly associated only with inferior physical health-related QoL. “This study presents the first compelling independent association between decreased muscle strength and adverse clinical outcomes in kidney

www.renalandurologynews.com SEPTEMBER/OCTOBER 2019

t­ ransplantation,” Dr Chan’s team wrote in a paper published in the Journal of Renal Nutrition. “Muscle strength assessment in routine clinical practice may serve as a novel tool for improving risk stratification in prevalent KTRs, setting the scene for future interventional research and therapeutic targets.”

The investigators said their findings imply causal relationships between muscle strength and clinical outcomes

and health-related QoL, “justifying interventional strategies to improve muscle strength in KTRs.” Dr Chan and her colleagues identified increased muscle mass, higher levels of hemoglobin and vitamin D, higher protein intake, and increased physical activity as modifiable independent predictors of increased muscle strength.

The mean age of the 138 patients was 49 years, but it was significantly higher

among those with low compared with normal muscle strength (52 vs 45 years).

The study population was 56% men and 78% white. The patients had a median time post-transplantation of 5 years.

The investigators defined low muscle strength using gender-specific handgrip strength cutoffs derived from a reference population—less than 30 kg for men and less than 20 kg for women. The study had a median follow-up ­duration

Renal & Urology News 3

of 64 months. The investigators evaluated health-related QoL using the Medical Outcomes Study Short Form36 questionnaire.

The authors acknowledged that the study’s small number of patients selected from a single center is a limitation. They also pointed out that “the inherent observational nature of the study precludes the establishment of causality between muscle strength and clinical outcomes.” ■

4 Renal & Urology News

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Nivolumab Found to Offer Long-Term Survival in RCC RESEARCHERS WHO conducted a secondary analysis of a phase 1 trial of nivolumab, a programmed cell death 1 inhibitor, found that treatment with the drug is associated with long-term survival in a subset of heavily pretreated patients with advanced renal cell carcinoma (RCC) and other malignancies.

“The results of this study suggest that survival benefits reported in the more limited follow-up of recent nivolumab randomized clinical trials may persist for prolonged periods in some patients, extending to at least 5 years,” a team led by Suzanne L. Topalian, MD, of the Sidney Kimmel Comprehensive

Cancer Center, Johns Hopkins Bloomberg-Kimmel Institute for Cancer Immunotherapy in Baltimore, reported in JAMA Oncology.

The trial included 270 patients with advanced RCC (34 patients), melanoma (107 patients), and non-small cell lung cancer (NSCLC) (129 patients)

recruited from 13 US medical centers.

Patients received nivolumab (0.1–10.0 mg/kg) every 2 weeks in 8-week cycles for up to 96 weeks, unless they experienced progressive disease, achieved a complete response, had unacceptable toxic effects, or withdrew consent.

Most patients were heavily pretreated, with 71.9% of patients having received 2 or more systemic cancer therapies, the investigators said.

The estimated 5-year overall survival rates were 27.7%, 34.2%, and 15.6% among patients with RCC, melanoma, and NSCLC, respectively, Dr Topalian and her collaborators reported. These rates exceed survival rates expected from conventional second-line or thirdline therapies available for patients at the time the trial was conducted, the investigators stated.

Patients with advanced RCC had an estimated overall survival rate of 27.7%, study finds.

On multivariable analysis, the presence of liver metastases and bone metastases each was independently associated with 69% decreased odds of survival at 5 years, according to investigators. An Eastern Cooperative Oncology Group performance status of 0 was independently associated with 2.7-fold increased odds of 5-year survival.

Patients who experienced treatmentrelated adverse events (TRAEs) had significantly longer overall survival (OS) than those who did not. Patients who experienced TRAEs of any grade or grade 3 or higher had median OS of 19.8 and 20.3 months, respectively, whereas patients who did not experienced TRAEs had a median OS of 5.8 months, the investigators reported.

“Characterizing factors associated with long-term survival may inform treatment approaches for individual patients and strategies for future clinical trial development in immune-oncology,” the authors concluded.

Study limitations included the post hoc nature of some of the analyses and the administration of different doses of nivolumab to different cohorts of patients, Dr Topalian’s team pointed out. In addition, the study population included a relatively small number of patients with RCC compared with melanoma or NSCLC. ■

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Contents

SEPTEMBER/OCTOBER 2019

SEPTEMBER/OCTOBER 2019

Urology 11

ONLINE

14

this month at renalandurologynews.com 16

Clinical Quiz Test your knowledge by taking our latest quiz at renalandurologynews.com/ run-quiz

18

HIPAA Compliance Read timely articles on various issues related to keeping protected health information secure.

Drug Information Search a comprehensive drug database for prescribing and other information on more than 4000 drugs.

Statins May Ease Prostate Growth In a study of men in the REDUCE trial, dutasteride recipients who used statins experienced a smaller increase in estimated mean prostate volume compared with nonusers.

Time on mRCC Drug Predicts Survival Patients with metastatic renal cell carcinoma who, within the first 2 lines of drug therapy, remain on a drug for 3 months or more have longer overall survival than those who do not.

10

High Red Meat Intake Increases CKD Risk Highest vs lowest quartile of total red meat consumption ups odds of chronic disease disease by 73%, according to researchers.

12

ESRD Risk Decreased With Intensive BP Lowering Intensive blood pressure control is associated with an 18% reduced risk of end-stage renal disease compared with usual control in patients aged 40 years or older.

16

Study: Kidney Tx Access Less Likely With For-Profit Dialysis Patients who receive dialysis at for-profit rather than nonprofit facilities are less likely to be placed on a kidney transplant waiting list.

News Coverage Visit our website for daily reports on the latest developments in clinical research.

Docetaxel After PCa Radiotherapy Not Beneficial Adjuvant docetaxel with ADT following radiation therapy for intermediate- or highrisk prostate cancer does not decrease the likelihood of biochemical progression.

Nephrology

Job Board Be sure to check our latest listings for professional openings across the United States.

Erectile Dysfunction in Former NFL Football Players Tied to Concussions Highest vs lowest concussion symptom score is associated with 1.8-fold increased odds of ED.

18

CKD Found to Raise Risk of Post-RP Complications Patients with chronic kidney disease (CKD) have a 36% increased risk of postoperative complications following radical prostatectomy compared with those who do not have CKD.

This study’s data suggest that concussion symptoms experienced during playing years may place NFL players at risk of low testosterone levels and ED decades later.

See our story on page 11

■

Renal & Urology News 5

VOLUME 18, ISSUE NUMBER 5

CALENDAR 2019 American Society of Nephrology Kidney Week 2019 Washington, DC November 5–10 Society of Urologic Oncology 20th Annual Meeting Washington, DC December 4–6 2020 Annual Dialysis Conference Kansas City February 8–11 Genitourinary Cancers Symposium San Francisco February 14–16 European Association of Urology Annual Congress 2020 Amsterdam, The Netherlands March 20–24 National Kidney Foundation 2020 Spring Clinical Meetings New Orleans March 25–29 American Urological Association Annual Meeting Washington, DC May 15–18

19

Departments 6

From the Medical Director A new national kidney initiative offers promise and unknowns

8

News in Brief FDA approves apalutamide for treating mCSPC

19

Ethical Issues in Medicine The positive effects of expressing gratitude

20

Practice Management Risk analyses are needed to decide how best to allocate funds for cybersecurity

6 Renal & Urology News

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FROM THE MEDICAL DIRECTOR EDITORIAL ADVISORY BOARD

Kidney Health Initiative Offers Promise, Unknowns

M

any nephrologists and other healthcare providers (HCPs) have enthusiastically embraced the July 10 presidential executive order titled, “Advancing American Kidney Health Initiative.”

The 3 main components include a reduction in the end-stage renal disease (ESRD) rate by 25% by 2030; a substantial increase in home dialysis so that 80% of new ESRD patients can receive dialysis treatment at home; and a doubling of the number of kidneys available for transplantation by 2030. The US Secretary of Health and Human Services has stated, “Ideally, we’d want to offer dialysis providers incentives to get patients off dialysis through transplants.” Some HCPs appear bewildered by the unprecedented extent of the overhaul, including the government’s plans for mandatory implementation.

The initiative includes some novel measures, such as the mandatory “ESRD Treatment Choices” (ETC) model, which empowers nephrologists to take the lead in care coordination. The goal is to adjust Medicare’s fee-for-service payments and provide financial incentives to increase rates of home dialysis and kidney transplantation. The plan calls for approximately 50% of the nation’s dialysis facilities and “managing clinicians” to be selected randomly on the basis of their “Hospital Referral Regions” (HRRs). The argument in support of the mandatory participation is that if it were voluntary, only a small sample of providers with higher rates of home dialysis or kidney transplants relative to national benchmarks would participate. Thus, out of some 300 HRRs in the nation, about 150 of them, including their dialysis clinics and affiliated nephrologists, will be randomly selected to be part of the ETC model. This is expected to be implemented as early as January 2020.

The dialysis industry is expected to align with the plans and suggested timeline. For the approximately 10,000 practicing nephrologists in the United States, this venturing into the unknown may cause some level of anxiety. Would the principles of public health and science justify this new practice pattern and mandatory randomization of doctors to expand home dialysis and kidney transplantation? If the planned inclusion of half of all nephrologists is inevitable, should those not randomly assigned into the ETC be given a chance to volunteer? What about the primary and secondary prevention of CKD, such as managing CKD risk factors and slowing disease progression rate, respectively?

These and other questions are expected to be answered throughout 2020 and beyond, but for now, the HCPs and patients that make up the kidney disease community are venturing into uncharted territory.

All of us must team up to make great things come out of this unprecedented time.

Medical Director, Urology

Medical Director, Nephrology

Robert G. Uzzo, MD, FACS G. Willing “Wing” Pepper Chair in Cancer Research Professor and Chairman Department of Surgery Fox Chase Cancer Center Temple University School of Medicine Philadelphia

Kamyar Kalantar-Zadeh, MD, PhD, MPH Professor & Chief Division of Nephrology & Hypertension UC Irvine School of Medicine Orange, CA

Nephrologists

Urologists

Anthony J. Bleyer, MD, MS Professor of Internal Medicine/Nephrology Wake Forest University School of Medicine Winston-Salem, NC

Christopher S. Cooper, MD Director, Pediatric Urology Children’s Hospital of Iowa Iowa City

David S. Goldfarb, MD Professor, Department of Medicine Clinical Chief New York University Langone Medical Center Chief of Nephrology NY Harbor VA Medical Center

R. John Honey, MD Head, Division of Urology, Endourology/Kidney Stone Diseases St. Michael’s Hospital University of Toronto Stanton Honig, MD Department of Urology Yale University School of Medicine New Haven, CT J. Stephen Jones, MD Chief Executive Officer Inova Health System Falls Church, VA Professor and Horvitz/Miller Distinguished Chair in Urologic Oncology (ret.)

Cleveland Clinic Lerner College of Medicine Cleveland Jaime Landman, MD Professor of Urology and Radiology Chairman, Department of Urology UC Irvine School of Medicine Orange, CA

Csaba P. Kovesdy, MD Chief of Nephrology Memphis VA Medical Center Fred Hatch Professor of Medicine University of Tennessee Health Science Center Memphis Edgar V. Lerma, MD Clinical Associate Professor of Medicine Section of Nephrology Department of Medicine University of Illinois at Chicago College of Medicine Chicago Allen Nissenson, MD Emeritus Professor of Medicine The David Geffen School of Medicine at UCLA Chief Medical Officer, DaVita Inc. Denver

James M. McKiernan, MD John K. Lattimer Professor of Urology Chair, Department of Urology Director, Urologic Oncology Columbia University College of Physicians and Surgeons New York

Rulan Parekh, MD, MS Associate Professor of Pediatrics and Medicine University of Toronto Robert Provenzano, MD Chief, Section of Nephrology St. John Hospital and Medical Center Detroit

Kenneth Pace, MD, MSc Assistant Professor, Division of Urology St. Michael’s Hospital University of Toronto Vancouver, Canada

Robert S. Rigolosi, MD Director, Regional Hemodialysis Center Holy Name Hospital Teaneck, NJ

Renal & Urology News Staff Editor

Jody A. Charnow

Web editor

Natasha Persaud

Production editor Group creative director, medical communications Senior production manager Vice president, sales operations and production Director of audience insights National accounts manager Associate director, editorial services

Kim Daigneau Jennifer Dvoretz Krassi Varbanov Louise Morrin Boyle Paul Silver William Canning Lauren Burke

Vice president, content, medical communications Kathleen Walsh Tulley

Kam Kalantar-Zadeh, MD, PhD, MPH Professor & Chief, Division of Nephrology & Hypertension UC Irvine School of Medicine Orange, California Twitter/Facebook: @KamKalantar

General manager, medical communications President, medical communications Chairman & CEO, Haymarket Media Inc.

James Burke, RPh Michael Graziani Lee Maniscalco

Renal & Urology News (ISSN 1550-9478) Volume 18, Number 5. Published bimonthly by Haymarket Media, Inc., 275 7th Avenue, 10th Floor, New York, NY 10001. For Advertising Sales & Editorial, call (646) 638-6000 (M–F, 9am–5pm, ET). Postmaster: Send address changes to Renal & Urology News, c/o Direct Medical Data, 10255 W. Higgins Rd., Suite 280, Rosemont, IL 60018.

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Marital status continued from page 1

c­ytoreductive nephrectomy, metastasectomy, and systemic therapy, respectively, Dr Rosiello and his collaborators reported in International Urology and Nephrology. Unmarried women had significant 37% and 20% decreased odds of receiving cytoreductive nephrectomy and systemic therapy, respectively, compared with married women. The investigators found no significant difference between married and unmarried women with regard to undergoing metastasectomy.

Cancer-specific mortality Among the men, the 5-year CSM rate was significantly higher among unmarried men compared with married men (77.4% vs 70.5%). Among women, unmarried and married women did not differ significantly with respect to 5-year CSM rate (76.6 vs 74.5%, respectively). In multivariable competing-risk regression analyses, unmarried men

CRPC complications continued from page 1

s­ urgical or medical castration with subsequent second-line systemic therapy.

Racial differences Of the 2234 men in the study, 56% had a history of SREs prior to any use of BTAs (alendronate, denosumab, ibandronate, pamidronate, risedronate, or zoledronic acid). The incidence rate of SRE was higher among those with a history of SREs compared with no such history (4.20 vs 3.33 per 100 person-months). In addition, the incidence rate of first SRE was significantly higher for whites than blacks (3.97 vs 2.58 per 100 person-months), a finding that the authors hypothesize may be due to higher bone density among black men.

David Y. T. Chen, MD, Director of the Urologic Oncology Fellowship Program at Fox Chase Cancer Center and Professor of Surgical Oncology at

RP caseload continued from page 1

75th to 89th percentile (VG3); and 90th percentile or higher (VG4). With regard to FAC, VG1, VG2, VG3, and VG4 facilities had less than 63, 63 to 115, 116 to 207, and more than 207 annual PCa encounters overall, respectively. For FASC, the annual numbers of RP cases were less than 22, 22 to 53,

had a significant 15% increased risk of CSM compared with married men, but unmarried and married women had similar CSM risk.

Less inclined to accept therapy?

“In clinical practice, we have the perception that patients who are alone or without a spouse appear to be less inclined to accept therapy as well as to follow medical recommendations,” Dr Rosiello said. “It may be related to the absence of a person who motivates or gives them a reason ‘to still be alive.’”

He added that this behavior is more pronounced among patients who already have a very short life expectancy, such as those with mRCC, whose life expectancy is approximately 20 months.

“For this reason, these patients are less likely to accept therapy as well as to undergo medical examination,” Dr Rosiello said.

Furthermore, among men, who already have a shorter life expectancy

Renal & Urology News 7

Unmarried vs Married mRCC Patients Shown here are the decreased odds of receiving various treatments among unmarried men and women compared with their married counterparts. Unlike unmarried vs married men, unmarried women did not differ from married women in the odds of receiving metastasectomy.

46%

39% 30%

■ Cytoreductive nephrectomy ■ Metastasectomy

37% 20%

■ Systemic therapy

Unmarried men (vs married men)

Unmarried women (vs married women)

Source: Rosiello G, Knipper S, Palumbo C, et al. Unmarried status is a barrier for access to treatment in patients with metastatic renal cell carcinoma [published online August 29, 2019]. Int Urol Nephrol. doi: 10.1007/s11255-019-02266-3

than women with mRCC, unmarried status also is significantly associated with worse mortality. “This may be related to the stronger role of women to take care of their husbands, more than what husbands do for their wives,” Dr Rosiello explained, adding: “We are glad to see that our data

support what we see in daily practice, hoping that our findings will sensitize the medical community about added vulnerability of unmarried patients and possibly greater vulnerability of unmarried males,” Dr Rosiello said.

Men might benefit from closer followup, he said. ■

associated with pain, reduced quality of life, and increased mortality.

major limitation. “It is very probable that a longer follow-up would result in a higher event rate. The finding that the majority of events occur within a year is probably a bias of the mean follow-up duration being 10.6 months,” Dr Chen told Renal & Urology News.

When metastatic CRPC develops, he said, more intensive surveillance for SREs is warranted. These events are

Need for bone targeting agents “We should be putting people on these bone targeting agents and this [study] supports what we should be doing in clinical practice,” said Nancy Dawson, MD, Professor of Oncology and Director of the Genito­urinary Medical Oncology Program at Georgetown Lombardi Comprehensive Cancer Center in Washington DC. “There have been many efforts focused on decreasing these [skeletal] events,” said Cathy Handy Marshall, MD, MPH, Assistant Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medicine in Baltimore. “Based on large phase 3 studies, [National Comprehensive Care Network (NCCN)] guidelines recommend using bone-targeted agents for men with metastatic CRPC and bone metastasis in order to decrease the rate of SREs. It is unclear why almost half

of the patients in this study were not on bone-targeted agents, but that should be considered when thinking about these results and highlights an opportunity to improve the care of these patients.”

“This particular study and other previous publications on this subject are important in providing information that ADT in CRPC patients as second-line therapy leads to side effects, including SREs, increased fat mass, metabolic syndrome, memory and cognitive dysfunction, which greatly affects quality of life of these patients,” said Sanjay Gupta, PhD, MS, Carter Kissell Associate Professor and Research Director at Case Western Reserve University School of Medicine in Cleveland. “Adverse events and side effects due to prolonged ADT use affect long-term quality of life of these patients, which can lead to higher morbidity and mortality rates. In fact, the patient death is not because of prostate cancer, but as a consequence of prostate cancer.” ■

54 to 111, and more than 111, respectively, Dr Sadeghi’s team reported.

Based on FAC, median overall survival (OS) was 13.2 months longer among men who underwent RP in VG4 vs VG1 facilities. For FASC, median OS was 11.3 months longer for those who underwent RP at VG4 vs VG1 facilities. Compared with VG4 patients (reference), VG1 patients had a significant 30% and 25% increased risk of

death by FAC and FASC, respectively, on multivariable analysis.

“The results of this analysis reveal an OS benefit associated with the annual caseload of the facility where radical prostatectomy was performed,” Dr Sadeghi and his collaborators wrote.

“This absolute all-cause mortality risk difference was up to 30% when the 2 ends of the caseload spectrum were compared.”

They concluded: “These data support the regionalization of radical prostatectomy in an effort to improve oncologic outcomes for this patient population.”

Dr Sadeghi’s team acknowledged that their study was limited because it was a retrospective analysis of a registry data set. “The variables are not comprehensive, may have missing values, and do not offer a complete picture of the care provided.” ■

Temple University School of Medicine in Philadelphia, said the study establishes an additional baseline point of reference for defining the incidence of bone complications associated with advanced prostate cancer. The study’s short follow-up period, however, is a

First skeletal-related events were less likely to occur among black men than white men.

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News in Brief

Please visit us at www.renalandurologynews.com for the latest news updates from the fields of urology and nephrology

Short Takes Rural PCa Patients Less Likely to Be Treated

Zhoupu Hospital, and colleagues

Men with prostate cancer (PCa) are

ciated with 2.4-fold increased odds of

less likely to receive treatment if

hypothyroidism in women. A separate

they live in a rural area, according

meta-analysis found that gout and

to study findings published in the

hyperuricemia were significantly as-

Journal of Urology.

sociated with 51% and 34% increased

found that gout was significantly asso-

In a study of 51,024 men diagnosed

odds of hypothyroidism and that gout

with localized or metastatic PCa in

was significantly associated with 25%

Pennsylvania from 2009 to 2015,

increased odds of hyperthyroidism.

Avinash Maganty, MD, and colleagues that patients with low-, intermediate-,

FDA Clears Darolutamide for Nonmetastatic CRPC

and high-risk disease who lived in rural

The FDA has approved darolutamide

areas were, respectively, 23%, 29%,

(Nubeqa), a nonsteroidal androgen

and 32% less likely than their urban

receptor inhibitor, for the treatment of

counterparts to undergo treatment, in

patients with nonmetastatic castration-

adjusted analyses.

resistant prostate cancer (nmCRPC).

at the University of Pittsburgh found

The agency based its approval

Gout May Increase Risk of Thyroid Disorders

on the phase 3 ARAMIS (Androgen

Gout may increase the risk of hypo-

Metastasis-free Survival) trial, in

and hyperthyroidism, according to

which 1509 men with nmCRPC

study findings published in Hormone

were randomly assigned to receive

and Metabolic Research.

darolutamide or placebo in addition to

­Receptor Antagonizing Agent for

In a cross-sectional study that includ-

androgen deprivation therapy (ADT).

ed 115 gout patients, 439 hyperuri-

The darolutamide arm had significantly

cemic patients, and 2254 individuals

prolonged metastasis-free survival

without gout or hyperuricemia, Jin-an

compared with placebo plus ADT (me-

Zhang, MD, of Shanghai University of

dian 40.4 vs 18.4 months), according

Medicine & Health Sciences Affiliated

to investigators.

BK Virus Infection and Transplant Outcomes BK virus infection in renal transplant recipients is associated with worse patient and graft survival, according to a new study. Shown here are the 5- and 10-year rates of these outcomes.

100 84%

92%

84%

80 60

85%

■ BKV infection ■ No-BKV infection

75%

71%

52% 33%

40 20 0

5-year 10-year Patient survival

5-year 10-year Graft survival

Source: Malik O, Saleh S, Suleiman B, et al. Prevalence, risk factors, freatment, and overall impact of BK viremia on kidney transplantation. Transplant Proc. 2019;51:1801-1809.

Certain Urinary Bacteria May Indicate Bladder Cancer U

rinary bacteria may be useful as a bladder cancer biomarker, researchers reported in the Journal of Medical Microbiology.

Hai Bi, MD, of Peking University Third Hospital in Beijing, China, and colleagues compared the bacteria in urine specimens from 29 bladder cancer patients and 26 control patients without cancer. All samples contained 5 genera—Streptococcus, Bifidobacterium, Lactobacillus, Veillonella, and Actinomyces—but the bladder cancer patients had a greater abundance of Actinomyces, in particular, A europaeus, whereas the other genera were enriched in the control group. “The higher abundance of A europaeus observed in bladder cancer patient samples also suggests that the strain may be indicative of bladder cancer,” the investigators concluded.

SWL, URS Offer Similar Stone-Free Rates in Kids S

hock wave lithotripsy (SWL) and ureteroscopy (URS) offer similar stone clearance rates in children, but SWL is associated with less morbidity, new data suggest.

In a study comparing 84 SWL and 175 URS procedures performed in pediatric patients from 2000 to 2017, Kathryn A. Marchetti, MD, of the University of Michigan in Ann Arbor, and colleagues found no significant difference between the procedures in the rates of complete stone clearance and residual stone fragments less than 4 mm (77% and 90.8%, respectively, after the final SWL procedure and 78.5% and 91.7%, respectively, for URS). Retreatment rates for both procedures also did not differ significantly (17.9% for SWL vs 18.9% for URS), Dr Marchetti’s team reported in the Journal of Pediatric Urology.

SWL, however, was associated with less morbidity than URS. Children who underwent SWL had lower rates of emergency room visits for urinary tract infection (0% vs 5.1%) and flank pain (3.6% vs 10.9%). SWL recipients also required fewer general anesthetics per treatment (1.2 vs 2.0), according to the investigators.

Apalutamide Receives FDA Approval for Treating mCSPC A

palutamide (Erleada) received FDA approval for treating metastatic castrationsensitive prostate cancer. The approval was based on findings from the phase 3 TITAN trial. In that trial, which included 1052 men with mCSPC, those who received apalutamide plus androgen deprivation therapy (ADT) had a significant 33% decreased risk of death and 52% decreased risk of radiographic progression or death compared with those who received placebo and ADT. After a median follow-up period of 22.7 months, the 2-year overall survival rates were 84% in the apalutamide arm compared with 78% for the placebo recipients.

In a press release from Janssen Pharmaceutical Companies of Johnson & Johnson, the makers of apalutamide, Kim Chi, MD, of BC Cancer and Vancouver Prostate Centre in Vancouver, British Columbia, and principal investigator on the TITAN trial stated, “Results from the TITAN study showed that, regardless of the extent of disease, patients with [mCSPC] have the potential to benefit from treatment with apalutamide in addition to ADT.”

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High Red Meat Intake Increases CKD Risk The highest vs lowest quartile of total red meat consumption was associated with 73% greater odds of CKD CHRONIC KIDNEY disease (CKD) is more likely to develop in individuals who have a high intake of total red and processed meat, according to investigators.

A study of 4881 participants in the Tehran Lipid and Glucose Study found that, compared with patients in the lowest quartile of total red meat consumption, those in the highest quartile had 73% increased odds of CKD, after adjusting for age, sex, smoking, diabetes, hypertension, and other potential confounders, Parvin Mirmiran, PhD, of the Shahid Beheshti University of Medical Sciences in Tehran, Iran, and colleagues reported in the Journal of Renal Nutrition. Patients in the highest quartile of processed red meat intake had significant 99% increased odds of CKD. The investigators found no significant association between consumption of unprocessed red meat and CKD risk.

Each 1 serving per day increase in total red meat and processed red meat was associated with significant 15% and 28% increased odds of CKD, respectively. In substitution analyses, replacing

Preeclampsia May Increase Risk of ESRD PREGNANT WOMEN with preeclampsia are at increased risk of endstage renal disease (ESRD), according to study findings published in PLoS One. Among 1,366,441 healthy pregnant women in Sweden during 1982 to 2012, 4.9% had preeclampsia, and ESRD developed in 410. The

Increased dietary acid load is one possible explanation for a link between high red meat intake and chronic kidney disease, according to investigators.

1 serving of total red meat and ­processed red meat with 1 serving of low-fat dairy, nuts, whole grains, and legumes was associated with a decreased risk of CKD, the investigators reported.

Study participants had a mean age of 40.1 years and normal kidney function at baseline; 47% were women. The investigators defined CKD as an estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m2 calculated

using the Modification of Diet in Renal Disease study equation.

The investigators offered some potential mechanisms by which dietary red meat could adversely impact renal function. Higher dietary intake of meat generally results in greater dietary acid load, which is associated with higher CKD risk, they noted. In addition, the high content of advanced glycation end products

in cooked red meat can have adverse effects on kidney function.

Regarding study limitations, Dr Mirmiran and colleagues noted that, like in most epidemiologic studies, their definition of CKD is based on a limited number of isolated creatinine measurements that were not repeated within 3 months to confirm a chronic reduction in eGFR. The new findings build upon previous investigations showing a link between meat consumption and CKD risk. For example, a study of 11,952 participants aged 44 to 66 years in the Atherosclerosis Risk in Communities study showed that the highest quintile of red meat intake was associated with a significant 19% increased risk of CKD compared with those in the first quintile, after adjusting for potential confounders, Bernhard Haring, MD, MPH, and colleagues reported in a 2017 article in the Journal of Renal Nutrition. The highest quintile of red and processed meat consumption was associated with a significant 23% increased risk. ■

PPIs Up Fracture Risk in HD Patients USE OF PROTON PUMP inhibitors (PPIs) by patients on hemodialysis (HD) puts them at increased risk of bone fractures, a new study suggests.

PPI users had a significant 35% increased risk for hip fractures and 22% increased risk for fractures other than those of the hip in multiple Cox models that considered the competitive risk of mortality, Maria Fusaro, MD, PhD, of the Institute of Clinical Physiology in Pisa and the University of Padua in Italy, and colleagues reported in the Journal of Bone and Mineral Research.

“Considering the major health and economic burden of bone fractures, it is of utmost importance to adopt strategies for bone fracture prevention in a fragile population such as hemodialysis patients,” the authors wrote.

The study included 27,097 HD patients in the Dialysis Outcomes and Practice Patterns Study. Of these, 13,283 (49%) were taking PPIs. Over a median follow-up period of 19 months, 528 patients experienced hip fractures, 1592 patients experienced bone fractures other than hip fractures, and 6249

patients died. The mortality rate was significantly higher in PPI users than nonusers (25.8% vs 20.4%), Dr Fusaro and colleagues reported.

In a previous study of HD patients in the US Renal Data System published in the Clinical Journal of the American Society of Nephrology, a team led by Chandan Vangala, MD, of the Baylor College of Medicine in Houston, found that PPI use in the 3 years preceding a hip fracture was associated with significant 19% increased odds of hip fracture in adjusted analyses. ■

ESRD rate was 12.35 per 100,000 group compared with 1.85 per 100,000 person-years in the nopreeclampsia group, Ali S. Khashan, PhD, of University College Cork in Ireland, and colleagues reported.

In adjusted analyses, women with preeclampsia had a significant 5-fold higher risk for ESRD than women who never had preeclampsia. ■

CKD Predicts Worse Outcomes in PAD CHRONIC KIDNEY disease (CKD) in patients with symptomatic peripheral artery disease (PAD) increases their risk of cardiovascular events, new study findings suggest.

In a study of 13,483 patients with symptomatic PAD, patients with CKD had a significant 45% higher risk of a

composite end point of cardiovascular death, myocardial infarction, or ischemic stroke than those without CKD in adjusted analyses, Charles W. Hopley, MD, of Dartmouth-Hitchcock in Hanover, New Hampshire, and colleagues reported in Vascular Medicine.

The investigators defined CKD as an

estimated glomerular filtration rate below 60 mL/min/1.73 m2.

Study patients were participants in the EUCLID (Examining Use of Ticagrelor in PAD) trial. Of the 13,483 patients, 3332 (25%) had CKD, including 237 with stage 4 or 5 disease. Patients had a median follow-up of about 30 months. ■

© RAFA ELIAS / GETTY IMAGES

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Elevated Uric Acid in PD Ups Mortality HIGH SERUM URIC acid is an independent risk factor for death in patients on peritoneal dialysis (PD), according to investigators.

Compared with serum uric acid levels in the third quintile (reference), levels in the fourth and fifth quintiles were significantly associated with a 1.3fold and nearly 1.5-fold increased risk of all-cause mortality, respectively, in a fully adjusted model, a team led by Jianghua Chen, MD, of the Zhejiang University in Hangzhou, China, reported in Nutrition & Metabolism.

The association between high uric acid and all-cause mortality was more pronounced in men than women, patients with relatively lower serum albumin levels and body mass index, and patients without diabetes mellitus. The investigators found no significant association between uric acid levels and cardiovascular mortality.

“Our results provide evidence regarding the treatment of hyperuricemia in the PD population,” the

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Erectile Dysfunction in Former NFL Football Players Tied to Concussions Study also reveals association between head injuries and low testosterone CONCUSSION SYMPTOMS at the time of injury among former professional football players may increase the risk of low testosterone levels and erectile dysfunction (ED), a study of former professional football players suggests.

The study included 3409 participants in the Football Players’ Health Study who played for the National Football League (NFL) after 1960. The prevalence of indicators of low testosterone and ED (a self-reported history of a medical provider’s recommendation or prescription for medications to treat these conditions) was 18.3% and 22.7%, respectively. Compared with players in the first quartile of concussion symptom score (reference), those in the second, third, and fourth quartiles had significant 1.3-, 1.6-, and 2.4-fold increased odds of low testosterone levels, respectively, and 1.3-, 1.5-, and 1.8-fold increased odds of ED, respectively, in fully adjusted models.

“This study’s data suggest that concussion symptoms experienced during playing years may place NFL players at risk of low testosterone levels and ED decades later,” a team led by Rachel Grashow, PhD, MS, of the Harvard

T.H. Chan School of Public Health in Boston, concluded in a paper published in JAMA Neurology. “These findings have implications for civilians and veterans who have experienced head injury, as well as for participants in combative and contact sports (eg, mixed martial arts, hockey, boxing, and soccer) who may experience repeated head trauma.”

For the study, participants were asked, “While playing or practicing football, did you experience a blow to the head, neck, or upper body followed by any of the

The link between concussions and ED could be due to trauma-induced pituitary damage.

following: headaches, nausea, dizziness, loss of consciousness, memory problems, disorientation, confusion, seizure, visual problems, or feeling unsteady on your feet?” Response options were: none, once, 2 to 5 times, 6 to 10 times, or 11 times or more for each symptom. Respondents also were asked if a medical provider ever recommended or prescribed medication for low testosterone or ED. An affirmative answer served as an indicator of a history of low testosterone or ED, respectively. Investigators created concussion symptom scores by coding concussion symptom frequency responses of none, once, 2 to 5 times, 6 to 10 times, or 11 or more times as 0, 1, 3.5, 8, and 13, respectively, and then adding the numbers.

Trauma-induced pituitary damage is among the hypothesized mechanisms that could explain the link between concussions and low testosterone and ED. The authors explained that the pituitary gland is perfused by long portal vessels branching off the internal carotid artery and, therefore, is susceptible to mechanical trauma, low cerebral blood flow, and increased intracranial pressure associated with head injury. ■

authors concluded.

The observational study included 9405 PD patients from the Zhejiang Renal Data system. Patients had a mean age of 52 years and a mean serum uric acid level of 7.07 mg/ dL at baseline. During a follow-up of 29.4 months, 1226 patients (13%) died. Of these, 515 (5.5%) died from cardiovascular causes.

The first, second, third, fourth, and fifth quintiles of serum uric acid were as follows: less than 6.06, 6.06 to 6.67, 6.68 to 7.27, 7.28 to 8.03, and 8.04 mg/dL or higher, respectively.

Patients in the third quintile had the highest overall and cardiovascular survival rates.

In a previous study, which was published in Kidney & Blood Pressure © CALLISTA IMAGES / GETTY IMAGES

Research in 2013, investigators found that PD patients in the highest quartile of serum uric acid had a nearly 3-fold increased risk of allcause mortality compared with those in the second and third quartiles. ■

Midlife to Late-Life HTN May Predict Dementia DEMENTIA MAY BE more likely to develop in individuals who have sustained hypertension in midlife to late life, according to a new study.

An analysis of 4761 participants in the Atherosclerosis Risk in Communities (ARIC) prospective population-based cohort study showed that individuals who had sustained midlife and late-life hypertension had a significant 49% increased risk of subsequent dementia compared with those who remained normotensive, Keenan A. Walker, PhD, of Johns Hopkins Hospital in Baltimore, and colleagues reported in JAMA. Individuals who had a pattern of midlife hypertension and late-life hypotension had a significant 62% increased risk.

Incidence rates The dementia incidence rate for participants with midlife and late-life normotension was 1.31 per 100 person-years.

For participants with midlife normotension and late-life hypertension, the

rate was 1.99 per 100 person-years.

The rate for those with midlife and late-life hypertension was 2.83 per 100 person-years. The rate for individuals with midlife normotension and late-life hypotension was 2.07 per 100 personyears. The rate for participants with midlife hypertension and late-life hypotension was 4.26 per 100 person-years.

In ARIC, investigators examined blood pressure at 6 in-person visits.

During visits 5 and 6, participants underwent detailed neurocognitive evaluations. The primary outcome was dementia onset after visit 5 based on responses to Ascertain Dementia-8 informant questionnaires, Six-Item Screener telephone assessments, hospital discharge and death certificate codes, and the visit 6 neurocognitive evaluation, the authors noted.

In a separate JAMA paper in the same issue, a team led by R. Nick Bryan, MD, PhD, of the University of Texas at Austin, reported on a substudy of 449 participants in SPRINT (Systolic Blood

Pressure Intervention Trial) suggesting that intensive systolic BP (SBP) control may attenuate growth of cerebral white matter lesions.

Rationale The investigators cited previous research suggesting that small vessel ischemic disease (SVID) is associated with cognitive decline and pathogenesis of Alzheimer disease and related dementias. Previous research has identified hypertension as a primary risk factor for SVID, particularly development of white matter lesions, they noted.

For the trial, investigators randomly assigned hypertensive patients to receive intensive SBP control (to a target of <120 mm Hg) or standard SBP control (to a target of <140 mm Hg). Patients underwent longitudinal brain magnetic resonance imaging. The intensive-treatment group experienced a smaller increase in white matter lesion volume than the standard-treatment arm (0.92 vs 1.45 cm3). ■

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ESRD Risk Decreased With Intensive BP Lowering INTENSIVE BLOOD pressure (BP) control in hypertensive patients with chronic kidney disease is associated with a lower risk of end-stage renal disease (ESRD) and death in certain subgroups of patients, according to a new study.

Achieving lower BP targets appears to be particularly beneficial in decreasing ESRD risk among patients who are older, are obese, or have greater proteinuria, a team led by Elaine Ku, MD, of the University of California, San Francisco, reported in the Journal of the American Heart Association.

Intensive BP lowering also is especially beneficial in decreasing mortality risk among patients with advanced kidney disease.

The study pooled data from 2 completed trials of intensive BP lowering: the Modification of Diet in Renal Disease (MDRD) and African American Study of Kidney Disease and Hypertension (AASK) trials. Dr Ku and her colleagues included 840 MDRD and 1067 AASK participants.

Patients had a mean age of 53 years

s­ ignificant 27% decreased risk of death among patients with a GFR below 30 mL/min/1.73 m2, but was not protective against death among those with higher GFRs. “We believe our study is unique in its provision of long-term follow-up that extends the mean duration of most

clinical trials (2–3 years),” the authors stated.

Strengths of the new study include the large number of ESRD events and deaths and the availability of nearly 2 decades of follow-up in MDRD and AASK trial participants, Dr Ku’s team noted. With regard to study ­limitations,

the authors pointed out that their results may not apply to patients with CKD attributed to diabetes mellitus, and they did not have detailed data on cardiovascular events such as stroke or new-onset heart failure that may have developed with each of the treatment strategies during long-term follow-up. ■

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Protective effect appears to be limited to patients aged 40 years or older.

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and median glomerular filtration rate (GFR) of 40 mL/min/1.73 m 2. The median follow-up duration from randomization until death or administrative censoring was 14.9 years. ESRD developed in 498 and 526 patients in the intensive control and usual control arms, respectively. A total of 438 and 482 deaths occurred in the intensive control and usual control arms, respectively.

Compared with usual control, intensive control was associated with a significant 18% decreased risk of ESRD among patients aged 40 years or older, a significant 23% decreased risk of ESRD among patients with proteinuria of 0.44 g/g or higher, and a significant 25% decreased risk of ESRD among patients with a body mass index (BMI) of 30 kg/m2 or higher. Intensive BP control was not protective against ESRD risk among patients younger than 40 years, those with proteinuria below 0.44 g/g, and those with a BMI less than 30 kg/m2. In addition, intensive control was associated with a

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Metastasis Site Predicts Death Risk in Advanced PCa

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CANCER-SPECIFIC and overall survival of men with advanced prostate cancer (PCa) may be linked to the anatomic site where metastasis develops, according to a new study.

Men with liver-only metastasis have worse cancer-specific and overall survival than men with bone-only and

lung-only metastasis, investigators at The First Hospital of Jilin University in Jilin, China, led by Chunxi Wang, MD, reported in Oncology Letters.

Their analysis of 2010 to 2013 data from 10,777 men with stage IV PCa in the Surveillance, Epidemiology, and End Results database revealed that

men with no liver metastasis had a significant 52.8% and 49.9% decreased risk of cancer-specific and all-cause mortality, respectively, compared with men who had liver-only metastasis.

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cancer-specific and all-cause mortality, respectively, than men with boneonly metastasis. Patients without lung metastasis had a significant 22.4% and 20.6% decreased risk of these outcomes, respectively, compared with those who had lung-only metastasis, according to the ­investigators. ■

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Docetaxel After PCa Radiotherapy Not Beneficial ADJUVANT DOCETAXEL without prednisone does not decrease the likelihood of biochemical progression of disease among men who have undergone radiation therapy (RT) for intermediateor high-risk prostate cancer (PCa) and are receiving androgen deprivation therapy (ADT), according to investigators.

The finding is from a phase 3 study

by Pirkko-Liisa Kellokumpu-Lehtnen, MD, of Tampere University Hospital in Tampere, Finland, and colleagues that included 376 patients who completed RT for intermediate- or high-risk PCa. They randomly assigned 188 patients to receive 6 cycles ofT:7"adjuvant docetaxel

without continuous prednisone and 188 to undergo surveillance. Neoadjuvant or adjuvant ADT was mandatory for all patients. Of the 188 men in the docetaxel arm, 147 (78%) completed all 6 cycles of the drug. Results showed that 58 patients in the docetaxel arm and 57 in the surveillance arm ­experienced

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the study’s primary end point of a 2 ng/ mL or greater rise in PSA above nadir values, Dr Kellokumpu-Lehtnen’s team reported in European Urology.

A Kaplan-Meier analysis revealed no significant difference in biochemical disease-free survival curves. On Cox multivariate analysis, the docetaxel and surveillance groups did not differ significantly with regard to PSA progression. The 5-year estimated biochemical progression rates were 31% in the docetaxel arm and 28% in the surveillance arm.

“In conclusion, based on our current results, there is no evidence that adjuvant docetaxel with ADT after RT would provide a benefit for intermediate- or high-risk PCa patients in general clinical practice.” ■

Prediabetes After KT Ups CV Risks PREDIABETES AT 12 months after kidney transplantation (KT) is associated with a 2.1-fold increased risk of fatal and nonfatal cardiovascular events beyond 12 months, investigaT:10"

tors reported in Kidney International.

The magnitude of the increased risk was similar to that of diabetes at 12 months, which was associated with a significant 2.4-fold increased risk.

“Since prediabetes is potentially a reversible condition, there is an opportunity to prevent cardiovascular disease in this population,” a team led

by Esteban Porrini, MD, of Instituto de Tecnologías Biomédicas, University of La Laguna, Tenerife, Spain, concluded.

The study included 603 KT recipients without diabetes after transplantation. The study population had median follow-up duration of almost 8.4 years. At 12 months, 163 patients (27%) had prediabetes, 98 (16%) had diabetes, and 342 (57%) had normal glucose metabolism. The incidence of CV events was significantly higher among patients with prediabetes and diabetes at 12 months than patients without these conditions (17% and 20% vs 7%, respectively). ■

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Study: Kidney Tx Access Less Likely With For-Profit Dialysis Chances of being placed on a waiting list or receiving a kidney are diminished PATIENTS IN THE United States who receive dialysis at for-profit rather than nonprofit facilities are less likely to have access to kidney transplantation, according to a new report published in JAMA. In a retrospective cohort study of 1,478,564 patients treated at 6511 dialysis facilities, Rachel E. Patzer, PhD, MPH, of Emory University School of Medicine in Atlanta, and colleagues found that receiving dialysis at a forprofit facility compared with a nonprofit facility was associated with a significant 64%, 48%, and 56% decreased likelihood of being placed on a deceased donor kidney (DDK) transplantation waiting list, receiving a living donor kidney transplant, and receiving a DDK transplant, respectively.

First study of its kind To the investigators’ knowledge, no previous studies have examined the relationship between dialysis facility profit status and both living donor or deceased donor kidney transplantation.

Dr Patzer’s team categorized dialysis facility ownership as nonprofit small chains, nonprofit independent facilities, for-profit large chains (>1000 facilities), for-profit small chains (<1000 facilities), and for-profit independent facilities.

They referred to DaVita and Fresenius Medical Care as large for-profit chain 1 and large for-profit chain 2, respectively.

Of the 1,478,564 patients, 109,030 (7.4%) received care at 435 nonprofit small chain facilities; 483,988 (32.7%) received care at 2239 large for-profit chain 1 facilities; 482,689 (32.6%) received care at 2082 large for-profit chain 2 facilities; 225,890 (15.3%) received care at 997 for-profit small chain facilities; and 98,680 (6.7%) received care at 434 for-profit independent facilities.

Compared with patients who received dialysis at nonprofit small chain dialysis facilities, those treated at nonprofit independent facilities were almost 2.4 times more likely to be placed on the deceased donor transplant waiting list, Dr Patzer and her collaborators reported. Patients who received dialysis at large for-profit chain 1, large forprofit chain 2, for-profit small chain, and for-profit independent chain facilities were 43%, 46%, 44%, and 40% less likely to be placed on the deceased donor transplant waiting list, respectively.

In addition, compared with patients receiving dialysis in nonprofit small chain dialysis facilities, those receiving dialysis at nonprofit independent facilities were 71% more likely to receive a deceased donor transplant, whereas patients treated at large for-profit chain 1, large for-profit chain 2, for-profit small chain, and for-profit independent chain facilities were 40%, 41%,

Transplantation Access and Dialysis Facility Ownership Patients who receive dialysis at for-profit facilities are less likely to be placed on the deceased donor kidney transplant waiting list, according to a new study. Shown below are the percentage of patients placed on the waiting list during the study period according to various categories of dialysis facility ownership.

NON PROFIT

FORPROFIT

11.9% 29.8% Small chain facilities

7.0%

Large chain 1 (DaVita)

Independent facilities

6.2% 6.6% 6.9%

Large chain 2 (Fresenius)

Small chain facilities

Independent facilities

Source: Gander JC, Zhang X, Ross K, et al. Association between dialysis facility ownership and access to kidney transplantation. JAMA. 2019;322:957-973.

40%, and 41% less likely to receive a deceased donor transplant, respectively.

Patients who switched from a nonprofit to a for-profit facility were more likely to be placed on the deceased donor transplant waiting list or to receive a deceased or living donor kidney compared with patients who initiated and continued dialysis at for-profit facilities, Dr Patzer and her colleagues reported.

Patients who received dialysis at all for-profit facilities were 48% less likely to receive a living donor transplant compared with patients who were treated at all nonprofit facilities, according to the investigators.

Regarding study limitations, the authors said they did not have the data to determine the differences between profit status and chain affiliations with respect to staffing resources, education policies, and transplant referral practices, factors that may be associated with increased access to kidney transplantation. They also acknowledged that they were unable to account for the nonrandom geographic location of for-profit and nonprofit chains, “which may lead to unmeasured differences in patient characteristics across profit status categories.”

A ‘bleak and discouraging picture’ In an accompanying editorial, L. Ebony Boulware, MD, MPH, of Duke University School of Medicine in Durham, North Carolina, and coauthors said findings of the new study, taken together, “paint a bleak and discouraging picture on the function of the dialysis industry in assisting patients’ access to kidney transplantation overall, and they draw a particularly concerning light on how the business practices of different dialysis organizations might influence patients’ access to lifeenhancing therapy.”

The editorialists also discussed potential limitations of the new study. They noted, for example, that the geographic distribution and rural-urban location of facilities varied among for-profit and nonprofit organizations. “If patients receiving care at for-profit facilities had a greater burden of adverse social and environmental contexts, findings could erroneously implicate for-profit facilities as delivering poorer quality of care.” ■

Statins May Ease Prostate Growth STATIN USE may be associated with a modest decrease in prostate volume (PV) growth, according to investigators.

The finding is from an analysis of data from 4106 men who participated in the REDUCE trial, a 4-year randomized, double-blind, controlled trial that compared dutasteride with placebo for the chemoprevention of prostate cancer. Of these men, 692 (17%) were statin users at baseline.

In the dutasteride arm, the estimated mean PV decreased from 45.7 cc at baseline to 39.6 cc at 2 years (a 13% reduction) and remained stable at 4 years (39.8 cc), a team led by Stephen J. Freedland, MD, of CedarsSinai Medical Center in Los Angeles, reported in BJU International.

The estimated mean PV increased over time in the placebo arm from 45.6 cc at baseline to 51.9 cc at 2 years

Among men taking dutasteride, statin users had a smaller increase in PV. and 58 cc at 4 years, corresponding to a mean increase in PV of 12.4 cc, or 27%, over the 4-year trial period.

In the dutasteride arm, statin users had a slightly but significantly smaller mean estimated PV compared with nonusers at 2 years (38.1 vs 39.9 cc) and 4 years (38.5 vs 40.1 cc). In the placebo arm, the mean estimated PV was slightly lower among statin users compared with nonusers at the 2- and 4-year time points (50.4 vs 52.1 cc and 56.6 vs 58.3 cc, respectively), but the differences were not significant. Statin use was not associated with PV at baseline.

Dr Freedland and his collaborators stated that their findings, if confirmed, support a role for statins in modestly attenuation PV growth, “with a magnitude of effect in line with previouslyreported PSA-lower effects of statins.

“Given that prostate enlargement and [benign prostatic hyperplasia] are prevalent conditions in Western society conferring a reduced quality of life, it is possible that even modest attenuation of prostate enlargement could have a clinical and public health benefit,” the authors concluded. ■

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PCa Link to BRCA Mutations Affirmed

Men with BRCA2 mutations have a 5-fold higher risk of aggressive disease than the general population

BY JOHN SCHIESZER FOR DECADES, it has been known that the mutations in the tumor suppressor genes BRCA1 and BRCA2 are associated with high risks of breast and ovarian cancer, but a new prospective cohort study provides the strongest evidence to date that these mutations are associated with the development of prostate cancer (PCa).

The BRCA2 mutation appears to be more strongly associated with PCa development than the BRCA1 mutation. In addition, the increased risk of PCa varies by family history of the malignancy and the location of the mutation within the genes.

Up to 17 years of follow-up “Our study is unique in that we have recruited healthy men across the UK and Ireland who have hereditary BRCA1 or BRCA2 mutations, and then followed them prospectively for up to 17 years to see if they would develop prostate cancer,” said corresponding author Tommy Nyberg, a PhD candidate at the Centre for Cancer Genetic Epidemiology at the University of Cambridge in the UK. The study, which was published online ahead of print in European Urology, included 376 male BRCA1 mutation carriers and 447 male BRCA2 mutation carriers who were identified in clinical genetics centers in the United Kingdom and Ireland. Of these, 16 BRCA1 and 26 BRCA2 carriers were diagnosed with PCa during follow-up.

The BRCA2 mutation was associated with a nearly 4.5-fold increased risk of PCa, whereas the BRCA1 mutation was associated with an approximately 2.4-fold increased risk. “This translates into estimated absolute lifetime risks for developing prostate cancer of 60% for BRCA2 and 29% for BRCA1 mutation carriers. We also found an association with more aggressive prostate cancer for men with BRCA2, but not BRCA1 mutations,” Nyberg told Renal & Urology News.

For the men with BRCA1/2 mutations, the risk was greater for those from

BRCA1 vs BRCA2 Men with BRCA2 mutations have a higher estimated absolute lifetime risk of prostate cancer compared with those who have BRCA1 mutations, a study found.

60%

29%

BRCA1

BRCA2

Source: Nyberg T, Frost D, Barrowdale D, et al. Prostate cancer risks for male BRCA1 and BRCA2 mutation carriers: A prospective cohort study. Eur Urol. 2019; published online ahead of print.

families where several family members had been diagnosed with PCa than for those without such a family history. “This probably reflects the complex genetic landscape of prostate cancer susceptibility, with several genetic variants besides BRCA1/2 mutations being known to influence the risk,” Nyberg said.

Mutation site affects risk Among carriers of the BRCA2 mutation, the risk of PCa increased nearly 1.7-fold with each relative diagnosed with PCa. Compared with the general population, BRCA2 mutations in the so-called ovarian cancer cluster region (bounded by positions c.2831 and c.6401) were associated with a nearly 2.5-fold higher incidence of PCa, a lower risk increase than for mutations elsewhere in the BRCA2 gene. BRCA2 mutations outside this region were associated with a 5.9-fold relative risk of PCa. Additionally, the BRCA2 mutation was associated with a 5-fold increased incidence of Gleason score 7 PCa and 3-fold increased incidence of Gleason 6 or less PCa. The mutation also was associated with an almost 3.9-fold increased incidence of PCa mortality.

“I see the primary clinical application of our research as facilitating genetic counseling and the early detection of prostate cancer,” Nyberg said. “Men

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who are discovered to carry a hereditary BRCA2 mutation, even if currently healthy, are at considerable risk of developing prostate cancer during their lifetime.” A greater understanding of genetic risk variants is continuously occurring, and consequently genetic counseling for prostate cancer is getting more and more accurate.

Anthony V. D’Amico, MD, PhD, Chief of the Division of Genitourinary Radiation Oncology at Dana-Farber Cancer Institute and Professor of Radiation Oncology at Harvard Medical School in Boston, said drugs already are available that target BRCA2 mutations. “Studies are needed in men who harbor BRCA mutations to investigate whether these drugs, such as PARP inhibitors and platinum-based chemotherapy, can reduce the risk of metastasis and death from prostate cancer,” Dr D’Amico said.

Moreover, the new findings support recommendations that men with a significant family history for PCa, especially those with multiple first-degree relatives with PCa, undergo genetic testing for the BRCA2 mutation and then to be seen by a genetics counselor to be considered for screening at an earlier age than recommended in standard guidelines.

“The major implication here is that men with BRCA2 in particular are at a significantly increased risk of developing clinically meaningful prostate cancer, and this risk might be influenced by factors such as family history and the type of mutation that is inherited,” said Amar U. Kishan, MD, Assistant Professor of Radiation Oncology at the David Geffen School of Medicine of UCLA. Although the therapeutic implications of the new findings are unclear, it is theoretically possible that men with mutations in DNA repair genes may benefit from drugs such as poly (ADPribose) polymerase (PARP) inhibitors, but the data to support such a strategy are limited to patients with advanced, metastatic castration-resistant PCa. “In this setting, olaparib and rucaparib are approved for men with BRCA1/2

mutant-tumors, though these mutations can be either inherited or restricted to the tumor,” Dr Kishan said. “Whether men with an inherited BRCA2 mutation, who develop an aggressive but early stage prostate cancer, would benefit from this type of therapy, in combination with surgery or radiotherapy, is not known. Several studies are investigating this concept.”

Todd Morgan, MD, Associate Professor of Urology and Chief of the Division of Urologic Oncology at the University of Michigan in Ann Arbor, said the new study adds important data to help guide patient counseling and may allow for improved early detection strategies in men with BRCA1/2 mutations. At his institution, Dr Morgan and his colleagues have implemented

Findings from a new prospective study may have implications for genetic counseling. an early detection clinic for men with BRCA1 or BRCA2 mutations, which is modeled after similar clinics for female carriers of these mutations.

New guidelines needed Medical oncologist David Wise, MD, PhD of NYU Langone Health in New York, said the new findings may change the conversation for men carrying the BRCA2 germline mutation.

“Based on this study and others, new guidelines are needed to personalize prostate cancer screening for men carrying the BRCA2 germline mutation.

Clinical trials testing PARP inhibitors, already FDA approved for ovarian and breast cancer, are ongoing in BRCA2associated prostate cancer. Based on promising data from these clinical trials, the FDA has granted breakthrough therapy status for 2 PARP inhibitors, rucaparib and olaparib, for men with castration-resistant prostate cancer,” Dr Wise said. ■

Renal & Urology News will be covering Kidney Week 2019 in Washington, DC, November 5 – 10.

Go to www.renalandurologynews.com for daily reports on noteworthy studies.

18 Renal & Urology News

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Time on mRCC Drug Predicts Survival Investigators observe survival benefit among patients remaining on a drug for at least 3 months PATIENTS WITH metastatic renal cell carcinoma (mRCC) who, within the first 2 lines of pharmacotherapy, remain on a drug for 3 months or more have longer overall survival (OS) than those who do not, according to a new study.

In addition, the study revealed a trend toward longer OS among patients who receive more total lines of therapy and found no direct evidence of universal cross-resistance among multiple targeted therapies for mRCC. Using the Stanford Renal Cell Car­ci­ no­ma Database, a team led by Alice C. Fan, MD, of Stanford University School of Medicine in Stanford, California, analyzed 194 patients with mRCC with known death dates treated from 20032017. The study population, which had a median age of 60 years and median OS time of 16.4 months, received a total of 504 independent lines of single-agent

CKD May Be Associated With Snoring HABITUAL SNORING may increase the risk of chronic kidney disease (CKD), according to a recent study.

In a community-based cohort study that prospectively followed 9062 individuals with normal renal function at baseline, Jung Tak Park, MD, of Yonsei University in Seoul, Korea, and colleagues found that participants who self-reported snoring at least 1 day per week had a significant 23% increased risk of developing CKD compared with nonsnorers, after adjusting for potential confounders.

“Self-reported snoring may be an effective and easy early screening method for risk stratification of patients with CKD,” Dr Park and colleagues concluded in BMJ Open.

The investigators defined incident CKD as an estimated glomerular filtration rate below 60 mL/min/1.73 m2 during the follow-up period.

The study population had a mean age of 52 years. Of the 9062 participants, 4372 (48.2%) were men. Dr Park’s team classified participants into 3 groups: non-snorers (3493 participants; 38.5%),

therapy, with very few patients receiving combination therapies during the study period. Based on the investigators’ definition of clinical benefit (maintenance on a line of drug therapy for at least 3 months), 293 (58%) lines of therapy were beneficial.

Study shows overall survival increases along with the number of lines of treatment.

Median OS was 0.28 years among patients who experienced no clinical benefit within the first 2 lines of targeted therapy compared with 1.74 and 1.71 years for patients who experienced ­clinical benefit from first-and second-

those who snored less than 1 day per week (3749 participants; 41.4%), and those who snored 1 day or more per week (1820 participants; 20.1%).

During a mean follow-up period of 8.9 years, CKD developed in 264 (7.6%), 314 (8.4%), and 186 (10.2%) participants in the non-snorer, less than 1 day per week snorer group, and 1 day or more per week snoring group, respectively.

Investigators used a self-reported sleep quality questionnaire at baseline to collect detailed information on sleep duration, quality, and disorders, including habitual snoring. They assessed snoring frequency using a 5-point scale: never, infrequently, sometimes (1 to 3 nights per week), often (4 or 5 nights per week), and almost every night. In a subset of participants, a bed partner or family member confirmed self-reported answers on snoring.

Previous recent studies have suggested possible associations between sleep problems and CKD. For example, Dr Park and colleagues cited a study of 11,040 Chinese adults showing that worse overall sleep quality was significantly associated with a greater likelihood of being at high or very high risk of CKD. The study, published in the Clinical Journal of the American Society of Nephrology in 2017, also found a significant association between worse overall sleep quality and an elevated risk of proteinuria. ■

line treatment, respectively, Dr Fan and her colleagues reported online ahead of print in Cancers. Median OS increased from 0.43 years with 1 line of treatment compared with 1.08, 1.82, 2.51, 2.75, and 3.65 years with 2, 3, 4, 5, and 6 lines of treatment, respectively.

The investigators observed that the current treatment paradigm in mRCC is evolving from single-agent targeted therapy to combination regimens aimed at maximizing antitumor activity. “Combi­nation therapy ultimately holds promise for potentially increasing long-term survival, but a major challenge now will be selecting ­appropriate ­combinations in the right sequence given the array of drugs currently available for use,” the authors wrote.

Of the 194 patients, 131 had clear cell RCC and 21 had non-clear cell RCC. Based on the risk classification scheme

developed by the International Met­a­ static Renal Cell Carcinoma Data­base Con­sortium, 21 patients (11%) had a favorable-risk prognosis and 173 (89%) had an intermediate- or poor-risk prognosis. During the study period, the authors noted, sunitinib was most commonly given as a first-line therapy in 46.9% of patients, followed by pazopanib in 25.8%, and sorafenib in 15.5%. The median number of therapies received per patient was 2. The median duration of therapy per patient was 9.92 months.

Overall, 53 patients (27.3%) experienced a clinical benefit from every line of therapy received and 49 patients (25.3%) experienced no clinical benefit from any line of therapy received.

Of the 194 patients in the study, 127 patients (65%) experienced a clinical benefit with first-line treatment. ■

CKD Found to Raise Risk of Post-RP Complications PATIENTS WITH chronic kidney disease

complications. Both the CKD and ESRD

(CKD) are more likely to experience

groups had significantly longer hospital

postoperative complications following

stays than the non-CKD group.

radical prostatectomy (RP) for prostate

“Patients receiving [RP] should be

cancer than those without CKD, accord-

carefully evaluated for kidney dysfunc-

ing to a new study.

tion, as this factor significantly affects

In a population-based retrospective investigation using data from the US National Inpatient Sample, Chen Ning,

post-surgical outcomes,” Dr Ning’s team concluded.

The investigators also examined

MD, of Capital Medical University

the effect of a surgical approach on

Beijing Friendship Hospital in Beijing,

clinical outcomes. For the overall

China, and colleagues studied 136,790

study population, patients undergoing

men who underwent RP for prostate

robotic-assisted radical prostatectomy

cancer from 2005 to 2014. The

(RARP) had significant 45% decreased

group included 134,751 men without

odds of postoperative complications

CKD, 1766 with CKD, and 273 with

compared with those undergoing open

end-stage renal disease (ESRD). In

RP. In the non-CKD, CKD, and ESRD

adjusted analyses, patients with CKD

groups, RARP was associated with sig-

had a significant 36% increased risk of

nificant 46%, 35%, and 57% decreased

postoperative complications and 5-fold

odds of postoperative complications,

increased risk of postoperative acute

respectively.

kidney injury (AKI) and urinary complica-

In a discussion of study limitations,

tions compared with patients without

the authors noted that they identified

CKD, the investigators reported in BMC

patients with CKD or ESRD using ICD-

Nephrology. The investigators did not

9-CM codes. The ICD-9-CM diagnosis

include the ESRD group in their analysis

for CKD is highly specific, but its sensi-

of postoperative AKI and urinary

tivity is only about 80%. ■

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Renal & Urology News 19

Ethical Issues in Medicine M

uch has been written recently about the use of “gratitude interventions” and professional coaching in helping healthcare professionals manage dissatisfaction and burnout. Professional coaching helps physicians increase their internal locus of control by enhancing self-awareness, questioning self-defeating thoughts and beliefs, and reframing and reconsidering maladaptive patterns in their professional practice.1 The conscious reflection of noticing and appreciating the positive in life—that is, expressing gratitude— is part of an orientation to help physicians cope with the challenges of professional life, improve satisfaction with patients, and manage the daily stresses of the job. Researchers hypothesize that gratitude helps to counterbalance strong and sometimes overwhelming negative emotions as shame, frustration, inadequacy, and anger that can powerfully influence one’s perspective and satisfaction with work.2 As symptoms of professional dissatisfaction and burnout can compromise the effective management of clinical ethical dilemmas, gratitude may have a useful role in helping to manage these issues when they arise.

Although ethical dilemmas commonly arise in clinical practice, physicians are often able to manage them in the regular course of their work. When physicians have less reserve to manage the regular challenges and when they are burned out and feeling less resilient, dilemmas that may normally have been manageable, may become overwhelming. A busy clinical practice may interfere with a physician’s ability to reflect on a problem. Gratitude may be a valuable tool that helps clinicians to develop “moral clarity” by improving the quality of their thought processes.

There is an emerging evidence base on the relationship between gratitude and positive outcomes as health and satisfaction. First, to be effective, gratitude should be expressed regularly and consistently. Some studies have found that individuals have improved feelings of well-being when they write down 3 things that went well that day before

going to bed; however, training oneself to do this regularly during the course of the day may be more effective.

This active process may help the brain develop patterns of scanning the environment for opportunities to feel gratitude and prime oneself for positive rather than negative experiences. Other studies suggest asking oneself a daily series of questions to raise self-awareness and build resilience: What did I learn today?

What 3 things am I grateful for today?

What inspired me? Did I take myself too seriously?3 Professional coaches also reinforce the concept of reframing previously negative patterns of thinking into more positive ones. For example, identifying a challenge as an opportunity rather than another example of bad luck may help reverse ingrained patterns that reinforce a fixed negative mindset.4 How does this apply to a specific ethical dilemma? Consider the case of a difficultto-help patient who monopolizes your time by blaming you for their medical problems and refuses to follow any of your reasonable clinical recommendations. It would not be uncommon to fall prey to a common set of responses

© TUTYE / GETTY IMAGES

Gratitude may be a valuable tool that helps physicians develop ‘moral clarity’ by improving the quality of their thought processes BY DAVID J. ALFANDRE, MD

for the opportunity to learn new skills in managing patients, and for one’s overall good fortune in spite of these encounters.

Some are likely to be skeptical of this approach. Stalin reportedly said, “Gratitude is an illness suffered by dogs,” suggesting with neither subtlety

Researchers hypothesize that gratitude helps to counterbalance strong and sometimes negative emotions as shame, frustration, and inadequacy. when caring for these complicated patients: feelings of frustration and “heart sink” for having to provide what feels like futile care; anger at the consistent delay it creates in your busy day; and ultimate withdrawal from the patient. These emotions together are unproductive, and both the physician and patient are left unsatisfied and unhappy. Gratitude may play a role in better understanding, experiencing, and responding to these clinical challenges. The physician can express gratitude in diverse ways, beginning with gratitude for the ability to help a suffering patient, for the skills one possesses,

nor empathy that there may be problematic forms of gratitude. Although pathologic expressions of gratitude are likely to be rare in the professional settings I have described (they primarily exist in abusive, intimate relationships), physicians should evaluate for themselves whether the benefit/burden ratio favors making some of the changes suggested. They may also wish to await further research that better characterizes how, when, and for whom gratitude is most helpful and promotes well-being.5 For now, there probably is not much risk or opportunity cost to expressing more gratitude or expressing it more

frequently in our professional lives. On balance, there may be a lot to gain with making these changes in your practice.

If gratitude has the potential to improve our helping behaviors, which are central to the practice of medicine, then it deserves at least some consideration in the work of medical professionals. ■ David J. Alfandre MD, MSPH, is a healthcare ethicist for the National Center for Ethics in Health Care (NCEHC) at the Department of Veterans Affairs (VA) and an Associate Professor in the Department of Medicine and the Department of Population Health at the NYU School of Medicine in New York. The views expressed in this article are those of the author and do not necessarily reflect the position or policy of the NCEHC or the VA. REFERENCES 1. Gazelle G, Liebschutz JM, Riess H. Physician burnout: coaching a way out. J Gen Intern Med. 2015;30:508-513.

2. Wood AM, Froh JJ, Geraghty AW. Gratitude and well-being: A review and theoretical integration.

Clin Psychol Rev. 2010;30:890-905.

3. Nedrow A, Steckler NA, Hardman J. Physician resilience and burnout: can you make the switch?

Fam Pract Manag. 2013;20:25-30.

4. Popova M. Fixed vs. growth: The two basic mindsets that shape our lives. Brain Pickings. https://www. brainpickings.org/2014/01/29/carol-dweck-mindset. Published January 29, 2014.

5. Wood AM, Emmons RA, Algoe SB, et al. A dark side of gratitude? Distinguishing between beneficial gratitude and its harmful impostors for the positive clinical psychology of gratitude and well-being. In: The Wiley Handbook of Positive Clinical Psychology.

2016:137-151.

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SEPTEMBER/OCTOBER 2019

Renal & Urology News 20

Practice Management A

task force assembled by the US Department of Health and Human Services (HHS) recently released Health Industry Cybersecur ity Practices: Managing Threats and Protecting Patients (HICP).

Thi s set of recommendations for healthcare providers offers ways to reduce cybersecurity risks. The group focused on such cybersecurity practices as email and end point protection, asset and access management, data protection, network and vulnerability management, incident response plans, medical device security, and cybersecurity policies.

KLAS Research and the College of Healthcare Information Management Executives (CHIME) recently worked together to survey organizations of all sizes to see where they stood in these areas. They found that many practices were doing what the task force recommended. Smaller organizations, however, frequently had room to improve cybersecurity measures. Possible reasons include financial constraints and lack of an information technology workforce.

Allocating a budget Jon Moore, Chief Risk Officer at Clearwater Compliance LLC, based in Nashville, said the survey essentially reflected what he sees in the industry.

Practices that “have a higher level of sophistication and scale” tend to have a stronger cybersecurity program.

“They have a better ability to address controls identified in HICP, which comes through clearly,” Moore said.

To improve their cybersecurity programs, practices should focus on the most effective programs they can implement for the dollars they have to spend, he said. Although that sounds relatively simple, it takes a solid

understanding of regulations and how their organization functions.

“They should be proactively thinking about how best to allocate the budget they have to reduce their risk,” Moore said. “It requires knowledge of what their risks are and where they reside.

This means doing a risk analysis, which is required, but not everyone is doing.”

In other words, organizations should know their strategic objectives and compare those with HIPAA regulations and HICP recommendations.

HIPAA requires organizations to have a security official named— though not necessarily a chief information security officer (CISO)—who is responsible for the development and implementation of the policies and procedures required by HIPAA, but Dan Dodson, president of Fortified Health Security, of Franklin, Tennessee, said “a lot of physician groups still do not have one.” Practices can outsource the position of security official, but this can be quite costly for smaller organizations. The HICP survey found that small organizations are 4 times less likely than big ones to have a CISO. Vulnerability testing is another HCIP-recommended cybersecurity measure. In the survey, about 90% of

© LEOWOLFERT / GETTY IMAGES

Practices need to perform risk analyses to determine how best to allocate money to improve cybersecurity BY TAMMY WORTH

Free online tools are available to help medical organizations improve cybersecurity.

must understand their options and associated costs and weigh that against their risk tolerance. “Most aren’t having that sophisticated a conversation about this,” Moore said.

Back to basics For smaller practices wanting to save money, Moore said free online tools as HHS Security Risk Assessment Tool

Organizations should know their strategic objectives and compare those with HIPAA regulations and HICP recommendations. large organizations and 60% of small ones said they were scanning their systems at least quarterly. Dodson said the best practice would be to scan monthly, but executing consistently each month requires resources and buy-in. Groups

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are an option. This will not guarantee a group is HIPAA-compliant, but “it’s better than nothing,” he said. It provides a starting point for an organization to understand what they need to do to move towards HIPAA

compliance and begin to understand their level of risk. Plugging the holes identified through the use of the tool can go a long way in reducing risk for the organization and its patients as well as preventing additional compliance problems should a breach occur.

Even though ransomware and phishing scams are changing constantly, organizations with good controls in place, such as encryption, decrease their vulnerability to whatever threats might come their way.

For instance, when HIPAA was new, Moore said there were constant reports of breaches related to stolen laptops. Those are happening less today because organizations are finally beginning to encrypt their data. Laptops are still stolen, but with encryption, they do not have to be reported to HHS. ■ Tammy Worth is a freelance medical journalist based in Blue Springs, MO.

Renal & Urology News will be covering Kidney Week 2019 in Washington, DC, November 5 – 10.

Go to www.renalandurologynews.com for daily reports on noteworthy studies.