Liam C. Macleod

Erectile dysfunction is not independently associated with cardiovascular death: data from the vitamins and lifestyle (VITAL) study.

INTRODUCTIONnErectile dysfunction (ED) is a significant problem among aging men. ED is independently associated with cardiovascular (CV) events (angina, myocardial infarction, and stroke).nnnAIMnWe sought to determine if ED was associated with CV death.nnnMAIN OUTCOME MEASURESnRisk of CV death in men with ED.nnnMETHODSnExactly 31,296 men in Washington aged 50-76 completed a questionnaire in 2000-2002 on supplements, diet, exercise, personal health, and ED. ED was determined by one question: Have you experienced impotence in the last year? We excluded patients with a history of coronary artery disease or stroke. Participants linked yearly through 2008 to the Washington State Death Certificate System. CV death was defined by death certificates listing CV-related deaths (International Classification of Diseases 10th Revision [ICD-10] codes: I00-I15, I20-I52, and I60-I99). We performed multivariate Cox proportional hazard regression adjusting for age, marital status, race, education, self-rating of health, body mass index (BMI), antihypertensive/lipid-lowering drug use, diabetes, family history of CV disease, smoking, and exercise.nnnRESULTSnAbout 7,762 men had ED and there were 486 CV deaths over 7.8-year average follow-up. The typical man who suffered CV death was older, single, reporting poor health, taking antihypertensives, higher BMI, a smoker, a diabetic, and had a family history of CV disease. When adjusting for age, marital status, and education only, men with ED had a 23% increased risk of CV death (hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.01, 1.49). With further adjustment for known risk factors for CV disease (diabetes, treatment for hypertension or hyperlipidemia, family history of myocardial infarction/stroke, BMI, and exercise), ED no longer predicted CV death (HR 0.93, 95% CI 0.76, 1.15).nnnCONCLUSIONSnIn this community-based cohort, ED was not independently associated with an elevated risk of CV death. These data do not contradict prior data associating ED and CV events but rather suggest that ED may be a manifestation of other known risk factors for CV disease.

Trends in Metastatic Kidney Cancer Survival From the Cytokine to the Targeted Therapy Era.

OBJECTIVEnTo evaluate population-based survival trends, compared to optimistic trial benchmarks, in metastatic renal cell carcinoma (mRCC). Advances in medical therapy for mRCC may be associated with survival improvements. Yet, targeted therapy trial results focus on patients with favorable-risk mRCC and may not be well disseminated at the population level.nnnMETHODSnSurveillance, Epidemiology, and End Results identified adult mRCC patients diagnosed between 1990 and 2009. Survival was analyzed by treatment era (cytokine, 1990-2005; targeted therapy, 2006-2009) and stratified by histology. Multivariate Cox regression identified factors independently associated with overall survival.nnnRESULTSnWe identified 14,521 eligible patients. For clear cell mRCC (Nxa0=xa04149), median survival improved from 11 to 14xa0months before and after targeted therapy (Pxa0<.001). For RCC with sarcomatoid features (Nxa0=xa0608) and RCC not otherwise specified (Nxa0=xa08860), survival did not change (median survival 4xa0months for both). For non-clear cell subtypes (Nxa0=xa0904), median survival improved from 7 to 9xa0months (Pxa0=xa0.008). On multivariate analysis, factors associated with increased overall survival were as follows: treatment in the targeted era (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.84-0.91), clear cell histology (HR, 0.76; 95% CI, 0.73-0.80), and receipt of surgery (HR, 0.43; 95% CI, 0.41-0.46).nnnCONCLUSIONnPopulation-based mRCC median survival improved but to a lesser degree than that reported in clinical trials. This represents opportunity for quality improvement in histologically guided care, use of cytoreductive nephrectomy, and development of strategies for trial-ineligible, poor-risk patients.

Relevance of graph literacy in the development of patient-centered communication tools

OBJECTIVEnTo determine the literacy skill sets of patients in the context of graphical interpretation of interactive dashboards.nnnMETHODSnWe assessed literacy characteristics of prostate cancer patients and assessed comprehension of quality of life dashboards. Health literacy, numeracy and graph literacy were assessed with validated tools. We divided patients into low vs. high numeracy and graph literacy. We report descriptive statistics on literacy, dashboard comprehension, and relationships between groups. We used correlation and multiple linear regressions to examine factors associated with dashboard comprehension.nnnRESULTSnDespite high health literacy in educated patients (78% college educated), there was variation in numeracy and graph literacy. Numeracy and graph literacy scores were correlated (r=0.37). In those with low literacy, graph literacy scores most strongly correlated with dashboard comprehension (r=0.59-0.90). On multivariate analysis, graph literacy was independently associated with dashboard comprehension, adjusting for age, education, and numeracy level.nnnCONCLUSIONSnEven among higher educated patients; variation in the ability to comprehend graphs exists.nnnPRACTICE IMPLICATIONSnClinicians must be aware of these differential proficiencies when counseling patients. Tools for patient-centered communication that employ visual displays need to account for literacy capabilities to ensure that patients can effectively engage these resources.

Comparative Effectiveness of a Patient Centered Pathology Report for Bladder Cancer Care

PURPOSEnPatients have unprecedented access to their medical records. However, many documents, such as pathology reports, may be beyond the health literacy of most patients. We compared the effectiveness of bladder biopsy patient centered pathology reports with standard reports.nnnMATERIALS AND METHODSnLocal bladder cancer experts reached consensus on the important elements of a bladder biopsy pathology report to inform prognosis and counseling. Patient focus groups identified the patient centered formats and language to convey these elements and constructed a pilot patient centered pathology report. A total of 40 patients undergoing bladder biopsy were block randomized to receive the standard report with or without the patient centered report. We assessed patient self-efficacy, and provider communication and empathy, and tested bladder cancer knowledge at pathology disclosure and 1xa0month later. We compared study groups with descriptive statistics.nnnRESULTSnExperts identified stage, grade and histology as the most important elements of a bladder biopsy pathology report. Patients prioritized 3 themes, including narrative format, tumor stage illustration and risk stratification for recurrence. A total of 39 patients completed initial and followup assessments. Patients with the patient centered pathology report had improved ability to identify cancer stage compared to those with the standard report. Initially 58% of patients with the standard report vs 20% with the patient centered report were unable to describe stage but at followup this incidence was 47% vs 15% (p = 0.02 and 0.03, respectively). Those with the patient centered report also trended toward improved identification of cancer grade. Provider communication trended toward improvement for the patient centered report. Ratings of patient self-efficacy did not differ by report.nnnCONCLUSIONSnPatient centered pathology reports are associated with greater patient knowledge about the bladder cancer diagnosis. The reports may aid patient-provider communication. This pilot study may serve as a model for the development of patient centered pathology reports for other cancers.

ORIGINAL RESEARCHErectile Dysfunction Is Not Independently Associated with Cardiovascular Death: Data from the Vitamins and Lifestyle (VITAL) Study

INTRODUCTIONnErectile dysfunction (ED) is a significant problem among aging men. ED is independently associated with cardiovascular (CV) events (angina, myocardial infarction, and stroke).nnnAIMnWe sought to determine if ED was associated with CV death.nnnMAIN OUTCOME MEASURESnRisk of CV death in men with ED.nnnMETHODSnExactly 31,296 men in Washington aged 50-76 completed a questionnaire in 2000-2002 on supplements, diet, exercise, personal health, and ED. ED was determined by one question: Have you experienced impotence in the last year? We excluded patients with a history of coronary artery disease or stroke. Participants linked yearly through 2008 to the Washington State Death Certificate System. CV death was defined by death certificates listing CV-related deaths (International Classification of Diseases 10th Revision [ICD-10] codes: I00-I15, I20-I52, and I60-I99). We performed multivariate Cox proportional hazard regression adjusting for age, marital status, race, education, self-rating of health, body mass index (BMI), antihypertensive/lipid-lowering drug use, diabetes, family history of CV disease, smoking, and exercise.nnnRESULTSnAbout 7,762 men had ED and there were 486 CV deaths over 7.8-year average follow-up. The typical man who suffered CV death was older, single, reporting poor health, taking antihypertensives, higher BMI, a smoker, a diabetic, and had a family history of CV disease. When adjusting for age, marital status, and education only, men with ED had a 23% increased risk of CV death (hazard ratio [HR] 1.23, 95% confidence interval [CI] 1.01, 1.49). With further adjustment for known risk factors for CV disease (diabetes, treatment for hypertension or hyperlipidemia, family history of myocardial infarction/stroke, BMI, and exercise), ED no longer predicted CV death (HR 0.93, 95% CI 0.76, 1.15).nnnCONCLUSIONSnIn this community-based cohort, ED was not independently associated with an elevated risk of CV death. These data do not contradict prior data associating ED and CV events but rather suggest that ED may be a manifestation of other known risk factors for CV disease.

Complications of Intravesical Bacillus Calmette-Guérin

Intravesical Bacillus Calmette-Guérin (BCG) is an important treatment for the management of non-muscle invasive bladder cancer because of its proven efficacy and favourable safety profile. The most common complications associated with BCG treatment are relatively minor. They include urinary frequency, cystitis, fever, and hematuria. Although serious complications are rare, patients can develop severe, life-threatening sepsis with disseminated mycobacterial infection. We report a rare case of periurethral diverticulum formation after intravesical BCG and review the literature on the potential complications of this treatment modality.

Timing of Adverse Prostate Cancer Reclassification on First Surveillance Biopsy: Results from the Canary Prostate Cancer Active Surveillance Study

Purpose: During active surveillance for localized prostate cancer, the timing of the first surveillance biopsy varies. We analyzed the Canary PASS (Prostate Cancer Active Surveillance Study) to determine biopsy timing influence on rates of prostate cancer adverse reclassification at the first active surveillance biopsy. Materials and Methods: Of 1,085 participants in PASS, 421 had fewer than 34% of cores involved with cancer and Gleason sum 6 or less, and thereafter underwent on‐study active surveillance biopsy. Reclassification was defined as an increase in Gleason sum and/or 34% or more of cores with prostate cancer. First active surveillance biopsy reclassification rates were categorized as less than 8, 8 to 13 and greater than 13 months after diagnosis. Multivariable logistic regression determined association between reclassification and first biopsy timing. Results: Of 421 men, 89 (21.1%) experienced reclassification at the first active surveillance biopsy. Median time from prostate cancer diagnosis to first active surveillance biopsy was 11 months (IQR 7.8–13.8). Reclassification rates at less than 8, 8 to 13 and greater than 13 months were 24%, 19% and 22% (p = 0.65). On multivariable analysis, compared to men biopsied at less than 8 months the OR of reclassification at 8 to 13 and greater than 13 months were 0.88 (95% CI 0.5,1.6) and 0.95 (95% CI 0.5,1.9), respectively. Prostate specific antigen density 0.15 or greater (referent less than 0.15, OR 1.9, 95% CI 1.1, 4.1) and body mass index 35 kg/m2 or greater (referent less than 25 kg/m2, OR 2.4, 95% CI 1.1,5.7) were associated with increased odds of reclassification. Conclusions: Timing of the first active surveillance biopsy was not associated with increased adverse reclassification but prostate specific antigen density and body mass index were. In low risk patients on active surveillance, it may be reasonable to perform the first active surveillance biopsy at a later time, reducing the overall cost and morbidity of active surveillance.

Metabolic syndrome, dyslipidemia and prostate cancer recurrence after primary surgery or radiation in a veterans cohort

BACKGROUND:Metabolic syndrome (MetS) has been hypothesized to be associated with cancer, including prostate cancer (PCa), but the relationship is not well characterized. We analyze the relationship between MetS features and localized PCa recurrence after treatment.METHODS:Men having primary treatment for localized PCa were included from a multi-site regional veteran network. Recurrence was defined as nadir PSA +2u2009ngu2009ml−1 (radiation) or PSA⩾0.2u2009ngu2009ml−1 (prostatectomy). MetS was based on consensus professional society guidelines from the American Heart Association and International Diabetes Federation (three of: hypertension >130/85u2009mmu2009Hg, fasting blood glucose ⩾100u2009mgu2009dl−1, waist circumference >102u2009cm, high-density lipoprotein <40u2009mgu2009dl−1, triglycerides ⩾150u2009mgu2009dl−1). Closely related abnormality in low-density lipoprotein (LDL; >130u2009mgu2009dl−1) was also examined. Analysis of PCa recurrence risk included multivariable Cox proportional hazards regression with propensity adjustment.RESULTS:Of the 1706 eligible men, 279 experienced recurrence over a median follow-up period of 41 months (range 1–120 months). Adjustment variables associated with PCa recurrence included: index PSA, Gleason, and tumor stage. Independent variables of interest associated with PCa recurrence were hyperglycemia and elevated LDL. Elevated LDL was associated with PCa recurrence (multivariable hazard ratio (HR) 1.34, 95% confidence interval (CI) 1.03, 1.74; propensity adjusted HR 1.33, 95% CI 1.03, 1.72). There was also an association between impaired fasting glucose and PCa recurrence in (multivariable HR 1.54, 95% CI 1.10, 2.15; propensity adjusted HR 1.41, 95% CI 1.01, 1.95). MetS was not associated with PCa recurrence (multivariable: HR 0.96, 95% CI 0.61, 1.50; propensity adjusted HR 1.04, 95% CI 0.67, 1.62).CONCLUSIONS:PCa recurrence is not associated with MetS but is associated with elevated LDL and impaired fasting glucose. If confirmed, these data may help provide modifiable targets in preventing recurrence of PCa.

Comparison of Selective Parenchymal Clamping to Hilar Clamping During Robotic-assisted Laparoscopic Partial Nephrectomy

OBJECTIVEnTo compare perioperative outcomes after robotic-assisted laparoscopic partial nephrectomy (RALPN) with hilar clamping vs parenchymal clamping.nnnMETHODSnA retrospective, single-institution review of the patients undergoing RALPN with hilar or parenchymal clamping was performed. Associations between perioperative factors and clinicopathologic outcomes were determined using the t test, Fishers exact test, and multivariate linear regression.nnnRESULTSnIn 51 patients undergoing RALPN, 36 (71%) and 15 (29%) were performed with hilar and parenchymal clamping, respectively. Median tumor diameter was 2.8 cm for both groups (range, 1.1-6.1; P = .93). Tumor complexity by nephrometry score was mild (69% vs 80%), moderate (29% vs 20%), and high (2% vs 0%) in the respective groups (P = .65). Operative time was significantly shorter in the parenchymal clamp group (median 245 vs 320 minutes; P <.0001). There was no difference in blood loss and need for transfusion. On multivariate analysis, hilar clamping (P <.01), higher body mass index (P = .01), and higher complexity tumors (P = .02) were significantly associated with longer operative times. The parenchymal clamp group had better preservation of immediate postoperative glomerular filtration rate (GFR) from baseline to postoperative day 2 (median ΔGFR 0 vs -18 mL/min/1.73 m(2), P = .02). These differences from baseline did not persist (median ΔGFR -6 vs -7 mL/min/1.73 m(2), P = .35) at a median follow-up of 6.6 months. Final pathology determination of malignancy (P = .51) and positive margin rates (P = .26) were similar in both groups.nnnCONCLUSIONnCompared with hilar clamping, selective regional ischemia with the parenchymal clamp for mild-moderately complex tumors is feasible and safe during RALPN. Parenchymal clamping is associated with enhanced immediate preservation of GFR and shorter operative times.

Characterizing the Morbidity of Postchemotherapy Retroperitoneal Lymph Node Dissection for Testis Cancer in a National Cohort of Privately Insured Patients

OBJECTIVEnTo characterize morbidity of postchemotherapy retroperitoneal lymph node dissection (PC-RPLND) for testis cancer, we analyze a contemporary national database. PC-RPLND is the standard for residual radiographic massesu2009≥1u2009cm (nonseminoma) and positron emission tomography-avid massesu2009≥3u2009cm (seminoma). Morbidity for PC-RPLND is greater than primary RPLND, which may be mitigated by performing surgery at a high-volume cancer center.nnnMETHODSnCurrent Procedural Terminology and International Classification of Diseases, Ninth Edition codes identified men with testis cancer undergoing PC- or primary RPLND in MarketScan (2007-2012). Multivariable logistic regression assessed factors associated with receiving adjunctive procedures (ie, nephrectomy, vascular reconstruction), prolonged hospitalization, and 90-day readmission. Geographic variables assessed regionalization of PC-RPLND.nnnRESULTSnOf 559 men with claims for PC- or primary RPLND (206, 37% PC-RPLND), 19% of PC-RPLND underwent adjunctive procedures (vs 1% among RPLND, P u2009< u2009.01). For PC-RPLND, the nephrectomy rate was 10% and the vascular reconstruction rate was 8%. On multivariable analysis, PC-RPLND was associated with undergoing adjunctive procedures (odds ratio 41.9; 95% confidence interval 11.7, 150) and prolonged hospitalization (odds ratio 3.75; 95% confidence interval 1.68, 8.42) compared to primary RPLND. PC-RPLND was not associated with 90-day readmission. Up to 29% of PC-RPLNDs are performed in centers, billing just a single case through MarketScan in the 6 years studied.nnnCONCLUSIONnPC-RPLND is associated with adjunctive procedures and longer hospitalizations. Given the morbidity of PC-RPLND in this young patient population, efforts are needed to establish quality benchmarks for, reduce the morbidity of, and to accurately discriminate risk during patient discussions prior to this complex, specialized surgery.