Identification of risk factors for mucosal injury during laparoscopic Heller myotomy for achalasia.

PubMed

Tsuboi, Kazuto; Omura, Nobuo; Yano, Fumiaki; Hoshino, Masato; Yamamoto, Se-Ryung; Akimoto, Shusuke; Masuda, Takahiro; Kashiwagi, Hideyuki; Yanaga, Katsuhiko

2016-02-01

Mucosal injury during myotomy is the most frequent complication seen with the Heller-Dor procedure for achalasia. The present study aimed to examine risk factors for such mucosal injury during this procedure. This was a retrospective analysis of patients who underwent the laparoscopic Heller-Dor procedure for achalasia at a single facility. Variables for evaluation included patient characteristics, preoperative pathophysiological findings, and surgeon's operative experience. Logistic regression was used to identify risk factors. We also examined surgical outcomes and the degree of patient satisfaction in relation to intraoperative mucosal injury. Four hundred thirty-five patients satisfied study criteria. Intraoperative mucosal injury occurred in 67 patients (15.4%). In univariate analysis, mucosal injury was significantly associated with the patient age ≥60 years, disease history ≥10 years, prior history of cardiac diseases, preoperative esophageal transverse diameter ≥80 mm, and surgeon's operative experience with fewer than five cases. In multivariate analysis involving these factors, the following variables were identified as risk factors: age ≥60 years, esophageal transverse diameter ≥80 mm, and surgeon's operative experience with fewer than five cases. The mucosal injury group had significant extension of the operative time and increased blood loss. However, there were no significant differences between the two groups in the incidence of reflux esophagitis or the degree of symptom alleviation postoperatively. The fragile esophagus caused by advanced patient age and/or dilatation were risk factor for mucosal injury during laparoscopic Heller-Dor procedure. And novice surgeon was also identified as an isolated risk factor for mucosal injury.

Phrenic nerve injury after radiofrequency ablation of lung tumors: retrospective evaluation of the incidence and risk factors.

PubMed

Matsui, Yusuke; Hiraki, Takao; Gobara, Hideo; Uka, Mayu; Masaoka, Yoshihisa; Tada, Akihiro; Toyooka, Shinichi; Mitsuhashi, Toshiharu; Mimura, Hidefumi; Kanazawa, Susumu

2012-06-01

To retrospectively investigate the incidence of and risk factors for phrenic nerve injury after radiofrequency (RF) ablation of lung tumors. The study included 814 RF ablation procedures of lung tumors. To evaluate the development of phrenic nerve injury, chest radiographs obtained before and after the procedure were examined. Phrenic nerve injury was assumed to have developed if the diaphragmatic level was elevated after the procedure. To identify risk factors for phrenic nerve injury, multiple variables were compared between cases of phrenic nerve injury and randomly selected controls by using univariate analyses. Multivariate analysis was then performed to identify independent risk factors. Evaluation of phrenic nerve injury from chest radiographs was possible after 786 procedures. Evidence of phrenic nerve injury developed after 10 cases (1.3%). Univariate analysis revealed that larger tumor size (≥ 20 mm; P = .014), proximity of the phrenic nerve to the tumor (< 10 mm; P < .001), the use of larger electrodes (array diameter or noninsulated tip length ≥ 3 cm; P = .001), and higher maximum power applied during ablation (≥ 100 W; P < .001) were significantly associated with the development of phrenic nerve injury. Multivariate analysis demonstrated that the proximity of the phrenic nerve to the tumor (< 10 mm; P < .001) was a significant independent risk factor. The incidence of phrenic nerve injury after RF ablation was 1.3%. The proximity of the phrenic nerve to the tumor was an independent risk factor for phrenic nerve injury. Copyright © 2012 SIR. Published by Elsevier Inc. All rights reserved.

Low-thrust mission risk analysis, with application to a 1980 rendezvous with the comet Encke

NASA Technical Reports Server (NTRS)

Yen, C. L.; Smith, D. B.

1973-01-01

A computerized failure process simulation procedure is used to evaluate the risk in a solar electric space mission. The procedure uses currently available thrust-subsystem reliability data and performs approximate simulations of the thrust sybsystem burn operation, the system failure processes, and the retargeting operations. The method is applied to assess the risks in carrying out a 1980 rendezvous mission to the comet Encke. Analysis of the results and evaluation of the effects of various risk factors on the mission show that system component failure rates are the limiting factors in attaining a high mission relability. It is also shown that a well-designed trajectory and system operation mode can be used effectively to partially compensate for unreliable thruster performance.

TU-FG-201-12: Designing a Risk-Based Quality Assurance Program for a Newly Implemented Y-90 Microspheres Procedure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vile, D; Zhang, L; Cuttino, L

2016-06-15

Purpose: To create a quality assurance program based upon a risk-based assessment of a newly implemented SirSpheres Y-90 procedure. Methods: A process map was created for a newly implemented SirSpheres procedure at a community hospital. The process map documented each step of this collaborative procedure, as well as the roles and responsibilities of each member. From the process map, different potential failure modes were determined as well as any current controls in place. From this list, a full failure mode and effects analysis (FMEA) was performed by grading each failure mode’s likelihood of occurrence, likelihood of detection, and potential severity.more » These numbers were then multiplied to compute the risk priority number (RPN) for each potential failure mode. Failure modes were then ranked based on their RPN. Additional controls were then added, with failure modes corresponding to the highest RPNs taking priority. Results: A process map was created that succinctly outlined each step in the SirSpheres procedure in its current implementation. From this, 72 potential failure modes were identified and ranked according to their associated RPN. Quality assurance controls and safety barriers were then added for failure modes associated with the highest risk being addressed first. Conclusion: A quality assurance program was created from a risk-based assessment of the SirSpheres process. Process mapping and FMEA were effective in identifying potential high-risk failure modes for this new procedure, which were prioritized for new quality assurance controls. TG 100 recommends the fault tree analysis methodology to design a comprehensive and effective QC/QM program, yet we found that by simply introducing additional safety barriers to address high RPN failure modes makes the whole process simpler and safer.« less

Uncertainty Analysis of A Flood Risk Mapping Procedure Applied In Urban Areas

NASA Astrophysics Data System (ADS)

Krause, J.; Uhrich, S.; Bormann, H.; Diekkrüger, B.

In the framework of IRMA-Sponge program the presented study was part of the joint research project FRHYMAP (flood risk and hydrological mapping). A simple con- ceptual flooding model (FLOODMAP) has been developed to simulate flooded areas besides rivers within cities. FLOODMAP requires a minimum of input data (digital el- evation model (DEM), river line, water level plain) and parameters and calculates the flood extent as well as the spatial distribution of flood depths. of course the simulated model results are affected by errors and uncertainties. Possible sources of uncertain- ties are the model structure, model parameters and input data. Thus after the model validation (comparison of simulated water to observed extent, taken from airborne pictures) the uncertainty of the essential input data set (digital elevation model) was analysed. Monte Carlo simulations were performed to assess the effect of uncertain- ties concerning the statistics of DEM quality and to derive flooding probabilities from the set of simulations. The questions concerning a minimum resolution of a DEM re- quired for flood simulation and concerning the best aggregation procedure of a given DEM was answered by comparing the results obtained using all available standard GIS aggregation procedures. Seven different aggregation procedures were applied to high resolution DEMs (1-2m) in three cities (Bonn, Cologne, Luxembourg). Basing on this analysis the effect of 'uncertain' DEM data was estimated and compared with other sources of uncertainties. Especially socio-economic information and monetary transfer functions required for a damage risk analysis show a high uncertainty. There- fore this study helps to analyse the weak points of the flood risk and damage risk assessment procedure.

Readability and Content Assessment of Informed Consent Forms for Medical Procedures in Croatia

PubMed Central

Vučemilo, Luka; Borovečki, Ana

2015-01-01

Background High quality of informed consent form is essential for adequate information transfer between physicians and patients. Current status of medical procedure consent forms in clinical practice in Croatia specifically in terms of the readability and the content is unknown. The aim of this study was to assess the readability and the content of informed consent forms for diagnostic and therapeutic procedures used with patients in Croatia. Methods 52 informed consent forms from six Croatian hospitals on the secondary and tertiary health-care level were tested for reading difficulty using Simple Measure of Gobbledygook (SMOG) formula adjusted for Croatian language and for qualitative analysis of the content. Results The averaged SMOG grade of analyzed informed consent forms was 13.25 (SD 1.59, range 10–19). Content analysis revealed that informed consent forms included description of risks in 96% of the cases, benefits in 81%, description of procedures in 78%, alternatives in 52%, risks and benefits of alternatives in 17% and risks and benefits of not receiving treatment or undergoing procedures in 13%. Conclusions Readability of evaluated informed consent forms is not appropriate for the general population in Croatia. The content of the forms failed to include in high proportion of the cases description of alternatives, risks and benefits of alternatives, as well as risks and benefits of not receiving treatments or undergoing procedures. Data obtained from this research could help in development and improvement of informed consent forms in Croatia especially now when Croatian hospitals are undergoing the process of accreditation. PMID:26376183

SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harry, T; University of California, San Diego, La Jolla, CA; Manger, R

Purpose: To evaluate the differences between the Veteran Affairs Healthcare Failure Modes and Effect Analysis (HFMEA) and the AAPM Task Group 100 Failure and Effect Analysis (FMEA) risk assessment techniques in the setting of a stereotactic radiosurgery (SRS) procedure were compared respectively. Understanding the differences in the techniques methodologies and outcomes will provide further insight into the applicability and utility of risk assessments exercises in radiation therapy. Methods: HFMEA risk assessment analysis was performed on a stereotactic radiosurgery procedure. A previous study from our institution completed a FMEA of our SRS procedure and the process map generated from this workmore » was used for the HFMEA. The process of performing the HFMEA scoring was analyzed, and the results from both analyses were compared. Results: The key differences between the two risk assessments are the scoring criteria for failure modes and identifying critical failure modes for potential hazards. The general consensus among the team performing the analyses was that scoring for the HFMEA was simpler and more intuitive then the FMEA. The FMEA identified 25 critical failure modes while the HFMEA identified 39. Seven of the FMEA critical failure modes were not identified by the HFMEA and 21 of the HFMEA critical failure modes were not identified by the FMEA. HFMEA as described by the Veteran Affairs provides guidelines on which failure modes to address first. Conclusion: HFMEA is a more efficient model for identifying gross risks in a process than FMEA. Clinics with minimal staff, time and resources can benefit from this type of risk assessment to eliminate or mitigate high risk hazards with nominal effort. FMEA can provide more in depth details but at the cost of elevated effort.« less

Finding Groups Using Model-Based Cluster Analysis: Heterogeneous Emotional Self-Regulatory Processes and Heavy Alcohol Use Risk

ERIC Educational Resources Information Center

Mun, Eun Young; von Eye, Alexander; Bates, Marsha E.; Vaschillo, Evgeny G.

2008-01-01

Model-based cluster analysis is a new clustering procedure to investigate population heterogeneity utilizing finite mixture multivariate normal densities. It is an inferentially based, statistically principled procedure that allows comparison of nonnested models using the Bayesian information criterion to compare multiple models and identify the…

Environmental Risk Assessment of dredging processes - application to Marin harbour (NW Spain)

NASA Astrophysics Data System (ADS)

Gómez, A. G.; García Alba, J.; Puente, A.; Juanes, J. A.

2014-04-01

A methodological procedure to estimate the environmental risk of dredging operations in aquatic systems has been developed. Environmental risk estimations are based on numerical models results, which provide an appropriated spatio-temporal framework analysis to guarantee an effective decision-making process. The methodological procedure has been applied on a real dredging operation in the port of Marin (NW Spain). Results from Marin harbour confirmed the suitability of the developed methodology and the conceptual approaches as a comprehensive and practical management tool.

The impact of resident involvement on post-operative morbidity and mortality following orthopaedic procedures: a study of 43,343 cases.

PubMed

Schoenfeld, Andrew J; Serrano, Jose A; Waterman, Brian R; Bader, Julia O; Belmont, Philip J

2013-11-01

Few studies have addressed the role of residents' participation in morbidity and mortality after orthopaedic surgery. The present study utilized the 2005-2010 National Surgical Quality Improvement Program (NSQIP) dataset to assess the risk of 30-day post-operative complications and mortality associated with resident participation in orthopaedic procedures. The NSQIP dataset was queried using codes for 12 common orthopaedic procedures. Patients identified as having received one of the procedures had their records abstracted to obtain demographic data, medical history, operative time, and resident involvement in their surgical care. Thirty-day post-operative outcomes, including complications and mortality, were assessed for all patients. A step-wise multivariate logistic regression model was constructed to evaluate the impact of resident participation on mortality- and complication-risk while controlling for other factors in the model. Primary analyses were performed comparing cases where the attending surgeon operated alone to all other case designations, while a subsequent sensitivity analysis limited inclusion to cases where resident participation was reported by post-graduate year. In the NSQIP dataset, 43,343 patients had received one of the 12 orthopaedic procedures queried. Thirty-five percent of cases were performed with resident participation. The mortality rate, overall, was 2.5 and 10 % sustained one or more complications. Multivariate analysis demonstrated a significant association between resident participation and the risk of one or more complications [OR 1.3 (95 % CI 1.1, 1.4); p < 0.001] as well as major systemic complications [OR 1.6 (95 % CI 1.3, 2.0); p < 0.001] for primary joint arthroplasty procedures only. These findings persisted even after sensitivity testing. A mild to moderate risk for complications was noted following resident involvement in joint arthroplasty procedures. No significant risk of post-operative morbidity or mortality was appreciated for the other orthopaedic procedures studied. II (Prognostic).

An analysis of US fertility centre educational materials suggests that informed consent for preimplantation genetic diagnosis may be inadequate.

PubMed

LaBonte, Michelle Lynne

2012-08-01

The use of preimplantation genetic diagnosis (PGD) has expanded both in number and scope over the past 2 decades. Initially carried out to avoid the birth of children with severe genetic disease, PGD is now used for a variety of medical and non-medical purposes. While some human studies have concluded that PGD is safe, animal studies and a recent human study suggest that the embryo biopsy procedure may result in neurological problems for the offspring. Given that the long-term safety of PGD has not been clearly established in humans, this study sought to determine how PGD safety is presented to prospective patients by means of a detailed website analysis. The websites of 262 US fertility centres performing PGD were analysed and comments about safety and risk were catalogued. Results of the analysis demonstrated that 78.2% of centre websites did not mention safety or risk of PGD at all. Of the 21.8% of centres that did contain safety or risk information about PGD, 28.1% included statements highlighting the potential risks, 38.6% presented information touting the procedure as safe and 33.3% included statements highlighting potential risks and the overall safety of the procedure. Thus, 86.6% of PGD-performing centres state that PGD is safe and/or fail to disclose any risks on their websites despite the fact that the impact of the procedure on the long-term health of offspring is unproven. This lack of disclosure suggests that informed consent is inadequate; this study examines numerous factors that are likely to inhibit comprehensive discussions of safety.

Development of a diagnosis- and procedure-based risk model for 30-day outcome after pediatric cardiac surgery.

PubMed

Crowe, Sonya; Brown, Kate L; Pagel, Christina; Muthialu, Nagarajan; Cunningham, David; Gibbs, John; Bull, Catherine; Franklin, Rodney; Utley, Martin; Tsang, Victor T

2013-05-01

The study objective was to develop a risk model incorporating diagnostic information to adjust for case-mix severity during routine monitoring of outcomes for pediatric cardiac surgery. Data from the Central Cardiac Audit Database for all pediatric cardiac surgery procedures performed in the United Kingdom between 2000 and 2010 were included: 70% for model development and 30% for validation. Units of analysis were 30-day episodes after the first surgical procedure. We used logistic regression for 30-day mortality. Risk factors considered included procedural information based on Central Cardiac Audit Database "specific procedures," diagnostic information defined by 24 "primary" cardiac diagnoses and "univentricular" status, and other patient characteristics. Of the 27,140 30-day episodes in the development set, 25,613 were survivals, 834 were deaths, and 693 were of unknown status (mortality, 3.2%). The risk model includes procedure, cardiac diagnosis, univentricular status, age band (neonate, infant, child), continuous age, continuous weight, presence of non-Down syndrome comorbidity, bypass, and year of operation 2007 or later (because of decreasing mortality). A risk score was calculated for 95% of cases in the validation set (weight missing in 5%). The model discriminated well; the C-index for validation set was 0.77 (0.81 for post-2007 data). Removal of all but procedural information gave a reduced C-index of 0.72. The model performed well across the spectrum of predicted risk, but there was evidence of underestimation of mortality risk in neonates undergoing operation from 2007. The risk model performs well. Diagnostic information added useful discriminatory power. A future application is risk adjustment during routine monitoring of outcomes in the United Kingdom to assist quality assurance. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Integrated risk assessment and screening analysis of drinking water safety of a conventional water supply system.

PubMed

Sun, F; Chen, J; Tong, Q; Zeng, S

2007-01-01

Management of drinking water safety is changing towards an integrated risk assessment and risk management approach that includes all processes in a water supply system from catchment to consumers. However, given the large number of water supply systems in China and the cost of implementing such a risk assessment procedure, there is a necessity to first conduct a strategic screening analysis at a national level. An integrated methodology of risk assessment and screening analysis is thus proposed to evaluate drinking water safety of a conventional water supply system. The violation probability, indicating drinking water safety, is estimated at different locations of a water supply system in terms of permanganate index, ammonia nitrogen, turbidity, residual chlorine and trihalomethanes. Critical parameters with respect to drinking water safety are then identified, based on which an index system is developed to prioritize conventional water supply systems in implementing a detailed risk assessment procedure. The evaluation results are represented as graphic check matrices for the concerned hazards in drinking water, from which the vulnerability of a conventional water supply system is characterized.

A probabilistic seismic risk assessment procedure for nuclear power plants: (I) Methodology

USGS Publications Warehouse

Huang, Y.-N.; Whittaker, A.S.; Luco, N.

2011-01-01

A new procedure for probabilistic seismic risk assessment of nuclear power plants (NPPs) is proposed. This procedure modifies the current procedures using tools developed recently for performance-based earthquake engineering of buildings. The proposed procedure uses (a) response-based fragility curves to represent the capacity of structural and nonstructural components of NPPs, (b) nonlinear response-history analysis to characterize the demands on those components, and (c) Monte Carlo simulations to determine the damage state of the components. The use of response-rather than ground-motion-based fragility curves enables the curves to be independent of seismic hazard and closely related to component capacity. The use of Monte Carlo procedure enables the correlation in the responses of components to be directly included in the risk assessment. An example of the methodology is presented in a companion paper to demonstrate its use and provide the technical basis for aspects of the methodology. ?? 2011 Published by Elsevier B.V.

A Tuned Single Parameter for Representing Conjunction Risk

NASA Technical Reports Server (NTRS)

Plakaloic, D.; Hejduk, M. D.; Frigm, R. C.; Newman, L. K.

2011-01-01

Satellite conjunction assessment risk analysis is a subjective enterprise that can benefit from quantitative aids and, to this end, NASA/GSFC has developed a fuzzy logic construct - called the F-value - to attempt to provide a statement of conjunction risk that amalgamates multiple indices and yields a more stable intra-event assessment. This construct has now sustained an extended tuning procedure against heuristic analyst assessment of event risk. The tuning effort has resulted in modifications to the calculation procedure and the adjustment of tuning coefficients, producing a construct with both more predictive force and a better statement of its error.

Prevention of bleeding after islet transplantation: lessons learned from a multivariate analysis of 132 cases at a single institution.

PubMed

Villiger, P; Ryan, E A; Owen, R; O'Kelly, K; Oberholzer, J; Al Saif, F; Kin, T; Wang, H; Larsen, I; Blitz, S L; Menon, V; Senior, P; Bigam, D L; Paty, B; Kneteman, N M; Lakey, J R T; Shapiro, A M James

2005-12-01

Islet transplantation is being offered increasingly for selected patients with unstable type 1 diabetes. Percutaneous transhepatic portal access avoids a need for surgery, but is associated with potential risk of bleeding. Between 1999 and 2005, we performed 132 percutaneous transhepatic islet transplants in 67 patients. We encountered bleeding in 18/132 cases (13.6%). In univariate analysis, the risk of bleeding in the absence of effective track ablation was associated with an increasing number of procedures (2nd and 3rd procedures with an odds ratio (OR) of 9.5 and 20.9, respectively), platelets count <150,000 (OR 4.4), elevated portal pressure (OR 1.1 per mm Hg rise), heparin dose > or =45 U/kg (OR 9.8) and pre-transplant aspirin (81 mg per day) (OR 2.6, p = 0.05). A multivariate analysis further confirmed the cumulative transplant procedure number (p < 0.001) and heparin dose > or =45 U/kg (p = 0.02) as independent risk factors for bleeding. Effective mechanical sealing of the intrahepatic portal catheter tract with thrombostatic coils and tissue fibrin glue completely prevented bleeding in all subsequent procedures (n = 26, p = 0.02). We conclude that bleeding after percutaneous islet implantation is an avoidable complication provided the intraparenchymal liver tract is sealed effectively.

Perceived risk of prenatal diagnostic procedure-related miscarriage and Down syndrome among pregnant women.

PubMed

Caughey, Aaron B; Washington, A Eugene; Kuppermann, Miriam

2008-03-01

The objective of the study was to identify correlates of perceived risk of carrying a Down syndrome-affected fetus or experiencing a procedure-related miscarriage among a diverse group of pregnant women. We conducted a cross-sectional survey of 1081 English-, Spanish-, or Chinese-speaking women receiving prenatal care in the San Francisco Bay area. Perceived risk of procedure-related miscarriage or carrying a Down syndrome-affected fetus was assessed using a linear rating scale from 0 (no risk) to 1 (high risk). Bivariate and multivariable analyses were used to explore associations between maternal characteristics including age, race/ethnicity, and socioeconomic status and perceived risks of carrying a Down syndrome-affected fetus or experiencing a procedure-related miscarriage. Women aged 35 years old or older had a higher perceived risk of Down syndrome than younger women (0.28 vs 0.22 on a scale from 0 to 1, P < .001) but a lower perceived risk of a procedure-related miscarriage (0.31 vs 0.36, P = .004). In multivariable linear regression analysis among women younger than age 35 years, the perceived risk of carrying a Down syndrome-affected fetus was higher in women who had not attended college (+0.06, P = .019) or had poor self-perceived health status (+0.08, P = .045). Latinas (+0.11, P = .008), women with an annual income less than $35,000 (+0.09, P = .003), and those who had difficulty conceiving (+0.09, P = .026) had higher perceived procedure-related miscarriage risk. Among women aged 35 years or older, perceived risk of carrying a Down syndrome-affected fetus was associated with the inclination to undergo prenatal diagnosis. Women's perceived risks of carrying a Down syndrome-affected fetus or having a procedure-related miscarriage are associated with numerous characteristics that have not been shown to be associated with the actual risks of these events. These perceived risks are associated with prenatal diagnostic test inclination. Understanding patients' risk perceptions and effectively communicating risk is critical to helping patients make informed decisions regarding use of invasive prenatal testing.

SU-E-T-635: Process Mapping of Eye Plaque Brachytherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huynh, J; Kim, Y

Purpose: To apply a risk-based assessment and analysis technique (AAPM TG 100) to eye plaque brachytherapy treatment of ocular melanoma. Methods: The role and responsibility of personnel involved in the eye plaque brachytherapy is defined for retinal specialist, radiation oncologist, nurse and medical physicist. The entire procedure was examined carefully. First, major processes were identified and then details for each major process were followed. Results: Seventy-one total potential modes were identified. Eight major processes (corresponding detailed number of modes) are patient consultation (2 modes), pretreatment tumor localization (11), treatment planning (13), seed ordering and calibration (10), eye plaque assembly (10),more » implantation (11), removal (11), and deconstruction (3), respectively. Half of the total modes (36 modes) are related to physicist while physicist is not involved in processes such as during the actual procedure of suturing and removing the plaque. Conclusion: Not only can failure modes arise from physicist-related procedures such as treatment planning and source activity calibration, but it can also exist in more clinical procedures by other medical staff. The improvement of the accurate communication for non-physicist-related clinical procedures could potentially be an approach to prevent human errors. More rigorous physics double check would reduce the error for physicist-related procedures. Eventually, based on this detailed process map, failure mode and effect analysis (FMEA) will identify top tiers of modes by ranking all possible modes with risk priority number (RPN). For those high risk modes, fault tree analysis (FTA) will provide possible preventive action plans.« less

Safe Anesthesia for Radiotherapy in Pediatric Oncology: St. Jude Children's Research Hospital Experience, 2004-2006

DOE Office of Scientific and Technical Information (OSTI.GOV)

Anghelescu, Doralina L.; Burgoyne, Laura L.; Liu Wei

2008-06-01

Purpose: To determine the incidence of anesthesia-related complications in children undergoing radiotherapy and the associated risk factors. Methods and Materials: We retrospectively investigated the incidence and types of anesthesia-related complications and examined their association with age, weight, oncology diagnosis, type of anesthetic (propofol vs. propofol and adjuncts), total propofol dose, anesthetic duration, type of radiotherapy procedure (simulation vs. radiotherapy) and patient position (prone vs. supine). Results: Between July 2004 and June 2006, propofol was used in 3,833 procedures (3,611 radiotherapy sessions and 222 simulations) in 177 patients. Complications occurred during 49 anesthetic sessions (1.3%). On univariate analysis, four factors weremore » significantly associated with the risk of complications: procedure duration (p <0.001), total propofol dose (p <0.001), use of adjunct agents (vs. propofol alone; p = 0.029), and simulation (vs. radiotherapy; p = 0.014). Patient position (prone vs. supine) was not significantly associated with the frequency of complications (odds ratio, 0.71; 95% confidence interval, 0.33-1.53; p = 0.38). On multivariate analysis, the procedure duration (p <0.0001) and total propofol dose (p {<=}0.03) were the most significant risk factors after adjustment for age, weight, anesthetic type, and procedure type. We found no evidence of the development of tolerance to propofol. Conclusion: The rate of anesthesia-related complications was low (1.3%) in our study. The significant risk factors were procedure duration, total propofol dose, the use of adjunct agents with propofol, and simulation (vs. radiotherapy)« less

Applying Latent Class Analysis to Risk Stratification for Perioperative Mortality in Patients Undergoing Intraabdominal General Surgery.

PubMed

Kim, Minjae; Wall, Melanie M; Li, Guohua

2016-07-01

Perioperative risk stratification is often performed using individual risk factors without consideration of the syndemic of these risk factors. We used latent class analysis (LCA) to identify the classes of comorbidities and risk factors associated with perioperative mortality in patients presenting for intraabdominal general surgery. The 2005 to 2010 American College of Surgeons National Surgical Quality Improvement Program was used to obtain a cohort of patients undergoing intraabdominal general surgery. Risk factors and comorbidities were entered into LCA models to identify the latent classes, and individuals were assigned to a class based on the highest posterior probability of class membership. Relative risk regression was used to determine the associations between the latent classes and 30-day mortality, with adjustments for procedure. A 9-class model was fit using LCA on 466,177 observations. After combining classes with similar adjusted mortality risks, 5 risk classes were obtained. Compared with the class with average mortality risk (class 4), the risk ratios (95% confidence interval) ranged from 0.020 (0.014-0.027) in the lowest risk class (class 1) to 6.75 (6.46-7.02) in the highest risk class. After adjusting for procedure and ASA physical status, the latent classes remained significantly associated with 30-day mortality. The addition of the risk class variable to a model containing ASA physical status and surgical procedure demonstrated a significant increase in the area under the receiver operator characteristic curve (0.892 vs 0.915; P < 0.0001). Latent classes of risk factors and comorbidities in patients undergoing intraabdominal surgery are predictive of 30-day mortality independent of the ASA physical status and improve risk prediction with the ASA physical status.

Quantitative Method for Analyzing the Allocation of Risks in Transportation Construction

DOT National Transportation Integrated Search

1979-04-01

The report presents a conceptual model of risk that was developed to analyze the impact on owner's cost of alternate allocations of risk among owner and contractor in mass transit construction. A model and analysis procedure are developed, based on d...

Aortic aneurysm in a 74-year-old man with coronary disease and obstructive lung disease: is double jeopardy enough?

PubMed

Hagen, M D; Eckman, M H; Pauker, S G

1989-01-01

A previous decision analysis examined a patient with severe CAD, diminished ventricular function, and an abdominal aortic aneurysm and also concluded that CABG followed by aneurysm repair was optimal. This patient, who had well-preserved cardiac function but severely compromised pulmonary status, stood to gain less from CABG than would a patient with more severe coronary disease, thus accounting for the "close-call" between the CABG-AAA and AAA only strategies. Nevertheless, the analysis did emphasize the benefit of aneurysm repair, whether done alone or after CABG. The analysis also highlighted the significant risk of aneurysm rupture the patient is exposed to while recovering from CABG surgery. The operative mortality risks of the two procedures are similar; thus, the patient's total operative risk is approximately doubled if he undergoes both procedures rather than aneurysm repair alone. The key question raised by the analysis is whether this double jeopardy is more than compensated by the degree to which prior CABG reduces both short-term cardiac risk at subsequent aneurysm repair and long-term cardiac mortality. For this patient, who had good cardiac function, the gains appeared sufficient to offset the interval risk of aneurysm rupture and the additional risk associated with a surgical procedures. THE REAL WORLD The patient indeed underwent and tolerated CABG, although he had a stormy prolonged postoperative course due to pulmonary failure. After discharge from the hospital, he declined readmission for repair of the aneurysm. We did not model that possibility, clearly an inadequacy in our tree. Some six months later, the patient was still alive and was, reluctantly, readmitted for aneurysmorrhaphy. At that time, however, his pulmonary function had deteriorated and both the anesthesiologist and the pulmonary consultant stated unequivocally that further surgery was now impossible. In retrospect, the expected utility of CABG without aneurysm repair (thus providing only a decrease in the long-term mortality risk from his CAD) would have been 1.95 (DEALE) or 2.06 (Markov) years. Sensitivity analysis revealed that, even if long-term cardiac risk were completely eliminated by CABG, immediate aneurysm repair would have been a better approach had the patient's physicians known he would be likely to refuse or not be a candidate for the second operation. In summary, although the patient's comorbidities did indeed place him at significant operative risk for either aneurysmorrhaphy alone or two sequential procedures, the benefits to be gained were shown to far outweigh the risks when compared with expectant observation.(ABSTRACT TRUNCATED AT 400 WORDS)

CT fluoroscopy-guided preoperative short hook wire placement for small pulmonary lesions: evaluation of safety and identification of risk factors for pneumothorax.

PubMed

Iguchi, Toshihiro; Hiraki, Takao; Gobara, Hideo; Fujiwara, Hiroyasu; Matsui, Yusuke; Miyoshi, Shinichiro; Kanazawa, Susumu

2016-01-01

To retrospectively evaluate the safety of computed tomography (CT) fluoroscopy-guided short hook wire placement for video-assisted thoracoscopic surgery and the risk factors for pneumothorax associated with this procedure. We analyzed 267 short hook wire placements for 267 pulmonary lesions (mean diameter, 9.9 mm). Multiple variables related to the patients, lesions, and procedures were assessed to determine the risk factors for pneumothorax. Complications (219 grade 1 and 4 grade 2 adverse events) occurred in 196 procedures. No grade 3 or above adverse events were observed. Univariate analysis revealed increased vital capacity (odds ratio [OR], 1.518; P = 0.021), lower lobe lesion (OR, 2.343; P =0.001), solid lesion (OR, 1.845; P = 0.014), prone positioning (OR, 1.793; P = 0.021), transfissural approach (OR, 11.941; P = 0.017), and longer procedure time (OR, 1.036; P = 0.038) were significant predictors of pneumothorax. Multivariate analysis revealed only the transfissural approach (OR, 12.171; P = 0.018) and a longer procedure time (OR, 1.048; P = 0.012) as significant independent predictors. Complications related to CT fluoroscopy-guided preoperative short hook wire placement often occurred, but all complications were minor. A transfissural approach and longer procedure time were significant independent predictors of pneumothorax. Complications related to CT fluoroscopy-guided preoperative short hook wire placement often occur. Complications are usually minor and asymptomatic. A transfissural approach and longer procedure time are significant independent predictors of pneumothorax.

LNG risk management

NASA Astrophysics Data System (ADS)

Martino, P.

1980-12-01

A general methodology is presented for conducting an analysis of the various aspects of the hazards associated with the storage and transportation of liquefied natural gas (LNG) which should be considered during the planning stages of a typical LNG ship terminal. The procedure includes the performance of a hazards and system analysis of the proposed site, a probability analysis of accident scenarios and safety impacts, an analysis of the consequences of credible accidents such as tanker accidents, spills and fires, the assessment of risks and the design and evaluation of risk mitigation measures.

Evaluating the risks of clinical research: direct comparative analysis.

PubMed

Rid, Annette; Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S; Wendler, David

2014-09-01

Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed "risks of daily life" standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. This study employed a conceptual and normative analysis, and use of an illustrative example. Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the "risks of daily life" standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Direct comparative analysis is a systematic method for applying the "risks of daily life" standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks.

Evaluating the Risks of Clinical Research: Direct Comparative Analysis

PubMed Central

Abdoler, Emily; Roberson-Nay, Roxann; Pine, Daniel S.; Wendler, David

2014-01-01

Abstract Objectives: Many guidelines and regulations allow children and adolescents to be enrolled in research without the prospect of clinical benefit when it poses minimal risk. However, few systematic methods exist to determine when research risks are minimal. This situation has led to significant variation in minimal risk judgments, raising concern that some children are not being adequately protected. To address this concern, we describe a new method for implementing the widely endorsed “risks of daily life” standard for minimal risk. This standard defines research risks as minimal when they do not exceed the risks posed by daily life activities or routine examinations. Methods: This study employed a conceptual and normative analysis, and use of an illustrative example. Results: Different risks are composed of the same basic elements: Type, likelihood, and magnitude of harm. Hence, one can compare the risks of research and the risks of daily life by comparing the respective basic elements with each other. We use this insight to develop a systematic method, direct comparative analysis, for implementing the “risks of daily life” standard for minimal risk. The method offers a way of evaluating research procedures that pose the same types of risk as daily life activities, such as the risk of experiencing anxiety, stress, or other psychological harm. We thus illustrate how direct comparative analysis can be applied in practice by using it to evaluate whether the anxiety induced by a respiratory CO2 challenge poses minimal or greater than minimal risks in children and adolescents. Conclusions: Direct comparative analysis is a systematic method for applying the “risks of daily life” standard for minimal risk to research procedures that pose the same types of risk as daily life activities. It thereby offers a method to protect children and adolescents in research, while ensuring that important studies are not blocked because of unwarranted concerns about research risks. PMID:25210944

Significant Association of Annual Hospital Volume With the Risk of Inhospital Stroke or Death Following Carotid Endarterectomy but Likely Not After Carotid Stenting: Secondary Data Analysis of the Statutory German Carotid Quality Assurance Database.

PubMed

Kuehnl, Andreas; Tsantilas, Pavlos; Knappich, Christoph; Schmid, Sofie; König, Thomas; Breitkreuz, Thorben; Zimmermann, Alexander; Mansmann, Ulrich; Eckstein, Hans-Henning

2016-11-01

Associations between hospital volume and the risk of stroke or death following carotid endarterectomy (CEA) and carotid artery stenting (CAS) on a national level in Germany were analyzed. Secondary data analysis using microdata from the nationwide statutory German quality assurance database on all surgical or endovascular carotid interventions on the extracranial carotid artery between 2009 and 2014. Hospitals were categorized into empirically determined quintiles according to the annual case volume. The resulting volume thresholds were 10, 25, 46, and 79 for CEA and 2, 6, 12, and 26 for CAS procedures. The primary outcome was any stroke or death before hospital discharge. For risk-adjusted analyses, a multilevel regression model was applied. The analysis included 161 448 CEA and 17 575 CAS procedures. In CEA patients, the crude risk of stroke or death decreased monotonically from 4.2% (95% confidence interval, 3.6%-4.9%) in low-volume hospitals (first quintile 1-10 CEA per year) to 2.1% (2.0%-2.2%) in hospitals providing ≥80 CEA per year (fifth quintile; P<0.001 for trend). The overall risk of any stroke or death in CAS patients was 3.7% (3.5%-4.0%), but no trend on annual volume was seen (P=0.304). Risk-adjusted analyses confirmed a significant inverse relationship between hospital volume (categorized or continuous) and the risk of stroke or death after CEA but not CAS procedures. An inverse volume-outcome relationship in CEA-treated patients was demonstrated. No significant association between hospital volume and the risk of stroke or death was found for CAS. © 2016 American Heart Association, Inc.

Retrieval medicine: a review and guide for UK practitioners. Part 2: safety in patient retrieval systems

PubMed Central

Hearns, S; Shirley, P J

2006-01-01

Retrieval and transfer of critically ill and injured patients is a high risk activity. Risk can be minimised with robust safety and clinical governance systems in place. This article describes the various governance systems that can be employed to optimise safety and efficiency in retrieval services. These include operating procedure development, equipment management, communications procedures, crew resource management, significant event analysis, audit and training. PMID:17130608

Military Ecological Risk Assessment Framework (MERAF) for Assessment of Risks of Military Training and Testing to Natural Resources

DOE Office of Scientific and Technical Information (OSTI.GOV)

Suter II, G.W.

2003-06-18

The objective of this research is to provide the DoD with a framework based on a systematic, risk-based approach to assess impacts for management of natural resources in an ecosystem context. This risk assessment framework is consistent with, but extends beyond, the EPA's ecological risk assessment framework, and specifically addresses DoD activities and management needs. MERAF is intended to be consistent with existing procedures for environmental assessment and planning with DoD testing and training. The intention is to supplement these procedures rather than creating new procedural requirements. MERAF is suitable for use for training and testing area assessment and management.more » It does not include human health risks nor does it address specific permitting or compliance requirements, although it may be useful in some of these cases. Use of MERAF fits into the National Environmental Policy Act (NEPA) process by providing a consistent and rigorous way of organizing and conducting the technical analysis for Environmental Impact Statements (EISs) (Sigal 1993; Carpenter 1995; Canter and Sadler 1997). It neither conflicts with, nor replaces, procedural requirements within the NEPA process or document management processes already in place within DoD.« less

Detailed Analysis of Peri-Procedural Strokes in Patients Undergoing Intracranial Stenting in SAMMPRIS

PubMed Central

Fiorella, David; Derdeyn, Colin P; Lynn, Michael J; Barnwell, Stanley L; Hoh, Brian L.; Levy, Elad I.; Harrigan, Mark R.; Klucznik, Richard P.; McDougall, Cameron G.; Pride, G. Lee; Zaidat, Osama O.; Lutsep, Helmi L.; Waters, Michael F.; Hourihane, J. Maurice; Alexandrov, Andrei V.; Chiu, David; Clark, Joni M.; Johnson, Mark D.; Torbey, Michel T.; Rumboldt, Zoran; Cloft, Harry J.; Turan, Tanya N.; Lane, Bethany F.; Janis, L. Scott; Chimowitz, Marc I.

2012-01-01

Background and Purpose Enrollment in the SAMMPRIS trial was halted due to the high risk of stroke or death within 30 days of enrollment in the percutaneous transluminal angioplasty and stenting (PTAS) arm relative to the medical arm. This analysis focuses on the patient and procedural factors that may have been associated with peri-procedural cerebrovascular events in the trial. Methods Bivariate and multivariate analyses were performed to evaluate whether patient and procedural variables were associated with cerebral ischemic or hemorrhagic events occurring within 30 days of enrollment (termed peri-procedural) in the PTAS arm. Results Of 224 patients randomized to PTAS, 213 underwent angioplasty alone (n=5) or with stenting (n=208). Of these, 13 had hemorrhagic strokes (7 parenchymal, 6 subarachnoid), 19 had ischemic stroke, and 2 had cerebral infarcts with temporary signs (CITS) within the peri-procedural period. Ischemic events were categorized as perforator occlusions (13), embolic (4), mixed perforator and embolic (2), and delayed stent occlusion (2). Multivariate analyses showed that higher percent stenosis, lower modified Rankin score, and clopidogrel load associated with an activated clotting time above the target range were associated (p ≤ 0.05) with hemorrhagic stroke. Non-smoking, basilar artery stenosis, diabetes, and older age were associated (p ≤ 0.05) with ischemic events. Conclusions Peri-procedural strokes in SAMMPRIS had multiple causes with the most common being perforator occlusion. Although risk factors for peri-procedural strokes could be identified, excluding patients with these features from undergoing PTAS to lower the procedural risk would limit PTAS to a small subset of patients. Moreover, given the small number of events, the present data should be used for hypothesis generation rather than to guide patient selection in clinical practice. PMID:22984008

Current outcomes and risk factors for the Norwood procedure.

PubMed

Stasik, Chad N; Gelehrter, S; Goldberg, Caren S; Bove, Edward L; Devaney, Eric J; Ohye, Richard G

2006-02-01

Tremendous strides have been made in the outcomes for hypoplastic left heart syndrome and other functional single-ventricle malformations over the past 25 years. This progress relates primarily to improvements in survival for patients undergoing the Norwood procedure. Previous reports on risk factors have been on smaller groups of patients or collected over relatively long periods of time, during which management has evolved. We analyzed our current results for the Norwood procedure with attention to risk factors for poor outcome. A single-institution review of all patients undergoing a Norwood procedure for a single-ventricle malformation from May 1, 2001, through April 30, 2003, was performed. Patient demographics, anatomy, clinical condition, associated anomalies, operative details, and outcomes were recorded. Of the 111 patients, there were 23 (21%) hospital deaths. Univariate analysis revealed noncardiac abnormalities (genetic or significant extracardiac diagnosis, P = .0018), gestational age (P = .03), diagnosis of unbalanced atrioventricular septal defect (P = .017), and weight of less than 2.5 kg (P = .0072) to be related to hospital death. On multivariate analysis, only weight of less than 2.5 kg and noncardiac abnormalities were found to be independent risk factors. Patients with either of these characteristics had a hospital survival of 52% (12/23), whereas those at standard risk had a survival of 86% (76/88). Although improvements in management might have lessened the effect of some of the traditionally reported risk factors related to variations in the cardiovascular anatomy, noncardiac abnormalities and low birth weight remain as a future challenge for the physician caring for the patient with single-ventricle physiology.

Analysis and classification of the tools for assessing the risks associated with industrial machines.

PubMed

Paques, Joseph-Jean; Gauthier, François; Perez, Alejandro

2007-01-01

To assess and plan future risk-analysis research projects, 275 documents describing methods and tools for assessing the risks associated with industrial machines or with other sectors such as the military, and the nuclear and aeronautics industries, etc., were collected. These documents were in the format of published books or papers, standards, technical guides and company procedures collected throughout industry. From the collected documents, 112 documents were selected for analysis; 108 methods applied or potentially applicable for assessing the risks associated with industrial machines were analyzed and classified. This paper presents the main quantitative results of the analysis of the methods and tools.

Cement Leakage in Percutaneous Vertebral Augmentation for Osteoporotic Vertebral Compression Fractures: Analysis of Risk Factors.

PubMed

Xie, Weixing; Jin, Daxiang; Ma, Hui; Ding, Jinyong; Xu, Jixi; Zhang, Shuncong; Liang, De

2016-05-01

The risk factors for cement leakage were retrospectively reviewed in 192 patients who underwent percutaneous vertebral augmentation (PVA). To discuss the factors related to the cement leakage in PVA procedure for the treatment of osteoporotic vertebral compression fractures. PVA is widely applied for the treatment of osteoporotic vertebral fractures. Cement leakage is a major complication of this procedure. The risk factors for cement leakage were controversial. A retrospective review of 192 patients who underwent PVA was conducted. The following data were recorded: age, sex, bone density, number of fractured vertebrae before surgery, number of treated vertebrae, severity of the treated vertebrae, operative approach, volume of injected bone cement, preoperative vertebral compression ratio, preoperative local kyphosis angle, intraosseous clefts, preoperative vertebral cortical bone defect, and ratio and type of cement leakage. To study the correlation between each factor and cement leakage ratio, bivariate regression analysis was employed to perform univariate analysis, whereas multivariate linear regression analysis was employed to perform multivariate analysis. The study included 192 patients (282 treated vertebrae), and cement leakage occurred in 100 vertebrae (35.46%). The vertebrae with preoperative cortical bone defects generally exhibited higher cement leakage ratio, and the leakage is typically type C. Vertebrae with intact cortical bones before the procedure tend to experience type S leakage. Univariate analysis showed that patient age, bone density, number of fractured vertebrae before surgery, and vertebral cortical bone were associated with cement leakage ratio (P<0.05). Multivariate analysis showed that the main factors influencing bone cement leakage are bone density and vertebral cortical bone defect, with standardized partial regression coefficients of -0.085 and 0.144, respectively. High bone density and vertebral cortical bone defect are independent risk factors associated with bone cement leakage.

Increased risk for complications following removal of hardware in patients with liver disease, pilon or pelvic fractures: A regression analysis.

PubMed

Brown, Bryan D; Steinert, Justin N; Stelzer, John W; Yoon, Richard S; Langford, Joshua R; Koval, Kenneth J

2017-12-01

Indications for removing orthopedic hardware on an elective basis varies widely. Although viewed as a relatively benign procedure, there is a lack of data regarding overall complication rates after fracture fixation. The purpose of this study is to determine the overall short-term complication rate for elective removal of orthopedic hardware after fracture fixation and to identify associated risk factors. Adult patients indicated for elective hardware removal after fracture fixation between July 2012 and July 2016 were screened for inclusion. Inclusion criteria included patients with hardware related pain and/or impaired cosmesis with complete medical and radiographic records and at least 3-month follow-up. Exclusion criteria were those patients indicated for hardware removal for a diagnosis of malunion, non-union, and/or infection. Data collected included patient age, gender, anatomic location of hardware removed, body mass index, ASA score, and comorbidities. Overall complications, as well as complications requiring revision surgery were recorded. Statistical analysis was performed with SPSS 20.0, and included univariate and multivariate regression analysis. 391 patients (418 procedures) were included for analysis. Overall complication rates were 8.4%, with a 3.6% revision surgery rate. Univariate regression analysis revealed that patients who had liver disease were at significant risk for complication (p=0.001) and revision surgery (p=0.036). Multivariate regression analysis showed that: 1) patients who had liver disease were at significant risk of overall complication (p=0.001) and revision surgery (p=0.039); 2) Removal of hardware following fixation for a pilon had significantly increased risk for complication (p=0.012), but not revision surgery (p=0.43); and 3) Removal of hardware for pelvic fixation had a significantly increased risk for revision surgery (p=0.017). Removal of hardware following fracture fixation is not a risk-free procedure. Patients with liver disease are at increased risk for complications, including increased risk for needing revision surgery following hardware removal. Patients having hardware removed following fixation for pilon fractures also are at increased risk for complication, although they may not require a return trip to the operating room. Finally, removal of pelvic hardware is associated with a higher return to the operating room. Copyright © 2017 Elsevier Ltd. All rights reserved.

Perioperative risk assessment in robotic general surgery: lessons learned from 884 cases at a single institution.

PubMed

Buchs, Nicolas C; Addeo, Pietro; Bianco, Francesco M; Gorodner, Veronica; Ayloo, Subhashini M; Elli, Enrique F; Oberholzer, José; Benedetti, Enrico; Giulianotti, Pier C

2012-08-01

To assess factors associated with morbidity and mortality following the use of robotics in general surgery. Case series. University of Illinois at Chicago. Eight hundred eighty-four consecutive patients who underwent a robotic procedure in our institution between April 2007 and July 2010. Perioperative morbidity and mortality. During the study period, 884 patients underwent a robotic procedure. The conversion rate was 2%, the mortality rate was 0.5%, and the overall postoperative morbidity rate was 16.7%. The reoperation rate was 2.4%. Mean length of stay was 4.5 days (range, 0.2-113 days). In univariate analysis, several factors were associated with increased morbidity and included either patient-related (cardiovascular and renal comorbidities, American Society of Anesthesiologists score ≥ 3, body mass index [calculated as weight in kilograms divided by height in meters squared] <30, age ≥ 70 years, and malignant disease) or procedure-related (blood loss ≥ 500 mL, transfusion, multiquadrant operation, and advanced procedure) factors. In multivariate analysis, advanced procedure, multiquadrant surgery, malignant disease, body mass index of less than 30, hypertension, and transfusion were factors significantly associated with a higher risk for complications. American Society of Anesthesiologists score of 3 or greater, age 70 years or older, cardiovascular comorbidity, and blood loss of 500 mL or more were also associated with increased risk for mortality. Use of the robotic approach for general surgery can be achieved safely with low morbidity and mortality. Several risk factors have been identified as independent causes for higher morbidity and mortality. These can be used to identify patients at risk before and during the surgery and, in the future, to develop a scoring system for the use of robotic general surgery

A smart Monte Carlo procedure for production costing and uncertainty analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Parker, C.; Stremel, J.

1996-11-01

Electric utilities using chronological production costing models to decide whether to buy or sell power over the next week or next few weeks need to determine potential profits or losses under a number of uncertainties. A large amount of money can be at stake--often $100,000 a day or more--and one party of the sale must always take on the risk. In the case of fixed price ($/MWh) contracts, the seller accepts the risk. In the case of cost plus contracts, the buyer must accept the risk. So, modeling uncertainty and understanding the risk accurately can improve the competitive edge ofmore » the user. This paper investigates an efficient procedure for representing risks and costs from capacity outages. Typically, production costing models use an algorithm based on some form of random number generator to select resources as available or on outage. These algorithms allow experiments to be repeated and gains and losses to be observed in a short time. The authors perform several experiments to examine the capability of three unit outage selection methods and measures their results. Specifically, a brute force Monte Carlo procedure, a Monte Carlo procedure with Latin Hypercube sampling, and a Smart Monte Carlo procedure with cost stratification and directed sampling are examined.« less

Residual tumor size and IGCCCG risk classification predict additional vascular procedures in patients with germ cell tumors and residual tumor resection: a multicenter analysis of the German Testicular Cancer Study Group.

PubMed

Winter, Christian; Pfister, David; Busch, Jonas; Bingöl, Cigdem; Ranft, Ulrich; Schrader, Mark; Dieckmann, Klaus-Peter; Heidenreich, Axel; Albers, Peter

2012-02-01

Residual tumor resection (RTR) after chemotherapy in patients with advanced germ cell tumors (GCT) is an important part of the multimodal treatment. To provide a complete resection of residual tumor, additional surgical procedures are sometimes necessary. In particular, additional vascular interventions are high-risk procedures that require multidisciplinary planning and adequate resources to optimize outcome. The aim was to identify parameters that predict additional vascular procedures during RTR in GCT patients. A retrospective analysis was performed in 402 GCT patients who underwent 414 RTRs in 9 German Testicular Cancer Study Group (GTCSG) centers. Overall, 339 of 414 RTRs were evaluable with complete perioperative data sets. The RTR database was queried for additional vascular procedures (inferior vena cava [IVC] interventions, aortic prosthesis) and correlated to International Germ Cell Cancer Collaborative Group (IGCCCG) classification and residual tumor volume. In 40 RTRs, major vascular procedures (23 IVC resections with or without prosthesis, 11 partial IVC resections, and 6 aortic prostheses) were performed. In univariate analysis, the necessity of IVC intervention was significantly correlated with IGCCCG (14.1% intermediate/poor vs 4.8% good; p=0.0047) and residual tumor size (3.7% size < 5 cm vs 17.9% size ≥ 5 cm; p < 0.0001). In multivariate analysis, IVC intervention was significantly associated with residual tumor size ≥ 5 cm (odds ratio [OR]: 4.61; p=0.0007). In a predictive model combining residual tumor size and IGCCCG classification, every fifth patient (20.4%) with a residual tumor size ≥ 5 cm and intermediate or poor prognosis needed an IVC intervention during RTR. The need for an aortic prosthesis showed no correlation to either IGCCCG (p=0.1811) or tumor size (p=0.0651). The necessity for IVC intervention during RTR is correlated to residual tumor size and initial IGCCCG classification. Patients with high-volume residual tumors and intermediate or poor risk features must initially be identified as high-risk patients for vascular procedures and therefore should be referred to specialized surgical centers with the ad hoc possibility of vascular interventions. Copyright © 2011 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Red blood cell transfusion probability and associated costs in neurosurgical procedures.

PubMed

Barth, Martin; Weiss, Christel; Schmieder, Kirsten

2018-03-20

The extent of red blood cell units (RBC) needed for different neurosurgical procedures and the time point of their administration are widely unknown, which results in generously cross-matching prior to surgery. However, RBC are increasingly requested in the aging western populations, and blood donations are significantly reduced. Therefore, the knowledge of the extent and time point of administration of RBC is of major importance. This is a retrospective single center analysis. The incidence of RBC transfusion during surgery or within 48 h after surgery was analyzed for all neurosurgical patients within 3 years. Costs for cross-matched and transfused RBC were calculated and risk factors for RBC transfusion analyzed. The risk of intraoperative RBC administration was low for spinal and intracranial tumor resections (1.87%) and exceeded 10% only in spinal fusion procedures. This was dependent on the number of fused segments with an intraoperative transfusion risk of > 12.5% with fusion of more than three levels. Multiple logistic regression analysis showed a significantly increased risk for RBC transfusion for female gender (p = 0.006; OR 1.655), higher age (N = 4812; p < 0.0001; OR 1.028), and number of fused segments (N = 737; p < 0.0001; OR 1.433). Annual costs for cross-matching were 783,820.88 USD and for intraoperative RBC administration 121,322.13 USD. Neurosurgical procedures are associated with a low number of RBC needed intraoperatively. Only elective spine fusion procedures with ≥ 3 levels involved and AVM resections seem to require cross-matching of RBC. The present data may allow changing the preoperative algorithm of RBC cross-matching in neurosurgical procedures and help to save resources and costs.

The Effects of Requiring Parental Consent for Research on Adolescents' Risk Behaviors: A Meta-analysis.

PubMed

Liu, Chao; Cox, Ronald B; Washburn, Isaac J; Croff, Julie M; Crethar, Hugh C

2017-07-01

Requiring parental consent may result in sampling biases that confound scientific conclusions and stifle the representation of children most at risk for adverse outcomes. This study aims to investigate whether active parental consent, compared with passive parental consent, creates a bias in response rate, demographic makeup, and adverse outcomes in adolescent samples. A meta-analysis was performed on peer-reviewed articles and unpublished dissertations from 1975 to 2016 in five computerized databases ERIC, PsycINFO, MEDLINE, PubMed and ProQuest. Quantitative studies were retained if they included the following keywords: active consent (or informed consent or parental consent), passive consent (or waiver of consent), risk behavior, adolescen*. Fifteen studies were identified with a total number of 104,074 children. Results showed (1) response rates were significantly lower for studies using active consent procedure than those using passive consent procedure (Z = 3.05, p = .002); (2) more females, younger participants, and less African-Americans were included in studies using active consent procedures than studies using passive procedures (Z = -2.73, p = .006; Z = -12.06, p < .00001; Z = 2.19, p = .03, respectively); (3) studies with passive consent procedures showed higher rates of self-reported substance use than studies using active consent procedures (Z = 3.07, p = .002). Requiring active parental consent can lead to a systematic bias in the sample where the population under study is misrepresented. Institutional review board committees should collaborate with researchers to find solutions that protect minors without silencing the voice of high-risk youth in the literature. Copyright © 2017 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Methods for external event screening quantification: Risk Methods Integration and Evaluation Program (RMIEP) methods development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ravindra, M.K.; Banon, H.

1992-07-01

In this report, the scoping quantification procedures for external events in probabilistic risk assessments of nuclear power plants are described. External event analysis in a PRA has three important goals; (1) the analysis should be complete in that all events are considered; (2) by following some selected screening criteria, the more significant events are identified for detailed analysis; (3) the selected events are analyzed in depth by taking into account the unique features of the events: hazard, fragility of structures and equipment, external-event initiated accident sequences, etc. Based on the above goals, external event analysis may be considered as amore » three-stage process: Stage I: Identification and Initial Screening of External Events; Stage II: Bounding Analysis; Stage III: Detailed Risk Analysis. In the present report, first, a review of published PRAs is given to focus on the significance and treatment of external events in full-scope PRAs. Except for seismic, flooding, fire, and extreme wind events, the contributions of other external events to plant risk have been found to be negligible. Second, scoping methods for external events not covered in detail in the NRC's PRA Procedures Guide are provided. For this purpose, bounding analyses for transportation accidents, extreme winds and tornadoes, aircraft impacts, turbine missiles, and chemical release are described.« less

Novel risk score of contrast-induced nephropathy after percutaneous coronary intervention.

PubMed

Ji, Ling; Su, XiaoFeng; Qin, Wei; Mi, XuHua; Liu, Fei; Tang, XiaoHong; Li, Zi; Yang, LiChuan

2015-08-01

Contrast-induced nephropathy (CIN) post-percutaneous coronary intervention (PCI) is a major cause of acute kidney injury. In this study, we established a comprehensive risk score model to assess risk of CIN after PCI procedure, which could be easily used in a clinical environment. A total of 805 PCI patients, divided into analysis cohort (70%) and validation cohort (30%), were enrolled retrospectively in this study. Risk factors for CIN were identified using univariate analysis and multivariate logistic regression in the analysis cohort. Risk score model was developed based on multiple regression coefficients. Sensitivity and specificity of the new risk score system was validated in the validation cohort. Comparisons between the new risk score model and previous reported models were applied. The incidence of post-PCI CIN in the analysis cohort (n = 565) was 12%. Considerably high CIN incidence (50%) was observed in patients with chronic kidney disease (CKD). Age >75, body mass index (BMI) >25, myoglobin level, cardiac function level, hypoalbuminaemia, history of chronic kidney disease (CKD), Intra-aortic balloon pump (IABP) and peripheral vascular disease (PVD) were identified as independent risk factors of post-PCI CIN. A novel risk score model was established using multivariate regression coefficients, which showed highest sensitivity and specificity (0.917, 95%CI 0.877-0.957) compared with previous models. A new post-PCI CIN risk score model was developed based on a retrospective study of 805 patients. Application of this model might be helpful to predict CIN in patients undergoing PCI procedure. © 2015 Asian Pacific Society of Nephrology.

An evaluation of risk estimation procedures for mixtures of carcinogens

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hwang, J.S.; Chen, J.J.

1999-12-01

The estimation of health risks from exposure to a mixture of chemical carcinogens is generally based on the combination of information from several available single compound studies. The current practice of directly summing the upper bound risk estimates of individual carcinogenic components as an upper bound on the total risk of a mixture is known to be generally too conservative. Gaylor and Chen (1996, Risk Analysis) proposed a simple procedure to compute an upper bound on the total risk using only the upper confidence limits and central risk estimates of individual carcinogens. The Gaylor-Chen procedure was derived based on anmore » underlying assumption of the normality for the distributions of individual risk estimates. IN this paper the authors evaluated the Gaylor-Chen approach in terms the coverages of the upper confidence limits on the true risks of individual carcinogens. In general, if the coverage probabilities for the individual carcinogens are all approximately equal to the nominal level, then the Gaylor-Chen approach should perform well. However, the Gaylor-Chen approach can be conservative or anti-conservative if some of all individual upper confidence limit estimates are conservative or anti-conservative.« less

Does the Type of Metal Instrumentation Affect the Risk of Surgical Site Infection in Pediatric Scoliosis Surgery?

PubMed

Wright, Margaret L; Skaggs, David L; Matsumoto, Hiroko; Woon, Regina P; Trocle, Ashley; Flynn, John M; Vitale, Michael G

2016-05-01

Retrospective cohort study. To determine the association of implant metal composition with the risk of surgical site infection (SSI) following pediatric spine surgery. SSI is a well-described complication following pediatric spine surgery. Many risk factors have been identified in the literature, but controversy remains regarding metal composition as a risk factor. This was a retrospective study of patients who underwent posterior spinal instrumentation procedures between January 1, 2006, and December 31, 2008, at three large children's hospitals for any etiology of scoliosis and had at least 1 year of postoperative follow-up. Procedures included posterior spinal fusion, growth-friendly instrumentation, and revision of spinal instrumentation. The Centers for Disease Control and Prevention definition of SSI was used. A chi-squared test was performed to determine the relationship between type of metal instrumentation and development of an SSI. The study included 874 patients who underwent 1,156 total procedures. Overall, 752 (65%) procedures used stainless steel instrumentation, 238 (21%) procedures used titanium instrumentation, and the remaining 166 (14%) procedures used cobalt chrome and titanium hybrid instrumentation. The overall risk of infection was 6.1% (70/1,156) per procedure, with 5.9% (44/752) for stainless steel, 6.7% (12/238) for titanium, and 6.0% (10/166) for cobalt chrome. The multiple regression analysis found no significant differences in the metal type used between patients with and without infection (p = .886) adjusting for etiology, instrumentation to pelvis, and type of procedures. When stratified based on etiology, the multiple regression analyses also found no significant difference in SSI between two metal type groups. This study found no difference in risk of infection with stainless steel, titanium, or cobalt chrome/titanium instrumentation and is adequately powered to detect a true difference in risk of SSI. Level II, prognostic. Copyright © 2016 Scoliosis Research Society. Published by Elsevier Inc. All rights reserved.

Predicting the difficulty of a lead extraction procedure: the LED index.

PubMed

Bontempi, Luca; Vassanelli, Francesca; Cerini, Manuel; D'Aloia, Antonio; Vizzardi, Enrico; Gargaro, Alessio; Chiusso, Francesco; Mamedouv, Rashad; Lipari, Alessandro; Curnis, Antonio

2014-08-01

According to recent surveys, many sites performing permanent lead extractions do not meet the minimum prerequisites concerning personnel training, procedures' volume, or facility requirements. The current Heart Rhythm Society consensus on lead extractions suggests that patients should be referred to more experienced sites when a better outcome could be achieved. The purpose of this study was to develop a score aimed at predicting the difficulty of a lead extraction procedure through the analysis of a high-volume center database. This score could help to discriminate patients who should be sent to a referral site. A total of 889 permanent leads were extracted from 469 patients. All procedures were performed from January 2009 to May 2012 by two expert electrophysiologists, at the University Hospital of Brescia. Factors influencing the difficulty of a procedure were assessed using a univariate and a multivariate logistic regression model. The fluoroscopy time of the procedure was taken as an index of difficulty. A Lead Extraction Difficulty (LED) score was defined, considering the strongest predictors. Overall, 873 of 889 (98.2%) leads were completely removed. Major complications were reported in one patient (0.2%) who manifested cardiac tamponade. Minor complications occurred in six (1.3%) patients. No deaths occurred. Median fluoroscopic time was 8.7 min (3.3-17.3). A procedure was classified as difficult when fluoroscopy time was more than 31.2 min [90th percentile (PCTL)].At a univariate analysis, the number of extracted leads and years from implant were significantly associated with an increased risk of fluoroscopy time above 90th PCTL [odds ratio (OR) 1.51, 95% confidence interval (CI) 1.08-2.11, P = 0.01; and OR 1.19, 95% CI 1.12-1.25, P < 0.001, respectively). After adjusting for patient age and sex, and combining with other covariates potentially influencing the extraction procedure, a multivariate analysis confirmed a 71% increased risk of fluoroscopy time above 90th PCTL for each additional lead extracted (OR 1.71, 95% CI 1.06-2.77, P = 0.028) and a 23% increased risk for each year of lead age (OR 1.23, 95% CI 1.15-1.31, P < 0.001). Further nonindependent factors increasing the risk were the presence of active fixation leads and dual-coil implantable cardiac defibrillator leads. Conversely, vegetations significantly favored lead extraction.The LED score was defined as: number of extracted leads within a procedure + lead age (years from implant) + 1 if dual-coil - 1 if vegetation. The LED score independently predicted complex procedure (with fluoroscopic time >90th PCTL) both at univariate and multivariate analysis. A receiver-operating characteristic analysis showed an area under the curve of 0.81. A LED score greater than 10 could predict fluoroscopy time above 90th PCTL with a sensitivity of 78.3% and a specificity of 76.7%. The LED score is easy to compute and potentially predicts fluoroscopy time above 90th PCTL with a relatively high accuracy.

The role of risk perception in making flood risk management more effective

NASA Astrophysics Data System (ADS)

Buchecker, M.; Salvini, G.; Di Baldassarre, G.; Semenzin, E.; Maidl, E.; Marcomini, A.

2013-11-01

Over the last few decades, Europe has suffered from a number of severe flood events and, as a result, there has been a growing interest in probing alternative approaches to managing flood risk via prevention measures. A literature review reveals that, although in the last decades risk evaluation has been recognized as key element of risk management, and risk assessment methodologies (including risk analysis and evaluation) have been improved by including social, economic, cultural, historical and political conditions, the theoretical schemes are not yet applied in practice. One main reason for this shortcoming is that risk perception literature is mainly of universal and theoretical nature and cannot provide the necessary details to implement a comprehensive risk evaluation. This paper therefore aims to explore a procedure that allows the inclusion of stakeholders' perceptions of prevention measures in risk assessment. It proposes to adopt methods of risk communication (both one-way and two-way communication) in risk assessment with the final aim of making flood risk management more effective. The proposed procedure not only focuses on the effect of discursive risk communication on risk perception, and on achieving a shared assessment of the prevention alternatives, but also considers the effects of the communication process on perceived uncertainties, accepted risk levels, and trust in the managing institutions. The effectiveness of this combined procedure has been studied and illustrated using the example of the participatory flood prevention assessment process on the Sihl River in Zurich, Switzerland. The main findings of the case study suggest that the proposed procedure performed well, but that it needs some adaptations for it to be applicable in different contexts and to allow a (semi-) quantitative estimation of risk perception to be used as an indicator of adaptive capacity.

Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability.

PubMed

López-Tarjuelo, Juan; Bouché-Babiloni, Ana; Santos-Serra, Agustín; Morillo-Macías, Virginia; Calvo, Felipe A; Kubyshin, Yuri; Ferrer-Albiach, Carlos

2014-11-01

Industrial companies use failure mode and effect analysis (FMEA) to improve quality. Our objective was to describe an FMEA and subsequent interventions for an automated intraoperative electron radiotherapy (IOERT) procedure with computed tomography simulation, pre-planning, and a fixed conventional linear accelerator. A process map, an FMEA, and a fault tree analysis are reported. The equipment considered was the radiance treatment planning system (TPS), the Elekta Precise linac, and TN-502RDM-H metal-oxide-semiconductor-field-effect transistor in vivo dosimeters. Computerized order-entry and treatment-automation were also analyzed. Fifty-seven potential modes and effects were identified and classified into 'treatment cancellation' and 'delivering an unintended dose'. They were graded from 'inconvenience' or 'suboptimal treatment' to 'total cancellation' or 'potentially wrong' or 'very wrong administered dose', although these latter effects were never experienced. Risk priority numbers (RPNs) ranged from 3 to 324 and totaled 4804. After interventions such as double checking, interlocking, automation, and structural changes the final total RPN was reduced to 1320. FMEA is crucial for prioritizing risk-reduction interventions. In a semi-surgical procedure like IOERT double checking has the potential to reduce risk and improve quality. Interlocks and automation should also be implemented to increase the safety of the procedure. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Outcomes of surgery in patients aged ≥90 years in the general surgical setting.

PubMed

Sudlow, A; Tuffaha, H; Stearns, A T; Shaikh, I A

2018-03-01

Introduction An increasing proportion of the population is living into their nineties and beyond. These high risk patients are now presenting more frequently to both elective and emergency surgical services. There is limited research looking at outcomes of general surgical procedures in nonagenarians and centenarians to guide surgeons assessing these cases. Methods A retrospective analysis was conducted of all patients aged ≥90 years undergoing elective and emergency general surgical procedures at a tertiary care facility between 2009 and 2015. Vascular, breast and endocrine procedures were excluded. Patient demographics and characteristics were collated. Primary outcomes were 30-day and 90-day mortality rates. The impact of ASA (American Society of Anesthesiologists) grade, operation severity and emergency presentation was assessed using multivariate analysis. Results Overall, 161 patients (58 elective, 103 emergency) were identified for inclusion in the study. The mean patient age was 92.8 years (range: 90-106 years). The 90-day mortality rates were 5.2% and 19.4% for elective and emergency procedures respectively (p=0.013). The median survival was 29 and 19 months respectively (p=0.001). Emergency and major gastrointestinal operations were associated with a significant increase in mortality. Patients undergoing emergency major colonic or upper gastrointestinal surgery had a 90-day mortality rate of 53.8%. Conclusions The risk for patients aged over 90 years having an elective procedure differs significantly in the short term from those having emergency surgery. In selected cases, elective surgery carries an acceptable mortality risk. Emergency surgery is associated with a significantly increased risk of death, particularly after major gastrointestinal resections.

A Model of Risk Analysis in Analytical Methodology for Biopharmaceutical Quality Control.

PubMed

Andrade, Cleyton Lage; Herrera, Miguel Angel De La O; Lemes, Elezer Monte Blanco

2018-01-01

One key quality control parameter for biopharmaceutical products is the analysis of residual cellular DNA. To determine small amounts of DNA (around 100 pg) that may be in a biologically derived drug substance, an analytical method should be sensitive, robust, reliable, and accurate. In principle, three techniques have the ability to measure residual cellular DNA: radioactive dot-blot, a type of hybridization; threshold analysis; and quantitative polymerase chain reaction. Quality risk management is a systematic process for evaluating, controlling, and reporting of risks that may affects method capabilities and supports a scientific and practical approach to decision making. This paper evaluates, by quality risk management, an alternative approach to assessing the performance risks associated with quality control methods used with biopharmaceuticals, using the tool hazard analysis and critical control points. This tool provides the possibility to find the steps in an analytical procedure with higher impact on method performance. By applying these principles to DNA analysis methods, we conclude that the radioactive dot-blot assay has the largest number of critical control points, followed by quantitative polymerase chain reaction, and threshold analysis. From the analysis of hazards (i.e., points of method failure) and the associated method procedure critical control points, we conclude that the analytical methodology with the lowest risk for performance failure for residual cellular DNA testing is quantitative polymerase chain reaction. LAY ABSTRACT: In order to mitigate the risk of adverse events by residual cellular DNA that is not completely cleared from downstream production processes, regulatory agencies have required the industry to guarantee a very low level of DNA in biologically derived pharmaceutical products. The technique historically used was radioactive blot hybridization. However, the technique is a challenging method to implement in a quality control laboratory: It is laborious, time consuming, semi-quantitative, and requires a radioisotope. Along with dot-blot hybridization, two alternatives techniques were evaluated: threshold analysis and quantitative polymerase chain reaction. Quality risk management tools were applied to compare the techniques, taking into account the uncertainties, the possibility of circumstances or future events, and their effects upon method performance. By illustrating the application of these tools with DNA methods, we provide an example of how they can be used to support a scientific and practical approach to decision making and can assess and manage method performance risk using such tools. This paper discusses, considering the principles of quality risk management, an additional approach to the development and selection of analytical quality control methods using the risk analysis tool hazard analysis and critical control points. This tool provides the possibility to find the method procedural steps with higher impact on method reliability (called critical control points). Our model concluded that the radioactive dot-blot assay has the larger number of critical control points, followed by quantitative polymerase chain reaction and threshold analysis. Quantitative polymerase chain reaction is shown to be the better alternative analytical methodology in residual cellular DNA analysis. © PDA, Inc. 2018.

Comparison of Traditional and Trial-Based Methodologies for Conducting Functional Analyses

ERIC Educational Resources Information Center

LaRue, Robert H.; Lenard, Karen; Weiss, Mary Jane; Bamond, Meredith; Palmieri, Mark; Kelley, Michael E.

2010-01-01

Functional analysis represents a sophisticated and empirically supported functional assessment procedure. While these procedures have garnered considerable empirical support, they are often underused in clinical practice. Safety risks resulting from the evocation of maladaptive behavior and the length of time required to conduct functional…

Wind Characterization for the Assessment of Collision Risk During Flight Level Changes

NASA Technical Reports Server (NTRS)

Carreno, Victor; Chartrand, Ryan

2009-01-01

A model of vertical wind gradient is presented based on National Oceanic and Atmospheric Administration (NOAA) wind data. The objective is to have an accurate representation of wind to be used in Collision Risk Models (CRM) of aircraft procedures. Depending on how an aircraft procedure is defined, wind and the different characteristics of the wind will have a more severe or less severe impact on distances between aircraft. For the In-Trail Procedure, the non-linearity of the vertical wind gradient has the greatest impact on longitudinal distance. The analysis in this paper extracts standard deviation, mean, maximum, and linearity characteristics from the NOAA data.

Interim reliability evaluation program, Browns Ferry 1

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mays, S.E.; Poloski, J.P.; Sullivan, W.H.

1981-01-01

Probabilistic risk analysis techniques, i.e., event tree and fault tree analysis, were utilized to provide a risk assessment of the Browns Ferry Nuclear Plant Unit 1. Browns Ferry 1 is a General Electric boiling water reactor of the BWR 4 product line with a Mark 1 (drywell and torus) containment. Within the guidelines of the IREP Procedure and Schedule Guide, dominant accident sequences that contribute to public health and safety risks were identified and grouped according to release categories.

Perioperative outcomes for pediatric neurosurgical procedures: analysis of the National Surgical Quality Improvement Program-Pediatrics.

PubMed

Kuo, Benjamin J; Vissoci, Joao Ricardo N; Egger, Joseph R; Smith, Emily R; Grant, Gerald A; Haglund, Michael M; Rice, Henry E

2017-03-01

OBJECTIVE Existing studies have shown a high overall rate of adverse events (AEs) following pediatric neurosurgical procedures. However, little is known regarding the morbidity of specific procedures or the association with risk factors to help guide quality improvement (QI) initiatives. The goal of this study was to describe the 30-day mortality and AE rates for pediatric neurosurgical procedures by using the American College of Surgeons (ACS) National Surgical Quality Improvement Program-Pediatrics (NSQIP-Peds) database platform. METHODS Data on 9996 pediatric neurosurgical patients were acquired from the 2012-2014 NSQIP-Peds participant user file. Neurosurgical cases were analyzed by the NSQIP-Peds targeted procedure categories, including craniotomy/craniectomy, defect repair, laminectomy, shunts, and implants. The primary outcome measure was 30-day mortality, with secondary outcomes including individual AEs, composite morbidity (all AEs excluding mortality and unplanned reoperation), surgical-site infection, and unplanned reoperation. Univariate analysis was performed between individual AEs and patient characteristics using Fischer's exact test. Associations between individual AEs and continuous variables (duration from admission to operation, work relative value unit, and operation time) were examined using the Student t-test. Patient characteristics and continuous variables associated with any AE by univariate analysis were used to develop category-specific multivariable models through backward stepwise logistic regression. RESULTS The authors analyzed 3383 craniotomy/craniectomy, 242 defect repair, 1811 laminectomy, and 4560 shunt and implant cases and found a composite overall morbidity of 30.2%, 38.8%, 10.2%, and 10.7%, respectively. Unplanned reoperation rates were highest for defect repair (29.8%). The mortality rate ranged from 0.1% to 1.2%. Preoperative ventilator dependence was a significant predictor of any AE for all procedure groups, whereas admission from outside hospital transfer was a significant predictor of any AE for all procedure groups except craniotomy/craniectomy. CONCLUSIONS This analysis of NSQIP-Peds, a large risk-adjusted national data set, confirms low perioperative mortality but high morbidity for pediatric neurosurgical procedures. These data provide a baseline understanding of current expected clinical outcomes for pediatric neurosurgical procedures, identify the need for collecting neurosurgery-specific risk factors and complications, and should support targeted QI programs and clinical management interventions to improve care of children.

Human Factors Process Task Analysis Liquid Oxygen Pump Acceptance Test Procedure for the Advanced Technology Development Center

NASA Technical Reports Server (NTRS)

Diorio, Kimberly A.

2002-01-01

A process task analysis effort was undertaken by Dynacs Inc. commencing in June 2002 under contract from NASA YA-D6. Funding was provided through NASA's Ames Research Center (ARC), Code M/HQ, and Industrial Engineering and Safety (IES). The John F. Kennedy Space Center (KSC) Engineering Development Contract (EDC) Task Order was 5SMA768. The scope of the effort was to conduct a Human Factors Process Failure Modes and Effects Analysis (HF PFMEA) of a hazardous activity and provide recommendations to eliminate or reduce the effects of errors caused by human factors. The Liquid Oxygen (LOX) Pump Acceptance Test Procedure (ATP) was selected for this analysis. The HF PFMEA table (see appendix A) provides an analysis of six major categories evaluated for this study. These categories include Personnel Certification, Test Procedure Format, Test Procedure Safety Controls, Test Article Data, Instrumentation, and Voice Communication. For each specific requirement listed in appendix A, the following topics were addressed: Requirement, Potential Human Error, Performance-Shaping Factors, Potential Effects of the Error, Barriers and Controls, Risk Priority Numbers, and Recommended Actions. This report summarizes findings and gives recommendations as determined by the data contained in appendix A. It also includes a discussion of technology barriers and challenges to performing task analyses, as well as lessons learned. The HF PFMEA table in appendix A recommends the use of accepted and required safety criteria in order to reduce the risk of human error. The items with the highest risk priority numbers should receive the greatest amount of consideration. Implementation of the recommendations will result in a safer operation for all personnel.

Probabilistic wind/tornado/missile analyses for hazard and fragility evaluations

DOE Office of Scientific and Technical Information (OSTI.GOV)

Park, Y.J.; Reich, M.

Detailed analysis procedures and examples are presented for the probabilistic evaluation of hazard and fragility against high wind, tornado, and tornado-generated missiles. In the tornado hazard analysis, existing risk models are modified to incorporate various uncertainties including modeling errors. A significant feature of this paper is the detailed description of the Monte-Carlo simulation analyses of tornado-generated missiles. A simulation procedure, which includes the wind field modeling, missile injection, solution of flight equations, and missile impact analysis, is described with application examples.

Risk factors for hospital morbidity and mortality after the Norwood procedure: A report from the Pediatric Heart Network Single Ventricle Reconstruction trial.

PubMed

Tabbutt, Sarah; Ghanayem, Nancy; Ravishankar, Chitra; Sleeper, Lynn A; Cooper, David S; Frank, Deborah U; Lu, Minmin; Pizarro, Christian; Frommelt, Peter; Goldberg, Caren S; Graham, Eric M; Krawczeski, Catherine Dent; Lai, Wyman W; Lewis, Alan; Kirsh, Joel A; Mahony, Lynn; Ohye, Richard G; Simsic, Janet; Lodge, Andrew J; Spurrier, Ellen; Stylianou, Mario; Laussen, Peter

2012-10-01

We sought to identify risk factors for mortality and morbidity during the Norwood hospitalization in newborn infants with hypoplastic left heart syndrome and other single right ventricle anomalies enrolled in the Single Ventricle Reconstruction trial. Potential predictors for outcome included patient- and procedure-related variables and center volume and surgeon volume. Outcome variables occurring during the Norwood procedure and before hospital discharge or stage II procedure included mortality, end-organ complications, length of ventilation, and hospital length of stay. Univariate and multivariable Cox regression analyses were performed with bootstrapping to estimate reliability for mortality. Analysis included 549 subjects prospectively enrolled from 15 centers; 30-day and hospital mortality were 11.5% (63/549) and 16.0% (88/549), respectively. Independent risk factors for both 30-day and hospital mortality included lower birth weight, genetic abnormality, extracorporeal membrane oxygenation (ECMO) and open sternum on the day of the Norwood procedure. In addition, longer duration of deep hypothermic circulatory arrest was a risk factor for 30-day mortality. Shunt type at the end of the Norwood procedure was not a significant risk factor for 30-day or hospital mortality. Independent risk factors for postoperative renal failure (n = 46), sepsis (n = 93), increased length of ventilation, and hospital length of stay among survivors included genetic abnormality, lower center/surgeon volume, open sternum, and post-Norwood operations. Innate patient factors, ECMO, open sternum, and lower center/surgeon volume are important risk factors for postoperative mortality and/or morbidity during the Norwood hospitalization. Copyright © 2012 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

When is carotid angioplasty and stenting the cost-effective alternative for revascularization of symptomatic carotid stenosis? A Canadian health system perspective.

PubMed

Almekhlafi, M A; Hill, M D; Wiebe, S; Goyal, M; Yavin, D; Wong, J H; Clement, F M

2014-02-01

Carotid revascularization procedures can be complicated by stroke. Additional disability adds to the already high costs of the procedure. To weigh the cost and benefit, we estimated the cost-utility of carotid angioplasty and stenting compared with carotid endarterectomy among patients with symptomatic carotid stenosis, with special emphasis on scenario analyses that would yield carotid angioplasty and stenting as the cost-effective alternative relative to carotid endarterectomy. A cost-utility analysis from the perspective of the health system payer was performed by using a Markov analytic model. Clinical estimates were based on a meta-analysis. The procedural costs were derived from a microcosting data base. The costs for hospitalization and rehabilitation of patients with stroke were based on a Canadian multicenter study. Utilities were based on a randomized controlled trial. In the base case analysis, carotid angioplasty and stenting were more expensive (incremental cost of $6107) and had a lower utility (-0.12 quality-adjusted life years) than carotid endarterectomy. The results are sensitive to changes in the risk of clinical events and the relative risk of death and stroke. Carotid angioplasty and stenting were more economically attractive among high-risk surgical patients. For carotid angioplasty and stenting to become the preferred option, their costs would need to fall from more than $7300 to $4350 or less and the risks of the periprocedural and annual minor strokes would have to be equivalent to that of carotid endarterectomy. In the base case analysis, carotid angioplasty and stenting were associated with higher costs and lower utility compared with carotid endarterectomy for patients with symptomatic carotid stenosis. Carotid angioplasty and stenting were cost-effective for patients with high surgical risk.

Risk factors for postoperative complications in robotic general surgery.

PubMed

Fantola, Giovanni; Brunaud, Laurent; Nguyen-Thi, Phi-Linh; Germain, Adeline; Ayav, Ahmet; Bresler, Laurent

2017-03-01

The feasibility and safety of robotically assisted procedures in general surgery have been reported from various groups worldwide. Because postoperative complications may lead to longer hospital stays and higher costs overall, analysis of risk factors for postoperative surgical complications in this subset of patients is clinically relevant. The goal of this study was to identify risk factors for postoperative morbidity after robotic surgical procedures in general surgery. We performed an observational monocentric retrospective study. All consecutive robotic surgical procedures from November 2001 to December 2013 were included. One thousand consecutive general surgery patients met the inclusion criteria. The mean overall postoperative morbidity and major postoperative morbidity (Clavien >III) rates were 20.4 and 6 %, respectively. This included a conversion rate of 4.4 %, reoperation rate of 4.5 %, and mortality rate of 0.2 %. Multivariate analysis showed that ASA score >3 [OR 1.7; 95 % CI (1.2-2.4)], hematocrit value <38 [OR 1.6; 95 % CI (1.1-2.2)], previous abdominal surgery [OR 1.5; 95 % CI (1-2)], advanced dissection [OR 5.8; 95 % CI (3.1-10.6)], and multiquadrant surgery [OR 2.5; 95 % CI (1.7-3.8)] remained independent risk factors for overall postoperative morbidity. It also showed that advanced dissection [OR 4.4; 95 % CI (1.9-9.6)] and multiquadrant surgery [OR 4.4; 95 % CI (2.3-8.5)] remained independent risk factors for major postoperative morbidity (Clavien >III). This study identifies independent risk factors for postoperative overall and major morbidity in robotic general surgery. Because these factors independently impacted postoperative complications, we believe they could be taken into account in future studies comparing conventional versus robot-assisted laparoscopic procedures in general surgery.

Incidence and Risk Factors for Perioperative Cardiovascular and Respiratory Adverse Events in Pediatric Patients With Congenital Heart Disease Undergoing Noncardiac Procedures.

PubMed

Lee, Sandra; Reddington, Elise; Koutsogiannaki, Sophia; Hernandez, Michael R; Odegard, Kirsten C; DiNardo, James A; Yuki, Koichi

2018-04-27

While mortality and adverse perioperative events after noncardiac surgery in children with a broad range of congenital cardiac lesions have been investigated using large multiinstitutional databases, to date single-center studies addressing adverse outcomes in children with congenital heart disease (CHD) undergoing noncardiac surgery have only included small numbers of patients with significant heart disease. The primary objective of this study was to determine the incidences of perioperative cardiovascular and respiratory events in a large cohort of patients from a single institution with a broad range of congenital cardiac lesions undergoing noncardiac procedures and to determine risk factors for these events. We identified 3010 CHD patients presenting for noncardiac procedures in our institution over a 5-year period. We collected demographic information, including procedure performed, cardiac diagnosis, ventricular function as assessed by echocardiogram within 6 months of the procedure, and classification of CHD into 3 groups (minor, major, or severe CHD) based on residual lesion burden and cardiovascular functional status. Characteristics related to conduct of anesthesia care were also collected. The primary outcome variables for our analysis were the incidences of intraoperative cardiovascular and respiratory events. Univariable and multivariable logistic regressions were used to determine risk factors for these 2 outcomes. The incidence of cardiovascular events was 11.5% and of respiratory events was 4.7%. Univariate analysis and multivariable analysis demonstrated that American Society of Anesthesiologists (≥3), emergency cases, major and severe CHD, single-ventricle physiology, ventricular dysfunction, orthopedic surgery, general surgery, neurosurgery, and pulmonary procedures were associated with perioperative cardiovascular events. Respiratory events were associated with American Society of Anesthesiologists (≥4) and otolaryngology, gastrointestinal, general surgery, and maxillofacial procedures. Intraoperative cardiovascular events and respiratory events in patients with CHD were relatively common. While cardiovascular events were highly associated with cardiovascular status, respiratory events were not associated with cardiovascular status.

Analysis of preoperative condition and interstage mortality in Norwood and hybrid procedures for hypoplastic left heart syndrome using the Aristotle scoring system.

PubMed

Lloyd, David F A; Cutler, Lindsay; Tibby, Shane M; Vimalesvaran, Sunitha; Qureshi, Shakeel Ahmed; Rosenthal, Eric; Anderson, David; Austin, Conal; Bellsham-Revell, Hannah; Krasemann, Thomas

2014-05-01

The 'hybrid procedure', consisting of surgical banding of the pulmonary arteries with intraoperative stenting of the arterial duct, was developed as primary palliation in hypoplastic left heart syndrome (HLHS), avoiding the risks of cardiopulmonary bypass. In many centres, it is reserved for low birth weight, premature or unstable neonates; however, its role in such high risk cases of HLHS has yet to be defined. The preoperative condition of all patients with HLHS who underwent either the hybrid or the Norwood procedure for HLHS between 2005-2011 was analysed retrospectively, using a modified comprehensive Aristotle score. We then compared operative, interstage and 1 year mortalities between the groups after Aristotle adjustment via Cox proportional hazards analyses. Of 138 patients with HLHS, 27 had hybrid and 111 Norwood procedures. The hybrid group had significantly higher Aristotle scores (mean 4.1 vs 1.8; p<0.001); however, there was no significant difference in mortality at any stage. At 1 year, the overall unadjusted survival among Norwood and hybrid patients was 58.6% and 51.9%, respectively, yielding an Aristotle adjusted hazard ratio for mortality among hybrid patients of 1.09 (95% CI 0.56 to 2.11, p=0.80). Applying a hybrid approach to high risk patients with HLHS produces a comparable early and interstage mortality risk to lower risk patients undergoing the Norwood procedure. Prospective studies are needed to establish whether the hybrid procedure is a viable alternative to the Norwood procedure in all HLHS patients in terms of both mortality and long term morbidity.

Retrospective Evaluation of Safety, Efficacy and Risk Factors for Pneumothorax in Simultaneous Localizations of Multiple Pulmonary Nodules Using Hook Wire System.

PubMed

Zhong, Yan; Xu, Xiao-Quan; Pan, Xiang-Long; Zhang, Wei; Xu, Hai; Yuan, Mei; Kong, Ling-Yan; Pu, Xue-Hui; Chen, Liang; Yu, Tong-Fu

2017-09-01

To evaluate the safety and efficacy of the hook wire system in the simultaneous localizations for multiple pulmonary nodules (PNs) before video-assisted thoracoscopic surgery (VATS), and to clarify the risk factors for pneumothorax associated with the localization procedure. Between January 2010 and February 2016, 67 patients (147 nodules, Group A) underwent simultaneous localizations for multiple PNs using a hook wire system. The demographic, localization procedure-related information and the occurrence rate of pneumothorax were assessed and compared with a control group (349 patients, 349 nodules, Group B). Multivariate logistic regression analyses were used to determine the risk factors for pneumothorax during the localization procedure. All the 147 nodules were successfully localized. Four (2.7%) hook wires dislodged before VATS procedure, but all these four lesions were successfully resected according to the insertion route of hook wire. Pathological diagnoses were acquired for all 147 nodules. Compared with Group B, Group A demonstrated significantly longer procedure time (p < 0.001) and higher occurrence rate of pneumothorax (p = 0.019). Multivariate logistic regression analysis indicated that position change during localization procedure (OR 2.675, p = 0.021) and the nodules located in the ipsilateral lung (OR 9.404, p < 0.001) were independent risk factors for pneumothorax. Simultaneous localizations for multiple PNs using a hook wire system before VATS procedure were safe and effective. Compared with localization for single PN, simultaneous localizations for multiple PNs were prone to the occurrence of pneumothorax. Position change during localization procedure and the nodules located in the ipsilateral lung were independent risk factors for pneumothorax.

Informed Consent for Radiation in Interventional Radiology Procedures.

PubMed

Zener, Rebecca; Johnson, Peter; Wiseman, Daniele; Pandey, Sachin; Mujoomdar, Amol

2018-02-01

To explore the patient perception on radiation-related cancer risk from interventional radiology (IR) procedures and whether informed radiation consent is warranted. A multiple-choice survey was prospectively administered to 68 adults undergoing a body or neuro-IR procedure with ionizing radiation exposure. Subgroup analysis with chi-square or Fisher exact test was performed based on patient past IR history (P < .05). A total of 81% of patients wanted to be informed if there was a radiation-related 3% increased cancer risk over 5 years. Although 55% considered 3% a small risk, 28% wanted to further discuss the risks and alternate options, and 15% would have only proceeded if it were a life-saving procedure: 89%, 80%, and 67% of patients wanted to be informed with exposure risks of 1 in 100, 1 in 1000, and 1 in 10,000, respectively. Only 53% were aware they were going to be exposed to radiation, irrespective of past IR history (P = .15). Most patients believed radiation consent should include radiation-related cancer risks (85%). No past IR history was significantly associated with wanting consent to include cancer-related risk (100% vs 76%; P = .01) and deterministic risks (70% vs 41%; P = .04). A majority (69%) believed both the referring physician and the interventional radiologist were responsible for obtaining radiation consent, and 65% of patients wanted verbal consent followed by signed written consent, regardless of past IR history. Many patients want to discuss cancer-related radiation risks with both radiologists and physicians. Informed radiation consent should be considered for procedures with high anticipated radiation doses. Copyright © 2017. Published by Elsevier Inc.

Poster — Thur Eve — 41: Considerations for Patients with Permanently Implant Radioactive Sources Requiring Unrelated Surgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Basran, P. S; Beckham, WA; Baxter, P

Permanent implant of sealed radioactive sources is an effective technique for treating cancer. Typically, the radioactive sources are implanted in and near the disease, depositing dose locally over several months. There may be instances where these patients must undergo unrelated surgical procedures when the radioactive material remains active enough to pose risks. This work explores these risks, discusses strategies to mitigate those risks, and describes a case study for a permanent I-125 prostate brachytherapy implant patient who developed colo-rectal cancer and required surgery 6 months after brachytherapy. The first consideration is identifying the risk from unwarranted radiation to the patientmore » and staff before, during, and after the surgical procedure. The second is identifying the risk the surgical procedure may have on the efficacy of the brachytherapy implant. Finally, there are considerations for controlling for radioactive substances from a regulatory perspective. After these risks are defined, strategies to mitigate those risks are considered. These strategies may include applying the concepts of ALARA, the use of protective equipment and developing a best practice strategy with the operating room team. We summarize this experience with some guidelines: If the surgical procedure is near (ex: 5 cm) of the implant; and, the surgical intervention may dislodge radioisotopes enough to compromise treatment or introduces radiation safety risks; and, the radioisotope has not sufficiently decayed to background levels; and, the surgery cannot be postponed, then a detailed analysis of risk is advised.« less

The Australian litigation landscape - oral and maxillofacial surgery and general dentistry (oral surgery procedures): an analysis of litigation cases.

PubMed

Badenoch-Jones, E K; White, B P; Lynham, A J

2016-09-01

There are persistent concerns about litigation in the dental and medical professions. These concerns arise in a setting where general dentists are more frequently undertaking a wider range of oral surgery procedures, potentially increasing legal risk. Judicial cases dealing with medical negligence in the fields of general dentistry (oral surgery procedure) and oral and maxillofacial surgery were located using the three main legal databases. Relevant cases were analysed to determine the procedures involved, the patients' claims of injury, findings of negligence and damages awarded. A thematic analysis of the cases was undertaken to determine trends. Fifteen cases over a 20-year period were located across almost all Australian jurisdictions (eight cases involved general dentists; seven cases involved oral and maxillofacial surgeons). Eleven of the 15 cases involved determinations of whether or not the practitioner had failed in their duty of care; negligence was found in six cases. Eleven of the 15 cases related to molar extractions (eight specifically to third molar). Dental and medical practitioners wanting to manage legal risk should have regard to circumstances arising in judicial cases. Adequate warning of risks is critical, as is offering referral in appropriate cases. Preoperative radiographs, good medical records and processes to ensure appropriate follow-up are also important. © 2015 Australian Dental Association.

Different Approaches for Ensuring Performance/Reliability of Plastic Encapsulated Microcircuits (PEMs) in Space Applications

NASA Technical Reports Server (NTRS)

Gerke, R. David; Sandor, Mike; Agarwal, Shri; Moor, Andrew F.; Cooper, Kim A.

2000-01-01

Engineers within the commercial and aerospace industries are using trade-off and risk analysis to aid in reducing spacecraft system cost while increasing performance and maintaining high reliability. In many cases, Commercial Off-The-Shelf (COTS) components, which include Plastic Encapsulated Microcircuits (PEMs), are candidate packaging technologies for spacecrafts due to their lower cost, lower weight and enhanced functionality. Establishing and implementing a parts program that effectively and reliably makes use of these potentially less reliable, but state-of-the-art devices, has become a significant portion of the job for the parts engineer. Assembling a reliable high performance electronic system, which includes COTS components, requires that the end user assume a risk. To minimize the risk involved, companies have developed methodologies by which they use accelerated stress testing to assess the product and reduce the risk involved to the total system. Currently, there are no industry standard procedures for accomplishing this risk mitigation. This paper will present the approaches for reducing the risk of using PEMs devices in space flight systems as developed by two independent Laboratories. The JPL procedure involves primarily a tailored screening with accelerated stress philosophy while the APL procedure is primarily, a lot qualification procedure. Both Laboratories successfully have reduced the risk of using the particular devices for their respective systems and mission requirements.

Risk factors for unplanned readmission within 30 days after pediatric neurosurgery: a nationwide analysis of 9799 procedures from the American College of Surgeons National Surgical Quality Improvement Program

PubMed Central

Sherrod, Brandon A.; Johnston, James M.; Rocque, Brandon G.

2017-01-01

Objective Readmission rate is increasingly used as a quality outcome measure after surgery. The purpose of this study was to establish, using a national database, the baseline readmission rates and risk factors for readmission after pediatric neurosurgical procedures. Methods The American College of Surgeons National Surgical Quality Improvement Program–Pediatric database was queried for pediatric patients treated by a neurosurgeon from 2012 to 2013. Procedures were categorized by current procedural terminology code. Patient demographics, comorbidities, preoperative laboratory values, operative variables, and postoperative complications were analyzed via univariate and multivariate techniques to find associations with unplanned readmission within 30 days of the primary procedure. Results A total of 9799 cases met the inclusion criteria, 1098 (11.2%) of which had an unplanned readmission within 30 days. Readmission occurred 14.0 ± 7.7 days postoperatively (mean ± standard deviation). The 4 procedures with the highest unplanned readmission rates were CSF shunt revision (17.3%), repair of myelomeningocele > 5 cm in diameter (15.4%), CSF shunt creation (14.1%), and craniectomy for infratentorial tumor excision (13.9%). Spine (6.5%), craniotomy for craniosynostosis (2.1%), and skin lesion (1.0%) procedures had the lowest unplanned readmission rates. On multivariate regression analysis, the odds of readmission were greatest in patients experiencing postoperative surgical site infection (SSI; deep, organ/space, superficial SSI and wound disruption: OR > 12 and p < 0.001 for each). Postoperative pneumonia (OR 4.294, p < 0.001), urinary tract infection (OR 4.262, p < 0.001), and sepsis (OR 2.616, p = 0.006) also independently increased the readmission risk. Independent patient risk factors for unplanned readmission included Native American race (OR 2.363, p = 0.019), steroid use > 10 days (OR 1.411, p = 0.010), oxygen supplementation (OR 1.645, p = 0.010), nutritional support (OR 1.403, p = 0.009), seizure disorder (OR 1.250, p = 0.021), and longer operative time (per hour increase, OR 1.059, p = 0.014). Conclusions This study may aid in identifying patients at risk for unplanned readmission following pediatric neurosurgery, potentially helping to focus efforts at lowering readmission rates, minimizing patient risk, and lowering costs for health care systems. PMID:27184348

Risk factors for unplanned readmission within 30 days after pediatric neurosurgery: a nationwide analysis of 9799 procedures from the American College of Surgeons National Surgical Quality Improvement Program.

PubMed

Sherrod, Brandon A; Johnston, James M; Rocque, Brandon G

2016-09-01

OBJECTIVE Hospital readmission rate is increasingly used as a quality outcome measure after surgery. The purpose of this study was to establish, using a national database, the baseline readmission rates and risk factors for patient readmission after pediatric neurosurgical procedures. METHODS The American College of Surgeons National Surgical Quality Improvement Program-Pediatric database was queried for pediatric patients treated by a neurosurgeon between 2012 and 2013. Procedures were categorized by current procedural terminology (CPT) code. Patient demographics, comorbidities, preoperative laboratory values, operative variables, and postoperative complications were analyzed via univariate and multivariate techniques to find associations with unplanned readmissions within 30 days of the primary procedure. RESULTS A total of 9799 cases met the inclusion criteria, 1098 (11.2%) of which had an unplanned readmission within 30 days. Readmission occurred 14.0 ± 7.7 days postoperatively (mean ± standard deviation). The 4 procedures with the highest unplanned readmission rates were CSF shunt revision (17.3%; CPT codes 62225 and 62230), repair of myelomeningocele > 5 cm in diameter (15.4%), CSF shunt creation (14.1%), and craniectomy for infratentorial tumor excision (13.9%). The lowest unplanned readmission rates were for spine (6.5%), craniotomy for craniosynostosis (2.1%), and skin lesion (1.0%) procedures. On multivariate regression analysis, the odds of readmission were greatest in patients experiencing postoperative surgical site infection (SSI; deep, organ/space, superficial SSI, and wound disruption: OR > 12 and p < 0.001 for each). Postoperative pneumonia (OR 4.294, p < 0.001), urinary tract infection (OR 4.262, p < 0.001), and sepsis (OR 2.616, p = 0.006) also independently increased the readmission risk. Independent patient risk factors for unplanned readmission included Native American race (OR 2.363, p = 0.019), steroid use > 10 days (OR 1.411, p = 0.010), oxygen supplementation (OR 1.645, p = 0.010), nutritional support (OR 1.403, p = 0.009), seizure disorder (OR 1.250, p = 0.021), and longer operative time (per hour increase, OR 1.059, p = 0.029). CONCLUSIONS This study may aid in identifying patients at risk for unplanned readmission following pediatric neurosurgery, potentially helping to focus efforts at lowering readmission rates, minimizing patient risk, and lowering costs for health care systems.

Geographic differences in the epidemiological features of HCV infection in Korea

PubMed Central

Kim, Kyung-Ah; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Jung, Eun Uk; Kim, In Hee; Cho, Sung Bum; Kee, Mee-Kyung; Kang, Chun

2014-01-01

Background/Aims The prevalence of hepatitis C virus (HCV) infection in Korea exhibits significant geographic variation, with it being higher in Busan and Jeonam than in other areas. The reason for this intranational geographic difference was investigated in this study by conducting a comparative analysis of the risk factors related to HCV infection among three geographic areas: the capital (Seoul), Busan, and the province of Jeolla. Methods In total, 990 patients with chronic HCV infection were prospectively enrolled at 5 university hospitals located in Seoul (n=374), Busan (n=264), and Jeolla (n=352). A standardized questionnaire survey on the risk factors for HCV infection was administered to these three groups of patients, and a comparative analysis of the findings was performed. Results The analysis revealed significant regional differences in exposure to the risk factors of HCV infection. By comparison with patients in Seoul as a control group in the multivariate analysis, patients in Busan had significantly more experience of invasive medical procedures, acupuncture, cosmetic procedures, and multiple sex partners. In contrast, patients in Jeolla were significantly older, and they had a higher prevalence of hepatocellular carcinoma, a lower prevalence of multiple sex partners, and had experienced fewer invasive procedures. Conclusions There was a significant geographic difference in the exposure to potential risk factors of HCV infection between patients from the three studied regions. This may explain the regional variation of the prevalence of HCV infection in Korea, and should be taken into account when planning strategies for the prevention and management of HCV infection. PMID:25548742

Command Process Modeling & Risk Analysis

NASA Technical Reports Server (NTRS)

Meshkat, Leila

2011-01-01

Commanding Errors may be caused by a variety of root causes. It's important to understand the relative significance of each of these causes for making institutional investment decisions. One of these causes is the lack of standardized processes and procedures for command and control. We mitigate this problem by building periodic tables and models corresponding to key functions within it. These models include simulation analysis and probabilistic risk assessment models.

[Failure mode effect analysis applied to preparation of intravenous cytostatics].

PubMed

Santos-Rubio, M D; Marín-Gil, R; Muñoz-de la Corte, R; Velázquez-López, M D; Gil-Navarro, M V; Bautista-Paloma, F J

2016-01-01

To proactively identify risks in the preparation of intravenous cytostatic drugs, and to prioritise and establish measures to improve safety procedures. Failure Mode Effect Analysis methodology was used. A multidisciplinary team identified potential failure modes of the procedure through a brainstorming session. The impact associated with each failure mode was assessed with the Risk Priority Number (RPN), which involves three variables: occurrence, severity, and detectability. Improvement measures were established for all identified failure modes, with those with RPN>100 considered critical. The final RPN (theoretical) that would result from the proposed measures was also calculated and the process was redesigned. A total of 34 failure modes were identified. The initial accumulated RPN was 3022 (range: 3-252), and after recommended actions the final RPN was 1292 (range: 3-189). RPN scores >100 were obtained in 13 failure modes; only the dispensing sub-process was free of critical points (RPN>100). A final reduction of RPN>50% was achieved in 9 failure modes. This prospective risk analysis methodology allows the weaknesses of the procedure to be prioritised, optimize use of resources, and a substantial improvement in the safety of the preparation of cytostatic drugs through the introduction of double checking and intermediate product labelling. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Methods for external event screening quantification: Risk Methods Integration and Evaluation Program (RMIEP) methods development

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ravindra, M.K.; Banon, H.

1992-07-01

In this report, the scoping quantification procedures for external events in probabilistic risk assessments of nuclear power plants are described. External event analysis in a PRA has three important goals; (1) the analysis should be complete in that all events are considered; (2) by following some selected screening criteria, the more significant events are identified for detailed analysis; (3) the selected events are analyzed in depth by taking into account the unique features of the events: hazard, fragility of structures and equipment, external-event initiated accident sequences, etc. Based on the above goals, external event analysis may be considered as amore » three-stage process: Stage I: Identification and Initial Screening of External Events; Stage II: Bounding Analysis; Stage III: Detailed Risk Analysis. In the present report, first, a review of published PRAs is given to focus on the significance and treatment of external events in full-scope PRAs. Except for seismic, flooding, fire, and extreme wind events, the contributions of other external events to plant risk have been found to be negligible. Second, scoping methods for external events not covered in detail in the NRC`s PRA Procedures Guide are provided. For this purpose, bounding analyses for transportation accidents, extreme winds and tornadoes, aircraft impacts, turbine missiles, and chemical release are described.« less

Probability of pregnancy after sterilization: a comparison of hysteroscopic versus laparoscopic sterilization.

PubMed

Gariepy, Aileen M; Creinin, Mitchell D; Smith, Kenneth J; Xu, Xiao

2014-08-01

To compare the expected probability of pregnancy after hysteroscopic versus laparoscopic sterilization based on available data using decision analysis. We developed an evidence-based Markov model to estimate the probability of pregnancy over 10 years after three different female sterilization procedures: hysteroscopic, laparoscopic silicone rubber band application and laparoscopic bipolar coagulation. Parameter estimates for procedure success, probability of completing follow-up testing and risk of pregnancy after different sterilization procedures were obtained from published sources. In the base case analysis at all points in time after the sterilization procedure, the initial and cumulative risk of pregnancy after sterilization is higher in women opting for hysteroscopic than either laparoscopic band or bipolar sterilization. The expected pregnancy rates per 1000 women at 1 year are 57, 7 and 3 for hysteroscopic sterilization, laparoscopic silicone rubber band application and laparoscopic bipolar coagulation, respectively. At 10 years, the cumulative pregnancy rates per 1000 women are 96, 24 and 30, respectively. Sensitivity analyses suggest that the three procedures would have an equivalent pregnancy risk of approximately 80 per 1000 women at 10 years if the probability of successful laparoscopic (band or bipolar) sterilization drops below 90% and successful coil placement on first hysteroscopic attempt increases to 98% or if the probability of undergoing a hysterosalpingogram increases to 100%. Based on available data, the expected population risk of pregnancy is higher after hysteroscopic than laparoscopic sterilization. Consistent with existing contraceptive classification, future characterization of hysteroscopic sterilization should distinguish "perfect" and "typical" use failure rates. Pregnancy probability at 1 year and over 10 years is expected to be higher in women having hysteroscopic as compared to laparoscopic sterilization. Copyright © 2014 Elsevier Inc. All rights reserved.

Engineering risk reduction in satellite programs

NASA Technical Reports Server (NTRS)

Dean, E. S., Jr.

1979-01-01

Methods developed in planning and executing system safety engineering programs for Lockheed satellite integration contracts are presented. These procedures establish the applicable safety design criteria, document design compliance and assess the residual risks where non-compliant design is proposed, and provide for hazard analysis of system level test, handling and launch preparations. Operations hazard analysis identifies product protection and product liability hazards prior to the preparation of operational procedures and provides safety requirements for inclusion in them. The method developed for documenting all residual hazards for the attention of program management assures an acceptable minimum level of risk prior to program deployment. The results are significant for persons responsible for managing or engineering the deployment and production of complex high cost equipment under current product liability law and cost/time constraints, have a responsibility to minimize the possibility of an accident, and should have documentation to provide a defense in a product liability suit.

Risk factors for postoperative urinary tract infection following midurethral sling procedures.

PubMed

Doganay, Melike; Cavkaytar, Sabri; Kokanali, Mahmut Kuntay; Ozer, Irfan; Aksakal, Orhan Seyfi; Erkaya, Salim

2017-04-01

To identify the potential risk factors for urinary tract infections following midurethral sling procedures. 556 women who underwent midurethral sling procedure due to stress urinary incontinence over a four-year period were reviewed in this retrospective study. Of the study population, 280 women underwent TVT procedures and 276 women underwent TOT procedures. Patients were evaluated at 4-8 weeks postoperatively and were investigated for the occurrence of a urinary tract infection. Patients who experienced urinary tract infection were defined as cases, and patients who didn't were defined as controls. All data were collected from medical records. Multivariate logistic regression model was used to identify the risk factors for urinary tract infection. Of 556 women, 58 (10.4%) were defined as cases while 498 (89.6%) were controls. The mean age of women in cases (57.8±12.9years) was significantly greater than in controls (51.8±11.2years) (p<0.001). The presence of menopausal status, previous abdominal surgery, preoperative antibiotic treatment due to urinary tract infection, concomitant vaginal hysterectomy and cystocele repair, TVT procedure and postoperative postvoiding residual bladder volume ≥100ml were more common in cases than in controls. However, in multivariate regression analysis model presence of preoperative urinary tract infection [OR (95% CI)=0.1 (0.1-0.7); p=0.013], TVT procedure [OR (95% CI)=8.4 (3.1-22.3); p=0.000] and postoperative postvoiding residual bladder volume ≥100ml [OR (95% CI)=4.6 (1.1-19.2); p=0.036] were significant independent risk factors for urinary tract infection following midurethral slings CONCLUSION: Urinary tract infection after midurethral sling procedures is a relatively common complication. The presence of preoperative urinary tract infection, TVT procedure and postoperative postvoiding residual bladder volume ≥100ml may increase the risk of this complication. Identification of these factors could help surgeons to minimize this complicationby developing effective strategies. Copyright © 2017. Published by Elsevier B.V.

Post-procedural/pre-hemostasis intra-arterial nitroglycerin after transradial catheterization: A gender based analysis.

PubMed

Dharma, Surya; Kedev, Sasko; Patel, Tejas; Sukmawan, Renan; Gilchrist, Ian C; Rao, Sunil V

2016-01-01

We analyzed the effect of nitroglycerin on radial artery occlusion (RAO) in women undergoing transradial catheterization. A total of 1706 patients undergoing transradial catheterization were randomized to receive either 500μg intra-arterial nitroglycerin or placebo at the end of the radial procedure. We explored the gender-based analysis between women (n=539) and men (n=1167). The primary outcome was the incidence of RAO as confirmed by absence of antegrade flow at one day after the transradial procedure evaluated by duplex ultrasound of the radial artery. The use of nitroglycerin, as compared with placebo, did not significantly reduce the risk of RAO in women patients [odds ratio, 0.69; 95% confidence interval (CI), 0.38 to 1.26; P=0.147]. The risk of RAO was higher in women age <60years as compared with women age ≥60years [5.6% vs. 3.5%; odds ratio, 2.16; 95% CI, 1.18 to 3.94; P=0.008]. In women age <60years (n=237), both counter puncture technique and a duration of hemostasis ≥4h were associated with a similar enhanced risk of developing RAO (odds ratio, 3.51; 95% CI, 1.59 to 7.72; P<0.001). The administration of nitroglycerin at the end of a transradial catheterization in women did not reduce the risk of RAO as determined by ultrasound one day after the radial procedure. Age <60years was associated with a higher risk of RAO compared with age ≥60years in women. Further strategies to reduce RAO in women are needed. Copyright © 2015 Elsevier Inc. All rights reserved.

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine

PubMed Central

Kapur, Ajay; Goode, Gina; Riehl, Catherine; Zuvic, Petrina; Joseph, Sherin; Adair, Nilda; Interrante, Michael; Bloom, Beatrice; Lee, Lucille; Sharma, Rajiv; Sharma, Anurag; Antone, Jeffrey; Riegel, Adam; Vijeh, Lili; Zhang, Honglai; Cao, Yijian; Morgenstern, Carol; Montchal, Elaine; Cox, Brett; Potters, Louis

2013-01-01

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice. PMID:24380074

Trust, confidence, procedural fairness, outcome fairness, moral conviction, and the acceptance of GM field experiments.

PubMed

Siegrist, Michael; Connor, Melanie; Keller, Carmen

2012-08-01

In 2005, Swiss citizens endorsed a moratorium on gene technology, resulting in the prohibition of the commercial cultivation of genetically modified crops and the growth of genetically modified animals until 2013. However, scientific research was not affected by this moratorium, and in 2008, GMO field experiments were conducted that allowed us to examine the factors that influence their acceptance by the public. In this study, trust and confidence items were analyzed using principal component analysis. The analysis revealed the following three factors: "economy/health and environment" (value similarity based trust), "trust and honesty of industry and scientists" (value similarity based trust), and "competence" (confidence). The results of a regression analysis showed that all the three factors significantly influenced the acceptance of GM field experiments. Furthermore, risk communication scholars have suggested that fairness also plays an important role in the acceptance of environmental hazards. We, therefore, included measures for outcome fairness and procedural fairness in our model. However, the impact of fairness may be moderated by moral conviction. That is, fairness may be significant for people for whom GMO is not an important issue, but not for people for whom GMO is an important issue. The regression analysis showed that, in addition to the trust and confidence factors, moral conviction, outcome fairness, and procedural fairness were significant predictors. The results suggest that the influence of procedural fairness is even stronger for persons having high moral convictions compared with persons having low moral convictions. © 2012 Society for Risk Analysis.

Risk Factors for Failure of Male Slings and Artificial Urinary Sphincters: Results from a Large Middle European Cohort Study.

PubMed

Hüsch, Tanja; Kretschmer, Alexander; Thomsen, Frauke; Kronlachner, Dominik; Kurosch, Martin; Obaje, Alice; Anding, Ralf; Pottek, Tobias; Rose, Achim; Olianas, Roberto; Friedl, Alexander; Hübner, Wilhelm; Homberg, Roland; Pfitzenmaier, Jesco; Grein, Ulrich; Queissert, Fabian; Naumann, Carsten Maik; Schweiger, Josef; Wotzka, Carola; Nyarangi-Dix, Joanne; Hofmann, Torben; Ulm, Kurt; Bauer, Ricarda M; Haferkamp, Axel

2017-01-01

We analysed the impact of predefined risk factors: age, diabetes, history of pelvic irradiation, prior surgery for stress urinary incontinence (SUI), prior urethral stricture, additional procedure during SUI surgery, duration of incontinence, ASA-classification and cause for incontinence on failure and complications in male SUI surgery. We retrospectively identified 506 patients with an artificial urinary sphincter (AUS) and 513 patients with a male sling (MS) in a multicenter cohort study. Complication rates were correlated to the risk factors in univariate analysis. Subsequently, a multivariate logistic regression adjusted to the risk factors was performed. A p value <0.05 was considered statistically significant. A history of pelvic irradiation was an independent risk factor for explantation in AUS (p < 0.001) and MS (p = 0.018). Moreover, prior urethral stricture (p = 0.036) and higher ASA-classification (p = 0.039) were positively correlated with explantation in univariate analysis for AUS. Urethral erosion was correlated with prior urethral stricture (p < 0.001) and a history of pelvic irradiation (p < 0.001) in AUS. Furthermore, infection was correlated with additional procedures during SUI surgery in univariate analysis (p = 0.037) in MS. We first identified the correlation of higher ASA-classification and explantation in AUS. Nevertheless, only a few novel risk factors had a significant influence on the failure of MS or AUS. © 2016 S. Karger AG, Basel.

Guidelines for Automatic Data Processing Physical Security and Risk Management. Federal Information Processing Standards Publication 31.

ERIC Educational Resources Information Center

National Bureau of Standards (DOC), Washington, DC.

These guidelines provide a handbook for use by federal organizations in structuring physical security and risk management programs for their automatic data processing facilities. This publication discusses security analysis, natural disasters, supporting utilities, system reliability, procedural measures and controls, off-site facilities,…

[Perioperative mortality. Risk factors associated with anaesthesia].

PubMed

Zajac, Krzysztof; Zajac, Małgorzata

2005-01-01

Perioperative mortality associated with anaesthesia has been closely monitored throughout half of the century. The breakthrough in anaesthesia safety occurred in the 80-ties and 90-ties of the last century, when we could witness 5-folded reduction in mortality associated with anaesthesia, i.e. from 1 death:2680 operations/anaesthetic procedures (the 50-ties of the 20 h century) to 1:10,000 (and even 20-folded reduction within the ASA 1 and 2 groups of the patients--1 death:185,000 procedures). However, the more detailed analysis showed that the perioperative mortality is significantly higher, namely 1 death: approximately 500 procedures, and in the ASA 5 group of patients 1:4.5 procedures; what is more meaningful, the numbers have not been changed since 50 years. This phenomenon supports the thesis of anaesthesia safety, however, it indicates the drawbacks within the models and scoring systems evaluating operative risk. Several available scoring scales which can predict death rate, at the same time are not able to assess the extent of the other than biological risk factors. The "extra-biological risk" (i.e. process of therapy) may in some cases increase the operative risk as a whole. The value of the operative risk, as the fraction given by predicted death rate, is located between the numbers 0 and 1 (or between survival and death in the binary model of the probability theory). Recognition of the "extrabiological risk" value depends however on the high sensitivity of the scales evaluating prediction of death rate.

Complications of botulinum toxin injections for treatment of esophageal motility disorders†.

PubMed

van Hoeij, Froukje B; Tack, Jan F; Pandolfino, John E; Sternbach, Joel M; Roman, Sabine; Smout, André J P M; Bredenoord, Albert J

2017-02-01

In achalasia and spastic esophageal motility disorders, botulinum toxin (botox) injection is considered an effective and low-risk procedure for short-term symptom relief. It is mainly offered to medically high-risk patients. However, no analysis of risks of botox injections has been performed. To determine the incidence and risk factors of procedure-related complications after esophageal botox injections, we analyzed the records of all patients undergoing botox injection therapy for esophageal motility disorders at four university hospitals in Europe and North America between 2008 and 2014. Complications were assigned grades according to the Clavien-Dindo classification. In 386 patients, 661 botox treatments were performed. Main indications were achalasia (51%) and distal esophageal spasm (DES) (30%). In total, 52 (7.9%) mild complications (Clavien-Dindo grade I) were reported by 48 patients, the majority consisting of chest pain or heartburn (29 procedures) or epigastric pain (5 procedures). No ulceration, perforation, pneumothorax, or abscess were reported. One patient died after developing acute mediastinitis (Clavien-Dindo grade V) following injections in the body of the esophagus. In univariate logistic regression, younger age was associated with an increased risk of complications (OR 1.43, 95%CI 1.03-1.96). Treatment for DES, injections into the esophageal body, more injections per procedure, more previous treatments and larger amount of injected botulinum toxin were no risk factors for complications. Esophageal botox injection seems particularly appropriate for high-risk patients due to low complication rate. However, it should not be considered completely safe, as it is associated with rare side effects that cannot be predicted. © 2016 International Society for Diseases of the Esophagus.

Benefit-risk reassessment of medicines: a retrospective analysis of all safety-related referral procedures in Europe during 2001-2012.

PubMed

Bouvy, Jacoline C; Huinink, Lotte; De Bruin, Marie L

2016-09-01

The aim of this study was to determine the outcomes and timing within the product life cycle of all benefit-risk reassessment procedures for marketed products that were completed by the committee for medicinal product for human use during 2001-2012. A cohort of all referral procedures for benefit-risk reassessment (Article 20, Article 31, Article 36, Article 107 procedures) for which committee for medicinal product for human use issued an opinion between 1 January 2001 and 31 December 2012 was created. The European Medicines Agency website and the Dutch Medicines Evaluation Board website were used to collect all data. There were a total of 73 benefit-risk reassessments during the study period; 61 reassessments for a single product and 12 reassessments for multiple products or an entire product class. Nineteen reassessments resulted in the recommendation to remove the product from the market. On average, a benefit-risk reassessment was performed 18.7 years after the product was first marketed. Seventeen products were marketed 5 years or less when the reassessment procedure was completed; six of these products were subsequently removed from the market. The majority of all benefit-risk reassessments that were performed during the study period did not result in removing the product from the market, but rather, in confirming the positive benefit-risk of the product, conditional to changes to the product's marketing authorisation. About half of all products that were removed from the market during the 2000s had been marketed for more than 20 years. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Performance of the European System for Cardiac Operative Risk Evaluation II: a meta-analysis of 22 studies involving 145,592 cardiac surgery procedures.

PubMed

Guida, Pietro; Mastro, Florinda; Scrascia, Giuseppe; Whitlock, Richard; Paparella, Domenico

2014-12-01

A systematic review of the European System for Cardiac Operative Risk Evaluation (euroSCORE) II performance for prediction of operative mortality after cardiac surgery has not been performed. We conducted a meta-analysis of studies based on the predictive accuracy of the euroSCORE II. We searched the Embase and PubMed databases for all English-only articles reporting performance characteristics of the euroSCORE II. The area under the receiver operating characteristic curve, the observed/expected mortality ratio, and observed-expected mortality difference with their 95% confidence intervals were analyzed. Twenty-two articles were selected, including 145,592 procedures. Operative mortality occurred in 4293 (2.95%), whereas the expected events according to euroSCORE II were 4802 (3.30%). Meta-analysis of these studies provided an area under the receiver operating characteristic curve of 0.792 (95% confidence interval, 0.773-0.811), an estimated observed/expected ratio of 1.019 (95% confidence interval, 0.899-1.139), and observed-expected difference of 0.125 (95% confidence interval, -0.269 to 0.519). Statistical heterogeneity was detected among retrospective studies including less recent procedures. Subgroups analysis confirmed the robustness of combined estimates for isolated valve procedures and those combined with revascularization surgery. A significant overestimation of the euroSCORE II with an observed/expected ratio of 0.829 (95% confidence interval, 0.677-0.982) was observed in isolated coronary artery bypass grafting and a slight underestimation of predictions in high-risk patients (observed/expected ratio 1.253 and observed-expected difference 1.859). Despite the heterogeneity, the results from this meta-analysis show a good overall performance of the euroSCORE II in terms of discrimination and accuracy of model predictions for operative mortality. Validation of the euroSCORE II in prospective populations needs to be further studied for a continuous improvement of patients' risk stratification before cardiac surgery. Copyright © 2014 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Meta‐analysis of the procedural risks of carotid endarterectomy and carotid artery stenting over time

PubMed Central

Lokuge, K.; de Waard, D. D.; Halliday, A.; Gray, A.; Bulbulia, R.

2017-01-01

Background Stroke/death rates within 30 days of carotid endarterectomy (CEA) and carotid artery stenting (CAS) in RCTs inform current clinical guidelines. However, the risks may have changed in recent years with wider use of effective stroke prevention therapies, especially statins, improved patient selection and growing operator expertise. The aim of this study was to investigate whether the procedural stroke/death risks from CEA and CAS have changed over time. Methods MEDLINE and Embase were searched systematically from inception to May 2016 for observational cohort studies of CEA and CAS. Studies included reported on more than 1000 patients, with 30‐day outcomes after the procedure according to patients' symptom status (recent stroke or transient ischaemic attack). Restricted maximum likelihood random‐effects and meta‐regressions methods were used to synthesize procedural stroke/death rates of CEA and CAS according to year of study recruitment completion. Results Fifty‐one studies, including 223 313 patients undergoing CEA and 72 961 undergoing CAS, were reviewed. Procedural stroke/death risks of CEA decreased over time in symptomatic and asymptomatic patients. Risks were substantially lower in studies completing recruitment in 2005 or later, both in symptomatic (5·11 per cent before 2005 versus 2·68 per cent from 2005 onwards; P = 0·002) and asymptomatic (3·17 versus 1·50 per cent; P < 0·001) patients. Procedural stroke/death rates of CAS did not change significantly over time (4·77 per cent among symptomatic and 2·59 per cent among asymptomatic patients). There was substantial heterogeneity in event rates and recruitment periods were long. Conclusions Risks of procedural stroke/death following CEA appear to have decreased substantially. There was no evidence of a change in stroke/death rates following CAS. PMID:29205297

Comparison of automatic procedures in the selection of peaks over threshold in flood frequency analysis: A Canadian case study in the context of climate change

NASA Astrophysics Data System (ADS)

Durocher, M.; Mostofi Zadeh, S.; Burn, D. H.; Ashkar, F.

2017-12-01

Floods are one of the most costly hazards and frequency analysis of river discharges is an important part of the tools at our disposal to evaluate their inherent risks and to provide an adequate response. In comparison to the common examination of annual streamflow maximums, peaks over threshold (POT) is an interesting alternative that makes better use of the available information by including more than one flood event per year (on average). However, a major challenge is the selection of a satisfactory threshold above which peaks are assumed to respect certain conditions necessary for an adequate estimation of the risk. Additionally, studies have shown that POT is also a valuable approach to investigate the evolution of flood regimes in the context of climate change. Recently, automatic procedures for the selection of the threshold were suggested to guide that important choice, which otherwise rely on graphical tools and expert judgment. Furthermore, having an automatic procedure that is objective allows for quickly repeating the analysis on a large number of samples, which is useful in the context of large databases or for uncertainty analysis based on a resampling approach. This study investigates the impact of considering such procedures in a case study including many sites across Canada. A simulation study is conducted to evaluate the bias and predictive power of the automatic procedures in similar conditions as well as investigating the power of derived nonstationarity tests. The results obtained are also evaluated in the light of expert judgments established in a previous study. Ultimately, this study provides a thorough examination of the considerations that need to be addressed when conducting POT analysis using automatic threshold selection.

Risk factors for early cytologic abnormalities after loop electrosurgical excision procedure.

PubMed

Dietrich, Charles S; Yancey, Michael K; Miyazawa, Kunio; Williams, David L; Farley, John

2002-02-01

To evaluate risk factors for early cytologic abnormalities and recurrent cervical dysplasia after loop electrosurgical excision procedure (LEEP). A retrospective analysis was performed of all pathology records for LEEPs performed at our institution from January 1996 through July 1998. Follow-up cytology from 2 through 12 months after LEEP was reviewed. Patients with abnormal cytology were referred for further colposcopic evaluation. Statistical analysis using chi2 test for trend, proportional hazards model test, Fisher exact tests, and life table analysis were performed to identify risk factors for early cytologic abnormalities after LEEP and to determine relative risk of recurrent dysplasia. A total of 298 women underwent LEEP during the study period, and 29% of these had cytologic abnormalities after LEEP. Grade of dysplasia, ectocervical marginal status, endocervical marginal status, and glandular involvement with dysplasia were not found to be independent risk factors for early cytologic abnormalities. However, when risk factors were analyzed cumulatively, the abnormal cytology rate increased from 24% with no risk factors to 67% with three risk factors present (P =.037). Of patients with abnormal cytology after LEEP, 40% developed subsequent dysplasia, and the mean time to diagnosis was approximately 6 months. The relative risk of subsequent dysplasia ranged from a 20% increase to twice the risk if post-LEEP cytology was low-grade squamous intraepithelial lesion or high-grade squamous intraepithelial lesion, respectively. Based on these results, consideration should be given for early colposcopic examination of patients who have evidence of marginal involvement or endocervical glandular involvement with dysplasia. These patients are at increased risk for abnormal cytology and recurrent dysplasia. This initial visit should occur at 6 months, as the mean time to recurrence of dysplasia was 6.5 months.

Is isomerism a risk factor for intestinal volvulus?

PubMed

Landisch, Rachel M; Loomba, Rohit S; Salazar, Jose H; Buelow, Matthew W; Frommelt, Michele; Anderson, Robert H; Wagner, Amy J

2018-03-06

Isomerism, or heterotaxy syndrome, affects many organ systems anatomically and functionally. Intestinal malrotation is common in patients with isomerism. Despite a low reported risk of volvulus, some physicians perform routine screening and prophylactic Ladd procedures on asymptomatic patients with isomerism who are found to have intestinal malrotation. The primary aim of this study was to determine if isomerism is an independent risk factor for volvulus. Kid's Inpatient Database data from 1997 to 2012 was utilized for this study. Characteristics of admissions with and without isomerism were compared with a particular focus on intestinal malrotation, volvulus, and Ladd procedure. A logistic regression was conducted to determine independent risk factors for volvulus with respect to isomerism. 15,962,403 inpatient admissions were included in the analysis, of which 7970 (0.05%) patients had isomerism, and 6 patients (0.1%) developed volvulus. Isomerism was associated with a 52-fold increase in the odds of intestinal malrotation by univariate analysis. Of 251 with isomerism and intestinal malrotation, only 2.4% experienced volvulus. Logistic regression demonstrated that isomerism was not an independent risk factor for volvulus. Isomerism is associated with an increased risk of intestinal malrotation but is not an independent risk factor for volvulus. Prognosis study. Level III. Copyright © 2018 Elsevier Inc. All rights reserved.

Surgical procedures in liver transplant patients: A monocentric retrospective cohort study.

PubMed

Sommacale, Daniele; Nagarajan, Ganesh; Lhuaire, Martin; Dondero, Federica; Pessaux, Patrick; Piardi, Tullio; Sauvanet, Alain; Kianmanesh, Reza; Belghiti, Jacques

2017-05-01

Pre-existing chronic liver diseases and the complexity of the transplant surgery procedures lead to a greater risk of further surgery in transplanted patients compared to the general population. The aim of this monocentric retrospective cohort study was to assess the epidemiology of surgical complications in liver transplanted patients who require further surgical procedures and to characterize their post-operative risk of complications to enhance their medical care. From January 1997 to December 2011, 1211 patients underwent orthotropic liver transplantation in our center. A retrospective analysis of prospectively collected data was performed considering patients who underwent surgical procedures more than three months after transplantation. We recorded liver transplantation technique, type of surgery, post-operative complications, time since the liver transplant and immunosuppressive regimens. Among these, 161 patients (15%) underwent a further 183 surgical procedures for conditions both related and unrelated to the transplant. The most common surgical procedure was for an incisional hernia repair (n = 101), followed by bilioenteric anastomosis (n = 44), intestinal surgery (n = 23), liver surgery (n = 8) and other surgical procedures (n = 7). Emergency surgery was required in 19 procedures (10%), while 162 procedures (90%) were performed electively. Post-operative mortality and morbidity were 1% and 30%, respectively. According to the Dindo-Clavien classification, the most common grade of morbidity was grade III (46%), followed by grade II (40%). Surgical procedures on liver transplanted patients are associated with a significantly high risk of complications, irrespective of the time elapsed since transplantation. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Symbolic dynamic filtering and language measure for behavior identification of mobile robots.

PubMed

Mallapragada, Goutham; Ray, Asok; Jin, Xin

2012-06-01

This paper presents a procedure for behavior identification of mobile robots, which requires limited or no domain knowledge of the underlying process. While the features of robot behavior are extracted by symbolic dynamic filtering of the observed time series, the behavior patterns are classified based on language measure theory. The behavior identification procedure has been experimentally validated on a networked robotic test bed by comparison with commonly used tools, namely, principal component analysis for feature extraction and Bayesian risk analysis for pattern classification.

14 CFR 437.55 - Hazard analysis.

Code of Federal Regulations, 2014 CFR

2014-01-01

... TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.55 Hazard analysis. (a) A permittee must...) Design inadequacies; or (vi) Procedural deficiencies. (2) Determine the likelihood of occurrence and... include one or more of the following: (i) Designing for minimum risk, (ii) Incorporating safety devices...

14 CFR 437.55 - Hazard analysis.

Code of Federal Regulations, 2010 CFR

2010-01-01

... TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.55 Hazard analysis. (a) A permittee must...) Design inadequacies; or (vi) Procedural deficiencies. (2) Determine the likelihood of occurrence and... include one or more of the following: (i) Designing for minimum risk, (ii) Incorporating safety devices...

14 CFR 437.55 - Hazard analysis.

Code of Federal Regulations, 2011 CFR

2011-01-01

... TRANSPORTATION LICENSING EXPERIMENTAL PERMITS Safety Requirements § 437.55 Hazard analysis. (a) A permittee must...) Design inadequacies; or (vi) Procedural deficiencies. (2) Determine the likelihood of occurrence and... include one or more of the following: (i) Designing for minimum risk, (ii) Incorporating safety devices...

Pregnancy after tubal sterilization with silicone rubber band and spring clip application.

PubMed

Peterson, H B; Xia, Z; Wilcox, L S; Tylor, L R; Trussell, J

2001-02-01

To determine risk factors for pregnancy after tubal sterilization with silicone rubber bands or spring clips. A total of 3329 women sterilized using silicone rubber bands and 1595 women sterilized using spring clips were followed for up to 14 years as part of a prospective cohort study conducted in medical centers in nine US cities. We assessed the risk of pregnancy by cumulative life-table probabilities and proportional hazards analysis. The risk of pregnancy for women who had silicone rubber band application differed by location of band application and study site. The 10-year cumulative probabilities of pregnancy varied from a low of 0.0 per 1000 procedures at one study site to a high of 42.5 per 1000 procedures in the four combined sites in which fewer than 100 procedures per site were performed. The risk of pregnancy for women who had spring clip application varied by location of clip application, study site, race or ethnicity, tubal disease, and history of abdominal or pelvic surgery. The probabilities across study sites ranged from 7.1 per 1000 procedures at 10 years to 78.0 per 1000 procedures at 5 years (follow-up was limited to 5 years at that site). The 10-year cumulative probability of pregnancy after silicone rubber band and spring clip application is low but varies substantially by both clinical and demographic characteristics.

An outcomes analysis of patients undergoing body contouring surgery after massive weight loss.

PubMed

Shermak, Michele A; Chang, David; Magnuson, Thomas H; Schweitzer, Michael A

2006-09-15

Although published reports about technical management of massive weight loss patients are beginning to appear, risk factors for complications following body contouring operations are not known. A retrospective analysis of massive weight loss patients who had body contouring operations between March of 1998 and October of 2004 was performed. Demographic and surgical factors were analyzed. Outcome measures included seroma, wound dehiscence, thromboembolic complications, blood transfusion after surgery, and extended lengths of stay (>2 days). A total of 139 patients were analyzed; 82.7 percent of them were female; mean age was 41 years. On multiple logistic regression, male gender was associated with significant risks for wound dehiscence (odds ratio, 6.4; p = 0.01). There were also trends toward increased risk for wound dehiscence with hypothyroidism (odds ratio, 4.3; p = 0.06) and Ehlers-Danlos syndrome (odds ratio, 18.7; p = 0.05). In terms of risk of blood transfusion, asthma and having three or more procedures were the two variables that emerged with significant association (odds ratio, 16.8 and 13.7, respectively; both p < 0.01). Increased length of stay to greater than 2 days was also significantly associated with having three or more procedures (odds ratio, 4.72; p < 0.01). Male gender, hypothyroidism, and Ehlers-Danlos syndrome may be risk factors for wound dehiscence following body contour operations for massive weight loss. Asthma may be a marker of poor general health status, and asthmatic patients are at increased risk for requiring blood transfusions. Having three or more procedures is associated with an increased risk of blood transfusion and increased length of stay.

Comparative Effect of Contrast Media Type on the Incidence of Contrast-Induced Nephropathy: A Systematic Review and Meta-analysis.

PubMed

Eng, John; Wilson, Renee F; Subramaniam, Rathan M; Zhang, Allen; Suarez-Cuervo, Catalina; Turban, Sharon; Choi, Michael J; Sherrod, Cheryl; Hutfless, Susan; Iyoha, Emmanuel E; Bass, Eric B

2016-03-15

Iodine contrast media are essential components of many imaging procedures. An important potential side effect is contrast-induced nephropathy (CIN). To compare CIN risk for contrast media within and between osmolality classes in patients receiving diagnostic or therapeutic imaging procedures. PubMed, EMBASE, Cochrane Library, Clinical Trials.gov, and Scopus through June 2015. Randomized, controlled trials that reported CIN-related outcomes in patients receiving low-osmolar contrast media (LOCM) or iso-osmolar contrast media for imaging. Independent study selection and quality assessment by 2 reviewers and dual extraction of study characteristics and results. None of the 5 studies that compared types of LOCM reported a statistically significant or clinically important difference among study groups, but the strength of evidence was low. Twenty-five randomized, controlled trials found a slight reduction in CIN risk with the iso-osmolar contrast media agent iodixanol compared with a diverse group of LOCM that just reached statistical significance in a meta-analysis (pooled relative risk, 0.80 [95% CI, 0.65 to 0.99]; P = 0.045). This comparison's strength of evidence was moderate. In a meta regression of randomized, controlled trials of iodixanol, no relationship was found between route of administration and comparative CIN risk. Few studies compared LOCM. Procedural details about contrast administration were not uniformly reported. Few studies specified clinical indications or severity of baseline renal impairment. No differences were found in CIN risk among types of LOCM. Iodixanol had a slightly lower risk for CIN than LOCM, but the lower risk did not exceed a criterion for clinical importance. Agency for Healthcare Research and Quality.

Adverse cardiac events in children with Williams syndrome undergoing cardiovascular surgery: An analysis of the Society of Thoracic Surgeons Congenital Heart Surgery Database.

PubMed

Hornik, Christoph P; Collins, Ronnie Thomas; Jaquiss, Robert D B; Jacobs, Jeffrey P; Jacobs, Marshall L; Pasquali, Sara K; Wallace, Amelia S; Hill, Kevin D

2015-06-01

Patients with Williams syndrome (WS) undergoing cardiac surgery are at risk for major adverse cardiac events (MACE). Prevalence and risk factors for such events have not been well described. We sought to define frequency and risk of MACE in patients with WS using a multicenter clinical registry. We identified cardiac operations performed in patients with WS using the Society of Thoracic Surgeons Congenital Heart Surgery Database (2000-2012). Operations were divided into 4 groups: isolated supravalvular aortic stenosis, complex left ventricular outflow tract (LVOT), isolated right ventricular outflow tract (RVOT), and combined LVOT/RVOT procedures. The proportion of patients with MACE (in-hospital mortality, cardiac arrest, or postoperative mechanical circulatory support) was described and the association with preoperative factors was examined. Of 447 index operations (87 centers), median (interquartile range) age and weight at surgery were 2.4 years (0.6-7.4 years) and 10.6 kg (6.5-21.5 kg), respectively. Mortality occurred in 20 patients (5%). MACE occurred in 41 patients (9%), most commonly after combined LVOT/RVOT (18 out of 87; 21%) and complex LVOT (12 out of 131; 9%) procedures, but not after isolated RVOT procedures. Odds of MACE decreased with age (odds ratio [OR], 0.99; 95% confidence interval [CI], 0.98-0.99), weight (OR, 0.97; 95% CI, 0.93-0.99), but increased in the presence of any preoperative risk factor (OR, 2.08; 95% CI, 1.06-4.00), and in procedures involving coronary artery repair (OR, 5.37; 95% CI, 2.05-14.06). In this multicenter analysis, MACE occurred in 9% of patients with WS undergoing cardiac surgery. Demographic and operative characteristics were associated with risk. Further study is needed to elucidate mechanisms of MACE in this high-risk population. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Surgical staging and prognosis in serous borderline ovarian tumours (BOT): A subanalysis of the AGO ROBOT study

PubMed Central

Trillsch, F; Mahner, S; Vettorazzi, E; Woelber, L; Reuss, A; Baumann, K; Keyver-Paik, M-D; Canzler, U; Wollschlaeger, K; Forner, D; Pfisterer, J; Schroeder, W; Muenstedt, K; Richter, B; Fotopoulou, C; Schmalfeldt, B; Burges, A; Ewald-Riegler, N; de Gregorio, N; Hilpert, F; Fehm, T; Meier, W; Hillemanns, P; Hanker, L; Hasenburg, A; Strauss, H-G; Hellriegel, M; Wimberger, P; Kommoss, S; Kommoss, F; Hauptmann, S; du Bois, A

2015-01-01

Background: Incomplete surgical staging is a negative prognostic factor for patients with borderline ovarian tumours (BOT). However, little is known about the prognostic impact of each individual staging procedure. Methods: Clinical parameters of 950 patients with BOT (confirmed by central reference pathology) treated between 1998 and 2008 at 24 German AGO centres were analysed. In 559 patients with serous BOT and adequate ovarian surgery, further recommended staging procedures (omentectomy, peritoneal biopsies, cytology) were evaluated applying Cox regression models with respect to progression-free survival (PFS). Results: For patients with one missing staging procedure, the hazard ratio (HR) for recurrence was 1.25 (95%-CI 0.66–2.39; P=0.497). This risk increased with each additional procedure skipped reaching statistical significance in case of two (HR 1.95; 95%-CI 1.06–3.58; P=0.031) and three missing steps (HR 2.37; 95%-CI 1.22–4.64; P=0.011). The most crucial procedure was omentectomy which retained a statistically significant impact on PFS in multiple analysis (HR 1.91; 95%-CI 1.15–3.19; P=0.013) adjusting for previously established prognostic factors as FIGO stage, tumour residuals, and fertility preservation. Conclusion: Individual surgical staging procedures contribute to the prognosis for patients with serous BOT. In this analysis, recurrence risk increased with each skipped surgical step. This should be considered when re-staging procedures following incomplete primary surgery are discussed. PMID:25562434

Surgical staging and prognosis in serous borderline ovarian tumours (BOT): a subanalysis of the AGO ROBOT study.

PubMed

Trillsch, F; Mahner, S; Vettorazzi, E; Woelber, L; Reuss, A; Baumann, K; Keyver-Paik, M-D; Canzler, U; Wollschlaeger, K; Forner, D; Pfisterer, J; Schroeder, W; Muenstedt, K; Richter, B; Fotopoulou, C; Schmalfeldt, B; Burges, A; Ewald-Riegler, N; de Gregorio, N; Hilpert, F; Fehm, T; Meier, W; Hillemanns, P; Hanker, L; Hasenburg, A; Strauss, H-G; Hellriegel, M; Wimberger, P; Kommoss, S; Kommoss, F; Hauptmann, S; du Bois, A

2015-02-17

Incomplete surgical staging is a negative prognostic factor for patients with borderline ovarian tumours (BOT). However, little is known about the prognostic impact of each individual staging procedure. Clinical parameters of 950 patients with BOT (confirmed by central reference pathology) treated between 1998 and 2008 at 24 German AGO centres were analysed. In 559 patients with serous BOT and adequate ovarian surgery, further recommended staging procedures (omentectomy, peritoneal biopsies, cytology) were evaluated applying Cox regression models with respect to progression-free survival (PFS). For patients with one missing staging procedure, the hazard ratio (HR) for recurrence was 1.25 (95%-CI 0.66-2.39; P=0.497). This risk increased with each additional procedure skipped reaching statistical significance in case of two (HR 1.95; 95%-CI 1.06-3.58; P=0.031) and three missing steps (HR 2.37; 95%-CI 1.22-4.64; P=0.011). The most crucial procedure was omentectomy which retained a statistically significant impact on PFS in multiple analysis (HR 1.91; 95%-CI 1.15-3.19; P=0.013) adjusting for previously established prognostic factors as FIGO stage, tumour residuals, and fertility preservation. Individual surgical staging procedures contribute to the prognosis for patients with serous BOT. In this analysis, recurrence risk increased with each skipped surgical step. This should be considered when re-staging procedures following incomplete primary surgery are discussed.

Preterm Versus Term Children: Analysis of Sedation/Anesthesia Adverse Events and Longitudinal Risk.

PubMed

Havidich, Jeana E; Beach, Michael; Dierdorf, Stephen F; Onega, Tracy; Suresh, Gautham; Cravero, Joseph P

2016-03-01

Preterm and former preterm children frequently require sedation/anesthesia for diagnostic and therapeutic procedures. Our objective was to determine the age at which children who are born <37 weeks gestational age are no longer at increased risk for sedation/anesthesia adverse events. Our secondary objective was to describe the nature and incidence of adverse events. This is a prospective observational study of children receiving sedation/anesthesia for diagnostic and/or therapeutic procedures outside of the operating room by the Pediatric Sedation Research Consortium. A total of 57,227 patients 0 to 22 years of age were eligible for this study. All adverse events and descriptive terms were predefined. Logistic regression and locally weighted scatterplot regression were used for analysis. Preterm and former preterm children had higher adverse event rates (14.7% vs 8.5%) compared with children born at term. Our analysis revealed a biphasic pattern for the development of adverse sedation/anesthesia events. Airway and respiratory adverse events were most commonly reported. MRI scans were the most commonly performed procedures in both categories of patients. Patients born preterm are nearly twice as likely to develop sedation/anesthesia adverse events, and this risk continues up to 23 years of age. We recommend obtaining birth history during the formulation of an anesthetic/sedation plan, with heightened awareness that preterm and former preterm children may be at increased risk. Further prospective studies focusing on the etiology and prevention of adverse events in former preterm patients are warranted. Copyright © 2016 by the American Academy of Pediatrics.

Are there risk factors that increase the rate of staple line leakage in patients undergoing primary sleeve gastrectomy for morbid obesity?

PubMed

Benedix, Frank; Benedix, Diana D; Knoll, Christian; Weiner, Rudolf; Bruns, Christiane; Manger, Thomas; Stroh, Christine

2014-10-01

Laparoscopic sleeve gastrectomy (LSG) is currently being performed with increasing frequency worldwide. It offers an excellent weight loss and resolution of comorbidities in the short term with a very low incidence of complications. However, the ever present risk of a staple line leak is still a major concern. Since 2005, data from obese patients that undergo bariatric procedures in Germany are prospectively registered in an online database and analyzed at the Institute of Quality Assurance in Surgical Medicine. For the current analysis, all patients that had undergone primary sleeve gastrectomy for morbid obesity within a 7-year period were considered. Using the GBSR, data from 5.400 LSGs were considered for analysis. Staple line leak rate decreased during the study period from 6.5 to 1.4 %. Male gender, higher BMI, concomitant sleep apnea, conversion to laparotomy, longer operation time, use of both buttresses and oversewing, and the occurrence of intraoperative complications were associated with a significantly higher leakage rate. On multivariate analysis, operation time and year of procedure only had a significant impact on staple line leak rate. The results of the current study demonstrated that there are factors that increase the risk of a leakage which would enable surgeons to define risk groups, to more carefully select patients, and to offer a closer follow-up during the postoperative course with early recognition and adequate treatment. All future efforts should be focused on a further reduction of serious complications to make the LSG a widely accepted and safer procedure.

Risk factors for indications of intraoperative blood transfusion among patients undergoing surgical treatment for colorectal adenocarcinoma.

PubMed

Gonçalves, Iara; Linhares, Marcelo; Bordin, Jose; Matos, Delcio

2009-01-01

Identification of risk factors for requiring transfusions during surgery for colorectal cancer may lead to preventive actions or alternative measures, towards decreasing the use of blood components in these procedures, and also rationalization of resources use in hemotherapy services. This was a retrospective case-control study using data from 383 patients who were treated surgically for colorectal adenocarcinoma at 'Fundação Pio XII', in Barretos-SP, Brazil, between 1999 and 2003. To recognize significant risk factors for requiring intraoperative blood transfusion in colorectal cancer surgical procedures. Univariate analyses were performed using Fisher's exact test or the chi-squared test for dichotomous variables and Student's t test for continuous variables, followed by multivariate analysis using multiple logistic regression. In the univariate analyses, height (P = 0.06), glycemia (P = 0.05), previous abdominal or pelvic surgery (P = 0.031), abdominoperineal surgery (P<0.001), extended surgery (P<0.001) and intervention with radical intent (P<0.001) were considered significant. In the multivariate analysis using logistic regression, intervention with radical intent (OR = 10.249, P<0.001, 95% CI = 3.071-34.212) and abdominoperineal amputation (OR = 3.096, P = 0.04, 95% CI = 1.445-6.623) were considered to be independently significant. This investigation allows the conclusion that radical intervention and the abdominoperineal procedure in the surgical treatment of colorectal adenocarcinoma are risk factors for requiring intraoperative blood transfusion.

Movement of Fuel Ashore: Storage, Capacity, Throughput, and Distribution Analysis

DTIC Science & Technology

2015-12-01

89  ix LIST OF FIGURES Figure 1.  Principles of Operational Maneuver from the Sea ........................... 7  Figure 2.  Compositing and...30  Table 2.  Force Mix Composition ...procedures, and force composition . Such alterations represent an acceptance of operational risk to buy down the foundational risk that the logistics network

Improved Survival After the Ross Procedure Compared With Mechanical Aortic Valve Replacement.

PubMed

Buratto, Edward; Shi, William Y; Wynne, Rochelle; Poh, Chin L; Larobina, Marco; O'Keefe, Michael; Goldblatt, John; Tatoulis, James; Skillington, Peter D

2018-03-27

It is unclear whether the Ross procedure offers superior survival compared with mechanical aortic valve replacement (AVR). This study evaluated experience and compared long-term survival between the Ross procedure and mechanical AVR. Between 1992 and 2016, a total of 392 Ross procedures were performed. These were compared with 1,928 isolated mechanical AVRs performed during the same time period as identified using the University of Melbourne and Australia and New Zealand Society of Cardiac and Thoracic Surgeons' Cardiac Surgery Databases. Only patients between 18 and 65 years of age were included. Propensity-score matching was performed for risk adjustment. Ross procedure patients were younger, and had fewer cardiovascular risk factors. The Ross procedure was associated with longer cardiopulmonary bypass and aortic cross-clamp times. Thirty-day mortality was similar (Ross, 0.3%; mechanical, 0.8%; p = 0.5). Ross procedure patients experienced superior unadjusted long-term survival at 20 years (Ross, 95%; mechanical, 68%; p < 0.001). Multivariable analysis showed the Ross procedure to be associated with a reduced risk of late mortality (hazard ratio: 0.34; 95% confidence internal: 0.17 to 0.67; p < 0.001). Among 275 propensity-score matched pairs, Ross procedure patients had superior survival at 20 years (Ross, 94%; mechanical, 84%; p = 0.018). In this Australian, propensity-score matched study, the Ross procedure was associated with better long-term survival compared with mechanical AVR. In younger patients, with a long life expectancy, the Ross procedure should be considered in centers with sufficient expertise. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

Human Factors Analysis of Pipeline Monitoring and Control Operations: Final Technical Report

DOT National Transportation Integrated Search

2008-11-26

The purpose of the Human Factors Analysis of Pipeline Monitoring and Control Operations project was to develop procedures that could be used by liquid pipeline operators to assess and manage the human factors risks in their control rooms that may adv...

The Importance of Human Reliability Analysis in Human Space Flight: Understanding the Risks

NASA Technical Reports Server (NTRS)

Hamlin, Teri L.

2010-01-01

HRA is a method used to describe, qualitatively and quantitatively, the occurrence of human failures in the operation of complex systems that affect availability and reliability. Modeling human actions with their corresponding failure in a PRA (Probabilistic Risk Assessment) provides a more complete picture of the risk and risk contributions. A high quality HRA can provide valuable information on potential areas for improvement, including training, procedural, equipment design and need for automation.

Optimal routing of hazardous substances in time-varying, stochastic transportation networks

DOE Office of Scientific and Technical Information (OSTI.GOV)

Woods, A.L.; Miller-Hooks, E.; Mahmassani, H.S.

This report is concerned with the selection of routes in a network along which to transport hazardous substances, taking into consideration several key factors pertaining to the cost of transport and the risk of population exposure in the event of an accident. Furthermore, the fact that travel time and the risk measures are not constant over time is explicitly recognized in the routing decisions. Existing approaches typically assume static conditions, possibly resulting in inefficient route selection and unnecessary risk exposure. The report described the application of recent advances in network analysis methodologies to the problem of routing hazardous substances. Severalmore » specific problem formulations are presented, reflecting different degrees of risk aversion on the part of the decision-maker, as well as different possible operational scenarios. All procedures explicitly consider travel times and travel costs (including risk measures) to be stochastic time-varying quantities. The procedures include both exact algorithms, which may require extensive computational effort in some situations, as well as more efficient heuristics that may not guarantee a Pareto-optimal solution. All procedures are systematically illustrated for an example application using the Texas highway network, for both normal and incident condition scenarios. The application illustrates the trade-offs between the information obtained in the solution and computational efficiency, and highlights the benefits of incorporating these procedures in a decision-support system for hazardous substance shipment routing decisions.« less

Risk-Informed Decision Making: Application to Technology Development Alternative Selection

NASA Technical Reports Server (NTRS)

Dezfuli, Homayoon; Maggio, Gaspare; Everett, Christopher

2010-01-01

NASA NPR 8000.4A, Agency Risk Management Procedural Requirements, defines risk management in terms of two complementary processes: Risk-informed Decision Making (RIDM) and Continuous Risk Management (CRM). The RIDM process is used to inform decision making by emphasizing proper use of risk analysis to make decisions that impact all mission execution domains (e.g., safety, technical, cost, and schedule) for program/projects and mission support organizations. The RIDM process supports the selection of an alternative prior to program commitment. The CRM process is used to manage risk associated with the implementation of the selected alternative. The two processes work together to foster proactive risk management at NASA. The Office of Safety and Mission Assurance at NASA Headquarters has developed a technical handbook to provide guidance for implementing the RIDM process in the context of NASA risk management and systems engineering. This paper summarizes the key concepts and procedures of the RIDM process as presented in the handbook, and also illustrates how the RIDM process can be applied to the selection of technology investments as NASA's new technology development programs are initiated.

Multiple Interacting Risk Factors: On Methods for Allocating Risk Factor Interactions.

PubMed

Price, Bertram; MacNicoll, Michael

2015-05-01

A persistent problem in health risk analysis where it is known that a disease may occur as a consequence of multiple risk factors with interactions is allocating the total risk of the disease among the individual risk factors. This problem, referred to here as risk apportionment, arises in various venues, including: (i) public health management, (ii) government programs for compensating injured individuals, and (iii) litigation. Two methods have been described in the risk analysis and epidemiology literature for allocating total risk among individual risk factors. One method uses weights to allocate interactions among the individual risk factors. The other method is based on risk accounting axioms and finding an optimal and unique allocation that satisfies the axioms using a procedure borrowed from game theory. Where relative risk or attributable risk is the risk measure, we find that the game-theory-determined allocation is the same as the allocation where risk factor interactions are apportioned to individual risk factors using equal weights. Therefore, the apportionment problem becomes one of selecting a meaningful set of weights for allocating interactions among the individual risk factors. Equal weights and weights proportional to the risks of the individual risk factors are discussed. © 2015 Society for Risk Analysis.

Risk Factors for Urinary Tract Infections in Cardiac Surgical Patients

PubMed Central

Gillen, Jacob R.; Isbell, James M.; Michaels, Alex D.; Lau, Christine L.

2015-01-01

Abstract Background: Risk factors for catheter-associated urinary tract infections (CAUTIs) in patients undergoing non-cardiac surgical procedures have been well documented. However, the variables associated with CAUTIs in the cardiac surgical population have not been clearly defined. Therefore, the purpose of this study was to investigate risk factors associated with CAUTIs in patients undergoing cardiac procedures. Methods: All patients undergoing cardiac surgery at a single institution from 2006 through 2012 (4,883 patients) were reviewed. Patients with U.S. Centers for Disease Control (CDC) criteria for CAUTI were identified from the hospital's Quality Assessment database. Pre-operative, operative, and post-operative patient factors were evaluated. Univariate and multivariable analyses were used to identify significant correlations between perioperative characteristics and CAUTIs. Results: There were 55 (1.1%) documented CAUTIs in the study population. On univariate analysis, older age, female gender, diabetes mellitus, cardiogenic shock, urgent or emergent operation, packed red blood cell (PRBC) units transfused, and intensive care unit length of stay (ICU LOS) were all significantly associated with CAUTI [p<0.05]. On multivariable logistic regression, older age, female gender, diabetes mellitus, and ICU LOS remained significantly associated with CAUTI. Additionally, there was a significant association between CAUTI and 30-d mortality on univariate analysis. However, when controlling for common predictors of operative mortality on multivariable analysis, CAUTI was no longer associated with mortality. Conclusions: There are several identifiable risk factors for CAUTI in patients undergoing cardiac procedures. CAUTI is not independently associated with increased mortality, but it does serve as a marker of sicker patients more likely to die from other comorbidities or complications. Therefore, awareness of the high-risk nature of these patients should lead to increased diligence and may help to improve peri-operative outcomes. Recognizing patients at high risk for CAUTI may lead to improved measures to decrease CAUTI rates within this population. PMID:26115336

Risk Factors for Urinary Tract Infections in Cardiac Surgical Patients.

PubMed

Gillen, Jacob R; Isbell, James M; Michaels, Alex D; Lau, Christine L; Sawyer, Robert G

2015-10-01

Risk factors for catheter-associated urinary tract infections (CAUTIs) in patients undergoing non-cardiac surgical procedures have been well documented. However, the variables associated with CAUTIs in the cardiac surgical population have not been clearly defined. Therefore, the purpose of this study was to investigate risk factors associated with CAUTIs in patients undergoing cardiac procedures. All patients undergoing cardiac surgery at a single institution from 2006 through 2012 (4,883 patients) were reviewed. Patients with U.S. Centers for Disease Control (CDC) criteria for CAUTI were identified from the hospital's Quality Assessment database. Pre-operative, operative, and post-operative patient factors were evaluated. Univariate and multivariable analyses were used to identify significant correlations between perioperative characteristics and CAUTIs. There were 55 (1.1%) documented CAUTIs in the study population. On univariate analysis, older age, female gender, diabetes mellitus, cardiogenic shock, urgent or emergent operation, packed red blood cell (PRBC) units transfused, and intensive care unit length of stay (ICU LOS) were all significantly associated with CAUTI [p<0.05]. On multivariable logistic regression, older age, female gender, diabetes mellitus, and ICU LOS remained significantly associated with CAUTI. Additionally, there was a significant association between CAUTI and 30-d mortality on univariate analysis. However, when controlling for common predictors of operative mortality on multivariable analysis, CAUTI was no longer associated with mortality. There are several identifiable risk factors for CAUTI in patients undergoing cardiac procedures. CAUTI is not independently associated with increased mortality, but it does serve as a marker of sicker patients more likely to die from other comorbidities or complications. Therefore, awareness of the high-risk nature of these patients should lead to increased diligence and may help to improve peri-operative outcomes. Recognizing patients at high risk for CAUTI may lead to improved measures to decrease CAUTI rates within this population.

Strengthening safety compliance in nuclear power operations: a role-based approach.

PubMed

Martínez-Córcoles, Mario; Gracia, Francisco J; Tomás, Inés; Peiró, José M

2014-07-01

Safety compliance is of paramount importance in guaranteeing the safe running of nuclear power plants. However, it depends mostly on procedures that do not always involve the safest outcomes. This article introduces an empirical model based on the organizational role theory to analyze the influence of legitimate sources of expectations (procedures formalization and leadership) on workers' compliance behaviors. The sample was composed of 495 employees from two Spanish nuclear power plants. Structural equation analysis showed that, in spite of some problematic effects of proceduralization (such as role conflict and role ambiguity), procedure formalization along with an empowering leadership style lead to safety compliance by clarifying a worker's role in safety. Implications of these findings for safety research are outlined, as well as their practical implications. © 2014 Society for Risk Analysis.

Ergonomic evaluation of a wheelchair transportation securement system.

PubMed

Ahmed, Madiha; Campbell-Kyureghyan, Naira; Frost, Karen; Bertocci, Gina

2012-01-01

The Americans with Disabilities Act (ADA) specifies guidelines covering the securement system and environment for wheeled mobility device (WhMD) passengers on the public bus system in the United States, referred to as the wheelchair tiedown and occupant restraint system (WTORS). The misuse or disuse of the WTORS system can be a source of injury for WhMD passengers riding the buses. The purpose of this study was to quantify the risks posed to the bus driver while performing the WTORS procedure using traditional ergonomic analysis methods. Four bus drivers completed the WTORS procedure for a representative passenger seated in three different WhMDs: manual wheelchair (MWC), scooter (SCTR), and power wheelchair (PWC). Potential work-related risks were identified using the four most applicable ergonomic assessment tools: PLIBEL, RULA, REBA, and iLMM. Task evaluation results revealed high levels of risk to be present to drivers during the WTORS procedure. The securement station space design and equipment layout were identified as contributing factors forcing drivers to adopt awkward postures while performing the WTORS task. These risk factors are known contributors to injury and the drivers could opt to improperly secure the passengers to avoid that risk.

Large scale seismic vulnerability and risk evaluation of a masonry churches sample in the historical centre of Naples

NASA Astrophysics Data System (ADS)

Formisano, Antonio; Ciccone, Giuseppe; Mele, Annalisa

2017-11-01

This paper investigates about the seismic vulnerability and risk of fifteen masonry churches located in the historical centre of Naples. The used analysis method is derived from a procedure already implemented by the University of Basilicata on the churches of Matera. In order to evaluate for the study area the seismic vulnerability and hazard indexes of selected churches, the use of appropriate technical survey forms is done. Data obtained from applying the employed procedure allow for both plotting of vulnerability maps and providing seismic risk indicators of all churches. The comparison among the indexes achieved allows for the evaluation of the health state of inspected churches so to program a priority scale in performing future retrofitting interventions.

The application of seismic risk-benefit analysis to land use planning in Taipei City.

PubMed

Hung, Hung-Chih; Chen, Liang-Chun

2007-09-01

In the developing countries of Asia local authorities rarely use risk analysis instruments as a decision-making support mechanism during planning and development procedures. The main purpose of this paper is to provide a methodology to enable planners to undertake such analyses. We illustrate a case study of seismic risk-benefit analysis for the city of Taipei, Taiwan, using available land use maps and surveys as well as a new tool developed by the National Science Council in Taiwan--the HAZ-Taiwan earthquake loss estimation system. We use three hypothetical earthquakes to estimate casualties and total and annualised direct economic losses, and to show their spatial distribution. We also characterise the distribution of vulnerability over the study area using cluster analysis. A risk-benefit ratio is calculated to express the levels of seismic risk attached to alternative land use plans. This paper suggests ways to perform earthquake risk evaluations and the authors intend to assist city planners to evaluate the appropriateness of their planning decisions.

Framing medical tourism: an analysis of persuasive appeals, risks and benefits, and new media features of medical tourism broker websites.

PubMed

Lee, Hyunmin; Wright, Kevin B; O'Connor, Michaela; Wombacher, Kevin

2014-01-01

This study explores the benefits and risks featured in medical tourism broker websites, as well as the types of persuasive appeals that these websites use to attract potential customers, from a framing theory perspective. In addition, it examines relationships among types of appeals and specific types of health-related services offered by medical facilities abroad and the role of new media modalities within medical tourism broker sites. A content analysis of 91 medical tourism broker websites was conducted. The results indicate that the websites highly emphasized benefits while downplaying the risks. Specifically, despite offering consumers complicated and risky medical procedures, the websites failed to report any procedural, postoperative, or legal concerns associated with them. Moreover, the results indicated that the websites relied on heavy use of new media features to enhance the appeal of the medical services that were offered. The implications of these findings, future directions for research, and limitations of the study are discussed.

Analysis of multiple activity manual materials handling tasks using A Guide to Manual Materials Handling.

PubMed

Mital, A

1999-01-01

Manual handling of materials continues to be a hazardous activity, leading to a very significant number of severe overexertion injuries. Designing jobs that are within the physical capabilities of workers is one approach ergonomists have adopted to redress this problem. As a result, several job design procedures have been developed over the years. However, these procedures are limited to designing or evaluating only pure lifting jobs or only the lifting aspect of a materials handling job. This paper describes a general procedure that may be used to design or analyse materials handling jobs that involve several different kinds of activities (e.g. lifting, lowering, carrying, pushing, etc). The job design/analysis procedure utilizes an elemental approach (breaking the job into elements) and relies on databases provided in A Guide to Manual Materials Handling to compute associated risk factors. The use of the procedure is demonstrated with the help of two case studies.

Risk analysis of gravity dam instability using credibility theory Monte Carlo simulation model.

PubMed

Xin, Cao; Chongshi, Gu

2016-01-01

Risk analysis of gravity dam stability involves complicated uncertainty in many design parameters and measured data. Stability failure risk ratio described jointly by probability and possibility has deficiency in characterization of influence of fuzzy factors and representation of the likelihood of risk occurrence in practical engineering. In this article, credibility theory is applied into stability failure risk analysis of gravity dam. Stability of gravity dam is viewed as a hybrid event considering both fuzziness and randomness of failure criterion, design parameters and measured data. Credibility distribution function is conducted as a novel way to represent uncertainty of influence factors of gravity dam stability. And combining with Monte Carlo simulation, corresponding calculation method and procedure are proposed. Based on a dam section, a detailed application of the modeling approach on risk calculation of both dam foundation and double sliding surfaces is provided. The results show that, the present method is feasible to be applied on analysis of stability failure risk for gravity dams. The risk assessment obtained can reflect influence of both sorts of uncertainty, and is suitable as an index value.

LASER treatment for women with high-grade vaginal intraepithelial neoplasia: A propensity-matched analysis on the efficacy of ablative versus excisional procedures.

PubMed

Bogani, Giorgio; Ditto, Antonino; Martinelli, Fabio; Mosca, Lavinia; Chiappa, Valentina; Rossetti, Diego; Leone Roberti Maggiore, Umberto; Sabatucci, Ilaria; Lorusso, Domenica; Raspagliesi, Francesco

2018-05-14

To investigate the long-term effectiveness of LASER treatment in women affected by high-grade vaginal intra-epithelial neoplasia. Data of consecutive women treated for high-grade vaginal intra-epithelial neoplasia were retrieved. Efficacy and long-term effectiveness of ablative and excisional procedures were tested using a propensity-matched algorithm. Risk of recurrence over the time was assessed using Kaplan-Meier and Cox models. Overall, 204 patients met the inclusion criteria. LASER ablation and exicision were performed in 169 (82.8%) and 35 (17.2%) patients. A total of 41 (20%) patients developed high-grade vaginal intraepithelial neoplasia at a median follow-up of 65 (range, 6-120) months. We observed that only HPV persistence (HR: 2.37 [95%CI:1.03, 5.42]; P = 0.04) was associated with the risk of recurrence at multivariate analysis. Seven (3.4%) invasive cancers of the lower genital tract were observed in our population. Considering the efficacy of type of procedure (after we applied the propensity-matched analysis), we observed that type of procedure did not influence persistence of HPV infection (22.8% after excision and 15.7% after ablation; P = 0.424). Similarly, recurrence (17.1% vs. 18.6%; P = 1.00) and lower genital tract (2.8% vs. 1.4%; P = 1.00) rates were similar between groups. Women affected by high-grade vaginal intra-epithelial neoplasia are at high risk of recurrence. LASER ablation seems to be equivalent to excision in term of long-term effectiveness. Lasers Surg. Med. 9999:1-7, 2018. © 2018 Wiley Periodicals, Inc. © 2018 Wiley Periodicals, Inc.

Risk analysis with a fuzzy-logic approach of a complex installation

NASA Astrophysics Data System (ADS)

Peikert, Tim; Garbe, Heyno; Potthast, Stefan

2016-09-01

This paper introduces a procedural method based on fuzzy logic to analyze systematic the risk of an electronic system in an intentional electromagnetic environment (IEME). The method analyzes the susceptibility of a complex electronic installation with respect to intentional electromagnetic interference (IEMI). It combines the advantages of well-known techniques as fault tree analysis (FTA), electromagnetic topology (EMT) and Bayesian networks (BN) and extends the techniques with an approach to handle uncertainty. This approach uses fuzzy sets, membership functions and fuzzy logic to handle the uncertainty with probability functions and linguistic terms. The linguistic terms add to the risk analysis the knowledge from experts of the investigated system or environment.

Exploration Laboratory Analysis - ARC

NASA Technical Reports Server (NTRS)

Krihak, Michael K.; Fung, Paul P.

2012-01-01

The Exploration Laboratory Analysis (ELA) project supports the Exploration Medical Capability (ExMC) risk, Risk of Inability to Adequately Treat an Ill or Injured Crew Member, and ExMC Gap 4.05: Lack of minimally invasive in-flight laboratory capabilities with limited consumables required for diagnosing identified Exploration Medical Conditions. To mitigate this risk, the availability of inflight laboratory analysis instrumentation has been identified as an essential capability in future exploration missions. Mission architecture poses constraints on equipment and procedures that will be available to treat evidence-based medical conditions according to the Space Medicine Exploration Medical Conditions List (SMEMCL). The SMEMCL provided diagnosis and treatment for the evidence-based medical conditions and hence, a basis for developing ELA functional requirements.

Safety assessment, detection and traceability, and societal aspects of genetically modified foods. European Network on Safety Assessment of Genetically Modified Food Crops (ENTRANSFOOD). Concluding remarks.

PubMed

Kuiper, H A; König, A; Kleter, G A; Hammes, W P; Knudsen, I

2004-07-01

The most important results from the EU-sponsored ENTRANSFOOD Thematic Network project are reviewed, including the design of a detailed step-wise procedure for the risk assessment of foods derived from genetically modified crops based on the latest scientific developments, evaluation of topical risk assessment issues, and the formulation of proposals for improved risk management and public involvement in the risk analysis process. Copyright 2004 Elsevier Ltd.

Body contouring surgery following bariatric surgery and dietetically induced massive weight reduction: a risk analysis.

PubMed

de Kerviler, S; Hüsler, R; Banic, A; Constantinescu, M A

2009-05-01

This study analyzed the impact of weight reduction method, preoperative, and intraoperative variables on the outcome of reconstructive body contouring surgery following massive weight reduction. All patients presenting with a maximal BMI >/=35 kg/m(2) before weight reduction who underwent body contouring surgery of the trunk following massive weight loss (excess body mass index loss (EBMIL) >/= 30%) between January 2002 and June 2007 were retrospectively analyzed. Incomplete records or follow-up led to exclusion. Statistical analysis focused on weight reduction method and pre-, intra-, and postoperative risk factors. The outcome was compared to current literature results. A total of 104 patients were included (87 female and 17 male; mean age 47.9 years). Massive weight reduction was achieved through bariatric surgery in 62 patients (59.6%) and dietetically in 42 patients (40.4%). Dietetically achieved excess body mass index loss (EBMIL) was 94.20% and in this cohort higher than surgically induced reduction EBMIL 80.80% (p < 0.01). Bariatric surgery did not present increased risks for complications for the secondary body contouring procedures. The observed complications (26.9%) were analyzed for risk factors. Total tissue resection weight was a significant risk factor (p < 0.05). Preoperative BMI had an impact on infections (p < 0.05). No impact on the postoperative outcome was detected in EBMIL, maximal BMI, smoking, hemoglobin, blood loss, body contouring technique or operation time. Corrective procedures were performed in 11 patients (10.6%). The results were compared to recent data. Bariatric surgery does not increase risks for complications in subsequent body contouring procedures when compared to massive dietetic weight reduction.

Education and Labor Market Risk: Understanding the Role of Data Cleaning

ERIC Educational Resources Information Center

Whalley, Alexander

2011-01-01

This paper examines whether conclusions about the relationship between education and labor market risk depend on the use of commonly applied procedures to clean data of extreme values. The analysis uses fifteen years of data from the Panel Study of Income Dynamics to demonstrate that conclusions about the relationship between education and labor…

Pre-procedural bioimpedance vectorial analysis of fluid status and prediction of contrast-induced acute kidney injury.

PubMed

Maioli, Mauro; Toso, Anna; Leoncini, Mario; Musilli, Nicola; Bellandi, Francesco; Rosner, Mitchell H; McCullough, Peter A; Ronco, Claudio

2014-04-15

The aim of this study was to evaluate the relationship between pre-procedural fluid status assessed by bioimpedance vector analysis (BIVA) and development of contrast-induced acute kidney injury (CI-AKI). Accurate fluid management in patients undergoing angiographic procedures is of critical importance in limiting the risk of CI-AKI. Therefore, establishing peri-procedural fluid volume related to increased risk of CI-AKI development is essential. We evaluated the fluid status by BIVA of 900 consecutive patients with stable coronary artery disease (CAD) immediately before coronary angiography, measuring the resistance/height (R/H) ratio and impedance/height (Z/H) vector. CI-AKI was defined as an increase in serum creatinine ≥0.5 mg/dl above baseline within 3 days after contrast administration (iodixanol). CI-AKI occurred in 54 patients (6.0%). Pre-procedural R/H ratios were significantly higher in patients with CI-AKI than without CI-AKI (395 ± 71 Ohm/m vs. 352 ± 58 Ohm/m, p = 0.001 for women; 303 ± 59 Ohm/m vs. 279 ± 45 Ohm/m, p = 0.009 for men), indicating lower fluid volume in the patients with CI-AKI. When patients were stratified according to R/H ratio, there was an almost 3-fold higher risk in patients with higher values (odds ratio [OR]: 2.9; 95% confidence interval [CI]: 1.5 to 5.5; p = 0.002). The optimal receiver-operating characteristic curve analysis threshold values of R/H ratio for predicting CI-AKI were 380 Ohm/m for women and 315 Ohm/m for men. R/H ratio above these thresholds was found to be a significant and independent predictor of CI-AKI (OR: 3.1; 95% CI: 1.8 to 5.5; p = 0.001). Lower fluid status evaluated by BIVA immediately before contrast medium administration resulted in a significant and independent predictor of CI-AKI in patients with stable CAD. This simple noninvasive analysis should be tested in guiding tailored volume repletion. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A Semantic Analysis Method for Scientific and Engineering Code

NASA Technical Reports Server (NTRS)

Stewart, Mark E. M.

1998-01-01

This paper develops a procedure to statically analyze aspects of the meaning or semantics of scientific and engineering code. The analysis involves adding semantic declarations to a user's code and parsing this semantic knowledge with the original code using multiple expert parsers. These semantic parsers are designed to recognize formulae in different disciplines including physical and mathematical formulae and geometrical position in a numerical scheme. In practice, a user would submit code with semantic declarations of primitive variables to the analysis procedure, and its semantic parsers would automatically recognize and document some static, semantic concepts and locate some program semantic errors. A prototype implementation of this analysis procedure is demonstrated. Further, the relationship between the fundamental algebraic manipulations of equations and the parsing of expressions is explained. This ability to locate some semantic errors and document semantic concepts in scientific and engineering code should reduce the time, risk, and effort of developing and using these codes.

Impact of Aneurysm Projection on Intraoperative Complications During Surgical Clipping of Ruptured Posterior Communicating Artery Aneurysms.

PubMed

Fukuda, Hitoshi; Hayashi, Kosuke; Yoshino, Kumiko; Koyama, Takashi; Lo, Benjamin; Kurosaki, Yoshitaka; Yamagata, Sen

2016-03-01

Surgical clipping of ruptured posterior communicating artery (PCoA) aneurysms is a well-established procedure to date. However, preoperative factors associated with procedure-related risk require further elucidation. To investigate the impact of the direction of aneurysm projection on the incidence of procedure-related complications during surgical clipping of ruptured PCoA aneurysms. A total of 65 patients with ruptured PCoA aneurysms who underwent surgical clipping were retrospectively analyzed from a single-center, prospective, observational cohort database in this study. The aneurysms were categorized into lateral and posterior projection groups, depending on direction of the dome. Characteristics and operative findings of each projection group were identified. We also evaluated any correlation of aneurysm projection with the incidence of procedure-related complications. Patients with ruptured PCoA aneurysms with posterior projection more likely presented with good-admission-grade subarachnoid hemorrhage (P = .01, χ test) and were less to also have intracerebral hematoma (P = .01). These aneurysms were found to be associated with higher incidence of intraoperative rupture (P = .02), complex clipping with fenestrated clips (P = .02), and dense adherence to PCoA or its perforators (P = .04) by univariate analysis. Aneurysms with posterior projection were also correlated with procedure-related complications, including postoperative cerebral infarction or hematoma formation (odds ratio, 5.87; 95% confidence interval, 1.11-31.1; P = .04) by multivariable analysis. Ruptured PCoA aneurysms with posterior projection carried a higher risk of procedure-related complications of surgical clipping than those with lateral projection.

Proceedings of the tenth annual DOE low-level waste management conference: Session 2: Site performance assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Not Available

1988-12-01

This document contains twelve papers on various aspects of low-level radioactive waste management. Topics of this volume include: performance assessment methodology; remedial action alternatives; site selection and site characterization procedures; intruder scenarios; sensitivity analysis procedures; mathematical models for mixed waste environmental transport; and risk assessment methodology. Individual papers were processed separately for the database. (TEM)

Effectiveness of nonpharmacological interventions to reduce procedural anxiety in children and adolescents undergoing treatment for cancer: A systematic review and meta-analysis.

PubMed

Nunns, Michael; Mayhew, Dominic; Ford, Tamsin; Rogers, Morwenna; Curle, Christine; Logan, Stuart; Moore, Darren

2018-04-30

Children and young people (CYP) with cancer undergo painful and distressing procedures. We aimed to systematically review the effectiveness of nonpharmacological interventions to reduce procedural anxiety in CYP. Extensive literature searches sought randomised controlled trials that quantified the effect of any nonpharmacological intervention for procedural anxiety in CYP with cancer aged 0 to 25. Study selection involved independent title and abstract screening and full text screening by two reviewers. Anxiety, distress, fear, and pain outcomes were extracted from included studies. Where similar intervention, comparator, and outcomes presented, meta-analysis was performed, producing pooled effect sizes (Cohen's d) and 95% confidence intervals (95% CI). All other data were narratively described. Quality and risk of bias appraisal was performed, based on the Cochrane risk of bias tool. Screening of 11 727 records yielded 56 relevant full texts. There were 15 included studies, eight trialling hypnosis, and seven nonhypnosis interventions. There were large, statistically significant reductions in anxiety and pain for hypnosis, particularly compared with treatment as usual (anxiety: d = 2.30; 95% CI, 1.30-3.30; P < .001; pain: d = 2.16; 95% CI, 1.41-2.92; P < .001). Evidence from nonhypnosis interventions was equivocal, with some promising individual studies. There was high risk of bias across included studies limiting confidence in some positive effects. Evidence suggests promise for hypnosis interventions to reduce procedural anxiety in CYP undergoing cancer treatment. These results largely emerge from one research group, therefore wider research is required. Promising evidence for individual nonhypnosis interventions must be evaluated through rigorously conducted randomised controlled trials. Copyright © 2018 John Wiley & Sons, Ltd.

Working postures of dental students: ergonomic analysis using the Ovako Working Analysis System and rapid upper limb assessment.

PubMed

Petromilli Nordi Sasso Garcia, Patrícia; Polli, Gabriela Scatimburgo; Campos, Juliana Alvares Duarte Bonini

2013-01-01

As dentistry is a profession that demands a manipulative precision of hand movements, musculoskeletal disorders are among the most common occupational diseases. This study estimated the risk of musculoskeletal disorders developing in dental students using the Ovako Working Analysis System (OWAS) and Rapid Upper Limb Assessment (RULA) methods, and estimated the diagnostic agreement between the 2 methods. Students (n = 75), enrolled in the final undergraduate year at the Araraquara School of Dentistry--UNESP--were studied. Photographs were taken of students while performing diverse clinical procedures (n = 283) using a digital camera, which were assessed using OWAS and RULA. A risk score was attributed following each procedure performed by the student. The prevalence of the risk of musculoskeletal disorders was estimated per point and for a 95% CI. To assess the agreement between the 2 methods, Kappa statistics with linear weighting were used. The level of significance adopted was 5%. There was a high prevalence of the mean score for risk of musculoskeletal disorders in the dental students evaluated according to the OWAS method (p = 97.88%; 95% CI: 96.20-99.56%), and a high prevalence of the high score (p = 40.6; 95% CI: 34.9-46.4%) and extremely high risk (p = 59.4%; 95% CI: 53.6-65.1%) according to RULA method Null agreement was verified (k = 0) in the risk di agnosis of the tested methods. The risk of musculoskeletal disorders in dental students estimated by the OWAS method was medium, whereas the same risk by the RULA method was extremely high. There was no diagnostic agreement between the OWAS and RULA methods.

Hysteroscopic sterilization success in outpatient vs office setting is not affected by patient or procedural characteristics.

PubMed

Anderson, Ted L; Yunker, Amanda C; Scheib, Stacey A; Callahan, Tamara L

2013-01-01

To determine factors associated with hysteroscopic sterilization success and whether it differs between the operating room and office settings. Retrospective cohort analysis (Canadian Task Force classification II-2). Major university medical center. Six hundred thirty-eight women who underwent hysteroscopic sterilization between July 1, 2005, and June 30, 2011. Data collected included age, body mass index, previous office procedures, previous cesarean section, and presence of myomas or retroverted uterus. Place of surgery, experience of surgeon, insurance type, bilateral device placement, compliance with hysterosalpingography, and confirmation of occlusion were also recorded. Bivariate analysis of patient characteristics between groups was performed using χ(2) and independent t tests, and identified confounders and associated variables. Multivariate analysis was performed using logistic regression to assess for association and to adjust for confounders. Procedures were performed in the operating room (57%) or in the office (43%). There was no association between success in bilateral device placement or occlusion and any patient characteristic, regardless of surgery setting. Private insurance, patient age, and performance of procedures in the office setting were positively associated with likelihood of compliance with hysterosalpingography. Successful device placement and tubal occlusion are independent of patient age, body mass index, or setting of the procedure. Association between insurance type and completing hysterosalpingography illustrates an important public health problem. Patients who fail to undergo hysterosalpingography to confirm tubal occlusion may unknowingly be at risk of pregnancy and increased risk of ectopic pregnancy. Copyright © 2013 AAGL. Published by Elsevier Inc. All rights reserved.

Risk analysis by FMEA as an element of analytical validation.

PubMed

van Leeuwen, J F; Nauta, M J; de Kaste, D; Odekerken-Rombouts, Y M C F; Oldenhof, M T; Vredenbregt, M J; Barends, D M

2009-12-05

We subjected a Near-Infrared (NIR) analytical procedure used for screening drugs on authenticity to a Failure Mode and Effects Analysis (FMEA), including technical risks as well as risks related to human failure. An FMEA team broke down the NIR analytical method into process steps and identified possible failure modes for each step. Each failure mode was ranked on estimated frequency of occurrence (O), probability that the failure would remain undetected later in the process (D) and severity (S), each on a scale of 1-10. Human errors turned out to be the most common cause of failure modes. Failure risks were calculated by Risk Priority Numbers (RPNs)=O x D x S. Failure modes with the highest RPN scores were subjected to corrective actions and the FMEA was repeated, showing reductions in RPN scores and resulting in improvement indices up to 5.0. We recommend risk analysis as an addition to the usual analytical validation, as the FMEA enabled us to detect previously unidentified risks.

Risk factors for surgical site infection following nonshunt pediatric neurosurgery: a review of 9296 procedures from a national database and comparison with a single-center experience

PubMed Central

Sherrod, Brandon A.; Arynchyna, Anastasia A.; Johnston, James M.; Rozzelle, Curtis J.; Blount, Jeffrey P.; Oakes, W. Jerry; Rocque, Brandon G.

2017-01-01

Objective Surgical site infection (SSI) following CSF shunt operations has been well studied, yet risk factors for nonshunt pediatric neurosurgery are less well understood. The purpose of this study was to determine SSI rates and risk factors following nonshunt pediatric neurosurgery using a nationwide patient cohort and an institutional dataset specifically for better understanding SSI. Methods The authors reviewed the American College of Surgeons National Surgical Quality Improvement Program Pediatric (ACS NSQIP-P) database for the years 2012–2014, including all neurosurgical procedures performed on pediatric patients except CSF shunts and hematoma evacuations. SSI included deep (intracranial abscesses, meningitis, osteomyelitis, and ventriculitis) and superficial wound infections. The authors performed univariate analyses of SSI association with procedure, demographic, comorbidity, operative, and hospital variables, with subsequent multivariate logistic regression analysis to determine independent risk factors for SSI within 30 days of the index procedure. A similar analysis was performed using a detailed institutional infection database from Children’s Hospital of Alabama (COA). Results A total of 9296 nonshunt procedures were identified in NSQIP-P with an overall 30-day SSI rate of 2.7%. The 30-day SSI rate in the COA institutional database was similar (3.3% of 1103 procedures, p = 0.325). Postoperative time to SSI in NSQIP-P and COA was 14.6 ± 6.8 days and 14.8 ± 7.3 days, respectively (mean ± SD). Myelomeningocele (4.3% in NSQIP-P, 6.3% in COA), spine (3.5%, 4.9%), and epilepsy (3.4%, 3.1%) procedure categoriess had the highest SSI rates by procedure category in both NSQIP-P and COA. Independent SSI risk factors in NSQIP-P included postoperative pneumonia (OR 4.761, 95% CI 1.269–17.857, p = 0.021), immune disease/immunosuppressant use (OR 3.671, 95% CI 1.371–9.827, p = 0.010), cerebral palsy (OR 2.835, 95% CI 1.463–5.494, p = 0.002), emergency operation (OR 1.843, 95% CI 1.011–3.360, p = 0.046), spine procedures (OR 1.673, 95% CI 1.036–2.702, p = 0.035), acquired CNS abnormality (OR 1.620, 95% CI 1.085–2.420, p = 0.018), and female sex (OR 1.475, 95% CI 1.062–2.049, p = 0.021). The only COA factor independently associated with SSI in the COA database included clean-contaminated wound classification (OR 3.887, 95% CI 1.354–11.153, p = 0.012), with public insurance (OR 1.966, 95% CI 0.957–4.041, p = 0.066) and spine procedures (OR 1.982, 95% CI 0.955–4.114, p = 0.066) approaching significance. Both NSQIP-P and COA multivariate model C-statistics were > 0.7. Conclusions NSQIP-P SSI rates, but not risk factors, were similar to data from a single center. PMID:28186476

CT fluoroscopy-guided renal tumour cutting needle biopsy: retrospective evaluation of diagnostic yield, safety, and risk factors for diagnostic failure.

PubMed

Iguchi, Toshihiro; Hiraki, Takao; Matsui, Yusuke; Fujiwara, Hiroyasu; Sakurai, Jun; Masaoka, Yoshihisa; Gobara, Hideo; Kanazawa, Susumu

2018-01-01

To evaluate retrospectively the diagnostic yield, safety, and risk factors for diagnostic failure of computed tomography (CT) fluoroscopy-guided renal tumour biopsy. Biopsies were performed for 208 tumours (mean diameter 2.3 cm; median diameter 2.1 cm; range 0.9-8.5 cm) in 199 patients. One hundred and ninety-nine tumours were ≤4 cm. All 208 initial procedures were divided into diagnostic success and failure groups. Multiple variables related to the patients, lesions, and procedures were assessed to determine the risk factors for diagnostic failure. After performing 208 initial and nine repeat biopsies, 180 malignancies and 15 benign tumours were pathologically diagnosed, whereas 13 were not diagnosed. In 117 procedures, 118 Grade I and one Grade IIIa adverse events (AEs) occurred. Neither Grade ≥IIIb AEs nor tumour seeding were observed within a median follow-up period of 13.7 months. Logistic regression analysis revealed only small tumour size (≤1.5 cm; odds ratio 3.750; 95% confidence interval 1.362-10.326; P = 0.011) to be a significant risk factor for diagnostic failure. CT fluoroscopy-guided renal tumour biopsy is a safe procedure with a high diagnostic yield. A small tumour size (≤1.5 cm) is a significant risk factor for diagnostic failure. • CT fluoroscopy-guided renal tumour biopsy has a high diagnostic yield. • CT fluoroscopy-guided renal tumour biopsy is safe. • Small tumour size (≤1.5 cm) is a risk factor for diagnostic failure.

Geomorphological hazards and environmental impact: Assessment and mapping

NASA Astrophysics Data System (ADS)

Panizza, Mario

In five sections the author develops the methods for the integration of geomorphological concepts into Environmental Impact and Mapping. The first section introduces the concepts of Impact and Risk through the relationships between Geomorphological Environment and Anthropical Element. The second section proposes a methodology for the determination of Geomorphological Hazard and the identification of Geomorphological Risk. The third section synthesizes the procedure for the compilation of a Geomorphological Hazards Map. The fourth section outlines the concepts of Geomorphological Resource Assessment for the analysis of the Environmental Impact. The fifth section considers the contribution of geomorphological studies and mapping in the procedure for Environmental Impact Assessment.

High Cost of Hospitalization for Colonic Diverticular Bleeding Depended on Repeated Bleeding and Blood Transfusion: Analysis with Diagnosis Procedure Combination Data in Japan.

PubMed

Ito, Yoichiro; Sakata, Yasuhisa; Yoshida, Hisako; Nonaka, Sayuri; Fujii, Susumu; Tanaka, Yuichiro; Shirai, Shimpei; Takeshita, Eri; Akutagawa, Takashi; Kawakubo, Hiroharu; Yamamoto, Koji; Tsuruoka, Nanae; Shimoda, Ryo; Iwakiri, Ryuichi; Fujimoto, Kazuma

2017-01-01

Bleeding from a colonic diverticulum is serious in aged patients. The aim of this study was to determine the risk factors for high-cost hospitalization of colonic diverticular bleeding using the diagnosis procedure combination (DPC) data. From January 2009 to December 2015, 78 patients with colonic diverticular bleeding were identified by DPC data in Saga Medical School Hospital. All patients underwent colonic endoscopy within 3 days. The patients were divided into 2 groups: the low-cost group (DPC cost of <500,000 yen) and the high-cost group (DPC cost of >500,000 yen). Univariate analysis revealed that aging, hypertension, rebleeding, a low hemoglobin concentration at admission, and blood transfusion were risk factors for high hospitalization cost. Multivariate analysis revealed that rebleeding (OR 5.3; 95% CI 1.3-21.3; p = 0.017) and blood transfusion (OR 3.8; 95% CI 1.01-14.2; p = 0.048) were definite risk factors for high hospitalization cost. Rebleeding and blood transfusion were related to high hospitalization cost for colonic diverticular bleeding. © 2017 S. Karger AG, Basel.

Flood Catastrophe Model for Designing Optimal Flood Insurance Program: Estimating Location-Specific Premiums in the Netherlands.

PubMed

Ermolieva, T; Filatova, T; Ermoliev, Y; Obersteiner, M; de Bruijn, K M; Jeuken, A

2017-01-01

As flood risks grow worldwide, a well-designed insurance program engaging various stakeholders becomes a vital instrument in flood risk management. The main challenge concerns the applicability of standard approaches for calculating insurance premiums of rare catastrophic losses. This article focuses on the design of a flood-loss-sharing program involving private insurance based on location-specific exposures. The analysis is guided by a developed integrated catastrophe risk management (ICRM) model consisting of a GIS-based flood model and a stochastic optimization procedure with respect to location-specific risk exposures. To achieve the stability and robustness of the program towards floods with various recurrences, the ICRM uses stochastic optimization procedure, which relies on quantile-related risk functions of a systemic insolvency involving overpayments and underpayments of the stakeholders. Two alternative ways of calculating insurance premiums are compared: the robust derived with the ICRM and the traditional average annual loss approach. The applicability of the proposed model is illustrated in a case study of a Rotterdam area outside the main flood protection system in the Netherlands. Our numerical experiments demonstrate essential advantages of the robust premiums, namely, that they: (1) guarantee the program's solvency under all relevant flood scenarios rather than one average event; (2) establish a tradeoff between the security of the program and the welfare of locations; and (3) decrease the need for other risk transfer and risk reduction measures. © 2016 Society for Risk Analysis.

Surgical risk factors associated with lung transplantation.

PubMed

Paradela, M; González, D; Parente, I; Fernández, R; De La Torre, M M; Delgado, M; García, J A; Fieira, E; Bonhome, C; Maté, J M B

2009-01-01

Despite years of experience with lung transplantation, perioperative morbidity rates remain high. The objective of this study was to analyze our series of lung transplant recipients, seeking to identify possible intra- and postoperative risk factors associated with mortality. We performed a descriptive, retrospective study of 224 consecutive patients undergoing lung transplantation over a period of 112 months; we excluded retransplant procedures. We gathered details of the surgical procedure and postoperative period in the recovery unit. Univariate analysis using the chi-square test identified variables associated with the incidence of mortality. From 1999 to 2008, we performed 224 lung transplants, including 66% in men and 34% in women. Their overall mean age was 49.9 +/- 13.5 years. The conditions that led to transplantation were pulmonary fibrosis (38.4%); chronic obstructive pulmonary disease emphysema (29%); cystic fibrosis (10.7%); bronchiectasis (8.9%); pulmonary hypertension (3.1%); and other diseases (9.9%). A total of 124 (55.4%) patients underwent single and 100 (44.6%) received sequential bilateral lung transplantations. Surgical risk factors were identified in 51.3% of the cases, the most frequent being hemorrhage (25.3%), followed by severe pulmonary hypertension (14.7%) and cardiopulmonary bypass (12.1%). Greater perioperative mortality was detected among patients with surgical risk factors, namely, significantly related to cardiopulmonary bypass, pulmonary hypertension, and air leak. A higher frequency of surgical risk factors was observed among patients with bilateral lung transplantations and longer procedures, but they were not associated with greater perioperative mortality. Reoperation was necessary in 16 patients (7.2%), mainly owing to bleeding, it was not significantly related to mortality risk. The incidence of surgical risk factors in lung transplantation was high, especially in bilateral lung transplantations and prolonged procedures. Postoperative bleeding requiring reoperation was not frequent and not associated with increased preoperative mortality in our series.

Towards Improved Considerations of Risk in Seismic Design (Plinius Medal Lecture)

NASA Astrophysics Data System (ADS)

Sullivan, T. J.

2012-04-01

The aftermath of recent earthquakes is a reminder that seismic risk is a very relevant issue for our communities. Implicit within the seismic design standards currently in place around the world is that minimum acceptable levels of seismic risk will be ensured through design in accordance with the codes. All the same, none of the design standards specify what the minimum acceptable level of seismic risk actually is. Instead, a series of deterministic limit states are set which engineers then demonstrate are satisfied for their structure, typically through the use of elastic dynamic analyses adjusted to account for non-linear response using a set of empirical correction factors. From the early nineties the seismic engineering community has begun to recognise numerous fundamental shortcomings with such seismic design procedures in modern codes. Deficiencies include the use of elastic dynamic analysis for the prediction of inelastic force distributions, the assignment of uniform behaviour factors for structural typologies irrespective of the structural proportions and expected deformation demands, and the assumption that hysteretic properties of a structure do not affect the seismic displacement demands, amongst other things. In light of this a number of possibilities have emerged for improved control of risk through seismic design, with several innovative displacement-based seismic design methods now well developed. For a specific seismic design intensity, such methods provide a more rational means of controlling the response of a structure to satisfy performance limit states. While the development of such methodologies does mark a significant step forward for the control of seismic risk, they do not, on their own, identify the seismic risk of a newly designed structure. In the U.S. a rather elaborate performance-based earthquake engineering (PBEE) framework is under development, with the aim of providing seismic loss estimates for new buildings. The PBEE framework consists of the following four main analysis stages: (i) probabilistic seismic hazard analysis to give the mean occurrence rate of earthquake events having an intensity greater than a threshold value, (ii) structural analysis to estimate the global structural response, given a certain value of seismic intensity, (iii) damage analysis, in which fragility functions are used to express the probability that a building component exceeds a damage state, as a function of the global structural response, (iv) loss analysis, in which the overall performance is assessed based on the damage state of all components. This final step gives estimates of the mean annual frequency with which various repair cost levels (or other decision variables) are exceeded. The realisation of this framework does suggest that risk-based seismic design is now possible. However, comparing current code approaches with the proposed PBEE framework, it becomes apparent that mainstream consulting engineers would have to go through a massive learning curve in order to apply the new procedures in practice. With this in mind, it is proposed that simplified loss-based seismic design procedures are a logical means of helping the engineering profession transition from what are largely deterministic seismic design procedures in current codes, to more rational risk-based seismic design methodologies. Examples are provided to illustrate the likely benefits of adopting loss-based seismic design approaches in practice.

Oral hydration for prevention of contrast-induced acute kidney injury in elective radiological procedures: a systematic review and meta-analysis of randomized controlled trials.

PubMed

Cheungpasitporn, Wisit; Thongprayoon, Charat; Brabec, Brady A; Edmonds, Peter J; O'Corragain, Oisin A; Erickson, Stephen B

2014-12-01

The reports on efficacy of oral hydration treatment for the prevention of contrast-induced acute kidney injury (CIAKI) in elective radiological procedures and cardiac catheterization remain controversial. The objective of this meta-analysis was to assess the use of oral hydration regimen for prevention of CIAKI. Comprehensive literature searches for randomized controlled trials (RCTs) of outpatient oral hydration treatment was performed using MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials Systematic Reviews, and clinicaltrials.gov from inception until July 4(th), 2014. Primary outcome was the incidence of CIAKI. Six prospective RCTs were included in our analysis. Of 513patients undergoing elective procedures with contrast exposures,45 patients (8.8%) had CIAKI. Of 241 patients with oral hydration regimen, 23 (9.5%) developed CIAKI. Of 272 patients with intravenous (IV) fluid regimen, 22 (8.1%) had CIAKI. Study populations in all included studies had relatively normal kidney function to chronic kidney disease (CKD) stage 3. There was no significant increased risk of CIAKI in oral fluid regimen group compared toIV fluid regimen group (RR = 0.94, 95% confidence interval, CI = 0.38-2.31). According to our analysis,there is no evidence that oral fluid regimen is associated with more risk of CIAKI in patients undergoing elective procedures with contrast exposures compared to IV fluid regimen. This finding suggests that the oral fluid regimen might be considered as a possible outpatient treatment option for CIAKI prevention in patients with normal to moderately reduced kidney function.

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study.

PubMed

Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter; Sedrakyan, Art

2015-10-13

To compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort. Population based cohort study. Outpatient interventional setting in New York State. Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. We identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making. © Mao et al 2015.

Risks of postextraction bleeding after receiving direct oral anticoagulants or warfarin: a retrospective cohort study

PubMed Central

Yagyuu, Takahiro; Kawakami, Mao; Ueyama, Yoshihiro; Imada, Mitsuhiko; Kurihara, Miyako; Matsusue, Yumiko; Imai, Yuichiro; Yamamoto, Kazuhiko; Kirita, Tadaaki

2017-01-01

Objective The effect of direct oral anticoagulants (DOACs) on the risk of bleeding after tooth extraction remains unclear. This study aimed to evaluate the incidence of postextraction bleeding among patients who received DOAC and vitamin K antagonists (VKAs), such as warfarin. Design This study was a retrospective cohort analysis. Incidence rates and propensity score-matched regression models were used to compare the risks of bleeding after tooth extractions involving DOACs and VKAs. Setting The study took place in a single university hospital in Japan. Participants Between April 2013 and April 2015, 543 patients underwent a total of 1196 simple tooth extractions. Primary outcome measure The primary outcome measure was the occurrence of postextraction bleeding, which was defined as bleeding that could not be stopped by biting down on gauze and required medical treatment between 30 min and 7 days after the extraction. Results A total of 1196 tooth extractions (634 procedures) in 541 patients fulfilled the study criteria, with 72 extractions (41 procedures) involving DOACs, 100 extractions (50 procedures) involving VKAs and 1024 extractions (543 procedures) involving no anticoagulants. The incidences of postextraction bleeding per tooth for the DOAC, VKA and no anticoagulant extractions were 10.4%, 12.0% and 0.9%, respectively. The incidences of postextraction bleeding per procedure for DOACs, VKAs and no anticoagulants were 9.7%, 10.0% and 1.1%, respectively. In comparison to the VKA extractions, the DOAC extractions did not significantly increase the risk of postextraction bleeding (OR 0.69, 95% CIs 0.24 to 1.97; p=0.49). Conclusions The risk of postextraction bleeding was similar for DOAC and VKA extractions. PMID:28827248

Transient Peripheral Immune Activation follows Elective Sigmoidoscopy or Circumcision in a Cohort Study of MSM at Risk of HIV Infection.

PubMed

Lama, Javier R; Karuna, Shelly T; Grant, Shannon P; Swann, Edith M; Ganoza, Carmela; Segura, Patricia; Montano, Silvia M; Lacherre, Martin; De Rosa, Stephen C; Buchbinder, Susan; Sanchez, Jorge; McElrath, M Juliana; Lemos, Maria P

2016-01-01

Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at high risk of HIV infection. Twenty-nine HIV-seronegative high-risk Peruvian MSM agreed to elective sigmoidoscopy biopsy collections (weeks 2 and 27) and circumcision (week 4) in a 28-week cohort study designed to mimic an HIV vaccine study mucosal collection protocol. We monitored adherence to abstinence recommendations, procedure-related complications, HIV infections, peripheral immune activation, and retention. Twenty-three (79.3%) underwent a first sigmoidoscopy, 21 (72.4%) were circumcised, and 16 (55.2%) completed a second sigmoidoscopy during the study period. All who underwent procedures completed the associated follow-up safety visits. Those completing the procedures reported they were well tolerated, and complication rates were similar to those reported in the literature. Immune activation was detected during the healing period (1 week post-sigmoidoscopy, 6 weeks post-circumcision), including increases in CCR5+CD4+T cells and α4β7+CD4+T cells. Most participants adhered to post-circumcision abstinence recommendations whereas reduced adherence occurred post-sigmoidoscopy. Rectosigmoid mucosal and genital tissue collections were safe in high-risk MSM. Although the clinical implications of the post-procedure increase in peripheral immune activation markers are unknown, they reinforce the need to provide ongoing risk reduction counseling and support for post-procedure abstinence recommendations. Future HIV vaccine studies should also consider the effects of mucosal and tissue collections on peripheral blood endpoints in trial design and analysis. ClinicalTrials.gov NCT02630082.

Increased risk of prosthetic joint infection associated with esophago-gastro-duodenoscopy with biopsy.

PubMed

Coelho-Prabhu, Nayantara; Oxentenko, Amy S; Osmon, Douglas R; Baron, Todd H; Hanssen, Arlen D; Wilson, Walter R; Steckelberg, James M; Baddour, Larry M; Harmsen, William S; Mandrekar, Jay; Berbari, Elie F

2013-02-01

There are no prospective data regarding the risk of prosthetic joint infection following routine gastrointestinal endoscopic procedures. We wanted to determine the risk of prosthetic hip or knee infection following gastrointestinal endoscopic procedures in patients with joint arthroplasty. We conducted a prospective, single-center, case-control study at a single, tertiary-care referral center. Cases were defined as adult patients hospitalized for prosthetic joint infection of the hip or knee between December 1, 2001 and May 31, 2006. Controls were adult patients with hip or knee arthroplasties but without a diagnosis of joint infection, hospitalized during the same time period at the same orthopedic hospital. The main outcome measure was the odds ratio (OR) of prosthetic joint infection after gastrointestinal endoscopic procedures performed within 2 years before admission. 339 cases and 339 controls were included in the study. Of these, 70 cases (21%) cases and 82 controls (24%) had undergone a gastrointestinal endoscopic procedure in the preceding 2 years. Among gastrointestinal procedures that were assessed, esophago-gastro-duodenoscopy (EGD) with biopsy was associated with an increased risk of prosthetic joint infection (OR = 3, 95% CI: 1.1-7). In a multivariable analysis adjusting for sex, age, joint age, immunosuppression, BMI, presence of wound drain, prior arthroplasty, malignancy, ASA score, and prothrombin time, the OR for infection after EGD with biopsy was 4 (95% CI: 1.5-10). EGD with biopsy was associated with an increased risk of prosthetic joint infection in patients with hip or knee arthroplasties. This association will need to be confirmed in other epidemiological studies and adequately powered prospective clinical trials prior to recommending antibiotic prophylaxis in these patients.

A discrete event simulation model of clinical and operating room efficiency outcomes of sugammadex versus neostigmine for neuromuscular block reversal in Canada.

PubMed

Insinga, Ralph P; Joyal, Cédric; Goyette, Alexandra; Galarneau, André

2016-11-16

The objective of this analysis is to explore potential impact on operating room (OR) efficiency and incidence of residual neuromuscular blockade (RNMB) with use of sugammadex (Bridion™, Merck & Co., Inc., Kenilworth, NJ USA) versus neostigmine for neuromuscular block reversal in Canada. A discrete event simulation (DES) model was developed to compare ORs using either neostigmine or sugammadex for NMB reversal over one month. Selected inputs included OR procedure and turnover times, hospital policies for paid staff overtime and procedural cancellations due to OR time over-run, and reductions in RNMB and associated complications with sugammadex use. Trials show sugammadex's impact on OR time and RNMB varies by whether full neuromuscular recovery (train-of-four ratio ≥0.9) is verified prior to extubation in the OR. Scenarios were therefore evaluated reflecting varied assumptions for neuromuscular reversal practices. With use of moderate neuromuscular block, when full neuromuscular recovery is verified prior to extubation (93 procedures performed with sugammadex, 91 with neostigmine), use of sugammadex versus neostigmine avoided 2.4 procedural cancellations due to OR time over-run and 33.5 h of paid staff overtime, while saving an average of 62 min per OR day. No difference was observed between comparators for these endpoints in the scenario when full neuromuscular recovery was not verified prior to extubation, however, per procedure risk of RNMB at extubation was reduced from 60% to 4% (reflecting 51 cases prevented), with associated reductions in risks of hypoxemia (12 cases avoided) and upper airway obstruction (23 cases avoided). Sugammadex impact in reversing deep neuromuscular block was evaluated in an exploratory analysis. When it was hypothetically assumed that 30 min of OR time were saved per procedure, the number of paid hours of staff over-time dropped from 84.1 to 32.0, with a 93% reduction in the per patient risk of residual blockade. In clinical practice within Canada, for the majority of patients currently managed with moderate neuromuscular block, the principal impact of substituting sugammadex for neostigmine is likely to be a reduction in the risk of residual blockade and associated complications. For patients maintained at a deep level of block to the end of the procedure, sugammadex is likely to both enhance OR efficiency and reduce residual block complications.

Shuttle user analysis (study 2.2). Volume 3: Business risk and value of operations in space (BRAVO). Part 2: User's manual

NASA Technical Reports Server (NTRS)

1974-01-01

The purpose of the BRAVO User's Manual is to describe the BRAVO methodology in terms of step-by-step procedures. The BRAVO methodology then becomes a tool which a team of analysts can utilize to perform cost effectiveness analyses on potential future space applications with a relatively general set of input information and a relatively small expenditure of resources. An overview of the BRAVO procedure is given by describing the complete procedure in a general form.

Finding Groups Using Model-based Cluster Analysis: Heterogeneous Emotional Self-regulatory Processes and Heavy Alcohol Use Risk

PubMed Central

Mun, Eun-Young; von Eye, Alexander; Bates, Marsha E.; Vaschillo, Evgeny G.

2010-01-01

Model-based cluster analysis is a new clustering procedure to investigate population heterogeneity utilizing finite mixture multivariate normal densities. It is an inferentially based, statistically principled procedure that allows comparison of non-nested models using the Bayesian Information Criterion (BIC) to compare multiple models and identify the optimum number of clusters. The current study clustered 36 young men and women based on their baseline heart rate (HR) and HR variability (HRV), chronic alcohol use, and reasons for drinking. Two cluster groups were identified and labeled High Alcohol Risk and Normative groups. Compared to the Normative group, individuals in the High Alcohol Risk group had higher levels of alcohol use and more strongly endorsed disinhibition and suppression reasons for use. The High Alcohol Risk group showed significant HRV changes in response to positive and negative emotional and appetitive picture cues, compared to neutral cues. In contrast, the Normative group showed a significant HRV change only to negative cues. Findings suggest that the individuals with autonomic self-regulatory difficulties may be more susceptible to heavy alcohol use and use alcohol for emotional regulation. PMID:18331138

The integration methods of fuzzy fault mode and effect analysis and fault tree analysis for risk analysis of yogurt production

NASA Astrophysics Data System (ADS)

Aprilia, Ayu Rizky; Santoso, Imam; Ekasari, Dhita Murita

2017-05-01

Yogurt is a product based on milk, which has beneficial effects for health. The process for the production of yogurt is very susceptible to failure because it involves bacteria and fermentation. For an industry, the risks may cause harm and have a negative impact. In order for a product to be successful and profitable, it requires the analysis of risks that may occur during the production process. Risk analysis can identify the risks in detail and prevent as well as determine its handling, so that the risks can be minimized. Therefore, this study will analyze the risks of the production process with a case study in CV.XYZ. The method used in this research is the Fuzzy Failure Mode and Effect Analysis (fuzzy FMEA) and Fault Tree Analysis (FTA). The results showed that there are 6 risks from equipment variables, raw material variables, and process variables. Those risks include the critical risk, which is the risk of a lack of an aseptic process, more specifically if starter yogurt is damaged due to contamination by fungus or other bacteria and a lack of sanitation equipment. The results of quantitative analysis of FTA showed that the highest probability is the probability of the lack of an aseptic process, with a risk of 3.902%. The recommendations for improvement include establishing SOPs (Standard Operating Procedures), which include the process, workers, and environment, controlling the starter of yogurt and improving the production planning and sanitation equipment using hot water immersion.

Safety and efficacy of rivaroxaban compared with warfarin in patients undergoing peripheral arterial procedures.

PubMed

Talukdar, Anjan; Wang, S Keisin; Czosnowski, Lauren; Mokraoui, Nassim; Gupta, Alok; Fajardo, Andres; Dalsing, Michael; Motaganahalli, Raghu

2017-10-01

Rivaroxaban is a United States Food and Drug Administration-approved oral anticoagulant for venous thromboembolic disease; however, there is no information regarding the safety and its efficacy to support its use in patients after open or endovascular arterial interventions. We report the safety and efficacy of rivaroxaban vs warfarin in patients undergoing peripheral arterial interventions. This single-institution retrospective study analyzed all sequential patients from December 2012 to August 2014 (21 months) who were prescribed rivaroxaban or warfarin after a peripheral arterial procedure. Our study population was then compared using American College of Chest Physicians guidelines with patients then stratified as low, medium, or high risk for bleeding complications. Statistical analyses were performed using the Student t-test and χ 2 test to compare demographics, readmissions because of bleeding, and the need for secondary interventions. Logistic regression models were used for analysis of variables associated with bleeding complications and secondary interventions. The Fisher exact test was used for power analysis. There were 44 patients in the rivaroxaban group and 50 patients in the warfarin group. Differences between demographics and risk factors for bleeding between groups or reintervention rate were not statistically significant (P = .297). However, subgroup evaluation of the safety profile suggests that patients who were aged ≤65 years and on warfarin had an overall higher incidence of major bleeding (P = .020). Patients who were aged >65 years, undergoing open operation, had a significant risk for reintervention (P = .047) when they received rivaroxaban. Real-world experience using rivaroxaban and warfarin in patients after peripheral arterial procedures suggests a comparable safety and efficacy profile. Subgroup analysis of those requiring an open operation demonstrated a decreased bleeding risk when rivaroxaban was used (in those aged <65 years) but an increased risk for secondary interventions. Further studies with a larger cohort are required to validate our results. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Cancer Risks Associated with External Radiation From Diagnostic Imaging Procedures

PubMed Central

Linet, Martha S.; Slovis, Thomas L.; Miller, Donald L.; Kleinerman, Ruth; Lee, Choonsik; Rajaraman, Preetha; de Gonzalez, Amy Berrington

2012-01-01

The 600% increase in medical radiation exposure to the US population since 1980 has provided immense benefit, but potential future cancer risks to patients. Most of the increase is from diagnostic radiologic procedures. The objectives of this review are to summarize epidemiologic data on cancer risks associated with diagnostic procedures, describe how exposures from recent diagnostic procedures relate to radiation levels linked with cancer occurrence, and propose a framework of strategies to reduce radiation from diagnostic imaging in patients. We briefly review radiation dose definitions, mechanisms of radiation carcinogenesis, key epidemiologic studies of medical and other radiation sources and cancer risks, and dose trends from diagnostic procedures. We describe cancer risks from experimental studies, future projected risks from current imaging procedures, and the potential for higher risks in genetically susceptible populations. To reduce future projected cancers from diagnostic procedures, we advocate widespread use of evidence-based appropriateness criteria for decisions about imaging procedures, oversight of equipment to deliver reliably the minimum radiation required to attain clinical objectives, development of electronic lifetime records of imaging procedures for patients and their physicians, and commitment by medical training programs, professional societies, and radiation protection organizations to educate all stakeholders in reducing radiation from diagnostic procedures. PMID:22307864

National Trends of Simple Prostatectomy for Benign Prostatic Hyperplasia With an Analysis of Risk Factors for Adverse Perioperative Outcomes.

PubMed

Pariser, Joseph J; Pearce, Shane M; Patel, Sanjay G; Bales, Gregory T

2015-10-01

To examine the national trends of simple prostatectomy (SP) for benign prostatic hyperplasia (BPH) focusing on perioperative outcomes and risk factors for complications. The National Inpatient Sample (2002-2012) was utilized to identify patients with BPH undergoing SP. Analysis included demographics, hospital details, associated procedures, and operative approach (open, robotic, or laparoscopic). Outcomes included complications, length of stay, charges, and mortality. Multivariate logistic regression was used to determine the risk factors for perioperative complications. Linear regression was used to assess the trends in the national annual utilization of SP. The study population included 35,171 patients. Median length of stay was 4 days (interquartile range 3-6). Cystolithotomy was performed concurrently in 6041 patients (17%). The overall complication rate was 28%, with bleeding occurring most commonly. In total, 148 (0.4%) patients experienced in-hospital mortality. On multivariate analysis, older age, black race, and overall comorbidity were associated with greater risk of complications while the use of a minimally invasive approach and concurrent cystolithotomy had a decreased risk. Over the study period, the national use of simple prostatectomy decreased, on average, by 145 cases per year (P = .002). By 2012, 135/2580 procedures (5%) were performed using a minimally invasive approach. The nationwide utilization of SP for BPH has decreased. Bleeding complications are common, but perioperative mortality is low. Patients who are older, black race, or have multiple comorbidities are at higher risk of complications. Minimally invasive approaches, which are becoming increasingly utilized, may reduce perioperative morbidity. Copyright © 2015 Elsevier Inc. All rights reserved.

Patient- and lesion-tailored algorithm of endovascular treatment for arterial occlusive disease of extracranial arteries supplying the brain: safety of the treatment at 30-day follow-up

PubMed Central

Simka, Marian; Brzegowy, Paweł; Janas, Piotr; Kazibudzki, Marek; Pieniążek, Piotr; Ochała, Andrzej; Popiela, Tadeusz; Mrowiecki, Tomasz

2017-01-01

Introduction Although surgical endarterectomy remains the treatment of choice for carotid artery stenosis, stenting plays an important role as an alternative treatment modality, especially in high-risk patients. The actual safety profile associated with stenting procedures is probably better than that reported by randomized controlled trials. Aim To assess the safety of stent implantations in extracranial arteries supplying the brain, and also to identify risk factors associated with this procedure. Material and methods This was a post hoc analysis, with 30-day follow-up. We analyzed the results of treatment of 372 patients who underwent 408 procedures, 197 such procedures in asymptomatic, and 211 in symptomatic individuals. Stenting procedures were performed using a technique and armamentarium which were tailored to the type and anatomy of lesions. Results There were 6 (1.5%) strokes, including 2 (0.5%) major strokes, 1 ipsi- and 1 contralateral, and 4 (1.0%) minor strokes. In asymptomatic patients there was 1 (0.3%) minor stroke. Transient ischemic attacks occurred in 5 (1.2%) patients. There were 2 (0.5%) non-STEMI myocardial infarctions and 2 (0.5%) non-stroke related fatalities. Risk factors of these adverse events were diabetes mellitus, lesions localized in a tortuous segment of the artery, embolic material in the filter and bilateral stenoses of carotid arteries. Additional risk factors in asymptomatic patients were renal impairment and advanced coronary artery disease; and in symptomatic patients, grade 3 arterial hypertension, dislipidemia, cigarette smoking and lesions requiring predilatation. Conclusions Stenting procedures of extracranial arteries supplying the brain, which are tailored to the type and anatomy of lesions, seem to be relatively safe. PMID:28344618

Patient- and lesion-tailored algorithm of endovascular treatment for arterial occlusive disease of extracranial arteries supplying the brain: safety of the treatment at 30-day follow-up.

PubMed

Latacz, Paweł; Simka, Marian; Brzegowy, Paweł; Janas, Piotr; Kazibudzki, Marek; Pieniążek, Piotr; Ochała, Andrzej; Popiela, Tadeusz; Mrowiecki, Tomasz

2017-01-01

Although surgical endarterectomy remains the treatment of choice for carotid artery stenosis, stenting plays an important role as an alternative treatment modality, especially in high-risk patients. The actual safety profile associated with stenting procedures is probably better than that reported by randomized controlled trials. To assess the safety of stent implantations in extracranial arteries supplying the brain, and also to identify risk factors associated with this procedure. This was a post hoc analysis, with 30-day follow-up. We analyzed the results of treatment of 372 patients who underwent 408 procedures, 197 such procedures in asymptomatic, and 211 in symptomatic individuals. Stenting procedures were performed using a technique and armamentarium which were tailored to the type and anatomy of lesions. There were 6 (1.5%) strokes, including 2 (0.5%) major strokes, 1 ipsi- and 1 contralateral, and 4 (1.0%) minor strokes. In asymptomatic patients there was 1 (0.3%) minor stroke. Transient ischemic attacks occurred in 5 (1.2%) patients. There were 2 (0.5%) non-STEMI myocardial infarctions and 2 (0.5%) non-stroke related fatalities. Risk factors of these adverse events were diabetes mellitus, lesions localized in a tortuous segment of the artery, embolic material in the filter and bilateral stenoses of carotid arteries. Additional risk factors in asymptomatic patients were renal impairment and advanced coronary artery disease; and in symptomatic patients, grade 3 arterial hypertension, dislipidemia, cigarette smoking and lesions requiring predilatation. Stenting procedures of extracranial arteries supplying the brain, which are tailored to the type and anatomy of lesions, seem to be relatively safe.

Surgical complications after open and laparoscopic surgery for perforated peptic ulcer in a nationwide cohort.

PubMed

Wilhelmsen, M; Møller, M H; Rosenstock, S

2015-03-01

Surgery for perforated peptic ulcer (PPU) is associated with a risk of complications. The frequency and severity of reoperative surgery is poorly described. The aims of the present study were to characterize the frequency, procedure-associated risk and mortality associated with reoperation after surgery for PPU. All patients treated surgically for PPU in Denmark between 2011 and 2013 were included. Baseline and clinical data, including 90-day mortality and detailed information on reoperative surgery, were collected from the Danish Clinical Register of Emergency Surgery. Distribution frequencies of reoperation stratified by type of surgical approach (laparoscopy or open) were reported. The crude and adjusted risk associations between surgical approach and reoperation were assessed by regression analysis and reported as odds ratio (OR) with 95 per cent c.i. Sensitivity analyses were carried out. A total of 726 patients were included, of whom 238 (32·8 per cent) were treated laparoscopically and 178 (24·5 per cent) had a laparoscopic procedure converted to laparotomy. Overall, 124 (17·1 per cent) of 726 patients underwent reoperation. A persistent leak was the most frequent cause (43 patients, 5·9 per cent), followed by wound dehiscence (34, 4·7 per cent). The crude risk of reoperative surgery was higher in patients who underwent laparotomy and those with procedures converted to open surgery than in patients who had laparoscopic repair: OR 1·98 (95 per cent c.i. 1·19 to 3·27) and 2·36 (1·37 to 4·08) respectively. The difference was confirmed when adjusted for age, surgical delay, co-morbidity and American Society of Anesthesiologists fitness grade. However, the intention-to-treat sensitivity analysis (laparoscopy including conversions) demonstrated no significant difference in risk. The risk of death within 90 days was greater in patients who had reoperation: crude and adjusted OR 1·53 (1·00 to 2·34) and 1·06 (0·65 to 1·72) respectively. Reoperation was necessary in almost one in every five patients operated on for PPU. Laparoscopy was associated with lower risk of reoperation than laparotomy or a converted procedure. However, there was a risk of bias, including confounding by indication. © 2015 BJS Society Ltd Published by John Wiley & Sons Ltd.

Bloody traditional procedures performed during infancy in the oropharyngeal area among HIV+ children: implication from the perspective of mother-to-child transmission of HIV.

PubMed

Mitke, Yifru Berhan

2010-12-01

Although bloody traditional procedures are very common in Ethiopia, this is the first report on infants. None of the literature attributed such practices as risk factor for mother-to-child transmission (MTCT) of HIV. Analysis was done to 1,163 children and found that 552 (47.5%) bloody traditional procedures were performed in the oral cavity to 399 (34.3%): uvulectomy 41.8%, milk tooth extraction 33.7% and tonsillectomy 24.5%. Multinomial logistic regression showed strong association of uvulectomy with Tigray ethnicity. Milk teeth extractions were highest among girls, rural residence, Tigray and Amhara ethnicity. When procedures performed, children were under 1 month (88.9% of tonsillectomies), under 6 months (83.5% of uvulectomies) and 4-6 months (54.3% of milk tooth extractions) of age. More than 97% for whom procedures performed were breast fed, and about 88% were from the northern part of the country. Taking into account the deep invasiveness of the procedures, they are assumed as one of the strong risk factors for MTCT of HIV during lactation.

Design of Training Systems. Computerization of the Educational Technology Assessment Model. Volume 1.

ERIC Educational Resources Information Center

Duffy, Larry B.; And Others

The Educational Technology Assessment Model (ETAM) is a set of comprehensive procedures and variables for the analysis, synthesis, and decision making, in regard to the benefits, costs, and risks associated with introducing technical innovations in education and training. This final report summarizes the analysis, design, and development…

What are the Rates, Reasons, and Risk Factors of 90-day Hospital Readmission After Lumbar Discectomy?: An Institutional Experience.

PubMed

Kohls, Morgan R; Jain, Nikhil; Khan, Safdar N

2018-06-07

This is a retrospective cohort study. To report the rate, reasons, and risk factors for 90-day readmissions after lumbar discectomy at an academic medical center. Several studies have reported complications and readmissions after spine surgery; however, only one previous study has focused specifically on lumbar discectomy. As the patient profile and morbidity of various spine procedures is different, focus on procedure-specific complications and readmissions will be beneficial. Patients who underwent lumbar discectomy for unrelieved symptoms of prolapsed intervertebral disk and had at least 90 days of follow-up at an academic institution (2013-2014) were included. Retrospective review of electronic medical record was performed to record demographic and clinical profile of patients. Details of lumbar discectomy, index hospital stay, discharge disposition, hospital readmission within 90 days, reason for readmission and treatment given have been reported. Risk factors for hospital readmission were analyzed by multivariate logistic regression analysis. A total of 356 patients with a mean age of 45.0±13.8 years were included. The 90-day readmission rate was 5.3% (19/360) of which two-third patients were admitted within 30 days giving a 30-day readmission rate of 3.7% (13/356). The top 2 primary reasons for readmission included back and/or leg pain, numbness, or tingling (42.9%), and persistent cerebrospinal fluid leak or seroma (25.0%). On adjusted analysis, risk factors associated with higher risk of readmission included incidental durotomy [odds ratio (OR), 26.2; 95% confidence interval (CI), 5.3-129.9] and discharge to skilled nursing facility/inpatient rehabilitation (OR, 25.2; 95% CI, 2.7-235.2). Increasing age was a negative predictor of readmission (OR, 0.95; 95% CI, 0.91-0.99). Incidental durotomy, younger age, and discharge to nursing facility were associated with higher risk of 90-day hospital readmission after lumbar discectomy. As compared with extensive spine procedures, patient comorbidity burden may not be as significant in predicting readmission after this relatively less invasive procedure.

Risk analysis based on the timing of tracheostomy procedures in patients with spinal cord injury requiring cervical spine surgery.

PubMed

Galeiras, Rita; Mourelo, Mónica; Bouza, María Teresa; Seoane, María Teresa; Ferreiro, María Elena; Montoto, Antonio; Salvador, Sebastián; Seoane, Leticia; Freire, David

2018-05-19

To determine the optimal moment to carry out a tracheostomy in a patient requiring anterior cervical fixation. A retrospective observational study was carried out over an 18-year period on 56 patients who had been admitted to the ICU with acute spinal cord injury (SCI), and who underwent a tracheostomy and surgical fixation. The sample was divided into two groups: An at-risk group (31 patients, who had undergone a tracheostomy prior to the cervical surgery or <4 days after the procedure), and a not at-risk group (25 patients, who had undergone a tracheostomy >4 day following the fixation surgery). Both a descriptive and a comparative study were carried out. The overall trend of the collected data was analysed using cubic splines (graphic methods). The only infectious complications diagnosed as related to the surgical procedure were infection of the surgical wound in two patients of the not at-risk group (12%) and deep-tissue infection in one patient of the at-risk group (3.2%). During the study period, we identified a tendency towards the conduct of early tracheostomies. Our results suggest that the presence of a tracheostomy stoma prior to, or immediately after surgery, is associated with a low risk of infection of the cervical surgical wound in instrumented spinal fusion. Copyright © 2018 Elsevier Inc. All rights reserved.

Behavioral and Healthcare-Associated Risk Factors for Chronic Hepatitis C Virus Infection in Korea

PubMed Central

Kim, Jong Yeop; Cho, Juhee; Hwang, Sung Ho; Kil, Ho; Bae, Si Hyun; Kim, Young Seok; Lee, Han Chu

2012-01-01

The risk factors related to hepatitis C virus (HCV) infection showed geographic and temporal differences. We investigated HCV-related risk factors in Korea where intravenous drug use (IVDU) is uncommon. The HCV-related risk factors were investigated in a prospective, multicenter chronic HCV cohort (n = 711) using a standardized questionnaire in four university hospitals. The results were compared with those of 206 patients with chronic liver diseases not related to either of HCV or hepatitis B virus infection (comparison group). The IVDU was found in 3.9% and remote blood transfusion (≥ 20 yr ago) in 18.3% in HCV cohort group, while that in comparison group was in none and 5.3%, respectively. In a multivariate logistic analysis, transfusion in the remote past (odds ratio [OR], 2.99), needle stick injury (OR, 4.72), surgery (OR, 1.89), dental procedures (OR, 2.96), tattooing (OR, 2.07), and multiple sexual partners (2-3 persons; OR, 2.14, ≥ 4 persons; OR, 3.19), were independent risk factors for HCV infection. In conclusion, the major risk factors for HCV infection in Korea are mostly related to conventional or alterative healthcare procedures such as blood transfusion in the remote past, needle stick injury, surgery, dental procedure, and tattooing although multiple sex partners or IVDU plays a minor role. PMID:23166420

Risk Classification with an Adaptive Naive Bayes Kernel Machine Model.

PubMed

Minnier, Jessica; Yuan, Ming; Liu, Jun S; Cai, Tianxi

2015-04-22

Genetic studies of complex traits have uncovered only a small number of risk markers explaining a small fraction of heritability and adding little improvement to disease risk prediction. Standard single marker methods may lack power in selecting informative markers or estimating effects. Most existing methods also typically do not account for non-linearity. Identifying markers with weak signals and estimating their joint effects among many non-informative markers remains challenging. One potential approach is to group markers based on biological knowledge such as gene structure. If markers in a group tend to have similar effects, proper usage of the group structure could improve power and efficiency in estimation. We propose a two-stage method relating markers to disease risk by taking advantage of known gene-set structures. Imposing a naive bayes kernel machine (KM) model, we estimate gene-set specific risk models that relate each gene-set to the outcome in stage I. The KM framework efficiently models potentially non-linear effects of predictors without requiring explicit specification of functional forms. In stage II, we aggregate information across gene-sets via a regularization procedure. Estimation and computational efficiency is further improved with kernel principle component analysis. Asymptotic results for model estimation and gene set selection are derived and numerical studies suggest that the proposed procedure could outperform existing procedures for constructing genetic risk models.

Bilateral benign multinodular goiter: What is the adequate surgical therapy? A review of literature.

PubMed

Mauriello, Claudio; Marte, Gianpaolo; Canfora, Alfonso; Napolitano, Salvatore; Pezzolla, Angela; Gambardella, Claudio; Tartaglia, Ernesto; Lanza, Michele; Candela, Giancarlo

2016-04-01

Benign multinodular goiter (BMNG) is the most common endocrine disease requiring surgery. During the last few years a more aggressive approach has become the trend for bilateral BMNG treatment. Randomized clinical trials of any size that compared bilateral subtotal resection, Dunhill procedure and total thyroidectomy for benign multinodular goiter, published between January 2000 and the end of March 2015, were reviewed. Total thyroidectomy can be considered the most reliable approach in preventing recurrence. The Dunhill procedure is related to a higher rate of recurrence, but rarely recurrences after Dunhill procedure lead to reoperation. Total thyroidectomy avoid completion thyroidectomy for incidental carcinoma and its related risks. Recurrent laryngeal nerve (RLN) palsy becomes less common as surgical experience increases. Transient and permanent hypoparathyroidism is strictly related to the extent of neck dissection. In the risk-cost analysis we must consider the type of patient candidated to surgery and the impact of the surgical protocol we apply. When thyroid surgery is taken in consideration, specific complication rates of different procedures in each hospital must be analyzed accordingly to patient-specific risk factors and local expertise. The Dunhill procedure seems to be a good compromise between radicality and prevention of complications, avoiding reoperation for recurrence or completion thyroidectomy for incidental thyroid carcinoma. More follow-up studies and prospective studies are necessary to better evaluate, definitively, whether to prefer total thyroidectomy or Dunhill procedure in case of benign goiter surgery. Copyright © 2015. Published by Elsevier Ltd.

Use of the Ishikawa diagram in a case-control analysis to assess the causes of a diffuse lamellar keratitis outbreak.

PubMed

Lira, Luis Henrique; Hirai, Flávio E; Oliveira, Marivaldo; Portellinha, Waldir; Nakano, Eliane Mayumi

2017-01-01

To identify the causes of a diffuse lamellar keratitis (DLK) outbreak using a systematic search tool in a case-control analysis. An Ishikawa diagram was used to guide physicians to determine the potential risk factors involved in this outbreak. Coherence between the occurrences and each possible cause listed in the diagram was verified, and the total number of eyes at risk was used to calculate the proportion of affected eyes. Multivariate analysis was performed using logistic regression to determine the independent effect of the risk factors, after controlling for confounders and test interactions. All DLK cases were reported in 2007 between June 13 and December 21; during this period, 3,698 procedures were performed. Of the 1,682 flap-related procedures, 204 eyes of 141 individuals presented with DLK. No direct relationship was observed between the occurrence of DLK and the presence of any specific factors; however, flap-lifting enhancements, procedures performed during the morning shift, and non-use of therapeutic contact lenses after the surgery were significantly related to higher occurrence percentages of this condition. The Ishikawa diagram, like most quality tools, is a visualization and knowledge organization tool. This systematization allowed the investigators to thoroughly assess all the possible causes of DLK outbreak. A clear view of the entire surgical logistics permitted even more rigid management of the main factors involved in the process and, as a result, highlighted factors that deserved attention. The case-control analysis on every factor raised by the Ishikawa diagram indicated that the commonly suspected factors such as biofilm contamination of the water reservoir in autoclaves, the air-conditioning filter system, glove powder, microkeratome motor oil, and gentian violet markers were not related to the outbreak.

A quality risk management model approach for cell therapy manufacturing.

PubMed

Lopez, Fabio; Di Bartolo, Chiara; Piazza, Tommaso; Passannanti, Antonino; Gerlach, Jörg C; Gridelli, Bruno; Triolo, Fabio

2010-12-01

International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator-introduced variations, and affected by heterogeneity of the processed organs/tissues and lot-dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell-based product manufacturing context (i.e., high dependence on human intervention and absence of reference standards for acceptable risk levels) are identified and addressed, and a risk management model approach applicable to manufacturing of cells for clinical use is described for the first time. The use of the heuristic and pseudo-quantitative failure mode and effect analysis/failure mode and critical effect analysis risk analysis technique associated with direct estimation of severity, occurrence, and detection is, in this specific context, as effective as, but more efficient than, the analytic hierarchy process. Moreover, a severity/occurrence matrix and Pareto analysis can be successfully adopted to identify priority failure modes on which to act to mitigate risks. The application of this approach to clinical cell therapy manufacturing in regenerative medicine is also discussed. © 2010 Society for Risk Analysis.

Risk factors for infective endocarditis in children with congenital heart diseases - A nationwide population-based case control study.

PubMed

Sun, Li-Chuan; Lai, Chih-Cheng; Wang, Cheng-Yi; Wang, Ya-Hui; Wang, Jen-Yu; Hsu, Yo-Ling; Hu, Yin-Lan; Wu, En-Ting; Lin, Ming-Tai; Sy, Leticia B; Chen, Likwang

2017-12-01

Infective endocarditis (IE) is uncommon in childhood. Its associated epidemiological characteristics in patients with congenital heart disease (CHD) remain unclear. The study population included children born in Taiwan during the years 1997 to 2005 who were diagnosed as having CHD before 3years of age. All children were followed up until the end year of 2010, the diagnosis of infective endocarditis, or death. The demographic characteristics of patients with and without IE, the invasive procedures performed during 6months before the index date, the prophylactic antibiotics related to dental procedures, and in-hospital mortality were collected. Information of 24,729 children with CHD were retrieved for our analysis and 237 patients with newly diagnosed IE were identified. The incidence rate of IE in all CHD lesions was 11.13 per 10,000person-years. Taking ASD for reference, the following CHD lesions were at risk for IE: cyanotic CHD (adjusted OR, 9.58; 95% confidence interval, 5.38-17.05), endocardial cushion defect (ECD) (8.01; 2.73-23.50), Left-sided lesions (4.36; 1.90-10.01) and VSD (2.93; 1.64-5.23). Patients who underwent procedures have a higher risk of acquiring IE which include central venous catheter (CVC) insertion (3.17; 2.36-4.27), cardiac catheterization (3.74; 2.67-5.22), open-heart surgery (2.47; 1.61-3.77), valve surgery (3.20; 1.70-6.02), and shunt surgery (7.43; 2.36-23.41). However, dental procedures did not increase the risk of IE, irrespective of antibiotic usage. The risk of IE varies markedly among CHD lesions in our study. Invasive heart procedures but not dental procedures, are more significantly associated with IE among children with CHD. Copyright © 2017. Published by Elsevier B.V.

Hospital volume and the risk of revision in Oxford unicompartmental knee arthroplasty in the Nordic countries -an observational study of 14,496 cases.

PubMed

Badawy, Mona; Fenstad, Anne M; Bartz-Johannessen, Christoffer A; Indrekvam, Kari; Havelin, Leif I; Robertsson, Otto; W-Dahl, Annette; Eskelinen, Antti; Mäkelä, Keijo; Pedersen, Alma B; Schrøder, Henrik M; Furnes, Ove

2017-09-07

High procedure volume and dedication to unicompartmental knee arthroplasty (UKA) has been suggested to improve revision rates. This study aimed to quantify the annual hospital volume effect on revision risk in Oxfordu nicompartmental knee arthroplasty in the Nordic countries. 14,496 cases of cemented medial Oxford III UKA were identified in 126 hospitals in the four countries included in the Nordic Arthroplasty Register Association (NARA) database from 2000 to 2012. Hospitals were divided by quartiles into 4 annual procedure volume groups (≤11, 12-23, 24-43 and ≥44). The outcome was revision risk after 2 and 10 years calculated using Kaplan Meier method. Multivariate Cox regression analysis was used to assess the Hazard Ratio (HR) of any revision due to specific reasons with 95% confidence intervals (CI). The implant survival was 80% at 10 years in the volume group ≤11 procedures per year compared to 83% in other volume groups. The HR adjusted for age category, sex, year of surgery and nation was 0.87 (95% CI: 0.76-0.99, p = 0.036) for the group 12-23 procedures per year, 0.78 (95% CI: 0.68-0.91, p = 0.002) for the group 24-43 procedures per year and 0.82 (95% CI: 0.70-0.94, p = 0.006) for the group ≥44 procedures per year compared to the low volume group. Log-rank test was p = 0.003. The risk of revision for unexplained pain was 40-50% higher in the low compared with other volume groups. Low volume hospitals performing ≤11 Oxford III UKAs per year were associated with an increased risk of revision compared to higher volume hospitals, and unexplained pain as revision cause was more common in low volume hospitals.

Risk of failure of primary hip arthroscopy—a population-based study

PubMed Central

Degen, Ryan M.; Pan, Ting J.; Chang, Brenda; Mehta, Nabil; Chamberlin, Peter D.; Ranawat, Anil S.; Nawabi, Danyal H.; Kelly, Bryan T.

2017-01-01

Abstract The aims of this study are (i) to report on the rates of subsequent surgery following hip arthroscopy and (ii) to identify prognostic variables associated with revision surgery, survival rates and complication rates. The Statewide Planning and Research Cooperative System database, a census of hospital admissions and ambulatory surgery in New York State, was used to identify cases of primary hip arthroscopy. Demographic information and rates of subsequent revision hip arthroscopy or arthroplasty were collected. The risks were modeled with use of age, sex, procedure and surgeon volume as risk factors. Survival analyses were also performed, and 30-day complication was recorded. We identified 8267 procedures in 7836 patients from 1998 to 2012. Revision surgery occurred in 1087 cases (13.2%) at a mean of 1.7 ± 1.6 (mean ± SD) years. Revision arthroscopy accounted for 311 cases (3.8%), and arthroplasty for 796 (9.7%) cases. Survival analysis showed a 2-year survival rate of 88.1%, 5-year of 80.7% and 10-year of 74.9%. Regression analysis revealed that age >50 years [hazard ratio (HR) 2.09; confidence interval (CI) 1.82–2.39, P < 0.01] and a diagnosis of osteoarthritis (HR 2.72; CI 2.21–3.34, P < 0.01) were associated with increased risk of re-operation. Labral repair was associated with a lower risk of re-operation (HR 0.71; CI 0.54–0.93, P = 0.01). Finally, higher surgeon volume (>164 cases/year) resulted in a lower risk of re-operation versus lower volume (<102 cases/year) (HR 0.42; CI 0.32–0.54, P < 0.01). The 30-day complication rate was 0.2%. Older age and pre-existing osteoarthritis increased the likelihood of re-operation following hip arthroscopy, whereas performing a labral repair and having the procedure performed by a higher-volume surgeon lowered the risk of re-operation. PMID:28948033

Risk analysis and its link with standards of the World Organisation for Animal Health.

PubMed

Sugiura, K; Murray, N

2011-04-01

Among the agreements included in the treaty that created the World Trade Organization (WTO) in January 1995 is the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) that sets out the basic rules for food safety and animal and plant health standards. The SPS Agreement designates the World Organisation for Animal Health (OIE) as the organisation responsible for developing international standards for animal health and zoonoses. The SPS Agreement requires that the sanitary measures that WTO members apply should be based on science and encourages them to either apply measures based on the OIE standards or, if they choose to adopt a higher level of protection than that provided by these standards, apply measures based on a science-based risk assessment. The OIE also provides a procedural framework for risk analysis for its Member Countries to use. Despite the inevitable challenges that arise in carrying out a risk analysis of the international trade in animals and animal products, the OIE risk analysis framework provides a structured approach that facilitates the identification, assessment, management and communication of these risks.

Thromboembolic Risk of Endovascular Intervention for Lower Extremity Deep Venous Thrombosis.

PubMed

Lindsey, Philip; Echeverria, Angela; Poi, Mun J; Matos, Jesus; Bechara, Carlos F; Cheung, Mathew; Lin, Peter H

2018-05-01

This study evaluated the risk of thromboembolism during endovascular interventions in patients with symptomatic lower extremity deep vein thrombosis (DVT) METHODS: Clinical records of all patients who underwent endovascular interventions for symptomatic lower extremity DVT from 2001 to 2017 were retrospectively analyzed using a prospectively maintained database. Only patients who received an inferior vena cava (IVC) filter were included in the analysis. Trapped intrafilter thrombus was assessed for procedure-related thromboembolism. Clinical outcomes of thrombus management and thromboembolism risk were analyzed. A total 172 patients (mean age 57.4 years, 98 females) who underwent 174 endovascular DVT interventions were included in the analysis. Treatment strategies included thrombolytic therapy (64%), mechanical thrombectomy (n = 86%), pharmacomechanical thrombolysis (51%), balloon angioplasty (98%), and stent placement (28%). Thrombectomy device used included AngioJet (56%), Trellis (19%), and Aspire (11%). Trapped IVC filter thrombus was identified in 58 patients (38%) based on the IVC venogram. No patient developed clinically evident pulmonary embolism (PE). IVC filter retrieval was performed in 98 patients (56%, mean 11.8 months after implantation). Multivariate analysis showed that iliac vein occlusion (P = 0.04) was predictive for procedure-related thromboembolism. Iliac vein thrombotic occlusion is associated with an increased thromboembolic risk in DVT intervention. Retrievable IVC filter should be considered when performing percutaneous thrombectomy in patients with iliac venous occlusion to prevent PE. Copyright © 2017 Elsevier Inc. All rights reserved.

A Model-Free Machine Learning Method for Risk Classification and Survival Probability Prediction.

PubMed

Geng, Yuan; Lu, Wenbin; Zhang, Hao Helen

2014-01-01

Risk classification and survival probability prediction are two major goals in survival data analysis since they play an important role in patients' risk stratification, long-term diagnosis, and treatment selection. In this article, we propose a new model-free machine learning framework for risk classification and survival probability prediction based on weighted support vector machines. The new procedure does not require any specific parametric or semiparametric model assumption on data, and is therefore capable of capturing nonlinear covariate effects. We use numerous simulation examples to demonstrate finite sample performance of the proposed method under various settings. Applications to a glioma tumor data and a breast cancer gene expression survival data are shown to illustrate the new methodology in real data analysis.

Preoperative short hookwire placement for small pulmonary lesions: evaluation of technical success and risk factors for initial placement failure.

PubMed

Iguchi, Toshihiro; Hiraki, Takao; Matsui, Yusuke; Fujiwara, Hiroyasu; Masaoka, Yoshihisa; Tanaka, Takashi; Sato, Takuya; Gobara, Hideo; Toyooka, Shinichi; Kanazawa, Susumu

2018-05-01

To retrospectively evaluate the technical success of computed tomography fluoroscopy-guided short hookwire placement before video-assisted thoracoscopic surgery and to identify the risk factors for initial placement failure. In total, 401 short hookwire placements for 401 lesions (mean diameter 9.3 mm) were reviewed. Technical success was defined as correct positioning of the hookwire. Possible risk factors for initial placement failure (i.e., requirement for placement of an additional hookwire or to abort the attempt) were evaluated using logistic regression analysis for all procedures, and for procedures performed via the conventional route separately. Of the 401 initial placements, 383 were successful and 18 failed. Short hookwires were finally placed for 399 of 401 lesions (99.5%). Univariate logistic regression analyses revealed that in all 401 procedures only the transfissural approach was a significant independent predictor of initial placement failure (odds ratio, OR, 15.326; 95% confidence interval, CI, 5.429-43.267; p < 0.001) and for the 374 procedures performed via the conventional route only lesion size was a significant independent predictor of failure (OR 0.793, 95% CI 0.631-0.996; p = 0.046). The technical success of preoperative short hookwire placement was extremely high. The transfissural approach was a predictor initial placement failure for all procedures and small lesion size was a predictor of initial placement failure for procedures performed via the conventional route. • Technical success of preoperative short hookwire placement was extremely high. • The transfissural approach was a significant independent predictor of initial placement failure for all procedures. • Small lesion size was a significant independent predictor of initial placement failure for procedures performed via the conventional route.

Risk analysis of ODOT's HMA percent within limits (PWL) specification.

DOT National Transportation Integrated Search

2007-08-01

The Oklahoma Department of Transportation (ODOT) is considering switching its method of payment : for hot mix asphalt (HMA) construction from their current procedure to a Percent Within Limits (PWL) : specification. Quality characteristics are percen...

Risk Factors For Stroke, Myocardial Infarction, or Death Following Carotid Endarterectomy: Results From the International Carotid Stenting Study.

PubMed

Doig, D; Turner, E L; Dobson, J; Featherstone, R L; de Borst, G J; Stansby, G; Beard, J D; Engelter, S T; Richards, T; Brown, M M

2015-12-01

Carotid endarterectomy (CEA) is standard treatment for symptomatic carotid artery stenosis but carries a risk of stroke, myocardial infarction (MI), or death. This study investigated risk factors for these procedural complications occurring within 30 days of endarterectomy in the International Carotid Stenting Study (ICSS). Patients with recently symptomatic carotid stenosis >50% were randomly allocated to endarterectomy or stenting. Analysis is reported of patients in ICSS assigned to endarterectomy and limited to those in whom CEA was initiated. The occurrence of stroke, MI, or death within 30 days of the procedure was reported by investigators and adjudicated. Demographic and technical risk factors for these complications were analysed sequentially in a binomial regression analysis and subsequently in a multivariable model. Eight-hundred and twenty-one patients were included in the analysis. The risk of stroke, MI, or death within 30 days of CEA was 4.0%. The risk was higher in female patients (risk ratio [RR] 1.98, 95% CI 1.02-3.87, p = .05) and with increasing baseline diastolic blood pressure (dBP) (RR 1.30 per +10 mmHg, 95% CI 1.02-1.66, p = .04). Mean baseline dBP, obtained at the time of randomization in the trial, was 78 mmHg (SD 13 mmHg). In a multivariable model, only dBP remained a significant predictor. The risk was not related to the type of surgical reconstruction, anaesthetic technique, or perioperative medication regimen. Patients undergoing CEA stayed a median of 4 days before discharge, and 21.2% of events occurred on or after the day of discharge. Increasing diastolic blood pressure was the only independent risk factor for stroke, MI, or death following CEA. Cautious attention to blood pressure control following symptoms attributable to carotid stenosis could reduce the risks associated with subsequent CEA. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Long-Term Evaluation of Changes in Operative Technique and Hardware-Related Complications With Deep Brain Stimulation.

PubMed

Falowski, Steven M; Ooi, Yinn Cher; Bakay, Roy A E

2015-12-01

Deep brain stimulation is the most frequent neurosurgical procedure for movement disorders. While this elective procedure carries a low-risk profile, it is not free of complications. As a new procedure, the pattern of complications changed with experience and modification of surgical technique and equipment. This review analyzes the most common hardware-related complications that may occur and techniques to avoid them. It is a retrospective review of 432 patients undergoing 1077 procedures over a 14-year period by one surgeon with emphasis on the analysis of surgical technique and the changes over time. Comparisons were made pre and postimplementation of different surgical techniques over different time periods. The epochs relate to the learning curve, new equipment, and new techniques. Overall lead revision was observed at 5.7%, extension revision at 3.2%, infection rate at 1.2%, infarct without intracerebral hemorrhage at 0.8%, and intracerebral hemorrhage at 2.5% with a permanent deficit of 0.2%. An analysis and change in surgical technique which involved isolating the lead from the skin surface at both the cranial and retro-auricular incision also demonstrated a substantial decrease in lead fracture rate and infection rate. There was no mortality. This large series of patients and long-term follow-up demonstrates that risks are very low in comparison with other neurosurgical procedures, but DBS is still an elective procedure that necessitates extensive care and precision. In a rapidly evolving field, attention to surgical technique is imperative and will keep rates of complications at a minimum. © 2015 International Neuromodulation Society.

Implications of cost-effectiveness analysis of medical technology. background paper number 5. four common x-ray procedures: problems and prospects for economic evaluation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wagner, J.L.; Krieger, M.J.

This paper is about the economic evaluation of diagnostic procedures. The issue of economic evaluation is explored in the context of four common diagnostic X-ray procedures: the chest X-ray, the skull X-ray, the barium enema study, and the excretory urogram. The paper is divided into two parts. The first part summarizes the different evaluative models underlying studies of the four diagnostic X-ray procedures and to lay out the strengths and weaknesses of each method. The second part contains four separate chapters summarizing what is known about the utilization, costs, risks, and benefits of each procedure, with particular emphasis on themore » evaluative methods employed.« less

Conscious worst case definition for risk assessment, part I: a knowledge mapping approach for defining most critical risk factors in integrative risk management of chemicals and nanomaterials.

PubMed

Sørensen, Peter B; Thomsen, Marianne; Assmuth, Timo; Grieger, Khara D; Baun, Anders

2010-08-15

This paper helps bridge the gap between scientists and other stakeholders in the areas of human and environmental risk management of chemicals and engineered nanomaterials. This connection is needed due to the evolution of stakeholder awareness and scientific progress related to human and environmental health which involves complex methodological demands on risk management. At the same time, the available scientific knowledge is also becoming more scattered across multiple scientific disciplines. Hence, the understanding of potentially risky situations is increasingly multifaceted, which again challenges risk assessors in terms of giving the 'right' relative priority to the multitude of contributing risk factors. A critical issue is therefore to develop procedures that can identify and evaluate worst case risk conditions which may be input to risk level predictions. Therefore, this paper suggests a conceptual modelling procedure that is able to define appropriate worst case conditions in complex risk management. The result of the analysis is an assembly of system models, denoted the Worst Case Definition (WCD) model, to set up and evaluate the conditions of multi-dimensional risk identification and risk quantification. The model can help optimize risk assessment planning by initial screening level analyses and guiding quantitative assessment in relation to knowledge needs for better decision support concerning environmental and human health protection or risk reduction. The WCD model facilitates the evaluation of fundamental uncertainty using knowledge mapping principles and techniques in a way that can improve a complete uncertainty analysis. Ultimately, the WCD is applicable for describing risk contributing factors in relation to many different types of risk management problems since it transparently and effectively handles assumptions and definitions and allows the integration of different forms of knowledge, thereby supporting the inclusion of multifaceted risk components in cumulative risk management. Copyright 2009 Elsevier B.V. All rights reserved.

Lead-Dependent Infective Endocarditis: The Role of Factors Predisposing to Its Development in an Analysis of 414 Clinical Cases.

PubMed

Polewczyk, Anna; Jacheć, Wojciech; Janion, Marianna; Podlaski, Rafał; Kutarski, Andrzej

2015-07-01

Lead-dependent infective endocarditis (LDIE) is a serious and insidious infective disease spreading along the leads to valve leaflets and endocardial surface. LDIE is still a lesser known disease with unclear risk factors, most often evaluated jointly for all infectious complications. Clinical data from 414 patients with the diagnosis of LDIE according to the Modified Duke Leads Criteria were analyzed. Patients with LDIE were identified in a population of 1,426 subjects submitted to transvenous lead extraction (TLE) in the Reference Center on Lead Extraction in Lublin, Poland, between March 2006 and July 2013 due to infectious (619 patients-43.4%) and noninfectious (807-56.6% of patients) reasons. During the period of 2006-2011, the analysis was conducted retrospectively; from early 2012 on, patients were enrolled prospectively. The effect of potential risk factors on the development of the disease was evaluated in a comparative analysis of clinical data from the LDIE patients and from 807 subjects with noninfectious indications for TLE. Additionally, in order to identify the factors predisposing to the development of LDIE, the population of infectious patients was divided into three subgroups: with isolated LDIE (157 patients), with LDIE and pocket infection (PI; 257 patients), and with isolated PI (205 patients). The groups and subgroups were analyzed for the presence of patient-dependent risk factors (age, gender, accompanying diseases, anticoagulation, or antiplatelet therapy) and procedure-related risk factors (the number and lead dwell time, pacing system, prior procedures, lead loops, and intracardiac abrasion of the leads). Furthermore, microbes' identification was conducted. The LDIE patients were older (67.3 vs 62.3; P = 0.001) and were more frequently male (68.6% vs 55.0%; P = 0.001) as compared with patients submitted to TLE for noninfectious reasons, but not in comparison with subjects diagnosed with isolated LDIE. In univariate analysis, the independent prognostic factors of LDIE were: type 2 diabetes-increase of risk by 37.7% (hazard ratio [HR] = 1,377; 95% confidence interval [CI] [1,088-1,742]), elevated above 2 mg% creatinine level-increase of risk by 61.5% (HR = 1,615; 95% CI [1,96-2,182]), antiplatelet therapy (HR = 1,285; 95% CI [1,052-1,057]), number of intracardiac leads prior to TLE (HR = 1,199; 95% CI [1,075-1,337]), intracardiac device with implantable cardioverter defibrillator (ICD) lead (HR = 1,909; 95% CI [1,492-2,444]), intracardiac device with coronary sinus lead (HR = 1,411; 95% CI [1,099-1,810]), number of procedures prior to TLE (HR = 1,092; 95% CI [1,017-1,172]), and abrasion of intracardiac leads (HR = 1,350; 95% CI [1,097-1,662]). Multivariate logistic regression demonstrated that the independent risk factors of LDIE were: chronic renal failure (HR = 1,406; 95% CI [1,033-1,915]), number of intracardiac leads prior to TLE (HR = 1,152; 95% CI [1,017-1,305]), intracardiac devices with ICD leads (HR = 1,719; 95% CI [1,330-2,223]), and presence of abrasion of intracardiac leads (HR = 1,405; 95% CI [1,129-1,750]). Microbiological analysis showed the domination of coagulase-negative staphylococci with relative advantage of Staphylococcus epidermidis in pathogenesis of LDIE. The factors predisposing to LDIE are mainly related to procedures performed on the patients. LDIE develops more frequently in patients with multiple leads, especially ICD. An important, until now lesser known, risk factor for LDIE is intracardiac abrasion of the leads strongly connected with procedural agents and properties of specific kind of bacteries. A new concept of the pathogenesis of LDIE was proposed on the basis of present analysis. ©2015 Wiley Periodicals, Inc.

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

Systems Architectures for a Tactical Naval Command and Control System

DTIC Science & Technology

2009-03-01

Supplement TST Time-sensitive Targeting TTP Tactics, Techniques, and Procedures WTP Weapons-target pairing xix GLOSSARY Analysis...target pairings ( WTPs ) and are presented to OTC [a]. 24. OTC conducts risk assessment of engagement options [a]. 25. OTC orders confirmed surface...engagement options are generated through weapon- target pairings ( WTPs ) and are presented to OTC [a]. 24. OTC conducts risk assessment of engagement

Frontal sinus revision rate after nasal polyposis surgery including frontal recess clearance and middle turbinectomy: A long-term analysis.

PubMed

Benkhatar, Hakim; Khettab, Idir; Sultanik, Philippe; Laccourreye, Ollivier; Bonfils, Pierre

2018-08-01

To determine the frontal sinus revision rate after nasal polyposis (NP) surgery including frontal recess clearance (FRC) and middle turbinectomy (MT), to search for predictive factors and to analyse surgical management. Longitudinal analysis of 153 patients who consecutively underwent bilateral sphenoethmoidectomy with FRC and MT for NP with a minimum follow-up of 7 years. Decision of revision surgery was made in case of medically refractory chronic frontal sinusitis or frontal mucocele. Univariate and multivariate analysis incorporating clinical and radiological variables were performed. The frontal sinus revision rate was 6.5% (10/153). The mean time between the initial procedure and revision surgery was 3 years, 10 months. Osteitis around the frontal sinus outflow tract (FSOT) was associated with a higher risk of frontal sinus revision surgery (p=0.01). Asthma and aspirin intolerance did not increase the risk, as well as frontal sinus ostium diameter or residual frontoethmoid cells. Among revised patients, 60% required multiple procedures and 70% required frontal sinus ostium enlargement. Our long-term study reports that NP surgery including FRC and MT is associated with a low frontal sinus revision rate (6.5%). Patients developing osteitis around the FSOT have a higher risk of frontal sinus revision surgery. As mucosal damage can lead to osteitis, FSOT mucosa should be preserved during initial NP surgery. However, as multiple procedures are common among NP patients requiring frontal sinus revision, frontal sinus ostium enlargement should be considered during first revision in the hope of reducing the need of further revisions. Copyright © 2018 Elsevier B.V. All rights reserved.

Post-ERCP acute pancreatitis and its risk factors.

PubMed

Iorgulescu, A; Sandu, I; Turcu, F; Iordache, N

2013-03-15

Endoscopic retrograde cholangiopancreatography (ERCP) is a complex endoscopic technique that evolved from a diagnostic to a mainly therapeutic procedure. This was due to the identification of post-procedural complications that can follow both simple ERCP and that associated with the instrumentation of the biliary and pancreatic ductals. The identification of post ERCP complications in a proportion of 5 to 10% of cases, with a mortality rate of 0.33%, imposed their analysis and study of risk factors involved in their occurrence. The significance of post ERCP complications reveals the necessity of their avoidance by adopting additional measures if risk factors are identified. We have retrospectively analyzed 900 cases that underwent ERCP in the Surgery Department of "Sf. Ioan" Clinical Hospital in a period of 17 years. The complications of the procedure were studied. Among them, a special attention was given to post-ERCP acute pancreatitis (pERCP-AP), the most common complication that occurred in the study group. We also tried to find out and highlight the risk factors for this complication. ERCP is a relatively safe invasive procedure, yet it has complications (8% of cases), some of them potentially fatal (mortality 0.43%). The most common complications after ERCP are acute pancreatitis (3.7%), papillary bleeding (1.04%), retroperitoneal duodenal perforation (0.69%) and biliary septic complications like acute cholecystitis and cholangitis (1.21%). Acute pancreatitis is by far the most common complication. Risk factors for its occurrence are difficult sphincterotomy with precut use, failure of CBD desobstruction, pancreatic sphincterotomy, repeated injection of contrast in the pancreatic ductal system, dysfunction of the sphincter of Oddi and the absence of changes of chronic pancreatitis. When risk factors are identified, the patients' selection must be very strict and diagnostic ERCP should be avoided in favor of non-invasive diagnostic methods (MRI-cholangiography, echo-endoscopy).

Preoperative Detection of Sarcopenic Obesity Helps to Predict the Occurrence of Gastric Leak After Sleeve Gastrectomy.

PubMed

Gaillard, Martin; Tranchart, Hadrien; Maitre, Sophie; Perlemuter, Gabriel; Lainas, Panagiotis; Dagher, Ibrahim

2018-03-02

Sleeve gastrectomy (SG) has become the primary procedure for many bariatric teams and staple-line leak represents its most feared complication. Sarcopenic obesity combines the risks of obesity and depleted lean mass leading possibly to an inferior surgical outcome after abdominal surgery. The aim of this study was to evaluate the existence of a potential link between radiologically determined sarcopenic obesity and staple-line leak risk after SG. A retrospective analysis of a prospective database was performed in consecutive patients undergoing SG as primary procedure. Total psoas muscles (TPA) and total visible muscles (TMA) areas were measured on a preoperative computed tomography (CT). Sarcopenia was defined as lowest tertile of skeletal muscular mass indexes (muscular areas over square of height) in each gender (using TPA or TMA). Multivariate analysis was performed to determine preoperative risk factors for staple-line leak. During the study period, 205 patients were included in the analysis. Median BMI was 40.8 kg/m 2 (34.2-49.6), and 9 patients (4.4%) presented a gastric leak. The sex-specific cut-offs for skeletal muscular mass index according to TPA were 8.2 cm 2 /m 2 for men and 6.08 cm 2 /m 2 for women. After multivariate analysis, preoperative weight (OR = 1043) and sarcopenia (TPA) (OR = 5204) were independent predictive factors for gastric leak. The present series suggests that CT scan-determined sarcopenic obesity is associated with increased risk of gastric leak after SG. This preoperatively radiological examination would be a useful clinical tool to tailor patient management according to gastric leak risk.

Risk based inspection for atmospheric storage tank

NASA Astrophysics Data System (ADS)

Nugroho, Agus; Haryadi, Gunawan Dwi; Ismail, Rifky; Kim, Seon Jin

2016-04-01

Corrosion is an attack that occurs on a metallic material as a result of environment's reaction.Thus, it causes atmospheric storage tank's leakage, material loss, environmental pollution, equipment failure and affects the age of process equipment then finally financial damage. Corrosion risk measurement becomesa vital part of Asset Management at the plant for operating any aging asset.This paper provides six case studies dealing with high speed diesel atmospheric storage tank parts at a power plant. A summary of the basic principles and procedures of corrosion risk analysis and RBI applicable to the Process Industries were discussed prior to the study. Semi quantitative method based onAPI 58I Base-Resource Document was employed. The risk associated with corrosion on the equipment in terms of its likelihood and its consequences were discussed. The corrosion risk analysis outcome used to formulate Risk Based Inspection (RBI) method that should be a part of the atmospheric storage tank operation at the plant. RBI gives more concern to inspection resources which are mostly on `High Risk' and `Medium Risk' criteria and less on `Low Risk' shell. Risk categories of the evaluated equipment were illustrated through case study analysis outcome.

Unanticipated hospital admission in pediatric patients with congenital heart disease undergoing ambulatory noncardiac surgical procedures.

PubMed

Yuki, Koichi; Koutsogiannaki, Sophia; Lee, Sandra; DiNardo, James A

2018-05-18

An increasing number of surgical and nonsurgical procedures are being performed on an ambulatory basis in children. Analysis of a large group of pediatric patients with congenital heart disease undergoing ambulatory procedures has not been undertaken. The objective of this study was to characterize the profile of children with congenital heart disease who underwent noncardiac procedures on an ambulatory basis at our institution, to determine the incidence of adverse cardiovascular and respiratory adverse events, and to determine the risk factors for unscheduled hospital admission. This is a retrospective study of children with congenital heart disease who underwent noncardiac procedures on an ambulatory basis in a single center. Using the electronic preoperative anesthesia evaluation form, we identified 3010 patients with congenital heart disease who underwent noncardiac procedures of which 1028 (34.1%) were scheduled to occur on an ambulatory basis. Demographic, echocardiographic and functional status data, cardiovascular and respiratory adverse events, and reasons for postprocedure admission were recorded. Univariable analysis was conducted. The unplanned hospital admission was 2.7% and univariable analysis demonstrated that performance of an echocardiogram within 6 mo of the procedure and procedures performed in radiology were associated with postoperative admission. Cardiovascular adverse event incidence was 3.9%. Respiratory adverse event incidence was 1.8%. Ambulatory, noncomplex procedures can be performed in pediatric patients with congenital heart disease and good functional status with a relatively low unanticipated hospital admission rate. © 2018 John Wiley & Sons Ltd.

48 CFR 252.239-7018 - Supply chain risk.

Code of Federal Regulations, 2014 CFR

2014-10-01

... subsystem(s) of equipment, that is used in the automatic acquisition, storage, analysis, evaluation..., ancillary equipment (including imaging peripherals, input, output, and storage devices necessary for... of a computer, software, firmware and similar procedures, services (including support services), and...

Ergonomic assessment for the task of repairing computers in a manufacturing company: A case study.

PubMed

Maldonado-Macías, Aidé; Realyvásquez, Arturo; Hernández, Juan Luis; García-Alcaraz, Jorge

2015-01-01

Manufacturing industry workers who repair computers may be exposed to ergonomic risk factors. This project analyzes the tasks involved in the computer repair process to (1) find the risk level for musculoskeletal disorders (MSDs) and (2) propose ergonomic interventions to address any ergonomic issues. Work procedures and main body postures were video recorded and analyzed using task analysis, the Rapid Entire Body Assessment (REBA) postural method, and biomechanical analysis. High risk for MSDs was found on every subtask using REBA. Although biomechanical analysis found an acceptable mass center displacement during tasks, a hazardous level of compression on the lower back during computer's transportation was detected. This assessment found ergonomic risks mainly in the trunk, arm/forearm, and legs; the neck and hand/wrist were also compromised. Opportunities for ergonomic analyses and interventions in the design and execution of computer repair tasks are discussed.

Glycopeptides versus β-lactams for the prevention of surgical site infections in cardiovascular and orthopedic surgery: a meta-analysis.

PubMed

Saleh, Anas; Khanna, Ashish; Chagin, Kevin M; Klika, Alison K; Johnston, Douglas; Barsoum, Wael K

2015-01-01

To compare the efficacy of glycopeptides and β-lactams in preventing surgical site infections (SSIs) in cardiac, vascular, and orthopedic surgery. The cost-effectiveness of switching from β-lactams to glycopeptides for preoperative antibiotic prophylaxis has been controversial. β-Lactams are generally recommended in clean surgical procedures, but they are ineffective against resistant gram-positive bacteria. PubMed, International Pharmaceuticals Abstracts, Scopus, and Cochrane were searched for randomized clinical trials comparing glycopeptides and β-lactams for prophylaxis in adults undergoing cardiac, vascular, or orthopedic surgery. Abstracts and conference proceedings were included. Two independent reviewers performed study selection, data extraction, and assessment of risk of bias. Fourteen studies with a total of 8952 patients were analyzed. No difference was detected in overall SSIs between antibiotic types. However, compared with β-lactams, glycopeptides reduced the risk of resistant staphylococcal SSIs by 48% (relative risk, 0.52; 95% confidence interval, 0.29-0.93; P = 0.03) and enterococcal SSIs by 64% (relative risk, 0.36; 95% confidence interval, 0.16-0.80; P = 0.01), but increased respiratory tract infections by 54% (relative risk, 1.54; 95% confidence interval, 1.19-2.01; P ≤ 0.01). Subgroup analysis of cardiac procedures showed superiority of β-lactams in preventing superficial and deep chest SSIs, susceptible staphylococcal SSIs, and respiratory tract infections. Glycopeptides reduce the risk of resistant staphylococcal SSIs and enterococcal SSIs, but increase the risk of respiratory tract infections. Additional high-quality randomized clinical trials are needed as these results are limited by high risk of bias.

How do women at increased breast cancer risk perceive and decide between risks of cancer and risk-reducing treatments? A synthesis of qualitative research.

PubMed

Fielden, Hannah G; Brown, Stephen L; Saini, Pooja; Beesley, Helen; Salmon, Peter

2017-09-01

Risk-reducing procedures can be offered to people at increased cancer risk, but many procedures can have iatrogenic effects. People therefore need to weigh risks associated with both cancer and the risk-reduction procedure in their decisions. By reviewing relevant literature on breast cancer (BC) risk reduction, we aimed to understand how women at relatively high risk of BC perceive their risk and how their risk perceptions influence their decisions about risk reduction. Synthesis of 15 qualitative studies obtained from systematic searches of SCOPUS, Web of Knowledge, PsychINFO, and Medline electronic databases (inception-June 2015). Women did not think about risk probabilistically. Instead, they allocated themselves to broad risk categories, typically influenced by their own or familial experiences of BC. In deciding about risk-reduction procedures, some women reported weighing the risks and benefits, but papers did not describe how they did so. For many women, however, an overriding wish to reduce intense worry about BC led them to choose aggressive risk-reducing procedures without such deliberation. Reasoning that categorisation is a fundamental aspect of risk perception, we argue that patients can be encouraged to develop more nuanced and accurate categorisations of their own risk through their interactions with clinicians. Empirically-based ethical reflection is required to determine whether and when it is appropriate to provide risk-reduction procedures to alleviate worry. © 2016 The Authors. Psycho-Oncology Published by John Wiley & Sons Ltd.

Combining abdominal and cosmetic breast surgery does not increase short-term complication rates: a comparison of each individual procedure and pretreatment risk stratification tool.

PubMed

Khavanin, Nima; Jordan, Sumanas W; Vieira, Brittany L; Hume, Keith M; Mlodinow, Alexei S; Simmons, Christopher J; Murphy, Robert X; Gutowski, Karol A; Kim, John Y S

2015-11-01

Combined abdominal and breast surgery presents a convenient and relatively cost-effective approach for accomplishing both procedures. This study is the largest to date assessing the safety of combined procedures, and it aims to develop a simple pretreatment risk stratification method for patients who desire a combined procedure. All women undergoing abdominoplasty, panniculectomy, augmentation mammaplasty, and/or mastopexy in the TOPS database were identified. Demographics and outcomes for combined procedures were compared to individual procedures using χ(2) and Student's t-tests. Multiple logistic regression provided adjusted odds ratios for the effect of a combined procedure on 30-day complications. Among combined procedures, a logistic regression model determined point values for pretreatment risk factors including diabetes (1 point), age over 53 (1), obesity (2), and 3+ ASA status (3), creating a 7-point pretreatment risk stratification tool. A total of 58,756 cases met inclusion criteria. Complication rates among combined procedures (9.40%) were greater than those of aesthetic breast surgery (2.66%; P < .001) but did not significantly differ from abdominal procedures (9.75%; P = .530). Nearly 77% of combined cases were classified as low-risk (0 points total) with a 9.78% complication rates. Medium-risk patients (1 to 3 points) had a 16.63% complication rate, and high-risk (4 to 7 points) 38.46%. Combining abdominal and breast procedures is safe in the majority of patients and does not increase 30-day complications rates. The risk stratification tool can continue to ensure favorable outcomes for patients who may desire a combined surgery. 4 Risk. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Endoscopy in patients on antiplatelet or anticoagulant therapy, including direct oral anticoagulants: British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines.

PubMed

Veitch, Andrew M; Vanbiervliet, Geoffroy; Gershlick, Anthony H; Boustiere, Christian; Baglin, Trevor P; Smith, Lesley-Ann; Radaelli, Franco; Knight, Evelyn; Gralnek, Ian M; Hassan, Cesare; Dumonceau, Jean-Marc

2016-04-01

The risk of endoscopy in patients on antithrombotics depends on the risks of procedural haemorrhage vs. thrombosis due to discontinuation of therapy. P2Y12 receptor antagonists (clopidogrel, prasugrel, ticagrelor): For low-risk endoscopic procedures we recommend continuing P2Y12 receptor antagonists as single or dual antiplatelet therapy (low quality evidence, strong recommendation);For high-risk endoscopic procedures in patients at low thrombotic risk, we recommend discontinuing P2Y12 receptor antagonists five days before the procedure (moderate quality evidence, strong recommendation). In patients on dual antiplatelet therapy, we suggest continuing aspirin (low quality evidence, weak recommendation).For high-risk endoscopic procedures in patients at high thrombotic risk, we recommend continuing aspirin and liaising with a cardiologist about the risk/benefit of discontinuation of P2Y12 receptor antagonists (high quality evidence, strong recommendation). Warfarin: The advice for warfarin is fundamentally unchanged from BSG 2008 guidance. Direct Oral Anticoagulants (DOAC): For low-risk endoscopic procedures we suggest omitting the morning dose of DOAC on the day of the procedure (very low quality evidence, weak recommendation). For high-risk endoscopic procedures, we recommend that the last dose of DOAC be taken ≥ 48 hours before the procedure (very low quality evidence, strong recommendation). For patients on dabigatran with CrCl (or estimated glomerular filtration rate, eGFR) of 30 - 50 mL/min we recommend that the last dose of DOAC be taken 72 hours before the procedure (very low quality evidence, strong recommendation). In any patient with rapidly deteriorating renal function a haematologist should be consulted (low quality evidence, strong recommendation). © Georg Thieme Verlag KG Stuttgart · New York.

Through ARIPAR-GIS the quantified area risk analysis supports land-use planning activities.

PubMed

Spadoni, G; Egidi, D; Contini, S

2000-01-07

The paper first summarises the main aspects of the ARIPAR methodology whose steps can be applied to quantify the impact on a territory of major accident risks due to processing, storing and transporting dangerous substances. Then the capabilities of the new decision support tool ARIPAR-GIS, implementing the mentioned procedure, are described, together with its main features and types of results. These are clearly shown through a short description of the updated ARIPAR study (reference year 1994), in which the impact of changes due to industrial and transportation dynamics on the Ravenna territory in Italy were evaluated. The brief explanation of how results have been used by local administrations offers the opportunity to discuss about advantages of the quantitative area risk analysis tool in supporting activities of risk management, risk control and land-use planning.

A spin column-free approach to sodium hydroxide-based glycan permethylation.

PubMed

Hu, Yueming; Borges, Chad R

2017-07-24

Glycan permethylation was introduced as a tool to facilitate the study of glycans in 1903. Since that time, permethylation procedures have been continually modified to improve permethylation efficiency and qualitative applicability. Typically, however, either laborious preparation steps or cumbersome and uneconomical spin columns have been needed to obtain decent permethylation yields on small glycan samples. Here we describe a spin column-free (SCF) glycan permethylation procedure that is applicable to both O- and N-linked glycans and can be employed upstream to intact glycan analysis by MALDI-MS, ESI-MS, or glycan linkage analysis by GC-MS. The SCF procedure involves neutralization of NaOH beads by acidified phosphate buffer, which eliminates the risk of glycan oxidative degradation and avoids the use of spin columns. Optimization of the new permethylation procedure provided high permethylation efficiency for both hexose (>98%) and HexNAc (>99%) residues-yields which were comparable to (or better than) those of some widely-used spin column-based procedures. A light vs. heavy labelling approach was employed to compare intact glycan yields from a popular spin-column based approach to the SCF approach. Recovery of intact N-glycans was significantly better with the SCF procedure (p < 0.05), but overall yield of O-glycans was similar or slightly diminished (p < 0.05 for tetrasaccharides or smaller). When the SCF procedure was employed upstream to hydrolysis, reduction and acetylation for glycan linkage analysis of pooled glycans from unfractionated blood plasma, analytical reproducibility was on par with that from previous spin column-based "glycan node" analysis results. When applied to blood plasma samples from stage III-IV breast cancer patients (n = 20) and age-matched controls (n = 20), the SCF procedure facilitated identification of three glycan nodes with significantly different distributions between the cases and controls (ROC c-statistics > 0.75; p < 0.01). In summary, the SCF permethylation procedure expedites and economizes both intact glycan analysis and linkage analysis of glycans from whole biospecimens.

A spin column-free approach to sodium hydroxide-based glycan permethylation†

PubMed Central

Hu, Yueming; Borges, Chad R.

2018-01-01

Glycan permethylation was introduced as a tool to facilitate the study of glycans in 1903. Since that time, permethylation procedures have been continually modified to improve permethylation efficiency and qualitative applicability. Typically, however, either laborious preparation steps or cumbersome and uneconomical spin columns have been needed to obtain decent permethylation yields on small glycan samples. Here we describe a spin column-free (SCF) glycan permethylation procedure that is applicable to both O- and N-linked glycans and can be employed upstream to intact glycan analysis by MALDI-MS, ESI-MS, or glycan linkage analysis by GC-MS. The SCF procedure involves neutralization of NaOH beads by acidified phosphate buffer, which eliminates the risk of glycan oxidative degradation and avoids the use of spin columns. Optimization of the new permethylation procedure provided high permethylation efficiency for both hexose (>98%) and HexNAc (>99%) residues—yields which were comparable to (or better than) those of some widely-used spin column-based procedures. A light vs. heavy labelling approach was employed to compare intact glycan yields from a popular spin-column based approach to the SCF approach. Recovery of intact N-glycans was significantly better with the SCF procedure (p < 0.05), but overall yield of O-glycans was similar or slightly diminished (p < 0.05 for tetrasaccharides or smaller). When the SCF procedure was employed upstream to hydrolysis, reduction and acetylation for glycan linkage analysis of pooled glycans from unfractionated blood plasma, analytical reproducibility was on par with that from previous spin column-based “glycan node” analysis results. When applied to blood plasma samples from stage III–IV breast cancer patients (n = 20) and age-matched controls (n = 20), the SCF procedure facilitated identification of three glycan nodes with significantly different distributions between the cases and controls (ROC c-statistics > 0.75; p < 0.01). In summary, the SCF permethylation procedure expedites and economizes both intact glycan analysis and linkage analysis of glycans from whole biospecimens. PMID:28635997

Quality and Safety in Health Care, Part XXI: PSOs and the Vascular Quality Initiative.

PubMed

Harolds, Jay A

2017-04-01

Congress provided for the formation of patient safety organizations (PSOs) so that physicians and other providers would come forward to improve the safety and quality of health care. Important legal safeguards for the providers and patients were put in place for PSOs. The Society for Vascular Surgery (SVS) PSO operates the Vascular Quality Initiative. The latter gathers information from certain commonly done vascular procedures. First, information is collected so a risk adjustment determination of each individual patient can be done. Then the details of every procedure are recorded for later analysis of the processes of the patient's care. In addition, outcome analysis from all procedures is carried out. This registry is an important source of data for research improving health care safety and quality.

Oral Hydration for Prevention of Contrast-Induced Acute Kidney Injury in Elective Radiological Procedures: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

PubMed Central

Cheungpasitporn, Wisit; Thongprayoon, Charat; Brabec, Brady A.; Edmonds, Peter J.; O'Corragain, Oisin A.; Erickson, Stephen B.

2014-01-01

Background: The reports on efficacy of oral hydration treatment for the prevention of contrast-induced acute kidney injury (CIAKI) in elective radiological procedures and cardiac catheterization remain controversial. Aims: The objective of this meta-analysis was to assess the use of oral hydration regimen for prevention of CIAKI. Materials and Methods: Comprehensive literature searches for randomized controlled trials (RCTs) of outpatient oral hydration treatment was performed using MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials Systematic Reviews, and clinicaltrials.gov from inception until July 4th, 2014. Primary outcome was the incidence of CIAKI. Results: Six prospective RCTs were included in our analysis. Of 513patients undergoing elective procedures with contrast exposures,45 patients (8.8%) had CIAKI. Of 241 patients with oral hydration regimen, 23 (9.5%) developed CIAKI. Of 272 patients with intravenous (IV) fluid regimen, 22 (8.1%) had CIAKI. Study populations in all included studies had relatively normal kidney function to chronic kidney disease (CKD) stage 3. There was no significant increased risk of CIAKI in oral fluid regimen group compared toIV fluid regimen group (RR = 0.94, 95% confidence interval, CI = 0.38-2.31). Conclusions: According to our analysis,there is no evidence that oral fluid regimen is associated with more risk of CIAKI in patients undergoing elective procedures with contrast exposures compared to IV fluid regimen. This finding suggests that the oral fluid regimen might be considered as a possible outpatient treatment option for CIAKI prevention in patients with normal to moderately reduced kidney function. PMID:25599049

Reliability of Laparoscopic Compared With Hysteroscopic Sterilization at One Year: A Decision Analysis

PubMed Central

Gariepy, Aileen M.; Creinin, Mitchell D.; Schwarz, Eleanor B.; Smith, Kenneth J.

2011-01-01

OBJECTIVE To estimate the probability of successful sterilization after hysteroscopic or laparoscopic sterilization procedure. METHODS An evidence-based clinical decision analysis using a Markov model was performed to estimate the probability of a successful sterilization procedure using laparoscopic sterilization, hysteroscopic sterilization in the operating room, and hysteroscopic sterilization in the office. Procedure and follow-up testing probabilities for the model were estimated from published sources. RESULTS In the base case analysis, the proportion of women having a successful sterilization procedure on first attempt is 99% for laparoscopic, 88% for hysteroscopic in the operating room and 87% for hysteroscopic in the office. The probability of having a successful sterilization procedure within one year is 99% with laparoscopic, 95% for hysteroscopic in the operating room, and 94% for hysteroscopic in the office. These estimates for hysteroscopic success include approximately 6% of women who attempt hysteroscopically but are ultimately sterilized laparoscopically. Approximately 5% of women who have a failed hysteroscopic attempt decline further sterilization attempts. CONCLUSIONS Women choosing laparoscopic sterilization are more likely than those choosing hysteroscopic sterilization to have a successful sterilization procedure within one year. However, the risk of failed sterilization and subsequent pregnancy must be considered when choosing a method of sterilization. PMID:21775842

Reliability of laparoscopic compared with hysteroscopic sterilization at 1 year: a decision analysis.

PubMed

Gariepy, Aileen M; Creinin, Mitchell D; Schwarz, Eleanor B; Smith, Kenneth J

2011-08-01

To estimate the probability of successful sterilization after an hysteroscopic or laparoscopic sterilization procedure. An evidence-based clinical decision analysis using a Markov model was performed to estimate the probability of a successful sterilization procedure using laparoscopic sterilization, hysteroscopic sterilization in the operating room, and hysteroscopic sterilization in the office. Procedure and follow-up testing probabilities for the model were estimated from published sources. In the base case analysis, the proportion of women having a successful sterilization procedure on the first attempt is 99% for laparoscopic sterilization, 88% for hysteroscopic sterilization in the operating room, and 87% for hysteroscopic sterilization in the office. The probability of having a successful sterilization procedure within 1 year is 99% with laparoscopic sterilization, 95% for hysteroscopic sterilization in the operating room, and 94% for hysteroscopic sterilization in the office. These estimates for hysteroscopic success include approximately 6% of women who attempt hysteroscopically but are ultimately sterilized laparoscopically. Approximately 5% of women who have a failed hysteroscopic attempt decline further sterilization attempts. Women choosing laparoscopic sterilization are more likely than those choosing hysteroscopic sterilization to have a successful sterilization procedure within 1 year. However, the risk of failed sterilization and subsequent pregnancy must be considered when choosing a method of sterilization.

The impact of obesity on 30-day complications in pediatric surgery.

PubMed

Train, A T; Cairo, S B; Meyers, H A; Harmon, C M; Rothstein, D H

2017-11-01

To examine the effects of obesity on specialty-specific surgical outcomes in children. Retrospective cohort study using the National Surgical Quality Improvement Program, Pediatric, 2012-2014. Patients included those aged 2-17 years who underwent a surgical procedure in one of six specialties. Obesity was the primary patient variable of interest. Outcomes of interest were postoperative complications and operative times. Odds ratios for development of postoperative complications were calculated using stepwise multivariate regression analysis. Obesity was associated with a significantly greater risk of wound complications (OR 1.24, 95% CI 1.13-1.36), but decreased risk of non-wound complications (OR 0.68, 95% CI 0.63-0.73) and morbidity (OR 0.79, 95% CI 0.75-0.84). Obesity was not a significant factor in predicting postoperative complications in patients undergoing otolaryngology or plastic surgery procedures. Anesthesia times and operative times were significantly longer for obese patients undergoing most types of pediatric surgical procedures. Obesity confers an increased risk of wound complications in some pediatric surgical specialties and is associated with overall decreased non-wound complications and morbidity. These findings suggest that the relationship between obesity and postoperative complications is complex and may be more dependent on underlying procedure- or specialty-related factors than previously suspected.

Comparison of risk assessment procedures used in OCRA and ULRA methods

PubMed Central

Roman-Liu, Danuta; Groborz, Anna; Tokarski, Tomasz

2013-01-01

The aim of this study was to analyse the convergence of two methods by comparing exposure and the assessed risk of developing musculoskeletal disorders at 18 repetitive task workstations. The already established occupational repetitive actions (OCRA) and the recently developed upper limb risk assessment (ULRA) produce correlated results (R = 0.84, p = 0.0001). A discussion of the factors that influence the values of the OCRA index and ULRA's repetitive task indicator shows that both similarities and differences in the results produced by the two methods can arise from the concepts that underlie them. The assessment procedure and mathematical calculations that the basic parameters are subjected to are crucial to the results of risk assessment. The way the basic parameters are defined influences the assessment of exposure and risk assessment to a lesser degree. The analysis also proved that not always do great differences in load indicator values result in differences in risk zones. Practitioner Summary: We focused on comparing methods that, even though based on different concepts, serve the same purpose. The results proved that different methods with different assumptions can produce similar assessment of upper limb load; sharp criteria in risk assessment are not the best solution. PMID:24041375

Breast cancer risk from different mammography screening practices.

PubMed

Bijwaard, Harmen; Brenner, Alina; Dekkers, Fieke; van Dillen, Teun; Land, Charles E; Boice, John D

2010-09-01

Mammography screening is an accepted procedure for early detection of breast tumors among asymptomatic women. Since this procedure involves the use of X rays, it is itself potentially carcinogenic. Although there is general consensus about the benefit of screening for older women, screening practices differ between countries. In this paper radiation risks for these different practices are estimated using a new approach. We model breast cancer induction by ionizing radiation in a cohort of patients exposed to frequent X-ray examinations. The biologically based, mechanistic model provides a better foundation for the extrapolation of risks to different mammography screening practices than empirical models do. The model predicts that the excess relative risk (ERR) doubles when screening starts at age 40 instead of 50 and that a continuation of screening at ages 75 and higher carries little extra risk. The number of induced fatal breast cancers is estimated to be considerably lower than derived from epidemiological studies and from internationally accepted radiation protection risks. The present findings, if used in a risk-benefit analysis for mammography screening, would be more favorable to screening than estimates currently recommended for radiation protection. This has implications for the screening ages that are currently being reconsidered in several countries.

Task analysis method for procedural training curriculum development.

PubMed

Riggle, Jakeb D; Wadman, Michael C; McCrory, Bernadette; Lowndes, Bethany R; Heald, Elizabeth A; Carstens, Patricia K; Hallbeck, M Susan

2014-06-01

A central venous catheter (CVC) is an important medical tool used in critical care and emergent situations. Integral to proper care in many circumstances, insertion of a CVC introduces the risk of central line-associated blood stream infections and mechanical adverse events; proper training is important for safe CVC insertion. Cognitive task analysis (CTA) methods have been successfully implemented in the medical field to improve the training of postgraduate medical trainees, but can be very time-consuming to complete and require a significant time commitment from many subject matter experts (SMEs). Many medical procedures such as CVC insertion are linear processes with well-documented procedural steps. These linear procedures may not require a traditional CTA to gather the information necessary to create a training curriculum. Accordingly, a novel, streamlined CTA method designed primarily to collect cognitive cues for linear procedures was developed to be used by medical professionals with minimal CTA training. This new CTA methodology required fewer trained personnel, fewer interview sessions, and less time commitment from SMEs than a traditional CTA. Based on this study, a streamlined CTA methodology can be used to efficiently gather cognitive information on linear medical procedures for the creation of resident training curricula and procedural skills assessments.

Upper extremity palsy following cervical decompression surgery results from a transient spinal cord lesion.

PubMed

Hasegawa, Kazuhiro; Homma, Takao; Chiba, Yoshikazu

2007-03-15

Retrospective analysis. To test the hypothesis that spinal cord lesions cause postoperative upper extremity palsy. Postoperative paresis, so-called C5 palsy, of the upper extremities is a common complication of cervical surgery. Although there are several hypotheses regarding the etiology of C5 palsy, convincing evidence with a sufficient study population, statistical analysis, and clear radiographic images illustrating the nerve root impediment has not been presented. We hypothesized that the palsy is caused by spinal cord damage following the surgical decompression performed for chronic compressive cervical disorders. The study population comprised 857 patients with chronic cervical cord compressive lesions who underwent decompression surgery. Anterior decompression and fusion was performed in 424 cases, laminoplasty in 345 cases, and laminectomy in 88 cases. Neurologic characteristics of patients with postoperative upper extremity palsy were investigated. Relationships between the palsy, and patient sex, age, diagnosis, procedure, area of decompression, and preoperative Japanese Orthopaedic Association score were evaluated with a risk factor analysis. Radiographic examinations were performed for all palsy cases. Postoperative upper extremity palsy occurred in 49 cases (5.7%). The common features of the palsy cases were solely chronic compressive spinal cord disorders and decompression surgery to the cord. There was no difference in the incidence of palsy among the procedures. Cervical segments beyond C5 were often disturbed with frequent multiple segment involvement. There was a tendency for spontaneous improvement of the palsy. Age, decompression area (anterior procedure), and diagnosis (ossification of the posterior longitudinal ligament) are the highest risk factors of the palsy. The results of the present study support our hypothesis that the etiology of the palsy is a transient disturbance of the spinal cord following a decompression procedure. It appears to be caused by reperfusion after decompression of a chronic compressive lesion of the cervical cord. We recommend that physicians inform patients and surgeons of the potential risk of a spinal cord deficit after cervical decompression surgery.

Anthropometry in cardio-metabolic risk assessment.

PubMed

Mišigoj-Duraković, Marjeta; Sorić, Maroje; Duraković, Zijad

2014-03-01

High prevalence of obesity, as a major public health problem, is connected with chronic cardiovascular and metabolic diseases. That is why some simple anthropometric parameters were developed to estimate overweight and obesity, and in the primary screening of risk groups. In this field, body mass index (BMI) is the most frequent parameter, both in epidemiological research and in everyday practice. It is a part of the algorithm used in the early detection of overweight and obese persons. However, BMI does not provide any data on body composition. This is why it is particularly insufficient in estimating body mass in physically active persons and in athletes who are often overweight, with a higher proportion of lean body mass but without any excess fat, as well as in those with normal weight but lower than normal lean body mass and/ or gentle skeleton. Over the last few decades, attention has been especially directed to different body fat distribution in relation to chronic cardio-vascular and metabolic diseases. Waist circumference (WC) is the best anthropometric predictor of cardiovascular risk. It is considered an indirect parameter of visceral fat. WC and waist-to-hip ratio are good parameters showing body fat distribution and cardio-metabolic risk. Waist-to-height ratio is suggested by some authors to be an even better parameter of cardio-vascular risk and metabolic syndrome. Hypertriglyceridemia combined with increased WC is considered a marker of atherogenic metabolic risk. The paper also deals with procedures of body composition analysis. Anthropometric assessment of body composition analysis belongs to a group of simple and inexpensive procedures. Development of generalised equations for body density prediction introduced anthropometric methods in the analysis of body composition in everyday practice.

Risk factors for technical failure of endoscopic double self-expandable metallic stent placement by partial stent-in-stent method.

PubMed

Kawakubo, Kazumichi; Kawakami, Hiroshi; Toyokawa, Yoshihide; Otani, Koichi; Kuwatani, Masaki; Abe, Yoko; Kawahata, Shuhei; Kubo, Kimitoshi; Kubota, Yoshimasa; Sakamoto, Naoya

2015-01-01

Endoscopic double self-expandable metallic stent (SEMS) placement by the partial stent-in-stent (PSIS) method has been reported to be useful for the management of unresectable hilar malignant biliary obstruction. However, it is technically challenging, and the optimal SEMS for the procedure remains unknown. The aim of this study was to identify the risk factors for technical failure of endoscopic double SEMS placement for unresectable malignant hilar biliary obstruction (MHBO). Between December 2009 and May 2013, 50 consecutive patients with MHBO underwent endoscopic double SEMS placement by the PSIS method. We retrospectively evaluated the rate of successful double SEMS placement and identified the risk factors for technical failure. The technical success rate for double SEMS placement was 82.0% (95% confidence interval [CI]: 69.2-90.2). On univariate analysis, the rate of technical failure was high in patients with metastatic disease and unilateral placement. Multivariate analysis revealed that metastatic disease was a significant risk factor for technical failure (odds ratio: 9.63, 95% CI: 1.11-105.5). The subgroup analysis after double guidewire insertion showed that the rate of technical success was higher in the laser-cut type SEMS with a large mesh and thick delivery system than in the braided type SEMS with a small mesh and thick delivery system. Metastatic disease was a significant risk factor for technical failure of double SEMS placement for unresectable MHBO. The laser-cut type SEMS with a large mesh and thin delivery system might be preferable for the PSIS procedure. © 2014 Japanese Society of Hepato-Biliary-Pancreatic Surgery.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cheong, S-K; Kim, J

Purpose: The aim of the study is the application of a Failure Modes and Effects Analysis (FMEA) to access the risks for patients undergoing a Low Dose Rate (LDR) Prostate Brachytherapy Treatment. Methods: FMEA was applied to identify all the sub processes involved in the stages of identifying patient, source handling, treatment preparation, treatment delivery, and post treatment. These processes characterize the radiation treatment associated with LDR Prostate Brachytherapy. The potential failure modes together with their causes and effects were identified and ranked in order of their importance. Three indexes were assigned for each failure mode: the occurrence rating (O),more » the severity rating (S), and the detection rating (D). A ten-point scale was used to score each category, ten being the number indicating most severe, most frequent, and least detectable failure mode, respectively. The risk probability number (RPN) was calculated as a product of the three attributes: RPN = O X S x D. The analysis was carried out by a working group (WG) at UPMC. Results: The total of 56 failure modes were identified including 32 modes before the treatment, 13 modes during the treatment, and 11 modes after the treatment. In addition to the protocols already adopted in the clinical practice, the prioritized risk management will be implanted to the high risk procedures on the basis of RPN score. Conclusion: The effectiveness of the FMEA method was established. The FMEA methodology provides a structured and detailed assessment method for the risk analysis of the LDR Prostate Brachytherapy Procedure and can be applied to other radiation treatment modes.« less

12 CFR 563.176 - Interest-rate-risk-management procedures.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 5 2011-01-01 2011-01-01 false Interest-rate-risk-management procedures. 563... ASSOCIATIONS-OPERATIONS Financial Management Policies § 563.176 Interest-rate-risk-management procedures... association's management of that risk. (b) The board of directors shall formerly adopt a policy for the...

12 CFR 563.176 - Interest-rate-risk-management procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 12 Banks and Banking 5 2010-01-01 2010-01-01 false Interest-rate-risk-management procedures. 563... ASSOCIATIONS-OPERATIONS Financial Management Policies § 563.176 Interest-rate-risk-management procedures... association's management of that risk. (b) The board of directors shall formerly adopt a policy for the...

Use of an operating microscope during spine surgery is associated with minor increases in operating room times and no increased risk of infection.

PubMed

Basques, Bryce A; Golinvaux, Nicholas S; Bohl, Daniel D; Yacob, Alem; Toy, Jason O; Varthi, Arya G; Grauer, Jonathan N

2014-10-15

Retrospective database review. To evaluate whether microscope use during spine procedures is associated with increased operating room times or increased risk of infection. Operating microscopes are commonly used in spine procedures. It is debated whether the use of an operating microscope increases operating room time or confers increased risk of infection. The American College of Surgeons National Surgical Quality Improvement Program database, which includes data from more than 370 participating hospitals, was used to identify patients undergoing elective spinal procedures with and without the use of an operating microscope for the years 2011 and 2012. Bivariate and multivariate linear regressions were used to test the association between microscope use and operating room times. Bivariate and multivariate logistic regressions were similarly conducted to test the association between microscope use and infection occurrence within 30 days of surgery. A total of 23,670 elective spine procedures were identified, of which 2226 (9.4%) used an operating microscope. The average patient age was 55.1±14.4 years. The average operative time (incision to closure) was 125.7±82.0 minutes.Microscope use was associated with minor increases in preoperative room time (+2.9 min, P=0.013), operative time (+13.2 min, P<0.001), and total room time (+18.6 min, P<0.001) on multivariate analysis.A total of 328 (1.4%) patients had an infection within 30 days of surgery. Multivariate analysis revealed no significant difference between the microscope and nonmicroscope groups for occurrence of any infection, superficial surgical site infection, deep surgical site infection, organ space infection, or sepsis/septic shock, regardless of surgery type. We did not find operating room times or infection risk to be significant deterrents for use of an operating microscope during spine surgery. 3.

Use of an operating microscope during spine surgery is associated with minor increases in operating room times and no increased risk of infection

PubMed Central

Basques, Bryce A.; Golinvaux, Nicholas S.; Bohl, Daniel D.; Yacob, Alem; Toy, Jason O.; Varthi, Arya G.; Grauer, Jonathan N.

2014-01-01

Study Design Retrospective database review. Objective To evaluate whether microscope use during spine procedures is associated with increased operating room times or increased risk of infection. Summary of Background Data Operating microscopes are commonly used in spine procedures. It is debated whether the use of an operating microscope increases operating room time or confers increased risk of infection. Methods The American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) database, which includes data from over 370 participating hospitals, was used to identify patients undergoing elective spinal procedures with and without an operating microscope for the years 2011 and 2012. Bivariate and multivariate linear regressions were used to test the association between microscope use and operating room times. Bivariate and multivariate logistic regressions were similarly conducted to test the association between microscope use and infection occurrence within 30 days of surgery. Results A total of 23,670 elective spine procedures were identified, of which 2,226 (9.4%) used an operating microscope. The average patient age was 55.1 ± 14.4 years. The average operative time (incision to closure) was 125.7 ± 82.0 minutes. Microscope use was associated with minor increases in preoperative room time (+2.9 minutes, p=0.013), operative time (+13.2 minutes, p<0.001), and total room time (+18.6 minutes, p<0.001) on multivariate analysis. A total of 328 (1.4%) patients had an infection within 30 days of surgery. Multivariate analysis revealed no significant difference between the microscope and non-microscope groups for occurrence of any infection, superficial surgical site infection (SSI), deep SSI, organ space infection, or sepsis/septic shock, regardless of surgery type. Conclusions We did not find operating room times or infection risk to be significant deterrents for use of an operating microscope during spine surgery. PMID:25188600

Academic status does not affect outcome following complex hepato-pancreato-biliary procedures.

PubMed

Altieri, Maria S; Yang, Jie; Groves, Donald; Yin, Donglei; Cagino, Kristen; Talamini, Mark; Pryor, Aurora

2018-05-01

There is a growing debate regarding outcomes following complex hepato-pancreato-biliary (HPB) procedures. The purpose of our study is to examine if facility type has any impact on complications, readmission rates, emergency department (ED) visit rates, and length of stay (LOS) for patients undergoing HPB surgery. The SPARCS administrative database was used to identify patients undergoing complex HPB procedures between 2012 and 2014 in New York. Univariate generalized linear mixed models were fit to estimate the marginal association between outcomes such as overall/severe complication rates, 30-day and 1-year readmission rates, 30-day and 1-year ED-visit rates, and potential risk factors. Univariate linear mixed models were used to estimate the marginal association between possible risk factors and LOS. Facility type, as well as any variables found to be significant in our univariate analysis (p = 0.05), was further included in the multivariable regression models. There were 4122 complex HPB procedures performed. Academic facilities were more likely to have a higher hospital volume (p < 0001). Surgery at academic facilities were less likely to have coexisting comorbidities; however, they were more likely to have metastatic cancer and/or liver disease (p = 0.0114, < 0. 0001, and = 0.0299, respectively). Postoperatively, patients at non-academic facilities experienced higher overall complication rates, and higher severe complication rates, when compared to those at academic facilities (p < 0.0001 and = 0.0018, respectively). Further analysis via adjustment for possible confounding factors, however, revealed no significant difference in the risk of severe complications between the two facility types. Such adjustment also demonstrated higher 30-day readmission risk in patients who underwent their surgery at an academic facility. No significant difference was found when comparing the outcomes of academic and non-academic facilities, after adjusting for age, gender, race, region, insurance, and hospital volume. Patients from academic facilities were more likely to be readmitted within the first 30-days after surgery.

Assessment of Various Risk Factors for Success of Delayed and Immediate Loaded Dental Implants: A Retrospective Analysis.

PubMed

Prasant, M C; Thukral, Rishi; Kumar, Sachin; Sadrani, Sannishth M; Baxi, Harsh; Shah, Aditi

2016-10-01

Ever since its introduction in 1977, a minimum of few months of period is required for osseointegration to take place after dental implant surgery. With the passage of time and advancements in the fields of dental implant, this healing period is getting smaller and smaller. Immediate loading of dental implants is becoming a very popular procedure in the recent time. Hence, we retrospectively analyzed the various risk factors for the failure of delayed and immediate loaded dental implants. In the present study, retrospective analysis of all the patients was done who underwent dental implant surgeries either by immediate loading procedure or by delayed loading procedures. All the patients were divided broadly into two groups with one group containing patients in which delayed loaded dental implants were placed while other consisted of patients in whom immediate loaded dental implants were placed. All the patients in whom follow-up records were missing and who had past medical history of any systemic diseases were excluded from the present study. Evaluation of associated possible risk factors was done by classifying the predictable factors as primary and secondary factors. All the results were analyzed by Statistical Package for the Social Sciences (SPSS) software. Kaplan-Meier survival analyses and chi-square test were used for assessment of level of significance. In delayed and immediate group of dental implants, mean age of the patients was 54.2 and 54.8 years respectively. Statistically significant results were obtained while comparing the clinical parameters of the dental implants in both the groups while demographic parameters showed nonsignificant correlation. Significant higher risk of dental implant failure is associated with immediate loaded dental implants. Tobacco smoking, shorter implant size, and other risk factors play a significant role in predicting the success and failure of dental implants. Delayed loaded dental implant placement should be preferred as they are associated with decreased risk of implant failure.

Model Development for Risk Assessment of Driving on Freeway under Rainy Weather Conditions

PubMed Central

Cai, Xiaonan; Wang, Chen; Chen, Shengdi; Lu, Jian

2016-01-01

Rainy weather conditions could result in significantly negative impacts on driving on freeways. However, due to lack of enough historical data and monitoring facilities, many regions are not able to establish reliable risk assessment models to identify such impacts. Given the situation, this paper provides an alternative solution where the procedure of risk assessment is developed based on drivers’ subjective questionnaire and its performance is validated by using actual crash data. First, an ordered logit model was developed, based on questionnaire data collected from Freeway G15 in China, to estimate the relationship between drivers’ perceived risk and factors, including vehicle type, rain intensity, traffic volume, and location. Then, weighted driving risk for different conditions was obtained by the model, and further divided into four levels of early warning (specified by colors) using a rank order cluster analysis. After that, a risk matrix was established to determine which warning color should be disseminated to drivers, given a specific condition. Finally, to validate the proposed procedure, actual crash data from Freeway G15 were compared with the safety prediction based on the risk matrix. The results show that the risk matrix obtained in the study is able to predict driving risk consistent with actual safety implications, under rainy weather conditions. PMID:26894434

Predicting complication risk in spine surgery: a prospective analysis of a novel risk assessment tool.

PubMed

Veeravagu, Anand; Li, Amy; Swinney, Christian; Tian, Lu; Moraff, Adrienne; Azad, Tej D; Cheng, Ivan; Alamin, Todd; Hu, Serena S; Anderson, Robert L; Shuer, Lawrence; Desai, Atman; Park, Jon; Olshen, Richard A; Ratliff, John K

2017-07-01

OBJECTIVE The ability to assess the risk of adverse events based on known patient factors and comorbidities would provide more effective preoperative risk stratification. Present risk assessment in spine surgery is limited. An adverse event prediction tool was developed to predict the risk of complications after spine surgery and tested on a prospective patient cohort. METHODS The spinal Risk Assessment Tool (RAT), a novel instrument for the assessment of risk for patients undergoing spine surgery that was developed based on an administrative claims database, was prospectively applied to 246 patients undergoing 257 spinal procedures over a 3-month period. Prospectively collected data were used to compare the RAT to the Charlson Comorbidity Index (CCI) and the American College of Surgeons National Surgery Quality Improvement Program (ACS NSQIP) Surgical Risk Calculator. Study end point was occurrence and type of complication after spine surgery. RESULTS The authors identified 69 patients (73 procedures) who experienced a complication over the prospective study period. Cardiac complications were most common (10.2%). Receiver operating characteristic (ROC) curves were calculated to compare complication outcomes using the different assessment tools. Area under the curve (AUC) analysis showed comparable predictive accuracy between the RAT and the ACS NSQIP calculator (0.670 [95% CI 0.60-0.74] in RAT, 0.669 [95% CI 0.60-0.74] in NSQIP). The CCI was not accurate in predicting complication occurrence (0.55 [95% CI 0.48-0.62]). The RAT produced mean probabilities of 34.6% for patients who had a complication and 24% for patients who did not (p = 0.0003). The generated predicted values were stratified into low, medium, and high rates. For the RAT, the predicted complication rate was 10.1% in the low-risk group (observed rate 12.8%), 21.9% in the medium-risk group (observed 31.8%), and 49.7% in the high-risk group (observed 41.2%). The ACS NSQIP calculator consistently produced complication predictions that underestimated complication occurrence: 3.4% in the low-risk group (observed 12.6%), 5.9% in the medium-risk group (observed 34.5%), and 12.5% in the high-risk group (observed 38.8%). The RAT was more accurate than the ACS NSQIP calculator (p = 0.0018). CONCLUSIONS While the RAT and ACS NSQIP calculator were both able to identify patients more likely to experience complications following spine surgery, both have substantial room for improvement. Risk stratification is feasible in spine surgery procedures; currently used measures have low accuracy.

Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator.

PubMed

Masini, Laura; Donis, Laura; Loi, Gianfranco; Mones, Eleonora; Molina, Elisa; Bolchini, Cesare; Krengli, Marco

2014-01-01

The aim of this study was to analyze the application of the failure modes and effects analysis (FMEA) to intracranial stereotactic radiation surgery (SRS) by linear accelerator in order to identify the potential failure modes in the process tree and adopt appropriate safety measures to prevent adverse events (AEs) and near-misses, thus improving the process quality. A working group was set up to perform FMEA for intracranial SRS in the framework of a quality assurance program. FMEA was performed in 4 consecutive tasks: (1) creation of a visual map of the process; (2) identification of possible failure modes; (3) assignment of a risk probability number (RPN) to each failure mode based on tabulated scores of severity, frequency of occurrence and detectability; and (4) identification of preventive measures to minimize the risk of occurrence. The whole SRS procedure was subdivided into 73 single steps; 116 total possible failure modes were identified and a score of severity, occurrence, and detectability was assigned to each. Based on these scores, RPN was calculated for each failure mode thus obtaining values from 1 to 180. In our analysis, 112/116 (96.6%) RPN values were <60, 2 (1.7%) between 60 and 125 (63, 70), and 2 (1.7%) >125 (135, 180). The 2 highest RPN scores were assigned to the risk of using the wrong collimator's size and incorrect coordinates on the laser target localizer frame. Failure modes and effects analysis is a simple and practical proactive tool for systematic analysis of risks in radiation therapy. In our experience of SRS, FMEA led to the adoption of major changes in various steps of the SRS procedure.

Human errors and measurement uncertainty

NASA Astrophysics Data System (ADS)

Kuselman, Ilya; Pennecchi, Francesca

2015-04-01

Evaluating the residual risk of human errors in a measurement and testing laboratory, remaining after the error reduction by the laboratory quality system, and quantifying the consequences of this risk for the quality of the measurement/test results are discussed based on expert judgments and Monte Carlo simulations. A procedure for evaluation of the contribution of the residual risk to the measurement uncertainty budget is proposed. Examples are provided using earlier published sets of expert judgments on human errors in pH measurement of groundwater, elemental analysis of geological samples by inductively coupled plasma mass spectrometry, and multi-residue analysis of pesticides in fruits and vegetables. The human error contribution to the measurement uncertainty budget in the examples was not negligible, yet also not dominant. This was assessed as a good risk management result.

Doctors or mid-level providers for abortion.

PubMed

Barnard, Sharmani; Kim, Caron; Park, Min Hae; Ngo, Thoai D

2015-07-27

The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system. Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct first trimester aspiration abortions and manage medical abortions has been proposed as a way to increase women's access to safe abortion procedures. To assess the safety and effectiveness of abortion procedures administered by mid-level providers compared to doctors. We searched the CENTRAL Issue 7, MEDLINE and POPLINE databases for comparative studies of doctor and mid-level providers of abortion services. We searched for studies published in any language from January 1980 until 15 August 2014. Randomised controlled trials (RCTs) (clustered or not clustered), prospective cohort studies or observational studies that compared the safety or effectiveness (or both) of any type of first trimester abortion procedure, administered by any type of mid-level provider or doctors, were eligible for inclusion in the review. Two independent review authors screened abstracts for eligibility and double-extracted data from the included studies using a pre-tested form. We meta-analysed primary outcome data using both fixed-effect and random-effects models to obtain pooled risk ratios (RR) with 95% confidence intervals (CIs). We carried out separate analyses by study design (RCT or cohort) and type of abortion procedure (medical versus surgical). Eight studies involving 22,018 participants met our eligibility criteria. Five studies (n = 18,962) assessed the safety and effectiveness of surgical abortion procedures administered by mid-level providers compared to doctors. Three studies (n = 3056) assessed the safety and effectiveness of medical abortion procedures. The surgical abortion studies (one RCT and four cohort studies) were carried out in the United States, India, South Africa and Vietnam. The medical abortion studies (two RCTs and one cohort study) were carried out in India, Sweden and Nepal. The studies included women with gestational ages up to 14 weeks for surgical abortion and nine weeks for medical abortion.Risk of selection bias was considered to be low in the three RCTs, unclear in four observational studies and high in one observational study. Concealment bias was considered to be low in the three RCTs and high in all five observational studies. Although none of the eight studies performed blinding of the participants to the provider type, we considered the performance bias to be low as this is part of the intervention. Detection bias was considered to be high in all eight studies as none of the eight studies preformed blinding of the outcome assessment. Attrition bias was low in seven studies and high in one, with over 20% attrition. We considered six studies to have unclear risk of selective reporting bias as their protocols had not been published. The remaining two studies had published their protocols. Few other sources of bias were found.Based on an analysis of three cohort studies, the risk of surgical abortion failure was significantly higher when provided by mid-level providers than when procedures were administered by doctors (RR 2.25, 95% CI 1.38 to 3.68), however the quality of evidence for this outcome was deemed to be very low. For surgical abortion procedures, we found no significant differences in the risk of complications between mid-level providers and doctors (RR 0.99, 95% CI 0.17 to 5.70 from RCTs; RR 1.38, 95% CI 0.70 to 2.72 from observational studies). When we combined the data for failure and complications for surgical abortion we found no significant differences between mid-level providers and doctors in both the observational study analysis (RR 1.36, 95% CI 0.86 to 2.14) and the RCT analysis (RR 3.07, 95% CI 0.16 to 59.08). The quality of evidence of the outcome for RCT studies was considered to be low and for observational studies very low. For medical abortion procedures the risk of failure was not different for mid-level providers or doctors (RR 0.81, 95% CI 0.48 to 1.36 from RCTs; RR 1.09, 95% CI 0.63 to 1.88 from observational studies). The quality of evidence of this outcome for the RCT analysis was considered to be high, although the quality of evidence of the observational studies was considered to be very low. There were no complications reported in the three medical abortion studies. There was no statistically significant difference in the risk of failure for medical abortions performed by mid-level providers compared with doctors. Observational data indicate that there may be a higher risk of abortion failure for surgical abortion procedures administered by mid-level providers, but the number of studies is small and more robust data from controlled trials are needed. There were no statistically significant differences in the risk of complications for first trimester surgical abortions performed by mid-level providers compared with doctors.

Age at menopause, reproductive history, and venous thromboembolism risk among postmenopausal women: the Women's Health Initiative Hormone Therapy clinical trials.

PubMed

Canonico, Marianne; Plu-Bureau, Geneviève; O'Sullivan, Mary Jo; Stefanick, Marcia L; Cochrane, Barbara; Scarabin, Pierre-Yves; Manson, Joann E

2014-03-01

This study aims to investigate venous thromboembolism (VTE) risk in relation to age at menopause, age at menarche, parity, bilateral oophorectomy, and time since menopause, as well as any interaction with randomized hormone therapy (HT) assignment, among postmenopausal women. Using pooled data from the Women's Health Initiative HT clinical trials including 27,035 postmenopausal women aged 50 to 79 years who had no history of VTE, we assessed the risk of VTE in relation to age at menopause, age at menarche, parity, bilateral oophorectomy, and time since menopause by Cox proportional hazards models. Linear trends, quadratic relationships, and interactions of reproductive life characteristics with HT on VTE risk were systematically tested. During follow-up, 426 women reported a first VTE, including 294 non-procedure-related events. No apparent interaction of reproductive life characteristics with HT assignment on VTE risk was detected, and there was not a significant association between VTE and age at menarche, age at menopause, parity, oophorectomy, or time since menopause. However, analyses restricted to non-procedure-related VTE showed a U-shaped relationship between age at menopause and thrombotic risk that persisted after multivariable analysis (P < 0.01). Compared with women aged 40 to 49 years at menopause, those who had early menopause (age <40 y) or late menopause (age >55 y) had a significantly increased VTE risk (hazard ratio [95% CI]: 1.8 [1.2-2.7] and 1.5 [1.0-2.4], respectively). Reproductive life characteristics have little association with VTE and do not seem to influence the effect of HT on thrombotic risk among postmenopausal women. Nevertheless, early and late onset of menopause might be newly identified risk factors for non-procedure-related VTE.

[Analysis of the incidence and causes of repeated surgical interventions in patients with early complications electrotherapy - 1 center experience from the period 2012-2015].

PubMed

Piątek, Łukasz; Polewczyk, Anna; Kurzawski, Jacek; Zachura, Małgorzata; Kaczmarczyk, Małgorzata; Janion, Marianna

Due to increasing number of patients treated by cardiac implantable electronic devices we observe increasing number of complications after these procedures We analysed causes of early surgical revision of implantable devices connected with 1673 procedures of implantation (871 procedures) or exchange (802 procedures) of pacing systems (PM), cardioverter-difibrillators (ICD) and resynchronisation systems (CRT) in one local centre of electrotherapy in years 2012 to 2015. We characterised risk factors and its influence on encountered complications. In analysed period 72 reinterventions after implantations or exchanges of PM/ICD/CRT were performed. Main causes of early complications were: lead malfunction (2.5%), including the dislodgement of the leads in 1.9%, pocket hematoma (1.4%) and other abnormalities of the pocket (0.4 %), including pocket infections in 0.2%. The most important risk factors of early complications were often implantations of the leads with passive fixation and anticoagulation therapy in perioperative period. The knowledge of the early complications after implantations and exchanges of PM/ICD/CRT should improve the safety of procedures through more often used of the leads with active fixation and properly preparation of the patients requering the antithrombic therapy.

Space shuttle/payload interface analysis. Volume 4: Business Risk and Value of Operations in Space (BRAVO). Part 1: Summary

NASA Technical Reports Server (NTRS)

1974-01-01

Background information is provided which emphasizes the philosophy behind analytical techniques used in the business risk and value of operations in space (BRAVO) study. The focus of the summary is on the general approach, operation of the procedures, and the status of the study. For Vol. 1, see N74-12493; for Vol. 2, see N74-14530.

Urinary Protein Biomarker Analysis

DTIC Science & Technology

2017-10-01

monitoring, in the case of low-risk cancers, to radiation or surgical procedures for higher risk cancers (Bill-Axelson et al., N. Engl. J. Med., 370:932...the methods can include administering at least one of watchful waiting, active surveillance, surgery, radiation , hormone therapy, chemotherapy...macrophage inflammatory protein 1-α (MIP1α), and tonsillar lymphocyte LD78 α Protein (LD78-α), CCL3 is a monokine involved in the acute inflammatory state

Risks and injuries in laser and high-frequency applications

NASA Astrophysics Data System (ADS)

Giering, K.; Philipp, Carsten M.; Berlien, Hans-Peter

1995-01-01

An analysis of injuries and risks using high frequency (HF) and lasers in medicine based on a literature search with MEDLINE was performed. The cases reported in the literature were classified according to the following criteria: (1) Avoidable in an optimal operational procedure. These kind of injuries are caused by a chain of unfortunate incidents. They are in principle avoidable by the 'right action at the right time' which presupposes an appropriate training of the operating team, selection of the optimal parameters for procedure and consideration of all safety instructions. (2) Avoidable, caused by malfunction of the equipment and/or accessories. The injuries classified into this group are avoidable if all safety regulations were fulfilled. This includes a pre-operational check-up and the use of medical lasers and high frequency devices only which meet the international safety standards. (3) Avoidable, caused by misuse/mistake. Injuries of this group were caused by an inappropriate selection of the procedure, wrong medical indication or mistakes during application. (4) Unavoidable, fateful. These injuries can be caused by risks inherent to the type of energy used, malfunction of the equipment and/or accessories though a pre-operational check-up was done. Some risks and complications are common to high frequency and laser application. But whereas these risks can be excluded easily in laser surgery there is often a great expenditure necessary or they are not avoidable if high frequency if used. No unavoidable risks due to laser energy occur.

Risk analysis of heat recovery steam generator with semi quantitative risk based inspection API 581

NASA Astrophysics Data System (ADS)

Prayogo, Galang Sandy; Haryadi, Gunawan Dwi; Ismail, Rifky; Kim, Seon Jin

2016-04-01

Corrosion is a major problem that most often occurs in the power plant. Heat recovery steam generator (HRSG) is an equipment that has a high risk to the power plant. The impact of corrosion damage causing HRSG power plant stops operating. Furthermore, it could be threaten the safety of employees. The Risk Based Inspection (RBI) guidelines by the American Petroleum Institute (API) 58 has been used to risk analysis in the HRSG 1. By using this methodology, the risk that caused by unexpected failure as a function of the probability and consequence of failure can be estimated. This paper presented a case study relating to the risk analysis in the HRSG, starting with a summary of the basic principles and procedures of risk assessment and applying corrosion RBI for process industries. The risk level of each HRSG equipment were analyzed: HP superheater has a medium high risk (4C), HP evaporator has a medium-high risk (4C), and the HP economizer has a medium risk (3C). The results of the risk assessment using semi-quantitative method of standard API 581 based on the existing equipment at medium risk. In the fact, there is no critical problem in the equipment components. Damage mechanisms were prominent throughout the equipment is thinning mechanism. The evaluation of the risk approach was done with the aim of reducing risk by optimizing the risk assessment activities.

Thromboembolic Risks of the Procedural Process in Second-Generation Cryoballoon Ablation Procedures: Analysis From Real-Time Transcranial Doppler Monitoring.

PubMed

Miyazaki, Shinsuke; Watanabe, Tomonori; Kajiyama, Takatsugu; Iwasawa, Jin; Ichijo, Sadamitsu; Nakamura, Hiroaki; Taniguchi, Hiroshi; Hirao, Kenzo; Iesaka, Yoshito

2017-12-01

Atrial fibrillation ablation is associated with substantial risks of silent cerebral events (SCEs) or silent cerebral lesions. We investigated which procedural processes during cryoballoon procedures carried a risk. Forty paroxysmal atrial fibrillation patients underwent pulmonary vein isolation using second-generation cryoballoons with single 28-mm balloon 3-minute freeze techniques. Microembolic signals (MESs) were monitored by transcranial Doppler throughout all procedures. Brain magnetic resonance imaging was obtained pre- and post-procedure in 34 patients (85.0%). Of 158 pulmonary veins, 152 (96.2%) were isolated using cryoablation, and 6 required touch-up radiofrequency ablation. A mean of 5.0±1.2 cryoballoon applications was applied, and the left atrial dwell time was 76.7±22.4 minutes. The total MES counts/procedures were 522 (426-626). Left atrial access and Flexcath sheath insertion generated 25 (11-44) and 34 (24-53) MESs. Using radiofrequency ablation for transseptal access increased the MES count during transseptal punctures. During cryoapplications, MES counts were greatest during first applications (117 [81-157]), especially after balloon stretch/deflations (43 [21-81]). Pre- and post-pulmonary vein potential mapping with Lasso catheters generated 57 (21-88) and 61 (36-88) MESs. Reinsertion of once withdrawn cryoballoons and subsequent applications produced 205 (156-310) MESs. Touch-up ablation generated 32 (19-62) MESs, whereas electric cardioversion generated no MESs. SCEs and silent cerebral lesions were detected in 11 (32.3%) and 4 (11.7%) patients, respectively. The patients with SCEs were older than those without; however, there were no significant factors associated with SCEs. A significant number of MESs and SCE/silent cerebral lesion occurrences were observed during second-generation cryoballoon ablation procedures. MESs were recorded during a variety of steps throughout the procedure; however, the majority occurred during phases with a high probability of gaseous emboli. © 2017 American Heart Association, Inc.

Operating room fires: a closed claims analysis.

PubMed

Mehta, Sonya P; Bhananker, Sanjay M; Posner, Karen L; Domino, Karen B

2013-05-01

To assess patterns of injury and liability associated with operating room (OR) fires, closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1985 were reviewed. All claims related to fires in the OR were compared with nonfire-related surgical anesthesia claims. An analysis of fire-related claims was performed to identify causative factors. There were 103 OR fire claims (1.9% of 5,297 surgical claims). Electrocautery was the ignition source in 90% of fire claims. OR fire claims more frequently involved older outpatients compared with other surgical anesthesia claims (P < 0.01). Payments to patients were more often made in fire claims (P < 0.01), but payment amounts were lower (median $120,166) compared to nonfire surgical claims (median $250,000, P < 0.01). Electrocautery-induced fires (n = 93) increased over time (P < 0.01) to 4.4% claims between 2000 and 2009. Most (85%) electrocautery fires occurred during head, neck, or upper chest procedures (high-fire-risk procedures). Oxygen served as the oxidizer in 95% of electrocautery-induced OR fires (84% with open delivery system). Most electrocautery-induced fires (n = 75, 81%) occurred during monitored anesthesia care. Oxygen was administered via an open delivery system in all high-risk procedures during monitored anesthesia care. In contrast, alcohol-containing prep solutions and volatile compounds were present in only 15% of OR fires during monitored anesthesia care. Electrocautery-induced fires during monitored anesthesia care were the most common cause of OR fires claims. Recognition of the fire triad (oxidizer, fuel, and ignition source), particularly the critical role of supplemental oxygen by an open delivery system during use of the electrocautery, is crucial to prevent OR fires. Continuing education and communication among OR personnel along with fire prevention protocols in high-fire-risk procedures may reduce the occurrence of OR fires.

Exchange nailing for nonunion of diaphyseal fractures of the tibia: our results and an analysis of the risk factors for failure.

PubMed

Tsang, S T J; Mills, L A; Frantzias, J; Baren, J P; Keating, J F; Simpson, A H R W

2016-04-01

The aim of this study was to identify risk factors for the failure of exchange nailing in nonunion of tibial diaphyseal fractures. A cohort of 102 tibial diaphyseal nonunions in 101 patients with a mean age of 36.9 years (15 to 74) were treated between January 1992 and December 2012 by exchange nailing. Of which 33 (32%) were initially open injuries. The median time from primary fixation to exchange nailing was 6.5 months (interquartile range (IQR) 4.3 to 9.8 months). The main outcome measures were union, number of secondary fixation procedures required to achieve union and time to union. Univariate analysis and multiple regression were used to identify risk factors for failure to achieve union. Multiple causes for the primary nonunion were found for 28 (27%) tibiae, with infection present in 32 (31%). Six patients were lost to follow-up. Further surgical procedures were required in 35 (36%) nonunions. Other fixation modalities were required in five fractures. A single nail exchange procedure achieved union in 60/96 (63%) of all nonunions. Only 11 out of 31 infected nonunions (35.4%) healed after one exchange nail procedure. Up to five repeated exchange nailings, with or without bone grafting, ultimately achieved union in 89 (93%) fractures. The median time to union after exchange nailing was 8.7 months (IQR 5.7 to 14.0 months). Univariate analysis confirmed that an oligotrophic/atrophic pattern of nonunion (p = 0.002), a bone gap of 5 mm or more (p = 0.04) and infection (p < 0.001), were predictive for failure of exchange nailing Multiple regression analysis found that infection was the strongest predictor of failure (p < 0.001). Exchange nailing is an effective treatment for aseptic tibial diaphyseal nonunion. However, in the presence of severe infection with a highly resistant organism, or extensive sclerosis of the bone, other fixation modalities, such as Ilizarov treatment, should be considered. Exchange nailing is an effective treatment for aseptic tibial diaphyseal nonunion. ©2016 The British Editorial Society of Bone & Joint Surgery.

Lessons learned from a single institution's retrospective analysis of emergent cesarean delivery following external cephalic version with and without neuraxial anesthesia.

PubMed

Ainsworth, A; Sviggum, H P; Tolcher, M C; Weaver, A L; Holman, M A; Arendt, K W

2017-05-01

To evaluate the risk of emergent cesarean delivery with the use of neuraxial anesthesia for external cephalic version in a single practice. Randomized trials have shown increased external cephalic version success when neuraxial anesthesia is used, without additional risk. We hypothesized that in our actual clinical practice, outside the confines of randomized trials, neuraxial anesthesia could be associated with an increased risk of emergent cesarean delivery. This retrospective cohort study included all women who underwent external cephalic version at a single institution with and without neuraxial anesthesia. The primary outcome was the incidence of emergent cesarean delivery (defined as delivery within 4hours of version). Secondary outcomes were version success and ultimate mode of delivery. A total of 135 women underwent external cephalic version procedures; 58 with neuraxial anesthesia (43.0%) and 77 without (57.0%). Location of the procedure, tocolytic therapy, and gestational age were different between groups. An increased rate of emergent cesarean delivery was found in procedures with neuraxial anesthesia compared to procedures without (5/58 (8.6%) compared to 0/77 (0.0%); 95% CI for difference, 1.4 to 15.8%; P=0.013). In this single hospital's practice, patients who may be at higher risk of complications and have a lesser likelihood of success were provided NA for ECV. As a result, the use of neuraxial anesthesia for external cephalic version was associated with a higher rate of emergent cesarean delivery. Obstetric and anesthetic practices should evaluate their patient selection and procedure protocol for external cephalic version under neuraxial anesthesia. Copyright © 2017 Elsevier Ltd. All rights reserved.

Is a Colectomy Always Just a Colectomy? Additional Procedures as a Proxy for Operative Complexity

PubMed Central

Simmons, Kristina D; Hoffman, Rebecca L; Kuo, Lindsay E; Bartlett, Edmund K; Holena, Daniel N; Kelz, Rachel R

2018-01-01

Background Studies of surgical outcomes can be confounded by operative complexity. Complexity is difficult to assess from claims data due to the absence of established measures, but information on additional procedures is typically available. We hypothesized that analyzing same-day procedures (SDPs) would provide a useful step toward including operative complexity in risk adjustment. Study Design Colon resections were identified in California, Florida, and New York (2008 to 2011). Same-day procedures were categorized using 6 definitions. In-hospital mortality and postoperative complications were examined. For all outcomes, we developed multivariable logistic regression models to measure the association between the SDP category and outcomes. Results Rates of SDP were 74.9% total, 69.5% surgical, 31.6% nonsurgical, 36.6% colon, 51.4% abdomen, and 34.3% other for the 215,041 colon resections examined. Mortality was associated with the inclusion of any SDP category in univariate (6.2% vs 1.7%; p < 0.001) and multivariable (odds ratio [OR] = 2.14; 95% CI, 1.99–2.30; p < 0.001) analysis. The association with mortality was high for nonsurgical (OR = 2.36; 95% CI, 2.26–2.46) and other (OR = 2.33; 95% CI, 2.23–2.43) procedures and moderate for surgical (OR = 1.45; 95% CI, 1.37–1.54) and colon (OR = 1.51; 95% CI, 1.44–1.57) procedures, but abdominal procedures were not independently associated with mortality (OR = 1.01; 95% CI, 0.97–1.06). The total number of SDPs was also associated with higher complication rates. Conclusions The risk of complications and mortality associated with colectomy was increased among patients with SDPs and the magnitude of the association was dependent on the type and quantity of additional procedures. Information on SDPs might reflect a component of operative risk not typically captured and should be considered as a candidate variable for risk adjustment when using claims to compare outcomes across large cohorts. PMID:26228014

Crisis management with applicability on fire fighting plants

NASA Astrophysics Data System (ADS)

Panaitescu, M.; Panaitescu, F. V.; Voicu, I.; Dumitrescu, L. G.

2017-08-01

The paper presents a case study for a crisis management analysis which address to fire fighting plants. The procedures include the steps of FTA (Failure tree analysis). The purpose of the present paper is to describe this crisis management plan with tools of FTA. The crisis management procedures have applicability on anticipated and emergency situations and help to describe and planning a worst-case scenario plan. For this issue must calculate the probabilities in different situations for fire fighting plants. In the conclusions of paper is analised the block diagram with components of fire fighting plant and are presented the solutions for each possible risk situations.

SU-E-T-269: Differential Hazard Analysis For Conventional And New Linac Acceptance Testing Procedures

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harry, T; Yaddanapudi, S; Mutic, S

Purpose: New techniques and materials have recently been developed to expedite the conventional Linac Acceptance Testing Procedure (ATP). The new ATP method uses the Electronic Portal Imaging Device (EPID) for data collection and is presented separately. This new procedure is meant to be more efficient then conventional methods. While not clinically implemented yet, a prospective risk assessment is warranted for any new techniques. The purpose of this work is to investigate the risks and establish the pros and cons between the conventional approach and the new ATP method. Methods: ATP tests that were modified and performed with the EPID weremore » analyzed. Five domain experts (Medical Physicists) comprised the core analysis team. Ranking scales were adopted from previous publications related to TG 100. The number of failure pathways for each ATP test procedure were compared as well as the number of risk priority numbers (RPN’s) greater than 100 were compared. Results: There were fewer failure pathways with the new ATP compared to the conventional, 262 and 556, respectively. There were fewer RPN’s > 100 in the new ATP compared to the conventional, 41 and 115. Failure pathways and RPN’s > 100 for individual ATP tests on average were 2 and 3.5 times higher in the conventional ATP compared to the new, respectively. The pixel sensitivity map of the EPID was identified as a key hazard to the new ATP procedure with an RPN of 288 for verifying beam parameters. Conclusion: The significant decrease in failure pathways and RPN’s >100 for the new ATP mitigates the possibilities of a catastrophic error occurring. The Pixel Sensitivity Map determining the response and inherent characteristics of the EPID is crucial as all data and hence results are dependent on that process. Grant from Varian Medical Systems Inc.« less

Country differences of psychosocial working conditions in Europe: the role of health and safety management practices.

PubMed

Lunau, Thorsten; Dragano, Nico; Siegrist, Johannes; Wahrendorf, Morten

2017-10-01

In times of demographic change, maintaining health and employability of older employees is important. In this context, studies show that stressful working conditions differ by countries. Yet, it is unclear if specific national management practices to deal with these conditions contribute towards explaining country differences. This study combines two different data sources. The first one provides detailed information on psychosocial working conditions in 17 European countries, based on 12,284 employees from the Survey of Health, Ageing and Retirement in Europe (SHARE) and the English Longitudinal Study of Ageing (ELSA). We link this information to the second data source that provides information on health and safety management practices in each of the countries under study (collected among 17,477 managers at the level of companies in the Enterprise survey on new and emerging risks (ESENER)). We distinguish six different types of risk management procedures in the analysis. Results show that levels of psychosocial risks are generally lower in countries with more developed management practices, in particular if national management practices are marked by (1) procedures to deal with work stress, (2) information about whom to address in case of work-related psychosocial problems, and (3) health and safety services provided by psychologists. The findings underline the importance of a comprehensive psychosocial risk management approach in reducing work-related stress, as lower levels of psychosocial risks are linked to specific psychosocial risk management practices within companies, in particular those pointing to clear responsibilities and coordinated procedures in dealing with psychosocial risks.

The development of a 3D risk analysis method.

PubMed

I, Yet-Pole; Cheng, Te-Lung

2008-05-01

Much attention has been paid to the quantitative risk analysis (QRA) research in recent years due to more and more severe disasters that have happened in the process industries. Owing to its calculation complexity, very few software, such as SAFETI, can really make the risk presentation meet the practice requirements. However, the traditional risk presentation method, like the individual risk contour in SAFETI, is mainly based on the consequence analysis results of dispersion modeling, which usually assumes that the vapor cloud disperses over a constant ground roughness on a flat terrain with no obstructions and concentration fluctuations, which is quite different from the real situations of a chemical process plant. All these models usually over-predict the hazardous regions in order to maintain their conservativeness, which also increases the uncertainty of the simulation results. On the other hand, a more rigorous model such as the computational fluid dynamics (CFD) model can resolve the previous limitations; however, it cannot resolve the complexity of risk calculations. In this research, a conceptual three-dimensional (3D) risk calculation method was proposed via the combination of results of a series of CFD simulations with some post-processing procedures to obtain the 3D individual risk iso-surfaces. It is believed that such technique will not only be limited to risk analysis at ground level, but also be extended into aerial, submarine, or space risk analyses in the near future.

A Framework for Flood Risk Analysis and Benefit Assessment of Flood Control Measures in Urban Areas

PubMed Central

Li, Chaochao; Cheng, Xiaotao; Li, Na; Du, Xiaohe; Yu, Qian; Kan, Guangyuan

2016-01-01

Flood risk analysis is more complex in urban areas than that in rural areas because of their closely packed buildings, different kinds of land uses, and large number of flood control works and drainage systems. The purpose of this paper is to propose a practical framework for flood risk analysis and benefit assessment of flood control measures in urban areas. Based on the concept of disaster risk triangle (hazard, vulnerability and exposure), a comprehensive analysis method and a general procedure were proposed for urban flood risk analysis. Urban Flood Simulation Model (UFSM) and Urban Flood Damage Assessment Model (UFDAM) were integrated to estimate the flood risk in the Pudong flood protection area (Shanghai, China). S-shaped functions were adopted to represent flood return period and damage (R-D) curves. The study results show that flood control works could significantly reduce the flood risk within the 66-year flood return period and the flood risk was reduced by 15.59%. However, the flood risk was only reduced by 7.06% when the flood return period exceeded 66-years. Hence, it is difficult to meet the increasing demands for flood control solely relying on structural measures. The R-D function is suitable to describe the changes of flood control capacity. This frame work can assess the flood risk reduction due to flood control measures, and provide crucial information for strategy development and planning adaptation. PMID:27527202

Ecological Risk Assessment with MCDM of Some Invasive Alien Plants in China

NASA Astrophysics Data System (ADS)

Xie, Guowen; Chen, Weiguang; Lin, Meizhen; Zheng, Yanling; Guo, Peiguo; Zheng, Yisheng

Alien plant invasion is an urgent global issue that threatens the sustainable development of the ecosystem health. The study of its ecological risk assessment (ERA) could help us to prevent and reduce the invasion risk more effectively. Based on the theory of ERA and methods of the analytic hierarchy process (AHP) of multi-criteria decision-making (MCDM), and through the analyses of the characteristics and processes of alien plant invasion, this paper discusses the methodologies of ERA of alien plant invasion. The assessment procedure consisted of risk source analysis, receptor analysis, exposure and hazard assessment, integral assessment, and countermeasure of risk management. The indicator system of risk source assessment as well as the indices and formulas applied to measure the ecological loss and risk were established, and the method for comprehensively assessing the ecological risk of alien plant invasion was worked out. The result of ecological risk analysis to 9 representative invasive alien plants in China shows that the ecological risk of Erigeron annuus, Ageratum conyzoides, Alternanthera philoxeroides and Mikania midrantha is high (grade1-2), that of Oxalis corymbosa and Wedelia chinensis comes next (grade3), while Mirabilis jalapa, Pilea microphylla and Calendula officinalis of the last (grade 4). Risk strategies are put forward on this basis.

Appraisal of clinical complications after 23,827 oocyte retrievals in a large assisted reproductive technology program.

PubMed

Levi-Setti, Paolo Emanuele; Cirillo, Federico; Scolaro, Valeria; Morenghi, Emanuela; Heilbron, Francesca; Girardello, Donatella; Zannoni, Elena; Patrizio, Pasquale

2018-06-01

To assess complications encountered after transvaginal oocyte retrieval procedures. Retrospective analysis. University hospital, fertility center. A total of 23,827 consecutive transvaginal oocyte retrieval procedures in 12,615 patients. Oocyte retrieval procedures performed between June 1996 and October 2016. All oocyte retrieval complications. Those requiring hospital admission for at least 24 hours were considered severe. A total of 96 patients (0.76 %) suffered complications, with hospital admission necessary for 71 patients (0.56 %). When calculated per retrieval, the overall complication rate was 0.4%, whereas 0.29% was the admission rate, with an average duration of hospital stay of 2.77 ± 2.5 days. A surgical procedure was necessary for 24 patients (0.1% per retrieval and 0.19% per patient). Multivariate analysis showed a significant correlation between complications and women age, body mass index (BMI), the number oocyte retrieved, and the mean time to complete oocyte retrieval. The incidence of complications was significantly higher for physicians who had performed <250 retrievals compared with those who had completed >250 retrievals (odds ratio 0.63, 95% confidence interval 0.40-0.99). Oocyte retrieval can be considered a safe procedure but is not without risks. The most important, identifiable, risk factors for the occurrence of complications are: [1] high number of oocytes retrieved, [2] a long duration of the procedure and mean time per oocyte retrieved, [3] inexperience of the surgeon, [4] younger patients with a lesser BMI, and [5] history of prior abdominal or pelvic surgery or pelvic inflammatory disease. NCT03282279. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Structured sedation programs in the emergency department, hospital and other acute settings: protocol for systematic review of effects and events.

PubMed

McCoy, Siobhán; Wakai, Abel; Blackburn, Carol; Barrett, Michael; Murphy, Adrian; Brenner, Maria; Larkin, Philip; Crispino-O'Connell, Gloria; Ratnapalan, Savithiri; O'Sullivan, Ronan

2013-10-01

The use of procedural sedation outside the operating theatre has increased in hospital settings and has gained popularity among non-anesthesiologists. Sedative agents used for procedural pain, although effective, also pose significant risks to the patient if used incorrectly. There is currently no universally accepted program of education for practitioners using or introducing procedural sedation into their practice. There is emerging literature identifying structured procedural sedation programs (PSPs) as a method of ensuring a standardized level of competency among staff and reducing risks to the patient. We hypothesize that programs of education for healthcare professionals using procedural sedation outside the operating theatre are beneficial in improving patient care, safety, practitioner competence and reducing adverse event rates. Electronic databases will be systematically searched for studies (randomized and non-randomized) examining the effectiveness of structured PSPs from 1966 to present. Database searches will be supplemented by contact with experts, reference and citation checking, and a grey literature search. No language restriction will be imposed. Screening of titles and abstracts, and data extraction will be performed by two independent reviewers. All disagreements will be resolved by discussion with an independent third party. Data analysis will be completed adhering to procedures outlined in the Cochrane Handbook of Systematic Reviews of Interventions. If the data allows, a meta-analysis will be performed. This review will cohere evidence on the effectiveness of structured PSPs on sedation events and patient outcomes within the hospital and other acute care settings. In addition, it will examine key components identified within a PSP associated with patient safety and improved patient outcomes. PROSPERO registration number: CRD42013003851.

Multiple-Tumor Analysis with MS_Combo Model (Use with BMDS Wizard)

EPA Pesticide Factsheets

Exercises and procedures on setting up and using the MS_Combo Wizard. The MS_Combo model provides BMD and BMDL estimates for the risk of getting one or more tumors for any combination of tumors observed in a single bioassay.

10 CFR 300.11 - Independent verification.

Code of Federal Regulations, 2011 CFR

2011-01-01

... verifiers, and has been empowered to make decisions relevant to the provision of a verification statement... methods; and (v) Risk assessment and methodologies and materiality analysis procedures outlined by other... Accreditation Board program for Environmental Management System auditors (ANSI-RAB-EMS); Board of Environmental...

10 CFR 300.11 - Independent verification.

Code of Federal Regulations, 2010 CFR

2010-01-01

... verifiers, and has been empowered to make decisions relevant to the provision of a verification statement... methods; and (v) Risk assessment and methodologies and materiality analysis procedures outlined by other... Accreditation Board program for Environmental Management System auditors (ANSI-RAB-EMS); Board of Environmental...

Avoid Age Discrimination.

ERIC Educational Resources Information Center

Bernstein, Michael I.

1982-01-01

Steps a school board can take to minimize the risk of age discrimination suits include reviewing all written policies, forms, files, and collective bargaining agreements for age discriminatory items; preparing a detailed statistical analysis of the age of personnel; and reviewing reduction-in-force procedures. (Author/MLF)

Risk prediction for myocardial infarction via generalized functional regression models.

PubMed

Ieva, Francesca; Paganoni, Anna M

2016-08-01

In this paper, we propose a generalized functional linear regression model for a binary outcome indicating the presence/absence of a cardiac disease with multivariate functional data among the relevant predictors. In particular, the motivating aim is the analysis of electrocardiographic traces of patients whose pre-hospital electrocardiogram (ECG) has been sent to 118 Dispatch Center of Milan (the Italian free-toll number for emergencies) by life support personnel of the basic rescue units. The statistical analysis starts with a preprocessing of ECGs treated as multivariate functional data. The signals are reconstructed from noisy observations. The biological variability is then removed by a nonlinear registration procedure based on landmarks. Thus, in order to perform a data-driven dimensional reduction, a multivariate functional principal component analysis is carried out on the variance-covariance matrix of the reconstructed and registered ECGs and their first derivatives. We use the scores of the Principal Components decomposition as covariates in a generalized linear model to predict the presence of the disease in a new patient. Hence, a new semi-automatic diagnostic procedure is proposed to estimate the risk of infarction (in the case of interest, the probability of being affected by Left Bundle Brunch Block). The performance of this classification method is evaluated and compared with other methods proposed in literature. Finally, the robustness of the procedure is checked via leave-j-out techniques. © The Author(s) 2013.

[Risk management--a new aspect of quality assessment in intensive care medicine: first results of an analysis of the DIVI's interdisciplinary quality assessment research group].

PubMed

Stiletto, R; Röthke, M; Schäfer, E; Lefering, R; Waydhas, Ch

2006-10-01

Patient security has become one of the major aspects of clinical management in recent years. The crucial point in research was focused on malpractice. In contradiction to the economic process in non medical fields, the analysis of errors during the in-patient treatment time was neglected. Patient risk management can be defined as a structured procedure in a clinical unit with the aim to reduce harmful events. A risk point model was created based on a Delphi process and founded on the DIVI data register. The risk point model was evaluated in clinically working ICU departments participating in the register data base. The results of the risk point evaluation will be integrated in the next data base update. This might be a step to improve the reliability of the register to measure quality assessment in the ICU.

Replica Analysis for Portfolio Optimization with Single-Factor Model

NASA Astrophysics Data System (ADS)

Shinzato, Takashi

2017-06-01

In this paper, we use replica analysis to investigate the influence of correlation among the return rates of assets on the solution of the portfolio optimization problem. We consider the behavior of an optimal solution for the case where the return rate is described with a single-factor model and compare the findings obtained from our proposed methods with correlated return rates with those obtained with independent return rates. We then analytically assess the increase in the investment risk when correlation is included. Furthermore, we also compare our approach with analytical procedures for minimizing the investment risk from operations research.

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

PubMed Central

Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter

2015-01-01

Objective To compare the safety and efficacy of hysteroscopic sterilization with the “Essure” device with laparoscopic sterilization in a large, all-inclusive, state cohort. Design Population based cohort study. Settings Outpatient interventional setting in New York State. Participants Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Main outcomes measures Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. Results We identified 8048 patients undergoing hysteroscopic sterilization and 44 278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Conclusions Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making. PMID:26462857

Identification of risk factors for post-endoscopic retrograde cholangiopancreatography pancreatitis in a high volume center.

PubMed

Phillip, Veit; Schwab, Miriam; Haf, David; Algül, Hana

2017-01-01

Pancreatitis is the most common complication of endoscopic retrograde cholangiopancreatography (ERCP). Several patients´ or procedure related risk factors for post-ERCP pancreatitis (PEP) have been suggested. The aim of this study was to validate the risk factors for PEP in a high-volume center. All patients undergoing first time ERCP at a tertiary referral center between December 2010 and October 2013 were retrospectively included. PEP was defined according to the Atlanta Classification. 344 patients were included in the final analysis. The risk to develop PEP was increased in patients with chronic pancreatitis (odds ratio 3.7) and after inadvertent cannulation of the pancreatic duct (odds ratio 2.2), which occurred in 26.5% of the patients. Inadvertent cannulation occurred significantly more frequently in patients with difficult cannulation of the papilla duodeni major (odds ratio 12.7; p<0.001). ERCP on call was associated with an increased risk for difficult cannulation (odds ratio 3.0). Inadvertent cannulation of the pancreatic duct is a procedure related risk factor for PEP. Measurements on preventing inadvertent cannulation of the pancreatic duct should be established and studies on prophylactic measurements should focus particularly on patients with inadvertent cannulation of the pancreatic duct.

The Deformity Angular Ratio: Does It Correlate With High-Risk Cases for Potential Spinal Cord Monitoring Alerts in Pediatric 3-Column Thoracic Spinal Deformity Corrective Surgery?

PubMed

Lewis, Noah D H; Keshen, Sam G N; Lenke, Lawrence G; Zywiel, Michael G; Skaggs, David L; Dear, Taylor E; Strantzas, Samuel; Lewis, Stephen J

2015-08-01

A retrospective analysis. The purpose of this study was to determine whether the deformity angular ratio (DAR) can reliably assess the neurological risks of patients undergoing deformity correction. Identifying high-risk patients and procedures can help ensure that appropriate measures are taken to minimize neurological complications during spinal deformity corrections. Subjectively, surgeons look at radiographs and evaluate the riskiness of the procedure. However, 2 curves of similar magnitude and location can have significantly different risks of neurological deficit during surgery. Whether the curve spans many levels or just a few can significantly influence surgical strategies. Lenke et al have proposed the DAR, which is a measure of curve magnitude per level of deformity. The data from 35 pediatric spinal deformity correction procedures with thoracic 3-column osteotomies were reviewed. Measurements from preoperative radiographs were used to calculate the DAR. Binary logistic regression was used to model the relationship between DARs (independent variables) and presence or absence of an intraoperative alert (dependent variable). In patients undergoing 3-column osteotomies, sagittal curve magnitude and total curve magnitude were associated with increased incidence of transcranial motor evoked potential changes. Total DAR greater than 45° per level and sagittal DAR greater than 22° per level were associated with a 75% incidence of a motor evoked potential alert, with the incidence increasing to 90% with sagittal DAR of 28° per level. In patients undergoing 3-column osteotomies for severe spinal deformities, the DAR was predictive of patients developing intraoperative motor evoked potential alerts. Identifying accurate radiographical, patient, and procedural risk factors in the correction of severe deformities can help prepare the surgical team to improve safety and outcomes when carrying out complex spinal corrections. 3.

Method of assessing a lipid-related health risk based on ion mobility analysis of lipoproteins

DOEpatents

Benner, W. Henry; Krauss, Ronald M.; Blanche, Patricia J.

2010-12-14

A medical diagnostic method and instrumentation system for analyzing noncovalently bonded agglomerated biological particles is described. The method and system comprises: a method of preparation for the biological particles; an electrospray generator; an alpha particle radiation source; a differential mobility analyzer; a particle counter; and data acquisition and analysis means. The medical device is useful for the assessment of human diseases, such as cardiac disease risk and hyperlipidemia, by rapid quantitative analysis of lipoprotein fraction densities. Initially, purification procedures are described to reduce an initial blood sample to an analytical input to the instrument. The measured sizes from the analytical sample are correlated with densities, resulting in a spectrum of lipoprotein densities. The lipoprotein density distribution can then be used to characterize cardiac and other lipid-related health risks.

Risk factors for venous thromboembolic events in pediatric surgical patients: Defining indications for prophylaxis.

PubMed

Cairo, Sarah B; Lautz, Timothy B; Schaefer, Beverly A; Yu, Guan; Naseem, Hibbut-Ur-Rauf; Rothstein, David H

2017-12-27

Venous thromboembolism (VTE) in pediatric surgical patients is a rare event. The risk factors for VTE in pediatric general surgery patients undergoing abdominopelvic procedures are unknown. The American College of Surgeon's National Surgical Quality Improvement Program-Pediatric (NSQIP-P) database (2012-2015) was queried for patients with VTE after abdominopelvic general surgery procedures. Patient and operative variables were assessed to identify risk factors associated with VTE and develop a pediatric risk score. From 2012-2015, 68 of 34,813 (0.20%) patients who underwent abdominopelvic general surgery procedures were diagnosed with VTE. On multivariate analysis, there was no increased risk of VTE based on concomitant malignancy, chemotherapy, inflammatory bowel disease, or laparoscopic surgical approach, while a higher rate of VTE was identified among female patients. The odds of experiencing VTE were increased on stepwise regression for patients older than 15 years and those with preexisting renal failure or a diagnosis of septic shock, patients with American Society of Anesthesia (ASA) classification ≥ 2, and for anesthesia time longer than 2 h. The combination of age > 15 years, ASA classification ≥ 2, anesthesia time > 2 h, renal failure, and septic shock was included in a model for predicting risk of VTE (AUC = 0.907, sensitivity 84.4%, specificity 88.2%). VTE is rare in pediatric patients, but prediction modeling may help identify those patients at heightened risk. Additional studies are needed to validate the factors identified in this study in a risk assessment model as well as to assess the efficacy and cost-effectiveness of prophylaxis methods. Level III, retrospective comparative study. Copyright © 2018. Published by Elsevier Inc.

Identification of modifiable factors for reducing readmission after colectomy: a national analysis.

PubMed

Lawson, Elise H; Hall, Bruce Lee; Louie, Rachel; Zingmond, David S; Ko, Clifford Y

2014-05-01

Rates of hospital readmission are currently used for public reporting and pay for performance. Colectomy procedures account for a large number of readmissions among operative procedures. Our objective was to compare the importance of 3 groups of clinical variables (demographics, preoperative risk factors, and postoperative complications) in predicting readmission after colectomy procedures. Patient records (2005-2008) from the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) were linked to Medicare inpatient claims. Patient demographics (n = 2), preoperative risk factors (n = 23), and 30-day postoperative complications (n = 17) were identified from ACS-NSQIP, whereas 30-day postoperative readmissions and costs were determined from Medicare. Multivariable logistic regression models were used to examine risk-adjusted predictors of colectomy readmission. Among 12,981 colectomy patients, the 30-day postoperative readmission rate was 13.5%. Readmitted patients had slightly greater rates of comorbidities and indicators of clinical severity and substantially greater rates of complications than non-readmitted patients. After risk adjustment, patients with a complication were 3.3 times as likely to be readmitted as patients without a complication. Among individual complications, progressive renal failure and organ-space surgical site infection had the highest risk-adjusted relative risks of readmission (4.6 and 4.0, respectively). Demographic, preoperative risk factor, and postoperative complication variables increased the ability to discriminate readmissions (reflected by the c-statistic) by 5.3%, 23.3%, and 35.4%, respectively. Postoperative complications after colectomy are more predictive of readmission than traditional risk factors. Focusing quality improvement efforts on preventing and managing postoperative complications may be the most important step toward reducing readmission rates. Copyright © 2014 Mosby, Inc. All rights reserved.

Analysis of occupational exposures to blood registered in the General Hospital in Zabrze in the years 2006-2015

PubMed

Kocur, Ewelina; Śliwa-Rak, Bożena; Grosicki, Sebastian

Viral hepatitis B and C are the most common occupational diseases among health care workers. Infection occurs during performance of medical procedures which carries a risk of contact with biological material derived from a patient. The aim of the study was to analyse cases of occupational exposure to biological material as recorded by the employees of the City Hospital in Zabrze, to attempt to determine which medical procedures are of greatest risk of occupational exposure, and to identify the most important actions aimed at reduction of their number. The analysis included all cases of exposure to biological material derived from a patient, which were reported by employees of the City Hospital in Zabrze in 2006–2015. The analysis included the percentage of exposure for individual occupational groups and wards of the hospital, the type of the procedure at performance of which the exposure occurred, the type of tools affecting the skin continuity and proper conduct of the proceedings of the employee after exposure. The occupational group most frequently affected by exposures were nurses/midwives. This occupational group accounted for 41.2% of all exposed people. The next highest percentage exposure of 5.9% concerned the occupational group of doctors, further paramedics with 3.8%, orderlies – 2.6%, nurses – 2.4%. The ward of internal diseases had most frequent occurrences of exposure, but the percentage of exposure was the highest for the operating room – 7.5%. Most often the injury occurred during sampling venous blood – 20.6%. People assisting at procedures performed with a use of sharp equipment made 13.4% of employees exposed to blood. Orderlies were the third occupational group in terms of most common cuts. The employees were injured by cutting themselves while disposing of waste as often as when performing/assisting with a surgery. In 24.7% of cases immediately after exposure to biological material the employees behaved contrary to the procedure. List of exposures should not be limited only to cases of injuries caused by sharp instruments. Analysis of the circumstances and type of procedures during performance of which occur exposures allows for modification of procedures and reduction of the amount of exposures. Trainings in prevention of exposure should include all occupational groups, which are in contact with patients and medical waste.

Developing a spatial-statistical model and map of historical malaria prevalence in Botswana using a staged variable selection procedure

PubMed Central

Craig, Marlies H; Sharp, Brian L; Mabaso, Musawenkosi LH; Kleinschmidt, Immo

2007-01-01

Background Several malaria risk maps have been developed in recent years, many from the prevalence of infection data collated by the MARA (Mapping Malaria Risk in Africa) project, and using various environmental data sets as predictors. Variable selection is a major obstacle due to analytical problems caused by over-fitting, confounding and non-independence in the data. Testing and comparing every combination of explanatory variables in a Bayesian spatial framework remains unfeasible for most researchers. The aim of this study was to develop a malaria risk map using a systematic and practicable variable selection process for spatial analysis and mapping of historical malaria risk in Botswana. Results Of 50 potential explanatory variables from eight environmental data themes, 42 were significantly associated with malaria prevalence in univariate logistic regression and were ranked by the Akaike Information Criterion. Those correlated with higher-ranking relatives of the same environmental theme, were temporarily excluded. The remaining 14 candidates were ranked by selection frequency after running automated step-wise selection procedures on 1000 bootstrap samples drawn from the data. A non-spatial multiple-variable model was developed through step-wise inclusion in order of selection frequency. Previously excluded variables were then re-evaluated for inclusion, using further step-wise bootstrap procedures, resulting in the exclusion of another variable. Finally a Bayesian geo-statistical model using Markov Chain Monte Carlo simulation was fitted to the data, resulting in a final model of three predictor variables, namely summer rainfall, mean annual temperature and altitude. Each was independently and significantly associated with malaria prevalence after allowing for spatial correlation. This model was used to predict malaria prevalence at unobserved locations, producing a smooth risk map for the whole country. Conclusion We have produced a highly plausible and parsimonious model of historical malaria risk for Botswana from point-referenced data from a 1961/2 prevalence survey of malaria infection in 1–14 year old children. After starting with a list of 50 potential variables we ended with three highly plausible predictors, by applying a systematic and repeatable staged variable selection procedure that included a spatial analysis, which has application for other environmentally determined infectious diseases. All this was accomplished using general-purpose statistical software. PMID:17892584

Predictors of perioperative major bleeding in patients who interrupt warfarin for an elective surgery or procedure: Analysis of the BRIDGE trial.

PubMed

Clark, Nathan P; Douketis, James D; Hasselblad, Vic; Schulman, Sam; Kindzelski, Andrei L; Ortel, Thomas L

2018-01-01

The use of low-molecular weight heparin bridge therapy during warfarin interruption for elective surgery/procedures increases bleeding. Other predictors of bleeding in this setting are not well described. BRIDGE was a randomized, double-blind, placebo-controlled trial of bridge therapy with dalteparin 100 IU/kg twice daily in patients with atrial fibrillation requiring warfarin interruption. Bleeding outcomes were documented from the time of warfarin interruption until up to 37 days postprocedure. Multiple logistic regression and time-dependent hazard models were used to identify major bleeding predictors. We analyzed 1,813 patients of whom 895 received bridging and 918 received placebo. Median patient age was 72.6 years, and 73.3% were male. Forty-one major bleeding events occurred at a median time of 7.0 days (interquartile range, 4.0-18.0 days) postprocedure. Bridge therapy was a baseline predictor of major bleeding (odds ratio [OR]=2.4, 95% CI: 1.2-4.8), as were a history of renal disease (OR=2.9, 95% CI: 1.4-6.0), and high-bleeding risk procedures (vs low-bleeding risk procedures) (OR=2.9, 95% CI: 1.4-5.9). Perioperative aspirin use (OR=3.6, 95% CI: 1.1-11.9) and postprocedure international normalized ratio >3.0 (OR=2.1, 95% CI: 1.5-3.1) were time-dependent predictors of major bleeding. Major bleeding was most common in the first 10 days compared with 11-37 days postprocedure (OR=3.5, 95% CI: 1.8-6.9). In addition to bridge therapy, perioperative aspirin use, postprocedure international normalized ratio >3.0, a history of renal failure, and having a high-bleeding risk procedure increase the risk of major bleeding around the time of an elective surgery/procedure requiring warfarin interruption. Copyright © 2017 Elsevier Inc. All rights reserved.

Risk factors for recurrent symptomatic pigmented biliary stones after percutaneous transhepatic biliary extraction.

PubMed

Kim, Dong Won; Lee, Sang Yun; Cho, Jin-Han; Kang, Myong Jin; Noh, Myung Hwan; Park, Byeong-Ho

2010-07-01

To evaluate risk factors for the recurrence of biliary stones after a percutaneous transhepatic biliary stone extraction. The procedures were performed on 339 patients between July 2004 and December 2008 (54 months). Medical records and images were retrospectively reviewed for 135 patients (mean age, 66.4 years; 83 men and 52 women) who had undergone follow-up for a mean of 13.2 months (range, 3-37 months). To evaluate risk factors for the recurrence of biliary stones, variables were evaluated with univariate and multivariate analyses. Variables included sex, age, stone location, number of stones, stone size, presence of a peripapillary diverticulum, application of antegrade sphincteroplasty, presence of a biliary stricture, largest biliary diameter before the procedure, and gallbladder status. Thirty-three of the 135 patients (24%) had recurrent symptomatic biliary stones and underwent an additional extraction. The mean time to recurrence was 17.2 months +/- 8.7. Univariate analysis of risk factors for recurrence of biliary stones demonstrated that location, number of stones, stone size, application of antegrade sphincteroplasty, presence of a biliary stricture, and biliary diameter were significant factors (P < .05). With use of multivariate analysis, the number of stones (> or =6; relative risk, 64.8; 95% confidence interval: 5.8, 717.6) and stone size (> or =14 mm; relative risk, 3.8; 95% confidence interval: 1.138, 13.231) were determined to be significant risk factors. The independent risk factors for recurrence of symptomatic biliary stones after percutaneous transhepatic biliary stone extraction were a stone size of at least 14 mm and the presence of at least six stones. Copyright 2010 SIR. Published by Elsevier Inc. All rights reserved.

The Effects of Intra-Aortic Balloon Pumps on Mortality in Patients Undergoing High-Risk Coronary Revascularization: A Meta-Analysis of Randomized Controlled Trials of Coronary Artery Bypass Grafting and Stenting Era

PubMed Central

Wan, You-Dong; Sun, Tong-Wen; Kan, Quan-Cheng; Guan, Fang-Xia; Liu, Zi-Qi; Zhang, Shu-Guang

2016-01-01

Background Intra-aortic balloon pumps (IABP) have generally been used for patients undergoing high-risk mechanical coronary revascularization. However, there is still insufficient evidence to determine whether they can improve outcomes in reperfusion therapy patients, mainly by percutaneous coronary intervention (PCI) with stenting or coronary artery bypass graft (CABG). This study was designed to determine the difference between high-risk mechanical coronary revascularization with and without IABPs on mortality, by performing a meta-analysis on randomized controlled trials of the current era. Methods Pubmed and Embase databases were searched from inception to May 2015. Unpublished data were obtained from the investigators. Randomized clinical trials of IABP and non-IABP in high-risk coronary revascularization procedures (PCI or CABG) were included. In the case of PCI procedures, stents should be used in more than 80% of patients. Numbers of events at the short-term and long-term follow-up were extracted. Results A total of 12 randomized trials enrolling 2155 patients were included. IABPs did not significantly decrease short-term mortality (relative risk (RR) 0.66; 95% CI, 0.42–1.01), or long-term mortality (RR 0.79; 95% CI, 0.47–1.35), with low heterogeneity across the studies. The findings remained stable in patients with acute myocardial infarction with or without cardiogenic shock. But in high-risk CABG patients, IABP was associated with reduced mortality (71 events in 846 patients; RR 0.40; 95%CI 0.25–0.67). Conclusion In patients undergoing high-risk coronary revascularization, IABP did not significantly decrease mortality. But high-risk CABG patients may be benefit from IABP. Rigorous criteria should be applied to the use of IABPs. PMID:26784578

Clinical predictors of mortality following rotational atherectomy and stent implantation in high‐risk patients: A single center experience

PubMed Central

Édes, István F.; Ruzsa, Zoltán; Szabó, György; Nardai, Sándor; Becker, Dávid; Benke, Kálmán; Szilveszter, Bálint

2015-01-01

Objectives Our aim was to assess the procedural success and determine the clinical predictors of postprocedure mortality, following rotational atherectomy (RA) and stenting in high‐risk patients. Background RA is mainly used to facilitate stenting in complex lesions. Outcomes involving RA and stenting have been investigated, yet high‐risk patients have not been adequately described. Methods Data of 218 consecutive patients who underwent RA were evaluated in a prospective register. Primary endpoints were the angiographic success and long‐term mortality. Secondary endpoints were procedural success, consumption of the angioplasty equipment, and periprocedural major adverse cardiac events. The impact of the relevant angiographic and clinical characteristics on long‐term mortality was analyzed using uni‐ and multivariate Cox regression analysis. Results Mean age of the patients was 70 ± 8.2 years, diabetes was present in 44%, and chronic renal failure in 29%. Prior myocardial infarction and three‐vessel disease amounted to 42.2% and 32.6%, respectively. Altogether, 52.8% of patients underwent RA after a failed, non‐RA intervention attempt, and 30.7% of cases presented as acute coronary syndromes. Angiographic success was 100%, and all patients received stents after RA. Periprocedural major adverse cardiac events occurred in five (2.3%) patients. Postprocedural death was investigated, with a mean follow‐up of 36 months. Mortality amounted to 37.2%. Multivariate analysis revealed that left ventricular ejection fraction < 50%, glomerular filtration rate < 60 ml/min, cardiogenic shock, and diabetes were the only independent mortality predictors. Conclusions We have found that RA and stenting is feasible and viable in an elderly high‐risk population, with exceptional procedural success and acceptable long‐term results. © 2015 Wiley Periodicals, Inc. PMID:26032270

Development of a list of high-risk operations for patients 65 years and older.

PubMed

Schwarze, Margaret L; Barnato, Amber E; Rathouz, Paul J; Zhao, Qianqian; Neuman, Heather B; Winslow, Emily R; Kennedy, Gregory D; Hu, Yue-Yung; Dodgion, Christopher M; Kwok, Alvin C; Greenberg, Caprice C

2015-04-01

No consensus exists regarding the definition of high-risk surgery in older adults. An inclusive and precise definition of high-risk surgery may be useful for surgeons, patients, researchers, and hospitals. To develop a list of high-risk operations. Retrospective cohort study and modified Delphi procedure. The setting included all Pennsylvania acute care hospitals (Pennsylvania Health Care Cost Containment Council [PHC4] April 1, 2001, to December 31, 2007) and a nationally representative sample of US acute care hospitals (Nationwide Inpatient Sample [NIS], Healthcare Cost and Utilization Project, Agency for Healthcare Research and Quality January 1, 2001, to December 31, 2006). Patients included were those 65 years and older admitted to PHC4 hospitals and those 18 years and older admitted to NIS hospitals. We identified International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) procedure codes associated with at least 1% inpatient mortality in the PHC4. We used a modified Delphi procedure with 5 board-certified surgeons to further refine this list by excluding nonoperative procedures and operations that were unlikely to be the proximate cause of mortality and were instead a marker of critical illness (eg, tracheostomy). We then cross-validated this list of ICD-9-CM codes in the NIS. Modified Delphi procedure consensus of at least 4 of 5 panelists and proportion agreement in the NIS. Among 4,739,522 admissions of patients 65 years and older in the PHC4, a total of 2,569,589 involved a procedure, encompassing 2853 unique procedures. Of 1130 procedures associated with a crude inpatient mortality of at least 1%, 264 achieved consensus as high-risk operations by the modified Delphi procedure. The observed inpatient mortality in the NIS was at least 1% for 227 of 264 procedures (86%) in patients 65 years and older. The pooled inpatient mortality for these identified high-risk procedures performed on patients 65 years and older was double the pooled inpatient mortality for correspondingly identified high-risk operations for patients younger than 65 years (6% vs 3%). We developed a list of procedure codes to identify high-risk surgical procedures in claims data. This list of high-risk operations can be used to standardize the definition of high-risk surgery in quality and outcomes-based studies and to design targeted clinical interventions.

Risk-taking attitudes and their association with process and outcomes of cardiac care: a cohort study

PubMed Central

King, Kathryn M; Norris, Colleen M; Knudtson, Merril L; Ghali, William A

2009-01-01

Background Prior research reveals that processes and outcomes of cardiac care differ across sociodemographic strata. One potential contributing factor to such differences is the personality traits of individuals within these strata. We examined the association between risk-taking attitudes and cardiac patients' clinical and demographic characteristics, the likelihood of undergoing invasive cardiac procedures and survival. Methods We studied a large inception cohort of patients who underwent cardiac catheterization between July 1998 and December 2001. Detailed clinical and demographic data were collected at time of cardiac catheterization and through a mailed survey one year post-catheterization. The survey included three general risk attitude items from the Jackson Personality Inventory. Patients' (n = 6294) attitudes toward risk were categorized as risk-prone versus non-risk-prone and were assessed for associations with baseline clinical and demographic characteristics, treatment received (i.e., medical therapy, coronary artery bypass graft (CABG) surgery, percutaneous coronary intervention (PCI)), and survival (to December 2005). Results 2827 patients (45%) were categorized as risk-prone. Having risk-prone attitudes was associated with younger age (p < .001), male sex (p < .001), current smoking (p < .001) and higher household income (p < .001). Risk-prone patients were more likely to have CABG surgery in unadjusted (Odds Ratio [OR] = 1.21; 95% CI 1.08–1.36) and adjusted (OR = 1.18; 95% CI 1.02–1.36) models, but were no more likely to have PCI or any revascularization. Having risk-prone attitudes was associated with better survival in an unadjusted survival analysis (Hazard Ratio [HR] = 0.78 (95% CI 0.66–0.93), but not in a risk-adjusted analysis (HR = 0.92, 95% CI 0.77–1.10). Conclusion These exploratory findings suggest that patient attitudes toward risk taking may contribute to some of the documented differences in use of invasive cardiac procedures. An awareness of these associations could help healthcare providers as they counsel patients regarding cardiac care decisions. PMID:19660137

A Risk Analysis Methodology to Address Human and Organizational Factors in Offshore Drilling Safety: With an Emphasis on Negative Pressure Test

NASA Astrophysics Data System (ADS)

Tabibzadeh, Maryam

According to the final Presidential National Commission report on the BP Deepwater Horizon (DWH) blowout, there is need to "integrate more sophisticated risk assessment and risk management practices" in the oil industry. Reviewing the literature of the offshore drilling industry indicates that most of the developed risk analysis methodologies do not fully and more importantly, systematically address the contribution of Human and Organizational Factors (HOFs) in accident causation. This is while results of a comprehensive study, from 1988 to 2005, of more than 600 well-documented major failures in offshore structures show that approximately 80% of those failures were due to HOFs. In addition, lack of safety culture, as an issue related to HOFs, have been identified as a common contributing cause of many accidents in this industry. This dissertation introduces an integrated risk analysis methodology to systematically assess the critical role of human and organizational factors in offshore drilling safety. The proposed methodology in this research focuses on a specific procedure called Negative Pressure Test (NPT), as the primary method to ascertain well integrity during offshore drilling, and analyzes the contributing causes of misinterpreting such a critical test. In addition, the case study of the BP Deepwater Horizon accident and their conducted NPT is discussed. The risk analysis methodology in this dissertation consists of three different approaches and their integration constitutes the big picture of my whole methodology. The first approach is the comparative analysis of a "standard" NPT, which is proposed by the author, with the test conducted by the DWH crew. This analysis contributes to identifying the involved discrepancies between the two test procedures. The second approach is a conceptual risk assessment framework to analyze the causal factors of the identified mismatches in the previous step, as the main contributors of negative pressure test misinterpretation. Finally, a rational decision making model is introduced to quantify a section of the developed conceptual framework in the previous step and analyze the impact of different decision making biases on negative pressure test results. Along with the corroborating findings of previous studies, the analysis of the developed conceptual framework in this paper indicates that organizational factors are root causes of accumulated errors and questionable decisions made by personnel or management. Further analysis of this framework identifies procedural issues, economic pressure, and personnel management issues as the organizational factors with the highest influence on misinterpreting a negative pressure test. It is noteworthy that the captured organizational factors in the introduced conceptual framework are not only specific to the scope of the NPT. Most of these organizational factors have been identified as not only the common contributing causes of other offshore drilling accidents but also accidents in other oil and gas related operations as well as high-risk operations in other industries. In addition, the proposed rational decision making model in this research introduces a quantitative structure for analysis of the results of a conducted NPT. This model provides a structure and some parametric derived formulas to determine a cut-off point value, which assists personnel in accepting or rejecting an implemented negative pressure test. Moreover, it enables analysts to assess different decision making biases involved in the process of interpreting a conducted negative pressure test as well as the root organizational factors of those biases. In general, although the proposed integrated research methodology in this dissertation is developed for the risk assessment of human and organizational factors contributions in negative pressure test misinterpretation, it can be generalized and be potentially useful for other well control situations, both offshore and onshore; e.g. fracking. In addition, this methodology can be applied for the analysis of any high-risk operations, in not only the oil and gas industry but also in other industries such as nuclear power plants, aviation industry, and transportation sector.

Wrist electrogoniometry: are current mathematical correction procedures effective in reducing crosstalk in functional assessment?

PubMed

Foltran, Fabiana A; Silva, Luciana C C B; Sato, Tatiana O; Coury, Helenice J C G

2013-01-01

The recording of human movement is an essential requirement for biomechanical, clinical, and occupational analysis, allowing assessment of postural variation, occupational risks, and preventive programs in physical therapy and rehabilitation. The flexible electrogoniometer (EGM), considered a reliable and accurate device, is used for dynamic recordings of different joints. Despite these advantages, the EGM is susceptible to measurement errors, known as crosstalk. There are two known types of crosstalk: crosstalk due to sensor rotation and inherent crosstalk. Correction procedures have been proposed to correct these errors; however no study has used both procedures in clinical measures for wrist movements with the aim to optimize the correction. To evaluate the effects of mathematical correction procedures on: 1) crosstalk due to forearm rotation, 2) inherent sensor crosstalk; and 3) the combination of these two procedures. 43 healthy subjects had their maximum range of motion of wrist flexion/extension and ulnar/radials deviation recorded by EGM. The results were analyzed descriptively, and procedures were compared by differences. There was no significant difference in measurements before and after the application of correction procedures (P<0.05). Furthermore, the differences between the correction procedures were less than 5° in most cases, having little impact on the measurements. Considering the time-consuming data analysis, the specific technical knowledge involved, and the inefficient results, the correction procedures are not recommended for wrist recordings by EGM.

Acoustic detection of Melolonthine larvae in Australian sugarcane

USDA-ARS?s Scientific Manuscript database

Decision support systems have been developed for risk analysis and control of root-feeding white grub pests in Queensland sugarcane, based partly on manual inspection of cane soil samples. Acoustic technology was considered as a potential alternative to this laborious procedure. Field surveys were...

Application of the Flood-IMPAT procedure in the Valle d'Aosta Region, Italy

NASA Astrophysics Data System (ADS)

Minucci, Guido; Mendoza, Marina Tamara; Molinari, Daniela; Atun, Funda; Menoni, Scira; Ballio, Francesco

2016-04-01

Flood Risk Management Plans (FRMPs) established by European "Floods" Directive (Directive 2007/60/EU) to Member States in order to address all aspects of flood risk management, taking into account costs and benefits of proposed mitigation tools must be reviewed by the same law every six years. This is aimed at continuously increasing the effectiveness of risk management, on the bases of the most advanced knowledge of flood risk and most (economically) feasible solutions, also taking into consideration achievements of the previous management cycle. Within this context, the Flood-IMPAT (i.e. Integrated Meso-scale Procedure to Assess Territorial flood risk) procedure has been developed aiming at overcoming limits of risk maps produced by the Po River Basin Authority and adopted for the first version of the Po River FRMP. The procedure allows the estimation of flood risk at the meso-scale and it is characterized by three main peculiarities. First is its feasibility for the entire Italian territory. Second is the possibility to express risk in monetary terms (i.e. expected damage), at least for those categories of damage for which suitable models are available. Finally, independent modules compose the procedure: each module allows the estimation of a certain type of damage (i.e. direct, indirect, intangibles) on a certain sector (e.g. residential, industrial, agriculture, environment, etc.) separately, guaranteeing flexibility in the implementation. This paper shows the application of the Flood-IMPAT procedure and the recent advancements in the procedure, aiming at increasing its reliability and usability. Through a further implementation of the procedure in the Dora Baltea River Basin (North of Italy), it was possible to test the sensitivity of risk estimates supplied by Flood-IMPAT with respect to different damage models and different approaches for the estimation of assets at risk. Risk estimates were also compared with observed damage data in the investigated areas to identify the most suitable damage model/exposure assessment approach to be implemented in the procedure. In the end, the procedure was adapted to be applied at the micro-scale, in such a way to supply risk estimates, which are coherent with those at the meso-scale. This way the procedure can be first implemented in the whole catchment to identify hotspots; the micro-scale approach can be implemented in a second run to investigate in depth (i) the most risk prone areas and (ii) the possible risk mitigation strategies.

Remote pre-procedural ischemic stroke as the greatest risk in carotid‑stenting‑associated stroke and death: a single center's experience.

PubMed

Rašiová, Mária; Špak, Ľubomír; Farkašová, Ľudmila; Pataky, Štefan; Koščo, Martin; Hudák, Marek; Moščovič, Matej; Leško, Norbert

2017-08-01

The goal of carotid artery stenting (CAS) is to decrease the stroke risk in patients with carotid stenosis. This procedure carries an immediate risk of stroke and death and many patients do not benefit from it, especially asymptomatic patients. It is crucial to accurately select the patients who would benefit from carotid procedure, and to rule out those for whom the procedure might be hazardous. Remote ischemic stroke is a known risk factor for stroke recurrence during surgery. The aim of our study was to determine the periprocedural complication risk (within 30 days after CAS) associated with carotid stenting (stroke, death) in patients with and without remote pre-procedural ischemic stroke, to analyze periprocedural risk in other specific patient subgroups treated with CAS, and to determine the impact of observed variables on all-cause mortality during long-term follow-up. We conducted a retrospective review of prospectively collected data from all patients treated with protected CAS between June 20, 2008 and December 31, 2015. Patient age, gender, type of carotid stenosis (symptomatic versus asymptomatic), side of stenosis (right or left carotid artery), type of cerebral protection (proximal versus distal), presence of comorbidities (remote ischemic pre-procedural ischemic stroke, coronary artery disease, diabetes mellitus, peripheral artery disease), previous ipsilateral carotid endarterectomy (CEA), contralateral carotid occlusion (CCO) and previous contralateral CAS/CEA were analyzed to identify higher CAS risk and to determine the impact of these variables on all-cause mortality during follow-up. Survival data were obtained from the Health Care Surveillance Authority registry. Mean follow-up was 1054 days (interquartile range 547.3; 1454.8). Remote pre-procedural ischemic stroke was defined as any-territory ischemic stroke >6 months prior to CAS. Primary periprocedural endpoint incidence (stroke/death) in 502 patients was 3.8% (N.=19) of all patients, 5.4% (N.=10) of symptomatic patients and 2.8% (N.=9) of asymptomatic patients. The risk of periprocedural stroke/death was 3.4 times higher in patients with (N.=198) compared to patients without remote ischemic stroke (N.=304) (6.6% versus 2.0% of patients without remote ischemic stroke; P=0.008). Periprocedural stroke/death in symptomatic patients (N.=186) was non-significantly higher in patients with remote ischemic stroke (N.=76) compared with patients without remote ischemic stroke (N.=110) (7.9% versus 3.6%; P=0.206). Asymptomatic patients with remote ischemic stroke (N.=122) had a 5.6-time-higher periprocedural risk of stroke/death compared with asymptomatic patients without remote ischemic stroke (N.=194) (5.7% versus 1.0%; P=0.014). Patients ≥75 years (N.=83) had a 3.0-time-higher periprocedural risk of stroke/death compared with younger patients (N.=419) (8.4% versus 2.9%; P=0.015); a non-significant increase of periprocedural stroke/death was found in both symptomatic (N.=35) and asymptomatic (N.=48) elderly patients (11.4% versus 4.0%, P=0.078; and 6.3% versus 2.4%, P=0.124, respectively). Increased periprocedural risk of stroke/death was not documented in other analyzed patient subgroups. During long-term follow-up, a 1.5-time-higher mortality risk was found in patients with remote ischemic stroke compared with patients without remote ischemic stroke in multivariable analysis; other patient subgroups (except older versus younger patients) did not differ in long-term mortality following carotid stenting. In our experience, all patients with remote pre-procedural any-territory ischemic stroke belong to risky subgroup for periprocedural stroke death after CAS. All asymptomatic patients with remote ischemic stroke should not be treated with CAS. Remote ischemic stroke increases all-cause mortality in long-term follow-up after carotid stenting. Patients aged ≥75 years also have increased risk of periprocedural stroke and death after CAS. These factors should help us to be more selective when planning carotid procedures.

Human health risk assessment: models for predicting the effective exposure duration of on-site receptors exposed to contaminated groundwater.

PubMed

Baciocchi, Renato; Berardi, Simona; Verginelli, Iason

2010-09-15

Clean-up of contaminated sites is usually based on a risk-based approach for the definition of the remediation goals, which relies on the well known ASTM-RBCA standard procedure. In this procedure, migration of contaminants is described through simple analytical models and the source contaminants' concentration is supposed to be constant throughout the entire exposure period, i.e. 25-30 years. The latter assumption may often result over-protective of human health, leading to unrealistically low remediation goals. The aim of this work is to propose an alternative model taking in account the source depletion, while keeping the original simplicity and analytical form of the ASTM-RBCA approach. The results obtained by the application of this model are compared with those provided by the traditional ASTM-RBCA approach, by a model based on the source depletion algorithm of the RBCA ToolKit software and by a numerical model, allowing to assess its feasibility for inclusion in risk analysis procedures. The results discussed in this work are limited to on-site exposure to contaminated water by ingestion, but the approach proposed can be extended to other exposure pathways. Copyright 2010 Elsevier B.V. All rights reserved.

Analysis of indication for laparoscopic right colectomy and conversion risks.

PubMed

Del Rio, Paolo; Bertocchi, Elisa; Madoni, Cristiana; Viani, Lorenzo; Dell'Abate, Paolo; Sianesi, Mario

2016-01-01

Laparoscopic surgery developed continuously over the past years becoming the gold standard for some surgical interventions. Laparoscopic colorectal surgery is well established as a safe and feasible procedure to treat benign and malignant pathologies. In this paper we studied in deep the role of laparoscopic right colectomy analysing the indications to this surgical procedure and the factors related to the conversion from laparoscopy to open surgery. We described the different surgical techniques of laparoscopic right colectomy comparing extra to intracorporeal anastomosis and we pointed out the different ways to access to the abdomen (multiport VS single incision). The indications for laparoscopic right colectomy are benign (inflammatory bowel disease and rare right colonic diverticulitis) and malignant diseases (right colon cancer and appendiceal neuroendocrine neoplasm): we described the good outcomes of laparoscopic right colectomy in all these illnesses. Laparoscopic conversion rates in right colectomy are reported as 12-16%; we described the different type of risk factors related to open conversion: patient-related, disease-related and surgeon-related factors, procedural factors and intraoperative complications. We conclude that laparoscopic right colectomy is considered superior to open surgery in the shortterm outcomes without difference in long-term outcomes. Conversion risks, Indication to treatment, Laparoscopy, Post-operative pain, Right colectomy.

The Abdominal Aortic Aneurysm Statistically Corrected Operative Risk Evaluation (AAA SCORE) for predicting mortality after open and endovascular interventions.

PubMed

Ambler, Graeme K; Gohel, Manjit S; Mitchell, David C; Loftus, Ian M; Boyle, Jonathan R

2015-01-01

Accurate adjustment of surgical outcome data for risk is vital in an era of surgeon-level reporting. Current risk prediction models for abdominal aortic aneurysm (AAA) repair are suboptimal. We aimed to develop a reliable risk model for in-hospital mortality after intervention for AAA, using rigorous contemporary statistical techniques to handle missing data. Using data collected during a 15-month period in the United Kingdom National Vascular Database, we applied multiple imputation methodology together with stepwise model selection to generate preoperative and perioperative models of in-hospital mortality after AAA repair, using two thirds of the available data. Model performance was then assessed on the remaining third of the data by receiver operating characteristic curve analysis and compared with existing risk prediction models. Model calibration was assessed by Hosmer-Lemeshow analysis. A total of 8088 AAA repair operations were recorded in the National Vascular Database during the study period, of which 5870 (72.6%) were elective procedures. Both preoperative and perioperative models showed excellent discrimination, with areas under the receiver operating characteristic curve of .89 and .92, respectively. This was significantly better than any of the existing models (area under the receiver operating characteristic curve for best comparator model, .84 and .88; P < .001 and P = .001, respectively). Discrimination remained excellent when only elective procedures were considered. There was no evidence of miscalibration by Hosmer-Lemeshow analysis. We have developed accurate models to assess risk of in-hospital mortality after AAA repair. These models were carefully developed with rigorous statistical methodology and significantly outperform existing methods for both elective cases and overall AAA mortality. These models will be invaluable for both preoperative patient counseling and accurate risk adjustment of published outcome data. Copyright © 2015 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

[Anesthesia-related cardiac arrest in children. Data from a tertiary referral hospital registry].

PubMed

Sanabria-Carretero, P; Ochoa-Osorio, C; Martín-Vega, A; Lahoz-Ramón, A; Rodríguez-Pérez, E; Reinoso-Barbero, F; Goldman-Tarlovsky, L

2013-10-01

The aim of this study is to analyze the cardiac arrests related to anesthesia in a tertiary children's hospital, in order to identify risk factors that would lead to opportunities for improvement. A 5-year retrospective study was conducted on anesthesia related cardiac arrest occurring in pediatric patients. All urgent and elective anesthetic procedures performed by anesthesiologists were included. Data collected included patient characteristics, the procedure, the probable cause, and outcome of the cardiac arrest. Odds ratio was calculated by univariate analysis to determine the clinical factors associated with cardiac arrest and mortality. There were a total of 15 cardiac arrests related to anesthesia in 43,391 anesthetic procedures (3.4 per 10,000), with an incidence in children with ASA I-II versus ASA≥III of 0.28 and 19.27 per 10,000, respectively. The main risk factors were children ASA≥III (P<.001), less than one month old (P<.001), less than one year old (P<.001), emergency procedures (P<.01), cardiac procedures (P<.001) and procedures performed in the catheterization laboratory (P<.05). The main causes of cardiac arrest were cardiovascular (53.3%), mainly due to hypovolemia, and cardiovascular depression associated with induction of anesthesia, followed by respiratory causes (20%), and medication causes (20%). The incidence of mortality and neurological injury within the first 24h after the cardiac arrest was 0.92 and 1.38 per 10,000, respectively. The mortality in the first 3 months was 1.6 per 10,000. The main causes of death were ASA≥III, age under one year, pulmonary arterial hypertension, cardiac arrest in areas remote from the surgery area, a duration of cardiopulmonary resuscitation over 20min, and when hypothermia was not applied after cardiac arrest. The main risk factors for cardiac arrest were ASA≥III, age under one year, emergency procedures, cardiology procedures and procedures performed in the catheterization laboratory. The main cause of the cardiac arrest was due mainly to cardiovascular hypovolemia. All patients who died or had neurological injury were ASA≥III. Pulmonary arterial hypertension is a risk of anesthesia-related mortality. Copyright © 2012 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

48 CFR 1850.403 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 6 2011-10-01 2011-10-01 false Special procedures for unusually hazardous or nuclear risks. 1850.403 Section 1850.403 Federal Acquisition Regulations System... Residual Powers 1850.403 Special procedures for unusually hazardous or nuclear risks. ...

48 CFR 1850.403 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 6 2010-10-01 2010-10-01 true Special procedures for unusually hazardous or nuclear risks. 1850.403 Section 1850.403 Federal Acquisition Regulations System... Residual Powers 1850.403 Special procedures for unusually hazardous or nuclear risks. ...

A simple prognostic model for overall survival in metastatic renal cell carcinoma.

PubMed

Assi, Hazem I; Patenaude, Francois; Toumishey, Ethan; Ross, Laura; Abdelsalam, Mahmoud; Reiman, Tony

2016-01-01

The primary purpose of this study was to develop a simpler prognostic model to predict overall survival for patients treated for metastatic renal cell carcinoma (mRCC) by examining variables shown in the literature to be associated with survival. We conducted a retrospective analysis of patients treated for mRCC at two Canadian centres. All patients who started first-line treatment were included in the analysis. A multivariate Cox proportional hazards regression model was constructed using a stepwise procedure. Patients were assigned to risk groups depending on how many of the three risk factors from the final multivariate model they had. There were three risk factors in the final multivariate model: hemoglobin, prior nephrectomy, and time from diagnosis to treatment. Patients in the high-risk group (two or three risk factors) had a median survival of 5.9 months, while those in the intermediate-risk group (one risk factor) had a median survival of 16.2 months, and those in the low-risk group (no risk factors) had a median survival of 50.6 months. In multivariate analysis, shorter survival times were associated with hemoglobin below the lower limit of normal, absence of prior nephrectomy, and initiation of treatment within one year of diagnosis.

A simple prognostic model for overall survival in metastatic renal cell carcinoma

PubMed Central

Assi, Hazem I.; Patenaude, Francois; Toumishey, Ethan; Ross, Laura; Abdelsalam, Mahmoud; Reiman, Tony

2016-01-01

Introduction: The primary purpose of this study was to develop a simpler prognostic model to predict overall survival for patients treated for metastatic renal cell carcinoma (mRCC) by examining variables shown in the literature to be associated with survival. Methods: We conducted a retrospective analysis of patients treated for mRCC at two Canadian centres. All patients who started first-line treatment were included in the analysis. A multivariate Cox proportional hazards regression model was constructed using a stepwise procedure. Patients were assigned to risk groups depending on how many of the three risk factors from the final multivariate model they had. Results: There were three risk factors in the final multivariate model: hemoglobin, prior nephrectomy, and time from diagnosis to treatment. Patients in the high-risk group (two or three risk factors) had a median survival of 5.9 months, while those in the intermediate-risk group (one risk factor) had a median survival of 16.2 months, and those in the low-risk group (no risk factors) had a median survival of 50.6 months. Conclusions: In multivariate analysis, shorter survival times were associated with hemoglobin below the lower limit of normal, absence of prior nephrectomy, and initiation of treatment within one year of diagnosis. PMID:27217858

Risk analysis of heat recovery steam generator with semi quantitative risk based inspection API 581

DOE Office of Scientific and Technical Information (OSTI.GOV)

Prayogo, Galang Sandy, E-mail: gasandylang@live.com; Haryadi, Gunawan Dwi; Ismail, Rifky

Corrosion is a major problem that most often occurs in the power plant. Heat recovery steam generator (HRSG) is an equipment that has a high risk to the power plant. The impact of corrosion damage causing HRSG power plant stops operating. Furthermore, it could be threaten the safety of employees. The Risk Based Inspection (RBI) guidelines by the American Petroleum Institute (API) 58 has been used to risk analysis in the HRSG 1. By using this methodology, the risk that caused by unexpected failure as a function of the probability and consequence of failure can be estimated. This paper presentedmore » a case study relating to the risk analysis in the HRSG, starting with a summary of the basic principles and procedures of risk assessment and applying corrosion RBI for process industries. The risk level of each HRSG equipment were analyzed: HP superheater has a medium high risk (4C), HP evaporator has a medium-high risk (4C), and the HP economizer has a medium risk (3C). The results of the risk assessment using semi-quantitative method of standard API 581 based on the existing equipment at medium risk. In the fact, there is no critical problem in the equipment components. Damage mechanisms were prominent throughout the equipment is thinning mechanism. The evaluation of the risk approach was done with the aim of reducing risk by optimizing the risk assessment activities.« less

Post-surgical infections and perioperative antibiotics usage in pediatric genitourinary procedures.

PubMed

Ellett, Justin; Prasad, Michaella M; Purves, J Todd; Stec, Andrew A

2015-12-01

Post-surgical infections (PSIs) are a source of preventable perioperative morbidity. No guidelines exist for the use of perioperative antibiotics in pediatric urologic procedures. This study reports the rate of PSIs in non-endoscopic pediatric genitourinary procedures at our institution. Secondary aims evaluate the association of PSI with other perioperative variables, including wound class (WC) and perioperative antibiotic administration. Data from consecutive non-endoscopic pediatric urologic procedures performed between August 2011 and April 2014 were examined retrospectively. The primary outcome was the rate of PSIs. PSIs were classified as superficial skin (SS) and deep/organ site (D/OS) according to Centers for Disease Control and Prevention guidelines, and urinary tract infection (UTI). PSIs were further stratified by WC1 and WC2 and perioperative antibiotic usage. A relative risk and chi-square analysis compared PSI rates between WC1 and WC2 procedures. A total of 1185 unique patients with 1384 surgical sites were reviewed; 1192 surgical sites had follow-up for inclusion into the study. Ten total PSIs were identified, for an overall infection rate of 0.83%. Of these, six were SS, one was D/OS, and three were UTIs. The PSI rate for WC1 (885 sites) and WC2 (307 sites) procedures was 0.34% and 2.28%, respectively, p < 0.01. Relative risk of infection in WC2 procedures was 6.7 (CI 1.75-25.85, p = 0.0055). The rate of infections in WC1 procedures was similar between those receiving and not receiving perioperative antibiotics (0.35% vs. 0.33%). All WC2 procedures received antibiotics. Post-surgical infections are associated with significant perioperative morbidity. In some studies, PSI can double hospital costs, and contribute to hospital length of stay, admission to intensive care units, and impact patient mortality. Our study demonstrates that the rate of PSI in WC1 operations is low, irrespective of whether the patient received perioperative antibiotics (0.35%) or no antibiotics (0.33%). WC2 operations were the larger source of morbidity with an infection rate of 2.28% and a 6.7 fold higher increase in relative risk. WC1 procedures have a rate of infection around 0.3%, which is independent of the use of perioperative antibiotics. WC2 procedures have a higher rate of infection, with a relative risk of 6.7 for the development of PSI, and should be the target of guidelines for periprocedural prophylaxis. Copyright © 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

An updated meta-analysis on the effectiveness of preoperative prophylactic antibiotics in patients undergoing breast surgical procedures.

PubMed

Sajid, Muhammad S; Hutson, Kristian; Akhter, Naved; Kalra, Lorain; Rapisarda, Ignacio F; Bonomi, Ricardo

2012-01-01

To systematically analyze published randomized trials on the effectiveness of preoperative prophylactic antibiotics in patients undergoing breast surgical procedures. Trials on the effectiveness of preoperative prophylactic antibiotics in patients undergoing breast surgery were selected and analyzed to generate summated data (expressed as risk ratio [RR]) by using RevMan 5.0. Nine randomized controlled trials encompassing 3720 patients undergoing breast surgery were retrieved from the electronic databases. The antibiotics group comprised a total of 1857 patients and non-antibiotics group, 1863 patients. There was no heterogeneity [χ(2) = 7.61, d.f. = 7, p < 0.37; I(2) = 8%] amongst trials. Therefore, in the fixed-effects model (RR, 0.64; 95% CI, 0.50-0.83; z = 3.48; p < 0.0005), the use of preoperative prophylactic antibiotics in patients undergoing breast surgical procedures was statistically significant in reducing the incidence of surgical site infection (SSI). Furthermore, in the fixed-effects model (RR, 1.30; 95% CI, 0.89-1.90; z = 1.37; p < 0.17), adverse reactions secondary to the use of prophylactic antibiotics was not statistically significant between the two groups. Preoperative prophylactic antibiotics significantly reduce the risk of SSI after breast surgical procedures. The risk of adverse reactions from prophylactic antibiotic administration is not significant in these patients. Therefore, preoperative prophylactic antibiotics in breast surgery patients may be routinely administered. Further research is required, however, on risk stratification for SSI, timing and duration of prophylaxis, and the need for prophylaxis in patients undergoing breast reconstruction versus no reconstruction. © 2012 Wiley Periodicals, Inc.

Spatial assessment of potential ecological risk of heavy metals in soils from informal e-waste recycling in Ghana.

PubMed

Kyere, Vincent Nartey; Greve, Klaus; Atiemo, Sampson Manukure; Ephraim, James

2017-01-01

The rapidly increasing annual global volume of e-waste, and of its inherently valuable fraction, has created an opportunity for individuals in Agbogbloshie, Accra, Ghana to make a living by using unconventional, uncontrolled, primitive and crude procedures to recycle and recover valuable metals from this waste. The current form of recycling procedures releases hazardous fractions, such as heavy metals, into the soil, posing a significant risk to the environment and human health. Using a handheld global positioning system, 132 soil samples based on 100 m grid intervals were collected and analysed for cadmium (Cd), chromium (Cr), copper (Cu), mercury (Hg), lead (Pb) and zinc (Zn). Using geostatistical techniques and sediment quality guidelines, this research seeks to assess the potential risk these heavy metals posed to the proposed Korle Ecological Restoration Zone by informal e-waste processing site in Agbogbloshie, Accra, Ghana. Analysis of heavy metals revealed concentrations exceeded the regulatory limits of both Dutch and Canadian soil quality and guidance values, and that the ecological risk posed by the heavy metals extended beyond the main burning and dismantling sites of the informal recyclers to the school, residential, recreational, clinic, farm and worship areas. The heavy metals Cr, Cu, Pb and Zn had normal distribution, spatial variability, and spatial autocorrelation. Further analysis revealed the decreasing order of toxicity, Hg>Cd>Pb> Cu>Zn>Cr, of contributing significantly to the potential ecological risk in the study area.

Spatial assessment of potential ecological risk of heavy metals in soils from informal e-waste recycling in Ghana

PubMed Central

Greve, Klaus; Atiemo, Sampson Manukure

2017-01-01

The rapidly increasing annual global volume of e-waste, and of its inherently valuable fraction, has created an opportunity for individuals in Agbogbloshie, Accra, Ghana to make a living by using unconventional, uncontrolled, primitive and crude procedures to recycle and recover valuable metals from this waste. The current form of recycling procedures releases hazardous fractions, such as heavy metals, into the soil, posing a significant risk to the environment and human health. Using a handheld global positioning system, 132 soil samples based on 100 m grid intervals were collected and analysed for cadmium (Cd), chromium (Cr), copper (Cu), mercury (Hg), lead (Pb) and zinc (Zn). Using geostatistical techniques and sediment quality guidelines, this research seeks to assess the potential risk these heavy metals posed to the proposed Korle Ecological Restoration Zone by informal e-waste processing site in Agbogbloshie, Accra, Ghana. Analysis of heavy metals revealed concentrations exceeded the regulatory limits of both Dutch and Canadian soil quality and guidance values, and that the ecological risk posed by the heavy metals extended beyond the main burning and dismantling sites of the informal recyclers to the school, residential, recreational, clinic, farm and worship areas. The heavy metals Cr, Cu, Pb and Zn had normal distribution, spatial variability, and spatial autocorrelation. Further analysis revealed the decreasing order of toxicity, Hg>Cd>Pb> Cu>Zn>Cr, of contributing significantly to the potential ecological risk in the study area. PMID:29056034

First Outbreak with MRSA in a Danish Neonatal Intensive Care Unit: Risk Factors and Control Procedures

PubMed Central

Ramsing, Benedicte Grenness Utke; Arpi, Magnus; Andersen, Erik Arthur; Knabe, Niels; Mogensen, Dorthe; Buhl, Dorte; Westh, Henrik; Østergaard, Christian

2013-01-01

Introduction The purpose of the study was to describe demographic and clinical characteristics and outbreak handling of a large methicillin-resistant Staphylococcus aureus (MRSA) outbreak in a neonatal intensive care unit (NICU) in Denmark June 25th–August 8th 2008, and to identify risk factors for MRSA transmission. Methods Data were collected retrospectively from medical records and the Danish Neobase database. All MRSA isolates obtained from neonates, relatives and NICU health care workers (HCW) as well as environmental cultures were typed. Results During the 46 day outbreak period, 102 neonates were admitted to the two neonatal wards. Ninety-nine neonates were subsequently sampled, and 32 neonates (32%) from 25 families were colonized with MRSA (spa-type t127, SCCmec V, PVL negative). Thirteen family members from 11 of those families (44%) and two of 161 HCWs (1%) were colonized with the same MRSA. No one was infected. Five environmental cultures were MRSA positive. In a multiple logistic regression analysis, nasal Continuous Positive Airway Pressure (nCPAP) treatment (p = 0.006) and Caesarean section (p = 0.016) were independent risk factors for MRSA acquisition, whereas days of exposure to MRSA was a risk factors in the unadjusted analysis (p = 0.04). Conclusions MRSA transmission occurs with high frequency in the NICU during hospitalization with unidentified MRSA neonates. Caesarean section and nCPAP treatment were identified as risk factors for MRSA colonization. The MRSA outbreak was controlled through infection control procedures. PMID:23825581

An overview of safety assessment, regulation, and control of hazardous material use at NREL

NASA Astrophysics Data System (ADS)

Nelson, B. P.; Crandall, R. S.; Moskowitz, P. D.; Fthenakis, V. M.

1992-12-01

This paper summarizes the methodology we use to ensure the safe use of hazardous materials at the National Renewable Energy Laboratory (NREL). First, we analyze the processes and the materials used in those processes to identify the hazards presented. Then we study federal, state, and local regulations and apply the relevant requirements to our operations. When necessary, we generate internal safety documents to consolidate this information. We design research operations and support systems to conform to these requirements. Before we construct the systems, we perform a semiquantitative risk analysis on likely accident scenarios. All scenarios presenting an unacceptable risk require system or procedural modifications to reduce the risk. Following these modifications, we repeat the risk analysis to ensure that the respective accident scenarios present an acceptable risk. Once all risks are acceptable, we conduct an operational readiness review (ORR). A management-appointed panel performs the ORR ensuring compliance with all relevant requirements. After successful completion of the ORR, operations can begin.

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

PubMed

Kapur, Ajay; Potters, Louis

2012-01-01

The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Safer Liquid Natural Gas

NASA Technical Reports Server (NTRS)

1976-01-01

After the disaster of Staten Island in 1973 where 40 people were killed repairing a liquid natural gas storage tank, the New York Fire Commissioner requested NASA's help in drawing up a comprehensive plan to cover the design, construction, and operation of liquid natural gas facilities. Two programs are underway. The first transfers comprehensive risk management techniques and procedures which take the form of an instruction document that includes determining liquid-gas risks through engineering analysis and tests, controlling these risks by setting up redundant fail safe techniques, and establishing criteria calling for decisions that eliminate or accept certain risks. The second program prepares a liquid gas safety manual (the first of its kind).

Building a computer program to support children, parents, and distraction during healthcare procedures.

PubMed

Hanrahan, Kirsten; McCarthy, Ann Marie; Kleiber, Charmaine; Ataman, Kaan; Street, W Nick; Zimmerman, M Bridget; Ersig, Anne L

2012-10-01

This secondary data analysis used data mining methods to develop predictive models of child risk for distress during a healthcare procedure. Data used came from a study that predicted factors associated with children's responses to an intravenous catheter insertion while parents provided distraction coaching. From the 255 items used in the primary study, 44 predictive items were identified through automatic feature selection and used to build support vector machine regression models. Models were validated using multiple cross-validation tests and by comparing variables identified as explanatory in the traditional versus support vector machine regression. Rule-based approaches were applied to the model outputs to identify overall risk for distress. A decision tree was then applied to evidence-based instructions for tailoring distraction to characteristics and preferences of the parent and child. The resulting decision support computer application, titled Children, Parents and Distraction, is being used in research. Future use will support practitioners in deciding the level and type of distraction intervention needed by a child undergoing a healthcare procedure.

Contemporary analysis of the intraoperative and perioperative complications of neurosurgical procedures performed in the sitting position.

PubMed

Himes, Benjamin T; Mallory, Grant W; Abcejo, Arnoley S; Pasternak, Jeffrey; Atkinson, John L D; Meyer, Fredric B; Marsh, W Richard; Link, Michael J; Clarke, Michelle J; Perkins, William; Van Gompel, Jamie J

2017-07-01

OBJECTIVE Historically, performing neurosurgery with the patient in the sitting position offered advantages such as improved visualization and gravity-assisted retraction. However, this position fell out of favor at many centers due to the perceived risk of venous air embolism (VAE) and other position-related complications. Some neurosurgical centers continue to perform sitting-position cases in select patients, often using modern monitoring techniques that may improve procedural safety. Therefore, this paper reports the risks associated with neurosurgical procedures performed in the sitting position in a modern series. METHODS The authors reviewed the anesthesia records for instances of clinically significant VAE and other complications for all neurosurgical procedures performed in the sitting position between January 1, 2000, and October 8, 2013. In addition, a prospectively maintained morbidity and mortality log of these procedures was reviewed for instances of subdural or intracerebral hemorrhage, tension pneumocephalus, and quadriplegia. Both overall and specific complication rates were calculated in relation to the specific type of procedure. RESULTS In a series of 1792 procedures, the overall complication rate related to the sitting position was 1.45%, which included clinically significant VAE, tension pneumocephalus, and subdural hemorrhage. The rate of any detected VAE was 4.7%, but the rate of VAE requiring clinical intervention was 1.06%. The risk of clinically significant VAE was highest in patients undergoing suboccipital craniotomy/craniectomy with a rate of 2.7% and an odds ratio (OR) of 2.8 relative to deep brain stimulator cases (95% confidence interval [CI] 1.2-70, p = 0.04). Sitting cervical spine cases had a comparatively lower complication rate of 0.7% and an OR of 0.28 as compared with all cranial procedures (95% CI 0.12-0.67, p < 0.01). Sitting cervical cases were further subdivided into extradural and intradural procedures. The rate of complications in intradural cases was significantly higher (OR 7.3, 95% CI 1.4-39, p = 0.02) than for extradural cases. The risk of VAE in intradural spine procedures did not differ significantly from sitting suboccipital craniotomy/craniectomy cases (OR 0.69, 95% CI 0.09-5.4, p = 0.7). Two cases (0.1%) had to be aborted intraoperatively due to complications. There were no instances of intraoperative deaths, although there was a single death within 30 days of surgery. CONCLUSIONS In this large, modern series of cases performed in the sitting position, the complication rate was low. Suboccipital craniotomy/craniectomy was associated with the highest risk of complications. When appropriately used with modern anesthesia techniques, the sitting position provides a safe means of surgical access.

SU-F-T-248: FMEA Risk Analysis Implementation (AAPM TG-100) in Total Skin Electron Irradiation Technique

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ibanez-Rosello, B; Bautista-Ballesteros, J; Bonaque, J

2016-06-15

Purpose: Total Skin Electron Irradiation (TSEI) is a radiotherapy treatment which involves irradiating the entire body surface as homogeneously as possible. It is composed of an extensive multi-step technique in which quality management requires high consumption of resources and a fluid communication between the involved staff, necessary to improve the safety of treatment. The TG-100 proposes a new perspective of quality management in radiotherapy, presenting a systematic method of risk analysis throughout the global flow of the stages through the patient. The purpose of this work has been to apply TG-100 approach to the TSEI procedure in our institution. Methods:more » A multidisciplinary team specifically targeting TSEI procedure was formed, that met regularly and jointly developed the process map (PM), following TG-100 guidelines of the AAPM. This PM is a visual representation of the temporal flow of steps through the patient since start until the end of his stay in the radiotherapy service. Results: This is the first stage of the full risk analysis, which is being carried out in the center. The PM provides an overview of the process and facilitates the understanding of the team members who will participate in the subsequent analysis. Currently, the team is implementing the analysis of failure modes and effects (FMEA). The failure modes of each of the steps have been identified and assessors are assigning a value of severity (S), frequency of occurrence (O) and lack of detection (D) individually. To our knowledge, this is the first PM made for the TSEI. The developed PM can be useful for those centers that intend to implement the TSEI technique. Conclusion: The PM of TSEI technique has been established, as the first stage of full risk analysis, performed in a reference center in this treatment.« less

Probabilistic seismic vulnerability and risk assessment of stone masonry structures

NASA Astrophysics Data System (ADS)

Abo El Ezz, Ahmad

Earthquakes represent major natural hazards that regularly impact the built environment in seismic prone areas worldwide and cause considerable social and economic losses. The high losses incurred following the past destructive earthquakes promoted the need for assessment of the seismic vulnerability and risk of the existing buildings. Many historic buildings in the old urban centers in Eastern Canada such as Old Quebec City are built of stone masonry and represent un-measurable architectural and cultural heritage. These buildings were built to resist gravity loads only and generally offer poor resistance to lateral seismic loads. Seismic vulnerability assessment of stone masonry buildings is therefore the first necessary step in developing seismic retrofitting and pre-disaster mitigation plans. The objective of this study is to develop a set of probability-based analytical tools for efficient seismic vulnerability and uncertainty analysis of stone masonry buildings. A simplified probabilistic analytical methodology for vulnerability modelling of stone masonry building with systematic treatment of uncertainties throughout the modelling process is developed in the first part of this study. Building capacity curves are developed using a simplified mechanical model. A displacement based procedure is used to develop damage state fragility functions in terms of spectral displacement response based on drift thresholds of stone masonry walls. A simplified probabilistic seismic demand analysis is proposed to capture the combined uncertainty in capacity and demand on fragility functions. In the second part, a robust analytical procedure for the development of seismic hazard compatible fragility and vulnerability functions is proposed. The results are given by sets of seismic hazard compatible vulnerability functions in terms of structure-independent intensity measure (e.g. spectral acceleration) that can be used for seismic risk analysis. The procedure is very efficient for conducting rapid vulnerability assessment of stone masonry buildings. With modification of input structural parameters, it can be adapted and applied to any other building class. A sensitivity analysis of the seismic vulnerability modelling is conducted to quantify the uncertainties associated with each of the input parameters. The proposed methodology was validated for a scenario-based seismic risk assessment of existing buildings in Old Quebec City. The procedure for hazard compatible vulnerability modelling was used to develop seismic fragility functions in terms of spectral acceleration representative of the inventoried buildings. A total of 1220 buildings were considered. The assessment was performed for a scenario event of magnitude 6.2 at distance 15km with a probability of exceedance of 2% in 50 years. The study showed that most of the expected damage is concentrated in the old brick and stone masonry buildings.

Postoperative glaucoma following infantile cataract surgery: an individual patient data meta-analysis.

PubMed

Mataftsi, Asimina; Haidich, Anna-Bettina; Kokkali, Stamatia; Rabiah, Peter K; Birch, Eileen; Stager, David R; Cheong-Leen, Richard; Singh, Vineet; Egbert, James E; Astle, William F; Lambert, Scott R; Amitabh, Purohit; Khan, Arif O; Grigg, John; Arvanitidou, Malamatenia; Dimitrakos, Stavros A; Nischal, Ken K

2014-09-01

Infantile cataract surgery bears a significant risk for postoperative glaucoma, and no consensus exists on factors that may reduce this risk. To assess the effect of primary intraocular lens implantation and timing of surgery on the incidence of postoperative glaucoma. We searched multiple databases to July 14, 2013, to identify studies with eligible patients, including PubMed, MEDLINE, EMBASE, ISI Web of Science, Scopus, Central, Google Scholar, Intute, and Tripdata. We also searched abstracts of ophthalmology society meetings. We included studies reporting on postoperative glaucoma in infants undergoing cataract surgery with regular follow-up for at least 1 year. Infants with concurrent ocular anomalies were excluded. Authors of eligible studies were invited to contribute individual patient data on infants who met the inclusion criteria. We also performed an aggregate data meta-analysis of published studies that did not contribute to the individual patient data. Data were pooled using a random-effects model. Time to glaucoma with the effect of primary implantation, additional postoperative intraocular procedures, and age at surgery. Seven centers contributed individual patient data on 470 infants with a median age at surgery of 3.0 months and median follow-up of 6.0 years. Eighty patients (17.0%) developed glaucoma at a median follow-up of 4.3 years. Only 2 of these patients had a pseudophakic eye. The risk for postoperative glaucoma appeared to be lower after primary implantation (hazard ratio [HR], 0.10 [95% CI, 0.01-0.70]; P = .02; I(2) = 34%), higher after surgery at 4 weeks or younger (HR, 2.10 [95% CI, 1.14-3.84]; P = .02; I(2) = 0%), and higher after additional procedures (HR, 2.52 [95% CI, 1.11-5.72]; P = .03; I(2) = 32%). In multivariable analysis, additional procedures independently increased the risk for glaucoma (HR, 2.25 [95% CI, 1.20-4.21]; P = .01), and primary implantation independently reduced it (HR, 0.10 [95% CI, 0.01-0.76]; P = .03). Results were similar in the aggregate data meta-analysis that included data from 10 published articles. Although confounding factors such as size of the eye and surgeon experience are not accounted for in this meta-analysis, the risk for postoperative glaucoma after infantile cataract surgery appears to be influenced by the timing of surgery, primary implantation, and additional intraocular surgery.

The risk of kidney stones following bariatric surgery: a systematic review and meta-analysis.

PubMed

Thongprayoon, Charat; Cheungpasitporn, Wisit; Vijayvargiya, Priya; Anthanont, Pimjai; Erickson, Stephen B

2016-01-01

With rising prevalence of morbid obesity, the number of bariatric surgeries performed each year has been increasing worldwide. The objective of this meta-analysis was to assess the risk of kidney stones following bariatric surgery. A literature search was performed using MEDLINE, EMBASE, and Cochrane Database of Systematic Reviews from inception through July 2015. Only studies reporting relative risks, odd ratios or hazard ratios (HRs) to compare risk of kidney stones in patients who underwent bariatric surgery versus no surgery were included. Pooled risk ratios (RR) and 95% confidence interval (CI) were calculated using a random-effect, generic inverse variance method. Four studies (One randomized controlled trial and three cohort studies) with 11,348 patients were included in analysis to assess the risk of kidney stones following bariatric surgery. The pooled RR of kidney stones in patients undergoing bariatric surgery was 1.22 (95% CI, 0.63-2.35). The type of bariatric surgery subgroup analysis demonstrated an increased risk of kidney stones in patients following Roux-en-Y gastric bypass (RYGB) with the pooled RR of 1.73 (95% CI, 1.30-2.30) and a decreased risk of kidney stones in patients following restrictive procedures including laparoscopic banding or sleeve gastrectomy with the pooled RR of 0.37 (95% CI, 0.16-0.85). Our meta-analysis demonstrates an association between RYGB and increased risk of kidney stones. Restrictive bariatric surgery, on the other hand, may decrease kidney stone risk. Future study with long-term follow-up data is needed to confirm this potential benefit of restrictive bariatric surgery.

Radiation-Induced Noncancer Risks in Interventional Cardiology: Optimisation of Procedures and Staff and Patient Dose Reduction

PubMed Central

Khairuddin Md Yusof, Ahmad

2013-01-01

Concerns about ionizing radiation during interventional cardiology have been increased in recent years as a result of rapid growth in interventional procedure volumes and the high radiation doses associated with some procedures. Noncancer radiation risks to cardiologists and medical staff in terms of radiation-induced cataracts and skin injuries for patients appear clear potential consequences of interventional cardiology procedures, while radiation-induced potential risk of developing cardiovascular effects remains less clear. This paper provides an overview of the evidence-based reviews of concerns about noncancer risks of radiation exposure in interventional cardiology. Strategies commonly undertaken to reduce radiation doses to both medical staff and patients during interventional cardiology procedures are discussed; optimisation of interventional cardiology procedures is highlighted. PMID:24027768

Metaprop: a Stata command to perform meta-analysis of binomial data.

PubMed

Nyaga, Victoria N; Arbyn, Marc; Aerts, Marc

2014-01-01

Meta-analyses have become an essential tool in synthesizing evidence on clinical and epidemiological questions derived from a multitude of similar studies assessing the particular issue. Appropriate and accessible statistical software is needed to produce the summary statistic of interest. Metaprop is a statistical program implemented to perform meta-analyses of proportions in Stata. It builds further on the existing Stata procedure metan which is typically used to pool effects (risk ratios, odds ratios, differences of risks or means) but which is also used to pool proportions. Metaprop implements procedures which are specific to binomial data and allows computation of exact binomial and score test-based confidence intervals. It provides appropriate methods for dealing with proportions close to or at the margins where the normal approximation procedures often break down, by use of the binomial distribution to model the within-study variability or by allowing Freeman-Tukey double arcsine transformation to stabilize the variances. Metaprop was applied on two published meta-analyses: 1) prevalence of HPV-infection in women with a Pap smear showing ASC-US; 2) cure rate after treatment for cervical precancer using cold coagulation. The first meta-analysis showed a pooled HPV-prevalence of 43% (95% CI: 38%-48%). In the second meta-analysis, the pooled percentage of cured women was 94% (95% CI: 86%-97%). By using metaprop, no studies with 0% or 100% proportions were excluded from the meta-analysis. Furthermore, study specific and pooled confidence intervals always were within admissible values, contrary to the original publication, where metan was used.

Report from a quality assurance program on patients undergoing the MILD procedure.

PubMed

Durkin, Brian; Romeiser, Jamie; Shroyer, A Laurie W; Schiller, Robin; Bae, Jin; Davis, Raphael P; Peyster, Robert; Benveniste, Helene

2013-05-01

To characterize trends in pain and functional outcomes and identify risk factors in patients with lumbar spinal stenosis (LSS) and neurogenic claudication undergoing the "Minimally Invasive Lumbar Decompression" (MILD) procedure. Retrospective observational cohort study. Academic multidisciplinary pain center at Stony Brook Medicine. Patients undergoing the MILD procedure from October 2010 to November 2012. De-identified perioperative, pain and function related data for 50 patients undergoing MILD were extracted from the Center for Pain Management's quality assessment database. Data included numerical rating scale (NRS), symptom severity and physical function (Zurich Claudication Questionnaire), functional status (Oswestry Disability Index [ODI]), pain interference scores (National Institutes of Health Patient-Reported Outcomes Measurement Information System [PROMIS]), and patients' self-reported low back and lower extremity pain distribution. No MILD patient incurred procedure-related complications. Average NRS scores decreased postoperatively and 64.3% of patients reported less pain at 3 months. Clinically meaningful functional ODI improvements of at least 20% from baseline were present in 25% of the patients at 6 months. Preliminary analysis of changes in PROMIS scores at 3 months revealed that pre-MILD "severe" lumbar canal stenosis may be associated with high risk of "no improvement." No such impact was observed for NRS or ODI outcomes. Overall, pain is reduced and functional status improved in LSS patients following the MILD procedure at 3 and 6 months. Given the small sample size, it is not yet possible to identify patient subgroups at risk for "no improvement." Continued follow-up of longer-term outcomes appears warranted to develop evidence-based patient selection criteria. Wiley Periodicals, Inc.

Age at Exposure to Surgery and Anesthesia in Children and Association With Mental Disorder Diagnosis.

PubMed

Ing, Caleb; Sun, Ming; Olfson, Mark; DiMaggio, Charles J; Sun, Lena S; Wall, Melanie M; Li, Guohua

2017-12-01

Animals exposed to anesthetics during specific age periods of brain development experience neurotoxicity, with neurodevelopmental changes subsequently observed during adulthood. The corresponding vulnerable age in children, however, is unknown. An observational cohort study was performed using a longitudinal dataset constructed by linking individual-level Medicaid claims from Texas and New York from 1999 to 2010. This dataset was evaluated to determine whether the timing of exposure to anesthesia ≤5 years of age for a single common procedure (pyloromyotomy, inguinal hernia, circumcision outside the perinatal period, or tonsillectomy and/or adenoidectomy) is associated with increased subsequent risk of diagnoses for any mental disorder, or specifically developmental delay (DD) such as reading and language disorders, and attention deficit hyperactivity disorder (ADHD). Exposure to anesthesia and surgery was evaluated in 11 separate age at exposure categories: ≤28 days old, >28 days and ≤6 months, >6 months and ≤1 year, and 6-month age intervals between >1 year old and ≤5 years old. For each exposed child, 5 children matched on propensity score calculated using sociodemographic and clinical covariates were selected for comparison. Cox proportional hazards models were used to measure the hazard ratio of a mental disorder diagnosis associated with exposure to surgery and anesthesia. A total of 38,493 children with a single exposure and 192,465 propensity score-matched children unexposed before 5 years of age were included in the analysis. Increased risk of mental disorder diagnosis was observed at all ages at exposure with an overall hazard ratio of 1.26 (95% confidence interval [CI], 1.22-1.30), which did not vary significantly with the timing of exposure. Analysis of DD and ADHD showed similar results, with elevated hazard ratios distributed evenly across all ages, and overall hazard ratios of 1.26 (95% CI, 1.20-1.32) for DD and 1.31 (95% CI, 1.25-1.37) for ADHD. Children who undergo minor surgery requiring anesthesia under age 5 have a small but statistically significant increased risk of mental disorder diagnoses and DD and ADHD diagnoses, but the timing of the surgical procedure does not alter the elevated risks. Based on these findings, there is little support for the concept of delaying a minor procedure to reduce long-term neurodevelopmental risks of anesthesia in children. In evaluating the influence of age at exposure, the types of procedures included may need to be considered, as some procedures are associated with specific comorbid conditions and are only performed at certain ages.

SU-E-T-421: Failure Mode and Effects Analysis (FMEA) of Xoft Electronic Brachytherapy for the Treatment of Superficial Skin Cancers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hoisak, J; Manger, R; Dragojevic, I

Purpose: To perform a failure mode and effects analysis (FMEA) of the process for treating superficial skin cancers with the Xoft Axxent electronic brachytherapy (eBx) system, given the recent introduction of expanded quality control (QC) initiatives at our institution. Methods: A process map was developed listing all steps in superficial treatments with Xoft eBx, from the initial patient consult to the completion of the treatment course. The process map guided the FMEA to identify the failure modes for each step in the treatment workflow and assign Risk Priority Numbers (RPN), calculated as the product of the failure mode’s probability ofmore » occurrence (O), severity (S) and lack of detectability (D). FMEA was done with and without the inclusion of recent QC initiatives such as increased staffing, physics oversight, standardized source calibration, treatment planning and documentation. The failure modes with the highest RPNs were identified and contrasted before and after introduction of the QC initiatives. Results: Based on the FMEA, the failure modes with the highest RPN were related to source calibration, treatment planning, and patient setup/treatment delivery (Fig. 1). The introduction of additional physics oversight, standardized planning and safety initiatives such as checklists and time-outs reduced the RPNs of these failure modes. High-risk failure modes that could be mitigated with improved hardware and software interlocks were identified. Conclusion: The FMEA analysis identified the steps in the treatment process presenting the highest risk. The introduction of enhanced QC initiatives mitigated the risk of some of these failure modes by decreasing their probability of occurrence and increasing their detectability. This analysis demonstrates the importance of well-designed QC policies, procedures and oversight in a Xoft eBx programme for treatment of superficial skin cancers. Unresolved high risk failure modes highlight the need for non-procedural quality initiatives such as improved planning software and more robust hardware interlock systems.« less

An improved approach for flight readiness certification: Methodology for failure risk assessment and application examples. Volume 2: Software documentation

NASA Technical Reports Server (NTRS)

Moore, N. R.; Ebbeler, D. H.; Newlin, L. E.; Sutharshana, S.; Creager, M.

1992-01-01

An improved methodology for quantitatively evaluating failure risk of spaceflight systems to assess flight readiness and identify risk control measures is presented. This methodology, called Probabilistic Failure Assessment (PFA), combines operating experience from tests and flights with engineering analysis to estimate failure risk. The PFA methodology is of particular value when information on which to base an assessment of failure risk, including test experience and knowledge of parameters used in engineering analyses of failure phenomena, is expensive or difficult to acquire. The PFA methodology is a prescribed statistical structure in which engineering analysis models that characterize failure phenomena are used conjointly with uncertainties about analysis parameters and/or modeling accuracy to estimate failure probability distributions for specific failure modes, These distributions can then be modified, by means of statistical procedures of the PFA methodology, to reflect any test or flight experience. Conventional engineering analysis models currently employed for design of failure prediction are used in this methodology. The PFA methodology is described and examples of its application are presented. Conventional approaches to failure risk evaluation for spaceflight systems are discussed, and the rationale for the approach taken in the PFA methodology is presented. The statistical methods, engineering models, and computer software used in fatigue failure mode applications are thoroughly documented.

An improved approach for flight readiness certification: Methodology for failure risk assessment and application examples, volume 1

NASA Technical Reports Server (NTRS)

Moore, N. R.; Ebbeler, D. H.; Newlin, L. E.; Sutharshana, S.; Creager, M.

1992-01-01

An improved methodology for quantitatively evaluating failure risk of spaceflight systems to assess flight readiness and identify risk control measures is presented. This methodology, called Probabilistic Failure Assessment (PFA), combines operating experience from tests and flights with engineering analysis to estimate failure risk. The PFA methodology is of particular value when information on which to base an assessment of failure risk, including test experience and knowledge of parameters used in engineering analyses of failure phenomena, is expensive or difficult to acquire. The PFA methodology is a prescribed statistical structure in which engineering analysis models that characterize failure phenomena are used conjointly with uncertainties about analysis parameters and/or modeling accuracy to estimate failure probability distributions for specific failure modes. These distributions can then be modified, by means of statistical procedures of the PFA methodology, to reflect any test or flight experience. Conventional engineering analysis models currently employed for design of failure prediction are used in this methodology. The PFA methodology is described and examples of its application are presented. Conventional approaches to failure risk evaluation for spaceflight systems are discussed, and the rationale for the approach taken in the PFA methodology is presented. The statistical methods, engineering models, and computer software used in fatigue failure mode applications are thoroughly documented.

Procedure for estimating orbital debris risks

NASA Technical Reports Server (NTRS)

Crafts, J. L.; Lindberg, J. P.

1985-01-01

A procedure for estimating the potential orbital debris risk to the world's populace from payloads or spent stages left in orbit on future missions is presented. This approach provides a consistent, but simple, procedure to assess the risk due to random reentry with an adequate accuracy level for making programmatic decisions on planned low Earth orbit missions.

48 CFR 1450.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 5 2014-10-01 2014-10-01 false Special procedures for unusually hazardous or nuclear risks. 1450.104-3 Section 1450.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 1450.104-3 Special procedures for unusually hazardous or nuclear risks. The CO...

48 CFR 1450.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Special procedures for unusually hazardous or nuclear risks. 1450.104-3 Section 1450.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 1450.104-3 Special procedures for unusually hazardous or nuclear risks. The CO...

48 CFR 1450.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 5 2013-10-01 2013-10-01 false Special procedures for unusually hazardous or nuclear risks. 1450.104-3 Section 1450.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 1450.104-3 Special procedures for unusually hazardous or nuclear risks. The CO...

48 CFR 1450.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 5 2011-10-01 2011-10-01 false Special procedures for unusually hazardous or nuclear risks. 1450.104-3 Section 1450.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 1450.104-3 Special procedures for unusually hazardous or nuclear risks. The CO...

Quantitative risk analysis of oil storage facilities in seismic areas.

PubMed

Fabbrocino, Giovanni; Iervolino, Iunio; Orlando, Francesca; Salzano, Ernesto

2005-08-31

Quantitative risk analysis (QRA) of industrial facilities has to take into account multiple hazards threatening critical equipment. Nevertheless, engineering procedures able to evaluate quantitatively the effect of seismic action are not well established. Indeed, relevant industrial accidents may be triggered by loss of containment following ground shaking or other relevant natural hazards, either directly or through cascade effects ('domino effects'). The issue of integrating structural seismic risk into quantitative probabilistic seismic risk analysis (QpsRA) is addressed in this paper by a representative study case regarding an oil storage plant with a number of atmospheric steel tanks containing flammable substances. Empirical seismic fragility curves and probit functions, properly defined both for building-like and non building-like industrial components, have been crossed with outcomes of probabilistic seismic hazard analysis (PSHA) for a test site located in south Italy. Once the seismic failure probabilities have been quantified, consequence analysis has been performed for those events which may be triggered by the loss of containment following seismic action. Results are combined by means of a specific developed code in terms of local risk contour plots, i.e. the contour line for the probability of fatal injures at any point (x, y) in the analysed area. Finally, a comparison with QRA obtained by considering only process-related top events is reported for reference.

The pitfalls of hair analysis for toxicants in clinical practice: three case reports.

PubMed Central

Frisch, Melissa; Schwartz, Brian S

2002-01-01

Hair analysis is used to assess exposure to heavy metals in patients presenting with nonspecific symptoms and is a commonly used procedure in patients referred to our clinic. We are frequently called on to evaluate patients who have health-related concerns as a result of hair analysis. Three patients first presented to outside physicians with nonspecific, multisystemic symptoms. A panel of analytes was measured in hair, and one or more values were interpreted as elevated. As a result of the hair analysis and other unconventional diagnostic tests, the patients presented to us believing they suffered from metal toxicity. In this paper we review the clinical efficacy of this procedure within the context of a patient population with somatic disorders and no clear risk factors for metal intoxication. We also review limitations of hair analysis in this setting; these limitations include patient factors such as low pretest probability of disease and test factors such as the lack of validation of analytic techniques, the inability to discern between exogenous contaminants and endogenous toxicants in hair, the variability of analytic procedures, low interlaboratory reliability, and the increased likelihood of false positive test results in the measurement of panels of analytes. PMID:11940463

Antecedent-Based Interventions for Young Children at Risk for Emotional and Behavioral Disorders

ERIC Educational Resources Information Center

Park, Kristy L.; Scott, Terrance M.

2009-01-01

Following descriptive functional assessment procedures, a brief structural analysis was used to confirm the hypothesized antecedent conditions that preceded problem behavior across three children enrolled in Head Start classrooms. A withdrawal design investigated the effectiveness of antecedent-based interventions to reduce disruptive behaviors…

Predictors of Youth Violence. Juvenile Justice Bulletin.

ERIC Educational Resources Information Center

Hawkins, J. David; Herrenkohl, Todd I.; Farrington, David P.; Brewer, Devon; Catalano, Richard F.; Harachi, Tracy W.; Cothern, Lynn

This Bulletin describes the strength and duration of changeable risk and protective factors for youth violence at points in youth development when they appear most salient. These predictors are potential targets for prevention and intervention. The quantitative results of a large number of studies were synthesized using meta-analysis procedures.…

Results of More Than 11,800 Sleeve Gastrectomies: Data Analysis of the German Bariatric Surgery Registry.

PubMed

Stroh, Christine; Köckerling, Ferdinand; Volker, Lange; Frank, Benedix; Stefanie, Wolff; Christian, Knoll; Christiane, Bruns; Thomas, Manger

2016-05-01

Laparoscopic sleeve gastrectomy (SG) is an upcoming procedure in bariatric surgery and is currently performed worldwide. Staple line leakage, as the most frequent and most feared complication, is still a major concern. Since 2005 data from patients undergoing bariatric procedures in Germany have been prospectively registered in an online database and analyzed. All patients who had undergone primary SG within a 7-year period were considered for analysis. Using the German Bariatric Surgery Registry, data from more than 11,800 SGs were collected between January 1, 2005, and December 31, 2013. Staple line leak rate decreased from 6.5% to 1.4%. Male sex, higher body mass index, concomitant sleep apnea, conversion to laparotomy, longer operation time, a combination of buttresses and oversewing, and the occurrence of intraoperative complications were associated with a significantly higher leakage rate compared with when using either buttresses or oversewing alone. On multivariable analysis, operation time and year of procedure only had a significant impact on staple line leakage rate. Owing to the growing experience a constant decrease in the leakage rate after SG has been observed. Staple line disruption may still lead to sepsis, multiorgan dysfunction, and increased mortality. The results of the current study demonstrated that there are factors that increase the risk of leakage and which would enable surgeons to define risk groups, select patients more carefully, and offer closer follow-up during the postoperative course with early recognition and adequate treatment.

Ion mobility analysis of lipoproteins

DOEpatents

Benner, W Henry [Danville, CA; Krauss, Ronald M [Berkeley, CA; Blanche, Patricia J [Berkeley, CA

2007-08-21

A medical diagnostic method and instrumentation system for analyzing noncovalently bonded agglomerated biological particles is described. The method and system comprises: a method of preparation for the biological particles; an electrospray generator; an alpha particle radiation source; a differential mobility analyzer; a particle counter; and data acquisition and analysis means. The medical device is useful for the assessment of human diseases, such as cardiac disease risk and hyperlipidemia, by rapid quantitative analysis of lipoprotein fraction densities. Initially, purification procedures are described to reduce an initial blood sample to an analytical input to the instrument. The measured sizes from the analytical sample are correlated with densities, resulting in a spectrum of lipoprotein densities. The lipoprotein density distribution can then be used to characterize cardiac and other lipid-related health risks.

30-Day morbidity after augmentation enterocystoplasty and appendicovesicostomy: A NSQIP pediatric analysis.

PubMed

McNamara, Erin R; Kurtz, Michael P; Schaeffer, Anthony J; Logvinenko, Tanya; Nelson, Caleb P

2015-08-01

Augmentation enterocystoplasty and appendicovesicostomy are complex pediatric urologic procedures. Although there is literature identifying long-term outcomes in these patients, the reporting of short-term postoperative outcomes has been limited by small numbers of cases and lack of prospective data collection. Here we report 30-day outcomes from the first nationally based, prospectively assembled cohort of pediatric patients undergoing these procedures. To determine 30-day complication, readmission and reoperation after augmentation enterocystoplasty and appendicovesicostomy in a large national sample of pediatric patients, and to explore the association between preoperative and intraoperative characteristics and occurrence of any 30-day event. We queried the 2012 and 2013 American College of Surgeons National Surgical Quality Improvement Program Pediatric database (ACS-NSQIPP) for all patients undergoing augmentation enterocystoplasty and/or appendicovesicostomy. Surgical risk score was classified on a linear scale using a validated pediatric-specific comorbidity score. Intraoperative characteristics and postoperative 30-day events were reported from prospectively collected data. A composite measure of complication, readmission and/or reoperation was used as primary outcome for the multivariate logistic regression. There were 461 patients included in the analysis: 245 had appendicovesicostomy, 97 had augmentation enterocystoplasty and 119 had both procedures. There were a total of 110 NSQIP complications seen in 87 patients. The most common complication was urinary tract infection (see Table for 30-day outcomes by patient). The composite measure of any 30-day event was seen in 27.8% of the cohort and this was associated with longer operative time, increased number of procedures done at time of primary surgical procedure and higher surgical risk score. The ACS-NSQIPP provides a tool to examine short-term outcomes for these complex urologic procedures that has not been possible before. Although ACS-NSQIP has been used extensively in the adult surgical literature to identify rates of complications, and to determine predictors of readmission and adverse events, its use in pediatric surgery is new. As in the adult literature, the goal is for standardization of practice and transparency in reporting outcomes that may lead to reduction in morbidity and mortality. In this cohort, any 30-day event is seen in almost 30% of the patients undergoing these urologic procedures. Operative time, number of concurrent procedures and higher surgical risk score all are associated with higher odds of the composite 30-day event of complication, readmission and/or reoperation. These data can be useful in counseling patients and families about expectations around surgery and in improving outcomes. Copyright © 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Application of Information-Theoretic Data Mining Techniques in a National Ambulatory Practice Outcomes Research Network

PubMed Central

Wright, Adam; Ricciardi, Thomas N.; Zwick, Martin

2005-01-01

The Medical Quality Improvement Consortium data warehouse contains de-identified data on more than 3.6 million patients including their problem lists, test results, procedures and medication lists. This study uses reconstructability analysis, an information-theoretic data mining technique, on the MQIC data warehouse to empirically identify risk factors for various complications of diabetes including myocardial infarction and microalbuminuria. The risk factors identified match those risk factors identified in the literature, demonstrating the utility of the MQIC data warehouse for outcomes research, and RA as a technique for mining clinical data warehouses. PMID:16779156

Selected considerations of implementation of the GNSS

NASA Astrophysics Data System (ADS)

Cwiklak, Janusz; Fellner, Andrzej; Fellner, Radoslaw; Jafernik, Henryk; Sledzinski, Janusz

2014-05-01

The article describes analysis of the safety and risk for the implementation of precise approach procedures (Localizer Performance and Vertical Guidance - LPV) with GNSS sensor at airports in Warsaw and Katowice. There were used some techniques of the identification of threats (inducing controlled flight into terrain, landing accident, mid-air collision) and evaluations methods based on Fault Tree Analysis, probability of the risk, safety risk evaluation matrix and Functional Hazard Assesment. Also safety goals were determined. Research led to determine probabilities of appearing of threats, as well as allow compare them with regard to the ILS. As a result of conducting the Preliminary System Safety Assessment (PSSA), there were defined requirements essential to reach the required level of the safety. It is worth to underline, that quantitative requirements were defined using FTA.

Determining the risk of cardiovascular disease using ion mobility of lipoproteins

DOEpatents

Benner, W. Henry; Krauss, Ronald M.; Blanche, Patricia J.

2010-05-11

A medical diagnostic method and instrumentation system for analyzing noncovalently bonded agglomerated biological particles is described. The method and system comprises: a method of preparation for the biological particles; an electrospray generator; an alpha particle radiation source; a differential mobility analyzer; a particle counter; and data acquisition and analysis means. The medical device is useful for the assessment of human diseases, such as cardiac disease risk and hyperlipidemia, by rapid quantitative analysis of lipoprotein fraction densities. Initially, purification procedures are described to reduce an initial blood sample to an analytical input to the instrument. The measured sizes from the analytical sample are correlated with densities, resulting in a spectrum of lipoprotein densities. The lipoprotein density distribution can then be used to characterize cardiac and other lipid-related health risks.

Ischemic Stroke After Treatment of Intraprocedural Thrombosis During Stent-Assisted Coiling and Flow Diversion.

PubMed

Adeeb, Nimer; Griessenauer, Christoph J; Moore, Justin M; Foreman, Paul M; Shallwani, Hussain; Motiei-Langroudi, Rouzbeh; Gupta, Raghav; Baccin, Carlos E; Alturki, Abdulrahman; Harrigan, Mark R; Siddiqui, Adnan H; Levy, Elad I; Ogilvy, Christopher S; Thomas, Ajith J

2017-04-01

Intraprocedural thrombosis poses a formidable challenge during neuroendovascular procedures because the risks of aggressive thromboembolic treatment must be balanced against the risk of postprocedural hemorrhage. The aim of this study was to identify predictors of ischemic stroke after intraprocedural thrombosis after stent-assisted coiling and pipeline embolization device placement. A retrospective analysis of intracranial aneurysms treated with stent-assisted coiling or pipeline embolization device placement between 2007 and 2016 at 4 major academic institutions was performed to identify procedures that were complicated by intraprocedural thrombosis. Intraprocedural thrombosis occurred in 34 (4.6%) procedures. Postprocedural ischemic stroke and hemorrhage occurred in 20.6% (7/34) and 11.8% (4/34) of procedures complicated by intraprocedural thrombosis, respectively. Current smoking was an independent predictor of ischemic stroke. There was no statistically significant difference in the rate of ischemic stroke or postprocedural hemorrhage with the use of abciximab compared with the use of eptifibatide in treatment of intraprocedural thrombosis. Current protocols for treatment of intraprocedural thrombosis associated with placement of intra-arterial devices were effective in preventing ischemic stroke in ≈80% of cases. Current smoking was the only independent predictor of ischemic stroke. © 2017 American Heart Association, Inc.

Intraoperative Reported Adverse Events in Children

PubMed Central

Kakavouli, Athina; Li, Guohua; Carson, Margaret P.; Sobol, Julia; Lin, Christine; Ohkawa, Susumu; Huang, Lin; Galiza, Carolyn; Wood, Alastair; Sun, Lena S.

2009-01-01

Background Significant intra-procedural adverse events(AE) are reported in children who receive anesthesia for procedures outside the Operating Rooms(NORA). No study, so far, has characterized AE in children who receive anesthesia in the operating rooms(ORA) and NORA when anesthesia care is provided by the same team in a consistent manner. Objective/Aim We used the same patient-specific Quality Assurance questionnaires(QAs), to elucidate incidences of intra-operative reported AE for children receiving anesthesia in NORA and ORA locations. Through multivariate logistic regression analysis we assessed the association between patient’s AE risk and procedure’s location while adjusting for ASA status, age and unscheduled nature of the procedure. Methods/Materials After IRB approval, we used returned QAs of patients under 21 years; who received anesthesia from our pediatric anesthesia faculty; from May 1, 2006 through September 30, 2007. We analyzed QA data on: service location, unscheduled/schedule procedure, age, ASA status, presence and type of AE. We excluded QAs with incomplete information on date, location, age and ASA status. Results We included 8,707 cases, with 3.5% incidence of reported AE. We had 1,898 NORA and 6,808 ORA cases with AE incidence of 2.5% and 3.7% respectively. Multivariate regression analysis revealed that patients with higher ASA status or younger age had higher incidence of reported AE, irrespective of location or unscheduled nature of the procedure. The most common AE type, for both sites, was respiratory-related (1.9%). Conclusions Pediatric reported AE incidence was comparable for NORA and ORA locations. Younger age or higher ASA status are associated with increased risk of AE. PMID:19624360

Incorporating Comorbidity Within Risk Adjustment for UK Pediatric Cardiac Surgery.

PubMed

Brown, Katherine L; Rogers, Libby; Barron, David J; Tsang, Victor; Anderson, David; Tibby, Shane; Witter, Thomas; Stickley, John; Crowe, Sonya; English, Kate; Franklin, Rodney C; Pagel, Christina

2017-07-01

When considering early survival rates after pediatric cardiac surgery it is essential to adjust for risk linked to case complexity. An important but previously less well understood component of case mix complexity is comorbidity. The National Congenital Heart Disease Audit data representing all pediatric cardiac surgery procedures undertaken in the United Kingdom and Ireland between 2009 and 2014 was used to develop and test groupings for comorbidity and additional non-procedure-based risk factors within a risk adjustment model for 30-day mortality. A mixture of expert consensus based opinion and empiric statistical analyses were used to define and test the new comorbidity groups. The study dataset consisted of 21,838 pediatric cardiac surgical procedure episodes in 18,834 patients with 539 deaths (raw 30-day mortality rate, 2.5%). In addition to surgical procedure type, primary cardiac diagnosis, univentricular status, age, weight, procedure type (bypass, nonbypass, or hybrid), and era, the new risk factor groups of non-Down congenital anomalies, acquired comorbidities, increased severity of illness indicators (eg, preoperative mechanical ventilation or circulatory support) and additional cardiac risk factors (eg, heart muscle conditions and raised pulmonary arterial pressure) all independently increased the risk of operative mortality. In an era of low mortality rates across a wide range of operations, non-procedure-based risk factors form a vital element of risk adjustment and their presence leads to wide variations in the predicted risk of a given operation. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Analgesic effect of intraperitoneal local anesthetic in surgery: an overview of systematic reviews.

PubMed

Hamill, James K; Rahiri, Jamie-Lee; Hill, Andrew G

2017-05-15

Intraperitoneal local anesthetic (IPLA) reduces postoperative pain as shown by previous systematic reviews. The purpose of this review was to compare the efficacy of IPLA between different types of procedure and to formulate GRADE recommendations for the use of IPLA. A systematic search for systematic reviews of the effect of IPLA, versus no IPLA or placebo, on pain after any surgical procedure. Databases included in the study were MEDLINE, EMBASE, CDSR, and DARE. Two reviewers independently undertook searches, selected studies, extracted data, and assessed the risk of bias. Meta-analysis was by random effects. Recommendation was by GRADE. The main outcome measure was self-reported early postoperative pain scores. Searches uncovered nine systematic reviews. This study included randomized trials numbered 76, representing 4000 participants, 2022 in IPLA and 1978 in control groups. Six reviews scored at low risk of bias and three at high risk. Meta-analysis demonstrated that IPLA reduced the mean pain score (0-10 scale) by 0.95 point (95% confidence interval: 0.73-1.17). Excluding laparoscopic cholecystectomy, the effect size increased to 1.52 (95% confidence interval: 1.15-1.88). Heterogeneity was high overall at I 2  = 91.7% but on excluding laparoscopic cholecystectomy trials reduced to I 2  = 31.3%. IPLA could be considered a viable option for early postoperative analgesia in certain laparoscopic operations. Further research on the effect of IPLA on procedures other than laparoscopic cholecystectomy would help clarify its place in a postoperative analgesia protocol. Copyright © 2017 Elsevier Inc. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ahmed, Osman, E-mail: osman1423@gmail.com; Patel, Mikin V.; Masrani, Abdulrahman

PurposeTo report hepatic arterial-related complications encountered during planning and treatment angiograms for radioembolization and understand any potential-associated risk factors.Materials and Methods518 mapping or treatment angiograms for 180 patients with primary or metastatic disease to the liver treated by Yttrium-90 radioembolization between 2/2010 and 12/2015 were retrospectively reviewed. Intra-procedural complications were recorded per SIR guidelines. Patient demographics, indication for treatment, prior exposure to chemotherapeutic agents, operator experience, and disease burden were reviewed. Technical variables including type of radioembolic (glass vs. resin microspheres), indication for angiography (mapping vs. treatment), variant anatomy, and attempts at coil embolization were also assessed.ResultsThirteen (13/518, 2.5%) arterial-relatedmore » complications occurred in 13 patients. All but two complications resulted during transcatheter coil embolization to prevent non-target embolization. Complications included coil migration (n = 6), arterial dissection (n = 2), focal vessel perforation (n = 2), arterial thrombus (n = 2), and vasospasm prohibiting further arterial sub-selection (n = 1). Transarterial coiling was identified as a significant risk factor of complications on both univariate and multivariate regression analysis (odds ratio 7.8, P = 0.004). Usage of resin microspheres was also a significant risk factor (odds ratio 9.5, P = 0.042). No other technical parameters or pre-procedural variables were significant after adjusting for confounding on multivariate analysis (P > 0.05).ConclusionIntra-procedural hepatic arterial complications encountered during radioembolization were infrequent but occurred mainly during coil embolization to prevent non-target delivery to extra-hepatic arteries.« less

Optimizing ACS NSQIP modeling for evaluation of surgical quality and risk: patient risk adjustment, procedure mix adjustment, shrinkage adjustment, and surgical focus.

PubMed

Cohen, Mark E; Ko, Clifford Y; Bilimoria, Karl Y; Zhou, Lynn; Huffman, Kristopher; Wang, Xue; Liu, Yaoming; Kraemer, Kari; Meng, Xiangju; Merkow, Ryan; Chow, Warren; Matel, Brian; Richards, Karen; Hart, Amy J; Dimick, Justin B; Hall, Bruce L

2013-08-01

The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) collects detailed clinical data from participating hospitals using standardized data definitions, analyzes these data, and provides participating hospitals with reports that permit risk-adjusted comparisons with a surgical quality standard. Since its inception, the ACS NSQIP has worked to refine surgical outcomes measurements and enhance statistical methods to improve the reliability and validity of this hospital profiling. From an original focus on controlling for between-hospital differences in patient risk factors with logistic regression, ACS NSQIP has added a variable to better adjust for the complexity and risk profile of surgical procedures (procedure mix adjustment) and stabilized estimates derived from small samples by using a hierarchical model with shrinkage adjustment. New models have been developed focusing on specific surgical procedures (eg, "Procedure Targeted" models), which provide opportunities to incorporate indication and other procedure-specific variables and outcomes to improve risk adjustment. In addition, comparative benchmark reports given to participating hospitals have been expanded considerably to allow more detailed evaluations of performance. Finally, procedures have been developed to estimate surgical risk for individual patients. This article describes the development of, and justification for, these new statistical methods and reporting strategies in ACS NSQIP. Copyright © 2013 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

[Pleural procedures in patients treated by platelet aggregation inhibitors: An opinion survey].

PubMed

Dangers, L; Similowski, T; Chenivesse, C

2016-01-01

When pleural procedures (thoracocentesis, blind pleural biopsies and chest tube insertion) are required in patients taking long-term platelet aggregation inhibitors, the risk of bleeding must be balanced against the risk of arterial thrombosis. Currently, the bleeding risk of pleural procedures is poorly understood. The objective of the survey was to gather the opinion of respiratory physicians regarding the bleeding risk of pleural procedures in patients taking platelet aggregation inhibitors. We emailed a standardized questionnaire designed by the French National Authority for Health to 2697 French respiratory physicians. One hundred and eighty-eight of the 2697 questionnaires were returned (response rate: 7 %). The respiratory physicians declared that they performed an average of 8 pleural procedures per month. One hundred and seventy-five responders (95 %) practised pleural procedures in patients receiving platelet aggregation inhibitors; 68 of them (39 %) reported experiencing haemorrhagic complications. The bleeding risk associated with thoracentesis and chest tube insertion was considered minor by 97.8 and 65 % of responders respectively, whereas it was considered major for blind pleural biopsies by 73.4 %. Respiratory physicians were more reticent about performing pleural procedures in patients treated with clopidogrel than in those taking aspirin. This study provides an overview of how respiratory physicians perceive the bleeding risk associated with pleural procedures in patients taking platelet aggregation inhibitors. Copyright © 2016 SPLF. Published by Elsevier Masson SAS. All rights reserved.

Incidence and Risk Factors for Health-Care Associated Infections after Hip Operation.

PubMed

Hessels, Amanda J; Agarwal, Mansi; Liu, Jianfang; Larson, Elaine L

2016-12-01

Hip operation reduces pain and improves mobility and quality of life for more than 300,000 people annually, most of whom are more than 65 years old. Substantial increases in surgical volume are projected between 2005 and 2030 in primary total (174%) and revision (137%) procedures. This projection demands that the impact of increasing age on the relative risk of health-care associated infections (HAI) after hip surgical procedures be assessed. Our aim was to examine the incidence and risk factors of HAI among patients who underwent hip operations between 2006 and 2012. This secondary analysis included data from patients 18 years old or older and having a hip prosthesis procedure in three New York City hospitals between 2006 and 2012. Procedures were categorized as total or partial hip replacements or revision and re-surfacing procedures. Outcomes of interest were blood stream infections (BSI), urinary tract infections (UTI), or surgical site infections (SSI). Patients in whom an infection developed during the hospital visit in which the hip procedure occurred were counted as cases. Of 2021 patients, approximately 11% (n = 218) had an HAI. There was no difference in infection rates by admission year despite an increase in surgical volume. SSI was associated with younger age, previous hospitalization, and hip revision surgical procedure whereas UTI and BSI were associated with older age, greater co-morbidity, longer pre-operative length of stay and intensive care unit stay, (p < 0.05). HAI after hip operation affected approximately one in 10 patients over a 7-year period in three high-volume hospitals. SSI occurred least frequently, predominantly among patients who underwent revision surgery (without previous SSI), were younger, and had a history of previous hospitalization. Infections such as BSI and UTI, although rare, occurred more frequently and in patients with more co-morbidities, longer pre-operative length of stay, and who required higher level care. Further research to understand these unexpected findings and target interventions is warranted.

TU-D-201-07: Severity Indication in High Dose Rate Brachytherapy Emergency Response Procedure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Li, K; Rustad, F

Purpose: Understanding the corresponding dose to different staff during the High Dose Rate (HDR) Brachytherapy emergency response procedure could help to develop a strategy in efficiency and effective action. In this study, the variation and risk analysis methodology was developed to simulation the HDR emergency response procedure based on severity indicator. Methods: A GammaMedplus iX HDR unit from Varian Medical System was used for this simulation. The emergency response procedure was decomposed based on risk management methods. Severity indexes were used to identify the impact of a risk occurrence on the step including dose to patient and dose to operationmore » staff by varying the time, HDR source activity, distance from the source to patient and staff and the actions. These actions in 7 steps were to press the interrupt button, press emergency shutoff switch, press emergency button on the afterloader keypad, turn emergency hand-crank, remove applicator from the patient, disconnect transfer tube and move afterloader from the patient, and execute emergency surgical recovery. Results: Given the accumulated time in second at the assumed 7 steps were 15, 5, 30, 15, 180, 120, 1800, and the dose rate of HDR source is 10 Ci, the accumulated dose in cGy to patient at 1cm distance were 188, 250, 625, 813, 3063, 4563 and 27063, and the accumulated exposure in rem to operator at outside the vault, 1m and 10cm distance were 0.0, 0.0, 0.1, 0.1, 22.6, 37.6 and 262.6. The variation was determined by the operators in action at different time and distance from the HDR source. Conclusion: The time and dose were estimated for a HDR unit emergency response procedure. It provided information in making optimal decision during the emergency procedure. Further investigation would be to optimize and standardize the responses for other emergency procedure by time-spatial-dose severity function.« less

Simple criteria to predict margin involvement after chemoradiotherapy and sphincter-sparing for low rectal cancer.

PubMed

Dumont, F; Tilly, C; Dartigues, P; Goéré, D; Honoré, C; Elias, D

2015-09-01

Low rectal cancers carry a high risk of circumferential margin involvement (CRM+). The anatomy of the lower part of the rectum and a long course of chemoradiotherapy (CRT) limit the accuracy of imaging to predict the CRM+. Additional criteria are required. Eighty six patients undergoing rectal resection with a sphincter-sparing procedure after CRT for low rectal cancer between 2000 and 2013 were retrospectively reviewed. Risk factors of CRM+ and the cut-off number of risk factors required to accurately predict the CRM+ were analyzed. The CRM+ rate was 9.3% and in the multivariate analysis, the significant risk factors were a tumor size exceeding 3 cm, poor response to CRT and a fixed tumor. The best cut-off to predict CRM+ was the presence of 2 risk factors. Patients with 0-1 and 2-3 risk factors had a CRM+ respectively in 1.3% and 50% of cases and a 3-year recurrence rate of 7% and 35% after a median follow-up of 50 months. Poor response, a residual tumor greater than 3 cm and a fixed tumor are predictive of CRM+. Sphincter sparing is an oncological safety procedure for patients with 0-1 criteria but not for patients with 2-3 criteria. Copyright © 2015 Elsevier Ltd. All rights reserved.

22 CFR 225.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2011 CFR

2011-04-01

... of research proposals which have been approved under the procedure. (d) The department or agency head... of research involving no more than minimal risk, and for minor changes in approved research. 225.110....110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and...

The integration of the risk management process with the lifecycle of medical device software.

PubMed

Pecoraro, F; Luzi, D

2014-01-01

The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

Serum Albumin Predicts Survival and Postoperative Course Following Surgery for Geriatric Hip Fracture.

PubMed

Bohl, Daniel D; Shen, Mary R; Hannon, Charles P; Fillingham, Yale A; Darrith, Brian; Della Valle, Craig J

2017-12-20

Serum albumin level is the most well-established serum marker of malnutrition, with a serum albumin concentration <3.5 g/dL considered to be suggestive of malnutrition. The purpose of this study was to test if serum albumin level is associated with death, specific postoperative complications (e.g., pneumonia), length of hospital stay, and readmission following a surgical procedure for geriatric hip fracture. A retrospective cohort study of geriatric patients (≥65 years of age) undergoing a hip fracture surgical procedure as part of the American College of Surgeons National Surgical Quality Improvement Program was conducted. Outcomes were compared between patients with and without hypoalbuminemia. All comparisons were adjusted for baseline and procedural differences between populations, and patients with missing serum albumin concentration were included in analyses using a missing data indicator. There were 29,377 geriatric patients undergoing a hip fracture surgical procedure who met inclusion criteria; of these patients, 17,651 (60.1%) had serum albumin available for analysis. The prevalence of hypoalbuminemia was 45.9%. Following adjustment for baseline and procedural characteristics, the risk of death was inversely associated with serum albumin concentration as a continuous variable (adjusted relative risk, 0.59 [95% confidence interval (CI), 0.53 to 0.65]; p < 0.001). In comparison with patients with normal albumin concentration, patients with hypoalbuminemia had higher rates of death (9.94% compared with 5.53% [adjusted relative risk, 1.52 (95% CI, 1.37 to 1.70); p < 0.001]), sepsis (1.19% compared with 0.53% [adjusted relative risk, 1.92 (95% CI, 1.36 to 2.72); p < 0.001]), and unplanned intubation (2.64% compared with 1.47% [adjusted relative risk, 1.51 (95% CI, 1.21 to 1.88); p < 0.001]). The mean length of stay (and standard deviation) was longer among patients with hypoalbuminemia at 5.67 ± 4.68 days compared with those without hypoalbuminemia at 4.99 ± 3.95 days; the adjusted difference was 0.50 day (95% CI, 0.38 to 0.63 day; p < 0.001). However, the rate of readmission did not differ (p = 0.054) between patients with hypoalbuminemia (10.91%) and those without hypoalbuminemia (9.03%); the adjusted relative risk was 1.10 (95% CI, 1.00 to 1.21). Hypoalbuminemia is a powerful independent risk factor for mortality following a surgical procedure for geriatric hip fracture. These data suggest that further investigation into postoperative nutritional supplementation is warranted to decrease the risk of complications. Prognostic Level IV. See Instructions for Authors for a complete description of levels of evidence.

Calibration and Measurement Uncertainty Estimation of Radiometric Data: Preprint

DOE Office of Scientific and Technical Information (OSTI.GOV)

Habte, A.; Sengupta, M.; Reda, I.

2014-11-01

Evaluating the performance of photovoltaic cells, modules, and arrays that form large solar deployments relies on accurate measurements of the available solar resource. Therefore, determining the accuracy of these solar radiation measurements provides a better understanding of investment risks. This paper provides guidelines and recommended procedures for estimating the uncertainty in calibrations and measurements by radiometers using methods that follow the International Bureau of Weights and Measures Guide to the Expression of Uncertainty (GUM). Standardized analysis based on these procedures ensures that the uncertainty quoted is well documented.

Effectiveness of landslide risk mitigation strategies in Shihmen Watershed, Taiwan

NASA Astrophysics Data System (ADS)

Wu, Chun-Yi; Chen, Su-Chin

2015-04-01

The purpose of this study was to establish landslide risk analysis procedures that can be used to analyze landslide risk in a watershed scale and to assess the effectiveness of risk mitigation strategies. Landslide risk analysis encompassed the landslide hazard, the vulnerability of elements at risk, and community resilience capacity. First, landslide spatial probability, landslide temporal probability, and landslide area probability were joined to estimate the probability of landslides with an area exceeding a certain threshold in each slope unit. Second, the expected property and life losses were both analyzed in vulnerability analysis. Different elements at risk were assigned corresponding values, and then used in conjunction with the vulnerabilities to carry out quantitative analysis. Third, the resilience capacity of different communities was calculated based on the scores obtained through community checklists and the weights of individual items, including "the participation experience of disaster prevention drill," "real-time monitoring mechanism of community," "autonomous monitoring of residents," and "disaster prevention volunteer." Finally, the landslide probabilities, vulnerability analysis results, and resilience capacities were combined to assess landslide risk in Shihmen Watershed. In addition, the risks before and after the implementation of non-structural disaster prevention strategies were compared to determine the benefits of various strategies, and subsequently benefit-cost analysis was performed. Communities with high benefit-cost ratios included Hualing, Yisheng, Siouluan, and Gaoyi. The watershed as a whole had a benefit-cost ratio far greater than 1, indicating that the effectiveness of strategies was greater than the investment cost, and these measures were thus cost-effective. The results of factor sensitivity analysis revealed that changes in vulnerability and mortality rates would increase the uncertainty of risk, and that raise in annual interest rates or reduction in life cycle of measures would decrease the benefit-cost ratio. However, with regard to effectiveness analysis, these changes did not reverse the cost-effective inference.

Human Factors Process Task Analysis: Liquid Oxygen Pump Acceptance Test Procedure at the Advanced Technology Development Center

NASA Technical Reports Server (NTRS)

Diorio, Kimberly A.; Voska, Ned (Technical Monitor)

2002-01-01

This viewgraph presentation provides information on Human Factors Process Failure Modes and Effects Analysis (HF PFMEA). HF PFMEA includes the following 10 steps: Describe mission; Define System; Identify human-machine; List human actions; Identify potential errors; Identify factors that effect error; Determine likelihood of error; Determine potential effects of errors; Evaluate risk; Generate solutions (manage error). The presentation also describes how this analysis was applied to a liquid oxygen pump acceptance test.

Software analysis handbook: Software complexity analysis and software reliability estimation and prediction

NASA Technical Reports Server (NTRS)

Lee, Alice T.; Gunn, Todd; Pham, Tuan; Ricaldi, Ron

1994-01-01

This handbook documents the three software analysis processes the Space Station Software Analysis team uses to assess space station software, including their backgrounds, theories, tools, and analysis procedures. Potential applications of these analysis results are also presented. The first section describes how software complexity analysis provides quantitative information on code, such as code structure and risk areas, throughout the software life cycle. Software complexity analysis allows an analyst to understand the software structure, identify critical software components, assess risk areas within a software system, identify testing deficiencies, and recommend program improvements. Performing this type of analysis during the early design phases of software development can positively affect the process, and may prevent later, much larger, difficulties. The second section describes how software reliability estimation and prediction analysis, or software reliability, provides a quantitative means to measure the probability of failure-free operation of a computer program, and describes the two tools used by JSC to determine failure rates and design tradeoffs between reliability, costs, performance, and schedule.

Hemodynamic outcomes of the Ross procedure versus other aortic valve replacement: a systematic review and meta-analysis.

PubMed

Um, Kevin J; Mcclure, Graham R; Belley-Cote, Emilie P; Gupta, Saurabh; Bouhout, Ismail; Lortie, Hugo; Alraddadi, Hatim; Alsagheir, Ali; Bossard, Matthias; Mcintyre, William F; Lengyel, Alexandra; Eikelboom, John W; Ouzounian, Maral; Chu, Michael W; Parry, Dominic; El-Hamamsy, Ismail; Whitlock, Richard P

2018-06-01

Life expectancy in young adults undergoing mechanical or bioprosthetic aortic valve replacement (AVR) may be reduced by up to 20 years compared to age matched controls. The Ross procedure is a durable, anticoagulation-sparing alternative. We performed a systematic review and meta-analysis to compare the valve hemodynamics of the Ross procedure versus other AVR. We searched Cochrane CENTRAL, MEDLINE and EMBASE from inception to February 2017 for randomized controlled trials (RCTs) and observational studies (n≥10 Ross). Independently and in duplicate, we performed title and abstract screening, full-text eligibility assessment, and data collection. We evaluated the risk of bias with the Cochrane and CLARITY tools, and the quality of evidence with the GRADE framework. We identified 2 RCTs and 13 observational studies that met eligibility criteria (N.=1412). In observational studies, the Ross procedure was associated with a lower mean aortic gradient at discharge (MD -9 mmHg, 95% CI: -13 to -5, P<0.0001, I2=97%) and latest follow-up (MD -5 mmHg, 95% CI: -7 to -3, P<0.0001, I2=92%). There was no significant difference in the incidence of severe aortic regurgitation at latest follow-up (RR 1.3, 95% CI: 0.3 to 5.8, P=0.70, I2=30%). In RCTs, the Ross procedure was associated with a lower mean gradient at latest follow-up (MD -15 mmHg, 95% CI: -32 to 2, P=0.08, I2=99%). The mean pulmonic gradient for the Ross procedure was 18.0 mmHg (95% CI: 16 to 20, P<0.0001) at latest follow-up. The evidence for all outcomes from observational studies was deemed to be of very low quality, while the evidence from RCTs was downgraded for imprecision and moderately serious risk of bias. Compared to conventional AVR, the Ross procedure was associated with better aortic valve hemodynamics. Future studies should evaluate the impact of the Ross procedure on exercise capacity and quality of life.

The Application of a Residual Risk Evaluation Technique Used for Expendable Launch Vehicles

NASA Technical Reports Server (NTRS)

Latimer, John A.

2009-01-01

This presentation provides a Residual Risk Evaluation Technique (RRET) developed by Kennedy Space Center (KSC) Safety and Mission Assurance (S&MA) Launch Services Division. This technique is one of many procedures used by S&MA at KSC to evaluate residual risks for each Expendable Launch Vehicle (ELV) mission. RRET is a straight forward technique that incorporates the proven methodology of risk management, fault tree analysis, and reliability prediction. RRET derives a system reliability impact indicator from the system baseline reliability and the system residual risk reliability values. The system reliability impact indicator provides a quantitative measure of the reduction in the system baseline reliability due to the identified residual risks associated with the designated ELV mission. An example is discussed to provide insight into the application of RRET.

Preprocedural C-Reactive Protein Predicts Outcomes after Primary Percutaneous Coronary Intervention in Patients with ST-elevation Myocardial Infarction a systematic meta-analysis

NASA Astrophysics Data System (ADS)

Mincu, Raluca-Ileana; Jánosi, Rolf Alexander; Vinereanu, Dragos; Rassaf, Tienush; Totzeck, Matthias

2017-01-01

Risk assessment in patients with acute coronary syndromes (ACS) is critical in order to provide adequate treatment. We performed a systematic meta-analysis to assess the predictive role of serum C-reactive protein (CRP) in patients with ST-segment elevation myocardial infarction (STEMI), treated with primary percutaneous coronary intervention (PPCI). We included 7 studies, out of 1,033 studies, with a total of 6,993 patients with STEMI undergoing PPCI, which were divided in the high or low CRP group, according to the validated cut-off values provided by the corresponding CRP assay. High CRP values were associated with increased in-hospital and follow-up all-cause mortality, in-hospital and follow-up major adverse cardiac events (MACE), and recurrent myocardial infarction (MI). The pre-procedural CRP predicted in-hospital target vessel revascularization (TVR), but was not associated with acute/subacute and follow-up in-stent restenosis (ISR), and follow-up TVR. Thus, pre-procedural serum CRP could be a valuable predictor of global cardiovascular risk, rather than a predictor of stent-related complications in patients with STEMI undergoing PPCI. This biomarker might have the potential to improve the management of these high-risk patients.

Risk factors for an additional port in single-incision laparoscopic cholecystectomy in patients with cholecystitis.

PubMed

Araki, Kenichiro; Shirabe, Ken; Watanabe, Akira; Kubo, Norio; Sasaki, Shigeru; Suzuki, Hideki; Asao, Takayuki; Kuwano, Hiroyuki

2017-01-01

Although single-incision laparoscopic cholecystectomy is now widely performed in patients with cholecystitis, some cases require an additional port to complete the procedure. In this study, we focused on risk factor of additional port in this surgery. We performed single-incision cholecystectomy in 75 patients with acute cholecystitis or after cholecystitis between 2010 and 2014 at Gunma University Hospital. Surgical indications followed the TG13 guidelines. Our standard procedure for single-incision cholecystectomy routinely uses two needlescopic devices. We used logistic regression analysis to identify the risk factors associated with use of an additional full-size port (5 or 10 mm). Surgical outcome was acceptable without biliary injury. Nine patients (12.0%) required an additional port, and one patient (1.3%) required conversion to open cholecystectomy because of severe adhesions around the cystic duct and common bile duct. In multivariate analysis, high C-reactive protein (CRP) values (>7.0 mg/dl) during cholecystitis attacks were significantly correlated with the need for an additional port (P = 0.009), with a sensitivity of 55.6%, specificity of 98.5%, and accuracy of 93.3%. This study indicated that the severe inflammation indicated by high CRP values during cholecystitis attacks predicts the need for an additional port. J. Med. Invest. 64: 245-249, August, 2017.

Vitrectomy for vitreous floaters: analysis of the benefits and risks.

PubMed

Sommerville, Drew N

2015-05-01

To review the pros and cons of small-gauge vitrectomy for symptomatic floaters. Current treatment options for floaters include Nd:YAG vitreolysis and pars plana vitrectomy. There are risks and benefits associated with vitrectomy for floaters. However, small-gauge vitrectomy is a minimally invasive way of removing the floaters. The current literature demonstrates vitrectomy has some risk, but is highly effective at improving vision, symptoms, contrast sensitivity, and quality of life. Small-gauge vitrectomy for floaters is a well tolerated and effective procedure to remove the symptomatic floaters. Symptomatic patients are willing to take some risk to have their troublesome vitreous floaters removed, often resulting in an improvement in their vision and quality of life.

When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints.

PubMed

Gogos, Andrew J; Clark, Richard B; Bismark, Marie M; Gruen, Russell L; Studdert, David M

2011-09-19

To describe the frequency, characteristics, and outcomes of medicolegal disputes over informed consent. Retrospective review and analysis of negligence claims against doctors insured by Avant Mutual Group Limited and complaints lodged with the Office of the Health Services Commissioner of Victoria that alleged failures in the informed consent process and were adjudicated between 1 January 2002 and 31 December 2008. Case frequency (by medical specialty), type of allegation, type of treatment. A total of 481 cases alleged deficiencies in the informed consent process (218 of 1898 conciliated complaints [11.5%]; 263 of 7846 negligence claims [3.4%]). 57% of these cases were against surgeons. Plastic surgeons experienced dispute rates that were more than twice those of any other specialty or subspecialty group. 92% of cases (442/481) involved surgical procedures and 16% (77/481) involved cosmetic procedures. The primary allegation in 71% of cases was that the clinician failed to mention or properly explain risks of complications. Five treatment types - procedures on reproductive organs (12% of cases), procedures on facial features excluding eyes (12%), prescription medications (8%), eye surgery (7%) and breast surgery (7%) - accounted for 46% of all cases. The typical dispute over informed consent involves an operation, often cosmetic, and allegations that a particular complication was not properly disclosed. With Australian courts now looking to patient preferences in setting legal standards of care for risk disclosure, medicolegal disputes provide valuable insights for targeting both quality improvement efforts and risk management activities.

SU-F-T-250: What Does It Take to Correctly Assess the High Failure Modes of an Advanced Radiotherapy Procedure Such as Stereotactic Body Radiation Therapy?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Han, D; Vile, D; Rosu, M

Purpose: Assess the correct implementation of risk-based methodology of TG 100 to optimize quality management and patient safety procedures for Stereotactic Body Radiation Therapy. Methods: A detailed process map of SBRT treatment procedure was generated by a team of three physicists with varying clinical experience at our institution to assess the potential high-risk failure modes. The probabilities of occurrence (O), severity (S) and detectability (D) for potential failure mode in each step of the process map were assigned by these individuals independently on the scale from1 to 10. The risk priority numbers (RPN) were computed and analyzed. The highest 30more » potential modes from each physicist’s analysis were then compared. Results: The RPN values assessed by the three physicists ranged from 30 to 300. The magnitudes of the RPN values from each physicist were different, and there was no concordance in the highest RPN values recorded by three physicists independently. The 10 highest RPN values belonged to sub steps of CT simulation, contouring and delivery in the SBRT process map. For these 10 highest RPN values, at least two physicists, irrespective of their length of experience had concordance but no general conclusions emerged. Conclusion: This study clearly shows that the risk-based assessment of a clinical process map requires great deal of preparation, group discussions, and participation by all stakeholders. One group albeit physicists cannot effectively implement risk-based methodology proposed by TG100. It should be a team effort in which the physicists can certainly play the leading role. This also corroborates TG100 recommendation that risk-based assessment of clinical processes is a multidisciplinary team effort.« less

Preoperative immobility significantly impacts the risk of postoperative complications in bariatric surgery patients.

PubMed

Higgins, Rana M; Helm, Melissa; Gould, Jon C; Kindel, Tammy L

2018-06-01

Preoperative immobility in general surgery patients has been associated with an increased risk of postoperative complications. It is unknown if immobility affects bariatric surgery outcomes. The aim of this study was to determine the impact of immobility on 30-day postoperative bariatric surgery outcomes. This study took place at a university hospital in the United States. The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program 2015 data set was queried for primary minimally invasive bariatric procedures. Preoperative immobility was defined as limited ambulation most or all the time. Logistic regression analysis was performed to determine if immobile patients are at increased risk (odds ratio [OR]) for 30-day complications. There were 148,710 primary minimally invasive bariatric procedures in 2015. Immobile patients had an increased risk of mortality (OR 4.59, P<.001) and greater operative times, length of stay, reoperation rates, and readmissions. Immobile patients had a greater risk of multiple complications, including acute renal failure (OR 6.42, P<.001), pulmonary embolism (OR 2.44, P = .01), cardiac arrest (OR 2.81, P = .05), and septic shock (OR 2.78, P = .02). Regardless of procedure type, immobile patients had a higher incidence of perioperative morbidity compared with ambulatory patients. This study is the first to specifically assess the impact of immobility on 30-day bariatric surgery outcomes. Immobile patients have a significantly increased risk of morbidity and mortality. This study provides an opportunity for the development of multiple quality initiatives to improve the safety and perioperative complication profile for immobile patients undergoing bariatric surgery. Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Rationale, design, and baseline characteristics of the Acetylcystein for Contrast-Induced nephropaThy (ACT) Trial: a pragmatic randomized controlled trial to evaluate the efficacy of acetylcysteine for the prevention of contrast-induced nephropathy

PubMed Central

2009-01-01

Background Aceltylcysteine has been evaluated in several small trials as a means of reducing the risk of contrast-induced nephropathy (CIN), however systematic reviews of these studies do not provide conclusive answers. Therefore, a large randomized controlled trial (RCT) is needed to provide a reliable answer as to whether acetylcysteine is effective in decreasing the risk of CIN in high-risk patients undergoing angiographic procedures. Methods ACT is a RCT of acetylcysteine versus placebo in 2,300 patients at-risk for CIN undergoing an intravascular angiographic procedure. The randomization list will be concealed. Participants, health care staff, investigators and outcome assessors will be blinded to whether patients receive acetylcysteine or placebo. All analysis will follow the intention-to-treat principle. The study drugs (acetylcysteine 1200 mg or placebo) will be administered orally twice daily for two doses before and two doses after the procedure. The primary outcome is the occurrence of CIN, defined as a 25% elevation of serum creatinine above baseline between 48 and 96 hours after angiography. Discussion The first patient entered the trial on September, 2008. Up to April 7, 2009, 810 patients had been included in 35 centers. The mean age was 69 (Standard deviation: 10), 18% had a baseline serum creatinine >1.5 mg/dL, 57% were diabetics and 13% had a history of heart failure. The ongoing ACT Trial is the largest multicentre RCT that will determine whether acetylcysteine is effective in decreasing the risk of CIN in patients at risk undergoing angiography. Trial registration Clinicaltrials.gov NCT00736866 PMID:19497091

76 FR 72956 - Submission for OMB Review; Comment Request; Cancer Risk in U.S. Radiologic Technologists: Fourth...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-28

... procedures, and other risk factors from all participants, plus detailed employment data from subgroups of... radiography procedures, and new or updated risk factors that may influence health risks. New occupational and...; Comment Request; Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI) Summary: Under the...

The benefit of silicone stents in primary endonasal dacryocystorhinostomy: a systematic review and meta-analysis.

PubMed

Sarode, D; Bari, D A; Cain, A C; Syed, M I; Williams, A T

2017-04-01

To critically evaluate the evidence comparing success rates of endonasal dacryocystorhinostomy (EN-DCR) with and without silicone tubing and to thus determine whether silicone intubation is beneficial in primary EN-DCR. Systematic review and meta-analysis. A literature search was performed on AMED, EMBASE, HMIC, MEDLINE, PsycINFO, BNI, CINAHL, HEALTH BUSINESS ELITE, CENTRAL and Cochrane Ear, Nose and Throat disorders groups trials register using a combination of various MeSH. The date of last search was January 2016. This review was limited to randomised controlled trials (RCTs) in English language. Risk of bias was assessed using the Cochrane Collaboration's risk of bias tool. Chi-square and I 2 statistics were calculated to determine the presence and extent of statistical heterogeneity. Study selection, data extraction and risk of bias scoring were performed independently by two authors in concordance with the PRISMA statement. Five RCTs (447 primary EN-DCR procedures in 426 patients) were included for analysis. Moderate interstudy statistical heterogeneity was demonstrated (Chi 2 = 6.18; d.f. = 4; I 2 = 35%). Bicanalicular silicone stents were used in 229 and not used in 218 procedures. The overall success rate of EN-DCR was 92.8% (415/447). The success rate of EN-DCR was 93.4% (214/229) with silicone tubing and 92.2% (201/218) without silicone tubing. Meta-analysis using a random-effects model showed no statistically significant difference in outcomes between the two groups (P = 0.63; RR = 0.79; 95% CI = 0.3-2.06). Our review and meta-analysis did not demonstrate an additional advantage of silicone stenting. A high-quality well-powered prospective multicentre RCT is needed to further clarify on the benefit of silicone stents. © 2016 John Wiley & Sons Ltd.

7 CFR 1c.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-01-01

... an expedited review procedure shall adopt a method for keeping all members advised of research... research involving no more than minimal risk, and for minor changes in approved research. 1c.110 Section 1c... review procedures for certain kinds of research involving no more than minimal risk, and for minor...

49 CFR 11.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

Code of Federal Regulations, 2010 CFR

2010-10-01

... an expedited review procedure shall adopt a method for keeping all members advised of research... research involving no more than minimal risk, and for minor changes in approved research. 11.110 Section 11... Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor...

Simplification and Transformation of ASTM F1292 Measurement Procedure for Fall Accident Injury Criteria

PubMed Central

KATO, Maki; SHIMODAIRA, Yoshie; SATO, Takeshi; IIDA, Hiromi

2014-01-01

Abstract: Protecting children from injuries caused by fall accidents from playground equipment is important. Therefore, measures toward minimizing the risk of fall accident injuries are required. The risk of injury can be evaluated using ASTM F1292. In this test, G-max and the HIC are used to estimate the risk of injury. However, the measurement procedure is too complicated for application to a large number of installed equipment. F1292 requires simplified by reducing the number of phases, even with a small risk of loss in accuracy. With this in mind, this study proposes a shortened measurement procedure and a transformation equation to estimate the risk as same as F1292. As the result of experiments, it was revealed that G-max and the HIC values for both procedures linearly increase with drop height. The differences in outcomes between the regression equations of the standardized procedure and those of the shortened procedure can be used as a correction value. They can be added to the value measured by the shortened procedure. This suggests that the combination of the shortened procedure and transformation equation would be equivalent to F1292, with the advantage of being more easily and efficiently applied to the evaluation of installed playground equipment. PMID:25088989

Simplification and transformation of ASTM F1292 measurement procedure for fall accident injury criteria.

PubMed

Kato, Maki; Shimodaira, Yoshie; Sato, Takeshi; Iida, Hiromi

2014-01-01

Protecting children from injuries caused by fall accidents from playground equipment is important. Therefore, measures toward minimizing the risk of fall accident injuries are required. The risk of injury can be evaluated using ASTM F1292. In this test, G-max and the HIC are used to estimate the risk of injury. However, the measurement procedure is too complicated for application to a large number of installed equipment. F1292 requires simplified by reducing the number of phases, even with a small risk of loss in accuracy. With this in mind, this study proposes a shortened measurement procedure and a transformation equation to estimate the risk as same as F1292. As the result of experiments, it was revealed that G-max and the HIC values for both procedures linearly increase with drop height. The differences in outcomes between the regression equations of the standardized procedure and those of the shortened procedure can be used as a correction value. They can be added to the value measured by the shortened procedure. This suggests that the combination of the shortened procedure and transformation equation would be equivalent to F1292, with the advantage of being more easily and efficiently applied to the evaluation of installed playground equipment.

Risk Factors for Proximal Junctional Kyphosis Associated With Dual-rod Growing-rod Surgery for Early-onset Scoliosis.

PubMed

Watanabe, Kota; Uno, Koki; Suzuki, Teppei; Kawakami, Noriaki; Tsuji, Taichi; Yanagida, Haruhisa; Ito, Manabu; Hirano, Toru; Yamazaki, Ken; Minami, Shohei; Taneichi, Hiroshi; Imagama, Shiro; Takeshita, Katsushi; Yamamoto, Takuya; Matsumoto, Morio

2016-10-01

A retrospective, multicenter study. To identify risk factors for proximal junctional kyphosis (PJK) when treating early-onset scoliosis (EOS) with dual-rod growing-rod (GR) procedure. The risk factors for PJK associated with GR treatment for EOS have not been adequately studied. We evaluated clinical and radiographic results from 88 patients with EOS who underwent dual-rod GR surgery in 12 spine centers in Japan. The mean age at the time of the initial surgery was 6.5±2.2 years (range, 1.5-9.8 y), and the mean follow-up period was 3.9±2.6 years (range, 2.0-12.0 y). Risk factors for PJK were analyzed by binomial multiple logistic regression analysis. The potential factors analyzed were sex, etiology, age, the number of rod-lengthening procedures, coronal and sagittal parameters on radiographs, the type of foundation (pedicle screws or hooks), the uppermost level of the proximal foundation, and the lowermost level of the distal foundation. PJK developed in 23 patients (26%); in 19 of these, the proximal foundation became dislodged following PJK. Binomial multiple logistic regression analysis identified the following significant independent risk factors for PJK: a lower instrumented vertebra at or cranial to L3 [odds ratio (OR), 3.32], a proximal thoracic scoliosis of ≥40 degrees (OR, 2.95), and a main thoracic kyphosis of ≥60 degrees (OR, 5.08). The significant independent risk factors for PJK during dual-rod GR treatment for EOS were a lower instrumented vertebra at or cranial to L3, a proximal thoracic scoliosis of ≥40 degrees, and a main thoracic kyphosis of ≥60 degrees.

The TVT-obturator surgical procedure for the treatment of female stress urinary incontinence: a clinical update.

PubMed

Waltregny, David; de Leval, Jean

2009-03-01

Six years ago, the inside-out transobturator tape TVT-O procedure was developed for the surgical treatment of female stress urinary incontinence (SUI) with the aim of minimizing the risk of urethra and bladder injuries and ensuring minimal tissue dissection. Initial feasibility and efficacy studies suggested that the TVT-O procedure is associated with high SUI cure rates and low morbidity at short term. A recent analysis of medium-term results indicated that the TVT-O procedure is efficient, with maintenance, after a 3-year minimum follow-up, of cure rates comparing favorably with those reported for TVT. No late complications were observed. As of July 2008, more than 35 clinical papers, including ten randomized trials and two national registries, have been published on the outcome of the TVT-O surgery. Results from these studies have confirmed that the TVT-O procedure is safe and as efficient as the TVT procedure, at least in the short/medium term.

Depth of anaesthesia monitoring during procedural sedation and analgesia: A systematic review and meta-analysis.

PubMed

Conway, Aaron; Sutherland, Joanna

2016-11-01

Processed electroencephalogram-based depth of anaesthesia monitoring devices provide an additional method to monitor level of consciousness during procedural sedation and analgesia. The objective of this systematic review was to determine whether using a depth of anaesthesia monitoring device improves the safety and efficacy of sedation. Systematic review and meta-analysis. Electronic databases (CENTRAL; Medline; CINAHL) were searched up to May 2015. Randomised controlled trials that compared use of a depth of anaesthesia monitoring device to a control group who received standard monitoring during procedural sedation and analgesia were included. Study selection, data extraction and risk of bias assessment (Cochrane risk of bias tool) were performed by two reviewers. Safety outcomes were hypoxaemia, hypotension and adverse events. Efficacy outcomes were amount of sedation used, duration of sedation recovery and rate of incomplete procedures. A total of 16 trials (2138 participants) were included. Evidence ratings were downgraded to either low or moderate quality due to study limitations and imprecision. Meta-analysis of 8 trials (766 participants) found no difference in hypoxaemia (RR 0.87; 95% CI=0.67-1.12). No statistically significant difference in hypotension was observed in meta-analysis of 8 trials (RR 0.96; 95% CI=0.54-1.7; 942 participants). Mean dose of propofol was 51mg lower for participants randomised to depth of anaesthesia monitoring (95% CI=-88.7 to -13.3mg) in meta-analysis of results from four trials conducted with 434 participants who underwent interventional endoscopy procedures with propofol infusions to maintain sedation. The difference in recovery time between depth of anaesthesia and standard monitoring groups was not clinically significant (standardised mean difference -0.41; 95% CI=-0.8 to -0.02; I 2 =86%; 8 trials; 809 participants). Depth of anaesthesia monitoring did impact sedation titration during interventional procedures with propofol infusions. For this reason, it seems reasonable for anaesthetists to utilise a depth of anaesthesia monitoring device for select populations of patients if it is decided that limiting the amount of sedation would be beneficial for the individual patient. However, there is no need to invest in purchasing extra equipment or training staff who are not familiar with this technology (e.g. nurses who do not routinely use a depth of anaesthesia monitoring device during general anaesthesia) because there is no high quality evidence suggestive of clear clinical benefits for patient safety or sedation efficacy. Copyright © 2016 Elsevier Ltd. All rights reserved.

Defining Research Risk in Standard of Care Trials: Lessons from SUPPORT.

PubMed

Press, Joel K; Rogers, Caryn J

2017-04-01

Recent controversy surrounding the Surfactant Positive Airway Pressure and Pulse Oximetry Trial (SUPPORT) and the Office for Human Resource Protection's (OHRP) judgment that its informed consent procedures were inadequate has unmasked considerable confusion about OHRP's definition of research risks. The controversy concerns application of that definition to trials comparing multiple treatments within the existing standard of care. Some have argued that it is impossible for such trials to pose research risks on the grounds that all risks associated with a standard-of-care treatment should instead be considered risks of treatment. However, analysis of OHRP's definition demonstrates that some risks in such trials can be research risks. © The Author 2017. Published by Oxford University Press, on behalf of the Journal of Medicine and Philosophy Inc. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

A non-Gaussian approach to risk measures

NASA Astrophysics Data System (ADS)

Bormetti, Giacomo; Cisana, Enrica; Montagna, Guido; Nicrosini, Oreste

2007-03-01

Reliable calculations of financial risk require that the fat-tailed nature of prices changes is included in risk measures. To this end, a non-Gaussian approach to financial risk management is presented, modelling the power-law tails of the returns distribution in terms of a Student- t distribution. Non-Gaussian closed-form solutions for value-at-risk and expected shortfall are obtained and standard formulae known in the literature under the normality assumption are recovered as a special case. The implications of the approach for risk management are demonstrated through an empirical analysis of financial time series from the Italian stock market and in comparison with the results of the most widely used procedures of quantitative finance. Particular attention is paid to quantify the size of the errors affecting the market risk measures obtained according to different methodologies, by employing a bootstrap technique.

90-day Readmission After Lumbar Spinal Fusion Surgery in New York State Between 2005 and 2014: A 10-year Analysis of a Statewide Cohort.

PubMed

Baaj, Ali A; Lang, Gernot; Hsu, Wei-Chun; Avila, Mauricio J; Mao, Jialin; Sedrakyan, Art

2017-11-15

MINI: We assessed 90-day readmission and evaluated risk factors associated with readmission after lumbar spinal fusion surgery in New York State. The overall 90-day readmission rate was 24.8%. Age, sex, race, insurance, procedure, number of operated spinal levels, health service area, and comorbidities are major risk factors for 90-day readmission. Retrospective cohort study. The aim of this study was to assess 90-day readmission and evaluate risk factors associated with readmission after lumbar fusion in New York State. Readmission is becoming an important metric for quality and efficiency of health care. Readmission and its predictors following spine surgery are overall poorly understood and limited evidence is available specifically in lumbar fusion. The New York Statewide Planning and Research Cooperative System (SPARCS) was utilized to capture patients undergoing lumbar fusion from 2005 to 2014. Temporal trend of 90-day readmission was assessed using Cochran-Armitage test. Logistic regression was used to examine predictors associated with 90-day readmission. There were 86,869 patients included in this cohort study. The overall 90-day readmission rate was 24.8%. On a multivariable analysis model, age (odds ratio [OR] comparing ≥75 versus <35 years: 1.24, 95% confidence interval [CI]: 1.13-1.35), sex (OR female to male: 1.19, 95% CI: 1.15-1.23), race (OR African-American to white: 1.60, 95% CI: 1.52-1.69), insurance (OR Medicaid to Medicare: 1.42, 95% CI: 1.33-1.53), procedure (OR comparing thoracolumbar fusion, combined [International Classification of Disease, Ninth Revision, ICD-9: 81.04] to posterior lumbar interbody fusion/transforaminal lumbar spinal fusion [ICD-9: 81.08]: 2.10, 95% CI: 1.49-2.97), number of operated spinal levels (OR comparing four to eight vertebrae to two to three vertebrae: 2.39, 95% CI: 2.07-2.77), health service area ([HSA]; OR comparing Finger Lakes to New York-Pennsylvania border: 0.67, 95% CI: 0.61-0.73), and comorbidity, i.e., coronary artery disease (OR: 1.26, 95% CI: 1.19-1.33) were significantly associated with 90-day readmission. Directions of the odds ratios for these factors were consistent after stratification by procedure type. Age, sex, race, insurance, procedure, number of operated spinal levels, HSA, and comorbidities are major risk factors for 90-day readmission. Our study allows risk calculation to determine high-risk patients before undergoing spinal fusion surgery to prevent early readmission, improve quality of care, and reduce health care expenditures. 3.

Hepatitis C virus acquisition among Egyptians: analysis of a 10-year surveillance of acute hepatitis C.

PubMed

Mohsen, Amira; Bernier, Adeline; LeFouler, Lenaig; Delarocque-Astagneau, Elisabeth; El-Daly, Mai; El-Kafrawy, Sherif; El-Mango, Salwa; Abdel-Hamid, Mohamed; Gadallah, Mohsen; Esmat, Gamal; Mohamed, Mostafa K; Fontanet, Arnaud

2015-01-01

To identify current risk factors for hepatitis C virus (HCV) acquisition among Egyptians. Patients with acute HCV were identified through a surveillance system of acute hepatitis in four fever hospitals in Egypt between 2002 and 2012. Case-control analysis was conducted, cases being incident acute symptomatic HCV and controls being acute hepatitis A identified at the same hospitals. The questionnaire covered iatrogenic, community and household exposures to HCV in the 1-6 months prior to onset of symptoms. Multivariate models were built to identify risk factors associated with HCV acquisition among non-drug users and drug users separately. Among non-drug users, hospital admission was independently associated with acute HCV infection (OR = 4.2, 95% CI = 1.7-10.5). Several iatrogenic procedures, for example admission in a surgery unit, sutures, IV injections and IV infusions, highly correlated with hospital admission, were also associated with acute HCV infection and could have been used in the final model instead of hospital admission. Among drug users, identified risk factors were multiple sexual relations (OR = 4.0, 95% CI = 1.1-14.7), intravenous drug use (OR = 3.9, 95% CI = 1.2-13.0) and shaving at the barbershops (OR = 8.7, 95% CI = 2.4-31.4). Illiteracy and marriage were significant risk factors in both groups. Invasive medical procedures are still a major risk for acquiring new HCV infections in Egypt, as is illicit drug use in spreading HCV infection. © 2014 John Wiley & Sons Ltd.

Prevention of post procedural acute kidney injury in the catheterization laboratory in a real-world population.

PubMed

Chorin, Ehud; Ben-Assa, Eyal; Konigstein, Maayan; Rofe, May-Tal; Hochstadt, Aviram; Galli, Naama; Schnapper, Michael; Arbel, Yaron; Rabey, Ilan; Shoshan, Jeremy Ben; Halkin, Amir; Herz, Itzhak; Finkelstein, Ariel; Bazan, Samuel; Keren, Gad; Banai, Shmuel

2017-01-01

Radiologists and cardiologists have a remarkably different approach to the clinical importance and to the need for prophylactic treatment of contrast-induced acute kidney injury (CI-AKI). To evaluate the efficacy of forced diuresis with matched controlled hydration (FMH) in a real-world, high risk population. This is an investigator-driven, single-center, retrospective analysis of prospectively collected data. A total of 150 consecutive patients undergoing coronary angiography, angioplasty or TAVR who were treated with FMH were compared to a matched historical control cohort. In the FMH treated patients, eGFR improved following the procedure from 37ml/min per 1.73m 2 at baseline to 39ml/min per 1.73m 2 (p<0.001); the net creatinine decreased from 1.85mg/dl to 1.78mg/dl (p<0.001). Among the matched control group, eGFR deteriorated from a baseline value of 36.7ml/min per 1.73m 2 to 33.2ml/min per 1.73m 2 post procedurally (p<0.001); the net creatinine increased from 1.88mg/dl to 2.14mg/dl (p<0.001). The incidence of post procedural AKI was substantially lower in the FMH treated group (2.7%) compared to the control group (26.7%). By multivariable analysis FMH treatment was independently correlated with reduced incidence of post procedural AKI compared with the control group (OR 0.06, p<0.001). Contrast volume did not correlate with AKI in neither univariate nor multivariate analyses. In patients undergoing coronary angiography, angioplasty or TAVR, who are considered high risk to develop post procedural AKI, forced diuresis with matched controlled hydration resulted in a significant net creatinine decrease, eGFR increase and a decrease in the incidence of AKI. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Implementation and Validation of Trial-Based Functional Analyses in Public Elementary School Settings

ERIC Educational Resources Information Center

Lloyd, Blair P.; Wehby, Joseph H.; Weaver, Emily S.; Goldman, Samantha E.; Harvey, Michelle N.; Sherlock, Daniel R.

2015-01-01

Although functional analysis (FA) remains the standard for identifying the function of problem behavior for students with developmental disabilities, traditional FA procedures are typically costly in terms of time, resources, and perceived risks. Preliminary research suggests that trial-based FA may be a less costly alternative. The purpose of…

Reliability considerations for the total strain range version of strainrange partitioning

NASA Technical Reports Server (NTRS)

Wirsching, P. H.; Wu, Y. T.

1984-01-01

A proposed total strainrange version of strainrange partitioning (SRP) to enhance the manner in which SRP is applied to life prediction is considered with emphasis on how advanced reliability technology can be applied to perform risk analysis and to derive safety check expressions. Uncertainties existing in the design factors associated with life prediction of a component which experiences the combined effects of creep and fatigue can be identified. Examples illustrate how reliability analyses of such a component can be performed when all design factors in the SRP model are random variables reflecting these uncertainties. The Rackwitz-Fiessler and Wu algorithms are used and estimates of the safety index and the probablity of failure are demonstrated for a SRP problem. Methods of analysis of creep-fatigue data with emphasis on procedures for producing synoptic statistics are presented. An attempt to demonstrate the importance of the contribution of the uncertainties associated with small sample sizes (fatique data) to risk estimates is discussed. The procedure for deriving a safety check expression for possible use in a design criteria document is presented.

Diabetes and Risk of Surgical Site Infection: A systematic review and meta-analysis

PubMed Central

Kaye, Keith S.; Knott, Caitlin; Nguyen, Huong; Santarossa, Maressa; Evans, Richard; Bertran, Elizabeth; Jaber, Linda

2016-01-01

Objective To determine the independent association between diabetes and SSI across multiple surgical procedures. Design Systematic review and meta-analysis. Methods Studies indexed in PubMed published between December 1985 and through July 2015 were identified through the search terms “risk factors” or “glucose” and “surgical site infection”. A total of 3,631 abstracts were identified through the initial search terms. Full texts were reviewed for 522 articles. Of these, 94 articles met the criteria for inclusion. Standardized data collection forms were used to extract study-specific estimates for diabetes, blood glucose levels, and body mass index (BMI). Random-effects meta-analysis was used to generate pooled estimates and meta-regression was used to evaluate specific hypothesized sources of heterogeneity. Results The primary outcome was SSI, as defined by the Centers for Disease Control and Prevention surveillance criteria. The overall effect size for the association between diabetes and SSI was OR=1.53 (95% Predictive Interval 1.11, 2.12, I2: 57.2%). SSI class, study design, or patient BMI did not significantly impact study results in a meta-regression model. The association was higher for cardiac surgery 2.03 (95% Predictive Interval 1.13, 4.05) compared to surgeries of other types (p=0.001). Conclusion These results support the consideration of diabetes as an independent risk factor for SSIs for multiple surgical procedure types. Continued efforts are needed to improve surgical outcomes for diabetic patients. PMID:26503187

The impact of operative time on complications after plastic surgery: a multivariate regression analysis of 1753 cases.

PubMed

Hardy, Krista L; Davis, Kathryn E; Constantine, Ryan S; Chen, Mo; Hein, Rachel; Jewell, James L; Dirisala, Karunakar; Lysikowski, Jerzy; Reed, Gary; Kenkel, Jeffrey M

2014-05-01

Little evidence within plastic surgery literature supports the precept that longer operative times lead to greater morbidity. The authors investigate surgery duration as a determinant of morbidity, with the goal of defining a clinically relevant time for increased risk. A retrospective chart review was conducted of patients who underwent a broad range of complex plastic surgical procedures (n = 1801 procedures) at UT Southwestern Medical Center in Dallas, Texas, from January 1, 2008 to January 31, 2012. Adjusting for possible confounders, multivariate logistic regression assessed surgery duration as an independent predictor of morbidity. To define a cutoff for increased risk, incidence of complications was compared among quintiles of surgery duration. Stratification by type of surgery controlled for procedural complexity. A total of 1753 cases were included in multivariate analyses with an overall complication rate of 27.8%. Most operations were combined (75.8%), averaging 4.9 concurrent procedures. Each hour increase in surgery duration was associated with a 21% rise in odds of morbidity (P < .0001). Compared with the first quintile of operative time (<2.0 hours), there was no change in complications until after 3.1 hours of surgery (odds ratio, 1.6; P = .017), with progressively greater odds increases of 3.1 times after 4.5 hours (P < .0001) and 4.7 times after 6.8 hours (P < .0001). When stratified by type of surgery, longer operations continued to be associated with greater morbidity. Surgery duration is an independent predictor of complications, with a significantly increased risk above 3 hours. Although procedural complexity undoubtedly affects morbidity, operative time should factor into surgical decision making.

The Association Between Operating Room Personnel and Turnover With Surgical Site Infection in More Than 12 000 Neurosurgical Cases.

PubMed

Wathen, Connor; Kshettry, Varun R; Krishnaney, Ajit; Gordon, Steven M; Fraser, Thomas; Benzel, Edward C; Modic, Michael T; Butler, Sam; Machado, Andre G

2016-12-01

Surgical site infection (SSI) contributes significantly to postoperative morbidity and mortality and greatly increases the cost of care. To identify the impact of workflow and personnel-related risk factors contributing to the incidence of SSIs in a large sample of neurological surgeries. Data were obtained using an enterprisewide electronic health record system, operating room, and anesthesia records for neurological procedures conducted between January 1, 2009, and November 30, 2012. SSI data were obtained from prospective surveillance by infection preventionists using Centers for Disease Control and Prevention definitions. A multivariate model was constructed and refined using backward elimination logistic regression methods. The analysis included 12 528 procedures. Most cases were elective (94.5%), and the average procedure length was 4.8 hours. The average number of people present in the operating room at any time during the procedure was 10.0. The overall infection rate was 2.3%. Patient body mass index (odds ratio, 1.03; 95% confidence interval [CI], 1.01-1.04) and sex (odds ratio, 1.36; 95% CI, 1.07-1.72) as well as procedure length (odds ratio, 1.19 per additional hour; 95% CI, 1.15-1.23) and nursing staff turnovers (odds ratio, 1.095 per additional turnover; 95% CI, 1.02-1.21) were significantly correlated with the risk of SSI. This study found that patient body mass index and male sex were associated with an increased risk of SSI. Operating room personnel turnover, a modifiable, work flow-related factor, was an independent variable positively correlated with SSI. This study suggests that efforts to reduce operating room turnover may be effective in preventing SSI. OR, operating roomSSI, surgical site infection.

Development of probabilistic multimedia multipathway computer codes.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yu, C.; LePoire, D.; Gnanapragasam, E.

2002-01-01

The deterministic multimedia dose/risk assessment codes RESRAD and RESRAD-BUILD have been widely used for many years for evaluation of sites contaminated with residual radioactive materials. The RESRAD code applies to the cleanup of sites (soils) and the RESRAD-BUILD code applies to the cleanup of buildings and structures. This work describes the procedure used to enhance the deterministic RESRAD and RESRAD-BUILD codes for probabilistic dose analysis. A six-step procedure was used in developing default parameter distributions and the probabilistic analysis modules. These six steps include (1) listing and categorizing parameters; (2) ranking parameters; (3) developing parameter distributions; (4) testing parameter distributionsmore » for probabilistic analysis; (5) developing probabilistic software modules; and (6) testing probabilistic modules and integrated codes. The procedures used can be applied to the development of other multimedia probabilistic codes. The probabilistic versions of RESRAD and RESRAD-BUILD codes provide tools for studying the uncertainty in dose assessment caused by uncertain input parameters. The parameter distribution data collected in this work can also be applied to other multimedia assessment tasks and multimedia computer codes.« less

Landslide risk impact management and web services for improving resilience: the LIFE+IMAGINE project approach

NASA Astrophysics Data System (ADS)

Congi, Maria Pia; Campo, Valentina; Cipolloni, Carlo; Delmonaco, Giuseppe; Guerrieri, Luca; Iadanza, Carla; Spizzichino, Daniele; Trigila, Alessandro

2014-05-01

The increasing damage caused by natural disasters in the last decades points out the need for interoperable added-value services to support environmental safety and human protection, by reducing vulnerability of exposed elements as well as improving the resilience of the involved communities. For this reason, to provide access to harmonized and customized data is only one of several steps towards delivering adequate support to risk assessment, reduction and management. Scope of the present work is to illustrate a methodology under development for analysis of potential impacts in areas prone to landslide hazard in the framework of the EC project LIFE+IMAGINE. The project aims to implement an infrastructure based on web services for environmental analysis, that integrates in its own architecture specifications and results from INSPIRE, SEIS and GMES. Existing web services will be customized during the project to provide functionalities for supporting the environmental integrated management. The implemented infrastructure will be applied to landslide risk scenarios, to be developed in selected pilot areas, aiming at: i) application of standard procedures to implement a landslide risk analysis; ii) definition of a procedure for assessment of potential environmental impacts, based on a set of indicators to estimate the different exposed elements with their specific vulnerability in the pilot area. More in detail, the landslide pilot will be aimed at providing a landslide risk scenario through the implementation and analysis of: 1) a landslide inventory from available historical databases and maps; 2) landslide susceptibility and hazard maps; 3) assessment of exposure and vulnerability on selected typologies of elements at risk; 4) implementation of a landslide risk scenario for different sets of exposed elements (e.g. population, road network, residential area, cultural heritage). The pilot will be implemented in Liguria, Italy, in two different catchment areas located in the Cinque Terre National Park, characterized by a high landslide susceptibility and low resilience, being highly vulnerable to landslides induced by heavy rainfall. The landslide risk impact analysis will be calibrated taking into account the socio-economic damage caused by landslides triggered by the October 2011 meteorological event. Most of landslides affected the diffuse system of anthropogenic terraces and caused the direct disruption of the walls as well as transportation of a large amount of loose sediments along the slopes and channels as induced consequence of the event. The final target of the landslide risk assessment scenario will be to improve the knowledge and awareness on hazard, exposure, vulnerability and landslide risk in the Cinque Terre National Park to the benefit of local authorities and population. In addition, the results of the application can have a practical and positive effects for i.e. i) updating the land planning process in order to improve the resilience of local communities, ii) implementing preliminary cost-benefit analysis aimed at the definition of guidelines for sustainable landslide risk mitigation strategies, iii) suggesting a general road map for the implementation of a local adaptation plan.

Risk assessment of vector-borne diseases for public health governance.

PubMed

Sedda, L; Morley, D W; Braks, M A H; De Simone, L; Benz, D; Rogers, D J

2014-12-01

In the context of public health, risk governance (or risk analysis) is a framework for the assessment and subsequent management and/or control of the danger posed by an identified disease threat. Generic frameworks in which to carry out risk assessment have been developed by various agencies. These include monitoring, data collection, statistical analysis and dissemination. Due to the inherent complexity of disease systems, however, the generic approach must be modified for individual, disease-specific risk assessment frameworks. The analysis was based on the review of the current risk assessments of vector-borne diseases adopted by the main Public Health organisations (OIE, WHO, ECDC, FAO, CDC etc…). Literature, legislation and statistical assessment of the risk analysis frameworks. This review outlines the need for the development of a general public health risk assessment method for vector-borne diseases, in order to guarantee that sufficient information is gathered to apply robust models of risk assessment. Stochastic (especially spatial) methods, often in Bayesian frameworks are now gaining prominence in standard risk assessment procedures because of their ability to assess accurately model uncertainties. Risk assessment needs to be addressed quantitatively wherever possible, and submitted with its quality assessment in order to enable successful public health measures to be adopted. In terms of current practice, often a series of different models and analyses are applied to the same problem, with results and outcomes that are difficult to compare because of the unknown model and data uncertainties. Therefore, the risk assessment areas in need of further research are identified in this article. Copyright © 2014 The Royal Society for Public Health. Published by Elsevier Ltd. All rights reserved.

Efficient runner safety assessment during early design phase and root cause analysis

NASA Astrophysics Data System (ADS)

Liang, Q. W.; Lais, S.; Gentner, C.; Braun, O.

2012-11-01

Fatigue related problems in Francis turbines, especially high head Francis turbines, have been published several times in the last years. During operation the runner is exposed to various steady and unsteady hydraulic loads. Therefore the analysis of forced response of the runner structure requires a combined approach of fluid dynamics and structural dynamics. Due to the high complexity of the phenomena and due to the limitation of computer power, the numerical prediction was in the past too expensive and not feasible for the use as standard design tool. However, due to continuous improvement of the knowledge and the simulation tools such complex analysis has become part of the design procedure in ANDRITZ HYDRO. This article describes the application of most advanced analysis techniques in runner safety check (RSC), including steady state CFD analysis, transient CFD analysis considering rotor stator interaction (RSI), static FE analysis and modal analysis in water considering the added mass effect, in the early design phase. This procedure allows a very efficient interaction between the hydraulic designer and the mechanical designer during the design phase, such that a risk of failure can be detected and avoided in an early design stage.The RSC procedure can also be applied to a root cause analysis (RCA) both to find out the cause of failure and to quickly define a technical solution to meet the safety criteria. An efficient application to a RCA of cracks in a Francis runner is quoted in this article as an example. The results of the RCA are presented together with an efficient and inexpensive solution whose effectiveness could be proven again by applying the described RSC technics. It is shown that, with the RSC procedure developed and applied as standard procedure in ANDRITZ HYDRO such a failure is excluded in an early design phase. Moreover, the RSC procedure is compatible with different commercial and open source codes and can be easily adapted to apply for other types of turbines, such as pump turbines and Pelton runners.

Central venous access by trainees: a systematic review and meta-analysis of the use of simulation to improve success rate on patients.

PubMed

Madenci, Arin L; Solis, Carolina V; de Moya, Marc A

2014-02-01

Simulation training for invasive procedures may improve patient safety by enabling efficient training. This study is a meta-analysis with rigorous inclusion and exclusion criteria designed to assess the real patient procedural success of simulation training for central venous access. Published randomized controlled trials and prospective 2-group cohort studies that used simulation for the training of procedures involving central venous access were identified. The quality of each study was assessed. The primary outcome was the proportion of trainees who demonstrated the ability to successfully complete the procedure. Secondary outcomes included the mean number of attempts to procedural success and periprocedural adverse events. Proportions were compared between groups using risk ratios (RRs), whereas continuous variables were compared using weighted mean differences. Random-effects analysis was used to determine pooled effect sizes. We identified 550 studies, of which 5 (3 randomized controlled trials, 2 prospective 2-group cohort studies) studies of central venous catheter (CVC) insertion were included in the meta-analysis, composed of 407 medical trainees. The simulation group had a significantly larger proportion of trainees who successfully placed CVCs (RR, 1.09; 95% confidence interval [CI], 1.03-1.16, P<0.01). In addition, the simulation group had significantly fewer mean attempts to CVC insertion (weighted mean difference, -1.42; 95% CI, -2.34 to -0.49, P<0.01). There was no significant difference in the rate of adverse events between the groups (RR, 0.50; 95% CI, 0.19-1.29; P=0.15). Training programs should consider adopting simulation training for CVC insertion to improve the real patient procedural success of trainees.

Risk management in waste water treatment.

PubMed

Wagner, M; Strube, I

2005-01-01

With the continuous restructuring of the water market due to liberalisation, privatisation and internationalisation processes, the requirements on waste water disposal companies have grown. Increasing competition requires a target-oriented and clearly structured procedure. At the same time it is necessary to meet the environment-relevant legal requirements and to design the processes to be environment-oriented. The implementation of risk management and the integration of such a management instrument in an existing system in addition to the use of modern technologies and procedures can help to make the operation of the waste water treatment safer and consequently strengthen market position. The risk management process consists of three phases, risk identification, risk analysis/risk assessment and risk handling, which are based on each other, as well as of the risk managing. To achieve an identification of the risks as complete as possible, a subdivision of the kind of risks (e.g. legal, financial, market, operational) is suggested. One possibility to assess risks is the portfolio method which offers clear representation. It allows a division of the risks into classes showing which areas need handling. The determination of the appropriate measures to handle a risk (e.g. avoidance, reduction, shift) is included in the concluding third phase. Different strategies can be applied here. On the one hand, the cause-oriented strategy, aiming at preventive measures which aim to reduce the probability of occurrence of a risk (e.g. creation of redundancy, systems with low susceptibility to malfunction). On the other hand, the effect-oriented strategy, aiming to minimise the level of damage in case of an undesired occurrence (e.g. use of alarm systems, insurance cover).

A new breast cancer risk analysis approach using features extracted from multiple sub-regions on bilateral mammograms

NASA Astrophysics Data System (ADS)

Sun, Wenqing; Tseng, Tzu-Liang B.; Zheng, Bin; Zhang, Jianying; Qian, Wei

2015-03-01

A novel breast cancer risk analysis approach is proposed for enhancing performance of computerized breast cancer risk analysis using bilateral mammograms. Based on the intensity of breast area, five different sub-regions were acquired from one mammogram, and bilateral features were extracted from every sub-region. Our dataset includes 180 bilateral mammograms from 180 women who underwent routine screening examinations, all interpreted as negative and not recalled by the radiologists during the original screening procedures. A computerized breast cancer risk analysis scheme using four image processing modules, including sub-region segmentation, bilateral feature extraction, feature selection, and classification was designed to detect and compute image feature asymmetry between the left and right breasts imaged on the mammograms. The highest computed area under the curve (AUC) is 0.763 ± 0.021 when applying the multiple sub-region features to our testing dataset. The positive predictive value and the negative predictive value were 0.60 and 0.73, respectively. The study demonstrates that (1) features extracted from multiple sub-regions can improve the performance of our scheme compared to using features from whole breast area only; (2) a classifier using asymmetry bilateral features can effectively predict breast cancer risk; (3) incorporating texture and morphological features with density features can boost the classification accuracy.

Estimating the probability of rare events: addressing zero failure data.

PubMed

Quigley, John; Revie, Matthew

2011-07-01

Traditional statistical procedures for estimating the probability of an event result in an estimate of zero when no events are realized. Alternative inferential procedures have been proposed for the situation where zero events have been realized but often these are ad hoc, relying on selecting methods dependent on the data that have been realized. Such data-dependent inference decisions violate fundamental statistical principles, resulting in estimation procedures whose benefits are difficult to assess. In this article, we propose estimating the probability of an event occurring through minimax inference on the probability that future samples of equal size realize no more events than that in the data on which the inference is based. Although motivated by inference on rare events, the method is not restricted to zero event data and closely approximates the maximum likelihood estimate (MLE) for nonzero data. The use of the minimax procedure provides a risk adverse inferential procedure where there are no events realized. A comparison is made with the MLE and regions of the underlying probability are identified where this approach is superior. Moreover, a comparison is made with three standard approaches to supporting inference where no event data are realized, which we argue are unduly pessimistic. We show that for situations of zero events the estimator can be simply approximated with 1/2.5n, where n is the number of trials. © 2011 Society for Risk Analysis.

Study of a risk-based piping inspection guideline system.

PubMed

Tien, Shiaw-Wen; Hwang, Wen-Tsung; Tsai, Chih-Hung

2007-02-01

A risk-based inspection system and a piping inspection guideline model were developed in this study. The research procedure consists of two parts--the building of a risk-based inspection model for piping and the construction of a risk-based piping inspection guideline model. Field visits at the plant were conducted to develop the risk-based inspection and strategic analysis system. A knowledge-based model had been built in accordance with international standards and local government regulations, and the rational unified process was applied for reducing the discrepancy in the development of the models. The models had been designed to analyze damage factors, damage models, and potential damage positions of piping in the petrochemical plants. The purpose of this study was to provide inspection-related personnel with the optimal planning tools for piping inspections, hence, to enable effective predictions of potential piping risks and to enhance the better degree of safety in plant operations that the petrochemical industries can be expected to achieve. A risk analysis was conducted on the piping system of a petrochemical plant. The outcome indicated that most of the risks resulted from a small number of pipelines.

Clinical predictors of challenging atrioventricular node ablation procedure for rate control in patients with atrial fibrillation.

PubMed

Polin, Baptiste; Behar, Nathalie; Galand, Vincent; Auffret, Vincent; Behaghel, Albin; Pavin, Dominique; Daubert, Jean-Claude; Mabo, Philippe; Leclercq, Christophe; Martins, Raphael P

2017-10-15

Atrioventricular node (AVN) ablation is usually a simple procedure but may sometimes be challenging. We aimed at identifying pre-procedural clinical predictors of challenging AVN ablation. Patients referred for AVN ablation from 2009 to 2015 were retrospectively included. Baseline clinical data, procedural variables and outcomes of AVN ablation were collected. A "challenging procedure" was defined 1) total radiofrequency delivery to get persistent AVN block≥400s, 2) need for left-sided arterial approach or 3) failure to obtain AVN ablation. 200 patients were included (71±10years). A total of 37 (18.5%) patients had "challenging" procedures (including 9 failures, 4.5%), while 163 (81.5%) had "non-challenging" ablations. In multivariable analysis, male sex (Odds ratio (OR)=4.66, 95% confidence interval (CI): 1.74-12.46), body mass index (BMI, OR=1.08 per 1kg/m 2 , 95%CI 1.01-1.16), operator experience (OR=0.40, 95%CI 0.17-0.94), and moderate-to-severe tricuspid regurgitation (TR, OR=3.65, 95%CI 1.63-8.15) were significant predictors of "challenging" ablations. The proportion as a function of number of predictors was analyzed (from 0 to 4, including male sex, operator inexperience, a BMI>23.5kg/m 2 and moderate-to-severe TR). There was a gradual increase in the risk of "challenging" procedure with the number of predictors by patient (No predictor: 0%; 1 predictor: 6.3%; 2 predictors: 16.5%; 3 predictors: 32.5%; 4 predictors: 77.8%). Operator experience, male sex, higher BMI and the degree of TR were independent predictors of "challenging" AVN ablation procedure. The risk increases with the number of predictors by patient. Copyright © 2017. Published by Elsevier B.V.

Ignoring correlation in uncertainty and sensitivity analysis in life cycle assessment: what is the risk?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Groen, E.A., E-mail: Evelyne.Groen@gmail.com; Heijungs, R.; Leiden University, Einsteinweg 2, Leiden 2333 CC

Life cycle assessment (LCA) is an established tool to quantify the environmental impact of a product. A good assessment of uncertainty is important for making well-informed decisions in comparative LCA, as well as for correctly prioritising data collection efforts. Under- or overestimation of output uncertainty (e.g. output variance) will lead to incorrect decisions in such matters. The presence of correlations between input parameters during uncertainty propagation, can increase or decrease the the output variance. However, most LCA studies that include uncertainty analysis, ignore correlations between input parameters during uncertainty propagation, which may lead to incorrect conclusions. Two approaches to include correlationsmore » between input parameters during uncertainty propagation and global sensitivity analysis were studied: an analytical approach and a sampling approach. The use of both approaches is illustrated for an artificial case study of electricity production. Results demonstrate that both approaches yield approximately the same output variance and sensitivity indices for this specific case study. Furthermore, we demonstrate that the analytical approach can be used to quantify the risk of ignoring correlations between input parameters during uncertainty propagation in LCA. We demonstrate that: (1) we can predict if including correlations among input parameters in uncertainty propagation will increase or decrease output variance; (2) we can quantify the risk of ignoring correlations on the output variance and the global sensitivity indices. Moreover, this procedure requires only little data. - Highlights: • Ignoring correlation leads to under- or overestimation of the output variance. • We demonstrated that the risk of ignoring correlation can be quantified. • The procedure proposed is generally applicable in life cycle assessment. • In some cases, ignoring correlation has a minimal effect on decision-making tools.« less

Using the failure mode and effects analysis model to improve parathyroid hormone and adrenocorticotropic hormone testing

PubMed Central

Magnezi, Racheli; Hemi, Asaf; Hemi, Rina

2016-01-01

Background Risk management in health care systems applies to all hospital employees and directors as they deal with human life and emergency routines. There is a constant need to decrease risk and increase patient safety in the hospital environment. The purpose of this article is to review the laboratory testing procedures for parathyroid hormone and adrenocorticotropic hormone (which are characterized by short half-lives) and to track failure modes and risks, and offer solutions to prevent them. During a routine quality improvement review at the Endocrine Laboratory in Tel Hashomer Hospital, we discovered these tests are frequently repeated unnecessarily due to multiple failures. The repetition of the tests inconveniences patients and leads to extra work for the laboratory and logistics personnel as well as the nurses and doctors who have to perform many tasks with limited resources. Methods A team of eight staff members accompanied by the Head of the Endocrine Laboratory formed the team for analysis. The failure mode and effects analysis model (FMEA) was used to analyze the laboratory testing procedure and was designed to simplify the process steps and indicate and rank possible failures. Results A total of 23 failure modes were found within the process, 19 of which were ranked by level of severity. The FMEA model prioritizes failures by their risk priority number (RPN). For example, the most serious failure was the delay after the samples were collected from the department (RPN =226.1). Conclusion This model helped us to visualize the process in a simple way. After analyzing the information, solutions were proposed to prevent failures, and a method to completely avoid the top four problems was also developed. PMID:27980440

Nature Disaster Risk Evaluation with a Group Decision Making Method Based on Incomplete Hesitant Fuzzy Linguistic Preference Relations.

PubMed

Tang, Ming; Liao, Huchang; Li, Zongmin; Xu, Zeshui

2018-04-13

Because the natural disaster system is a very comprehensive and large system, the disaster reduction scheme must rely on risk analysis. Experts' knowledge and experiences play a critical role in disaster risk assessment. The hesitant fuzzy linguistic preference relation is an effective tool to express experts' preference information when comparing pairwise alternatives. Owing to the lack of knowledge or a heavy workload, information may be missed in the hesitant fuzzy linguistic preference relation. Thus, an incomplete hesitant fuzzy linguistic preference relation is constructed. In this paper, we firstly discuss some properties of the additive consistent hesitant fuzzy linguistic preference relation. Next, the incomplete hesitant fuzzy linguistic preference relation, the normalized hesitant fuzzy linguistic preference relation, and the acceptable hesitant fuzzy linguistic preference relation are defined. Afterwards, three procedures to estimate the missing information are proposed. The first one deals with the situation in which there are only n-1 known judgments involving all the alternatives; the second one is used to estimate the missing information of the hesitant fuzzy linguistic preference relation with more known judgments; while the third procedure is used to deal with ignorance situations in which there is at least one alternative with totally missing information. Furthermore, an algorithm for group decision making with incomplete hesitant fuzzy linguistic preference relations is given. Finally, we illustrate our model with a case study about flood disaster risk evaluation. A comparative analysis is presented to testify the advantage of our method.

Percutaneous closure of patent foramen ovale and atrial septal defect in adults: the impact of clinical variables and hospital procedure volume on in-hospital adverse events.

PubMed

Opotowsky, Alexander R; Landzberg, Michael J; Kimmel, Stephen E; Webb, Gary D

2009-05-01

Percutaneous closure of patent foramen ovale/atrial septal defect (PFO/ASD) is an increasingly common procedure perceived as having minimal risk. There are no population-based estimates of in-hospital adverse event rates of percutaneous PFO/ASD closure. We used nationally representative data from the 2001-2005 Nationwide Inpatient Sample to identify patients >or-=20 years old admitted to an acute care hospital with an International Classification of Diseases, Ninth Revision code designating percutaneous PFO/ASD closure on the first or second hospital day. Variables analyzed included age, sex, number of comorbidities, year, same-day use of intracardiac or other echocardiography, same-day left heart catheterization, hospital size and teaching status, PFO/ASD procedural volume, and coronary intervention volume. Outcomes of interest included length of stay, charges, and adverse events. The study included 2,555 (weighted to United States population: 12,544 +/- 1,987) PFO/ASD closure procedures. Mean age was 52.0 +/- 0.4 years, and 57.3% +/- 1.0% were women. Annual hospital volume averaged 40.8 +/- 7.7 procedures (range, 1-114). Overall, 8.2 +/- 0.8% of admissions involved an adverse event. Older patients and those with comorbidities were more likely to sustain adverse events. Use of intracardiac echocardiography was associated with fewer adverse events. The risk of adverse events was inversely proportional to annual hospital volume (odds ratio [OR] 0.91, 95% confidence interval [CI] 0.86-0.96, per 10 procedures), even after limiting the analysis to hospitals performing >or=10 procedures annually (OR 0.91, 95% CI 0.85-0.98). Adverse events were more frequent at hospitals in the lowest volume quintile as compared with the highest volume quintile (13.3% vs 5.4%, OR 2.42, 95% CI 1.55-3.78). The risk of adverse events of percutaneous PFO/ASD closure is inversely correlated with hospital volume. This relationship applies even to hospitals meeting the current guidelines, performing >or=10 procedures annually.

Heart Rate Variability Dynamics for the Prognosis of Cardiovascular Risk

PubMed Central

Ramirez-Villegas, Juan F.; Lam-Espinosa, Eric; Ramirez-Moreno, David F.; Calvo-Echeverry, Paulo C.; Agredo-Rodriguez, Wilfredo

2011-01-01

Statistical, spectral, multi-resolution and non-linear methods were applied to heart rate variability (HRV) series linked with classification schemes for the prognosis of cardiovascular risk. A total of 90 HRV records were analyzed: 45 from healthy subjects and 45 from cardiovascular risk patients. A total of 52 features from all the analysis methods were evaluated using standard two-sample Kolmogorov-Smirnov test (KS-test). The results of the statistical procedure provided input to multi-layer perceptron (MLP) neural networks, radial basis function (RBF) neural networks and support vector machines (SVM) for data classification. These schemes showed high performances with both training and test sets and many combinations of features (with a maximum accuracy of 96.67%). Additionally, there was a strong consideration for breathing frequency as a relevant feature in the HRV analysis. PMID:21386966

76 FR 58520 - Proposed Collection; Comment Request; Cancer Risk in U.S. Radiologic Technologists: Fourth Survey...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-09-21

... medical outcomes, personal medical radiation procedures, and other risk factors from all participants... worked with radioisotopes and interventional radiography procedures, and new or updated risk factors that... Request; Cancer Risk in U.S. Radiologic Technologists: Fourth Survey (NCI) SUMMARY: In compliance with the...

48 CFR 50.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2012 CFR

2012-10-01

... unusually hazardous or nuclear risks. 50.104-3 Section 50.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 50.104-3 Special procedures for unusually hazardous or nuclear risks. (a... nuclear risks should be submitted to the contracting officer and shall include the following information...

48 CFR 50.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2013 CFR

2013-10-01

... unusually hazardous or nuclear risks. 50.104-3 Section 50.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 50.104-3 Special procedures for unusually hazardous or nuclear risks. (a... nuclear risks should be submitted to the contracting officer and shall include the following information...

48 CFR 50.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2014 CFR

2014-10-01

... unusually hazardous or nuclear risks. 50.104-3 Section 50.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 50.104-3 Special procedures for unusually hazardous or nuclear risks. (a... nuclear risks should be submitted to the contracting officer and shall include the following information...

48 CFR 50.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2011 CFR

2011-10-01

... unusually hazardous or nuclear risks. 50.104-3 Section 50.104-3 Federal Acquisition Regulations System... Extraordinary Contractual Actions 50.104-3 Special procedures for unusually hazardous or nuclear risks. (a... nuclear risks should be submitted to the contracting officer and shall include the following information...

Meta-analysis for aggregated survival data with competing risks: a parametric approach using cumulative incidence functions.

PubMed

Bonofiglio, Federico; Beyersmann, Jan; Schumacher, Martin; Koller, Michael; Schwarzer, Guido

2016-09-01

Meta-analysis of a survival endpoint is typically based on the pooling of hazard ratios (HRs). If competing risks occur, the HRs may lose translation into changes of survival probability. The cumulative incidence functions (CIFs), the expected proportion of cause-specific events over time, re-connect the cause-specific hazards (CSHs) to the probability of each event type. We use CIF ratios to measure treatment effect on each event type. To retrieve information on aggregated, typically poorly reported, competing risks data, we assume constant CSHs. Next, we develop methods to pool CIF ratios across studies. The procedure computes pooled HRs alongside and checks the influence of follow-up time on the analysis. We apply the method to a medical example, showing that follow-up duration is relevant both for pooled cause-specific HRs and CIF ratios. Moreover, if all-cause hazard and follow-up time are large enough, CIF ratios may reveal additional information about the effect of treatment on the cumulative probability of each event type. Finally, to improve the usefulness of such analysis, better reporting of competing risks data is needed. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

An improved approach for flight readiness certification: Methodology for failure risk assessment and application examples. Volume 3: Structure and listing of programs

NASA Technical Reports Server (NTRS)

Moore, N. R.; Ebbeler, D. H.; Newlin, L. E.; Sutharshana, S.; Creager, M.

1992-01-01

An improved methodology for quantitatively evaluating failure risk of spaceflight systems to assess flight readiness and identify risk control measures is presented. This methodology, called Probabilistic Failure Assessment (PFA), combines operating experience from tests and flights with engineering analysis to estimate failure risk. The PFA methodology is of particular value when information on which to base an assessment of failure risk, including test experience and knowledge of parameters used in engineering analyses of failure phenomena, is expensive or difficult to acquire. The PFA methodology is a prescribed statistical structure in which engineering analysis models that characterize failure phenomena are used conjointly with uncertainties about analysis parameters and/or modeling accuracy to estimate failure probability distributions for specific failure modes. These distributions can then be modified, by means of statistical procedures of the PFA methodology, to reflect any test or flight experience. Conventional engineering analysis models currently employed for design of failure prediction are used in this methodology. The PFA methodology is described and examples of its application are presented. Conventional approaches to failure risk evaluation for spaceflight systems are discussed, and the rationale for the approach taken in the PFA methodology is presented. The statistical methods, engineering models, and computer software used in fatigue failure mode applications are thoroughly documented.

Reducing risk of spinal haematoma from spinal and epidural pain procedures.

PubMed

Breivik, Harald; Norum, Hilde; Fenger-Eriksen, Christian; Alahuhta, Seppo; Vigfússon, Gísli; Thomas, Owain; Lagerkranser, Michael

2018-04-25

Central neuraxial blocks (CNB: epidural, spinal and their combinations) and other spinal pain procedures can cause serious harm to the spinal cord in patients on antihaemostatic drugs or who have other risk-factors for bleeding in the spinal canal. The purpose of this narrative review is to provide a practise advisory on how to reduce risk of spinal cord injury from spinal haematoma (SH) during CNBs and other spinal pain procedures. Scandinavian guidelines from 2010 are part of the background for this practise advisory. We searched recent guidelines, PubMed (MEDLINE), SCOPUS and EMBASE for new and relevant randomised controlled trials (RCT), case-reports and original articles concerning benefits of neuraxial blocks, risks of SH due to anti-haemostatic drugs, patient-related risk factors, especially renal impairment with delayed excretion of antihaemostatic drugs, and specific risk factors related to the neuraxial pain procedures. Epidural and spinal analgesic techniques, as well as their combination provide superior analgesia and reduce the risk of postoperative and obstetric morbidity and mortality. Spinal pain procedure can be highly effective for cancer patients, less so for chronic non-cancer patients. We did not identify any RCT with SH as outcome. We evaluated risks and recommend precautions for SH when patients are treated with antiplatelet, anticoagulant, or fibrinolytic drugs, when patients' comorbidities may increase risks, and when procedure-specific risk factors are present. Inserting and withdrawing epidural catheters appear to have similar risks for initiating a SH. Invasive neuraxial pain procedures, e.g. spinal cord stimulation, have higher risks of bleeding than traditional neuraxial blocks. We recommend robust monitoring routines and treatment protocol to ensure early diagnosis and effective treatment of SH should this rare but potentially serious complication occur. When neuraxial analgesia is considered for a patient on anti-haemostatic medication, with patient-related, or procedure-related risk factors, the balance of benefits against risks of bleeding is decisive; when CNB are offered exclusively to patients who will have a reduction of postoperative morbidity and mortality, then a higher risk of bleeding may be accepted. Robust routines should ensure appropriate discontinuation of anti-haemostatic drugs and early detection and treatment of SH. There is an on-going development of drugs for prevention of thromboembolic events following surgery and childbirth. The present practise advisory provides up-to-date knowledge and experts' experiences so that patients who will greatly benefit from neuraxial pain procedures and have increased risk of bleeding can safely benefit from these procedures. There are always individual factors for the clinician to evaluate and consider. Increasingly it is necessary for the anaesthesia and analgesia provider to collaborate with specialists in haemostasis. Surgeons and obstetricians must be equally well prepared to collaborate for the best outcome for their patients suffering from acute or chronic pain. Optimal pain management is a prerequisite for enhanced recovery after surgery, but there is a multitude of additional concerns, such as early mobilisation, early oral feeding and ileus prevention that surgeons and anaesthesia providers need to optimise for the best outcome and least risk of complications.

Risk factors for early post-operative neurological deterioration in dogs undergoing a cervical dorsal laminectomy or hemilaminectomy: 100 cases (2002-2014).

PubMed

Taylor-Brown, F E; Cardy, T J A; Liebel, F X; Garosi, L; Kenny, P J; Volk, H A; De Decker, S

2015-12-01

Early post-operative neurological deterioration is a well-known complication following dorsal cervical laminectomies and hemilaminectomies in dogs. This study aimed to evaluate potential risk factors for early post-operative neurological deterioration following these surgical procedures. Medical records of 100 dogs that had undergone a cervical dorsal laminectomy or hemilaminectomy between 2002 and 2014 were assessed retrospectively. Assessed variables included signalment, bodyweight, duration of clinical signs, neurological status before surgery, diagnosis, surgical site, type and extent of surgery and duration of procedure. Outcome measures were neurological status immediately following surgery and duration of hospitalisation. Univariate statistical analysis was performed to identify variables to be included in a multivariate model. Diagnoses included osseous associated cervical spondylomyelopathy (OACSM; n = 41), acute intervertebral disk extrusion (IVDE; 31), meningioma (11), spinal arachnoid diverticulum (10) and vertebral arch anomalies (7). Overall 54% (95% CI 45.25-64.75) of dogs were neurologically worse 48 h post-operatively. Multivariate statistical analysis identified four factors significantly related to early post-operative neurological outcome. Diagnoses of OACSM or meningioma were considered the strongest variables to predict early post-operative neurological deterioration, followed by higher (more severely affected) neurological grade before surgery and longer surgery time. This information can aid in the management of expectations of clinical staff and owners with dogs undergoing these surgical procedures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Building a Computer Program to Support Children, Parents, and Distraction during Healthcare Procedures

PubMed Central

McCarthy, Ann Marie; Kleiber, Charmaine; Ataman, Kaan; Street, W. Nick; Zimmerman, M. Bridget; Ersig, Anne L.

2012-01-01

This secondary data analysis used data mining methods to develop predictive models of child risk for distress during a healthcare procedure. Data used came from a study that predicted factors associated with children’s responses to an intravenous catheter insertion while parents provided distraction coaching. From the 255 items used in the primary study, 44 predictive items were identified through automatic feature selection and used to build support vector machine regression models. Models were validated using multiple cross-validation tests and by comparing variables identified as explanatory in the traditional versus support vector machine regression. Rule-based approaches were applied to the model outputs to identify overall risk for distress. A decision tree was then applied to evidence-based instructions for tailoring distraction to characteristics and preferences of the parent and child. The resulting decision support computer application, the Children, Parents and Distraction (CPaD), is being used in research. Future use will support practitioners in deciding the level and type of distraction intervention needed by a child undergoing a healthcare procedure. PMID:22805121

Ordinary risks and accepted fictions: how contrasting and competing priorities work in risk assessment and mental health care planning.

PubMed

Coffey, Michael; Cohen, Rachel; Faulkner, Alison; Hannigan, Ben; Simpson, Alan; Barlow, Sally

2017-06-01

Communication and information sharing are considered crucial to recovery-focused mental health services. Effective mental health care planning and coordination includes assessment and management of risk and safety. Using data from our cross-national mixed-method study of care planning and coordination, we examined what patients, family members and workers say about risk assessment and management and explored the contents of care plans. Thematic analysis of qualitative research interviews (n = 117) with patients, family members and workers, across four English and two Welsh National Health Service sites. Care plans were reviewed (n = 33) using a structured template. Participants have contrasting priorities in relation to risk. Patients see benefit in discussions about risk, but cast the process as a worker priority that may lead to loss of liberty. Relationships with workers are key to family members and patients; however, worker claims of involving people in the care planning process do not extend to risk assessment and management procedures for fear of causing upset. Workers locate risk as coming from the person rather than social or environmental factors, are risk averse and appear to prioritize the procedural aspects of assessment. Despite limitations, risk assessment is treated as legitimate work by professionals. Risk assessment practice operates as a type of fiction in which poor predictive ability and fear of consequences are accepted in the interests of normative certainty by all parties. As a consequence, risk adverse options are encouraged by workers and patients steered away from opportunities for ordinary risks thereby hindering the mobilization of their strengths and abilities. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

Antegrade or Retrograde Cerebral Perfusion in Ascending Aorta and Hemiarch Surgery? A Propensity-Matched Analysis.

PubMed

Perreas, Konstantinos; Samanidis, George; Thanopoulos, Apostolis; Georgiopoulos, Georgios; Antoniou, Theofani; Khoury, Mazen; Michalis, Alkiviadis; Bairaktaris, Andreas

2016-01-01

Over the years, numerous options have been proposed for surgical management of ascending aorta and aortic arch pathology in an attempt to minimize postoperative morbidity and probability of death. We present a propensity score-matching analysis of 259 patients from a single unit who were operated on under deep hypothermic arrest with retrograde cerebral perfusion (DHCA/RCP) or moderate hypothermic circulatory arrest with selective antegrade cerebral perfusion (via common carotid artery) (MHCA/ACP). Between 2006 and 2014 a total of 259 consecutive patients underwent ascending aorta and hemiarch correction under HCA. DHCA/RCP and MHCA/ACP were performed on 207 and 52 patients, respectively. Baseline patient characteristics accounted for in the propensity matching were age, sex, acute aortic dissection, emergency operation, re-operation, preoperative hemodynamic instability, preoperative kidney injury, and CA time. After propensity scoring 40 pairs (80 patients) were successfully matched (p = 0.732). Outcomes were defined as the incidence of postoperative neurologic complications, 30-day mortality, and all-cause midterm mortality. Surgical procedure that involved the MHCA/ACP technique was associated with 76.5% decreased risk (risk ratio, 0.235; 95% CI, 0.079 to 0.699) of postoperative neurologic complications (p = 0.009). In addition to MHCA/ACP in surgical procedure for acute aortic dissection a relevant trend was established for 30-day mortality (risk ratio, 0.333; 95% CI, 0.09 to 1.23). For midterm all-cause mortality, MHCA/ACP modestly decreased the number of deaths (p = 0.0456) in comparison with the DHCA/RCP technique. MHCA/ACP in aortic arch surgical procedure is associated with a decreased risk of all types of neurologic complications and a trend toward decreased 30-day and midterm mortality in comparison with DHCA/RCP. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

Surgical strategies in the treatment of chronic pancreatitis: An updated systematic review and meta-analysis of randomized controlled trials.

PubMed

Zhao, Xin; Cui, Naiqiang; Wang, Ximo; Cui, Yunfeng

2017-03-01

Chronic pancreatitis (CP) is a common and frequently occurring disease. Pancreaticoduodenectomy (PD), pylorus-preserving pancreaticoduodenectomy (PPPD), and duodenum-preserving pancreatic head resection (DPPHR) are important treatment options for patients with chronic pancreatitis. The Beger and Frey procedures are 2 main duodenum-preserving techniques in duodenum-preserving pancreatic head resection (DPPHR) strategies. We conducted this systematic review and meta-analysis to compare the clinical efficacy of DPPHR versus PD, the Beger procedure versus PD, the Frey procedure versus PD, and the Beger procedure versus the Frey procedure in the treatment of pancreatitis. The optimal surgical option for chronic pancreatitis is still under debate. The aim of this systematic review and meta-analysis was to evaluate the clinical efficacy of different surgical strategies for chronic pancreatitis. Five databases (PubMed, Medline, SinoMed, Embase, and Cochrane Library) were searched with the limitations of human subjects and randomized controlled trials (RCTs) text. Data were extracted by 2 of the coauthors independently and analyzed using the RevMan statistical software, version 5.3. Weighted mean differences (WMDs), risk ratios (RRs), and 95% confidence intervals (CIs) were calculated. Cochrane Collaboration's Risk of Bias Tool was used to assess the risk of bias. Seven studies involving a total of 385 patients who underwent the surgical treatments were assessed. The methodological quality of the trials ranged from low to moderate and included PD (n = 134) and DPPHR (n = 251 [Beger procedure = 100; Frey procedure = 109; Beger or Frey procedure = 42]). There were no significant differences between DPPHR and PD in post-operation mortality (RR = 2.89, 95% CI = 0.31-26.87, P = 0.36), pain relief (RR = 1.09, 95% CI = 0.94-1.25, P = 0.26), exocrine insufficiency (follow-up time > 60 months: RR = 0.91, 95% CI = 0.72-1.15, P = 0.41), and endocrine insufficiency (RR = 0.75, 95% CI = 0.52-1.08, P = 0.12). Concerning the follow-up time < 60 months, the DPPHR group had better results of exocrine insufficiency (RR = 0.22, 95% CI = 0.08-0.62, P = 0.04). However, operation time (P < 0.0001), blood transfusion (P = 0.02), hospital stay (P = 0.0002), postoperation morbidity (P = 0.0007), weight gain (P < 0.00001), quality of life (P = 0.01), and occupational rehabilitation (P = 0.007) were significantly better for patients who underwent the DPPHR procedure compared with the PD procedure. The comparison results of the Frey procedure and PD showed that both procedures had an equal effect in the pain relief, postoperation mortality, exocrine and endocrine function, and quality of life (QoL) (P > 0.05), whereas patients who underwent the Frey procedure had significantly reduced operative times (P < 0.05) and less blood transfusions (P < 0.05). Comparing the Beger procedure to the PD procedure, there were no significant differences in hospital stay, blood transfusion, postoperation morbidity or mortality, pain relief, weight gain, exocrine insufficiency, and occupational rehabilitation (P > 0.05). Two studies comparing the Beger and Frey procedures showed no differences in postoperative morbidity, pain relief, exocrine insufficiency, and quality of life (P > 0.05). In terms of operative time, blood transfusion, hospital stay, postoperation morbidity, weight gain, quality of life, and occupational rehabilitation, the results also favored duodenum-preserving pancreatic head resection (DPPHR) strategies. All procedures are equally effective for the management of pain, postoperation morbidity, exocrine insufficiency, and endocrine insufficiency for chronic pancreatitis. Improved short- and long-term outcomes, including operative time, blood transfusion, hospital stay, quality of life, weight gain, and occupational rehabilitation make DPPHR a more favorable surgical strategy for patients with chronic pancreatitis. Further, relevant trails are eager to prove these findings.

Assessing the extent and use of risk analysis methodologies in Africa, using data derived from the Performance of Veterinary Services (PVS) Pathway.

PubMed

Bastiaensen, P; Abernethy, D; Etter, E

2017-04-01

African countries that wish to export are increasingly faced with import risk assessments from importing countries concerned about the sources of their imported goods. Other risk analysis methodologies and approaches are also employed, which focus on animal and human health within countries and communities. Based on an analysis of evaluations conducted by the World Organisation for Animal Health (OIE), using the Performance of Veterinary Services Tool, the authors attempt to define current practice in Africa and degrees of compliance with the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures ('SPS Agreement') and OIE standards. To assist in this task, the authors also make use of a review of selected risk assessment reports. Results point to a lack of technical capacity and capability to conduct risk assessments in compliance with OIE standards (except in the case of three countries), ranging from an outright absence of any form of (documented) risk assessment and consecutive risk management decisions (level of advancement 1) to shortcomings in one or several aspects of the risk assessment process. This is confirmed by a number of case studies, half of which have been produced by international consultants. The major recommendations of this paper are i) to strengthen the human resources pool for conducting risk assessments and ii) to establish dedicated risk assessment units, with clear terms of reference, job descriptions and policies, procedures and protocols.

Documentary analysis of risk-assessment and safety-planning policies and tools in a mental health context.

PubMed

Higgins, Agnes; Doyle, Louise; Morrissey, Jean; Downes, Carmel; Gill, Ailish; Bailey, Sive

2016-08-01

Despite the articulated need for policies and processes to guide risk assessment and safety planning, limited guidance exists on the processes or procedures to be used to develop such policies, and there is no body of research that examines the quality or content of the risk-management policies developed. The aim of the present study was to analyse the policies of risk and safety management used to guide mental health nursing practice in Ireland. A documentary analysis was performed on 123 documents received from 22 of the 23 directors of nursing contacted. Findings from the analysis revealed a wide variation in how risk, risk assessment, and risk management were defined. Emphasis within the risk documentation submitted was on risk related to self and others, with minimal attention paid to other types of risks. In addition, there was limited evidence of recovery-focused approaches to positive risk taking that involved service users and their families within the risk-related documentation. Many of the risk-assessment tools had not been validated, and lacked consistency or guidance in relation to how they were to be used or applied. The tick-box approach and absence of space for commentary within documentation have the potential to impact severely on the quality of information collected and documented, and subsequent clinical decision-making. Managers, and those tasked with ensuring safety and quality, need to ensure that policies and processes are, where possible, informed by best evidence and are in line with national mental health policy on recovery. © 2016 Australian College of Mental Health Nurses Inc.

Adverse outcomes in maternity care for women with a low risk profile in The Netherlands: a case series analysis

PubMed Central

2013-01-01

Background This study aimed to perform a structural analysis of determinants of risk of critical incidents in care for women with a low risk profile at the start of pregnancy with a view on improving patient safety. Methods We included 71 critical incidents in primary midwifery care and subsequent hospital care in case of referral after 36 weeks of pregnancy that were related to substandard care and for that reason were reported to the Health Care Inspectorate in The Netherlands in 36 months (n = 357). We performed a case-by-case analysis, using a previously validated instrument which covered five broad domains: healthcare organization, communication between healthcare providers, patient risk factors, clinical management, and clinical outcomes. Results Determinants that were associated with risk concerned healthcare organization (n = 20 incidents), communication about treatment procedures (n = 39), referral processes (n = 19), risk assessment by telephone triage (n = 10), and clinical management in an out of hours setting (n = 19). The 71 critical incidents included three cases of maternal death, eight cases of severe maternal morbidity, 42 perinatal deaths and 12 critical incidents with severe morbidity for the child. Suboptimal prenatal risk assessment, a delay in availability of health care providers in urgent situations, miscommunication about treatment between care providers, and miscommunication with patients in situations with a language barrier were associated with safety risks. Conclusions Systematic analysis of critical incidents improves insight in determinants of safety risk. The wide variety of determinants of risk of critical incidents implies that there is no single intervention to improve patient safety in the care for pregnant women with initially a low risk profile. PMID:24286376

Ontology-based specification, identification and analysis of perioperative risks.

PubMed

Uciteli, Alexandr; Neumann, Juliane; Tahar, Kais; Saleh, Kutaiba; Stucke, Stephan; Faulbrück-Röhr, Sebastian; Kaeding, André; Specht, Martin; Schmidt, Tobias; Neumuth, Thomas; Besting, Andreas; Stegemann, Dominik; Portheine, Frank; Herre, Heinrich

2017-09-06

Medical personnel in hospitals often works under great physical and mental strain. In medical decision-making, errors can never be completely ruled out. Several studies have shown that between 50 and 60% of adverse events could have been avoided through better organization, more attention or more effective security procedures. Critical situations especially arise during interdisciplinary collaboration and the use of complex medical technology, for example during surgical interventions and in perioperative settings (the period of time before, during and after surgical intervention). In this paper, we present an ontology and an ontology-based software system, which can identify risks across medical processes and supports the avoidance of errors in particular in the perioperative setting. We developed a practicable definition of the risk notion, which is easily understandable by the medical staff and is usable for the software tools. Based on this definition, we developed a Risk Identification Ontology (RIO) and used it for the specification and the identification of perioperative risks. An agent system was developed, which gathers risk-relevant data during the whole perioperative treatment process from various sources and provides it for risk identification and analysis in a centralized fashion. The results of such an analysis are provided to the medical personnel in form of context-sensitive hints and alerts. For the identification of the ontologically specified risks, we developed an ontology-based software module, called Ontology-based Risk Detector (OntoRiDe). About 20 risks relating to cochlear implantation (CI) have already been implemented. Comprehensive testing has indicated the correctness of the data acquisition, risk identification and analysis components, as well as the web-based visualization of results.

Higher plasma level of STIM1, OPG are correlated with stent restenosis after PCI.

PubMed

Li, Haibin; Jiang, Zhian; Liu, Xiangdong; Yang, Zhihui

2015-01-01

Percutaneous Coronary Intervention (PCI) is one of the most effective treatments for Coronary Heart Disease (CHD), but the high rate of In Stent Restenosis (ISR) has plagued clinicians after PCI. We aim to investigate the correlation of plasma Stromal Interaction Molecular 1 (STIM1) and Osteoprotegerin (OPG) level with stent restenosis after PCI. A total of 100 consecutive patients with Coronary Heart Disease (CHD) received PCI procedure were recruited. Coronary angiography was performed 8 months after their PCI. Then patients were divided into 2 groups: observation group was composed by patients who existing postoperative stenosis after intervention; Control group was composed by patients with no postoperative stenosis. The plasma levels of STIM, OPG in all patients were tested before and after intervention. Pearson correlation and multiple linear regression analysis were performed to analysis the correlation between STIM, OPG level and postoperative stenosis. 35 cases were divided into observation group and other 65 were divided into control group. The plasma levels of STIM, OPG have no statistical difference before their PCI procedure, but we observed higher level of High-sensitivity C-reactive protein (Hs-CRP) existed in observation group. We observed higher level of plasma STIM, OPG in observation group when compared with control group after PCI procedure (P < 0.05). Regression analysis demonstrated that Hs-CRP, STIM1, OPG are independent risk factors for ISR. Elevated levels of plasma STIM1, OPG are independent risk factors for ISR in patients received PCI, which could provide useful information for the restenosis control after PCI.

Chapter 8. Medical procedures. Recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza epidemic or mass disaster.

PubMed

Zimmerman, Janice L; Sprung, Charles L

2010-04-01

To provide recommendations and standard operating procedures for intensive care unit and hospital preparations for an influenza pandemic or mass disaster with a specific focus on ensuring that adequate resources are available and appropriate protocols are developed to safely perform procedures in patients with and without influenza illness. Based on a literature review and expert opinion, a Delphi process was used to define the essential topics including performing medical procedures. Key recommendations include: (1) specify high-risk procedures (aerosol generating-procedures); (2) determine if certain procedures will not be performed during a pandemic; (3) develop protocols for safe performance of high-risk procedures that include appropriateness, qualifications of personnel, site, personal protection equipment, safe technique and equipment needs; (4) ensure adequate training of personnel in high-risk procedures; (5) procedures should be performed at the bedside whenever possible; (6) ensure safe respiratory therapy practices to avoid aerosols; (7) provide safe respiratory equipment; and (8) determine criteria for cancelling and/or altering elective procedures. Judicious planning and adoption of protocols for safe performance of medical procedures are necessary to optimize outcomes during a pandemic.

Sex differences in mortality in children undergoing congenital heart disease surgery: a United States population-based study.

PubMed

Marelli, Ariane; Gauvreau, Kimberlee; Landzberg, Mike; Jenkins, Kathy

2010-09-14

The changing demographics of the adult congenital heart disease (CHD) population requires an understanding of the factors that impact patient survival to adulthood. We sought to investigate sex differences in CHD surgical mortality in children. Children <18 years old hospitalized for CHD surgery were identified using the Kids' Inpatient Database in 2000, 2003, and 2006. Demographic, diagnostic, and procedural variables were grouped according to RACHS-1 (Risk Adjustment for Congenital Heart Surgery) method. Logistic regression was used to determine the odds ratio of death in females versus males adjusting for RACHS-1 risk category, age, prematurity, major noncardiac anomalies, and multiple procedures. Analyses were stratified by RACHS-1 risk categories and age. Of 33 848 hospitalizations for CHD surgery, 54.7% were in males. Males were more likely than females to have CHD surgery in infancy, high-risk CHD surgery, and multiple CHD procedures. Females had more major noncardiac structural anomalies and more low-risk procedures. However, the adjusted risk of in-hospital death was higher in females (odds ratio, 1.21; 95% confidence interval, 1.08 to 1.36) on account of the subgroup with high-risk surgeries who were <1 year of age (odds ratio, 1.39; 95% confidence interval, 1.16 to 1.67). In this large US population study, more male children underwent CHD surgery and had high-risk procedures. Female infants who had high-risk procedures were at higher risk for death, but this accounted for a small proportion of females and is therefore unlikely to have a major impact on the changing demographics in adults in CHD.

The ADOPT-LC score: a novel predictive index of in-hospital mortality of cirrhotic patients following surgical procedures, based on a national survey.

PubMed

Sato, Masaya; Tateishi, Ryosuke; Yasunaga, Hideo; Horiguchi, Hiromasa; Matsui, Hiroki; Yoshida, Haruhiko; Fushimi, Kiyohide; Koike, Kazuhiko

2017-03-01

We aimed to develop a model for predicting in-hospital mortality of cirrhotic patients following major surgical procedures using a large sample of patients derived from a Japanese nationwide administrative database. We enrolled 2197 cirrhotic patients who underwent elective (n = 1973) or emergency (n = 224) surgery. We analyzed the risk factors for postoperative mortality and established a scoring system for predicting postoperative mortality in cirrhotic patients using a split-sample method. In-hospital mortality rates following elective or emergency surgery were 4.7% and 20.5%, respectively. In multivariate analysis, patient age, Child-Pugh (CP) class, Charlson Comorbidity Index (CCI), and duration of anesthesia in elective surgery were significantly associated with in-hospital mortality. In emergency surgery, CP class and duration of anesthesia were significant factors. Based on multivariate analysis in the training set (n = 987), the Adequate Operative Treatment for Liver Cirrhosis (ADOPT-LC) score that used patient age, CP class, CCI, and duration of anesthesia to predict in-hospital mortality following elective surgery was developed. This scoring system was validated in the testing set (n = 986) and produced an area under the curve of 0.881. We also developed iOS/Android apps to calculate ADOPT-LC scores to allow easy access to the current evidence in daily clinical practice. Patient age, CP class, CCI, and duration of anesthesia were identified as important risk factors for predicting postoperative mortality in cirrhotic patients. The ADOPT-LC score effectively predicts in-hospital mortality following elective surgery and may assist decisions regarding surgical procedures in cirrhotic patients based on a quantitative risk assessment. © 2016 The Authors Hepatology Research published by John Wiley & Sons Australia, Ltd on behalf of Japan Society of Hepatology.

Proximal balloon occlusion versus distal filter protection in carotid artery stenting: A meta-analysis and review of the literature.

PubMed

Omran, Jad; Mahmud, Ehtisham; White, Christopher J; Aronow, Herbert D; Drachman, Douglas E; Gray, William; Abdullah, Obai; Abu-Fadel, Mazen; Firwana, Belal; Mishkel, Gergory; Al-Dadah, Ashraf S

2017-04-01

Carotid artery stenting (CAS) is typically performed using embolic protection devices (EPDs) as a means to reduce the risk of procedure-related stroke. In this study, we compared procedural morbidity and mortality associated with distal (D-EPD) vs. proximal (P-EPD) protection. MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials were queried from January 1998 through May 2015. Only studies comparing (D-EPD) and (P-EPD) were included. Two independent reviewers selected and appraised studies and extracted data in duplicate. Random-effects meta-analysis was used to pool outcomes across studies. Heterogeneity of treatment effect among studies was assessed using the I 2 statistics. Publication bias was assessed using inspection of funnel plots. The primary endpoints included 30-day mortality and stroke. Secondary endpoints included new cerebral lesions on diffusion-weighted magnetic resonance imaging (DW-MRI) and contralateral lesions on DW-MRI. A total of 12,281 patients were included from 18 studies (13 prospective and 5 retrospective) comparing (D-EPD) and (P-EPD) in the setting of CAS. The mean patient age was 69 years and 64% of patients were male. No evidence of publication bias was detected. There was no significant difference between the two modalities in terms of the risk of stroke (risk difference [RD] 0.0, 95% confidence interval [CI] -0.01 to 0.01) or mortality (RD 0.0, 95% CI -0.01 to 0.01) nor was there any difference in the incidence of new cerebral lesions on DW-MRI or contralateral DW-MRI lesions. In patients undergoing CAS, both D-EPD and P-EPD provide similar levels of protection from peri-procedural stroke and 30 days mortality. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Demonstration of a modelling-based multi-criteria decision analysis procedure for prioritisation of occupational risks from manufactured nanomaterials.

PubMed

Hristozov, Danail; Zabeo, Alex; Alstrup Jensen, Keld; Gottardo, Stefania; Isigonis, Panagiotis; Maccalman, Laura; Critto, Andrea; Marcomini, Antonio

2016-11-01

Several tools to facilitate the risk assessment and management of manufactured nanomaterials (MN) have been developed. Most of them require input data on physicochemical properties, toxicity and scenario-specific exposure information. However, such data are yet not readily available, and tools that can handle data gaps in a structured way to ensure transparent risk analysis for industrial and regulatory decision making are needed. This paper proposes such a quantitative risk prioritisation tool, based on a multi-criteria decision analysis algorithm, which combines advanced exposure and dose-response modelling to calculate margins of exposure (MoE) for a number of MN in order to rank their occupational risks. We demonstrated the tool in a number of workplace exposure scenarios (ES) involving the production and handling of nanoscale titanium dioxide, zinc oxide (ZnO), silver and multi-walled carbon nanotubes. The results of this application demonstrated that bag/bin filling, manual un/loading and dumping of large amounts of dry powders led to high emissions, which resulted in high risk associated with these ES. The ZnO MN revealed considerable hazard potential in vivo, which significantly influenced the risk prioritisation results. In order to study how variations in the input data affect our results, we performed probabilistic Monte Carlo sensitivity/uncertainty analysis, which demonstrated that the performance of the proposed model is stable against changes in the exposure and hazard input variables.

Drafting guidelines for occupational exposure to chemicals: the Dutch experience with the assessment of reproductive risks.

PubMed

Stijkel, A; van Eijndhoven, J C; Bal, R

1996-12-01

The Dutch procedure for standard setting for occupational exposure to chemicals, just like the European Union (EU) procedure, is characterized by an organizational separation between considerations of health on the one side, and of technology, economics, and policy on the other side. Health considerations form the basis for numerical guidelines. These guidelines are next combined with technical-economical considerations. Standards are then proposed, and are finally set by the Ministry of Social Affairs and Employment. An analysis of this procedure might be of relevance to the US, where other procedures are used and criticized. In this article we focus on the first stage of the standard-setting procedure. In this stage, the Dutch Expert Committee on Occupational Standards (DECOS) drafts a criteria document in which a health-based guideline is proposed. The drafting is based on a set of starting points for assessing toxicity. We raise the questions, "Does DECOS limit itself only to health considerations? And if not, what are the consequences of such a situation?" We discuss DECOS' starting points and analyze the relationships between those starting points, and then explore eight criteria documents where DECOS was considering reproductive risks as a possible critical effect. For various reasons, it will be concluded that the starting points leave much interpretative space, and that this space is widened further by the manner in which DECOS utilizes it. This is especially true in situations involving sex-specific risks and uncertainties in knowledge. Consequently, even at the first stage, where health considerations alone are intended to play a role, there is much room for other than health-related factors to influence decision making, although it is unavoidable that some interpretative space will remain. We argue that separating the various types of consideration should not be abandoned. Rather, through adjustments in the starting points and aspects of the procedure, clarity should be guaranteed about the way the interpretative space is being employed.

Comparative Safety of Simultaneous and Staged Anterior and Posterior Spinal Surgery

PubMed Central

Passias, Peter G.; Ma, Yan; Chiu, Ya Lin; Mazumdar, Madhu; Girardi, Federico P.; Memtsoudis, Stavros G.

2011-01-01

Study Design Analysis of population based national hospital discharge data collected for the Nationwide Inpatient Sample. Objective To study perioperative outcomes of circumferential spine surgery performed on either the same or different days of the same hospitalization. Summary of Background Data Circumferential spine fusion surgery has been linked to an increased adjusted risk in perioperative morbidity and mortality compared to procedures involving only one site. In order to minimize these risks some surgeons elect to perform the two components of this procedure in separate sessions during the same hospitalization. The value of this approach is uncertain. Methods Data collected between 1998 and 2006 for the Nationwide Inpatient Sample were analyzed. Hospitalizations during which a circumferential non-cervical spine fusion was performed were identified. Patients were divided into those who had their anterior and posterior portion performed on the same and those performed on different days of the same hospitalization. The prevalence of patient and health care system related demographics were evaluated. Frequencies of procedure-related complications and mortality were determined. Multivariate regression models were created to identify if timing of procedures was associated with an independent increase in risk for adverse events. Results We identified a total of 11,265 entries for circumferential spine fusion. Of those, 71.2% (8022) were operated in one session. Complications were more frequent among staged versus same day surgery patients (28.4% vs. 21.7% P<0.0001). The incidence of venous thrombosis, and ARDS was also increased among staged candidates while the trend toward higher mortality (0.5 vs. 0.4%) did not reach significance. In the regression model staged circumferential spine fusions were associated with a 29% increase in the odds morbidity and mortality compared to same day procedures. Conclusion Staging circumferential spine surgery procedures during the same hospitalization offers no mortality benefit, and may even expose patients to increased morbidity. PMID:21301391

Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark

PubMed Central

Kirkfeldt, Rikke Esberg; Johansen, Jens Brock; Nohr, Ellen Aagaard; Jørgensen, Ole Dan; Nielsen, Jens Cosedis

2014-01-01

Aims Complications after cardiac implantable electronic device (CIED) treatment, including permanent pacemakers (PMs), cardiac resynchronization therapy devices with defibrillators (CRT-Ds) or without (CRT-Ps), and implantable cardioverter defibrillators (ICDs), are associated with increased patient morbidity, healthcare costs, and possibly increased mortality. Methods and results Population-based cohort study in all Danish patients who underwent a CIED procedure from May 2010 to April 2011. Data on complications were gathered on review of all patient charts while baseline data were obtained from the Danish Pacemaker and ICD Register. Adjusted risk ratios (aRRs) with 95% confidence intervals were estimated using binary regression. The study population consisted of 5918 consecutive patients. A total of 562 patients (9.5%) experienced at least one complication. The risk of any complication was higher if the patient was a female (aRR 1.3; 1.1–1.6), underweight (aRR 1.5; 1.1–2.3), implanted in a centre with an annual volume <750 procedures (0–249 procedures: aRR 1.6; 1.1–2.2, 250–499: aRR 2.0; 1.6–2.7, 500–749: aRR 1.5; 1.2–1.8), received a dual-chamber ICD (aRR 2.0; 1.4–2.7) or CRT-D (aRR 2.6; 1.9–3.4), underwent system upgrade or lead revision (aRR 1.3; 1.0–1.7), had an operator with an annual volume <50 procedures (aRR 1.9; 1.4–2.6), or underwent an emergency, out-of-hours procedure (aRR 1.5; 1.0–2.3). Conclusion CIED complications are more frequent than generally acknowledged. Both patient- and procedure-related predictors may identify patients with a particularly high risk of complications. This information should be taken into account both in individual patient treatment and in the planning of future organization of CIED treatment. PMID:24347317

Applicability of the Common Safety Method for Risk Evaluation and Assessment (CSM-RA) to the Space Domain

NASA Astrophysics Data System (ADS)

Moreira, Francisco; Silva, Nuno

2016-08-01

Safety systems require accident avoidance. This is covered by application standards, processes, techniques and tools that support the identification, analysis, elimination or reduction to an acceptable level of system risks and hazards. Ideally, a safety system should be free of hazards. However, both industry and academia have been struggling to ensure appropriate risk and hazard analysis, especially in what concerns completeness of the hazards, formalization, and timely analysis in order to influence the specifications and the implementation. Such analysis is also important when considering a change to an existing system. The Common Safety Method for Risk Evaluation and Assessment (CSM- RA) is a mandatory procedure whenever any significant change is proposed to the railway system in a European Member State. This paper provides insights on the fundamentals of CSM-RA based and complemented with Hazard Analysis. When and how to apply them, and the relation and similarities of these processes with industry standards and the system life cycles is highlighted. Finally, the paper shows how CSM-RA can be the basis of a change management process, guiding the identification and management of the hazards helping ensuring the similar safety level as the initial system. This paper will show how the CSM-RA principles can be used in other domains particularly for space system evolution.

Comparative analysis of dosimetry parameters for nuclear medicine

DOE Office of Scientific and Technical Information (OSTI.GOV)

Toohey, R.E.; Stabin, M.G.

For years many have employed the concept of ``total-body dose`` or ``whole-body dose,`` i.e., the total energy deposited in the body divided by the mass of the body, when evaluating the risks of different nuclear medicine procedures. The effective dose equivalent (H{sub E}), first described in ICRP Publication 26, has been accepted by some as a better quantity to use in evaluating the total risk of a procedure, but its use has been criticized by others primarily because the tissue weighting factors were intended for use in the radiation worker, rather than the nuclear medicine patient population. Nevertheless, in ICRPmore » Publication 52, the ICRP has suggested that the H{sub E} may be used in nuclear medicine. The ICRP also has published a compendium of dose estimates, including H{sub E} values, for various nuclear medicine procedures at various ages in ICRP Publication 53. The effective dose (E) of ICRP Publication 60 is perhaps more suitable for use in nuclear medicine, with tissue weighting factors based on the entire population. Other comparisons of H{sub E} and E have been published. The authors have used the program MIRDOSE 3.1 to compute total-body dose, H{sub E}, and E for 62 radiopharmaceutical procedures, based on the best current biokinetic data available.« less

Early phase drug discovery: cheminformatics and computational techniques in identifying lead series.

PubMed

Duffy, Bryan C; Zhu, Lei; Decornez, Hélène; Kitchen, Douglas B

2012-09-15

Early drug discovery processes rely on hit finding procedures followed by extensive experimental confirmation in order to select high priority hit series which then undergo further scrutiny in hit-to-lead studies. The experimental cost and the risk associated with poor selection of lead series can be greatly reduced by the use of many different computational and cheminformatic techniques to sort and prioritize compounds. We describe the steps in typical hit identification and hit-to-lead programs and then describe how cheminformatic analysis assists this process. In particular, scaffold analysis, clustering and property calculations assist in the design of high-throughput screening libraries, the early analysis of hits and then organizing compounds into series for their progression from hits to leads. Additionally, these computational tools can be used in virtual screening to design hit-finding libraries and as procedures to help with early SAR exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

[Application of virtual instrumentation technique in toxicological studies].

PubMed

Moczko, Jerzy A

2005-01-01

Research investigations require frequently direct connection of measuring equipment to the computer. Virtual instrumentation technique considerably facilitates programming of sophisticated acquisition-and-analysis procedures. In standard approach these two steps are performed subsequently with separate software tools. The acquired data are transfered with export / import procedures of particular program to the another one which executes next step of analysis. The described procedure is cumbersome, time consuming and may be potential source of the errors. In 1987 National Instruments Corporation introduced LabVIEW language based on the concept of graphical programming. Contrary to conventional textual languages it allows the researcher to concentrate on the resolved problem and omit all syntactical rules. Programs developed in LabVIEW are called as virtual instruments (VI) and are portable among different computer platforms as PCs, Macintoshes, Sun SPARCstations, Concurrent PowerMAX stations, HP PA/RISK workstations. This flexibility warrants that the programs prepared for one particular platform would be also appropriate to another one. In presented paper basic principles of connection of research equipment to computer systems were described.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rodriguez, Mario E.

An area in earthquake risk reduction that needs an urgent examination is the selection of earthquake records for nonlinear dynamic analysis of structures. An often-mentioned shortcoming from results of nonlinear dynamic analyses of structures is that these results are limited to the type of records that these analyses use as input data. This paper proposes a procedure for selecting earthquake records for nonlinear dynamic analysis of structures. This procedure uses a seismic damage index evaluated using the hysteretic energy dissipated by a Single Degree of Freedom System (SDOF) representing a multi-degree-of freedom structure responding to an earthquake record, and themore » plastic work capacity of the system at collapse. The type of structural system is considered using simple parameters. The proposed method is based on the evaluation of the damage index for a suite of earthquake records and a selected type of structural system. A set of 10 strong ground motion records is analyzed to show an application of the proposed procedure for selecting earthquake records for structural design.« less

Factors associated with post-ERCP pancreatitis and the effect of pancreatic duct stenting in a pediatric population.

PubMed

Troendle, David M; Abraham, Omana; Huang, Rong; Barth, Bradley A

2015-01-01

Risk factors for the development of post-ERCP pancreatitis (PEP) have not been identified in the pediatric population. It remains unclear what constitutes appropriate prophylaxis in this patient population. To assess the prevalence and severity of PEP in the pediatric population and identify factors associated with developing PEP and to evaluate the effect of prophylactic pancreatic duct stenting in high-risk patients. Retrospective analysis of an ERCP database at a single large pediatric center. Academic center. A total of 432 ERCPs performed on 313 patients younger than 19 years of age from January 2004 to October 2013. ERCP for any indication. Rates and severity of PEP, preprocedural and procedural risk factors for the development of PEP, and the effect of pancreatic stents on preventing PEP in high-risk patients. PEP occurred after 47 procedures (prevalence, 10.9%). Thirty-four cases were mild, 9 were moderate, and 4 were severe. There was no mortality. On multiple logistic analysis, pancreatic duct injection (P<.0001; odds ratio 30.8; 95% confidence interval [CI], 9.1-103.9) and pancreatic sphincterotomy (P<.01; OR 3.8; 95% CI, 1.6-9.8) were positively associated with PEP. A history of chronic pancreatitis was negatively associated with PEP (P<.05; OR 0.37; 95% CI, 0.15-0.93). On subset analysis, placing a prophylactic pancreatic stent was associated with significantly increased rates of PEP in patients with pancreatic duct injection compared with those who had no attempt at stent placement (P<.01). Two patients with severe pancreatitis had prophylactic pancreatic stents in place. Retrospective investigation. In the pediatric population, pancreatic duct injection and pancreatic sphincterotomy are associated with significantly increased rates of PEP, whereas a history of chronic pancreatitis is negatively associated. Prophylactic pancreatic stenting is associated with higher rates of PEP in high-risk patients and does not eliminate severe PEP. Copyright © 2015 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Is the HAS-BLED score useful in predicting post-extraction bleeding in patients taking warfarin? A retrospective cohort study

PubMed Central

Kataoka, Toshiyuki; Hoshi, Keika; Ando, Tomohiro

2016-01-01

Objective Unexpected post-extraction bleeding is often experienced in clinical practice. Therefore, determining the risk of post-extraction bleeding in patients receiving anticoagulant therapy prior to surgery is beneficial. This study aimed to verify whether the HAS-BLED score was useful in predicting post-extraction bleeding in patients taking warfarin. Design Retrospective cohort study. Setting Department of Oral and Maxillofacial Surgery, Tokyo Women's Medical University. Participants Participants included 258 sequential cases (462 teeth) who had undergone tooth extraction between 1 January 2010 and 31 December 2012 while continuing warfarin therapy. Main outcome measure Post-extraction risk factors for bleeding. The following data were collected as the predicting variables for multivariate logistic analysis: the HAS-BLED score, extraction site, tooth type, stability of teeth, extraction procedure, prothrombin time-international normalised ratio value, platelet count and the use of concomitant antiplatelet agents. Results Post-extraction bleeding was noted in 21 (8.1%) of the 258 cases. Haemostasis was achieved with localised haemostatic procedures in all the cases of post-extraction bleeding. The HAS-BLED score was found to be insufficient in predicting post-extraction bleeding (area under the curve=0.548, p=0.867, multivariate analysis). The risk of post-extraction bleeding was approximately three times greater in patients taking concomitant oral antiplatelet agents (risk ratio=2.881, p=0.035, multivariate analysis). Conclusions The HAS-BLED score alone could not predict post-extraction bleeding. The concomitant use of oral antiplatelet agents was a risk factor for post-extraction bleeding. No episodes of post-extraction bleeding required more than local measures for haemostasis. However, because this was a retrospective study conducted at a single institution, large-scale prospective cohort studies, which include cases of outpatient tooth extraction, will be necessary in the future. PMID:26936909

Framework for managing mycotoxin risks in the food industry.

PubMed

Baker, Robert C; Ford, Randall M; Helander, Mary E; Marecki, Janusz; Natarajan, Ramesh; Ray, Bonnie

2014-12-01

We propose a methodological framework for managing mycotoxin risks in the food processing industry. Mycotoxin contamination is a well-known threat to public health that has economic significance for the food processing industry; it is imperative to address mycotoxin risks holistically, at all points in the procurement, processing, and distribution pipeline, by tracking the relevant data, adopting best practices, and providing suitable adaptive controls. The proposed framework includes (i) an information and data repository, (ii) a collaborative infrastructure with analysis and simulation tools, (iii) standardized testing and acceptance sampling procedures, and (iv) processes that link the risk assessments and testing results to the sourcing, production, and product release steps. The implementation of suitable acceptance sampling protocols for mycotoxin testing is considered in some detail.

A risk-factor analysis of medical litigation judgments related to fall injuries in Korea.

PubMed

Kim, Insook; Won, Seonae; Lee, Mijin; Lee, Won

2018-01-01

The aim of this study was to find out the risk factors through analysis of seven medical malpractice judgments related to fall injuries. The risk factors were analysed by using the framework that approaches falls from a systems perspective and comprised people, organisational or environmental factors, with each factor being comprised of subfactors. The risk factors found in each of the seven judgments were aggregated into one framework. The risk factors related to patients (i.e. the people factor) were age, pain, related disease, activities and functional status, urination state, cognitive function impairment, past history of fall, blood transfusion, sleep endoscopy state and uncooperative attitude. The risk factors related to the medical staff and caregivers (i.e. people factor) were observation negligence, no fall prevention activities and negligence in managing high-risk group for fall. Organisational risk factors were a lack of workforce, a lack of training, neglecting the management of the high-risk group, neglecting the management of caregivers and the absence of a fall prevention procedure. Regarding the environment, the risk factors were found to be the emergency room, chairs without a backrest and the examination table. Identifying risk factors is essential for preventing fall accidents, since falls are preventable patient-safety incidents. Falls do not happen as a result of a single risk factor. Therefore, a systems approach is effective to identify risk factors, especially organisational and environmental factors.

17 CFR 40.10 - Special certification procedures for submission of rules by systemically important derivatives...

Code of Federal Regulations, 2012 CFR

2012-04-01

... affect financial resources, participant and product eligibility, risk management (including matters relating to margin and stress testing), daily or intraday settlement procedures, default procedures, system... settlement activities and the sufficiency of any proposed risk management techniques. (d) Notice of objection...

17 CFR 40.10 - Special certification procedures for submission of rules by systemically important derivatives...

Code of Federal Regulations, 2013 CFR

2013-04-01

... affect financial resources, participant and product eligibility, risk management (including matters relating to margin and stress testing), daily or intraday settlement procedures, default procedures, system... settlement activities and the sufficiency of any proposed risk management techniques. (d) Notice of objection...

17 CFR 40.10 - Special certification procedures for submission of rules by systemically important derivatives...

Code of Federal Regulations, 2014 CFR

2014-04-01

... affect financial resources, participant and product eligibility, risk management (including matters relating to margin and stress testing), daily or intraday settlement procedures, default procedures, system... settlement activities and the sufficiency of any proposed risk management techniques. (d) Notice of objection...

46 CFR 309.1 - Procedure.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 8 2014-10-01 2014-10-01 false Procedure. 309.1 Section 309.1 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS VALUES FOR WAR RISK INSURANCE § 309.1 Procedure... vessels upon which interim binders for war risk hull insurance have been issued. Such values shall be...

46 CFR 309.1 - Procedure.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 46 Shipping 8 2011-10-01 2011-10-01 false Procedure. 309.1 Section 309.1 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS VALUES FOR WAR RISK INSURANCE § 309.1 Procedure... vessels upon which interim binders for war risk hull insurance have been issued. Such values shall be...

46 CFR 309.1 - Procedure.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 8 2013-10-01 2013-10-01 false Procedure. 309.1 Section 309.1 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS VALUES FOR WAR RISK INSURANCE § 309.1 Procedure... vessels upon which interim binders for war risk hull insurance have been issued. Such values shall be...

46 CFR 309.1 - Procedure.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Procedure. 309.1 Section 309.1 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS VALUES FOR WAR RISK INSURANCE § 309.1 Procedure... vessels upon which interim binders for war risk hull insurance have been issued. Such values shall be...

46 CFR 309.1 - Procedure.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 8 2012-10-01 2012-10-01 false Procedure. 309.1 Section 309.1 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS VALUES FOR WAR RISK INSURANCE § 309.1 Procedure... vessels upon which interim binders for war risk hull insurance have been issued. Such values shall be...

78 FR 74212 - Self-Regulatory Organizations; BATS Exchange, Inc.; Order Granting Approval of Proposed Rule...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-12-10

... subject to procedures designed to prevent the use and dissemination of material, non-public information... investment objective and in the best interest of the Fund. For example, the Fund may hold a higher- than... determination, the Adviser may consider internal analyses and risk ratings, third party research and analysis...

Transferable Competences of Young People with a High Dropout Risk in Vocational Training in Germany

ERIC Educational Resources Information Center

Frey, Andreas; Balzer, Lars; Ruppert, Jean-Jacques

2014-01-01

This paper examines whether the subjective beliefs on their competences of 409 trainees in machinery, sales, and logistics constitute a reliable and valid way to measure transferable competences. The analysis of results attributes satisfactory to good reliability values to the assessment procedure. Furthermore, it could be shown that young people…

A Step-by-Step Guide to Tier 2 Behavioral Progress Monitoring

ERIC Educational Resources Information Center

Bruhn, Allison L.; McDaniel, Sara C.; Rila, Ashley; Estrapala, Sara

2018-01-01

Students who are at risk for or show low-intensity behavioral problems may need targeted, Tier 2 interventions. Often, Tier 2 problem-solving teams are charged with monitoring student responsiveness to intervention. This process may be difficult for those who are not trained in data collection and analysis procedures. To aid practitioners in these…

An integrated multi-scale risk analysis procedure for pluvial flooding

NASA Astrophysics Data System (ADS)

Tader, Andreas; Mergili, Martin; Jäger, Stefan; Glade, Thomas; Neuhold, Clemens; Stiefelmeyer, Heinz

2016-04-01

Mitigation of or adaptation to the negative impacts of natural processes on society requires a better understanding of the spatio-temporal distribution not only of the processes themselves, but also of the elements at risk. Information on their values, exposures and vulnerabilities towards the expected impact magnitudes/intensities of the relevant processes is needed. GIS-supported methods are particularly useful for integrated spatio-temporal analyses of natural processes and their potential consequences. Hereby, pluvial floods are of particular concern for many parts of Austria. The overall aim of the present study is to calculate the hazards emanating from pluvial floods, to determine the exposure of given elements at risk, to determine their vulnerabilities towards given pluvial flood hazards and to analyze potential consequences in terms of monetary losses. The whole approach builds on data available on a national scale. We introduce an integrated, multi-scale risk analysis procedure with regard to pluvial flooding. Focusing on the risk to buildings, we firstly exemplify this procedure with a well-documented event in the city of Graz (Austria), in order to highlight the associated potentials and limitations. Secondly, we attempt to predict the possible consequences of pluvial flooding triggered by rainfall events with recurrence intervals of 30, 100 and 300 years. (i) We compute spatially distributed inundation depths using the software FloodArea. Infiltration capacity and surface roughness are estimated from the land cover units given by the official cadastre. Various assumptions are tested with regard to the inflow to the urban sewer system. (ii) Based on the inundation depths and the official building register, we employ a set of rules and functions to deduce the exposure, vulnerability and risk for each building. A risk indicator for each building, expressed as the expected damage associated to a given event, is derived by combining the building value and its vulnerability. (iii) The object-based hazards, exposures, vulnerabilities and risks can be scaled to any spatial unit desired. For this purpose we have developed an automated work flow building on the Python programming language in combination with ArcGIS and the R statistical software. This enables us to easily adapt the resulting risk indication maps to different zooming levels; to build statistics for various types of units; to flexibly react to the needs of the end users; and to account for the availability of reference data for validation. In the present study, we scale the results to the level of postal code zones. The evaluation of the results is based on loss reports of an insurance company and on photographs and videos obtained from various sources. We show a potential of the suggested work flow to reproduce the documented damages at the level of postal code zones. However, the results are very sensitive to the input parameters and model assumptions, and a robust back-calculation even of well-documented events remains a major challenge. Ultimately, we aim at integrating the procedure presented in a work flow for generating risk indication maps for pluvial flooding throughout the entire territory of Austria.

[Pressure distribution measurements during use of wheelchairs].

PubMed

Meiners, T; Friedrich, G; Krüger, A; Böhm, V

2001-04-01

There is a growing number of mobility-impaired and wheelchair-dependent patients caused by diseases and injuries of the central nervous system. The risk is high for pressure sores to develop due to disturbances of the motor, sensory, and autonomic nervous system. Numerous seating systems for prophylaxis and treatment of decubitus ulcer are available. To identify risk parameters, the literature on animal experiments regarding pressure ulcers was reviewed. A study on the reproducibility of the analysis method with capacitive sensors tested in ten paraplegics with 470 measurements is presented. It shows the reliability of the procedure.

Risk of infective endocarditis in patients with systemic lupus erythematosus in Taiwan: a nationwide population-based study.

PubMed

Chang, Y S; Chang, C C; Chen, Y H; Chen, W S; Chen, J H

2017-10-01

Objectives Patients with systemic lupus erythematosus are considered vulnerable to infective endocarditis and prophylactic antibiotics are recommended before an invasive dental procedure. However, the evidence is insufficient. This nationwide population-based study evaluated the risk and related factors of infective endocarditis in systemic lupus erythematosus. Methods We identified 12,102 systemic lupus erythematosus patients from the National Health Insurance research-oriented database, and compared the incidence rate of infective endocarditis with that among 48,408 non-systemic lupus erythematosus controls. A Cox multivariable proportional hazards model was employed to evaluate the risk of infective endocarditis in the systemic lupus erythematosus cohort. Results After a mean follow-up of more than six years, the systemic lupus erythematosus cohort had a significantly higher incidence rate of infective endocarditis (42.58 vs 4.32 per 100,000 person-years, incidence rate ratio = 9.86, p < 0.001) than that of the control cohort. By contrast, the older systemic lupus erythematosus cohort had lower risk (adjusted hazard ratio 11.64) than that of the younger-than-60-years systemic lupus erythematosus cohort (adjusted hazard ratio 15.82). Cox multivariate proportional hazards analysis revealed heart disease (hazard ratio = 5.71, p < 0.001), chronic kidney disease (hazard ratio = 2.98, p = 0.034), receiving a dental procedure within 30 days (hazard ratio = 36.80, p < 0.001), and intravenous steroid therapy within 30 days (hazard ratio = 39.59, p < 0.001) were independent risk factors for infective endocarditis in systemic lupus erythematosus patients. Conclusions A higher risk of infective endocarditis was observed in systemic lupus erythematosus patients. Risk factors for infective endocarditis in the systemic lupus erythematosus cohort included heart disease, chronic kidney disease, steroid pulse therapy within 30 days, and a recent invasive dental procedure within 30 days.

Laparoscopic surgery complications: postoperative peritonitis.

PubMed

Drăghici, L; Drăghici, I; Ungureanu, A; Copăescu, C; Popescu, M; Dragomirescu, C

2012-09-15

Complications within laparoscopic surgery, similar to classic surgery are inevitable and require immediate actions both to diminish intraoperative risks and to choose the appropriate therapeutic attitude. Peritonitis and hemorrhagic incidents are both part of the complications aspect of laparoscopic surgery. Fortunately, the incidence is limited, thus excluding the rejection of celioscopic methods. Patient's risks and benefits are to be analyzed carefully prior recommending laparoscopic surgery. This study presents a statistical analysis of peritonitis consecutive to laparoscopic surgery, experience of "Sf. Ioan" Emergency Hospital, Bucharest, and Department of Surgery (2000-2010). There were 180 (0,96%) complicated situations requiring reinterventions, from a total of 18676 laparoscopic procedures. 106 cases (0,56%) represented different grades of postoperative peritonitis. Most frequently, there were consecutive laparoscopic appendicectomia and colecistectomia. During the last decade, few severe cases of peritonitis followed laparoscopic bariatric surgical procedures. This study reflects the possibility of unfavorable evolution of postoperative peritonitis comparing with hemorrhagic incidents within laparoscopic surgery.

48 CFR 250.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Special procedures for unusually hazardous or nuclear risks. 250.104-3 Section 250.104-3 Federal Acquisition Regulations System... unusually hazardous or nuclear risks. ...

48 CFR 250.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 3 2014-10-01 2014-10-01 false Special procedures for unusually hazardous or nuclear risks. 250.104-3 Section 250.104-3 Federal Acquisition Regulations System... unusually hazardous or nuclear risks. ...

48 CFR 250.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 48 Federal Acquisition Regulations System 3 2013-10-01 2013-10-01 false Special procedures for unusually hazardous or nuclear risks. 250.104-3 Section 250.104-3 Federal Acquisition Regulations System... unusually hazardous or nuclear risks. ...

48 CFR 250.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2011 CFR

2011-10-01

... 48 Federal Acquisition Regulations System 3 2011-10-01 2011-10-01 false Special procedures for unusually hazardous or nuclear risks. 250.104-3 Section 250.104-3 Federal Acquisition Regulations System... unusually hazardous or nuclear risks. ...

48 CFR 250.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 3 2012-10-01 2012-10-01 false Special procedures for unusually hazardous or nuclear risks. 250.104-3 Section 250.104-3 Federal Acquisition Regulations System... unusually hazardous or nuclear risks. ...

Local versus general anesthesia for transcatheter aortic valve implantation (TAVR)--systematic review and meta-analysis.

PubMed

Fröhlich, Georg M; Lansky, Alexandra J; Webb, John; Roffi, Marco; Toggweiler, Stefan; Reinthaler, Markus; Wang, Duolao; Hutchinson, Nevil; Wendler, Olaf; Hildick-Smith, David; Meier, Pascal

2014-03-10

The hypothesis of this study was that local anesthesia with monitored anesthesia care (MAC) is not harmful in comparison to general anesthesia (GA) for patients undergoing Transcatheter Aortic Valve Implantation (TAVR).TAVR is a rapidly spreading treatment option for severe aortic valve stenosis. Traditionally, in most centers, this procedure is done under GA, but more recently procedures with MAC have been reported. This is a systematic review and meta-analysis comparing MAC versus GA in patients undergoing transfemoral TAVR. Trials were identified through a literature search covering publications from 1 January 2005 through 31 January 2013. The main outcomes of interest of this literature meta-analysis were 30-day overall mortality, cardiac-/procedure-related mortality, stroke, myocardial infarction, sepsis, acute kidney injury, procedure time and duration of hospital stay. A random effects model was used to calculate the pooled relative risks (RR) with 95% confidence intervals. Seven observational studies and a total of 1,542 patients were included in this analysis. None of the studies were randomized. Compared to GA, MAC was associated with a shorter hospital stay (-3.0 days (-5.0 to -1.0); P = 0.004) and a shorter procedure time (MD -36.3 minutes (-58.0 to -15.0 minutes); P <0.001). Overall 30-day mortality was not significantly different between MAC and GA (RR 0.77 (0.38 to 1.56); P = 0.460), also cardiac- and procedure-related mortality was similar between both groups (RR 0.90 (0.34 to 2.39); P = 0.830). These data did not show a significant difference in short-term outcomes for MAC or GA in TAVR. MAC may be associated with reduced procedural time and shorter hospital stay. Now randomized trials are needed for further evaluation of MAC in the setting of TAVR.

The Use Of Computational Human Performance Modeling As Task Analysis Tool

DOE Office of Scientific and Technical Information (OSTI.GOV)

Jacuqes Hugo; David Gertman

2012-07-01

During a review of the Advanced Test Reactor safety basis at the Idaho National Laboratory, human factors engineers identified ergonomic and human reliability risks involving the inadvertent exposure of a fuel element to the air during manual fuel movement and inspection in the canal. There were clear indications that these risks increased the probability of human error and possible severe physical outcomes to the operator. In response to this concern, a detailed study was conducted to determine the probability of the inadvertent exposure of a fuel element. Due to practical and safety constraints, the task network analysis technique was employedmore » to study the work procedures at the canal. Discrete-event simulation software was used to model the entire procedure as well as the salient physical attributes of the task environment, such as distances walked, the effect of dropped tools, the effect of hazardous body postures, and physical exertion due to strenuous tool handling. The model also allowed analysis of the effect of cognitive processes such as visual perception demands, auditory information and verbal communication. The model made it possible to obtain reliable predictions of operator performance and workload estimates. It was also found that operator workload as well as the probability of human error in the fuel inspection and transfer task were influenced by the concurrent nature of certain phases of the task and the associated demand on cognitive and physical resources. More importantly, it was possible to determine with reasonable accuracy the stages as well as physical locations in the fuel handling task where operators would be most at risk of losing their balance and falling into the canal. The model also provided sufficient information for a human reliability analysis that indicated that the postulated fuel exposure accident was less than credible.« less

PubMed Central

DE MATOS, L.L.; BELLI, M.; KULCSAR, M.A.V.; CERNEA, C.R.; GARCIA BRANDÃO, L.; PINTO, F.R.

2014-01-01

SUMMARY The pectoralis major myocutaneous flap (PMMF) is a safe and versatile flap used widely for head and neck cancer reconstructions, but one of the major and most feared complications is oro- or pharyngocutaneous fistula. Herein, we attempt to establish risk factors for fistula formation in reconstructions of mucosal defects in the head and neck using PMMF through retrospective analysis of PMMF performed during 3 years at a single institution, with a total of 84 procedures. There were 69 men and 15 women, with a mean age of 59.5 years. There were 15 cases of partial flap loss, two total flap losses and 31 fistulas. The independent risk factors for fistula formation were preoperative serum hemoglobin < 13 g/dl, preoperative serum albumin < 3.4 g/dl and hypopharynx reconstruction. The PMMF is still a very useful flap and this is the first multivariate analysis analysing risk factors for fistula formation. These findings are helpful in selecting patients with elevated risk of fistula formation, and therefore preventive measures can be undertaken to avoid potentially serious complications. PMID:25762830

The Optimal Timing of Stage 2 Palliation for Hypoplastic Left Heart Syndrome: An Analysis of the Pediatric Heart Network Single Ventricle Reconstruction Trial Public Data Set.

PubMed

Meza, James M; Hickey, Edward J; Blackstone, Eugene H; Jaquiss, Robert D B; Anderson, Brett R; Williams, William G; Cai, Sally; Van Arsdell, Glen S; Karamlou, Tara; McCrindle, Brian W

2017-10-31

In infants requiring 3-stage single-ventricle palliation for hypoplastic left heart syndrome, attrition after the Norwood procedure remains significant. The effect of the timing of stage 2 palliation (S2P), a physician-modifiable factor, on long-term survival is not well understood. We hypothesized that an optimal interval between the Norwood and S2P that both minimizes pre-S2P attrition and maximizes post-S2P survival exists and is associated with individual patient characteristics. The National Institutes of Health/National Heart, Lung, and Blood Institute Pediatric Heart Network Single Ventricle Reconstruction Trial public data set was used. Transplant-free survival (TFS) was modeled from (1) Norwood to S2P and (2) S2P to 3 years by using parametric hazard analysis. Factors associated with death or heart transplantation were determined for each interval. To account for staged procedures, risk-adjusted, 3-year, post-Norwood TFS (the probability of TFS at 3 years given survival to S2P) was calculated using parametric conditional survival analysis. TFS from the Norwood to S2P was first predicted. TFS after S2P to 3 years was then predicted and adjusted for attrition before S2P by multiplying by the estimate of TFS to S2P. The optimal timing of S2P was determined by generating nomograms of risk-adjusted, 3-year, post-Norwood, TFS versus the interval from the Norwood to S2P. Of 547 included patients, 399 survived to S2P (73%). Of the survivors to S2P, 349 (87%) survived to 3-year follow-up. The median interval from the Norwood to S2P was 5.1 (interquartile range, 4.1-6.0) months. The risk-adjusted, 3-year, TFS was 68±7%. A Norwood-S2P interval of 3 to 6 months was associated with greatest 3-year TFS overall and in patients with few risk factors. In patients with multiple risk factors, TFS was severely compromised, regardless of the timing of S2P and most severely when S2P was performed early. No difference in the optimal timing of S2P existed when stratified by shunt type. In infants with few risk factors, progressing to S2P at 3 to 6 months after the Norwood procedure was associated with maximal TFS. Early S2P did not rescue patients with greater risk factor burdens. Instead, referral for heart transplantation may offer their best chance at long-term survival. URL: https://www.clinicaltrials.gov. Unique identifier: NCT00115934. © 2017 American Heart Association, Inc.

Death and Dialysis After Transcatheter Aortic Valve Replacement: An Analysis of the STS/ACC TVT Registry.

PubMed

Hansen, James W; Foy, Andrew; Yadav, Pradeep; Gilchrist, Ian C; Kozak, Mark; Stebbins, Amanda; Matsouaka, Roland; Vemulapalli, Sreekanth; Wang, Alice; Wang, Dee Dee; Eng, Marvin H; Greenbaum, Adam B; O'Neill, William O

2017-10-23

The authors sought to elucidate the true incidence of renal replacement therapy (RRT) after transcatheter aortic valve replacement (TAVR). There is a wide discrepancy in the reported rate of RRT after TAVR (1.4% to 40%). The true incidence of RRT after TAVR is unknown. The STS/ACC TVT (Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy) registry was linked to the Centers for Medicare & Medicaid database to identify all patients that underwent TAVR from November 2011 through September 2015 and their outcomes. The authors compared rates of death, new RRT, and a composite of both as a function of pre-procedure glomerular filtration rate (GFR), both in stages of chronic kidney disease (CKD), as well as on a continuous scale. Pre-procedure GFR is associated with the risk of death and new RRT after TAVR when GFR is <60 ml/min/m 2 , and increases significantly when GFR falls below 30 ml/min/m 2 . Incremental increases in GFR of 5 ml/min/m 2 were statistically significant (unadjusted hazard ratio: 0.71; p < 0.001) at 30 days, and continued to be significant at 1 year when pre-procedure GFR was <60 ml/min/m 2 . One in 3 CKD stage 4 patients will be dead within 1 year, with 14.6% (roughly 1 in 6) requiring dialysis. In CKD stage 5, more than one-third of patients will require RRT within 30 days; nearly two-thirds will require RRT at 1 year. In both unadjusted and adjusted analysis, pre-procedural GFR was associated with the outcomes of death and new RRT. Increasing CKD stage leads to an increased risk of death and/or RRT. Continuous analysis showed significant differences in outcomes in all levels of CKD when GFR was <60 ml/min/m 2 . Pre-procedure GFR should be considered when selecting CKD patients for TAVR. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Access site-related complications after transradial catheterization can be reduced with smaller sheath size and statins.

PubMed

Honda, Tsuyoshi; Fujimoto, Kazuteru; Miyao, Yuji; Koga, Hidenobu; Hirata, Yoshihiro

2012-09-01

The aim of this study was to investigate the risk factors for access site-related complications after transradial coronary angiography (CAG) or percutaneous coronary intervention (PCI). Transradial PCI has been shown to reduce access site-related bleeding complications compared with procedures performed through a femoral approach. Although previous studies focused on risk factors for access site-related complications after a transfemoral approach or transfemoral and transradial approaches, it is uncertain which factors affect vascular complications after transradial catheterization. We enrolled 500 consecutive patients who underwent transradial CAG or PCI. We determined the incidence and risk factors for access site-related complications such as radial artery occlusion and bleeding complications. Age, sheath size, the dose of heparin and the frequency of PCI (vs. CAG) were significantly greater in patients with than without bleeding complications. However, body mass index (BMI) was significantly lower in patients with than without bleeding complications. Sheath size was significantly higher and the frequency of statin use was significantly lower in patients with than without radial artery occlusion. Multiple logistic analysis revealed that sheath size [odds ratio (OR) 5.5; P < 0.05] and BMI (OR 0.86; P < 0.01) were risk factors for bleeding complications; and sheath size (OR 5.2; P < 0.05) and the lack of statin pretreatment (OR 0.50; P < 0.05) were risk factors for occlusive complications. In conclusion, these findings indicate that down-sizing of the devices used in transradial procedures might attenuate access site-related complications after transradial CAG or PCI. Statin pretreatment might also be a strategy that could prevent radial artery occlusion after transradial procedures.

Risk of miscarriage following amniocentesis and chorionic villus sampling: a systematic review of the literature.

PubMed

Beta, Jaroslaw; Lesmes-Heredia, Cristina; Bedetti, Chiara; Akolekar, Ranjit

2018-04-01

The aim of this paper was to estimate the risk of miscarriage after amniocentesis or chorionic villus sampling (CVS) based on a systematic review of the literature. A search of Medline, Embase, and The Cochrane Library (2000-2017) was carried out to identify studies reporting complications following CVS or amniocentesis. The inclusion criteria for the systematic review were studies reporting results from large controlled studies (N.≥1000 invasive procedures) and those reporting data for pregnancy loss prior to 24 weeks' gestation. Data for cases that had invasive procedure and controls were inputted in contingency tables and risk of miscarriage was estimated for each study. Summary statistics were calculated after taking into account the weighting for each study included in the systematic review. Procedure-related risk of miscarriage was estimated as a weighted risk difference from the summary statistics for cases and controls. The electronic search from the databases yielded 2465 potential citations of which 2431 were excluded, leaving 34 studies for full-text review. The final review included 10 studies for amniocentesis and 6 studies for CVS, which were used to estimate risk of miscarriage in pregnancies that had an invasive procedure and the control pregnancies that did not. The procedure-related risk of miscarriage following amniocentesis was 0.35% (95% confidence interval [CI]: 0.07 to 0.63) and that following CVS was 0.35% (95% CI: -0.31 to 1.00). The procedure-related risks of miscarriage following amniocentesis and CVS are lower than currently quoted to women.

Comparison of pure laparoscopic versus open left hemihepatectomy by multivariate analysis: a retrospective cohort study.

PubMed

Cho, Hwui-Dong; Kim, Ki-Hun; Hwang, Shin; Ahn, Chul-Soo; Moon, Deok-Bog; Ha, Tae-Yong; Song, Gi-Won; Jung, Dong-Hwan; Park, Gil-Chun; Lee, Sung-Gyu

2018-02-01

To compare the outcomes of pure laparoscopic left hemihepatectomy (LLH) versus open left hemihepatectomy (OLH) for benign and malignant conditions using multivariate analysis. All consecutive cases of LLH and OLH between October 2007 and December 2013 in a tertiary referral hospital were enrolled in this retrospective cohort study. All surgical procedures were performed by one surgeon. The LLH and OLH groups were compared in terms of patient demographics, preoperative data, clinical perioperative outcomes, and tumor characteristics in patients with malignancy. Multivariate analysis of the prognostic factors associated with severe complications was then performed. The LLH group (n = 62) had a significantly shorter postoperative hospital stay than the OLH group (n = 118) (9.53 ± 3.30 vs 14.88 ± 11.36 days, p < 0.001). Multivariate analysis revealed that the OLH group had >4 times the risk of the LLH group in terms of developing severe complications (Clavien-Dindo grade ≥III) (odds ratio 4.294, 95% confidence intervals 1.165-15.832, p = 0.029). LLH was a safe and feasible procedure for selected patients. LLH required shorter hospital stay and resulted in less operative blood loss. Multivariate analysis revealed that LLH was associated with a lower risk of severe complications compared to OLH. The authors suggest that LLH could be a reasonable treatment option for selected patients.

Development of a safety evaluation procedure for identifying high-risk signalized intersections in the Virginia Department of Transportation's Northern Virginia district.

DOT National Transportation Integrated Search

2007-01-01

This research was undertaken to develop an evaluation procedure to identify high-risk four-legged signalized intersections in VDOT's Northern Virginia district by traffic movements and times of day. By using the developed procedure, traffic engineers...

Risk Factors for Revision Surgery After Superior Labral Anterior-Posterior Repair: A National Perspective.

PubMed

Taylor, Samuel A; Degen, Ryan M; White, Alexander E; McCarthy, Moira M; Gulotta, Lawrence V; O'Brien, Stephen J; Werner, Brian C

2017-06-01

Data regarding risk factors for revision surgery after superior labral anterior-posterior (SLAP) repair are limited to institutional series. To define risk factors for revision surgery after SLAP repair among patients in a large national database. Case-control study; Level of evidence, 3. A national insurance database was queried for patients undergoing arthroscopic SLAP repair (Current Procedural Terminology [CPT] code 29807) for the diagnosis of a SLAP tear. Patients without a CPT modifier for laterality were excluded. Revision surgery was defined as (1) subsequent ipsilateral SLAP repair (CPT 29807), (2) ipsilateral arthroscopic debridement for the diagnosis of a SLAP tear (CPT 29822 or 29823, with diagnosis code 840.7), (3) subsequent ipsilateral arthroscopic biceps tenodesis (CPT 29828), (4) subsequent ipsilateral open biceps tenodesis (CPT 23430), and (5) subsequent biceps tenotomy (CPT 23405). Multivariable binomial logistic regression analysis was performed to identify risk factors for revision surgery after SLAP repair, including patient demographics/comorbidities, concomitant diagnoses, and concomitant procedures performed. Odds ratios (ORs), 95% CIs, and P values were calculated. The estimated financial impact of revision surgery was also calculated. There were 4751 patients who met inclusion and exclusion criteria. Overall, 121 patients (2.5%) required revision surgery after SLAP repair. Regression analysis identified numerous risk factors for revision surgery, including age >40 years (OR, 1.5; 95% CI, 1.2-1.8; P = .045), female sex (OR, 1.5; 95% CI, 1.3-1.8; P = .010), obesity (OR, 1.8; 95% CI, 1.5-2.2; P = .001), smoking (OR, 2.0; 95% CI, 1.6-2.4; P < .0001), and diagnosis of biceps tendinitis (OR, 3.5; 95% CI, 3.0-4.2; P < .0001) or long head of the biceps tearing (OR, 5.1; 95% CI, 4.1-6.3; P < .0001) at or before the time of surgery. Concomitant rotator cuff repair and distal clavicle excision were not significant risk factors for revision surgery. The cost of revision surgery averaged almost $9000. Risk factors for revision surgery after SLAP repair include age >40 years, female sex, obesity, smoking, and diagnosis of biceps tendinitis or long head of the biceps tearing. The diagnosis of biceps tendinitis (OR, 3.5) or long head of the biceps tearing (OR, 5.1) at or before the time of surgery was an especially significant risk factor for revision surgery. The high cost of revision surgery highlights the importance of appropriate indications to avoid the need for subsequent procedures.

Flapless versus Conventional Flapped Dental Implant Surgery: A Meta-Analysis

PubMed Central

Chrcanovic, Bruno Ramos; Albrektsson, Tomas; Wennerberg, Ann

2014-01-01

The aim of this study was to test the null hypothesis of no difference in the implant failure rates, postoperative infection, and marginal bone loss for patients being rehabilitated by dental implants being inserted by a flapless surgical procedure versus the open flap technique, against the alternative hypothesis of a difference. An electronic search without time or language restrictions was undertaken in March 2014. Eligibility criteria included clinical human studies, either randomized or not. The search strategy resulted in 23 publications. The I2 statistic was used to express the percentage of the total variation across studies due to heterogeneity. The inverse variance method was used for random-effects model or fixed-effects model, when indicated. The estimates of relative effect were expressed in risk ratio (RR) and mean difference (MD) in millimeters. Sixteen studies were judged to be at high risk of bias, whereas two studies were considered of moderate risk of bias, and five studies of low risk of bias. The funnel plots indicated absence of publication bias for the three outcomes analyzed. The test for overall effect showed that the difference between the procedures (flapless vs. open flap surgery) significantly affect the implant failure rates (P = 0.03), with a RR of 1.75 (95% CI 1.07–2.86). However, a sensitivity analysis revealed differences when studies of high and low risk of bias were pooled separately. Thus, the results must be interpreted carefully. No apparent significant effects of flapless technique on the occurrence of postoperative infection (P = 0.96; RR 0.96, 95% CI 0.23–4.03) or on the marginal bone loss (P = 0.16; MD −0.07 mm, 95% CI −0.16–0.03) were observed. PMID:24950053

Cardiopulmonary events during primary colonoscopy screening in an average risk population.

PubMed

Khalid-de Bakker, C A; Jonkers, D M; Hameeteman, W; de Ridder, R J; Masclee, A A; Stockbrügger, R W

2011-04-01

Large colorectal cancer screening studies using primary colonoscopy have reported a low risk of major complications. Studies on diagnostic and therapeutic colonoscopy have pointed to a frequent occurrence of(minor) cardiopulmonary events, and with the steady increase of colonoscopy screening, it is important to investigate their occurrence in colonoscopy screening. This study describes the frequency of bradycardia(pulse rate <60 min-1), hypotension (systolic blood pressure(SB P) <90 mmHg), hypoxaemia (blood oxygenation, SaO2<90%) and ECG changes during colonoscopy screening in an average-risk population (hospital personnel, n=214,mean age 54.0±3.8, 39.3% male), without significant comorbidity) and aims at identifying subject-related and/or endoscopic factors associated with their occurrence. All data were collected prospectively. During 214 consecutive primary screening colonoscopies under conscious sedation(midazolam and pethidine), on top of pulse rate and SaO2,blood pressure and a three-channel ECG were recorded every five minutes. No major complications or relevant ECG changes occurred. Hypoxaemia occurred in 119 (55.6%),hypotension in 19 (8.9%) and bradycardia in 12 subjects(5.6%). In multivariate analysis, the sedation level 3 increased the risk of hypoxaemia (OR 4.8, CI 1.7-13.7), and incomplete colonoscopy (OR 5.3, CI 1.6-18.1) was associated with hypotension. Subjects with bradycardia had a longer mean procedure time (38±12 vs. 29±12 min, p<0.05), which did not turn out as a risk factor in a multivariate analysis. Mainly procedure-related and not subject-related factors were found to be associated with the occurrence of cardiopulmonary events in primary colonoscopy screening in this relatively healthy screening population.

Comparison of intraoperative versus delayed enteral feeding tube placement in patients undergoing a Whipple procedure.

PubMed

Scaife, Courtney L; Hewitt, Kelly C; Mone, Mary C; Hansen, Heidi J; Nelson, Edward T; Mulvihill, Sean J

2014-01-01

The intraoperative placement of an enteral feeding tube (FT) during pancreaticoduodenectomy (PD) is based on the surgeon's perception of need for postoperative nutrition. Published preoperative risk factors predicting postoperative morbidity may be used to predict FT need and associated intraoperative placement. A retrospective review of patients who underwent PD during 2005-2011 was performed by querying the National Surgical Quality Improvement Program (NSQIP) database with specific procedure codes. Patients were categorized based on how many of 10 possible preoperative risk factors they demonstrated. Groups of patients with scores of ≤ 1 (low) and ≥ 2 (high), respectively, were compared for FT need, length of stay (LoS) and organ space surgical site infections (SSIs). Of 138 PD patients, 82 did not have an FT placed intraoperatively, and, of those, 16 (19.5%) required delayed FT placement. High-risk patients were more likely to require a delayed FT (29.3%) compared with low-risk patients (9.8%) (P = 0.026). The 16 patients who required a delayed FT had a median LoS of 15.5 days, whereas the 66 patients who did not require an FT had a median LoS of 8 days (P < 0.001). In this analysis, subjects considered as high-risk patients were more likely to require an FT than low-risk patients. Assessment of preoperative risk factors may improve decision making for selective intraoperative FT placement. © 2013 International Hepato-Pancreato-Biliary Association.

Hyperhomocysteinemia in bilateral anterior ischemic optic neuropathy after conventional coronary artery bypass graft: a case report.

PubMed

Niro, A; Sborgia, G; Sborgia, A; Alessio, G

2018-01-17

The incidence of anterior ischemic optic neuropathy after coronary artery bypass graft procedures ranges from 1.3 to 0.25%. The mechanisms of anterior ischemic optic neuropathy after cardiovascular procedures remain undefined but many systemic and related-to-surgery risk factors could underlie anterior ischemic optic neuropathy. In this case, we report a rare presentation of a bilateral anterior ischemic optic neuropathy after coronary artery bypass graft and speculate on the preoperative hyperhomocysteinemia as an independent risk factor for anterior ischemic optic neuropathy. A 56-year-old white man, a tobacco smoker with type 2 diabetes and coronary artery disease, underwent a conventional coronary artery bypass graft with extracorporeal circulation. In spite of ongoing anti-aggregation, antithrombotic, and vasodilator therapy, 10 days after the surgery he complained of severe bilateral visual loss. Funduscopy and fluorescein angiography revealed a bilateral anterior ischemic optic neuropathy. Analysis of preoperative laboratory tests revealed hyperhomocysteinemia. Hyperhomocysteinemia could increase the risk of ocular vascular damage and bilateral ocular involvement in patients who have undergone conventional coronary artery bypass graft.

Do instability markers predict satisfactory reduction and requirement for later surgery in emergency department patients with wrist fracture?

PubMed

Winayak, Amar; Gossat, Alyza; Cooper, Jenny; Ritchie, Peter; Lim, Wei; Klim, Sharon; Kelly, Anne-Maree

2018-02-01

Research suggests that the presence of instability markers in patients with displaced distal radial fractures is associated with poorer outcome. Our aims were to determine whether the presence of previously defined instability markers could predict the likelihood of successful ED reduction and requirement for a secondary procedure after ED reduction. Retrospective cohort study performed by medical record review. Adult ED patients coded as having an isolated wrist fracture and having fracture reduction in ED were eligible for inclusion. Data collected included demographics, history of osteoporosis, mechanism of injury, radiological features on X-rays and performance of a secondary procedure. Outcomes of interest were the rate of successful fracture reduction in ED (against defined radiological criteria), the rate of secondary procedures and the association between the number of defined instability risk factors and successful reduction and performance of a secondary surgical procedure. Analysis was by χ 2 test, receiver operating characteristic curve, logistic regression analyses. Three hundred and nineteen patients were studied; median age 62 years, 77% female. Sixty-five per cent of patients had satisfactory fracture reduction in ED (95% CI 59%-70%). Eighty-six patients underwent a secondary procedure to reduce/stabilise their fracture (28%, 95% CI 23%-33%). Younger age, lack of satisfactory ED reduction and increased number of instability factors were independently predictive of the performance of a secondary procedure. Instability risk factors are common in patients with wrist fractures requiring reduction in ED. The number of instability factors is not a strong predictor of the performance of secondary procedures. © 2017 Australasian College for Emergency Medicine and Australasian Society for Emergency Medicine.

A multi-criteria decision analysis of management alternatives for anaerobically digested kraft pulp mill sludge

PubMed Central

Eikelboom, Martijn; Lopes, Alice do Carmo Precci; Silva, Claudio Mudadu; Rodrigues, Fábio de Ávila; Zanuncio, José Cola

2018-01-01

The Multi-Criteria Decision Analysis (MCDA) procedure was used to compare waste management options for kraft pulp mill sludge following its anaerobic digestion. Anaerobic digestion of sludge is advantageous because it produces biogas that may be used to generate electricity, heat and biofuels. However, adequate management of the digested sludge is essential. Landfill disposal is a non-sustainable waste management alternative. Kraft pulp mill digested sludge applied to land may pose risks to the environment and public health if the sludge has not been properly treated. This study is aimed to compare several recycling alternatives for anaerobically digested sludge from kraft pulp mills: land application, landfill disposal, composting, incineration, pyrolysis/gasification, and biofuel production by algae. The MCDA procedure considered nine criteria into three domains to compare digested sludge recycling alternatives in a kraft pulp mill: environmental (CO2 emission, exposure to pathogens, risk of pollution, material and energy recovery), economic (overall costs, value of products) and technical (maintenance and operation, feasibility of implementation). The most suitable management options for digested sludge from kraft pulp mills were found to be composting and incineration (when the latter was coupled with recycling ash to the cement industry). Landfill disposal was the worst option, presenting low performance in feasibility of implementation, risk of pollution, material and energy recovery. PMID:29298296

Quality Interaction Between Mission Assurance and Project Team Members

NASA Technical Reports Server (NTRS)

Kwong-Fu, Helenann H.; Wilson, Robert K.

2006-01-01

Mission Assurance independent assessments started during the development cycle and continued through post launch operations. In operations, Health and Safety of the Observatory is of utmost importance. Therefore, Mission Assurance must ensure requirements compliance and focus on process improvements required across the operational systems including new/modified products, tools, and procedures. The deployment of the interactive model involves three objectives: Team member Interaction, Good Root Cause Analysis Practices, and Risk Assessment to avoid reoccurrences. In applying this model, we use a metric based measurement process and was found to have the most significant effect, which points to the importance of focuses on a combination of root cause analysis and risk approaches allowing the engineers the ability to prioritize and quantify their corrective actions based on a well-defined set of root cause definitions (i.e. closure criteria for problem reports), success criteria and risk rating definitions.

Conceptual design study of Fusion Experimental Reactor (FY86 FER): Safety

NASA Astrophysics Data System (ADS)

Seki, Yasushi; Iida, Hiromasa; Honda, Tsutomu

1987-08-01

This report describes the study on safety for FER (Fusion Experimental Reactor) which has been designed as a next step machine to the JT-60. Though the final purpose of this study is to have an image of design base accident, maximum credible accident and to assess their risk or probability, etc., as FER plant system, the emphasis of this years study is placed on fuel-gas circulation system where the tritium inventory is maximum. The report consists of two chapters. The first chapter summarizes the FER system and describes FMEA (Failure Mode and Effect Analysis) and related accident progression sequence for FER plant system as a whole. The second chapter of this report is focused on fuel-gas circulation system including purification, isotope separation and storage. Probability of risk is assessed by the probabilistic risk analysis (PRA) procedure based on FMEA, ETA and FTA.

Taking Risk Assessment and Management to the Next Level: Program-Level Risk Analysis to Enable Solid Decision-Making on Priorities and Funding

DOE Office of Scientific and Technical Information (OSTI.GOV)

Nelson, J. G.; Morton, R. L.; Castillo, C.

2011-02-01

A multi-level (facility and programmatic) risk assessment was conducted for the facilities in the Nevada National Security Site (NNSS) Readiness in Technical Base and Facilities (RTBF) Program and results were included in a new Risk Management Plan (RMP), which was incorporated into the fiscal year (FY) 2010 Integrated Plans. Risks, risk events, probability, consequence(s), and mitigation strategies were identified and captured, for most scope areas (i.e., risk categories) during the facilitated risk workshops. Risk mitigations (i.e., efforts in addition to existing controls) were identified during the facilitated risk workshops when the risk event was identified. Risk mitigation strategies fell intomore » two broad categories: threats or opportunities. Improvement projects were identified and linked to specific risks they mitigate, making the connection of risk reduction through investments for the annual Site Execution Plan. Due to the amount of that was collected, analysis to be performed, and reports to be generated, a Risk Assessment/ Management Tool (RAMtool) database was developed to analyze the risks in real-time, at multiple levels, which reinforced the site-level risk management process and procedures. The RAMtool database was developed and designed to assist in the capturing and analysis of the key elements of risk: probability, consequence, and impact. The RAMtool calculates the facility-level and programmatic-level risk factors to enable a side-by-side comparison to see where the facility manager and program manager should focus their risk reduction efforts and funding. This enables them to make solid decisions on priorities and funding to maximize the risk reduction. A more active risk management process was developed where risks and opportunities are actively managed, monitored, and controlled by each facility more aggressively and frequently. risk owners have the responsibility and accountability to manage their assigned risk in real-time, using the RAMtool database.« less

Pre-Procedural Patient Education Reduces Fall Risk in an Outpatient Endoscopy Suite.

PubMed

Hilscher, Moira B; Niesen, Cynthia R; Tynsky, Desiree A; Kane, Sunanda V

The purpose of this article was to determine whether scripted pre-procedural fall risk patient education and nurses' intention to assist patients after receiving sedation improves receptiveness of nursing assistance during recovery and decreases fall risk in an outpatient endoscopy suite. We prospectively identified high fall risk patients using the following criteria: (1) use of an assistive device, (2) fallen two or more times within the last year, (3) sustained an injury in a fall within a year, (4) age greater than 85 years, or (5) nursing judgment of high fall risk. Using a scripted dialogue, nurses educated high-risk patients of their fall risk and the nurses' intent to assist them to and in the bathroom. Documentation of patient education, script use, and assistance was monitored. Over 24 weeks, 892 endoscopy patients were identified as high fall risk; 790 (88.5%) accepted post-procedural assistance. Documentation of assistance significantly increased from 33% to 100%. Patients receiving education and postprocedural assistance increased from 27.9% to 100% at week 24. No patient falls occurred 12 months following implementation among patients identified as high fall risk. Scripted pre-procedural fall risk education increases patient awareness and receptiveness to assistance and can lead to decreased fall rates.

Aerosol preparation of intact lipoproteins

DOEpatents

Benner, W Henry [Danville, CA; Krauss, Ronald M [Berkeley, CA; Blanche, Patricia J [Berkeley, CA

2012-01-17

A medical diagnostic method and instrumentation system for analyzing noncovalently bonded agglomerated biological particles is described. The method and system comprises: a method of preparation for the biological particles; an electrospray generator; an alpha particle radiation source; a differential mobility analyzer; a particle counter; and data acquisition and analysis means. The medical device is useful for the assessment of human diseases, such as cardiac disease risk and hyperlipidemia, by rapid quantitative analysis of lipoprotein fraction densities. Initially, purification procedures are described to reduce an initial blood sample to an analytical input to the instrument. The measured sizes from the analytical sample are correlated with densities, resulting in a spectrum of lipoprotein densities. The lipoprotein density distribution can then be used to characterize cardiac and other lipid-related health risks.

Risk analysis theory applied to fishing operations: A new approach on the decision-making problem

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cunha, J.C.S.

1994-12-31

In the past the decisions concerning whether to continue or interrupt a fishing operation were based primarily on the operator`s previous experience. This procedure often led to wrong decisions and unnecessary loss of money and time. This paper describes a decision-making method based on risk analysis theory and previous operation results from a field under study. The method leads to more accurate decisions on a daily basis allowing the operator to verify each day of the operation if the decision being carried out is the one with the highest probability to conduct to the best economical result. An example ofmore » the method application is provided at the end of the paper.« less

Dental procedures and risk of experiencing a second vascular event in a Medicare population.

PubMed

Skaar, Daniel; O'Connor, Heidi; Lunos, Scott; Luepker, Russell; Michalowicz, Bryan S

2012-11-01

Practice guidelines historically have recommended postponing dental care after ischemic vascular events. The authors examined an administrative data set to determine whether dental procedures increased patients' risk of experiencing a second vascular event. The authors examined a data set of 50,329 participants in the Medicare Current Beneficiary Survey to identify those who had had a vascular event (n = 2,035) and a second event (n = 445) while in the survey. They used Cox proportional hazards regression to study associations between dental procedures performed within 30, 60, 90 or 180 days after a first event and the risk of experiencing a second vascular event. Dental procedures of any kind, and invasive procedures considered separately, were not associated with patients' risk of experiencing second vascular events across all periods examined. Most hazard ratios associated with dental procedures were less than 1.0, although none differed significantly from 1.0. The authors found that community-dwelling Medicare beneficiaries who underwent dental procedures within 30 to 180 days after an ischemic vascular event, including those that produce a bacteremia consistently, were not at an increased risk of experiencing a second event. The results of this study suggest that clinicians should reassess historical recommendations that dental care in this population be postponed for as long as six months after an ischemic vascular event.

WE-G-BRC-02: Risk Assessment for HDR Brachytherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mayadev, J.

2016-06-15

Failure Mode and Effects Analysis (FMEA) originated as an industrial engineering technique used for risk management and safety improvement of complex processes. In the context of radiotherapy, the AAPM Task Group 100 advocates FMEA as the framework of choice for establishing clinical quality management protocols. However, there is concern that widespread adoption of FMEA in radiation oncology will be hampered by the perception that implementation of the tool will have a steep learning curve, be extremely time consuming and labor intensive, and require additional resources. To overcome these preconceptions and facilitate the introduction of the tool into clinical practice, themore » medical physics community must be educated in the use of this tool and the ease in which it can be implemented. Organizations with experience in FMEA should share their knowledge with others in order to increase the implementation, effectiveness and productivity of the tool. This session will include a brief, general introduction to FMEA followed by a focus on practical aspects of implementing FMEA for specific clinical procedures including HDR brachytherapy, physics plan review and radiosurgery. A description of common equipment and devices used in these procedures and how to characterize new devices for safe use in patient treatments will be presented. This will be followed by a discussion of how to customize FMEA techniques and templates to one’s own clinic. Finally, cases of common failure modes for specific procedures (described previously) will be shown and recommended intervention methodologies and outcomes reviewed. Learning Objectives: Understand the general concept of failure mode and effect analysis Learn how to characterize new equipment for safety Be able to identify potential failure modes for specific procedures and learn mitigation techniques Be able to customize FMEA examples and templates for use in any clinic.« less

WE-G-BRC-01: Risk Assessment for Radiosurgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, G.

2016-06-15

Failure Mode and Effects Analysis (FMEA) originated as an industrial engineering technique used for risk management and safety improvement of complex processes. In the context of radiotherapy, the AAPM Task Group 100 advocates FMEA as the framework of choice for establishing clinical quality management protocols. However, there is concern that widespread adoption of FMEA in radiation oncology will be hampered by the perception that implementation of the tool will have a steep learning curve, be extremely time consuming and labor intensive, and require additional resources. To overcome these preconceptions and facilitate the introduction of the tool into clinical practice, themore » medical physics community must be educated in the use of this tool and the ease in which it can be implemented. Organizations with experience in FMEA should share their knowledge with others in order to increase the implementation, effectiveness and productivity of the tool. This session will include a brief, general introduction to FMEA followed by a focus on practical aspects of implementing FMEA for specific clinical procedures including HDR brachytherapy, physics plan review and radiosurgery. A description of common equipment and devices used in these procedures and how to characterize new devices for safe use in patient treatments will be presented. This will be followed by a discussion of how to customize FMEA techniques and templates to one’s own clinic. Finally, cases of common failure modes for specific procedures (described previously) will be shown and recommended intervention methodologies and outcomes reviewed. Learning Objectives: Understand the general concept of failure mode and effect analysis Learn how to characterize new equipment for safety Be able to identify potential failure modes for specific procedures and learn mitigation techniques Be able to customize FMEA examples and templates for use in any clinic.« less

WE-G-BRC-03: Risk Assessment for Physics Plan Review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Parker, S.

2016-06-15

Failure Mode and Effects Analysis (FMEA) originated as an industrial engineering technique used for risk management and safety improvement of complex processes. In the context of radiotherapy, the AAPM Task Group 100 advocates FMEA as the framework of choice for establishing clinical quality management protocols. However, there is concern that widespread adoption of FMEA in radiation oncology will be hampered by the perception that implementation of the tool will have a steep learning curve, be extremely time consuming and labor intensive, and require additional resources. To overcome these preconceptions and facilitate the introduction of the tool into clinical practice, themore » medical physics community must be educated in the use of this tool and the ease in which it can be implemented. Organizations with experience in FMEA should share their knowledge with others in order to increase the implementation, effectiveness and productivity of the tool. This session will include a brief, general introduction to FMEA followed by a focus on practical aspects of implementing FMEA for specific clinical procedures including HDR brachytherapy, physics plan review and radiosurgery. A description of common equipment and devices used in these procedures and how to characterize new devices for safe use in patient treatments will be presented. This will be followed by a discussion of how to customize FMEA techniques and templates to one’s own clinic. Finally, cases of common failure modes for specific procedures (described previously) will be shown and recommended intervention methodologies and outcomes reviewed. Learning Objectives: Understand the general concept of failure mode and effect analysis Learn how to characterize new equipment for safety Be able to identify potential failure modes for specific procedures and learn mitigation techniques Be able to customize FMEA examples and templates for use in any clinic.« less

Risk factors for acquisition of OXA-48-producing Klebsiella pneumonia among contact patients: a multicentre study.

PubMed

Hilliquin, D; Le Guern, R; Thepot Seegers, V; Neulier, C; Lomont, A; Marie, V; Legeay, C; Merrer, J; Lepelletier, D; Rogues, A M; Grandbastien, B; Lucet, J C; Zahar, J R

2018-03-01

Cohorting carbapenemase-producing Enterobacteriaceae (CPE) carriers during hospitalization limits in-hospital spreading. To identify risk factors for CPE acquisition among contacts of an index patient in non-cohorted populations. A multicentre retrospective matched case-control study was conducted in five hospitals. Each contact patient (case) who acquired Klebsiella pneumoniae (KP)-OXA-48 from an index patient was compared to three contact (controls) with the same index patients matched with hospitalization in the same unit and similar exposure times. Fifty-one secondary cases and 131 controls were included. By univariate analysis, exposure time (odds ratio: 1.06; 95% confidence interval: 1.02-1.1; P = 0.006), concomitant infection at admission (3.23; 1.42-7.35; P = 0.005), antimicrobial therapy within the last month before hospitalization (2.88; 1.34-6.2; P = 0.007), antimicrobial therapy during the exposure time (5.36; 2.28-12.6; P < 0.001), use of at least one invasive procedure (2.99; 1.25-7.15; P = 0.014), number of invasive procedures (1.52; 1.05-2.19; P = 0.025), and geographical proximity (2.84; 1.15-7.00; P = 0.023) were associated with CPE acquisition. By multivariate analysis, antimicrobial therapy during the exposure time (odds ratio: 6.36; 95% confidence interval: 2.46-16.44; P < 0.001), at least one invasive procedure (2.92; 1.04-8.17; P = 0.041), and geographical proximity (3.69; 1.15-11.86; P = 0.028) were associated with acquisition. In this study, geographical proximity, invasive procedure, and antimicrobial therapy during exposure time were significantly associated with KP-OXA-48 acquisition. Copyright © 2017 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

78 FR 65718 - Submission for OMB Review; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-01

... maintain certain risk management controls and supervisory procedures as well as regularly review such... supervisory procedures and a written description of its risk management controls as part of its books and... providing sponsored or direct market access to customers or other persons, to implement risk management...

12 CFR 234.5 - Changes to rules, procedures, or operations.

Code of Federal Regulations, 2013 CFR

2013-01-01

... risk-management techniques. (4) A designated financial market utility shall not implement a change to...) Participant eligibility or access criteria; (ii) Product eligibility; (iii) Risk management; (iv) Settlement..., procedures, or operations that could materially affect the nature or level of risks presented by the...

12 CFR 234.5 - Changes to rules, procedures, or operations.

Code of Federal Regulations, 2014 CFR

2014-01-01

... risk-management techniques. (4) A designated financial market utility shall not implement a change to...) Participant eligibility or access criteria; (ii) Product eligibility; (iii) Risk management; (iv) Settlement..., procedures, or operations that could materially affect the nature or level of risks presented by the...

From breeder reactors to butterflies: risk, culture, and biotechnology.

PubMed

Lomax, G P

2000-10-01

Social theories of risk suggest that a combination of scientific and cultural perspectives converge to influence risk perception. This article first surveys sociological perspectives suggesting that risks from modern technological development have become predominant concerns in the social consciousness. Particular attention is given to those theses describing how social elements work to create perception of risks in relation to new technologies. The themes that emerge from this survey are then related to contemporary debates concerning biotechnology. Specific attention is given to recent controversies regarding genetically modified crops, and parallels are drawn between debates over nuclear power and biotechnology. A procedural ethic for public discourse and decision making over the diffusion of genetically modified foods is offered. Ethical and social theories are linked with the hope that by recognizing the social dimensions of debates over new technologies a broader framework for conducting risk analysis may emerge.

Annual Systems Engineering Conference: Focusing on Improving Performance of Defense Systems Programs (10th). Volume 3. Thursday Presentations

DTIC Science & Technology

2007-10-25

the Phit <.0001 requirement) restricts tactical delivery conditions, the probability of a fragment hit may be further qualified by considering only...Pkill – UK uses “self damage” metric • Risk Analysis: “If the above procedures ( Phit or Pkill <.0001) still result in restricting tactical delivery...10 (From NAWCWD Briefing) 4 Safe Escape Analysis Requirements Calculate Phit ,Pkill, and Pdet Is Phit <= .0001 for all launch conditions Done NO YES

Vulnerability-attention analysis for space-related activities

NASA Technical Reports Server (NTRS)

Ford, Donnie; Hays, Dan; Lee, Sung Yong; Wolfsberger, John

1988-01-01

Techniques for representing and analyzing trouble spots in structures and processes are discussed. Identification of vulnerable areas usually depends more on particular and often detailed knowledge than on algorithmic or mathematical procedures. In some cases, machine inference can facilitate the identification. The analysis scheme proposed first establishes the geometry of the process, then marks areas that are conditionally vulnerable. This provides a basis for advice on the kinds of human attention or machine sensing and control that can make the risks tolerable.

Guidelines for Neurotoxicity Risk Assessment

EPA Pesticide Factsheets

These Guidelines set forth principles and procedures to guide EPA scientists in evaluating environmental contaminants that may pose neurotoxic risks, and inform Agency decision makers and the public about these procedures.

Priority of a Hesitant Fuzzy Linguistic Preference Relation with a Normal Distribution in Meteorological Disaster Risk Assessment.

PubMed

Wang, Lihong; Gong, Zaiwu

2017-10-10

As meteorological disaster systems are large complex systems, disaster reduction programs must be based on risk analysis. Consequently, judgment by an expert based on his or her experience (also known as qualitative evaluation) is an important link in meteorological disaster risk assessment. In some complex and non-procedural meteorological disaster risk assessments, a hesitant fuzzy linguistic preference relation (HFLPR) is often used to deal with a situation in which experts may be hesitant while providing preference information of a pairwise comparison of alternatives, that is, the degree of preference of one alternative over another. This study explores hesitation from the perspective of statistical distributions, and obtains an optimal ranking of an HFLPR based on chance-restricted programming, which provides a new approach for hesitant fuzzy optimisation of decision-making in meteorological disaster risk assessments.

Failure mode and effect analysis in blood transfusion: a proactive tool to reduce risks.

PubMed

Lu, Yao; Teng, Fang; Zhou, Jie; Wen, Aiqing; Bi, Yutian

2013-12-01

The aim of blood transfusion risk management is to improve the quality of blood products and to assure patient safety. We utilize failure mode and effect analysis (FMEA), a tool employed for evaluating risks and identifying preventive measures to reduce the risks in blood transfusion. The failure modes and effects occurring throughout the whole process of blood transfusion were studied. Each failure mode was evaluated using three scores: severity of effect (S), likelihood of occurrence (O), and probability of detection (D). Risk priority numbers (RPNs) were calculated by multiplying the S, O, and D scores. The plan-do-check-act cycle was also used for continuous improvement. Analysis has showed that failure modes with the highest RPNs, and therefore the greatest risk, were insufficient preoperative assessment of the blood product requirement (RPN, 245), preparation time before infusion of more than 30 minutes (RPN, 240), blood transfusion reaction occurring during the transfusion process (RPN, 224), blood plasma abuse (RPN, 180), and insufficient and/or incorrect clinical information on request form (RPN, 126). After implementation of preventative measures and reassessment, a reduction in RPN was detected with each risk. The failure mode with the second highest RPN, namely, preparation time before infusion of more than 30 minutes, was shown in detail to prove the efficiency of this tool. FMEA evaluation model is a useful tool in proactively analyzing and reducing the risks associated with the blood transfusion procedure. © 2013 American Association of Blood Banks.

Risk factors for stent graft thrombosis after transjugular intrahepatic portosystemic shunt creation.

PubMed

Jahangiri, Younes; Kerrigan, Timothy; Li, Lei; Prosser, Dominik; Brar, Anantnoor; Righetti, Johnathan; Schenning, Ryan C; Kaufman, John A; Farsad, Khashayar

2017-12-01

To identify risk factors of stent graft thrombosis after transjugular intrahepatic portosystemic shunt (TIPS) creation. Patients who underwent TIPS creation between June 2003 and January 2016 and with follow-up assessing stent graft patency were included (n=174). Baseline comorbidities, liver function, procedural details and follow-up liver function tests were analyzed in association with hazards of thrombosis on follow-up. Competing risk cox regression models were used considering liver transplant after TIPS creation as the competing risk variable. One-, 2- and 5-year primary patency rates were 94.1%, 91.7% and 78.2%, respectively. Patient age [sub-hazard ratio (sHR): 1.13; P=0.001], body mass index (BMI) <30 (sHR: 33.08; P=0.008) and a higher post-TIPS portosystemic pressure gradient (sHR: 1.14; P=0.023) were significantly associated with TIPS thrombosis in multivariate analysis. A higher rate of TIPS thrombosis was observed in those for whom the procedure was clinically unsuccessful (P=0.014). A significant increase in incidence of thrombosis was noted with increasing tertiles of post-TIPS portosystemic gradients (P value for trend=0.017). Older age, lower BMI and higher post-TIPS portosystemic gradients were associated with higher hazards of shunt thrombosis after TIPS creation using stent grafts. Higher rates of shunt thrombosis were seen in patients for whom TIPS creation was clinically unsuccessful. The association between TIPS thrombosis and higher post-TIPS portosystemic gradients may indicate impaired flow through the shunt, a finding which may be technical or anatomic in nature and should be assessed before procedure completion.

IT-CARES: an interactive tool for case-crossover analyses of electronic medical records for patient safety.

PubMed

Caron, Alexandre; Chazard, Emmanuel; Muller, Joris; Perichon, Renaud; Ferret, Laurie; Koutkias, Vassilis; Beuscart, Régis; Beuscart, Jean-Baptiste; Ficheur, Grégoire

2017-03-01

The significant risk of adverse events following medical procedures supports a clinical epidemiological approach based on the analyses of collections of electronic medical records. Data analytical tools might help clinical epidemiologists develop more appropriate case-crossover designs for monitoring patient safety. To develop and assess the methodological quality of an interactive tool for use by clinical epidemiologists to systematically design case-crossover analyses of large electronic medical records databases. We developed IT-CARES, an analytical tool implementing case-crossover design, to explore the association between exposures and outcomes. The exposures and outcomes are defined by clinical epidemiologists via lists of codes entered via a user interface screen. We tested IT-CARES on data from the French national inpatient stay database, which documents diagnoses and medical procedures for 170 million inpatient stays between 2007 and 2013. We compared the results of our analysis with reference data from the literature on thromboembolic risk after delivery and bleeding risk after total hip replacement. IT-CARES provides a user interface with 3 columns: (i) the outcome criteria in the left-hand column, (ii) the exposure criteria in the right-hand column, and (iii) the estimated risk (odds ratios, presented in both graphical and tabular formats) in the middle column. The estimated odds ratios were consistent with the reference literature data. IT-CARES may enhance patient safety by facilitating clinical epidemiological studies of adverse events following medical procedures. The tool's usability must be evaluated and improved in further research. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association.

Risk communication and informed consent in the medical tourism industry: a thematic content analysis of Canadian broker websites.

PubMed

Penney, Kali; Snyder, Jeremy; Crooks, Valorie A; Johnston, Rory

2011-09-26

Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists.

Risk communication and informed consent in the medical tourism industry: A thematic content analysis of canadian broker websites

PubMed Central

2011-01-01

Background Medical tourism, thought of as patients seeking non-emergency medical care outside of their home countries, is a growing industry worldwide. Canadians are amongst those engaging in medical tourism, and many are helped in the process of accessing care abroad by medical tourism brokers - agents who specialize in making international medical care arrangements for patients. As a key source of information for these patients, brokers are likely to play an important role in communicating the risks and benefits of undergoing surgery or other procedures abroad to their clientele. This raises important ethical concerns regarding processes such as informed consent and the liability of brokers in the event that complications arise from procedures. The purpose of this article is to examine the language, information, and online marketing of Canadian medical tourism brokers' websites in light of such ethical concerns. Methods An exhaustive online search using multiple search engines and keywords was performed to compile a comprehensive directory of English-language Canadian medical tourism brokerage websites. These websites were examined using thematic content analysis, which included identifying informational themes, generating frequency counts of these themes, and comparing trends in these counts to the established literature. Results Seventeen websites were identified for inclusion in this study. It was found that Canadian medical tourism broker websites varied widely in scope, content, professionalism and depth of information. Three themes emerged from the thematic content analysis: training and accreditation, risk communication, and business dimensions. Third party accreditation bodies of debatable regulatory value were regularly mentioned on the reviewed websites, and discussion of surgical risk was absent on 47% of the websites reviewed, with limited discussion of risk on the remaining ones. Terminology describing brokers' roles was somewhat inconsistent across the websites. Finally, brokers' roles in follow up care, their prices, and the speed of surgery were the most commonly included business dimensions on the reviewed websites. Conclusion Canadian medical tourism brokers currently lack a common standard of care and accreditation, and are widely lacking in providing adequate risk communication for potential medical tourists. This has implications for the informed consent and consequent safety of Canadian medical tourists. PMID:21943392

The Effectiveness and Risks of Fluoroscopically-Guided Cervical Medial Branch Thermal Radiofrequency Neurotomy: A Systematic Review with Comprehensive Analysis of the Published Data.

PubMed

Engel, Andrew; Rappard, George; King, Wade; Kennedy, David J

2016-04-01

To determine the effectiveness and risks of fluoroscopically-guided cervical medial branch thermal radiofrequency neurotomy (CMBTRFN) for treating chronic neck pain of zygapophysial joint origin. Systematic review of the literature with comprehensive analysis of the published data. Four reviewers formally trained in evidence-based medicine searched the literature on CMBTRFN. Each assessed the methodologies of studies found and appraised the quality of evidence presented. The primary outcomes assessed were 100% relief of pain 6 and 12 months after treatment. Other outcomes were noted if reported. The evidence was evaluated in accordance with the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) system. The searches yielded eight primary publications on the effectiveness of the procedure. The evidence shows a majority of patients were pain free at 6 months and over a third were pain free at 1 year. The number needed to treat for complete pain relief at 6 months is 2. The evidence of effectiveness is of high quality according to the GRADE system. Twelve papers were found reporting unwanted effects, most of which are minor and temporary. No serious complications have ever been reported from procedures performed according to the published guidelines. The evidence of risks is of low quality according to the GRADE system. If performed as described in the International Spine Intervention Society Guidelines, fluoroscopically-guided CMBTRFN is effective for abolishing zygapophysial joint pain and carries only minor risks. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Pulmonary edema predictive scoring index (PEPSI), a new index to predict risk of reperfusion pulmonary edema and improvement of hemodynamics in percutaneous transluminal pulmonary angioplasty.

PubMed

Inami, Takumi; Kataoka, Masaharu; Shimura, Nobuhiko; Ishiguro, Haruhisa; Yanagisawa, Ryoji; Taguchi, Hiroki; Fukuda, Keiichi; Yoshino, Hideaki; Satoh, Toru

2013-07-01

This study sought to identify useful predictors for hemodynamic improvement and risk of reperfusion pulmonary edema (RPE), a major complication of this procedure. Percutaneous transluminal pulmonary angioplasty (PTPA) has been reported to be effective for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH). PTPA has not been widespread because RPE has not been well predicted. We included 140 consecutive procedures in 54 patients with CTEPH. The flow appearance of the target vessels was graded into 4 groups (Pulmonary Flow Grade), and we proposed PEPSI (Pulmonary Edema Predictive Scoring Index) = (sum total change of Pulmonary Flow Grade scores) × (baseline pulmonary vascular resistance). Correlations between occurrence of RPE and 11 variables, including hemodynamic parameters, number of target vessels, and PEPSI, were analyzed. Hemodynamic parameters significantly improved after median observation period of 6.4 months, and the sum total changes in Pulmonary Flow Grade scores were significantly correlated with the improvement in hemodynamics. Multivariate analysis revealed that PEPSI was the strongest factor correlated with the occurrence of RPE (p < 0.0001). Receiver-operating characteristic curve analysis demonstrated PEPSI to be a useful marker of the risk of RPE (cutoff value 35.4, negative predictive value 92.3%). Pulmonary Flow Grade score is useful in determining therapeutic efficacy, and PEPSI is highly supportive to reduce the risk of RPE after PTPA. Using these 2 indexes, PTPA could become a safe and common therapeutic strategy for CTEPH. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Epidural Abscess: A Propensity Analysis of Surgical Treatment Strategies.

PubMed

Chaker, Anisse N; Bhimani, Abhiraj D; Esfahani, Darian R; Rosinski, Clayton L; Geever, Brett W; Patel, Akash S; Hobbs, Jonathan G; Burch, Taylor G; Patel, Saavan; Mehta, Ankit I

2018-06-18

Observational analysis of retrospectively collected data. A retrospective study was performed in order to compare the surgical profile of risk factors and perioperative complications for laminectomy and laminectomy with fusion procedures in the treatment of SEA. Spinal epidural abscess (SEA) is a highly morbid condition typically presenting with back pain, fever, and neurologic deficits. Posterior fusion has been used to supplement traditional laminectomy of SEA to improve spinal stability. At present, the ideal surgical strategy - laminectomy with or without fusion - remains elusive. 30-day outcomes such as reoperation and readmission following laminectomy and laminectomy with fusion in patients with SEA were investigated utilizing the American College of Surgeons National Quality Improvement Program database. Demographics and clinical risk factors were collected, and propensity matching was performed to account for differences in risk profiles between the groups. 738 patients were studied (608 laminectomy alone, 130 fusion). The fusion population was in worse health. The fusion population experienced significantly greater rate of return to the operating room (odds ratio (OR) 1.892), with the difference primarily accounted for by cervical spine operations. Additionally, fusion patients had significantly greater rates of blood transfusion. Infection was the most common reason for reoperation in both populations. Both laminectomy and laminectomy with fusion effectively treat SEA, but addition of fusion is associated with significantly higher rates of transfusion and perioperative return to the operating room. In operative situations where either procedure is reasonable, surgeons should consider that fusion nearly doubles the odds of reoperation in the short-term, and weigh this risk against the benefit of added stability. 3.

Risk factors for baclofen pump infection in children: a multivariate analysis.

PubMed

Spader, Heather S; Bollo, Robert J; Bowers, Christian A; Riva-Cambrin, Jay

2016-06-01

OBJECTIVE Intrathecal baclofen infusion systems to manage severe spasticity and dystonia are associated with higher infection rates in children than in adults. Factors unique to this population, such as poor nutrition and physical limitations for pump placement, have been hypothesized as the reasons for this disparity. The authors assessed potential risk factors for infection in a multivariate analysis. METHODS Patients who underwent implantation of a programmable pump and intrathecal catheter for baclofen infusion at a single center between January 1, 2000, and March 1, 2012, were identified in this retrospective cohort study. The primary end point was infection. Potential risk factors investigated included preoperative (i.e., demographics, body mass index [BMI], gastrostomy tube, tracheostomy, previous spinal fusion), intraoperative (i.e., surgeon, antibiotics, pump size, catheter location), and postoperative (i.e., wound dehiscence, CSF leak, and number of revisions) factors. Univariate analysis was performed, and a multivariate logistic regression model was created to identify independent risk factors for infection. RESULTS A total of 254 patients were evaluated. The overall infection rate was 9.8%. Univariate analysis identified young age, shorter height, lower weight, dehiscence, CSF leak, and number of revisions within 6 months of pump placement as significantly associated with infection. Multivariate analysis identified young age, dehiscence, and number of revisions as independent risk factors for infection. CONCLUSIONS Young age, wound dehiscence, and number of revisions were independent risk factors for infection in this pediatric cohort. A low BMI and the presence of either a gastrostomy or tracheostomy were not associated with infection and may not be contraindications for this procedure.

In-office diagnostic arthroscopy for knee and shoulder intra-articular injuries its potential impact on cost savings in the United States

PubMed Central

2014-01-01

Background The purpose of this analysis was to determine whether in office diagnostic needle arthroscopy (Visionscope Imaging System [VSI]) can provide for improved diagnostic assessment and; more cost effective care. Methods Data on arthroscopy procedures in the US for deep seated pathology in the knee and shoulder were used (Calendar Year 2012). These procedures represent approximately 25-30% of all arthroscopic procedures performed annually. Sensitivities, specificities, positive predictive, and negative predictive values for MRI analysis of this deep seated pathology from systematic reviews and meta-analyses were used in assessing for false positive and false negative MRI findings. The costs of performing diagnostic and surgical arthroscopy procedures (using 2013 Medicare reimbursement amounts); costs associated with false negative findings; and the costs for treating associated complications arising from diagnostic and therapeutic arthroscopy procedures were then assessed. Results In patients presenting with medial meniscal pathology (ICD9CM diagnosis 836.0 over 540,000 procedures in CY 2012); use of the VSI system in place of MRI assessment (standard of care) resulted in a net cost savings to the system of $151 million. In patients presenting with rotator cuff pathology (ICD9CM 840.4 over 165,000 procedures in CY2012); use of VSI in place of MRI similarly saved $59 million. These savings were realized along with more appropriate care as; fewer patients were exposed to higher risk surgical arthroscopic procedures. Conclusions The use of an in-office arthroscopy system can: possibly save the US healthcare system money; shorten the diagnostic odyssey for patients; potentially better prepare clinicians for arthroscopic surgery (when needed) and; eliminate unnecessary outpatient arthroscopy procedures, which commonly result in surgical intervention. PMID:24885678

Dangers resulting from DNA profiling of biological materials derived from patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) with regard to forensic genetic analysis.

PubMed

Jacewicz, R; Lewandowski, K; Rupa-Matysek, J; Jędrzejczyk, M; Berent, J

The study documents the risk that comes with DNA analysis of materials derived from patients after allogeneic hematopoietic stem cell transplantation (allo-HSCT) in forensic genetics. DNA chimerism was studied in 30 patients after allo-HSCT, based on techniques applied in contemporary forensic genetics, i.e. real-time PCR and multiplex PCR-STR with the use of autosomal DNA as well as Y-DNA markers. The results revealed that the DNA profile of the recipient's blood was identical with the donor's in the majority of cases. Therefore, blood analysis can lead to false conclusions in personal identification as well as kinship analysis. An investigation of buccal swabs revealed a mixture of DNA in the majority of recipients. Consequently, personal identification on the basis of stain analysis of the same origin may be impossible. The safest (but not ideal) material turned out to be the hair root. Its analysis based on autosomal DNA revealed 100% of the recipient's profile. However, an analysis based on Y-chromosome markers performed in female allo-HSCT recipients with male donors demonstrated the presence of donor DNA in hair cells - similarly to the blood and buccal swabs. In the light of potential risks arising from DNA profiling of biological materials derived from persons after allotransplantation in judicial aspects, certain procedures were proposed to eliminate such dangers. The basic procedures include abandoning the approach based exclusively on blood collection, both for kinship analysis and personal identification; asking persons who are to be tested about their history of allo-HSCT before sample collection and profile entry in the DNA database, and verification of DNA profiling based on hair follicles in uncertain cases.

Diagnosing Expertise: Human Capital, Decision Making, and Performance among Physicians

PubMed Central

Currie, Janet; MacLeod, W. Bentley

2017-01-01

Expert performance is often evaluated assuming that good experts have good outcomes. We examine expertise in medicine and develop a model that allows for two dimensions of physician performance: decision making and procedural skill. Better procedural skill increases the use of intensive procedures for everyone, while better decision making results in a reallocation of procedures from fewer low-risk to high-risk cases. We show that poor diagnosticians can be identified using administrative data and that improving decision making improves birth outcomes by reducing C-section rates at the bottom of the risk distribution and increasing them at the top of the distribution. PMID:29276336

48 CFR 1850.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 48 Federal Acquisition Regulations System 6 2014-10-01 2014-10-01 false Special procedures for unusually hazardous or nuclear risks. 1850.104-3 Section 1850.104-3 Federal Acquisition Regulations System... nuclear risks. (a) Indemnification requests. (1) Contractor indemnification requests must be submitted to...

48 CFR 1850.104-3 - Special procedures for unusually hazardous or nuclear risks.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 48 Federal Acquisition Regulations System 6 2012-10-01 2012-10-01 false Special procedures for unusually hazardous or nuclear risks. 1850.104-3 Section 1850.104-3 Federal Acquisition Regulations System... nuclear risks. (a) Indemnification requests. (1) Contractor indemnification requests must be submitted to...

Risk of Hemorrhage Attributed to Underlying Chronic Diseases and Uninterrupted Aspirin Therapy of Patients Undergoing Minor Oral Surgical Procedures: A Retrospective Cohort Study.

PubMed

Rojanaworarit, Chanapong; Limsawan, Soontaree

2017-01-01

This study aimed to estimate the risk of bleeding following minor oral surgical procedures and uninterrupted aspirin therapy in high-risk patients or patients with existing chronic diseases compared to patients who did not use aspirin during minor oral surgery at a public hospital. This retrospective cohort study analyzed the data of 2912 patients, aged 20 years or older, who underwent 5251 minor oral surgical procedures at a district hospital in Thailand. The aspirin group was comprised of patients continuing aspirin therapy during oral surgery. The non-aspirin group (reference) included all those who did not use aspirin during surgery. Immediate and late-onset bleeding was evaluated in each procedure. The risk ratio of bleeding was estimated using a multilevel Poisson regression. The overall cumulative incidence of immediate bleeding was 1.3% of total procedures. No late-onset bleeding was found. A significantly greater incidence of bleeding was found in the aspirin group (5.8% of procedures, p<0.001). After adjusting for covariates, a multilevel Poisson regression model estimated that the bleeding risk in the aspirin group was 4.5 times higher than that of the non-aspirin group (95% confidence interval, 2.0 to 10.0; p<0.001). However, all bleeding events were controlled by simple hemostatic measures. High-risk patients or patients with existing chronic diseases who continued aspirin therapy following minor oral surgery were at a higher risk of hemorrhage than general patients who had not used aspirin. Nonetheless, bleeding complications were not life-threatening and could be promptly managed by simple hemostatic measures. The procedures could therefore be provided with an awareness of increased bleeding risk, prepared hemostatic measures, and postoperative monitoring, without the need for discontinuing aspirin, which could lead to more serious complications.

Intra- and Postoperative Complications of Lateral Maxillary Sinus Augmentation in Smokers vs Nonsmokers: A Systematic Review and Meta-Analysis.

PubMed

Ghasemi, Samaneh; Fotouhi, Akbar; Moslemi, Neda; Chinipardaz, Zahra; Kolahi, Jafar; Paknejad, Mojgan

This meta-analysis and systematic review focused on the following question: Does tobacco smoking increase the risk of intra- or postoperative complications of lateral maxillary sinus floor elevation? The following electronic databases were searched up to and including November 2015 without language restriction: CENTRAL, MEDLINE, Google Scholar, Scopus, Sirous, and Doaj. Studies were included if rates of intra-or postoperative complications of sinus floor elevation in smokers and nonsmokers were recorded separately. The following complications were assessed: sinus membrane perforation, bleeding, wound dehiscence, wound infection, sinusitis, hematoma, and oroantral fistula. The Critical Appraisal Skills Programme was used to assess the risk of bias in included studies. Random-effects meta-analyses were used to assess the number of each complication in smokers and nonsmokers. Out of 929 eligible publications, 11 articles were included. Meta-analysis of the studies revealed a significantly increased risk of developing wound dehiscence after sinus floor elevation among smokers compared with nonsmokers (Risk Ratio [RR]: 7.82; 95% confidence interval [CI]: 2.38, 25.74; P = .0007). Moreover, risk of developing wound infection was greater in smokers when prospective studies were included in the meta-analysis (RR: 5.33; 95% CI: 1.34, 21.25; P = .02). However, the meta-analysis of included studies did not show significant differences between smokers and nonsmokers concerning risk of sinus membrane perforation and bleeding during sinus floor elevation (P = .46 and P = .33, respectively). Considering the lack of randomized controlled trials and the small number of included studies, the results indicate that smoking seems to be associated with increased risk of wound dehiscence and infection after the sinus augmentation procedure.

Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation.

PubMed

McMillan, Matthew T; Soi, Sameer; Asbun, Horacio J; Ball, Chad G; Bassi, Claudio; Beane, Joal D; Behrman, Stephen W; Berger, Adam C; Bloomston, Mark; Callery, Mark P; Christein, John D; Dixon, Elijah; Drebin, Jeffrey A; Castillo, Carlos Fernandez-Del; Fisher, William E; Fong, Zhi Ven; House, Michael G; Hughes, Steven J; Kent, Tara S; Kunstman, John W; Malleo, Giuseppe; Miller, Benjamin C; Salem, Ronald R; Soares, Kevin; Valero, Vicente; Wolfgang, Christopher L; Vollmer, Charles M

2016-08-01

To evaluate surgical performance in pancreatoduodenectomy using clinically relevant postoperative pancreatic fistula (CR-POPF) occurrence as a quality indicator. Accurate assessment of surgeon and institutional performance requires (1) standardized definitions for the outcome of interest and (2) a comprehensive risk-adjustment process to control for differences in patient risk. This multinational, retrospective study of 4301 pancreatoduodenectomies involved 55 surgeons at 15 institutions. Risk for CR-POPF was assessed using the previously validated Fistula Risk Score, and pancreatic fistulas were stratified by International Study Group criteria. CR-POPF variability was evaluated and hierarchical regression analysis assessed individual surgeon and institutional performance. There was considerable variability in both CR-POPF risk and occurrence. Factors increasing the risk for CR-POPF development included increasing Fistula Risk Score (odds ratio 1.49 per point, P < 0.00001) and octreotide (odds ratio 3.30, P < 0.00001). When adjusting for risk, performance outliers were identified at the surgeon and institutional levels. Of the top 10 surgeons (≥15 cases) for nonrisk-adjusted performance, only 6 remained in this high-performing category following risk adjustment. This analysis of pancreatic fistulas following pancreatoduodenectomy demonstrates considerable variability in both the risk and occurrence of CR-POPF among surgeons and institutions. Disparities in patient risk between providers reinforce the need for comprehensive, risk-adjusted modeling when assessing performance based on procedure-specific complications. Furthermore, beyond inherent patient risk factors, surgical decision-making influences fistula outcomes.

Programmed Multiphasic Health Testing

NASA Technical Reports Server (NTRS)

Hershberg, P. I.

1970-01-01

Multiphase health screening procedures are advocated for detection and prevention of disease at an early stage through risk factor analysis. The use of an automated medical history questionnaire together with scheduled physical examination data provides a scanning input for computer printout. This system makes it possible to process laboratory results from 1,000 to 2,000 patients for biochemical determinations on an economically feasible base.

Laying down the Family Burden: A Cross-Cultural Analysis of Resilience in the Midst of Family Violence

ERIC Educational Resources Information Center

Kassis, Wassilis; Artz, Sibylle; Moldenhauer, Stephanie

2013-01-01

Questionnaire data from a cross-sectional study of a randomly selected sample of 5,149 middle-school students from four EU countries (Austria, Germany, Slovenia, and Spain) were used to explore the effects of family violence burden level, structural and procedural risk and protective factors, and personal characteristics on adolescents who are…

Procedures, Requirements and Challenges Associated with Analysis of Environmental Samples for Chemical Warfare Material (CWM)

DTIC Science & Technology

2012-03-29

DOD Environmental Monitoring Data Quality (EMDQ) Workshop John Schwarz, Laboratory Manager; Environmental Monitoring Laboratory ( EML ) March 29, 2012...Center (ECBC),Environmental Monitoring Laboratory ( EML ),5183 Blackhawk RD,Aberdeen Proving Ground,MD,21010-5424 8. PERFORMING ORGANIZATION REPORT...Biological Applications and Risk Reduction (CBARR) Environmental Monitoring Laboratory ( EML ) Approved for Public Release Environmental Monitoring

Use of a systematic risk analysis method (FMECA) to improve quality in a clinical laboratory procedure.

PubMed

Serafini, A; Troiano, G; Franceschini, E; Calzoni, P; Nante, N; Scapellato, C

2016-01-01

Risk management is a set of actions to recognize or identify risks, errors and their consequences and to take the steps to counter it. The aim of our study was to apply FMECA (Failure Mode, Effects and Criticality Analysis) to the Activated Protein C resistance (APCR) test in order to detect and avoid mistakes in this process. We created a team and the process was divided in phases and sub phases. For each phase we calculated the probability of occurrence (O) of an error, the detectability score (D) and the severity (S). The product of these three indexes yields the RPN (Risk Priority Number). Phases with a higher RPN need corrective actions with a higher priority. The calculation of RPN showed that more than 20 activities have a score higher than 150 and need important preventive actions; 8 have a score between 100 and 150. Only 23 actions obtained an acceptable score lower than 100. This was one of the first experience of application of FMECA analysis to a laboratory process, and the first one which applies this technique to the identification of the factor V Leiden, and our results confirm that FMECA could be a simple, powerful and useful tool in risk management and helps to identify quickly the criticality in a laboratory process.

Comparison of revision surgeries for one- to two-level cervical TDR and ACDF from 2002 to 2011.

PubMed

Nandyala, Sreeharsha V; Marquez-Lara, Alejandro; Fineberg, Steven J; Singh, Kern

2014-12-01

Cervical total disc replacement (TDR) and anterior cervical discectomy and fusion (ACDF) provide comparable outcomes for degenerative cervical pathology. However, revisions of these procedures are not well characterized. The purpose of this study is to examine the rates, epidemiology, perioperative complications, and costs between the revision procedures and to compare these outcomes with those of primary cases. This study is a retrospective database analysis. A total of 3,792 revision and 183,430 primary cases from the Nationwide Inpatient Sample (NIS) database from 2002 to 2011 were included. Incidence of revision cases, patient demographics, length of stay (LOS), in-hospital costs, mortality, and perioperative complications. Patients who underwent revision for either one- to two-level cervical TDR or ACDF were identified. SPSS v.20 was used for statistical analysis with χ(2) test for categorical data and independent sample t test for continuous data. The relative risk for perioperative complications with revisions was calculated in comparison with primary cases using a 95% confidence interval. An alpha level of less than 0.05 denoted statistical significance. There were 3,536 revision one- to two-level ACDFs and 256 revision cervical TDRs recorded in the NIS database from 2002 to 2011. The revision cervical TDR cohort demonstrated a significantly greater LOS (3.18 vs. 2.25, p<.001), cost ($16,998 vs. $15,222, p=.03), and incidence of perioperative wound infections (13.6 vs. 5.3 per 1,000, p<.001) compared with the ACDF revision cohort (p<.001). There were no differences in mortality between the revision surgical cohorts. Compared with primary cases, both revision cohorts demonstrated a significantly greater LOS and cost. Furthermore, patients who underwent revision demonstrated a greater incidence and risk for perioperative wound infections, hematomas, dysphagia, and neurologic complications relative to the primary procedures. This study demonstrated a significantly greater incidence of perioperative wound infection, LOS, and costs associated with a TDR revision compared with a revision ACDF. We propose that these differences are by virtue of the inherently more invasive nature of revising TDRs. In addition, compared with primary cases, revision procedures are associated with greater costs, LOS, and complications including wound infections, dysphagia, hematomas, and neurologic events. These additional risks must be considered before opting for a revision procedure. Copyright © 2014 Elsevier Inc. All rights reserved.

[THE FAILURE MODES AND EFFECTS ANALYSIS FACILITATES A SAFE, TIME AND MONEY SAVING OPEN ACCESS COLONOSCOPY SERVICE].

PubMed

Gingold-Belfer, Rachel; Niv, Yaron; Horev, Nehama; Gross, Shuli; Sahar, Nadav; Dickman, Ram

2017-04-01

Failure modes and effects analysis (FMEA) is used for the identification of potential risks in health care processes. We used a specific FMEA - based form for direct referral for colonoscopy and assessed it for procedurerelated perforations. Ten experts in endoscopy evaluated and computed the entire referral process, modes of preparation for the endoscopic procedure, the endoscopic procedure itself and the discharge process. We used FMEA assessing for likelihood of occurrence, detection and severity and calculated the risk profile number (RPN) for each of the above points. According to the highest RPN results we designed a specific open access referral form and then compared the occurrence of colonic perforations (between 2010 and 2013) in patients who were referred through the open access arm (Group 1) to those who had a prior clinical consultation (non-open access, Group 2). Our experts in endoscopy (5 physicians and 5 nurses) identified 3 categories of failure modes that, on average, reached the highest RPNs. We identified 9,558 colonoscopies in group 1, and 12,567 in group 2. Perforations were identified in three patients from the open access group (1:3186, 0.03%) and in 10 from group 2 (1:1256, 0.07%) (p = 0.024). Direct referral for colonoscopy saved 9,558 pre-procedure consultations and the sum of $850,000. The FMEA tool-based specific referral form facilitates a safe, time and money saving open access colonoscopy service. Our form may be adopted by other gastroenterological clinics in Israel.

Kidney stones may increase the risk of coronary heart disease and stroke: A PRISMA-Compliant meta-analysis.

PubMed

Peng, Jian-Ping; Zheng, Hang

2017-08-01

We aimed to quantitatively assess the potential relationship between kidney stones and coronary heart disease or stroke. A meta-analysis was conducted on eligibly studies published before 31 May 2016 in PubMed or Embase. The data were pooled, and the relationship was assessed by the random-effect model with inverse variance-weighted procedure. The results were expressed as relative risk (RR) with 95% confidence intervals (95%CI). Eight studies of 11 cohorts (n = 11) were included in our analysis with 3,658,360 participants and 157,037 cases. We found that a history of kidney stones was associated with increased risk of coronary heart disease (CHD) (RR = 1.24; 95%CI: 1.14-1.36; I = 79.0%, n = 11); similar effect on myocardial infarction, a serious condition of CHD, was observed (RR = 1.24; 95%CI: 1.10-1.40; I = 80.4%, n = 8). We also found that a history of kidney stones may increase the risk of stroke (RR = 1.21, 95%CI: 1.06-1.38; I = 54.7%, n = 4). In subgroup analysis, the risk of coronary heart disease was higher in men (RR = 1.23, 95%CI: 1.02-1.49) while the risk for stroke was higher in women (RR = 1.12; 95%CI: 1.03-1.21). No obvious publications bias was detected (Egger test: P = .47). Kidney stones are associated with increased risk of coronary heart disease and stroke, and the effect may differ by sex.

Effect of the full implementation of the European Working Time Directive on operative training in adult cardiac surgery.

PubMed

Mahesh, Balakrishnan; Sharples, Linda; Codispoti, Massimiliano

2014-01-01

Surgical specialties rely on practice and apprenticeship to acquire technical skills. In 2009, the final reduction in working hours to 48 per week, in accordance with the European Working Time Directive (EWTD), has also led to an expansion in the number of trainees. We examined the effect of these changes on operative training in a single high-volume [>1500 procedures/year] adult cardiac surgical center. Setting: A single high-volume [>1500 procedures/year] adult cardiac surgical center. Design: Consecutive data were prospectively collected into a database and retrospectively analyzed. Procedures and Main Outcome Measures: Between January 2006 and August 2010, 6688 consecutive adult cardiac surgical procedures were analyzed. The proportion of cases offered for surgical training were compared for 2 non-overlapping consecutive time periods: 4504 procedures were performed before the final implementation of the EWTD (Phase 1: January 2006-December 2008) and 2184 procedures after the final implementation of the EWTD (Phase 2: January 2009-August 2010). Other predictors of training considered in the analysis were grade of trainee, logistic European system for cardiac operative risk evaluation (EuroSCORE), type of surgical procedure, weekend or late procedure, and consultant. Logistic regression analysis was used to determine the predictors of training cases (procedure performed by trainee) and to evaluate the effect of the EWTD on operative surgical training after correcting for confounding factors. Proportion of training cases rose from 34.6% (1558/4504) during Phase 1 to 43.6% (953/2184) in Phase 2 (p < 0.0001), despite higher mean logistic EuroSCORE [4.29 (6.8) during Phase 1 vs 4.95 (7.2) during Phase 2, p < 0.0001] and higher proportion of cases performed out of hours [153 (3.4) during Phase 1 vs 116 (5.3) during Phase 2, p < 0.0001]. During Phase 1, senior trainees (last 2 years of training) performed 803 (17.8%) procedures, whereas other trainees (first 4 years of training) performed 755(16.8%) cases. During Phase 2, senior trainees performed 763 (34.9%) procedures, whereas other trainees performed 190 (8.7%) cases (p < 0.0001). Independent positive predictors of training cases emerging from the multivariable logistic regression model included consultant in charge, final EWTD, and senior trainees. Independent negative predictors of training cases included logistic EuroSCORE, out-of-hours' procedures, and surgery other than coronary artery bypass grafts. Implementation of the final phase of EWTD has not decreased training in a high-volume center. The positive adjustment of trainers' attitudes and efforts to match trainees' needs allow maintenance of adequate training, despite reduction in working hours and increasing patients' risk profile. Copyright © 2014 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Stenting versus endarterectomy for restenosis following prior ipsilateral carotid endarterectomy: an individual patient data meta-analysis.

PubMed

Fokkema, Margriet; Vrijenhoek, Joyce E P; Den Ruijter, Hester M; Groenwold, Rolf H H; Schermerhorn, Marc L; Bots, Michiel L; Pasterkamp, Gerard; Moll, Frans L; De Borst, Gert Jan

2015-03-01

To study perioperative results and restenosis during follow-up of carotid artery stenting (CAS) versus carotid endarterectomy (CEA) for restenosis after prior ipsilateral CEA in an individual patient data (IPD) meta-analysis. The optimal treatment strategy for patients with restenosis after CEA remains unknown. A comprehensive search of electronic databases (Medline, Embase) until July 1, 2013, was performed, supplemented by a review of references. Studies were considered for inclusion if they reported procedural outcome of CAS or CEA after prior ipsilateral CEA of a minimum of 5 patients. IPD were combined into 1 data set and an IPD meta-analysis was performed. The primary endpoint was perioperative stroke or death and the secondary endpoint was restenosis greater than 50% during follow-up, comparing CAS and CEA. In total, 13 studies were included, contributing to 1132 unique patients treated by CAS (10 studies, n = 653) or CEA (7 studies; n = 479). Among CAS and CEA patients, 30% versus 40% were symptomatic, respectively (P < 0.01). After adjusting for potential confounders, the primary endpoint did not differ between CAS and CEA groups (2.3% vs 2.7%, adjusted odds ratio 0.8, 95% confidence interval (CI): 0.4-1.8). Also, the risk of restenosis during a median follow-up of 13 months was similar for both groups (hazard ratio 1.4, 95% (CI): 0.9-2.2). Cranial nerve injury (CNI) was 5.5% in the CEA group, while CAS was in 5% associated with other procedural related complications. In patients with restenosis after CEA, CAS and CEA showed similar low rates of stroke, death, and restenosis at short-term follow-up. Still, the risk of CNI and other procedure-related complications should be taken into account.

Constellation Probabilistic Risk Assessment (PRA): Design Consideration for the Crew Exploration Vehicle

NASA Technical Reports Server (NTRS)

Prassinos, Peter G.; Stamatelatos, Michael G.; Young, Jonathan; Smith, Curtis

2010-01-01

Managed by NASA's Office of Safety and Mission Assurance, a pilot probabilistic risk analysis (PRA) of the NASA Crew Exploration Vehicle (CEV) was performed in early 2006. The PRA methods used follow the general guidance provided in the NASA PRA Procedures Guide for NASA Managers and Practitioners'. Phased-mission based event trees and fault trees are used to model a lunar sortie mission of the CEV - involving the following phases: launch of a cargo vessel and a crew vessel; rendezvous of these two vessels in low Earth orbit; transit to th$: moon; lunar surface activities; ascension &om the lunar surface; and return to Earth. The analysis is based upon assumptions, preliminary system diagrams, and failure data that may involve large uncertainties or may lack formal validation. Furthermore, some of the data used were based upon expert judgment or extrapolated from similar componentssystemsT. his paper includes a discussion of the system-level models and provides an overview of the analysis results used to identify insights into CEV risk drivers, and trade and sensitivity studies. Lastly, the PRA model was used to determine changes in risk as the system configurations or key parameters are modified.