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Background/Objective: Stroke patients may be unable to provide medical history. Given the urgency of decision-making in acute stroke and importance of medication compliance post-stroke, prompt access to prior health records could reduce delays and errors. We hypothesized that stroke patients often have fragmented care in the Chicago Health Atlas. Methods: The Chicago Health Atlas encompasses clinical data on over 1 million unique patients within the 606xx ZIP codes of Chicago. A unique ID is created for each patient through the use of a secure one-way hash function. The creation of a unique ID enables longitudinal tracking of a patient’s care across participating sites. We identified all acute stroke admissions to any of 4 Chicago Health Atlas hospitals using ICD-9 codes (430-436) and searched for prior inpatient or outpatient encounters at any of those sites. Fragmented care was defined as having prior encounters at a site different from the site of stroke hospitalization. In the same cohort, we assessed post-hospitalization outpatient encounters within the Health Atlas. Results: There were 5,980 stroke patients with emergency department or inpatient visits between 2006 and 2010. Of these, 3,732 (62.4%, mean age 61.1 years, 47% black) had non-fragmented care prior to stroke while 2,066 (34.5%, mean age 58.1 years, 31% black) were completely new encounters (first-ever) in the Health Atlas and only 182 (3.0%, mean age 57.5 years, 59% black) had fragmented care. The percent with fragmented care increased from 1.3% in 2006 to 3.3% in 2010 (p Conclusions: Two-thirds of stroke patients have previously accessed the health care system, with a majority having records at the same site of stroke hospitalization. However, 3% of patients have fragmented care, a rate that is increasing over time. Our estimate of fragmentation may be an underestimate since only 4 sites were included in this analysis. Having health information exchange may be valuable in reducing fragmentation of care for stroke patients.

We sought to examine a large nationwide (United States) sample of emergency department (ED) visits to determine data related to utilization and costs of care for urolithiasis in this setting.Nationwide Emergency Department Sample was analyzed from 2006 to 2009. All patients presenting to the ED with a diagnosis of upper tract urolithiasis were analyzed. Admission rates and total cost were compared by region, hospital type, and payer type. Numbers are weighted estimates that are designed to approximate the total national rate.An average of 1.2 million patients per year were identified with the diagnosis of urolithiasis out of 120 million visits to the ED annually. Overall average rate of admission was 19.21%. Admission rates were highest in the Northeast (24.88%), among teaching hospitals (22.27%), and among Medicare patients (42.04%). The lowest admission rates were noted for self-pay patients (9.76%) and nonmetropolitan hospitals (13.49%). The smallest increases in costs over time were noted in the Northeast. Total costs were least in nonmetropolitan hospitals; however, more patients were transferred to other hospitals. When assessing hospital ownership status, private for-profit hospitals had similar admission rates compared with private not-for-profit hospitals (16.6% vs 15.9%); however, costs were 64% and 48% higher for ED and inpatient admission costs, respectively.Presentation of urolithiasis to the ED is common, and is associated with significant costs to the medical system, which are increasing over time. Costs and rates of admission differ by region, payer type, and hospital type, which may allow us to identify the causes for cost discrepancies and areas to improve efficiency of care delivery.

Objective To determine the temporal relationship between vasectomy, varicocele, and hypogonadism diagnosis. Many young men undergo their first thorough genitourinary examination in their adult lives at the time of vasectomy consultation, providing a unique opportunity for diagnosis of asymptomatic varicoceles. Varicoceles have recently been implicated as a possible reversible contributor to hypogonadism. Hypogonadism may be associated with significant adverse effect, including decreased libido, impaired cognitive function, and increased cardiovascular events. Early diagnosis and treatment of hypogonadism may prevent these adverse sequelae. Methods Data were collected from the Truven Health Analytics MarketScan database, a large outpatient claims database. We reviewed records between 2003 and 2010 for male patients between the ages of 25 and 50 years with International Classification of Diseases , Ninth Revision codes for hypogonadism, vasectomy, and varicocele, and queried dates of first claim. Results A total of 15,679 men undergoing vasectomies were matched with 156,790 men with nonvasectomy claims in the same year. Vasectomy patients were diagnosed with varicocele at an earlier age (40.9 vs 42.5 years; P = .009). We identified 224,817 men between the ages of 25 and 50 years with a claim of hypogonadism, of which 5883 (2.6%) also had a claim of varicocele. Men with hypogonadism alone were older at presentation compared with men with an accompanying varicocele (41.3 [standard deviation ± 6.5] vs 34.9 [standard deviation ± 6.1]; P Conclusion Men undergoing vasectomies are diagnosed with varicoceles at a younger age than age-matched controls. Men with varicoceles present with hypogonadism earlier than men without varicoceles. Earlier diagnosis of varicocele at the time of vasectomy allows for earlier detection of hypogonadism.

Introduction The epidemiology of priapism is not well characterized. A small number of studies based on inpatient data or small population samples have estimated the incidence to range from 0.34 to 1.5 cases per 100,000 males. Aim To estimate the current epidemiology and impact on resource utilization of priapism in the United States (US). Main Outcome Measures Rate of emergency department encounters for priapism in the US. Methods Emergency department (ED) visits for priapism were analyzed using discharge data from the Nationwide Emergency Department Sample (NEDS), Healthcare Cost and Utilization Project (HCUP). Priapism encounters were identified by ICD9 code. Priapism encounters were analyzed for patient and hospital characteristics, associated diagnoses, and hospital charge. Established weighting in the sample was used to calculate nationwide estimates. Results A total of 8,738 ED encounters for priapism were identified between 2006 and 2009 in the NEDS. This translated to an estimated 39,964 encounters out of a total of 496,195,793 ED visits, or 8.05 per 100,000 ED visits (95% confidence interval [CI] 7.59–8.51). 21.1% of patients had a concurrent diagnosis of sickle cell disease (SCD). 72.1% of all patients were discharged home from the ED, while only 49.6% of patients with SCD were discharged home. A concurrent diagnosis of SCD was associated with an odds ratio (OR) of 3.84 (95% CI 3.65–4.05) for admission to the hospital when controlling for age, region, hospital and payer type. The mean hospital charge was $1,778 per encounter if discharged home and $41,909 per encounter if admitted. The estimated mean total annual charge for priapism was $123,860,432 with 86.8% of charges attributed to inpatient admissions. Conclusions Our estimate of the rate of ED visits for priapism was significantly higher than prior estimates with a SCD concurrence rate lower than previously estimated. Stein DM, Flum AS, Cashy J, Zhao LC, and McVary KT. Nationwide emergency department visits for priapism in the United States. J Sex Med 2013;10:2418–2422.

Testosterone replacement therapy is commonly used to treat men with hypogonadism. However, there has been caution in using testosterone replacement therapy in men with moderate to severe lower urinary tract symptoms for fear of worsening the symptoms. In this study we examine the effect of testosterone replacement therapy on lower urinary tract symptoms in hypogonadal men.We retrospectively reviewed our outpatient database and identified patients with a diagnosis of hypogonadism who received testosterone replacement therapy from 2002 to 2012. Lower urinary tract symptoms were assessed using the AUASI (American Urological Association symptom index) before and after testosterone replacement therapy. Testosterone and prostate specific antigen were also continuously measured, and all patients were closely monitored for side effects of testosterone replacement therapy. Patients who had progression of lower urinary tract symptoms to the point of requiring surgery were included in the study.We identified 120 hypogonadal men who received testosterone replacement therapy, the majority of whom had topical therapy or a combination of topical and pellet based therapy (57.5% and 20.8%, respectively). Mean baseline AUASI (±SD) was 10.8 (±7.8) and mean duration of testosterone replacement therapy was 692 days (±773). Mean change in AUASI was -1.07 (±6.06). Mean baseline prostate specific antigen was 1.6 ng/dl (±1.9) and mean change in prostate specific antigen was 0.44 (±2.2). Of the patients 8.1% had a baseline prostate specific antigen greater than 4.0 ng/dl, and these patients had greater improvement in AUASI than those with a baseline prostate specific antigen less than 4.0 ng/dl (-1.9 vs -1.0, p not significant). Overall 45.8% of patients had a less than 3-point change in AUASI in either direction. Of the 120 patients 38 (31.7%) had improvement in AUASI 3 or more points while 27 (22.5%) had worsening of AUASI 3 or more points. Patients with an improved AUASI had a mean prostate specific antigen change of 0.3 (±3.4), while those who had worsening of AUASI had a mean prostate specific antigen change of 0.7 (±2.2) (p not significant). Approximately 9 of 120 (7.5%) of these men initiated new medications for lower urinary tract symptoms during the course of the study. There was no significant change in AUASI compared to patients without any use of lower urinary tract symptoms medications. In addition, 4 (3.3%) patients had progression of lower urinary tract symptoms and required transurethral resection of the prostate.We demonstrate that initiating testosterone replacement therapy in hypogonadal men involves a low risk of worsening lower urinary tract symptoms. In fact, many men experience symptom improvement while changes in prostate specific antigen appear minor. Future research should focus on larger patient population studies to further examine this relationship.

To elucidate disease associations and possible etiology of lichen sclerosus (LS), we identified comorbidities present in men with LS. LS is a chronic inflammatory disease of unknown etiology affecting genitals and urethra of men commonly resulting in strictures. Men with LS of the urethra, penis, prepuce and scrotum were identified. A control population was generated from men seen in the Department of Urology matched by age and race in a 5:1 ratio. A case–control study was performed and comorbidities identified by ICD9, CPT codes and medication use via systematic electronic medical record review. Subgroup analysis of men with urethral strictures was performed based on their LS status. Men with LS had a significantly higher mean body mass index [31.0 (range 18.9–52.6)] compared to controls [28.1 (16.8–64.1), p = 0.001], significantly increased rate of coronary artery disease (CAD) (15.3 vs. 8.9 %, p = 0.05) as well as a twofold higher rate of diabetes mellitus (15.5 vs. 8.3 %, p = 0.02). Of men with LS and stricture disease, 11/19 (58 %) were current or former smokers, compared to 28 % of men with strictures without LS (p = 0.006). No association of LS with other morbidities like hyperlipidemia, hypertension, cerebrovascular disease, peripheral vascular disease or dermatologic disorders was found. Men suffering from LS have an increased BMI and a higher prevalence of concomitant CAD, diabetes mellitus and tobacco use. Development and chronicity of LS may not be a purely dermatologic condition, but be associated or confounded by systemic or vascular compromise from disorders of CAD, DM and smoking.

Despite the recent advances in cancer therapeutics for lymphoma (Lym), a continuum of disease, treatment and psychological challenges, adversely impacting health-related quality of life, remain for the clinical management of the patient with Lym. In response, this study presents the development and validation of the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) Lymphoma Symptom Index-18 (FLymSI-18). Patients with advanced Lym (n = 50) rated the significance of 40 symptoms, and hematologist-oncologists (n = 10) rated these symptoms according to importance and disease-related or treatment-related origin. Patient symptom priorities were unified with clinician priorities for symptom measurement in Lym for instrument development. Reliability estimates indicate that FLymSI-18 has acceptable internal consistency (α = 0.87), content validity and concurrent validity as indicated by moderate to strong correlations with the FACIT (Functional Assessment of Chronic Illness Therapy). Overall, the FLymSI-18 provides evidence for its reliability and validity as a brief assessment of the most important symptoms associated with advanced Lym in the clinical trial research environment.

Objective To describe the longitudinal demographics and family planning attitudes of vasectomized men with the use of the National Survey for Family Growth (NSFG). Design Retrospective cohort analysis of the NSFG with the use of national projections and multivariable regressions. Setting In-home survey. Patient(s) The NSFG sampled 10,403 men aged 15–45 years from 2006 to 2010 regarding family planning attitudes. Intervention(s) None. Main Outcome Measure(s) Vasectomy and desire for children. Result(s) There were 3,646,339 (6.6%) vasectomized men aged 18–45 years in the U.S. On multivariable regression the following factors increased the odds of having a vasectomy: currently married (odds ratio [OR] 7.814), previously married (OR 5.865), and increased age (OR 1.122) and income (OR 1.003). The odds of having a vasectomy increased with number of children. The following factors decreased the odds of having a vasectomy: immigrant status (OR 0.186), African American (OR 0.226), Hispanic (OR 0.543), Catholic (OR 0.549), and other non-Protestant religion (OR 0.109). Surprisingly, an estimated 714,682 (19.6%) vasectomized men in the U.S. desire future children. Men practicing a religion (OR 8.575–15.843) were more likely than atheists to desire children after vasectomy. 71,886 (2.0%) vasectomized men reported having a vasectomy reversal. Conclusion(s) This study highlights the importance of preoperative counseling for permanency of vasectomy and reveals an opportunity to counsel couples about vasectomy versus tubal ligation.

Objective To evaluate the presence of spermatogenesis in orchiectomy specimens of patients with testicular cancer to determine possible predictors of success with oncologic testicular sperm extraction of the cancerous testis at orchiectomy. Materials and Methods We retrospectively reviewed the pathology reports and slides from 83 men who underwent radical orchiectomy for testicular cancer at 2 institutions from 1999 to 2010. The presence or absence of spermatogenesis in each specimen was determined. Data on tumor histopathologic type, serum tumor markers, and tumor size were also obtained and analyzed to detect any associations with the presence of spermatogenesis. Results The 83 specimens included 41 pure seminomas, 36 nonseminomatous and mixed germ cell tumors, and 6 benign lesions. Overall, spermatogenesis was detected in 48 of 77 (62%) cancerous specimens. Spermatogenesis was present in 22 of 41 (54%) pure seminomas and 26 of 36 (72%) nonseminomatous and mixed germ cell tumors, with no significant difference found between the 2 subtypes (P = .11). No association was found between tumor marker levels and the presence of spermatogenesis. A logistic regression model revealed a statistically significant inverse relationship between tumor size and spermatogenesis presence (P = .004). Conclusion At orchiectomy, most cancerous testes contained active spermatogenesis and, thus, represent a viable source for sperm cryopreservation with oncologic testicular sperm extraction. A small tumor size proved to be a positive prognostic indicator for the presence of spermatogenesis, although a larger tumor size did not preclude the presence of spermatogenesis.

To use the national Surveillance, Epidemiology, and End Results (SEER) cancer registry to describe the natural history, national incidence and treatment patterns for ductal prostate cancer (PCa) over the last 20 years, as the available literature on ductal PCa is limited to small case series because of few patient numbers.From the SEER registry, 693 men with ductal PCa were identified from 1970. The demographics, clinical features and cause of death data were collected from men with ductal and acinar histological types.The incidence of ductal PCa has increased over each decade, but the overall percentage of ductal relative to acinar PCa has remained stable. Men with ductal PCa were more likely to present with advanced disease (30% T3 with ductal PCa, compared with 7% with acinar PCa). Men with ductal PCa underwent similar rates of radical surgery, lower rates of radiotherapy but a higher frequency of outlet (transurethral resection) procedures. Men with ductal PCa had a significantly greater rate of death from PCa (12% vs 4%) than men with acinar PCa. Comparing PCa-specific mortality, men with ductal PCa had similar rates of death to men with Gleason 4 + 4 grade acinar PCa.Despite a stable incidence, ductal PCa remains an aggressive PCa usually presenting with advanced clinical stage and resulting in a high rate of PCa-specific mortality similar to Gleason 4 + 4 acinar PCa. Patients would probably benefit from combined modalities including radical surgery, radiotherapy and palliative outlet procedures.

Survival to reproductive age among men with cancer has steadily increased and yet cancer therapy and cancer itself may carry the risk of infertility. Since 2006, we have used a formalized fertility preservation program with expedited fertility care at our institution. We assessed the impact of this program by comparing the frequency of sperm cryopreservation and patient characteristics before and after its implementation.Men 18 to 55 years old diagnosed with cancer at our institution from 2002 to 2010 were included in our study. We retrospectively reviewed patient charts to identify those who were offered and subsequently used fertility preservation services before and after program formalization.From 2002 to 2010 at our institution 4,818 men 18 to 55 years old were diagnosed with cancer, of whom 411 were offered fertility preservation consultation and 249 underwent sperm cryopreservation. Since program implementation, the annual number of men receiving fertility preservation consultation and undergoing sperm cryopreservation increased by 2.4 and 2.7-fold, respectively, while the total number diagnosed with cancer remained fairly constant. Upon substratifying patients into the more conventional reproductive age range of 18 to 40 years 23.4% of all men with cancer in this group were offered consultation before formalization vs 43.3% after formalization (p0.05). The overall sperm use and discard rates were 8.4% and 14.8%, respectively.A formalized institutional fertility preservation program significantly increased the overall number and percent of male patients with cancer who received fertility preservation consultation and pursued sperm cryopreservation. These increases were seen in men with all types of cancer and across all demographics assessed at our institution.

We determined whether data mining derived algorithms from electronic databases can improve empirical antimicrobial therapy in outpatients with a urinary tract infection.The electronic medical records from 3,308 visits associated with a positive urine culture at Northwestern's outpatient Urology and Internal Medicine clinics and Emergency Department from 2005 to 2009 were interrogated. Bacterial species and susceptibility rates for trimethoprim-sulfamethoxazole, ciprofloxacin and nitrofurantoin were compared. Using data mining techniques we created algorithms for empirical therapy of urinary tract infections and compared the theoretical outcomes from data mining derived therapy to those from conventional therapy.Patients were significantly older in the Department of Urology vs Internal Medicine vs Emergency Department, and more patients in the Department of Urology were male. During the 5-year period the susceptibility rates for ciprofloxacin in the Department of Urology and trimethoprim-sulfamethoxazole in Internal Medicine decreased significantly. In the Department of Urology the susceptibility rate for nitrofurantoin was greater than for ciprofloxacin, which was greater than for trimethoprim-sulfamethoxazole. In all departments, bacteria were more resistant to trimethoprim-sulfamethoxazole than to ciprofloxacin or nitrofurantoin. All drugs were more effective in the Emergency Department and Internal Medicine than the Department of Urology. Prior resistance patterns were the strongest predictor of current susceptibility profiles. In the Department of Urology the algorithms for patients with or without prior cultures theoretically outperformed conventional therapy in men (13.2%) and women (10.1%).Antimicrobial resistance patterns in outpatient urinary tract infections are time dependent, and drug and site specific. Data mining directed therapy significantly improved theoretical outcomes compared to conventional therapy for Department of Urology outpatients and for female patients in the Emergency Department.

INTRODUCTION AND OBJECTIVES: Small cell bladder cancer (SCBC) is a rare and aggressive histologic subtype of bladder cancer thought to be derived in part from neuroendocrine cells. Given its rarity, the natural history, prognosis, and response to treatment have not been described. METHODS: From the Surveillance, Epidemiology and End Results (SEER) National Cancer Registry, 498 patients with SCBC were identified between the year of 1998 and 2007. For comparison, 33624 patients with urothelial bladder cancer (UC) were identified for comparison. RESULTS: The incidence of SCBC has increased over time from 0.8% to 2% of all cases of bladder cancer (p 0.0001) with an absolute increase of 14 to 77 cases per year from 1998 to 2007. The median age of diagnosis was 72 years, and 80% were male compared to 74% male of UC. The majority of patients with SCBC were white (89%). SCBC was more aggressive, with greater frequency of high grade compared to UC (42% vs. 31%), and muscle invasive disease at presentation (T2, 45% vs. 31%, p 0.001). In terms of treatment, a similar percentage of patients underwent radical cystectomy (18% with SCBC vs 19% with UC) and 19% had a lymph node dissection. Patients with SCBC were more likely to receive adjuvant radiotherapy (23% vs. 9%). Patients with SCBC had a higher rate of metastatic disease to regional lymph nodes (19% vs. 10%), with SCBC patients having higher rates of N1 (13% vs. 7%), N2 (6% vs. 3%) and N3 (0.4% vs. 0.3%) disease. Distant metastasis were present in 18% of SCBC compared to 7.5% in UC. At the time of diagnosis, 18% of patients with SCBC and only 8% of UC had evidence of metastatic disease. A significantly higher percentage of patients with SCBC died of bladder cancer compared to UC (54% vs. 32%, p 0.0001). For nearly every stage, SCBC had a higher cancer specific mortality including T1 (25% vs 14%, p 0.06), T2 (43% vs. 35%, p 0.04) and T3 (55% vs. 38%, p 0.02). Of those patients that died of bladder cancer, the mean time of survival was significantly shorter for SCBC (11 months vs. 15 months, p 0.0001). CONCLUSIONS: SCBC is a rare and aggressive form of bladder cancer, with increasing incidence. Compared to standard UC, SCBC has a higher grade, stage, rate of metastasis and cancerspecific mortality. Patients with SCBC may benefit from early aggressive multi-modal therapy.

for unilateral adrenalectomies and 80 ml (50–300ml) for bilateral ones. No major complication occurred. The median time to discharge was 3 days (range 2 to 6). The median tumor size was 5,5 cm (range 3.5 to 10). The pathologic analysis revealed renal cell carcinoma metastases in 10 patients and transitional cell carcinoma metastases in two men who underwent bilateral laparoscopic adrenalectomy. Metastasis from papillary renal cell carcinoma, poorly differentiate lung carcinoma, colorectal carcinoma and melanoma were respectively detected in the other four patients. Surgical margins were negative in all patients and local recurrence occurred in one patient. At a mean follow-up of 39 months 75% of patients were alive and 25% were disease free. The mean time to recurrence was 15 months (range 4–50). When analyzed for primary tumor histology, recurrence free survival rate in the group of patients with renal cell carcinoma metastasis was 40% and cancer specific survival rate was 91%. No patients with primary tumor histology different by renal cell carcinoma was recurrence free and 4 out of 5 five patients died of disease. CONCLUSIONS: Laparoscopic removal of adrenal metastasis is minimally invasive and oncologically effective. The final outcome of patients mainly depends on the primary tumor histology and on the chances of treatment of metastases subsequently developed.

To present our operative and postoperative functional outcomes of sutured compared with endovascular staple ligation of the dorsal venous complex (DVC) during robot-assisted laparoscopic radical prostatectomy (RALP). Ligation of the DVC during RALP with an endovascular stapler has purported advantages of decreased apical positive surgical margin (PSM) rate, blood loss, and operative time when compared with suture ligation.In all, 162 patients who underwent RALP between October 2005 and April 2008 by one surgeon (R.B.N.) were assessed. We retrospectively analysed two different treatment groups: group 1 underwent DVC ligation with a single suture, while group 2 underwent endovascular staple ligation.Of the 162 patients evaluated, 67 had suture ligation (group 1) and 95 had staple ligation (group 2) of the DVC. Baseline patient characteristics (age, body mass index, biopsy Gleason score, clinical stage) and tumour characteristics (specimen weight, tumour volume, pathological Gleason score and stage) did not differ between the groups. Estimated blood loss (494 mL vs 288 mL), time to dissect out, ligate and transect the DVC (30 min vs 24 min), apical PSM rate (13.4% vs 2.1%) differed significantly between groups 1 and 2 respectively, favouring staple ligation of the DVC. At 6 months follow-up, there was no difference between the groups for PSA recurrence (3.7% vs 0%), complete continence (63.4% vs 55.7%) and Sexual Health Inventory for Men score (8.4 vs 8.6).In the present study, staple ligation of the DVC during RALP resulted in improved apical PSM rates, faster operative times and less blood loss.

Anterior urethroplasty has been shown to negatively impact erectile function. Recovery of function is common but the likelihood and extent of recovery have not been fully elucidated.Between October 2006 and May 2008 men undergoing anterior urethroplasty were enrolled in a prospective study to evaluate the effects of urethroplasty on erectile function. The International Index of Erectile Function was completed preoperatively and on all subsequent postoperative visits. Preoperative and postoperative erectile function was compared.A total of 52 patients who underwent anterior urethroplasty were included in the study. Repair locations were bulbar (35) and penile (17). Of the patients undergoing bulbar urethroplasty 20 had excision and primary anastomosis, and 15 had augmented anastomotic repair. All penile repairs were ventral onlay repair (11) or inlay repair in 2 stages (6). Postoperative erectile dysfunction was noted in 20 (38%) men, of whom 18 recovered fully at a mean postoperative period of 190 days (range 92 to 398). In patients with normal preoperative erectile function bulbar urethroplasty was more likely than penile urethroplasty to cause erectile dysfunction (76% vs 38%, p = 0.05). Within the bulbar urethra excision and primary anastomosis repairs led to slightly higher erectile dysfunction rates than augmented anastomotic repairs (50% vs 26%, p = 0.16).Anterior urethroplasty caused erectile dysfunction in approximately 40% of patients, although recovery was seen in most by 6 months. Bulbar urethroplasty appears to affect erectile function to a greater extent than penile urethroplasty, which may be explained by the proximity of the bulbar urethra to the nerves responsible for erection.

Uropathogenic Escherichia coli are the leading cause of urinary tract infection. We recently demonstrated that deletion of the O antigen ligase gene, waaL, from the uropathogenic E. coliisolate NU14 results in a strain that stimulates enhanced urothelial cytokine secretion. Because enhanced innate immune responses are of interest in vaccine development, we examined the therapeutic potential of NU14 DeltawaaL as a vaccine for urinary tract infection. NU14 DeltawaaL stimulated enhanced interleukin-6 secretion by mouse macrophages, compared with secretion by the wild type. Mice vaccinated via instillation into the bladder developed protective responses that prevented persistent colonization after bladder challenge with NU14, yet NU14 DeltawaaL failed to persistently colonize the mouse bladder. Inoculation with the vaccine strain protected mice against challenge with a broad range of clinical uropathogenic E. coli isolates and produced immunity that lasted 8 weeks. Therefore, NU14 DeltawaaL is a candidate live-attenuated vaccine for the treatment and prevention of acute and recurrent urinary tract infection by caused by uropathogenic E. coli.

Introduction Performance status (PS) is a standard functional classification in oncology research and practice. However, despite its widespread use, little is known about the prevalence of poor PS in lung cancer patients, in relation to other cancers, based on the assessments of health care providers and patients. Methods Data from two quality of life studies were pooled for analysis. Analyses were performed on the subset of patients with lung cancer (n = 503) from the entire population of cancer patients (n = 2885). The prevalence of poor PS (defined as PS=2–4 on a 0–4 scale) was determined for lung cancer patients. Results Prevalence of poor PS among lung cancer patients was 34% when estimated by providers and 48% when estimated by patients themselves. Agreement between providers and patients was only fair (weighted [ kappa ] = 0.41). For both advanced and early stage disease, lung cancer patients were at the highest risk for poor PS compared with other common cancers. Conclusions The prevalence of poor PS is quite high in lung cancer patients. Providers tend to underestimate poor PS. Specific clinical trials and treatment guidelines for this patient population are urgently needed.

We performed a genome-wide association scan to search for sequence variants conferring risk of prostate cancer using 1,501 Icelandic men with prostate cancer and 11,290 controls. Follow-up studies involving three additional case-control groups replicated an association of two variants on chromosome 17 with the disease. These two variants, 33 Mb apart, fall within a region previously implicated by family-based linkage studies on prostate cancer. The risks conferred by these variants are moderate individually (allele odds ratio of about 1.20), but because they are common, their joint population attributable risk is substantial. One of the variants is in TCF2 (HNF1beta), a gene known to be mutated in individuals with maturity-onset diabetes of the young type 5. Results from eight case-control groups, including one West African and one Chinese, demonstrate that this variant confers protection against type 2 diabetes. AD - [1] deCODE genetics, Sturlugata 8, 101 Reykjavik, Iceland. [2] These authors contributed equally to this work.

Contains fulltext : 51723.pdf (Publisher’s version ) (Closed access) Prostate cancer is the most prevalent noncutaneous cancer in males in developed regions, with African American men having among the highest worldwide incidence and mortality rates. Here we report a second genetic variant in the 8q24 region that, in conjunction with another variant we recently discovered, accounts for about 11%-13% of prostate cancer cases in individuals of European descent and 31% of cases in African Americans. We made the current discovery through a genome-wide association scan of 1,453 affected Icelandic individuals and 3,064 controls using the Illumina HumanHap300 BeadChip followed by four replication studies. A key step in the discovery was the construction of a 14-SNP haplotype that efficiently tags a relatively uncommon (2%-4%) susceptibility variant in individuals of European descent that happens to be very common (approximately 42%) in African Americans. The newly identified variant shows a stronger association with affected individuals who have an earlier age at diagnosis.

Fatigue, a common symptom of cancer patients, particularly those on active treatment, is generally evaluated using self-report methods, yet it remains unclear how self-reported fatigue scores relate to performance of daily activities. This study examines the relationships among self-reported and performance-based measures of function in patients receiving chemotherapy (CT) to link self-reported fatigue measures to self-report and performance-based measures of function. Self-reported fatigue using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and self-reported physical function using the physical function 10 subscale of the Short Form 36 (SF-36) (PF-10) were measured in 64 patients within 2 weeks of beginning CT (n=64) and after three cycles of CT (n=48). Motor and cognitive functions were captured using five self-reported and seven observed-performance measures at each time point. Significant correlations between self-reported and observed measures ranged from 0.30 to 0.71. Self-reported fatigue correlated (0.30-0.45) with performance-based function. FACIT-F scores in the range of 30 and below and PF-10 scores in the range of 50 and below were related to an increased difficulty performing everyday activities. Observed measures of physical performance correlate moderately with self-reported fatigue and self-reported physical function. These relationships enable one to begin linking fatigue scores directly to a person's ability to perform everyday activities.

Given the number of new cancer cases diagnosed each year and the increases in survival rates, the importance of having a clinically useful health-related quality of life (HRQOL) instrument has increased. The Functional Assessment of Cancer Therapy-General (FACT-G) is one such instrument that has been used worldwide to assess HRQOL. Previously, the use of the FACT-G had been limited because of a lack of published normative data. Normative data are useful for consumers to place their results in an appropriate context by comparing their scores of individuals or group of individuals to a reference group. Here, we present normative data for the FACT-G for two reference groups: (a) a sample of the general U.S. adult population and (b) a large, heterogeneous sample of adult patients with cancer. In addition, we demonstrate various uses of the normative data.

INTRODUCTION: Health outcomes in oncology have broadened to now include the concept of patient-reported, health-related quality of life (HRQOL). Numerous reliable and well-validated measures are available to choose from, including the Functional Assessment of Cancer Therapy (FACT) measurement system. An important next step in the advancement of the field is translating HRQOL scores into clinically meaningful outcomes for patients, clinicians, and researchers. SIGNIFICANCE: In this study we sought to refine our understanding of clinically meaningful change in HRQOL scores of cancer patients, paying particular attention to the meaning of the direction of change. An earlier study asked patients to first indicate whether they experienced a change in their HRQOL, and if so, to rate the degree of change on a -/-point scale. Overall, patients who reported worsening of HRQOL had considerably larger mean change scores than those who reported improvements. A large percentage of patients reported experiencing no change in HRQOL (46%-63%), yet some of them also (unexpectedly) rated some degree of change. Based on these findings, we hypothesized that the direction of the change would be an important determining factor in patients’ assessment of the meaningfulness of the change. OBJECTIVE: To better understand conflicting responses and to determine whether such findings might be measurement related, we sought to replicate the findings of the first study using a further modification of a global rating of change (GRC) scale, revising it to be a single 15point scale. We also examined the relationship between GRC and the FACT Trial Outcome Index (TOI), which is a combination of the physical and functional well-being subscales along with disease-specific questions. METHODS: We assessed patients with cancer using the FACT-General (FACT-G) instrument with disease-specific additional concerns and an adapted GRC scale. The FACT-G, a measure designed for patients with any form of cancer, contains 27 questions comprising 4 primary HRQOL domains: physical, social/family, functional, and emotional well-being. Disease-specific additional concern subscales contain 7 to 12 items for each of 5 diagnoses (breast, colorectal, lung, head and neck, and prostate cancer). The FACT generates scores for each

Abstract 4541 Background: Allogeneic stem cell transplant (SCT) is currently the standard of care in the consolidative treatment of several hematologic malignancies. Typically after a stem cell transplant the monocytes engraft first, followed by the granulocytes, macrophages and then natural killer cells. Lymphocyte recovery is considered to be an indicator of immune reconstitution during SCT and correlation between rate of recovery of lymphocyte count and patient outcome has been reported in patients after a myeloablative allogeneic transplant. Studies suggest that early lymphocyte recovery may be a predictive marker of engraftment and survival post-myeloablative SCT. However, there is minimal data on lymphocyte recovery after reduced intensity conditioning allogeneic SCT. We report our institutional experience on the correlation between rate of absolute lymphocyte recovery and survival in patients with a hematological malignancy after a reduced intensity conditioning allogeneic SCT. Methods: We performed a retrospective review of all adult patients who underwent reduced intensity conditioning chemotherapy followed by an allogeneic SCT at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University from March 2001 to March 2008. We looked at the post- allograft absolute lymphocyte count (ALC) at 3 different time points – day 15, 21 and 28. Patients were then analyzed based on ALC cutoff values of 200/mm3, 500/mm3 and 1000/mm3. For each of the cutoff values, patients were divided into 2 groups: those with absolute lymphocyte count of less than or equal to the cutoff value and those with ALC of greater than the cutoff value. Results: A total of 131 consecutive patients were included in the analysis; 46.6% were male and 53.4% were female. 51.1% patients underwent matched sibling (MSD) while 48.9% had matched unrelated donor (MUD) SCT. Overall survival was determined in 117 patients; 14 patients were excluded due to incomplete data. At day 15 and 28, patients with an ALC of greater 200/mm3 had a statistically significant overall survival compared to those that were less than 200/mm3, p= 0.016 and p=0.05, respectively. An ALC of greater than 1000/mm3 at day 15 seemed to predict for a worse outcome compared to those with an ALC of less than 1000/mm3 (p=0.008). There were however six times more people in the group with ALC less than 1000/mm3 at day 15, compared to those with ALC greater than 1000/mm3. An ALC of greater than or less than 500/mm3did not significantly appear to affect overall survival at any of the time points evaluated. Conclusion: ALC of greater than 200/mm3 at day 15 and 28 in our patient population appears to be predictive of overall survival after a reduced intensity conditioning stem cell transplant in patients with a hematological malignancy. However, the relationship between ALC and outcome is inconsistent and needs to be explored further in the context of other prognostic factors. Disclosures: No relevant conflicts of interest to declare.

2532 Background: Breast cancers in men (BCM) account for

Background: The FACT-Lym was developed to address the disease-specific quality-of-life (QOL) issues for patients with non-Hodgkin’s lymphoma (NHL). Methods: Items for inclusion in the lymphoma subscale for the FACT instrument were generated from interviews with health care providers and published literature on NHL. Items were selected based on symptom relevance, disease-specificity and clinical relevance. Validation testing was conducted with NHL patients. Patients completed the FACT-Lym and other measures at three timepoints: baseline (T1), 3–7 days (T2), and 8–12 weeks (T3). These patients were also interviewed about item content. Results: From a pool of 69 items, 22 items were selected for testing based on relevance ratings of 17 experts. Items included B symptoms, sleep disturbance, anorexia, pruritus, pain, swelling, dyspnea, fatigue, emotional lability, worries, and uncertainty about the future. 75 NHL patients participated in validation testing (55% female, 59% with indolent disease, and 84% currently receiving treatment). Patient interviews confirmed item relevance and comprehensiveness. Item correlations, expert relevancy ratings, and patient input further reduced the subscale to 15 items. Internal consistency coefficients (alpha) for the 15–item subscale (.80, .86, .83) and test-retest stability (.85) suggest very good reliability. Correlations between the subscale and the SF-36 physical (r=.62) and mental (r=.47) summary scores reflect concurrent validity. Responsiveness to ECOG performance status rating and treatment status (on vs. off) equaled or exceeded that of the more established FACT subscale scores. From T1 to T3, subscale scores declined (−6.8, effect size= −0.86) in 14 patients who reported themselves as worsened, increased (3.9, effect size= 0.49) in 28 patients who reported themselves as improved, and did not change (−0.2, effect size= −0.02) in 18 patients who reported themselves as unchanged. Conclusions: The FACT-Lym addresses QOL concerns that are relevant to NHL patients and is reliable and valid for use in clinical research.