Preparing women experiencing symptoms of menopause for shared decision making about treatment.

OBJECTIVE: To develop a decision support intervention that can be used with women experiencing menopausal symptoms to facilitate treatment shared decision making. METHODS: Our research team contacted patients with reported menopausal symptoms by telephone to obtain consent and administer a baseline survey. Subsequently, we sent participants a booklet on the treatment of menopausal symptoms. A nurse educator then contacted participants by telephone to review the booklet and guide them through a structured decision counseling exercise designed to help clarify treatment preference. A 60-day endpoint telephone survey was completed. RESULTS: Forty-eight consenting participants completed the baseline survey and 37 (77%) also completed a decision counseling session. At baseline, 19 of the women who had decision counseling were not being treated for menopausal symptoms and 18 were being treated. After decision counseling, 13 (68%) participants who were not being treated and 14 (78%) who were being treated identified a preferred treatment. Comparison of baseline and endpoint survey data showed that participant treatment knowledge increased (P = 0.007) and treatment decisional conflict decreased (P < 0.001). Furthermore, 71% of participants reported that they had received new information about treatment and 94% said they believed better prepared to discuss treatment with their healthcare provider. CONCLUSIONS: Nurse-led decision counseling increased participant treatment knowledge, reduced treatment decisional conflict, and helped to clarify treatment preference. Implementation of this strategy could help to facilitate provider-patient shared decision making about the treatment of menopausal symptoms.

A Randomized Trial to Improve Adherence to Follow-up Eye Examinations Among People With Glaucoma.

INTRODUCTION: Appointment nonadherence is common among people with glaucoma, making it difficult for eye care providers to monitor glaucoma progression. Our objective was to determine whether the use of patient navigators, in conjunction with social worker support, could increase adherence to recommended follow-up eye appointments. METHODS: A randomized, controlled trial evaluated the effectiveness of an intervention that used patient navigators and social workers to improve patient adherence to follow-up eye care compared with usual care. Participants with glaucoma and other eye diseases (N = 344) were identified at primary care clinics in community settings through telemedicine screening of imaging and then randomized to enhanced intervention (EI) or usual care (UC). Data on participants' visits with local ophthalmologists were collected for up to 3 years from randomization. Groups were compared for timely attendance at the first visit with the local ophthalmologist and adherence to recommended follow-up visits. RESULTS: Timely attendance at the first visit was higher for EI than UC (74.4% vs 39.0%; average relative risk [aRR] = 1.85; 95% CI, 1.51-2.28; P < .001). Rates of adherence to recommended annual follow-up during year 1 were 18.6% in the EI group and 8.1% in the usual care group (aRR = 2.08; 95% CI, 1.14-3.76; P = .02). The aRR across years 2 and 3 was 3.92 (95% CI, 1.24-12.43; P = .02). CONCLUSION: An intervention using patient navigators and social workers doubled the rate of adherence to annual recommended follow-up eye care compared with usual care in community settings, and was effective at increasing connections with local ophthalmologists. Interventions to further improve long-term adherence are needed.

Resected WHO grade I meningioma and predictors of local control.

INTRODUCTION: Despite optimal surgical resection, meningiomas may recur, with increasing grade and the degree of resection being predictive of risk. We hypothesize that an increasing Ki67 correlates with a higher risk of recurrence of resected WHO grade I meningiomas. METHODS: The study population consisted of patients with resected WHO grade 1 meningiomas in locations outside of the base of skull. Digitally scanned slides stained for Ki67 were analyzed using automatic image analysis software in a standardized fashion. RESULTS: Recurrence was observed in 53 (17.7%) of cases with a median follow up time of 25.8 months. Ki67 ranged from 0 to 30%. Median Ki67 was 5.1% for patients with recurrence and 3.5% for patients without recurrence. In unadjusted analyses, high Ki-67 (≥ 5 vs. < 5) vs. ≥ 5) was associated with over a twofold increased risk of recurrence (13.1% vs. 27% respectively; HR 2.1731; 95% CI [1.2534, 3.764]; p = 0.006). After Adjusting for patient or tumor characteristics, elevated Ki-67 remained significantly correlated with recurrence. Grade 4 Simpson resection was noted in 71 (23.7%) of patients and it was associated with a significantly increased risk of recurrence (HR 2.56; 95% CI [1.41, 4.6364]; p = 0.002). CONCLUSIONS: WHO grade 1 meningiomas exhibit a significant rate of recurrence following resection. While Ki-67 is not part of the WHO grading criteria of meningiomas, a value greater than 5% is an independent predictor for increased risk of local recurrence following surgical resection.

Prevalence of Suspected Hereditary Cancer Syndromes and Germline Mutations Among a Diverse Cohort of Probands Reporting a Family History of Prostate Cancer: Toward Informing Cascade Testing for Men.

BACKGROUND: Prostate cancer (PCa) is increasingly recognized as part of hereditary cancer syndromes (HCSs). HCS prevalence among diverse probands seeking genetic evaluation with PCa family history (FHx) has not been reported and has implications for cascade genetic testing. OBJECTIVE: To evaluate the rates of HCSs among probands reporting PCa FHx and germline mutations among probands. DESIGN, SETTING, AND PARTICIPANTS: A prospective genetic testing database queried for individuals with PCa FHx. Pedigrees analyzed for three HCSs: hereditary breast and ovarian cancer (HBOC), hereditary PCa, and Lynch syndrome. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Associations between HCS overall, and with plausible link to PCA FHx and race evaluated using Fisher's exact test. Germline mutation rates described among probands with a suspicion of an HCS connected with PCa FHx. RESULTS AND LIMITATIONS: A total of 345 probands reported PCa FHx: 53 African American (AA) and 292 Caucasian (Wh). Overall, 220 probands (63.8%) met the criteria for at least one HCS with a potential link to PCa FHx (75.5% AA; 61.6% Wh). HBOC linked to PCa FHx was identified in a higher percentage of AA than Wh probands (90.2% vs 74.6%, p=0.04). Among probands who underwent genetic testing with any HCS potentially linked to PCa FHx (n=169), 19.5% had germline mutations identified; five AA probands had germline mutations (all in BRCA1/2), while 28 Wh probands had mutations in a spectrum of genes. CONCLUSIONS: A significant percentage of AA probands with PCa FHx meet the criteria for HCSs, with HBOC identified at the highest rate. Although limited in sample size, our findings implicate BRCA mutations in AA families with HCSs linked with PCa, underscoring the need for greater enrollment of AA participants in genetic studies. PATIENT SUMMARY: Hereditary cancer syndromes potentially linked to prostate cancer are common in patients reporting a family history of prostate cancer. African-American patients may need special attention with regard to testing for hereditary breast and ovarian cancer syndrome, which may impact men with prostate cancer in these families.

Evaluation of Care Processes and Health Care Utilization in Newly Implemented Medical Homes in Italy: A Population-Based Cross-sectional Study.

In the Local Health Authority (LHA) of Parma, Emilia Romagna, Italy, 16 medical homes were established between 2011 and 2014. The authors implemented a 1-year (January 1, 2015, to December 31, 2015) cross-sectional population-based design to compare utilization and processes of care between medical homes and comparison practices using the Parma LHA administrative health care database. Residents (n = 372 396) attributed to a primary care physician practicing in a medical home as of January 1, 2015, were considered exposed to medical homes. Adjusted rates of emergency department (ED) use (incidence rate ratio [IRR] = 0.86; 95% CI = 0.82-0.90), potentially avoidable ED use (IRR = 0.78; 95% CI = 0.72-0.84), and hospitalization for chronic ambulatory care sensitive conditions (ACSCs; IRR = 0.87, 95% CI = 0.78-0.97) were lower among patients in medical homes. Performance on process of care measures favored the medical home group; however, associations were generally weak. Receipt of care in medical homes in Parma LHA was associated with lower rates of avoidable ED visits and hospitalizations for chronic ACSCs.

Mortality and Hospitalization Risk Following Oral Androgen Signaling Inhibitors Among Men with Advanced Prostate Cancer by Pre-existing Cardiovascular Comorbidities.

BACKGROUND: Elderly patients (≥65yr) with advanced prostate cancer and cardiovascular disease (CVD) conditions are often excluded from clinical trials of abiraterone acetate (AA) or enzalutamide (ENZ). Consequently, little is known about the effects of these medications on these vulnerable patients. OBJECTIVE: To assess the short-term outcomes of AA and ENZ in patients with pre-existing CVDs. DESIGN, SETTING, AND PARTICIPANTS: A population-based retrospective study. The Surveillance, Epidemiology, and End Results-Medicare-linked database was used to identify prostate cancer patients using AA or ENZ. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was 6-mo all-cause mortality, analyzed using modified Poisson regression modeling of relative risk (RR) adjusted for confounders and comorbidities. RESULTS AND LIMITATIONS: Among eligible patients (2845 with AA and 1031 with ENZ), 67% had at least one pre-existing CVD. Compared with those without pre-existing CVDs, having one to two pre-existing CVDs was associated with 16% higher 6-mo mortality (RR=1.16, 95% confidence interval [CI]: 1.00-1.36), and the risk increased further among those having three or more CVDs (RR=1.56, 95% CI: 1.29-1.88). Most of the differences in survival of patients with pre-existing CVD condition occurred within the first 6mo of treatment. CONCLUSIONS: After treatment with AA or ENZ, elderly prostate cancer patients with pre-existing CVDs experienced higher short-term mortality than otherwise similar patients without CVDs. Mortality associated with CVDs did not depend on having received AA versus ENZ. PATIENT SUMMARY: Patients with pre-existing cardiovascular diseases (CVDs) experienced higher short-term mortality after abiraterone acetate or enzalutamide than those without pre-existing CVDs. It is recommended that a multidisciplinary team, including a cardiologist, evaluate patients having pre-existing CVDs in the process of making treatment decisions and monitoring potential side effects.

Strabismus Surgery Infection Prophylaxis and Timing of First Postoperative Visit.

PURPOSE: To characterize the practice patterns of pediatric ophthalmologists regarding infection prophylaxis for strabismus surgery and timing of the first postoperative visit. METHODS: A ten-question multiple-choice, close-ended questionnaire was e-mailed to members of the American Association for Pediatric Ophthalmology and Strabismus listserv. Survey responses were summarized using frequencies and percentages. Univariable tests of association between prophylactic measures and surgeons reporting a prior episode of postoperative cellulitis or endophthalmitis were performed. RESULTS: Three hundred eighty pediatric ophthalmologists completed the survey. Most ophthalmologists instill 5% povidone-iodine solution during surgical preparation (88.4%), use topical antibiotics with or without steroids at the conclusion of surgery (90%), and prescribe oral or topical antibiotics postoperatively (85.5%). Eighty-five percent of strabismus surgeons routinely see patients for the first postoperative visit within the first week, although there is no consensus as to which day is preferred. Responders previously reporting experience with a postoperative infection were more likely to use intraoperative intravenous antibiotics (P = .002) and Tegaderm tape (3M, St. Paul, MN) or other adhesive drape to isolate the eyelids/eyelashes (P = .047). CONCLUSIONS: A common practice pattern appears to exist regarding the use of 5% povidone-iodine solution in surgical preparation, application of topical antibiotics at the end of surgery, and a postoperative regimen of topical antibiotics/steroids. There is no prevailing practice pattern regarding the timing of the first postoperative visit. Previous experience with postoperative cellulitis or endophthalmitis may lead to the adoption of more formidable infection prophylaxis measures such as intravenous antibiotics prior to surgery. [J Pediatr Ophthalmol Strabismus. 2019;56(6):354-359.].

Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Intraocular Pressure Measurements Found in a Population at High Risk for Glaucoma.

PRECIS: Intraocular pressure (IOP) measurements, when used during telemedicine eye screening alongside nonmydriatic fundus photography, were shown to improve the likelihood of accurate glaucoma and glaucoma-related diagnoses at the follow-up eye examination. PURPOSE: To determine if IOP measurements, used as an adjunct to nonmydriatic fundus photography, are useful in glaucoma telemedicine screening. MATERIALS AND METHODS: A total of 902 high-risk individuals were screened for glaucoma at 7 primary care practices and 4 Federally Qualified Health Centers using telemedicine. Screening at visit 1 included fundus photography, assessing family history of glaucoma, and IOP measurements using a hand-held rebound tonometer. Participants with suspicious nerve findings for glaucoma, IOP>21 mm Hg or other ocular pathologies were invited for a follow-up appointment with an ophthalmologist (visit 2). RESULTS: Of the 902 individuals screened at visit 1, 19.6% (n=177/902) had elevated IOP (>21 mm Hg). Fifteen participants were found to have an IOP>30 mm Hg at visit 1, including 2 with an IOP of >40 mm Hg. Among all who attended visit 2 (n=347), 10.9% had glaucoma and 7.2% had ocular hypertension. For participants having both suspicious nerve findings and IOP>21 mm Hg compared with those with neither, the odds ratio (OR) of being diagnosed with glaucoma was 4.48 (95% CI, 1.50-13.93; P=0.007), whereas for participants with suspicious discs and IOP≤21 mm Hg the OR was 2.04 (95% CI, 0.83-5.53; P=0.15). CONCLUSIONS: In this telemedicine vision screening setting, having a higher IOP at the screening visit increased the likelihood of receiving a final diagnosis of glaucoma. Therefore, this study supports incorporating IOP measurements, using a portable tonometer, into vision screening programs in high-risk populations.

Quantitative sensory testing in children with sickle cell disease: additional insights and future possibilities.

Quantitative sensory testing (QST) is used in a variety of pain disorders to characterize pain and predict prognosis and response to specific therapies. In this study, we aimed to confirm results in the literature documenting altered QST thresholds in sickle cell disease (SCD) and assess the test-retest reliability of results over time. Fifty-seven SCD and 60 control subjects aged 8-20 years underwent heat and cold detection and pain threshold testing using a Medoc TSAII. Participants were tested at baseline and 3 months; SCD subjects were additionally tested at 6 months. An important facet of our study was the development and use of a novel QST modelling approach, allowing us to model all data together across modalities. We have not demonstrated significant differences in thermal thresholds between subjects with SCD and controls. Thermal thresholds were consistent over a 3- to 6-month period. Subjects on whom hydroxycarbamide (HC) was initiated shortly before or after baseline testing (new HC users) exhibited progressive decreases in thermal sensitivity from baseline to 6 months, suggesting that thermal testing may be sensitive to effective therapy to prevent vasoocclusive pain. These findings inform the use of QST as an endpoint in the evaluation of preventative pain therapies.

Decision Support and Navigation to Increase Colorectal Cancer Screening Among Hispanic Patients.

BACKGROUND: Effective strategies are needed to raise colorectal cancer screening rates among Hispanics. METHODS: We surveyed and randomized 400 Hispanic primary care patients either to a Decision Support and Navigation Intervention (DSNI) Group (n = 197) or a Standard Intervention (SI) Group (n = 203). Both groups received a colorectal cancer screening kit [bilingual informational booklet, fecal immunochemical stool blood test (SBT), and colonoscopy screening instructions]. The DSNI Group received a telephone contact from a patient navigator. The navigator clarified screening test preference and likelihood of test performance, helped to develop a screening plan, and provided guidance through test performance. An endpoint telephone survey and medical chart review were completed. Multivariable analyses were conducted to assess 12-month screening adherence, change in decision stage, and knowledge and perceptions. RESULTS: Screening adherence was significantly higher in the DSNI Group than the SI Group [OR, 4.8; 95% confidence interval (CI), 3.1-7.6]. The DSNI Group, compared with the SI Group, also displayed higher SBT screening [OR, 4.2; 95% CI, 2.6-6.7), higher colonoscopy screening (OR, 8.8; 95% CI, 4.1-18.7), and greater forward change in screening decision stage (OR, 4.9; 95% CI, 2.6-9.5). At endpoint, study groups did not differ in screening knowledge or perceptions. CONCLUSIONS: The DSNI had a greater positive impact on colorectal cancer screening outcomes than the SI. IMPACT: Health system implementation of DSNI strategies may help to reduce Hispanic colorectal cancer screening disparities in primary care.

Germline genetic testing for inherited prostate cancer in practice: Implications for genetic testing, precision therapy, and cascade testing.

BACKGROUND: Genetic testing capability and guidelines are rapidly expanding to assess inherited prostate cancer (PCA). Clinical genetic data from multigene testing can provide insights into the germline pathogenic variant (PV) spectrum and correlates in men with PCA unselected for metastatic disease to optimize identification of men for genetic evaluation and management. METHODS: A retrospective cross-sectional analysis was conducted of de-identified clinical genetic testing data from a large commercial genetic testing laboratory in the US. ICD-10 claims codes were used to identify men with PCA, along with family history data. Gleason score was abstracted from test request forms. Overall PV rate among men with PCA was estimated, along with PVs in DNA repair genes. Family history and Gleason score association to germline DNA repair PVs was assessed using Fisher's exact test with correction for false-discovery. RESULTS: As of August 2017, genetic results were available on 1328 men with PCA. Overall PV rate was 15.6%, with 10.9% of PV in DNA repair genes. PVs were most commonly identified in BRCA2 (4.5%), CHEK2 (2.2%), ATM (1.8%), and BRCA1 (1.1%). Breast cancer family history was significantly associated with germline DNA repair PVs (OR 1.89, [95%CI 1.33, 2.68], P = 0.003). Among men with Gleason score>= 6 (n = 706), Gleason> = 8 was significantly associated with DNA repair PVs (OR 1.85 [95%CI 1.22, 2.80], P = 0.004). CONCLUSIONS: A substantial proportion of men with PCA unselected for metastatic disease carry germline DNA repair PVs. Breast cancer family history and high Gleason score are important predictors to identify men with PCA who may carry germline DNA repair PVs. Our findings support current NCCN guidelines and have implications for genetic assessment, therapeutic management, and cascade testing for men with PCA and their families.

Philadelphia Telemedicine Glaucoma Detection and Follow-up Study: Analysis of Unreadable Fundus Images.

PURPOSE: The purpose of this study was to ascertain determinants of unreadable fundus images for participants enrolled in the Philadelphia Telemedicine Glaucoma Detection and Follow-up Study. METHODS: Individuals were screened for glaucoma at 7 primary care practices and 4 Federally Qualified Health Centers using telemedicine. Screening (visit 1) included fundus photography, assessing family history of glaucoma, and intraocular pressure (IOP) measurements. Participants with an unreadable image in at least one eye were deemed unreadable and invited to return for a confirmatory eye examination (visit 2). RESULTS: A total of 906 participants completed the visit 1 eye screening and 17.1% (n=155/906) were "unreadable." In the multivariable logistic regression analysis, older age, male sex, smoking, and worse visual acuity were significantly associated with an unreadable fundus image finding at the eye screening (P<0.05). Of the 89 participants who were invited for the confirmatory eye examination solely for unreadable images and attended visit 2, 58 (65.2%) were diagnosed with at least one ocular pathology. The most frequent diagnoses were cataracts (n=71; 15 visually significant, 56 nonvisually significant), glaucoma suspects (n=27), and anatomical narrow angle (n=10). CONCLUSIONS: Understanding the causes of unreadable fundus images will foster improvements in telemedicine techniques to optimize the predictive accuracy, efficiency, and cost in ophthalmology. A high proportion of participants with unreadable images (65.2%) in our study were diagnosed with some ocular pathology, indicating that the finding of an unreadable fundus image warrants a referral for a comprehensive follow-up eye examination.

Effectiveness of palliative care services: A population-based study of end-of-life care for cancer patients.

BACKGROUND: Multiple studies demonstrate substantial utilization of acute hospital care and, potentially excessive, intensive medical and surgical treatments at the end-of-life. AIM: To evaluate the relationship between the use of home and facility-based hospice palliative care for patients dying with cancer and service utilization at the end of life. DESIGN: Retrospective, population-level study using administrative databases. The effect of palliative care was analyzed between coarsened exact matched cohorts and evaluated through a conditional logistic regression model. SETTING/PARTICIPANTS: The study was conducted on the cohort of 34,357 patients, resident in Emilia-Romagna Region, Italy, admitted to hospital with a diagnosis of metastatic or poor-prognosis cancer during the 6 months before death between January 2013 and December 2015. RESULTS: Patients who received palliative care experienced significantly lower rates of all indicators of aggressive care such as hospital admission (odds ratio (OR) = 0.05, 95% confidence interval (CI): 0.04-0.06), emergency department visits (OR = 0.23, 95% CI: 0.21-0.25), intensive care unit stays (OR = 0.29, 95% CI: 0.26-0.32), major operating room procedures (OR = 0.22, 95% CI: 0.21-0.24), and lower in-hospital death (OR = 0.11, 95% CI: 0.10-0.11). This cohort had significantly higher rates of opiate prescriptions (OR = 1.27, 95% CI: 1.21-1.33) ( p < 0.01 for all comparisons). CONCLUSION: Use of palliative care at the end of life for cancer patients is associated with a reduction of the use of high-cost, intensive services. Future research is necessary to evaluate the impact of increasing use of palliative care services on other health outcomes. Administrative databases linked at the patient level are a useful data source for assessment of care at the end of life.

Understanding of multigene test results among males undergoing germline testing for inherited prostate cancer: Implications for genetic counseling.

BACKGROUND: Genetic testing (GT) for prostate cancer (PCA) is rising, with limited insights regarding genetic counseling (GC) needs of males. Genetic Evaluation of Men (GEM) is a prospective multigene testing study for inherited PCA. Men undergoing GC were surveyed on knowledge of cancer risk and genetics (CRG) and understanding of personal GT results to identify GC needs. METHODS: GEM participants with or high-risk for PCA were recruited. Pre-test GC was in-person, with video and handout, or via telehealth. Post-test disclosure was in-person, by phone, or via telehealth. Clinical and family history data were obtained from participant surveys and medical records. Participants completed measures of knowledge of CRG, literacy, and numeracy pre-test and post-test. Understanding of personal genetic results was assessed post-test. Factors associated with knowledge of CRG and understanding of personal genetic results were examined using multivariable linear regression or McNemar's test. RESULTS: Among 109 men who completed pre- and post-GT surveys, multivariable analysis revealed family history meeting hereditary cancer syndrome (HCS) criteria was significantly predictive of higher baseline knowledge (P = 0.040). Of 101 men who responded definitively regarding understanding of results, 13 incorrectly reported their result (McNemar's P < 0.001). Factors significantly associated with discordance between reported and actual results included having a variant of uncertain significance (VUS) (P < 0.001) and undergoing GC via pre-test video and post-test phone disclosure (P = 0.015). CONCLUSIONS: While meeting criteria for HCS was associated with higher knowledge of CRG, understanding of personal GT results was lacking among a subset of males with VUS. A more exploratory finding was lack of understanding of results among men who underwent GC utilizing video and phone. Studies optimizing GC strategies for males undergoing multigene testing for inherited PCA are warranted.

Decision Support and Shared Decision Making About Active Surveillance Versus Active Treatment Among Men Diagnosed with Low-Risk Prostate Cancer: a Pilot Study.

This study aimed to explore the effects of a decision support intervention (DSI) and shared decision making (SDM) on knowledge, perceptions about treatment, and treatment choice among men diagnosed with localized low-risk prostate cancer (PCa). At a multidisciplinary clinic visit, 30 consenting men with localized low-risk PCa completed a baseline survey, had a nurse-mediated online DS session to clarify preference for active surveillance (AS) or active treatment (AT), and met with clinicians for SDM. Participants also completed a follow-up survey at 30 days. We assessed change in treatment knowledge, decisional conflict, and perceptions and identified predictors of AS. At follow-up, participants exhibited increased knowledge (p < 0.001), decreased decisional conflict (p < 0.001), and more favorable perceptions of AS (p = 0.001). Furthermore, 25 of the 30 participants (83 %) initiated AS. Increased family and clinician support predicted this choice (p < 0.001). DSI/SDM prepared patients to make an informed decision. Perceived support of the decision facilitated patient choice of AS.

Hospitalization rates during potentially inappropriate medication use in a large population-based cohort of older adults.

BACKGROUND AND AIMS: The temporal relationship between potentially inappropriate medication (PIM) use and hospitalization remains uncertain. We examined whether current PIM use increases the rate of hospitalization and estimated the rate of hospitalization during exposure to individual PIMs. METHODS: A retrospective population-based cohort study of 1 480 137 older adults was conducted using the 2003-2013 Italian Emilia-Romagna Regional administrative healthcare database (~4.5 million residents), which includes demographic, hospital and outpatient prescription information. Each day of follow-up was defined as exposed/unexposed to PIMs that 'should always be avoided', according to the Maio criteria, an Italian modified version of the Beers criteria. The study outcome was all-cause hospitalizations. Crude PIM-related hospitalization rates were calculated for individual PIMs. Repeated-events Cox proportional hazards models with time-dependent covariates estimated adjusted hazard ratios for hospitalization during PIM exposure, as defined by three versions of the Maio criteria (v2007, v2011, v2014). RESULTS: During >10 million person-years of follow-up, 54.2% of individuals used ≥1 PIM and 10.9% of all person-time was exposed to v2014 PIMs. Among 1 604 901 hospitalizations, 15.6% occurred during v2014 PIM exposure. Crude hospitalization rates during v2014 PIM-exposed and unexposed person-time were 228.1 and 152.1 per 1000 person-years, respectively. The PIM with the highest rate of hospitalization was ketorolac, while nonsteroidal anti-inflammatory drugs had the most exposure time. The hazard of hospitalization was 16% greater (hazard ratio = 1.16; 95% confidence interval 1.14, 1.18) among patients exposed to v2014 PIMs. The v2007 and v2011 estimates were similar. CONCLUSIONS: In this large population-based cohort of older adults, we found a 16% increased hospitalization risk associated with PIM exposure.

Prevalence and Characteristics of Patients with Suspected Inherited Renal Cell Cancer: Application of the ACMG/NSGC Genetic Referral Guidelines to Patient Cohorts.

Patients with suspected hereditary renal cell cancer (RCC) are under-referred for genetic evaluation. Characterizing the prevalence and characteristics of suspected inherited RCC is a crucial step toward advancing personalized, genetically-based cancer risk management for patients and their families. To evaluate the prevalence and characteristics of suspected inherited RCC syndromes based on consensus criteria, we performed a cross-sectional analysis of patients with a diagnosis of RCC in SEER (2001-2011, n = 105,754) and in our institutional cancer registry (2004-2013, n = 998). Consensus criteria for referral of patients with RCC for genetic evaluation from the American College of Medical Genetics and Genomics and National Society of Genetic Counselors (ACMG/NSGC) were applied to the two cohorts. The associations between meeting referral criteria with demographic characteristics were assessed with chi-square tests. Overall, 24.0 % of the SEER cohort and 33.7 % of our institutional cohort met ACMG/NSGC referral criteria for genetic counseling. While white patients more commonly met early onset clear cell RCC criteria, black patients met papillary RCC criteria at twice the rate of whites in both cohorts (p < 0.0001). As many as 1 in 5 individuals with RCC meet referral criteria for genetic evaluation based on newly emerging guidelines, with differences in pathology noted by race. Prospective genetic testing studies utilizing emerging referral guidelines should help to refine the genetic spectrum of inherited kidney cancer. This study supports efforts to increase awareness of referral of patients with RCC for genetic counseling particularly among urologic providers.

Definitive Radiation Therapy for Stage I-II Endometrial Cancer: An Observational Study of Nonoperative Management.

OBJECTIVE: There is limited evidence to inform the management of patients with endometrial cancer who are not candidates for hysterectomy, and treatment alternatives have not been compared directly in randomized trials. We analyzed the prognostic factors and outcomes for patients with stage I or II endometrial adenocarcinoma in the National Cancer Institute's Surveillance, Epidemiology, and End Results public database. METHODS: We identified a cohort of patients with stage I-II endometrial adenocarcinoma who were managed without hysterectomy and who were diagnosed during 1989 to 2010. Patients with prior primary tumors were excluded. Statistical analyses were performed to test associations between patient characteristics, radiotherapy modality, and overall and endometrial cancer-specific survival. Multivariable analyses were performed to evaluate the impact of radiation therapy (RT) type on survival outcomes after adjusting for other factors. RESULTS: Among the 997 women included in the analyses, 605 received no RT (60.7%), 207 (20.8%) received external-beam radiation therapy (EBRT) alone, and 185 (18.6%) received brachytherapy, either alone or in combination with EBRT. After adjusting for other tumor and demographic factors, RT type was not associated with overall or endometrial cancer-specific survival. Significant predictors of survival included: tumor stage and grade, age at diagnosis, and marital status. CONCLUSIONS: For patients in this population-based cohort with early-stage endometrial cancer managed without hysterectomy, the delivery of brachytherapy was not associated with improved survival, compared with EBRT alone. It seems worthwhile to pursue future clinical trials to evaluate definitive EBRT-alone strategies, omitting brachytherapy, for selected patients with medically inoperable endometrial cancer.

Inherited Mutations in Men Undergoing Multigene Panel Testing for Prostate Cancer: Emerging Implications for Personalized Prostate Cancer Genetic Evaluation.

PURPOSE: Multigene panels are commercially available for the evaluation of prostate cancer (PCA) predisposition, which necessitates tailored genetic counseling (GC) for men. Here we describe emerging results of Genetic Evaluation of Men, prospective multigene testing study in PCA to inform personalized genetic counseling, with emerging implications for referrals, cancer screening, and precision therapy. PATIENTS AND METHODS: Eligibility criteria for men affected by or at high risk for PCA encompass age, race, family history (FH), and PCA stage/grade. Detailed demographic, clinical, and FH data were obtained from participants and medical records. Multigene testing was conducted after GC. Mutation rates were summarized by eligibility criteria and compared across FH data. The 95% CI of mutation prevalence was constructed by using Poisson distribution. RESULTS: Of 200 men enrolled, 62.5% had PCA. Eleven (5.5%; 95% CI, 3.0% to 9.9%) had mutations; 63.6% of mutations were in DNA repair genes. FH of breast cancer was significantly associated with mutation status (P = .004), and FH that met criteria for hereditary breast and ovarian cancer syndrome was significantly associated with PCA (odds ratio, 2.33; 95% CI, 1.05 to 5.18). Variants of uncertain significance were reported in 70 men (35.0%). Among mutation carriers, 45.5% had personal/FH concordant with the gene. A tailored GC model was developed based on emerging findings. CONCLUSION: Multigene testing for PCA identifies mutations mostly in DNA repair genes, with implications for precision therapy. The study highlights the importance of comprehensive genetic evaluation for PCA beyond metastatic disease, including early-stage disease with strong FH. Detailed FH is important for referrals of men for genetic evaluation. The results inform precision GC and cancer screening for men and their male and female blood relatives.