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Study Objective To compare resident, fellow, and attending urologic and gynecologic surgeons' musculoskeletal and mental strain during laparoscopic and robotic sacrocolpopexy. Design Prospective cohort study (Canadian Task Force classification II-2). Setting Academic medical center. Patients Patients who underwent robotic or laparoscopic sacrocolpopexy from October 2009 to January 2011. Interventions The Body Part Discomfort (BPD) survey was completed before cases, and the National Aeronautics and Space Administration Task Load Index and BPD survey were completed after cases. Higher scores on BPD and the National Aeronautics and Space Administration Task Load Index indicate greater musculoskeletal discomfort and mental strain. BPD scores were averaged over the following body regions: head/neck, back, hand/wrist, arms, and knees/ankles/feet. Changes in body region–specific discomfort scores were the primary outcomes. Measurements and Main Results Multivariable analysis was performed using mixed-effects linear regression with surgeon as a random effect. Sixteen surgeons participated (53% fellows, 34% residents, and 13% attendings). Thirty-three robotic and 53 laparoscopic cases were analyzed, with a median surgical time of 231 minutes (interquartile range, 204–293 minutes) versus 227 minutes (interquartile range, 203–272 minutes; p = .31), a median estimated blood loss of 100 mL (interquartile range, 50–175 mL) versus 150 mL (interquartile range, 50–200 mL; p = .22), and a mean patient body mass index of 27 ± 4 versus 26 ± 4 kg/m 2 (p = .26), respectively. Robotic surgeries were associated with lower neck/shoulder (−0.19 [interquartile range, −0.32 to −0.01], T = −2.49) and back discomfort scores (−0.35 [interquartile range, −0.58 to 0], T = −2.38) than laparoscopic surgeries. Knee/ankle/foot and arm discomfort increased with case length (0.18 [interquartile range, 0.02–0.3], T = 2.81) and (0.07 [interquartile range, 0.01–0.14], p = .03), respectively. Conclusion Surgeons performing minimally invasive sacrocolpopexy experienced less neck, shoulder, and back discomfort when surgery was performed robotically.

To study the relationship between health literacy (HL) and socioeconomic, demographic factors and disease-specific illness beliefs among patients who present to the emergency department with heart failure (HF).Maintenance of well-being for patients with HF is partially dependent on appropriate self-care behaviors, which, in turn, are influenced by underlying illness beliefs. HL is a potential modifier of the interaction between behaviors and beliefs. There have been limited investigations studying this relationship among individuals with acute HF.A cross-sectional study of patients with hemodynamically stable acute HF was conducted. Demographic, education, and social support data were obtained from all patients along with self-reported responses to the 36-item STOFHLA survey, a 14 item HF-specific illness belief questionnaire, and a 5-item self-care adherence survey. General association was assessed using the χ or Fisher exact test, and comparisons were made using the Kruskal-Wallis test.A total of 100 patients (51 females and 49 males) were included, 94% of whom were African-American (mean age [SD]: 57.5 [13.2] years). Inadequate, marginal, and adequate health literacy were present in 35%, 17%, and 48%, respectively, with increasing adequacy among the higher educated (P0.001). Overall, HF illness beliefs were considered to be "inaccurate" (mean score [SD] on a 4-point Likert scale: 2.8 [0.3]) but did correlate positively with improved HL (r = 0.26; P = 0.008).In this cohort of relatively young, predominantly African-American patients with acute HF, HL was positively correlated with level of education and negatively associated with age and was an important determinant of disease-specific illness beliefs.

OBJECTIVES Vancomycin and daptomycin are the two most frequently prescribed parenteral antimicrobials for resistant Gram-positive bacterial infections. The purpose of this study was to compare antimicrobial adverse event rates and associated healthcare interventions and healthcare utilization in patients treated with the two antimicrobials. METHODS All patients aged ≥18 years, discharged home from Cleveland Clinic on outpatient parenteral antimicrobial therapy (OPAT) with daptomycin or vancomycin between 1 July 2007 and 30 June 2010 were screened. Logistic regression models were built to calculate propensity to be treated with daptomycin for each patient. Propensity score-matched vancomycin-treated controls were identified for each daptomycin-treated patient. Adverse event, healthcare intervention and healthcare utilization rates during OPAT were compared in the matched cohort using negative binomial regression models. RESULTS One thousand, two hundred and eighty-eight patients were identified. Three-to-one matching provided the best matching characteristics and identified 119 daptomycin-treated subjects (2518 OPAT days) and 357 vancomycin-treated controls (6649 OPAT days). The mean patient age was 56 years and the mean OPAT duration was 19 days. Antimicrobial adverse event rates for the daptomycin and vancomycin groups were 3.2 and 7.7 per 1000 OPAT days, respectively [relative risk (RR) 0.38; 95% CI 0.15-0.86; P = 0.02]. Antimicrobial intervention rates were 5.6 and 27.1 per 1000 OPAT days, respectively (RR 0.21; 95% CI 0.11-0.36; P

Heart failure (HF) emergency department (ED) visits are commonly due to HF self-care nonadherence.Our objective was to assess the accuracy of HF beliefs and adherence to self care in patients using an ED for acute HF.A cross-sectional, correlational study using validated surveys of HF beliefs and self-care adherence was conducted. A multivariable regression model was used to control for significant baseline factors.In 195 adults, mean HF beliefs score was 2.8 ± 0.3, significantly below the accurate cutoff score of 3.0 (p0.001). Mean HF self-care adherence score was 5.1 (10 reflects best adherence). Of HF-related self-care behaviors, adherence was highest for taking medications without skipping or missing doses (7.8 ± 3.3) and lowest for daily weight monitoring (3.5 ± 3.5). Higher accuracy in HF beliefs was associated with higher education level (p = 0.01), younger age (p0.001), and choosing low-sodium restaurant foods (p = 0.04), but not with adherence to other self-care behaviors. Self-care adherence was associated with the belief that the HF care plan must be followed forever (p = 0.04), but not with other HF beliefs; and there was a trend toward lower HF self-care adherence when HF belief scores were more accurate. After controlling for significant baseline factors, HF beliefs were not associated with self-care adherence (p = 0.15).Patients seeking ED care for decompensated HF had inaccurate HF beliefs and poor self-care adherence. Lack of association between HF beliefs and self care (and trend of an inverse relationship) reflects a need for predischarge HF education, including an explanation of what HF means and how it can be better controlled through self-care behaviors.

Objective We sought to assess the impact of myocardial scar burden (MSB) on the association between implantable cardioverter defibrillator (ICD) implantation and mortality in patients with ischaemic cardiomyopathy (ICM) and left ventricular EF ≤40%. In addition, we sought to determine the impact of gender on survival benefit with ICD implantation. Design Retrospective observational study. Setting Single US tertiary care centre. Patients Consecutive patients with significant ICM who underwent delayed hyperenhancement-MRI between 2002 and 2006. Interventions ICD implantation. Main outcome measures All-cause mortality and cardiac transplantation. Results Follow-up of 450 consecutive patients, over a mean of 5.8 years, identified 186 deaths. Cox proportional hazard modelling was used to evaluate associations among MSB, gender and ICD with respect to all-cause death as the primary endpoint. ICDs were implanted in 163 (36%) patients. On multivariable analysis, Scar% (χ 2 28.21, p 2 12.39, p=0.015) and ICD (χ 2 9.57, p=0.022) were independent predictors of mortality after adjusting for multiple parameters. An interaction between MSB×ICD (χ 2 9.47, p=0.009) demonstrated significant differential survival with ICD based on MSB severity. Additionally, Scar%×ICD×Gender (χ 2 6.18, p=0.048) suggested that men with larger MSB had significant survival benefit with ICD, but men with smaller MSB derived limited benefit with ICD implantation. However, the inverse relationship was found in women. Conclusions MSB is a powerful independent predictor of mortality in patients with and without ICD implantation. In addition, MSB may predict gender-based significant differences in survival benefit from ICDs in patients with severe ICM.

Background Currently, fluid restriction recommendations in heart failure (HF) are based on expert opinion. After implementing a 1,000-mL/d fluid restriction for 60 days after discharge, outcomes were examined. Methods and Results In a randomized controlled design, hyponatremic patients (serum sodium ≤137 mg/dL) received usual care (UC; n = 26) or 1,000 mL/d fluid restriction (n = 20) at discharge. Quality of life (QoL), thirst, difficulty following fluid recommendations, adherence to fluid restriction, HF emergency care, HF rehospitalization, and all-cause death were examined. Mean age was 62.8 ± 12.8 years; 46% were white. There were no differences by group in baseline demographics, comorbidities, and QoL, except that more UC patients had New York Heart Association (NYHA) functional class III/IV status ( P = .019). Median [interquartile range] QoL scores were better in the 1,000 mL/d group for symptom burden (83.3 [68.8–91.7] vs 50 [29.2–79.2]; P = .018), total symptoms (77.1 [58.1–91.7] vs 54.2 [30.2–73.9]; P = .022), overall QoL summary (72.6 [52.2–86.3] vs 51.0 [37.7–68.5]; P = .038), and clinical QoL summary (75.5 [57.8–92.9] vs 59.1 [35.7–77.3]; P = .039). There were no group differences in thirst, difficulty adhering to fluid recommendations, adherence to fluid restriction, or health care consumption. Conclusions The 1,000 mL/d fluid restriction led to improved QoL at 60 days after discharge. Future research in a larger more heterogeneous sample is needed.

Background A seven-item cancer-specific fall risk tool (Cleveland Clinic Capone-Albert [CC-CA] Fall Risk Score) was shown to have a strong concordance index for predicting falls; however, validation of the model is needed. Objectives The aims of this study were to validate that the CC-CA Fall Risk Score, made up of six factors, predicts falls in patients with cancer and to determine if the CC-CA Fall Risk Score performs better than the Morse Fall Tool. Methods Using a prospective, comparative methodology, data were collected from electronic health records of patients hospitalized for cancer care in four hospitals. Risk factors from each tool were recorded, when applicable. Multivariable models were created to predict the probability of a fall. A concordance index for each fall tool was calculated. Findings The CC-CA Fall Risk Score provided higher discrimination than the Morse Fall Tool in predicting fall events in patients hospitalized for cancer management.

To evaluate risk factors for complications of tissue expander/implant and autologous tissue breast reconstructions and determine if radiation increases complication rates.We performed a retrospective review of patients who underwent mastectomy plus autologous tissue or expander/implant reconstruction at the Cleveland Clinic. Univariate and multivariate analysis were performed in each group to evaluate for risk factors for complications. A complication was considered major if it required reoperation. A predictive model was used to compare the 2 groups to one another.A total of 1037 patients were included in the study. In the tissue expander/implant population, there was a total complication rate of 31.8% and overall major complication rate of 24.4%. Radiation increased the major complication rate from 21.2 to 45.4%. However, 70.1% of the radiated patients ultimately had a successful implant-based reconstruction while an additional 10.3% went on to have autologous reconstruction. Age and body mass index (BMI) 30 also led to higher major complication rates in tissue expander/implant reconstruction while smoking, hypertension, and chemotherapy had no impact. In the autologous reconstruction group, there was a total complication rate of 31.5% and a major complication rate of 19.7%. There was no statistically significant difference between the radiated and nonradiated autologous tissue reconstructions with major complication rates of 17.9 and 20.5%, respectively. BMI 30 was the only significant factor leading to higher major complications in the autologous reconstructions.Total complication rates were similar between tissue expander and autologous reconstructions. Increased major complication rates in patients with tissue expander reconstructions occurred in those with radiation, but was still successful in the majority of patients. Radiation had no influence on autologous tissue reconstruction major complication rates.

To evaluate whether intravitreal fluocinolone acetonide (FA) implantation (Retisert) leads to scleral thinning.Scleral thickness was measured at the pars plana region (4 quadrants) with anterior segment OCT (Visante) in FA implanted eyes (18) with noninfectious posterior uveitis in comparison to eyes with prior vitrectomy (8), and normal eyes without prior surgery (30).Mean scleral thickness in normal (nonsurgical) eyes was 0.99/0.93/0.88/0.86, and 0.92 mm in the inferonasal/inferotemporal/superotemporal/superonasal quadrants, and overall, respectively. Sclera was thinner in each quadrant of the FA implanted eyes compared to the fellow or nonsurgical eyes, although none reached statistical significance, as the differences were small. However, a few FA implanted eyes demonstrated more dramatic scleral thinning than others.FA implant appears to lead to statistically nonsignificant scleral thinning overall with few exceptions. Clinicians should be aware of potential scleral thinning in select cases, important for reimplantation and long-term follow-up.

Liver involvement is common in patients with inflammatory bowel disease (IBD). However, the frequency and the significance of liver function test (LFT) abnormalities in patients with ileal pouch-anal anastomosis (IPAA) for underlying IBD have not been studied. The aim of this study was to evaluate the prevalence and to identify risk factors for abnormal LFTs in patients with IPAA and underlying IBD.All patients were identified from our prospectively maintained Pouchitis Database between 2002 and 2008. Abnormal LFTs were classified as the following: (i) any abnormal elevation of transaminases, and/or alkaline phosphatase (ALP), and/or bilirubin; (ii) hepatitis, if there was more than twice the elevation of transaminases; and (iii) cholestatic, if there was more than 1.5 times elevation of ALP. Clinical, endoscopic, and histological variables were assessed using Cox proportional hazard models for evaluating risk for abnormal LFTs.A total of 545 IPAA patients with underlying IBD were identified from the database, of which 373 patients who had LFTs done after their pouch surgery were included. This included 346 patients with ulcerative colitis, 25 with indeterminate colitis, and 2 with Crohn's colitis before surgery. Their mean age was 45.9+/-13.8 years. A total of 65 patients (17.4%) (40 men, 25 women, median age: 47 years) had abnormal LFTs. Of the patients, 52 (13.9%) had abnormal transaminases, whereas 15 (4%) were classified as having hepatitis. Thirty-five (9.4%) patients had an abnormal ALP level, with 18 (4.8%) classified as cholestatic. The most common cause of an abnormal LFT was transient elevation in 32 (49.2%) patients, followed by fatty liver (fatty change on imaging with body mass index (BMI)or =25 kg/m(2) in the absence of other causes, including alcohol abuse and drug-induced hepatitis) in 10 (15.4%), drug-induced abnormal LFTs in 7 (10.7%), and chronic hepatitis B or C in 6 (9.2%). Primary sclerosing cholangitis (PSC) was responsible for abnormal LFTs in 10 patients (15.4%). Cox proportional hazard model analysis showed that BMI (hazard ratio (HR)=1.07, 95% confidence interval (95% CI): 1.02, 1.12; P=0.003), the presence of PSC (HR=4.49, 95% CI: 1.45, 13.89; P=0.009), autoimmune disorder (HR=2.54, 95% CI: 1.09, 5.93; P=0.031), a family history of IBD (HR=2.32, 95% CI: 1.29, 4.17; P=0.005), and extensive colitis before colectomy (HR=4.59, 95% CI: 2.04, 10.33; P0.001) predicted any abnormal LFTs.Abnormal LFTs were common in patients with IPAA in this cohort. The presence of co-existing autoimmune disorder, a family history of IBD, extensive colitis before colectomy, the presence of PSC, and a high BMI appear to be a significant risk factors for abnormal LFTs. Whether abnormal LFTs affect health-related quality of life, pouch survival, and selection of pouch-related medical therapy requires further investigation.

Autoimmune disorders (ADs) frequently coexist with inflammatory bowel disease. The aim of the study was to determine whether coexisting AD in patients with ileal pouches increases the risk for chronic antibiotic-refractory pouchitis (CARP) and other inflammatory conditions of the pouch.A total of 622 patients seen in our Pouchitis Clinic were enrolled. We compared the prevalence of adverse outcomes of the pouch (including CARP, Crohn's disease of the pouch, and pouch failure) in patients with or without concurrent AD and assessed the factors for these adverse outcomes.There were seven pouch disease categories: normal (N=60), irritable pouch syndrome (N=112), active pouchitis (N=131), CARP (N=67), Crohn's disease (N=131), cuffitis (N=83), surgical complications (N=36), and anismus (N=2). The prevalence of AD in these pouch disease categories was 4.5%, 12.5%, 9.2%, 13.4%, 10.7%, 3.8%, 1.5%, and 0%, respectively. The presence of at least one AD at time of pouch surgery was shown to be associated with a twofold increase in the risk for CARP (hazard ratio=2.29; 95% CI: 1.52, 3.46; P0.001) and for pouch-associated hospitalization (hazard ratio=2.39; 95% CI: 1.59, 3.58; P0.001). The presence of AD was not associated with increased risk for irritable pouch syndrome, active pouchitis, Crohn's disease, cuffitis, surgical complications, or pouch failure. Patients with Crohn's disease of the pouch had a 2.42 times higher risk for pouch failure (P=0.042) than these without. Active smoking or a history of smoking was shown to be associated with an increased risk for pouch-associated hospitalization and pouch failure.AD appears to be associated with an increased risk for CARP, and the presence of the association between these AD and pouch disorders may stimulate further research on the link of these organ systems on an immunological basis.

To compare conventional minimally invasive (MIS) approaches and newer technology approaches in women undergoing hysterectomy for benign disease. PubMed was searched for all pertinent randomized-controlled trials (RCTs). Selected outcomes were compared using standard meta-analysis methods. Three RCTs compared conventional MIS to robotic-assisted hysterectomy and 5 RCTs compared conventional laparoscopy to single-incision hysterectomy. There were no significant differences in outcomes. A subanalysis comparing conventional to robotic-assisted laparoscopy found an association between conventional laparoscopy and shorter operative time. Newer technology approaches do not confer an advantage over conventional MIS approaches in women undergoing hysterectomy for benign disease.

To investigate the impact of pelvic radiation on survival in patients with uterine clear cell carcinoma (UCC) who received adjuvant chemotherapy.Patients with stage I-IV UCC who had undergone surgery and chemotherapy were identified from the Surveillance, Epidemiology, and End Results (SEER) programm 2000-2009. Patients were divided into those who received only chemotherapy and those who received both chemotherapy and radiation therapy. Kaplan-Meier curves and Cox regression models were used for analysis.Of the 317 patients included, 195 (62%) were in the chemotherapy only group and 122 (38%) were in the chemotherapy and radiation therapy group. Pelvic radiation was associated with significant improvement in overall survival (median 88 versus 25 months, 5 year survival: 58% versus 33%, P0.001) in the chemotherapy and radiation therapy group compared with the chemotherapy only group for the entire cohort. On subset analysis, chemotherapy and radiation therapy was associated with improved overall survival in late stage disease (III-IV) (5 year 54% versus 22%, P0.001) compared with the chemotherapy only group, whereas in stage I-II UCC, there was no difference in overall survival between the chemotherapy and radiotherapy group and the chemotherapy only group (5 year 65% versus 67%, P=0.69). In multivariable analysis, pelvic radiation was associated with improved survival in patients with late stage disease (hazard ratio 0.57, 95% confidence interval 0.35-0.94, P=0.03) but not for early stage disease (hazard ratio 0.81, 95% confidence interval 0.33-2.0, P=0.65). Other significant predictors were advanced stage, positive cytology and extensive lymphadenectomy.Radiation was associated with significant improvement in survival in advanced stage UCC, but not in early stage UCC. These data support the beneficial role of radiation therapy in UCC, especially in patients with advanced stage disease.

To investigate the role of CA-125 percent reduction after neoadjuvant chemotherapy in predicting the extent of the interval debulking surgery (IDS) and outcomes in patients with advanced-stage müllerian carcinoma.Patients who received neoadjuvant chemotherapy for advanced-stage müllerian carcinoma from 2000 to 2013 were identified. Percent reduction in CA-125 was categorized into 2 groups: ≥ 90% (CA ≥ 90%) and90% (CA90%) reduction from prechemotherapy to preoperative CA-125.Of the 115 patients identified, 73% had CA ≥ 90% and 27% had CA90%. Optimal and complete IDS were achieved in 87% and 38%, respectively. Compared with the CA90% group, the CA ≥ 90% group was more likely to have complete IDS (P = 0.035), less likely to have a bowel resection (P0.001), and more likely to have no viable tumor/microscopic disease with treatment effect (P0.001). No difference in overall survival (OS; P = 0.81) and progression-free survival (PFS; P = 0.60) was noted between the groups. In multivariable analysis, CA ≥ 90% was not a predictor of PFS (hazard ratio [HR], 1.08; 95% confidence interval [CI], 0.65-1.79; P = 0.77) or OS (HR, 1.45; 95% CI, 0.73-2.9; P = 0.29). Patients with preoperative CA-12520 had significantly longer OS (P = 0.05) and PFS (P = 0.005) than did those with preoperative CA-125 ≥ 20. In multivariable analysis, preoperative CA-12520 was a predictor of PFS (HR, 0.37; 95% CI, 0.20-0.66; P0.001) but not OS (HR, 0.64; 95% CI, 0.34-1.21; P = 0.17).A reduction in CA-125 of at least 90% is associated with complete IDS, favorable pathologic response, and fewer bowel resections. A preoperative CA-12520 suggests improved outcome. These findings are helpful for treatment planning and patient counseling.

The first trimester aneuploidy screen (FTS) continues to be a leading approach to identify the risk of fetal aneuploidy. This study evaluated how obstetric (OB) professionals counsel women about FTS as one of a growing number of options to assess fetal health. A survey was completed by OB professionals (board-certified obstetrician/gynecologists and certified nurse midwives) between February and March 2011: (1) to identify knowledge and practice patterns with regard to FTS, and (2) to compare pregnant women's educational needs and decision-making preferences with clinicians' perceptions of these factors. A total of 216 surveys (11 percent) were completed by OB professionals and analyzed. Several barriers to effective patient counseling were identified, including gaps in obstetric professionals' mastery of the screening test characteristics and variable approaches to discuss concepts of aneuploidy risk. OB participants reported limited confidence in discussing patient-valued topics, specifically post-screen options and pregnancy termination. Discordance was identified between OB professionals' perceptions of pregnant women's educational needs and decision-making preferences specific to FTS and historical data recently collected from 139 pregnant women who underwent the FTS. Study findings illustrate the need for clinician-targeted strategies to support pregnant women as they formulate informed decisions about the tests that may have a salient impact on their prenatal care decisions.

Objectives Advances in laparoscopy have demonstrated that supraumbilical primary ports can be desirable in complex cases with large masses. This study evaluated distances to vital retroperitoneal vasculature that were encountered with 45- and 90-degree angle entry from the umbilicus and 2 commonly described supraumbilical entry points at 3 and 5 cm cephalad from the umbilicus. Study Design Retrospective analysis of computed tomography scans of the abdomen and pelvis from 100 randomly selected women who were 18-50 years old with normal anatomy was performed. Three-dimensional models of sagittal sections were generated using IMPAX software. Measurements from the abdominal wall at the umbilicus and 3 and 5 cm cephalad with 45- and 90-degree angles to retroperitoneal structures were performed. Results With 90-degree angle entry, the abdominal wall thickness (AWT) was thinnest at the umbilicus; however, the thickness at 3 and 5 cm was similar. AWT increased at all sites with 45-degree angle entry, and the same pattern was observed. AWT and intraperitoneal distance positively correlated with body mass index and supraumbilical entry points. With 90-degree angle entry, the aorta was 1.9 cm (95% confidence interval [CI], 1.4–2.4) and 2.5 cm (95% CI, 2.0–2.9) farther away at 3 and 5 cm cephalad compared with umbilical entry. In one-third of the cases, regardless of port placement, a vascular structure other than the aorta was the most anterior vessel. With 45-degree angle entry at the umbilicus, no vessels were encountered. With 45-degree angle entry at 3 and 5 cm cephalad, the aorta was the most anterior vessel in 1% and 2% of cases, respectively, and was noted to be 1.0 cm (95% CI, 1.0–1.0) and 2.3 cm (95% CI, 1.2–3.3) farther away than with 90-degree angle entry. A vessel other than the aorta was encountered in 4% and 7% of cases at 3 and 5 cm, respectively. Conclusion According to theoretic modeling, supraumbilical primary port placement can be implemented safely in laparoscopy. With supraumbilical entry, the distance to retroperitoneal vessels was greater than at the umbilicus. Compared with a 90-degree angle, with a 45-degree angle entry, it was uncommon to encounter vasculature, and all measured distances were greater.

Fatigue affects 40% to 50% of all PD patients and is a leading cause of disability, with no clearly established or efficacious established treatments.In this double-blinded, placebo-controlled, pilot trial, we investigated whether rasagiline improved fatigue among PD patients. Subjects were randomized to 1 mg daily of rasagiline or placebo for 12 weeks. The primary endpoint was a change in the Modified Fatigue Impact Scale from baseline to week 12.Thirty PD subjects (16 men), with Modified Fatigue Impact Scale baseline score of 67 ± 15, were randomized (16 to rasagiline vs. 14 to placebo). Significant improvement was noted in the mean Modified Fatigue Impact Scale score of the rasagiline group (12 points) as compared to placebo (8.5 points) from baseline to week 12 (P = 0.003).In this pilot study, rasagiline at a dose of 1 mg per day improved fatigue. Larger randomized studies are needed to confirm this finding.

OBJECTIVE To investigate the rate, predictors of lymph node metastasis (LNM) and pattern of recurrence in clinically early stage endometrial cancer (EC) with positive lymphovascular space invasion (LVSI). METHODS Women with clinically early stage EC and positive LVSI 2005 to 2012 were identified. Kaplan-Meier curves and logistic regression models were used. RESULTS One hundred forty-eight women were identified. Of them, 25.7% had LNM (21.7% pelvic LNM, 18.5% para-aortic LNM). Among patients with LNM who had both pelvic and para-aortic lymphadenectomy, isolated pelvic, para-aortic and both LNM were noted in 51.4%, 17.1%, and 31.4% respectively. Age and depth of myometrial invasion were significant predictors of LNM in LVSI positive EC. Node positive patients had high recurrence rate (47% vs. 11.8%, p

Objective To evaluate the effect of adding bevacizumab to adjuvant paclitaxel and carboplatin and as maintenance on progression-free survival (PFS) in advanced or recurrent endometrial carcinoma (EMCA). Methods A phase II trial was conducted in patients with measurable disease. Paclitaxel (175mg/m 2 /3h), carboplatin (AUC 5) and bevacizumab (15mg/kg) were administered q 21 days. Patients with a complete response after 6–8cycles received maintenance therapy with bevacizumab 15mg/kg q 21 days for 16cycles. Based on GOG 177 which had a 6-month PFS rate of 59%, an increase in 6-month PFS to 72% with the treatment regimen was considered of clinical interest. Results 15 patients were enrolled on protocol when accrual to the study was discontinued due to the initiation of a national randomized phase II trial. A total of 127 courses (median 8, range 1–20) of carboplatin, paclitaxel, and bevacizumab combination therapy were administered. One patient suffered a bowel perforation after her first course of therapy and was inevaluable for response. Fourteen of the 15 patients (93%, 95% CI: 82–100) were progression free at 6months. The median follow-up was 36months (7–58+). The median PFS was 18months (CI: 11–25). Five complete responses and 6 partial responses were seen for an overall response rate of 73% (CI: 45–91). The median overall survival was 58months (CI: 48–68). Conclusions The bevacizumab, paclitaxel, and carboplatin regimen is active and tolerable in advanced and recurrent EMCA. Its impact awaits results of the recently completed randomized phase II trial.

Study Objective To describe the long-term fertility outcomes in young patients with endometriosis-associated pelvic pain treated with laparoscopic surgery. Design Retrospective case series (Canadian Task Force classification II-2). Setting Tertiary care hospital. Patients Women aged 18 to 25 years who underwent laparoscopic surgery between 2000 and 2005 at the Cleveland Clinic Foundation solely to treat endometriosis-associated pelvic pain. Interventions Patients answered a telephone or mail survey questionnaire assessing fertility outcome after surgery. Measurements and Main Results Twenty-eight of 74 eligible patients (37.8%) were enrolled in the study. With a median (interquartile range) age of 23.5 (1.5) years at follow-up, these patients completed the telephone or postal questionnaire to assess fertility outcomes at follow-up of 102.5 (16.6) months. In most participants the diagnosis was less advanced endometriosis (stage I, 60.7%; stage II, 28.6%). Twenty women (71.4%) had at least 1 pregnancy during follow-up that resulted in a live birth, of which >80% were spontaneous without the use of assisted reproductive technologies. Conclusion Long-term pregnancy rates are excellent in young women undergoing laparoscopic surgery to treat pelvic pain. However, a future prospective study is needed to determine whether laparoscopy has any hindrance on future fertility.

Study Objective To determine the fertility benefit of controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI) in surgically treated endometriosis. Design Retrospective cohort study (Canadian Task Force classification II-2). Setting Cleveland Clinic Foundation, tertiary care center. Patients Ninety-six women of reproductive age who underwent operative laparoscopy to treat endometriosis-related infertility (endometriosis stage I/II n = 67; stage III/IV n = 29) from 2001 to 2011 at the Cleveland Clinic Foundation. Interventions COH via letrozole, clomiphene, or gonadotropins, with or without IUI. Measurements and Main Results Kaplan-Meier estimations of cumulative pregnancy rates were compared by stage between COH/IUI and spontaneous cycles. Patients with stage I/II endometriosis attempted spontaneous pregnancy for 669 months and 216 COH + IUI cycles, and patients with stage III/IV endometriosis attempted spontaneous pregnancy for 379 months and 74 COH + IUI cycles. Crude pregnancy rates were 45.7% in stage I/II and 40.5% in stage III/IV. Twelve-month cumulative pregnancy rates in stage I/II were 45% for spontaneous attempts and 42% for COH + IUI, and in stage III/IV were 20% for spontaneous attempts and 10% for COH + IUI (not significant). Cumulative pregnancy rates for COH/IUI in stage I/II were significantly higher than in stage III/IV. Monthly fecundity rates were 3.81% for stage I/II spontaneous, 4.59% for COH/IUI, 3.05% for stage III/IV spontaneous, and 1.68% for COH/IUI (not significant). Conclusions COH + IUI did not improve pregnancy rates in any stage of endometriosis. In stage III/IV we recommend postoperative in vitro fertilization.

There is increasing evidence that oxidative stress is one of the key factors for progression of endometriosis. In this prospective controlled trial, we measured 6 different biomarkers of oxidative stress targeting protein, lipid, and DNA to quantify the severity and progression of endometriosis and establish a diagnostic marker for the disease.A total of 62 consecutive patients were identified and enrolled in this study. After exclusion criteria, 44 patients were allocated to 3 groups: stage I/II (n = 14), stage III/IV (n = 16), and a control group (n = 14). The levels of 8-hydroxy-2-deoxyguanosine (8-OHdG), 8-oxoguanine DNA glycosylase (OGG1), protein carbonyl (PC), lipid peroxidation (LPO), reactive oxygen species (ROS), and total antioxidant capacity (TAC) were accessed in peritoneal fluid and tissue.Significantly higher levels of 8-OHdG and PC were seen in patients with endometriosis, in addition OGG1 expression was found to be significantly lower in patients with endometriosis (P.001, P = .001, P = .033, respectively); ROS, TAC, and LPO were similar in stages I/II, stages III/IV, and control group. A predictive model was built using multivariable analyses and receiver-operating characteristics curves. The ability to predict and distinguish between patients without endometriosis, stage I/II endometriosis, and stage III/IV was very high. This model was highly discriminatory and had a concordance index of 0.87.In this cohort, higher DNA damage and lower DNA repair activity was related to endometriosis progression. Our results indicate that oxidative stress as a biomarker of cell injury can be used as a reliable quantitative test of endometriosis severity.

Radiation therapy has been shown to increase complication rates of tissue expander/implant breast reconstructions. The purpose of this study was to evaluate patient characteristics to assess their impact on complications. A retrospective review of patients who underwent mastectomy plus tissue expander/implant reconstruction from January 2000 to December 2006 was performed. The main outcome of interest was the development of postoperative complications. Analyses were performed to detect risk factors for complications. A total of 560 patients were included in the study. A total of 385 patients underwent unilateral and 174 underwent bilateral tissue expander/implant reconstructions, for a total of 733 reconstructions. A total complication rate of 31.8% and a major complication rate of 24.4% were calculated. The risk factors associated with a significantly increased incidence of complications were age greater than 50 years, body mass index (BMI) greater than 30, and radiation. Women younger than 50 years had a complication rate of 28.4%, whereas women older than 50 years had a complication rate of 37.0%. Women with a BMI less than 30 had a complication rate of 27.5%, whereas women with a BMI greater than 30 had a complication rate of 49%. The major complication rate in nonradiated and radiated patients was 21.2% and 45.4%, respectively. Despite higher complication rates, tissue expander/implant reconstructions were successful in 70.1% of radiated patients. Based on this study, the ideal radiated patient would have a BMI less than 30 and be younger than 50 years of age to maximize the likelihood of a successful tissue expander/implant reconstruction.

First trimester aneuploidy screening introduces unique challenges to patient education and informed decision-making. Our study assessed the decision-making process among those pregnant patients presenting for this new form of aneuploidy screening.A survey instrument was used to assess components of decision-making among women who presented for first trimester aneuploidy screening. Knowledge and leading factors in the decision-making process were measured.Participants (n = 139) demonstrated understanding of the etiology of Down syndrome, but less understanding of its cognitive (65.2%) and physical manifestations (58.7%). Few were able to determine risk from first trimester screen results (36.7%). Participants were more familiar with amniocentesis (84.2%) than chorionic villus sampling (73.4%), though less familiar with procedural risks (29.5% and 28.1%, respectively). The majority of participants ranked the following as key information in their decision: knowledge of their intentions about the outcome of the pregnancy based on the test results (92.4%), knowledge of chorionic villus sampling to evaluate an abnormal result (92.0%), and values and beliefs about termination (89.1%).First trimester aneuploidy screening generates education and decision-making benchmarks for patients and providers. It is important to address these barriers as this new screen becomes a growing part of current prenatal genetic testing offerings.

OBJECTIVE To compare the surgical outcomes of robot-assisted laparoscopic myomectomy (robot-assisted), standard laparoscopic myomectomy (laparoscopic), and open myomectomy (abdominal). METHODS Myomectomy patients were identified from the case records of the Cleveland Clinic and stratified into three groups. Operative and immediate postoperative outcomes were compared. Data analysis was performed using analysis of variance, Kruskal-Wallis analysis of ranks, χ2, and Fisher exact tests where appropriate. RESULTS From a total of 575 myomectomies, 393 (68.3%) were abdominal, 93 (16.2%) were laparoscopic, and 89 (15.5%) were robot-assisted. The three groups were comparable regarding the size, number, and location. Significantly heavier myomas were removed in the robot-assisted group (223 [85.25, 391.50] g) compared with the laparoscopic group (96.65 [49.50, 227.25] g, P

African Americans have greater misperceptions about heart failure (HF) than Caucasians. We examined socioeconomic and medical history factors to determine if they explain differences in accuracy of HF illness beliefs by race. 519 patients completed an illness beliefs and socioeconomic status survey. After establishing univariate associations by race, linear regression with backward selection was used to identify factors associated with HF illness beliefs accuracy. HF illness beliefs were less accurate among African Americans (p < .01). In multivariate models, race remained a predictor of HF illness beliefs accuracy, as did education level and living status (all ps ≤ .01). Illness beliefs of African Americans were inaccurate and independently associated with social support and education level. Health care providers must consider patient education processes as a possible cause of differences and focus on what and how they teach, literacy level, materials used, and family engagement and education.

Gastrointestinal (GI) complications after coronary artery bypass graft surgery (CABG) are uncommon but associated with a disproportionate share of mortality. We thus identified variables associated with GI complications and analyzed their effect on postoperative mortality in patients undergoing isolated CABG.Information from patients who underwent isolated CABG at our institution during a 12-year period was obtained from the Anesthesiology Institute patient registry. Patients who experienced one or more postoperative GI complication(s) during their initial intensive care unit stay were identified. Multivariable logistic regression with backward variable selection was used to determine variables associated with GI complications and to evaluate their effect on mortality.Among 16,043 patients who underwent isolated CABG, 213 (1.43%) had one or more GI complication(s). The main patient variables associated with postoperative GI complications included preoperative (odds ratio, 2.43; 95% confidence interval [CI], 1.39 to 4.23; p0.001) and intraoperative (odds ratio, 5.07; 95% CI, 3.08 to 8.35; p0.001) intraaortic balloon pump insertion, patient age (odds ratio, 1.65; 95% CI, 1.41 to 1.94; p0.001), intraoperative fresh-frozen plasma transfusion (odds ratio, 3.38; 95% CI, 2.12 to 5.41; p0.001), and cardiogenic shock (odds ratio, 3.04; 95% CI, 1.12 to 8.24). No difference was detected in complication rates between off-pump and on-pump CABG procedures (1.50% versus 1.30%, respectively; p = 0.63). Postoperative GI complication(s) after CABG was associated with a 12.98 times increase in mortality (p0.001).This single-center cohort study indicates that GI complications after isolated CABG remain rare with an incidence 1.43%. However, GI complications portend a significant mortality. The implications of intraoperative administration of fresh-frozen plasma and insertion of an intraaortic balloon pump deserve further investigation as they are associated with GI complications.

SummaryBackgroundWe explored the prevalence, clinical and physiologic correlates of pulmonary hypertension (PH), and screening strategies in patients with severe emphysema evaluated for the National Emphysema Treatment Trial (NETT).MethodsPatients undergoing Doppler echocardiography (DE) and right heart catheterization were included. Patients with mean pulmonary arterial pressure ≥25 mmHg (PH Group) were compared to the remainder (non-PH Group).ResultsOf 797 patients, 302 (38%) had PH and 18 (2.2%) had severe PH. Compared to the non-PH Group, patients with PH had lower % predicted FEV1 (p