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.

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.

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.

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.

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.

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.

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.

Diagnosis of obesity by primary care physicians and impact on obesity management.

OBJECTIVE: To evaluate whether primary care physicians document obesity as a diagnosis and formulate a management plan. PATIENTS AND METHODS: The Mayo Clinic primary care database was used to identify general medical examinations performed from November 1, 2004, to October 31, 2005, in a primary care clinic for obese patients (body mass index [BMI] equals 30). Data on demographic variables, BMI, comorbidities, documentation of obesity, and obesity management strategy were obtained through the database. Multivariate logistic regression analyses were conducted to estimate multivariate odds ratios (ORs) and 95 percent confidence intervals (CIs). RESULTS: A total of 9827 patients were seen for a general medical examination. Of the 2543 obese patients, 505 (19.9 percent) had a diagnosis of obesity documented, and 574 (22.6 percent) had an obesity management plan documented. Older patients (OR, 0.97 per year; 95 percent CI, 0.96-0.98) and men (OR, 0.60; 95% CI, 0.47-0.76) were significantly less likely to be diagnosed as having obesity, whereas those with a BMI greater than 35 (OR, 2.54; 95 percent CI, 2.10-3.16), diabetes mellitus (OR, 1.40; 95 percent CI, 1.09-1.78), and obstructive sleep apnea (OR, 2.34; 95 percent CI, 1.79 to 3.07) were significantly more likely to have the diagnosis made. Staff physicians were less likely than residents to document obesity as a diagnosis (OR, 0.55; 95 percent CI, 0.44 to 0.69). Diagnosis of obesity was the strongest predictor of formulation of an obesity plan (OR, 2.39; 95 percent CI, 1.90 to 3.02). CONCLUSION: Most obese patients did not have a diagnosis of obesity or an obesity management plan made by their primary care physician. Diagnosis of obesity results in a higher chance of formulation of an obesity plan.

Stratification of patient risk based on prostate-specific antigen doubling time after radical retropubic prostatectomy.

OBJECTIVE: To assess the risk of local recurrence, systemic progression, and death from cancer among patients who experience biochemical relapse after radical retropubic prostatectomy and to stratify those patients by prostate-specific antigen (PSA) doubling time (DT). PATIENTS AND METHODS: We identified patients who experienced biochemical recurrence (defined as a PSA level < or =0.4 ng/mL) after radical prostatectomy from January 1, 1990, to December 31, 1999, for prostate adenocarcinoma. The PSA-DT was calculated by log linear regression using all PSA values within 2 years of biochemical recurrence. Local recurrence- and systemic progression- free survival and cancer-specific survival were estimated using the Kaplan-Meier method and analyzed by the log-rank test and Cox models. RESULTS: Biochemical recurrence was noted in 1521 (27%) of 5533 men during the follow-up period. Of the 1064 patients with a calculable PSA-DT, 322 (30%) had a PSA-DT of less than 1 year, 357 (34%) had a PSA-DT of 1 to 9.9 years, and 385 (36%) had a PSA-DT of 10 years or more. Patients with a PSA-DT of 10 years or more were less likely to have a higher preoperative PSA level, Gleason score, advanced pathologic stage, and seminal vesicle invasion. Patients with a PSA-DT of 10 years or more were at low risk of local recurrence (hazard ratio [HR], 0.09; 95% confidence interval [CI], 0.06-0.14; compared with patients with a PSA-DT of <1 year), systemic progression (HR, 0.05; 95% CI, 0.02-0.13), or death from cancer (HR, 0.15; 95% CI, 0.05-0.43). CONCLUSIONS: Prostate-specific antigen DT is an independent predictor of clinical disease recurrence and mortality after surgical biochemical failure. Risk stratification into high-, intermediate-, and low-risk categories based on the PSA-DT provides helpful clinical information and assists in the development of salvage therapy trials.

Correlating routine cytology, quantitative nuclear morphometry by digital image analysis, and genetic alterations by fluorescence in situ hybridization to assess the sensitivity of cytology for detecting pancreatobiliary tract malignancy.

Routine cytologic (RC), fluorescence in situ hybridization (FISH), digital image analysis (DIA), and quantifiable morphometric results from 284 pancreatobiliary stricture brushings were compared. We chose specific DIA nuclear features assessed by pathologists in evaluating RC specimens, such as area and shape. A visual nuclear morphometric score (VNMS) was calculated. There was a difference (P < .001) in the mean VNMS when RC results were classified as negative (11.5), atypical (12.5), suspicious (13.8), and positive (16.5). The mean VNMS of specimens diagnosed as disomy (11.3), trisomy 7 (12.1), and polysomy (14.7) by FISH was also different (P < .001). There was no difference in the VNMS of false-negative and true-negative cytologic specimens (P = .225). Our findings substantiate the relationship between cell nuclear visual alterations and genetic FISH abnormalities. The low sensitivity of cytologic examination for pancreatobiliary carcinoma is due to an absence of tumor cells or the presence of well-differentiated tumor lacking recognizable nuclear atypia.

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.

Satisfaction after contralateral prophylactic mastectomy: the significance of mastectomy type, reconstructive complications, and body appearance.

PURPOSE: Contralateral prophylactic mastectomy (CPM) is one option for reducing the risk of a second breast cancer in women with a personal and family history of breast cancer. Few data are available regarding satisfaction, psychological, and social function after CPM. The purpose of this research is to evaluate women's long-term satisfaction with CPM, factors influencing satisfaction, and psychological and social function after CPM. PATIENTS AND METHODS: This was a descriptive study of all women with a family history of breast cancer, known to be alive, who elected CPM at Mayo Clinic (Rochester, MN) between 1960 and 1993 (n = 621). Ninety-four percent of the women (n = 583) completed a study-specific questionnaire. RESULTS: A mean of 10.3 years after the procedure, the majority of women (83%) were satisfied with their CPM. A smaller number were neutral (8%) or dissatisfied (9%). Women who had a subcutaneous mastectomy had more problems with reconstruction, and fewer of these women were satisfied than women with simple mastectomy. Decreased satisfaction with CPM was associated with decreased satisfaction with appearance, complications with reconstruction, reconstruction after CPM, and increased level of stress in life. The majority of women experienced no change or favorable effects in self-esteem (83%), level of stress in life (83%), and emotional stability (88%). Satisfaction with body appearance, feelings of femininity, and sexual relationships were the most adversely affected with 33%, 26%, and 23% of the women responding negatively. CONCLUSION: Although most women are satisfied with CPM, each woman should weigh the benefits alongside the potential adverse effects.

Diabetes mellitus and the risk of urinary tract stones: a population-based case-control study.

BACKGROUND: Because nephrolithiasis has been associated with obesity, an important risk factor for type 2 diabetes mellitus (DM), we tested the hypothesis that DM prevalence is increased in individuals who develop renal stones. METHODS: In an initial electronic analysis, prior diagnoses of DM, hypertension, and obesity were compared between all Olmsted County, MN, residents with a diagnosis code for nephrolithiasis between 1980 and 1999 and matched residents of similar age and sex (N = 3,561 case-control pairs). A random sample of 260 cases and corresponding controls was selected for detailed medical record review to confirm and characterize the stone event and obtain heights, weights, blood pressures, and glucose and cholesterol values. RESULTS: In the electronic analysis, unadjusted odds ratios (ORs) for DM (OR, 1.29; 95% confidence interval [CI], 1.09 to 1.53), obesity (OR, 1.15; 95% CI, 1.02 to 1.31), and hypertension (OR, 1.19; 95% CI, 1.04 to 1.35) were increased significantly for nephrolithiasis cases versus controls; DM remained significant after adjustment for age, sex, calendar year, hypertension, and obesity (OR, 1.22; 95% CI, 1.03 to 1.46). Detailed record review of a subset showed significant increases for cases versus controls for body mass index (OR, 1.05; 95% CI, 1.01 to -1.09) and hypertension (OR, 1.71; 95% CI, 1.17 to 2.59). Odds for DM were increased, but not significantly, in the subsample (OR, 1.44; 95% CI, 0.76 to 2.72). Among cases with stone analyses, those with uric acid stones (n = 10) had a greater percentage of DM compared with those with all other stone types (n = 112; 40% versus 9%; P = 0.02). CONCLUSION: Findings from this population-based study suggest that DM, obesity, and hypertension are associated with nephrolithiasis, and DM may be a factor in the development of uric acid stones.

Follow-up study of long-term survivors of osteosarcoma in the prechemotherapy era.

Osteosarcoma is the most common primary bone sarcoma. Several studies published in the 1960s established that approximately one fifth of patients survive when treated with surgery alone. There is no information, however, about the long-term consequences of osteosarcoma. It is especially relevant to know if these patients are at risk for a second malignancy. We reviewed all clinical records from long-term (defined as more than 10 years) osteosarcoma survivors treated at Mayo Clinic in the prechemotherapeutic era from 1900 to 1960. We re-reviewed histological sections for most cases. Patients or next of kin provided follow-up information during telephone interviews. Rates of second malignancy were compared with expected rates in the population at large. We identified 465 patients treated for osteosarcoma. Of these patients, 83 (17.8%) were long-term survivors, including 19 who were alive up to 65 years after treatment. Of the 7 patients with pulmonary metastases, 3 died. A second malignancy developed in 26 patients, 15 of whom died of the malignancy. Although long-term survivors of osteosarcoma have a higher incidence of a second malignant tumor than a normal population, this increase was not statistically significant. No demographic or histological variables predicted long-term survival.

Correlations between measures of insulin sensitivity and weight loss.

OBJECTIVE: Many formulas have been proposed to calculate insulin sensitivity and studies have shown their effectiveness. However, few studies have been done to compare formulas. METHODS: Seventy-two obese participants completed a randomized weight loss study. Weight loss, change in body fat and change in waist circumference were used as surrogates for change in insulin sensitivity. Correlation coefficients were calculated for each of these surrogates with proposed formulas for insulin sensitivity found in the literature. RESULTS: The change in insulin sensitivity using the formula proposed by McAuley (exp(2.63-0.28 x ln(fasting insulin)-0.31 x ln(fasting triglyceride in mmol/l)) showed the greatest correlation with weight loss (r=-0.59, p<0.0001) and was statistically superior to change in fasting glucose, fasting insulin and homeostasis model assessment (HOMA). CONCLUSIONS: The insulin sensitivity formula proposed by McAuley provides an accurate means of detecting insulin resistance. As it does not require a glucose tolerance test, it is also easier and less expensive than most other formulas. Use of this formula rather than fasting glucose would detect many more patients with insulin resistance who are at risk for subsequent diabetes and other complications.