Objectives: 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). Background: 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. Methods: 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 2 or Fisher exact test, and comparisons were made using the Kruskal–Wallis test. Results: 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 ( P < 0.001). 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). Conclusion: 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.
Aims: To investigate the impact of pelvic radiation on survival in patients with uterine clear cell carcinoma (UCC) who received adjuvant chemotherapy.Materials and methods: 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.Results: 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%, P < 0.001) 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%, P < 0.001) 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.Conclusions: 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. (C) 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.
Objective: To investigate the impact of pelvic radiation on survival in patients with uterine serous carcinoma (USC) who received adjuvant chemotherapy.Methods: Patients with stage I-IV USC were identified from the Surveillance, Epidemiology, and End Results program 2000 to 2009. Patients were included if treated with surgery and chemotherapy. Patients were divided into two groups: those who received chemotherapy and pelvic radiation therapy (CT_RT) and those who received chemotherapy only (CT). Kaplan-Meier curves and Cox regression proportional hazard models were used.Results: Of the 1,838 included patients, 1,272 (69%) were CT and 566 (31%) were CT_RT. Adjuvant radiation was associated with significant improvement in overall survival (OS; p<0.001) and disease-specific survival (DSS; p<0.001) for entire cohort. These findings were consistent for the impact of radiation on OS (p<0.001) and DSS (p<0.001) in advanced stage (III-IV) disease but not for early stage (I-II) disease (p=0.21 for OS and p=0.82 for DSS). In multivariable analysis adjusting for age, stage, race and extent of lymphadenectomy, adjuvant radiation was a significant predictor of OS and DSS for entire cohort (p=0.003 and p=0.05) and in subset of patients with stage III (p=0.02 and p=0.07) but not for patients with stage I (p=0.59 and p=0.49), II (p=0.83 and p=0.82), and IV USC (p=0.50 and p=0.96). Other predictors were stage, positive cytology, African American race and extent of lymphadenectomy.Conclusion: In USC patients who received adjuvant chemotherapy, adjuvant radiation was associated with significantly improved outcome in stage III disease but not for other stages. Positive cytology, extent of lymphadenectomy and African race were significant predictors of outcome.
Background/Aims. To compare long-term fertility and bleeding outcomes of women who underwent robotic-assisted, laparoscopic, and abdominal myomectomy at our institution over a 15-year period. Methods. This was a retrospective cohort study of myomectomy patients 18–39 years old that had surgery between January 1995 and December 2009 at our institution. Long-term follow-up on fertility and bleeding outcomes was collected from the patient directly. The uterine fibroid symptom and quality of life survey was also administered to assess current bleeding patterns. Baseline characteristics were compared across groups. Univariable comparisons of fertility and bleeding outcomes based on surgical approach were made using analysis of variance, Kruskal-Wallis analysis of ranks, and Chi-square tests as appropriate. Results. 134/374 (36%) subjects agreed to participate in the study. 81 subjects underwent an open procedure versus 28 and 25 subjects in the laparoscopic and robotic groups, respectively. Median follow-up after surgery was 8 years. 50% of patients desired pregnancy following surgery and, of those, 60% achieved spontaneous pregnancy; the spontaneous pregnancy rate did not differ between groups. Additionally, UFS-QOL scores and/or subscores did not differ between groups. Conclusion. There is no significant difference in long-term bleeding or fertility outcomes in robotic-assisted, laparoscopic, or abdominal myomectomy.
BackgroundThe goal of this study was to quantitatively evaluate the reproducibility of current manual counting methods of colony forming units (CFUs) from umbilical cord blood samplesMethodsFresh and reconstituted frozen cells from 10 cord blood samples were cultured under standard conditions. The number of BFU‐Es, CFU‐GMs, and CFU‐GEMMs were counted by three expert reviewers using the standard microscope method and manually traced CFUs on digital images of cell cultures.ResultsThe mean colony count based on the traced digital images was 82 (22% CV) and 52 (15% CV) for the fresh and frozen samples, respectively. This was significantly greater than that observed using the microscope, 61 (13% CV) for fresh and 43 (16% CV) for frozen. The difference was mainly due to the reviewers observing more CFU‐GMs in the digital images than through the microscope review. All three reviewers agreed on the presence of a colony 72% of the time based on the digital review in both fresh and frozen samples. Reviewer agreement with respect to colony type in the fresh samples was 38% (22%CV), 25% (51%CV), and 6% (115%CV) for BFU‐Es, CFU‐GMs, and CFU‐GEMMs, respectively. Reviewer agreement increased for BFU‐Es and CFU‐GMs in the frozen samples where fewer colonies were present.ConclusionsAlthough this study showed marked variability between reviewers, the analysis of manually traced digital images has the potential to improve inter‐observer variation when compared to current methods by identifying features that lead to discrepancies in colony counting and providing cases with consensus results. © 2016 International Clinical Cytometry Society
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.
BACKGROUND:Cardiac (123)I-metaiodobenzylguanidine ((123)I-mIBG) imaging improves prognostication in patients with left ventricular (LV) dysfunction. Whether (123)I-mIBG can identify optimal candidates for implantable cardiac defibrillator (ICD) placement is unclear. We examined whether (123)I-mIBG enhances risk assessment and identifies patients with enhanced survival with ICD in a patient cohort with reduced LV function who were candidates for ICD implantation.METHODS AND RESULTS:We identified 777 patients (66 sites, 12 countries) without ICD at the time of enrollment in Adreview Myocardial Imaging for Risk Evaluation in Heart Failure (ADMIRE-HF) and index (123)I-mIBG study. Patients completed prescribed study protocol and follow-up. Heart-to-mediastinum (H/M) ratio was determined from (123)I-mIBG results. Survival modeling used a Cox proportional hazards mixed-effects model, including a propensity score, to adjust for nonrandomized ICD implantation after (123)I-mIBG. All-cause death occurred in 75 patients (9.6%), and 196 (25%) patients had ICD implantation on follow-up. After adjusting for multiple factors, although the H/M ratio added incremental prognostic value and enhanced reclassification, neither H/M results, BNP levels, nor left ventricular ejection fraction interacted with ICD use in the survival model, indicating that these variables did not identify patients with enhanced survival with ICD implantation. Nonetheless, H/M results did identify the number of lives saved by ICD use per 100 treated.CONCLUSIONS:We found that although (123)I-mIBG imaging enhances the risk stratification of patients with left ventricular dysfunction who are ICD candidates, it does not identify which patients may have improved survival with ICD placement. However, (123)I-mIBG identifies the absolute benefit gained with ICD use, thus may play a role in optimizing the cost-effectiveness of this intervention.CLINICAL TRIAL REGISTRATION:URL: http://www.clinicaltrials.gov. Unique identifiers: NCT00126425 and NCT00126438.
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 11-2).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/m2 (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. (C) 2015 AAGL. All rights reserved.
ABSTRACT Background Fatigue affects 40% to 50% of all PD patients and is a leading cause of disability, with no clearly established or efficacious established treatments. Methods 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. Results 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). Conclusion In this pilot study, rasagiline at a dose of 1 mg per day improved fatigue. Larger randomized studies are needed to confirm this finding. © 2015 International Parkinson and Movement Disorder Society.
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 (175 mg/m(2)/3 h), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q 21 days. Patients with a complete response after 6-8 cycles received maintenance therapy with bevacizumab 15 mg/kg q 21 days for 16 cycles. 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 6 months. The median follow-up was 36 months (7-58 +). The median PFS was 18 months (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 58 months (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. (C) 2014 Elsevier Inc. All rights reserved.
Objectives. To investigate whether patients with germline BRCA1/2 mutations who received neoadjuvant chemotherapy (NAC) for advanced-stage Mullerian cancer (MC) have an improved outcome compared to patients who did not undergo genetic testing.Methods. Three hundred and two patients who received NAC for stage III-IV MC were identified from a multi-institutional study involving Cleveland Clinic and Brigham and Women's Hospital for 2000-2014 and 2010-2014 respectively. Patients were divided into 3 cohorts: patients with germline BRCA1/2 mutations (BRCA_mut +; N = 30), patients with no genetic testing (BRCA_mut_unk; N = 166) and patients with negative genetic testing (BRCA_mut N = 106).Results. There were no differences in the clinical characteristics and rates of complete cytoreduction and bowel resection between the three groups. BRCA_mut + had longer PFS compared to BRCA_mut_unk and BRCA_mut - (19.1 vs. 15.1 vs. 15.7 months respectively. However, this difference was not statistically significant (p = 0.48). Patients with BRCA2 mutation had non-significant trend toward longer PFS compared to patients with unknown BRCA or BRCA1 mutation (20.2 vs. 15.1 vs. 14.8 months respectively, p = 0.58). BRCA_mut + and BRCA_mut had longer overall survivals (OS) compared to BRCA_mut_unk patients (50.5 vs. 54.1 vs. 36.5 months respectively, p = 0.009). In multivariable analyses, controlling for age, stage and complete cytoreduction, BRCA_mut_unk was associated with worse PFS (HR 1.44, 95% CI 1.01-2.05, p = 0.045) and OS (HR 2.67, 95% CI 1.33-5.36, p = 0.006).Conclusions. Patients with germline BRCA mutations had improved outcomes with NAC compared to patients with unknown BRCA status. These outcomes were more favorable compared to the outcome of NAC in prior studies. (C) 2015 Elsevier Inc. All rights reserved.
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<0.05) especially distant (60.9% vs. 7.9%, p<0.001) and para-aortic (13.2% vs. 1.8%, p=0.017) recurrences compared to node negative EC. LNM was associated with lower progression-free survival (p=0.002) but not overall survival (p=0.73).Conclusion: EC with positive LVSI is associated with high risk of LNM. LNM is associated with high recurrence rate especially distant and para-aortic recurrences. Adjuvant treatments should target prevention of recurrences in these areas.
Objective 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. Methods 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%) and <90% (CA < 90%) reduction from prechemotherapy to preoperative CA-125. Results Of the 115 patients identified, 73% had CA ≥ 90% and 27% had CA < 90%. Optimal and complete IDS were achieved in 87% and 38%, respectively. Compared with the CA < 90% group, the CA ≥ 90% group was more likely to have complete IDS (P = 0.035), less likely to have a bowel resection (P < 0.001), and more likely to have no viable tumor/microscopic disease with treatment effect (P < 0.001). 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-125 < 20 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-125 < 20 was a predictor of PFS (HR, 0.37; 95% CI, 0.20–0.66; P < 0.001) but not OS (HR, 0.64; 95% CI, 0.34–1.21; P = 0.17). Conclusions A reduction in CA-125 of at least 90% is associated with complete IDS, favorable pathologic response, and fewer bowel resections. A preoperative CA-125 < 20 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.
Objective: To evaluate effectiveness of Rasagline for fatigue in PD Background: Fatigue in patients with PD and is often a leading cause of disability with no established treatment. In this double-blinded, placebo-controlled, parallel-group, pilot trial, we investigated whether rasagiline improved fatigue among PD patients. We initially presented the data at the Movement Disorders Congress in 2013 with a negative result however after re-analysis the study now shows significant findings. Method: Subjects were randomized in a 1:1 fashion to 1 mg per day of rasagiline or placebo for 12 weeks. A battery of fatigue, sleep, quality of life, mood and motor assessments were administered at baseline, 4, 8 and 12 weeks. The primary endpoint was a change in the Modified Fatigue Impact Scale (MFIS) from baseline to Week 12. Initially, the results were computed using linear regression to plot the rate of change of fatigue over time. The re-analysis was performed with dependent t-test. Results: Thirty subjects, with an average age of 67, MFIS baseline score of 67, modified Unified Parkinson’s Disease Rating Scale motor score of 31.7 were randomized. No differences in baseline characteristics were noted. Using linear regression, the mean MFIS score of the rasagiline group was noted, this was not statistically significant compared to the placebo group (-11.73 points vs. -9.13 points, p=0.81). In the reanalysis, there was improvement in the mean MFIS score of the rasagiline group (17 points) as compared to placebo (8.5 points) from baseline to week 12 [p=0.003]. Similarly, there was improvement between groups from baseline to Week 12 in the mean Fatigue Severity Scale of the rasagiline group (14 points) compared to placebo (3 points)[p=0.018]. Discussion: Rasagiline improved fatigue more than placebo after re-analysis using 2-tailed t-test and larger randomized studies are needed to confirm this finding. Study Supported by: Teva Pharmaceuticals Disclosure: Dr. Patel has nothing to disclose. Dr. Lim has nothing to disclose. Dr. Kluger has received research support from Teva Neuroscience. Dr. Rodriguez has received personal compensation for activities with Allergan, Inc., Merz Pharma, Lundbeck Research USA, Inc., and Teva Neuroscience as a consultant and/or advisory board participant. Dr. Malaty has received personal compensation for activities with Prime-CME as a speaker. Dr. Palacio has nothing to disclose. Dr. Ojo has nothing to disclose. Dr. Gujrati has nothing to disclose. Dr. Swartz has nothing to disclose. Dr. Nutter has nothing to disclose. Dr. Hennessy has nothing to disclose. Dr. Fernandez has received personal compensation for activities with Advanced Health Media, Cleveland Clinic, Medical Communications Media, the Movement Disorders Society, and Vindico Medical Education as a speaker.
Objectives: To determine if the degree of pathologic response correlates with survival in cases of ovarian cancer treated with neoadjuvant chemotherapy.
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 < 0.001). Readmissions for worsening infection or treatment complication were not significantly different between daptomycin (5%) and vancomycin (7%).CONCLUSIONS:Patients receiving daptomycin at home have 60% fewer antimicrobial adverse events and require 80% fewer antimicrobial interventions than similar patients receiving vancomycin.
To determine outcomes in relation to duration of maintenance therapy in patients with granulomatosis with polyangiitis (Wegener’s) (GPA), we conducted a retrospective chart review of patients with GPA seen at a single vasculitis center from 1992 to 2010. All patients achieved remission defined by a Birmingham Vasculitis Activity Score for Wegener Granulomatosis (BVAS/WG) of 0 with either cyclophosphamide or methotrexate. After achieving remission all patients were started on maintenance therapy with either methotrexate or azathioprine. The study comprised 157 patients with a median follow-up of 3.1 years. Using a univariate model, the continuation of maintenance medications for >18 months showed a 29% reduction in hazard ratio (HR) for relapse (HR, 0.71; 95% confidence interval [CI], 0.42–1.19; p = 0.19). Treatment for >36 months showed a 66% reduction in hazard ratio for relapse (HR, 0.34; 95% CI, 0.15–0.76; p = 0.008). When length of treatment was considered as a continuous factor, longer courses had an inverse relationship with the risk of relapse (HR, 0.70; 95% CI, 0.58–0.84; p < 0.001), which remained significant after adjusting for prednisone dose (HR, 0.59; 95% CI, 0.42–0.83; p = 0.003). Fifty-two percent of relapses occurred while the patients were off maintenance therapy. Among all patients who relapsed on therapy, 52% of those receiving methotrexate were on <15 mg/week, and 67% of those receiving azathioprine were on ≤50 mg/d. There were no differences between the short- and long-term maintenance therapy groups in overall adverse events or GPA-related morbidity. Discontinuation or use of low doses of maintenance therapy is associated with a higher relapse rate.