Unexploded ordnance (UXO) site characterization must consider both how the contamination is generated and how we observe that contamination. Within the generation and observation processes, ...dependence structures can be exploited at multiple scales. We describe a conceptual site characterization process, the dependence structures available at several scales, and consider their statistical estimation aspects. It is evident that most of the statistical methods that are needed to address the estimation problems are known but their application-specific implementation may not be available. We demonstrate estimation at one scale and propose a representation for site contamination intensity that takes full account of uncertainty, is flexible enough to answer regulatory requirements, and is a practical tool for managing detailed spatial site characterization and remediation. The representation is based on point process spatial estimation methods that require modern computational resources for practical application. These methods have provisions for including prior and covariate information.
Background High-volume center surgery and gynecologic oncology care are associated with improved outcomes for women with uterine cancer. Referral patterns, from biopsy through to chemotherapy, may ...have patients interacting with high-volume centers for all, a portion, or none of their care. The relative frequency, the underlying factors that contribute to referral, and the potential impact of these referral patterns on treatment outcomes are unknown. Objective We sought to analyze the referral patterns and subsequent impact of care sites on treatment for women with high- and low-risk uterine cancer. Study Design This is a population-based retrospective cohort study of uterine cancer cases from 2004 through 2009 in North Carolina. Using state cancer registry files linked to Medicare, Medicaid, and private payer insurance claims, we analyzed referral and treatment patterns by annual surgical volume (high ≥12/y). We examined clinical and demographic factors associated with referral and used modified Poisson regression to evaluate risk of referral, lymphadenectomy, and chemotherapy. Stratified Kaplan-Meier plots and Cox proportional hazard models were used to examine survival. Results A total of 2053 women were analyzed, including 34% (n = 677) with grade 3 histology. Of 1630 (80%) women with preoperative biopsies, referral patterns (biopsy to surgery) were: low volume to high volume (n = 652, 40%), followed by high volume to high volume (n = 605, 37%), then low volume to low volume (n = 318, 20%), and the rare high volume to low volume (n = 50, 3%). Women retained in low-volume centers after biopsy were older, were less likely to have private insurance, and had more comorbidities. High-risk histology (aRR, 1.14; 95% confidence interval, 1.04–1.25) was positively associated with referral, while Medicaid insurance was negatively associated with referral (aRR, 0.64; 95% confidence interval, 0.42–0.96). Most women (74%, n = 1557) had surgery at high-volume centers. Lymphadenectomy was less likely at low-volume centers (aRR, 0.71; 95% confidence interval, 0.64–0.77). Similarly, for high-risk patients, the relationship between low-volume center surgery and subsequent chemotherapy was aRR, 0.71 (95% confidence interval, 0.48–1.02). Of 290 women who received chemotherapy, the referral patterns (surgery to chemotherapy) were: high volume–all (high volume to high volume), high volume–hybrid (high volume to low volume, or low volume to high volume), and high volume–none (low volume to low volume). In all, 36% (n = 104/290) received chemotherapy at a low-volume center, the majority (68%, n = 71/104) of whom were referred from high-volume centers after surgery. Crude, unadjusted mortality risk of chemotherapy recipients differed by referral pattern (surgery to chemotherapy): high volume–all patients (hazard ratio, 1.0; referent), followed by high volume–hybrid (hazard ratio, 1.33; 95% confidence interval, 0.93–1.91) then high volume–none patients (RR, 1.95; 95% confidence interval, 1.24–3.08). Conclusion Most women with uterine cancer treated at high-volume centers arrive through referral, which is affected by age and type of insurance, in addition to histology. For high-risk women who require chemotherapy, survival may be related to the extent of treatment received at high-volume centers.
Objective We sought to determine if fetal hypertrophic cardiomyopathy (HCM) or cardiac dysfunction is associated with elevated maternal or neonatal insulin-like growth factor (IGF)-I levels in women ...with diabetes. Study Design In a prospective cohort study, fetal echocardiogram findings at 36 weeks' gestation in women with pregestational diabetes mellitus were compared to those in women without diabetes mellitus. HCM was defined as septal or free wall thickness ≥5 mm and cardiac dysfunction as a modified myocardial performance index ≥0.43. Cord serum IGF-I levels at delivery were measured with enzyme-linked immunosorbent assay. Neonates with abnormal fetal echocardiogram were followed up until resolution or 6 months of life. Results In all, 75 participants completed fetal echocardiography (55 diabetics and 20 controls). In the diabetic group, 33 of 55 (60%) had abnormal fetal echocardiograms with cardiac dysfunction in 21 of 55 (38.2%) and HCM in 8 of 55 (14.5%) and both in 4 of 55 (7.3%). At 6 months of age, 1 of 12 (8%) had persistent HCM. None in the comparison group had abnormal findings. There were no significant clinical differences in those diabetic women with normal vs abnormal fetal echocardiograms. However, among diabetic women, mean neonatal IGF-I was significantly higher in fetuses with HCM (80 ± 16 ng/mL) as compared to those without HCM (61 ± 18 ng/mL), ( P < .001). Conclusion Elevated neonatal IGF-I appears to be associated with fetal HCM in fetuses of diabetic women.
Background There are currently no assessments of the impact of surgical complications on health-related quality of life in gynecology and gynecologic oncology. This is despite complications being a ...central focus of surgical outcome measurement, and an increasing awareness of the need for patient-reported data when measuring surgical quality. Objective We sought to measure the impact of surgical complications on health-related quality of life at 1 month postoperatively, in women undergoing gynecologic and gynecologic oncology procedures. Study Design This is a prospective cohort study of women undergoing surgery by gynecologic oncologists at a tertiary care academic center from October 2013 through October 2014. Patients were enrolled preoperatively and interviewed at baseline and 1, 3, and 6 months postoperatively. Health-related quality of life measures included validated general and disease-specific instruments, measuring multiple aspects of health-related quality of life, including anxiety and depression. The medical record was abstracted for clinical data and surgical complications were graded using validated Clavien-Dindo criteria, and women grouped into those with and without postoperative complications. Bivariate statistics, analysis of covariance, responder analysis, and multivariate modeling was used to analyze the relationship of postoperative complications to change health-related quality of life from baseline to 1 month. Plots of mean scores and change over time were constructed. Results Of 281 women enrolled, response rates were 80% (n = 231/281) at baseline, and from that cohort, 81% (n = 187/231), 74% (n = 170/231), and 75% (n = 174/231) at 1, 3, and 6 months, respectively. The primary analytic cohort comprised 185 women with completed baseline and 1-month interviews, and abstracted clinical data. Uterine (n = 84, 45%), ovarian (n = 23, 12%), cervical (n = 17, 9%), vulvar (n = 3, 2%), and other (n = 4, 2%) cancers were represented, along with 53 (30%) cases of benign disease. There were 42 (24%) racial/ethnic minority women. Minimally invasive (n = 115, 63%) and laparotomy (n = 60, 32%) procedures were performed. Postoperative complications occurred in 47 (26%) of patients who experienced grade 1 (n = 12), grade 2 (n = 29), and grade 3 (n = 6) complications. At 1 month, physical (20.6 vs 22.5, P = .04) and functional (15.4 vs 18.3, P = .02) well-being, global physical health (43.1 vs 46.3, P = .02), and work ability (3 vs 7.2, P = .001) were lower in postoperative complication vs non-postoperative complication women. Relative change, however, in most health-related quality of life domains from baseline to 1 month did not differ between postoperative complication and nonpostoperative complication groups. Postoperative complication patients did have increased odds of sustained or worsened anxiety at 1 month vs baseline (odds ratio, 2.5; 95% confidence interval, 1.2–5.0) compared to nonpostoperative complication patients. Conclusion Collectively, women who experienced postoperative complications after gynecologic and gynecologic oncology procedures did not appear to have differences in most health-related quality of life trends over time compared to those who did not. An exception was anxiety, where postoperative complications were associated with sustained or worsened levels of high anxiety after surgery.
The fungal plant pathogen Microsphaeropsis amaranthi is a candidate bioherbicide for the control of weedy Amaranthus species since it grows and sporulates readily in culture, is a pathogen of a ...number of important weed species, and is host-restricted to the family Amaranthaceae. This study was designed to determine the optimum and limiting environmental conditions for the efficacy of foliar applications of M. amaranthi for the control of common waterhemp. The greatest disease severity and the greatest plant biomass reductions were found when a prolonged leaf wetness period of greater than or equal to 12 h at 18 to 24 degrees C was provided after application. Disease severity and plant biomass reductions were greater when plants were treated at an earlier stage of development. Disease severity and impact were limited when shorter leaf wetness periods were provided, with negligible disease observed on plants provided with less than or equal to 6 h leaf wetness. When common waterhemp seedlings were sprayed in the field weekly through the summer of 2004 with conidial suspensions of M. amaranthi, only 7 of 14 applications resulted in disease and only 3 applications resulted in more than slight disease flecks. Moderate levels of disease were observed when applications had been made on days with moderate temperatures and leaf wetness duration in excess of 12 h following application. We confirm the pathogenicity of M. amaranthi against common waterhemp and demonstrate that the unformulated pathogen can cause disease in the field. Nonetheless, the weather conditions of the Midwestern United States, where common waterhemp control would be desired, are infrequently conducive to infection. The continued candidacy of M. amaranthi as a bioherbicide for the control of common waterhemp in the Midwestern United States will require that its efficacy under suboptimal environmental conditions be improved.
Climate change and its impacts already pose considerable challenges for societies that will further increase with global warming (IPCC, 2014a, b). Uncertainties of the climatic response to greenhouse ...gas emissions include the potential passing of large-scale tipping points (e.g. Lenton et al., 2008; Levermann et al., 2012; Schellnhuber, 2010) and changes in extreme meteorological events (Field et al., 2012) with complex impacts on societies (Hallegatte et al., 2013). Thus climate change mitigation is considered a necessary societal response for avoiding uncontrollable impacts (Conference of the Parties, 2010). On the other hand, large-scale climate change mitigation itself implies fundamental changes in, for example, the global energy system. The associated challenges come on top of others that derive from equally important ethical imperatives like the fulfilment of increasing food demand that may draw on the same resources. For example, ensuring food security for a growing population may require an expansion of cropland, thereby reducing natural carbon sinks or the area available for bio-energy production. So far, available studies addressing this problem have relied on individual impact models, ignoring uncertainty in crop model and biome model projections. Here, we propose a probabilistic decision framework that allows for an evaluation of agricultural management and mitigation options in a multi-impact-model setting. Based on simulations generated within the Inter-Sectoral Impact Model Intercomparison Project (ISI-MIP), we outline how cross-sectorally consistent multi-model impact simulations could be used to generate the information required for robust decision making. Using an illustrative future land use pattern, we discuss the trade-off between potential gains in crop production and associated losses in natural carbon sinks in the new multiple crop- and biome-model setting. In addition, crop and water model simulations are combined to explore irrigation increases as one possible measure of agricultural intensification that could limit the expansion of cropland required in response to climate change and growing food demand. This example shows that current impact model uncertainties pose an important challenge to long-term mitigation planning and must not be ignored in long-term strategic decision making.
This study evaluated the results for minimally invasive mitral valve (MV) surgery in patients who had undergone previous cardiac operations through a sternotomy.
From March 1, 1999 to January 2008, ...minimally invasive MV reoperations were performed in 181 consecutive patients (110 men) with a mean age of 64.5 +/- 12 years. A right-sided lateral minithoracotomy with femoral cannulation for cardiopulmonary bypass (CPB) was used. The principal indication was symptomatic severe mitral regurgitation (mean grade, 3.0 +/- 0.8). Previous procedures were isolated coronary bypass grafting (CABG) in 76 (42%), isolated valve operation, 55 (30%); combined CABG and valve, 16 (9%); and other cardiac operations, 34 (19%). MV replacement was previously performed in 19 patients and MV repair in 31. Mean preoperative left ventricular ejection fraction was 0.54 +/- 0.16.
MV repair, including repeat repair, was performed in 109 patients (60%) and MV replacement in 72 (40%). Operations were performed during ventricular fibrillation in 140 (77%), and a transthoracic aortic cross-clamp was used in 31 (17%). Ten patients (6%) underwent beating heart operations with CPB support. Mean total operating time was 176 +/- 50 min. Mean CPB time was 135 +/- 40 min. Thirty-day mortality was 6.6%. Early echocardiographic follow-up revealed excellent valve function in most patients.
A minimally invasive approach is a useful alternative for patients requiring a MV procedure after a previous cardiac operation, particularly in patients with patent coronary bypass grafts or previous aortic valve replacement. Very good perioperative results can be achieved with this method.
Abstract Objectives This study sought to determine variability and stability in risk-standardized mortality rates (RSMR) of percutaneous coronary intervention (PCI) operators meeting minimum case ...volume standards and identify differences in case mix and practice patterns that may account for RSMR variability. Background RSMR has been suggested as a metric to evaluate the performance of PCI operators; however, variability of operator-level RSMR and the stability of this metric over time among the same operator are unknown. Methods The authors calculated mean RSMRs for PCI operators with average annual volume of ≥50 cases in the National Cardiovascular Data Registry CathPCI Registry. Funnel plots were used to account for operator case volume. Demographic, clinical, and treatment variables of patients treated by operators with outlying high or low RSMRs (identified by RMSR greater than or less than 2 σ above or below the mean analogous to 2 SD, respectively) were compared with nonoutlier operators. RMSR stability was assessed by calculating average annual operator RMSR during the study period and by determining if operators were consistently classified into RMSR categories in each year. Results Between October 1, 2009, and September 30, 2014, a total of 2,352,174 PCIs were performed at 1,373 hospitals by 3,760 operators. Of these, 242 operators (6.5%) had RSMR >2 σ above the mean and 156 operators (4.1%) had RSMR >2 σ below the mean. Both high and low RSMR outlier operators treated patients with lower expected mortality risk, compared with nonoutlier operators. There was significant instability in annual operator RMSR during the study period. Conclusions There is significant variability in risk-standardized PCI mortality among U.S. operators meeting minimum volume standards that is not explained by case mix or procedure characteristics. Operator RMSR was unstable from year to year, thus limiting its utility as a sole performance measure for PCI quality.
Nasal Polyp Score (NPS) and Nasal Congestion Score (NCS) are commonly used clinical trial endpoints to determine improvements in response to treatment in patients with chronic rhinosinusitis with ...nasal polyps (CRSwNP). However, limited information is available on within-patient meaningful change thresholds (MCTs) and between-group minimal important differences (MIDs) for NPS and NCS, which would aid interpretation of results.
Data from phase 3 placebo-controlled trials of omalizumab in patients with CRSwNP (POLYP 1 and POLYP 2) were used to estimate MCTs and MIDs for both NPS and NCS using anchor-based methods. Sino-Nasal Outcome Test-22 (SNOT-22) and SNOT-22 Sino-Nasal Symptoms Subscale (SNSS) scores were used as anchors (≥0.35 correlation with NPS and NCS). Within- and between-group differences in NPS and NCS change scores were used to estimate MCTs and MIDs, respectively. Identified MCTs were used in unblinded responder analyses to compare the proportions of patients per treatment group achieving a meaningful improvement.
MCTs and MIDs were estimated at −1.0 and −0.5 for NPS and −0.50 and −0.35 for NCS, respectively, and were consistent across studies. Overall, 57.0% of patients achieved the MCT in NPS with omalizumab vs 29.9% with placebo (p < 0.0001). Similarly, 58.9% of patients achieved the MCT in NCS with omalizumab vs 30.7% with placebo (p < 0.0001). Group differences in mean change were statistically significant and exceeded the estimated MIDs.
Meaningful change estimates for NPS and NCS could be used to assess response to treatment for patients with chronic rhinosinusitis with nasal polyps.
Trial registration: POLYP1: clinicaltrails.gov NCT03280550; registered September 12, 2017; https://clinicaltrials.gov/ct2/show/NCT03280550). POLYP2 (clinicaltrials.gov NCT03280537; registered September 12, 2017; https://clinicaltrials.gov/ct2/show/NCT03280537).
Dynamic annuloplasty for mitral regurgitation Langer, Frank, MD; Borger, Michael A., MD; Czesla, Markus, MD ...
The Journal of thoracic and cardiovascular surgery,
02/2013, Letnik:
145, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Objective The MiCardia DYANA annuloplasty system (MiCardia Corp, Irvine, Calif) is a nitinol-based dynamic complete ring that allows modification of the septal-lateral diameter under transesophageal ...echocardiography guidance in the loaded beating heart after mitral valve repair. Shape alteration is induced by radiofrequency via detachable activation wires. This multicenter study reports the first human experience with this device. Methods Patients (n = 35, 67 ± 8 years) with degenerative (n = 29), functional/ischemic (n = 5), or rheumatic (n = 1) mitral regurgitation underwent mitral valve repair using the new device. We analyzed the occurrence of death, endocarditis, ring dehiscence, systolic anterior motion, thromboembolism, pulmonary edema, heart block, ventricular arrhythmia, hemolysis, or myocardial infarction at 30 days (primary end point) and 6 months (secondary end point) postprocedure. Results All patients exhibited mitral regurgitation of 2 or less early postoperatively and at 6 months follow-up. In 29 patients, the initial mitral valve repair result was satisfactory and no ring activation was required. In 6 patients, the nitinol-based ring was deformed intraoperatively postrepair with further improvement of mitral regurgitation in all cases (preactivation: 0.9 ± 0.2, postactivation: 0.2 ± 0.3; P = .001). One death (2.9%, multisystem organ failure, non–device related), 2 ventricular arrhythmias (5.7%), and 1 heart block (2.9%) occurred, all in the first 30 days after surgery. No additional major adverse clinical events occurred later than 1 month postprocedure (total observed major adverse clinical event rate 11.5%). Conclusions The implantation of the new dynamic annuloplasty ring allows for safe mitral valve repair. The option of postrepair modification of the septal-lateral diameter by radiofrequency may further optimize repair results.
PDF
