Bowel Preparations Administered the Morning of Colonoscopy Provide Similar Efficacy to a Split Dose Regimen: A Meta Analysis.

BACKGROUND: Comparative efficacy of same-day bowel preparations for colonoscopy remains unclear. AIMS: A meta-analysis of randomized controlled trials comparing the efficacy of same-day versus split dose bowel preparations for colonoscopy. METHODS: A systematic search was conducted in MEDLINE, clinicaltrials.gov, Cochrane Registry, EMBASE, SCOPUS, Web of Science and CINAHL. Studies were gathered using keywords: "morning preparation", "morning bowel preparation", "same day bowel preparation", and "colonoscopy." Pooled estimates of bowel preparation quality were analyzed among studies with categorical and continuous outcomes according to relative risk (RR) or mean difference (MD). A random effects model was chosen a priori for all analyses. RESULTS: A total of 1216 studies were retrieved with 15 trials meeting inclusion criteria. The categorical outcome of high quality bowel preparation for any same-day bowel preparation versus any split preparation was no different with a RR 0.95 [0.90;1.00] (P=0.62). Adenoma detection rate (ADR) was not different between groups, RR 0.97 [0.79;1.20] (P=0.81). Willingness to repeat and tolerability did not differ (RR 1.14 [0.96,1.36] (P=0.14) and RR 1.00 [0.96;1.04] (P=0.98), respectively. Adverse events were similar except for bloating, which was less frequent among the same-day preparation group, RR 0.68 [0.40;0.94] (P=0.02). CONCLUSION: No clinically significant differences were noted among recipients of same day or split dose regimens. Adenoma detection rate, willingness to repeat and tolerability were similar, but bloating and interference with sleep favored the same-day preparations. Given lack of clinical differences, patient preference should dictate timing of colonoscopy preparation.

Rasagiline for the symptomatic treatment of fatigue in Parkinson's disease.

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.

A phase II trial of paclitaxel, carboplatin, and bevacizumab in advanced and recurrent endometrial carcinoma (EMCA).

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.

Outcome of neoadjuvant chemotherapy in BRCA1/2 mutation positive women with advanced-stage Müllerian cancer.

OBJECTIVES: To investigate whether patients with germline BRCA1/2 mutations who received neoadjuvant chemotherapy (NAC) for advanced-stage Müllerian 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. 15.7months 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. 14.8months 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. 36.5months 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.

Supraumbilical primary trocar insertion for laparoscopic access: the relationship between points of entry and retroperitoneal vital vasculature by imaging.

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.

The Impact of Percent Reduction in CA-125 Levels on Prediction of the Extent of Interval Cytoreduction and Outcome in Patients With Advanced-Stage Cancer of Müllerian Origin Treated With Neoadjuvant Chemotherapy.

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.

Comparison of postural ergonomics between laparoscopic and robotic sacrocolpopexy: a pilot study.

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.

Minimally Invasive Hysterectomy: An Analysis of Different Techniques.

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.

Patient-centered prenatal counseling: aligning obstetric healthcare professionals with needs of pregnant women.

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.

Adverse events, healthcare interventions and healthcare utilization during home infusion therapy with daptomycin and vancomycin: a propensity score-matched cohort study.

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.

What women want: lead considerations for current and future applications of noninvasive prenatal testing in prenatal care.

BACKGROUND: Noninvasive prenatal testing (NIPT) will change the delivery of prenatal care for all women, including those considered low risk for fetal chromosomal abnormalities. This study investigated pregnant women's attitudes, informational needs, and decision-making preferences with respect to current and future applications of NIPT. METHODS: A survey instrument was used to identify aspects of the decision-making process for NIPT among low-risk and high-risk populations. RESULTS: Both low-risk and high-risk women (n = 334) expressed interest in incorporating NIPT as a screening test into their prenatal care. Information specific to NIPT's detection rate (86%), indications (77%), and performance in comparison with conventional screens and diagnostic tests (63%) were identified as lead factors when considering its use. The future availability of NIPT as a diagnostic test increased women's willingness to undergo testing for fetal aneuploidy, cancer susceptibility, and childhood-onset and adult-onset diseases. Despite its noninvasive aspects, participants expressed the need for a formal informed consent process (71%) to take place before testing. CONCLUSIONS: This study demonstrates that NIPT will introduce new challenges for pregnant women and their health care practitioners who will be charged with supporting informed decision making about its use. It is critical that obstetric professionals are prepared to facilitate a patient-centered decision-making process as its clinical application rapidly changes.

Long-term fertility after laparoscopy for endometriosis-associated pelvic pain in young adult women.

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.

Determining the fertility benefit of controlled ovarian hyperstimulation with intrauterine insemination after operative laparoscopy in patients with endometriosis.

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.

Heart failure beliefs and self-care adherence while being treated in an emergency department.

BACKGROUND: Heart failure (HF) emergency department (ED) visits are commonly due to HF self-care nonadherence. OBJECTIVE: Our objective was to assess the accuracy of HF beliefs and adherence to self care in patients using an ED for acute HF. METHODS: 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. RESULTS: In 195 adults, mean HF beliefs score was 2.8 ± 0.3, significantly below the accurate cutoff score of 3.0 (p < 0.001). 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 (p < 0.001), 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). CONCLUSIONS: 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.

A randomized controlled pilot study of outcomes of strict allowance of fluid therapy in hyponatremic heart failure (SALT-HF).

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.

Risk factors for complications of radiation therapy on tissue expander breast reconstructions.

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.

Meeting patients' education and decision-making needs for first trimester prenatal aneuploidy screening.

OBJECTIVE: 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. METHOD: 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. RESULTS: 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%). CONCLUSION: 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.

Complication rates of radiation on tissue expander and autologous tissue breast reconstruction.

BACKGROUND: To evaluate risk factors for complications of tissue expander/implant and autologous tissue breast reconstructions and determine if radiation increases complication rates. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: 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.

Characteristics associated with racial disparities in illness beliefs of patients with heart failure.

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 < or = .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.

Risk factors for abnormal liver function tests in patients with ileal pouch-anal anastomosis for underlying inflammatory bowel disease.

OBJECTIVES: 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. METHODS: 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. RESULTS: 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; P<0.001) predicted any abnormal LFTs. CONCLUSIONS: 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.