Prevalence of Adolescents Meeting Criteria for Metabolic and Bariatric Surgery.

BACKGROUND AND OBJECTIVES: The American Academy of Pediatrics endorses metabolic and bariatric surgery (MBS) as a safe and effective treatment of severe obesity in children with class 3 obesity or with class 2 obesity and qualifying comorbidities. The study objective was to determine eligibility and characteristics of adolescents who qualify for MBS based on American Academy of Pediatrics guidelines. METHODS: This retrospective cohort study analyzed electronic health record data of 603 051 adolescents aged 13 to 17 years between January 1, 2018, and December 31, 2021. Centers for Disease Control and Prevention criteria were used to define obesity classes 2 and 3. Multivariable logistic regression was used to evaluate the factors associated with meeting MBS eligibility criteria. RESULTS: Of the 603 041 adolescents evaluated, 22.2% had obesity (12.9% class 1, 5.4% class 2, and 3.9% class 3). The most frequently diagnosed comorbid conditions were gastroesophageal reflux disease (3.2%), hypertension (0.5%), and nonalcoholic fatty liver disease (0.5%). Among adolescents with class 2 obesity, 9.1% had 1 or more comorbidities qualifying for MBS, and 4.4% of all adolescents met the eligibility criteria for MBS. In multivariable modeling, males, Black and Hispanic adolescents, and those living in more deprived neighborhoods were more likely to meet MBS eligibility criteria. CONCLUSIONS: Overall, 1 in 23 adolescents met the eligibility criteria for MBS. Demographic and social determinants were associated with a higher risk for meeting these criteria. The study suggests that the health care system may face challenges in accommodating the demand for MBS among eligible adolescents.

Follow-up of Abnormal Estimated GFR Results Within a Large Integrated Health Care Delivery System: A Mixed-Methods Study.

BACKGROUND: Timely follow-up of abnormal laboratory results is important for high-quality care. We sought to identify risk factors, facilitators, and barriers to timely follow-up of an abnormal estimated glomerular filtration rate (eGFR) for the diagnosis of chronic kidney disease. STUDY DESIGN: Mixed-methods study: retrospective electronic health record (EHR) analyses, physician interviews. SETTING & PARTICIPANTS: Large integrated health care delivery system. Quantitative analyses included 244,540 patients 21 years or older with incident abnormal eGFRs from January 1, 2010, to December 31, 2015, ordered by 7,164 providers. Qualitative analyses included 15 physician interviews. EXPOSURES: Patient-, physician-, and system-level factors. OUTCOME: Timely follow-up of incident abnormal eGFRs, defined as repeat eGFR obtained within 60 to 150 days, follow-up testing before 60 days that indicated normal kidney function, or diagnosis before 60 days of chronic kidney disease or kidney cancer. ANALYTICAL APPROACH: Multivariable robust Poisson regression models accounting for clustering within provider were used to estimate risk ratios (RRs) and 95% CIs for lack of timely follow-up. Team coding was used to identify themes from physician interviews. RESULTS: 58% of patients lacked timely follow-up of their incident abnormal eGFRs (ie, had a care gap). An abnormal creatinine result flag in the EHR was associated with better follow-up (RR for care gap, 0.65; 95% CI, 0.64-0.66). Patient online portal use and physician panel size were weakly associated with follow-up. Patients seen by providers behind on managing their EHR message box were at higher risk for care gaps. Physician interviews identified system-level (eg, panel size and assistance in managing laboratory results) and provider-level (eg, proficiency using EHR tools) factors that influence laboratory result management. LIMITATIONS: Unable to capture intentional delays in follow-up testing. CONCLUSIONS: Timely follow-up of abnormal results remains challenging in an EHR-based integrated health care delivery system. Strategies improving provider EHR message box management and leveraging health information technology (eg, flagging abnormal eGFR results), making organizational/staffing changes (eg, increasing the role of nurses in managing laboratory results), and boosting patient engagement through better patient portals may improve test follow-up.

The Relationship Between Nonsteroidal Anti-inflammatory Drug Use and Age-related Macular Degeneration.

PURPOSE: To describe the relationship between the incidence of age-related macular degeneration (AMD) and nonsteroidal anti-inflammatory drug (NSAIDs) use. DESIGN: Prospective cohort study. METHODS: This study consisted of participants in the California Men's Health Study. Those who completed surveys in 2002-2003 and 2006 were included. Men who self-reported use of aspirin, ibuprofen, naproxen, valdecoxib, celecoxib, and/or rofecoxib at least 3 days per week were considered NSAID users. Patients were categorized as non-users, former users, new users, or longer-term users based on survey responses. NSAID use was also categorized by type: any NSAIDs, aspirin, and/or non-aspirin NSAIDs. Age, race/ethnicity, smoking status, education, income, alcohol use, and Charlson comorbidity index score were included in the multivariate analysis as risk factors for AMD. RESULTS: A total of 51 371 men were included. Average follow-up time was 7.4 years. There were 292 (0.6%) and 1536 (3%) cases of exudative and nonexudative AMD, respectively. Longer-term use of any NSAID was associated with lower risk of exudative AMD (hazard ratio [HR] 0.69, 95% confidence interval [CI] 0.50-0.96, P = .029). New users of any NSAIDs (HR = 0.79, 95% CI 0.68-0.93, P = .0039) and aspirin (HR = 0.82, 95% CI 0.70-0.97, P = .018) had a lower risk of nonexudative AMD, although this trend did not persist in longer-term users. The relationship between exudative or nonexudative AMD and the remaining categories of NSAID use were not significant. CONCLUSION: The overall impact of NSAIDs on AMD incidence is small; however, the lower risk of exudative AMD in longer-term NSAID users may point to a protective effect and deserves further study as a possible mechanism to modulate disease risk.

Ten-Year Trends in Preventive Service Use Before and After Prostate Cancer Diagnosis: A Comparison with Noncancer Controls.

CONTEXT: Few studies have assessed the longer-term quality of preventive care in prostate cancer (PCa) survivors. OBJECTIVE: To compare the rates of preventive services among PCa survivors five years before and after diagnosis, to men without PCa. DESIGN: Men enrolled in Kaiser Permanente Southern California with newly diagnosed PCa (2002-2008) were matched 1:1 to men without a PCa diagnosis on age, race, and timing of prostate-specific antigen test (N = 31,180). The use of preventive services, including colorectal cancer screening, diabetes tests, lipid panels, and influenza and pneumococcal vaccinations was assessed 5 years before and after diagnosis (or index date for controls). MAIN OUTCOME MEASURES: Relative rates (RRs) of use were calculated for cases and controls separately and compared using Poisson regression, adjusting for comorbidities and outpatient utilization in 2014. RESULTS: Overall, the rates of preventive services were lower among men with PCa vs men without PCa. However, in the 5 years after diagnosis, rates of preventive service use for all services were greater among PCa survivors vs men without PCa (colorectal cancer: RR = 1.05, 95% confidence interval [CI] = 1.01-1.10; lipids: RR = 1.10, 95% CI = 1.08-1.11; hemoglobin A1C: RR = 1.17, 95% CI = 1.14-1.19; glucose: RR = 1.24, 95% CI = 1.23-1.26; influenza vaccine: RR = 1.05, 95% CI = 1.03-1.07; pneumococcal vaccine: RR = 1.03, 95% CI = 0.97-1.09). CONCLUSION: Delivery of preventive care improved after PCa diagnosis, with survivors receiving comparable preventive care to men without PCa during the five years following diagnosis.

Racial and Ethnic Variation in Health-Related Quality of Life Scores Prior to Prostate Cancer Treatment.

INTRODUCTION: Many men diagnosed with prostate cancer are concerned with how the disease and its course of treatment could affect their health-related quality of life (HRQOL). To aid in the decision-making process on a course of treatment and to better understand how these treatments can affect HRQOL, knowledge of pretreatment HRQOL is essential. AIMS: To assess the racial and ethnic variations in HRQOL scores in men newly diagnosed with prostate cancer before electing a course of treatment. METHODS: Male members of the Kaiser Permanente of Southern California health plan who were newly diagnosed with prostate cancer completed the five-domain specific Expanded Prostate Index Composite-26 (EPIC-26) HRQOL questionnaire from March 1, 2011 through August 31, 2013 (N = 2,579). Domain scores were compared across racial and ethnic subgroups and multiple logistic regression analyses were used to assess the association after adjusting for sociodemographic and clinical characteristics. MAIN OUTCOME MEASURES: The five EPIC-26 domain scores (sexual, bowel, hormonal, urinary incontinence, and urinary irritation and obstruction). RESULTS: Results from the fully adjusted analyses indicated that non-Hispanic black men were more likely to be above the sample median on the sexual (odds ratio [OR] = 1.43, 95% CI = 1.09-1.88), hormonal (OR = 1.35, 95% CI = 1.03-1.77), and urinary irritation and obstruction (OR = 1.34, 95% CI = 1.03-1.74) domains compared with non-Hispanic white men. The Asian or Pacific Islander men were less likely to be above the sample median on the sexual domain (OR = 0.60, 95% CI = 0.44-0.83) compared with non-Hispanic white men. No additional statistically significant differences were identified. CONCLUSIONS: Within an integrated health care organization, we found minimal racial and ethnic differences, aside from sexual function, in pretreatment HRQOL in men newly diagnosed with prostate cancer. These findings provide important insight with which to interpret HRQOL changes in men newly diagnosed with prostate cancer during and after prostate cancer treatment. Reading SR, Porter KR, Slezak JM, et al. Racial and Ethnic Variation in Health-Related Quality of Life Scores Prior to Prostate Cancer Treatment. Sex Med 2017;5:e219-e228.

Safety of Quadrivalent Meningococcal Conjugate Vaccine in Children 2-10 Years.

BACKGROUND: Quadrivalent meningococcal conjugate vaccine is recommended for children, adolescents and adults at increased risk of meningococcal disease. In 2011, MenACWY-CRM (Menveo, GSK, Siena, Italy) was approved for children 2-10 years of age in the United States. Although no safety concerns arose from clinical trials, it remains important to monitor its safety in routine clinical settings. METHODS: Kaiser Permanente Southern California members 2-10 years old who received MenACWY-CRM between September 2011 and September 2014 were included. Electronic health records were searched using a validated algorithm to identify 26 prespecified events of interests (EOIs) and serious medically attended events (SMAEs) from inpatient or emergency settings up to 1 year after MenACWY-CRM vaccination. SMAEs were categorized by International Classification of Diseases, 9th revision diagnostic categories. All events were reviewed to confirm the diagnosis and symptom onset date. The study was descriptive (NCT01452438); no statistical tests were performed. RESULTS: Among 387 vaccinated children, 327 with ≥6 months membership before vaccination were analyzed. Among EOIs, 9 asthma cases and 1 myasthenia gravis case underwent chart review which confirmed 1 incident asthma case occurring 237 days after concomitant vaccination with MenACWY-CRM and typhoid vaccine. Thirty-one children experienced SMAEs, most commonly because of unrelated injury and poisoning. The remaining events occurred sporadically after vaccination and most were unlikely related to vaccination based on medical record review. CONCLUSIONS: One incident EOI of asthma late in the 1-year observation period and sporadic distribution of SMAEs were observed. These data do not suggest safety concerns associated with MenACWY-CRM vaccination in children 2-10 years old.

Safety of Quadrivalent Meningococcal Conjugate Vaccine in 11- to 21-Year-Olds.

BACKGROUND: Meningococcal conjugate vaccination is recommended in the United States. This study evaluates the safety of quadrivalent meningococcal conjugate vaccine in a cohort aged 11 to 21 years. METHODS: This cohort study with self-controlled case-series analysis was conducted at Kaiser Permanente Southern California. Individuals receiving MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, during September 30, 2011 to June 30, 2013, were included. Twenty-six prespecified events of interest (EOIs), including neurologic, rheumatologic, hematologic, endocrine, renal, pediatric, and pediatric infectious disease EOIs, were identified through electronic health records 1 year after vaccination. Of these, 16 were reviewed by case review committees. Specific risk and comparison windows after vaccination were predefined for each EOI. The relative incidence (RI) and 95% confidence intervals (CIs) were estimated through conditional Poisson regression models, adjusted for seasonality. RESULTS: This study included 48 899 vaccinated individuals. No cases were observed in the risk window for 14 of 26 EOIs. The RI for Bell's palsy, a case review committee-reviewed EOI, was statistically significant (adjusted RI: 2.9, 95% CI: 1.1-7.5). Stratified analyses demonstrated an increased risk for Bell's palsy in subjects receiving concomitant vaccines (RI = 5.0, 95% CI = 1.4-17.8), and no increased risk for those without concomitant vaccine (RI = 1.1, 95% CI = 0.2-5.5). CONCLUSIONS: We observed a temporal association between occurrence of Bell's palsy and receipt of MenACWY-CRM concomitantly with other vaccines. The association needs further investigation as it could be due to chance, concomitant vaccination, or underlying medical history predisposing to Bell's palsy.

Comparison of biochemical failure rates between permanent prostate brachytherapy and radical retropubic prostatectomy as a function of posttherapy PSA nadir plus 'X'.

BACKGROUND: Prostate-specific antigen (PSA) nadir + 2 ng/mL, also known as the Phoenix definition, is the definition most commonly used to establish biochemical failure (BF) after external beam radiotherapy for prostate cancer management. The purpose of this study is to compare BF rates between permanent prostate brachytherapy (PPB) and radical retropubic prostatectomy (RRP) as a function of PSA nadir plus varying values of X and examine the associated implications. METHODS AND MATERIALS: We retrospectively searched for patients who underwent PPB or RRP at our institution between 1998 and 2004. Only primary patients not receiving androgen-deprivation therapy were included in the study. Three RRP patients were matched to each PPB patient on the basis of prognostic factors. BF rates were estimated for PSA nadirs + different values of X. RESULTS: A total of 1,164 patients were used for analysis: 873 in the RRP group and 291 in the PPB group. Patients were equally matched by clinical stage, biopsy Gleason sum, primary Gleason grade, and pretherapy PSA value. Median follow-up was 3.1 years for RRP patients and 3.6 years in the PPB group (P = .01). Using PSA nadir + 0.1 ng/mL for the definition of BF, the 5-year BF rate was 16.3% for PPB patients and 13.5% for RRP patients (P = .007), whereas at nadir + 2 ng/mL or greater, the BF rates were less than 3% and were indistinguishable between PPB and RRP patients. CONCLUSIONS: In a cohort of well-matched patients who had prostatectomy or brachytherapy, we examined BF as a function of nadir + X, where X was treated as a continuous variable. As X increases from 0.1 to 2.0 ng/mL, the BF curves converge, and above 2.0 ng/mL they are essentially indistinguishable. The data presented are of interest as BF definitions continue to evolve.

Effects of physical activity and sedentary time on the risk of heart failure.

BACKGROUND: Although the benefits of physical activity for risk of coronary heart disease are well established, less is known about its effects on heart failure (HF). The risk of prolonged sedentary behavior on HF is unknown. METHODS AND RESULTS: The study cohort included 82 695 men aged≥45 years from the California Men's Health Study without prevalent HF who were followed up for 10 years. Physical activity, sedentary time, and behavioral covariates were obtained from questionnaires, and clinical covariates were determined from electronic medical records. Incident HF was identified through International Classification of Diseases, Ninth Revision codes recorded in electronic records. During a mean follow-up of 7.8 years (646 989 person-years), 3473 men were diagnosed with HF. Controlling for sedentary time, sociodemographics, hypertension, diabetes mellitus, unfavorable lipid levels, body mass index, smoking, and diet, the hazard ratio (95% confidence interval [CI]) of HF in the lowest physical activity category compared with those in the highest category was 1.52 (95% CI, 1.39-1.68). Those in the medium physical activity category were also at increased risk (hazard ratio, 1.17 [95% CI, 1.06-1.29]). Controlling for the same covariates and physical activity, the hazard ratio (95% CI) of HF in the highest sedentary category compared with the lowest was 1.34 (95% CI, 1.21-1.48). Medium sedentary time also conveyed risk (hazard ratio, 1.13 [95% CI, 1.04-1.24]). Results showed similar trends across white and Hispanic subgroups, body mass index categories, baseline hypertension status, and prevalent coronary heart disease. CONCLUSIONS: Both physical activity and sedentary time may be appropriate intervention targets for preventing HF.

Observation versus adjuvant radiation or chemotherapy in the management of stage I seminoma: clinical outcomes and prognostic factors for relapse in a large US cohort.

PURPOSE: The management of stage I seminoma has evolved over the past 20 years. Contemporary management options after orchiectomy include adjuvant radiation, adjuvant chemotherapy, and observation. This analysis defines the experience at Kaiser Permanente Southern California from 1990 to 2010. We examined outcomes for stage I seminoma patients and reviewed prognostic factors for recurrence in those managed with observation. MATERIALS AND METHODS: This is a retrospective study of 502 stage I seminoma patients who underwent orchiectomy from 1990 to 2010. Outcomes examined were relapse-free survival (RFS), overall survival (OS), and cause-specific survival (CSS). Risk factors for recurrence evaluated were age, preoperative hCG elevation, preoperative LDH elevation, tumor size, lymphovascular invasion, rete testis invasion, epididymis invasion, and invasion through the tunica albuginea. RESULTS: Among radiation patients, 5-year RFS was 97.2%, OS was 98.0%, and CSS was 99.3%. Among chemotherapy patients, 2-year RFS was 98.3% and OS and CSS were 100%. Among observation patients, 5-year RFS was 89.2%, OS was 98.8%, and CSS was 100%. There was no difference in OS or CSS among the groups. RFS was significantly lower for observation patients. Among observation patients, univariate analysis identified tumor size, lymphovascular invasion, and rete testis invasion as risk factors for relapse. No factors were significant on multivariate analysis. CONCLUSIONS: Our data show that adjuvant radiation and chemotherapy yield similar outcomes in the management of stage I seminoma. Observation results in a lower RFS, but patients who relapse can be salvaged; OS and CSS are not affected.

Impact of median lobe anatomy: does its presence affect surgical margin rates during robot-assisted laparoscopic prostatectomy?

PURPOSE: To measure and describe the impact of median lobe anatomy on surgical margin status after robot-assisted laparoscopic prostatectomy (RALP). PATIENTS AND METHODS: We prospectively collected median lobe status, surgical margin status, and other perioperative data on 791 patients who underwent RALP at our institution by 12 surgeons between August 2008 and December 2010. We performed univariable and multivariable analysis to measure the association between median lobe status and positive surgical margin rates, including site. RESULTS: Compared with patients without a median lobe (n=672), patients with a median lobe (n=119) were less likely to have a positive surgical margin (16% vs 24.4%). They had a higher prostate-specific antigen (PSA) level (6.1 ng/dL vs 5.4 ng/dL), lower Gleason scores (<7, 58.1% vs 42.1%), lower pathologic stages (T(2), 87.4% vs 75.4%), and larger prostates (64 g vs 48 g) (all P<0.05). In our multivariable model, the effect of median lobe anatomy on surgical margin status, after adjusting for these factors, was not statistically significant (relative risk 0.97, 95% confidence interval, 0.64-1.47, P=0.88). Lower PSA level, Gleason score, and pathologic stage and larger prostates, however, predicted decreased positive surgical margin rates (P<0.01). CONCLUSION: Although presence of median lobe anatomy is not an independent predictor of positive surgical margins in RALP, it is associated with favorable pathologic characteristics that are known to predict decreased positive surgical margins.

Regular nonsteroidal anti-inflammatory drug use and erectile dysfunction.

PURPOSE: Previous data suggest a potential relationship between inflammation and erectile dysfunction. If it is causal, nonsteroidal anti-inflammatory drug use should be inversely associated with erectile dysfunction. To this end we examined the association between nonsteroidal anti-inflammatory drug use and erectile dysfunction in a large, ethnically diverse cohort of men enrolled in the California Men's Health Study. MATERIALS AND METHODS: This prospective cohort study enrolled male members of the Kaiser Permanente managed care plans who were 45 to 69 years old beginning in 2002. Erectile dysfunction was assessed by questionnaire. Nonsteroidal anti-inflammatory drug exposure was determined by automated pharmacy data and self-reported use. RESULTS: Of the 80,966 men in this study 47.4% were considered nonsteroidal anti-inflammatory drug users based on the definitions used and 29.3% reported moderate or severe erectile dysfunction. Nonsteroidal anti-inflammatory drug use and erectile dysfunction strongly correlated with age with regular drug use increasing from 34.5% in men at ages 45 to 49 years to 54.7% in men 60 to 69 years old with erectile dysfunction increasing from 13% to 42%. The unadjusted OR for the association of nonsteroidal anti-inflammatory drugs and erectile dysfunction was 2.40 (95% CI 2.27, 2.53). With adjustment for age, race/ethnicity, smoking status, diabetes mellitus, hypertension, hyperlipidemia, peripheral vascular disease, coronary artery disease and body mass index, a positive association persisted (adjusted OR 1.38). The association persisted when using a stricter definition of nonsteroidal anti-inflammatory drug exposure. CONCLUSIONS: These data suggest that regular nonsteroidal anti-inflammatory drug use is associated with erectile dysfunction beyond what would be expected due to age and comorbidity.

Pneumococcal vaccination and risk of acute myocardial infarction and stroke in men.

CONTEXT: Multiple studies have shown that preventing influenza by vaccination reduces the risk of vascular events. However, the effect of pneumococcal polysaccharide vaccine on vascular events remains controversial. OBJECTIVE: To examine the association between pneumococcal vaccination and risk of acute myocardial infarction (MI) and stroke among men. DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study of Kaiser Permanente Northern and Southern California health plans with 84 170 participants aged 45 to 69 years from the California Men's Health Study who were recruited between January 2002 and December 2003, and followed up until December 31, 2007. The cohort was similar to the population of health plan members and men who responded to a general health survey in California on important demographic and clinical characteristics. Demographic and detailed lifestyle characteristics were collected from surveys. Vaccination records were obtained from the Kaiser Immunization Tracking System. MAIN OUTCOME MEASURE: Incidence of acute MI and stroke during the follow-up period in men who had no history of such conditions. RESULTS: During follow-up, there were 1211 first MIs in 112,837 vaccinated person-years (10.73 per 1000 person-years) compared with 1494 first MI events in 246,170 unvaccinated person-years (6.07 per 1000 person-years). For stroke, there were 651 events in 122,821 vaccinated person-years (5.30 per 1000 person-years) compared with 483 events in 254,541 unvaccinated person-years (1.90 per 1000 person-years). With propensity score adjustment, we found no evidence for an association between pneumococcal vaccination and reduced risk of acute MI (adjusted hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.98-1.21) or stroke (adjusted HR, 1.14; 95% CI, 1.00-1.31). An inverse association was also not found in men of different age and risk groups. The results appeared to be consistent, because using more specific International Classification of Diseases, Ninth Revision codes for the outcome definition did not change the estimations. CONCLUSION: Among a cohort of men aged 45 years or older, receipt of pneumococcal vaccine was not associated with subsequent reduced risk of acute MI and stroke.

Locally recurrent prostate cancer after initial radiation therapy: a comparison of salvage radical prostatectomy versus cryotherapy.

PURPOSE: We compared the treatment outcomes of salvage radical prostatectomy and salvage cryotherapy for patients with locally recurrent prostate cancer after initial radiation therapy. MATERIALS AND METHODS: We retrospectively reviewed the medical records of patients who underwent salvage radical prostatectomy at the Mayo Clinic between 1990 and 1999, and those who underwent salvage cryotherapy at M. D. Anderson Cancer Center between 1992 and 1995. Eligibility criteria were prostate specific antigen less than 10 ng/ml, post-radiation therapy biopsy showing Gleason score 8 or less and prior radiation therapy alone without pre-salvage or post-salvage hormonal therapy. We assessed the rates of biochemical disease-free survival, disease specific survival and overall survival in each group. Biochemical failure was assessed using the 2 definitions of 1) prostate specific antigen greater than 0.4 ng/ml and 2) 2 increases above the nadir prostate specific antigen. RESULTS: Mean followup was 7.8 years for the salvage radical prostatectomy group and 5.5 years for the salvage cryotherapy group. Compared to salvage cryotherapy, salvage radical prostatectomy resulted in superior biochemical disease-free survival by both definitions of biochemical failure (prostate specific antigen greater than 0.4 ng/ml, salvage cryotherapy 21% vs salvage radical prostatectomy 61% at 5 years, p <0.001; 2 increases above nadir with salvage cryotherapy 42% vs salvage radical prostatectomy 66% at 5 years, p = 0.002) and in superior overall survival (at 5 years salvage cryotherapy 85% vs salvage radical prostatectomy 95%, p = 0.001). There was no significant difference in disease specific survival (at 5 years salvage cryotherapy 96% vs salvage radical prostatectomy 98%, p = 0.283). After adjusting for post-radiation therapy biopsy Gleason sum and pre-salvage treatment serum prostate specific antigen on multivariate analysis salvage radical prostatectomy remained superior to salvage cryotherapy for the end points of any increase in prostate specific antigen greater than 0.4 ng/ml (HR 0.24, p <0.0001), 2 increases in prostate specific antigen (HR 0.47, p = 0.02) and overall survival (HR 0.21, p = 0.01). CONCLUSIONS: Young, healthy patients with recurrent prostate cancer after radiation therapy should consider salvage radical prostatectomy as it offers superior biochemical disease-free survival and may potentially offer the best chance of cure.

Development of a standardized curriculum for teaching cystoscopic skills using a computer-based endourologic simulator.

INTRODUCTION: Educational opportunities with simulation are now available to teach endoscopic skills outside the clinical setting. The goal of this study is to assess the learning curve and subjective impressions of cystoscopic tasks performed by untrained subjects on a computer-based simulator using a standardized curriculum. METHODS: We evaluated ten novice subjects on a computer-based cystoscopic simulator (URO Mentor, Simbionix, Lod, Israel) during a standardized cystoscopy skills course developed for the study. All trainees performed three basic cystoscopic tasks as part of the curriculum. Subjects were evaluated until a steady state of performance was observed. Subjectively, participants assessed their performance and opinions regarding the computer-based simulator. RESULTS: Among the ten novice subjects (five men, five women), a median of six training sessions were required to achieve a steady state of performance. Significant performance improvements were noted with additional simulator time (P<0.001), however, the rate of improvement declined with time. Regression analysis of completion times revealed significant gender effects for one cystoscopic task. At study end, gender performance differences for any task were not significant. Uniformly, novices felt that URO Mentor was easy to use and provided an overall realistic training experience. CONCLUSION: In this study a computer-based simulator was successfully incorporated into a training curriculum for cystoscopy education. For simulated tasks performed with rigid and flexible cystoscopes, a median of six training sessions was necessary. Objectively, performance on the testing scenarios significantly increased with experience. Subjectively based on nonvalidated criteria, comfort level, and perceived competency increased significantly from the pre- to postcourse evaluations.

After radical retropubic prostatectomy 'insignificant' prostate cancer has a risk of progression similar to low-risk 'significant' cancer.

OBJECTIVE: To assess progression and survival among patients with small-volume, well-differentiated, organ-confined prostate cancer found at radical retropubic prostatectomy (RRP), often defined as being 'insignificant', thus testing whether they are indeed 'insignificant'. PATIENTS AND METHODS: We identified 6496 men treated for prostate cancer by RRP between 1990 and 1999, and defined 'insignificant' tumours as those in men having a prostate-specific antigen (PSA) level of < 10 ng/mL before RRP, a cancer volume of < or = 0.5 mL, a specimen Gleason of score < or = 6 and stage < or = pT2. Survival was assessed using the Kaplan-Meier method and compared using the two-sided log-rank test. RESULTS: 'Insignificant' tumours were found in 354 (5.5%) men, of whom only one had metastatic progression and none died from prostate cancer, with a median (range) follow-up of 9.2 (0.8-15.6) years. Biochemical progression-free survival (87% vs 85%, respectively, at 10 years, P = 0.5), systemic progression-free survival (100% vs 99%, P = 0.3), overall survival (91% vs 88%, P = 0.16) and cancer-specific survival (100% in each group, P = 0.32) were each similar among men with 'insignificant' prostate cancer and men with low-risk (defined by Gleason score, preoperative PSA level, seminal vesicle and surgical margin status) 'significant' cancer. Clinical stage, biopsy Gleason score and preoperative PSA doubling time were multivariably predictive of 'insignificant' tumours at RRP. CONCLUSIONS: 'Insignificant' prostate cancer at RRP is associated with a comparable risk of biochemical progression as low-risk 'significant' cancer. Although clinical predictors for 'insignificant' pathology can be identified, it remains to be established whether such patients can be safely managed conservatively.

Analysis of a computer based simulator as an educational tool for cystoscopy: subjective and objective results.

PURPOSE: Resident education in cystoscopy has traditionally relied on clinical instruction. However, simulators are now available outside the clinical setting. We evaluated a simulator for flexible and rigid cystoscopy. MATERIALS AND METHODS: We evaluated 30 novice and 27 expert cystoscopists on a computer based cystoscopic simulator (UroMentor, Simbionix, Lod, Israel). All subjects performed 5 trials of 3 basic cystoscopic tasks. The objective measurement was procedure time, and subjective measures were assessment of the simulator and individual tasks by the cystoscopist. Repeated measures analyses were performed using mixed effects regression models. RESULTS: There was a significant difference in median age between novice and expert cystoscopists at 46 (range 25 to 63) and 35 (range 28 to 68) years old, respectively (p = 0.014). Experts completed simulations significantly faster than novices in all trials. For the first trial median times (novice vs expert) were 300 vs 68 seconds (p <0.001) for guide wire placement, 650 vs 179 seconds (p <0.001) for bladder examination and 119 vs 71 seconds (p <0.001) for bladder lesion fulguration. At the fifth trial median times (novice vs expert) were 57 vs 31 seconds (p = 0.001) for guide wire placement, 164 vs 67 seconds (p <0.001) for bladder examination and 55 vs 40 seconds (p = 0.007) for bladder lesion fulguration. Subjective task evaluations were lower in novice subjects but improved after training. Subjective simulator evaluations were more favorable in novice subjects. CONCLUSIONS: Objectively, expert and novice performance of cystoscopic tasks can be distinguished with the UroMentor. Subjective assessments suggest ongoing refinement of the simulator as a learning tool for cystoscopic skills training.

Increased optical magnification from 2.5x to 4.3x with technical modification lowers the positive margin rate in open radical retropubic prostatectomy.

PURPOSE: We compared the positive surgical margin rate of 2.5x and 4.3x optical loupe magnification with associated technical improvement during open radical retropubic prostatectomy. MATERIALS AND METHODS: From January 2, 2004 to September 16, 2005, 511 consecutive patients underwent open radical retropubic prostatectomy, as performed by 1 surgeon. Because 10 patients refused authorization for a retrospective chart review, 501 were evaluable. For the first 265 patients 2.5x power loupes were used and for the subsequent 236 we used 4.3x power loupes. We used the chi-square test for univariate analysis, followed by multivariate logistic regression analysis adjusted for commonly recognized predictors of positive surgical margins in the 2 successive cohorts. Focusing on the apex, which was the most commonly reported site of positive surgical margins, we include operative video segments mimicking 4.3x magnification to demonstrate the surgical precision possible at 4.3x for managing the periurethral fascial bands of Walsh and urethral transection at the prostato-urethral junction. RESULTS: Positive surgical margins were identified in 39 of 265 patients (14.7%) at 2.5x and in 12 of 236 (5.1%) at 4.3x. Apical positive surgical margins were identified in 25 of 265 patients (9.4%) at 2.5x and in 5 of 236 (2.1%) at 4.3x. On multivariate analysis 4.3x magnification was independently associated with a 75% decrease in the odds of a positive surgical margin overall and in the apex alone (p <0.001 and 0.003, respectively). CONCLUSIONS: This exploratory retrospective study suggests that, compared with 2.5x magnification, the use of 4.3x magnification with technical refinements that are not possible or deemed safe at 2.5x resulted in a substantial decrease in the positive surgical margin rate.

Population-based case-control study of PSA and DRE screening on prostate cancer mortality.

OBJECTIVES: The efficacy of screening for prostate cancer (PCa) with digital rectal examination (DRE) and prostate-specific antigen (PSA) measurement has not been proved in randomized clinical trials. In an earlier case-control study, we found that DRE might reduce PCa mortality. The present case-control study assessed the association between PSA and DRE testing and PCa mortality. METHODS: The case subjects included 74 Olmsted County residents who had died from 1992 to 2005 with PCa as the underlying cause of death. From 1 to 3 community control subjects (alive at time of case subject's death) were matched to each case subject. The medical records were reviewed to identify DREs and PSA determinations performed 0 to 5 years before the date the case was diagnosed (index date). Tests performed in the absence of symptoms were considered to be "screening tests." Conditional logistic regression analysis was used to estimate the odds ratios and 95% confidence intervals for the association of screening (defined in multiple ways) and PCa mortality. RESULTS: From 1 to 5 years before the index date, control subjects were more likely than case subjects to have undergone a previous screening PSA test or DRE (81.3% versus 60.8%, P = 0.0005). The unadjusted odds ratio associated with a previous screening PSA test or DRE was 0.34 (95% confidence interval 0.18 to 0.63), and the odds ratio adjusted for potential confounders was 0.35 (95% confidence interval 0.17 to 0.71). PSA testing was frequently done in conjunction with DRE, making evaluation of the individual effects difficult. CONCLUSIONS: The results of this case-control study suggest a potential benefit of screening by PSA testing and/or DRE on PCa mortality.