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.

Management of heart failure in the new era: the role of scores.

PubMed

Mantegazza, Valentina; Badagliacca, Roberto; Nodari, Savina; Parati, Gianfranco; Lombardi, Carolina; Di Somma, Salvatore; Carluccio, Erberto; Dini, Frank Lloyd; Correale, Michele; Magrì, Damiano; Agostoni, Piergiuseppe

2016-08-01

Heart failure is a widespread syndrome involving several organs, still characterized by high mortality and morbidity, and whose clinical course is heterogeneous and hardly predictable.In this scenario, the assessment of heart failure prognosis represents a fundamental step in clinical practice. A single parameter is always unable to provide a very precise prognosis. Therefore, risk scores based on multiple parameters have been introduced, but their clinical utility is still modest. In this review, we evaluated several prognostic models for acute, right, chronic, and end-stage heart failure based on multiple parameters. In particular, for chronic heart failure we considered risk scores essentially based on clinical evaluation, comorbidities analysis, baroreflex sensitivity, heart rate variability, sleep disorders, laboratory tests, echocardiographic imaging, and cardiopulmonary exercise test parameters. What is at present established is that a single parameter is not sufficient for an accurate prediction of prognosis in heart failure because of the complex nature of the disease. However, none of the scoring systems available is widely used, being in some cases complex, not user-friendly, or based on expensive or not easily available parameters. We believe that multiparametric scores for risk assessment in heart failure are promising but their widespread use needs to be experienced.

Risk of renal failure with the non-vitamin K antagonist oral anticoagulants: systematic review and meta-analysis.

PubMed

Caldeira, Daniel; Gonçalves, Nilza; Pinto, Fausto J; Costa, João; Ferreira, Joaquim J

2015-07-01

Vitamin K antagonists (VKA)-related nephropathy is a novel entity characterized by acute kidney injury related to International Normalized Ratio supratherapeutic levels. Non-vitamin K antagonists oral anticoagulants (NOACs) have a predictable dose-response relationship and an improved safety profile. We hypothesized that these drugs do not have an increased risk of incident renal failure, which may be detrimental for the use of NOACs. Systematic review and meta-analysis of phase III randomized controlled trials (RCTs). Trials were searched through Medline, Cochrane Library and public assessment reports in August 2014. Primary outcome was renal failure. NOACs were evaluated against any comparator. Random-effects meta-analysis was performed by default, and pooled estimates were expressed as Risk Ratio (RR) and 95%CI. Heterogeneity was evaluated with I(2) test. Ten RCTs fulfilled inclusion criteria (one apixaban RCT, three dabigatran RCTs, and six rivaroxaban RCTs), enrolling 75 100 patients. Overall NOACs did not increase the risk of renal failure with an RR 0.96, 95%CI 0.88-1.05 compared with VKA or Low-molecular weight heparin (LMWH), without significant statistical heterogeneity (I(2)  = 3.5%). Compared with VKA, NOACs did not increase the risk of renal failure (RR 0.96, 95%CI 0.87-1.07; I(2)  = 17.8%; six RCTs). Rivaroxaban did not show differences in the incidence of renal failure compared with LMWH (RR 1.20, 95%CI 0.37-3.94; four trials), but there was an increased risk of creatinine elevation RR 1.25, 95%CI 1.08-1.45; I(2)  = 0%. NOACs had a similar risk of renal failure compared with VKA/LMWH in phase III RCTs. Post-marketing surveillance should be warranted. Copyright © 2015 John Wiley & Sons, Ltd.

Mechanical Restoration and Failure Analyses of a Hydrogel and Scaffold Composite Strategy for Annulus Fibrosus Repair

PubMed Central

Long, Rose G; Bürki, Alexander; Zysset, Philippe; Eglin, David; Grijpma, Dirk W.; Blanquer, Sebastien BG; Hecht, Andrew C; Iatridis, James C

2015-01-01

Unrepaired defects in the annulus fibrosus of intervertebral discs are associated with degeneration and persistent back pain. A clinical need exists for a disc repair strategy that can seal annular defects, be easily delivered during surgical procedures, and restore biomechanics with low risk of herniation. Multiple annulus repair strategies were developed using poly(trimethylene carbonate) scaffolds optimized for cell delivery, polyurethane membranes designed to prevent herniation, and fibrin-genipin adhesive tuned to annulus fibrosus shear properties. This three-part study evaluated repair strategies for biomechanical restoration, herniation risk and failure mode in torsion, bending and compression at physiological and hyper-physiological loads using a bovine injury model. Fibrin-genipin hydrogel restored some torsional stiffness, bending ROM and disc height loss, with negligible herniation risk and failure was observed histologically at the fibrin-genipin mid-substance following rigorous loading. Scaffold-based repairs partially restored biomechanics, but had high herniation risk even when stabilized with sutured membranes and failure was observed histologically at the interface between scaffold and fibrin-genipin adhesive. Fibrin-genipin was the simplest annulus fibrosus repair solution evaluated that involved an easily deliverable adhesive that filled irregularly-shaped annular defects and partially restored disc biomechanics with low herniation risk, suggesting further evaluation for disc repair may be warranted. PMID:26577987

Evaluating the risk of water distribution system failure: A shared frailty model

NASA Astrophysics Data System (ADS)

Clark, Robert M.; Thurnau, Robert C.

2011-12-01

Condition assessment (CA) Modeling is drawing increasing interest as a technique that can assist in managing drinking water infrastructure. This paper develops a model based on the application of a Cox proportional hazard (PH)/shared frailty model and applies it to evaluating the risk of failure in drinking water networks using data from the Laramie Water Utility (located in Laramie, Wyoming, USA). Using the risk model a cost/ benefit analysis incorporating the inspection value method (IVM), is used to assist in making improved repair, replacement and rehabilitation decisions for selected drinking water distribution system pipes. A separate model is developed to predict failures in prestressed concrete cylinder pipe (PCCP). Various currently available inspection technologies are presented and discussed.

Does early reading failure decrease children's reading motivation?

PubMed

Morgan, Paul L; Fuchs, Douglas; Compton, Donald L; Cordray, David S; Fuchs, Lynn S

2008-01-01

The authors used a pretest-posttest control group design with random assignment to evaluate whether early reading failure decreases children's motivation to practice reading. First, they investigated whether 60 first-grade children would report substantially different levels of interest in reading as a function of their relative success or failure in learning to read. Second, they evaluated whether increasing the word reading ability of 15 at-risk children would lead to gains in their motivation to read. Multivariate analyses of variance suggest marked differences in both motivation and reading practice between skilled and unskilled readers. However, bolstering at-risk children's word reading ability did not yield evidence of a causal relationship between early reading failure and decreased motivation to engage in reading activities. Instead, hierarchical regression analyses indicate a covarying relationship among early reading failure, poor motivation, and avoidance of reading.

Serum creatinine and bilirubin predict renal failure and mortality in patients with spontaneous bacterial peritonitis: a retrospective study.

PubMed

Terg, Rubén; Gadano, Adrian; Cartier, Mariano; Casciato, Paola; Lucero, Romina; Muñoz, Alberto; Romero, Gustavo; Levi, Diana; Terg, Gonzalo; Miguez, Carlos; Abecasis, Raquel

2009-03-01

Patients with spontaneous bacterial peritonitis (SBP) are at a high risk for renal failure and death despite successful treatment of infection. Intravenous (IV) albumin administration combined with antibiotic treatment has been shown to significantly decrease these risks. Clinical evidence is lacking on which patients are appropriate candidates for albumin treatment. To retrospectively analyse the usefulness of serum creatinine and bilirubin levels in predicting renal failure and mortality of patients hospitalized for SBP. Between March 1995 and September 1998, 127 cirrhotic patients with SBP who had not received plasma expansion were evaluated. Eighty-one patients (64%) were classified as having a high risk for renal failure and mortality (serum bilirubin >4 mg/dl or serum creatinine >1 mg/dl) and 46 (36%) as having a low risk. At admission, 36.3% of all patients presented renal failure. Mortality during their hospitalization was 23% among those with a high risk and 6.5% among those with a low risk (P=0.01). Renal failure occurred in 23% of the high-risk patients, compared with 2.6% of the low-risk patients (P=0.006). The presence of hyponatraemia was significantly associated with higher mortality and renal failure in the high-risk group. Our retrospective review of patients with SBP suggests that serum bilirubin levels >4 mg and serum creatinine levels >1 mg/dl at the time of diagnosis represent significant risk factors for the clinical outcomes of patients with SBP. Patients without these risk factors may have a very low likelihood of death or renal failure.

Use of Failure Mode and Effects Analysis to Improve Emergency Department Handoff Processes.

PubMed

Sorrentino, Patricia

2016-01-01

The purpose of this article is to describe a quality improvement process using failure mode and effects analysis (FMEA) to evaluate systems handoff communication processes, improve emergency department (ED) throughput and reduce crowding through development of a standardized handoff, and, ultimately, improve patient safety. Risk of patient harm through ineffective communication during handoff transitions is a major reason for breakdown of systems. Complexities of ED processes put patient safety at risk. An increased incidence of submitted patient safety event reports for handoff communication failures between the ED and inpatient units solidified a decision to implement the use of FMEA to identify handoff failures to mitigate patient harm through redesign. The clinical nurse specialist implemented an FMEA. Handoff failure themes were created from deidentified retrospective reviews. Weekly meetings were held over a 3-month period to identify failure modes and determine cause and effect on the process. A functional block diagram process map tool was used to illustrate handoff processes. An FMEA grid was used to list failure modes and assign a risk priority number to quantify results. Multiple areas with actionable failures were identified. A majority of causes for high-priority failure modes were specific to communications. Findings demonstrate the complexity of transition and handoff processes. The FMEA served to identify and evaluate risk of handoff failures and provide a framework for process improvement. A focus on mentoring nurses to quality handoff processes so that it becomes habitual practice is crucial to safe patient transitions. Standardizing content and hardwiring within the system are best practice. The clinical nurse specialist is prepared to provide strong leadership to drive and implement system-wide quality projects.

Pouch functional outcomes after restorative proctocolectomy with ileal-pouch reconstruction in patients with ulcerative colitis: Japanese multi-center nationwide cohort study.

PubMed

Uchino, Motoi; Ikeuchi, Hiroki; Sugita, Akira; Futami, Kitaro; Watanabe, Toshiaki; Fukushima, Kouhei; Tatsumi, Kenji; Koganei, Kazutaka; Kimura, Hideaki; Hata, Keisuke; Takahashi, Kenichi; Watanabe, Kazuhiro; Mizushima, Tsunekazu; Funayama, Yuji; Higashi, Daijiro; Araki, Toshimitsu; Kusunoki, Masato; Ueda, Takeshi; Koyama, Fumikazu; Itabashi, Michio; Nezu, Riichiro; Suzuki, Yasuo

2018-05-01

Although several complications capable of causing pouch failure may develop after restorative proctocolectomy (RPC) for ulcerative colitis (UC), the incidences and causes are conflicting and vary according to country, race and institution. To avoid pouch failure, this study aimed to evaluate the rate of pouch failure and its risk factors in UC patients over the past decade via a nationwide cohort study. We conducted a retrospective, observational, multicenter study that included 13 institutions in Japan. Patients who underwent RPC between January 2005 and December 2014 were included. The characteristics and backgrounds of the patients before and during surgery and their postoperative courses and complications were reviewed. A total of 2376 patients were evaluated over 6.7 ± 3.5 years of follow-up. Twenty-seven non-functional pouches were observed, and the functional pouch rate was 98.9% after RPC. Anastomotic leakage (odds ratio, 9.1) was selected as a risk factor for a non-functional pouch. The cumulative pouch failure rate was 4.2%/10 years. A change in diagnosis to Crohn's disease/indeterminate colitis (hazard ratio, 13.2) was identified as an independent risk factor for pouch failure. The significant risk factor for a non-functional pouch was anastomotic leakage. The optimal staged surgical procedure should be selected according to a patient's condition to avoid anastomotic failure during RPC. Changes in diagnosis after RPC confer a substantial risk of pouch failure. Additional cohort studies are needed to obtain an understanding of the long-standing clinical course of and proper treatment for pouch failure.

An improved approach for flight readiness certification: Probabilistic models for flaw propagation and turbine blade failure. Volume 1: Methodology and applications

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 analytical modeling of failure phenomena 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 analytical modeling, is expensive or difficult to acquire. The PFA methodology is a prescribed statistical structure in which analytical 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. State-of-the-art analytical models currently employed for designs failure prediction, or performance analysis are used in this methodology. The rationale for the statistical approach taken in the PFA methodology is discussed, the PFA methodology is described, and examples of its application to structural failure modes are presented. The engineering models and computer software used in fatigue crack growth and fatigue crack initiation applications are thoroughly documented.

An improved approach for flight readiness certification: Probabilistic models for flaw propagation and turbine blade failure. 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 spaceflights 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 analytical modeling of failure phenomena 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 analytical modeling, is expensive or difficult to acquire. The PFA methodology is a prescribed statistical structure in which analytical 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. State-of-the-art analytical models currently employed for design, failure prediction, or performance analysis are used in this methodology. The rationale for the statistical approach taken in the PFA methodology is discussed, the PFA methodology is described, and examples of its application to structural failure modes are presented. The engineering models and computer software used in fatigue crack growth and fatigue crack initiation applications are thoroughly documented.

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 management of key issues of FPSO

NASA Astrophysics Data System (ADS)

Sun, Liping; Sun, Hai

2012-12-01

Risk analysis of key systems have become a growing topic late of because of the development of offshore structures. Equipment failures of offloading system and fire accidents were analyzed based on the floating production, storage and offloading (FPSO) features. Fault tree analysis (FTA), and failure modes and effects analysis (FMEA) methods were examined based on information already researched on modules of relex reliability studio (RRS). Equipment failures were also analyzed qualitatively by establishing a fault tree and Boolean structure function based on the shortage of failure cases, statistical data, and risk control measures examined. Failure modes of fire accident were classified according to the different areas of fire occurrences during the FMEA process, using risk priority number (RPN) methods to evaluate their severity rank. The qualitative analysis of FTA gave the basic insight of forming the failure modes of FPSO offloading, and the fire FMEA gave the priorities and suggested processes. The research has practical importance for the security analysis problems of FPSO.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct.

PubMed

Lee, Howard; Lee, Heechan; Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

Data Analysis

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

Powell, Danny H; Elwood Jr, Robert H

2011-01-01

Analysis of the material protection, control, and accountability (MPC&A) system is necessary to understand the limits and vulnerabilities of the system to internal threats. A self-appraisal helps the facility be prepared to respond to internal threats and reduce the risk of theft or diversion of nuclear material. The material control and accountability (MC&A) system effectiveness tool (MSET) fault tree was developed to depict the failure of the MPC&A system as a result of poor practices and random failures in the MC&A system. It can also be employed as a basis for assessing deliberate threats against a facility. MSET uses faultmore » tree analysis, which is a top-down approach to examining system failure. The analysis starts with identifying a potential undesirable event called a 'top event' and then determining the ways it can occur (e.g., 'Fail To Maintain Nuclear Materials Under The Purview Of The MC&A System'). The analysis proceeds by determining how the top event can be caused by individual or combined lower level faults or failures. These faults, which are the causes of the top event, are 'connected' through logic gates. The MSET model uses AND-gates and OR-gates and propagates the effect of event failure using Boolean algebra. To enable the fault tree analysis calculations, the basic events in the fault tree are populated with probability risk values derived by conversion of questionnaire data to numeric values. The basic events are treated as independent variables. This assumption affects the Boolean algebraic calculations used to calculate results. All the necessary calculations are built into the fault tree codes, but it is often useful to estimate the probabilities manually as a check on code functioning. The probability of failure of a given basic event is the probability that the basic event primary question fails to meet the performance metric for that question. The failure probability is related to how well the facility performs the task identified in that basic event over time (not just one performance or exercise). Fault tree calculations provide a failure probability for the top event in the fault tree. The basic fault tree calculations establish a baseline relative risk value for the system. This probability depicts relative risk, not absolute risk. Subsequent calculations are made to evaluate the change in relative risk that would occur if system performance is improved or degraded. During the development effort of MSET, the fault tree analysis program used was SAPHIRE. SAPHIRE is an acronym for 'Systems Analysis Programs for Hands-on Integrated Reliability Evaluations.' Version 1 of the SAPHIRE code was sponsored by the Nuclear Regulatory Commission in 1987 as an innovative way to draw, edit, and analyze graphical fault trees primarily for safe operation of nuclear power reactors. When the fault tree calculations are performed, the fault tree analysis program will produce several reports that can be used to analyze the MPC&A system. SAPHIRE produces reports showing risk importance factors for all basic events in the operational MC&A system. The risk importance information is used to examine the potential impacts when performance of certain basic events increases or decreases. The initial results produced by the SAPHIRE program are considered relative risk values. None of the results can be interpreted as absolute risk values since the basic event probability values represent estimates of risk associated with the performance of MPC&A tasks throughout the material balance area (MBA). The RRR for a basic event represents the decrease in total system risk that would result from improvement of that one event to a perfect performance level. Improvement of the basic event with the greatest RRR value produces a greater decrease in total system risk than improvement of any other basic event. Basic events with the greatest potential for system risk reduction are assigned performance improvement values, and new fault tree calculations show the improvement in total system risk. The operational impact or cost-effectiveness from implementing the performance improvements can then be evaluated. The improvements being evaluated can be system performance improvements, or they can be potential, or actual, upgrades to the system. The RIR for a basic event represents the increase in total system risk that would result from failure of that one event. Failure of the basic event with the greatest RIR value produces a greater increase in total system risk than failure of any other basic event. Basic events with the greatest potential for system risk increase are assigned failure performance values, and new fault tree calculations show the increase in total system risk. This evaluation shows the importance of preventing performance degradation of the basic events. SAPHIRE identifies combinations of basic events where concurrent failure of the events results in failure of the top event.« less

[Use of antihypertensive drug therapy and risk of development of congestive heart failure].

PubMed

Sobrino, Javier; Plana, Jaume; Felip, Angela; Doménech, Mónica; Reth, Peter; Adrián, María Jesús; de la Sierra, Alejandro

2004-09-18

It has been suggested that the use of some antihypertensive agents may favour the development of congestive heart failure. The aim of the present study was to evaluate such a possible association in patients who had a new diagnosis of congestive heart failure. This was a retrospective case-control study of 81 patients who had a first hospital admission with a new diagnosis of congestive heart failure (cases) and 162 patients admitted for other hypertensive complications (controls). Previous antihypertensive drug use was registered and the possible association with congestive heart failure was evaluated. The presence of congestive heart failure was not associated with the use of any antihypertensive drug class. When treatments were grouped in classic (diuretics and betablockers) or modern (calcium channel blockers, angiotensin-converting-enzyme inhibitors, alphablockers or angiotensin receptor blockers), a negative association was observed with the latter group, which was observed in 48.1% of cases and 63.6% of controls (odds ratio: 0.532; 95% confidence interval, 0.310-0.913). This association was lost after adjustment for other cardiovascular risk factors or previous hypertensive complications. The development of congestive heart failure was not associated with the use of any specific antihypertensive drug class. From the present evidence, it is not possible to recommend a specific antihypertensive agent in patients at risk of developing congestive heart failure but without evidence of such disease.

The Use of Probabilistic Methods to Evaluate the Systems Impact of Component Design Improvements on Large Turbofan Engines

NASA Technical Reports Server (NTRS)

Packard, Michael H.

2002-01-01

Probabilistic Structural Analysis (PSA) is now commonly used for predicting the distribution of time/cycles to failure of turbine blades and other engine components. These distributions are typically based on fatigue/fracture and creep failure modes of these components. Additionally, reliability analysis is used for taking test data related to particular failure modes and calculating failure rate distributions of electronic and electromechanical components. How can these individual failure time distributions of structural, electronic and electromechanical component failure modes be effectively combined into a top level model for overall system evaluation of component upgrades, changes in maintenance intervals, or line replaceable unit (LRU) redesign? This paper shows an example of how various probabilistic failure predictions for turbine engine components can be evaluated and combined to show their effect on overall engine performance. A generic model of a turbofan engine was modeled using various Probabilistic Risk Assessment (PRA) tools (Quantitative Risk Assessment Software (QRAS) etc.). Hypothetical PSA results for a number of structural components along with mitigation factors that would restrict the failure mode from propagating to a Loss of Mission (LOM) failure were used in the models. The output of this program includes an overall failure distribution for LOM of the system. The rank and contribution to the overall Mission Success (MS) is also given for each failure mode and each subsystem. This application methodology demonstrates the effectiveness of PRA for assessing the performance of large turbine engines. Additionally, the effects of system changes and upgrades, the application of different maintenance intervals, inclusion of new sensor detection of faults and other upgrades were evaluated in determining overall turbine engine reliability.

Recipient Risk Factors for Graft Failure in the Cornea Donor Study

PubMed Central

Sugar, Alan; Tanner, Jean Paul; Dontchev, Mariya; Tennant, Brad; Schultze, Robert L.; Dunn, Steven P.; Lindquist, Thomas D.; Gal, Robin L.; Beck, Roy W.; Kollman, Craig; Mannis, Mark J.; Holland, Edward J.

2009-01-01

Purpose Identify recipient factors which may be related to risk of corneal graft failure Design Multi-center prospective, double-masked, controlled clinical trial Participants 1090 subjects undergoing corneal transplantation for a moderate risk condition (principally Fuchs’ dystrophy or pseudophakic corneal edema) Methods Donor corneas were assigned using a random approach without respect to recipient factors, and surgeons were masked to information about the donor cornea including donor age. Surgery and post-operative care were performed according to the surgeons’ usual routines and subjects were followed for five years. Baseline factors were evaluated for their association with graft failure. Main Outcome Measures Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque to compromise vision for a minimum of three consecutive months. Results Preoperative diagnosis of pseudophakic/aphakic corneal edema increased graft failure risk approximately 4-fold compared with Fuchs’ dystrophy (27% vs. 7%). Prior glaucoma surgery with preoperative glaucoma medication use substantially increased the graft failure rate. Factors not strongly associated with graft failure included age, gender, diabetes, smoking, and graft size. Conclusion The risk of graft failure is significantly increased in eyes with pseudophakic or aphakic corneal edema compared with Fuchs’ dystrophy, independent of lens status, and in eyes with a history of glaucoma. PMID:19395036

The effect of adhesive failure and defects on the stress distribution in all-ceramic crowns.

PubMed

Liu, Yonggang; Xu, Yuanzhi; Su, Bo; Arola, Dwayne; Zhang, Dongsheng

2018-05-29

To explore the effect of adhesive failure and defects between the crown and cement on the stress distribution within all-ceramic crowns and the corresponding risk of failure. An IPS e.max crown of lithium disilicate produced by CAD/CAM for a first mandibular molar was modeled using finite element analysis based on X-ray micro-CT scanned images. Predefined debonding states and interfacial defects between the crown and cement were simulated using the model. The first principal stress distribution of the crown and cement was analyzed under a vertical occlusal load of 600 N. A concept of failure risk was proposed to evaluate the crown. Stress concentrations in the crown were identified on the occlusal surface surrounding the region of loading, beneath the area of loading and at the margin of the interior surface. Stress concentrations in the cement were also evident at the boundary of the debonded areas. The lower surface of the crown is safe to sustain the 600 N vertical load, but the top surface of the cement would undergo cohesive failure. According to the evaluation of failure risk of the crown, the conditions of highest risk corresponded to the conditions with highest percentage of cement damage. The risk of failure is not only associated with debonding between the crown and cement, but also associated with its distribution. Debonding related defects and cementing defects are more deleterious to the interfacial stress than debonding itself. The axial wall plays a critical role in maintaining the principal tensile stress of the crown at an acceptable level. Copyright © 2018 Elsevier Ltd. All rights reserved.

Study on Failure of Third-Party Damage for Urban Gas Pipeline Based on Fuzzy Comprehensive Evaluation.

PubMed

Li, Jun; Zhang, Hong; Han, Yinshan; Wang, Baodong

2016-01-01

Focusing on the diversity, complexity and uncertainty of the third-party damage accident, the failure probability of third-party damage to urban gas pipeline was evaluated on the theory of analytic hierarchy process and fuzzy mathematics. The fault tree of third-party damage containing 56 basic events was built by hazard identification of third-party damage. The fuzzy evaluation of basic event probabilities were conducted by the expert judgment method and using membership function of fuzzy set. The determination of the weight of each expert and the modification of the evaluation opinions were accomplished using the improved analytic hierarchy process, and the failure possibility of the third-party to urban gas pipeline was calculated. Taking gas pipelines of a certain large provincial capital city as an example, the risk assessment structure of the method was proved to conform to the actual situation, which provides the basis for the safety risk prevention.

BMI change during puberty and the risk of heart failure.

PubMed

Kindblom, J M; Bygdell, M; Sondén, A; Célind, J; Rosengren, A; Ohlsson, C

2018-03-12

Hospitalization for heart failure amongst younger men has increased. The reason for this is unknown but it coincides with the obesity epidemic. The aim of this study was to evaluate the association between childhood BMI (Body Mass Index) and BMI change during puberty for risk of adult heart failure in men. Using the BMI Epidemiology Study (BEST), a population-based study in Gothenburg, Sweden, we collected information on childhood BMI at age 8 years and BMI change during puberty (BMI at age 20 - BMI at 8) for men born 1945-1961, followed until December 2013 (n = 37 670). BMI was collected from paediatric growth charts and mandatory military conscription tests. Information on heart failure was retrieved from high-quality national registers (342 first hospitalizations for heart failure). BMI change during puberty was independently of childhood BMI associated with risk of heart failure in a nonlinear J-shaped manner. Subjects in the upper quartile of BMI change during puberty (Q4) had more than twofold increased risk of heart failure compared with subjects in Q1 [HR (Hazard Ratio) = 2.29, 95% CI (Confidence Interval) 1.68-3.12]. Childhood BMI was not independently associated with risk of heart failure. Boys developing overweight during puberty (HR 3.14; 95% CI 2.25-4.38) but not boys with childhood overweight that normalized during puberty (HR 1.12, 95% CI 0.63-2.00) had increased risk of heart failure compared with boys without childhood or young adult overweight. BMI change during puberty is a novel risk factor for adult heart failure in men. © 2018 The Association for the Publication of the Journal of Internal Medicine.

Development and evaluation of a composite risk score to predict kidney transplant failure.

PubMed

Moore, Jason; He, Xiang; Shabir, Shazia; Hanvesakul, Rajesh; Benavente, David; Cockwell, Paul; Little, Mark A; Ball, Simon; Inston, Nicholas; Johnston, Atholl; Borrows, Richard

2011-05-01

Although risk factors for kidney transplant failure are well described, prognostic risk scores to estimate risk in prevalent transplant recipients are limited. Development and validation of risk-prediction instruments. The development data set included 2,763 prevalent patients more than 12 months posttransplant enrolled into the LOTESS (Long Term Efficacy and Safety Surveillance) Study. The validation data set included 731 patients who underwent transplant at a single UK center. Estimated glomerular filtration rate (eGFR) and other risk factors were evaluated using Cox regression. Scores for death-censored and overall transplant failure were based on the summed hazard ratios for baseline predictor variables. Predictive performance was assessed using calibration (Hosmer-Lemeshow statistic), discrimination (C statistic), and clinical reclassification (net reclassification improvement) compared with eGFR alone. In the development data set, 196 patients died and another 225 experienced transplant failure. eGFR, recipient age, race, serum urea and albumin levels, declining eGFR, and prior acute rejection predicted death-censored transplant failure. eGFR, recipient age, sex, serum urea and albumin levels, and declining eGFR predicted overall transplant failure. In the validation data set, 44 patients died and another 101 experienced transplant failure. The weighted scores comprising these variables showed adequate discrimination and calibration for death-censored (C statistic, 0.83; 95% CI, 0.75-0.91; Hosmer-Lemeshow χ(2)P = 0.8) and overall (C statistic, 0.70; 95% CI, 0.64-0.77; Hosmer-Lemeshow χ(2)P = 0.5) transplant failure. However, the scores failed to reclassify risk compared with eGFR alone (net reclassification improvements of 7.6% [95% CI, -0.2 to 13.4; P = 0.09] and 4.3% [95% CI, -2.7 to 11.8; P = 0.3] for death-censored and overall transplant failure, respectively). Retrospective analysis of predominantly cyclosporine-treated patients; limited study size and categorization of variables may limit power to detect effect. Although the scores performed well regarding discrimination and calibration, clinically relevant risk reclassification over eGFR alone was not evident, emphasizing the stringent requirements for such scores. Further studies are required to develop and refine this process. Copyright © 2011 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

PubMed Central

Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Background Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. Methods A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. Results A total of 114 failure modes were identified with an RPN score ranging 3–378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. Conclusions FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes. PMID:29089745

High-sensitivity cardiac troponin I and risk of heart failure in patients with suspected acute coronary syndrome: a cohort study.

PubMed

Stelzle, Dominik; Shah, Anoop S V; Anand, Atul; Strachan, Fiona E; Chapman, Andrew R; Denvir, Martin A; Mills, Nicholas L; McAllister, David A

2018-01-01

Heart failure may occur following acute myocardial infarction, but with the use of high-sensitivity cardiac troponin assays we increasingly diagnose patients with minor myocardial injury. Whether troponin concentrations remain a useful predictor of heart failure in patients with acute coronary syndrome is uncertain. We identified all consecutive patients (n = 4748) with suspected acute coronary syndrome (61 ± 16 years, 57% male) presenting to three secondary and tertiary care hospitals. Cox-regression models were used to evaluate the association between high-sensitivity cardiac troponin I concentration and subsequent heart failure hospitalization. C-statistics were estimated to evaluate the predictive value of troponin for heart failure hospitalization. Over 2071 years of follow-up there were 83 heart failure hospitalizations. Patients with troponin concentrations above the upper reference limit (URL) were more likely to be hospitalized with heart failure than patients below the URL (118/1000 vs. 17/1000 person years, adjusted hazard ratio: 7.0). Among patients with troponin concentrations

Risk management for outsourcing biomedical waste disposal – Using the failure mode and effects analysis

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

Liao, Ching-Jong; Ho, Chao Chung, E-mail: ho919@pchome.com.tw

Highlights: • This study is based on a real case in hospital in Taiwan. • We use Failure Mode and Effects Analysis (FMEA) as the evaluation method. • We successfully identify the evaluation factors of bio-medical waste disposal risk. - Abstract: Using the failure mode and effects analysis, this study examined biomedical waste companies through risk assessment. Moreover, it evaluated the supervisors of biomedical waste units in hospitals, and factors relating to the outsourcing risk assessment of biomedical waste in hospitals by referring to waste disposal acts. An expert questionnaire survey was conducted on the personnel involved in waste disposalmore » units in hospitals, in order to identify important factors relating to the outsourcing risk of biomedical waste in hospitals. This study calculated the risk priority number (RPN) and selected items with an RPN value higher than 80 for improvement. These items included “availability of freezing devices”, “availability of containers for sharp items”, “disposal frequency”, “disposal volume”, “disposal method”, “vehicles meeting the regulations”, and “declaration of three lists”. This study also aimed to identify important selection factors of biomedical waste disposal companies by hospitals in terms of risk. These findings can serve as references for hospitals in the selection of outsourcing companies for biomedical waste disposal.« less

Failure mode and effects analysis using intuitionistic fuzzy hybrid weighted Euclidean distance operator

NASA Astrophysics Data System (ADS)

Liu, Hu-Chen; Liu, Long; Li, Ping

2014-10-01

Failure mode and effects analysis (FMEA) has shown its effectiveness in examining potential failures in products, process, designs or services and has been extensively used for safety and reliability analysis in a wide range of industries. However, its approach to prioritise failure modes through a crisp risk priority number (RPN) has been criticised as having several shortcomings. The aim of this paper is to develop an efficient and comprehensive risk assessment methodology using intuitionistic fuzzy hybrid weighted Euclidean distance (IFHWED) operator to overcome the limitations and improve the effectiveness of the traditional FMEA. The diversified and uncertain assessments given by FMEA team members are treated as linguistic terms expressed in intuitionistic fuzzy numbers (IFNs). Intuitionistic fuzzy weighted averaging (IFWA) operator is used to aggregate the FMEA team members' individual assessments into a group assessment. IFHWED operator is applied thereafter to the prioritisation and selection of failure modes. Particularly, both subjective and objective weights of risk factors are considered during the risk evaluation process. A numerical example for risk assessment is given to illustrate the proposed method finally.

High Risk of Graft Failure in Emerging Adult Heart Transplant Recipients.

PubMed

Foster, B J; Dahhou, M; Zhang, X; Dharnidharka, V; Ng, V; Conway, J

2015-12-01

Emerging adulthood (17-24 years) is a period of high risk for graft failure in kidney transplant. Whether a similar association exists in heart transplant recipients is unknown. We sought to estimate the relative hazards of graft failure at different current ages, compared with patients between 20 and 24 years old. We evaluated 11 473 patients recorded in the Scientific Registry of Transplant Recipients who received a first transplant at <40 years old (1988-2013) and had at least 6 months of graft function. Time-dependent Cox models were used to estimate the association between current age (time-dependent) and failure risk, adjusted for time since transplant and other potential confounders. Failure was defined as death following graft failure or retransplant; observation was censored at death with graft function. There were 2567 failures. Crude age-specific graft failure rates were highest in 21-24 year olds (4.2 per 100 person-years). Compared to individuals with the same time since transplant, 21-24 year olds had significantly higher failure rates than all other age periods except 17-20 years (HR 0.92 [95%CI 0.77, 1.09]) and 25-29 years (0.86 [0.73, 1.03]). Among young first heart transplant recipients, graft failure risks are highest in the period from 17 to 29 years of age. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

Failure mode and effect analysis: improving intensive care unit risk management processes.

PubMed

Askari, Roohollah; Shafii, Milad; Rafiei, Sima; Abolhassani, Mohammad Sadegh; Salarikhah, Elaheh

2017-04-18

Purpose Failure modes and effects analysis (FMEA) is a practical tool to evaluate risks, discover failures in a proactive manner and propose corrective actions to reduce or eliminate potential risks. The purpose of this paper is to apply FMEA technique to examine the hazards associated with the process of service delivery in intensive care unit (ICU) of a tertiary hospital in Yazd, Iran. Design/methodology/approach This was a before-after study conducted between March 2013 and December 2014. By forming a FMEA team, all potential hazards associated with ICU services - their frequency and severity - were identified. Then risk priority number was calculated for each activity as an indicator representing high priority areas that need special attention and resource allocation. Findings Eight failure modes with highest priority scores including endotracheal tube defect, wrong placement of endotracheal tube, EVD interface, aspiration failure during suctioning, chest tube failure, tissue injury and deep vein thrombosis were selected for improvement. Findings affirmed that improvement strategies were generally satisfying and significantly decreased total failures. Practical implications Application of FMEA in ICUs proved to be effective in proactively decreasing the risk of failures and corrected the control measures up to acceptable levels in all eight areas of function. Originality/value Using a prospective risk assessment approach, such as FMEA, could be beneficial in dealing with potential failures through proposing preventive actions in a proactive manner. The method could be used as a tool for healthcare continuous quality improvement so that the method identifies both systemic and human errors, and offers practical advice to deal effectively with them.

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

Mankamo, T.; Kim, I.S.; Yang, Ji Wu

Failures in the auxiliary feedwater (AFW) system of pressurized water reactors (PWRs) are considered to involve substantial risk whether a decision is made to either continue power operation while repair is being done, or to shut down the plant to undertake repairs. Technical specification action requirements usually require immediate plant shutdown in the case of multiple failures in the system (in some cases, immediate repair of one train is required when all AFW trains fail). This paper presents a probabilistic risk assessment-based method to quantitatively evaluate and compare both the risks of continued power operation and of shutting the plantmore » down, given known failures in the system. The method is applied to the AFW system for four different PWRs. Results show that the risk of continued power operation and plant shutdown both are substantial, but the latter is larger than the former over the usual repair time. This was proven for four plants with different designs: two operating Westinghouse plants, one operating Asea-Brown Boveri Combustion Engineering Plant, and one of evolutionary design. The method can be used to analyze individual plant design and to improve AFW action requirements using risk-informed evaluations.« less

Construct validity of the Heart Failure Screening Tool (Heart-FaST) to identify heart failure patients at risk of poor self-care: Rasch analysis.

PubMed

Reynolds, Nicholas A; Ski, Chantal F; McEvedy, Samantha M; Thompson, David R; Cameron, Jan

2018-02-14

The aim of this study was to psychometrically evaluate the Heart Failure Screening Tool (Heart-FaST) via: (1) examination of internal construct validity; (2) testing of scale function in accordance with design; and (3) recommendation for change/s, if items are not well adjusted, to improve psychometric credential. Self-care is vital to the management of heart failure. The Heart-FaST may provide a prospective assessment of risk, regarding the likelihood that patients with heart failure will engage in self-care. Psychometric validation of the Heart-FaST using Rasch analysis. The Heart-FaST was administered to 135 patients (median age = 68, IQR = 59-78 years; 105 males) enrolled in a multidisciplinary heart failure management program. The Heart-FaST is a nurse-administered tool for screening patients with HF at risk of poor self-care. A Rasch analysis of responses was conducted which tested data against Rasch model expectations, including whether items serve as unbiased, non-redundant indicators of risk and measure a single construct and that rating scales operate as intended. The results showed that data met Rasch model expectations after rescoring or deleting items due to poor discrimination, disordered thresholds, differential item functioning, or response dependence. There was no evidence of multidimensionality which supports the use of total scores from Heart-FaST as indicators of risk. Aggregate scores from this modified screening tool rank heart failure patients according to their "risk of poor self-care" demonstrating that the Heart-FaST items constitute a meaningful scale to identify heart failure patients at risk of poor engagement in heart failure self-care. © 2018 John Wiley & Sons Ltd.

Risk measures for power failures in transmission systems

NASA Astrophysics Data System (ADS)

Cassidy, Alex; Feinstein, Zachary; Nehorai, Arye

2016-11-01

We present a novel framework for evaluating the risk of failures in power transmission systems. We use the concept of systemic risk measures from the financial mathematics literature with models of power system failures in order to quantify the risk of the entire power system for design and comparative purposes. The proposed risk measures provide the collection of capacity vectors for the components in the system that lead to acceptable outcomes. Keys to the formulation of our measures of risk are two elements: a model of system behavior that provides the (distribution of) outcomes based on component capacities and an acceptability criterion that determines whether a (random) outcome is acceptable from an aggregated point of view. We examine the effects of altering the line capacities on energy not served under a variety of networks, flow manipulation methods, load shedding schemes, and load profiles using Monte Carlo simulations. Our results provide a quantitative comparison of the performance of these schemes, measured by the required line capacity. These results provide more complete descriptions of the risks of power failures than the previous, one-dimensional metrics.

Failure environment analysis tool applications

NASA Astrophysics Data System (ADS)

Pack, Ginger L.; Wadsworth, David B.

1993-02-01

Understanding risks and avoiding failure are daily concerns for the women and men of NASA. Although NASA's mission propels us to push the limits of technology, and though the risks are considerable, the NASA community has instilled within, the determination to preserve the integrity of the systems upon which our mission and, our employees lives and well-being depend. One of the ways this is being done is by expanding and improving the tools used to perform risk assessment. The Failure Environment Analysis Tool (FEAT) was developed to help engineers and analysts more thoroughly and reliably conduct risk assessment and failure analysis. FEAT accomplishes this by providing answers to questions regarding what might have caused a particular failure; or, conversely, what effect the occurrence of a failure might have on an entire system. Additionally, FEAT can determine what common causes could have resulted in other combinations of failures. FEAT will even help determine the vulnerability of a system to failures, in light of reduced capability. FEAT also is useful in training personnel who must develop an understanding of particular systems. FEAT facilitates training on system behavior, by providing an automated environment in which to conduct 'what-if' evaluation. These types of analyses make FEAT a valuable tool for engineers and operations personnel in the design, analysis, and operation of NASA space systems.

Failure environment analysis tool applications

NASA Technical Reports Server (NTRS)

Pack, Ginger L.; Wadsworth, David B.

1993-01-01

Understanding risks and avoiding failure are daily concerns for the women and men of NASA. Although NASA's mission propels us to push the limits of technology, and though the risks are considerable, the NASA community has instilled within, the determination to preserve the integrity of the systems upon which our mission and, our employees lives and well-being depend. One of the ways this is being done is by expanding and improving the tools used to perform risk assessment. The Failure Environment Analysis Tool (FEAT) was developed to help engineers and analysts more thoroughly and reliably conduct risk assessment and failure analysis. FEAT accomplishes this by providing answers to questions regarding what might have caused a particular failure; or, conversely, what effect the occurrence of a failure might have on an entire system. Additionally, FEAT can determine what common causes could have resulted in other combinations of failures. FEAT will even help determine the vulnerability of a system to failures, in light of reduced capability. FEAT also is useful in training personnel who must develop an understanding of particular systems. FEAT facilitates training on system behavior, by providing an automated environment in which to conduct 'what-if' evaluation. These types of analyses make FEAT a valuable tool for engineers and operations personnel in the design, analysis, and operation of NASA space systems.

Failure environment analysis tool applications

NASA Technical Reports Server (NTRS)

Pack, Ginger L.; Wadsworth, David B.

1994-01-01

Understanding risks and avoiding failure are daily concerns for the women and men of NASA. Although NASA's mission propels us to push the limits of technology, and though the risks are considerable, the NASA community has instilled within it, the determination to preserve the integrity of the systems upon which our mission and, our employees lives and well-being depend. One of the ways this is being done is by expanding and improving the tools used to perform risk assessment. The Failure Environment Analysis Tool (FEAT) was developed to help engineers and analysts more thoroughly and reliably conduct risk assessment and failure analysis. FEAT accomplishes this by providing answers to questions regarding what might have caused a particular failure; or, conversely, what effect the occurrence of a failure might have on an entire system. Additionally, FEAT can determine what common causes could have resulted in other combinations of failures. FEAT will even help determine the vulnerability of a system to failures, in light of reduced capability. FEAT also is useful in training personnel who must develop an understanding of particular systems. FEAT facilitates training on system behavior, by providing an automated environment in which to conduct 'what-if' evaluation. These types of analyses make FEAT a valuable tool for engineers and operations personnel in the design, analysis, and operation of NASA space systems.

A model for predicting embankment slope failures in clay-rich soils; A Louisiana example

NASA Astrophysics Data System (ADS)

Burns, S. F.

2015-12-01

A model for predicting embankment slope failures in clay-rich soils; A Louisiana example It is well known that smectite-rich soils significantly reduce the stability of slopes. The question is how much smectite in the soil causes slope failures. A study of over 100 sites in north and south Louisiana, USA, compared slopes that failed during a major El Nino winter (heavy rainfall) in 1982-1983 to similar slopes that did not fail. Soils in the slopes were tested for per cent clay, liquid limits, plasticity indices and semi-quantitative clay mineralogy. Slopes with the High Risk for failure (85-90% chance of failure in 8-15 years after construction) contained soils with a liquid limit > 54%, a plasticity index over 29%, and clay contents > 47%. Slopes with an Intermediate Risk (55-50% chance of failure in 8-15 years) contained soils with a liquid limit between 36-54%, plasticity index between 16-19%, and clay content between 32-47%. Slopes with a Low Risk chance of failure (< 5% chance of failure in 8-15 years after construction) contained soils with a liquid limit < 36%, a plasticity index < 16%, and a clay content < 32%. These data show that if one is constructing embankments and one wants to prevent slope failure of the 3:1 slopes, check the above soil characteristics before construction. If the soils fall into the Low Risk classification, construct the embankment normally. If the soils fall into the High Risk classification, one will need to use lime stabilization or heat treatments to prevent failures. Soils in the Intermediate Risk class will have to be evaluated on a case by case basis.

a New Method for Fmeca Based on Fuzzy Theory and Expert System

NASA Astrophysics Data System (ADS)

Byeon, Yoong-Tae; Kim, Dong-Jin; Kim, Jin-O.

2008-10-01

Failure Mode Effects and Criticality Analysis (FMECA) is one of most widely used methods in modern engineering system to investigate potential failure modes and its severity upon the system. FMECA evaluates criticality and severity of each failure mode and visualize the risk level matrix putting those indices to column and row variable respectively. Generally, those indices are determined subjectively by experts and operators. However, this process has no choice but to include uncertainty. In this paper, a method for eliciting expert opinions considering its uncertainty is proposed to evaluate the criticality and severity. In addition, a fuzzy expert system is constructed in order to determine the crisp value of risk level for each failure mode. Finally, an illustrative example system is analyzed in the case study. The results are worth considering in deciding the proper policies for each component of the system.

Rock Slide Risk Assessment: A Semi-Quantitative Approach

NASA Astrophysics Data System (ADS)

Duzgun, H. S. B.

2009-04-01

Rock slides can be better managed by systematic risk assessments. Any risk assessment methodology for rock slides involves identification of rock slide risk components, which are hazard, elements at risk and vulnerability. For a quantitative/semi-quantitative risk assessment for rock slides, a mathematical value the risk has to be computed and evaluated. The quantitative evaluation of risk for rock slides enables comparison of the computed risk with the risk of other natural and/or human-made hazards and providing better decision support and easier communication for the decision makers. A quantitative/semi-quantitative risk assessment procedure involves: Danger Identification, Hazard Assessment, Elements at Risk Identification, Vulnerability Assessment, Risk computation, Risk Evaluation. On the other hand, the steps of this procedure require adaptation of existing or development of new implementation methods depending on the type of landslide, data availability, investigation scale and nature of consequences. In study, a generic semi-quantitative risk assessment (SQRA) procedure for rock slides is proposed. The procedure has five consecutive stages: Data collection and analyses, hazard assessment, analyses of elements at risk and vulnerability and risk assessment. The implementation of the procedure for a single rock slide case is illustrated for a rock slope in Norway. Rock slides from mountain Ramnefjell to lake Loen are considered to be one of the major geohazards in Norway. Lake Loen is located in the inner part of Nordfjord in Western Norway. Ramnefjell Mountain is heavily jointed leading to formation of vertical rock slices with height between 400-450 m and width between 7-10 m. These slices threaten the settlements around Loen Valley and tourists visiting the fjord during summer season, as the released slides have potential of creating tsunami. In the past, several rock slides had been recorded from the Mountain Ramnefjell between 1905 and 1950. Among them, four of the slides caused formation of tsunami waves which washed up to 74 m above the lake level. Two of the slides resulted in many fatalities in the inner part of the Loen Valley as well as great damages. There are three predominant joint structures in Ramnefjell Mountain, which controls failure and the geometry of the slides. The first joint set is a foliation plane striking northeast-southwest and dipping 35˚ -40˚ to the east-southeast. The second and the third joint sets are almost perpendicular and parallel to the mountain side and scarp, respectively. These three joint sets form slices of rock columns with width ranging between 7-10 m and height of 400-450 m. It is stated that the joints in set II are opened between 1-2 m, which may bring about collection of water during heavy rainfall or snow melt causing the slices to be pressed out. It is estimated that water in the vertical joints both reduces the shear strength of sliding plane and causes reduction of normal stress on the sliding plane due to formation of uplift force. Hence rock slides in Ramnefjell mountain occur in plane failure mode. The quantitative evaluation of rock slide risk requires probabilistic analysis of rock slope stability and identification of consequences if the rock slide occurs. In this study failure probability of a rock slice is evaluated by first-order reliability method (FORM). Then in order to use the calculated probability of failure value (Pf) in risk analyses, it is required to associate this Pf with frequency based probabilities (i.ePf / year) since the computed failure probabilities is a measure of hazard and not a measure of risk unless they are associated with the consequences of the failure. This can be done by either considering the time dependent behavior of the basic variables in the probabilistic models or associating the computed Pf with frequency of the failures in the region. In this study, the frequency of previous rock slides in the previous century in Remnefjell is used for evaluation of frequency based probability to be used in risk assessment. The major consequence of a rock slide is generation of a tsunami in the lake Loen, causing inundation of residential areas around the lake. Risk is assessed by adapting damage probability matrix approach, which is originally developed for risk assessment for buildings in case of earthquake.

An Accidental Scientist: Chance, Failure, Risk-Taking, and Mentoring.

PubMed

McGrath, Patrick J

2018-04-06

I never intended to become a scientist. My career developed on the basis of chance happenings, repeated failure, the willingness to take risks and the acceptance and provision of mentoring. My career has included periods of difficulty and shifted back and forth between academic health centers and universities in Canada. Although I have been amply recognized for my successes, my greatest learning has come from my failures. My greatest satisfaction has been in the development, evaluation and dissemination of interventions. The combination of intellectual stimulation and emotional gratification has meant a rewarding career.

Elective neck irradiation for nasopharyngeal carcinoma.

PubMed

Wang, C J; Chen, H C; Huang, E Y; Lee, S P

2000-07-01

This study was conducted to evaluate the effectiveness of elective neck irradiation (ENI) for nasopharyngeal carcinoma (NPC), and to analyze factors associated with ENI failure. A radiation port covering the side of a neck without gross nodal metastasis was qualified for evaluation of the effectiveness of ENI. From 1988 through 1992, a total of 261 patients with N0 (130 cases), N1 (91 cases), and N3 (40 cases) NPCs were studied. All patients were irradiated with 60Co teletherapy or 10 MV x-ray to a total dose of 46.8 Gy/26 fractions, followed by a boost treatment to the primary site to a total dose of 64.8 to 75.6 Gy/36-42 fractions. All ENI ports received irradiation to a dose of 46.8 to 60.8 Gy. The duration of follow-up was 6 to 10 years, with a median of 8.1 years. Factors associated with to the risk of ENI failure were analyzed. (1) The overall 5-year actuarial local control rate and actuarial survival rate were 74% and 63%, respectively. (2) Among the 261 cases in which ENI treatment was used, the treatment failed in 12 cases, accounting for a crude ENI failure rate of 5%. The overall 5- and 10-year cumulative risk of ENI failure was 5% and 7%, respectively. (3) Time from the start of treatment to ENI failure ranged from 9 to 66 months, with a median of 17 months. (4) Of the 12 patients for whom EMI failed, 11 (92%) had recurrence in the upper neck, and one in the lower neck. (5) Existence of prior failure at the primary site was the only factor significantly correlated with the risk of ENI failure (p < 0.001). The 5-year cumulative risk of ENI failure for patients with local failure vs. those without was 16% vs. 1% (p < 0.0001). Moderate-dose ENI was highly effective in the control of subclinical disease in the neck for NPC. ENI failure was closely associated with prior failure at the primary site, implying that local primary tumor failure may lead to an increased potential for metastasis to the neck.

Plastic Pipe Failure, Risk, and Threat Analysis

DOT National Transportation Integrated Search

2009-04-29

The three primary failure modes that may be exhibited by polyethylene (PE) gas pipe materials were described in detail. The modes are: ductile rupture, slow crack growth (SCG), and rapid crack propagation (RCP). Short term mechanical tests were evalu...

Evaluation of Enhanced Risk Monitors for Use on Advanced Reactors

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

Ramuhalli, Pradeep; Veeramany, Arun; Bonebrake, Christopher A.

This study provides an overview of the methodology for integrating time-dependent failure probabilities into nuclear power reactor risk monitors. This prototypic enhanced risk monitor (ERM) methodology was evaluated using a hypothetical probabilistic risk assessment (PRA) model, generated using a simplified design of a liquid-metal-cooled advanced reactor (AR). Component failure data from industry compilation of failures of components similar to those in the simplified AR model were used to initialize the PRA model. Core damage frequency (CDF) over time were computed and analyzed. In addition, a study on alternative risk metrics for ARs was conducted. Risk metrics that quantify the normalizedmore » cost of repairs, replacements, or other operations and management (O&M) actions were defined and used, along with an economic model, to compute the likely economic risk of future actions such as deferred maintenance based on the anticipated change in CDF due to current component condition and future anticipated degradation. Such integration of conventional-risk metrics with alternate-risk metrics provides a convenient mechanism for assessing the impact of O&M decisions on safety and economics of the plant. It is expected that, when integrated with supervisory control algorithms, such integrated-risk monitors will provide a mechanism for real-time control decision-making that ensure safety margins are maintained while operating the plant in an economically viable manner.« less

Study on Failure of Third-Party Damage for Urban Gas Pipeline Based on Fuzzy Comprehensive Evaluation

PubMed Central

Li, Jun; Zhang, Hong; Han, Yinshan; Wang, Baodong

2016-01-01

Focusing on the diversity, complexity and uncertainty of the third-party damage accident, the failure probability of third-party damage to urban gas pipeline was evaluated on the theory of analytic hierarchy process and fuzzy mathematics. The fault tree of third-party damage containing 56 basic events was built by hazard identification of third-party damage. The fuzzy evaluation of basic event probabilities were conducted by the expert judgment method and using membership function of fuzzy set. The determination of the weight of each expert and the modification of the evaluation opinions were accomplished using the improved analytic hierarchy process, and the failure possibility of the third-party to urban gas pipeline was calculated. Taking gas pipelines of a certain large provincial capital city as an example, the risk assessment structure of the method was proved to conform to the actual situation, which provides the basis for the safety risk prevention. PMID:27875545

Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.

PubMed

Bonfant, Giovanna; Belfanti, Pietro; Paternoster, Giuseppe; Gabrielli, Danila; Gaiter, Alberto M; Manes, Massimo; Molino, Andrea; Pellu, Valentina; Ponzetti, Clemente; Farina, Massimo; Nebiolo, Pier E

2010-01-01

The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients' safety. Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients. FMEA steps: (i) process study: we recorded phases and activities. (ii) Hazard analysis: we listed activity-related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN. (iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures. (iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one. Our failure modes with the highest RPN came from communication and organization problems. Two tools have been created to ameliorate information flow: "dialysis agenda" software and nursing datasheets. We scheduled nephrological examinations, and we changed both medical and nursing organization. Total RPN value decreased from 892 to 815 (8.6%) after reorganization. Employing FMEA, we worked on a few critical activities, and we reduced patients' clinical risk. A priority matrix also takes into account the weight of the control measures: we believe this evaluation is quick, because of simple priority selection, and that it decreases action times.

Predicting Vulnerability of the Integrity and Connectivity Associated with Culverts in Low Order Streams of Northern Michigan

NASA Astrophysics Data System (ADS)

King, C. H.; Wagenbrenner, J.; Fedora, M.; Watkins, D.; Watkins, M. K.; Huckins, C.

2017-12-01

The Great Lakes Region of North America has experienced more frequent extreme precipitation events in recent decades, resulting in a large number of stream crossing failures. While there are accepted methods for designing stream crossings to accommodate peak storm discharges, less attention has been paid to assessing the risk of failure. To evaluate failure risk and potential impacts, coarse-resolution stream crossing surveys were completed on 51 stream crossings and dams in the North Branch Paint River watershed in Michigan's Upper Peninsula. These inventories determined stream crossing dimensions along with stream and watershed characteristics. Eleven culverts were selected from the coarse surveys for high resolution hydraulic analysis to estimate discharge conditions expected at crossing failure. Watershed attributes upstream of the crossing, including area, slope, and storage, were acquired. Sediment discharge and the economic impact associated with a failure event were also estimated for each stream crossing. Impacts to stream connectivity and fish passability were assessed from the coarse-level surveys. Using information from both the coarse and high-resolution surveys, we also developed indicators to predict failure risk without the need for complex hydraulic modeling. These passability scores and failure risk indicators will help to prioritize infrastructure replacement and improve the overall connectivity of river systems throughout the upper Great Lakes Region.

Application of failure mode and effect analysis in an assisted reproduction technology laboratory.

PubMed

Intra, Giulia; Alteri, Alessandra; Corti, Laura; Rabellotti, Elisa; Papaleo, Enrico; Restelli, Liliana; Biondo, Stefania; Garancini, Maria Paola; Candiani, Massimo; Viganò, Paola

2016-08-01

Assisted reproduction technology laboratories have a very high degree of complexity. Mismatches of gametes or embryos can occur, with catastrophic consequences for patients. To minimize the risk of error, a multi-institutional working group applied failure mode and effects analysis (FMEA) to each critical activity/step as a method of risk assessment. This analysis led to the identification of the potential failure modes, together with their causes and effects, using the risk priority number (RPN) scoring system. In total, 11 individual steps and 68 different potential failure modes were identified. The highest ranked failure modes, with an RPN score of 25, encompassed 17 failures and pertained to "patient mismatch" and "biological sample mismatch". The maximum reduction in risk, with RPN reduced from 25 to 5, was mostly related to the introduction of witnessing. The critical failure modes in sample processing were improved by 50% in the RPN by focusing on staff training. Three indicators of FMEA success, based on technical skill, competence and traceability, have been evaluated after FMEA implementation. Witnessing by a second human operator should be introduced in the laboratory to avoid sample mix-ups. These findings confirm that FMEA can effectively reduce errors in assisted reproduction technology laboratories. Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Reliability of pathogen control in direct potable reuse: Performance evaluation and QMRA of a full-scale 1 MGD advanced treatment train.

PubMed

Pecson, Brian M; Triolo, Sarah C; Olivieri, Simon; Chen, Elise C; Pisarenko, Aleksey N; Yang, Chao-Chun; Olivieri, Adam; Haas, Charles N; Trussell, R Shane; Trussell, R Rhodes

2017-10-01

To safely progress toward direct potable reuse (DPR), it is essential to ensure that DPR systems can provide public health protection equivalent to or greater than that of conventional drinking water sources. This study collected data over a one-year period from a full-scale DPR demonstration facility, and used both performance distribution functions (PDFs) and quantitative microbial risk assessment (QMRA) to define and evaluate the reliability of the advanced water treatment facility (AWTF). The AWTF's ability to control enterovirus, Giardia, and Cryptosporidium was characterized using online monitoring of surrogates in a treatment train consisting of ozone, biological activated carbon, microfiltration, reverse osmosis, and ultraviolet light with an advanced oxidation process. This process train was selected to improve reliability by providing redundancy, defined as the provision of treatment beyond the minimum needed to meet regulatory requirements. The PDFs demonstrated treatment that consistently exceeded the 12/10/10-log thresholds for virus, Giardia, and Cryptosporidium, as currently required for potable reuse in California (via groundwater recharge and surface water augmentation). Because no critical process failures impacted pathogen removal performance during the yearlong testing, hypothetical failures were incorporated into the analysis to understand the benefit of treatment redundancy on performance. Each unit process was modeled with a single failure per year lasting four different failure durations: 15 min, 60 min, 8 h, and 24 h. QMRA was used to quantify the impact of failures on pathogen risk. The median annual risk of infection for Cryptosporidium was 4.9 × 10 -11 in the absence of failures, and reached a maximum of 1.1 × 10 -5 assuming one 24-h failure per process per year. With the inclusion of free chlorine disinfection as part of the treatment process, enterovirus had a median annual infection risk of 1.5 × 10 -14 (no failures) and a maximum annual value of 2.1 × 10 -5 (assuming one 24-h failure per year). Even with conservative failure assumptions, pathogen risk from this treatment train remains below the risk targets for both the U.S. (10 -4 infections/person/year) and the WHO (approximately 10 -3 infections/person/year, equivalent to 10 -6 DALY/person/year), demonstrating the value of a failure prevention strategy based on treatment redundancy. Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

De novo noncutaneous malignancies after kidney transplantation are associated with an increased risk of graft failure: results from a time-dependent analysis on 672 patients.

PubMed

Cena, Tiziana; Musetti, Claudio; Quaglia, Marco; Magnani, Corrado; Stratta, Piero; Bagnardi, Vincenzo; Cantaluppi, Vincenzo

2016-10-01

The aim of this study was to evaluate the association between cancer occurrence and risk of graft failure in kidney transplant recipients. From November 1998 to November 2013, 672 adult patients received their first kidney transplant from a deceased donor and had a minimum follow-up of 6 months. During a median follow-up of 4.7 years (3523 patient-years), 47 patients developed a nonmelanoma skin cancer (NMSC) and 40 a noncutaneous malignancy (NCM). A total of 59 graft failures were observed. The failure rate was 6 per 100 patient-year (pt-yr) after NCM versus 1.5 per 100 pt-yr in patients without NCM. In a time-dependent multivariable model, the occurrence of NCM appeared to be associated with failure (HR = 3.27; 95% CI = 1.44-7.44). The effect of NCM on the cause-specific graft failure was different (P = 0.002) when considering events due to chronic rejection (HR = 0.55) versus other causes (HR = 15.59). The reduction of the immunosuppression after NCM was not associated with a greater risk of graft failure. In conclusion, our data suggest that post-transplant NCM may be a strong risk factor for graft failure, particularly for causes other than chronic rejection. © 2016 Steunstichting ESOT.

Predictors of Post-discharge Mortality Among Patients Hospitalized for Acute Heart Failure

PubMed Central

Collins, Sean P; Greene, Stephen J; Pang, Peter S; Ambrosy, Andrew P; Antohi, Elena-Laura; Vaduganathan, Muthiah; Butler, Javed; Gheorghiade, Mihai

2017-01-01

Acute Heart Failure (AHF) is a “ multi-event disease” and hospitalisation is a critical event in the clinical course of HF. Despite relatively rapid relief of symptoms, hospitalisation for AHF is followed by an increased risk of death and re-hospitalisation. In AHF, risk stratification from clinically available data is increasingly important in evaluating long-term prognosis. From the perspective of patients, information on the risk of mortality and re-hospitalisation would be helpful in providing patients with insight into their disease. From the perspective of care providers, it may facilitate management decisions, such as who needs to be admitted and to what level of care (i.e. floor, step-down, ICU). Furthermore, risk-stratification may help identify patients who need to be evaluated for advanced HF therapies (i.e. left-ventricle assistance device or transplant or palliative care), and patients who need early a post-discharge follow-up plan. Finally, risk stratification will allow for more robust efforts to identify among risk markers the true targets for therapies that may direct treatment strategies to selected high-risk patients. Further clinical research will be needed to evaluate if appropriate risk stratification of patients could improve clinical outcome and resources allocation. PMID:29387465

A risk assessment methodology using intuitionistic fuzzy set in FMEA

NASA Astrophysics Data System (ADS)

Chang, Kuei-Hu; Cheng, Ching-Hsue

2010-12-01

Most current risk assessment methods use the risk priority number (RPN) value to evaluate the risk of failure. However, conventional RPN methodology has been criticised as having five main shortcomings as follows: (1) the assumption that the RPN elements are equally weighted leads to over simplification; (2) the RPN scale itself has some non-intuitive statistical properties; (3) the RPN elements have many duplicate numbers; (4) the RPN is derived from only three factors mainly in terms of safety; and (5) the conventional RPN method has not considered indirect relations between components. To address the above issues, an efficient and comprehensive algorithm to evaluate the risk of failure is needed. This article proposes an innovative approach, which integrates the intuitionistic fuzzy set (IFS) and the decision-making trial and evaluation laboratory (DEMATEL) approach on risk assessment. The proposed approach resolves some of the shortcomings of the conventional RPN method. A case study, which assesses the risk of 0.15 µm DRAM etching process, is used to demonstrate the effectiveness of the proposed approach. Finally, the result of the proposed method is compared with the listing approaches of risk assessment methods.

Assessment of Risk Evaluation Procedures for USACE Bridges

DTIC Science & Technology

2018-03-19

upon a well-suited inventory management system, it is too heavily dependent upon subjective assessments by select individuals and that risk of failure...3 Bridge Management Systems...4 3 USACE Bridge Management

Causes of corneal graft failure in India.

PubMed

Dandona, L; Naduvilath, T J; Janarthanan, M; Rao, G N

1998-09-01

The success of corneal grafting in visual rehabilitation of the corneal blind in India depends on survival of the grafts. Understanding the causes of graft failure may help reduce the risk of failure. We studied these causes in a series of 638 graft failures at our institution. Multivariate logistic regression analysis was used to evaluate the association of particular causes of graft failure with indications for grafting, socioeconomic status, age, sex, host corneal vascularization, donor corneal quality, and experience of surgeon. The major causes of graft failure were allograft rejection (29.2%), increased intraocular pressure (16.9%), infection excluding endophthalmitis (15.4%), and surface problems (12.7%). The odds of infection causing graft failure were significantly higher in patients of lower socioeconomic status (odds ratio 2.45, 95% CI 1.45-4.15). Surface problems as a cause of graft failure was significantly associated with grafts done for corneal scarring or for regrafts (odds ratio 3.36, 95% CI 1.80-6.30). Increased intraocular pressure as a cause of graft failure had significant association with grafts done for aphakic or pseudophakic bullous keratopathy, congenital conditions or glaucoma, or regrafts (odds ratio 2.19, 95% CI 1.25-3.84). Corneal dystrophy was the indication for grafting in 12 of the 13 cases of graft failure due to recurrence of host disease. Surface problems, increased intraocular pressure, and infection are modifiable risk factors that are more likely to cause graft failure in certain categories of patients in India. Knowledge about these associations can be helpful in looking for and aggressively treating these modifiable risk factors in the at-risk categories of corneal graft patients. This can possibly reduce the chance of graft failure.

Can the Seattle heart failure model be used to risk-stratify heart failure patients for potential left ventricular assist device therapy?

PubMed

Levy, Wayne C; Mozaffarian, Dariush; Linker, David T; Farrar, David J; Miller, Leslie W

2009-03-01

According to results of the REMATCH trial, left ventricular assist device therapy in patients with severe heart failure has resulted in a 48% reduction in mortality. A decision tool will be necessary to aid in the selection of patients for destination left ventricular assist devices (LVADs) as the technology progresses for implantation in ambulatory Stage D heart failure patients. The purpose of this analysis was to determine whether the Seattle Heart Failure Model (SHFM) can be used to risk-stratify heart failure patients for potential LVAD therapy. The SHFM was applied to REMATCH patients with the prospective addition of inotropic agents and intra-aortic balloon pump (IABP) +/- ventilator. The SHFM was highly predictive of survival (p = 0.0004). One-year SHFM-predicted survival was similar to actual survival for both the REMATCH medical (30% vs 28%) and LVAD (49% vs 52%) groups. The estimated 1-year survival with medical therapy for patients in REMATCH was 30 +/- 21%, but with a range of 0% to 74%. The 1- and 2-year estimated survival was

Heart failure, saxagliptin, and diabetes mellitus: observations from the SAVOR-TIMI 53 randomized trial.

PubMed

Scirica, Benjamin M; Braunwald, Eugene; Raz, Itamar; Cavender, Matthew A; Morrow, David A; Jarolim, Petr; Udell, Jacob A; Mosenzon, Ofri; Im, KyungAh; Umez-Eronini, Amarachi A; Pollack, Pia S; Hirshberg, Boaz; Frederich, Robert; Lewis, Basil S; McGuire, Darren K; Davidson, Jaime; Steg, Ph Gabriel; Bhatt, Deepak L

2014-10-28

Diabetes mellitus and heart failure frequently coexist. However, few diabetes mellitus trials have prospectively evaluated and adjudicated heart failure as an end point. A total of 16 492 patients with type 2 diabetes mellitus and a history of, or at risk of, cardiovascular events were randomized to saxagliptin or placebo (mean follow-up, 2.1 years). The primary end point was the composite of cardiovascular death, myocardial infarction, or ischemic stroke. Hospitalization for heart failure was a predefined component of the secondary end point. Baseline N-terminal pro B-type natriuretic peptide was measured in 12 301 patients. More patients treated with saxagliptin (289, 3.5%) were hospitalized for heart failure compared with placebo (228, 2.8%; hazard ratio, 1.27; 95% confidence intercal, 1.07-1.51; P=0.007). Corresponding rates at 12 months were 1.9% versus 1.3% (hazard ratio, 1.46; 95% confidence interval, 1.15-1.88; P=0.002), with no significant difference thereafter (time-varying interaction, P=0.017). Subjects at greatest risk of hospitalization for heart failure had previous heart failure, an estimated glomerular filtration rate ≤60 mL/min, or elevated baseline levels of N-terminal pro B-type natriuretic peptide. There was no evidence of heterogeneity between N-terminal pro B-type natriuretic peptide and saxagliptin (P for interaction=0.46), although the absolute risk excess for heart failure with saxagliptin was greatest in the highest N-terminal pro B-type natriuretic peptide quartile (2.1%). Even in patients at high risk of hospitalization for heart failure, the risk of the primary and secondary end points were similar between treatment groups. In the context of balanced primary and secondary end points, saxagliptin treatment was associated with an increased risk or hospitalization for heart failure. This increase in risk was highest among patients with elevated levels of natriuretic peptides, previous heart failure, or chronic kidney disease. http://www.clinicaltrials.gov. Unique identifier: NCT01107886. © 2014 American Heart Association, Inc.

Gastric Bypass Surgery Produces a Durable Reduction in Cardiovascular Disease Risk Factors and Reduces the Long-Term Risks of Congestive Heart Failure.

PubMed

Benotti, Peter N; Wood, G Craig; Carey, David J; Mehra, Vishal C; Mirshahi, Tooraj; Lent, Michelle R; Petrick, Anthony T; Still, Christopher; Gerhard, Glenn S; Hirsch, Annemarie G

2017-05-23

Obesity and its association with reduced life expectancy are well established, with cardiovascular disease as one of the major causes of fatality. Metabolic surgery is a powerful intervention for severe obesity, resulting in improvement in comorbid diseases and in cardiovascular risk factors. This study investigates the relationship between metabolic surgery and long-term cardiovascular events. A cohort of Roux-en-Y gastric bypass surgery (RYGB) patients was tightly matched by age, body mass index, sex, Framingham Risk Score, smoking history, use of antihypertension medication, diabetes mellitus status, and calendar year with a concurrent cohort of nonoperated control patients. The primary study end points of major cardiovascular events (myocardial infarction, stroke, and congestive heart failure) were evaluated using Cox regression. Secondary end points of longitudinal cardiovascular risk factors were evaluated using repeated-measures regression. The RYGB and matched controls (N=1724 in each cohort) were followed for up to 12 years after surgery (overall median of 6.3 years). Kaplan-Meier analysis revealed a statistically significant reduction in incident major composite cardiovascular events ( P =0.017) and congestive heart failure (0.0077) for the RYGB cohort. Adjusted Cox regression models confirmed the reductions in severe composite cardiovascular events in the RYGB cohort (hazard ratio=0.58, 95% CI=0.42-0.82). Improvements of cardiovascular risk factors (eg, 10-year cardiovascular risk score, total cholesterol, high-density lipoprotein, systolic blood pressure, and diabetes mellitus) were observed within the RYGB cohort after surgery. Gastric bypass is associated with a reduced risk of major cardiovascular events and the development of congestive heart failure. © 2017 The Authors and Geisinger Clinic. Published on behalf of the American Heart Association, Inc., by Wiley.

The use of failure mode and effects analysis to construct an effective disposal and prevention mechanism for infectious hospital waste

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

Ho, Chao Chung, E-mail: ho919@pchome.com.tw; Liao, Ching-Jong

Highlights: > This study is based on a real case in a regional teaching hospital in Taiwan. > We use Failure mode and effects analysis (FMEA) as the evaluation method. > We successfully identify the risk factors of infectious waste disposal. > We propose plans for the detection of exceptional cases of infectious waste. - Abstract: In recent times, the quality of medical care has been continuously improving in medical institutions wherein patient-centred care has been emphasized. Failure mode and effects analysis (FMEA) has also been promoted as a method of basic risk management and as part of total qualitymore » management (TQM) for improving the quality of medical care and preventing mistakes. Therefore, a study was conducted using FMEA to evaluate the potential risk causes in the process of infectious medical waste disposal, devise standard procedures concerning the waste, and propose feasible plans for facilitating the detection of exceptional cases of infectious waste. The analysis revealed the following results regarding medical institutions: (a) FMEA can be used to identify the risk factors of infectious waste disposal. (b) During the infectious waste disposal process, six items were scored over 100 in the assessment of uncontrolled risks: erroneous discarding of infectious waste by patients and their families, erroneous discarding by nursing staff, erroneous discarding by medical staff, cleaning drivers pierced by sharp articles, cleaning staff pierced by sharp articles, and unmarked output units. Therefore, the study concluded that it was necessary to (1) provide education and training about waste classification to the medical staff, patients and their families, nursing staff, and cleaning staff; (2) clarify the signs of caution; and (3) evaluate the failure mode and strengthen the effects.« less

Risk Prediction Models of Locoregional Failure After Radical Cystectomy for Urothelial Carcinoma: External Validation in a Cohort of Korean Patients

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

Ku, Ja Hyeon; Kim, Myong; Jeong, Chang Wook

2014-08-01

Purpose: To evaluate the predictive accuracy and general applicability of the locoregional failure model in a different cohort of patients treated with radical cystectomy. Methods and Materials: A total of 398 patients were included in the analysis. Death and isolated distant metastasis were considered competing events, and patients without any events were censored at the time of last follow-up. The model included the 3 variables pT classification, the number of lymph nodes identified, and margin status, as follows: low risk (≤pT2), intermediate risk (≥pT3 with ≥10 nodes removed and negative margins), and high risk (≥pT3 with <10 nodes removed ormore » positive margins). Results: The bootstrap-corrected concordance index of the model 5 years after radical cystectomy was 66.2%. When the risk stratification was applied to the validation cohort, the 5-year locoregional failure estimates were 8.3%, 21.2%, and 46.3% for the low-risk, intermediate-risk, and high-risk groups, respectively. The risk of locoregional failure differed significantly between the low-risk and intermediate-risk groups (subhazard ratio [SHR], 2.63; 95% confidence interval [CI], 1.35-5.11; P<.001) and between the low-risk and high-risk groups (SHR, 4.28; 95% CI, 2.17-8.45; P<.001). Although decision curves were appropriately affected by the incidence of the competing risk, decisions about the value of the models are not likely to be affected because the model remains of value over a wide range of threshold probabilities. Conclusions: The model is not completely accurate, but it demonstrates a modest level of discrimination, adequate calibration, and meaningful net benefit gain for prediction of locoregional failure after radical cystectomy.« less

Cardio-respiratory outcomes associated with exposure to wildfire smoke are modified by measures of community health

PubMed Central

2012-01-01

Background Characterizing factors which determine susceptibility to air pollution is an important step in understanding the distribution of risk in a population and is critical for setting appropriate policies. We evaluate general and specific measures of community health as modifiers of risk for asthma and congestive heart failure following an episode of acute exposure to wildfire smoke. Methods A population-based study of emergency department visits and daily concentrations of fine particulate matter during a wildfire in North Carolina was performed. Determinants of community health defined by County Health Rankings were evaluated as modifiers of the relative risk. A total of 40 mostly rural counties were included in the study. These rankings measure factors influencing health: health behaviors, access and quality of clinical care, social and economic factors, and physical environment, as well as, the outcomes of health: premature mortality and morbidity. Pollutant concentrations were obtained from a mathematically modeled smoke forecasting system. Estimates of relative risk for emergency department visits were based on Poisson mixed effects regression models applied to daily visit counts. Results For asthma, the strongest association was observed at lag day 0 with excess relative risk of 66%(28,117). For congestive heart failure the excess relative risk was 42%(5,93). The largest difference in risk was observed after stratifying on the basis of Socio-Economic Factors. Difference in risk between bottom and top ranked counties by Socio-Economic Factors was 85% and 124% for asthma and congestive heart failure respectively. Conclusions The results indicate that Socio-Economic Factors should be considered as modifying risk factors in air pollution studies and be evaluated in the assessment of air pollution impacts. PMID:23006928

Cardio-respiratory outcomes associated with exposure to wildfire smoke are modified by measures of community health.

PubMed

Rappold, Ana G; Cascio, Wayne E; Kilaru, Vasu J; Stone, Susan L; Neas, Lucas M; Devlin, Robert B; Diaz-Sanchez, David

2012-09-24

Characterizing factors which determine susceptibility to air pollution is an important step in understanding the distribution of risk in a population and is critical for setting appropriate policies. We evaluate general and specific measures of community health as modifiers of risk for asthma and congestive heart failure following an episode of acute exposure to wildfire smoke. A population-based study of emergency department visits and daily concentrations of fine particulate matter during a wildfire in North Carolina was performed. Determinants of community health defined by County Health Rankings were evaluated as modifiers of the relative risk. A total of 40 mostly rural counties were included in the study. These rankings measure factors influencing health: health behaviors, access and quality of clinical care, social and economic factors, and physical environment, as well as, the outcomes of health: premature mortality and morbidity. Pollutant concentrations were obtained from a mathematically modeled smoke forecasting system. Estimates of relative risk for emergency department visits were based on Poisson mixed effects regression models applied to daily visit counts. For asthma, the strongest association was observed at lag day 0 with excess relative risk of 66% (28,117). For congestive heart failure the excess relative risk was 42% (5,93). The largest difference in risk was observed after stratifying on the basis of Socio-Economic Factors. Difference in risk between bottom and top ranked counties by Socio-Economic Factors was 85% and 124% for asthma and congestive heart failure respectively. The results indicate that Socio-Economic Factors should be considered as modifying risk factors in air pollution studies and be evaluated in the assessment of air pollution impacts.

A phase II, multicentre trial evaluating the efficacy of de-escalated bisphosphonate therapy in metastatic breast cancer patients at low-risk of skeletal-related events.

PubMed

Addison, Christina L; Bouganim, Nathaniel; Hilton, John; Vandermeer, Lisa; Dent, Susan; Amir, Eitan; Hopkins, Sean; Kuchuk, Iryna; Segal, Roanne; Song, Xinni; Gertler, Stan; Mazzarello, Sasha; Dranitsaris, George; Ooi, Daylily; Pond, Gregory; Clemons, Mark

2014-04-01

The optimal frequency of intravenous (IV) bisphosphonate administration is unclear. We thus performed a study evaluating the effects of switching from 3-4 to 12 weekly therapy in patients with biochemically defined low-risk bone metastases. Patients with serum C-telopeptide (CTx) levels ≤600 ng/L after ≥3 months of 3-4 weekly IV pamidronate were switched to 12 weekly therapy for 48 weeks. Primary endpoint was the proportion of patients maintaining CTx levels in the lower-risk range. All endpoints (serum CTx and bone-specific alkaline phosphatase (BSAP), skeletal-related events (SREs) and self-reported pain) were measured at baseline, 6, 12, 24, 36 and 48 weeks. Treatment failure was defined as biochemical failure (CTx > 600 ng/L) or a SRE. Exploratory biomarkers including; serum TGF-β, activin-A, bone sialoprotein (BSP), procollagen type 1 N-terminal propeptide and urinary N-telopeptide (NTx) were assessed at baseline as predictors for failure to complete treatment. Seventy-one patients accrued and 43 (61 %) completed 48 weeks of de-escalated therapy. Reasons for failure to complete treatment included; biochemical failure (CTx > 600 ng/L) (n = 10, 14.1 %), on-study SRE (n = 9, 12.7 %), disease progression (n = 7, 9.9 % including death from disease [n = 1, 1.4 %]) or patient choice (n = 2, 2.8 %). Elevated baseline levels of CTx, BSAP, NTx and BSP were associated with treatment failure. The majority of patients in this biochemically defined low-risk population could switch from 3-4 weekly to 12 weekly bisphosphonate therapy with no effect on CTx levels or SREs during the 48 week study. Larger trials are required to assess the roles of biomarkers as predictors of adequacy of de-escalated therapy.

Serving the Needs of At-Risk Refugee Youth: A Program Evaluation

ERIC Educational Resources Information Center

McBrien, J. Lynn

2006-01-01

Refugee students, although frequently subsumed under the "immigrant" heading, often suffer from effects of significant trauma that can make them more vulnerable than children of voluntary immigrant families. This study evaluated a program created specifically for refugee youth at-risk for academic failure and "social death." The program goals…

[Biochemical failure after curative treatment for localized prostate cancer].

PubMed

Zouhair, Abderrahim; Jichlinski, Patrice; Mirimanoff, René-Olivier

2005-12-07

Biochemical failure after curative treatment for localized prostate cancer is frequent. The diagnosis of biochemical failure is clear when PSA levels rise after radical prostatectomy, but may be more difficult after external beam radiation therapy. The main difficulty once biochemical failure is diagnosed is to distinguish between local and distant failure, given the low sensitivity of standard work-up exams. Metabolic imaging techniques currently under evaluation may in the future help us to localize the site of failures. There are several therapeutic options depending on the initial curative treatment, each with morbidity risks that should be considered in multidisciplinary decision-making.

Fault tree analysis of failure cause of crushing plant and mixing bed hall at Khoy cement factory in Iran☆

PubMed Central

Nouri.Gharahasanlou, Ali; Mokhtarei, Ashkan; Khodayarei, Aliasqar; Ataei, Mohammad

2014-01-01

Evaluating and analyzing the risk in the mining industry is a new approach for improving the machinery performance. Reliability, safety, and maintenance management based on the risk analysis can enhance the overall availability and utilization of the mining technological systems. This study investigates the failure occurrence probability of the crushing and mixing bed hall department at Azarabadegan Khoy cement plant by using fault tree analysis (FTA) method. The results of the analysis in 200 h operating interval show that the probability of failure occurrence for crushing, conveyor systems, crushing and mixing bed hall department is 73, 64, and 95 percent respectively and the conveyor belt subsystem found as the most probable system for failure. Finally, maintenance as a method of control and prevent the occurrence of failure is proposed. PMID:26779433

Fault tree analysis of failure cause of crushing plant and mixing bed hall at Khoy cement factory in Iran.

PubMed

Nouri Gharahasanlou, Ali; Mokhtarei, Ashkan; Khodayarei, Aliasqar; Ataei, Mohammad

2014-04-01

Evaluating and analyzing the risk in the mining industry is a new approach for improving the machinery performance. Reliability, safety, and maintenance management based on the risk analysis can enhance the overall availability and utilization of the mining technological systems. This study investigates the failure occurrence probability of the crushing and mixing bed hall department at Azarabadegan Khoy cement plant by using fault tree analysis (FTA) method. The results of the analysis in 200 h operating interval show that the probability of failure occurrence for crushing, conveyor systems, crushing and mixing bed hall department is 73, 64, and 95 percent respectively and the conveyor belt subsystem found as the most probable system for failure. Finally, maintenance as a method of control and prevent the occurrence of failure is proposed.

A novel approach for evaluating the risk of health care failure modes.

PubMed

Chang, Dong Shang; Chung, Jenq Hann; Sun, Kuo Lung; Yang, Fu Chiang

2012-12-01

Failure mode and effects analysis (FMEA) can be employed to reduce medical errors by identifying the risk ranking of the health care failure modes and taking priority action for safety improvement. The purpose of this paper is to propose a novel approach of data analysis. The approach is to integrate FMEA and a mathematical tool-Data envelopment analysis (DEA) with "slack-based measure" (SBM), in the field of data analysis. The risk indexes (severity, occurrence, and detection) of FMEA are viewed as multiple inputs of DEA. The practicality and usefulness of the proposed approach is illustrated by one case of health care. Being a systematic approach for improving the service quality of health care, the approach can offer quantitative corrective information of risk indexes that thereafter reduce failure possibility. For safety improvement, these new targets of the risk indexes could be used for management by objectives. But FMEA cannot provide quantitative corrective information of risk indexes. The novel approach can surely overcome this chief shortcoming of FMEA. After combining DEA SBM model with FMEA, the two goals-increase of patient safety, medical cost reduction-can be together achieved.

Vacuum extraction failure is associated with a large head circumference.

PubMed

Kabiri, Doron; Lipschuetz, Michal; Cohen, Sarah M; Yagel, Oren; Levitt, Lorinne; Herzberg, Shmuel; Ezra, Yossef; Yagel, Simcha; Amsalem, Hagai

2018-04-24

To determine whether large head circumference increases the risk of vacuum extraction failure. This EMR-based study included all attempted vacuum extractions performed in a tertiary center between January 2010 and June 2015. All term singleton live births were eligible. Cases were divided into four groups: head circumference ≥90th percentile both with birth weight ≥90th percentile and <90th percentile and fetal head circumference <90th percentile with birth weight ≥90th and <90th percentile. Risk of failed vacuum extraction was compared among these groups. Other neonatal and maternal parameters were also evaluated as potential risk factors. Multinomial multivariable regression provided adjusted odds ratio for vacuum extraction failure while controlling for potential confounders. During the study period, 48,007 deliveries met inclusion criteria, of which 3835 had an attempt at vacuum extraction. We identified 215 (5.6%) cases of vacuum extraction failure. The adjusted odds ratios (aOR) for vacuum extraction failure in cases of large fetal head circumference was 2.31 (95%CI, 1.7-3.15, p < .001). Primiparity, prolonged second stage and occipito-posterior presentation were also found to be significant risk factors for failed vacuum extraction. In this study, we found that large head circumference was associated with vacuum extraction failure rather than high birth weight.

Outcome of High-Risk Myelodysplastic Syndrome After Azacitidine Treatment Failure

PubMed Central

Prébet, Thomas; Gore, Steven D.; Esterni, Benjamin; Gardin, Claude; Itzykson, Raphael; Thepot, Sylvain; Dreyfus, François; Rauzy, Odile Beyne; Recher, Christian; Adès, Lionel; Quesnel, Bruno; Beach, C.L.; Fenaux, Pierre; Vey, Norbert

2011-01-01

Purpose Azacitidine (AZA) is the current standard of care for high-risk (ie, International Prognostic Scoring System high or intermediate 2) myelodysplastic syndrome (MDS), but most patients will experience primary or secondary treatment failure. The outcome of these patients has not yet been described. Patients and Methods Overall, 435 patients with high-risk MDS and former refractory anemia with excess blasts in transformation (RAEB-T) were evaluated for outcome after AZA failure. The cohort of patients included four data sets (ie, AZA001, J9950, and J0443 trials and the French compassionate use program). Results The median follow-up after AZA failure was 15 months. The median overall survival was 5.6 months, and the 2-year survival probability was 15%. Increasing age, male sex, high-risk cytogenetics, higher bone marrow blast count, and the absence of prior hematologic response to AZA were associated with significantly worse survival in multivariate analysis. Data on treatment administered after AZA failure were available for 270 patients. Allogeneic stem-cell transplantation and investigational agents were associated with a better outcome when compared with conventional clinical care. Conclusion Outcome after AZA failure is poor. Our results should serve as a basis for designing second-line clinical trials in this population. PMID:21788559

[Failure mode and effects analysis (FMEA) of insulin in a mother-child university-affiliated health center].

PubMed

Berruyer, M; Atkinson, S; Lebel, D; Bussières, J-F

2016-01-01

Insulin is a high-alert drug. The main objective of this descriptive cross-sectional study was to evaluate the risks associated with insulin use in healthcare centers. The secondary objective was to propose corrective measures to reduce the main risks associated with the most critical failure modes in the analysis. We conducted a failure mode and effects analysis (FMEA) in obstetrics-gynecology, neonatology and pediatrics. Five multidisciplinary meetings occurred in August 2013. A total of 44 out of 49 failure modes were analyzed. Nine out of 44 (20%) failure modes were deemed critical, with a criticality score ranging from 540 to 720. Following the multidisciplinary meetings, everybody agreed that an FMEA was a useful tool to identify failure modes and their relative importance. This approach identified many corrective measures. This shared experience increased awareness of safety issues with insulin in our mother-child center. This study identified the main failure modes and associated corrective measures. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Failure to recognize preoperatively high-risk endometrial carcinoma is associated with a poor outcome.

PubMed

Di Cello, Annalisa; Rania, Erika; Zuccalà, Valeria; Venturella, Roberta; Mocciaro, Rita; Zullo, Fulvio; Morelli, Michele

2015-11-01

To evaluate the misdiagnosis between endometrial biopsy and definitive surgical pathology and to assess whether the failure in recognizing preoperatively high-risk endometrial carcinoma (EC) can impact oncological outcomes. A retrospective study was conducted to evaluate patients with EC diagnosed by preoperative endometrial biopsy who subsequently underwent surgical staging between 2006 and 2013 at our institution. In patients with a surgical diagnosis of high-risk EC, histotype and grade change between the endometrial biopsy and surgical specimen (discordance diagnosis) were evaluated and correlated to survival outcomes. Cox's regression model for multivariable analysis was used to evaluate the effect of several variables (age, stage, discordance in diagnosis, co-morbidities, frozen section, extensive surgical staging and adjuvant chemotherapy) on the survival rate. Data from 447 patients were reviewed. Among 109 women with surgical diagnosis of high-risk EC, 35 (32.1%) were preoperatively misdiagnosed. Of these 35 women, 24 (68.6%) cases were upgraded to grade 3, and 11 (3.4%) were upgraded to serous or clear cell type in the definitive specimen. The 5-year overall survival (OS; 70.2 vs. 86.8%; p=0.029), disease-specific survival (DSS; 72.5 vs. 88.2%; p=0.039) and recurrence free survival (RFS; 62.6 vs. 82.5%; p=0.024) were significantly lower in the high-risk EC patients who were preoperatively undiagnosed in the endometrial biopsy compared with patients with an appropriate preoperative histological diagnosis. Controlling for age, stage, co-morbidities, frozen section, extensive surgical staging and adjuvant chemotherapy, multivariable analysis revealed that discordance in diagnosis was associated with poorer survival outcomes. Failure to recognize preoperatively high-risk ECs is associated with worse outcomes. Copyright © 2015 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Risk Factors for Noninvasive Ventilation Failure in Critically Ill Subjects With Confirmed Influenza Infection.

PubMed

Rodríguez, Alejandro; Ferri, Cristina; Martin-Loeches, Ignacio; Díaz, Emili; Masclans, Joan R; Gordo, Federico; Sole-Violán, Jordi; Bodí, María; Avilés-Jurado, Francesc X; Trefler, Sandra; Magret, Monica; Moreno, Gerard; Reyes, Luis F; Marin-Corral, Judith; Yebenes, Juan C; Esteban, Andres; Anzueto, Antonio; Aliberti, Stefano; Restrepo, Marcos I

2017-10-01

Despite wide use of noninvasive ventilation (NIV) in several clinical settings, the beneficial effects of NIV in patients with hypoxemic acute respiratory failure (ARF) due to influenza infection remain controversial. The aim of this study was to identify the profile of patients with risk factors for NIV failure using chi-square automatic interaction detection (CHAID) analysis and to determine whether NIV failure is associated with ICU mortality. This work was a secondary analysis from prospective and observational multi-center analysis in critically ill subjects admitted to the ICU with ARF due to influenza infection requiring mechanical ventilation. Three groups of subjects were compared: (1) subjects who received NIV immediately after ICU admission for ARF and then failed (NIV failure group); (2) subjects who received NIV immediately after ICU admission for ARF and then succeeded (NIV success group); and (3) subjects who received invasive mechanical ventilation immediately after ICU admission for ARF (invasive mechanical ventilation group). Profiles of subjects with risk factors for NIV failure were obtained using CHAID analysis. Of 1,898 subjects, 806 underwent NIV, and 56.8% of them failed. Acute Physiology and Chronic Health Evaluation II (APACHE II) score, Sequential Organ Failure Assessment (SOFA) score, infiltrates in chest radiograph, and ICU mortality (38.4% vs 6.3%) were higher ( P < .001) in the NIV failure than in the NIV success group. SOFA score was the variable most associated with NIV failure, and 2 cutoffs were determined. Subjects with SOFA ≥ 5 had a higher risk of NIV failure (odds ratio = 3.3, 95% CI 2.4-4.5). ICU mortality was higher in subjects with NIV failure (38.4%) compared with invasive mechanical ventilation subjects (31.3%, P = .018), and NIV failure was associated with increased ICU mortality (odds ratio = 11.4, 95% CI 6.5-20.1). An automatic and non-subjective algorithm based on CHAID decision-tree analysis can help to define the profile of patients with different risks of NIV failure, which might be a promising tool to assist in clinical decision making to avoid the possible complications associated with NIV failure. Copyright © 2017 by Daedalus Enterprises.

Carbon/graphite fiber risk analysis and assessment study: Assessment of risk to the Lockheed Model L-1011 commercial transport aircraft

NASA Technical Reports Server (NTRS)

Daniledes, J.; Koch, J. R.

1980-01-01

The risk associated with the accidental release of carbon/graphite fibers (CF) from fires on commercial transport aircraft incorporating composite materials was assessed. Data are developed to evaluate the potential for CF damage to electrical and electronic equipment, assess the cost risk, and evaluate the hazard to continued operation. The subjects covered include identification of susceptible equipments, determination of infiltration transfer functions, analysis of airport operations, calculation of probabilities of equipment failures, assessment of the cost risk, and evaluation of the hazard to continued operation. The results show the risks associated with CF contamination are negligible through 1993.

Organ dysfunction, injury and failure in acute heart failure: from pathophysiology to diagnosis and management. A review on behalf of the Acute Heart Failure Committee of the Heart Failure Association (HFA) of the European Society of Cardiology (ESC).

PubMed

Harjola, Veli-Pekka; Mullens, Wilfried; Banaszewski, Marek; Bauersachs, Johann; Brunner-La Rocca, Hans-Peter; Chioncel, Ovidiu; Collins, Sean P; Doehner, Wolfram; Filippatos, Gerasimos S; Flammer, Andreas J; Fuhrmann, Valentin; Lainscak, Mitja; Lassus, Johan; Legrand, Matthieu; Masip, Josep; Mueller, Christian; Papp, Zoltán; Parissis, John; Platz, Elke; Rudiger, Alain; Ruschitzka, Frank; Schäfer, Andreas; Seferovic, Petar M; Skouri, Hadi; Yilmaz, Mehmet Birhan; Mebazaa, Alexandre

2017-07-01

Organ injury and impairment are commonly observed in patients with acute heart failure (AHF), and congestion is an essential pathophysiological mechanism of impaired organ function. Congestion is the predominant clinical profile in most patients with AHF; a smaller proportion presents with peripheral hypoperfusion or cardiogenic shock. Hypoperfusion further deteriorates organ function. The injury and dysfunction of target organs (i.e. heart, lungs, kidneys, liver, intestine, brain) in the setting of AHF are associated with increased risk for mortality. Improvement in organ function after decongestive therapies has been associated with a lower risk for post-discharge mortality. Thus, the prevention and correction of organ dysfunction represent a therapeutic target of interest in AHF and should be evaluated in clinical trials. Treatment strategies that specifically prevent, reduce or reverse organ dysfunction remain to be identified and evaluated to determine if such interventions impact mortality, morbidity and patient-centred outcomes. This paper reflects current understanding among experts of the presentation and management of organ impairment in AHF and suggests priorities for future research to advance the field. © 2017 The Authors. European Journal of Heart Failure © 2017 European Society of Cardiology.

Management of Arrhythmias in Heart Failure

PubMed Central

Masarone, Daniele; Limongelli, Giuseppe; Rubino, Marta; Valente, Fabio; Vastarella, Rossella; Ammendola, Ernesto; Gravino, Rita; Verrengia, Marina; Salerno, Gemma; Pacileo, Giuseppe

2017-01-01

Heart failure patients are predisposed to develop arrhythmias. Supraventricular arrhythmias can exacerbate the heart failure symptoms by decreasing the effective cardiac output and their control require pharmacological, electrical, or catheter-based intervention. In the setting of atrial flutter or atrial fibrillation, anticoagulation becomes paramount to prevent systemic or cerebral embolism. Patients with heart failure are also prone to develop ventricular arrhythmias that can present a challenge to the managing clinician. The management strategy depends on the type of arrhythmia, the underlying structural heart disease, the severity of heart failure, and the range from optimization of heart failure therapy to catheter ablation. Patients with heart failure, irrespective of ejection fraction are at high risk for developing sudden cardiac death, however risk stratification is a clinical challenge and requires a multiparametric evaluation for identification of patients who should undergo implantation of a cardioverter defibrillator. Finally, patients with heart failure can also develop symptomatic bradycardia, caused by sinus node dysfunction or atrio-ventricular block. The treatment of bradycardia in these patients with pacing is usually straightforward but needs some specific issue. PMID:29367535

Local Failure in Resected N1 Lung Cancer: Implications for Adjuvant Therapy

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

Higgins, Kristin A., E-mail: kristin.higgins@duke.edu; Chino, Junzo P.; Berry, Mark

2012-06-01

Purpose: To evaluate actuarial rates of local failure in patients with pathologic N1 non-small-cell lung cancer and to identify clinical and pathologic factors associated with an increased risk of local failure after resection. Methods and Materials: All patients who underwent surgery for non-small-cell lung cancer with pathologically confirmed N1 disease at Duke University Medical Center from 1995-2008 were identified. Patients receiving any preoperative therapy or postoperative radiotherapy or with positive surgical margins were excluded. Local failure was defined as disease recurrence within the ipsilateral hilum, mediastinum, or bronchial stump/staple line. Actuarial rates of local failure were calculated with the Kaplan-Meiermore » method. A Cox multivariate analysis was used to identify factors independently associated with a higher risk of local recurrence. Results: Among 1,559 patients who underwent surgery during the time interval, 198 met the inclusion criteria. Of these patients, 50 (25%) received adjuvant chemotherapy. Actuarial (5-year) rates of local failure, distant failure, and overall survival were 40%, 55%, and 33%, respectively. On multivariate analysis, factors associated with an increased risk of local failure included a video-assisted thoracoscopic surgery approach (hazard ratio [HR], 2.5; p = 0.01), visceral pleural invasion (HR, 2.1; p = 0.04), and increasing number of positive N1 lymph nodes (HR, 1.3 per involved lymph node; p = 0.02). Chemotherapy was associated with a trend toward decreased risk of local failure that was not statistically significant (HR, 0.61; p = 0.2). Conclusions: Actuarial rates of local failure in pN1 disease are high. Further investigation of conformal postoperative radiotherapy may be warranted.« less

Probabilistic confidence for decisions based on uncertain reliability estimates

NASA Astrophysics Data System (ADS)

Reid, Stuart G.

2013-05-01

Reliability assessments are commonly carried out to provide a rational basis for risk-informed decisions concerning the design or maintenance of engineering systems and structures. However, calculated reliabilities and associated probabilities of failure often have significant uncertainties associated with the possible estimation errors relative to the 'true' failure probabilities. For uncertain probabilities of failure, a measure of 'probabilistic confidence' has been proposed to reflect the concern that uncertainty about the true probability of failure could result in a system or structure that is unsafe and could subsequently fail. The paper describes how the concept of probabilistic confidence can be applied to evaluate and appropriately limit the probabilities of failure attributable to particular uncertainties such as design errors that may critically affect the dependability of risk-acceptance decisions. This approach is illustrated with regard to the dependability of structural design processes based on prototype testing with uncertainties attributable to sampling variability.

Risk assessment of component failure modes and human errors using a new FMECA approach: application in the safety analysis of HDR brachytherapy.

PubMed

Giardina, M; Castiglia, F; Tomarchio, E

2014-12-01

Failure mode, effects and criticality analysis (FMECA) is a safety technique extensively used in many different industrial fields to identify and prevent potential failures. In the application of traditional FMECA, the risk priority number (RPN) is determined to rank the failure modes; however, the method has been criticised for having several weaknesses. Moreover, it is unable to adequately deal with human errors or negligence. In this paper, a new versatile fuzzy rule-based assessment model is proposed to evaluate the RPN index to rank both component failure and human error. The proposed methodology is applied to potential radiological over-exposure of patients during high-dose-rate brachytherapy treatments. The critical analysis of the results can provide recommendations and suggestions regarding safety provisions for the equipment and procedures required to reduce the occurrence of accidental events.

Independent Review Support for Phoenix Mars Mission Robotic Arm Brush Motor Failure

NASA Technical Reports Server (NTRS)

McManamen, John P.; Pellicciotti, Joseph; DeKramer, Cornelis; Dube, Michael J.; Peeler, Deborah; Muirhead, Brian K.; Sevilla, Donald R.; Sabahi, Dara; Knopp, Michael D.

2007-01-01

The Phoenix Project requested the NASA Engineering and Safety Center (NESC) perform an independent peer review of the Robotic Arm (RA) Direct Current (DC) motor brush anomalies that originated during the Mars Exploration Rover (MER) Project and recurred during the Phoenix Project. The request was to evaluate the Phoenix Project investigation efforts and provide an independent risk assessment. This includes a recommendation for additional work and assessment of the flight worthiness of the RA DC motors. Based on the investigation and findings contained within this report, the IRT concurs with the risk assessment Failure Cause / Corrective Action (FC/CA) by the project, "Failure Effect Rating "3"; Major Degradation or Total Loss of Function, Failure Cause/Corrective Action Rating Currently "4"; Unknown Cause, Uncertainty in Corrective Action."

Revised Risk Priority Number in Failure Mode and Effects Analysis Model from the Perspective of Healthcare System

PubMed Central

Rezaei, Fatemeh; Yarmohammadian, Mohmmad H.; Haghshenas, Abbas; Fallah, Ali; Ferdosi, Masoud

2018-01-01

Background: Methodology of Failure Mode and Effects Analysis (FMEA) is known as an important risk assessment tool and accreditation requirement by many organizations. For prioritizing failures, the index of “risk priority number (RPN)” is used, especially for its ease and subjective evaluations of occurrence, the severity and the detectability of each failure. In this study, we have tried to apply FMEA model more compatible with health-care systems by redefining RPN index to be closer to reality. Methods: We used a quantitative and qualitative approach in this research. In the qualitative domain, focused groups discussion was used to collect data. A quantitative approach was used to calculate RPN score. Results: We have studied patient's journey in surgery ward from holding area to the operating room. The highest priority failures determined based on (1) defining inclusion criteria as severity of incident (clinical effect, claim consequence, waste of time and financial loss), occurrence of incident (time - unit occurrence and degree of exposure to risk) and preventability (degree of preventability and defensive barriers) then, (2) risks priority criteria quantified by using RPN index (361 for the highest rate failure). The ability of improved RPN scores reassessed by root cause analysis showed some variations. Conclusions: We concluded that standard criteria should be developed inconsistent with clinical linguistic and special scientific fields. Therefore, cooperation and partnership of technical and clinical groups are necessary to modify these models. PMID:29441184

[Analysis of the failures of a cemented constrained liner model in patients with a high dislocation risk].

PubMed

Gallart, X; Gomez, J C; Fernández-Valencia, J A; Combalía, A; Bori, G; García, S; Rios, J; Riba, J

2014-01-01

To evaluate the short-term results of an ultra high molecular weight polyethylene retentive cup in patients at high risk of dislocation, either primary or revision surgery. Retrospective review of 38 cases in order to determine the rate of survival and failure analysis of a constrained cemented cup, with a mean follow-up of 27 months. We studied demographic data, complications, especially re-dislocations of the prosthesis and, also the likely causes of system failure analyzed. In 21.05% (8 cases) were primary surgery and 78.95% were revision surgery (30 cases). The overall survival rate by Kaplan-Meier method was 70.7 months. During follow-up 3 patients died due to causes unrelated to surgery and 2 infections occurred. 12 hips had at least two previous surgeries done. It wasn't any case of aseptic loosening. Four patients presented dislocation, all with a 22 mm head (P=.008). Our statistical analysis didn't found relationship between the abduction cup angle and implant failure (P=.22). The ultra high molecular weight polyethylene retentive cup evaluated in this series has provided satisfactory short-term results in hip arthroplasty patients at high risk of dislocation. Copyright © 2014 SECOT. Published by Elsevier Espana. All rights reserved.

The Indiana Chronic Disease Management Program

PubMed Central

Rosenman, Marc B; Holmes, Ann M; Ackermann, Ronald T; Murray, Michael D; Doebbeling, Caroline Carney; Katz, Barry; Li, Jingjin; Zillich, Alan; Prescott, Victoria M; Downs, Stephen M; Inui, Thomas S

2006-01-01

The Indiana Chronic Disease Management Program (ICDMP) is intended to improve the quality and cost-effectiveness of care for Medicaid members with congestive heart failure (chronic heart failure), diabetes, asthma, and other conditions. The ICDMP is being assembled by Indiana Medicaid primarily from state and local resources and has seven components: (1) identification of eligible participants to create regional registries, (2) risk stratification of eligible participants, (3) nurse care management for high-risk participants, (4) telephonic intervention for all participants, (5) an Internet-based information system, (6) quality improvement collaboratives for primary care practices, and (7) program evaluation. The evaluation involves a randomized controlled trial in two inner-city group practices, as well as a statewide observational design. This article describes the ICDMP, highlights challenges, and discusses approaches to its evaluation. PMID:16529571

The Indiana Chronic Disease Management Program.

PubMed

Rosenman, Marc B; Holmes, Ann M; Ackermann, Ronald T; Murray, Michael D; Doebbeling, Caroline Carney; Katz, Barry; Li, Jingjin; Zillich, Alan; Prescott, Victoria M; Downs, Stephen M; Inui, Thomas S

2006-01-01

The Indiana Chronic Disease Management Program (ICDMP) is intended to improve the quality and cost-effectiveness of care for Medicaid members with congestive heart failure (chronic heart failure), diabetes, asthma, and other conditions. The ICDMP is being assembled by Indiana Medicaid primarily from state and local resources and has seven components: (1) identification of eligible participants to create regional registries, (2) risk stratification of eligible participants, (3) nurse care management for high-risk participants, (4) telephonic intervention for all participants, (5) an Internet-based information system, (6) quality improvement collaboratives for primary care practices, and (7) program evaluation. The evaluation involves a randomized controlled trial in two inner-city group practices, as well as a statewide observational design. This article describes the ICDMP, highlights challenges, and discusses approaches to its evaluation.

A comparison of two prospective risk analysis methods: Traditional FMEA and a modified healthcare FMEA.

PubMed

Rah, Jeong-Eun; Manger, Ryan P; Yock, Adam D; Kim, Gwe-Ya

2016-12-01

To examine the abilities of a traditional failure mode and effects analysis (FMEA) and modified healthcare FMEA (m-HFMEA) scoring methods by comparing the degree of congruence in identifying high risk failures. The authors applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation were based on the risk priority number (RPN). The RPN is a product of three indices: occurrence, severity, and detectability. The m-HFMEA approach utilized two indices, severity and frequency. A risk inventory matrix was divided into four categories: very low, low, high, and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. The two methods were independently compared to determine if the results and rated risks matched. The authors' results showed an agreement of 85% between FMEA and m-HFMEA approaches for top 20 risks of SIG-RS-specific failure modes. The main differences between the two approaches were the distribution of the values and the observation that failure modes (52, 54, 154) with high m-HFMEA scores do not necessarily have high FMEA-RPN scores. In the m-HFMEA analysis, when the risk score is determined, the basis of the established HFMEA Decision Tree™ or the failure mode should be more thoroughly investigated. m-HFMEA is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allows the prioritization of high risks and mitigation measures. It is therefore a useful tool for the prospective risk analysis method to radiotherapy.

Simple motor tasks independently predict extubation failure in critically ill neurological patients

PubMed Central

Kutchak, Fernanda Machado; Rieder, Marcelo de Mello; Victorino, Josué Almeida; Meneguzzi, Carla; Poersch, Karla; Forgiarini, Luiz Alberto; Bianchin, Marino Muxfeldt

2017-01-01

ABSTRACT Objective: To evaluate the usefulness of simple motor tasks such as hand grasping and tongue protrusion as predictors of extubation failure in critically ill neurological patients. Methods: This was a prospective cohort study conducted in the neurological ICU of a tertiary care hospital in the city of Porto Alegre, Brazil. Adult patients who had been intubated for neurological reasons and were eligible for weaning were included in the study. The ability of patients to perform simple motor tasks such as hand grasping and tongue protrusion was evaluated as a predictor of extubation failure. Data regarding duration of mechanical ventilation, length of ICU stay, length of hospital stay, mortality, and incidence of ventilator-associated pneumonia were collected. Results: A total of 132 intubated patients who had been receiving mechanical ventilation for at least 24 h and who passed a spontaneous breathing trial were included in the analysis. Logistic regression showed that patient inability to grasp the hand of the examiner (relative risk = 1.57; 95% CI: 1.01-2.44; p < 0.045) and protrude the tongue (relative risk = 6.84; 95% CI: 2.49-18.8; p < 0.001) were independent risk factors for extubation failure. Acute Physiology and Chronic Health Evaluation II scores (p = 0.02), Glasgow Coma Scale scores at extubation (p < 0.001), eye opening response (p = 0.001), MIP (p < 0.001), MEP (p = 0.006), and the rapid shallow breathing index (p = 0.03) were significantly different between the failed extubation and successful extubation groups. Conclusions: The inability to follow simple motor commands is predictive of extubation failure in critically ill neurological patients. Hand grasping and tongue protrusion on command might be quick and easy bedside tests to identify neurocritical care patients who are candidates for extubation. PMID:28746528

Randomised trial of low-dose amiodarone in severe congestive heart failure. Grupo de Estudio de la Sobrevida en la Insuficiencia Cardiaca en Argentina (GESICA)

PubMed

Doval, H C; Nul, D R; Grancelli, H O; Perrone, S V; Bortman, G R; Curiel, R

1994-08-20

In severe heart failure many deaths are sudden and are presumed to be due to ventricular arrhythmias. The GESICA trial evaluated the effect of low-dose amiodarone on two-year mortality in patients with severe heart failure. Our prospective multicentre trial included 516 patients on optimal standard treatment for heart failure. Patients were randomised to 300 mg/day amiodarone (260) or to standard treatment (256). Intention-to-treat analysis showed 87 deaths in the amiodarone group (33.5%) compared with 106 in the control group (41.4%) (risk reduction 28%; 95% CI 4%-45%; log rank test p = 0.024). There were reductions in both sudden death (risk reduction 27%; p = 0.16) and death due to progressive heart failure (risk reduction 23%; p = 0.16). Fewer patients in the amiodarone group died or were admitted to hospital due to worsening heart failure (119 versus 149 in the control group; risk reduction 31%; 95% CI 13-46%; p = 0.0024). The decrease in mortality and hospital admission was present in all subgroups examined and independent of the presence of non-sustained ventricular tachycardia. Side-effects were reported in 17 patients (6.1%); amiodarone was withdrawn in 12. Low-dose amiodarone proved to be an effective and reliable treatment, reducing mortality and hospital admission in patients with severe heart failure independently of the presence of complex ventricular arrhythmias.

Risk factors for oral methotrexate failure in patients with inflammatory polyarthritis: results from a UK prospective cohort study.

PubMed

Bluett, James; Sergeant, Jamie C; MacGregor, Alex J; Chipping, Jacqueline R; Marshall, Tarnya; Symmons, Deborah P M; Verstappen, Suzanne M M

2018-03-20

Oral methotrexate (MTX) is the first-line therapy for patients with rheumatoid arthritis (RA). However, approximately one quarter of patients discontinue MTX within 12 months. MTX failure, defined as MTX cessation or the addition of another anti-rheumatic drug, is usually due adverse event(s) and/or inefficacy. The aims of this study were to evaluate the rate and predictors of oral MTX failure. Subjects were recruited from the Norfolk Arthritis Register (NOAR), a primary care-based inception cohort of patients with early inflammatory polyarthritis (IP). Subjects were eligible if they commenced MTX as their first DMARD and were recruited between 2000 and 2008. Patient-reported reasons for MTX failure were recorded and categorised as adverse event, inefficacy or other. The addition of a second DMARD during the study period was categorised as failure due to inefficacy. Cox proportional hazards regression models were used to assess potential predictors of MTX failure, accounting for competing risks. A total of 431 patients were eligible. The probability of patients remaining on MTX at 2 years was 82%. Competing risk analysis revealed that earlier MTX failure due to inefficacy was associated with rheumatoid factor (RF) positivity, younger age at symptom onset and higher baseline disease activity (DAS-28). MTX cessation due to an adverse event was less likely in the RF-positive cohort. RF-positive inflammatory polyarthritis patients who are younger with higher baseline disease activity have an increased risk of MTX failure due to inefficacy. Such patients may require combination therapy as a first-line treatment.

Outpatient management of febrile neutropenia: time to revise the present treatment strategy.

PubMed

Carstensen, Mads; Sørensen, Jens Benn

2008-01-01

We reviewed medical literature on the efficacy and safety of outpatient versus hospital-based therapy of low-risk febrile neutropenia in adult cancer patients. A PubMed search for all studies evaluating the outpatient treatment of adults diagnosed with solid tumors who suffered from low-risk febrile neutropenia was completed; reference lists from identified articles also were used. In all, 10 trials were included in the analysis, which showed no significant difference in clinical failure rates and mortality for ambulatory regimens and standard hospital-based therapy. Subgroup analysis according to the type of fever episode showed no significant differences in clinical failure rates for fever of unknown origin and fever due to documented infections. Subgroup analyses in two independent trials identified an absolute neutrophil count < 100 cells/ mm3 as being predictive of outpatient treatment failure (P < 0.04). These findings need to be confirmed by further trials. Thus, outpatient management of adult cancer patients with low-risk febrile neutropenia is safe, effective, and comparable to standard hospital-based therapy. Patients at low risk are outpatients and are hemodynamically stable; they have no organ failure, they are able to take oral medications, and they do not suffer from acute leukemia. Low-risk prediction also may be based on the Multinational Association for Supportive Care in Cancer risk index.

Both high and low HbA1c predict incident heart failure in type 2 diabetes mellitus.

PubMed

Parry, Helen M; Deshmukh, Harshal; Levin, Daniel; Van Zuydam, Natalie; Elder, Douglas H J; Morris, Andrew D; Struthers, Allan D; Palmer, Colin N A; Doney, Alex S F; Lang, Chim C

2015-03-01

Type 2 diabetes mellitus is an independent risk factor for heart failure development, but the relationship between incident heart failure and antecedent glycemia has not been evaluated. The Genetics of Diabetes Audit and Research in Tayside Study study holds data for 8683 individuals with type 2 diabetes mellitus. Dispensed prescribing, hospital admission data, and echocardiography reports were linked to extract incident heart failure cases from December 1998 to August 2011. All available HbA1c measures until heart failure development or end of study were used to model HbA1c time-dependently. Individuals were observed from study enrolment until heart failure development or end of study. Proportional hazard regression calculated heart failure development risk associated with specific HbA1c ranges accounting for comorbidities associated with heart failure, including blood pressure, body mass index, and coronary artery disease. Seven hundred and one individuals with type 2 diabetes mellitus (8%) developed heart failure during follow up (mean 5.5 years, ±2.8 years). Time-updated analysis with longitudinal HbA1c showed that both HbA1c <6% (hazard ratio =1.60; 95% confidence interval, 1.38-1.86; P value <0.0001) and HbA1c >10% (hazard ratio =1.80; 95% confidence interval, 1.60-2.16; P value <0.0001) were independently associated with the risk of heart failure. Both high and low HbA1c predicted heart failure development in our cohort, forming a U-shaped relationship. © 2015 American Heart Association, Inc.

Risk of heart failure after community acquired pneumonia: prospective controlled study with 10 years of follow-up

PubMed Central

Marrie, Thomas J; Minhas-Sandhu, Jasjeet K; Majumdar, Sumit R

2017-01-01

Abstract Objective To determine the attributable risk of community acquired pneumonia on incidence of heart failure throughout the age range of affected patients and severity of the infection. Design Cohort study. Setting Six hospitals and seven emergency departments in Edmonton, Alberta, Canada, 2000-02. Participants 4988 adults with community acquired pneumonia and no history of heart failure were prospectively recruited and matched on age, sex, and setting of treatment (inpatient or outpatient) with up to five adults without pneumonia (controls) or prevalent heart failure (n=23 060). Main outcome measures Risk of hospital admission for incident heart failure or a combined endpoint of heart failure or death up to 2012, evaluated using multivariable Cox proportional hazards analyses. Results The average age of participants was 55 years, 2649 (53.1%) were men, and 63.4% were managed as outpatients. Over a median of 9.9 years (interquartile range 5.9-10.6), 11.9% (n=592) of patients with pneumonia had incident heart failure compared with 7.4% (n=1712) of controls (adjusted hazard ratio 1.61, 95% confidence interval 1.44 to 1.81). Patients with pneumonia aged 65 or less had the lowest absolute increase (but greatest relative risk) of heart failure compared with controls (4.8% v 2.2%; adjusted hazard ratio 1.98, 95% confidence interval 1.5 to 2.53), whereas patients with pneumonia aged more than 65 years had the highest absolute increase (but lowest relative risk) of heart failure (24.8% v 18.9%; adjusted hazard ratio 1.55, 1.36 to 1.77). Results were consistent in the short term (90 days) and intermediate term (one year) and whether patients were treated in hospital or as outpatients. Conclusion Our results show that community acquired pneumonia substantially increases the risk of heart failure across the age and severity range of cases. This should be considered when formulating post-discharge care plans and preventive strategies, and assessing downstream episodes of dyspnoea. PMID:28193610

Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery.

PubMed

Manger, Ryan P; Paxton, Adam B; Pawlicki, Todd; Kim, Gwe-Ya

2015-05-01

Surface image guided, Linac-based radiosurgery (SIG-RS) is a modern approach for delivering radiosurgery that utilizes optical stereoscopic imaging to monitor the surface of the patient during treatment in lieu of using a head frame for patient immobilization. Considering the novelty of the SIG-RS approach and the severity of errors associated with delivery of large doses per fraction, a risk assessment should be conducted to identify potential hazards, determine their causes, and formulate mitigation strategies. The purpose of this work is to investigate SIG-RS using the combined application of failure modes and effects analysis (FMEA) and fault tree analysis (FTA), report on the effort required to complete the analysis, and evaluate the use of FTA in conjunction with FMEA. A multidisciplinary team was assembled to conduct the FMEA on the SIG-RS process. A process map detailing the steps of the SIG-RS was created to guide the FMEA. Failure modes were determined for each step in the SIG-RS process, and risk priority numbers (RPNs) were estimated for each failure mode to facilitate risk stratification. The failure modes were ranked by RPN, and FTA was used to determine the root factors contributing to the riskiest failure modes. Using the FTA, mitigation strategies were formulated to address the root factors and reduce the risk of the process. The RPNs were re-estimated based on the mitigation strategies to determine the margin of risk reduction. The FMEA and FTAs for the top two failure modes required an effort of 36 person-hours (30 person-hours for the FMEA and 6 person-hours for two FTAs). The SIG-RS process consisted of 13 major subprocesses and 91 steps, which amounted to 167 failure modes. Of the 91 steps, 16 were directly related to surface imaging. Twenty-five failure modes resulted in a RPN of 100 or greater. Only one of these top 25 failure modes was specific to surface imaging. The riskiest surface imaging failure mode had an overall RPN-rank of eighth. Mitigation strategies for the top failure mode decreased the RPN from 288 to 72. Based on the FMEA performed in this work, the use of surface imaging for monitoring intrafraction position in Linac-based stereotactic radiosurgery (SRS) did not greatly increase the risk of the Linac-based SRS process. In some cases, SIG helped to reduce the risk of Linac-based RS. The FMEA was augmented by the use of FTA since it divided the failure modes into their fundamental components, which simplified the task of developing mitigation strategies.

Association between vitamin D deficiency and heart failure risk in the elderly.

PubMed

Porto, Catarina Magalhães; Silva, Vanessa De Lima; da Luz, João Soares Brito; Filho, Brivaldo Markman; da Silveira, Vera Magalhães

2018-02-01

The aim of this study was to evaluate the association between vitamin D deficiency and risk of heart failure in elderly patients of cardiology outpatient clinics. A cross-sectional study with an analytical approach was employed. Clinical data were collected from the elderly from August 2015 to February 2016. The dependent variable was the risk of heart failure; the independent variable was vitamin D deficiency; and intervening factors were age, gender, education, ethnicity, hypertension, diabetes mellitus, hypothyroidism, renal failure, dementia, stroke, dyslipidaemia, depression, smoking, alcoholism, obesity, andropause, and cardiac arrhythmia. To analyse the association between vitamin D deficiency and risk of heart failure, we used the bivariate logistic analysis, followed by analysis through the multivariate logistic regression model. Of the 137 elderly, the study found the following: women (75.9%); overweight (48.2%); obese (30.6%); increase in the index waist/hip (88.3%); dyslipidaemia (94.2%) and hypertension (91.2%); coronary artery disease (35.0%); and 27.7% with cardiac arrhythmia or left ventricular hypertrophy. Sixty-five per cent of the elderly were deficient in vitamin D. The risk of heart failure was significantly associated with vitamin D deficiency [odds ratio (OR): 12.19; 95% confidence interval (CI) = 4.23-35.16; P = 0.000], male gender (OR: 15.32; 95% CI = 3.39-69.20, P = 0.000), obesity (OR: 4.17; 95% CI = 1.36-12.81; P = 0.012), and cardiac arrhythmia (OR: 3.69; 95% CI = 1.23-11.11; P = 0.020). There was a high prevalence of vitamin D deficiency in the elderly, and the evidence shows a strong association between vitamin D deficiency and increased risk of heart failure in this population. © 2017 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

Use of mechanistic simulations as a quantitative risk-ranking tool within the quality by design framework.

PubMed

Stocker, Elena; Toschkoff, Gregor; Sacher, Stephan; Khinast, Johannes G

2014-11-20

The purpose of this study is to evaluate the use of computer simulations for generating quantitative knowledge as a basis for risk ranking and mechanistic process understanding, as required by ICH Q9 on quality risk management systems. In this specific publication, the main focus is the demonstration of a risk assessment workflow, including a computer simulation for the generation of mechanistic understanding of active tablet coating in a pan coater. Process parameter screening studies are statistically planned under consideration of impacts on a potentially critical quality attribute, i.e., coating mass uniformity. Based on computer simulation data the process failure mode and effects analysis of the risk factors is performed. This results in a quantitative criticality assessment of process parameters and the risk priority evaluation of failure modes. The factor for a quantitative reassessment of the criticality and risk priority is the coefficient of variation, which represents the coating mass uniformity. The major conclusion drawn from this work is a successful demonstration of the integration of computer simulation in the risk management workflow leading to an objective and quantitative risk assessment. Copyright © 2014. Published by Elsevier B.V.

Multinational Assessment of Accuracy of Equations for Predicting Risk of Kidney Failure: A Meta-analysis.

PubMed

Tangri, Navdeep; Grams, Morgan E; Levey, Andrew S; Coresh, Josef; Appel, Lawrence J; Astor, Brad C; Chodick, Gabriel; Collins, Allan J; Djurdjev, Ognjenka; Elley, C Raina; Evans, Marie; Garg, Amit X; Hallan, Stein I; Inker, Lesley A; Ito, Sadayoshi; Jee, Sun Ha; Kovesdy, Csaba P; Kronenberg, Florian; Heerspink, Hiddo J Lambers; Marks, Angharad; Nadkarni, Girish N; Navaneethan, Sankar D; Nelson, Robert G; Titze, Stephanie; Sarnak, Mark J; Stengel, Benedicte; Woodward, Mark; Iseki, Kunitoshi

2016-01-12

Identifying patients at risk of chronic kidney disease (CKD) progression may facilitate more optimal nephrology care. Kidney failure risk equations, including such factors as age, sex, estimated glomerular filtration rate, and calcium and phosphate concentrations, were previously developed and validated in 2 Canadian cohorts. Validation in other regions and in CKD populations not under the care of a nephrologist is needed. To evaluate the accuracy of the risk equations across different geographic regions and patient populations through individual participant data meta-analysis. Thirty-one cohorts, including 721,357 participants with CKD stages 3 to 5 in more than 30 countries spanning 4 continents, were studied. These cohorts collected data from 1982 through 2014. Cohorts participating in the CKD Prognosis Consortium with data on end-stage renal disease. Data were obtained and statistical analyses were performed between July 2012 and June 2015. Using the risk factors from the original risk equations, cohort-specific hazard ratios were estimated and combined using random-effects meta-analysis to form new pooled kidney failure risk equations. Original and pooled kidney failure risk equation performance was compared, and the need for regional calibration factors was assessed. Kidney failure (treatment by dialysis or kidney transplant). During a median follow-up of 4 years of 721,357 participants with CKD, 23,829 cases kidney failure were observed. The original risk equations achieved excellent discrimination (ability to differentiate those who developed kidney failure from those who did not) across all cohorts (overall C statistic, 0.90; 95% CI, 0.89-0.92 at 2 years; C statistic at 5 years, 0.88; 95% CI, 0.86-0.90); discrimination in subgroups by age, race, and diabetes status was similar. There was no improvement with the pooled equations. Calibration (the difference between observed and predicted risk) was adequate in North American cohorts, but the original risk equations overestimated risk in some non-North American cohorts. Addition of a calibration factor that lowered the baseline risk by 32.9% at 2 years and 16.5% at 5 years improved the calibration in 12 of 15 and 10 of 13 non-North American cohorts at 2 and 5 years, respectively (P = .04 and P = .02). Kidney failure risk equations developed in a Canadian population showed high discrimination and adequate calibration when validated in 31 multinational cohorts. However, in some regions the addition of a calibration factor may be necessary.

Clinical risk factors related to failures with zirconia-based restorations: an up to 9-year retrospective study.

PubMed

Koenig, Vinciane; Vanheusden, Alain J; Le Goff, Stéphane O; Mainjot, Amélie K

2013-12-01

The first objective of this study was to retrospectively evaluate zirconia-based restorations (ZBR). The second was to correlate failures with clinical parameters and to identify and to analyse chipping failures using fractographic analysis. 147 ZBR (tooth- and implant-supported crowns and fixed partial dentures (FPDs)) were evaluated after a mean observation period of 41.5 ± 31.8 months. Accessorily, zirconia implant abutments (n=46) were also observed. The technical (USPHS criteria) and the biological outcomes of the ZBR were evaluated. Occlusal risk factors were examined: occlusal relationships, parafunctional habits, and the presence of occlusal nightguard. SEM fractographic analysis was performed using the intra-oral replica technique. The survival rate of crowns and FPDs was 93.2%, the success rate was 81.63% and the 9-year Kaplan-Meier estimated success rate was 52.66%. The chipping rate was 15% and the framework fracture rate was 2.7%. Most fractographic analyses revealed that veneer fractures originated from occlusal surface roughness. Several parameters were shown to significantly influence veneer fracture: the absence of occlusal nightguard (p=0.0048), the presence of a ceramic restoration as an antagonist (p=0.013), the presence of parafunctional activity (p=0.018), and the presence of implants as support (p=0.026). The implant abutments success rate was 100%. The results of the present study confirm that chipping is the first cause of ZBR failure. They also underline the importance of clinical parameters in regards to the explanation of this complex problem. This issue should be considered in future prospective clinical studies. Practitioners can reduce chipping failures by taking into account several risk parameters, such as the presence of a ceramic restoration as an antagonist, the presence of parafunctional activity and the presence of implants as support. The use of an occlusal nightguard can also decrease failure rate. Copyright © 2013 Elsevier Ltd. All rights reserved.

Failure-free survival after second-line systemic treatment of chronic graft-versus-host disease

PubMed Central

Storer, Barry E.; Lee, Stephanie J.; Carpenter, Paul A.; Sandmaier, Brenda M.; Flowers, Mary E. D.; Martin, Paul J.

2013-01-01

This study attempted to characterize causes of treatment failure, identify associated prognostic factors, and develop shorter-term end points for trials testing investigational products or regimens for second-line systemic treatment of chronic graft-versus-host disease (GVHD). The study cohort (312 patients) received second-line systemic treatment of chronic GVHD. The primary end point was failure-free survival (FFS) defined by the absence of third-line treatment, nonrelapse mortality, and recurrent malignancy during second-line treatment. Treatment change was the major cause of treatment failure. FFS was 56% at 6 months after second-line treatment. Lower steroid doses at 6 months correlated with subsequent withdrawal of immunosuppressive treatment. Multivariate analysis showed that high-risk disease at transplantation, lower gastrointestinal involvement at second-line treatment, and severe NIH global score at second-line treatment were associated with increased risks of treatment failure. These three factors were used to define risk groups, and success rates at 6 months were calculated for each risk group either without or with various steroid dose limits at 6 months as an additional criterion of success. These success rates could be used as the basis for a clinically relevant and efficient shorter-term end point in clinical studies that evaluate agents for second-line systemic treatment of chronic GVHD. PMID:23321253

Improving online risk assessment with equipment prognostics and health monitoring

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

Coble, Jamie B.; Liu, Xiaotong; Briere, Chris

The current approach to evaluating the risk of nuclear power plant (NPP) operation relies on static probabilities of component failure, which are based on industry experience with the existing fleet of nominally similar light water reactors (LWRs). As the nuclear industry looks to advanced reactor designs that feature non-light water coolants (e.g., liquid metal, high temperature gas, molten salt), this operating history is not available. Many advanced reactor designs use advanced components, such as electromagnetic pumps, that have not been used in the US commercial nuclear fleet. Given the lack of rich operating experience, we cannot accurately estimate the evolvingmore » probability of failure for basic components to populate the fault trees and event trees that typically comprise probabilistic risk assessment (PRA) models. Online equipment prognostics and health management (PHM) technologies can bridge this gap to estimate the failure probabilities for components under operation. The enhanced risk monitor (ERM) incorporates equipment condition assessment into the existing PRA and risk monitor framework to provide accurate and timely estimates of operational risk.« less

Use of failure mode, effect and criticality analysis to improve safety in the medication administration process.

PubMed

Rodriguez-Gonzalez, Carmen Guadalupe; Martin-Barbero, Maria Luisa; Herranz-Alonso, Ana; Durango-Limarquez, Maria Isabel; Hernandez-Sampelayo, Paloma; Sanjurjo-Saez, Maria

2015-08-01

To critically evaluate the causes of preventable adverse drug events during the nurse medication administration process in inpatient units with computerized prescription order entry and profiled automated dispensing cabinets in order to prioritize interventions that need to be implemented and to evaluate the impact of specific interventions on the criticality index. This is a failure mode, effects and criticality analysis (FMECA) study. A multidisciplinary consensus committee composed of pharmacists, nurses and doctors evaluated the process of administering medications in a hospital setting in Spain. By analysing the process, all failure modes were identified and criticality was determined by rating severity, frequency and likelihood of failure detection on a scale of 1 to 10, using adapted versions of already published scales. Safety strategies were identified and prioritized. Through consensus, the committee identified eight processes and 40 failure modes, of which 20 were classified as high risk. The sum of the criticality indices was 5254. For the potential high-risk failure modes, 21 different potential causes were found resulting in 24 recommendations. Thirteen recommendations were prioritized and developed over a 24-month period, reducing total criticality from 5254 to 3572 (a 32.0% reduction). The recommendations with a greater impact on criticality were the development of an electronic medication administration record (-582) and the standardization of intravenous drug compounding in the unit (-168). Other improvements, such as barcode medication administration technology (-1033), were scheduled for a longer period of time because of lower feasibility. FMECA is a useful approach that can improve the medication administration process. © 2015 John Wiley & Sons, Ltd.

Moving toward comprehensive acute heart failure risk assessment in the emergency department: the importance of self-care and shared decision making.

PubMed

Collins, Sean P; Storrow, Alan B

2013-08-01

Nearly 700,000 emergency department (ED) visits were due to acute heart failure (AHF) in 2009. Most visits result in a hospital admission and account for the largest proportion of a projected $70 billion to be spent on heart failure care by 2030. ED-based risk prediction tools in AHF rarely impact disposition decision making. This is a major factor contributing to the 80% admission rate for ED patients with AHF, which has remained unchanged over the last several years. Self-care behaviors such as symptom monitoring, medication taking, dietary adherence, and exercise have been associated with decreased hospital readmissions, yet self-care remains largely unaddressed in ED patients with AHF and thus represents a significant lost opportunity to improve patient care and decrease ED visits and hospitalizations. Furthermore, shared decision making encourages collaborative interaction between patients, caregivers, and providers to drive a care path based on mutual agreement. The observation that “difficult decisions now will simplify difficult decisions later” has particular relevance to the ED, given this is the venue for many such issues. We hypothesize patients as complex and heterogeneous as ED patients with AHF may need both an objective evaluation of physiologic risk as well as an evaluation of barriers to ideal self-care, along with strategies to overcome these barriers. Combining physician gestalt, physiologic risk prediction instruments, an evaluation of self-care, and an information exchange between patient and provider using shared decision making may provide the critical inertia necessary to discharge patients home after a brief ED evaluation.

Concealed renal failure and adverse drug reactions in older patients with type 2 diabetes mellitus.

PubMed

Corsonello, Andrea; Pedone, Claudio; Corica, Francesco; Mazzei, Bruno; Di Iorio, Angelo; Carbonin, Pierugo; Incalzi, Raffaele Antonelli

2005-09-01

In elderly patients serum creatinine may be normal despite decreased glomerular filtration rate (GFR). The aim of this study was to evaluate the prevalence of this "concealed" renal failure, i.e., renal failure with normal serum creatinine levels, in elderly diabetic patients, and to verify whether it is a risk factor for adverse drug reactions (ADR) to hydrosoluble drugs. We used data on 2257 hospitalized patients with type 2 diabetes mellitus enrolled in the Gruppo Italiano di Farmacovigilanza nell'Anziano study. On the basis of serum creatinine and calculated GFR, patients were grouped as follows: normal renal function (normal serum creatinine levels and normal GFR), concealed (normal serum creatinine levels and reduced GFR), or overt (increased creatinine levels and reduced GFR) renal failure. GFR was calculated using the Modification of Diet in Renal Disease (MDRD) equation. The outcome of the study was the incidence of ADR to hydrosoluble drugs during the hospital stay. The relationship between renal function and ADR was evaluated using Cox regression analysis including potential confounders. Concealed renal failure was observed in 363 (16.1%) of patients studied. Patients with concealed or overt renal failure were older, had more frequently cognitive impairment and polypharmacy, and had lower serum albumin levels than did those with normal renal function. Both concealed (hazard ratio = 1.90; 95% confidence interval, 1.04-3.48; p =.036) and overt (hazard ratio = 2.23; 95% confidence interval, 1.40-3.55; p =.001) renal failure were significantly associated with ADR to hydrosoluble drugs. The use of more than four drugs also qualified as an independent risk factor for ADRs to hydrosoluble drugs during hospital stay. Older diabetic patients should be systematically screened to ascertain the presence of concealed renal failure in an attempt to optimize the pharmacological treatment and reduce the risk of ADRs.

TU-FG-201-11: Evaluating the Validity of Prospective Risk Analysis Methods: A Comparison of Traditional FMEA and Modified Healthcare FMEA

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

Lah, J; Manger, R; Kim, G

Purpose: To examine the ability of traditional Failure mode and effects analysis (FMEA) and a light version of Healthcare FMEA (HFMEA), called Scenario analysis of FMEA (SAFER) by comparing their outputs in terms of the risks identified and their severity rankings. Methods: We applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation are based on risk priority number (RPN). RPN is a product of three indices: occurrence, severity and detectability. The SAFER approach; utilized two indices-frequency and severity-which were defined by a multidisciplinarymore » team. A criticality matrix was divided into 4 categories; very low, low, high and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. Results: Two methods were independently compared to determine if the results and rated risks were matching or not. Our results showed an agreement of 67% between FMEA and SAFER approaches for the 15 riskiest SIG-specific failure modes. The main differences between the two approaches were the distribution of the values and the failure modes (No.52, 54, 154) that have high SAFER scores do not necessarily have high FMEA RPN scores. In our results, there were additional risks identified by both methods with little correspondence. In the SAFER, when the risk score is determined, the basis of the established decision tree or the failure mode should be more investigated. Conclusion: The FMEA method takes into account the probability that an error passes without being detected. SAFER is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allow the prioritization of risks and mitigation measures, and thus is perfectly applicable to clinical parts of radiotherapy.« less

Eliminating Contractor Inspections of Federal Water Projects Could Save Millions.

DTIC Science & Technology

1981-09-29

of the Buffalo Creek, West Virginia, Mine Refuse Embankment and the 1976 Teton Dam failure in Idaho have been fairly recent reminders of the risk...project failures, heightened by the Teton Dam failure, prompted several Government-sponsored dam safety reviews in the late 1970’s. Following these reviews...inspection approach was evaluated as part of the Government-wide,’ Presidentially directed Dam Safety Review of 1977. The Bureau’s 1976 Teton Dam

An electronic patient risk communication board.

PubMed

Ohashi, Kumiko; Caligtan, Christine A; Benoit, Angela N; Breydo, Eugene M; Carroll, Diane L; Keohane, Carol A; Bates, David W; Dykes, John S; Dykes, Patricia C

2012-01-01

Communication failures have been identified as the root cause of the majority of medical malpractice claims and patient safety violations. We believe it is essential to share key patient risk information with healthcare team members at the patient's bedside. In this study, we developed an electronic Patient Risk Communication Board (ePRCB) to assist in bridging the communication gap between all health care team members. The goal of the ePRCB is to effectively communicate the patient's key risk factors, such as a fall risk or risk of aspiration, to the healthcare team and to reduce adverse events caused by communication failures. The ePRCB will transmit patient risk information and tailored interventions with easy-to-understand icons on an LCD screen at the point of care. A set of patient risk reminder icons was developed and validated by focus groups. We used the results of the evaluation to refine the icons for the ePRCB.

An Electronic Patient Risk Communication Board

PubMed Central

Ohashi, Kumiko; Caligtan, Christine A.; Benoit, Angela N.; Breydo, Eugene M.; Carroll, Diane L.; Keohane, Carol A.; Bates, David W.; Dykes, John S.; Dykes, Patricia C.

2012-01-01

Communication failures have been identified as the root cause of the majority of medical malpractice claims and patient safety violations. We believe it is essential to share key patient risk information with healthcare team members at the patient’s bedside. In this study, we developed an electronic Patient Risk Communication Board (ePRCB) to assist in bridging the communication gap between all health care team members. The goal of the ePRCB is to effectively communicate the patient’s key risk factors, such as a fall risk or risk of aspiration, to the healthcare team and to reduce adverse events caused by communication failures. The ePRCB will transmit patient risk information and tailored interventions with easy-to-understand icons on an LCD screen at the point of care. A set of patient risk reminder icons was developed and validated by focus groups. We used the results of the evaluation to refine the icons for the ePRCB. PMID:24199109

Hospital delivery volume, severe obstetrical morbidity, and failure to rescue.

PubMed

Friedman, Alexander M; Ananth, Cande V; Huang, Yongmei; D'Alton, Mary E; Wright, Jason D

2016-12-01

In the setting of persistently high risk for maternal death and severe obstetric morbidity, little is known about the relationship between hospital delivery volume and maternal outcomes. The objectives of this analysis were (1) to determine maternal risk for severe morbidity during delivery hospitalizations by hospital delivery volume in the United States and (2) to characterize, by hospital volume, the risk for death in the setting of severe obstetric morbidity, a concept known as failure to rescue. This cohort study evaluated 50,433,539 delivery hospitalizations across the United States from 1998-2010. The main outcome measures were (1) severe morbidity that was defined as a composite of any 1 of 15 diagnoses that are representative of acute organ injury and critical illness and (2) failure to rescue that was defined as death in the setting of severe morbidity. The prevalence of severe morbidity rose from 471.2-751.5 cases per 100,000 deliveries from 1998-2010, which was an increase of 59.5%. Failure to rescue was highest in 1998 (1.5%), decreased to 0.6% in 2007, and rose to 0.9% in 2010. In models that were adjusted for comorbid risk and hospital factors, both low and high annualized delivery volume were associated with increased risk for failure to rescue and severe morbidity. However, the relative importance of hospital volume for both outcomes compared with other factors was relatively small. Although low-and high-delivery volume are associated with increased risk for both failure to rescue and severe maternal morbidity, other factors, in particular characteristics of individual centers, may be more important in the determination of outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Falls in Patients With Heart Failure: A Systematic Review.

PubMed

Lee, Kayoung; Pressler, Susan J; Titler, Marita

Many heart failure patients show fall-related signs/symptoms including postural hypotension, cerebellar injury, and cognitive impairments. Falls contribute to injuries, increased healthcare use, and death, but falls have been understudied in this population. The purpose of this review is to identify fall rates, fall injuries, and risk factors for falls in heart failure patients. A systematic literature review was conducted using MEDLINE, CINAHL, PubMed, PsycINFO, and Cochrane Library to identify publications from August 1973 to June 2013. Keywords were accidental falls, heart failure, fall rates, fall injuries, and fall risk. Inclusion criteria were publications that were primary data based, included heart failure sample, had falls/fall risk as study variables, and were written in English language. Exclusion criteria were quality improvement/evaluation, case reports/studies, news, opinions, narrative reviews, meeting reports, reflections, and letters to editors. Data were abstracted using a standardized data collection form. Four publications met the inclusion criteria. In the first study, fall rate was 43%, which is higher than the fall rates among community-dwelling older adults. Fall-related injuries were not examined in any of studies. Benzodiazepines and digoxin were identified as medications that increased risk of falls in 1 case-control study. Loop diuretics were not significantly associated with falls in 1 cohort study. In the fourth study, patients who had poor gait and balance were at greater risk of falling. Future studies are needed to determine factors associated with falls, characterize injuries resulting from falls, and most importantly design testable interventions to prevent falls in heart failure patients.

Use of nesiritide before and after publications suggesting drug-related risks in patients with acute decompensated heart failure.

PubMed

Hauptman, Paul J; Schnitzler, Mark A; Swindle, Jason; Burroughs, Thomas E

2006-10-18

The rate of adoption of new therapies for cardiovascular diseases following the publication of favorable clinical trial results has been studied; however, less is known about the rates of de-adoption of a drug when negative studies are published. To evaluate the use of nesiritide before and after March and April 2005 publications in 2 high-impact journals that suggested an increased risk of renal failure and mortality with intravenous nesiritide for acute decompensated heart failure. Analysis of a large prospective hospital database, developed for quality and utilization benchmarking, of 491 acute care US hospitals at which 385,627 inpatient admissions occurred with a primary International Classification of Diseases, Ninth Revision (ICD-9) code for heart failure between January and August 2001 (prior to nesiritide release) and January 2004 to December 2005 (before and after publication periods). In addition, any patient admitted who received nesiritide in the absence of a primary or secondary heart failure code was evaluated for potential off-label use of the drug. Use of nesiritide and other intravenous vasoactive therapy among patients admitted with heart failure. Nesiritide use decreased from a peak of 16.6% (2351 of 14,167 admissions) in March 2005 to 5.6% (611 of 10,822 admissions) in December 2005 (P<.001). Among those patients treated with nesiritide, the mean duration of treatment changed minimally, from 2.3 to 2.1 days. Although the use of inotropes also decreased during the period under study, the changes were more modest; furthermore, of those patients who were prescribed intravenous vasoactive therapy, a higher percentage were prescribed inotropes after publication (3272 [21.5%] of 15 193 patients from January-April 2005 vs 5750 [29.6%] of 19 445 patients from May-December 2005, P<.001). The use of nesiritide, in the absence of an ICD-9 heart failure code, was small. Rapid de-adoption of nesiritide occurred following 2 publications suggesting risk with the drug. Further analyses are required to evaluate the consequences of these changes on patient outcomes and to anticipate how publications of adverse findings can influence practice.

Biomarkers and low risk in heart failure. Data from COACH and TRIUMPH.

PubMed

Meijers, Wouter C; de Boer, Rudolf A; van Veldhuisen, Dirk J; Jaarsma, Tiny; Hillege, Hans L; Maisel, Alan S; Di Somma, Salvatore; Voors, Adriaan A; Peacock, W Frank

2015-12-01

Traditionally, risk stratification in heart failure (HF) emphasizes assessment of high risk. We aimed to determine if biomarkers could identify patients with HF at low risk for death or HF rehospitalization. This analysis was a substudy of The Coordinating Study Evaluating Outcomes of Advising and Counselling in Heart Failure (COACH) trial. Enrolment of HF patients occurred before discharge. We defined low risk as the absence of death and/or HF rehospitalizations at 180 days. We tested a diverse group of 29 biomarkers on top of a clinical risk model, with and without N-terminal pro-B-type natriuretic peptide (NT-proBNP), and defined the low risk biomarker cut-off at the 10th percentile associated with high positive predictive value. The best performing biomarkers together with NT-proBNP and cardiac troponin I (cTnI) were re-evaluated in a validation cohort of 285 HF patients. Of 592 eligible COACH patients, the mean (± SD) age was 71 (± 11) years and median (IQR) NT-proBNP was 2521 (1301-5634) pg/mL. Logistic regression analysis showed that only galectin-3, fully adjusted, was significantly associated with the absence of events at 180 days (OR 8.1, 95% confidence interval 1.06-50.0, P = 0.039). Galectin-3, showed incremental value when added to the clinical risk model without NT-proBNP (increase in area under the curve from 0.712 to 0.745, P = 0.04). However, no biomarker showed significant improvement by net reclassification improvement on top of the clinical risk model, with or without NT-proBNP. We confirmed our results regarding galectin-3, NT-proBNP, and cTnI in the independent validation cohort. We describe the value of various biomarkers to define low risk, and demonstrate that galectin-3 identifies HF patients at (very) low risk for 30-day and 180-day mortality and HF rehospitalizations after an episode of acute HF. Such patients might be safely discharged. © 2015 The Authors European Journal of Heart Failure © 2015 European Society of Cardiolog.

Measurement and Internalization of Systemic Risk in a Global Banking Network

NASA Astrophysics Data System (ADS)

Feng, Xiaobing; Hu, Haibo

2013-12-01

The negative externalities from an individual bank failure to the whole system can be huge. One of the key purposes of bank regulation is to internalize the social costs of potential bank failures via capital charges. This study proposes a method to evaluate and allocate the systemic risk to different countries/regions using a Susceptible-Infected-Removable (SIR) type of epidemic spreading model and the Shapley value (SV) in game theory. The paper also explores features of a constructed bank network using real globe-wide banking data.

Pediatric keratoplasty.

PubMed

Vanathi, M; Panda, Anita; Vengayil, Sujith; Chaudhuri, Zia; Dada, Tanuj

2009-01-01

Penetrating keratoplasty in children is a highly challenging and demanding procedure associated with a high risk of graft failure or failure of amblyopia therapy in clear grafts. Nonetheless, keratoplasty remains the surgery of choice for the management of pediatric corneal stromal opacities or edema. Allograft rejection, graft infection, corneal neovascularization, glaucoma, trauma to the anterior segment, vitreous pathology, and additional surgical interventions, especially those related to glaucoma management, are important risk factors. Successful penetrating keratoplasty in children requires careful preoperative evaluation and selection of patients follow-up by well-motivated parents, an expert corneal transplant surgeon, and a devoted pediatric ophthalmologist.

Risk assessment of turbine rotor failure using probabilistic ultrasonic non-destructive evaluations

NASA Astrophysics Data System (ADS)

Guan, Xuefei; Zhang, Jingdan; Zhou, S. Kevin; Rasselkorde, El Mahjoub; Abbasi, Waheed A.

2014-02-01

The study presents a method and application of risk assessment methodology for turbine rotor fatigue failure using probabilistic ultrasonic nondestructive evaluations. A rigorous probabilistic modeling for ultrasonic flaw sizing is developed by incorporating the model-assisted probability of detection, and the probability density function (PDF) of the actual flaw size is derived. Two general scenarios, namely the ultrasonic inspection with an identified flaw indication and the ultrasonic inspection without flaw indication, are considered in the derivation. To perform estimations for fatigue reliability and remaining useful life, uncertainties from ultrasonic flaw sizing and fatigue model parameters are systematically included and quantified. The model parameter PDF is estimated using Bayesian parameter estimation and actual fatigue testing data. The overall method is demonstrated using a realistic application of steam turbine rotor, and the risk analysis under given safety criteria is provided to support maintenance planning.

A Case Study on Improving Intensive Care Unit (ICU) Services Reliability: By Using Process Failure Mode and Effects Analysis (PFMEA)

PubMed Central

Yousefinezhadi, Taraneh; Jannesar Nobari, Farnaz Attar; Goodari, Faranak Behzadi; Arab, Mohammad

2016-01-01

Introduction: In any complex human system, human error is inevitable and shows that can’t be eliminated by blaming wrong doers. So with the aim of improving Intensive Care Units (ICU) reliability in hospitals, this research tries to identify and analyze ICU’s process failure modes at the point of systematic approach to errors. Methods: In this descriptive research, data was gathered qualitatively by observations, document reviews, and Focus Group Discussions (FGDs) with the process owners in two selected ICUs in Tehran in 2014. But, data analysis was quantitative, based on failures’ Risk Priority Number (RPN) at the base of Failure Modes and Effects Analysis (FMEA) method used. Besides, some causes of failures were analyzed by qualitative Eindhoven Classification Model (ECM). Results: Through FMEA methodology, 378 potential failure modes from 180 ICU activities in hospital A and 184 potential failures from 99 ICU activities in hospital B were identified and evaluated. Then with 90% reliability (RPN≥100), totally 18 failures in hospital A and 42 ones in hospital B were identified as non-acceptable risks and then their causes were analyzed by ECM. Conclusions: Applying of modified PFMEA for improving two selected ICUs’ processes reliability in two different kinds of hospitals shows that this method empowers staff to identify, evaluate, prioritize and analyze all potential failure modes and also make them eager to identify their causes, recommend corrective actions and even participate in improving process without feeling blamed by top management. Moreover, by combining FMEA and ECM, team members can easily identify failure causes at the point of health care perspectives. PMID:27157162

Morphologic Risk Factors in Predicting Symptomatic Structural Failure of Arthroscopic Rotator Cuff Repairs: Tear Size, Location, and Atrophy Matter.

PubMed

Gasbarro, Gregory; Ye, Jason; Newsome, Hillary; Jiang, Kevin; Wright, Vonda; Vyas, Dharmesh; Irrgang, James J; Musahl, Volker

2016-10-01

To evaluate whether morphologic characteristics of rotator cuff tear have prognostic value in determining symptomatic structural failure of arthroscopic rotator cuff repair independent of age or gender. Arthroscopic rotator cuff repair cases performed by five fellowship-trained surgeons at our institution from 2006 to 2013 were retrospectively reviewed. Data extraction included demographics, comorbidities, repair technique, clinical examination, and radiographic findings. Failure in symptomatic patients was defined as structural defect on postoperative magnetic resonance imaging or pseudoparalysis on examination. Failures were age and gender matched with successful repairs in a 1:2 ratio. A total of 30 failures and 60 controls were identified. Supraspinatus atrophy (P = .03) and tear size (18.3 mm failures v 13.9 mm controls; P = .02) were significant risk factors for failure, as was the presence of an infraspinatus tear greater than 10 mm (62% v 17%, P < .01). Single-row repair (P = .06) and simple suture configuration (P = .17) were more common but similar between groups. Diabetes mellitus and active tobacco use were not significantly associated with increased failure risk but psychiatric medication use was more frequent in the failure group. This study confirms previous suspicions that tear size and fatty infiltration are associated with failure of arthroscopic rotator cuff repair but independent of age or gender in symptomatic patients. There is also a quantitative cutoff on magnetic resonance imaging for the size of infraspinatus involvement that can be used clinically as a predicting factor. Although reported in the literature, smoking and diabetes were not associated with failure. Level III, retrospective case control. Copyright © 2016 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

A portfolio approach to evaluating natural hazard mitigation policies: An Application to lateral-spread ground failure in Coastal California

USGS Publications Warehouse

Bernknopf, R.L.; Dinitz, L.B.; Rabinovici, S.J.M.; Evans, A.M.

2001-01-01

In the past, efforts to prevent catastrophic losses from natural hazards have largely been undertaken by individual property owners based on site-specific evaluations of risks to particular buildings. Public efforts to assess community vulnerability and encourage mitigation have focused on either aggregating site-specific estimates or adopting standards based upon broad assumptions about regional risks. This paper develops an alternative, intermediate-scale approach to regional risk assessment and the evaluation of community mitigation policies. Properties are grouped into types with similar land uses and levels of hazard, and hypothetical community mitigation strategies for protecting these properties are modeled like investment portfolios. The portfolios consist of investments in mitigation against the risk to a community posed by a specific natural hazard, and are defined by a community's mitigation budget and the proportion of the budget invested in locations of each type. The usefulness of this approach is demonstrated through an integrated assessment of earthquake-induced lateral-spread ground failure risk in the Watsonville, California area. Data from the magnitude 6.9 Loma Prieta earthquake of 1989 are used to model lateral-spread ground failure susceptibility. Earth science and economic data are combined and analyzed in a Geographic Information System (GIS). The portfolio model is then used to evaluate the benefits of mitigating the risk in different locations. Two mitigation policies, one that prioritizes mitigation by land use type and the other by hazard zone, are compared with a status quo policy of doing no further mitigation beyond that which already exists. The portfolio representing the hazard zone rule yields a higher expected return than the land use portfolio does: However, the hazard zone portfolio experiences a higher standard deviation. Therefore, neither portfolio is clearly preferred. The two mitigation policies both reduce expected losses and increase overall expected community wealth compared to the status quo policy.

Pioglitazone use and heart failure in patients with type 2 diabetes and preexisting cardiovascular disease: data from the PROactive study (PROactive 08).

PubMed

Erdmann, Erland; Charbonnel, Bernard; Wilcox, Robert G; Skene, Allan M; Massi-Benedetti, Massimo; Yates, John; Tan, Meng; Spanheimer, Robert; Standl, Eberhard; Dormandy, John A

2007-11-01

PROspective pioglitAzone Clinical Trial In macroVascular Events (PROactive) enrolled patients with type 2 diabetes and preexisting cardiovascular disease. These patients were at high risk for heart failure, so any therapeutic benefit could potentially be offset by risk of associated heart failure mortality. We analyzed the heart failure cases to assess the effects of treatment on morbidity and mortality after reports of serious heart failure. PROactive was an outcome study in 5,238 patients randomized to pioglitazone or placebo. Patients with New York Heart Association Class II-IV heart failure at screening were excluded. A serious adverse event of heart failure was defined as heart failure that required hospitalization or prolonged a hospitalization stay, was fatal or life threatening, or resulted in persistent significant disability or incapacity. Heart failure risk was evaluated by multivariate regression. More pioglitazone (5.7%) than placebo patients (4.1%) had a serious heart failure event during the study (P = 0.007). However, mortality due to heart failure was similar (25 of 2,605 [0.96%] for pioglitazone vs. 22 of 2,633 [0.84%] for placebo; P = 0.639). Among patients with a serious heart failure event, subsequent all-cause mortality was proportionately lower with pioglitazone (40 of 149 [26.8%] vs. 37 of 108 [34.3%] with placebo; P = 0.1338). Proportionately fewer pioglitazone patients with serious heart failure went on to have an event in the primary (47.7% with pioglitazone vs. 57.4% with placebo; P = 0.0593) or main secondary end point (34.9% with pioglitazone vs. 47.2% with placebo; P = 0.025). Although the incidence of serious heart failure was increased with pioglitazone versus placebo in the total PROactive population of patients with type 2 diabetes and macrovascular disease, subsequent mortality or morbidity was not increased in patients with serious heart failure.

Fault tree analysis for integrated and probabilistic risk analysis of drinking water systems.

PubMed

Lindhe, Andreas; Rosén, Lars; Norberg, Tommy; Bergstedt, Olof

2009-04-01

Drinking water systems are vulnerable and subject to a wide range of risks. To avoid sub-optimisation of risk-reduction options, risk analyses need to include the entire drinking water system, from source to tap. Such an integrated approach demands tools that are able to model interactions between different events. Fault tree analysis is a risk estimation tool with the ability to model interactions between events. Using fault tree analysis on an integrated level, a probabilistic risk analysis of a large drinking water system in Sweden was carried out. The primary aims of the study were: (1) to develop a method for integrated and probabilistic risk analysis of entire drinking water systems; and (2) to evaluate the applicability of Customer Minutes Lost (CML) as a measure of risk. The analysis included situations where no water is delivered to the consumer (quantity failure) and situations where water is delivered but does not comply with water quality standards (quality failure). Hard data as well as expert judgements were used to estimate probabilities of events and uncertainties in the estimates. The calculations were performed using Monte Carlo simulations. CML is shown to be a useful measure of risks associated with drinking water systems. The method presented provides information on risk levels, probabilities of failure, failure rates and downtimes of the system. This information is available for the entire system as well as its different sub-systems. Furthermore, the method enables comparison of the results with performance targets and acceptable levels of risk. The method thus facilitates integrated risk analysis and consequently helps decision-makers to minimise sub-optimisation of risk-reduction options.

“Risk factors associated with virologic failure in HIV-infected patients receiving antiretroviral therapy at a public hospital in Peru”

PubMed Central

Jorge, Alave R; Jorge, Paz B; Elsa, Gonzalez L; Miguel, Campos S; Rodriguez, Martin; Willig, James; Juan, Echevarría Z

2013-01-01

OBJECTIVE To describe clinical and biological characteristics of subjects with virologic failure who participated in the sexually transmitted diseases HIV/AIDS National Program from a Peruvian public hospital. MATERIALS AND METHODS An exploratory descriptive study was performed with data from subjects older than 18 who started high activity antiretroviral therapy (HAART) between May 2004 and December 2009 and who had a viral load control after 24 weeks of HAART. Virologic failure was defined as a viral load value above 1000 copies/mL on follow up after 24 weeks on HAART. RESULTS Of 1 478 records of patients on HAART analized, the median age was 35 years [IQR, 29-41] and 69.6% were male. Also, virologic failure occurred in 24% and 3.7% died. Of subjects with virologic failure, 9.5% died. On multivariate analysis, age, history of antiretroviral use before starting HAART, change of antiretroviral therapy due to toxicity, opportunistic infections during HAART, level of CD4 + lymphocytes below 100 cells/ml at start of HAART, adherence and clinical stage were independently associated with virologic failure. In the group of patient with no history of antiretroviral use before starting HAART, age, opportunistic infections during HAART were associated with virologic failure. CONCLUSION This study identified factors associated with virologic failure. Further studies are needed to evaluate whether the use of these factors can help to identify prospectively patients at high risk of failure, and to design interventions aimed to reduce this risk. PMID:23450408

Conversion of Questionnaire Data

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

Powell, Danny H; Elwood Jr, Robert H

During the survey, respondents are asked to provide qualitative answers (well, adequate, needs improvement) on how well material control and accountability (MC&A) functions are being performed. These responses can be used to develop failure probabilities for basic events performed during routine operation of the MC&A systems. The failure frequencies for individual events may be used to estimate total system effectiveness using a fault tree in a probabilistic risk analysis (PRA). Numeric risk values are required for the PRA fault tree calculations that are performed to evaluate system effectiveness. So, the performance ratings in the questionnaire must be converted to relativemore » risk values for all of the basic MC&A tasks performed in the facility. If a specific material protection, control, and accountability (MPC&A) task is being performed at the 'perfect' level, the task is considered to have a near zero risk of failure. If the task is performed at a less than perfect level, the deficiency in performance represents some risk of failure for the event. As the degree of deficiency in performance increases, the risk of failure increases. If a task that should be performed is not being performed, that task is in a state of failure. The failure probabilities of all basic events contribute to the total system risk. Conversion of questionnaire MPC&A system performance data to numeric values is a separate function from the process of completing the questionnaire. When specific questions in the questionnaire are answered, the focus is on correctly assessing and reporting, in an adjectival manner, the actual performance of the related MC&A function. Prior to conversion, consideration should not be given to the numeric value that will be assigned during the conversion process. In the conversion process, adjectival responses to questions on system performance are quantified based on a log normal scale typically used in human error analysis (see A.D. Swain and H.E. Guttmann, 'Handbook of Human Reliability Analysis with Emphasis on Nuclear Power Plant Applications,' NUREG/CR-1278). This conversion produces the basic event risk of failure values required for the fault tree calculations. The fault tree is a deductive logic structure that corresponds to the operational nuclear MC&A system at a nuclear facility. The conventional Delphi process is a time-honored approach commonly used in the risk assessment field to extract numerical values for the failure rates of actions or activities when statistically significant data is absent.« less

Risk Factors for Incident Hospitalized Heart Failure With Preserved Versus Reduced Ejection Fraction in a Multiracial Cohort of Postmenopausal Women.

PubMed

Eaton, Charles B; Pettinger, Mary; Rossouw, Jacques; Martin, Lisa Warsinger; Foraker, Randi; Quddus, Abdullah; Liu, Simin; Wampler, Nina S; Hank Wu, Wen-Chih; Manson, JoAnn E; Margolis, Karen; Johnson, Karen C; Allison, Matthew; Corbie-Smith, Giselle; Rosamond, Wayne; Breathett, Khadijah; Klein, Liviu

2016-10-01

Heart failure is an important and growing public health problem in women. Risk factors for incident hospitalized heart failure with preserved ejection fraction (HFpEF) compared with heart failure with reduced ejection fraction (HFrEF) in women and differences by race/ethnicity are not well characterized. We prospectively evaluated the risk factors for incident hospitalized HFpEF and HFrEF in a multiracial cohort of 42 170 postmenopausal women followed up for a mean of 13.2 years. Cox regression models with time-dependent covariate adjustment were used to define risk factors for HFpEF and HFrEF. Differences by race/ethnicity about incidence rates, baseline risk factors, and their population-attributable risk percentage were analyzed. Risk factors for both HFpEF and HFrEF were as follows: older age, white race, diabetes mellitus, cigarette smoking, and hypertension. Obesity, history of coronary heart disease (other than myocardial infarction), anemia, atrial fibrillation, and more than one comorbidity were associated with HFpEF but not with HFrEF. History of myocardial infarction was associated with HFrEF but not with HFpEF. Obesity was found to be a more potent risk factor for African American women compared with white women for HFpEF (P for interaction=0.007). For HFpEF, the population-attributable risk percentage was greatest for hypertension (40.9%) followed by obesity (25.8%), with the highest population-attributable risk percentage found in African Americans for these risk factors. In this multiracial cohort of postmenopausal women, obesity stands out as a significant risk factor for HFpEF, with the strongest association in African American women. URL: http://www.clinicaltrials.gov. Unique identifier: NCT00000611. © 2016 American Heart Association, Inc.

Management of atrial fibrillation: focus on the role of dronedarone.

PubMed

Cheng, Judy Wm

2011-01-01

Dronedarone is an amiodarone derivative that was approved in the US in July 2009 to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AF), who are in sinus rhythm (SR), or who will be cardioverted. This article reviews the pharmacology, adverse effects, and clinical evidence available to date on the use of dronedarone in the management of AF and its potential role in the emergency department setting. In the EURIDIS and ADONIS studies evaluating the efficacy of dronedarone in maintaining SR, dronedarone significantly reduced the risk of recurrence of AF compared to placebo, by 22% and 27%, respectively. The ERATO study examined the ability of dronedarone to control ventricular rate in permanent AF. The DIONYSOS study demonstrated that recurrences of AF were more frequent with dronedarone. However, discontinuation of therapy due to intolerance was more frequent with amiodarone. Furthermore, the ATHENA study demonstrated that dronedarone reduced mortality and cardiovascular hospitalization by 24% (P < 0.05) in patients in SR but with other associated risks and a history of AF. However, the ANDROMEDA study, evaluating the use of dronedarone in patients with recent decompensated heart failure, and the PALLAS study, evaluating the use of dronedarone in patients with chronic AF, were both terminated prematurely due to a trend toward an increased risk of cardiovascular events. Dronedarone has been demonstrated to be effective in reducing the incidence of AF recurrence. It appears to be less effective but better tolerated than amiodarone. Dronedarone appears to have a low proarrhythmic risk and is the first anti-arrhythmic that has been demonstrated to reduce cardiovascular mortality and cardiovascular hospitalization in clinically stable patients with other risk factors for recurrent AF. Therefore, dronedarone can be recommended as an anti-arrhythmic of choice in clinically stable patients for maintaining SR. If dronedarone is to be used in a patient with chronic stable heart failure, the patient must be monitored closely for any worsening of heart failure symptoms. The drug must be discontinued should the heart failure symptoms worsen.

Evaluation of the appropriateness of the preclinical phase (stage A and stage B) of heart failure Management in Outpatient clinics in Italy rationale and design of the 'VASTISSIMO' study.

PubMed

Mureddu, Gian F; Nistri, Stefano; Faggiano, Pompilio; Fimiani, Biagio; Misuraca, Gianfranco; Maggi, Antonio; Gori, Anna M; Uguccioni, Massimo; Tavazzi, Luigi; Zito, Giovanni B

2016-07-01

Early detection of heart failure, when still preclinical, is fundamental. Therefore, it is important to assess whether preclinical heart failure management by cardiologists is adequate. The VASTISSIMO study ('EValuation of the AppropriateneSs of The preclInical phase (Stage A and Stage B) of heart failure Management in Outpatient clinics in Italy') is a prospective nationwide study aimed to evaluate the appropriateness of diagnosis and management of preclinical heart failure (stages A and B) by cardiologists working in outpatient clinics in Italy. Secondary goals are to verify if an online educational course for cardiologists can improve management of preclinical heart failure, and evaluate how well cardiologists are aware of patients' adherence to medications. The study involves 80 outpatient cardiology clinics distributed throughout Italy, affiliated either to the Hospital Cardiologists Association or to the Regional Association of Outpatient Cardiologists, and is designed with two phases of consecutive outpatient enrolment each lasting 1 month. In phase 1, physicians' awareness of the risk of heart failure and their decision-making process are recorded. Subsequently, half of the cardiologists are randomized to undergo an online educational course aimed to improve preclinical heart failure management through implementation of guideline recommendations. At the end of the course, all cardiologists are evaluated (phase 2) to see whether changes in clinical management have occurred in those who underwent the educational program versus those who did not. Patients' adherence to prescribed medications will be assessed through the Morisky Self-report Questionnaire. This study should provide valuable information about cardiologists' awareness of preclinical heart failure and the appropriateness of clinical practice in outpatient cardiology clinics in Italy.

A comprehensive Network Security Risk Model for process control networks.

PubMed

Henry, Matthew H; Haimes, Yacov Y

2009-02-01

The risk of cyber attacks on process control networks (PCN) is receiving significant attention due to the potentially catastrophic extent to which PCN failures can damage the infrastructures and commodity flows that they support. Risk management addresses the coupled problems of (1) reducing the likelihood that cyber attacks would succeed in disrupting PCN operation and (2) reducing the severity of consequences in the event of PCN failure or manipulation. The Network Security Risk Model (NSRM) developed in this article provides a means of evaluating the efficacy of candidate risk management policies by modeling the baseline risk and assessing expectations of risk after the implementation of candidate measures. Where existing risk models fall short of providing adequate insight into the efficacy of candidate risk management policies due to shortcomings in their structure or formulation, the NSRM provides model structure and an associated modeling methodology that captures the relevant dynamics of cyber attacks on PCN for risk analysis. This article develops the NSRM in detail in the context of an illustrative example.

Failure tolerance strategy of space manipulator for large load carrying tasks

NASA Astrophysics Data System (ADS)

Chen, Gang; Yuan, Bonan; Jia, Qingxuan; Sun, Hanxu; Guo, Wen

2018-07-01

During the execution of large load carrying tasks in long term service, there is a notable risk of space manipulator suffering from locked-joint failure, thus space manipulator should be with enough failure tolerance performance. A research on evaluating failure tolerance performance and re-planning feasible task trajectory for space manipulator performing large load carrying tasks is conducted in this paper. The effects of locked-joint failure on critical performance(reachability and load carrying capacity) of space manipulator are analyzed at first. According to the requirements of load carrying tasks, we further propose a new concept of failure tolerance workspace with load carrying capacity(FTWLCC) to evaluate failure tolerance performance, and improve the classic A* algorithm to search the feasible task trajectory. Through the normalized FTWLCC and the improved A* algorithm, the reachability and load carrying capacity of the degraded space manipulator are evaluated, and the reachable and capable trajectory can be obtained. The establishment of FTWLCC provides a novel idea that combines mathematical statistics with failure tolerance performance to illustrate the distribution of load carrying capacity in three-dimensional space, so multiple performance indices can be analyzed simultaneously and visually. And the full consideration of all possible failure situations and motion states makes FTWLCC and improved A* algorithm be universal and effective enough to be appropriate for random joint failure and variety of requirement of large load carrying tasks, so they can be extended to other types of manipulators.

Comparing the risks of hospitalized heart failure associated with glinide, sulfonylurea, and acarbose use in type 2 diabetes: A nationwide study.

PubMed

Lee, Yen-Chieh; Chang, Chia-Hsuin; Dong, Yaa-Hui; Lin, Jou-Wei; Wu, Li-Chiu; Hwang, Jing-Shiang; Chuang, Lee-Ming

2017-02-01

Increasing evidence suggests that certain newer anti-diabetic drugs are associated with an increased risk of hospitalized heart failure (HHF). However, the potential risks associated with the use of sulfonylurea and glinide have not been carefully evaluated. A retrospective cohort study using the Taiwan National Health Insurance claims database was conducted to examine the risks of HHF among newly diagnosed type 2 diabetic patients who initiated glinide, sulfonylurea, or acarbose therapy during 2006-2012. The outcome of interest was hospitalization due to heart failure after treatment initiation, defined by ICD-9-CM code. A Cox proportional hazard regression model was used to calculate the hazard ratio (HR) and 95% confidence interval (CI) using acarbose as the reference group. A total of 25,638 glinide, 272,140 sulfonylurea, and 29,376 acarbose initiators were included in the analysis. Patients who initiated glinide had the highest crude HHF incidence. In the analysis adjusted for baseline differences, a significantly higher risk of HHF was found for glinide (adjusted HR, 1.53; 95% CI, 1.24-1.88), but not for sulfonylurea (adjusted HR, 0.94; 95% CI, 0.80-1.11), as compared with acarbose. The elevated risk remained consistent across different subgroups of patients as well as several sensitivity analyses including exploring the impact of potential unmeasured confounding. These findings indicated that, as compared with acarbose, glinide may be associated with a higher risk of HHF for type 2 diabetic patients. Further researchis needed to fully evaluate the risks and benefits of glinide therapy relative to other oral anti-diabetic agents. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

The -174G/C Interleukin-6 Gene Promoter Polymorphism as a Genetic Marker of Differences in Therapeutic Response to Methotrexate and Leflunomide in Rheumatoid Arthritis.

PubMed

Ruiz-Padilla, A J; Gamez-Nava, J I; Saldaña-Cruz, A M; Murillo-Vazquez, J D; Vazquez-Villegas, M L; Zavaleta-Muñiz, S A; Martín-Márquez, B T; Ponce-Guarneros, J M; Rodriguez Jimenez, N A; Flores-Chavez, A; Sandoval-Garcia, F; Vasquez-Jimenez, J C; Cardona-Muñoz, E G; Totsuka-Sutto, S E; Gonzalez-Lopez, L

2016-01-01

Objective . To evaluate the association of -174G/C IL-6 polymorphism with failure in therapeutic response to methotrexate (MTX) or leflunomide (LEF). This prospective, observational cohort included 96 Mexican-Mestizo patients with moderate or severe rheumatoid arthritis (RA), initiating MTX or LEF, genotyped for IL-6 -174G/C polymorphism by PCR-RFLP. Therapeutic response was strictly defined: only if patients achieved remission or low disease activity (DAS-28 < 3.2). Results . Patients with MTX or LEF had significant decrement in DAS-28 ( p < 0.001); nevertheless, only 14% and 12.5% achieved DAS-28 < 3.2 at 3 and 6 months. After 6 months with any of these drugs the -174G/G genotype carriers (56%) had higher risk of therapeutic failure compared with GC (RR: 1.19, 95% CI: 1.07-1.56). By analyzing each drug separately, after 6 months with LEF, GG genotype confers higher risk of therapeutic failure than GC (RR = 1.56; 95% CI = 1.05-2.3; p = 0.003), or CC (RR = 1.83; 95% CI = 1.07-3.14; p = 0.001). This risk was also observed in the dominant model (RR = 1.33; 95% CI = 1.03-1.72; p = 0.02). Instead, in patients receiving MTX no genotype was predictor of therapeutic failure. We concluded that IL-6 -174G/G genotype confers higher risk of failure in therapeutic response to LEF in Mexicans and if confirmed in other populations this can be used as promissory genetic marker to differentiate risk of therapeutic failure to LEF.

Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy

PubMed Central

2013-01-01

Background A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to the actively scanned proton beam radiotherapy process implemented at CNAO (Centro Nazionale di Adroterapia Oncologica), aiming at preventing accidental exposures to the patient. Methods FMEA was applied to the treatment planning stage and consisted of three steps: i) identification of the involved sub-processes; ii) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, iii) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. Results Thirty-four sub-processes were identified, twenty-two of them were judged to be potentially prone to one or more failure modes. A total of forty-four failure modes were recognized, 52% of them characterized by an RPN score equal to 80 or higher. The threshold of 125 for RPN was exceeded in five cases only. The most critical sub-process appeared related to the delineation and correction of artefacts in planning CT data. Failures associated to that sub-process were inaccurate delineation of the artefacts and incorrect proton stopping power assignment to body regions. Other significant failure modes consisted of an outdated representation of the patient anatomy, an improper selection of beam direction and of the physical beam model or dose calculation grid. The main effects of these failures were represented by wrong dose distribution (i.e. deviating from the planned one) delivered to the patient. Additional strategies for risk mitigation, easily and immediately applicable, consisted of a systematic information collection about any known implanted prosthesis directly from each patient and enforcing a short interval time between CT scan and treatment start. Moreover, (i) the investigation of dedicated CT image reconstruction algorithms, (ii) further evaluation of treatment plan robustness and (iii) implementation of independent methods for dose calculation (such as Monte Carlo simulations) may represent novel solutions to increase patient safety. Conclusions FMEA is a useful tool for prospective evaluation of patient safety in proton beam radiotherapy. The application of this method to the treatment planning stage lead to identify strategies for risk mitigation in addition to the safety measures already adopted in clinical practice. PMID:23705626

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

La, Trang H.; Wolden, Suzanne L.; Rodeberg, David A.

Purpose: To evaluate the incidence and prognostic factors for regional failure, with attention to the in-transit pathways of spread, in children with nonmetastatic rhabdomyosarcoma of the extremity. Methods and Materials: The Intergroup rhabdomyosarcoma studies III, IV-Pilot, and IV enrolled 226 children with rhabdomyosarcoma of the extremity. Failure at the in-transit (epitrochlear/brachial and popliteal) and proximal (axillary/infraclavicular and inguinal/femoral) lymph nodes was evaluated. The median follow-up for the surviving patients was 10.4 years. Results: Of the 226 children, 55 (24%) had clinical or pathologic evidence of either in-transit and/or proximal lymph node involvement at diagnosis. The actuarial 5-year risk of regionalmore » failure was 12%. The prognostic factors for poor regional control were female gender and lymph node involvement at diagnosis. In the 116 patients with a distal extremity primary tumor, 5% had in-transit lymph node involvement at diagnosis. The estimated 5-year incidences of in-transit and proximal nodal failure was 12% and 8%, respectively. The in-transit failure rate was 0% for patients who underwent radiotherapy and/or underwent lymph node sampling of the in-transit nodal site but was 15% for those who did not (p = .07). However, the 5-year event-free survival rate did not differ between these two groups (64% vs. 55%, respectively, p = .47). Conclusion: The high incidence of regional involvement necessitates aggressive identification and treatment of regional lymph nodes in patients with rhabdomyosarcoma of the extremity. In patients with distal extremity tumors, in-transit failures were as common as failures in more proximal regional sites. Patients who underwent complete lymph node staging with appropriate radiotherapy to the in-transit nodal site, if indicated, were at a slightly lower risk of in-transit failure.« less

Exploring potential biomarkers associated with health-related quality of life in patients with coronary artery disease and heart failure.

PubMed

Kazukauskiene, Nijole; Burkauskas, Julius; Macijauskiene, Jurate; Mickuviene, Narseta; Brozaitiene, Julija

2018-04-01

There has been a lack of research examining associations between biomarkers and health-related quality of life (HRQoL) in patients with coronary artery disease and heart failure. In patients with coronary artery disease and heart failure, we aimed to explore potential associations between biomarkers of health such as serum levels of thyroid hormones, N-terminal pro-B-type natriuretic peptide (NT-pro-BNP), inflammatory biomarkers and HRQoL. In sum, 482 patients (75% male; mean age 58±10 years) with coronary artery disease and heart failure were evaluated for socio-demographic and clinical coronary artery disease risk factors. Blood samples were drawn to evaluate thyroid hormones, NT-pro-BNP, high-sensitivity C-reactive protein and interleukin-6 (IL-6). Additional data was collected on HRQoL (the Minnesota Living with Heart Failure Questionnaire), anxiety and depressive symptoms (Hospital Anxiety and Depression Scale), Type D personality (DS14 scale). In multivariable models, lower levels of high-sensitivity C-reactive protein and interleukin-6 were associated with worse results on the Minnesota Living with Heart Failure Questionnaire emotional subscale (β = -0.107, p = 0.003; β = -0.106, p = 0.004). Lower levels of interleukin-6 were associated with worse perceived global health (β = -0.101, p = 0.011). Even after controlling for socio-demographic and clinical risk factors including mental distress symptoms, lower levels of inflammatory biomarkers were associated with worse HRQoL.

Overview of the recommended procedures dealing with the evaluation of liquefaction-induced deformation allong a pipeline corridor

NASA Astrophysics Data System (ADS)

Papathanassiou, George

2016-04-01

The last decade several pipeline corridors have been designed in order to transmit to Europe natural gas and oil from Asia. Although the fact that a pipeline is considered as an underground structure, an analysis of earthquake-induced structural failures should be conducted in prone to earthquake countries e.g. Greece, Italy in EU. The aim of these specific analyses is to assess and evaluate the hazard and the relevant risk induced by earthquake-induced slope failures and soil liquefaction. The latter is a phenomenon that is triggered under specific site conditions. In particular the basic ingredients for the occurrence of liquefaction is the surficial water table, the existence of non-plastic or low plasticity soil layer and the generation of strong ground motion. Regarding the liquefaction-induced deformation that should be assessed and evaluated in order to minimize the risk, it is concluded that the pervasive types of ground failures for level to gently sloping sites are the ground settlements and lateral spreads. The goal of this study is to overview the most widely approaches used for the computation of liquefaction-induced settlement and to present a more detailed description, step by step, of the methodology that is recommended to follow for the evaluation of lateral spreading.

Risk Scan: A Review of Risk Assessment Capability and Maturity within the Canadian Safety and Security Program

DTIC Science & Technology

2014-06-01

SCADA / ICS Cyber Test Lab initiated in 2013 Psychosocial – academic research exists,; opportunity for sharing and developing impact assessment...ecosystems and species at risk), accidents / system failure (rail; pipelines ; ferries CSSP strategy for the North Focus on regional l(and local) problem...Guidance; business planning; environmental scan; proposal evaluation; and performance measurement Program Risk Management – Guidelines for project

Trade Studies of Space Launch Architectures using Modular Probabilistic Risk Analysis

NASA Technical Reports Server (NTRS)

Mathias, Donovan L.; Go, Susie

2006-01-01

A top-down risk assessment in the early phases of space exploration architecture development can provide understanding and intuition of the potential risks associated with new designs and technologies. In this approach, risk analysts draw from their past experience and the heritage of similar existing systems as a source for reliability data. This top-down approach captures the complex interactions of the risk driving parts of the integrated system without requiring detailed knowledge of the parts themselves, which is often unavailable in the early design stages. Traditional probabilistic risk analysis (PRA) technologies, however, suffer several drawbacks that limit their timely application to complex technology development programs. The most restrictive of these is a dependence on static planning scenarios, expressed through fault and event trees. Fault trees incorporating comprehensive mission scenarios are routinely constructed for complex space systems, and several commercial software products are available for evaluating fault statistics. These static representations cannot capture the dynamic behavior of system failures without substantial modification of the initial tree. Consequently, the development of dynamic models using fault tree analysis has been an active area of research in recent years. This paper discusses the implementation and demonstration of dynamic, modular scenario modeling for integration of subsystem fault evaluation modules using the Space Architecture Failure Evaluation (SAFE) tool. SAFE is a C++ code that was originally developed to support NASA s Space Launch Initiative. It provides a flexible framework for system architecture definition and trade studies. SAFE supports extensible modeling of dynamic, time-dependent risk drivers of the system and functions at the level of fidelity for which design and failure data exists. The approach is scalable, allowing inclusion of additional information as detailed data becomes available. The tool performs a Monte Carlo analysis to provide statistical estimates. Example results of an architecture system reliability study are summarized for an exploration system concept using heritage data from liquid-fueled expendable Saturn V/Apollo launch vehicles.

High Reliability Organizations--Medication Safety.

PubMed

Yip, Luke; Farmer, Brenna

2015-06-01

High reliability organizations (HROs), such as the aviation industry, successfully engage in high-risk endeavors and have low incidence of adverse events. HROs have a preoccupation with failure and errors. They analyze each event to effect system wide change in an attempt to mitigate the occurrence of similar errors. The healthcare industry can adapt HRO practices, specifically with regard to teamwork and communication. Crew resource management concepts can be adapted to healthcare with the use of certain tools such as checklists and the sterile cockpit to reduce medication errors. HROs also use The Swiss Cheese Model to evaluate risk and look for vulnerabilities in multiple protective barriers, instead of focusing on one failure. This model can be used in medication safety to evaluate medication management in addition to using the teamwork and communication tools of HROs.

Class III obesity is a risk factor for the development of acute-on-chronic liver failure in patients with decompensated cirrhosis.

PubMed

Sundaram, Vinay; Jalan, Rajiv; Ahn, Joseph C; Charlton, Michael R; Goldberg, David S; Karvellas, Constantine J; Noureddin, Mazen; Wong, Robert J

2018-04-28

Acute-on-chronic liver failure (ACLF) is a syndrome of systemic inflammation and organ failures. Obesity, also characterized by chronic inflammation, is a risk factor among patients with cirrhosis for decompensation, infection, and mortality. Our aim was to test the hypothesis that obesity predisposes patients with decompensated cirrhosis to the development of ACLF. We examined the United Network for Organ Sharing (UNOS) database, from 2005-2016, characterizing patients at wait-listing as non-obese (body mass index [BMI] <30), obese class I-II (BMI 30-39.9) and obese class III (BMI ≥40). ACLF was determined based on the CANONIC study definition. We used Cox proportional hazards regression to assess the association between obesity and ACLF development at liver transplantation (LT). We confirmed our findings using the Nationwide Inpatient Sample (NIS), years 2009-2013, using validated diagnostic coding algorithms to identify obesity, hepatic decompensation and ACLF. Logistic regression evaluated the association between obesity and ACLF occurrence. Among 387,884 patient records with decompensated cirrhosis, 116,704 (30.1%) were identified as having ACLF in both databases. Multivariable modeling from the UNOS database revealed class III obesity to be an independent risk factor for ACLF at LT (hazard ratio 1.24; 95% CI 1.09-1.41; p <0.001). This finding was confirmed using the NIS (odds ratio 1.30; 95% CI 1.25-1.35; p <0.001). Regarding specific organ failures, analysis of both registries demonstrated patients with class I-II and class III obesity had a greater prevalence of renal failure. Class III obesity is a newly identified risk factor for ACLF development in patients with decompensated cirrhosis. Obese patients have a particularly high prevalence of renal failure as a component of ACLF. These findings have important implications regarding stratifying risk and preventing the occurrence of ACLF. In this study, we identify that among patients with decompensated cirrhosis, class III obesity (severe/morbid obesity) is a modifiable risk factor for the development of acute-on-chronic liver failure (ACLF). We further demonstrate that regarding the specific organ failures associated with ACLF, renal failure is significantly more prevalent in obese patients, particularly those with class III obesity. These findings underscore the importance of weight management in cirrhosis, to reduce the risk of ACLF. Patients with class III obesity should be monitored closely for the development of renal failure. Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Hyper-X Stage Separation: Simulation Development and Results

NASA Technical Reports Server (NTRS)

Reubush, David E.; Martin, John G.; Robinson, Jeffrey S.; Bose, David M.; Strovers, Brian K.

2001-01-01

This paper provides an overview of stage separation simulation development and results for NASA's Hyper-X program; a focused hypersonic technology effort designed to move hypersonic, airbreathing vehicle technology from the laboratory environment to the flight environment. This paper presents an account of the development of the current 14 degree of freedom stage separation simulation tool (SepSim) and results from use of the tool in a Monte Carlo analysis to evaluate the risk of failure for the separation event. Results from use of the tool show that there is only a very small risk of failure in the separation event.

Updated hazard rate equations for dual safeguard systems.

PubMed

Rothschild, Marc

2007-04-11

A previous paper by this author [M.J. Rothschild, Updated hazard rate equation for single safeguards, J. Hazard. Mater. 130 (1-2) (2006) 15-20] showed that commonly used analytical methods for quantifying failure rates overestimates the risk in some circumstances. This can lead the analyst to mistakenly believe that a given operation presents an unacceptable risk. For a single safeguard system, a formula was presented in that paper that accurately evaluates the risk over a wide range of conditions. This paper expands on that analysis by evaluating the failure rate for dual safeguard systems. The safeguards can be activated at the same time or at staggered times, and the safeguard may provide an indication whether it was successful upon a challenge, or its status may go undetected. These combinations were evaluated using a Monte Carlo simulation. Empirical formulas for evaluating the hazard rate were developed from this analysis. It is shown that having the safeguards activate at the same time while providing positive feedback of their individual actions is the most effective arrangement in reducing the hazard rate. The hazard rate can also be reduced by staggering the testing schedules of the safeguards.

Evaluation and treatment of failed shoulder instability procedures.

PubMed

Ho, Anthony G; Gowda, Ashok L; Michael Wiater, J

2016-09-01

Management of the unstable shoulder after a failed stabilization procedure can be difficult and challenging. Detailed understanding of the native shoulder anatomy, including its static and dynamic restraints, is necessary for determining the patient's primary pathology. In addition, evaluation of the patient's history, physical exam, and imaging is important for identifying the cause for failure after the initial procedure. Common mistakes include under-appreciation of bony defects, failure to recognize capsular laxity, technical errors, and missed associated pathology. Many potential treatment options exist for revision surgery, including open or arthroscopic Bankart repair, bony augmentation procedures, and management of Hill Sachs defects. The aim of this narrative review is to discuss in-depth the common risk factors for post-surgical failure, components for appropriate evaluation, and the different surgical options available for revision stabilization. Level of evidence Level V.

Evaluating the Effect of Comorbidities on the Success, Risk, and Cost of Digital Replantation.

PubMed

Hustedt, Joshua W; Chung, Andrew; Bohl, Daniel D; Olmscheid, Neil; Edwards, Scott

2016-12-01

The clinical decision to replant an amputated digit is driven primarily by surgical indication. However, the extent to which patient comorbidity should play into this decision is less well defined. This study was designed to determine the effect of patient comorbidities on the success, risk, and cost of digital replantation. All amputation injuries and digital replantation procedures captured by the National Inpatient Sample during 2001 to 2012 were identified. A successful replantation procedure was defined as one in which a replantation occurred without a subsequent revision amputation. Patient comorbidities were tested for association with failure of replantation, risk of postoperative complications, and overall hospital costs. We identified 11,788 digital replantation procedures. A total of 3,604 patients (30.6%) experienced revascularization failure associated with replantation. The risk for replant failure was highest among patients with psychotic disorders, peripheral vascular disease, and electrolyte imbalances. The risk for postoperative complications was highest among patients with electrolyte imbalances, drug abuse, or chronic obstructive pulmonary disease. Hospital costs were greatest among patients with deficiency anemias, electrolyte imbalances, or psychotic disorders. Patients with more than 3 comorbidities experienced significantly higher failure, risk of postoperative complications, and cost of digital replantation. These data suggest that even when surgical indications are met, patients with more than 3 comorbidities and those who have a history of alcohol abuse, deficiency anemias, electrolyte imbalances, obesity, peripheral vascular disease, or psychotic disorders are at increased risk of replantation failure and associated postoperative complications. Assessment of this risk should have a role in decision making regarding whether a digit should be replanted. Patients at high risk should be carefully counseled regarding the difficult perioperative course before undergoing digital replantation. Prognostic III. Copyright © 2016 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Failures in risk assessment and risk management for cosmetic preservatives in Europe and the impact on public health.

PubMed

Schwensen, Jakob F; White, Ian R; Thyssen, Jacob P; Menné, Torkil; Johansen, Jeanne D

2015-09-01

In view of the current and unprecedented increase in contact allergy to methylisothiazolinone (MI), we characterized and evaluated two recent epidemics of contact allergy to preservatives used in cosmetic products to address failures in risk assessment and risk management. To evaluate temporal trends of preservative contact allergy. The study population included consecutive patch tested eczema patients seen at a university hospital between 1985 and 2013. A total of 23 138 patients were investigated for a contact allergy. The overall prevalence of contact allergy to at least one preservative increased significantly over the study period, from 6.7% in 1985 to 11.8% in 2013 (p < 0.001). Importantly, the preservatives methyldibromo glutaronitrile and MI rapidly resulted in high sensitization prevalence rates, which reached epidemic proportions. Although the proportion of patients with current clinical disease attributable to methyldibromo glutaronitrile contact allergy decreased significantly following the ban on its use in cosmetic products (p < 0.001), the sudden and high proportion of current sensitization to MI requires immediate attention (p < 0.001). The introduction of new preservatives in Europe with inadequate pre-market risk assessment has rapidly increased the overall burden of cutaneous disease caused by preservatives. We suggest that the cosmetic industry has a responsibility to react faster and replace troublesome preservatives when a preservative contact allergy epidemic is recognized, but the European Commission has the ultimate responsibility for failures in risk management after new, major sensitizing preservatives are introduced onto the market. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Risk factors for failure of glass fiber-reinforced composite post restorations: a prospective observational clinical study.

PubMed

Naumann, Michael; Blankenstein, Felix; Kiessling, Saskia; Dietrich, Thomas

2005-12-01

Glass fiber-reinforced endodontic posts are considered to have favorable mechanical properties for the reconstruction of endodontically treated teeth. The aim of the present investigation was to evaluate the survival of two tapered and one parallel-sided glass fiber-reinforced endodontic post systems in teeth with different stages of hard tissue loss and to identify risk factors for restoration failure. One-hundred and forty-nine glass fiber-reinforced endodontic posts in 122 patients were followed-up for 5-56 months [mean +/- standard deviation (SD): 39 +/- 11 months]. Glass fiber-reinforced endodontic posts were adhesively luted and the core was built with a composite resin. Cox proportional hazards models were used to evaluate the association of clinical variables and failure rate. Higher failure rates were found for restorations of anterior teeth compared with posterior teeth [Hazard-Ratios (HR): 3.1; 95% confidence interval (CI): 1.3-7.4], for restorations in teeth with no proximal contacts compared with at least one proximal contact (HR: 3.0; 95% CI: 1.0-9.0), and for teeth restored with single crowns compared with fixed bridges (HR: 4.3; 95% CI: 1.1-16.2). Tooth type, type of final restoration and the presence of adjacent teeth were found to be significant predictors of failure rates in endodontically treated teeth restored with glass fiber-reinforced endodontic posts.

Assessment of cerebral microbleeds by susceptibility-weighted imaging at 3T in patients with end-stage organ failure.

PubMed

Sparacia, Gianvincenzo; Cannella, Roberto; Lo Re, Vincenzina; Gambino, Angelo; Mamone, Giuseppe; Miraglia, Roberto

2018-02-17

Cerebral microbleeds (CMBs) are small rounded lesions representing cerebral hemosiderin deposits surrounded by macrophages that results from previous microhemorrhages. The aim of this study was to review the distribution of cerebral microbleeds in patients with end-stage organ failure and their association with specific end-stage organ failure risk factors. Between August 2015 and June 2017, we evaluated 15 patients, 9 males, and 6 females, (mean age 65.5 years). Patients population was subdivided into three groups according to the organ failure: (a) chronic kidney failure (n = 8), (b) restrictive cardiomyopathy undergoing heart transplantation (n = 1), and (c) end-stage liver failure undergoing liver transplantation (n = 6). The MR exams were performed on a 3T MR unit and the SWI sequence was used for the detection of CMBs. CMBs were subdivided in supratentorial lobar distributed, supratentorial non-lobar distributed, and infratentorial distributed. A total of 91 microbleeds were observed in 15 patients. Fifty-nine CMBs lesions (64.8%) had supratentorial lobar distribution, 17 CMBs lesions (18.8%) had supratentorial non-lobar distribution and the remaining 15 CMBs lesions (16.4%) were infratentorial distributed. An overall predominance of supratentorial multiple lobar localizations was found in all types of end-stage organ failure. The presence of CMBs was significantly correlated with age, hypertension, and specific end-stage organ failure risk factors (p < 0.001). CMBs are mostly founded in supratentorial lobar localization in end-stage organ failure. The improved detection of CMBs with SWI sequences may contribute to a more accurate identification of patients with cerebral risk factors to prevent complications during or after the organ transplantation.

Limited experience, high body mass index and previous urethral surgery are risk factors for failure in open urethroplasty due to penile strictures.

PubMed

Ekerhult, Teresa O; Lindqvist, Klas; Peeker, Ralph; Grenabo, Lars

2015-01-01

The aim of this study was to evaluate outcomes and possible risk factors for failure of open urethroplasty due to penile urethral strictures. A retrospective chart review was undertaken of 90 patients with penile stricture undergoing 109 open urethroplasties between 2000 and 2011. In 80 urethroplasties, a one-stage procedure was performed: 68 of these had a pediculated penile skin flap, nine had a free buccal mucosal graft and three had a free skin graft. A two-stage procedure using buccal mucosa was performed in 29 urethroplasties. Failure was defined as when further urethral instrumentation was needed. The mean age in the one-stage and two-stage groups were 50 and 54 years, respectively. The success rates in the corresponding groups were 65% and 72%, with follow-up times of 63 and 40 months, respectively. Multivariable analyses disclosed body mass index (BMI) and previous urethral surgery to be significant risk factors for failure in the one-stage group. Failure over time significantly decreased during the study period. Both one- and two-stage penile urethroplasty demonstrated success rates in line with previous reports. Limited experience, high BMI and previous urethral surgery appear to be associated with less favourable outcome.

Risk factors for tuberculosis treatment failure, default, or relapse and outcomes of retreatment in Morocco

PubMed Central

2011-01-01

Background Patients with tuberculosis require retreatment if they fail or default from initial treatment or if they relapse following initial treatment success. Outcomes among patients receiving a standard World Health Organization Category II retreatment regimen are suboptimal, resulting in increased risk of morbidity, drug resistance, and transmission.. In this study, we evaluated the risk factors for initial treatment failure, default, or early relapse leading to the need for tuberculosis retreatment in Morocco. We also assessed retreatment outcomes and drug susceptibility testing use for retreatment patients in urban centers in Morocco, where tuberculosis incidence is stubbornly high. Methods Patients with smear- or culture-positive pulmonary tuberculosis presenting for retreatment were identified using clinic registries in nine urban public clinics in Morocco. Demographic and outcomes data were collected from clinical charts and reference laboratories. To identify factors that had put these individuals at risk for failure, default, or early relapse in the first place, initial treatment records were also abstracted (if retreatment began within two years of initial treatment), and patient characteristics were compared with controls who successfully completed initial treatment without early relapse. Results 291 patients presenting for retreatment were included; 93% received a standard Category II regimen. Retreatment was successful in 74% of relapse patients, 48% of failure patients, and 41% of default patients. 25% of retreatment patients defaulted, higher than previous estimates. Retreatment failure was most common among patients who had failed initial treatment (24%), and default from retreatment was most frequent among patients with initial treatment default (57%). Drug susceptibility testing was performed in only 10% of retreatment patients. Independent risk factors for failure, default, or early relapse after initial treatment included male gender (aOR = 2.29, 95% CI 1.10-4.77), positive sputum smear after 3 months of treatment (OR 7.14, 95% CI 4.04-13.2), and hospitalization (OR 2.09, 95% CI 1.01-4.34). Higher weight at treatment initiation was protective. Male sex, substance use, missed doses, and hospitalization appeared to be risk factors for default, but subgroup analyses were limited by small numbers. Conclusions Outcomes of retreatment with a Category II regimen are suboptimal and vary by subgroup. Default among patients receiving tuberculosis retreatment is unacceptably high in urban areas in Morocco, and patients who fail initial tuberculosis treatment are at especially high risk of retreatment failure. Strategies to address risk factors for initial treatment default and to identify patients at risk for failure (including expanded use of drug susceptibility testing) are important given suboptimal retreatment outcomes in these groups. PMID:21356062

Risk factors for tuberculosis treatment failure, default, or relapse and outcomes of retreatment in Morocco.

PubMed

Dooley, Kelly E; Lahlou, Ouafae; Ghali, Iraqi; Knudsen, Janine; Elmessaoudi, My Driss; Cherkaoui, Imad; El Aouad, Rajae

2011-02-28

Patients with tuberculosis require retreatment if they fail or default from initial treatment or if they relapse following initial treatment success. Outcomes among patients receiving a standard World Health Organization Category II retreatment regimen are suboptimal, resulting in increased risk of morbidity, drug resistance, and transmission.. In this study, we evaluated the risk factors for initial treatment failure, default, or early relapse leading to the need for tuberculosis retreatment in Morocco. We also assessed retreatment outcomes and drug susceptibility testing use for retreatment patients in urban centers in Morocco, where tuberculosis incidence is stubbornly high. Patients with smear- or culture-positive pulmonary tuberculosis presenting for retreatment were identified using clinic registries in nine urban public clinics in Morocco. Demographic and outcomes data were collected from clinical charts and reference laboratories. To identify factors that had put these individuals at risk for failure, default, or early relapse in the first place, initial treatment records were also abstracted (if retreatment began within two years of initial treatment), and patient characteristics were compared with controls who successfully completed initial treatment without early relapse. 291 patients presenting for retreatment were included; 93% received a standard Category II regimen. Retreatment was successful in 74% of relapse patients, 48% of failure patients, and 41% of default patients. 25% of retreatment patients defaulted, higher than previous estimates. Retreatment failure was most common among patients who had failed initial treatment (24%), and default from retreatment was most frequent among patients with initial treatment default (57%). Drug susceptibility testing was performed in only 10% of retreatment patients. Independent risk factors for failure, default, or early relapse after initial treatment included male gender (aOR = 2.29, 95% CI 1.10-4.77), positive sputum smear after 3 months of treatment (OR 7.14, 95% CI 4.04-13.2), and hospitalization (OR 2.09, 95% CI 1.01-4.34). Higher weight at treatment initiation was protective. Male sex, substance use, missed doses, and hospitalization appeared to be risk factors for default, but subgroup analyses were limited by small numbers. Outcomes of retreatment with a Category II regimen are suboptimal and vary by subgroup. Default among patients receiving tuberculosis retreatment is unacceptably high in urban areas in Morocco, and patients who fail initial tuberculosis treatment are at especially high risk of retreatment failure. Strategies to address risk factors for initial treatment default and to identify patients at risk for failure (including expanded use of drug susceptibility testing) are important given suboptimal retreatment outcomes in these groups.

Determining the influence of calcification on the failure properties of abdominal aortic aneurysm (AAA) tissue.

PubMed

O'Leary, Siobhan A; Mulvihill, John J; Barrett, Hilary E; Kavanagh, Eamon G; Walsh, Michael T; McGloughlin, Tim M; Doyle, Barry J

2015-02-01

Varying degrees of calcification are present in most abdominal aortic aneurysms (AAAs). However, their impact on AAA failure properties and AAA rupture risk is unclear. The aim of this work is evaluate and compare the failure properties of partially calcified and predominantly fibrous AAA tissue and investigate the potential reasons for failure. Uniaxial mechanical testing was performed on AAA samples harvested from 31 patients undergoing open surgical repair. Individual tensile samples were divided into two groups: fibrous (n=31) and partially calcified (n=38). The presence of calcification was confirmed by fourier transform infrared spectroscopy (FTIR). A total of 69 mechanical tests were performed and the failure stretch (λf), failure stress (σf) and failure tension (Tf) were recorded for each test. Following mechanical testing, the failure sites of a subset of both tissue types were examined using scanning electron microscopy (SEM)/energy dispersive X-ray spectroscopy (EDS) to investigate the potential reasons for failure. It has been shown that the failure properties of partially calcified tissue are significantly reduced compared to fibrous tissue and SEM and EDS results suggest that the junction between a calcification deposit and the fibrous matrix is highly susceptible to failure. This study implicates the presence of calcification as a key player in AAA rupture risk and provides further motivation for the development of non-invasive methods of measuring calcification. Copyright © 2014 Elsevier Ltd. All rights reserved.

Renal failure in a patient with postpolio syndrome and a normal creatinine level.

PubMed

Leming, Melissa K; Breyer, Michael J

2012-01-01

Patients with renal failure who are taking trimethoprim have an increased risk of developing hyperkalemia, which can cause muscle weakness. In patients with postpolio syndrome, a normal creatinine level could be abnormally high, renal failure is possible because of lack of creatinine production, and the muscle weakness from resultant hyperkalemia could be more severe because of their underlying condition. This abnormally high creatinine level has been termed from this point relative renal failure. The objective of the study was to review a case in which relative renal failure and hyperkalemia caused muscle weakness that manifested as shortness of breath and confusion with electrocardiographic changes. A dehydrated patient with relative renal failure and postpolio syndrome had taken trimethoprim-sulfamethoxazole that caused symptomatic hyperkalemia. The patient presented with muscle weakness, shortness of breath, and confusion, with her postpolio syndrome compounding the situation and likely making the muscle weakness more severe. A patient on trimethoprim with renal failure is at an increased risk of developing hyperkalemia. Patients with postpolio syndrome could have severe muscle weakness from the hyperkalemia and could have renal failure even with a normal creatinine level. This case report will remind treating physicians to evaluate such patients for hyperkalemia if they present with muscle weakness, especially if the patient has renal failure and is on trimethoprim. Copyright © 2012 Elsevier Inc. All rights reserved.

Influenza vaccination and risk of respiratory failure in patients with chronic obstructive pulmonary disease: A nationwide population-based case-cohort study.

PubMed

Huang, Hsin-Hui; Chen, Su-Jung; Chao, Tze-Fan; Liu, Chia-Jen; Chen, Tzeng-Ji; Chou, Pesus; Wang, Fu-Der

2017-09-06

Chronic obstructive pulmonary disease (COPD) is a chronic inflammatory disease which causes a considerable disease burden. Patients with COPD are at a higher risk for influenza infection and influenza vaccination are recommended at this high risk patient group. In the current study, we aimed to evaluate the association between influenza vaccination and the risk of respiratory failure (RF) in COPD patients. From 2001 to 2005, patients with newly diagnosed COPD were identified from the NHIRD, and were followed until 2010. We explored the influenza vaccination rate among this COPD cohort. Furthermore, patients who experienced RF were defined as case group, whereas the others were defined as control group. Baseline characteristic were compared and association between influenza vaccination and RF were evaluated. The rate of influenza vaccination was significantly higher in patients age ≥65 years than those age <65 years (54.8% vs. 4%, p < 0.001). The vaccine cohort had more comorbidities, more health care utilization and more frequent acute exacerbations as compared with nonvaccine cohort. In multivariable logistic regression, influenza vaccination was associated with a reduced risk of respiratory failure (adjusted odds ratio [aOR] 0.87, 95% confidence interval [CI] 0.79-0.96). In subgroup analysis, we found that the association was insignificant in patients age <65 years, patients with relatively unstable disease status and patient did not receive influenza vaccination annually. Influenza vaccination was associated with a decreased risk of RF in patients with COPD. Recommendation of annual influenza vaccination should be made when managing this high-risk patient group. Copyright © 2017. Published by Elsevier B.V.

Prognostic Value of the Interaction between Galectin-3 and Antigen Carbohydrate 125 in Acute Heart Failure

PubMed Central

Núñez, Julio; Rabinovich, Gabriel A.; Sandino, Justo; Mainar, Luis; Palau, Patricia; Santas, Enrique; Villanueva, Maria Pilar; Núñez, Eduardo; Bodí, Vicent; Chorro, Francisco J.; Miñana, Gema; Sanchis, Juan

2015-01-01

Aims Galectin-3 (Gal-3) and carbohydrate antigen 125 (CA125) have emerged as robust prognostic biomarkers in heart failure. Experimental data have also suggested a potential molecular interaction between CA125 and Gal-3; however, the biological and clinical relevance of this interaction is still uncertain. We sought to evaluate, in patients admitted for acute heart failure, the association between plasma Gal-3 with all-cause mortality and the risk for rehospitalizations among high and low levels of CA125. Methods and Results We included 264 consecutive patients admitted for acute heart failure to the Cardiology Department in a third-level center. Both biomarkers were measured on admission. Negative binomial and Cox regression models were used to evaluate the prognostic effect of the interaction between Gal-3 and CA125 (dichotomized by its median) with hospital readmission and all-cause mortality, respectively. During a median follow-up of 2 years (IQR = 1-2.8), 108 (40.9%) patients deaths and 365 rehospitalizations in 171 (69.5%) patients were registered. In a multivariable setting, the effect of Gal-3 on mortality and rehospitalization was differentially mediated by CA125 (p = 0.007 and p<0.001, respectively). Indeed, in patients with CA125 above median (>67 U/ml), values across the continuum of Gal-3 showed a positive and almost linear relationship with either the risk of death or rehospitalization. Conversely, when CA125 was below median (≤67 U/ml), Gal-3 lacked any prognostic effect on both endpoints. Conclusion In patients with acute heart failure, Gal-3 was strongly associated with higher risk of long-term mortality and repeated rehospitalizations, but only in those patients exhibiting higher values of CA125 (above 67 U/ml). PMID:25875367

At-Risk Students: Evaluating the Impact of School Counselors Regarding Academic Achievement

ERIC Educational Resources Information Center

Williams, Tuawana

2012-01-01

According to the American School Counselor Association (ASCA; "The ASCA National Model for School Counseling Programs," 2003), school counselors are trained to counsel students regarding academics, social and emotional issues, attendance, and so forth. Because of the growing number of students who are at risk of academic failure, it…

The At Risk Child: Early Identification, Intervention, and Evaluation of Early Childhood Strategies.

ERIC Educational Resources Information Center

Lennon, Joan M.

A review of literature was conducted in order to: (1) determine whether factors placing the young child at risk for school failure can be identified; (2) determine whether early family interventions and early childhood programs are effective; and (3) identify policy implications. Findings are summarized, and recommendations are offered. Research…

Fostering At-Risk Preschoolers' Number Sense

ERIC Educational Resources Information Center

Baroody, Arthur; Eiland, Michael; Thompson, Bradley

2009-01-01

Research Findings: A 9-month study served to evaluate the effectiveness of a pre-kindergarten number sense curriculum. Phase 1 of the intervention involved manipulative-, game-based number sense instruction; Phase 2, computer-aided mental-arithmetic training with the simplest sums. Eighty 4- and 5-year-olds at risk for school failure were randomly…

Glycated albumin and direct low density lipoprotein cholesterol levels in type 2 diabetes mellitus

USDA-ARS?s Scientific Manuscript database

Diabetes mellitus is a major risk factor for coronary heart disease (CHD), renal failure, retinopathy, and neuropathy. Lowering glycosylated hemoglobin (HbA1c) as well as low-density lipoprotein-cholesterol (LDL-C) has been associated with a decreased risk of these complications. We evaluated the ut...

Risk Assessment of Carbon Fiber Composite in Surface Transportation

NASA Technical Reports Server (NTRS)

Hathaway, W. T.; Hergenrother, K. M.

1980-01-01

The vulnerability of surface transportation to airborne carbon fibers and the national risk associated with the potential use of carbon fibers in the surface transportation system were evaluated. Results show airborne carbon fibers may cause failure rates in surface transportation of less than one per year by 1995. The national risk resulting from the use of carbon fibers in the surface transportation system is discussed.

Lower Education Level Is a Risk Factor for Peritonitis and Technique Failure but Not a Risk for Overall Mortality in Peritoneal Dialysis under Comprehensive Training System

PubMed Central

Kim, Hyo Jin; Lee, Joongyub; Park, Miseon; Kim, Yuri; Lee, Hajeong; Kim, Dong Ki; Joo, Kwon Wook; Kim, Yon Su; Cho, Eun Jin; Ahn, Curie

2017-01-01

Background Lower education level could be a risk factor for higher peritoneal dialysis (PD)-associated peritonitis, potentially resulting in technique failure. This study evaluated the influence of lower education level on the development of peritonitis, technique failure, and overall mortality. Methods Patients over 18 years of age who started PD at Seoul National University Hospital between 2000 and 2012 with information on the academic background were enrolled. Patients were divided into three groups: middle school or lower (academic year≤9, n = 102), high school (912, n = 324). Outcomes were analyzed using Cox proportional hazards models and competing risk regression. Results A total of 655 incident PD patients (60.9% male, age 48.4±14.1 years) were analyzed. During follow-up for 41 (interquartile range, 20–65) months, 255 patients (38.9%) experienced more than one episode of peritonitis, 138 patients (21.1%) underwent technique failure, and 78 patients (11.9%) died. After adjustment, middle school or lower education group was an independent risk factor for peritonitis (adjusted hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.10–2.36; P = 0.015) and technique failure (adjusted HR, 1.87; 95% CI, 1.10–3.18; P = 0.038), compared with higher than high school education group. However, lower education was not associated with increased mortality either by as-treated (adjusted HR, 1.11; 95% CI, 0.53–2.33; P = 0.788) or intent-to-treat analysis (P = 0.726). Conclusions Although lower education was a significant risk factor for peritonitis and technique failure, it was not associated with increased mortality in PD patients. Comprehensive training and multidisciplinary education may overcome the lower education level in PD. PMID:28056058

Lower Education Level Is a Risk Factor for Peritonitis and Technique Failure but Not a Risk for Overall Mortality in Peritoneal Dialysis under Comprehensive Training System.

PubMed

Kim, Hyo Jin; Lee, Joongyub; Park, Miseon; Kim, Yuri; Lee, Hajeong; Kim, Dong Ki; Joo, Kwon Wook; Kim, Yon Su; Cho, Eun Jin; Ahn, Curie; Oh, Kook-Hwan

2017-01-01

Lower education level could be a risk factor for higher peritoneal dialysis (PD)-associated peritonitis, potentially resulting in technique failure. This study evaluated the influence of lower education level on the development of peritonitis, technique failure, and overall mortality. Patients over 18 years of age who started PD at Seoul National University Hospital between 2000 and 2012 with information on the academic background were enrolled. Patients were divided into three groups: middle school or lower (academic year≤9, n = 102), high school (912, n = 324). Outcomes were analyzed using Cox proportional hazards models and competing risk regression. A total of 655 incident PD patients (60.9% male, age 48.4±14.1 years) were analyzed. During follow-up for 41 (interquartile range, 20-65) months, 255 patients (38.9%) experienced more than one episode of peritonitis, 138 patients (21.1%) underwent technique failure, and 78 patients (11.9%) died. After adjustment, middle school or lower education group was an independent risk factor for peritonitis (adjusted hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.10-2.36; P = 0.015) and technique failure (adjusted HR, 1.87; 95% CI, 1.10-3.18; P = 0.038), compared with higher than high school education group. However, lower education was not associated with increased mortality either by as-treated (adjusted HR, 1.11; 95% CI, 0.53-2.33; P = 0.788) or intent-to-treat analysis (P = 0.726). Although lower education was a significant risk factor for peritonitis and technique failure, it was not associated with increased mortality in PD patients. Comprehensive training and multidisciplinary education may overcome the lower education level in PD.

High Pressure Coolant Injection (HPCI) System Risk-Based Inspection Guide for Browns Ferry Nuclear Power Station

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

Wong, S.; DiBiasio, A.; Gunther, W.

1993-09-01

The High Pressure Coolant Injection (HPCI) system has been examined from a risk perspective. A System Risk-Based Inspection Guide (S-RIG) has been developed as an aid to HPCI system inspections at the Browns Ferry Nuclear Power Plant, Units 1, 2 and 3. The role of. the HPCI system in mitigating accidents is discussed in this S-RIG, along with insights on identified risk-based failure modes which could prevent proper operation of the system. The S-RIG provides a review of industry-wide operating experience, including plant-specific illustrative examples to augment the PRA and operational considerations in identifying a catalogue of basic PRA failuremore » modes for the HPCI system. It is designed to be used as a reference for routine inspections, self-initiated safety system functional inspections (SSFIs), and the evaluation of risk significance of component failures at the nuclear power plant.« less

Risk assessment techniques with applicability in marine engineering

NASA Astrophysics Data System (ADS)

Rudenko, E.; Panaitescu, F. V.; Panaitescu, M.

2015-11-01

Nowadays risk management is a carefully planned process. The task of risk management is organically woven into the general problem of increasing the efficiency of business. Passive attitude to risk and awareness of its existence are replaced by active management techniques. Risk assessment is one of the most important stages of risk management, since for risk management it is necessary first to analyze and evaluate risk. There are many definitions of this notion but in general case risk assessment refers to the systematic process of identifying the factors and types of risk and their quantitative assessment, i.e. risk analysis methodology combines mutually complementary quantitative and qualitative approaches. Purpose of the work: In this paper we will consider as risk assessment technique Fault Tree analysis (FTA). The objectives are: understand purpose of FTA, understand and apply rules of Boolean algebra, analyse a simple system using FTA, FTA advantages and disadvantages. Research and methodology: The main purpose is to help identify potential causes of system failures before the failures actually occur. We can evaluate the probability of the Top event.The steps of this analize are: the system's examination from Top to Down, the use of symbols to represent events, the use of mathematical tools for critical areas, the use of Fault tree logic diagrams to identify the cause of the Top event. Results: In the finally of study it will be obtained: critical areas, Fault tree logical diagrams and the probability of the Top event. These results can be used for the risk assessment analyses.

Reliability and risk assessment of structures

NASA Technical Reports Server (NTRS)

Chamis, C. C.

1991-01-01

Development of reliability and risk assessment of structural components and structures is a major activity at Lewis Research Center. It consists of five program elements: (1) probabilistic loads; (2) probabilistic finite element analysis; (3) probabilistic material behavior; (4) assessment of reliability and risk; and (5) probabilistic structural performance evaluation. Recent progress includes: (1) the evaluation of the various uncertainties in terms of cumulative distribution functions for various structural response variables based on known or assumed uncertainties in primitive structural variables; (2) evaluation of the failure probability; (3) reliability and risk-cost assessment; and (4) an outline of an emerging approach for eventual certification of man-rated structures by computational methods. Collectively, the results demonstrate that the structural durability/reliability of man-rated structural components and structures can be effectively evaluated by using formal probabilistic methods.

Temporal Trends and Factors Associated with Home Hemodialysis Technique Survival in Canada.

PubMed

Perl, Jeffrey; Na, Yingbo; Tennankore, Karthik K; Chan, Christopher T

2017-07-24

The last 15 years has seen growth in home hemodialysis (HD) utilization in Canada owing to reports of improved outcomes relative to patients on conventional in-center HD. What effect growth has had on home HD technique and patient survival during this period is not known. We compared the risk of home HD technique failure, mortality, and the composite outcome among three incident cohorts of patients on home HD in Canada: 1996-2002, 2003-2007, and 2008-2012. A multivariable piece-wise exponential model was used to evaluate all outcomes using inverse probability of treatment and censoring weights. A total of 1869 incident patients on home HD were identified from the Canadian Organ Replacement Register. Relative to those treated between 2003 and 2007 ( n =568), the risk of home HD technique failure was similar between patients treated between 1996 and 2002 ( n =233; adjusted hazard ratio [AHR], 1.39; 95% confidence interval [95% CI], 0.78 to 2.46) but higher among incident patients on home HD treated between 2008 and 2012 ( n =1068; AHR, 1.51; 95% CI, 1.06 to 2.15). Relative to patients treated between 2003 and 2007, adjusted mortality was similar among those treated between 2008 and 2012 (AHR, 0.83; 95% CI, 0.58 to 1.19) and those treated between 1996 and 2002 (AHR, 0.67; 95% CI, 0.38 to 1.21). The risk of the composite outcome of death and technique failure was similar across cohorts, as was the risk of receiving a kidney transplant. Increasing age, diabetes as a comorbidity, and smoking status were associated with an increased risk of death as well as the composite outcome. Medium-sized facilities had a lower risk of death, technique failure, and the composite outcome compared with larger facilities. A higher risk of technique failure was seen in the most contemporary era. Further characterization of the risk factors for, and causes of technique failure is needed to develop strategies to improve patient retention on home HD. Copyright © 2017 by the American Society of Nephrology.

Worker Entrepreneurship.

ERIC Educational Resources Information Center

Doucouliagos, Chris

1992-01-01

Evaluates the experience of worker entrepreneurship, highlighting successes and failures in Europe, and analyzes the relative importance of factors to worker entrepreneurship such as access to finance, education and training, organizational culture, and worker risk taking. (JOW)

Engineering risk assessment for emergency disposal projects of sudden water pollution incidents.

PubMed

Shi, Bin; Jiang, Jiping; Liu, Rentao; Khan, Afed Ullah; Wang, Peng

2017-06-01

Without an engineering risk assessment for emergency disposal in response to sudden water pollution incidents, responders are prone to be challenged during emergency decision making. To address this gap, the concept and framework of emergency disposal engineering risks are reported in this paper. The proposed risk index system covers three stages consistent with the progress of an emergency disposal project. Fuzzy fault tree analysis (FFTA), a logical and diagrammatic method, was developed to evaluate the potential failure during the process of emergency disposal. The probability of basic events and their combination, which caused the failure of an emergency disposal project, were calculated based on the case of an emergency disposal project of an aniline pollution incident in the Zhuozhang River, Changzhi, China, in 2014. The critical events that can cause the occurrence of a top event (TE) were identified according to their contribution. Finally, advices on how to take measures using limited resources to prevent the failure of a TE are given according to the quantified results of risk magnitude. The proposed approach could be a potential useful safeguard for the implementation of an emergency disposal project during the process of emergency response.

Estimation of the risk of failure for an endodontically treated maxillary premolar with MODP preparation and CAD/CAM ceramic restorations.

PubMed

Lin, Chun-Li; Chang, Yen-Hsiang; Pa, Che-An

2009-10-01

This study evaluated the risk of failure for an endodontically treated premolar with mesio occlusodistal palatal (MODP) preparation and 3 different computer-aided design/computer-aided manufacturing (CAD/CAM) ceramic restoration configurations. Three 3-dimensional finite element (FE) models designed with CAD/CAM ceramic onlay, endocrown, and conventional crown restorations were constructed to perform simulations. The Weibull function was incorporated with FE analysis to calculate the long-term failure probability relative to different load conditions. The results indicated that the stress values on the enamel, dentin, and luting cement for endocrown restoration were the lowest values relative to the other 2 restorations. Weibull analysis revealed that the individual failure probability in the endocrown enamel, dentin, and luting cement obviously diminished more than those for onlay and conventional crown restorations. The overall failure probabilities were 27.5%, 1%, and 1% for onlay, endocrown, and conventional crown restorations, respectively, in normal occlusal condition. This numeric investigation suggests that endocrown and conventional crown restorations for endodontically treated premolars with MODP preparation present similar longevity.

Risk management.

PubMed

Chambers, David W

2010-01-01

Every plan contains risk. To proceed without planning some means of managing that risk is to court failure. The basic logic of risk is explained. It consists in identifying a threshold where some corrective action is necessary, the probability of exceeding that threshold, and the attendant cost should the undesired outcome occur. This is the probable cost of failure. Various risk categories in dentistry are identified, including lack of liquidity; poor quality; equipment or procedure failures; employee slips; competitive environments; new regulations; unreliable suppliers, partners, and patients; and threats to one's reputation. It is prudent to make investments in risk management to the extent that the cost of managing the risk is less than the probable loss due to risk failure and when risk management strategies can be matched to type of risk. Four risk management strategies are discussed: insurance, reducing the probability of failure, reducing the costs of failure, and learning. A risk management accounting of the financial meltdown of October 2008 is provided.

Habitual chocolate consumption and the risk of incident heart failure among healthy men and women.

PubMed

Kwok, C S; Loke, Y K; Welch, A A; Luben, R N; Lentjes, M A H; Boekholdt, S M; Pfister, R; Mamas, M A; Wareham, N J; Khaw, K-T; Myint, P K

2016-08-01

We aimed to examine the association between chocolate intake and the risk of incident heart failure in a UK general population. We conducted a systematic review and meta-analysis to quantify this association. We used data from a prospective population-based study, the European Prospective Investigation into Cancer (EPIC)-Norfolk cohort. Chocolate intake was quantified based on a food frequency questionnaire obtained at baseline (1993-1997) and incident heart failure was ascertained up to March 2009. We supplemented the primary data with a systematic review and meta-analysis of studies which evaluated risk of incident heart failure with chocolate consumption. A total of 20,922 participants (53% women; mean age 58 ± 9 years) were included of whom 1101 developed heart failure during the follow up (mean 12.5 ± 2.7 years, total person years 262,291 years). After adjusting for lifestyle and dietary factors, we found 19% relative reduction in heart failure incidence in the top (up to 100 g/d) compared to the bottom quintile of chocolate consumption (HR 0.81 95%CI 0.66-0.98) but the results were no longer significant after controlling for comorbidities (HR 0.87 95%CI 0.71-1.06). Additional adjustment for potential mediators did not attenuate the results further. We identified five relevant studies including the current study (N = 75,408). The pooled results showed non-significant 19% relative risk reduction of heart failure incidence with higher chocolate consumption (HR 0.81 95%CI 0.66-1.01). Our results suggest that higher chocolate intake is not associated with subsequent incident heart failure. Copyright © 2016 The Italian Society of Diabetology, the Italian Society for the Study of Atherosclerosis, the Italian Society of Human Nutrition, and the Department of Clinical Medicine and Surgery, Federico II University. Published by Elsevier B.V. All rights reserved.

Application of Failure Mode and Effects Analysis to Intraoperative Radiation Therapy Using Mobile Electron Linear Accelerators

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

Ciocca, Mario, E-mail: mario.ciocca@cnao.it; Cantone, Marie-Claire; Veronese, Ivan

2012-02-01

Purpose: Failure mode and effects analysis (FMEA) represents a prospective approach for risk assessment. A multidisciplinary working group of the Italian Association for Medical Physics applied FMEA to electron beam intraoperative radiation therapy (IORT) delivered using mobile linear accelerators, aiming at preventing accidental exposures to the patient. Methods and Materials: FMEA was applied to the IORT process, for the stages of the treatment delivery and verification, and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system,more » based on the product of three parameters (severity, frequency of occurrence and detectability, each ranging from 1 to 10); 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. Results: Twenty-four subprocesses were identified. Ten potential failure modes were found and scored, in terms of RPN, in the range of 42-216. The most critical failure modes consisted of internal shield misalignment, wrong Monitor Unit calculation and incorrect data entry at treatment console. Potential causes of failure included shield displacement, human errors, such as underestimation of CTV extension, mainly because of lack of adequate training and time pressures, failure in the communication between operators, and machine malfunctioning. The main effects of failure were represented by CTV underdose, wrong dose distribution and/or delivery, unintended normal tissue irradiation. As additional safety measures, the utilization of a dedicated staff for IORT, double-checking of MU calculation and data entry and finally implementation of in vivo dosimetry were suggested. Conclusions: FMEA appeared as a useful tool for prospective evaluation of patient safety in radiotherapy. The application of this method to IORT lead to identify three safety measures for risk mitigation.« less

Frequency and clinical predictors of coronary artery disease in chronic renal failure renal transplant candidates.

PubMed

de Albuquerque Seixas, Emerson; Carmello, Beatriz Leone; Kojima, Christiane Akemi; Contti, Mariana Moraes; Modeli de Andrade, Luiz Gustavo; Maiello, José Roberto; Almeida, Fernando Antonio; Martin, Luis Cuadrado

2015-05-01

Cardiovascular diseases are major causes of mortality in chronic renal failure patients before and after renal transplantation. Among them, coronary disease presents a particular risk; however, risk predictors have been used to diagnose coronary heart disease. This study evaluated the frequency and importance of clinical predictors of coronary artery disease in chronic renal failure patients undergoing dialysis who were renal transplant candidates, and assessed a previously developed scoring system. Coronary angiographies conducted between March 2008 and April 2013 from 99 candidates for renal transplantation from two transplant centers in São Paulo state were analyzed for associations between significant coronary artery diseases (≥70% stenosis in one or more epicardial coronary arteries or ≥50% in the left main coronary artery) and clinical parameters. Univariate logistic regression analysis identified diabetes, angina, and/or previous infarction, clinical peripheral arterial disease and dyslipidemia as predictors of coronary artery disease. Multiple logistic regression analysis identified only diabetes and angina and/or previous infarction as independent predictors. The results corroborate previous studies demonstrating the importance of these factors when selecting patients for coronary angiography in clinical pretransplant evaluation.

High-sensitivity c-reactive protein (hs-CRP) value with 90 days mortality in patients with heart failure

NASA Astrophysics Data System (ADS)

Nursyamsiah; Hasan, R.

2018-03-01

Hospitalization in patients with chronic heart failure is associated with high rates of mortality and morbidity that during treatment and post-treatment. Despite the various therapies available today, mortality and re-hospitalization rates within 60 to 90 days post-hospitalization are still quite high. This period is known as the vulnerable phase. With the prognostic evaluation tools in patients with heart failure are expected to help identify high-risk individuals, then more rigorous monitoring and interventions can be undertaken. To determine whether hs-CRP have an impact on mortality within 90 days in hospitalized patients with heart failure, an observational cohort study was conducted in 39 patients with heart failure who were hospitalized due to worsening chronic heart failure. Patients were followed for up to 90 days after initial evaluation with the primary endpoint is death. Hs-CRP value >4.25 mg/L we found 70% was dead and hs-CRP value <4.25 mg/L only 6.9% was dead whereas the survival within 90 days. p:0.000.In conclusion, there were differences in hs-CRP values between in patients with heart failure who died and survival within 90 days.

Failure mode and effects analysis based risk profile assessment for stereotactic radiosurgery programs at three cancer centers in Brazil.

PubMed

Teixeira, Flavia C; de Almeida, Carlos E; Saiful Huq, M

2016-01-01

The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of risk priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.

Visual field defects may not affect safe driving.

PubMed

Dow, Jamie

2011-10-01

In Quebec a driver whose acquired visual field defect renders them ineligible for a driver's permit renewal may request an exemption from the visual field standard by demonstrating safe driving despite the defect. For safety reasons it was decided to attempt to identify predictors of failure on the road test in order to avoid placing driving evaluators in potentially dangerous situations when evaluating drivers with visual field defects. During a 4-month period in 2009 all requests for exemptions from the visual field standard were collected and analyzed. All available medical and visual field data were collated for 103 individuals, of whom 91 successfully completed the evaluation process and obtained a waiver. The collated data included age, sex, type of visual field defect, visual field characteristics, and concomitant medical problems. No single factor, or combination of factors, could predict failure of the road test. All 5 failures of the road test had cognitive problems but 6 of the successful drivers also had known cognitive problems. Thus, cognitive problems influence the risk of failure but do not predict certain failure. Most of the applicants for an exemption were able to complete the evaluation process successfully, thereby demonstrating safe driving despite their handicap. Consequently, jurisdictions that have visual field standards for their driving permit should implement procedures to evaluate drivers with visual field defects that render them unable to meet the standard but who wish to continue driving.

The Simulation Heuristic.

DTIC Science & Technology

1981-05-15

Crane. is capable of imagining unicorns -- and we expect he is -- why does he find it relatively difficult to imagine himself avoiding a 30 minute...probability that the plan will succeed and to evaluate the risk of various causes of failure . We have suggested that the construction of scenarios is...expect that events will unfold as planned. However, the cumulative probability of at least one fatal failure could be overwhelmingly high even when

Do heart and respiratory rate variability improve prediction of extubation outcomes in critically ill patients?

PubMed Central

2014-01-01

Introduction Prolonged ventilation and failed extubation are associated with increased harm and cost. The added value of heart and respiratory rate variability (HRV and RRV) during spontaneous breathing trials (SBTs) to predict extubation failure remains unknown. Methods We enrolled 721 patients in a multicenter (12 sites), prospective, observational study, evaluating clinical estimates of risk of extubation failure, physiologic measures recorded during SBTs, HRV and RRV recorded before and during the last SBT prior to extubation, and extubation outcomes. We excluded 287 patients because of protocol or technical violations, or poor data quality. Measures of variability (97 HRV, 82 RRV) were calculated from electrocardiogram and capnography waveforms followed by automated cleaning and variability analysis using Continuous Individualized Multiorgan Variability Analysis (CIMVA™) software. Repeated randomized subsampling with training, validation, and testing were used to derive and compare predictive models. Results Of 434 patients with high-quality data, 51 (12%) failed extubation. Two HRV and eight RRV measures showed statistically significant association with extubation failure (P <0.0041, 5% false discovery rate). An ensemble average of five univariate logistic regression models using RRV during SBT, yielding a probability of extubation failure (called WAVE score), demonstrated optimal predictive capacity. With repeated random subsampling and testing, the model showed mean receiver operating characteristic area under the curve (ROC AUC) of 0.69, higher than heart rate (0.51), rapid shallow breathing index (RBSI; 0.61) and respiratory rate (0.63). After deriving a WAVE model based on all data, training-set performance demonstrated that the model increased its predictive power when applied to patients conventionally considered high risk: a WAVE score >0.5 in patients with RSBI >105 and perceived high risk of failure yielded a fold increase in risk of extubation failure of 3.0 (95% confidence interval (CI) 1.2 to 5.2) and 3.5 (95% CI 1.9 to 5.4), respectively. Conclusions Altered HRV and RRV (during the SBT prior to extubation) are significantly associated with extubation failure. A predictive model using RRV during the last SBT provided optimal accuracy of prediction in all patients, with improved accuracy when combined with clinical impression or RSBI. This model requires a validation cohort to evaluate accuracy and generalizability. Trial registration ClinicalTrials.gov NCT01237886. Registered 13 October 2010. PMID:24713049

Risk Analysis of Earth-Rock Dam Failures Based on Fuzzy Event Tree Method

PubMed Central

Fu, Xiao; Gu, Chong-Shi; Su, Huai-Zhi; Qin, Xiang-Nan

2018-01-01

Earth-rock dams make up a large proportion of the dams in China, and their failures can induce great risks. In this paper, the risks associated with earth-rock dam failure are analyzed from two aspects: the probability of a dam failure and the resulting life loss. An event tree analysis method based on fuzzy set theory is proposed to calculate the dam failure probability. The life loss associated with dam failure is summarized and refined to be suitable for Chinese dams from previous studies. The proposed method and model are applied to one reservoir dam in Jiangxi province. Both engineering and non-engineering measures are proposed to reduce the risk. The risk analysis of the dam failure has essential significance for reducing dam failure probability and improving dam risk management level. PMID:29710824

Preeclampsia and Future Cardiovascular Health: A Systematic Review and Meta-Analysis.

PubMed

Wu, Pensée; Haththotuwa, Randula; Kwok, Chun Shing; Babu, Aswin; Kotronias, Rafail A; Rushton, Claire; Zaman, Azfar; Fryer, Anthony A; Kadam, Umesh; Chew-Graham, Carolyn A; Mamas, Mamas A

2017-02-01

Preeclampsia is a pregnancy-specific disorder resulting in hypertension and multiorgan dysfunction. There is growing evidence that these effects persist after pregnancy. We aimed to systematically evaluate and quantify the evidence on the relationship between preeclampsia and the future risk of cardiovascular diseases. We studied the future risk of heart failure, coronary heart disease, composite cardiovascular disease, death because of coronary heart or cardiovascular disease, stroke, and stroke death after preeclampsia. A systematic search of MEDLINE and EMBASE was performed to identify relevant studies. We used random-effects meta-analysis to determine the risk. Twenty-two studies were identified with >6.4 million women including >258 000 women with preeclampsia. Meta-analysis of studies that adjusted for potential confounders demonstrated that preeclampsia was independently associated with an increased risk of future heart failure (risk ratio [RR], 4.19; 95% confidence interval [CI], 2.09-8.38), coronary heart disease (RR, 2.50; 95% CI, 1.43-4.37), cardiovascular disease death (RR, 2.21; 95% CI, 1.83-2.66), and stroke (RR, 1.81; 95% CI, 1.29-2.55). Sensitivity analyses showed that preeclampsia continued to be associated with an increased risk of future coronary heart disease, heart failure, and stroke after adjusting for age (RR, 3.89; 95% CI, 1.83-8.26), body mass index (RR, 3.16; 95% CI, 1.41-7.07), and diabetes mellitus (RR, 4.19; 95% CI, 2.09-8.38). Preeclampsia is associated with a 4-fold increase in future incident heart failure and a 2-fold increased risk in coronary heart disease, stroke, and death because of coronary heart or cardiovascular disease. Our study highlights the importance of lifelong monitoring of cardiovascular risk factors in women with a history of preeclampsia. © 2017 American Heart Association, Inc.

Implantable cardiac resynchronization therapy devices to monitor heart failure clinical status.

PubMed

Fung, Jeffrey Wing-Hong; Yu, Cheuk-Man

2007-03-01

Cardiac resynchronization therapy is a standard therapy for selected patients with heart failure. With advances in technology and storage capacity, the device acts as a convenient platform to provide valuable information about heart failure status in these high-risk patients. Unlike other modalities of investigation which may only allow one-off evaluation, heart failure status can be monitored by device diagnostics including heart rate variability, activity status, and intrathoracic impedance in a continuous basis. These parameters do not just provide long-term prognostic information but also may be useful to predict upcoming heart failure exacerbation. Prompt and early intervention may abort decompensation, prevent hospitalization, improve quality of life, and reduce health care cost. Moreover, this information may be applied to titrate the dosage of medication and monitor response to heart failure treatment. This review will focus on the prognostic and predictive values of heart failure status monitoring provided by these devices.

Health information systems: failure, success and improvisation.

PubMed

Heeks, Richard

2006-02-01

The generalised assumption of health information systems (HIS) success is questioned by a few commentators in the medical informatics field. They point to widespread HIS failure. The purpose of this paper was therefore to develop a better conceptual foundation for, and practical guidance on, health information systems failure (and success). Literature and case analysis plus pilot testing of developed model. Defining HIS failure and success is complex, and the current evidence base on HIS success and failure rates was found to be weak. Nonetheless, the best current estimate is that HIS failure is an important problem. The paper therefore derives and explains the "design-reality gap" conceptual model. This is shown to be robust in explaining multiple cases of HIS success and failure, yet provides a contingency that encompasses the differences which exist in different HIS contexts. The design-reality gap model is piloted to demonstrate its value as a tool for risk assessment and mitigation on HIS projects. It also throws into question traditional, structured development methodologies, highlighting the importance of emergent change and improvisation in HIS. The design-reality gap model can be used to address the problem of HIS failure, both as a post hoc evaluative tool and as a pre hoc risk assessment and mitigation tool. It also validates a set of methods, techniques, roles and competencies needed to support the dynamic improvisations that are found to underpin cases of HIS success.

A meta-analysis of the association between diabetic patients and AVF failure in dialysis.

PubMed

Yan, Yan; Ye, Dan; Yang, Liu; Ye, Wen; Zhan, Dandan; Zhang, Li; Xiao, Jun; Zeng, Yan; Chen, Qinkai

2018-11-01

The most preferable vascular access for patients with end-stage renal failure needing hemodialysis is native arteriovenous fistula (AVF) on account of its access longevity, patient morbidity, hospitalization costs, lower risks of infection and fewer incidence of thrombotic complications. Meanwhile, according to National Kidney Foundation (NKF)̸Dialysis Out-comes Quality Initiative (DOQI) guidelines, AVF is more used than before. However, a significant percentage of AVF fails to support dialysis therapy due to lack of adequate maturity. Among all factors, the presence of diabetes mellitus was shown to be one of the risk factors for the development of vascular access failure by some authors. Therefore, this review evaluates the current evidence concerning the correlation of diabetes and AVF failure. A search was conducted using MEDLINE, SCIENCE DIRECT, SPRINGER, WILEY-BLACKWELL, KARGER, EMbase, CNKI and WanFang Data from the establishment time of databases to January 2016. The analysis involved studies that contained subgroups of diabetic patients and compared their outcomes with those of non-diabetic adults. In total, 23 articles were retrieved and included in the review. The meta-analysis revealed a statistically significantly higher rate of AVF failure in diabetic patients compared with non-diabetic patients (OR = 1.682; 95% CI, 1.429-1.981, Test of OR = 1: z = 6.25, p <.001). This review found an increased risk of AVF failure in diabetes patients. If confirmed by further prospective studies, preventive measure should be considered when planning AVF in diabetic patients.

Preventing blood transfusion failures: FMEA, an effective assessment method.

PubMed

Najafpour, Zhila; Hasoumi, Mojtaba; Behzadi, Faranak; Mohamadi, Efat; Jafary, Mohamadreza; Saeedi, Morteza

2017-06-30

Failure Mode and Effect Analysis (FMEA) is a method used to assess the risk of failures and harms to patients during the medical process and to identify the associated clinical issues. The aim of this study was to conduct an assessment of blood transfusion process in a teaching general hospital, using FMEA as the method. A structured FMEA was recruited in our study performed in 2014, and corrective actions were implemented and re-evaluated after 6 months. Sixteen 2-h sessions were held to perform FMEA in the blood transfusion process, including five steps: establishing the context, selecting team members, analysis of the processes, hazard analysis, and developing a risk reduction protocol for blood transfusion. Failure modes with the highest risk priority numbers (RPNs) were identified. The overall RPN scores ranged from 5 to 100 among which, four failure modes were associated with RPNs over 75. The data analysis indicated that failures with the highest RPNs were: labelling (RPN: 100), transfusion of blood or the component (RPN: 100), patient identification (RPN: 80) and sampling (RPN: 75). The results demonstrated that mis-transfusion of blood or blood component is the most important error, which can lead to serious morbidity or mortality. Provision of training to the personnel on blood transfusion, knowledge raising on hazards and appropriate preventative measures, as well as developing standard safety guidelines are essential, and must be implemented during all steps of blood and blood component transfusion.

Survey of critical failure events in on-chip interconnect by fault tree analysis

NASA Astrophysics Data System (ADS)

Yokogawa, Shinji; Kunii, Kyousuke

2018-07-01

In this paper, a framework based on reliability physics is proposed for adopting fault tree analysis (FTA) to the on-chip interconnect system of a semiconductor. By integrating expert knowledge and experience regarding the possibilities of failure on basic events, critical issues of on-chip interconnect reliability will be evaluated by FTA. In particular, FTA is used to identify the minimal cut sets with high risk priority. Critical events affecting the on-chip interconnect reliability are identified and discussed from the viewpoint of long-term reliability assessment. The moisture impact is evaluated as an external event.

Herpes Zoster Infection in Patients With Ulcerative Colitis Receiving Tofacitinib.

PubMed

Winthrop, Kevin L; Melmed, Gil Y; Vermeire, Séverine; Long, Millie D; Chan, Gary; Pedersen, Ronald D; Lawendy, Nervin; Thorpe, Andrew J; Nduaka, Chudy I; Su, Chinyu

2018-05-30

Tofacitinib is an oral, small molecule Janus kinase inhibitor that is being investigated for ulcerative colitis (UC). Tofacitinib is approved for rheumatoid arthritis and psoriatic arthritis, where it has been shown to increase herpes zoster (HZ) risk. We evaluated HZ risk among UC patients using tofacitinib. HZ cases were identified in tofacitinib phase II/III/ongoing, open-label, long-term extension (OLE) UC trials. We calculated HZ incidence rates (IRs) per 100 patient-years of tofacitinib exposure within phase III maintenance (Maintenance Cohort) and phase II/III/OLE (Overall Cohort) studies, stratified by baseline demographics and other factors. HZ risk factors were evaluated in the Overall Cohort using Cox proportional hazard models. Overall, 65 (5.6%) patients developed HZ. Eleven patients had multidermatomal involvement (2 nonadjacent or 3-6 adjacent dermatomes), and 1 developed encephalitis (resolved upon standard treatment). Five (7.7%) events led to treatment discontinuation. HZ IR (95% confidence interval [CI]) in the Overall Cohort was 4.07 (3.14-5.19) over a mean (range) of 509.1 (1-1606) days, with no increased risk observed with increasing tofacitinib exposure. IRs (95% CI) were highest in patients age ≥65 years, 9.55 (4.77-17.08); Asian patients, 6.49 (3.55-10.89); patients with prior tumor necrosis factor inhibitor (TNFi) failure, 5.38 (3.86-7.29); and patients using tofacitinib 10 mg twice daily, 4.25 (3.18-5.56). Multivariate analysis identified older age and prior TNFi failure as independent risk factors. In tofacitinib-treated UC patients, there was an elevated risk of HZ, although complicated HZ was infrequent. Increased HZ rates occurred in patients who were older, Asian, or had prior TNFi failure (NCT00787202, NCT01465763, NCT01458951, NCT01458574, NCT01470612).

Analytical Method to Evaluate Failure Potential During High-Risk Component Development

NASA Technical Reports Server (NTRS)

Tumer, Irem Y.; Stone, Robert B.; Clancy, Daniel (Technical Monitor)

2001-01-01

Communicating failure mode information during design and manufacturing is a crucial task for failure prevention. Most processes use Failure Modes and Effects types of analyses, as well as prior knowledge and experience, to determine the potential modes of failures a product might encounter during its lifetime. When new products are being considered and designed, this knowledge and information is expanded upon to help designers extrapolate based on their similarity with existing products and the potential design tradeoffs. This paper makes use of similarities and tradeoffs that exist between different failure modes based on the functionality of each component/product. In this light, a function-failure method is developed to help the design of new products with solutions for functions that eliminate or reduce the potential of a failure mode. The method is applied to a simplified rotating machinery example in this paper, and is proposed as a means to account for helicopter failure modes during design and production, addressing stringent safety and performance requirements for NASA applications.

Global resilience analysis of water distribution systems.

PubMed

Diao, Kegong; Sweetapple, Chris; Farmani, Raziyeh; Fu, Guangtao; Ward, Sarah; Butler, David

2016-12-01

Evaluating and enhancing resilience in water infrastructure is a crucial step towards more sustainable urban water management. As a prerequisite to enhancing resilience, a detailed understanding is required of the inherent resilience of the underlying system. Differing from traditional risk analysis, here we propose a global resilience analysis (GRA) approach that shifts the objective from analysing multiple and unknown threats to analysing the more identifiable and measurable system responses to extreme conditions, i.e. potential failure modes. GRA aims to evaluate a system's resilience to a possible failure mode regardless of the causal threat(s) (known or unknown, external or internal). The method is applied to test the resilience of four water distribution systems (WDSs) with various features to three typical failure modes (pipe failure, excess demand, and substance intrusion). The study reveals GRA provides an overview of a water system's resilience to various failure modes. For each failure mode, it identifies the range of corresponding failure impacts and reveals extreme scenarios (e.g. the complete loss of water supply with only 5% pipe failure, or still meeting 80% of demand despite over 70% of pipes failing). GRA also reveals that increased resilience to one failure mode may decrease resilience to another and increasing system capacity may delay the system's recovery in some situations. It is also shown that selecting an appropriate level of detail for hydraulic models is of great importance in resilience analysis. The method can be used as a comprehensive diagnostic framework to evaluate a range of interventions for improving system resilience in future studies. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Close Analysis of Texts with Structure (CATS): An Intervention to Teach Reading Comprehension to At-Risk Second Graders

ERIC Educational Resources Information Center

Williams, Joanna P.; Kao, Jenny C.; Pao, Lisa S.; Ordynans, Jill G.; Atkins, J. Grant; Cheng, Rong; DeBonis, Daniel

2016-01-01

We developed and evaluated an intervention that teaches reading comprehension via expository text structure training to second graders in urban public schools at risk for academic failure. Fifty lessons on 5 basic text structures (sequence, comparison, causation, description, and problem-solution) were embedded in a social studies curriculum that…

Evaluation of Synchronous Online Tutoring for Students at Risk of Reading Failure

ERIC Educational Resources Information Center

Vasquez, Eleazar, III; Slocum, Timothy A.

2012-01-01

This study examined the effects of online reading instruction for at-risk fourth-grade students in Philadelphia. The authors used a multiple baseline design to assess the extent to which the students increased their oral reading rate given systematic supplemental online reading instruction. Tutoring consisted of 4 sessions per week with 50-min…

Evaluation of a Successful High Risk Nursing Student Assistance Program: One ADN Program's Journey

ERIC Educational Resources Information Center

O'Sullivan, Ciaran Anthony Mary

2013-01-01

A college education is, for many in America, part and parcel of the American Dream, and is certainly achievable. For countless reasons, students may enroll at community colleges underprepared, unprepared, anxious, and destined for a high risk of failure. Although community colleges are higher education institutions open and accessible to all who…

77 FR 42317 - Establish a Patient-Based Registry To Evaluate the Association of Gadolinium Based Contrast...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-07-18

... renal failure appear to be at highest risk. In one, early retrospective study of 370 patients with... (Ref. 1). In a recent retrospective chart review study by Wang of 52,954 contrast MR examinations with... prospective registry study of the risk of NSF associated with GBCAs among renal patients. Patients already...

Simulation Assisted Risk Assessment Applied to Launch Vehicle Conceptual Design

NASA Technical Reports Server (NTRS)

Mathias, Donovan L.; Go, Susie; Gee, Ken; Lawrence, Scott

2008-01-01

A simulation-based risk assessment approach is presented and is applied to the analysis of abort during the ascent phase of a space exploration mission. The approach utilizes groupings of launch vehicle failures, referred to as failure bins, which are mapped to corresponding failure environments. Physical models are used to characterize the failure environments in terms of the risk due to blast overpressure, resulting debris field, and the thermal radiation due to a fireball. The resulting risk to the crew is dynamically modeled by combining the likelihood of each failure, the severity of the failure environments as a function of initiator and time of the failure, the robustness of the crew module, and the warning time available due to early detection. The approach is shown to support the launch vehicle design process by characterizing the risk drivers and identifying regions where failure detection would significantly reduce the risk to the crew.

Emergency Heart Failure Mortality Risk Grade score performance for 7-day mortality prediction in patients with heart failure attended at the emergency department: validation in a Spanish cohort.

PubMed

Gil, Víctor; Miró, Òscar; Schull, Michael J; Llorens, Pere; Herrero-Puente, Pablo; Jacob, Javier; Ríos, José; Lee, Douglas S; Martín-Sánchez, Francisco J

2018-06-01

The Emergency Heart Failure Mortality Risk Grade (EHMRG) scale, derived in 86 Canadian emergency departments (EDs), stratifies patients with acute-decompensated heart failure (ADHF) according to their 7-day mortality risk. We evaluated its external validity in a Spanish cohort. We applied the EHMRG scale to ADHF patients consecutively included in the Epidemiology of Acute Heart Failure in Emergency departments (EAHFE) registry (29 Spanish EDs) and measured its performance. Patients were distributed into quintiles according to the original and their self-defined score cutoffs. The 7-day mortality rates were compared internally among different categories and with categories of Canadian cohorts. The EAHFE group [n: 1553 patients; 80 (10) years; 55.6% women] had a 5.5% 7-day mortality rate and the EHMRG scale c-statistic was 0.741 (95% confidence interval: 0.688-0.793) compared with 0.807 (0.761-0.842) and 0.804 (0.763-0.840) obtained in the Canadian derivation and validation cohorts. The mortality rate of the EAHFE group mortality increased progressively as the quintile categories increased using intervals defined by either the Canadian or the Spanish EHMRG score cutoffs, although with more regular increments with the EAHFE-defined intervals; using the latter, patients at quintiles 2, 3, 4, 5a and 5b had (compared with quintile 1) odds ratios of 1.77, 3.36, 4.44, 9.39 and 16.19, respectively. The EHMRG scale stratified risk in an ADHF cohort that included both palliative and nonpalliative patients in Spanish EDs, showing an extrapolation to a higher mortality risk cohort than the original derivation sample. Stratification improved when the score was recalibrated in the Spanish cohort.

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.

Perineural invasion is associated with increased relapse after external beam radiotherapy for men with low-risk prostate cancer and may be a marker for occult, high-grade cancer.

PubMed

Beard, C J; Chen, M H; Cote, K; Loffredo, M; Renshaw, A A; Hurwitz, M; D'Amico, A V

2004-01-01

To investigate the risk of postradiotherapy prostate-specific antigen (PSA) failure on the basis of pretreatment risk factors in prostate cancer patients with and without perineural invasion (PNI) in prostate biopsy specimens and to explain the observation that otherwise low-risk patients with PNI experience decreased freedom from PSA failure after external beam radiotherapy (RT). The study cohort consisted of 381 patients who underwent RT between 1989 and 2000 for clinically localized prostate cancer. A single genitourinary pathologist scored the absence or presence of PNI on all prostate biopsy specimens. Patients were divided into low-, intermediate- and high-risk subgroups on the basis of their 1992 American Joint Committee on Cancer T-stage, pretreatment PSA level, and Gleason score. Cox regression uni- and multivariate analyses were performed to evaluate whether the presence or absence of PNI in the biopsy specimen was a predictor of the time to post-RT PSA failure for patients in each pretreatment risk group. PSA failure was defined using the American Society for Therapeutic Radiology and Oncology consensus definition. Actuarial PSA failure-free survival was estimated using the Kaplan-Meier method, and comparisons were performed using the log-rank test. Cox regression univariate analysis revealed that PNI was a significant predictor of the time to PSA failure in the low-risk (p = 0.04) and high-risk (p = 0.03) cohorts. The 5-year PSA failure-free survival rate was 50% vs. 80% (p = 0.04) in low-risk patients, 70% vs. 75% (p = 0.72) in intermediate-risk patients, and 29% vs. 53% (p = 0.03) in high-risk patients with and without PNI, respectively. Cox regression multivariate analysis within the high-risk group revealed that a PSA level > or =20 ng/mL (p = 0.01) and Gleason score > or =8 (p = 0.02), but not PNI, were the only significant predictors of the time to PSA failure after RT. However, an association was found between the presence of PNI in the needle biopsy specimen and a biopsy Gleason score of 8-10 (p = 0.06). The association was stronger between the presence of PNI in the needle biopsy specimen and a biopsy Gleason score of 7-10 (p = 0. 033). A decrement in PSA outcome after RT for low-risk patients with PNI-positive biopsy specimens was found. The association between PNI and high Gleason score provides a possible explanation for the loss of statistical significance of PNI in the Cox regression multivariate analysis of the high-risk cohort. The data suggest that PNI found in the biopsy specimen of an otherwise low-risk patient predicts for occult high-grade disease that is missed owing to the sampling error associated with prostate biopsy. The association between PNI and a high Gleason score argues for the use of more aggressive therapy, such as hormonal therapy with RT and/or dose escalation, in these select patients.

Weighing of risk factors for penetrating keratoplasty graft failure: application of Risk Score System.

PubMed

Tourkmani, Abdo Karim; Sánchez-Huerta, Valeria; De Wit, Guillermo; Martínez, Jaime D; Mingo, David; Mahillo-Fernández, Ignacio; Jiménez-Alfaro, Ignacio

2017-01-01

To analyze the relationship between the score obtained in the Risk Score System (RSS) proposed by Hicks et al with penetrating keratoplasty (PKP) graft failure at 1y postoperatively and among each factor in the RSS with the risk of PKP graft failure using univariate and multivariate analysis. The retrospective cohort study had 152 PKPs from 152 patients. Eighteen cases were excluded from our study due to primary failure (10 cases), incomplete medical notes (5 cases) and follow-up less than 1y (3 cases). We included 134 PKPs from 134 patients stratified by preoperative risk score. Spearman coefficient was calculated for the relationship between the score obtained and risk of failure at 1y. Univariate and multivariate analysis were calculated for the impact of every single risk factor included in the RSS over graft failure at 1y. Spearman coefficient showed statistically significant correlation between the score in the RSS and graft failure ( P <0.05). Multivariate logistic regression analysis showed no statistically significant relationship ( P >0.05) between diagnosis and lens status with graft failure. The relationship between the other risk factors studied and graft failure was significant ( P <0.05), although the results for previous grafts and graft failure was unreliable. None of our patients had previous blood transfusion, thus, it had no impact. After the application of multivariate analysis techniques, some risk factors do not show the expected impact over graft failure at 1y.

Weighing of risk factors for penetrating keratoplasty graft failure: application of Risk Score System

PubMed Central

Tourkmani, Abdo Karim; Sánchez-Huerta, Valeria; De Wit, Guillermo; Martínez, Jaime D.; Mingo, David; Mahillo-Fernández, Ignacio; Jiménez-Alfaro, Ignacio

2017-01-01

AIM To analyze the relationship between the score obtained in the Risk Score System (RSS) proposed by Hicks et al with penetrating keratoplasty (PKP) graft failure at 1y postoperatively and among each factor in the RSS with the risk of PKP graft failure using univariate and multivariate analysis. METHODS The retrospective cohort study had 152 PKPs from 152 patients. Eighteen cases were excluded from our study due to primary failure (10 cases), incomplete medical notes (5 cases) and follow-up less than 1y (3 cases). We included 134 PKPs from 134 patients stratified by preoperative risk score. Spearman coefficient was calculated for the relationship between the score obtained and risk of failure at 1y. Univariate and multivariate analysis were calculated for the impact of every single risk factor included in the RSS over graft failure at 1y. RESULTS Spearman coefficient showed statistically significant correlation between the score in the RSS and graft failure (P<0.05). Multivariate logistic regression analysis showed no statistically significant relationship (P>0.05) between diagnosis and lens status with graft failure. The relationship between the other risk factors studied and graft failure was significant (P<0.05), although the results for previous grafts and graft failure was unreliable. None of our patients had previous blood transfusion, thus, it had no impact. CONCLUSION After the application of multivariate analysis techniques, some risk factors do not show the expected impact over graft failure at 1y. PMID:28393027

Biophysical risks to carbon sequestration and storage in Australian drylands.

PubMed

Nolan, Rachael H; Sinclair, Jennifer; Eldridge, David J; Ramp, Daniel

2018-02-15

Carbon abatement schemes that reduce land clearing and promote revegetation are now an important component of climate change policy globally. There is considerable potential for these schemes to operate in drylands which are spatially extensive. However, projects in these environments risk failure through unplanned release of stored carbon to the atmosphere. In this review, we identify factors that may adversely affect the success of vegetation-based carbon abatement projects in dryland ecosystems, evaluate their likelihood of occurrence, and estimate the potential consequences for carbon storage and sequestration. We also evaluate management strategies to reduce risks posed to these carbon abatement projects. Identified risks were primarily disturbances, including unplanned fire, drought, and grazing. Revegetation projects also risk recruitment failure, thereby failing to reach projected rates of sequestration. Many of these risks are dependent on rainfall, which is highly variable in drylands and susceptible to further variation under climate change. Resprouting vegetation is likely to be less vulnerable to disturbance and have faster recovery rates upon release from disturbance. We conclude that there is a strong impetus for identifying management strategies and risk reduction mechanisms for carbon abatement projects. Risk mitigation would be enhanced by effective co-ordination of mitigation strategies at scales larger than individual abatement project boundaries, and by implementing risk assessment throughout project planning and implementation stages. Reduction of risk is vital for maximising carbon sequestration of individual projects and for reducing barriers to the establishment of new projects entering the market. Copyright © 2017 Elsevier Ltd. All rights reserved.

Influence of Acute Kidney Injury Defined by the Pediatric Risk, Injury, Failure, Loss, End-Stage Renal Disease Score on the Clinical Course of PICU Patients.

PubMed

Cabral, Felipe Cezar; Ramos Garcia, Pedro Celiny; Mattiello, Rita; Dresser, Daiane; Fiori, Humberto Holmer; Korb, Cecilia; Dalcin, Tiago Chagas; Piva, Jefferson Pedro

2015-10-01

To evaluate the predictive value of the pediatric-modified Risk, Injury, Failure, Loss, End-stage renal disease criteria for disease course severity in patients with or without acute kidney injury admitted to a PICU. Retrospective cohort study. A 12-bed PICU at a tertiary referral center in Southern Brazil. All patients admitted to the study unit over a 1-year period. A database of all eligible patients was analyzed retrospectively. Patients were classified by pediatric-modified Risk, Injury, Failure, Loss, End-stage renal disease score at admission and worst pediatric-modified Risk, Injury, Failure, Loss, End-stage renal disease score during PICU hospitalization. The outcomes of interest were length of PICU stay, duration of mechanical ventilation, duration of vasoactive drug therapy, and mortality. The Pediatric Index of Mortality 2 was used to assess overall disease severity at the time of PICU admission. Of 375 patients, 169 (45%) presented acute kidney injury at the time of admission and 37 developed acute kidney injury during PICU stay, for a total of 206 of 375 patients (55%) diagnosed with acute kidney injury during the study period. The median Pediatric Index of Mortality 2 score predicted a mortality rate of 9% among non-acute kidney injury patients versus a mortality rate of 16% among acute kidney injury patients (p = 0.006). The mortality of patients classified as pediatric-modified Risk, Injury, Failure, Loss, End-stage renal disease F was double that predicted by Pediatric Index of Mortality 2 (7 vs 3.2). Patients classified as having severe acute kidney injury (pediatric-modified Risk, Injury, Failure, Loss, End-stage renal disease I + F) exhibited higher mortality (14.1%; p = 0.001) and prolonged PICU length of stay (median, 7 d; p = 0.001) when compared with other patients. Acute kidney injury is a very frequent occurrence among patients admitted to PICUs. The degree of acute kidney injury severity, as assessed by the pediatric-modified Risk, Injury, Failure, Loss, End-stage renal disease criteria, is a good predictor of morbidity and mortality in this population. Pediatric Index of Mortality 2 tends to underestimate mortality in pediatric patients with severe acute kidney injury.

Estimation of the failure risk of a maxillary premolar with different crack depths with endodontic treatment by computer-aided design/computer-aided manufacturing ceramic restorations.

PubMed

Lin, Chun-Li; Chang, Yen-Hsiang; Hsieh, Shih-Kai; Chang, Wen-Jen

2013-03-01

This study evaluated the risk of failure for an endodontically treated premolar with different crack depths, which was shearing toward the pulp chamber and was restored by using 3 different computer-aided design/computer-aided manufacturing ceramic restoration configurations. Three 3-dimensional finite element models designed with computer-aided design/computer-aided manufacturing ceramic onlay, endocrown, and conventional crown restorations were constructed to perform simulations. The Weibull function was incorporated with finite element analysis to calculate the long-term failure probability relative to different load conditions. The results indicated that the stress values on the enamel, dentin, and luting cement for endocrown restorations exhibited the lowest values relative to the other 2 restoration methods. Weibull analysis revealed that the overall failure probabilities in a shallow cracked premolar were 27%, 2%, and 1% for the onlay, endocrown, and conventional crown restorations, respectively, in the normal occlusal condition. The corresponding values were 70%, 10%, and 2% for the depth cracked premolar. This numeric investigation suggests that the endocrown provides sufficient fracture resistance only in a shallow cracked premolar with endodontic treatment. The conventional crown treatment can immobilize the premolar for different cracked depths with lower failure risk. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

The safety of sacubitril-valsartan for the treatment of chronic heart failure.

PubMed

Tyler, Jeffrey M; Teerlink, John R

2017-02-01

Sacubitril-valsartan is a combination drug that contains the neprilysin inhibitor sacubitril and angiotensin II receptor blocker valsartan. In 2015, the US Food and Drug Administration approved sacubitril-valsartan for treatment of heart failure patients with reduced ejection fraction and New York Heart Association class II-IV symptoms following a large, Phase III clinical trial (PARADIGM-HF) that demonstrated a 20% reduction in the combined primary end-point of death from cardiovascular cause or hospitalization for heart failure compared to enalapril. Areas covered: This review discusses the clinical efficacy and safety of angiotensin receptor neprilysin inhibitor sacubitril-valsartan in heart failure with reduced ejection fraction. Expert opinion: Based on the PARADIGM-HF trial, sacubitril-valsartan offers compelling reductions in meaningful clinical endpoints, independent of age or severity of disease. The rate of adverse events was comparable between the enalapril and sacubitril-valsartan groups, although the absolute rates are likely underestimated due to the entry criteria and run-in period. Future trials and post-market surveillance are critical to better understand the risk of angioedema in high risk populations, particularly African-Americans, as well as long-term theoretical risks including the potential for increased cerebral amyloid plaque deposition with possible development of neurocognitive disease. Current trials are underway to evaluate potential benefit in patients with heart failure with preserved ejection fraction.

Probabilistic structural analysis of aerospace components using NESSUS

NASA Technical Reports Server (NTRS)

Shiao, Michael C.; Nagpal, Vinod K.; Chamis, Christos C.

1988-01-01

Probabilistic structural analysis of a Space Shuttle main engine turbopump blade is conducted using the computer code NESSUS (numerical evaluation of stochastic structures under stress). The goal of the analysis is to derive probabilistic characteristics of blade response given probabilistic descriptions of uncertainties in blade geometry, material properties, and temperature and pressure distributions. Probability densities are derived for critical blade responses. Risk assessment and failure life analysis is conducted assuming different failure models.

The Positive Alternative Credit Experience (PACE) Program a Quantitative Comparative Study

ERIC Educational Resources Information Center

Warren, Rebecca Anne

2011-01-01

The purpose of this quantitative comparative study was to evaluate the Positive Alternative Credit Experience (PACE) Program using an objectives-oriented approach to a formative program evaluation. The PACE Program was a semester-long high school alternative education program designed to serve students at-risk for academic failure or dropping out…

A Risk Management Framework to Characterize Black Swan Risks: A Case Study of Lightning Effects on Insensitive High Explosives

NASA Astrophysics Data System (ADS)

Sanders, Gary A.

Effective and efficient risk management processes include the use of high fidelity modeling and simulation during the concept exploration phase as part of the technology and risk assessment activities, with testing and evaluation tasks occurring in later design development phases. However, some safety requirements and design architectures may be dominated by the low probability/high consequence "Black Swan" vulnerabilities that require very early testing to characterize and efficiently mitigate. Failure to address these unique risks has led to catastrophic systems failures including the space shuttle Challenger, Deepwater Horizon, Fukushima nuclear reactor, and Katrina dike failures. Discovering and addressing these risks later in the design and development process can be very costly or even lead to project cancellation. This paper examines the need for risk management process adoption of early hazard phenomenology testing to inform the technical risk assessment, requirements definition and conceptual design. A case study of the lightning design vulnerability of the insensitive high explosives being used in construction, mining, demolition, and defense industries will be presented to examine the impact of this vulnerability testing during the concept exploration phase of the design effort. While these insensitive high explosives are far less sensitive to accidental initiation by fire, impact, friction or even electrical stimuli, their full range of sensitivities have not been characterized and ensuring safe engineering design and operations during events such as lightning storms requires vulnerability testing during the risk assessment phase.

An observational study of the frequency, severity, and etiology of failures in postoperative care after major elective general surgery.

PubMed

Symons, Nicholas R A; Almoudaris, Alex M; Nagpal, Kamal; Vincent, Charles A; Moorthy, Krishna

2013-01-01

To investigate the nature of process failures in postoperative care, to assess their frequency and preventability, and to explore their relationship to adverse events. Adverse events are common and are frequently caused by failures in the process of care. These processes are often evaluated independently using clinical audit. There is little understanding of process failures in terms of their overall frequency, relative risk, and cumulative effect on the surgical patient. Patients were observed daily from the first postoperative day until discharge by an independent surgeon. Field notes on the circumstances surrounding any nonroutine or atypical event were recorded. Field notes were assessed by 2 surgeons to identify failures in the process of care. Preventability, the degree of harm caused to the patient, and the underlying etiology of process failures were evaluated by 2 independent surgeons. Fifty patients undergoing major elective general surgery were observed for a total of 659 days of postoperative care. A total of 256 process failures were identified, of which 85% were preventable and 51% directly led to patient harm. Process failures occurred in all aspects of care, the most frequent being medication prescribing and administration, management of lines, tubes, and drains, and pain control interventions. Process failures accounted for 57% of all preventable adverse events. Communication failures and delays were the main etiologies, leading to 54% of process failures. Process failures are common in postoperative care, are highly preventable, and frequently cause harm to patients. Interventions to prevent process failures will improve the reliability of surgical postoperative care and have the potential to reduce hospital stay.

Prevalence and Predictors of Immunological Failure among HIV Patients on HAART in Southern Ethiopia.

PubMed

Yirdaw, Kesetebirhan Delele; Hattingh, Susan

2015-01-01

Immunological monitoring is part of the standard of care for patients on antiretroviral treatment. Yet, little is known about the routine implementation of immunological laboratory monitoring and utilization in clinical care in Ethiopia. This study assessed the pattern of immunological monitoring, immunological response, level of immunological treatment failure and factors related to it among patients on antiretroviral therapy in selected hospitals in southern Ethiopia. A retrospective longitudinal analytic study was conducted using documents of patients started on antiretroviral therapy. Adequacy of timely immunological monitoring was assessed every six months the first year and every one year thereafter. Immunological response was assessed every six months at cohort level. Immunological failure was based on the criteria: fall of follow-up CD4 cell count to baseline (or below), or CD4 levels persisting below 100 cells/mm3, or 50% fall from on-treatment peak value. A total of 1,321 documents of patients reviewed revealed timely immunological monitoring were inadequate. There was adequate immunological response, with pediatric patients, females, those with less advanced illness (baseline WHO Stage I or II) and those with higher baseline CD4 cell count found to have better immunological recovery. Thirty-nine patients (3%) were not evaluated for immunological failure because they had frequent treatment interruption. Despite overall adequate immunological response at group level, the prevalence of those who ever experienced immunological failure was 17.6% (n=226), while after subsequent re-evaluation it dropped to 11.5% (n=147). Having WHO Stage III/IV of the disease or a higher CD4 cell count at baseline was identified as a risk for immunological failure. Few patients with confirmed failure were switched to second line therapy. These findings highlight the magnitude of the problem of immunological failure and the gap in management. Prioritizing care for high risk patients may help in effective utilization of meager resources.

Prevalence and Predictors of Immunological Failure among HIV Patients on HAART in Southern Ethiopia

PubMed Central

2015-01-01

Immunological monitoring is part of the standard of care for patients on antiretroviral treatment. Yet, little is known about the routine implementation of immunological laboratory monitoring and utilization in clinical care in Ethiopia. This study assessed the pattern of immunological monitoring, immunological response, level of immunological treatment failure and factors related to it among patients on antiretroviral therapy in selected hospitals in southern Ethiopia. A retrospective longitudinal analytic study was conducted using documents of patients started on antiretroviral therapy. Adequacy of timely immunological monitoring was assessed every six months the first year and every one year thereafter. Immunological response was assessed every six months at cohort level. Immunological failure was based on the criteria: fall of follow-up CD4 cell count to baseline (or below), or CD4 levels persisting below 100 cells/mm3, or 50% fall from on-treatment peak value. A total of 1,321 documents of patients reviewed revealed timely immunological monitoring were inadequate. There was adequate immunological response, with pediatric patients, females, those with less advanced illness (baseline WHO Stage I or II) and those with higher baseline CD4 cell count found to have better immunological recovery. Thirty-nine patients (3%) were not evaluated for immunological failure because they had frequent treatment interruption. Despite overall adequate immunological response at group level, the prevalence of those who ever experienced immunological failure was 17.6% (n=226), while after subsequent re-evaluation it dropped to 11.5% (n=147). Having WHO Stage III/IV of the disease or a higher CD4 cell count at baseline was identified as a risk for immunological failure. Few patients with confirmed failure were switched to second line therapy. These findings highlight the magnitude of the problem of immunological failure and the gap in management. Prioritizing care for high risk patients may help in effective utilization of meager resources. PMID:25961732

Evaluation of Kidney Donors: Core Curriculum 2018.

PubMed

Sawinski, Deirdre; Locke, Jayme E

2018-05-01

Nearly 100,000 patients are waiting for a kidney transplant, yet each year only 11,000 undergo transplantation with a deceased donor kidney. Annual death rates among waitlist registrants range from 5% to 15%; many die before receiving a transplant. Not surprisingly, registrants turn to family and friends to become living kidney donors on their behalf. Living kidney donor selection practices aim to quantify lifetime risk for kidney failure based on a candidate's predonation demographic and health characteristics. It has been established that estimated lifetime risk for kidney failure varies considerably based on predonation comorbid conditions, and as such, it is of paramount importance that potential living donor candidates undergo proper medical, surgical, and psychosocial screening before donation. This installment of AJKD's Core Curriculum in Nephrology provides readers with the tools necessary for proper evaluation of living kidney donor candidates. Copyright © 2017 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Association between bilirubin and mode of death in severe systolic heart failure.

PubMed

Wu, Audrey H; Levy, Wayne C; Welch, Kathleen B; Neuberg, Gerald W; O'Connor, Christopher M; Carson, Peter E; Miller, Alan B; Ghali, Jalal K

2013-04-15

The bilirubin level has been associated with worse outcomes, but it has not been studied as a predictor for the mode of death in patients with systolic heart failure. The Prospective Randomized Amlodipine Evaluation Study (PRAISE) cohort (including New York Heart Association class IIIB-IV patients with left ventricular ejection fraction <30%, n = 1,135) was analyzed, divided by bilirubin level: ≤0.6 mg/dl, group 1; >0.6 to 1.2 mg/dl, group 2; and >1.2 mg/dl, group 3. Multivariate Cox proportional hazards models were used to determine the association of bilirubin with the risk of sudden or pump failure death. Total bilirubin was entered as a base 2 log-transformed variable (log2 bilirubin), indicating doubling of the bilirubin level corresponding to each increase in variable value. The higher bilirubin groups had a lower ejection fraction (range 19% to 21%), sodium (range 138 to 139 mmol/L), and systolic blood pressure (range 111 to 120 mm Hg), a greater heart rate (range 79 to 81 beats/min), and greater diuretic dosages (range 86 to 110 furosemide-equivalent total daily dose in mg). The overall survival rates declined with increasing bilirubin (24.3, 31.3, and 44.3 deaths per 100 person-years, respectively, for groups 1, 2, and 3). Although a positive relation was seen between log2 bilirubin and both pump failure risk and sudden death risk, the relation in multivariate modeling was significant only for pump failure mortality (hazard ratio 1.47, 95% confidence interval 1.19 to 1.82, p = 0.0004), not for sudden death mortality (hazard ratio 1.21, 95% confidence interval 0.98 to 1.49, p = 0.08). In conclusion, an increasing bilirubin level was significantly associated with the risk of pump failure death but not for sudden death in patients with severe systolic heart failure. Copyright © 2013 Elsevier Inc. All rights reserved.

Urinary sodium excretion and kidney failure in non-diabetic chronic kidney disease

PubMed Central

Fan, Li; Tighiouart, Hocine; Levey, Andrew S.; Beck, Gerald J.; Sarnak, Mark J.

2014-01-01

Current guidelines recommend under 2g/day sodium intake in chronic kidney disease, but there are few studies relating sodium intake to long-term outcomes. Here we evaluated the association of mean baseline 24-hour urinary sodium excretion with kidney failure and a composite outcome of kidney failure or all-cause mortality using Cox regression in 840 participants enrolled in the Modification of Diet in Renal Disease Study. Mean 24-hour urinary sodium excretion was 3.46 g/day. Kidney failure developed in 617 and the composite outcome was reached in 723. In the primary analyses there was no association between 24-hour urine sodium and kidney failure [HR 0.99 (95% CI 0.91–1.08)] nor on the composite outcome [HR 1.01 (95% CI 0.93–1.09),] each per 1g/day higher urine sodium. In exploratory analyses there was a significant interaction of baseline proteinuria and sodium excretion with kidney failure. Using a 2-slope model, when urine sodium was under 3g/day, higher urine sodium was associated with increased risk of kidney failure in those with baseline proteinuria under 1g/day, and lower risk of kidney failure in those with baseline proteinuria of 1g/day or more. There was no association between urine sodium and kidney failure when urine sodium was 3g/day or more. Results were consistent using first baseline and time-dependent urine sodium. Thus, we noted no association of urine sodium with kidney failure. Results of the exploratory analyses need to be verified in additional studies and the mechanism explored. PMID:24646858

Computational hydraulics of a cascade of experimental-scale landside dam failures

NASA Astrophysics Data System (ADS)

Wright, N.; Guan, M.

2015-12-01

Abstract: Landslide dams typically comprise unconsolidated and poorly sorted material, and are vulnerable to rapid failure and breaching, particularly in mountainous areas during high intense rainfalls. A large flash flood with high-concentrated sediment can be formed in a short period, and the magnitude is likely to be amplified along the flow direction due to the inclusion of a large amount of sediment. This can result in significant and sudden flood risk downstream for human life and property. Numerous field evidence has indicated the various risks of landslide dam failures. In general, cascading landslide dams can be formed along the sloping channel due to the randomness and unpredictability of landslides, which complexes the hydraulics of landslide dam failures. The failure process of a single dam and subsequent floods has attracted attention in multidisciplinary studies. However, the dynamic failure process of cascading landslide dams has been poorly understood. From a viewpoint of simulation, this study evaluates the formation and development of rapid sediment-charged floods due to cascading failure of landslide dams through detailed hydro-morphodynamic modelling. The model used is based on shallow water theory and it has been successful in predicting the flow and morphological process during sudden dam-break, as well as full and partial dyke-breach. Various experimental-scale scenarios are modelled, including: (1) failure of a single full dam in a sloping channel, (2) failure of two dams in a sloping channel, (3) failure of multiple landslide dams (four) in a sloping channel. For each scenario, different failure modes (sudden/gradual) and bed boundary (fixed /mobile) are assumed and simulated. The study systematically explores the tempo-spatial evolution of landslide-induced floods (discharge, flow velocity, and flow concentration) and geomorphic properties along the sloping channel. The effects of in-channel erosion and flow-driven sediment from dams on the development of flood process are investigated. The results improve the understanding of the formation and development mechanism of flash floods due to cascading landslide dam failures. The findings are beneficial for downstream flood risk assessment and developing control strategies for landslide-induced floods.

Biomechanical evaluation of the risk of secondary fracture around short versus long cephalomedullary nails.

PubMed

Daner, William E; Owen, John R; Wayne, Jennifer S; Graves, Ryan B; Willis, Mark C

2017-12-01

For proximal femur fractures, long cephalomedullary nails (CMNs) are often selected to avoid a diaphyseal stress riser at the tip of a shorter nail. Secondary peri-implant fracture rates for long and short CMN have not been shown to differ clinically. This study biomechanically compares both CMN in a cadaveric model. Ten matched pairs of cadaveric femora with short or long CMN were axially loaded and internally rotated to failure. Resulting fractures involved distal interlocking screws of the short and long CMN. Energy and rotation to failure were significantly greater for short CMN. Torque at failure trended higher for short CMN but not significantly. No statistical difference was detected in stiffness of the short and long CMN. A greater risk of secondary fracture is not indicated for short versus long CMN under torsional stress. Short CMN may be suitable in the younger patient.

Reliability and availability analysis of a 10 kW@20 K helium refrigerator

NASA Astrophysics Data System (ADS)

Li, J.; Xiong, L. Y.; Liu, L. Q.; Wang, H. R.; Wang, B. M.

2017-02-01

A 10 kW@20 K helium refrigerator has been established in the Technical Institute of Physics and Chemistry, Chinese Academy of Sciences. To evaluate and improve this refrigerator’s reliability and availability, a reliability and availability analysis is performed. According to the mission profile of this refrigerator, a functional analysis is performed. The failure data of the refrigerator components are collected and failure rate distributions are fitted by software Weibull++ V10.0. A Failure Modes, Effects & Criticality Analysis (FMECA) is performed and the critical components with higher risks are pointed out. Software BlockSim V9.0 is used to calculate the reliability and the availability of this refrigerator. The result indicates that compressors, turbine and vacuum pump are the critical components and the key units of this refrigerator. The mitigation actions with respect to design, testing, maintenance and operation are proposed to decrease those major and medium risks.

Familial Risks of Kidney Failure in Sweden: A Nationwide Family Study

PubMed Central

Akrawi, Delshad Saleh; Li, Xinjun; Sundquist, Jan; Sundquist, Kristina; Zöller, Bengt

2014-01-01

Background The value of family history as a risk factor for kidney failure has not been determined in a nationwide setting. Aim This nationwide family study aimed to determine familial risks for kidney failure in Sweden. Methods The Swedish multi-generation register on 0–78-year-old subjects were linked to the Swedish patient register and the Cause of death register for 1987–2010. Individuals diagnosed with acute kidney failure (n = 10063), chronic kidney failure (n = 18668), or unspecified kidney failure (n = 3731) were included. Kidney failure patients with cystic kidney disease, congenital kidney and urinary tract malformations, urolithiasis, and rare inherited kidney syndromes, and hyperoxaluria were excluded. Standardized incidence ratios (SIRs) were calculated for individuals whose parents/siblings were diagnosed with kidney failure compared to those whose parents or siblings were not. Results The concordant (same disease) familial risks (sibling/parent history) were increased for chronic kidney failure SIR = 2.02 (95% confidence interval, CI 1.90–2.14) but not for acute kidney failure SIR = 1.08 (95% CI 0.94–1.22) and for unspecified kidney failure SIR = 1.25 (95% CI 0.94–1.63). However, the discordant (different disease) familial risk for acute kidney failure SIR = 1.19 (95% CI 1.06–1.32) and unspecified kidney failure SIR = 1.63 (95% CI 1.40–1.90) was significantly increased in individuals with a family history of chronic kidney failure. The familial risk for chronic kidney failure was similar for males SIR = 2.04 (95% CI 1.90–2.20) and females SIR = 1.97 (95% CI 1.78–2.17). Familial risks for chronic kidney failure were highest at age of 10–19 years SIR = 6.33 (95% CI 4.16–9.22). Conclusions The present study shows that family history is an important risk factor for chronic kidney failure but to a lower degree for acute kidney failure and unspecified kidney failure. PMID:25423475

A case study of a real-time evaluation of the risk of disease transmission associated with a failure to follow recommended sterilization procedures

PubMed Central

2014-01-01

Background Failures to follow recommendations for reprocessing of surgical instruments may place patients at risk for exposure to pathogenic microorganisms. When such failures occur, medical facilities often face considerable uncertainty and challenges in assessing the actual risks of disease transmission. Methods In 2011, staff at an Ohio hospital determined that surgical instruments inside a Steriset Container had inadvertently been autoclaved on a gravity cycle rather than on the recommended pre-vacuum cycle, potentially exposing 72 patients who underwent surgery with the instruments to risk of infection. To provide an assessment of the level of risk, we tested the effectiveness of the machine washer/disinfector step and of the sterilization process inside the Steriset Container on the gravity cycle for killing of Geobacillus stearothermophilus spores, Clostridium difficile spores, and methicillin-resistant Staphylococcus aureus (MRSA). Based on the test results, the risk of transmission of MRSA by the instruments was calculated and the risk of transmission of hepatitis B virus was estimated. Results The machine washer/disinfector consistently reduced MRSA recovery by a factor of 1:100,000. The sterilization process inside the Steriset Container consistently reduced MRSA concentrations by a factor of >1:10,000,000 and killed 105C. difficile spores and 105G. stearothermophilus spores. The risk of MRSA transmission due to the incident was calculated to be 1 in 100 trillion. Conclusions The risk for transmission of infection due to the failure to follow recommended sterilization processes was negligible based upon complete killing of G. stearothermophilus biological indicator spores, C. difficile spores, and MRSA under conditions that replicated the incident where proper procedures were not followed. Such real-time assessments of the risks associated with specific incidents may provide evidence-based information that can be used to inform decisions regarding disclosure of the incident to patients. PMID:24447336

A case study of a real-time evaluation of the risk of disease transmission associated with a failure to follow recommended sterilization procedures.

PubMed

Donskey, Curtis J; Yowler, Marian; Falck-Ytter, Yngve; Kundrapu, Sirisha; Salata, Robert A; Rutala, William A

2014-01-21

Failures to follow recommendations for reprocessing of surgical instruments may place patients at risk for exposure to pathogenic microorganisms. When such failures occur, medical facilities often face considerable uncertainty and challenges in assessing the actual risks of disease transmission. In 2011, staff at an Ohio hospital determined that surgical instruments inside a Steriset Container had inadvertently been autoclaved on a gravity cycle rather than on the recommended pre-vacuum cycle, potentially exposing 72 patients who underwent surgery with the instruments to risk of infection. To provide an assessment of the level of risk, we tested the effectiveness of the machine washer/disinfector step and of the sterilization process inside the Steriset Container on the gravity cycle for killing of Geobacillus stearothermophilus spores, Clostridium difficile spores, and methicillin-resistant Staphylococcus aureus (MRSA). Based on the test results, the risk of transmission of MRSA by the instruments was calculated and the risk of transmission of hepatitis B virus was estimated. The machine washer/disinfector consistently reduced MRSA recovery by a factor of 1:100,000. The sterilization process inside the Steriset Container consistently reduced MRSA concentrations by a factor of >1:10,000,000 and killed 105C. difficile spores and 105G. stearothermophilus spores. The risk of MRSA transmission due to the incident was calculated to be 1 in 100 trillion. The risk for transmission of infection due to the failure to follow recommended sterilization processes was negligible based upon complete killing of G. stearothermophilus biological indicator spores, C. difficile spores, and MRSA under conditions that replicated the incident where proper procedures were not followed. Such real-time assessments of the risks associated with specific incidents may provide evidence-based information that can be used to inform decisions regarding disclosure of the incident to patients.

Automated identification and predictive tools to help identify high-risk heart failure patients: pilot evaluation.

PubMed

Evans, R Scott; Benuzillo, Jose; Horne, Benjamin D; Lloyd, James F; Bradshaw, Alejandra; Budge, Deborah; Rasmusson, Kismet D; Roberts, Colleen; Buckway, Jason; Geer, Norma; Garrett, Teresa; Lappé, Donald L

2016-09-01

Develop and evaluate an automated identification and predictive risk report for hospitalized heart failure (HF) patients. Dictated free-text reports from the previous 24 h were analyzed each day with natural language processing (NLP), to help improve the early identification of hospitalized patients with HF. A second application that uses an Intermountain Healthcare-developed predictive score to determine each HF patient's risk for 30-day hospital readmission and 30-day mortality was also developed. That information was included in an identification and predictive risk report, which was evaluated at a 354-bed hospital that treats high-risk HF patients. The addition of NLP-identified HF patients increased the identification score's sensitivity from 82.6% to 95.3% and its specificity from 82.7% to 97.5%, and the model's positive predictive value is 97.45%. Daily multidisciplinary discharge planning meetings are now based on the information provided by the HF identification and predictive report, and clinician's review of potential HF admissions takes less time compared to the previously used manual methodology (10 vs 40 min). An evaluation of the use of the HF predictive report identified a significant reduction in 30-day mortality and a significant increase in patient discharges to home care instead of to a specialized nursing facility. Using clinical decision support to help identify HF patients and automatically calculating their 30-day all-cause readmission and 30-day mortality risks, coupled with a multidisciplinary care process pathway, was found to be an effective process to improve HF patient identification, significantly reduce 30-day mortality, and significantly increase patient discharges to home care. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Associations of Conventional Echocardiographic Measures with Incident Heart Failure and Mortality: The Chronic Renal Insufficiency Cohort.

PubMed

Dubin, Ruth F; Deo, Rajat; Bansal, Nisha; Anderson, Amanda H; Yang, Peter; Go, Alan S; Keane, Martin; Townsend, Ray; Porter, Anna; Budoff, Matthew; Malik, Shaista; He, Jiang; Rahman, Mahboob; Wright, Jackson; Cappola, Thomas; Kallem, Radhakrishna; Roy, Jason; Sha, Daohang; Shlipak, Michael G

2017-01-06

Heart failure is the most frequent cardiac complication of CKD. Left ventricular hypertrophy is common and develops early in CKD, but studies have not adequately evaluated the association of left ventricular mass index with heart failure incidence among men and women with CKD. We evaluated echocardiograms of 2567 participants without self-reported heart failure enrolled in the Chronic Renal Insufficiency Cohort Study. Two-dimensional echocardiograms were performed at the year 1 study visit and interpreted at a central core laboratory. Left ventricular mass index was calculated using the linear method, indexed to height 2.7 , and analyzed using sex-specific quartiles. The primary outcomes of incident heart failure and all-cause mortality were adjudicated over a median of 6.6 (interquartile range, 5.7-7.6) years. Among 2567 participants, 45% were women, and 54% were nonwhite race; mean (SD) age was 59±11 years old, and mean eGFR was 44±17 ml/min per 1.73 m 2 . During a median follow-up period of 6.6 years, 262 participants developed heart failure, and 470 participants died. Compared with participants in the first quartile of left ventricular mass index, those in the highest quartile had higher rates of incident heart failure (hazard ratio, 3.96; 95% confidence interval, 1.96 to 8.02) and mortality (hazard ratio, 1.86; 95% confidence interval, 1.22 to 2.85), even after adjustment for B-type natriuretic peptide, troponin T, mineral metabolism markers, and other cardiovascular disease risk factors. Those in the lowest quartile of ejection fraction had higher rates of incident heart failure (hazard ratio, 3.01; 95% confidence interval, 1.94 to 4.67) but similar mortality rates (hazard ratio, 1.18; 95% confidence interval, 0.89 to 1.57) compared with those in the highest quartile. Diastolic dysfunction was not significantly associated with heart failure or death. Among persons with CKD and without history of cardiovascular disease, left ventricular mass index is strongly associated with incident heart failure, even after adjustment for major cardiovascular risk factors and biomarkers. Copyright © 2016 by the American Society of Nephrology.

Associations of Conventional Echocardiographic Measures with Incident Heart Failure and Mortality: The Chronic Renal Insufficiency Cohort

PubMed Central

Deo, Rajat; Bansal, Nisha; Anderson, Amanda H.; Yang, Peter; Go, Alan S.; Keane, Martin; Townsend, Ray; Porter, Anna; Budoff, Matthew; Malik, Shaista; He, Jiang; Rahman, Mahboob; Wright, Jackson; Cappola, Thomas; Kallem, Radhakrishna; Roy, Jason; Sha, Daohang; Shlipak, Michael G.

2017-01-01

Background and objectives Heart failure is the most frequent cardiac complication of CKD. Left ventricular hypertrophy is common and develops early in CKD, but studies have not adequately evaluated the association of left ventricular mass index with heart failure incidence among men and women with CKD. Design, setting, participants, & measurements We evaluated echocardiograms of 2567 participants without self–reported heart failure enrolled in the Chronic Renal Insufficiency Cohort Study. Two-dimensional echocardiograms were performed at the year 1 study visit and interpreted at a central core laboratory. Left ventricular mass index was calculated using the linear method, indexed to height2.7, and analyzed using sex-specific quartiles. The primary outcomes of incident heart failure and all-cause mortality were adjudicated over a median of 6.6 (interquartile range, 5.7–7.6) years. Results Among 2567 participants, 45% were women, and 54% were nonwhite race; mean (SD) age was 59±11 years old, and mean eGFR was 44±17 ml/min per 1.73 m2. During a median follow-up period of 6.6 years, 262 participants developed heart failure, and 470 participants died. Compared with participants in the first quartile of left ventricular mass index, those in the highest quartile had higher rates of incident heart failure (hazard ratio, 3.96; 95% confidence interval, 1.96 to 8.02) and mortality (hazard ratio, 1.86; 95% confidence interval, 1.22 to 2.85), even after adjustment for B–type natriuretic peptide, troponin T, mineral metabolism markers, and other cardiovascular disease risk factors. Those in the lowest quartile of ejection fraction had higher rates of incident heart failure (hazard ratio, 3.01; 95% confidence interval, 1.94 to 4.67) but similar mortality rates (hazard ratio, 1.18; 95% confidence interval, 0.89 to 1.57) compared with those in the highest quartile. Diastolic dysfunction was not significantly associated with heart failure or death. Conclusions Among persons with CKD and without history of cardiovascular disease, left ventricular mass index is strongly associated with incident heart failure, even after adjustment for major cardiovascular risk factors and biomarkers. PMID:28062676

Neurodevelopmental and Cognitive Outcomes in Children With Intestinal Failure.

PubMed

Chesley, Patrick M; Sanchez, Sabrina E; Melzer, Lilah; Oron, Assaf P; Horslen, Simon P; Bennett, F Curt; Javid, Patrick J

2016-07-01

Recent advances in medical and surgical management have led to improved long-term survival in children with intestinal failure. Yet, limited data exist on their neurodevelopmental and cognitive outcomes. The aim of the present study was to measure neurodevelopmental outcomes in children with intestinal failure. Children enrolled in a regional intestinal failure program underwent prospective neurodevelopmental and psychometric evaluation using a validated scoring tool. Cognitive impairment was defined as a mental developmental index <70. Neurodevelopmental impairment was defined as cerebral palsy, visual or hearing impairment, or cognitive impairment. Univariate analyses were performed using the Wilcoxon rank-sum test. Data are presented as median (range). Fifteen children with a remnant bowel length of 18 (5-85) cm were studied at age 17 (12-67) months. Thirteen patients remained dependent on parenteral nutrition. Twelve (80%) subjects scored within the normal range on cognitive testing. Each child with cognitive impairment was noted to have additional risk factors independent of intestinal failure including cardiac arrest and extreme prematurity. On univariate analysis, cognitive impairment was associated with longer inpatient hospital stays, increased number of surgical procedures, and prematurity (P < 0.02). In total, 4 (27%) children demonstrated findings consistent with neurodevelopmental impairment. A majority of children with intestinal failure demonstrated normal neurodevelopmental and cognitive outcomes on psychometric testing. These data suggest that children with intestinal failure without significant comorbidity may be at low risk for long-term neurodevelopmental impairment.

Application and Evaluation of Control Modes for Risk-Based Engine Performance Enhancements

NASA Technical Reports Server (NTRS)

Liu, Yuan; Litt, Jonathan S.; Sowers, T. Shane; Owen, A. Karl (Compiler); Guo, Ten-Huei

2014-01-01

The engine control system for civil transport aircraft imposes operational limits on the propulsion system to ensure compliance with safety standards. However, during certain emergency situations, aircraft survivability may benefit from engine performance beyond its normal limits despite the increased risk of failure. Accordingly, control modes were developed to improve the maximum thrust output and responsiveness of a generic high-bypass turbofan engine. The algorithms were designed such that the enhanced performance would always constitute an elevation in failure risk to a consistent predefined likelihood. This paper presents an application of these risk-based control modes to a combined engine/aircraft model. Through computer and piloted simulation tests, the aim is to present a notional implementation of these modes, evaluate their effects on a generic airframe, and demonstrate their usefulness during emergency flight situations. Results show that minimal control effort is required to compensate for the changes in flight dynamics due to control mode activation. The benefits gained from enhanced engine performance for various runway incursion scenarios are investigated. Finally, the control modes are shown to protect against potential instabilities during propulsion-only flight where all aircraft control surfaces are inoperable.

Application and Evaluation of Control Modes for Risk-Based Engine Performance Enhancements

NASA Technical Reports Server (NTRS)

Liu, Yuan; Litt, Jonathan S.; Sowers, T. Shane; Owen, A. Karl; Guo, Ten-Huei

2015-01-01

The engine control system for civil transport aircraft imposes operational limits on the propulsion system to ensure compliance with safety standards. However, during certain emergency situations, aircraft survivability may benefit from engine performance beyond its normal limits despite the increased risk of failure. Accordingly, control modes were developed to improve the maximum thrust output and responsiveness of a generic high-bypass turbofan engine. The algorithms were designed such that the enhanced performance would always constitute an elevation in failure risk to a consistent predefined likelihood. This paper presents an application of these risk-based control modes to a combined engine/aircraft model. Through computer and piloted simulation tests, the aim is to present a notional implementation of these modes, evaluate their effects on a generic airframe, and demonstrate their usefulness during emergency flight situations. Results show that minimal control effort is required to compensate for the changes in flight dynamics due to control mode activation. The benefits gained from enhanced engine performance for various runway incursion scenarios are investigated. Finally, the control modes are shown to protect against potential instabilities during propulsion-only flight where all aircraft control surfaces are inoperable.

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

Daling, P.M.; Marler, J.E.; Vo, T.V.

This study evaluates the values (benefits) and impacts (costs) associated with potential resolutions to Generic Issue 143, ``Availability of HVAC and Chilled Water Systems.`` The study identifies vulnerabilities related to failures of HVAC, chilled water, and room cooling systems; develops estimates of room heatup rates and safety-related equipment vulnerabilities following losses of HVAC/room cooler systems; develops estimates of the core damage frequencies and public risks associated with failures of these systems; develops three proposed resolution strategies to this generic issue; and performs a value/impact analysis of the proposed resolutions. Existing probabilistic risk assessments for four representative plants, including one plantmore » from each vendor, form the basis for the core damage frequency and public risk calculations. Both internal and external events were considered. It was concluded that all three proposed resolution strategies exceed the $1,000/person-rem cost-effectiveness ratio. Additional evaluations were performed to develop ``generic`` insights on potential design-related and configuration-related vulnerabilities and potential high-frequency ({approximately}1E-04/RY) accident sequences that involve failures of HVAC/room cooling functions. It was concluded that, although high-frequency accident sequences may exist at some plants, these high-frequency sequences are plant-specific in nature or have been resolved through hardware and/or operational changes. The plant-specific Individual Plant Examinations are an effective vehicle for identification and resolution of these plant-specific anomalies and hardware configurations.« less

Risk Based Reliability Centered Maintenance of DOD Fire Protection Systems

DTIC Science & Technology

1999-01-01

2.2.3 Failure Mode and Effect Analysis ( FMEA )............................ 2.2.4 Failure Mode Risk Characterization...Step 2 - System functions and functional failures definition Step 3 - Failure mode and effect analysis ( FMEA ) Step 4 - Failure mode risk...system). The Interface Location column identifies the location where the FMEA of the fire protection system began or stopped. For example, for the fire

No post-no core approach to restore severely damaged posterior teeth: An up to 10-year retrospective study of documented endocrown cases.

PubMed

Belleflamme, Marcia M; Geerts, Sabine O; Louwette, Marie M; Grenade, Charlotte F; Vanheusden, Alain J; Mainjot, Amélie K

2017-08-01

The objectives of the present study were to (1) retrospectively evaluate documented cases of ceramic and composite endocrowns performed using immediate dentin sealing (IDS); (2) correlate failures with clinical parameters such as tooth preparation characteristics and occlusal parameters. 99 documented cases of endocrowns were evaluated after a mean observation period of 44.7±34.6months. A classification of restorations was established in function of the level of damage of residual tooth tissues after preparation, from 1 to 3. Evaluation was performed according to FDI criteria and endodontic outcomes were analyzed. Occlusal risk factors were examined and fractographic analysis was performed in case of fracture. 48.4% of patients were shown to present occlusal risk factors. 75.8% of restorations were Class 3 endocrowns. 56.6% were performed on molars, 41.4% on premolars and 2.0% on canines. 84.8% were performed in lithium-disilicate glass-ceramic and 12.1% in Polymer-Infiltrated Ceramic Network (PICN) material. The survival and success rates of endocrowns were 99.0% and 89.9% respectively, while the 10-year Kaplan-Meier estimated survival and success rates were 98.8% and 54.9% respectively. Ten failures were detected: periodontal disease (n=3), endocrown debonding (n=2), minor chipping (n=2), caries recurrence (n=2) and major fractures (n=1). Due to the reduced amount of failures, no statistical correlation could be established with clinical parameters. Endocrowns were shown to constitute a reliable approach to restore severely damaged molars and premolars, even in the presence of extensive coronal tissue loss or occlusal risk factors, such as bruxism or unfavorable occlusal relationships. Practitioners should consider the endocrown instead of the post and core approach to restore severely damaged non-vital posterior teeth. This minimally invasive solution reduces the risk of catastrophic failures and is easily performed. The use of IDS procedure and lithium-disilicate glass-ceramic as prosthesis material gave very good results. Copyright © 2017 Elsevier Ltd. All rights reserved.

Acute Rejection Increases Risk of Graft Failure and Death in Recent Liver Transplant Recipients.

PubMed

Levitsky, Josh; Goldberg, David; Smith, Abigail R; Mansfield, Sarah A; Gillespie, Brenda W; Merion, Robert M; Lok, Anna S F; Levy, Gary; Kulik, Laura; Abecassis, Michael; Shaked, Abraham

2017-04-01

Acute rejection is detrimental to most transplanted solid organs, but is considered to be less of a consequence for transplanted livers. We evaluated risk factors for and outcomes after biopsy-proven acute rejection (BPAR) based on an analysis of a more recent national sample of recipients of liver transplants from living and deceased donors. We analyzed data from the Adult-to-Adult Living Donor Liver Transplantation Cohort Study (A2ALL) from 2003 through 2014 as the exploratory cohort and the Scientific Registry of Transplant Recipients (SRTR) from 2005 through 2013 as the validation cohort. We examined factors associated with time to first BPAR using multivariable Cox regression or discrete-survival analysis. Competing risks methods were used to compare causes of death and graft failure between recipients of living and deceased donors. At least 1 BPAR episode occurred in 239 of 890 recipients in A2ALL (26.9%) and 7066 of 45,423 recipients in SRTR (15.6%). In each database, risk of rejection was significantly lower when livers came from biologically related living donors (A2ALL hazard ratio [HR], 0.57; 95% confidence interval [CI], 0.43-0.76; and SRTR HR, 0.78; 95% CI, 0.66-0.91) and higher in liver transplant recipients with primary biliary cirrhosis, of younger age, or with hepatitis C. In each database, BPAR was associated with significantly higher risks of graft failure and death. The risks were highest in the 12 month post-BPAR period in patients whose first episode occurred more than 1 year after liver transplantation: HRs for graft failure were 6.79 in A2ALL (95% CI, 2.64-17.45) and 4.41 in SRTR (95% CI, 3.71-5.23); HRs for death were 8.81 in A2ALL (95% CI, 3.37-23.04) and 3.94 in SRTR (95% CI, 3.22-4.83). In analyses of cause-specific mortality, associations were observed for liver-related (graft failure) causes of death but not for other causes. Contrary to previous data, acute rejection after liver transplant is associated with significantly increased risk of graft failure, all-cause mortality, and graft failure-related death, regardless of primary liver disease etiology. Living donor liver transplantation from a biologically related donor is associated with decreased risk of rejection. Copyright © 2017 AGA Institute. Published by Elsevier Inc. All rights reserved.

Does neighborhood deprivation modify the effect of preterm birth on children's first grade academic performance?

PubMed

Richards, Jennifer L; Chapple-McGruder, Theresa; Williams, Bryan L; Kramer, Michael R

2015-05-01

Children's cognitive development and academic performance are linked to both fetal and early childhood factors, including preterm birth and family socioeconomic status. We evaluated whether the relationship between preterm birth (PTB) and first grade standardized test performance among Georgia public school students was modified by neighborhood deprivation in early childhood. The Georgia Birth to School cohort followed 327,698 children born in Georgia from 1998 to 2002 through to end-of-year first grade standardized tests. Binomial and log-binomial generalized estimating equations were used to estimate risk differences and risk ratios for the associations of both PTB and the Neighborhood Deprivation Index for the census tract in which each child's mother resided at the time of birth with test failure (versus passing). The presence of additive and multiplicative interaction was assessed. PTB was strongly associated with test failure, with increasing risk for earlier gestational ages. There was positive additive interaction between PTB and neighborhood deprivation. The main effect of PTB versus term birth increased risk of mathematics failure: 15.9% (95%CI: 13.3-18.5%) for early, 5.0% (95% CI: 4.1-5.9%) for moderate, and 1.3% (95%CI: 0.9-1.7%) for late preterm. Each 1 standard deviation increase in neighborhood deprivation was associated with 0.6% increased risk of mathematics failure. For children exposed to both PTB and higher neighborhood deprivation, test failure was 4.8%, 1.5%, and 0.8% greater than the sum of two main effects for early, moderate, and late PTB, respectively. Results were similar, but slightly attenuated, for reading and English/language arts. Our results suggest that PTB and neighborhood deprivation additively interact to produce greater risk among doubly exposed children than would be predicted from the sum of the effects of the two exposures. Understanding socioeconomic disparities in the effect of PTB on academic outcomes at school entry is important for targeting of early childhood interventions. Copyright © 2015 Elsevier Ltd. All rights reserved.

Association of helicobacter pylori dupA with the failure of primary eradication.

PubMed

Shiota, Seiji; Nguyen, Lam Tung; Murakami, Kazunari; Kuroda, Akiko; Mizukami, Kazuhiro; Okimoto, Tadayoshi; Kodama, Masaaki; Fujioka, Toshio; Yamaoka, Yoshio

2012-04-01

To determine whether the presence of dupA Helicobacter pylori (H. pylori) influences the cure rate of primary eradication therapy. Several virulence factors of H. pylori have been reported to affect the efficacy of the eradication rate. However, no study has investigated whether the presence of dupA affects eradication failure. The presence of dupA was evaluated in 142 H. pylori strains isolated from 142 patients with gastrointestinal diseases. Of these patients, 104 received primary eradication therapy for 1 week. The risk factors for eradication failure were determined using univariate and multivariate analyses. Among 142 strains, 44 (31.0%) were dupA positive. There was no association between dupA status and gastroduodenal diseases (P>0.05). The clarithromycin (CLR) resistance rate was generally lower in the dupA-positive than in the dupA-negative group (20.4% vs. 35.7%, P=0.06). However, dupA prevalence was higher in the eradication failure group than in the success group (36.3% vs. 21.9%). Among the CLR-resistant H. pylori infected group, the successful eradication rate was significantly lower in patients infected with dupA-positive H. pylori than dupA-negative H. pylori (P=0.04). In multivariate analysis adjusted for age, sex, and type of disease, not only CLR resistance but also dupA presence was independent risk factors for eradication failure (adjusted odds ratio=3.71; 95% confidence interval,1.07-12.83). Although CLR resistant was more reliable predictor, the presence of dupA may also be an independent risk factor for eradication failure.

Association of Helicobacter pylori dupA with the failure of primary eradication

PubMed Central

Shiota, Seiji; Nguyen, Lam Tung; Murakami, Kazunari; Kuroda, Akiko; Mizukami, Kazuhiro; Okimoto, Tadayoshi; Kodama, Masaaki; Fujioka, Toshio; Yamaoka, Yoshio

2012-01-01

Goals To determine whether the presence of dupA Helicobacter pylori (H. pylori) influences the cure rate of primary eradication therapy. Background Several virulence factors of H. pylori have been reported to affect the efficacy of the eradication rate. However, no study has investigated whether the presence of dupA affects eradication failure. Study The presence of dupA was evaluated in 142 H. pylori strains isolated from 142 patients with gastrointestinal diseases. Of these patients, 104 received primary eradication therapy for 1 week. The risk factors for eradication failure were determined using univariate and multivariate analyses. Results Among 142 strains, 44 (31.0%) were dupA-positive. There was no association between dupA status and gastroduodenal diseases (P > 0.05). The clarithromycin (CLR) resistance rate was generally lower in the dupA-positive than in the dupA-negative group (20.4 vs. 35.7%, P = 0.06). However, dupA prevalence was higher in the eradication failure group than in the success group (36.3 vs. 21.9%). Among the CLR-resistant H. pylori infected group, the successful eradication rate was significantly lower in patients infected with dupA-positive H. pylori than -negative H. pylori (P = 0.04). In multivariate analysis adjusted for age, gender, and type of disease, not only CLR resistance but also dupA presence was independent risk factors for eradication failure (adjusted odds ratio = 3.71, 95% confidence interval = 1.07–12.83). Conclusions Although CLR resistant was more reliable predictor, the presence of dupA may also be an independent risk factor for eradication failure. PMID:22298090

OHI--Randomized Control Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Custom AFO

ClinicalTrials.gov

2018-05-25

Accidental Falls; Fall Due to Loss of Equilibrium; High Risk of Falls Due to Mobility Limitation; Diabetes; Arthritis; Cancer; Peripheral Arterial Disease; Parkinson's Disease; End Stage Renal Failure on Dialysis

[Outcome of living kidney donors for transplantation].

PubMed

Lanot, Antoine; Bouvier, Nicolas; Chatelet, Valérie; Lecouf, Angélique; Tillou, Xavier; Hurault de Ligny, Bruno

2017-11-01

Nowadays, several treatments exist to treat terminal chronic renal failure. Best results for the recipients are obtained with kidney transplantation concerning mortality and quality of life. Transplantation is also the cheaper option for society. Living kidney donation raises the issue of the becoming of the donor, an absolutely healthy subject who gets to a surgical procedure. The becoming of living kidney donors has been compared with the one of controls subjects in several studies. The evaluations focused on the complications of nephrectomy in the short and long-term: kidney failure, hypertension, proteinuria, possibility of pregnancy, quality of life, and mortality. The first results did not show any risk linked to kidney donation, compared to general population. However, since 2013, kidney donors were found at higher risk for kidney failure and even for mortality, compared with controls selected like donor candidates. The risk of kidney donation is nevertheless acceptable and minimal, on the condition of rigorous selection of candidates and regular follow-up. Copyright © 2017 Société francophone de néphrologie, dialyse et transplantation. Published by Elsevier Masson SAS. All rights reserved.

Pioglitazone and the risk of cardiovascular events in patients with Type 2 diabetes receiving concomitant treatment with nitrates, renin-angiotensin system blockers, or insulin: results from the PROactive study (PROactive 20).

PubMed

Erdmann, Erland; Spanheimer, Robert; Charbonnel, Bernard

2010-09-01

Patients with Type 2 diabetes mellitus (T2DM) are often treated with multiple glucose-lowering and cardiovascular agents. The concomitant use of nitrates, renin-angiotensin system (RAS) blockers, or insulin has been linked to a potential increase in myocardial ischemic risk with rosiglitazone. The PROactive database provides an opportunity to investigate the effects of these medications on the potential macrovascular benefits reported with pioglitazone. The PROactive study was a randomized double-blind prospective trial that evaluated mortality and cardiovascular morbidity in 5238 patients with T2DM and macrovascular disease. Patients received pioglitazone or placebo in addition to their baseline glucose-lowering and cardiovascular medications. The effect of pioglitazone on composite endpoints was evaluated, including all-cause death, myocardial infarction (MI), and stroke, as well as safety events of edema and serious heart failure, in subgroups using nitrates, RAS blockers, or insulin at baseline. The risk of all-cause death, MI, and stroke for pioglitazone versus placebo was similar regardless of the baseline use of nitrates, RAS blockers, or insulin, with hazard ratios ranging from 0.81 to 0.87. Similar results were obtained for the other composite endpoints analyzed. There were no significant interactions between baseline medication subgroups and treatment. The increased risk of edema and serious heart failure was consistent across the baseline medication subgroups. This post hoc analysis did not reveal an increased risk of macrovascular events with pioglitazone in patients receiving nitrates, RAS blockers, or insulin. Rather, all patients realized the same trend towards benefit with pioglitazone, and adverse events of edema and heart failure were predictable. © 2010 Ruijin Hospital, Shanghai Jiaotong University School of Medicine and Blackwell Publishing Asia Pty Ltd.

Failure mode and effects analysis: a comparison of two common risk prioritisation methods.

PubMed

McElroy, Lisa M; Khorzad, Rebeca; Nannicelli, Anna P; Brown, Alexandra R; Ladner, Daniela P; Holl, Jane L

2016-05-01

Failure mode and effects analysis (FMEA) is a method of risk assessment increasingly used in healthcare over the past decade. The traditional method, however, can require substantial time and training resources. The goal of this study is to compare a simplified scoring method with the traditional scoring method to determine the degree of congruence in identifying high-risk failures. An FMEA of the operating room (OR) to intensive care unit (ICU) handoff was conducted. Failures were scored and ranked using both the traditional risk priority number (RPN) and criticality-based method, and a simplified method, which designates failures as 'high', 'medium' or 'low' risk. The degree of congruence was determined by first identifying those failures determined to be critical by the traditional method (RPN≥300), and then calculating the per cent congruence with those failures designated critical by the simplified methods (high risk). In total, 79 process failures among 37 individual steps in the OR to ICU handoff process were identified. The traditional method yielded Criticality Indices (CIs) ranging from 18 to 72 and RPNs ranging from 80 to 504. The simplified method ranked 11 failures as 'low risk', 30 as medium risk and 22 as high risk. The traditional method yielded 24 failures with an RPN ≥300, of which 22 were identified as high risk by the simplified method (92% agreement). The top 20% of CI (≥60) included 12 failures, of which six were designated as high risk by the simplified method (50% agreement). These results suggest that the simplified method of scoring and ranking failures identified by an FMEA can be a useful tool for healthcare organisations with limited access to FMEA expertise. However, the simplified method does not result in the same degree of discrimination in the ranking of failures offered by the traditional method. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Hypertension, Obesity, Diabetes, and Heart Failure-Free Survival: The Cardiovascular Disease Lifetime Risk Pooling Project.

PubMed

Ahmad, Faraz S; Ning, Hongyan; Rich, Jonathan D; Yancy, Clyde W; Lloyd-Jones, Donald M; Wilkins, John T

2016-12-01

This study was designed to quantify the relationship between the absence of heart failure risk factors in middle age and incident heart failure, heart failure-free survival, and overall survival. Quantification of years lived free from heart failure in the context of risk factor burden in mid-life may improve risk communication and prevention efforts. We conducted a pooled, individual-level analysis sampling from communities across the United States as part of 4 cohort studies: the Framingham Heart, Framingham Offspring, Chicago Heart Association Detection Project in Industry, and ARIC (Atherosclerosis Risk In Communities) studies. Participants with and without hypertension (blood pressure ≥140/90 mm Hg or treatment), obesity (body mass index ≥30 kg/m 2 ), or diabetes (fasting glucose ≥126 mg/dl or treatment), and combinations of these factors, at index ages of 45 years and 55 years through 95 years. Competing risk-adjusted Cox models, a modified Kaplan-Meier estimator, and Irwin's restricted mean were used to estimate the association between the absence of risk factors at mid-life and incident heart failure, heart failure-free survival, and overall survival. For participants at age 45 years, over 516,537 person-years of follow-up, 1,677 incident heart failure events occurred. Men and women with no risk factors, compared to those with all 3, had 73% to 85% lower risks of incident heart failure. Men and women without hypertension, obesity, or diabetes at age 45 years lived on average 34.7 years and 38.0 years without incident heart failure, and they lived on average an additional 3 years to 15 years longer free of heart failure than those with 1, 2, or 3 risk factors. Similar trends were seen when stratified by race and at index age 55 years. Prevention of hypertension, obesity, and diabetes by ages 45 years and 55 years may substantially prolong heart failure-free survival, decrease heart failure-related morbidity, and reduce the public health impact of heart failure. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

An evaluation of the nursing success program: reading comprehension, graduation rates, and diversity.

PubMed

Symes, Lene; Tart, Kathryn; Travis, Lucille

2005-01-01

The Nursing Success Program was developed to enhance retention of baccalaureate nursing students. Reading comprehension scores are used to identify students who are at risk for failure and direct them into the retention program that addresses their skill deficits. To evaluate the program, the authors assessed reading comprehension, graduation rates, and ethnic diversity.

A Review of Non-Medication Interventions to Improve the Academic Performance of Children and Youth with ADHD

ERIC Educational Resources Information Center

Trout, Alexandra L.; Epstein, Michael H.

2007-01-01

Children with attention-deficit/hyperactivity disorder (ADHD) are at risk for academic failure. Although studies have evaluated the effects of medication on academic outcomes, the literature on non-medication interventions has not received equal attention. This review examined 41 studies that evaluated the impact of non-medication interventions on…

Failure probability under parameter uncertainty.

PubMed

Gerrard, R; Tsanakas, A

2011-05-01

In many problems of risk analysis, failure is equivalent to the event of a random risk factor exceeding a given threshold. Failure probabilities can be controlled if a decisionmaker is able to set the threshold at an appropriate level. This abstract situation applies, for example, to environmental risks with infrastructure controls; to supply chain risks with inventory controls; and to insurance solvency risks with capital controls. However, uncertainty around the distribution of the risk factor implies that parameter error will be present and the measures taken to control failure probabilities may not be effective. We show that parameter uncertainty increases the probability (understood as expected frequency) of failures. For a large class of loss distributions, arising from increasing transformations of location-scale families (including the log-normal, Weibull, and Pareto distributions), the article shows that failure probabilities can be exactly calculated, as they are independent of the true (but unknown) parameters. Hence it is possible to obtain an explicit measure of the effect of parameter uncertainty on failure probability. Failure probability can be controlled in two different ways: (1) by reducing the nominal required failure probability, depending on the size of the available data set, and (2) by modifying of the distribution itself that is used to calculate the risk control. Approach (1) corresponds to a frequentist/regulatory view of probability, while approach (2) is consistent with a Bayesian/personalistic view. We furthermore show that the two approaches are consistent in achieving the required failure probability. Finally, we briefly discuss the effects of data pooling and its systemic risk implications. © 2010 Society for Risk Analysis.

Cardiac stress and inflammatory markers as predictors of heart failure in patients with type 2 diabetes: the ADVANCE trial

PubMed Central

Ohkuma, Toshiaki; Jun, Min; Woodward, Mark; Zoungas, Sophia; Cooper, Mark E.; Grobbee, Diederick E.; Hamet, Pavel; Mancia, Giuseppe; Williams, Bryan; Welsh, Paul; Sattar, Naveed; Shaw, Jonathan E.; Rahimi, Kazem; Chalmers, John

2018-01-01

Objective This study examined the individual and combined impact of N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), interleukin-6 (IL-6), and high-sensitivity C-reactive protein (hs-CRP) on the prediction of heart failure incidence or progression in patients with type 2 diabetes. Research Design and Methods A nested case-cohort study was conducted in 3,098 participants with type 2 diabetes in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. Results A higher value of each biomarker was significantly associated with a higher risk of heart failure incidence or progression, after adjustment for major risk factors. The hazard ratios per 1-SD increase were 3.06 (95% CI 2.37-3.96) for NT-proBNP, 1.50 (1.27-1.77) for hs-cTnT, 1.48 (1.27-1.72) for IL-6, and 1.32 (1.12-1.55) for hs-CRP. Addition of NT-proBNP to the model including conventional risk factors meaningfully improved 5-year risk predictive performance (c-statistic 0.8162 to 0.8800; continuous net reclassification improvement [NRI] 73.1%; categorical NRI [<5%, 5-10%, >10% 5-year risk] 24.2%). In contrast, addition of hs-cTnT, IL-6 or hs-CRP did not improve the prediction metrics consistently either in combination or when added to NT-proBNP. Conclusions Only NT-proBNP, strongly and consistently improved prediction of heart failure in patients with type 2 diabetes beyond a wide range of clinical risk factors and biomarkers. PMID:28684396

Cardiac Stress and Inflammatory Markers as Predictors of Heart Failure in Patients With Type 2 Diabetes: The ADVANCE Trial.

PubMed

Ohkuma, Toshiaki; Jun, Min; Woodward, Mark; Zoungas, Sophia; Cooper, Mark E; Grobbee, Diederick E; Hamet, Pavel; Mancia, Giuseppe; Williams, Bryan; Welsh, Paul; Sattar, Naveed; Shaw, Jonathan E; Rahimi, Kazem; Chalmers, John

2017-09-01

This study examined the individual and combined effect of N-terminal pro-B-type natriuretic peptide (NT-proBNP), high-sensitivity cardiac troponin T (hs-cTnT), interleukin-6 (IL-6), and hs-CRP on the prediction of heart failure incidence or progression in patients with type 2 diabetes. A nested case-cohort study was conducted in 3,098 participants with type 2 diabetes in the Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation (ADVANCE) trial. A higher value of each biomarker was significantly associated with a higher risk of heart failure incidence or progression, after adjustment for major risk factors. The hazard ratios per 1-SD increase were 3.06 (95% CI 2.37, 3.96) for NT-proBNP, 1.50 (1.27, 1.77) for hs-cTnT, 1.48 (1.27, 1.72) for IL-6, and 1.32 (1.12, 1.55) for hs-CRP. The addition of NT-proBNP to the model including conventional risk factors meaningfully improved 5-year risk-predictive performance (C statistic 0.8162 to 0.8800; continuous net reclassification improvement [NRI] 73.1%; categorical NRI [<5%, 5-10%, >10% 5-year risk] 24.2%). In contrast, the addition of hs-cTnT, IL-6, or hs-CRP did not improve the prediction metrics consistently in combination or when added to NT-proBNP. Only NT-proBNP strongly and consistently improved the prediction of heart failure in patients with type 2 diabetes beyond a wide range of clinical risk factors and biomarkers. © 2017 by the American Diabetes Association.

Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation: A meta-analysis and systematic review of randomized controlled trials.

PubMed

Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A; Arima, Hisatomi; Wang, Dao Wen

2016-06-01

Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin-angiotensin-aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin-angiotensin-aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive.A pooled study of 6 randomized controlled trials assessing the efficacy of renin-angiotensin-aldosterone blockers on subjects with atrial fibrillation was performed.A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76- 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70-0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2-2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0-6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0-0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: -0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction.This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation.

Effect of RAAS blockers on adverse clinical outcomes in high CVD risk subjects with atrial fibrillation

PubMed Central

Chaugai, Sandip; Sherpa, Lhamo Yanchang; Sepehry, Amir A.; Arima, Hisatomi; Wang, Dao Wen

2016-01-01

Abstract Recent studies have demonstrated that atrial fibrillation significantly increases the risk of adverse clinical outcomes in high cardiovascular disease risk subjects. Application of renin–angiotensin–aldosterone system blockers for prevention of recurrence of atrial fibrillation and adverse clinical outcomes in subjects with atrial fibrillation is a theoretically appealing concept. However, results of clinical trials evaluating the effect of renin–angiotensin–aldosterone blockers on adverse clinical outcomes in high cardiovascular disease risk subjects with atrial fibrillation remain inconclusive. A pooled study of 6 randomized controlled trials assessing the efficacy of renin–angiotensin–aldosterone blockers on subjects with atrial fibrillation was performed. A total of 6 randomized controlled trials enrolled a total of 53,510 patients followed for 1 to 5 years. RAAS blockade therapy was associated with 14% reduction in the incidence of heart failure (OR: 0.86, [95%CI: 0.76– 0.97], P=0.018) and 17% reduction in the incidence of CVE (OR: 0.83, [95%CI: 0.70–0.99], P = 0.038). The corresponding decline in absolute risk against heart failure (ARR: 1.4%, [95%CI: 0.2–2.6%], P = 0.018) and CVE (ARR: 3.5%, [95%CI: 0.0–6.9%], P = 0.045) in the AF group was much higher than the non-AF group for heart failure (ARR: 0.4%, [95%CI: 0.0–0.7%], P = 0.057) and CVE (ARR: 1.6%, [95%CI: –0.1% to 3.3%], P = 0.071). No significant effect was noted on all-cause or cardiovascular mortality, stroke, or myocardial infarction. This study suggests that RAAS blockade offers protection against heart failure and cardiovascular events in high cardiovascular disease risk subjects with atrial fibrillation. PMID:27368043

Could anterior papillary muscle partial necrosis explain early mitral valve repair failure?

PubMed

Pozzi, Matteo; Generali, Tommaso; Henaine, Roland; Mitchell, Julia; Lemaire, Anais; Chiari, Pascal; Fran, Jean; Obadia, Jean François

2014-09-01

Standardized techniques of mitral valve repair (MVR) have recently witnessed the introduction of a 'respect rather than resect' concept, the strategy of which involves the use of artificial chordae. MVR displays several advantages over mitral valve replacement in degenerative mitral regurgitation (MR), but the risk of reoperation for MVR failure must be taken into account. Different mechanisms could be advocated as the leading cause of MVR failure; procedure-related mechanisms are usually involved in early MVR failure, while valve-related mechanisms are common in late failure. Here, the case is reported of an early failure of MVR using artificial chordae that could be explained by an unusual procedure-related mechanism, namely anterior papillary muscle necrosis. MVR failure is a well-known complication after surgical repair of degenerative MR, but anterior papillary muscle partial necrosis might also be considered a possible mechanism of procedure-related MVR failure, especially when considering the increasing use of artificial chordae. Owing to the encouraging results obtained, mitral valve re-repair might be considered a viable solution, but must be selected after only a meticulous evaluation of the underlying mechanism of MVR failure.

Evaluation of cough peak expiratory flow as a predictor of successful mechanical ventilation discontinuation: a narrative review of the literature.

PubMed

Jiang, Chuan; Esquinas, Antonio; Mina, Bushra

2017-01-01

A crucial step in the transition from mechanical ventilation to extubation is the successful performance of a spontaneous breathing trial (SBT). The American College of Chest Physicians (ACCP) Guidelines recommend removal of the endotracheal tube upon successful completion of a SBT. However, this does not guarantee successful extubation as there remains a risk of re-intubation. Guidelines have outlined ventilator liberation protocols, selected use of non-invasive ventilation on extubation, early mobilization, and dynamic ventilator metrics to prevent and better predict extubation failure. However, a significant percentage of patients still fail mechanical ventilation discontinuation. A common reason for re-intubation is having a weak cough strength, which reflects the inability to protect the airway. Evaluation of cough strength via objective measures using peak expiratory flow rate is a non-invasive and easily reproducible assessment which can predict extubation failure. We conducted a narrative review of the literature regarding use of cough strength as a predictive index for extubation failure risk. Results of our review show that cough strength, quantified objectively with a cough peak expiratory flow measurement (CPEF), is strongly associated with extubation success. Furthermore, various cutoff thresholds have been identified and can provide reasonable diagnostic accuracy and predictive power for extubation failure. These results demonstrate that measurement of the CPEF can be a useful tool to predict extubation failure in patients on MV who have passed a SBT. In addition, the data suggest that this diagnostic modality may reduce ICU length of stay, ICU expenditures, and morbidity and mortality.

Minimizing treatment planning errors in proton therapy using failure mode and effects analysis

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

Zheng, Yuanshui, E-mail: yuanshui.zheng@okc.procure.com; Johnson, Randall; Larson, Gary

Purpose: Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. Methods: The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authorsmore » estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. Results: In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. Conclusions: The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at their clinic have proven to be useful in error reduction in proton treatment planning, thus improving the effectiveness and safety of proton therapy.« less

Intensity-Modulated Radiation Therapy in Oropharyngeal Carcinoma: Effect of Tumor Volume on Clinical Outcomes

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

Lok, Benjamin H.; New York University School of Medicine, New York, NY; Setton, Jeremy

2012-04-01

Purpose: To analyze the effect of primary gross tumor volume (pGTV) and nodal gross tumor volume (nGTV) on treatment outcomes in patients treated with definitive intensity-modulated radiation therapy (IMRT) for oropharyngeal cancer (OPC). Methods and Materials: Between September 1998 and April 2009, a total of 442 patients with squamous cell carcinoma of the oropharynx were treated with IMRT with curative intent at our center. Thirty patients treated postoperatively and 2 additional patients who started treatment more than 6 months after diagnosis were excluded. A total of 340 patients with restorable treatment plans were included in this present study. The majoritymore » of the patients underwent concurrent platinum-based chemotherapy. The pGTV and nGTV were calculated using the original clinical treatment plans. Cox proportional hazards models and log-rank tests were used to evaluate the correlation between tumor volumes and overall survival (OS), and competing risks analysis tools were used to evaluate the correlation between local failure (LF), regional failure (RF), distant metastatic failure (DMF) vs. tumor volumes with death as a competing risk. Results: Median follow-up among surviving patients was 34 months (range, 5-67). The 2-year cumulative incidence of LF, RF and DF in this cohort of patients was 6.1%, 5.2%, and 12.2%, respectively. The 2-year OS rate was 88.6%. Univariate analysis determined pGTV and T-stage correlated with LF (p < 0.0001 and p = 0.004, respectively), whereas nGTV was not associated with RF. On multivariate analysis, pGTV and N-stage were independent risk factors for overall survival (p = 0.0003 and p = 0.0073, respectively) and distant control (p = 0.0008 and p = 0.002, respectively). Conclusions: In this cohort of patients with OPC treated with IMRT, pGTV was found to be associated with overall survival, local failure, and distant metastatic failure.« less

Minimizing treatment planning errors in proton therapy using failure mode and effects analysis.

PubMed

Zheng, Yuanshui; Johnson, Randall; Larson, Gary

2016-06-01

Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authors estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at their clinic have proven to be useful in error reduction in proton treatment planning, thus improving the effectiveness and safety of proton therapy.

Failure detection system risk reduction assessment

NASA Technical Reports Server (NTRS)

Aguilar, Robert B. (Inventor); Huang, Zhaofeng (Inventor)

2012-01-01

A process includes determining a probability of a failure mode of a system being analyzed reaching a failure limit as a function of time to failure limit, determining a probability of a mitigation of the failure mode as a function of a time to failure limit, and quantifying a risk reduction based on the probability of the failure mode reaching the failure limit and the probability of the mitigation.

Clinical performance of long-span zirconia frameworks for fixed dental prostheses: 5-year results.

PubMed

Schmitter, M; Mussotter, K; Rammelsberg, P; Gabbert, O; Ohlmann, B

2012-07-01

The purpose of this prospective cohort study was to assess the performance of tooth-supported, long-span, zirconia fixed dental prostheses (FDPs). Thirty FDPs with span lengths from 36 to 46 mm (mean 40·33 mm), with 4-7 units and with connector dimensions ∼9 mm(2) were inserted (19 in the posterior region, 11 including anterior teeth) using glass-ionomer cement. The performance of the FDPs was assessed (aesthetic evaluation, failures, hypersensitivity/tooth vitality, secondary caries, pocket depth, decementation, and chipping) at baseline and after 5 years. Cox regression analysis was performed to identify risk factors. There were 16 failures after 5 years. Framework fracture occurred for two FDPs, four FDPs had to be re-cemented, one abutment tooth had to be treated endodontically, one abutment tooth fractured and cohesive failure of the veneer occurred for eight. Four FDPs had to be replaced, so survival was 82%. The aesthetics were rated as excellent by the patients at baseline and good at the 5-year recall. Cox regression analysis showed that both length [P = 0·05, exp(B) = 1·22] and location [P = 0·019, exp(B) = 4·09] of the FDP were risk factors for failure. Compared with the previously published 2-year results, the incidence of complications increased dramatically. Additionally, it was shown that long-span FDPs in the molar region are at greater risk of failure than FDPs in the anterior region. © 2012 Blackwell Publishing Ltd.

Association of polymorphisms in genes involved in lipoprotein metabolism with plasma concentrations of remnant lipoproteins and HDL subpopulations before and after hormone therapy in postmenopausal women

USDA-ARS?s Scientific Manuscript database

Diabetes mellitus is a major risk factor for coronary heart disease (CHD), renal failure, retinopathy, and neuropathy. Lowering glycosylated hemoglobin (HbA1c) as well as low-density lipoprotein-cholesterol (LDL-C) has been associated with a decreased risk of these complications. We evaluated the ut...

Risk assessment for enterprise resource planning (ERP) system implementations: a fault tree analysis approach

NASA Astrophysics Data System (ADS)

Zeng, Yajun; Skibniewski, Miroslaw J.

2013-08-01

Enterprise resource planning (ERP) system implementations are often characterised with large capital outlay, long implementation duration, and high risk of failure. In order to avoid ERP implementation failure and realise the benefits of the system, sound risk management is the key. This paper proposes a probabilistic risk assessment approach for ERP system implementation projects based on fault tree analysis, which models the relationship between ERP system components and specific risk factors. Unlike traditional risk management approaches that have been mostly focused on meeting project budget and schedule objectives, the proposed approach intends to address the risks that may cause ERP system usage failure. The approach can be used to identify the root causes of ERP system implementation usage failure and quantify the impact of critical component failures or critical risk events in the implementation process.

Modeling Finite-Time Failure Probabilities in Risk Analysis Applications.

PubMed

Dimitrova, Dimitrina S; Kaishev, Vladimir K; Zhao, Shouqi

2015-10-01

In this article, we introduce a framework for analyzing the risk of systems failure based on estimating the failure probability. The latter is defined as the probability that a certain risk process, characterizing the operations of a system, reaches a possibly time-dependent critical risk level within a finite-time interval. Under general assumptions, we define two dually connected models for the risk process and derive explicit expressions for the failure probability and also the joint probability of the time of the occurrence of failure and the excess of the risk process over the risk level. We illustrate how these probabilistic models and results can be successfully applied in several important areas of risk analysis, among which are systems reliability, inventory management, flood control via dam management, infectious disease spread, and financial insolvency. Numerical illustrations are also presented. © 2015 Society for Risk Analysis.

A Prognostic Indicator for Patients Hospitalized with Heart Failure.

PubMed

Snow, Richard; Vogel, Karen; Vanderhoff, Bruce; Kelch, Benjamin P; Ferris, Frank D

2016-12-01

Current methods for identifying patients at risk of dying within six months suffer from clinician biases resulting in underestimation of this risk. As a result, patients who are potentially eligible for hospice and palliative care services frequently do not benefit from these services until they are very close to the end of their lives. To develop a prospective prognostic indicator based on actual survival within Centers for Medicare and Medicaid Services (CMS) claims data that identifies patients with congestive heart failure (CHF) who are at risk of six-month mortality. CMS claims data from January 1, 2008 to June 30, 2009 were reviewed to find the first hospitalization for CHF patients with episode of care diagnosis-related groups (DRGs) 291, 292, and 293. Univariate and multivariable analyses were used to determine the associations between demographic and clinical factors and six-month mortality. The resulting model was evaluated for discrimination and calibration. The resulting prospective prognostic model demonstrated fair discrimination with an ROC of 0.71 and good calibration with a Hosmer-Lemshow statistic of 0.98. Across all DRGs, 5% of discharged patients had a six-month mortality risk of greater than 50%. This prospective approach appears to provide a method to identify patients with CHF who would potentially benefit from a clinical evaluation for referral to hospice care or for a palliative care consult due to high predicted risk of dying within 180 days after discharge from a hospital. This approach can provide a model to match at-risk patients with evidenced-based care in a more consistent manner. This method of identifying patients at risk needs further prospective evaluation to see if it has value for clinicians, increases referrals to hospice and palliative care services, and benefits patients and families.

Risk analysis of analytical validations by probabilistic modification of FMEA.

PubMed

Barends, D M; Oldenhof, M T; Vredenbregt, M J; Nauta, M J

2012-05-01

Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure. Copyright © 2012 Elsevier B.V. All rights reserved.

Cost of a recall of a single-center experience managing the Riata defibrillator lead.

PubMed

Hussain, Sarah; Moorman, Liza; Moorman, J Randall; DiMarco, John P; Malhotra, Rohit; Darby, Andrew; Bilchick, Kenneth; Mangrum, J Michael; Ferguson, John D; Mason, Pamela K

2015-01-15

Riata and Riata ST defibrillator leads (St. Jude Medical, Sylmar, California) were recalled in 2011 due to increased risk of insulation failure leading to externalized cables. Fluoroscopic screening can identify insulation failure, although the relation between mechanical failure and electrical failure is unclear. At the time of the recall, the University of Virginia developed a screening program, including fluoroscopic evaluation, education sessions, device interrogation, and remote monitoring for patients with this defibrillator lead. The aim of this study was to review the outcomes of the screening program, including costs, which were absorbed by our institution. Costs were calculated using Medicare reimbursement estimates. Forty-eight patients participated in the screening program. At initial screening, 31% were found to have evidence of insulation failure but electrical function was normal in all leads. The cost of this program was $35,358.72. The cost per diagnosis of mechanical lead failure was $2,357.25. During 2 years of follow-up, 1 patient experienced Riata lead electrical failure without fluoroscopic evidence of insulation failure. Patients were more likely to have a lead revision if there was evidence of insulation failure. Lead revisions occurred at the time of generator change in 88% of patients with insulation failure but in only 14% of patients with a fluoroscopically normal lead (p = 0.04). The cost of recall-related defibrillator lead revisions was $81,704.55. In conclusion, our Riata screening program added expense without clear benefit to patients. In fact, patients may have been put at more risk by undergoing defibrillator lead revisions based solely on the results of the fluoroscopic screening. Copyright © 2015 Elsevier Inc. All rights reserved.

Early Caffeine Prophylaxis and Risk of Failure of Initial Continuous Positive Airway Pressure in Very Low Birth Weight Infants.

PubMed

Patel, Ravi M; Zimmerman, Kanecia; Carlton, David P; Clark, Reese; Benjamin, Daniel K; Smith, P Brian

2017-11-01

To test the hypothesis that early caffeine treatment on the day of birth, compared with later treatment in very low birth weight (VLBW, <1500 g) infants receiving continuous positive airway pressure (CPAP) therapy, is associated with a decreased risk of CPAP failure in the first week of life. Multicenter, observational cohort study in 366 US neonatal intensive care units. We evaluated inborn, VLBW infants discharged from 2000 to 2014, who received only CPAP therapy without surfactant treatment on day of life (DOL) 0, had a 5-minute Apgar ≥3, and received caffeine in the first week of life. We used multivariable conditional logistic regression to compare the risk of CPAP failure, defined as invasive mechanical ventilation or surfactant therapy on DOL 1-6, by timing of caffeine treatment as either early (initiation on DOL 0) or routine (initiation on DOL 1-6). We identified 11 133 infants; 4528 (41%) received early caffeine and 6605 (59%) received routine caffeine. Median gestational age was lower in the early caffeine group, 29 weeks (25th, 75th percentiles; 28, 30) vs the routine caffeine group, 30 weeks (29, 31); P < 0.001. The incidence of CPAP failure on DOL 1-6 was similar between the early and routine caffeine groups: 22% vs 21%; adjusted OR = 1.05 (95% CI: 0.93, 1.18). Early caffeine treatment on the day of birth was not associated with a decreased risk of CPAP failure in the first week of life for VLBW infants initially treated with CPAP. Copyright © 2017 Elsevier Inc. All rights reserved.

CT fluoroscopy-guided core needle biopsy of anterior mediastinal masses.

PubMed

Iguchi, T; Hiraki, T; Matsui, Y; Fujiwara, H; Sakurai, J; Masaoka, Y; Uka, M; Tanaka, T; Gobara, H; Kanazawa, S

2018-02-01

To retrospectively evaluate the safety, diagnostic yield, and risk factors of diagnostic failure of computed tomography (CT) fluoroscopy-guided biopsies of anterior mediastinal masses. Biopsy procedures and results of anterior mediastinal masses in 71 patients (32 women/39 men; mean [±standard deviation] age, 53.8±20.0years; range, 14-88years) were analyzed. Final diagnoses were based on surgical outcomes, imaging findings, or clinical follow-up findings. The biopsy results were compared with the final diagnosis, and the biopsy procedures grouped by pathologic findings into diagnostic success and failure groups. Multiple putative risk factors for diagnostic failure were then assessed. Seventy-one biopsies (71 masses; mean size, 67.5±27.3mm; range 8.6-128.2mm) were analyzed. We identified 17 grade 1 and one grade 2 adverse events (25.4% overall) according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Sixty-nine biopsies (97.2%) provided samples fit for pathologic analysis. Diagnostic failure was found for eight (11.3%) masses; the 63 masses diagnosed successfully included thymic carcinoma (n=17), lung cancer (n=14), thymoma (n=12), malignant lymphoma (n=11), germ cell tumor (n=3), and others (n=6). Using a thinner needle (i.e., a 20-gauge needle) was the sole significant risk factor for diagnostic failure (P=0.039). CT fluoroscopy-guided biopsy of anterior mediastinal masses was safe and had a high diagnostic yield; however, using a thinner biopsy needle significantly increased the risk of a failed diagnosis. Copyright © 2017 Éditions françaises de radiologie. Published by Elsevier Masson SAS. All rights reserved.

Risk management for outsourcing biomedical waste disposal - using the failure mode and effects analysis.

PubMed

Liao, Ching-Jong; Ho, Chao Chung

2014-07-01

Using the failure mode and effects analysis, this study examined biomedical waste companies through risk assessment. Moreover, it evaluated the supervisors of biomedical waste units in hospitals, and factors relating to the outsourcing risk assessment of biomedical waste in hospitals by referring to waste disposal acts. An expert questionnaire survey was conducted on the personnel involved in waste disposal units in hospitals, in order to identify important factors relating to the outsourcing risk of biomedical waste in hospitals. This study calculated the risk priority number (RPN) and selected items with an RPN value higher than 80 for improvement. These items included "availability of freezing devices", "availability of containers for sharp items", "disposal frequency", "disposal volume", "disposal method", "vehicles meeting the regulations", and "declaration of three lists". This study also aimed to identify important selection factors of biomedical waste disposal companies by hospitals in terms of risk. These findings can serve as references for hospitals in the selection of outsourcing companies for biomedical waste disposal. Copyright © 2014 Elsevier Ltd. All rights reserved.

Stratification of the Risk of Sudden Death in Nonischemic Heart Failure

PubMed Central

Pimentel, Maurício; Zimerman, Leandro Ioschpe; Rohde, Luis Eduardo

2014-01-01

Despite significant therapeutic advancements, heart failure remains a highly prevalent clinical condition associated with significant morbidity and mortality. In 30%-40% patients, the etiology of heart failure is nonischemic. The implantable cardioverter-defibrillator (ICD) is capable of preventing sudden death and decreasing total mortality in patients with nonischemic heart failure. However, a significant number of patients receiving ICD do not receive any kind of therapy during follow-up. Moreover, considering the situation in Brazil and several other countries, ICD cannot be implanted in all patients with nonischemic heart failure. Therefore, there is an urgent need to identify patients at an increased risk of sudden death because these would benefit more than patients at a lower risk, despite the presence of heart failure in both risk groups. In this study, the authors review the primary available methods for the stratification of the risk of sudden death in patients with nonischemic heart failure. PMID:25352509

What is prescription labeling communicating to doctors about hepatotoxic drugs? A study of FDA approved product labeling.

PubMed

Willy, Mary E; Li, Zili

2004-04-01

The objective of this study was to evaluate the informativeness and consistency of product labeling of hepatotoxic drugs marketed in the United States. We searched the Physicians' Desk Reference-2000 for prescription drugs with hepatic failure and/or hepatic necrosis listed in the labeling. We used a six-item checklist to evaluate the 'informativeness' and consistency of the labeling content. An informativeness score equaled the proportion of checklist items present in each drug's labeling. Ninety-five prescription drugs were included in the study. Eleven (12%) of the drugs had information related to hepatic failure in a Black Boxed Warning, 52 (54%) in the Warnings section and 32 (34%) in the Adverse Reactions section of the label. The mean informativeness score was 35%; the score was significantly higher, 61%, when the risk was perceived to be high. The informativeness of labeling was not affected by the time of the labeling, but differed across the Center for Drug Evaluation and Research (CDER) Review Division responsible for the labeling. The information provided in labeling is variable and affected by many factors, including the perceived level of risk and review division strategy. Product labeling may benefit from current FDA initiatives to improve the consistency of risk-related labeling.

Interrelation of structure and operational states in cascading failure of overloading lines in power grids

NASA Astrophysics Data System (ADS)

Xue, Fei; Bompard, Ettore; Huang, Tao; Jiang, Lin; Lu, Shaofeng; Zhu, Huaiying

2017-09-01

As the modern power system is expected to develop to a more intelligent and efficient version, i.e. the smart grid, or to be the central backbone of energy internet for free energy interactions, security concerns related to cascading failures have been raised with consideration of catastrophic results. The researches of topological analysis based on complex networks have made great contributions in revealing structural vulnerabilities of power grids including cascading failure analysis. However, existing literature with inappropriate assumptions in modeling still cannot distinguish the effects between the structure and operational state to give meaningful guidance for system operation. This paper is to reveal the interrelation between network structure and operational states in cascading failure and give quantitative evaluation by integrating both perspectives. For structure analysis, cascading paths will be identified by extended betweenness and quantitatively described by cascading drop and cascading gradient. Furthermore, the operational state for cascading paths will be described by loading level. Then, the risk of cascading failure along a specific cascading path can be quantitatively evaluated considering these two factors. The maximum cascading gradient of all possible cascading paths can be used as an overall metric to evaluate the entire power grid for its features related to cascading failure. The proposed method is tested and verified on IEEE30-bus system and IEEE118-bus system, simulation evidences presented in this paper suggests that the proposed model can identify the structural causes for cascading failure and is promising to give meaningful guidance for the protection of system operation in the future.

Control of Risks Through the Use of Procedures: A Method for Evaluating the Change in Risk

NASA Technical Reports Server (NTRS)

Praino, Gregory T.; Sharit, Joseph

2010-01-01

This paper considers how procedures can be used to control risks faced by an organization and proposes a means of recognizing if a particular procedure reduces risk or contributes to the organization's exposure. The proposed method was developed out of the review of work documents and the governing procedures performed in the wake of the Columbia accident by NASA and the Space Shuttle prime contractor, United Space Alliance, LLC. A technique was needed to understand the rules, or procedural controls, in place at the time in the context of how important the role of each rule was. The proposed method assesses procedural risks, the residual risk associated with a hazard after a procedure's influence is accounted for, by considering each clause of a procedure as a unique procedural control that may be beneficial or harmful. For procedural risks with consequences severe enough to threaten the survival of the organization, the method measures the characteristics of each risk on a scale that is an alternative to the traditional consequence/likelihood couple. The dual benefits of the substitute scales are that they eliminate both the need to quantify a relationship between different consequence types and the need for the extensive history a probabilistic risk assessment would require. Control Value is used as an analog for the consequence, where the value of a rule is based on how well the control reduces the severity of the consequence when operating successfully. This value is composed of two parts: the inevitability of the consequence in the absence of the control, and the opportunity to intervene before the consequence is realized. High value controls will be ones where there is minimal need for intervention but maximum opportunity to actively prevent the outcome. Failure Likelihood is used as the substitute for the conventional likelihood of the outcome. For procedural controls, a failure is considered to be any non-malicious violation of the rule, whether intended or not. The model used for describing the Failure Likelihood considers how well a task was established by evaluating that task on five components. The components selected to define a well established task are: that it be defined, assigned to someone capable, that they be trained appropriately, that the actions be organized to enable proper completion and that some form of independent monitoring be performed. Validation of the method was based on the information provided by a group of experts in Space Shuttle ground processing when they were presented with 5 scenarios that identified a clause from a procedure. For each scenario, they recorded their perception of how important the associated rule was and how likely it was to fail. They then rated the components of Control Value and Failure Likelihood for all the scenarios. The order in which each reviewer ranked the scenarios Control Value and Failure Likelihood was compared to the order in which they ranked the scenarios for each of the associated components; inevitability and opportunity for Control Value and definition, assignment, training, organization and monitoring for Failure Likelihood. This order comparison showed how the components contributed to a relative relationship to the substitute risk element. With the relationship established for Space Shuttle ground processing, this method can be used to gauge if the introduction or removal of a particular rule will increase or decrease the .risk associated with the hazard it is intended to control.

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets.

PubMed

Claycamp, H Gregg; Kona, Ravikanth; Fahmy, Raafat; Hoag, Stephen W

2016-04-01

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.

Effects Five Years Later: The Michigan School Readiness Program Evaluation through Age 10.

ERIC Educational Resources Information Center

Xiang, Zongping; Schweinhart, Lawrence J.

This follow-up study examined the outcomes of children who had participated in the Michigan School Readiness Program (MSRP), a preschool program for 4-year-olds identified as being at risk for school failure, up to 5 years following their participation in the program. For the evaluation, 338 children who had participated in the state-funded…

Final Environmental Assessment of the Joint Air-to-Surface Stand-Off Missile (JASSM) Development and Evaluation Testing, White Sands Missile Range, New Mexico

DTIC Science & Technology

2001-12-01

Explosive Test Site Program Definition and Risk Reduction Permissible Exposure Limit Program Executive Office Propellants, Explosives, and...each test vehicle is flown in the captive mode and critical systems are functioned to further remove risk of failure due to the flight environment...of other inferior missiles would require a larger number of missiles, at increased procurement costs and risk to aircraft and crew, in order to

Liver transplantation for fulminant hepatitis at Stanford University.

PubMed

Lu, Amy; Monge, Humberto; Drazan, Kenneth; Millan, Maria; Esquivel, Carlos O

2002-01-01

To review the clinical characteristics and outcomes of 26 patients evaluated for liver transplantation for fulminant hepatic failure at Stanford University and Lucile Packard Children's Hospital in an attempt to identify risk factors and prognostic predictors of survival. A retrospective review of the records of 26 consecutive patients who were evaluated for possible liver transplantation for acute liver failure from May 1, 1995, to January 1, 2000. Pretransplant patient demographics and clinical characteristics were collected, and the data were analyzed by univariate and multivariate analysis. Clinical assessment of encephalopathy did not predict outcome. Patients with abnormal computed tomography (CT) of the brain had a twofold increase in mortality compared with those patients with normal studies (p = 0.03). Patients requiring mechanical ventilation and continuous venovenous hemofiltration (CVVH) also had a poor prognosis. Predictors of poor outcome after fulminant hepatic failure include abnormal CT scan, mechanical ventilation, and requirement for hemofiltration.

Risk factors associated with early implant failure: A 5-year retrospective clinical study.

PubMed

Olmedo-Gaya, Maris Victoria; Manzano-Moreno, Francisco J; Cañaveral-Cavero, Esther; de Dios Luna-del Castillo, Juan; Vallecillo-Capilla, Manuel

2016-02-01

The replacement of lost teeth with dental implants is a widespread treatment whose associated problems are also frequently encountered. Nevertheless, the factors associated with early implant failure have not been well documented. Further analyses of the factors influencing osseointegration establishment are required to maximize the predictability of the procedure and minimize implant failures. The purpose of this retrospective clinical study was to explore the association between possible risk factors and early implant failure. This retrospective clinical study evaluated 142 participants who received 276 external connection BTI implants between 2007 and 2011. Participant variables (age, sex, systemic disease, tobacco use, alcohol consumption, bruxism, and degree of periodontal disease), implant variables (type of edentulism, localization, area, diameter, length, and bone quality), intervention variables (expansion mechanisms, sinus augmentation techniques, bone regeneration, and implant insertion), and postoperative variables (presence of pain/inflammation at 1 week postsurgery) were studied. A multilevel logistic regression model (mixed effects-type model) was used to determine the influence of variables on early implant failure. Early implant failure was significantly associated with the male sex (P=.001), severe periodontal disease (P=.005), short implants (P=.001), expansion technique (P=.002), and postoperative pain/inflammation at 1 week postsurgery (P<.001). Early dental implant failure is more frequent in men and in individuals with severe periodontal disease, short implants, pain/inflammation at 1 week postsurgery, or bone expansion treatment. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Concurrent Anemia and Elevated C-Reactive Protein Predicts HIV Clinical Treatment Failure, Including Tuberculosis, After Antiretroviral Therapy Initiation

PubMed Central

Shivakoti, Rupak; Yang, Wei-Teng; Gupte, Nikhil; Berendes, Sima; Rosa, Alberto La; Cardoso, Sandra W.; Mwelase, Noluthando; Kanyama, Cecilia; Pillay, Sandy; Samaneka, Wadzanai; Riviere, Cynthia; Sugandhavesa, Patcharaphan; Santos, Brento; Poongulali, Selvamuthu; Tripathy, Srikanth; Bollinger, Robert C.; Currier, Judith S.; Tang, Alice M.; Semba, Richard D.; Christian, Parul; Campbell, Thomas B.; Gupta, Amita

2015-01-01

Background. Anemia is a known risk factor for clinical failure following antiretroviral therapy (ART). Notably, anemia and inflammation are interrelated, and recent studies have associated elevated C-reactive protein (CRP), an inflammation marker, with adverse human immunodeficiency virus (HIV) treatment outcomes, yet their joint effect is not known. The objective of this study was to assess prevalence and risk factors of anemia in HIV infection and to determine whether anemia and elevated CRP jointly predict clinical failure post-ART. Methods. A case-cohort study (N = 470 [236 cases, 234 controls]) was nested within a multinational randomized trial of ART efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings [PEARLS]). Cases were incident World Health Organization stage 3, 4, or death by 96 weeks of ART treatment (clinical failure). Multivariable logistic regression was used to determine risk factors for pre-ART (baseline) anemia (females: hemoglobin <12.0 g/dL; males: hemoglobin <13.0 g/dL). Association of anemia as well as concurrent baseline anemia and inflammation (CRP ≥10 mg/L) with clinical failure were assessed using multivariable Cox models. Results. Baseline anemia prevalence was 51% with 15% prevalence of concurrent anemia and inflammation. In analysis of clinical failure, multivariate-adjusted hazard ratios were 6.41 (95% confidence interval [CI], 2.82–14.57) for concurrent anemia and inflammation, 0.77 (95% CI, .37–1.58) for anemia without inflammation, and 0.45 (95% CI, .11–1.80) for inflammation without anemia compared to those without anemia and inflammation. Conclusions. ART-naive, HIV-infected individuals with concurrent anemia and inflammation are at particularly high risk of failing treatment, and understanding the pathogenesis could lead to new interventions. Reducing inflammation and anemia will likely improve HIV disease outcomes. Alternatively, concurrent anemia and inflammation could represent individuals with occult opportunistic infections in need of additional screening. PMID:25828994

Fracture of Fully-coated Femoral Stem after Primary Total Hip Arthroplasty for Nonunion of Intertrochanteric Fracture: A Case Report.

PubMed

Chun, Young Soo; Juh, Hyung Suk; Cho, Yoon Je; Rhyu, Kee Hyung

2015-09-01

Femoral stem fracture is an uncommon reason for the failure of total hip arthroplasty, with only 16 cases of fully coated stem fractures reported to date. Here we report a case in which a fully coated primary femoral stem fracture occurred after conversion to total hip arthroplasty for the non-union of an intertrochanteric fracture of the femur. Metallurgic evaluation of the etiology and mechanism revealed that the fracture was initiated by fatigue-related failure and completed by ductile failure on the posterior side of the fracture. Considering the recent trend of treating an intertrochanteric fracture with hip arthroplasty, possible stem failure should be considered, since most patients will have at least one of the known risk factors for stem fracture.

Fracture of Fully-coated Femoral Stem after Primary Total Hip Arthroplasty for Nonunion of Intertrochanteric Fracture: A Case Report

PubMed Central

Chun, Young Soo; Juh, Hyung Suk; Cho, Yoon Je

2015-01-01

Femoral stem fracture is an uncommon reason for the failure of total hip arthroplasty, with only 16 cases of fully coated stem fractures reported to date. Here we report a case in which a fully coated primary femoral stem fracture occurred after conversion to total hip arthroplasty for the non-union of an intertrochanteric fracture of the femur. Metallurgic evaluation of the etiology and mechanism revealed that the fracture was initiated by fatigue-related failure and completed by ductile failure on the posterior side of the fracture. Considering the recent trend of treating an intertrochanteric fracture with hip arthroplasty, possible stem failure should be considered, since most patients will have at least one of the known risk factors for stem fracture. PMID:27536622

Epidemiology of invasive pulmonary aspergillosis in patients with liver failure: Clinical presentation, risk factors, and outcomes.

PubMed

Zhang, Xuan; Yang, Meifang; Hu, Jianhua; Zhao, Hong; Li, Lanjuan

2018-02-01

Objective Invasive pulmonary aspergillosis (IPA) is a severe and often lethal infection. The possible risk factors, clinical presentation, and treatment of patients with simultaneous liver failure and IPA have received little attention in previous studies. The aim of this study was to investigate the epidemiology of IPA in patients with liver failure in an effort to reduce patient mortality. Methods The patients with liver failure (including acute liver failure , sub-acute liver failure , acute-on-chronic liver failure and chronic liver failure) were recruited from 2011 to 2016. The clinical data of these patients were retrieved for the study. Results In total, 1077 patients with liver failure were included in this study. Of the 1077 patients, 53 (4.9%) had IPA. Forty-four (83%) patients with IPA died. Independent risk factors for IPA were male sex (hazard ratio [HR] = 2.542), hepatorenal syndrome (HR = 2.463), antibiotic use (HR = 4.631), and steroid exposure (HR = 18.615). Conclusions IPA is a fatal complication in patients with liver failure. Male sex, hepatorenal syndrome, antibiotic use, and steroid exposure were independent risk factors for IPA. When patients with liver failure have these risk factors and symptoms of pneumonia such as cough or hemoptysis, clinicians should be cautious about the possibility of IPA.

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.

Multidrug Resistance Acinetobacter Bacteremia Secondary to Ventilator-Associated Pneumonia: Risk Factors and Outcome.

PubMed

Brotfain, Evgeni; Borer, Abraham; Koyfman, Leonid; Saidel-Odes, Lisa; Frenkel, Amit; Gruenbaum, Shaun E; Rosenzweig, Vsevolod; Zlotnik, Alexander; Klein, Moti

2017-10-01

Acinetobacter baumannii is a multidrug resistant (MDR), gram-negative bacterium commonly implicated in ventilator-associated pneumonia (VAP) in critically ill patients. Patients in the intensive care unit (ICU) with VAP often subsequently develop A baumannii bacteremia, which may significantly worsen outcomes. In this study, we retrospectively reviewed the clinical and laboratory records of 129 ICU patients spanning 6 years with MDR A baumannii VAP; 46 (35%) of these patients had concomitant MDR A baumannii bacteremia. The ICU mortality rate was higher in patients with VAP having A baumannii bacteremia compared to nonbacteremic patients (32.4% vs 9.6% respectively, P < .005). Age >65 years, an Acute Physiology and Chronic Health Evaluation II (APACHE-II) score higher than 20, a Sequential Organ Failure Assessment (SOFA) score higher than 7 on the day of bacteremia, and the presence of comorbid disease (chronic obstructive pulmonary disease [COPD] and chronic renal failure) were found to be independent risk factors for in-hospital mortality in this population. Multidrug resistant A baumannii was not an independent risk factor for mortality. Although the presence of comorbid diseases (COPD and chronic renal failure) and severity of disease (APACHE > 20 and SOFA >7) were found to be independent risk factors for ICU mortality, MDR A baumannii bacteremia was not an independent risk factor for mortality in our critically ill population.

Access to Heart Transplantation: A Proper Analysis of the Competing Risks of Death and Transplantation Is Required to Optimize Graft Allocation.

PubMed

Cantrelle, Christelle; Legeai, Camille; Latouche, Aurélien; Tuppin, Philippe; Jasseron, Carine; Sebbag, Laurent; Bastien, Olivier; Dorent, Richard

2017-08-01

Heart allocation systems are usually urgency-based, offering grafts to candidates at high risk of waitlist mortality. In the context of a revision of the heart allocation rules, we determined observed predictors of 1-year waitlist mortality in France, considering the competing risk of transplantation, to determine which candidate subgroups are favored or disadvantaged by the current allocation system. Patients registered on the French heart waitlist between 2010 and 2013 were included. Cox cause-specific hazards and Fine and Gray subdistribution hazards were used to determine candidate characteristics associated with waitlist mortality and access to transplantation. Of the 2053 candidates, 7 variables were associated with 1-year waitlist mortality by the Fine and Gray method including 4 candidate characteristics related to heart failure severity (hospitalization at listing, serum natriuretic peptide level, systolic pulmonary artery pressure, and glomerular filtration rate) and 3 characteristics not associated with heart failure severity but with lower access to transplantation (blood type, age, and body mass index). Observed waitlist mortality for candidates on mechanical circulatory support was like that of others. The heart allocation system strongly modifies the risk of pretransplant mortality related to heart failure severity. An in-depth competing risk analysis is therefore a more appropriate method to evaluate graft allocation systems. This knowledge should help to prioritize candidates in the context of a limited donor pool.

Echocardiography and risk prediction in advanced heart failure: incremental value over clinical markers.

PubMed

Agha, Syed A; Kalogeropoulos, Andreas P; Shih, Jeffrey; Georgiopoulou, Vasiliki V; Giamouzis, Grigorios; Anarado, Perry; Mangalat, Deepa; Hussain, Imad; Book, Wendy; Laskar, Sonjoy; Smith, Andrew L; Martin, Randolph; Butler, Javed

2009-09-01

Incremental value of echocardiography over clinical parameters for outcome prediction in advanced heart failure (HF) is not well established. We evaluated 223 patients with advanced HF receiving optimal therapy (91.9% angiotensin-converting enzyme inhibitor/angiotensin receptor blocker, 92.8% beta-blockers, 71.8% biventricular pacemaker, and/or defibrillator use). The Seattle Heart Failure Model (SHFM) was used as the reference clinical risk prediction scheme. The incremental value of echocardiographic parameters for event prediction (death or urgent heart transplantation) was measured by the improvement in fit and discrimination achieved by addition of standard echocardiographic parameters to the SHFM. After a median follow-up of 2.4 years, there were 38 (17.0%) events (35 deaths; 3 urgent transplants). The SHFM had likelihood ratio (LR) chi(2) 32.0 and C statistic 0.756 for event prediction. Left ventricular end-systolic volume, stroke volume, and severe tricuspid regurgitation were independent echocardiographic predictors of events. The addition of these parameters to SHFM improved LR chi(2) to 72.0 and C statistic to 0.866 (P < .001 and P=.019, respectively). Reclassifying the SHFM-predicted risk with use of the echocardiography-added model resulted in improved prognostic separation. Addition of standard echocardiographic variables to the SHFM results in significant improvement in risk prediction for patients with advanced HF.

Pre-Antiretroviral Therapy Serum Selenium Concentrations Predict WHO Stages 3, 4 or Death but not Virologic Failure Post-Antiretroviral Therapy

PubMed Central

Shivakoti, Rupak; Gupte, Nikhil; Yang, Wei-Teng; Mwelase, Noluthando; Kanyama, Cecilia; Tang, Alice M.; Pillay, Sandy; Samaneka, Wadzanai; Riviere, Cynthia; Berendes, Sima; Lama, Javier R.; Cardoso, Sandra W.; Sugandhavesa, Patcharaphan; Semba, Richard D.; Christian, Parul; Campbell, Thomas B.; Gupta, Amita

2014-01-01

A case-cohort study, within a multi-country trial of antiretroviral therapy (ART) efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings (PEARLS)), was conducted to determine if pre-ART serum selenium deficiency is independently associated with human immunodeficiency virus (HIV) disease progression after ART initiation. Cases were HIV-1 infected adults with either clinical failure (incident World Health Organization (WHO) stage 3, 4 or death by 96 weeks) or virologic failure by 24 months. Risk factors for serum selenium deficiency (<85 μg/L) pre-ART and its association with outcomes were examined. Median serum selenium concentration was 82.04 μg/L (Interquartile range (IQR): 57.28–99.89) and serum selenium deficiency was 53%, varying widely by country from 0% to 100%. In multivariable models, risk factors for serum selenium deficiency were country, previous tuberculosis, anemia, and elevated C-reactive protein. Serum selenium deficiency was not associated with either clinical failure or virologic failure in multivariable models. However, relative to people in the third quartile (74.86–95.10 μg/L) of serum selenium, we observed increased hazards (adjusted hazards ratio (HR): 3.50; 95% confidence intervals (CI): 1.30–9.42) of clinical failure but not virologic failure for people in the highest quartile. If future studies confirm this relationship of high serum selenium with increased clinical failure, a cautious approach to selenium supplementation might be needed, especially in HIV-infected populations with sufficient or unknown levels of selenium. PMID:25401501

Compound estimation procedures in reliability

NASA Technical Reports Server (NTRS)

Barnes, Ron

1990-01-01

At NASA, components and subsystems of components in the Space Shuttle and Space Station generally go through a number of redesign stages. While data on failures for various design stages are sometimes available, the classical procedures for evaluating reliability only utilize the failure data on the present design stage of the component or subsystem. Often, few or no failures have been recorded on the present design stage. Previously, Bayesian estimators for the reliability of a single component, conditioned on the failure data for the present design, were developed. These new estimators permit NASA to evaluate the reliability, even when few or no failures have been recorded. Point estimates for the latter evaluation were not possible with the classical procedures. Since different design stages of a component (or subsystem) generally have a good deal in common, the development of new statistical procedures for evaluating the reliability, which consider the entire failure record for all design stages, has great intuitive appeal. A typical subsystem consists of a number of different components and each component has evolved through a number of redesign stages. The present investigations considered compound estimation procedures and related models. Such models permit the statistical consideration of all design stages of each component and thus incorporate all the available failure data to obtain estimates for the reliability of the present version of the component (or subsystem). A number of models were considered to estimate the reliability of a component conditioned on its total failure history from two design stages. It was determined that reliability estimators for the present design stage, conditioned on the complete failure history for two design stages have lower risk than the corresponding estimators conditioned only on the most recent design failure data. Several models were explored and preliminary models involving bivariate Poisson distribution and the Consael Process (a bivariate Poisson process) were developed. Possible short comings of the models are noted. An example is given to illustrate the procedures. These investigations are ongoing with the aim of developing estimators that extend to components (and subsystems) with three or more design stages.

A novel risk assessment method for landfill slope failure: Case study application for Bhalswa Dumpsite, India.

PubMed

Jahanfar, Ali; Amirmojahedi, Mohsen; Gharabaghi, Bahram; Dubey, Brajesh; McBean, Edward; Kumar, Dinesh

2017-03-01

Rapid population growth of major urban centres in many developing countries has created massive landfills with extraordinary heights and steep side-slopes, which are frequently surrounded by illegal low-income residential settlements developed too close to landfills. These extraordinary landfills are facing high risks of catastrophic failure with potentially large numbers of fatalities. This study presents a novel method for risk assessment of landfill slope failure, using probabilistic analysis of potential failure scenarios and associated fatalities. The conceptual framework of the method includes selecting appropriate statistical distributions for the municipal solid waste (MSW) material shear strength and rheological properties for potential failure scenario analysis. The MSW material properties for a given scenario is then used to analyse the probability of slope failure and the resulting run-out length to calculate the potential risk of fatalities. In comparison with existing methods, which are solely based on the probability of slope failure, this method provides a more accurate estimate of the risk of fatalities associated with a given landfill slope failure. The application of the new risk assessment method is demonstrated with a case study for a landfill located within a heavily populated area of New Delhi, India.

Implementation of predictive data mining techniques for identifying risk factors of early AVF failure in hemodialysis patients.

PubMed

Rezapour, Mohammad; Khavanin Zadeh, Morteza; Sepehri, Mohammad Mehdi

2013-01-01

Arteriovenous fistula (AVF) is an important vascular access for hemodialysis (HD) treatment but has 20-60% rate of early failure. Detecting association between patient's parameters and early AVF failure is important for reducing its prevalence and relevant costs. Also predicting incidence of this complication in new patients is a beneficial controlling procedure. Patient safety and preservation of early AVF failure is the ultimate goal. Our research society is Hasheminejad Kidney Center (HKC) of Tehran, which is one of Iran's largest renal hospitals. We analyzed data of 193 HD patients using supervised techniques of data mining approach. There were 137 male (70.98%) and 56 female (29.02%) patients introduced into this study. The average of age for all the patients was 53.87 ± 17.47 years. Twenty eight patients had smoked and the number of diabetic patients and nondiabetics was 87 and 106, respectively. A significant relationship was found between "diabetes mellitus," "smoking," and "hypertension" with early AVF failure in this study. We have found that these mentioned risk factors have important roles in outcome of vascular surgery, versus other parameters such as "age." Then we predicted this complication in future AVF surgeries and evaluated our designed prediction methods with accuracy rates of 61.66%-75.13%.

Risk assessment and comparative effectiveness of left ventricular assist device and medical management in ambulatory heart failure patients: design and rationale of the ROADMAP clinical trial.

PubMed

Rogers, Joseph G; Boyle, Andrew J; O'Connell, John B; Horstmanshof, Douglas A; Haas, Donald C; Slaughter, Mark S; Park, Soon J; Farrar, David J; Starling, Randall C

2015-02-01

Mechanical circulatory support is now a proven therapy for the treatment of patients with advanced heart failure and cardiogenic shock. The role for this therapy in patients with less severe heart failure is unknown. The objective of this study is to examine the impact of mechanically assisted circulation using the HeartMate II left ventricular assist device in patients who meet current US Food and Drug Administration-defined criteria for treatment but are not yet receiving intravenous inotropic therapy. This is a prospective, nonrandomized clinical trial of 200 patients treated with either optimal medical management or a mechanical circulatory support device. This trial will be the first prospective clinical evaluation comparing outcomes of patients with advanced ambulatory heart failure treated with either ongoing medical therapy or a left ventricular assist device. It is anticipated to provide novel insights regarding relative outcomes with each treatment and an understanding of patient and provider acceptance of the ventricular assist device therapy. This trial will also provide information regarding the risk of events in "stable" patients with advanced heart failure and guidance for the optimal timing of left ventricular assist device therapy. Copyright © 2014 Elsevier Inc. All rights reserved.

Dynamic decision making for dam-break emergency management - Part 2: Application to Tangjiashan landslide dam failure

NASA Astrophysics Data System (ADS)

Peng, M.; Zhang, L. M.

2013-02-01

Tangjiashan landslide dam, which was triggered by the Ms = 8.0 Wenchuan earthquake in 2008 in China, threatened 1.2 million people downstream of the dam. All people in Beichuan Town 3.5 km downstream of the dam and 197 thousand people in Mianyang City 85 km downstream of the dam were evacuated 10 days before the breaching of the dam. Making such an important decision under uncertainty was difficult. This paper applied a dynamic decision-making framework for dam-break emergency management (DYDEM) to help rational decision in the emergency management of the Tangjiashan landslide dam. Three stages are identified with different levels of hydrological, geological and social-economic information along the timeline of the landslide dam failure event. The probability of dam failure is taken as a time series. The dam breaching parameters are predicted with a set of empirical models in stage 1 when no soil property information is known, and a physical model in stages 2 and 3 when knowledge of soil properties has been obtained. The flood routing downstream of the dam in these three stages is analyzed to evaluate the population at risk (PAR). The flood consequences, including evacuation costs, flood damage and monetized loss of life, are evaluated as functions of warning time using a human risk analysis model based on Bayesian networks. Finally, dynamic decision analysis is conducted to find the optimal time to evacuate the population at risk with minimum total loss in each of these three stages.

Dual-chamber pacemakers for treating symptomatic bradycardia due to sick sinus syndrome without atrioventricular block: a systematic review and economic evaluation.

PubMed

Edwards, Steven J; Karner, Charlotta; Trevor, Nicola; Wakefield, Victoria; Salih, Fatima

2015-08-01

Bradycardia [resting heart rate below 60 beats per minute (b.p.m.)] can be caused by conditions affecting the natural pacemakers of the heart, such as sick sinus syndrome (SSS) and atrioventricular (AV) blocks. People suffering from bradycardia may present with palpitations, exercise intolerance and fainting. The only effective treatment for patients suffering from symptomatic bradycardia is implantation of a permanent pacemaker. To appraise the clinical effectiveness and cost-effectiveness of dual-chamber pacemakers compared with single-chamber atrial pacemakers for treating symptomatic bradycardia in people with SSS and no evidence of AV block. All databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) were searched from inception to June 2014. A systematic review of the clinical and economic literature was carried out in accordance with the general principles published by the Centre for Reviews and Dissemination. Randomised controlled trials (RCTs) evaluating dual-chamber and single-chamber atrial pacemakers and economic evaluations were included. Pairwise meta-analysis was carried out. A de novo economic model was developed. Of 493 references, six RCTs were included in the review. The results were predominantly influenced by the largest trial DANPACE. Dual-chamber pacing was associated with a statistically significant reduction in reoperation [odds ratio (OR) 0.48, 95% confidence interval (CI) 0.36 to 0.63] compared with single-chamber atrial pacing. The difference is primarily because of the development of AV block requiring upgrade to a dual-chamber device. The risk of paroxysmal atrial fibrillation was also reduced with dual-chamber pacing compared with single-chamber atrial pacing (OR 0.75, 95% CI 0.59 to 0.96). No statistically significant difference was found between the pacing modes for mortality, heart failure, stroke, chronic atrial fibrillation or quality of life. However, the risk of developing heart failure may vary with age and device. The de novo economic model shows that dual-chamber pacemakers are more expensive and more effective than single-chamber atrial devices, resulting in a base-case incremental cost-effectiveness ratio (ICER) of £6506. The ICER remains below £20,000 in probabilistic sensitivity analysis, structural sensitivity analysis and most scenario analyses and one-way sensitivity analyses. The risk of heart failure may have an impact on the decision to use dual-chamber or single-chamber atrial pacemakers. Results from an analysis based on age (> 75 years or ≤ 75 years) and risk of heart failure indicate that dual-chamber pacemakers dominate single-chamber atrial pacemakers (i.e. are less expensive and more effective) in older patients, whereas dual-chamber pacemakers are dominated by (i.e. more expensive and less effective) single-chamber atrial pacemakers in younger patients. However, these results are based on a subgroup analysis and should be treated with caution. In patients with SSS without evidence of impaired AV conduction, dual-chamber pacemakers appear to be cost-effective compared with single-chamber atrial pacemakers. The risk of developing a complete AV block and the lack of tools to identify patients at high risk of developing the condition argue for the implantation of a dual-chamber pacemaker programmed to minimise unnecessary ventricular pacing. However, considerations have to be made around the risk of developing heart failure, which may depend on age and device. This study is registered as PROSPERO CRD42013006708. The National Institute for Health Research Health Technology Assessment programme.

Branch-and-Bound algorithm applied to uncertainty quantification of a Boiling Water Reactor Station Blackout

DOE PAGES

Nielsen, Joseph; Tokuhiro, Akira; Hiromoto, Robert; ...

2015-11-13

Evaluation of the impacts of uncertainty and sensitivity in modeling presents a significant set of challenges in particular to high fidelity modeling. Computational costs and validation of models creates a need for cost effective decision making with regards to experiment design. Experiments designed to validate computation models can be used to reduce uncertainty in the physical model. In some cases, large uncertainty in a particular aspect of the model may or may not have a large impact on the final results. For example, modeling of a relief valve may result in large uncertainty, however, the actual effects on final peakmore » clad temperature in a reactor transient may be small and the large uncertainty with respect to valve modeling may be considered acceptable. Additionally, the ability to determine the adequacy of a model and the validation supporting it should be considered within a risk informed framework. Low fidelity modeling with large uncertainty may be considered adequate if the uncertainty is considered acceptable with respect to risk. In other words, models that are used to evaluate the probability of failure should be evaluated more rigorously with the intent of increasing safety margin. Probabilistic risk assessment (PRA) techniques have traditionally been used to identify accident conditions and transients. Traditional classical event tree methods utilize analysts’ knowledge and experience to identify the important timing of events in coordination with thermal-hydraulic modeling. These methods lack the capability to evaluate complex dynamic systems. In these systems, time and energy scales associated with transient events may vary as a function of transition times and energies to arrive at a different physical state. Dynamic PRA (DPRA) methods provide a more rigorous analysis of complex dynamic systems. Unfortunately DPRA methods introduce issues associated with combinatorial explosion of states. This study presents a methodology to address combinatorial explosion using a Branch-and-Bound algorithm applied to Dynamic Event Trees (DET), which utilize LENDIT (L – Length, E – Energy, N – Number, D – Distribution, I – Information, and T – Time) as well as a set theory to describe system, state, resource, and response (S2R2) sets to create bounding functions for the DET. The optimization of the DET in identifying high probability failure branches is extended to create a Phenomenological Identification and Ranking Table (PIRT) methodology to evaluate modeling parameters important to safety of those failure branches that have a high probability of failure. The PIRT can then be used as a tool to identify and evaluate the need for experimental validation of models that have the potential to reduce risk. Finally, in order to demonstrate this methodology, a Boiling Water Reactor (BWR) Station Blackout (SBO) case study is presented.« less

The US and Canadian Army Strategies: Failures in Understanding

DTIC Science & Technology

2003-04-07

methodology for identifying risks as associated with each core competency. Program Evaluation Groups (PEGs) perform the task of identifying competencies...stable group is completely immune to change. New ideas are insulated within the organization and allowed to develop. It features risk control as a...however, must be balanced with the ability to receive first-hand knowledge from the group with the greatest emotional stake in the future of the Army

Retrospective evaluation of the incidence and prognostic significance of spontaneous echocardiographic contrast in relation to cardiac disease and congestive heart failure in cats: 725 cases (2006-2011).

PubMed

Peck, Courtney M; Nielsen, Lindsey K; Quinn, Rebecca L; Laste, Nancy J; Price, Lori Lyn

2016-09-01

To determine whether the presence of spontaneous echocardiographic contrast (SEC) in cats with cardiomyopathy is associated with increased mortality. To establish whether specific types of cardiomyopathy are more often associated with SEC in an attempt to provide a risk-stratification scheme for cats with increased risk of thromboembolic events. Retrospective study 2006-2011. Tertiary referral and teaching hospital. Seven hundred twenty-five client-owned cats undergoing echocardiographic evaluation. Patient characteristics, including age, breed, clinical signs, type of cardiovascular disease, presence of SEC, and survival time were recorded. Thyroxine, HCT, and blood pressure were recorded when available. Among cats diagnosed with cardiac abnormalities based on echocardiographic findings, those with SEC were at significantly increased risk of death as compared to those without SEC. Cats with dilated cardiomyopathy, unclassified cardiomyopathy, and hypertrophic cardiomyopathy were significantly more likely to have SEC compared to cats with other types of cardiac disease. Cats with cardiomyopathy and SEC have an increased risk of death compared to cats without SEC, although other previously identified factors such as the presence of congestive heart failure and increased left atrium to aorta ratio remain important determinants of mortality. Cats with hypertrophic cardiomyopathy, unclassified cardiomyopathy, and dilated cardiomyopathy may benefit from anticoagulant therapy due to the increased risk of SEC in these subpopulations. © Veterinary Emergency and Critical Care Society 2016.

Predicting device failure after percutaneous repair of functional mitral regurgitation in advanced heart failure: Implications for patient selection.

PubMed

Stolfo, Davide; De Luca, Antonio; Morea, Gaetano; Merlo, Marco; Vitrella, Giancarlo; Caiffa, Thomas; Barbati, Giulia; Rakar, Serena; Korcova, Renata; Perkan, Andrea; Pinamonti, Bruno; Pappalardo, Aniello; Berardini, Alessandra; Biagini, Elena; Saia, Francesco; Grigioni, Francesco; Rapezzi, Claudio; Sinagra, Gianfranco

2018-04-15

Patients with heart failure (HF) and severe symptomatic functional mitral regurgitation (FMR) may benefit from MitraClip implantation. With increasing numbers of patients being treated the success of procedure becomes a key issue. We sought to investigate the pre-procedural predictors of device failure in patients with advanced HF treated with MitraClip. From April 2012 to November 2016, 76 patients with poor functional class (NYHA class III-IV) and severe left ventricular (LV) remodeling underwent MitraClip implantation at University Hospitals of Trieste and Bologna (Italy). Device failure was assessed according to MVARC criteria. Patients were subsequently followed to additionally assess the patient success after 12months. Mean age was 67±12years, the mean Log-EuroSCORE was 23.4±16.5%, and the mean LV end-diastolic volume index and ejection fraction (EF) were 112±33ml/m 2 and 30.6±8.9%, respectively. At short-term evaluation, device failure was observed in 22 (29%) patients. Univariate predictors of device failure were LVEF, LV and left atrial volumes and anteroposterior mitral annulus diameter. Annulus dimension (OR 1.153, 95% CI 1.002-1.327, p=0.043) and LV end-diastolic volume (OR 1.024, 95% CI 1.000-1.049, p=0.049) were the only variables independently associated with the risk of device failure at the multivariate model. Pre-procedural anteroposterior mitral annulus diameter accurately predicted the risk of device failure after MitraClip in the setting of advanced HF. Its assessment might aid the selection of the best candidates to percutaneous correction of FMR. Copyright © 2018 Elsevier B.V. All rights reserved.

Risk Analysis and Prediction of Floor Failure Mechanisms at Longwall Face in Parvadeh-I Coal Mine using Rock Engineering System (RES)

NASA Astrophysics Data System (ADS)

Aghababaei, Sajjad; Saeedi, Gholamreza; Jalalifar, Hossein

2016-05-01

The floor failure at longwall face decreases productivity and safety, increases operation costs, and causes other serious problems. In Parvadeh-I coal mine, the timber is used to prevent the puncture of powered support base into the floor. In this paper, a rock engineering system (RES)-based model is presented to evaluate the risk of floor failure mechanisms at the longwall face of E 2 and W 1 panels. The presented model is used to determine the most probable floor failure mechanism, effective factors, damaged regions and remedial actions. From the analyzed results, it is found that soft floor failure is dominant in the floor failure mechanism at Parvadeh-I coal mine. The average of vulnerability index (VI) for soft, buckling and compressive floor failure mechanisms was estimated equal to 52, 43 and 30 for both panels, respectively. By determining the critical VI for soft floor failure mechanism equal to 54, the percentage of regions with VIs beyond the critical VI in E 2 and W 1 panels is equal to 65.5 and 30, respectively. The percentage of damaged regions showed that the excess amount of used timber to prevent the puncture of weak floor below the powered support base is equal to 4,180,739 kg. RES outputs and analyzed results showed that setting and yielding load of powered supports, length of face, existent water at face, geometry of powered supports, changing the cutting pattern at longwall face and limiting the panels to damaged regions with supercritical VIs could be considered to control the soft floor failure in this mine. The results of this research could be used as a useful tool to identify the damaged regions prior to mining operation at longwall panel for the same conditions.

Comprehensive risk assessment method of catastrophic accident based on complex network properties

NASA Astrophysics Data System (ADS)

Cui, Zhen; Pang, Jun; Shen, Xiaohong

2017-09-01

On the macro level, the structural properties of the network and the electrical characteristics of the micro components determine the risk of cascading failures. And the cascading failures, as a process with dynamic development, not only the direct risk but also potential risk should be considered. In this paper, comprehensively considered the direct risk and potential risk of failures based on uncertain risk analysis theory and connection number theory, quantified uncertain correlation by the node degree and node clustering coefficient, then established a comprehensive risk indicator of failure. The proposed method has been proved by simulation on the actual power grid. Modeling a network according to the actual power grid, and verified the rationality of the proposed method.

Ares-I-X Vehicle Preliminary Range Safety Malfunction Turn Analysis

NASA Technical Reports Server (NTRS)

Beaty, James R.; Starr, Brett R.; Gowan, John W., Jr.

2008-01-01

Ares-I-X is the designation given to the flight test version of the Ares-I rocket (also known as the Crew Launch Vehicle - CLV) being developed by NASA. As part of the preliminary flight plan approval process for the test vehicle, a range safety malfunction turn analysis was performed to support the launch area risk assessment and vehicle destruct criteria development processes. Several vehicle failure scenarios were identified which could cause the vehicle trajectory to deviate from its normal flight path, and the effects of these failures were evaluated with an Ares-I-X 6 degrees-of-freedom (6-DOF) digital simulation, using the Program to Optimize Simulated Trajectories Version 2 (POST2) simulation framework. The Ares-I-X simulation analysis provides output files containing vehicle state information, which are used by other risk assessment and vehicle debris trajectory simulation tools to determine the risk to personnel and facilities in the vicinity of the launch area at Kennedy Space Center (KSC), and to develop the vehicle destruct criteria used by the flight test range safety officer. The simulation analysis approach used for this study is described, including descriptions of the failure modes which were considered and the underlying assumptions and ground rules of the study, and preliminary results are presented, determined by analysis of the trajectory deviation of the failure cases, compared with the expected vehicle trajectory.

Management and risk factors for mortality in very elderly patients with acute myocardial infarction.

PubMed

Renilla, Alfredo; Barreiro, Manuel; Barriales, Vicente; Torres, Francisco; Alvarez, Paloma; Lambert, Jose L

2013-01-01

Elderly patients often remain underrepresented in clinical trials. The aim of our study was to analyze the treatment, clinical outcome and risk factors for mortality in patients aged ≥85 years with ST-segment elevation myocardial infarction (STEMI). From 2005-2011, 102 patients aged ≥85 years with STEMI admitted to a coronary care unit were retrospectively reviewed. Clinical data, treatment and outcome were recorded. Reperfusion strategy and its influence in hospital morbidity and mortality were evaluated. Morbidity was defined as the presence of heart failure (Killip-Kimball >1), arrhythmias, mechanical complications, stroke or major bleeding. Risk factors for mortality were assessed by multivariate analysis. The mean age was 87.5±2.5 years (range 85-96). Therapeutic strategy on admission was: primary-angioplasty (PCI) for 33 patients (32.3%) fibrinolysis for 30 patients (29.4%) and conservative treatment for 35 patients (34.3%). In the four remaining patients, rescue angioplasty was required. A total of 29 patients (28.4%) died, and morbidity was seen in 63 patients (61.7%). The morbidity and mortality rates in the conservative treatment group (77.1% and 48.5%) were higher than that found in the reperfusion strategy group (primary-PCI and fibrinolysis; 53.7% and 17.9%; P=0.02 and P=0.002, respectively). Regarding mortality, the univariate analysis showed that heart failure on admission (P=0.0001) and previous coronary artery disease (P=0.01) were prognostic variables. Only heart failure was an independent risk factor for mortality (odds ratio=3.64, 95% CI 0.78-21.87, P<0.0001). Mortality and morbidity in very elderly patients with STEMI are very high, especially in those not receiving reperfusion therapies. Heart failure on admission was an independent risk factor for hospital mortality. © 2012 Japan Geriatrics Society.

Common-Cause Failure Treatment in Event Assessment: Basis for a Proposed New Model

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

Dana Kelly; Song-Hua Shen; Gary DeMoss

2010-06-01

Event assessment is an application of probabilistic risk assessment in which observed equipment failures and outages are mapped into the risk model to obtain a numerical estimate of the event’s risk significance. In this paper, we focus on retrospective assessments to estimate the risk significance of degraded conditions such as equipment failure accompanied by a deficiency in a process such as maintenance practices. In modeling such events, the basic events in the risk model that are associated with observed failures and other off-normal situations are typically configured to be failed, while those associated with observed successes and unchallenged components aremore » assumed capable of failing, typically with their baseline probabilities. This is referred to as the failure memory approach to event assessment. The conditioning of common-cause failure probabilities for the common cause component group associated with the observed component failure is particularly important, as it is insufficient to simply leave these probabilities at their baseline values, and doing so may result in a significant underestimate of risk significance for the event. Past work in this area has focused on the mathematics of the adjustment. In this paper, we review the Basic Parameter Model for common-cause failure, which underlies most current risk modelling, discuss the limitations of this model with respect to event assessment, and introduce a proposed new framework for common-cause failure, which uses a Bayesian network to model underlying causes of failure, and which has the potential to overcome the limitations of the Basic Parameter Model with respect to event assessment.« less

Evaluation of the Effect of the Volume Throughput and Maximum Flux of Low-Surface-Tension Fluids on Bacterial Penetration of 0.2 Micron-Rated Filters during Process-Specific Filter Validation Testing.

PubMed

Folmsbee, Martha

2015-01-01

Approximately 97% of filter validation tests result in the demonstration of absolute retention of the test bacteria, and thus sterile filter validation failure is rare. However, while Brevundimonas diminuta (B. diminuta) penetration of sterilizing-grade filters is rarely detected, the observation that some fluids (such as vaccines and liposomal fluids) may lead to an increased incidence of bacterial penetration of sterilizing-grade filters by B. diminuta has been reported. The goal of the following analysis was to identify important drivers of filter validation failure in these rare cases. The identification of these drivers will hopefully serve the purpose of assisting in the design of commercial sterile filtration processes with a low risk of filter validation failure for vaccine, liposomal, and related fluids. Filter validation data for low-surface-tension fluids was collected and evaluated with regard to the effect of bacterial load (CFU/cm(2)), bacterial load rate (CFU/min/cm(2)), volume throughput (mL/cm(2)), and maximum filter flux (mL/min/cm(2)) on bacterial penetration. The data set (∼1162 individual filtrations) included all instances of process-specific filter validation failures performed at Pall Corporation, including those using other filter media, but did not include all successful retentive filter validation bacterial challenges. It was neither practical nor necessary to include all filter validation successes worldwide (Pall Corporation) to achieve the goals of this analysis. The percentage of failed filtration events for the selected total master data set was 27% (310/1162). Because it is heavily weighted with penetration events, this percentage is considerably higher than the actual rate of failed filter validations, but, as such, facilitated a close examination of the conditions that lead to filter validation failure. In agreement with our previous reports, two of the significant drivers of bacterial penetration identified were the total bacterial load and the bacterial load rate. In addition to these parameters, another three possible drivers of failure were also identified: volume throughput, maximum filter flux, and pressure. Of the data for which volume throughput information was available, 24% (249/1038) of the filtrations resulted in penetration. However, for the volume throughput range of 680-2260 mL/cm(2), only 9 out of 205 bacterial challenges (∼4%) resulted in penetration. Of the data for which flux information was available, 22% (212/946) resulted in bacterial penetration. However, in the maximum filter flux range from 7 to 18 mL/min/cm(2), only one out of 121 filtrations (0.6%) resulted in penetration. A slight increase in filter failure was observed in filter bacterial challenges with a differential pressure greater than 30 psid. When designing a commercial process for the sterile filtration of a low-surface-tension fluid (or any other potentially high-risk fluid), targeting the volume throughput range of 680-2260 mL/cm(2) or flux range of 7-18 mL/min/cm(2), and maintaining the differential pressure below 30 psid, could significantly decrease the risk of validation filter failure. However, it is important to keep in mind that these are general trends described in this study and some test fluids may not conform to the general trends described here. Ultimately, it is important to evaluate both filterability and bacterial retention of the test fluid under proposed process conditions prior to finalizing the manufacturing process to ensure successful process-specific filter validation of low-surface-tension fluids. An overwhelming majority of process-specific filter validation (qualification) tests result in the demonstration of absolute retention of test bacteria by sterilizing-grade membrane filters. As such, process-specific filter validation failure is rare. However, while bacterial penetration of sterilizing-grade filters during process-specific filter validation is rarely detected, some fluids (such as vaccines and liposomal fluids) have been associated with an increased incidence of bacterial penetration. The goal of the following analysis was to identify important drivers of process-specific filter validation failure. The identification of these drivers will possibly serve to assist in the design of commercial sterile filtration processes with a low risk of filter validation failure. Filter validation data for low-surface-tension fluids was collected and evaluated with regard to bacterial concentration and rates, as well as filtered fluid volume and rate (Pall Corporation). The master data set (∼1160 individual filtrations) included all recorded instances of process-specific filter validation failures but did not include all successful filter validation bacterial challenge tests. This allowed for a close examination of the conditions that lead to process-specific filter validation failure. As previously reported, two significant drivers of bacterial penetration were identified: the total bacterial load (the total number of bacteria per filter) and the bacterial load rate (the rate at which bacteria were applied to the filter). In addition to these parameters, another three possible drivers of failure were also identified: volumetric throughput, filter flux, and pressure. When designing a commercial process for the sterile filtration of a low-surface-tension fluid (or any other penetrative-risk fluid), targeting the identified bacterial challenge loads, volume throughput, and corresponding flux rates could decrease, and possibly eliminate, the risk of validation filter failure. However, it is important to keep in mind that these are general trends described in this study and some test fluids may not conform to the general trends described here. Ultimately, it is important to evaluate both filterability and bacterial retention of the test fluid under proposed process conditions prior to finalizing the manufacturing process to ensure successful filter validation of low-surface-tension fluids. © PDA, Inc. 2015.

First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases.

PubMed

Richter-Schrag, Hans-Jürgen; Glatz, Torben; Walker, Christine; Fischer, Andreas; Thimme, Robert

2016-11-07

To evaluate rebleeding, primary failure (PF) and mortality of patients in whom over-the-scope clips (OTSCs) were used as first-line and second-line endoscopic treatment (FLET, SLET) of upper and lower gastrointestinal bleeding (UGIB, LGIB). A retrospective analysis of a prospectively collected database identified all patients with UGIB and LGIB in a tertiary endoscopic referral center of the University of Freiburg, Germany, from 04-2012 to 05-2016 ( n = 93) who underwent FLET and SLET with OTSCs. The complete Rockall risk scores were calculated from patients with UGIB. The scores were categorized as < or ≥ 7 and were compared with the original Rockall data. Differences between FLET and SLET were calculated. Univariate and multivariate analysis were performed to evaluate the factors that influenced rebleeding after OTSC placement. Primary hemostasis and clinical success of bleeding lesions (without rebleeding) was achieved in 88/100 (88%) and 78/100 (78%), respectively. PF was significantly lower when OTSCs were applied as FLET compared to SLET (4.9% vs 23%, P = 0.008). In multivariate analysis, patients who had OTSC placement as SLET had a significantly higher rebleeding risk compared to those who had FLET (OR 5.3; P = 0.008). Patients with Rockall risk scores ≥ 7 had a significantly higher in-hospital mortality compared to those with scores < 7 (35% vs 10%, P = 0.034). No significant differences were observed in patients with scores < or ≥ 7 in rebleeding and rebleeding-associated mortality. Our data show for the first time that FLET with OTSC might be the best predictor to successfully prevent rebleeding of gastrointestinal bleeding compared to SLET. The type of treatment determines the success of primary hemostasis or primary failure.

Reflex cough PEF as a predictor of successful extubation in neurological patients*

PubMed Central

Kutchak, Fernanda Machado; Debesaitys, Andressa Maciel; Rieder, Marcelo de Mello; Meneguzzi, Carla; Skueresky, Amanda Soares; Alberto, Luiz; Bianchin, Marino Muxfeldt

2015-01-01

Abstract Objective: To evaluate the use of reflex cough PEF as a predictor of successful extubation in neurological patients who were candidates for weaning from mechanical ventilation. Methods: This was a cross-sectional study of 135 patients receiving mechanical ventilation for more than 24 h in the ICU of Cristo Redentor Hospital, in the city of Porto Alegre, Brazil. Reflex cough PEF, the rapid shallow breathing index, MIP, and MEP were measured, as were ventilatory, hemodynamic, and clinical parameters. Results: The mean age of the patients was 47.8 ± 17 years. The extubation failure rate was 33.3%. A reflex cough PEF of < 80 L/min showed a relative risk of 3.6 (95% CI: 2.0-6.7), and the final Glasgow Coma Scale score showed a relative risk of 0.64 (95% CI: 0.51-0.83). For every 1-point increase in a Glasgow Coma Scale score of 8, there was a 36% reduction in the risk of extubation failure. Conclusions: Reflex cough PEF and the Glasgow Coma Scale score are independent predictors of extubation failure in neurological patients admitted to the ICU. PMID:26398756

Establishing a preoperative evaluation system for lumboperitoneal shunt: Approach to attenuate the risk of shunt failure.

PubMed

Sun, Tong; Yuan, Yikai; Zhang, Qiuming; Zhou, Yicheng; Li, Xuepei; Yu, Hang; Tian, Meng; Guan, Junwen

2018-06-12

Lumboperitoneal shunt (LPS) has been demonstrated an effective method for the treatment of communicating hydrocephalus in the presence of frequent shunt failure. To determine if establishing a preoperative evaluation system could benefit patients thus attenuating the risk of LPS failure. In this three-year study, treated by LPS, patients undergoing preoperative evaluation were included into study group and others without preoperative evaluation were included into control group. Perioperative conditions, including Keifer's hydrocephalus score (KHS), symptomatic control rate (SCR), Evans index, complications, long-term shunt revision rate, and quality of life (QOL), were synchronously investigated. 93 eligible patients were included in the study (study group: 51, control group: 42). The baseline characteristics of two groups were basically similar. The results showed patients in study group had better short-term improvement in symptoms and imageology, including higher SCR (Median, 62.5% vs 50%, P=0.001), more reduction in Evans index (0.08±0.05 vs 0.05±0.04, P=0.002), and lower incidence of postoperative complications (Median, 35.3% vs 57.1%, P=0.04). Similarly, the incidence of shunt revision in study group was dramatically lower than control group (Median, 15.7% vs 40.9%, P=0.006) in line with the revision-free curve (P=0.002), in which suggested most of patients received revision, if needed, within 3 months. Additionally, patients in study group had better QOL. In conclusion, patients who underwent the evaluation before LPS had better short-term and long-term outcomes, suggesting it would be a promising strategy to correctly select patients for LPS with prolonged favorable shunt outcomes. Copyright © 2018 Elsevier Inc. All rights reserved.

Prediction of muscle performance during dynamic repetitive movement

NASA Technical Reports Server (NTRS)

Byerly, D. L.; Byerly, K. A.; Sognier, M. A.; Squires, W. G.

2003-01-01

BACKGROUND: During long-duration spaceflight, astronauts experience progressive muscle atrophy and often perform strenuous extravehicular activities. Post-flight, there is a lengthy recovery period with an increased risk for injury. Currently, there is a critical need for an enabling tool to optimize muscle performance and to minimize the risk of injury to astronauts while on-orbit and during post-flight recovery. Consequently, these studies were performed to develop a method to address this need. METHODS: Eight test subjects performed a repetitive dynamic exercise to failure at 65% of their upper torso weight using a Lordex spinal machine. Surface electromyography (SEMG) data was collected from the erector spinae back muscle. The SEMG data was evaluated using a 5th order autoregressive (AR) model and linear regression analysis. RESULTS: The best predictor found was an AR parameter, the mean average magnitude of AR poles, with r = 0.75 and p = 0.03. This parameter can predict performance to failure as early as the second repetition of the exercise. CONCLUSION: A method for predicting human muscle performance early during dynamic repetitive exercise was developed. The capability to predict performance to failure has many potential applications to the space program including evaluating countermeasure effectiveness on-orbit, optimizing post-flight recovery, and potential future real-time monitoring capability during extravehicular activity.

A tri-reference point theory of decision making under risk.

PubMed

Wang, X T; Johnson, Joseph G

2012-11-01

The tri-reference point (TRP) theory takes into account minimum requirements (MR), the status quo (SQ), and goals (G) in decision making under risk. The 3 reference points demarcate risky outcomes and risk perception into 4 functional regions: success (expected value of x ≥ G), gain (SQ < × < G), loss (MR ≤ x < SQ), and failure (x < MR). The psychological impact of achieving or failing to achieve these reference points is rank ordered as MR > G > SQ. We present TRP assumptions and value functions and a mathematical formalization of the theory. We conducted empirical tests of crucial TRP predictions using both explicit and implicit reference points. We show that decision makers consider both G and MR and give greater weight to MR than G, indicating failure aversion (i.e., the disutility of a failure is greater than the utility of a success in the same task) in addition to loss aversion (i.e., the disutility of a loss is greater than the utility of the same amount of gain). Captured by a double-S shaped value function with 3 inflection points, risk preferences switched between risk seeking and risk aversion when the distribution of a gamble straddled a different reference point. The existence of MR (not G) significantly shifted choice preference toward risk aversion even when the outcome distribution of a gamble was well above the MR. Single reference point based models such as prospect theory cannot consistently account for these findings. The TRP theory provides simple guidelines for evaluating risky choices for individuals and organizational management. (PsycINFO Database Record (c) 2012 APA, all rights reserved).

Prediction of mode of death in heart failure: the Seattle Heart Failure Model.

PubMed

Mozaffarian, Dariush; Anker, Stefan D; Anand, Inder; Linker, David T; Sullivan, Mark D; Cleland, John G F; Carson, Peter E; Maggioni, Aldo P; Mann, Douglas L; Pitt, Bertram; Poole-Wilson, Philip A; Levy, Wayne C

2007-07-24

Prognosis and mode of death in heart failure patients are highly variable in that some patients die suddenly (often from ventricular arrhythmia) and others die of progressive failure of cardiac function (pump failure). Prediction of mode of death may facilitate decisions about specific medications or devices. We used the Seattle Heart Failure Model (SHFM), a validated prediction model for total mortality in heart failure, to assess the mode of death in 10,538 ambulatory patients with New York Heart Association class II to IV heart failure and predominantly systolic dysfunction enrolled in 6 randomized trials or registries. During 16,735 person-years of follow-up, 2014 deaths occurred, which included 1014 sudden deaths and 684 pump-failure deaths. Compared with a SHFM score of 0, patients with a score of 1 had a 50% higher risk of sudden death, patients with a score of 2 had a nearly 3-fold higher risk, and patients with a score of 3 or 4 had a nearly 7-fold higher risk (P<0.001 for all comparisons; 1-year area under the receiver operating curve, 0.68). Stratification of risk of pump-failure death was even more pronounced, with a 4-fold higher risk with a score of 1, a 15-fold higher risk with a score of 2, a 38-fold higher risk with a score of 3, and an 88-fold higher risk with a score of 4 (P<0.001 for all comparisons; 1-year area under the receiver operating curve, 0.85). The proportion of deaths caused by sudden death versus pump-failure death decreased from a ratio of 7:1 with a SHFM score of 0 to a ratio of 1:2 with a SHFM score of 4 (P trend <0.001). The SHFM score provides information about the likely mode of death among ambulatory heart failure patients. Investigation is warranted to determine whether such information might predict responses to or cost-effectiveness of specific medications or devices in heart failure patients.

An Evaluation of Graduates of a Toddlerhood Home Visiting Program at Kindergarten Age

ERIC Educational Resources Information Center

Allen, LaRue; Sethi, Anita; Astuto, Jennifer

2007-01-01

Overview: A recent evaluation of children who had participated in the Parent-Child Home Program (PCHP) as toddlers found that at kindergarten age, these children were performing at levels expected for their age, despite the fact that they had multiple factors putting them at risk for school failure. The Study: In the winter and spring of 2002, 135…

Identifying the necessary and sufficient number of risk factors for predicting academic failure.

PubMed

Lucio, Robert; Hunt, Elizabeth; Bornovalova, Marina

2012-03-01

Identifying the point at which individuals become at risk for academic failure (grade point average [GPA] < 2.0) involves an understanding of which and how many factors contribute to poor outcomes. School-related factors appear to be among the many factors that significantly impact academic success or failure. This study focused on 12 school-related factors. Using a thorough 5-step process, we identified which unique risk factors place one at risk for academic failure. Academic engagement, academic expectations, academic self-efficacy, homework completion, school relevance, school safety, teacher relationships (positive relationship), grade retention, school mobility, and school misbehaviors (negative relationship) were uniquely related to GPA even after controlling for all relevant covariates. Next, a receiver operating characteristic curve was used to determine a cutoff point for determining how many risk factors predict academic failure (GPA < 2.0). Results yielded a cutoff point of 2 risk factors for predicting academic failure, which provides a way for early identification of individuals who are at risk. Further implications of these findings are discussed. PsycINFO Database Record (c) 2012 APA, all rights reserved.

The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management

PubMed Central

Patel, Teresa; Fisher, Stanley P.

2016-01-01

Objective This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. Methods The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks. Results Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest‐ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy. Conclusions The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success. PMID:27477689

Interim reliability-evaluation program: analysis of the Browns Ferry, Unit 1, nuclear plant. Appendix C - sequence quantification

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

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

1982-07-01

This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix C generally describes the methods used to estimate accident sequence frequency values. Information is presented concerning the approach, example collection, failure data, candidate dominant sequences, uncertainty analysis, and sensitivity analysis.

Dipeptidyl Peptidase-4 Inhibitors and Heart Failure Exacerbation in the Veteran Population: An Observational Study.

PubMed

Cobretti, Michael R; Bowman, Benjamin; Grabarczyk, Ted; Potter, Emily

2018-03-01

The dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors) are effective modulators of fasting and postprandial hyperglycemia in patients with type 2 diabetes mellitus (T2DM). In 2013 the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus-Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53) clinical trial found an increased risk of heart failure exacerbation, as a secondary outcome, among patients treated with saxagliptin. This study examines the safety of DPP-4 inhibitors as a class in T2DM in relation to risk of heart failure exacerbations. Retrospective cohort study of two groups of patients using data from the national Department of Veteran's Affairs (VA) Health Care System: patients initially prescribed DPP-4 inhibitors with or without second-generation sulfonylureas and/or metformin (exposed group) compared with patients initially prescribed only second-generation sulfonylureas and/or metformin (unexposed group) between August 1, 2013, and August 30, 2016. The primary aim of this study was to determine the difference in 1-year heart failure exacerbation rate in patients with T2DM between the exposed and unexposed groups. Data were analyzed using the χ 2 Student t test and Kaplan-Meier analysis. Significance was set at p<0.05. The study evaluated 672,265 patients: 33,614 patients in the exposed group and 638,651 patients in the unexposed group. Overall, 130 (0.38%) heart failure exacerbations were documented in the exposed group, and 2222 (0.34%) heart failure exacerbations were documented in the unexposed group; the difference in exacerbation rate was nonsignificant between groups (p=0.24). In a subgroup analysis of patients with a baseline diagnosis of heart failure, the difference in rate of heart failure exacerbations remained nonsignificant (p=0.334). Patients in the veteran population with T2DM treated with DPP-4 inhibitors did not demonstrate a significant increase in risk for heart failure exacerbation, regardless of whether a patient had been previously diagnosed with heart failure. This finding potentially supports safe usage of DPP-4 inhibitors in this patient population regardless of heart failure diagnosis. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

Prognostic Significance of Baseline Serum Sodium in Heart Failure With Preserved Ejection Fraction.

PubMed

Patel, Yash R; Kurgansky, Katherine E; Imran, Tasnim F; Orkaby, Ariela R; McLean, Robert R; Ho, Yuk-Lam; Cho, Kelly; Gaziano, J Michael; Djousse, Luc; Gagnon, David R; Joseph, Jacob

2018-06-13

The purpose of this study was to evaluate the relationship between serum sodium at the time of diagnosis and long term clinical outcomes in a large national cohort of patients with heart failure with preserved ejection fraction. We studied 25 440 patients with heart failure with preserved ejection fraction treated at Veterans Affairs medical centers across the United States between 2002 and 2012. Serum sodium at the time of heart failure diagnosis was analyzed as a continuous variable and in categories as follows: low (115.00-134.99 mmol/L), low-normal (135.00-137.99 mmol/L), referent group (138.00-140.99 mmol/L), high normal (141.00-143.99 mmol/L), and high (144.00-160.00 mmol/L). Multivariable Cox regression and negative binomial regression were performed to estimate hazard ratios (95% confidence interval [CI]) and incidence density ratios (95% CI) for the associations of serum sodium with mortality and hospitalizations (heart failure and all-cause), respectively. The average age of patients was 70.8 years, 96.2% were male, and 14% were black. Compared with the referent group, low, low-normal, and high sodium values were associated with 36% (95% CI, 28%-44%), 6% (95% CI, 1%-12%), and 9% (95% CI, 1%-17%) higher risk of all-cause mortality, respectively. Low and low-normal serum sodium were associated with 48% (95% CI, 10%-100%) and 38% (95% CI, 8%-77%) higher risk of number of days of heart failure hospitalizations per year, and with 44% (95% CI, 32%-56%) and 18% (95% CI, 10%-27%) higher risk of number of days of all-cause hospitalizations per year, respectively. Both elevated and reduced serum sodium, including values currently considered within normal range, are associated with adverse outcomes in patients with heart failure with preserved ejection fraction. © 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.

Super Learner Analysis of Electronic Adherence Data Improves Viral Prediction and May Provide Strategies for Selective HIV RNA Monitoring.

PubMed

Petersen, Maya L; LeDell, Erin; Schwab, Joshua; Sarovar, Varada; Gross, Robert; Reynolds, Nancy; Haberer, Jessica E; Goggin, Kathy; Golin, Carol; Arnsten, Julia; Rosen, Marc I; Remien, Robert H; Etoori, David; Wilson, Ira B; Simoni, Jane M; Erlen, Judith A; van der Laan, Mark J; Liu, Honghu; Bangsberg, David R

2015-05-01

Regular HIV RNA testing for all HIV-positive patients on antiretroviral therapy (ART) is expensive and has low yield since most tests are undetectable. Selective testing of those at higher risk of failure may improve efficiency. We investigated whether a novel analysis of adherence data could correctly classify virological failure and potentially inform a selective testing strategy. Multisite prospective cohort consortium. We evaluated longitudinal data on 1478 adult patients treated with ART and monitored using the Medication Event Monitoring System (MEMS) in 16 US cohorts contributing to the MACH14 consortium. Because the relationship between adherence and virological failure is complex and heterogeneous, we applied a machine-learning algorithm (Super Learner) to build a model for classifying failure and evaluated its performance using cross-validation. Application of the Super Learner algorithm to MEMS data, combined with data on CD4 T-cell counts and ART regimen, significantly improved classification of virological failure over a single MEMS adherence measure. Area under the receiver operating characteristic curve, evaluated on data not used in model fitting, was 0.78 (95% confidence interval: 0.75 to 0.80) and 0.79 (95% confidence interval: 0.76 to 0.81) for failure defined as single HIV RNA level >1000 copies per milliliter or >400 copies per milliliter, respectively. Our results suggest that 25%-31% of viral load tests could be avoided while maintaining sensitivity for failure detection at or above 95%, for a cost savings of $16-$29 per person-month. Our findings provide initial proof of concept for the potential use of electronic medication adherence data to reduce costs through behavior-driven HIV RNA testing.

Super learner analysis of electronic adherence data improves viral prediction and may provide strategies for selective HIV RNA monitoring

PubMed Central

Petersen, Maya L.; LeDell, Erin; Schwab, Joshua; Sarovar, Varada; Gross, Robert; Reynolds, Nancy; Haberer, Jessica E.; Goggin, Kathy; Golin, Carol; Arnsten, Julia; Rosen, Marc; Remien, Robert; Etoori, David; Wilson, Ira; Simoni, Jane M.; Erlen, Judith A.; van der Laan, Mark J.; Liu, Honghu; Bangsberg, David R

2015-01-01

Objective Regular HIV RNA testing for all HIV positive patients on antiretroviral therapy (ART) is expensive and has low yield since most tests are undetectable. Selective testing of those at higher risk of failure may improve efficiency. We investigated whether a novel analysis of adherence data could correctly classify virological failure and potentially inform a selective testing strategy. Design Multisite prospective cohort consortium. Methods We evaluated longitudinal data on 1478 adult patients treated with ART and monitored using the Medication Event Monitoring System (MEMS) in 16 United States cohorts contributing to the MACH14 consortium. Since the relationship between adherence and virological failure is complex and heterogeneous, we applied a machine-learning algorithm (Super Learner) to build a model for classifying failure and evaluated its performance using cross-validation. Results Application of the Super Learner algorithm to MEMS data, combined with data on CD4+ T cell counts and ART regimen, significantly improved classification of virological failure over a single MEMS adherence measure. Area under the ROC curve, evaluated on data not used in model fitting, was 0.78 (95% CI: 0.75, 0.80) and 0.79 (95% CI: 0.76, 0.81) for failure defined as single HIV RNA level >1000 copies/ml or >400 copies/ml, respectively. Our results suggest 25–31% of viral load tests could be avoided while maintaining sensitivity for failure detection at or above 95%, for a cost savings of $16–$29 per person-month. Conclusions Our findings provide initial proof-of-concept for the potential use of electronic medication adherence data to reduce costs through behavior-driven HIV RNA testing. PMID:25942462

Personnel reliability impact on petrochemical facilities monitoring system's failure skipping probability

NASA Astrophysics Data System (ADS)

Kostyukov, V. N.; Naumenko, A. P.

2017-08-01

The paper dwells upon urgent issues of evaluating impact of actions conducted by complex technological systems operators on their safe operation considering application of condition monitoring systems for elements and sub-systems of petrochemical production facilities. The main task for the research is to distinguish factors and criteria of monitoring system properties description, which would allow to evaluate impact of errors made by personnel on operation of real-time condition monitoring and diagnostic systems for machinery of petrochemical facilities, and find and objective criteria for monitoring system class, considering a human factor. On the basis of real-time condition monitoring concepts of sudden failure skipping risk, static and dynamic error, monitoring systems, one may solve a task of evaluation of impact that personnel's qualification has on monitoring system operation in terms of error in personnel or operators' actions while receiving information from monitoring systems and operating a technological system. Operator is considered as a part of the technological system. Although, personnel's behavior is usually a combination of the following parameters: input signal - information perceiving, reaction - decision making, response - decision implementing. Based on several researches on behavior of nuclear powers station operators in USA, Italy and other countries, as well as on researches conducted by Russian scientists, required data on operator's reliability were selected for analysis of operator's behavior at technological facilities diagnostics and monitoring systems. The calculations revealed that for the monitoring system selected as an example, the failure skipping risk for the set values of static (less than 0.01) and dynamic (less than 0.001) errors considering all related factors of data on reliability of information perception, decision-making, and reaction fulfilled is 0.037, in case when all the facilities and error probability are under control - not more than 0.027. In case when only pump and compressor units are under control, the failure skipping risk is not more than 0.022, when the probability of error in operator's action is not more than 0.011. The work output shows that on the basis of the researches results an assessment of operators' reliability can be made in terms of almost any kind of production, but considering only technological capabilities, since operators' psychological and general training considerable vary in different production industries. Using latest technologies of engineering psychology and design of data support systems, situation assessment systems, decision-making and responding system, as well as achievement in condition monitoring in various production industries one can evaluate hazardous condition skipping risk probability considering static, dynamic errors and human factor.

Development of an Electronic Medical Record Based Alert for Risk of HIV Treatment Failure in a Low-Resource Setting

PubMed Central

Puttkammer, Nancy; Zeliadt, Steven; Balan, Jean Gabriel; Baseman, Janet; Destiné, Rodney; Domerçant, Jean Wysler; France, Garilus; Hyppolite, Nathaelf; Pelletier, Valérie; Raphael, Nernst Atwood; Sherr, Kenneth; Yuhas, Krista; Barnhart, Scott

2014-01-01

Background The adoption of electronic medical record systems in resource-limited settings can help clinicians monitor patients' adherence to HIV antiretroviral therapy (ART) and identify patients at risk of future ART failure, allowing resources to be targeted to those most at risk. Methods Among adult patients enrolled on ART from 2005–2013 at two large, public-sector hospitals in Haiti, ART failure was assessed after 6–12 months on treatment, based on the World Health Organization's immunologic and clinical criteria. We identified models for predicting ART failure based on ART adherence measures and other patient characteristics. We assessed performance of candidate models using area under the receiver operating curve, and validated results using a randomly-split data sample. The selected prediction model was used to generate a risk score, and its ability to differentiate ART failure risk over a 42-month follow-up period was tested using stratified Kaplan Meier survival curves. Results Among 923 patients with CD4 results available during the period 6–12 months after ART initiation, 196 (21.2%) met ART failure criteria. The pharmacy-based proportion of days covered (PDC) measure performed best among five possible ART adherence measures at predicting ART failure. Average PDC during the first 6 months on ART was 79.0% among cases of ART failure and 88.6% among cases of non-failure (p<0.01). When additional information including sex, baseline CD4, and duration of enrollment in HIV care prior to ART initiation were added to PDC, the risk score differentiated between those who did and did not meet failure criteria over 42 months following ART initiation. Conclusions Pharmacy data are most useful for new ART adherence alerts within iSanté. Such alerts offer potential to help clinicians identify patients at high risk of ART failure so that they can be targeted with adherence support interventions, before ART failure occurs. PMID:25390044

Development of an electronic medical record based alert for risk of HIV treatment failure in a low-resource setting.

PubMed

Puttkammer, Nancy; Zeliadt, Steven; Balan, Jean Gabriel; Baseman, Janet; Destiné, Rodney; Domerçant, Jean Wysler; France, Garilus; Hyppolite, Nathaelf; Pelletier, Valérie; Raphael, Nernst Atwood; Sherr, Kenneth; Yuhas, Krista; Barnhart, Scott

2014-01-01

The adoption of electronic medical record systems in resource-limited settings can help clinicians monitor patients' adherence to HIV antiretroviral therapy (ART) and identify patients at risk of future ART failure, allowing resources to be targeted to those most at risk. Among adult patients enrolled on ART from 2005-2013 at two large, public-sector hospitals in Haiti, ART failure was assessed after 6-12 months on treatment, based on the World Health Organization's immunologic and clinical criteria. We identified models for predicting ART failure based on ART adherence measures and other patient characteristics. We assessed performance of candidate models using area under the receiver operating curve, and validated results using a randomly-split data sample. The selected prediction model was used to generate a risk score, and its ability to differentiate ART failure risk over a 42-month follow-up period was tested using stratified Kaplan Meier survival curves. Among 923 patients with CD4 results available during the period 6-12 months after ART initiation, 196 (21.2%) met ART failure criteria. The pharmacy-based proportion of days covered (PDC) measure performed best among five possible ART adherence measures at predicting ART failure. Average PDC during the first 6 months on ART was 79.0% among cases of ART failure and 88.6% among cases of non-failure (p<0.01). When additional information including sex, baseline CD4, and duration of enrollment in HIV care prior to ART initiation were added to PDC, the risk score differentiated between those who did and did not meet failure criteria over 42 months following ART initiation. Pharmacy data are most useful for new ART adherence alerts within iSanté. Such alerts offer potential to help clinicians identify patients at high risk of ART failure so that they can be targeted with adherence support interventions, before ART failure occurs.

B-type natriuretic peptide-guided treatment for heart failure.

PubMed

McLellan, Julie; Heneghan, Carl J; Perera, Rafael; Clements, Alison M; Glasziou, Paul P; Kearley, Karen E; Pidduck, Nicola; Roberts, Nia W; Tyndel, Sally; Wright, F Lucy; Bankhead, Clare

2016-12-22

Heart failure is a condition in which the heart does not pump enough blood to meet all the needs of the body. Symptoms of heart failure include breathlessness, fatigue and fluid retention. Outcomes for patients with heart failure are highly variable; however on average, these patients have a poor prognosis. Prognosis can be improved with early diagnosis and appropriate use of medical treatment, use of devices and transplantation. Patients with heart failure are high users of healthcare resources, not only due to drug and device treatments, but due to high costs of hospitalisation care. B-type natriuretic peptide levels are already used as biomarkers for diagnosis and prognosis of heart failure, but could offer to clinicians a possible tool to guide drug treatment. This could optimise drug management in heart failure patients whilst allaying concerns over potential side effects due to drug intolerance. To assess whether treatment guided by serial BNP or NT-proBNP (collectively referred to as NP) monitoring improves outcomes compared with treatment guided by clinical assessment alone. Searches were conducted up to 15 March 2016 in the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library; MEDLINE (OVID), Embase (OVID), the Database of Abstracts of Reviews of Effects (DARE) and the NHS Economic Evaluation Database in the Cochrane Library. Searches were also conducted in the Science Citation Index Expanded, the Conference Proceedings Citation Index on Web of Science (Thomson Reuters), World Health Organization International Clinical Trials Registry and ClinicalTrials.gov. We applied no date or language restrictions. We included randomised controlled trials of NP-guided treatment of heart failure versus treatment guided by clinical assessment alone with no restriction on follow-up. Adults treated for heart failure, in both in-hospital and out-of-hospital settings, and trials reporting a clinical outcome were included. Two review authors independently selected studies for inclusion, extracted data and evaluated risk of bias. Risk ratios (RR) were calculated for dichotomous data, and pooled mean differences (MD) (with 95% confidence intervals (CI)) were calculated for continuous data. We contacted trial authors to obtain missing data. Using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach, we assessed the quality of the evidence and GRADE profiler (GRADEPRO) was used to import data from Review Manager to create a 'Summary of findings' table. We included 18 randomised controlled trials with 3660 participants (range of mean age: 57 to 80 years) comparing NP-guided treatment with clinical assessment alone. The evidence for all-cause mortality using NP-guided treatment showed uncertainty (RR 0.87, 95% CI 0.76 to 1.01; patients = 3169; studies = 15; low quality of the evidence), and for heart failure mortality (RR 0.84, 95% CI 0.54 to 1.30; patients = 853; studies = 6; low quality of evidence).The evidence suggested heart failure admission was reduced by NP-guided treatment (38% versus 26%, RR 0.70, 95% CI 0.61 to 0.80; patients = 1928; studies = 10; low quality of evidence), but the evidence showed uncertainty for all-cause admission (57% versus 53%, RR 0.93, 95% CI 0.84 to 1.03; patients = 1142; studies = 6; low quality of evidence).Six studies reported on adverse events, however the results could not be pooled (patients = 1144; low quality of evidence). Only four studies provided cost of treatment results, three of these studies reported a lower cost for NP-guided treatment, whilst one reported a higher cost (results were not pooled; patients = 931, low quality of evidence). The evidence showed uncertainty for quality of life data (MD -0.03, 95% CI -1.18 to 1.13; patients = 1812; studies = 8; very low quality of evidence).We completed a 'Risk of bias' assessment for all studies. The impact of risk of bias from lack of blinding of outcome assessment and high attrition levels was examined by restricting analyses to only low 'Risk of bias' studies. In patients with heart failure low-quality evidence showed a reduction in heart failure admission with NP-guided treatment while low-quality evidence showed uncertainty in the effect of NP-guided treatment for all-cause mortality, heart failure mortality, and all-cause admission. Uncertainty in the effect was further shown by very low-quality evidence for patient's quality of life. The evidence for adverse events and cost of treatment was low quality and we were unable to pool results.

Evaluating the Benefits of Adaptation of Critical Infrastructures to Hydrometeorological Risks.

PubMed

Thacker, Scott; Kelly, Scott; Pant, Raghav; Hall, Jim W

2018-01-01

Infrastructure adaptation measures provide a practical way to reduce the risk from extreme hydrometeorological hazards, such as floods and windstorms. The benefit of adapting infrastructure assets is evaluated as the reduction in risk relative to the "do nothing" case. However, evaluating the full benefits of risk reduction is challenging because of the complexity of the systems, the scarcity of data, and the uncertainty of future climatic changes. We address this challenge by integrating methods from the study of climate adaptation, infrastructure systems, and complex networks. In doing so, we outline an infrastructure risk assessment that incorporates interdependence, user demands, and potential failure-related economic losses. Individual infrastructure assets are intersected with probabilistic hazard maps to calculate expected annual damages. Protection measure costs are integrated to calculate risk reduction and associated discounted benefits, which are used to explore the business case for investment in adaptation. A demonstration of the methodology is provided for flood protection of major electricity substations in England and Wales. We conclude that the ongoing adaptation program for major electricity assets is highly cost beneficial. © 2017 Society for Risk Analysis.

Dynamic loads during failure risk assessment of bridge crane structures

NASA Astrophysics Data System (ADS)

Gorynin, A. D.; Antsev, V. Yu; Shaforost, A. N.

2018-03-01

The paper presents the method of failure risk assessment associated with a bridge crane metal structure at the design stage. It also justifies the necessity of taking into account dynamic loads with regard to the operational cycle of a bridge crane during failure risk assessment of its metal structure.

46 CFR 308.516 - Failure to comply with Clause 21.

Code of Federal Regulations, 2014 CFR

2014-10-01

... 46 Shipping 8 2014-10-01 2014-10-01 false Failure to comply with Clause 21. 308.516 Section 308.516 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Cargo Insurance Open Policy War Risk Cargo Insurance § 308.516 Failure to comply with...

A Big Data Analysis Approach for Rail Failure Risk Assessment.

PubMed

Jamshidi, Ali; Faghih-Roohi, Shahrzad; Hajizadeh, Siamak; Núñez, Alfredo; Babuska, Robert; Dollevoet, Rolf; Li, Zili; De Schutter, Bart

2017-08-01

Railway infrastructure monitoring is a vital task to ensure rail transportation safety. A rail failure could result in not only a considerable impact on train delays and maintenance costs, but also on safety of passengers. In this article, the aim is to assess the risk of a rail failure by analyzing a type of rail surface defect called squats that are detected automatically among the huge number of records from video cameras. We propose an image processing approach for automatic detection of squats, especially severe types that are prone to rail breaks. We measure the visual length of the squats and use them to model the failure risk. For the assessment of the rail failure risk, we estimate the probability of rail failure based on the growth of squats. Moreover, we perform severity and crack growth analyses to consider the impact of rail traffic loads on defects in three different growth scenarios. The failure risk estimations are provided for several samples of squats with different crack growth lengths on a busy rail track of the Dutch railway network. The results illustrate the practicality and efficiency of the proposed approach. © 2017 The Authors Risk Analysis published by Wiley Periodicals, Inc. on behalf of Society for Risk Analysis.

Risk factors for heart failure in patients with type 2 diabetes mellitus and stage 4 chronic kidney disease treated with bardoxolone methyl.

PubMed

Chin, Melanie P; Wrolstad, Danielle; Bakris, George L; Chertow, Glenn M; de Zeeuw, Dick; Goldsberry, Angie; Linde, Peter G; McCullough, Peter A; McMurray, John J; Wittes, Janet; Meyer, Colin J

2014-12-01

A phase 3 randomized clinical trial was designed to test whether bardoxolone methyl, a nuclear factor erythroid-2-related factor 2 (Nrf2) activator, slows progression to end-stage renal disease in patients with stage 4 chronic kidney disease and type 2 diabetes mellitus. The trial was terminated because of an increase in heart failure in the bardoxolone methyl group; many of the events were clinically associated with fluid retention. We randomized 2,185 patients with type 2 diabetes mellitus (T2DM) and stage 4 chronic kidney disease (CKD) (estimated glomerular filtration rate 15 to <30 mL min(-1) 1.73 m(-2)) to once-daily bardoxolone methyl (20 mg) or placebo. We used classification and regression tree analysis to identify baseline factors predictive of heart failure or fluid overload events. Elevated baseline B-type natriuretic peptide and previous hospitalization for heart failure were identified as predictors of heart failure events; bardoxolone methyl increased the risk of heart failure by 60% in patients with these risk factors. For patients without these baseline characteristics, the risk for heart failure events among bardoxolone methyl- and placebo-treated patients was similar (2%). The same risk factors were also identified as predictors of fluid overload and appeared to be related to other serious adverse events. Bardoxolone methyl contributed to events related to heart failure and/or fluid overload in a subpopulation of susceptible patients with an increased risk for heart failure at baseline. Careful selection of participants and vigilant monitoring of the study drug will be required in any future trials of bardoxolone methyl to mitigate the risk of heart failure and other serious adverse events. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

Association between health literacy and 30-day healthcare use after hospital discharge in the heart failure population.

PubMed

Cox, Sarah R; Liebl, Michael G; McComb, Meghan N; Chau, Jason Q; Wilson, Allison A; Achi, May; Garey, Kevin W; Wallace, David

Low health literacy increases the risk for hospital readmissions. Despite this, the measurement and use of health literacy to guide discharge counseling and planning in heart failure patients is not commonly performed. A short 3-Question Brief Health Literacy Screen (BHLS) is available and takes less than three minutes to complete, but has never been evaluated to help determine whether health literacy affects healthcare use after discharge in patients with heart failure. The purpose of this study was to assess 30-day readmissions and emergency department visits based on health literacy evaluated by the BHLS in an acute care heart failure population. This was a prospective observational cohort study conducted at a large quaternary health system. Hospitalized patients with a diagnosis of heart failure were assessed for health literacy using the BHLS. Unplanned healthcare use after discharge including 30-day, all-cause ED visits and hospital readmissions was assessed using univariate and logistic regression models. Two hundred and sixty four patients aged 66.6 ± 14.3 (mean ± SD) years met inclusion/exclusion criteria of whom 175 (66.3%) had a BHLS score >9 (adequate health literacy) and 89 (33.7%) had a BHLS score ≤9 (low health literacy). Predictors of low health literacy included older age (p = 0.019), lower education level (p < 0.001) and unemployed (p = 0.048). After controlling for potential confounders, low health literacy was independently associated with 30-day healthcare use after hospital discharge (OR:1.80; 95% CI: 1.04-3.11; p = 0.035). Using a short, 3-question validated survey instrument, it was demonstrated that low health literacy was associated with increased 30-day unplanned healthcare use after discharge in this heart failure population. These results provide a clinically useful, easily incorporated tool that could identify high-risk patients at need for clinical interventions. Copyright © 2016 Elsevier Inc. All rights reserved.

Predictors of incident heart failure in patients after an acute coronary syndrome: The LIPID heart failure risk-prediction model.

PubMed

Driscoll, Andrea; Barnes, Elizabeth H; Blankenberg, Stefan; Colquhoun, David M; Hunt, David; Nestel, Paul J; Stewart, Ralph A; West, Malcolm J; White, Harvey D; Simes, John; Tonkin, Andrew

2017-12-01

Coronary heart disease is a major cause of heart failure. Availability of risk-prediction models that include both clinical parameters and biomarkers is limited. We aimed to develop such a model for prediction of incident heart failure. A multivariable risk-factor model was developed for prediction of first occurrence of heart failure death or hospitalization. A simplified risk score was derived that enabled subjects to be grouped into categories of 5-year risk varying from <5% to >20%. Among 7101 patients from the LIPID study (84% male), with median age 61years (interquartile range 55-67years), 558 (8%) died or were hospitalized because of heart failure. Older age, history of claudication or diabetes mellitus, body mass index>30kg/m 2 , LDL-cholesterol >2.5mmol/L, heart rate>70 beats/min, white blood cell count, and the nature of the qualifying acute coronary syndrome (myocardial infarction or unstable angina) were associated with an increase in heart failure events. Coronary revascularization was associated with a lower event rate. Incident heart failure increased with higher concentrations of B-type natriuretic peptide >50ng/L, cystatin C>0.93nmol/L, D-dimer >273nmol/L, high-sensitivity C-reactive protein >4.8nmol/L, and sensitive troponin I>0.018μg/L. Addition of biomarkers to the clinical risk model improved the model's C statistic from 0.73 to 0.77. The net reclassification improvement incorporating biomarkers into the clinical model using categories of 5-year risk was 23%. Adding a multibiomarker panel to conventional parameters markedly improved discrimination and risk classification for future heart failure events. Copyright © 2017 Elsevier Ireland Ltd. All rights reserved.

Fired ceramic inlays: a 6-year follow up.

PubMed

van Dijken, J W; Höglund-Aberg, C; Olofsson, A L

1998-03-01

The aim of this study was to evaluate feldspathic ceramic inlays luted with dual-cured resin composite or glass polyalkenoate (ionomer) cement (GIC) during a 6-year follow-up. One-hundred and eighteen Class II fired feldspathic ceramic inlays were placed in 50 patients. In each patient half of the inlays were luted with a dual-cured resin composite and the other half with a conventional glass ionomer cement. The inlays were evaluated clinically, according to modified USPHS criteria, at baseline, after 6 months and then annually over a 6-year period. Of the 115 inlays evaluated at 6 years, 12% in the resin composite group and 26% in the GIC group were assessed as having failed. The main reason for failure in both groups was partial fracture or total loss of the inlays. Secondary caries was found to be associated with three inlays in one high caries risk patient. One inlay was replaced because of postoperative sensitivity. A relatively high and increasing failure rate was observed over the 6-year period of the study. The failure rate was more pronounced in the GIC group.

Recognising and referring children exposed to domestic abuse: a multi-professional, proactive systems-based evaluation using a modified Failure Mode and Effects Analysis (FMEA).

PubMed

Ashley, Laura; Armitage, Gerry; Taylor, Julie

2017-03-01

Failure Modes and Effects Analysis (FMEA) is a prospective quality assurance methodology increasingly used in healthcare, which identifies potential vulnerabilities in complex, high-risk processes and generates remedial actions. We aimed, for the first time, to apply FMEA in a social care context to evaluate the process for recognising and referring children exposed to domestic abuse within one Midlands city safeguarding area in England. A multidisciplinary, multi-agency team of 10 front-line professionals undertook the FMEA, using a modified methodology, over seven group meetings. The FMEA included mapping out the process under evaluation to identify its component steps, identifying failure modes (potential errors) and possible causes for each step and generating corrective actions. In this article, we report the output from the FMEA, including illustrative examples of the failure modes and corrective actions generated. We also present an analysis of feedback from the FMEA team and provide future recommendations for the use of FMEA in appraising social care processes and practice. Although challenging, the FMEA was unequivocally valuable for team members and generated a significant number of corrective actions locally for the safeguarding board to consider in its response to children exposed to domestic abuse. © 2016 John Wiley & Sons Ltd.

Mortality and cardiovascular morbidity within 30 days of discharge following acute coronary syndrome in a contemporary European cohort of patients: How can early risk prediction be improved? The six-month GRACE risk score.

PubMed

Raposeiras-Roubín, Sergio; Abu-Assi, Emad; Cambeiro-González, Cristina; Álvarez-Álvarez, Belén; Pereira-López, Eva; Gestal-Romaní, Santiago; Pedreira-López, Milagros; Rigueiro-Veloso, Pedro; Virgós-Lamela, Alejandro; García-Acuña, José María; González-Juanatey, José Ramón

2015-06-01

Given the increasing focus on early mortality and readmission rates among patients with acute coronary syndrome (ACS), this study was designed to evaluate the accuracy of the GRACE risk score for identifying patients at high risk of 30-day post-discharge mortality and cardiovascular readmission. This was a retrospective study carried out in a single center with 4229 ACS patients discharged between 2004 and 2010. The study endpoint was the combination of 30-day post-discharge mortality and readmission due to reinfarction, heart failure or stroke. One hundred and fourteen patients had 30-day events: 0.7% mortality, 1% reinfarction, 1.3% heart failure, and 0.2% stroke. After multivariate analysis, the six-month GRACE risk score was associated with an increased risk of 30-day events (HR 1.03, 95% CI 1.02-1.04; p<0.001), demonstrating good discrimination (C-statistic: 0.79 ± 0.02) and optimal fit (Hosmer-Lemeshow p=0.83). The sensitivity and specificity were adequate (78.1% and 63.3%, respectively), and negative predictive value was excellent (99.1%). In separate analyses for each event of interest (all-cause mortality, reinfarction, heart failure and stroke), assessment of the six-month GRACE risk score also demonstrated good discrimination and fit, as well as adequate predictive values. The six-month GRACE risk score is a useful tool to predict 30-day post-discharge death and early cardiovascular readmission. Clinicians may find it simple to use with the online and mobile app score calculator and applicable to clinical daily practice. Copyright © 2014 Sociedade Portuguesa de Cardiologia. Published by Elsevier España. All rights reserved.

The evaluation of acute physiology and chronic health evaluation II score, poisoning severity score, sequential organ failure assessment score combine with lactate to assess the prognosis of the patients with acute organophosphate pesticide poisoning.

PubMed

Yuan, Shaoxin; Gao, Yusong; Ji, Wenqing; Song, Junshuai; Mei, Xue

2018-05-01

The aim of this study was to assess the ability of acute physiology and chronic health evaluation II (APACHE II) score, poisoning severity score (PSS) as well as sequential organ failure assessment (SOFA) score combining with lactate (Lac) to predict mortality in the Emergency Department (ED) patients who were poisoned with organophosphate.A retrospective review of 59 stands-compliant patients was carried out. Receiver operating characteristic (ROC) curves were constructed based on the APACHE II score, PSS, SOFA score with or without Lac, respectively, and the areas under the ROC curve (AUCs) were determined to assess predictive value. According to SOFA-Lac (a combination of SOFA and Lac) classification standard, acute organophosphate pesticide poisoning (AOPP) patients were divided into low-risk and high-risk groups. Then mortality rates were compared between risk levels.Between survivors and non-survivors, there were significant differences in the APACHE II score, PSS, SOFA score, and Lac (all P < .05). The AUCs of the APACHE II score, PSS, and SOFA score were 0.876, 0.811, and 0.837, respectively. However, after combining with Lac, the AUCs were 0.922, 0.878, and 0.956, respectively. According to SOFA-Lac, the mortality of high-risk group was significantly higher than low-risk group (P < .05) and the patients of the non-survival group were all at high risk.These data suggest the APACHE II score, PSS, SOFA score can all predict the prognosis of AOPP patients. For its simplicity and objectivity, the SOFA score is a superior predictor. Lac significantly improved the predictive abilities of the 3 scoring systems, especially for the SOFA score. The SOFA-Lac system effectively distinguished the high-risk group from the low-risk group. Therefore, the SOFA-Lac system is significantly better at predicting mortality in AOPP patients.

Application of correspondence analysis in the assessment of mine tailings dam breakage risk in the Mediterranean region.

PubMed

Salgueiro, Ana Rita; Pereira, Henrique Garcia; Rico, Maria-Teresa; Benito, Gerado; Díez-Herreo, Andrés

2008-02-01

A new statistical approach for preliminary risk evaluation of breakage in tailings dam is presented and illustrated by a case study regarding the Mediterranean region. The objective of the proposed method is to establish an empirical scale of risk, from which guidelines for prioritizing the collection of further specific information can be derived. The method relies on a historical database containing, in essence, two sets of qualitative data: the first set concerns the variables that are observable before the disaster (e.g., type and size of the dam, its location, and state of activity), and the second refers to the consequences of the disaster (e.g., failure type, sludge characteristics, fatalities categorization, and downstream range of damage). Based on a modified form of correspondence analysis, where the second set of attributes are projected as "supplementary variables" onto the axes provided by the eigenvalue decomposition of the matrix referring to the first set, a "qualitative regression" is performed, relating the variables to be predicted (contained in the second set) with the "predictors" (the observable variables). On the grounds of the previously derived relationship, the risk of breakage in a new case can be evaluated, given observable variables. The method was applied in a case study regarding a set of 13 test sites where the ranking of risk obtained was validated by expert knowledge. Once validated, the procedure was included in the final output of the e-EcoRisk UE project (A Regional Enterprise Network Decision-Support System for Environmental Risk and Disaster Management of Large-Scale Industrial Spills), allowing for a dynamic historical database updating and providing a prompt rough risk evaluation for a new case. The aim of this section of the global project is to provide a quantified context where failure cases occurred in the past for supporting analogue reasoning in preventing similar situations.

Genital marginal failures after intensity-modulated radiation therapy (IMRT) in squamous cell anal cancer: no higher risk with IMRT when compared to 3DCRT.

PubMed

Dell'Acqua, V; Kobiela, J; Kraja, F; Leonardi, M C; Surgo, A; Zerella, M A; Arculeo, S; Fodor, C; Ricotti, R; Zampino, M G; Ravenda, S; Spinoglio, G; Biffi, R; Bazani, A; Luraschi, R; Vigorito, S; Spychalski, P; Orecchia, R; Glynne-Jones, R; Jereczek-Fossa, B A

2018-03-28

Intensity-modulated radiotherapy (IMRT) is considered the preferred option in squamous cell canal cancer (SCAC), delivering high doses to tumor volumes while minimizing dose to surrounding normal tissues. IMRT has steep dose gradients, but the technique is more demanding as deep understanding of target structures is required. To evaluate genital marginal failure in a cohort of patients with non-metastatic SCAC treated either with IMRT or 3DCRT and concurrent chemotherapy, 117 patients with SCAC were evaluated: 64 and 53 patients were treated with IMRT and 3DCRT techniques, respectively. All patients underwent clinical and radiological examination during their follow-up. Tumor response was evaluated with response evaluation criteria in solid tumors v1.1 guideline on regular basis. All patients' data were analyzed, and patients with marginal failure were identified. Concomitant chemotherapy was administered in 97 and 77.4% of patients in the IMRT and 3DCRT groups, respectively. In the IMRT group, the median follow-up was 25 months (range 6-78). Progressive disease was registered in 15.6% of patients; infield recurrence, distant recurrence and both infield recurrence and distant recurrence were identified in 5, 4 and 1 patient, respectively. Two out of 64 patients (3.1%) had marginal failures, localized at vagina/recto-vaginal septum and left perineal region. In the 3DCRT group, the median follow-up was 71.3 months (range 6-194 months). Two out of 53 patients (3.8%) had marginal failures, localized at recto-vaginal septum and perigenital structures. The rate of marginal failures was comparable in IMRT and 3DCRT groups (χ 2 test p = 0.85). In this series, the use of IMRT for the treatment of SCAC did not increase the rate of marginal failures offering improved dose conformity to the target. Dose constraints should be applied with caution-particularly in females with involvement of the vagina or the vaginal septum.

Incidence, predictors and outcomes of acute-on-chronic liver failure in outpatients with cirrhosis.

PubMed

Piano, Salvatore; Tonon, Marta; Vettore, Elia; Stanco, Marialuisa; Pilutti, Chiara; Romano, Antonietta; Mareso, Sara; Gambino, Carmine; Brocca, Alessandra; Sticca, Antonietta; Fasolato, Silvano; Angeli, Paolo

2017-12-01

Acute-on-chronic liver failure (ACLF) is the most life-threatening complication of cirrhosis. Prevalence and outcomes of ACLF have recently been described in hospitalized patients with cirrhosis. However, no data is currently available on the prevalence and the risk factors of ACLF in outpatients with cirrhosis. The aim of this study was to evaluate incidence, predictors and outcomes of ACLF in a large cohort of outpatients with cirrhosis. A total of 466 patients with cirrhosis consecutively evaluated in the outpatient clinic of a tertiary hospital were included and followed up until death and/or liver transplantation for a mean of 45±44months. Data on development of hepatic and extrahepatic organ failures were collected during this period. ACLF was defined and graded according to the EASL-CLIF Consortium definition. During the follow-up, 118 patients (25%) developed ACLF: 57 grade-1, 33 grade-2 and 28 grade-3. The probability of developing ACLF was 14%, 29%, and 41% at 1year, 5years, and 10years, respectively. In the multivariate analysis, baseline mean arterial pressure (hazard ratio [HR] 0.96; p=0.012), ascites (HR 2.53; p=0.019), model of end-stage liver disease score (HR 1.26; p<0.001) and baseline hemoglobin (HR 0.07; p=0.012) were found to be independent predictors of the development of ACLF at one year. As expected, ACLF was associated with a poor prognosis, with a 3-month probability of transplant-free survival of 56%. Outpatients with cirrhosis have a high risk of developing ACLF. The degree of liver failure and circulatory dysfunction are associated with the development of ACLF, as well as low values of hemoglobin. These simple variables may help to identify patients at a high risk of developing ACLF and to plan a program of close surveillance and prevention in these patients. There is a need to identify predictors of acute-on-chronic liver failure (ACLF) in patients with cirrhosis in order to identify patients at high risk of developing ACLF and to plan strategies of prevention. In this study, we identified four simple predictors of ACLF: model of end-stage liver disease (MELD) score, ascites, mean arterial pressure and hemoglobin. These variables may help to identify patients with cirrhosis, at a high risk of developing ACLF, that are candidates for new strategies of surveillance and prevention. Anemia is a potential new target for treating these patients. Copyright © 2017 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Assessment of Heart Transplant Waitlist Time and Pre- and Post-transplant Failure: A Mixed Methods Approach.

PubMed

Goldstein, Benjamin A; Thomas, Laine; Zaroff, Jonathan G; Nguyen, John; Menza, Rebecca; Khush, Kiran K

2016-07-01

Over the past two decades, there have been increasingly long waiting times for heart transplantation. We studied the relationship between heart transplant waiting time and transplant failure (removal from the waitlist, pretransplant death, or death or graft failure within 1 year) to determine the risk that conservative donor heart acceptance practices confer in terms of increasing the risk of failure among patients awaiting transplantation. We studied a cohort of 28,283 adults registered on the United Network for Organ Sharing heart transplant waiting list between 2000 and 2010. We used Kaplan-Meier methods with inverse probability censoring weights to examine the risk of transplant failure accumulated over time spent on the waiting list (pretransplant). In addition, we used transplant candidate blood type as an instrumental variable to assess the risk of transplant failure associated with increased wait time. Our results show that those who wait longer for a transplant have greater odds of transplant failure. While on the waitlist, the greatest risk of failure is during the first 60 days. Doubling the amount of time on the waiting list was associated with a 10% (1.01, 1.20) increase in the odds of failure within 1 year after transplantation. Our findings suggest a relationship between time spent on the waiting list and transplant failure, thereby supporting research aimed at defining adequate donor heart quality and acceptance standards for heart transplantation.

Effective technologies for noninvasive remote monitoring in heart failure.

PubMed

Conway, Aaron; Inglis, Sally C; Clark, Robyn A

2014-06-01

Trials of new technologies to remotely monitor for signs and symptoms of worsening heart failure are continually emerging. The extent to which technological differences impact the effectiveness of noninvasive remote monitoring for heart failure management is unknown. This study examined the effect of specific technology used for noninvasive remote monitoring of people with heart failure on all-cause mortality and heart failure-related hospitalizations. A subanalysis of a large systematic review and meta-analysis was conducted. Studies were stratified according to the specific type of technology used, and separate meta-analyses were performed. Four different types of noninvasive remote monitoring technologies were identified, including structured telephone calls, videophone, interactive voice response devices, and telemonitoring. Only structured telephone calls and telemonitoring were effective in reducing the risk of all-cause mortality (relative risk [RR]=0.87; 95% confidence interval [CI], 0.75-1.01; p=0.06; and RR=0.62; 95% CI, 0.50-0.77; p<0.0001, respectively) and heart failure-related hospitalizations (RR=0.77; 95% CI, 0.68-0.87; p<0.001; and RR=0.75; 95% CI, 0.63-0.91; p=0.003, respectively). More research data are required for videophone and interactive voice response technologies. This subanalysis identified that only two of the four specific technologies used for noninvasive remote monitoring in heart failure improved outcomes. When results of studies that involved these disparate technologies were combined in previous meta-analyses, significant improvements in outcomes were identified. As such, this study has highlighted implications for future meta-analyses of randomized controlled trials focused on evaluating the effectiveness of remote monitoring in heart failure.

A prospective study of the Bedside Index for Severity in Acute Pancreatitis (BISAP) score in acute pancreatitis: an Indian perspective.

PubMed

Senapati, Debadutta; Debata, Prasanna Kumar; Jenasamant, Saumya Sekhar; Nayak, Anil Kumar; Gowda S, Manoj; Swain, Narendra Nath

2014-01-01

A simple and easily applicable system for stratifying patients with acute pancreatitis is lacking. The aim of our study was to evaluate the ability of BISAP score to predict mortality in acute pancreatitis patients from our institution and to predict which patients are at risk for development of organ failure, persistent organ failure and pancreatic necrosis. All patients with acute pancreatitis were included in the study. BISAP score was calculated within 24 h of admission. A Contrast CT was used to differentiate interstitial from necrotizing pancreatitis within seven days of hospitalization whereas Marshall Scoring System was used to characterize organ failure. Among 246 patients M:F = 153:93, most common aetiology among men was alcoholism and among women was gallstone disease. 207 patients had no organ failure and remaining 39 developed organ failure. 17 patients had persistent organ failure, 16 of those with BISAP score ≥3. 13 patients in our study died, out of which 12 patients had BISAP score ≥3. We also found that a BISAP score of ≥3 had a sensitivity of 92%, specificity of 76%, a positive predictive value of 17%, and a negative predictive value of 99% for mortality. The BISAP score is a simple and accurate method for the early identification of patients at increased risk for in hospital mortality and morbidity. Copyright © 2014 IAP and EPC. Published by Elsevier B.V. All rights reserved.

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

PRA and Risk Informed Analysis

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

Bernsen, Sidney A.; Simonen, Fredric A.; Balkey, Kenneth R.

2006-01-01

The Boiler and Pressure Vessel Code (BPVC) of the American Society of Mechanical Engineers (ASME) has introduced a risk based approach into Section XI that covers Rules for Inservice Inspection of Nuclear Power Plant Components. The risk based approach requires application of the probabilistic risk assessments (PRA). Because no industry consensus standard existed for PRAs, ASME has developed a standard to evaluate the quality level of an available PRA needed to support a given risk based application. The paper describes the PRA standard, Section XI application of PRAs, and plans for broader applications of PRAs to other ASME nuclear codesmore » and standards. The paper addresses several specific topics of interest to Section XI. Important consideration are special methods (surrogate components) used to overcome the lack of PRA treatments of passive components in PRAs. The approach allows calculations of conditional core damage probabilities both for component failures that cause initiating events and failures in standby systems that decrease the availability of these systems. The paper relates the explicit risk based methods of the new Section XI code cases to the implicit consideration of risk used in the development of Section XI. Other topics include the needed interactions of ISI engineers, plant operating staff, PRA specialists, and members of expert panels that review the risk based programs.« less

EVALUATION OF SAFETY IN A RADIATION ONCOLOGY SETTING USING FAILURE MODE AND EFFECTS ANALYSIS

PubMed Central

Ford, Eric C.; Gaudette, Ray; Myers, Lee; Vanderver, Bruce; Engineer, Lilly; Zellars, Richard; Song, Danny Y.; Wong, John; DeWeese, Theodore L.

2013-01-01

Purpose Failure mode and effects analysis (FMEA) is a widely used tool for prospectively evaluating safety and reliability. We report our experiences in applying FMEA in the setting of radiation oncology. Methods and Materials We performed an FMEA analysis for our external beam radiation therapy service, which consisted of the following tasks: (1) create a visual map of the process, (2) identify possible failure modes; assign risk probability numbers (RPN) to each failure mode based on tabulated scores for the severity, frequency of occurrence, and detectability, each on a scale of 1 to 10; and (3) identify improvements that are both feasible and effective. The RPN scores can span a range of 1 to 1000, with higher scores indicating the relative importance of a given failure mode. Results Our process map consisted of 269 different nodes. We identified 127 possible failure modes with RPN scores ranging from 2 to 160. Fifteen of the top-ranked failure modes were considered for process improvements, representing RPN scores of 75 and more. These specific improvement suggestions were incorporated into our practice with a review and implementation by each department team responsible for the process. Conclusions The FMEA technique provides a systematic method for finding vulnerabilities in a process before they result in an error. The FMEA framework can naturally incorporate further quantification and monitoring. A general-use system for incident and near miss reporting would be useful in this regard. PMID:19409731

The Genomic Architecture of Sporadic Heart Failure

PubMed Central

Dorn, Gerald W

2011-01-01

Common or sporadic systolic heart failure (heart failure) is the clinical syndrome of insufficient forward cardiac output resulting from myocardial disease. Most heart failure is the consequence of ischemic or idiopathic cardiomyopathy. There is a clear familial predisposition to heart failure, with a genetic component estimated to confer between 20 and 30% of overall risk. The multifactorial etiology of this syndrome has complicated identification of its genetic underpinnings. Until recently, almost all genetic studies of heart failure were designed and deployed according to the common disease-common variant hypothesis, in which individual risk alleles impart a small positive or negative effect and overall genetic risk is the cumulative impact of all functional genetic variations. Early studies employed a candidate gene approach, focused mainly on factors within adrenergic and renin-angiotensin pathways that affect heart failure progression and are targeted by standard pharmacotherapeutics. Many of these reported allelic associations with heart failure have not been replicated. However, the preponderance of data support risk-modifier effects for the Arg389Gly polymorphism of β1-adrenergic receptors and the intron 16 in/del polymorphism of angiotensin converting enzyme. Recent unbiased studies using genome-wide single nucleotide polymorphism (SNP) microarrays have shown fewer positive results than when these platforms were applied to hypertension, myocardial infarction, or diabetes, possibly reflecting the complex etiology of heart failure. A new cardiovascular gene-centric sub-genome SNP array identified a common heat failure risk allele at 1p36 in multiple independent cohorts, but the biological mechanism for this association is still uncertain. It is likely that common gene polymorphisms account for only a fraction of individual genetic heart failure risk, and future studies using deep resequencing are likely to identify rare gene variants with larger biological effects. PMID:21566223

Interaction Effects of Acute Kidney Injury, Acute Respiratory Failure, and Sepsis on 30-Day Postoperative Mortality in Patients Undergoing High-Risk Intraabdominal General Surgical Procedures.

PubMed

Kim, Minjae; Brady, Joanne E; Li, Guohua

2015-12-01

Acute kidney injury (AKI), acute respiratory failure, and sepsis are distinct but related pathophysiologic processes. We hypothesized that these 3 processes may interact to synergistically increase the risk of short-term perioperative mortality in patients undergoing high-risk intraabdominal general surgery procedures. We performed a retrospective, observational cohort study of data (2005-2011) from the American College of Surgeons-National Surgical Quality Improvement Program, a high-quality surgical outcomes data set. High-risk procedures were those with a risk of AKI, acute respiratory failure, or sepsis greater than the average risk in all intraabdominal general surgery procedures. The effects of AKI, acute respiratory failure, and sepsis on 30-day mortality were assessed using a Cox proportional hazards model. Additive interactions were assessed with the relative excess risk due to interaction. Of 217,994 patients, AKI, acute respiratory failure, and sepsis developed in 1.3%, 3.7%, and 6.8%, respectively. The 30-day mortality risk with sepsis, acute respiratory failure, and AKI were 11.4%, 24.1%, and 25.1%, respectively, compared with 0.85% without these complications. The adjusted hazard ratios and 95% confidence intervals for a single complication (versus no complication) on mortality were 7.24 (6.46-8.11), 10.8 (8.56-13.6), and 14.2 (12.8-15.7) for sepsis, AKI, and acute respiratory failure, respectively. For 2 complications, the adjusted hazard ratios were 30.8 (28.0-33.9), 42.6 (34.3-52.9), and 65.2 (53.9-78.8) for acute respiratory failure/sepsis, AKI/sepsis, and acute respiratory failure/AKI, respectively. Finally, the adjusted hazard ratio for all 3 complications was 105 (92.8-118). Positive additive interactions, indicating synergism, were found for each combination of 2 complications. The relative excess risk due to interaction for all 3 complications was not statistically significant. In high-risk general surgery patients, the development of AKI, acute respiratory failure, or sepsis is independently associated with an increase in 30-day mortality. In addition, the development of 2 complications shows significant positive additive interactions to further increase the risk of mortality. Our findings suggest that interactions between these 3 perioperative complications increase the risk of mortality more than would be expected by the independent effects of each complication alone.

A risk assessment methodology to evaluate the risk failure of managed aquifer recharge in the Mediterranean Basin

NASA Astrophysics Data System (ADS)

Rodríguez-Escales, Paula; Canelles, Arnau; Sanchez-Vila, Xavier; Folch, Albert; Kurtzman, Daniel; Rossetto, Rudy; Fernández-Escalante, Enrique; Lobo-Ferreira, João-Paulo; Sapiano, Manuel; San-Sebastián, Jon; Schüth, Christoph

2018-06-01

Managed aquifer recharge (MAR) can be affected by many risks. Those risks are related to different technical and non-technical aspects of recharge, like water availability, water quality, legislation, social issues, etc. Many other works have acknowledged risks of this nature theoretically; however, their quantification and definition has not been developed. In this study, the risk definition and quantification has been performed by means of fault trees and probabilistic risk assessment (PRA). We defined a fault tree with 65 basic events applicable to the operation phase. After that, we have applied this methodology to six different managed aquifer recharge sites located in the Mediterranean Basin (Portugal, Spain, Italy, Malta, and Israel). The probabilities of the basic events were defined by expert criteria, based on the knowledge of the different managers of the facilities. From that, we conclude that in all sites, the perception of the expert criteria of the non-technical aspects were as much or even more important than the technical aspects. Regarding the risk results, we observe that the total risk in three of the six sites was equal to or above 0.90. That would mean that the MAR facilities have a risk of failure equal to or higher than 90 % in the period of 2-6 years. The other three sites presented lower risks (75, 29, and 18 % for Malta, Menashe, and Serchio, respectively).

Assessment of the risk of failure of high voltage substations due to environmental conditions and pollution on insulators.

PubMed

Castillo Sierra, Rafael; Oviedo-Trespalacios, Oscar; Candelo, John E; Soto, Jose D

2015-07-01

Pollution on electrical insulators is one of the greatest causes of failure of substations subjected to high levels of salinity and environmental pollution. Considering leakage current as the main indicator of pollution on insulators, this paper focuses on establishing the effect of the environmental conditions on the risk of failure due to pollution on insulators and determining the significant change in the magnitude of the pollution on the insulators during dry and humid periods. Hierarchical segmentation analysis was used to establish the effect of environmental conditions on the risk of failure due to pollution on insulators. The Kruskal-Wallis test was utilized to determine the significant changes in the magnitude of the pollution due to climate periods. An important result was the discovery that leakage current was more common on insulators during dry periods than humid ones. There was also a higher risk of failure due to pollution during dry periods. During the humid period, various temperatures and wind directions produced a small change in the risk of failure. As a technical result, operators of electrical substations can now identify the cause of an increase in risk of failure due to pollution in the area. The research provides a contribution towards the behaviour of the leakage current under conditions similar to those of the Colombian Caribbean coast and how they affect the risk of failure of the substation due to pollution.

Risk Importance Measures in the Designand Operation of Nuclear Power Plants

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

Vrbanic I.; Samanta P.; Basic, I

This monograph presents and discusses risk importance measures as quantified by the probabilistic risk assessment (PRA) models of nuclear power plants (NPPs) developed according to the current standards and practices. Usually, PRA tools calculate risk importance measures related to a single ?basic event? representing particular failure mode. This is, then, reflected in many current PRA applications. The monograph focuses on the concept of ?component-level? importance measures that take into account different failure modes of the component including common-cause failures (CCFs). In opening sections the roleof risk assessment in safety analysis of an NPP is introduced and discussion given of ?traditional?,more » mainly deterministic, design principles which have been established to assign a level of importance to a particular system, structure or component. This is followed by an overview of main risk importance measures for risk increase and risk decrease from current PRAs. Basic relations which exist among the measures are shown. Some of the current practical applications of risk importancemeasures from the field of NPP design, operation and regulation are discussed. The core of the monograph provides a discussion on theoreticalbackground and practical aspects of main risk importance measures at the level of ?component? as modeled in a PRA, starting from the simplest case, single basic event, and going toward more complexcases with multiple basic events and involvements in CCF groups. The intent is to express the component-level importance measures via theimportance measures and probabilities of the underlying single basic events, which are the inputs readily available from a PRA model andits results. Formulas are derived and discussed for some typical cases. The formulas and their results are demonstrated through some practicalexamples, done by means of a simplified PRA model developed in and run by RiskSpectrum? tool, which are presented in the appendices. The monograph concludes with discussion of limitations of the use of risk importance measures and a summary of component-level importance cases evaluated.« less

Analysis of risk factors for cluster behavior of dental implant failures.

PubMed

Chrcanovic, Bruno Ramos; Kisch, Jenö; Albrektsson, Tomas; Wennerberg, Ann

2017-08-01

Some studies indicated that implant failures are commonly concentrated in few patients. To identify and analyze cluster behavior of dental implant failures among subjects of a retrospective study. This retrospective study included patients receiving at least three implants only. Patients presenting at least three implant failures were classified as presenting a cluster behavior. Univariate and multivariate logistic regression models and generalized estimating equations analysis evaluated the effect of explanatory variables on the cluster behavior. There were 1406 patients with three or more implants (8337 implants, 592 failures). Sixty-seven (4.77%) patients presented cluster behavior, with 56.8% of all implant failures. The intake of antidepressants and bruxism were identified as potential negative factors exerting a statistically significant influence on a cluster behavior at the patient-level. The negative factors at the implant-level were turned implants, short implants, poor bone quality, age of the patient, the intake of medicaments to reduce the acid gastric production, smoking, and bruxism. A cluster pattern among patients with implant failure is highly probable. Factors of interest as predictors for implant failures could be a number of systemic and local factors, although a direct causal relationship cannot be ascertained. © 2017 Wiley Periodicals, Inc.

Periodontitis in Chronic Heart Failure.

PubMed

Fröhlich, Hanna; Herrmann, Kristina; Franke, Jennifer; Karimi, Alamara; Täger, Tobias; Cebola, Rita; Katus, Hugo A; Zugck, Christian; Frankenstein, Lutz

2016-08-01

Periodontal disease has been associated with an increased risk of cardiovascular events. The purpose of our study was to investigate whether a correlation between periodontitis and chronic heart failure exists, as well as the nature of the underlying cause. We enrolled 71 patients (mean age, 54 ± 13 yr; 56 men) who had stable chronic heart failure; all underwent complete cardiologic and dental evaluations. The periodontal screening index was used to quantify the degree of periodontal disease. We compared the findings to those in the general population with use of data from the 4th German Dental Health Survey. Gingivitis, moderate periodontitis, and severe periodontitis were present in 17 (24%), 17 (24%), and 37 (52%) patients, respectively. Severe periodontitis was more prevalent among chronic heart failure patients than in the general population. In contrast, moderate periodontitis was more prevalent in the general population (P <0.00001). The severity of periodontal disease was not associated with the cause of chronic heart failure or the severity of heart failure symptoms. Six-minute walking distance was the only independent predictor of severe periodontitis. Periodontal disease is highly prevalent in chronic heart failure patients regardless of the cause of heart failure. Prospective trials are warranted to clarify the causal relationship between both diseases.

Failure prediction using machine learning and time series in optical network.

PubMed

Wang, Zhilong; Zhang, Min; Wang, Danshi; Song, Chuang; Liu, Min; Li, Jin; Lou, Liqi; Liu, Zhuo

2017-08-07

In this paper, we propose a performance monitoring and failure prediction method in optical networks based on machine learning. The primary algorithms of this method are the support vector machine (SVM) and double exponential smoothing (DES). With a focus on risk-aware models in optical networks, the proposed protection plan primarily investigates how to predict the risk of an equipment failure. To the best of our knowledge, this important problem has not yet been fully considered. Experimental results showed that the average prediction accuracy of our method was 95% when predicting the optical equipment failure state. This finding means that our method can forecast an equipment failure risk with high accuracy. Therefore, our proposed DES-SVM method can effectively improve traditional risk-aware models to protect services from possible failures and enhance the optical network stability.

46 CFR 308.516 - Failure to comply with Clause 21.

Code of Federal Regulations, 2010 CFR

2010-10-01

... 46 Shipping 8 2010-10-01 2010-10-01 false Failure to comply with Clause 21. 308.516 Section 308.516 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Cargo Insurance Ii-Open Policy War Risk Cargo Insurance § 308.516 Failure to comply with...

46 CFR 308.516 - Failure to comply with Clause 21.

Code of Federal Regulations, 2013 CFR

2013-10-01

... 46 Shipping 8 2013-10-01 2013-10-01 false Failure to comply with Clause 21. 308.516 Section 308.516 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Cargo Insurance Ii-Open Policy War Risk Cargo Insurance § 308.516 Failure to comply with...

46 CFR 308.516 - Failure to comply with Clause 21.

Code of Federal Regulations, 2012 CFR

2012-10-01

... 46 Shipping 8 2012-10-01 2012-10-01 false Failure to comply with Clause 21. 308.516 Section 308.516 Shipping MARITIME ADMINISTRATION, DEPARTMENT OF TRANSPORTATION EMERGENCY OPERATIONS WAR RISK INSURANCE War Risk Cargo Insurance Ii-Open Policy War Risk Cargo Insurance § 308.516 Failure to comply with...

Assessing response to interferon-β in a multicenter dataset of patients with MS.

PubMed

Sormani, Maria Pia; Gasperini, Claudio; Romeo, Marzia; Rio, Jordi; Calabrese, Massimiliano; Cocco, Eleonora; Enzingher, Christian; Fazekas, Franz; Filippi, Massimo; Gallo, Antonio; Kappos, Ludwig; Marrosu, Maria Giovanna; Martinelli, Vittorio; Prosperini, Luca; Rocca, Maria Assunta; Rovira, Alex; Sprenger, Till; Stromillo, Maria Laura; Tedeschi, Gioacchino; Tintorè, Mar; Tortorella, Carla; Trojano, Maria; Montalban, Xavier; Pozzilli, Carlo; Comi, Giancarlo; De Stefano, Nicola

2016-07-12

To provide new insights into the role of markers of response to interferon-β therapy in multiple sclerosis (MS) in a multicenter setting, focusing on the relevance of MRI lesions in combination with clinical variables. A large multicenter clinical dataset was collected within the Magnetic Resonance Imaging in MS (MAGNIMS) network. This included a large cohort of patients with relapsing-remitting MS on interferon-β treatment, MRI and clinical assessments during the first year of treatment, and clinical follow-up of at least 2 additional years. Heterogeneity among centers was assessed before pooling the data. The association of 1-year MRI or clinical relapses with the risk of treatment failure (defined as Expanded Disability Status Scale [EDSS] worsening or treatment switch for inefficacy) and of EDSS worsening alone was evaluated using multivariate Cox models. A pooled dataset of 1,280 patients with relapsing-remitting MS from 9 MAGNIMS centers was analyzed. The risk of failure had a relevant increase with 1 relapse (hazard ratio [HR] 1.84, 95% confidence interval [CI] 1.39-2.44, p < 0.001) and ≥3 new T2 lesions (HR 1.55, 95% CI 0.92-2.60, p = 0.09). In patients without relapses and less than 3 new T2 lesions, the 3-year risk of failure and EDSS worsening were 17% and 15%; in patients with 1 relapse or ≥3 new T2 lesions, the risks were 27% and 22%; in patients with both conditions or more than 1 relapse, the risks were 48% (p < 0.001) and 29% (p < 0.001). Substantial MRI activity, particularly if in combination with clinical relapses, during the first year of treatment with interferon-β indicates significant risk of treatment failure and EDSS worsening in the short term. © 2016 American Academy of Neurology.

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.

Medication Safety of Five Oral Chemotherapies: A Proactive Risk Assessment

PubMed Central

Weingart, Saul N.; Spencer, Justin; Buia, Stephanie; Duncombe, Deborah; Singh, Prabhjyot; Gadkari, Mrinalini; Connor, Maureen

2011-01-01

Purpose: Oral chemotherapies represent an emerging risk area in ambulatory oncology practice. To examine the hazards associated with five oral chemotherapies, we performed a proactive risk assessment. Methods: We convened interdisciplinary teams and conducted failure mode and effects analyses (FMEAs) for five oral chemotherapy agents: capecitabine, imatinib, temozolomide, 6-mercaptopurine, and an investigational agent. This involved the creation of process maps for each medication, identification of failure modes, selection of high-risk failure modes, and development of recommendations to mitigate these risks. We analyzed the number of steps and types of failure modes and compared this information across the study drugs. Results: Key vulnerabilities include patient education about drug handling and adverse effects, prescription writing, patient self-administration and medication adherence, and failure to monitor and manage toxicities. Many of these failure modes were common across the five oral chemotherapies, suggesting the presence of common targets for improvement. Streamlining the FMEA itself may promote the dissemination of this method. Conclusion: Each stage of the medication process poses risks to the safe use of oral chemotherapies. FMEAs may identify opportunities to improve medication safety and reduce the risk of patient harm. PMID:21532801

SU-F-T-247: Collision Risks in a Modern Radiation Oncology Department: An Efficient Approach to Failure Modes and Effects Analysis

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

Schubert, L; Westerly, D; Vinogradskiy, Y

Purpose: Collisions between treatment equipment and patients are potentially catastrophic. Modern technology now commonly involves automated remote motion during imaging and treatment, yet a systematic assessment to identify and mitigate collision risks has yet to be performed. Failure modes and effects analysis (FMEA) is a method of risk assessment that has been increasingly used in healthcare, yet can be resource intensive. This work presents an efficient approach to FMEA to identify collision risks and implement practical interventions within a modern radiation therapy department. Methods: Potential collisions (e.g. failure modes) were assessed for all treatment and simulation rooms by teams consistingmore » of physicists, therapists, and radiation oncologists. Failure modes were grouped into classes according to similar characteristics. A single group meeting was held to identify implementable interventions for the highest priority classes of failure modes. Results: A total of 60 unique failure modes were identified by 6 different teams of physicists, therapists, and radiation oncologists. Failure modes were grouped into four main classes: specific patient setups, automated equipment motion, manual equipment motion, and actions in QA or service mode. Two of these classes, unusual patient setups and automated machine motion, were identified as being high priority in terms severity of consequence and addressability by interventions. The two highest risk classes consisted of 33 failure modes (55% of the total). In a single one hour group meeting, 6 interventions were identified. Those interventions addressed 100% of the high risk classes of failure modes (55% of all failure modes identified). Conclusion: A class-based approach to FMEA was developed to efficiently identify collision risks and implement interventions in a modern radiation oncology department. Failure modes and interventions will be listed, and a comparison of this approach against traditional FMEA methods will be presented.« less

Spatial variation of heart failure and air pollution in Warwickshire, UK: an investigation of small scale variation at the ward-level.

PubMed

Bennett, Oscar; Kandala, Ngianga-Bakwin; Ji, Chen; Linnane, John; Clarke, Aileen

2014-12-02

To map using geospatial modelling techniques the morbidity and mortality caused by heart failure within Warwickshire to characterise and quantify any influence of air pollution on these risks. Cross-sectional. Warwickshire, UK. Data from all of the 105 current Warwickshire County wards were collected on hospital admissions and deaths due to heart failure. In multivariate analyses, the presence of higher mono-nitrogen oxide (NOx) in a ward (3.35:1.89, 4.99), benzene (Ben) (31.9:8.36, 55.85) and index of multiple deprivation (IMD; 0.02: 0.01, 0.03), were consistently associated with a higher risk of heart failure morbidity. Particulate matter (Pm; -12.93: -20.41, -6.54) was negatively associated with the risk of heart failure morbidity. No association was found between sulfur dioxide (SO2) and heart failure morbidity. The risk of heart failure mortality was higher in wards with a higher NOx (4.30: 1.68, 7.37) and wards with more inhabitants 50+ years old (1.60: 0.47, 2.92). Pm was negatively associated (-14.69: -23.46, -6.50) with heart failure mortality. SO2, Ben and IMD scores were not associated with heart failure mortality. There was a prominent variation in heart failure morbidity and mortality risk across wards, the highest risk being in the regions around Nuneaton and Bedworth. This study showed distinct spatial patterns in heart failure morbidity and mortality, suggesting the potential role of environmental factors beyond individual-level risk factors. Air pollution levels should therefore be taken into account when considering the wider determinants of public health and the impact that changes in air pollution might have on the health of a population. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Spatial variation of heart failure and air pollution in Warwickshire, UK: an investigation of small scale variation at the ward-level

PubMed Central

Bennett, Oscar; Kandala, Ngianga-Bakwin; Ji, Chen; Linnane, John; Clarke, Aileen

2014-01-01

Objectives To map using geospatial modelling techniques the morbidity and mortality caused by heart failure within Warwickshire to characterise and quantify any influence of air pollution on these risks. Design Cross-sectional. Setting Warwickshire, UK. Participants Data from all of the 105 current Warwickshire County wards were collected on hospital admissions and deaths due to heart failure. Results In multivariate analyses, the presence of higher mono-nitrogen oxide (NOx) in a ward (3.35:1.89, 4.99), benzene (Ben) (31.9:8.36, 55.85) and index of multiple deprivation (IMD; 0.02: 0.01, 0.03), were consistently associated with a higher risk of heart failure morbidity. Particulate matter (Pm; −12.93: −20.41, −6.54) was negatively associated with the risk of heart failure morbidity. No association was found between sulfur dioxide (SO2) and heart failure morbidity. The risk of heart failure mortality was higher in wards with a higher NOx (4.30: 1.68, 7.37) and wards with more inhabitants 50+ years old (1.60: 0.47, 2.92). Pm was negatively associated (−14.69: −23.46, −6.50) with heart failure mortality. SO2, Ben and IMD scores were not associated with heart failure mortality. There was a prominent variation in heart failure morbidity and mortality risk across wards, the highest risk being in the regions around Nuneaton and Bedworth. Conclusions This study showed distinct spatial patterns in heart failure morbidity and mortality, suggesting the potential role of environmental factors beyond individual-level risk factors. Air pollution levels should therefore be taken into account when considering the wider determinants of public health and the impact that changes in air pollution might have on the health of a population. PMID:25468504

Pitfalls and Precautions When Using Predicted Failure Data for Quantitative Analysis of Safety Risk for Human Rated Launch Vehicles

NASA Technical Reports Server (NTRS)

Hatfield, Glen S.; Hark, Frank; Stott, James

2016-01-01

Launch vehicle reliability analysis is largely dependent upon using predicted failure rates from data sources such as MIL-HDBK-217F. Reliability prediction methodologies based on component data do not take into account risks attributable to manufacturing, assembly, and process controls. These sources often dominate component level reliability or risk of failure probability. While consequences of failure is often understood in assessing risk, using predicted values in a risk model to estimate the probability of occurrence will likely underestimate the risk. Managers and decision makers often use the probability of occurrence in determining whether to accept the risk or require a design modification. Due to the absence of system level test and operational data inherent in aerospace applications, the actual risk threshold for acceptance may not be appropriately characterized for decision making purposes. This paper will establish a method and approach to identify the pitfalls and precautions of accepting risk based solely upon predicted failure data. This approach will provide a set of guidelines that may be useful to arrive at a more realistic quantification of risk prior to acceptance by a program.

Rationale and design of a randomised controlled trial evaluating the effectiveness of an exercise program to improve the quality of life of patients with heart failure in primary care: The EFICAR study protocol.

PubMed

Zuazagoitia, Ana; Grandes, Gonzalo; Torcal, Jesús; Lekuona, Iñaki; Echevarria, Pilar; Gómez, Manuel A; Domingo, Mar; de la Torre, Maria M; Ramírez, Jose I; Montoya, Imanol; Oyanguren, Juana; Pinilla, Ricardo Ortega-Sánchez

2010-01-25

Quality of life (QoL) decreases as heart failure worsens, which is one of the greatest worries of these patients. Physical exercise has been shown to be safe for people with heart failure. Previous studies have tested heterogeneous exercise programs using different QoL instruments and reported inconsistent effects on QoL. The aim of this study is to evaluate the effectiveness of a new exercise program for people with heart failure (EFICAR), additional to the recommended optimal treatment in primary care, to improve QoL, functional capacity and control of cardiovascular risk factors. Multicenter clinical trial in which 600 patients with heart failure in NYHA class II-IV will be randomized to two parallel groups: EFICAR and control. After being recruited, through the reference cardiology services, in six health centres from the Spanish Primary Care Prevention and Health Promotion Research Network (redIAPP), patients are followed for 1 year after the beginning of the intervention. Both groups receive the optimized treatment according to the European Society of Cardiology guidelines. In addition, the EFICAR group performs a 3 month supervised progressive exercise program with an aerobic (high-intensity intervals) and a strength component; and the programme continues linked with community resources for 9 months. The main outcome measure is the change in health-related QoL measured by the SF-36 and the Minnesota Living with Heart Failure Questionnaires at baseline, 3, 6 and 12 months. Secondary outcomes considered are changes in functional capacity measured by the 6-Minute Walking Test, cardiac structure (B-type natriuretic peptides), muscle strength and body composition. Both groups will be compared on an intention to treat basis, using multi-level longitudinal mixed models. Sex, age, social class, co-morbidity and cardiovascular risk factors will be considered as potential confounding and predictor variables. A key challenges of this study is to guarantee the safety of the patients; however, the current scientific evidence supports the notion of there being no increase in the risk of decompensation, cardiac events, hospitalizations and deaths associated with exercise, but rather the opposite. Safety assurance will be based on an optimized standardised pharmacological therapy and health education for all the participants. Clinical Trials.gov Identifier: NCT01033591.

Numerical simulation of backward erosion piping in heterogeneous fields

NASA Astrophysics Data System (ADS)

Liang, Yue; Yeh, Tian-Chyi Jim; Wang, Yu-Li; Liu, Mingwei; Wang, Junjie; Hao, Yonghong

2017-04-01

Backward erosion piping (BEP) is one of the major causes of seepage failures in levees. Seepage fields dictate the BEP behaviors and are influenced by the heterogeneity of soil properties. To investigate the effects of the heterogeneity on the seepage failures, we develop a numerical algorithm and conduct simulations to study BEP progressions in geologic media with spatially stochastic parameters. Specifically, the void ratio e, the hydraulic conductivity k, and the ratio of the particle contents r of the media are represented as the stochastic variables. They are characterized by means and variances, the spatial correlation structures, and the cross correlation between variables. Results of the simulations reveal that the heterogeneity accelerates the development of preferential flow paths, which profoundly increase the likelihood of seepage failures. To account for unknown heterogeneity, we define the probability of the seepage instability (PI) to evaluate the failure potential of a given site. Using Monte-Carlo simulation (MCS), we demonstrate that the PI value is significantly influenced by the mean and the variance of ln k and its spatial correlation scales. But the other parameters, such as means and variances of e and r, and their cross correlation, have minor impacts. Based on PI analyses, we introduce a risk rating system to classify the field into different regions according to risk levels. This rating system is useful for seepage failures prevention and assists decision making when BEP occurs.

Launch Vehicle Abort Analysis for Failures Leading to Loss of Control

NASA Technical Reports Server (NTRS)

Hanson, John M.; Hill, Ashley D.; Beard, Bernard B.

2013-01-01

Launch vehicle ascent is a time of high risk for an onboard crew. There is a large fraction of possible failures for which time is of the essence and a successful abort is possible if the detection and action happens quickly enough. This paper focuses on abort determination based on data already available from the Guidance, Navigation, and Control system. This work is the result of failure analysis efforts performed during the Ares I launch vehicle development program. The two primary areas of focus are the derivation of abort triggers to ensure that abort occurs as quickly as possible when needed, but that false aborts are avoided, and evaluation of success in aborting off the failing launch vehicle.

Use of cardiopulmonary pump support during coronary artery bypass grafting in the high-risk: a meta-analysis.

PubMed

Yousif, A; Addison, D; Lakkis, N; Rosengart, T; Virani, S S; Birnbaum, Y; Alam, M

2018-05-01

Data from randomized trials evaluating the efficacy of on- versus off-pump coronary artery bypass grafting remain inconclusive, particularly in high-risk populations. The aim of this study is to compare the outcomes associated with on- versus off-pump coronary artery bypass grafting among high-risk patients. We performed a meta-analysis of randomized control trials comparing on- versus off-pump coronary artery bypass grafting, focusing on high-risk populations. Studies focusing on "high-risk" features: European System of Cardiac Operative Risk Evaluation (EuroSCORE) ≥ 5, age > 70 years, preexisting renal insufficiency, history of stroke(s), and the presence of left ventricular dysfunction were included. MEDLINE, Scopus, and Embase were searched for all publications between January 1, 2000 and August 1, 2016, using the following terms: on-pump, off-pump, coronary artery bypass, high-risk, left ventricular dysfunction, elderly, aged, and renal insufficiency. Endpoints included cardiovascular and all-cause mortality, non-fatal myocardial infarction, stroke, need for revascularization, renal failure, and length of hospital stay. Nine studies incorporating 11,374 patients with a mean age of 70 years were selected. There was no statistical difference in cardiovascular mortality, all-cause mortality, non-fatal myocardial infarction, and renal failure between the two groups. There was a decrease in further revascularization at 1 year with on-pump (OR 0.67 (0.50-0.89)). However, there was an increase in length of hospital stay by 2.24 days (p = 0.03) among the on-pump group with no difference in stroke (OR 1.34 (1.00-1.80)). On-pump is associated with a decreased risk of additional revascularization by 1 year. However, this appears to be a cost of longer hospitalization.

Baseline Hemodynamics and Response to Contrast Media During Diagnostic Cardiac Catheterization Predict Adverse Events in Heart Failure Patients.

PubMed

Denardo, Scott J; Vock, David M; Schmalfuss, Carsten M; Young, Gregory D; Tcheng, James E; O'Connor, Christopher M

2016-07-01

Contrast media administered during cardiac catheterization can affect hemodynamic variables. However, little is documented about the effects of contrast on hemodynamics in heart failure patients or the prognostic value of baseline and changes in hemodynamics for predicting subsequent adverse events. In this prospective study of 150 heart failure patients, we measured hemodynamics at baseline and after administration of iodixanol or iopamidol contrast. One-year Kaplan-Meier estimates of adverse event-free survival (death, heart failure hospitalization, and rehospitalization) were generated, grouping patients by baseline measures of pulmonary capillary wedge pressure (PCWP) and cardiac index (CI), and by changes in those measures after contrast administration. We used Cox proportional hazards modeling to assess sequentially adding baseline PCWP and change in CI to 5 validated risk models (Seattle Heart Failure Score, ESCAPE [Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness], CHARM [Candesartan in Heart Failure: Assessment of Reduction in Mortality and Morbidity], CORONA [Controlled Rosuvastatin Multinational Trial in Heart Failure], and MAGGIC [Meta-Analysis Global Group in Chronic Heart Failure]). Median contrast volume was 109 mL. Both contrast media caused similarly small but statistically significant changes in most hemodynamic variables. There were 39 adverse events (26.0%). Adverse event rates increased using the composite metric of baseline PCWP and change in CI (P<0.01); elevated baseline PCWP and decreased CI after contrast correlated with the poorest prognosis. Adding both baseline PCWP and change in CI to the 5 risk models universally improved their predictive value (P≤0.02). In heart failure patients, the administration of contrast causes small but significant changes in hemodynamics. Calculating baseline PCWP with change in CI after contrast predicts adverse events and increases the predictive value of existing models. Patients with elevated baseline PCWP and decreased CI after contrast merit greatest concern. © 2016 American Heart Association, Inc.

A Proposal of Operational Risk Management Method Using FMEA for Drug Manufacturing Computerized System

NASA Astrophysics Data System (ADS)

Takahashi, Masakazu; Nanba, Reiji; Fukue, Yoshinori

This paper proposes operational Risk Management (RM) method using Failure Mode and Effects Analysis (FMEA) for drug manufacturing computerlized system (DMCS). The quality of drug must not be influenced by failures and operational mistakes of DMCS. To avoid such situation, DMCS has to be conducted enough risk assessment and taken precautions. We propose operational RM method using FMEA for DMCS. To propose the method, we gathered and compared the FMEA results of DMCS, and develop a list that contains failure modes, failures and countermeasures. To apply this list, we can conduct RM in design phase, find failures, and conduct countermeasures efficiently. Additionally, we can find some failures that have not been found yet.

Decomposition-Based Failure Mode Identification Method for Risk-Free Design of Large Systems

NASA Technical Reports Server (NTRS)

Tumer, Irem Y.; Stone, Robert B.; Roberts, Rory A.; Clancy, Daniel (Technical Monitor)

2002-01-01

When designing products, it is crucial to assure failure and risk-free operation in the intended operating environment. Failures are typically studied and eliminated as much as possible during the early stages of design. The few failures that go undetected result in unacceptable damage and losses in high-risk applications where public safety is of concern. Published NASA and NTSB accident reports point to a variety of components identified as sources of failures in the reported cases. In previous work, data from these reports were processed and placed in matrix form for all the system components and failure modes encountered, and then manipulated using matrix methods to determine similarities between the different components and failure modes. In this paper, these matrices are represented in the form of a linear combination of failures modes, mathematically formed using Principal Components Analysis (PCA) decomposition. The PCA decomposition results in a low-dimensionality representation of all failure modes and components of interest, represented in a transformed coordinate system. Such a representation opens the way for efficient pattern analysis and prediction of failure modes with highest potential risks on the final product, rather than making decisions based on the large space of component and failure mode data. The mathematics of the proposed method are explained first using a simple example problem. The method is then applied to component failure data gathered from helicopter, accident reports to demonstrate its potential.

Multinational assessment of accuracy of equations for predicting risk of kidney failure: a meta-analysis

PubMed Central

Tangri, Navdeep; Grams, Morgan E.; Levey, Andrew S.; Coresh, Josef; Appel, Lawrence; Astor, Brad C.; Chodick, Gabriel; Collins, Allan J.; Djurdjev, Ognjenka; Elley, C. Raina; Evans, Marie; Garg, Amit X.; Hallan, Stein I.; Inker, Lesley; Ito, Sadayoshi; Jee, Sun Ha; Kovesdy, Csaba P.; Kronenberg, Florian; Lambers Heerspink, Hiddo J.; Marks, Angharad; Nadkarni, Girish N.; Navaneethan, Sankar D.; Nelson, Robert G.; Titze, Stephanie; Sarnak, Mark J.; Stengel, Benedicte; Woodward, Mark; Iseki, Kunitoshi

2016-01-01

Importance Identifying patients at risk of chronic kidney disease (CKD) progression may facilitate more optimal nephrology care. Kidney failure risk equations (KFREs) were previously developed and validated in two Canadian cohorts. Validation in other regions and in CKD populations not under the care of a nephrologist is needed. Objective To evaluate the accuracy of the KFREs across different geographic regions and patient populations through individual-participant data meta-analysis. Data Sources Thirty-one cohorts, including 721,357 participants with CKD Stages 3–5 in over 30 countries spanning 4 continents, were studied. These cohorts collected data from 1982 through 2014. Study Selection Cohorts participating in the CKD Prognosis Consortium with data on end-stage renal disease. Data Extraction and Synthesis Data were obtained and statistical analyses were performed between July 2012 and June 2015. Using the risk factors from the original KFREs, cohort-specific hazard ratios were estimated, and combined in meta-analysis to form new “pooled” KFREs. Original and pooled equation performance was compared, and the need for regional calibration factors was assessed. Main Outcome and Measure Kidney failure (treatment by dialysis or kidney transplantation). Results During a median follow-up of 4 years, 23,829 cases of kidney failure were observed. The original KFREs achieved excellent discrimination (ability to differentiate those who developed kidney failure from those who did not) across all cohorts (overall C statistic, 0.90 (95% CI 0.89–0.92) at 2 years and 0.88 (95% CI 0.86–0.90) at 5 years); discrimination in subgroups by age, race, and diabetes status was similar. There was no improvement with the pooled equations. Calibration (the difference between observed and predicted risk) was adequate in North American cohorts, but the original KFREs overestimated risk in some non-North American cohorts. Addition of a calibration factor that lowered the baseline risk by 32.9% at 2 years and 16.5% at 5 years improved the calibration in 12/15 and 10/13 non-North American cohorts at 2 and 5 years, respectively (p=0.04 and p=0.02). Conclusions and Relevance KFREs developed in a Canadian population showed high discrimination and adequate calibration when validated in 31 multinational cohorts. However, in some regions the addition of a calibration factor may be necessary. PMID:26757465

Integration and Assessment of Component Health Prognostics in Supervisory Control Systems

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

Ramuhalli, Pradeep; Bonebrake, Christopher A.; Dib, Gerges

Enhanced risk monitors (ERMs) for active components in advanced reactor concepts use predictive estimates of component failure to update, in real time, predictive safety and economic risk metrics. These metrics have been shown to be capable of use in optimizing maintenance scheduling and managing plant maintenance costs. Integrating this information with plant supervisory control systems increases the potential for making control decisions that utilize real-time information on component conditions. Such decision making would limit the possibility of plant operations that increase the likelihood of degrading the functionality of one or more components while maintaining the overall functionality of the plant.more » ERM uses sensor data for providing real-time information about equipment condition for deriving risk monitors. This information is used to estimate the remaining useful life and probability of failure of these components. By combining this information with plant probabilistic risk assessment models, predictive estimates of risk posed by continued plant operation in the presence of detected degradation may be estimated. In this paper, we describe this methodology in greater detail, and discuss its integration with a prototypic software-based plant supervisory control platform. In order to integrate these two technologies and evaluate the integrated system, software to simulate the sensor data was developed, prognostic models for feedwater valves were developed, and several use cases defined. The full paper will describe these use cases, and the results of the initial evaluation.« less

Constructive Failure in Mathematics Classes

ERIC Educational Resources Information Center

Rowlett, Joel E.

2011-01-01

Great strides in the real world are usually accompanied by failure. Mathematics teachers should accept some failure as their students take risks during mathematical explorations. This is not to imply that students should fail an entire course, but they should have opportunities to take risks that may lead to failure, especially in the area of…

[Actuarial analysis of time-failure data and its rrelevance for interpretation of results. Audit of the journal "Strahlentherapie und Onkologie" (Radiotherapy and Oncology)].

PubMed

Dubben, H H; Beck-Bornholdt, H P

2000-12-01

The statistical quality of the contributions to "Strahlentherapie und Onkologie" is assessed, aiming for improvement of the journal and consequently its impact factor. All 181 articles published during 1998 and 1999 in the categories "review", "original contribution", and "short communication" were analyzed concerning actuarial analysis of time-failure data. One hundred and twenty-three publications without time-failure data were excluded from analysis. Forty-five of the remaining 58 publications with time-failure data were evaluated actuarially. This corresponds to 78% (95% confidence interval: 64 to 88%) of papers, in which data were adequately analyzed. Complications were reported in 16 of 58 papers, but in only 3 cases actuarially. The number of patients at risk during the course of follow-up was documented adequately in 22 of the 45 publications with actuarial analysis. Authors, peer reviewers, and editors could contribute to improve the quality of the journal by setting value on acturial analysis of time-failure data.

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

Chaudhuri, T.K.; Fink, S.

The records of 18 consecutive patients referred to a Veterans Administration Hospital nuclear medicine service for renal scintigraphic tests to rule out renovascular hypertension were reviewed. The men were elderly (mean age, 62 years), and risk factors for untoward reactions, including long-standing hypertension, severe peripheral vascular disease, diabetes, chronic renal failure, and recent diuretic use were present. Despite these risks, there was no test morbidity, and the authors conclude that the renal scintigraphic test with captopril enhancement is well tolerated and deserves continued application and evaluation.

Appropriate evaluation and treatment of heart failure patients after implantable cardioverter-defibrillator discharge: time to go beyond the initial shock.

PubMed

Mishkin, Joseph D; Saxonhouse, Sherry J; Woo, Gregory W; Burkart, Thomas A; Miles, William M; Conti, Jamie B; Schofield, Richard S; Sears, Samuel F; Aranda, Juan M

2009-11-24

Multiple clinical trials support the use of implantable cardioverter-defibrillators (ICDs) for prevention of sudden cardiac death in patients with heart failure (HF). Unfortunately, several complicating issues have arisen from the universal use of ICDs in HF patients. An estimated 20% to 35% of HF patients who receive an ICD for primary prevention will experience an appropriate shock within 1 to 3 years of implant, and one-third of patients will experience an inappropriate shock. An ICD shock is associated with a 2- to 5-fold increase in mortality, with the most common cause being progressive HF. The median time from initial ICD shock to death ranges from 168 to 294 days depending on HF etiology and the appropriateness of the ICD therapy. Despite this prognosis, current guidelines do not provide a clear stepwise approach to managing these high-risk patients. An ICD shock increases HF event risk and should trigger a thorough evaluation to determine the etiology of the shock and guide subsequent therapeutic interventions. Several combinations of pharmacologic and device-based interventions such as adding amiodarone to baseline beta-blocker therapy, adjusting ICD sensitivity, and employing antitachycardia pacing may reduce future appropriate and inappropriate shocks. Aggressive HF surveillance and management is required after an ICD shock, as the risk of sudden cardiac death is transformed to an increased HF event risk.

Clavicular bone tunnel malposition leads to early failures in coracoclavicular ligament reconstructions.

PubMed

Cook, Jay B; Shaha, James S; Rowles, Douglas J; Bottoni, Craig R; Shaha, Steven H; Tokish, John M

2013-01-01

Modern techniques for the treatment of acromioclavicular (AC) joint dislocations have largely centered on free tendon graft reconstructions. Recent biomechanical studies have demonstrated that an anatomic reconstruction with 2 clavicular bone tunnels more closely matches the properties of native coracoclavicular (CC) ligaments than more traditional techniques. No study has analyzed tunnel position in regard to risk of early failure. To evaluate the effect of clavicular tunnel position in CC ligament reconstruction as a risk of early failure. Case series; Level of evidence, 4. A retrospective review was performed of a consecutive series of CC ligament reconstructions performed with 2 clavicular bone tunnels and a free tendon graft. The population was largely a young, active-duty military group of patients. Radiographs were analyzed for the maintenance of reduction and location of clavicular bone tunnels using a picture archiving and communication system. The distance from the lateral border of the clavicle to the center of each bone tunnel was divided by the total clavicular length to establish a ratio. Medical records were reviewed for operative details and functional outcome. Failure was defined as loss of intraoperative reduction. The overall failure rate was 28.6% (8/28) at an average of 7.4 weeks postoperatively. Comparison of bone tunnel position showed that medialized bone tunnels were a significant predictor for early loss of reduction for the conoid (a ratio of 0.292 vs 0.248; P = .012) and trapezoid bone tunnels (a ratio of 0.171 vs 0.128; P = .004); this correlated to an average of 7 to 9 mm more medial in the reconstructions that failed. Reconstructions performed with a conoid ratio of ≥0.30 were significantly more likely to fail (5/5, 100%) than were those performed lateral to a ratio of 0.30 (3/23, 13.0%) (P < .01). There were no failures when the conoid ratio was <0.25 (0/10, 0%). Conoid tunnel placement was also statistically significant for predicting return to duty in our active-duty population. Medial tunnel placement is a significant factor in risk for early failures when performing anatomic CC ligament reconstructions. Preoperative templating is recommended to evaluate optimal placement of the clavicular bone tunnels. Placement of the conoid tunnel at 25% of the clavicular length from the lateral border of the clavicle is associated with a lower rate of lost reduction and a higher rate of return to military duty.

Heart Transplant and Mechanical Circulatory Support in Patients With Advanced Heart Failure.

PubMed

Sánchez-Enrique, Cristina; Jorde, Ulrich P; González-Costello, José

2017-05-01

Patients with advanced heart failure have a poor prognosis and heart transplant is still the best treatment option. However, the scarcity of donors, long waiting times, and an increasing number of unstable patients have favored the development of mechanical circulatory support. This review summarizes the indications for heart transplant, candidate evaluation, current immunosuppression strategies, the evaluation and treatment of rejection, infectious prophylaxis, and short and long-term outcomes. Regarding mechanical circulatory support, we distinguish between short- and long-term support and the distinct strategies that can be used: bridge to decision, recovery, candidacy, transplant, and destination therapy. We then discuss indications, risk assessment, management of complications, especially with long-term support, and outcomes. Finally, we discuss future challenges and how the widespread use of long-term support for patients with advanced heart failure will only be viable if their complications and costs are reduced. Copyright © 2017 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

Persistent high serum bicarbonate and the risk of heart failure in patients with chronic kidney disease (CKD): A report from the Chronic Renal Insufficiency Cohort (CRIC) study.

PubMed

Dobre, Mirela; Yang, Wei; Pan, Qiang; Appel, Lawrence; Bellovich, Keith; Chen, Jing; Feldman, Harold; Fischer, Michael J; Ham, L L; Hostetter, Thomas; Jaar, Bernard G; Kallem, Radhakrishna R; Rosas, Sylvia E; Scialla, Julia J; Wolf, Myles; Rahman, Mahboob

2015-04-20

Serum bicarbonate varies over time in chronic kidney disease (CKD) patients, and this variability may portend poor cardiovascular outcomes. The aim of this study was to conduct a time-updated longitudinal analysis to evaluate the association of serum bicarbonate with long-term clinical outcomes: heart failure, atherosclerotic events, renal events (halving of estimated glomerular filtration rate [eGFR] or end-stage renal disease), and mortality. Serum bicarbonate was measured annually, in 3586 participants with CKD, enrolled in the Chronic Renal Insufficiency Cohort (CRIC) study. Marginal structural models were created to allow for integration of all available bicarbonate measurements and proper adjustment for time-dependent confounding. During the 6 years follow-up, 512 participants developed congestive heart failure (26/1000 person-years) and 749 developed renal events (37/1000 person-years). The risk of heart failure and death was significantly higher for participants who maintained serum bicarbonate >26 mmol/L for the entire duration of follow-up (hazard ratio [HR] 1.66; 95% confidence interval [CI], 1.23 to 2.23, and HR 1.36, 95% CI 1.02 to 1.82, respectively) compared with participants who kept their bicarbonate 22 to 26 mmol/L, after adjusting for demographics, co-morbidities, medications including diuretics, eGFR, and proteinuria. Participants who maintained serum bicarbonate <22 mmol/L had almost a 2-fold increased risk of renal disease progression (HR 1.97; 95% CI, 1.50 to 2.57) compared with participants with bicarbonate 22 to 26 mmol/L. In this large CKD cohort, persistent serum bicarbonate >26 mmol/L was associated with increased risk of heart failure events and mortality. Further studies are needed to determine the optimal range of serum bicarbonate in CKD to prevent adverse clinical outcomes. © 2015 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Persistent High Serum Bicarbonate and the Risk of Heart Failure in Patients With Chronic Kidney Disease (CKD): A Report From the Chronic Renal Insufficiency Cohort (CRIC) Study

PubMed Central

Dobre, Mirela; Yang, Wei; Pan, Qiang; Appel, Lawrence; Bellovich, Keith; Chen, Jing; Feldman, Harold; Fischer, Michael J.; Ham, L. L.; Hostetter, Thomas; Jaar, Bernard G.; Kallem, Radhakrishna R.; Rosas, Sylvia E.; Scialla, Julia J.; Wolf, Myles; Rahman, Mahboob

2015-01-01

Background Serum bicarbonate varies over time in chronic kidney disease (CKD) patients, and this variability may portend poor cardiovascular outcomes. The aim of this study was to conduct a time‐updated longitudinal analysis to evaluate the association of serum bicarbonate with long‐term clinical outcomes: heart failure, atherosclerotic events, renal events (halving of estimated glomerular filtration rate [eGFR] or end‐stage renal disease), and mortality. Methods and Results Serum bicarbonate was measured annually, in 3586 participants with CKD, enrolled in the Chronic Renal Insufficiency Cohort (CRIC) study. Marginal structural models were created to allow for integration of all available bicarbonate measurements and proper adjustment for time‐dependent confounding. During the 6 years follow‐up, 512 participants developed congestive heart failure (26/1000 person‐years) and 749 developed renal events (37/1000 person‐years). The risk of heart failure and death was significantly higher for participants who maintained serum bicarbonate >26 mmol/L for the entire duration of follow‐up (hazard ratio [HR] 1.66; 95% confidence interval [CI], 1.23 to 2.23, and HR 1.36, 95% CI 1.02 to 1.82, respectively) compared with participants who kept their bicarbonate 22 to 26 mmol/L, after adjusting for demographics, co‐morbidities, medications including diuretics, eGFR, and proteinuria. Participants who maintained serum bicarbonate <22 mmol/L had almost a 2‐fold increased risk of renal disease progression (HR 1.97; 95% CI, 1.50 to 2.57) compared with participants with bicarbonate 22 to 26 mmol/L. Conclusion In this large CKD cohort, persistent serum bicarbonate >26 mmol/L was associated with increased risk of heart failure events and mortality. Further studies are needed to determine the optimal range of serum bicarbonate in CKD to prevent adverse clinical outcomes. PMID:25896890

Short- and long-term major cardiovascular adverse events in carotid artery interventions: a nationwide population-based cohort study in Taiwan.

PubMed

Tsai, Ming-Lung; Mao, Chun-Tai; Chen, Dong-Yi; Hsieh, I-Chang; Wen, Ming-Shien; Chen, Tien-Hsing

2015-01-01

Carotid artery stenosis is one of the leading causes of ischemic stroke. Carotid artery stenting has become well-established as an effective treatment option for carotid artery stenosis. For this study, we aimed to determine the efficacy and safety of carotid stenting in a population-based large cohort of patients by analyzing the Taiwan National Healthcare Insurance (NHI) database. 2,849 patients who received carotid artery stents in the NHI database from 2004 to 2010 were identified. We analyzed the risk factors of outcomes including major adverse cardiovascular events including death, acute myocardial infarction, and cerebral vascular accidents at 30 days, 1 year, and overall period and further evaluated cause of death after carotid artery stenting. The periprocedural stroke rate was 2.7% and the recurrent stroke rate for the overall follow-up period was 20.3%. Male, diabetes mellitus, and heart failure were significant risk factors for overall recurrent stroke (Hazard Ratio (HR) = 1.35, p = 0.006; HR = 1.23, p = 0.014; HR = 1.61, p < 0.001, respectively). The periprocedural acute myocardial infarction rate was 0.3%. Age and Diabetes mellitus were the significant factors to predict periprocedural myocardial infarction (HR = 3.06, p = 0.019; HR = 1.68, p < 0.001, respectively). Periprocedural and overall mortality rates were 1.9% and 17.3%, respectively. The most significant periprocedural mortality risk factor was acute renal failure. Age, diabetes mellitus, acute or chronic renal failure, heart failure, liver disease, and malignancy were factors correlated to the overall period mortality. Periprocedural acute renal failure significantly increased the mortality rate and the number of major adverse cardiovascular events, and the predict power persisted more than one year after the procedure. Age and diabetes mellitus were significant risk factors to predict acute myocardial infarction after carotid artery stenting.

The reliability-quality relationship for quality systems and quality risk management.

PubMed

Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M

2012-01-01

Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality systems and quality risk management.

Illinois Prekindergarten Program for Children At Risk of Academic Failure. FY 93 Summary Report.

ERIC Educational Resources Information Center

Illinois State Board of Education, Springfield, Dept. of Planning, Research and Evaluation.

The Illinois Prekindergarten Program for Children at Risk of Academic Failure was a grant program for public school districts to enhance growth and development of children ages 3 to 5 who are at risk of academic failure. The program has experienced significant growth since its initial implementation, and the number of participating projects…

Prognostic incremental role of right ventricular function in acute decompensation of advanced chronic heart failure.

PubMed

Frea, Simone; Pidello, Stefano; Bovolo, Virginia; Iacovino, Cristina; Franco, Erica; Pinneri, Francesco; Galluzzo, Alessandro; Volpe, Alessandra; Visconti, Massimiliano; Peirone, Andrea; Morello, Mara; Bergerone, Serena; Gaita, Fiorenzo

2016-05-01

The purpose of this study was to evaluate the additional prognostic value of echocardiography in acute decompensation of advanced chronic heart failure (CHF), focusing on right ventricular (RV) dysfunction and its interaction with loading conditions. Few data are available on the prognostic role of echocardiography in acute HF and on the significance of pulmonary hypertension in patients with severe RV failure. A total of 265 NYHA IV patients admitted for acute decompensation of advanced CHF (EF 22 ± 7%, systolic blood pressure 107 ± 20 mmHg) were prospectively enrolled. Fifty-nine patients met the primary composite endpoint of cardiac death, urgent heart transplantation, and urgent mechanical circulatory support implantation at 90 days. Pulmonary hypertension failed to predict events, while patients with a low transtricuspid systolic gradient (TR gradient <20 mmHg) showed a worse outcome [hazard ratio (HR) 2.37, 95% confidence interval (CI) 1.12-5.00, P = 0.02]. RV dysfunction [tricuspid annular plane systolic excursion (TAPSE) ≤14 mm] in the presence of a low TR gradient identified patients at higher risk of events (HR 2.97, 95% CI 1.19-7.41, P = 0.02). Multivariate analysis showed as best predictors of outcome low RV contraction pressure index (RVCPI), defined as TAPSE × TR gradient, and high estimated right atrial pressure (eRAP). Adding RVCPI (<400 mm*mmHg) and eRAP (≥20 mmHg) to conventional clinical (ADHERE risk tree and NT-proBNP) and echocardiographic risk evaluation resulted in an increase in net reclassification improvement of +19.1% and +20.1%, respectively (P = 0.01) and in c-statistic from 0.59 to 0.73 (P < 0.01). In acute decompensation of advanced CHF, pulmonary hypertension failed to predict events. The in-hospital and short-term prognosis can be better predicted by eRAP and RVCPI. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

Risk factors for postoperative liver failure after hepatectomy for hepatocellular carcinoma.

PubMed

Maeda, Yoshitaka; Nishida, Minekatsu; Takao, Takashi; Mori, Naohide; Tamesa, Takao; Tangoku, Akira; Oka, Masaaki

2004-01-01

Selection of patients for hepatectomy for hepatocellular carcinoma conventionally has been based upon Child-Pugh grading. However, postoperative liver failure after hepatectomy is a major cause of hospital mortality. A new predictor of postoperative liver failure is required. The objective of this study was to identify risk factors for postoperative liver failure after hepatectomy. Perioperative risk factors for liver failure after hepatectomy were analyzed in 112 patients with hepatocellular carcinoma Eight of these patients died of liver failure. Stepwise multivariate logistic regression was performed to investigate significant independent factors among 17 variables, including the serum alkaline phosphatase ratio (ALPR) on the first day after hepatectomy. ALPR was calculated as the postoperative ALP level divided by the ALP level before surgery. Significant risk factors of postoperative liver failure were ALPR on postoperative day 1 (ALPR1), sex, operative blood loss, and operative procedure. As an indicator of liver failure, the diagnostic accuracy of the ALPR1 was 93.7% when the ALPR was less than 0.4 on the first postoperative day. The ALPR and the serum total bilirubin concentration after hepatectomy were uncorrelated. ALPR1 is a useful predictor of liver failure after hepatectomy.

Risk-based planning analysis for a single levee

NASA Astrophysics Data System (ADS)

Hui, Rui; Jachens, Elizabeth; Lund, Jay

2016-04-01

Traditional risk-based analysis for levee planning focuses primarily on overtopping failure. Although many levees fail before overtopping, few planning studies explicitly include intermediate geotechnical failures in flood risk analysis. This study develops a risk-based model for two simplified levee failure modes: overtopping failure and overall intermediate geotechnical failure from through-seepage, determined by the levee cross section represented by levee height and crown width. Overtopping failure is based only on water level and levee height, while through-seepage failure depends on many geotechnical factors as well, mathematically represented here as a function of levee crown width using levee fragility curves developed from professional judgment or analysis. These levee planning decisions are optimized to minimize the annual expected total cost, which sums expected (residual) annual flood damage and annualized construction costs. Applicability of this optimization approach to planning new levees or upgrading existing levees is demonstrated preliminarily for a levee on a small river protecting agricultural land, and a major levee on a large river protecting a more valuable urban area. Optimized results show higher likelihood of intermediate geotechnical failure than overtopping failure. The effects of uncertainty in levee fragility curves, economic damage potential, construction costs, and hydrology (changing climate) are explored. Optimal levee crown width is more sensitive to these uncertainties than height, while the derived general principles and guidelines for risk-based optimal levee planning remain the same.

Risk factors of surgical failure following sacrospinous colpopexy for the treatment of uterovaginal prolapse.

PubMed

Qatawneh, Ayman; Thekrallah, Fida; Bata, Majed; Al-Kazaleh, Fawaz; Almustafa, Mahmoud; Abu-Kader, Ilham

2013-06-01

Trans-vaginal sacrospinous colpopexy is one of the surgical procedures used to repair varying degrees of vaginal vault and uterovaginal prolapse. The purpose of this study is to analyse the potential risk factors of surgical failure following sacrospinous colpopexy. A retrospective study of 114 women who underwent unilateral sacrospinous colpopexy at Jordan University Hospital from January 2005 to January 2008 were included. Patient demographics, clinical characteristics and concomitant pelvic organ prolapse surgery were assessed. The patients were evaluated at 6 weeks, and every 6 months thereafter. Twelve (11 %) had recurrent apical (vaginal cuff) prolapse, 26 (23 %) had recurrent prolapse at any compartment were compared with those who had successful surgery. Univariate and logistic regression analyses were used to assess the independent prognostic values of the variables associated with surgical failure. After a mean follow-up of 40 months, the statistically significant predictors of surgical failure included the presence of advanced pre-operative stages of prolapse (stages III and IV), the more distally located points Ba, Bp and C and a lack of mesh augmentation of the anterior vaginal wall during surgery (P = 0.01, 0.027, 0.024, 0.034 and 0.006, respectively). However, a history of prior vaginal repair, the more distally located point Ba and a lack of anterior vaginal wall mesh augmentation were defined as independent predictive variables based on logistic regression analyses (P = 0.04, 0.005 and 0.046, respectively). The presence of advanced anterior vaginal wall prolapse, prior vaginal repair and a lack of mesh augmentation of the anterior compartment are significant risk factors for the surgical failure of sacrospinous suspension surgery.

Risk factors for poor visual outcome in patients with idiopathic intracranial hypertension.

PubMed

Wall, Michael; Falardeau, Julie; Fletcher, William A; Granadier, Robert J; Lam, Byron L; Longmuir, Reid A; Patel, Anil D; Bruce, Beau B; He, Hua; McDermott, Michael P

2015-09-01

Determine potential risk factors for progressive visual field loss in the Idiopathic Intracranial Hypertension Treatment Trial, a randomized placebo-controlled trial of acetazolamide in patients with idiopathic intracranial hypertension and mild visual loss concurrently receiving a low sodium, weight reduction diet. Logistic regression and classification tree analyses were used to evaluate potential risk factors for protocol-defined treatment failure (>2 dB perimetric mean deviation [PMD] change in patients with baseline PMD -2 to -3.5 dB or >3 dB PMD change with baseline PMD -3.5 to -7 dB). Seven participants (6 on diet plus placebo) met criteria for treatment failure. The odds ratio for patients with grades III to V papilledema vs those with grades I and II was 8.66 (95% confidence interval [CI] 1.65-∞, p = 0.025). A 1-unit decrease in the number of letters correct on the ETDRS (Early Treatment Diabetic Retinopathy Study) chart at baseline was associated with an increase in the odds of treatment failure by a factor of 1.16 (95% CI 1.04-1.30, p = 0.005). Compared with female participants, the odds ratio for male participants was 26.21 (95% CI 1.61-433.00, p = 0.02). The odds of treatment failure were 10.59 times higher (95% CI 1.63-116.83, p = 0.010) for patients with >30 transient visual obscurations per month vs those with ≤30 per month. Male patients, those with high-grade papilledema, and those with decreased visual acuity at baseline were more likely to experience treatment failure. All but one of these patients were treated with diet alone. These patients should be monitored closely and be considered for aggressive treatment of their idiopathic intracranial hypertension. © 2015 American Academy of Neurology.

Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report

PubMed Central

Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio

2012-01-01

Objective Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Design and setting Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. Primary outcome To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. Results In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. Conclusions FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children. PMID:23253870

Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report.

PubMed

Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio

2012-01-01

Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children.

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

Concurrent Anemia and Elevated C-Reactive Protein Predicts HIV Clinical Treatment Failure, Including Tuberculosis, After Antiretroviral Therapy Initiation.

PubMed

Shivakoti, Rupak; Yang, Wei-Teng; Gupte, Nikhil; Berendes, Sima; Rosa, Alberto La; Cardoso, Sandra W; Mwelase, Noluthando; Kanyama, Cecilia; Pillay, Sandy; Samaneka, Wadzanai; Riviere, Cynthia; Sugandhavesa, Patcharaphan; Santos, Brento; Poongulali, Selvamuthu; Tripathy, Srikanth; Bollinger, Robert C; Currier, Judith S; Tang, Alice M; Semba, Richard D; Christian, Parul; Campbell, Thomas B; Gupta, Amita

2015-07-01

Anemia is a known risk factor for clinical failure following antiretroviral therapy (ART). Notably, anemia and inflammation are interrelated, and recent studies have associated elevated C-reactive protein (CRP), an inflammation marker, with adverse human immunodeficiency virus (HIV) treatment outcomes, yet their joint effect is not known. The objective of this study was to assess prevalence and risk factors of anemia in HIV infection and to determine whether anemia and elevated CRP jointly predict clinical failure post-ART. A case-cohort study (N = 470 [236 cases, 234 controls]) was nested within a multinational randomized trial of ART efficacy (Prospective Evaluation of Antiretrovirals in Resource Limited Settings [PEARLS]). Cases were incident World Health Organization stage 3, 4, or death by 96 weeks of ART treatment (clinical failure). Multivariable logistic regression was used to determine risk factors for pre-ART (baseline) anemia (females: hemoglobin <12.0 g/dL; males: hemoglobin <13.0 g/dL). Association of anemia as well as concurrent baseline anemia and inflammation (CRP ≥ 10 mg/L) with clinical failure were assessed using multivariable Cox models. Baseline anemia prevalence was 51% with 15% prevalence of concurrent anemia and inflammation. In analysis of clinical failure, multivariate-adjusted hazard ratios were 6.41 (95% confidence interval [CI], 2.82-14.57) for concurrent anemia and inflammation, 0.77 (95% CI, .37-1.58) for anemia without inflammation, and 0.45 (95% CI, .11-1.80) for inflammation without anemia compared to those without anemia and inflammation. ART-naive, HIV-infected individuals with concurrent anemia and inflammation are at particularly high risk of failing treatment, and understanding the pathogenesis could lead to new interventions. Reducing inflammation and anemia will likely improve HIV disease outcomes. Alternatively, concurrent anemia and inflammation could represent individuals with occult opportunistic infections in need of additional screening. © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Risky Business: condom failures as experienced by female sex workers in Mombasa, Kenya.

PubMed

Bradburn, Caitlyn K; Wanje, George; Pfeiffer, James; Jaoko, Walter; Kurth, Ann E; McClelland, R Scott

2017-03-01

Limited research exists about condom failure as experienced by female sex workers. We conducted a qualitative study to examine how female sex workers in Mombasa, Kenya contextualise and explain the occurrence of condom failure. In-depth, semi-structured interviews were conducted with thirty female sex workers to ascertain their condom failure experiences. We qualitatively analysed interview transcripts to determine how the women mitigate risk and cope with condom failure. Condom failure was not uncommon, but women mitigated the risk by learning about correct use, and by supplying and applying condoms themselves. Many female sex workers felt that men intentionally rupture condoms. Few women were aware of or felt empowered to prevent HIV, STIs, and pregnancy after condom failure. Interventions to equip female sex workers with strategies for minimising the risk of HIV, STIs, and pregnancy in the aftermath of a condom failure should be investigated.

Utility of the Seattle Heart Failure Model in patients with advanced heart failure.

PubMed

Kalogeropoulos, Andreas P; Georgiopoulou, Vasiliki V; Giamouzis, Grigorios; Smith, Andrew L; Agha, Syed A; Waheed, Sana; Laskar, Sonjoy; Puskas, John; Dunbar, Sandra; Vega, David; Levy, Wayne C; Butler, Javed

2009-01-27

The aim of this study was to validate the Seattle Heart Failure Model (SHFM) in patients with advanced heart failure (HF). The SHFM was developed primarily from clinical trial databases and extrapolated the benefit of interventions from published data. We evaluated the discrimination and calibration of SHFM in 445 advanced HF patients (age 52 +/- 12 years, 68.5% male, 52.4% white, ejection fraction 18 +/- 8%) referred for cardiac transplantation. The primary end point was death (n = 92), urgent transplantation (n = 14), or left ventricular assist device (LVAD) implantation (n = 3); a secondary analysis was performed on mortality alone. Patients were receiving optimal therapy (angiotensin-II modulation 92.8%, beta-blockers 91.5%, aldosterone antagonists 46.3%), and 71.0% had an implantable device (defibrillator 30.4%, biventricular pacemaker 3.4%, combined 37.3%). During a median follow-up of 21 months, 109 patients (24.5%) had an event. Although discrimination was adequate (c-statistic >0.7), the SHFM overall underestimated absolute risk (observed vs. predicted event rate: 11.0% vs. 9.2%, 21.0% vs. 16.6%, and 27.9% vs. 22.8% at 1, 2, and 3 years, respectively). Risk underprediction was more prominent in patients with an implantable device. The SHFM had different calibration properties in white versus black patients, leading to net underestimation of absolute risk in blacks. Race-specific recalibration improved the accuracy of predictions. When analysis was restricted to mortality, the SHFM exhibited better performance. In patients with advanced HF, the SHFM offers adequate discrimination, but absolute risk is underestimated, especially in blacks and in patients with devices. This is more prominent when including transplantation and LVAD implantation as an end point.

Post-Challenger evaluation of space shuttle risk assessment and management

NASA Technical Reports Server (NTRS)

1988-01-01

As the shock of the Space Shuttle Challenger accident began to subside, NASA initiated a wide range of actions designed to ensure greater safety in various aspects of the Shuttle system and an improved focus on safety throughout the National Space Transportation System (NSTS) Program. Certain specific features of the NASA safety process are examined: the Critical Items List (CIL) and the NASA review of the Shuttle primary and backup units whose failure might result in the loss of life, the Shuttle vehicle, or the mission; the failure modes and effects analyses (FMEA); and the hazard analysis and their review. The conception of modern risk management, including the essential element of objective risk assessment is described and it is contrasted with NASA's safety process in general terms. The discussion, findings, and recommendations regarding particular aspects of the NASA STS safety assurance process are reported. The 11 subsections each deal with a different aspect of the process. The main lessons learned by SCRHAAC in the course of the audit are summarized.

Interim reliability-evaluation program: analysis of the Browns Ferry, Unit 1, nuclear plant. Appendix B - system descriptions and fault trees

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

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

1982-07-01

This report describes a risk study of the Browns Ferry, Unit 1, nuclear plant. The study is one of four such studies sponsored by the NRC Office of Research, Division of Risk Assessment, as part of its Interim Reliability Evaluation Program (IREP), Phase II. This report is contained in four volumes: a main report and three appendixes. Appendix B provides a description of Browns Ferry, Unit 1, plant systems and the failure evaluation of those systems as they apply to accidents at Browns Ferry. Information is presented concerning front-line system fault analysis; support system fault analysis; human error models andmore » probabilities; and generic control circuit analyses.« less

Leakage Currents and Gas Generation in Advanced Wet Tantalum Capacitors

NASA Technical Reports Server (NTRS)

Teverovsky, Alexander

2015-01-01

Currently, military grade, established reliability wet tantalum capacitors are among the most reliable parts used for space applications. This has been achieved over the years by extensive testing and improvements in design and materials. However, a rapid insertion of new types of advanced, high volumetric efficiency capacitors in space systems without proper testing and analysis of degradation mechanisms might increase risks of failures. The specifics of leakage currents in wet electrolytic capacitors is that the conduction process is associated with electrolysis of electrolyte and gas generation resulting in building up of internal gas pressure in the parts. The risk associated with excessive leakage currents and increased pressure is greater for high value advanced wet tantalum capacitors, but it has not been properly evaluated yet. In this work, in Part I, leakages currents in various types of tantalum capacitors have been analyzed in a wide range of voltages, temperatures, and time under bias. Gas generation and the level of internal pressure have been calculated in Part II for different case sizes and different hermeticity leak rates to assess maximal allowable leakage currents. Effects related to electrolyte penetration to the glass seal area have been studied and the possibility of failures analyzed in Part III. Recommendations for screening and qualification to reduce risks of failures have been suggested.

Stingray Failure Mode, Effects and Criticality Analysis: WEC Risk Registers

DOE Data Explorer

Ken Rhinefrank

2016-07-25

Analysis method to systematically identify all potential failure modes and their effects on the Stingray WEC system. This analysis is incorporated early in the development cycle such that the mitigation of the identified failure modes can be achieved cost effectively and efficiently. The FMECA can begin once there is enough detail to functions and failure modes of a given system, and its interfaces with other systems. The FMECA occurs coincidently with the design process and is an iterative process which allows for design changes to overcome deficiencies in the analysis.Risk Registers for major subsystems completed according to the methodology described in "Failure Mode Effects and Criticality Analysis Risk Reduction Program Plan.pdf" document below, in compliance with the DOE Risk Management Framework developed by NREL.

Implant experience with an implantable hemodynamic monitor for the management of symptomatic heart failure.

PubMed

Steinhaus, David; Reynolds, Dwight W; Gadler, Fredrik; Kay, G Neal; Hess, Mike F; Bennett, Tom

2005-08-01

Management of congestive heart failure is a serious public health problem. The use of implantable hemodynamic monitors (IHMs) may assist in this management by providing continuous ambulatory filling pressure status for optimal volume management. The Chronicle system includes an implanted monitor, a pressure sensor lead with passive fixation, an external pressure reference (EPR), and data retrieval and viewing components. The tip of the lead is placed near the right ventricular outflow tract to minimize risk of sensor tissue encapsulation. Implant technique and lead placement is similar to that of a permanent pacemaker. After the system had been successfully implanted in 148 patients, the type and frequency of implant-related adverse events were similar to a single-chamber pacemaker implant. R-wave amplitude was 15.2 +/- 6.7 mV and the pressure waveform signal was acceptable in all but two patients in whom presence of artifacts required lead repositioning. Implant procedure time was not influenced by experience, remaining constant throughout the study. Based on this evaluation, permanent placement of an IHM in symptomatic heart failure patients is technically feasible. Further investigation is warranted to evaluate the use of the continuous hemodynamic data in management of heart failure patients.

Enhanced Component Performance Study: Emergency Diesel Generators 1998–2014

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

Schroeder, John Alton

2015-11-01

This report presents an enhanced performance evaluation of emergency diesel generators (EDGs) at U.S. commercial nuclear power plants. This report evaluates component performance over time using (1) Institute of Nuclear Power Operations (INPO) Consolidated Events Database (ICES) data from 1998 through 2014 and (2) maintenance unavailability (UA) performance data from Mitigating Systems Performance Index (MSPI) Basis Document data from 2002 through 2014. The objective is to show estimates of current failure probabilities and rates related to EDGs, trend these data on an annual basis, determine if the current data are consistent with the probability distributions currently recommended for use inmore » NRC probabilistic risk assessments, show how the reliability data differ for different EDG manufacturers and for EDGs with different ratings; and summarize the subcomponents, causes, detection methods, and recovery associated with each EDG failure mode. Engineering analyses were performed with respect to time period and failure mode without regard to the actual number of EDGs at each plant. The factors analyzed are: sub-component, failure cause, detection method, recovery, manufacturer, and EDG rating. Six trends with varying degrees of statistical significance were identified in the data.« less

Evaluating Failures and near Misses in Human Spaceflight History for Lessons for Future Human Spaceflight

NASA Technical Reports Server (NTRS)

Barr, Stephanie

2010-01-01

Studies done in the past have drawn on lessons learned with regard to human loss-of-life events. However, an examination of near-fatal accidents can be equally useful, not only in detecting causes, both proximate and systemic, but also for determining what factors averted disaster, what design decisions and/or operator actions prevented catastrophe. Binary pass/fail launch history is often used for risk, but this also has limitations. A program with a number of near misses can look more reliable than a consistently healthy program with a single out-of-family failure. Augmenting reliability evaluations with this near miss data can provide insight and expand on the limitations of a strictly pass/fail evaluation. This paper intends to show how near-miss lessons learned can provide crucial data for any new human spaceflight programs that are interested in sending man into space

Evaluating Failures and Near Misses in Human Spaceflight History for Lessons for Future Human Spaceflight

NASA Astrophysics Data System (ADS)

Barr, Stephanie

2010-09-01

Studies done in the past have drawn on lessons learned with regard to human loss-of-life events. However, an examination of near-fatal accidents can be equally useful, not only in detecting causes, both proximate and systemic, but also for determining what factors averted disaster, what design decisions and/or operator actions prevented catastrophe. Binary pass/fail launch history is often used for risk, but this also has limitations. A program with a number of near misses can look more reliable than a consistently healthy program with a single out-of-family failure. Augmenting reliability evaluations with this near miss data can provide insight and expand on the limitations of a strictly pass/fail evaluation. This paper intends to show how near-miss lessons learned can provide crucial data for any new human spaceflight programs that are interested in sending man into space.

Expectations and high school change: teacher-researcher collaboration to prevent school failure.

PubMed

Weinstein, R S; Soulé, C R; Collins, F; Cone, J; Mehlhorn, M; Simontacchi, K

1991-06-01

Describes the multilevel outcomes of a collaborative preventive intervention for ninth-graders at risk for school failure using qualitative and quasi-experimental methods. Teachers, administrators, and researchers implemented innovative practices communicating positive expectations for low-achieving adolescents in their transition to high school. Changes were made in the practices of curriculum, grouping, evaluation, motivation, student responsibility, and relationships (in the classroom, with parents, and in the school). Both implementation and evaluation evolved as a function of collaboration. Change was promising but not uniform. Project teachers became more positive about students and colleagues, expanded their roles, and changed school tracking policies. The 158 project students, in contrast to the 154 comparison students showed improved grades and disciplinary referrals post-intervention and increased retention in school 1 year later, but their absences rose and improved performance was not maintained. The implications of this analysis for school-based interventions and its evaluation are discussed.

Failure of operative treatment for glenohumeral instability: etiology and management.

PubMed

Shah, Apurva S; Karadsheh, Mark S; Sekiya, Jon K

2011-05-01

Failure of primary shoulder stabilization procedures is often related to uncorrected anatomic pathology. Orthopaedic surgeons must recognize excessive capsular laxity or large glenohumeral bone defects preoperatively to avoid recurrence of instability. When history, physical examination, and radiographic evaluation are used in conjunction, patients at risk for failure can be identified. The instability severity index score permits precise identification of patients at risk. When treating patients in whom prior surgical intervention has failed, the success of revision procedures correlates to the surgeon's ability to identify the essential pathology and use lesion-specific treatment strategies. Revision procedures remain technically demanding. Keen preoperative and intraoperative judgment is required to avoid additional recurrence of instability after revision procedures, particularly because results deteriorate with each successive operation. Glenoid or humeral defects with greater than 25% bone loss compromise stability provided through the mechanism of concavity compression. These defects must be specifically addressed to avoid recurrence of instability. We prefer anatomic reconstruction techniques combined with capsulolabral repair and, if bone defects are present, anatomic reconstruction with osteochondral allograft. Copyright © 2011 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

USE OF BROMOERGOCRYPTINE IN THE VALIDATION OF PROTOCOLS FOR THE ASSESSMENT OF MECHANISMS OF EARLY PREGNANCY LOSS IN THE RAT

EPA Science Inventory

Validated protocols for evaluating maternally mediated mechanisms of early pregnancy failure in rodents are needed for use in the risk assessment process. To supplement previous efforts in the validation of a panel of protocols assembled for this purpose, bromoergocryptine (BEC) ...

A Methodology for Making Early Comparative Architecture Performance Evaluations

ERIC Educational Resources Information Center

Doyle, Gerald S.

2010-01-01

Complex and expensive systems' development suffers from a lack of method for making good system-architecture-selection decisions early in the development process. Failure to make a good system-architecture-selection decision increases the risk that a development effort will not meet cost, performance and schedule goals. This research provides a…

77 FR 61446 - Proposed Revision Probabilistic Risk Assessment and Severe Accident Evaluation for New Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-09

... documents online in the NRC Library at http://www.nrc.gov/reading-rm/adams.html . To begin the search... of digital instrumentation and control system PRAs, including common cause failures in PRAs and uncertainty analysis associated with new reactor digital systems, and (4) incorporation of additional...

77 FR 66649 - Proposed Revision to Probabilistic Risk Assessment and Severe Accident Evaluation for New Reactors

Federal Register 2010, 2011, 2012, 2013, 2014

2012-11-06

... in the NRC Library at http://www.nrc.gov/reading-rm/adams.html . To begin the search, select ``ADAMS... of digital instrumentation and control system PRAs, including common cause failures in PRAs and uncertainty analysis associated with new reactor digital systems, and (4) incorporation of additional...

Outcomes after an excisional procedure for cervical intraepithelial neoplasia in HIV-infected women

PubMed Central

Reimers, Laura L.; Sotardi, Susan; Daniel, David; Chiu, Lydia G.; Arsdale, Anne Van; Wieland, Daryl L.; Leider, Jason M.; Xue, Xiaonan; Strickler, Howard D.; Garry, David J.; Goldberg, Gary L.; Einstein, Mark H.

2011-01-01

Objective To determine predictors of treatment failure and recurrence after surgical excisional procedures for CIN in HIV-infected women. Methods A retrospective cohort study was conducted in which 136 eligible HIV-infected women treated for CIN between 1999 and 2005 were included. Data were abstracted from charts and computer databases. Treatment failures were defined as the presence of CIN 1+ at initial follow-up. Recurrences were defined as the presence of CIN 1+ subsequent to initial normal follow-up. Results Treatment failure at initial follow-up was common, occurring in 51% of CIN 1 and 55% of CIN 2+. Most lesions detected at treatment failure were high grade (>70%), regardless of the grade of initial lesion. Significant risk factors for treatment failure were loop electrosurgical excision procedure (LEEP) compared to cold knife conization (RR=1.76; 95% CI: 1.15–2.64), and low CD4+ count (p = 0.04). Among those with an initial normal clinical evaluation, 55% eventually recurred. As with treatment failure, most lesions detected at recurrence were high grade. Risk factors for recurrence included use of LEEP (hazard ratio [HR] = 3.38; 95% CI: 1.55–7.39), higher HIV RNA level, and the presence of positive margins at treatment (HR = 6.12; 95% CI: 1.90–19.73). Conclusions Most CIN treatment of HIV-infected women studied either failed or resulted in recurrence. Of particular concern, many of these subsequent lesions were high grade. Conization, however, was associated with significantly less failure/recurrence than LEEP. Clinicians treating CIN in HIV-infected women should avoid raising expectations of cure and instead focus on the achievable goal of cancer prevention until there are better therapies for this patient population. PMID:20605046

Single- versus double-row repair for full-thickness rotator cuff tears using suture anchors. A systematic review and meta-analysis of basic biomechanical studies.

PubMed

Hohmann, Erik; König, Anya; Kat, Cor-Jacques; Glatt, Vaida; Tetsworth, Kevin; Keough, Natalie

2018-07-01

The purpose of this study was to perform a systematic review and meta-analysis comparing single- and double-row biomechanical studies to evaluate load to failure, mode of failure and gap formation. A systematic review of MEDLINE, Embase, Scopus and Google Scholar was performed from 1990 through 2016. The inclusion criteria were: documentation of ultimate load to failure, failure modes and documentation of elongation or gap formation. Studies were excluded if the study protocol did not use human specimens. Publication bias was assessed by funnel plot and Egger's test. The risk of bias was established using the Cochrane Collaboration's risk of bias tool. Heterogeneity was assessed using χ 2 and I 2 statistic. Eight studies were included. The funnel plot was asymmetric suggesting publication bias, which was confirmed by Egger's test (p = 0.04). The pooled estimate for load to failure demonstrated significant differences (SMD 1.228, 95% CI: 0.55-5.226, p = 0.006, I 2  = 60.47%), favouring double-row repair. There were no differences for failure modes. The pooled estimate for elongation/gap formation demonstrated significant differences (SMD 0.783, 95% CI: 0.169-1.398, p = 0.012, I 2  = 58.8%), favouring double-row repair. The results of this systematic review and meta-analysis suggest that double-row repair is able to tolerate a significantly greater load to failure. Gap formation was also significantly lower in the double-row repair group, but both of these findings should be interpreted with caution because of the inherent interstudy heterogeneity. Systematic review and meta-analysis.

Predicting Failure in Early Acute Prosthetic Joint Infection Treated With Debridement, Antibiotics, and Implant Retention: External Validation of the KLIC Score.

PubMed

Löwik, Claudia A M; Jutte, Paul C; Tornero, Eduard; Ploegmakers, Joris J W; Knobben, Bas A S; de Vries, Astrid J; Zijlstra, Wierd P; Dijkstra, Baukje; Soriano, Alex; Wouthuyzen-Bakker, Marjan

2018-03-27

Debridement, antibiotics, and implant retention (DAIR) is a widely used treatment modality for early acute prosthetic joint infection (PJI). A preoperative risk score was previously designed for predicting DAIR failure, consisting of chronic renal failure (K), liver cirrhosis (L), index surgery (I), cemented prosthesis (C), and C-reactive protein >115 mg/L (KLIC). The aim of this study was to validate the KLIC score in an external cohort. We retrospectively evaluated patients with early acute PJI treated with DAIR between 2006 and 2016 in 3 Dutch hospitals. Early acute PJI was defined as <21 days of symptoms and DAIR performed within 90 days after index surgery. Failure was defined as the need for (1) second DAIR, (2) implant removal, (3) suppressive antimicrobial treatment, or (4) infection-related death within 60 days after debridement. A total of 386 patients were included. Failure occurred in 148 patients (38.3%). Patients with KLIC scores of ≤2, 2.5-3.5, 4-5, 5.5-6.5, and ≥7 had failure rates of 27.9%, 37.1%, 49.3%, 54.5%, and 85.7%, respectively (P < .001). The receiver-operating characteristic curve showed an area under the curve of 0.64 (95% confidence interval 0.59-0.69). A KLIC score higher than 6 points showed a specificity of 97.9%. The KLIC score is a relatively good preoperative risk score for DAIR failure in patients with early acute PJI and appears to be most useful in clinical practice for patients with low or high KLIC scores. Copyright © 2018 Elsevier Inc. All rights reserved.

[Diagnostics and antimicrobial therapy of severe community-acquired pneumonia].

PubMed

Sinopalnikov, A I; Zaitsev, A A

2015-04-01

In the current paper authors presented the latest information concerning etiology of severe community-acquired pneumonia. Most cases are caused by a relatively small number ofpathogenic bacterial and viral natures. The frequency of detection of various pathogens of severe community-acquired pneumonia may vary greatly depending on the region, season and clinical profile of patients, availability of relevant risk factors. Authors presented clinical characteristics of severe community-acquired pneumonia and comparative evaluation of a number of scales to assess the risk of adverse outcome of the disease. Diagnosis of severe community-acquired pneumonia includes the following: collecting of epidemiological history, identification of pneumonia, detection of sepsis and identification of multiple organ dysfunction syndrome, detection of acute respiratory failure, assessment of comorbidity. Authors gave recommendations concerning evaluation of the clinical manifestations of the disease, the use of instrumental and laboratory methods for diagnosis of severe community-acquired pneumonia. To select the mode of antimicrobial therapy is most important local monitoring antimicrobial resistance of pathogens. The main criteria for the effectiveness of treatment are to reduce body temperature, severe intoxication, respiratory and organ failure.

SU-E-T-87: A TG-100 Approach for Quality Improvement of Associated Dosimetry Equipment

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

Manger, R; Pawlicki, T; Kim, G

2015-06-15

Purpose: Dosimetry protocols devote so much time to the discussion of ionization chamber choice, use and performance that is easy to forget about the importance of the associated dosimetry equipment (ADE) in radiation dosimetry - barometer, thermometer, electrometer, phantoms, triaxial cables, etc. Improper use and inaccuracy of these devices may significantly affect the accuracy of radiation dosimetry. The purpose of this study is to evaluate the risk factors in the monthly output dosimetry procedure and recommend corrective actions using a TG-100 approach. Methods: A failure mode and effects analysis (FMEA) of the monthly linac output check procedure was performed tomore » determine which steps and failure modes carried the greatest risk. In addition, a fault tree analysis (FTA) was performed to expand the initial list of failure modes making sure that none were overlooked. After determining the failure modes with the highest risk priority numbers (RPNs), 11 physicists were asked to score corrective actions based on their ease of implementation and potential impact. The results were aggregated into an impact map to determine the implementable corrective actions. Results: Three of the top five failure modes were related to the thermometer and barometer. The two highest RPN-ranked failure modes were related to barometric pressure inaccuracy due to their high lack-of-detectability scores. Six corrective actions were proposed to address barometric pressure inaccuracy, and the survey results found the following two corrective actions to be implementable: 1) send the barometer for recalibration at a calibration laboratory and 2) check the barometer accuracy against the local airport and correct for elevation. Conclusion: An FMEA on monthly output measurements displayed the importance of ADE for accurate radiation dosimetry. When brainstorming for corrective actions, an impact map is helpful for visualizing the overall impact versus the ease of implementation.« less

Efficacy of an integrated hospital-primary care program for heart failure: a population-based analysis of 56,742 patients.

PubMed

Comín-Colet, Josep; Verdú-Rotellar, José María; Vela, Emili; Clèries, Montse; Bustins, Montserrat; Mendoza, Lola; Badosa, Neus; Cladellas, Mercè; Ferré, Sofía; Bruguera, Jordi

2014-04-01

The efficacy of heart failure programs has been demonstrated in clinical trials but their applicability in the real world practice setting is more controversial. This study evaluates the feasibility and efficacy of an integrated hospital-primary care program for the management of patients with heart failure in an integrated health area covering a population of 309,345. For the analysis, we included all patients consecutively admitted with heart failure as the principal diagnosis who had been discharged alive from all of the hospitals in Catalonia, Spain, from 2005 to 2011, the period when the program was implemented, and compared mortality and readmissions among patients exposed to the program with the rates in the patients of all the remaining integrated health areas of the Servei Català de la Salut (Catalan Health Service). We included 56,742 patients in the study. There were 181,204 hospital admissions and 30,712 deaths during the study period. In the adjusted analyses, when compared to the 54,659 patients from the other health areas, the 2083 patients exposed to the program had a lower risk of death (hazard ratio=0.92 [95% confidence interval, 0.86-0.97]; P=.005), a lower risk of clinically-related readmission (hazard ratio=0.71 [95% confidence interval, 0.66-0.76]; P<.001), and a lower risk of readmission for heart failure (hazard ratio=0.86 [95% confidence interval, 0.80-0.94]; P<.001). The positive impact on the morbidity and mortality rates was more marked once the program had become well established. The implementation of multidisciplinary heart failure management programs that integrate the hospital and the community is feasible and is associated with a significant reduction in patient morbidity and mortality. Copyright © 2013 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

Prognostic impact of plasma N-terminal pro-brain natriuretic peptide in severe chronic congestive heart failure: a substudy of the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

PubMed

Hartmann, Franz; Packer, Milton; Coats, Andrew J S; Fowler, Michael B; Krum, Henry; Mohacsi, Paul; Rouleau, Jean L; Tendera, Michal; Castaigne, Alain; Anker, Stefan D; Amann-Zalan, Ildiko; Hoersch, Silke; Katus, Hugo A

2004-09-28

The utility of N-terminal proBNP (NT-proBNP) to predict the occurrence of death and hospitalization was prospectively evaluated in the COPERNICUS study, which enrolled patients with an ejection fraction <25% and symptoms of chronic congestive heart failure at rest or on minimal exertion. Baseline plasma concentrations of NT-proBNP were measured in a subgroup of 814 men and 197 women with symptoms at rest or on minimal exertion who were enrolled in the COPERNICUS study and were randomized to placebo (n=506) or carvedilol (n=505). Values of NT-proBNP were markedly increased despite the requirement that patients be euvolemic before the start of treatment (mean+/-SD, 3235+/-4392 pg/mL; median, 1767 pg/mL). By univariate Cox regression analysis, NT-proBNP was found to be a powerful predictor of subsequent all-cause mortality (relative risk [RR], 2.7; 95% CI, 1.7 to 4.3; P=0.0001 for above versus below median) and all-cause mortality or hospitalization for heart failure (RR, 2.4; 95% CI, 1.8 to 3.4; P=0.0001 for above versus below median). The predictive value of NT-proBNP was similar when both placebo and carvedilol patients were analyzed separately. No significant interaction was found between NT-proBNP and treatment group (P=0.93 for above- versus below-median NT-proBNP). NT-proBNP was consistently associated with increased risk for all-cause mortality and for all-cause mortality or hospitalization for heart failure in patients with severe congestive heart failure, even in those who were clinically euvolemic. This marker therefore may be a useful tool in risk stratification of patients with severe congestive heart failure.

Overview of Threats and Failure Models for Safety-Relevant Computer-Based Systems

NASA Technical Reports Server (NTRS)

Torres-Pomales, Wilfredo

2015-01-01

This document presents a high-level overview of the threats to safety-relevant computer-based systems, including (1) a description of the introduction and activation of physical and logical faults; (2) the propagation of their effects; and (3) function-level and component-level error and failure mode models. These models can be used in the definition of fault hypotheses (i.e., assumptions) for threat-risk mitigation strategies. This document is a contribution to a guide currently under development that is intended to provide a general technical foundation for designers and evaluators of safety-relevant systems.

Maternal smoking during pregnancy and failure of the georgia first grade criterion-referenced competency test.

PubMed

Feng, Jia; Kramer, Michael R; Dever, Bridget V; Dunlop, Anne L; Williams, Bryan; Jain, Lucky

2013-05-01

Maternal smoking during pregnancy (MSDP) has been reported to be associated with impaired measures of cognitive function, but it remains unclear whether exposure to MSDP has an impact upon offspring school performance. We examined the association between MSDP and failure of the Criterion-Referenced Competency Tests (CRCT) among Georgia first grade students. A retrospective cohort was created by deterministically linking 331 531 children born in Georgia from 1998 to 2002 (inclusive) to their individual CRCT education records from 2005 to 2009. We evaluated the association between MSDP (yes/no) and failure of the CRCT Reading, English/Language Arts (ELA), and Mathematics tests, with adjustment for maternal and child sociodemographic characteristics and birth outcomes. Log-binomial models estimated the risk ratios and 95% confidence intervals. Conditional models were fitted to paired sibling data. MSDP was associated with CRCT failure with an adjusted risk ratios for Reading: 1.16 [95% CI 1.12, 1.21]; ELA: 1.12 [95%CI 1.10, 1.15]; and Mathematics: 1.13 [95%CI 1.10, 1.16]. The association remained significant in paired sibling analyses. MSDP may have independent long-term effects on offspring school performance, which does not appear to be through smoking-related adverse birth outcomes. © 2013 Blackwell Publishing Ltd.

Association of Medical Comorbidities, Surgical Outcomes, and Failure to Rescue: An Analysis of the Rhode Island Hospital NSQIP Database.

PubMed

Chiulli, Larissa C; Stephen, Andrew H; Heffernan, Daithi S; Miner, Thomas J

2015-12-01

Failure to rescue (FTR) is a key metric of perioperative morbidity and mortality. We review perioperative medical comorbidities (MCMs) to determine what factors are associated with complications and rates of FTR. A retrospective review of a NSQIP database including general, vascular, and surgical subspecialty patients from a tertiary referral center between March 2008 and March 2013 was performed. Demographics, MCMs, complications, 30-day mortality, and risk of FTR associated with specific complications and MCM were evaluated. A total of 7,763 patients were included; 52.6% had MCMs and 14% (n = 1,099) experienced a complication. Patients with complications were older (64.9 vs 55 years; p < 0.001), more likely male (54% vs 44%; p < 0.001), and had more MCMs per patient (1.6 vs 1.4; p < 0.001). Complications were also associated with renal failure (odds ratio [OR] = 1.4; 95% CI, 1.0-2.0), steroid use (OR = 1.9; 95% CI, 1.4-2.5), CHF (OR = 2.5; 95% CI, 1.2-5.1), and ascites (OR = 9.1; 95% CI, 3.7-21.7), but not diabetes, hypertension, or COPD. There were 117 (11%) deaths among patients with complications. Adjusting for age, sex, American Society of Anesthesiologists class, and number of comorbidities, FTR was associated with postoperative respiratory failure, sepsis, and renal failure, as well as comorbid CHF, renal failure, ascites, and disseminated cancer. Specific comorbidities are associated with higher rates of complications and FTR. Preoperative CHF, renal failure, and ascites, which were associated with FTR, can reflect a physiologic inability to tolerate complication-induced fluid shifts. Postoperative mortality was associated with signs of end organ damage, including sepsis, respiratory failure, and renal failure. Earlier recognition of these complications in at-risk patients should improve rates of FTR. Copyright © 2015 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Risk Analysis of On-Orbit Spacecraft Refueling Concepts

NASA Technical Reports Server (NTRS)

Cirillo, William M.; Stromgren, Chel; Cates, Grant R.

2010-01-01

On-orbit refueling of spacecraft has been proposed as an alternative to the exclusive use of Heavy-lift Launch Vehicles to enable human exploration beyond Low Earth Orbit (LEO). In these scenarios, beyond LEO spacecraft are launched dry (without propellant) or partially dry into orbit, using smaller or fewer element launch vehicles. Propellant is then launched into LEO on separate launch vehicles and transferred to the spacecraft. Refueling concepts are potentially attractive because they reduce the maximum individual payload that must be placed in Earth orbit. However, these types of approaches add significant complexity to mission operations and introduce more uncertainty and opportunities for failure to the mission. In order to evaluate these complex scenarios, the authors developed a Monte Carlo based discrete-event model that simulates the operational risks involved with such strategies, including launch processing delays, transportation system failures, and onorbit element lifetimes. This paper describes the methodology used to simulate the mission risks for refueling concepts, the strategies that were evaluated, and the results of the investigation. The results of the investigation show that scenarios that employ refueling concepts will likely have to include long launch and assembly timelines, as well as the use of spare tanker launch vehicles, in order to achieve high levels of mission success through Trans Lunar Injection.

Risk factors associated with rural water supply failure: A 30-year retrospective study of handpumps on the south coast of Kenya.

PubMed

Foster, Tim; Willetts, Juliet; Lane, Mike; Thomson, Patrick; Katuva, Jacob; Hope, Rob

2018-06-01

An improved understanding of failure risks for water supplies in rural sub-Saharan Africa will be critical to achieving the global goal of safe water for all by 2030. In the absence of longitudinal biophysical and operational data, investigations into water point failure risk factors have to date been limited to cross-sectional research designs. This retrospective cohort study applies survival analysis to identify factors that predict failure risks for handpumps installed on boreholes along the south coast of Kenya from the 1980s. The analysis is based on a unique dataset linking attributes of >300 water points at the time of installation with their operational lifespan over the following decades. Cox proportional hazards and accelerated failure time models suggest water point failure risks are higher and lifespans are shorter when water supplied is more saline, static water level is deeper, and groundwater is pumped from an unconsolidated sand aquifer. The risk of failure also appears to grow as distance to spare part suppliers increases. To bolster the sustainability of rural water services and ensure no community is left behind, post-construction support mechanisms will need to mitigate heterogeneous environmental and geographical challenges. Further studies are needed to better understand the causal pathways that underlie these risk factors in order to inform policies and practices that ensure water services are sustained even where unfavourable conditions prevail. Copyright © 2018 Elsevier B.V. All rights reserved.

Biomarkers of Myocardial Stress and Fibrosis as Predictors of Mode of Death in Patients with Chronic Heart Failure

PubMed Central

Ahmad, Tariq; Fiuzat, Mona; Neely, Ben; Neely, Megan; Pencina, Michael J.; Kraus, William E.; Zannad, Faiez; Whellan, David J.; Donahue, Mark; Piña, Ileana L.; Adams, Kirkwood; Kitzman, Dalane W.; O’Connor, Christopher M.; Felker, G. Michael

2014-01-01

Objective To determine whether biomarkers of myocardial stress and fibrosis improve prediction of mode of death in patients with chronic heart failure. Background The two most common modes of death in patients with chronic heart failure are pump failure and sudden cardiac death. Prediction of mode of death may facilitate treatment decisions. The relationship between NT-proBNP, galectin-3, and ST2, biomarkers that reflect different pathogenic pathways in heart failure (myocardial stress and fibrosis), and mode of death is unknown. Methods HF-ACTION was a randomized controlled trial of exercise training vs. usual care in patients with chronic heart failure due to left ventricular systolic dysfunction (LVEF<35%). An independent clinical events committee prospectively adjudicated mode of death. NT-proBNP, galectin-3, and ST2 levels were assessed at baseline in 813 subjects. Associations between biomarkers and mode of death were assessed using cause-specific Cox-proportional hazards modeling, and interaction testing was used to measure differential association between biomarkers and pump failure versus sudden cardiac death. Discrimination and risk reclassification metrics were used to assess the added value of galectin-3 and ST2 in predicting mode of death risk beyond a clinical model that included NT-proBNP. Results After a median follow up of 2.5 years, there were 155 deaths: 49 from pump failure 42 from sudden cardiac death, and 64 from other causes. Elevations in all biomarkers were associated with increased risk of both pump failure and sudden cardiac death in both adjusted and unadjusted analyses. In each case, increases in the biomarker had a stronger association with pump failure than sudden cardiac death but this relationship was attenuated after adjustment for clinical risk factors. Clinical variables along with NT-proBNP levels were stronger predictors of pump failure (C statistic: 0.87) than sudden cardiac death (C statistic: 0.73). Addition of ST2 and galectin-3 led to improved net risk classification of 11% for sudden cardiac death, but not pump failure. Conclusions Clinical predictors along with NT-proBNP levels were strong predictors of pump failure risk, with insignificant incremental contributions of ST2 and galectin-3. Predictability of sudden cardiac death risk was less robust and enhanced by information provided by novel biomarkers. PMID:24952693

Safety Evaluation of an Automated Remote Monitoring System for Heart Failure in an Urban, Indigent Population.

PubMed

Gross-Schulman, Sandra; Sklaroff, Laura Myerchin; Hertz, Crystal Coyazo; Guterman, Jeffrey J

2017-12-01

Heart Failure (HF) is the most expensive preventable condition, regardless of patient ethnicity, race, socioeconomic status, sex, and insurance status. Remote telemonitoring with timely outpatient care can significantly reduce avoidable HF hospitalizations. Human outreach, the traditional method used for remote monitoring, is effective but costly. Automated systems can potentially provide positive clinical, fiscal, and satisfaction outcomes in chronic disease monitoring. The authors implemented a telephonic HF automated remote monitoring system that utilizes deterministic decision tree logic to identify patients who are at risk of clinical decompensation. This safety study evaluated the degree of clinical concordance between the automated system and traditional human monitoring. This study focused on a broad underserved population and demonstrated a safe, reliable, and inexpensive method of monitoring patients with HF.

Baseline HBV load increases the risk of anti-tuberculous drug-induced hepatitis flares in patients with tuberculosis.

PubMed

Zhu, Chun-Hui; Zhao, Man-Zhi; Chen, Guang; Qi, Jun-Ying; Song, Jian-Xin; Ning, Qin; Xu, Dong

2017-02-01

Hepatitis associated anti-tuberculous treatment (HATT) has been a main obstacle in managing patients co-infected with Mycobacterium tuberculosis and hepatitis B virus (HBV). Therefore, we evaluated the factors related to the severity of adverse effects during HATT, especially those associated with liver failure. A retrospective study was carried out at Tongji Hospital from 2007 to 2012. Increases in serum transaminase levels of >3, 5, and 10 times the upper limit of normal (ULN) were used to define liver damage as mild, moderate, and severe, respectively. Patients with elevated total bilirubin (TBil) levels that were more than 10 times the ULN (>171 μmol/L) with or without decreased (<40%) prothrombin activity (PTA) were diagnosed with liver failure. A cohort of 87 patients was analyzed. The incidence of liver damage and liver failure was 59.8% (n=52) and 25.3% (n=22), respectively. The following variables were correlated with the severity of hepatotoxicity: albumin (ALB) levels, PTA, platelet counts (PLT), and the use of antiretroviral therapies (P<0.05). Hypo-proteinemia and antiretroviral therapy were significantly associated with liver failure, and high viral loads were a significant risk factor with an odds ratio (OR) of 2.066. Judicious follow-up of clinical conditions, liver function tests, and coagulation function, especially in patients with high HBV loads and hypoalbuminemia is recommended. It may be advisable to reconsider the use of antiviral drugs failure during the course of anti-tuberculous treatment of HBV infection patients to avoid the occurrence of furious liver failure.

Using failure mode and effects analysis to improve the safety of neonatal parenteral nutrition.

PubMed

Arenas Villafranca, Jose Javier; Gómez Sánchez, Araceli; Nieto Guindo, Miriam; Faus Felipe, Vicente

2014-07-15

Failure mode and effects analysis (FMEA) was used to identify potential errors and to enable the implementation of measures to improve the safety of neonatal parenteral nutrition (PN). FMEA was used to analyze the preparation and dispensing of neonatal PN from the perspective of the pharmacy service in a general hospital. A process diagram was drafted, illustrating the different phases of the neonatal PN process. Next, the failures that could occur in each of these phases were compiled and cataloged, and a questionnaire was developed in which respondents were asked to rate the following aspects of each error: incidence, detectability, and severity. The highest scoring failures were considered high risk and identified as priority areas for improvements to be made. The evaluation process detected a total of 82 possible failures. Among the phases with the highest number of possible errors were transcription of the medical order, formulation of the PN, and preparation of material for the formulation. After the classification of these 82 possible failures and of their relative importance, a checklist was developed to achieve greater control in the error-detection process. FMEA demonstrated that use of the checklist reduced the level of risk and improved the detectability of errors. FMEA was useful for detecting medication errors in the PN preparation process and enabling corrective measures to be taken. A checklist was developed to reduce errors in the most critical aspects of the process. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Risk of Resource Failure and Toolkit Variation in Small-Scale Farmers and Herders

PubMed Central

Collard, Mark; Ruttle, April; Buchanan, Briggs; O’Brien, Michael J.

2012-01-01

Recent work suggests that global variation in toolkit structure among hunter-gatherers is driven by risk of resource failure such that as risk of resource failure increases, toolkits become more diverse and complex. Here we report a study in which we investigated whether the toolkits of small-scale farmers and herders are influenced by risk of resource failure in the same way. In the study, we applied simple linear and multiple regression analysis to data from 45 small-scale food-producing groups to test the risk hypothesis. Our results were not consistent with the hypothesis; none of the risk variables we examined had a significant impact on toolkit diversity or on toolkit complexity. It appears, therefore, that the drivers of toolkit structure differ between hunter-gatherers and small-scale food-producers. PMID:22844421

Women-specific risk factors for heart failure: A genetic approach.

PubMed

van der Kemp, Jet; van der Schouw, Yvonne T; Asselbergs, Folkert W; Onland-Moret, N Charlotte

2018-03-01

Heart failure is a complex disease, which is presented differently by men and women. Several studies have shown that reproductive factors, such as age at natural menopause, parity and polycystic ovarian syndrome (PCOS), may play a role in the development of heart failure. Shared genetics may provide clues to underlying mechanisms; however, this has never been examined. Therefore, the aim of the current study was to explore whether any reproductive factor is potentially related to heart failure in women, based on genetic similarities. Conducting a systematic literature review, single nucleotide polymorphisms (SNPs) associated with reproductive factors, heart failure and its risk factors were extracted from recent genome-wide association studies. We tested whether there was any overlap between the SNPs and their proxies of reproductive risk factors with those known for heart failure or its risk factors. In total, 520 genetic variants were found that are associated with reproductive factors, namely age at menarche, age at natural menopause, menstrual cycle length, PCOS, preeclampsia, preterm delivery and spontaneous dizygotic twinning. For heart failure and associated phenotypes, 25 variants were found. Genetic variants for reproductive factors did not overlap with those for heart failure. However, age at menarche, gestational diabetes and PCOS were found to be genetically linked to risk factors for heart failure, such as atrial fibrillation, diabetes and smoking. Corresponding implicated genes, such as TNNI3K, ErbB3, MKL2, MTNR1B and PRKD1, may explain the associations between reproductive factors and heart failure. Exact effector mechanisms of these genes remain to be investigated further. Copyright © 2017. Published by Elsevier B.V.

Improving the treatment planning and delivery process of Xoft electronic skin brachytherapy.

PubMed

Manger, Ryan; Rahn, Douglas; Hoisak, Jeremy; Dragojević, Irena

2018-05-14

To develop an improved Xoft electronic skin brachytherapy process and identify areas of further improvement. A multidisciplinary team conducted a failure modes and effects analysis (FMEA) by developing a process map and a corresponding list of failure modes. The failure modes were scored for their occurrence, severity, and detectability, and a risk priority number (RPN) was calculated for each failure mode as the product of occurrence, severity, and detectability. Corrective actions were implemented to address the higher risk failure modes, and a revised process was generated. The RPNs of the failure modes were compared between the initial process and final process to assess the perceived benefits of the corrective actions. The final treatment process consists of 100 steps and 114 failure modes. The FMEA took approximately 20 person-hours (one physician, three physicists, and two therapists) to complete. The 10 most dangerous failure modes had RPNs ranging from 336 to 630. Corrective actions were effective at addressing most failure modes (10 riskiest RPNs ranging from 189 to 310), yet the RPNs were higher than those published for alternative systems. Many of these high-risk failure modes remained due to hardware design limitations. FMEA helps guide process improvement efforts by emphasizing the riskiest steps. Significant risks are apparent when using a Xoft treatment unit for skin brachytherapy due to hardware limitations such as the lack of several interlocks, a short source lifespan, and variability in source output. The process presented in this article is expected to reduce but not eliminate these risks. Copyright © 2018 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Inherent Risk or Risky Decision? Coach's Failure to Use Safety Device an Assumed Risk

ERIC Educational Resources Information Center

Dodds, Mark A.; Bochicchio, Kristi Schoepfer

2013-01-01

The court examined whether a coach's failure to implement a safety device during pitching practice enhanced the risk to the athlete or resulted in a suboptimal playing condition, in the context of the assumption of risk doctrine.

Identifying Differences Between Biochemical Failure and Cure: Incidence Rates and Predictors

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

Vicini, Frank A., E-mail: fvicini@beaumont.edu; Shah, Chirag; Kestin, Larry

2011-11-15

Background: Patients treated with radiation therapy (RT) for prostate cancer were evaluated to estimate the length of time required to document biochemical cure (BC) after treatment and the variables associated with long-term treatment efficacy. Patients and Methods: 2,100 patients received RT alone for localized prostate carcinoma (external-beam RT, n = 1,504; brachytherapy alone, n = 241; or brachytherapy + pelvic radiation, n = 355). The median external-beam dose was 68.4 Gy, and the median follow-up time was 8.6 years. Biochemical failure (BF) was defined according to the Phoenix definition. Results: Biochemical failure was experienced by 685 patients (32.6%). The medianmore » times to BF for low-, intermediate-, and high-risk groups were 6.0, 5.6, and 4.5 years respectively (p < 0.001). The average annual incidence rates of BF for years 1-5, 5-10,11-15, and 16-20 in low-risk patients were 2.0%, 2.0%, 0.3%, and 0.06% (p < 0.001); for intermediate-risk patients, 4%, 3%, 0.3%, and 0% (p < 0.001); and for high-risk patients, 10.0%, 5.0%, 0.3%, and 0.3% (p < 0.001). After 5 years of treatment, 36.9% of all patients experienced BF. The percentage of total failures occurring during years 1-5, 5-10, 11-15, and 16-20 were 48.7%, 43.5%, 6.5%, and 1.3% for low-risk patients; 64.0%, 32.2%, 3.8%, and 0% for intermediate-risk patients; and 71.9%, 25.9%, 1.1%, and 1.1% for high-risk patients, respectively. Increasing time to nadir was associated with increased time to BF. On multivariate analysis, factors significantly associated with 10-year BC included prostate-specific antigen nadir and time to nadir. Conclusions: The incidence rates for BF did not plateau until later than 10 years after treatment, suggesting that extended follow-up time is required to monitor patients after treatment. Prostate-specific antigen nadir and time to nadir have the strongest association with long-term BC.« less

Risk factors for end stage renal disease in non-WT1-syndromic Wilms tumor.

PubMed

Lange, Jane; Peterson, Susan M; Takashima, Janice R; Grigoriev, Yevgeny; Ritchey, Michael L; Shamberger, Robert C; Beckwith, J Bruce; Perlman, Elizabeth; Green, Daniel M; Breslow, Norman E

2011-08-01

We assessed risk factors for end stage renal disease in patients with Wilms tumor without known WT1 related syndromes. We hypothesized that patients with characteristics suggestive of a WT1 etiology (early onset, stromal predominant histology, intralobar nephrogenic rests) would have a higher risk of end stage renal disease due to chronic renal failure. We predicted a high risk of end stage renal disease due to progressive bilateral Wilms tumor in patients with metachronous bilateral disease. End stage renal disease was ascertained in 100 of 7,950 nonsyndromic patients enrolled in a National Wilms Tumor Study during 1969 to 2002. Risk factors were evaluated with cumulative incidence curves and proportional hazard regressions. The cumulative incidence of end stage renal disease due to chronic renal failure 20 years after Wilms tumor diagnosis was 0.7%. For end stage renal disease due to progressive bilateral Wilms tumor the incidence was 4.0% at 3 years after diagnosis in patients with synchronous bilateral Wilms tumor and 19.3% in those with metachronous bilateral Wilms tumor. For end stage renal disease due to chronic renal failure stromal predominant histology had a HR of 6.4 relative to mixed (95% CI 3.4, 11.9; p<0.001), intralobar rests had a HR of 5.9 relative to no rests (95% CI 2.0, 17.3; p=0.001), and Wilms tumor diagnosis at less than 24 months had a HR of 1.7 relative to 24 to 48 months and 2.8 relative to greater than 48 months (p=0.003 for trend). Metachronous bilateral Wilms tumor is associated with high rates of end stage renal disease due to surgery for progressive Wilms tumor. Characteristics associated with a WT1 etiology markedly increased the risk of end stage renal disease due to chronic renal failure despite the low risk in non-WT1 syndromic cases overall. Copyright © 2011 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Comparison of atazanavir/ritonavir and darunavir/ritonavir based antiretroviral therapy for antiretroviral naïve patients.

PubMed

Antoniou, Tony; Szadkowski, Leah; Walmsley, Sharon; Cooper, Curtis; Burchell, Ann N; Bayoumi, Ahmed M; Montaner, Julio S G; Loutfy, Mona; Klein, Marina B; Machouf, Nima; Tsoukas, Christos; Wong, Alexander; Hogg, Robert S; Raboud, Janet

2017-04-11

Atazanavir/ritonavir and darunavir/ritonavir are common protease inhibitor-based regimens for treating patients with HIV. Studies comparing these drugs in clinical practice are lacking. We conducted a retrospective cohort study of antiretroviral naïve participants in the Canadian Observational Cohort (CANOC) collaboration initiating atazanavir/ritonavir- or darunavir/ritonavir-based treatment. We used separate Fine and Gray competing risk regression models to compare times to regimen failure (composite of virologic failure or discontinuation for any reason). Additional endpoints included virologic failure, discontinuation due to virologic failure, discontinuation for other reasons, and virologic suppression. We studied 222 patients treated with darunavir/ritonavir and 1791 patients treated with atazanavir/ritonavir. Following multivariable adjustment, there was no difference between darunavir/ritonavir and atazanavir-ritonavir in the risk of regimen failure (adjusted hazard ratio 0.76, 95% CI 0.56 to 1.03) Darunavir/ritonavir-treated patients were at lower risk of virologic failure relative to atazanavir/ritonavir treated patients (aHR 0.50, 95% CI 0.28 to 0.91), findings driven largely by high rates of virologic failure among atazanavir/ritonavir-treated patients in the province of British Columbia. Of 108 discontinuations due to virologic failure, all occurred in patients starting atazanavir/ritonavir. There was no difference between regimens in time to discontinuation for reasons other than virologic failure (aHR 0.93; 95% CI 0.65 to 1.33) or virologic suppression (aHR 0.99, 95% CI 0.82 to 1.21). The risk of regimen failure was similar between patients treated with darunavir/ritonavir and atazanavir/ritonavir. Although darunavir/ritonavir was associated with a lower risk of virologic failure relative to atazanavir/ritonavir, this difference varied substantially by Canadian province and likely reflects regional variation in prescribing practices and patient characteristics.

Identification of risk factors for failure in patients with skin and soft tissue infections.

PubMed

Cieri, Brittany; Conway, Erin L; Sellick, John A; Mergenhagen, Kari A

2018-04-23

The purpose was to determine significant predictors of treatment failure of skin and soft tissue infections (SSTI) in the inpatient and outpatient setting. A retrospective chart review of patients treated between January 1, 2005 to July 1, 2016 with ICD-9 or ICD-10 code of cellulitis or abscess. The primary outcome was failure defined as an additional prescription or subsequent hospital admission within 30 days of treatment. Risk factors for failure were identified through multivariate logistic regression. A total of 541 patients were included. Seventeen percent failed treatment. In the outpatient group, 24% failed treatment compared to 9% for inpatients. Overweight/obesity (body mass index (BMI) > 25 kg/m 2 ) was identified in 80%, with 15% having a BMI >40 kg/m 2 . BMI, heart failure, and outpatient treatment were determined to be significant predictors of failure. The unit odds ratio for failure with BMI was 1.04 (95% [Cl] = 1.01 to 1.1, p = 0.0042). Heart failure increased odds by 2.48 (95% [Cl] = 1.3 to 4.7, p = 0.0056). Outpatients were more likely to fail with an odds ratio of 3.36. Patients with an elevated BMI and heart failure were found to have increased odds of failure with treatment for SSTIs. However, inpatients had considerably less risk of failure than outpatients. These risk factors are important to note when making the decision whether to admit a patient who presents with SSTI in the emergency department. Thoughtful strategies are needed with this at-risk population to prevent subsequent admission. Copyright © 2018. Published by Elsevier Inc.

EVALUATION OF A NURSE-LED HYPERTENSION MANAGEMENT INTERVENTION IN AUSTRALIAN GENERAL PRACTICE: THE IMPRESS INTERVENTION.

PubMed

Stephen, Catherine

2016-08-01

Hypertension is currently the most frequently seen condition in Australian general practice (Britt et al. 2015). Of the 4.6 million Australians living with hypertension, many struggle to keep their blood pressure under control and are at increased risk of renal failure, cardiovascular disease and premature death (Australian Institute of Health and Welfare, 2015; Cadilhac et al. 2012). The General Practice Nurse (GPN) has a significant role to play in supporting self-management and lifestyle risk factor reduction.

Clinician time used for decision making: a best case workflow study using cardiovascular risk assessments and Ask Mayo Expert algorithmic care process models.

PubMed

North, Frederick; Fox, Samuel; Chaudhry, Rajeev

2016-07-20

Risk calculation is increasingly used in lipid management, congestive heart failure, and atrial fibrillation. The risk scores are then used for decisions about statin use, anticoagulation, and implantable defibrillator use. Calculating risks for patients and making decisions based on these risks is often done at the point of care and is an additional time burden for clinicians that can be decreased by automating the tasks and using clinical decision-making support. Using Morae Recorder software, we timed 30 healthcare providers tasked with calculating the overall risk of cardiovascular events, sudden death in heart failure, and thrombotic event risk in atrial fibrillation. Risk calculators used were the American College of Cardiology Atherosclerotic Cardiovascular Disease risk calculator (AHA-ASCVD risk), Seattle Heart Failure Model (SHFM risk), and CHA2DS2VASc. We also timed the 30 providers using Ask Mayo Expert care process models for lipid management, heart failure management, and atrial fibrillation management based on the calculated risk scores. We used the Mayo Clinic primary care panel to estimate time for calculating an entire panel risk. Mean provider times to complete the CHA2DS2VASc, AHA-ASCVD risk, and SHFM were 36, 45, and 171 s respectively. For decision making about atrial fibrillation, lipids, and heart failure, the mean times (including risk calculations) were 85, 110, and 347 s respectively. Even under best case circumstances, providers take a significant amount of time to complete risk assessments. For a complete panel of patients this can lead to hours of time required to make decisions about prescribing statins, use of anticoagulation, and medications for heart failure. Informatics solutions are needed to capture data in the medical record and serve up automatically calculated risk assessments to physicians and other providers at the point of care.

Systems Reliability Framework for Surface Water Sustainability and Risk Management

NASA Astrophysics Data System (ADS)

Myers, J. R.; Yeghiazarian, L.

2016-12-01

With microbial contamination posing a serious threat to the availability of clean water across the world, it is necessary to develop a framework that evaluates the safety and sustainability of water systems in respect to non-point source fecal microbial contamination. The concept of water safety is closely related to the concept of failure in reliability theory. In water quality problems, the event of failure can be defined as the concentration of microbial contamination exceeding a certain standard for usability of water. It is pertinent in watershed management to know the likelihood of such an event of failure occurring at a particular point in space and time. Microbial fate and transport are driven by environmental processes taking place in complex, multi-component, interdependent environmental systems that are dynamic and spatially heterogeneous, which means these processes and therefore their influences upon microbial transport must be considered stochastic and variable through space and time. A physics-based stochastic model of microbial dynamics is presented that propagates uncertainty using a unique sampling method based on artificial neural networks to produce a correlation between watershed characteristics and spatial-temporal probabilistic patterns of microbial contamination. These results are used to address the question of water safety through several sustainability metrics: reliability, vulnerability, resilience and a composite sustainability index. System reliability is described uniquely though the temporal evolution of risk along watershed points or pathways. Probabilistic resilience describes how long the system is above a certain probability of failure, and the vulnerability metric describes how the temporal evolution of risk changes throughout a hierarchy of failure levels. Additionally our approach allows for the identification of contributions in microbial contamination and uncertainty from specific pathways and sources. We expect that this framework will significantly improve the efficiency and precision of sustainable watershed management strategies through providing a better understanding of how watershed characteristics and environmental parameters affect surface water quality and sustainability. With microbial contamination posing a serious threat to the availability of clean water across the world, it is necessary to develop a framework that evaluates the safety and sustainability of water systems in respect to non-point source fecal microbial contamination. The concept of water safety is closely related to the concept of failure in reliability theory. In water quality problems, the event of failure can be defined as the concentration of microbial contamination exceeding a certain standard for usability of water. It is pertinent in watershed management to know the likelihood of such an event of failure occurring at a particular point in space and time. Microbial fate and transport are driven by environmental processes taking place in complex, multi-component, interdependent environmental systems that are dynamic and spatially heterogeneous, which means these processes and therefore their influences upon microbial transport must be considered stochastic and variable through space and time. A physics-based stochastic model of microbial dynamics is presented that propagates uncertainty using a unique sampling method based on artificial neural networks to produce a correlation between watershed characteristics and spatial-temporal probabilistic patterns of microbial contamination. These results are used to address the question of water safety through several sustainability metrics: reliability, vulnerability, resilience and a composite sustainability index. System reliability is described uniquely though the temporal evolution of risk along watershed points or pathways. Probabilistic resilience describes how long the system is above a certain probability of failure, and the vulnerability metric describes how the temporal evolution of risk changes throughout a hierarchy of failure levels. Additionally our approach allows for the identification of contributions in microbial contamination and uncertainty from specific pathways and sources. We expect that this framework will significantly improve the efficiency and precision of sustainable watershed management strategies through providing a better understanding of how watershed characteristics and environmental parameters affect surface water quality and sustainability.

Simulation Assisted Risk Assessment: Blast Overpressure Modeling

NASA Technical Reports Server (NTRS)

Lawrence, Scott L.; Gee, Ken; Mathias, Donovan; Olsen, Michael

2006-01-01

A probabilistic risk assessment (PRA) approach has been developed and applied to the risk analysis of capsule abort during ascent. The PRA is used to assist in the identification of modeling and simulation applications that can significantly impact the understanding of crew risk during this potentially dangerous maneuver. The PRA approach is also being used to identify the appropriate level of fidelity for the modeling of those critical failure modes. The Apollo launch escape system (LES) was chosen as a test problem for application of this approach. Failure modes that have been modeled and/or simulated to date include explosive overpressure-based failure, explosive fragment-based failure, land landing failures (range limits exceeded either near launch or Mode III trajectories ending on the African continent), capsule-booster re-contact during separation, and failure due to plume-induced instability. These failure modes have been investigated using analysis tools in a variety of technical disciplines at various levels of fidelity. The current paper focuses on the development and application of a blast overpressure model for the prediction of structural failure due to overpressure, including the application of high-fidelity analysis to predict near-field and headwinds effects.

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

Failure mode and effects analysis: A community practice perspective.

PubMed

Schuller, Bradley W; Burns, Angi; Ceilley, Elizabeth A; King, Alan; LeTourneau, Joan; Markovic, Alexander; Sterkel, Lynda; Taplin, Brigid; Wanner, Jennifer; Albert, Jeffrey M

2017-11-01

To report our early experiences with failure mode and effects analysis (FMEA) in a community practice setting. The FMEA facilitator received extensive training at the AAPM Summer School. Early efforts focused on department education and emphasized the need for process evaluation in the context of high profile radiation therapy accidents. A multidisciplinary team was assembled with representation from each of the major department disciplines. Stereotactic radiosurgery (SRS) was identified as the most appropriate treatment technique for the first FMEA evaluation, as it is largely self-contained and has the potential to produce high impact failure modes. Process mapping was completed using breakout sessions, and then compiled into a simple electronic format. Weekly sessions were used to complete the FMEA evaluation. Risk priority number (RPN) values > 100 or severity scores of 9 or 10 were considered high risk. The overall time commitment was also tracked. The final SRS process map contained 15 major process steps and 183 subprocess steps. Splitting the process map into individual assignments was a successful strategy for our group. The process map was designed to contain enough detail such that another radiation oncology team would be able to perform our procedures. Continuous facilitator involvement helped maintain consistent scoring during FMEA. Practice changes were made responding to the highest RPN scores, and new resulting RPN scores were below our high-risk threshold. The estimated person-hour equivalent for project completion was 258 hr. This report provides important details on the initial steps we took to complete our first FMEA, providing guidance for community practices seeking to incorporate this process into their quality assurance (QA) program. Determining the feasibility of implementing complex QA processes into different practice settings will take on increasing significance as the field of radiation oncology transitions into the new TG-100 QA paradigm. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions

PubMed Central

Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R

2005-01-01

Background: Until recently, the preparation of paediatric parenteral nutrition formulations in our institution included re-transcription and manual compounding of the mixture. Although no significant clinical problems have occurred, re-engineering of this high risk activity was undertaken to improve its safety. Several changes have been implemented including new prescription software, direct recording on a server, automatic printing of the labels, and creation of a file used to pilot a BAXA MM 12 automatic compounder. The objectives of this study were to compare the risks associated with the old and new processes, to quantify the improved safety with the new process, and to identify the major residual risks. Methods: A failure modes, effects, and criticality analysis (FMECA) was performed by a multidisciplinary team. A cause-effect diagram was built, the failure modes were defined, and the criticality index (CI) was determined for each of them on the basis of the likelihood of occurrence, the severity of the potential effect, and the detection probability. The CIs for each failure mode were compared for the old and new processes and the risk reduction was quantified. Results: The sum of the CIs of all 18 identified failure modes was 3415 for the old process and 1397 for the new (reduction of 59%). The new process reduced the CIs of the different failure modes by a mean factor of 7. The CI was smaller with the new process for 15 failure modes, unchanged for two, and slightly increased for one. The greatest reduction (by a factor of 36) concerned re-transcription errors, followed by readability problems (by a factor of 30) and chemical cross contamination (by a factor of 10). The most critical steps in the new process were labelling mistakes (CI 315, maximum 810), failure to detect a dosage or product mistake (CI 288), failure to detect a typing error during the prescription (CI 175), and microbial contamination (CI 126). Conclusions: Modification of the process resulted in a significant risk reduction as shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities. PMID:15805453

Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions.

PubMed

Bonnabry, P; Cingria, L; Sadeghipour, F; Ing, H; Fonzo-Christe, C; Pfister, R E

2005-04-01

Until recently, the preparation of paediatric parenteral nutrition formulations in our institution included re-transcription and manual compounding of the mixture. Although no significant clinical problems have occurred, re-engineering of this high risk activity was undertaken to improve its safety. Several changes have been implemented including new prescription software, direct recording on a server, automatic printing of the labels, and creation of a file used to pilot a BAXA MM 12 automatic compounder. The objectives of this study were to compare the risks associated with the old and new processes, to quantify the improved safety with the new process, and to identify the major residual risks. A failure modes, effects, and criticality analysis (FMECA) was performed by a multidisciplinary team. A cause-effect diagram was built, the failure modes were defined, and the criticality index (CI) was determined for each of them on the basis of the likelihood of occurrence, the severity of the potential effect, and the detection probability. The CIs for each failure mode were compared for the old and new processes and the risk reduction was quantified. The sum of the CIs of all 18 identified failure modes was 3415 for the old process and 1397 for the new (reduction of 59%). The new process reduced the CIs of the different failure modes by a mean factor of 7. The CI was smaller with the new process for 15 failure modes, unchanged for two, and slightly increased for one. The greatest reduction (by a factor of 36) concerned re-transcription errors, followed by readability problems (by a factor of 30) and chemical cross contamination (by a factor of 10). The most critical steps in the new process were labelling mistakes (CI 315, maximum 810), failure to detect a dosage or product mistake (CI 288), failure to detect a typing error during the prescription (CI 175), and microbial contamination (CI 126). Modification of the process resulted in a significant risk reduction as shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities.

A Methodology for Modeling Nuclear Power Plant Passive Component Aging in Probabilistic Risk Assessment under the Impact of Operating Conditions, Surveillance and Maintenance Activities

NASA Astrophysics Data System (ADS)

Guler Yigitoglu, Askin

In the context of long operation of nuclear power plants (NPPs) (i.e., 60-80 years, and beyond), investigation of the aging of passive systems, structures and components (SSCs) is important to assess safety margins and to decide on reactor life extension as indicated within the U.S. Department of Energy (DOE) Light Water Reactor Sustainability (LWRS) Program. In the traditional probabilistic risk assessment (PRA) methodology, evaluating the potential significance of aging of passive SSCs on plant risk is challenging. Although passive SSC failure rates can be added as initiating event frequencies or basic event failure rates in the traditional event-tree/fault-tree methodology, these failure rates are generally based on generic plant failure data which means that the true state of a specific plant is not reflected in a realistic manner on aging effects. Dynamic PRA methodologies have gained attention recently due to their capability to account for the plant state and thus address the difficulties in the traditional PRA modeling of aging effects of passive components using physics-based models (and also in the modeling of digital instrumentation and control systems). Physics-based models can capture the impact of complex aging processes (e.g., fatigue, stress corrosion cracking, flow-accelerated corrosion, etc.) on SSCs and can be utilized to estimate passive SSC failure rates using realistic NPP data from reactor simulation, as well as considering effects of surveillance and maintenance activities. The objectives of this dissertation are twofold: The development of a methodology for the incorporation of aging modeling of passive SSC into a reactor simulation environment to provide a framework for evaluation of their risk contribution in both the dynamic and traditional PRA; and the demonstration of the methodology through its application to pressurizer surge line pipe weld and steam generator tubes in commercial nuclear power plants. In the proposed methodology, a multi-state physics based model is selected to represent the aging process. The model is modified via sojourn time approach to reflect the operational and maintenance history dependence of the transition rates. Thermal-hydraulic parameters of the model are calculated via the reactor simulation environment and uncertainties associated with both parameters and the models are assessed via a two-loop Monte Carlo approach (Latin hypercube sampling) to propagate input probability distributions through the physical model. The effort documented in this thesis towards this overall objective consists of : i) defining a process for selecting critical passive components and related aging mechanisms, ii) aging model selection, iii) calculating the probability that aging would cause the component to fail, iv) uncertainty/sensitivity analyses, v) procedure development for modifying an existing PRA to accommodate consideration of passive component failures, and, vi) including the calculated failure probability in the modified PRA. The proposed methodology is applied to pressurizer surge line pipe weld aging and steam generator tube degradation in pressurized water reactors.

Early Ahmed Glaucoma Valve Implantation after Penetrating Keratoplasty Leads to Better Outcomes in an Asian Population with Preexisting Glaucoma

PubMed Central

Tai, Ming-Cheng; Chen, Yi-Hao; Cheng, Jen-Hao; Liang, Chang-Min; Chen, Jiann-Torng; Chen, Ching-Long; Lu, Da-Wen

2012-01-01

Background To evaluate the efficacy of Ahmed Glaucoma Valve (AGV) surgery and the optimal interval between penetrating keratoplasty (PKP) and AGV implantation in a population of Asian patients with preexisting glaucoma who underwent PKP. Methodology/Principal Findings In total, 45 eyes of 45 patients were included in this retrospective chart review. The final intraocular pressures (IOPs), graft survival rate, and changes in visual acuity were assessed to evaluate the outcomes of AGV implantations in eyes in which AGV implantation occurred within 1 month of post-PKP IOP elevation (Group 1) and in eyes in which AGV implantation took place more than 1 month after the post-PKP IOP evaluation (Group 2). Factors that were associated with graft failure were analyzed, and the overall patterns of complications were reviewed. By their final follow-up visits, 58% of the patients had been successfully treated for glaucoma. After the operation, there were no statistically significant differences between the groups with respect to graft survival (p = 0.98), but significant differences for IOP control (p = 0.049) and the maintenance of visual acuity (VA) (p<0.05) were observed. One year after surgery, the success rates of IOP control in Group 1 and Group 2 were 80% and 46.7%, respectively, and these rates fell to 70% and 37.3%, respectively, by 2 years. Factors that were associated with a high risk of AGV failure were a diagnosis of preexisting angle-closure glaucoma, a history of previous PKP, and a preoperative IOP that was >21 mm Hg. The most common surgical complication, aside from graft failure, was hyphema. Conclusions/Significance Early AGV implantation results in a higher probability of AGV survival and a better VA outcome without increasing the risk of corneal graft failure as a result of post-PKP glaucoma drainage tube implantation. PMID:22629464

Age-Dependent Risk of Graft Failure in Young Kidney Transplant Recipients.

PubMed

Kaboré, Rémi; Couchoud, Cécile; Macher, Marie-Alice; Salomon, Rémi; Ranchin, Bruno; Lahoche, Annie; Roussey-Kesler, Gwenaelle; Garaix, Florentine; Decramer, Stéphane; Pietrement, Christine; Lassalle, Mathilde; Baudouin, Véronique; Cochat, Pierre; Niaudet, Patrick; Joly, Pierre; Leffondré, Karen; Harambat, Jérôme

2017-06-01

The risk of graft failure in young kidney transplant recipients has been found to increase during adolescence and early adulthood. However, this question has not been addressed outside the United States so far. Our objective was to investigate whether the hazard of graft failure also increases during this age period in France irrespective of age at transplantation. Data of all first kidney transplantation performed before 30 years of age between 1993 and 2012 were extracted from the French kidney transplant database. The hazard of graft failure was estimated at each current age using a 2-stage modelling approach that accounted for both age at transplantation and time since transplantation. Hazard ratios comparing the risk of graft failure during adolescence or early adulthood to other periods were estimated from time-dependent Cox models. A total of 5983 renal transplant recipients were included. The risk of graft failure was found to increase around the age of 13 years until the age of 21 years, and decrease thereafter. Results from the Cox model indicated that the hazard of graft failure during the age period 13 to 23 years was almost twice as high as than during the age period 0 to 12 years, and 25% higher than after 23 years. Among first kidney transplant recipients younger than 30 years in France, those currently in adolescence or early adulthood have the highest risk of graft failure.

Heart failure: a weak link in CHA2 DS2 -VASc.

PubMed

Friberg, Leif; Lund, Lars H

2018-06-01

In atrial fibrillation, stroke risk is assessed by the CHA 2 DS 2 -VASc score. Heart failure is included in CHA 2 DS 2 -VASc, but the rationale is uncertain. Our objective was to test if heart failure is a risk factor for stroke, independent of other risk factors in CHA 2 DS 2 -VASc. We studied 300 839 patients with atrial fibrillation in the Swedish Patient Register 2005-11. Three definitions of heart failure were used in order to assess the robustness of the results. In the main analysis, heart failure was defined by a hospital discharge diagnosis of heart failure as first or second diagnosis and a filled prescription of a diuretic within 3 months before index + 30 days. The second definition counted first or second discharge diagnoses <1 year before index + 30 days and the third definition any heart failure diagnosis in open or hospital care before index + 30 days. Associations with outcomes were assessed with multivariable Cox analyses. Patients with heart failure were older (80.5 vs. 74.0 years, P < 0.001) and had higher CHA 2 DS 2 -VASc score (4.4 vs. 2.7, P < 0.001). The 1 year incidence of ischaemic stroke without warfarin was 4.4% with heart failure and 3.1% without. Adjustment for the cofactors in CHA 2 DS 2 -VASc eradicated the difference in stroke risk between patients with and without heart failure (hazard ratio 1.01 with 95% confidence interval 0.96-1.05). The area under the receiver operating characteristic curve for CHA 2 DS 2 -VASc was not improved by points for heart failure. A clinical diagnosis of heart failure was not an independent risk factor for stroke in patients with atrial fibrillation, which may have implications for anticoagulation management. © 2018 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of the European Society of Cardiology.

High burden of kidney disease in youth-onset type 2 diabetes.

PubMed

Dart, Allison B; Sellers, Elizabeth A; Martens, Patricia J; Rigatto, Claudio; Brownell, Marni D; Dean, Heather J

2012-06-01

To evaluate renal outcomes and survival in youth with type 2 diabetes (T2DM) versus type 1 diabetes (T1DM) versus nondiabetic control subjects. In total, 342 prevalent youth (aged 1-18 years) with T2DM, 1,011 youth with T1DM, and 1,710 control subjects identified from 1986 to 2007 were anonymously linked to health care records housed at the Manitoba Centre for Health Policy to assess long-term outcomes using ICD codes. Youth with T2DM were found to have a fourfold increased risk of renal failure versus youth with T1DM. Risk factors associated with renal failure were renin angiotensin aldosterone system inhibitor use and albuminuria in adolescence. Compared with control subjects (age, sex, and postal code matched), youth with T2DM had a 23-fold increased risk of renal failure and a 39-fold increased risk of dialysis. Kaplan-Meier survival at 10 years was 91.4% in the type 2 diabetic group versus 99.5% in the type 1 diabetic group (P < 0.0001). Renal survival was 100% at 10 years in both groups. It decreased to 92.0% at 15 years and 55.0% at 20 years in the type 2 diabetic group but remained stable in the type 1 diabetic group (P < 0.0001). Youth with T2DM are at high risk of adverse renal outcomes and death. Albuminuria and angiotensin aldosterone system inhibitor use, which may be a marker of severity of disease, are associated with poor outcomes in early adulthood.

Probabilistic Fatigue Life Updating for Railway Bridges Based on Local Inspection and Repair.

PubMed

Lee, Young-Joo; Kim, Robin E; Suh, Wonho; Park, Kiwon

2017-04-24

Railway bridges are exposed to repeated train loads, which may cause fatigue failure. As critical links in a transportation network, railway bridges are expected to survive for a target period of time, but sometimes they fail earlier than expected. To guarantee the target bridge life, bridge maintenance activities such as local inspection and repair should be undertaken properly. However, this is a challenging task because there are various sources of uncertainty associated with aging bridges, train loads, environmental conditions, and maintenance work. Therefore, to perform optimal risk-based maintenance of railway bridges, it is essential to estimate the probabilistic fatigue life of a railway bridge and update the life information based on the results of local inspections and repair. Recently, a system reliability approach was proposed to evaluate the fatigue failure risk of structural systems and update the prior risk information in various inspection scenarios. However, this approach can handle only a constant-amplitude load and has limitations in considering a cyclic load with varying amplitude levels, which is the major loading pattern generated by train traffic. In addition, it is not feasible to update the prior risk information after bridges are repaired. In this research, the system reliability approach is further developed so that it can handle a varying-amplitude load and update the system-level risk of fatigue failure for railway bridges after inspection and repair. The proposed method is applied to a numerical example of an in-service railway bridge, and the effects of inspection and repair on the probabilistic fatigue life are discussed.

Probabilistic Fatigue Life Updating for Railway Bridges Based on Local Inspection and Repair

PubMed Central

Lee, Young-Joo; Kim, Robin E.; Suh, Wonho; Park, Kiwon

2017-01-01

Railway bridges are exposed to repeated train loads, which may cause fatigue failure. As critical links in a transportation network, railway bridges are expected to survive for a target period of time, but sometimes they fail earlier than expected. To guarantee the target bridge life, bridge maintenance activities such as local inspection and repair should be undertaken properly. However, this is a challenging task because there are various sources of uncertainty associated with aging bridges, train loads, environmental conditions, and maintenance work. Therefore, to perform optimal risk-based maintenance of railway bridges, it is essential to estimate the probabilistic fatigue life of a railway bridge and update the life information based on the results of local inspections and repair. Recently, a system reliability approach was proposed to evaluate the fatigue failure risk of structural systems and update the prior risk information in various inspection scenarios. However, this approach can handle only a constant-amplitude load and has limitations in considering a cyclic load with varying amplitude levels, which is the major loading pattern generated by train traffic. In addition, it is not feasible to update the prior risk information after bridges are repaired. In this research, the system reliability approach is further developed so that it can handle a varying-amplitude load and update the system-level risk of fatigue failure for railway bridges after inspection and repair. The proposed method is applied to a numerical example of an in-service railway bridge, and the effects of inspection and repair on the probabilistic fatigue life are discussed. PMID:28441768

High Burden of Kidney Disease in Youth-Onset Type 2 Diabetes

PubMed Central

Dart, Allison B.; Sellers, Elizabeth A.; Martens, Patricia J.; Rigatto, Claudio; Brownell, Marni D.; Dean, Heather J.

2012-01-01

OBJECTIVE To evaluate renal outcomes and survival in youth with type 2 diabetes (T2DM) versus type 1 diabetes (T1DM) versus nondiabetic control subjects. RESEARCH DESIGN AND METHODS In total, 342 prevalent youth (aged 1–18 years) with T2DM, 1,011 youth with T1DM, and 1,710 control subjects identified from 1986 to 2007 were anonymously linked to health care records housed at the Manitoba Centre for Health Policy to assess long-term outcomes using ICD codes. RESULTS Youth with T2DM were found to have a fourfold increased risk of renal failure versus youth with T1DM. Risk factors associated with renal failure were renin angiotensin aldosterone system inhibitor use and albuminuria in adolescence. Compared with control subjects (age, sex, and postal code matched), youth with T2DM had a 23-fold increased risk of renal failure and a 39-fold increased risk of dialysis. Kaplan-Meier survival at 10 years was 91.4% in the type 2 diabetic group versus 99.5% in the type 1 diabetic group (P < 0.0001). Renal survival was 100% at 10 years in both groups. It decreased to 92.0% at 15 years and 55.0% at 20 years in the type 2 diabetic group but remained stable in the type 1 diabetic group (P < 0.0001). CONCLUSIONS Youth with T2DM are at high risk of adverse renal outcomes and death. Albuminuria and angiotensin aldosterone system inhibitor use, which may be a marker of severity of disease, are associated with poor outcomes in early adulthood. PMID:22432116

Ferritin levels and risk of heart failure-the Atherosclerosis Risk in Communities Study.

PubMed

Silvestre, Odilson M; Gonçalves, Alexandra; Nadruz, Wilson; Claggett, Brian; Couper, David; Eckfeldt, John H; Pankow, James S; Anker, Stefan D; Solomon, Scott D

2017-03-01

Severe iron overload is associated with cardiac damage, while iron deficiency has been related to worse outcomes in subjects with heart failure (HF). This study investigated the relationship between ferritin, a marker of iron status, and the incidence of HF in a community-based cohort. We examined 1063 participants who were free of heart failure from the Atherosclerosis Risk in Communities (ARIC) Study in whom ferritin serum levels were measured at baseline (1987-1989). The participants (mean age 52.7 ± 5.5 years, 62% women), were categorized in low (<30 ng/mL; n = 153), normal (30-200 ng/mL in women and 30-300 ng/mL in men; n = 663), and high (>200 ng/mL in women and >300 ng/mL in men; n = 247) ferritin levels. Multivariable Cox proportional hazards models were used to evaluate the relationship between ferritin and incident HF. After 21 ± 4.6 years of follow-up, HF occurred in 144 (13.5%) participants. When compared with participants with normal ferritin levels, participants with low ferritin levels had a higher risk of HF [hazard ratio (HR) = 2.24, 95% confidence interval (CI) 1.15-4.35; P = 0.02] as did those with high ferritin levels (HR = 1.81, 95% CI 1.01-3.25; P = 0.04), after adjusting for potential confounders. Notably, low ferritin levels remained associated with incident HF even after excluding subjects with anaemia (HR = 2.28, 95% CI 1.11-4.68; P = 0.03). Derangements in iron metabolism, either low or high ferritin serum levels, were associated with higher risk of incident HF in a general population, even without concurrent anaemia. These findings suggest that iron imbalance might play a role in the development of HF. © 2016 The Authors. European Journal of Heart Failure © 2016 European Society of Cardiology.

MO-D-213-02: Quality Improvement Through a Failure Mode and Effects Analysis of Pediatric External Beam Radiotherapy

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

Gray, J; Lukose, R; Bronson, J

2015-06-15

Purpose: To conduct a failure mode and effects analysis (FMEA) as per AAPM Task Group 100 on clinical processes associated with teletherapy, and the development of mitigations for processes with identified high risk. Methods: A FMEA was conducted on clinical processes relating to teletherapy treatment plan development and delivery. Nine major processes were identified for analysis. These steps included CT simulation, data transfer, image registration and segmentation, treatment planning, plan approval and preparation, and initial and subsequent treatments. Process tree mapping was utilized to identify the steps contained within each process. Failure modes (FM) were identified and evaluated with amore » scale of 1–10 based upon three metrics: the severity of the effect, the probability of occurrence, and the detectability of the cause. The analyzed metrics were scored as follows: severity – no harm = 1, lethal = 10; probability – not likely = 1, certainty = 10; detectability – always detected = 1, undetectable = 10. The three metrics were combined multiplicatively to determine the risk priority number (RPN) which defined the overall score for each FM and the order in which process modifications should be deployed. Results: Eighty-nine procedural steps were identified with 186 FM accompanied by 193 failure effects with 213 potential causes. Eighty-one of the FM were scored with a RPN > 10, and mitigations were developed for FM with RPN values exceeding ten. The initial treatment had the most FM (16) requiring mitigation development followed closely by treatment planning, segmentation, and plan preparation with fourteen each. The maximum RPN was 400 and involved target delineation. Conclusion: The FMEA process proved extremely useful in identifying previously unforeseen risks. New methods were developed and implemented for risk mitigation and error prevention. Similar to findings reported for adult patients, the process leading to the initial treatment has an associated high risk.« less

Timing of Biochemical Failure and Distant Metastasis for Low, Intermediate, and High Risk Prostate Cancer after Radiotherapy

PubMed Central

Morgan, Peter B.; Hanlon, Alexandra L.; Horwitz, Eric M.; Buyyounouski, Mark K.; Uzzo, Robert G.; Pollack, Alan

2007-01-01

Condensed Abstract The timing of biochemical failure and distant metastasis after radiotherapy for low, intermediate and high-risk prostate cancer was determined. The patterns of failure suggest that the majority of early failures were due to subclinical micrometastases present at diagnosis, whereas a late wave of metastasis at 10–12 years in every risk group was consistent with tumor spread from local persistence of disease. Background The relationship of prostate cancer risk group stratification and the timing of biochemical failure (BF) and distant metastasis (DM) is not well defined. We sought to differentiate early failures due to subclinical micrometastasis at presentation from late failures due to local persistence. Methods A total of 1833 men with clinically localized prostate cancer treated with 3D-conformal radiotherapy with or without short-term androgen deprivation were retrospectively analyzed. The interval hazard rates of DM and BF, using ASTRO and Phoenix (Nadir+2) definitions, were determined for men with low, intermediate, and high risk disease. Results Median follow-up was 67 months. Multivariate analysis showed that increasing risk group was independently associated with higher ASTRO BF (P<.0001) and Nadir+2 BF (P<.0001). The preponderance (87%) of ASTRO BF occurred ≤4 years after RT, while Nadir+2 BF was more evenly spread over years 1–12, with 43% at >4 years. The hazard of Nadir+2 BF persisted in years 8–12 in all risk groups. The interval hazard function for DM appeared to be biphasic (early and late peaks) for intermediate and high risk patients, but no distinct early wave was evident for low risk patients. Conclusions ASTRO BF underestimates late BF due to backdating. Local persistence of disease is suggested by delayed Nadir+2 BF and subsequent late DM in every risk group. The paucity of early DM among those with low risk tumors supports the hypothesis that occult micrometastases contributed to the early wave. PMID:17520705

Developing and implementing a heart failure data mart for research and quality improvement.

PubMed

Abu-Rish Blakeney, Erin; Wolpin, Seth; Lavallee, Danielle C; Dardas, Todd; Cheng, Richard; Zierler, Brenda

2018-04-19

The purpose of this project was to build and formatively evaluate a near-real time heart failure (HF) data mart. Heart Failure (HF) is a leading cause of hospital readmissions. Increased efforts to use data meaningfully may enable healthcare organizations to better evaluate effectiveness of care pathways and quality improvements, and to prospectively identify risk among HF patients. We followed a modified version of the Systems Development Life Cycle: 1) Conceptualization, 2) Requirements Analysis, 3) Iterative Development, and 4) Application Release. This foundational work reflects the first of a two-phase project. Phase two (in process) involves the implementation and evaluation of predictive analytics for clinical decision support. We engaged stakeholders to build working definitions and established automated processes for creating an HF data mart containing actionable information for diverse audiences. As of December 2017, the data mart contains information from over 175,000 distinct patients and >100 variables from each of their nearly 300,000 visits. The HF data mart will be used to enhance care, assist in clinical decision-making, and improve overall quality of care. This model holds the potential to be scaled and generalized beyond the initial focus and setting.

Predicting the failure of retrograde ureteral stent insertion for managing malignant ureteral obstruction in outpatients

PubMed Central

WANG, JIN-YOU; ZHANG, HAI-LIANG; ZHU, YAO; QIN, XIAO-JIAN; DAI, BO; YE, DING-WEI

2016-01-01

Malignant ureteral obstruction (MUO) is an unpropitious sign that is commonly observed in patients with advanced incurable cancer. The present study aimed to evaluate predictive factors for the failure of retrograde ureteral stent insertion in the management of MUO in outpatients. A total of 164 patients with MUO were retrospectively assessed in this study. Clinical factors, including age, gender, type of malignancy, level of obstruction, cause of obstruction, pre-operative creatinine level, degree of hydronephrosis, condition of the contralateral ureter, prior radiotherapy, Eastern Cooperative Oncology Group performance status (ECOG PS), bladder wall invasion and technical failure, were recorded for each case. Univariate and multivariate logistic regression analyses were used to investigate the risk factors for predicting the failure of retrograde ureteral stent insertion. In total, 38 out of 164 patients experienced bilateral obstruction, therefore, a total of 202 ureteral units were available for data analysis. The rate of insertion failure in MUO was 34.65%. Multivariate analyses identified ECOG PS, degree of hydronephrosis and bladder wall invasion as independent predictors for insertion failure. Overall, the present study found that rate of retrograde ureteral stent insertion failure is high in outpatients with MUO, and that ECOG PS, degree of hydronephrosis and bladder invasion are potential independent predictors of insertion failure. PMID:26870299

Periodontitis in Chronic Heart Failure

PubMed Central

Fröhlich, Hanna; Herrmann, Kristina; Franke, Jennifer; Karimi, Alamara; Täger, Tobias; Cebola, Rita; Katus, Hugo A.; Zugck, Christian

2016-01-01

Periodontal disease has been associated with an increased risk of cardiovascular events. The purpose of our study was to investigate whether a correlation between periodontitis and chronic heart failure exists, as well as the nature of the underlying cause. We enrolled 71 patients (mean age, 54 ± 13 yr; 56 men) who had stable chronic heart failure; all underwent complete cardiologic and dental evaluations. The periodontal screening index was used to quantify the degree of periodontal disease. We compared the findings to those in the general population with use of data from the 4th German Dental Health Survey. Gingivitis, moderate periodontitis, and severe periodontitis were present in 17 (24%), 17 (24%), and 37 (52%) patients, respectively. Severe periodontitis was more prevalent among chronic heart failure patients than in the general population. In contrast, moderate periodontitis was more prevalent in the general population (P <0.00001). The severity of periodontal disease was not associated with the cause of chronic heart failure or the severity of heart failure symptoms. Six-minute walking distance was the only independent predictor of severe periodontitis. Periodontal disease is highly prevalent in chronic heart failure patients regardless of the cause of heart failure. Prospective trials are warranted to clarify the causal relationship between both diseases. PMID:27547136

Influence of pretreatment systolic blood pressure on the effect of carvedilol in patients with severe chronic heart failure: the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) study.

PubMed

Rouleau, Jean L; Roecker, Ellen B; Tendera, Michal; Mohacsi, Paul; Krum, Henry; Katus, Hugo A; Fowler, Michael B; Coats, Andrew J S; Castaigne, Alain; Scherhag, Armin; Holcslaw, Terry L; Packer, Milton

2004-04-21

We sought to evaluate the influence of pretreatment systolic blood pressure (SBP) on the efficacy and safety of carvedilol in patients with chronic heart failure (CHF). Although beta-blockers reduce the risk of death in CHF, there is little reported experience with these drugs in patients with a low pretreatment SBP, who may respond poorly to beta-blockade. We studied 2,289 patients with severe CHF who participated in the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial. Compared with placebo, carvedilol improved the clinical status and reduced the risk of death and the combined risk of death or hospitalization for any reason, for a cardiovascular reason, or for worsening heart failure (p < 0.001 for all). The relative magnitude of these benefits did not vary as a function of the pretreatment SBP (all interaction: p > 0.10). However, because patients with the lowest SBP were at highest risk of an event, they experienced the greatest absolute benefit from treatment with carvedilol. The lower the pretreatment SBP, the more likely that patients would report an adverse event, be intolerant of high doses of the study drug, or require permanent withdrawal of treatment (p < 0.001 for all). However, these risks were primarily related to the severity of the underlying illness and not to treatment with carvedilol. The current study provides little support for concerns about using beta-blockers (particularly those with vasodilatory actions) in patients with severe CHF who have a low SBP. Pretreatment blood pressure can identify patients who have the greatest need for risk reduction with carvedilol.

The Loss of GSTM1 Associates with Kidney Failure and Heart Failure.

PubMed

Tin, Adrienne; Scharpf, Robert; Estrella, Michelle M; Yu, Bing; Grove, Megan L; Chang, Patricia P; Matsushita, Kunihiro; Köttgen, Anna; Arking, Dan E; Boerwinkle, Eric; Le, Thu H; Coresh, Josef; Grams, Morgan E

2017-11-01

Glutathione S-transferase mu 1 ( GSTM1) encodes an enzyme that catalyzes the conjugation of electrophilic compounds with glutathione to facilitate their degradation or excretion. The loss of one or both copies of GSTM1 is common in many populations and has been associated with CKD progression. With the hypothesis that the loss of GSTM1 is also associated with incident kidney failure and heart failure, we estimated GSTM1 copy number using exome sequencing reads in the Atherosclerosis Risk in Communities (ARIC) Study, a community-based prospective cohort of white and black participants. Overall, 51.2% and 39.8% of white participants and 25.6% and 48.5% of black participants had zero or one copy of GSTM1 , respectively. Over a median follow-up of 24.6 years, 256 kidney failure events occurred in 5715 participants without prevalent kidney failure, and 1028 heart failure events occurred in 5368 participants without prevalent heart failure. In analysis adjusted for demographics, diabetes, and hypertension, having zero or one copy of GSTM1 associated with higher risk of kidney failure and heart failure (adjusted hazard ratio [95% confidence interval] for zero or one versus two copies of GSTM1 : kidney failure, 1.66 [1.27 to 2.17]; heart failure, 1.16 [1.04 to 1.29]). Risk did not differ significantly between participants with zero and one copy of GSTM1 ( P >0.10). In summary, the loss of GSTM1 was significantly associated with incident kidney and heart failure, independent of traditional risk factors. These results suggest GSTM1 function is a potential treatment target for the prevention of kidney and heart failure. Copyright © 2017 by the American Society of Nephrology.

Evaluating conditional release in not guilty by reason of insanity acquittees: a prospective follow-up study in Virginia.

PubMed

Vitacco, Michael J; Vauter, Rebecca; Erickson, Steven K; Ragatz, Laurie

2014-08-01

Detailed research on treatment and risk management approaches with not guilty by reason of insanity acquittees (NGRI) during their conditional release is needed as states increasingly use community-based services for these individuals. Grounded in case law, and supported by follow-up studies demonstrating low recidivism rates, states have been encouraged in their efforts to conditionally release NGRI acquittees. The authors evaluated a state-wide sample of 127 NGRI acquittees released into the community after spending a mean of 61.63 months (SD = 76.54) in the hospital. One hundred individuals were committed to the hospital for lengthier treatment (M hospital time = 77.23 months, SD = 79.84), but 27 individuals were released to the community after a relatively short hospital stay (M hospital time = 5.60 months, SD = 3.01). Regarding release, 96 individuals (75.6%) maintained their conditional release. After evaluating a host of demographic and standardized risk data, the following variables predicted revocation on conditional release: previous failure on conditional release, nonadherence with hospital treatment, dangerousness to others, and previous violent charges. A multivariate survival analysis determined criminal behavior and previous failure on conditional release predicted time to revocation. The results of this study demonstrate the importance of considering standardized risk variables in the community-based management of forensic patients. In addition, the data are supportive of continued attempts at moving insanity acquittees from the hospital to the community via conditional release.

A hazard and risk classification system for catastrophic rock slope failures in Norway

NASA Astrophysics Data System (ADS)

Hermanns, R.; Oppikofer, T.; Anda, E.; Blikra, L. H.; Böhme, M.; Bunkholt, H.; Dahle, H.; Devoli, G.; Eikenæs, O.; Fischer, L.; Harbitz, C. B.; Jaboyedoff, M.; Loew, S.; Yugsi Molina, F. X.

2012-04-01

The Geological Survey of Norway carries out systematic geologic mapping of potentially unstable rock slopes in Norway that can cause a catastrophic failure. As catastrophic failure we describe failures that involve substantial fragmentation of the rock mass during run-out and that impact an area larger than that of a rock fall (shadow angle of ca. 28-32° for rock falls). This includes therefore rock slope failures that lead to secondary effects, such as a displacement wave when impacting a water body or damming of a narrow valley. Our systematic mapping revealed more than 280 rock slopes with significant postglacial deformation, which might represent localities of large future rock slope failures. This large number necessitates prioritization of follow-up activities, such as more detailed investigations, periodic monitoring and permanent monitoring and early-warning. In the past hazard and risk were assessed qualitatively for some sites, however, in order to compare sites so that political and financial decisions can be taken, it was necessary to develop a quantitative hazard and risk classification system. A preliminary classification system was presented and discussed with an expert group of Norwegian and international experts and afterwards adapted following their recommendations. This contribution presents the concept of this final hazard and risk classification that should be used in Norway in the upcoming years. Historical experience and possible future rockslide scenarios in Norway indicate that hazard assessment of large rock slope failures must be scenario-based, because intensity of deformation and present displacement rates, as well as the geological structures activated by the sliding rock mass can vary significantly on a given slope. In addition, for each scenario the run-out of the rock mass has to be evaluated. This includes the secondary effects such as generation of displacement waves or landslide damming of valleys with the potential of later outburst floods. It became obvious that large rock slope failures cannot be evaluated on a slope scale with frequency analyses of historical and prehistorical events only, as multiple rockslides have occurred within one century on a single slope that prior to the recent failures had been inactive for several thousand years. In addition, a systematic analysis on temporal distribution indicates that rockslide activity following deglaciation after the Last Glacial Maximum has been much higher than throughout the Holocene. Therefore the classification system has to be based primarily on the geological conditions on the deforming slope and on the deformation rates and only to a lesser weight on a frequency analyses. Our hazard classification therefore is primarily based on several criteria: 1) Development of the back-scarp, 2) development of the lateral release surfaces, 3) development of the potential basal sliding surface, 4) morphologic expression of the basal sliding surface, 5) kinematic feasibility tests for different displacement mechanisms, 6) landslide displacement rates, 7) change of displacement rates (acceleration), 8) increase of rockfall activity on the unstable rock slope, 9) Presence post-glacial events of similar size along the affected slope and its vicinity. For each of these criteria several conditions are possible to choose from (e.g. different velocity classes for the displacement rate criterion). A score is assigned to each condition and the sum of all scores gives the total susceptibility score. Since many of these observations are somewhat uncertain, the classification system is organized in a decision tree where probabilities can be assigned to each condition. All possibilities in the decision tree are computed and the individual probabilities giving the same total score are summed. Basic statistics show the minimum and maximum total scores of a scenario, as well as the mean and modal value. The final output is a cumulative frequency distribution of the susceptibility scores that can be divided into several classes, which are interpreted as susceptibility classes (very high, high, medium, low, and very low). Today the Norwegian Planning and Building Act uses hazard classes with annual probabilities of impact on buildings producing damages (<1/100, <1/1000, <1/5000 and zero for critical buildings). However, up to now there is not enough scientific knowledge to predict large rock slope failures in these strict classes. Therefore, the susceptibility classes will be matched with the hazard classes from the Norwegian Building Act (e.g. very high susceptibility represents the hazard class with annual probability >1/100). The risk analysis focuses on the potential fatalities of a worst case rock slide scenario and its secondary effects only and is done in consequence classes with a decimal logarithmic scale. However we recommend for all high risk objects that municipalities carry out detailed risk analyses. Finally, the hazard and risk classification system will give recommendations where surveillance in form of continuous 24/7 monitoring systems coupled with early-warning systems (high risk class) or periodic monitoring (medium risk class) should be carried out. These measures are understood as to reduce the risk of life loss due to a rock slope failure close to 0 as population can be evacuated on time if a change of stability situation occurs. The final hazard and risk classification for all potentially unstable rock slopes in Norway, including all data used for its classification will be published within the national landslide database (available on www.skrednett.no).

ARAMIS project: a more explicit demonstration of risk control through the use of bow-tie diagrams and the evaluation of safety barrier performance.

PubMed

de Dianous, Valérie; Fiévez, Cécile

2006-03-31

Over the last two decades a growing interest for risk analysis has been noted in the industries. The ARAMIS project has defined a methodology for risk assessment. This methodology has been built to help the industrialist to demonstrate that they have a sufficient risk control on their site. Risk analysis consists first in the identification of all the major accidents, assuming that safety functions in place are inefficient. This step of identification of the major accidents uses bow-tie diagrams. Secondly, the safety barriers really implemented on the site are taken into account. The barriers are identified on the bow-ties. An evaluation of their performance (response time, efficiency, and level of confidence) is performed to validate that they are relevant for the expected safety function. At last, the evaluation of their probability of failure enables to assess the frequency of occurrence of the accident. The demonstration of the risk control based on a couple gravity/frequency of occurrence is also possible for all the accident scenarios. During the risk analysis, a practical tool called risk graph is used to assess if the number and the reliability of the safety functions for a given cause are sufficient to reach a good risk control.

An analysis of hearing screening test results in 2291 premature infants of Chinese population.

PubMed

Huang, Lili; Xiong, Fei; Li, Jinrong; Yang, Fan

2017-04-01

The aim of this study was to analyze the hearing screening program among preterm infants as well as to identify risk factors associated with failing primary newborn hearing screening. The retrospectively selected population included all preterm infants who had primary hearing screening in a neonatal ward from January 1st, 2013 to December 31st, 2015 at West China Second University Hospital, Sichuan University. The newborn hearing screening (NHS) procedure was performed in all preterm infants by automated auditory brainstem response (AABR). Infants who failed the primary hearing screening received a second screening at 42 days after birth. Infants who failed both tests were referred to a tertiary audiology center for diagnostic confirmation and management before 6 months of age. The final diagnosis for referred infants was obtained by telephone follow-up. The risk factors associated with failure to pass the primary hearing screen were evaluated and analyzed for preterm infants. Among 2291 preterm infants recruited, 155 infants (6.8%) failed the primary hearing screening with an abnormal AABR. Of these 155 infants, 113 (72.9%) passed the secondary screening. At the end of the follow-up, 1 infant (0.04%) was diagnosed with hearing loss, 3 infants had delayed language development, and 40 infants were lost to follow up. Multivariate regression analysis revealed that gestational age ≤32 weeks (Odds ratio [OR] = 2.093, 95% confidence interval [CI] 1.370-3.196), super hyperbilirubinemia (≥25 mg/dl) (OR = 3.560, 95% CI 1.009-12.560), and respiratory failure (OR = 1.971, 95% CI 1.188-3.265) were associated with failure to pass newborn hearing screening. The prevalence of failure to pass primary hearing screening among preterm infants was 6.8% in our study, and we found a relatively low prevalence of hearing loss (0.04%). Super hyperbilirubinemia, gestational age ≤32weeks, and respiratory failure were risk factors associated with failure of preterm infants to pass the primary hearing screening. Our results suggest that preterm infants with hyperbilirubinemia, gestational age ≤32 weeks, and respiratory failure should be closely followed. Copyright © 2017 Elsevier B.V. All rights reserved.

Biomarkers of myocardial stress and fibrosis as predictors of mode of death in patients with chronic heart failure.

PubMed

Ahmad, Tariq; Fiuzat, Mona; Neely, Benjamin; Neely, Megan L; Pencina, Michael J; Kraus, William E; Zannad, Faiez; Whellan, David J; Donahue, Mark P; Piña, Ileana L; Adams, Kirkwood F; Kitzman, Dalane W; O'Connor, Christopher M; Felker, G Michael

2014-06-01

The aim of this study was to determine whether biomarkers of myocardial stress and fibrosis improve prediction of the mode of death in patients with chronic heart failure. The 2 most common modes of death in patients with chronic heart failure are pump failure and sudden cardiac death. Prediction of the mode of death may facilitate treatment decisions. The relationship between amino-terminal pro-brain natriuretic peptide (NT-proBNP), galectin-3, and ST2, biomarkers that reflect different pathogenic pathways in heart failure (myocardial stress and fibrosis), and mode of death is unknown. HF-ACTION (Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training) was a randomized controlled trial of exercise training versus usual care in patients with chronic heart failure due to left ventricular systolic dysfunction (left ventricular ejection fraction ≤35%). An independent clinical events committee prospectively adjudicated mode of death. NT-proBNP, galectin-3, and ST2 levels were assessed at baseline in 813 subjects. Associations between biomarkers and mode of death were assessed using cause-specific Cox proportional hazards modeling, and interaction testing was used to measure differential associations between biomarkers and pump failure versus sudden cardiac death. Discrimination and risk reclassification metrics were used to assess the added value of galectin-3 and ST2 in predicting mode of death risk beyond a clinical model that included NT-proBNP. After a median follow-up period of 2.5 years, there were 155 deaths: 49 from pump failure, 42 from sudden cardiac death, and 64 from other causes. Elevations in all biomarkers were associated with increased risk for both pump failure and sudden cardiac death in both adjusted and unadjusted analyses. In each case, increases in the biomarker had a stronger association with pump failure than sudden cardiac death, but this relationship was attenuated after adjustment for clinical risk factors. Clinical variables along with NT-proBNP levels were stronger predictors of pump failure (C statistic: 0.87) than sudden cardiac death (C statistic: 0.73). Addition of ST2 and galectin-3 led to improved net risk classification of 11% for sudden cardiac death, but not pump failure. Clinical predictors along with NT-proBNP levels were strong predictors of pump failure risk, with insignificant incremental contributions of ST2 and galectin-3. Predictability of sudden cardiac death risk was less robust and enhanced by information provided by novel biomarkers. Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

[Evaluation of the capacity of the APR-DRG classification system to predict hospital mortality].

PubMed

De Marco, Maria Francesca; Lorenzoni, Luca; Addari, Piero; Nante, Nicola

2002-01-01

Inpatient mortality has increasingly been used as an hospital outcome measure. Comparing mortality rates across hospitals requires adjustment for patient risks before making inferences about quality of care based on patient outcomes. Therefore it is essential to dispose of well performing severity measures. The aim of this study is to evaluate the ability of the All Patient Refined DRG system to predict inpatient mortality for congestive heart failure, myocardial infarction, pneumonia and ischemic stroke. Administrative records were used in this analysis. We used two statistics methods to assess the ability of the APR-DRG to predict mortality: the area under the receiver operating characteristics curve (referred to as the c-statistic) and the Hosmer-Lemeshow test. The database for the study included 19,212 discharges for stroke, pneumonia, myocardial infarction and congestive heart failure from fifteen hospital participating in the Italian APR-DRG Project. A multivariate analysis was performed to predict mortality for each condition in study using age, sex and APR-DRG risk mortality subclass as independent variables. Inpatient mortality rate ranges from 9.7% (pneumonia) to 16.7% (stroke). Model discrimination, calculated using the c-statistic, was 0.91 for myocardial infarction, 0.68 for stroke, 0.78 for pneumonia and 0.71 for congestive heart failure. The model calibration assessed using the Hosmer-Leme-show test was quite good. The performance of the APR-DRG scheme when used on Italian hospital activity records is similar to that reported in literature and it seems to improve by adding age and sex to the model. The APR-DRG system does not completely capture the effects of these variables. In some cases, the better performance might be due to the inclusion of specific complications in the risk-of-mortality subclass assignment.

A joint model for longitudinal and time-to-event data to better assess the specific role of donor and recipient factors on long-term kidney transplantation outcomes.

PubMed

Fournier, Marie-Cécile; Foucher, Yohann; Blanche, Paul; Buron, Fanny; Giral, Magali; Dantan, Etienne

2016-05-01

In renal transplantation, serum creatinine (SCr) is the main biomarker routinely measured to assess patient's health, with chronic increases being strongly associated with long-term graft failure risk (death with a functioning graft or return to dialysis). Joint modeling may be useful to identify the specific role of risk factors on chronic evolution of kidney transplant recipients: some can be related to the SCr evolution, finally leading to graft failure, whereas others can be associated with graft failure without any modification of SCr. Sample data for 2749 patients transplanted between 2000 and 2013 with a functioning kidney at 1-year post-transplantation were obtained from the DIVAT cohort. A shared random effect joint model for longitudinal SCr values and time to graft failure was performed. We show that graft failure risk depended on both the current value and slope of the SCr. Deceased donor graft patient seemed to have a higher SCr increase, similar to patient with diabetes history, while no significant association of these two features with graft failure risk was found. Patient with a second graft was at higher risk of graft failure, independent of changes in SCr values. Anti-HLA immunization was associated with both processes simultaneously. Joint models for repeated and time-to-event data bring new opportunities to improve the epidemiological knowledge of chronic diseases. For instance in renal transplantation, several features should receive additional attention as we demonstrated their correlation with graft failure risk was independent of the SCr evolution.

A study on risk factors and diagnostic efficiency of posthepatectomy liver failure in the nonobstructive jaundice.

PubMed

Wang, He; Lu, Shi-Chun; He, Lei; Dong, Jia-Hong

2018-02-01

Liver failure remains as the most common complication and cause of death after hepatectomy, and continues to be a challenge for doctors.t test and χ test were used for single factor analysis of data-related variables, then results were introduced into the model to undergo the multiple factors logistic regression analysis. Pearson correlation analysis was performed for related postoperative indexes, and a diagnostic evaluation was performed using the receiver operating characteristic (ROC) of postoperative indexes.Differences in age, body mass index (BMI), portal vein hypertension, bile duct cancer, total bilirubin, alkaline phosphatase (ALP), gamma-glutamyl transpeptidase (GGT), operation time, cumulative portal vein occlusion time, intraoperative blood volume, residual liver volume (RLV)/entire live rvolume, ascites volume at postoperative day (POD)3, supplemental albumin amount at POD3, hospitalization time after operation, and the prothrombin activity (PTA) were statistically significant. Furthermore, there were significant differences in total bilirubin and the supplemental albumin amount at POD3. ROC analysis of the average PTA, albumin amounts, ascites volume at POD3, and their combined diagnosis were performed, which had diagnostic value for postoperative liver failure (area under the curve (AUC): 0.895, AUC: 0.798, AUC: 0.775, and AUC: 0.903).Preoperative total bilirubin level and the supplemental albumin amount at POD3 were independent risk factors. PTA can be used as the index of postoperative liver failure, and the combined diagnosis of the indexes can improve the early prediction of postoperative liver failure.

Long-term effectiveness of telephone-based health coaching for heart failure patients: A post-only randomised controlled trial.

PubMed

Tiede, Michel; Dwinger, Sarah; Herbarth, Lutz; Härter, Martin; Dirmaier, Jörg

2017-09-01

Introduction The * Equal contributors. health-status of heart failure patients can be improved to some extent by disease self-management. One method of developing such skills is telephone-based health coaching. However, the effects of telephone-based health coaching remain inconclusive. The aim of this study was to evaluate the effects of telephone-based health coaching for people with heart failure. Methods A total sample of 7186 patients with various chronic diseases was randomly assigned to either the coaching or the control group. Then 184 patients with heart failure were selected by International Classification of Diseases (ICD)-10 code for subgroup analysis. Data were collected at 24 and 48 months after the beginning of the coaching. The primary outcome was change in quality of life. Secondary outcomes were changes in depression and anxiety, health-related control beliefs, control preference, health risk behaviour and health-related behaviours. Statistical analyses included a per-protocol evaluation, employing analysis of variance and analysis of covariance (ANCOVA) as well as Mann-Whitney U tests. Results Participants' average age was 73 years (standard deviation (SD) = 9) and the majority were women (52.8%). In ANCOVA analyses there were no significant differences between groups for the change in quality of life (QoL) . However, the coaching group reported a significantly higher level of physical activity ( p = 0.03), lower intake of non-prescribed drugs ( p = 0.04) and lower levels of stress ( p = 0.02) than the control group. Mann-Whitney U tests showed a different external locus of control ( p = 0.014), and higher reduction in unhealthy nutrition ( p = 0.019), physical inactivity ( p = 0.004) and stress ( p = 0.028). Discussion Our results suggest that telephone-based health coaching has no effect on QoL, anxiety and depression of heart failure patients, but helps in improving certain risk behaviours and changes the locus of control to be more externalised.

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

Mossahebi, S; Feigenberg, S; Nichols, E

Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis. Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1–10). An RPN of highermore » than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies. Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planning with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150. Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments. Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.« less

Pretreatment HIV Drug Resistance and HIV-1 Subtype C Are Independently Associated With Virologic Failure: Results From the Multinational PEARLS (ACTG A5175) Clinical Trial

PubMed Central

Kantor, Rami; Smeaton, Laura; Vardhanabhuti, Saran; Hudelson, Sarah E.; Wallis, Carol L.; Tripathy, Srikanth; Morgado, Mariza G.; Saravanan, Shanmugham; Balakrishnan, Pachamuthu; Reitsma, Marissa; Hart, Stephen; Mellors, John W.; Halvas, Elias; Grinsztejn, Beatriz; Hosseinipour, Mina C.; Kumwenda, Johnstone; La Rosa, Alberto; Lalloo, Umesh G.; Lama, Javier R.; Rassool, Mohammed; Santos, Breno R.; Supparatpinyo, Khuanchai; Hakim, James; Flanigan, Timothy; Kumarasamy, Nagalingeswaran; Campbell, Thomas B.; Eshleman, Susan H.

2015-01-01

Background. Evaluation of pretreatment HIV genotyping is needed globally to guide treatment programs. We examined the association of pretreatment (baseline) drug resistance and subtype with virologic failure in a multinational, randomized clinical trial that evaluated 3 antiretroviral treatment (ART) regimens and included resource-limited setting sites. Methods. Pol genotyping was performed in a nested case-cohort study including 270 randomly sampled participants (subcohort), and 218 additional participants failing ART (case group). Failure was defined as confirmed viral load (VL) >1000 copies/mL. Cox proportional hazards models estimated resistance–failure association. Results. In the representative subcohort (261/270 participants with genotypes; 44% women; median age, 35 years; median CD4 cell count, 151 cells/µL; median VL, 5.0 log10 copies/mL; 58% non-B subtypes), baseline resistance occurred in 4.2%, evenly distributed among treatment arms and subtypes. In the subcohort and case groups combined (466/488 participants with genotypes), used to examine the association between resistance and treatment failure, baseline resistance occurred in 7.1% (9.4% with failure, 4.3% without). Baseline resistance was significantly associated with shorter time to virologic failure (hazard ratio [HR], 2.03; P = .035), and after adjusting for sex, treatment arm, sex–treatment arm interaction, pretreatment CD4 cell count, baseline VL, and subtype, was still independently associated (HR, 2.1; P = .05). Compared with subtype B, subtype C infection was associated with higher failure risk (HR, 1.57; 95% confidence interval [CI], 1.04–2.35), whereas non-B/C subtype infection was associated with longer time to failure (HR, 0.47; 95% CI, .22–.98). Conclusions. In this global clinical trial, pretreatment resistance and HIV-1 subtype were independently associated with virologic failure. Pretreatment genotyping should be considered whenever feasible. Clinical Trials Registration. NCT00084136. PMID:25681380

Vital Signs: How Early Can Resident Evaluation Predict Acquisition of Competency in Surgical Pathology?

PubMed Central

Ducatman, Barbara S.; Williams, H. James; Hobbs, Gerald; Gyure, Kymberly A.

2009-01-01

Objectives To determine whether a longitudinal, case-based evaluation system can predict acquisition of competency in surgical pathology and how trainees at risk can be identified early. Design Data were collected for trainee performance on surgical pathology cases (how well their diagnosis agreed with the faculty diagnosis) and compared with training outcomes. Negative training outcomes included failure to complete the residency, failure to pass the anatomic pathology component of the American Board of Pathology examination, and/or failure to obtain or hold a position immediately following training. Findings Thirty-three trainees recorded diagnoses for 54 326 surgical pathology cases, with outcome data available for 15 residents. Mean case-based performance was significantly higher for those with positive outcomes, and outcome status could be predicted as early as postgraduate year-1 (P  =  .0001). Performance on the first postgraduate year-1 rotation was significantly associated with the outcome (P  =  .02). Although trainees with unsuccessful outcomes improved their performance more rapidly, they started below residents with successful outcomes and did not make up the difference during training. There was no significant difference in Step 1 or 2 United States Medical Licensing Examination (USMLE) scores when compared with performance or final outcomes (P  =  .43 and P  =  .68, respectively) and the resident in-service examination (RISE) had limited predictive ability. Discussion Differences between successful- and unsuccessful-outcome residents were most evident in early residency, ideal for designing interventions or counseling residents to consider another specialty. Conclusion Our longitudinal case-based system successfully identified trainees at risk for failure to acquire critical competencies for surgical pathology early in the program. PMID:21975705

Gender-specific risk factors for virologic failure in KwaZulu-Natal: Automobile ownership and financial insecurity

PubMed Central

HARE, Anna Q.; ORDÓÑEZ, Claudia E.; JOHNSON, Brent A.; RIO, Carlos DEL; KEARNS, Rachel A.; WU, Baohua; HAMPTON, Jane; WU, Peng; SUNPATH, Henry; MARCONI, Vincent C.

2014-01-01

We sought to examine which socioeconomic indicators are risk factors for virologic failure among HIV-1 infected patients receiving antiretroviral therapy in KwaZulu-Natal, South Africa. A case-control study of virologic failure was conducted among patients recruited from the outpatient clinic at McCord Hospital in Durban, South Africa between October 1, 2010 and June 30, 2012. Cases were those failing first-line antiretroviral therapy (ART), defined as viral load > 1000 copies/mL. Univariate logistic regression was performed on sociodemographic data for the outcome of virologic failure. Variables found significant (p<.05) were used in multivariate models and all models were stratified by gender. Of 158 cases and 300 controls, 35% were male and median age was 40 years. Gender stratification of models revealed automobile ownership was a risk factor among males, while variables of financial insecurity (unemployment, non-spouse family paying for care, staying with family) were risk factors for women. In this cohort, financial insecurity among women and automobile ownership among men were risk factors for virologic failure. Risk factor differences between genders demonstrate limitations of generalized risk factor analysis. PMID:25037488

Gender-specific risk factors for virologic failure in KwaZulu-Natal: automobile ownership and financial insecurity.

PubMed

Hare, Anna Q; Ordóñez, Claudia E; Johnson, Brent A; Del Rio, Carlos; Kearns, Rachel A; Wu, Baohua; Hampton, Jane; Wu, Peng; Sunpath, Henry; Marconi, Vincent C

2014-11-01

We sought to examine which socioeconomic indicators are risk factors for virologic failure among HIV-1 infected patients receiving antiretroviral therapy (ART) in KwaZulu-Natal, South Africa. A case-control study of virologic failure was conducted among patients recruited from the outpatient clinic at McCord Hospital in Durban, South Africa between October 1, 2010 and June 30, 2012. Cases were those failing first-line ART, defined as viral load >1,000 copies/mL. Univariate logistic regression was performed on sociodemographic data for the outcome of virologic failure. Variables found significant (p < 0.05) were used in multivariate models and all models were stratified by gender. Of 158 cases and 300 controls, 35 % were male and median age was 40 years. Gender stratification of models revealed automobile ownership was a risk factor among males, while variables of financial insecurity (unemployment, non-spouse family paying for care, staying with family) were risk factors for women. In this cohort, financial insecurity among women and automobile ownership among men were risk factors for virologic failure. Risk factor differences between genders demonstrate limitations of generalized risk factor analysis.

[Acute renal failure after cardiac surgery: evaluation of the RIFLE criteria].

PubMed

Kallel, Sami; Triki, Zied; Abdenadher, Mohammed; Frikha, Imed; Jemel, Amine; Karoui, Abdelhamid

2013-04-01

Acute renal failure is a common complication is a common complication in cardiac surgery under cardiopulmonary bypass. It is associated with increased morbidity and mortality. Acute kidney injury (AKI) is a clinical entity encompassing the entire spectrum of acute renal failure, since minor alterations to the need for renal replacement therapy. The RIFLE criteria have been proposed for defining and classifying AKI. The aim of our study was to apply the RIFLE to a population of patients undergoing cardiac surgery with cardiopulmonary bypass (CPB) and to assess its relevance in terms of risk factor for hospital mortality compared to other risk factors. In this prospective observational study, we included patients who were operated for programmed cardiac surgery. The assay of blood creatinine was performed at admission, after surgery and daily for 5 days post-surgery. The AKI was evaluated according to the criteria of classification RIFLE. The patients were divided into three levels of severity based on plasmatic creatinine (R: Risk=creatinine×1.5; I: Injury=creatinine×2; F: Failure=creatinine×3). We have analyzed the different perioperative parameters and we sought associations with the occurrence of AKI. We also studied the impact of AKI on length of stay in ICU and mortality early and late. One hundred and thirty-six patients were included. AKI was diagnosed in 17.6% of patients (RIFLE-R: 8.8%, RIFLE-I: 5.9% and RIFLE-F: 2.9%). AKI significantly prolongs the duration of ICU stay (7±3.8 versus 5±2.3 days; P=0.02). RIFLE-R patients had a mortality of 8.3%, compared to 12.5% for I and 50% for F. Patients without PORD had a mortality of 1.8%. In univariate analysis, age, the EURO score, preoperative renal dysfunction, duration of aortic clamping, duration of CPB and C-reactive protein (CRP) were significantly associated with the occurrence of AKI. In multivariate analysis only preoperative renal dysfunction (clearance less than 63 mL/min) and CRP greater than 158 mg/L were found as independent factors of occurrence of AKI. RIFLE classification seems to be a reliable way to detect acute renal failure and to classify its severity. The AKI is a common complication and is associated with increased morbidity and mortality. Identifying the risk factors allows a better prevention strategy. Copyright © 2012 Association Société de néphrologie. Published by Elsevier SAS. All rights reserved.

Functional correlation approach to operational risk in banking organizations

NASA Astrophysics Data System (ADS)

Kühn, Reimer; Neu, Peter

2003-05-01

A Value-at-Risk-based model is proposed to compute the adequate equity capital necessary to cover potential losses due to operational risks, such as human and system process failures, in banking organizations. Exploring the analogy to a lattice gas model from physics, correlations between sequential failures are modeled by as functionally defined, heterogeneous couplings between mutually supportive processes. In contrast to traditional risk models for market and credit risk, where correlations are described as equal-time-correlations by a covariance matrix, the dynamics of the model shows collective phenomena such as bursts and avalanches of process failures.

Evaluating the Phoenix definition of biochemical failure after (125)I prostate brachytherapy: Can PSA kinetics distinguish PSA failures from PSA bounces?

PubMed

Thompson, Anna; Keyes, Mira; Pickles, Tom; Palma, David; Moravan, Veronika; Spadinger, Ingrid; Lapointe, Vincent; Morris, W James

2010-10-01

To evaluate the prostate-specific antigen (PSA) kinetics of PSA failure (PSAf) and PSA bounce (PSAb) after permanent (125)I prostate brachytherapy (PB). The study included 1,006 consecutive low and "low tier" intermediate-risk patients treated with (125)I PB, with a potential minimum follow-up of 4 years. Patients who met the Phoenix definition of biochemical failure (nadir + 2 ng/mL(-1)) were identified. If the PSA subsequently fell to ≤0.5 ng/mL(-1)without intervention, this was considered a PSAb. All others were scored as true PSAf. Patient, tumor and dosimetric characteristics were compared between groups using the chi-square test and analysis of variance to evaluate factors associated with PSAf or PSAb. Median follow-up was 54 months. Of the 1,006 men, 57 patients triggered the Phoenix definition of PSA failure, 32 (56%) were true PSAf, and 25 PSAb (44%). The median time to trigger nadir + 2 was 20.6 months (range, 6-36) vs. 49 mo (range, 12-83) for PSAb vs. PSAf groups (p < 0.001). The PSAb patients were significantly younger (p < 0.0001), had shorter time to reach the nadir (median 6 vs. 11.5 months, p = 0.001) and had a shorter PSA doubling time (p = 0.05). Men younger than age 70 who trigger nadir +2 PSA failure within 38 months of implant have an 80% likelihood of having PSAb and 20% chance of PSAf. With adequate follow-up, 44% of PSA failures by the Phoenix definition in our cohort were found to be benign PSA bounces. Our study reinforces the need for adequate follow-up when reporting PB PSA outcomes, to ensure accurate estimates of treatment efficacy and to avoid unnecessary secondary interventions. 2010. Published by Elsevier Inc. All rights reserved.

A Road Map for 21st Century Genetic Restoration: Gene Pool Enrichment of the Black-Footed Ferret

PubMed Central

Ryder, Oliver A.; Santymire, Rachel M.; Engelhardt, John F.; Novak, Ben J.

2015-01-01

Interspecies somatic cell nuclear transfer (iSCNT) could benefit recovery programs of critically endangered species but must be weighed with the risks of failure. To weigh the risks and benefits, a decision-making process that evaluates progress is needed. Experiments that evaluate the efficiency and efficacy of blastocyst, fetal, and post-parturition development are necessary to determine the success or failure or species-specific iSCNT programs. Here, we use the black-footed ferret (Mustela nigripes) as a case study for evaluating this emerging biomedical technology as a tool for genetic restoration. The black-footed ferret has depleted genetic variation yet genome resource banks contain genetic material of individuals not currently represented in the extant lineage. Thus, genetic restoration of the species is in theory possible and could help reduce the persistent erosion of genetic diversity from drift. Extensive genetic, genomic, and reproductive science tools have previously been developed in black-footed ferrets and would aid in the process of developing an iSCNT protocol for this species. Nonetheless, developing reproductive cloning will require years of experiments and a coordinated effort among recovery partners. The information gained from a well-planned research effort with the goal of genetic restoration via reproductive cloning could establish a 21st century model for evaluating and implementing conservation breeding that would be applicable to other genetically impoverished species. PMID:26304983

A Road Map for 21st Century Genetic Restoration: Gene Pool Enrichment of the Black-Footed Ferret.

PubMed

Wisely, Samantha M; Ryder, Oliver A; Santymire, Rachel M; Engelhardt, John F; Novak, Ben J

2015-01-01

Interspecies somatic cell nuclear transfer (iSCNT) could benefit recovery programs of critically endangered species but must be weighed with the risks of failure. To weigh the risks and benefits, a decision-making process that evaluates progress is needed. Experiments that evaluate the efficiency and efficacy of blastocyst, fetal, and post-parturition development are necessary to determine the success or failure or species-specific iSCNT programs. Here, we use the black-footed ferret (Mustela nigripes) as a case study for evaluating this emerging biomedical technology as a tool for genetic restoration. The black-footed ferret has depleted genetic variation yet genome resource banks contain genetic material of individuals not currently represented in the extant lineage. Thus, genetic restoration of the species is in theory possible and could help reduce the persistent erosion of genetic diversity from drift. Extensive genetic, genomic, and reproductive science tools have previously been developed in black-footed ferrets and would aid in the process of developing an iSCNT protocol for this species. Nonetheless, developing reproductive cloning will require years of experiments and a coordinated effort among recovery partners. The information gained from a well-planned research effort with the goal of genetic restoration via reproductive cloning could establish a 21st century model for evaluating and implementing conservation breeding that would be applicable to other genetically impoverished species. © The American Genetic Association. 2015.

Lower early postnatal oxygen saturation target and risk of ductus arteriosus closure failure.

PubMed

Inomata, Kei; Taniguchi, Shinji; Yonemoto, Hiroki; Inoue, Takeshi; Kawase, Akihiko; Kondo, Yuichi

2016-11-01

Early postnatal hyperoxia is a major risk factor for retinopathy of prematurity (ROP) in extremely premature infants. To reduce the occurrence of ROP, we adopted a lower early postnatal oxygen saturation (SpO 2 ) target range (85-92%) from April 2011. Lower SpO 2 target range, however, may lead to hypoxemia and an increase in the risk of ductus arteriosus (DA) closure failure. The aim of this study was therefore to determine whether a lower SpO 2 target range, during the early postnatal stage, increases the risk of DA closure failure. Infants born at <28 weeks' gestation were enrolled in this study. Oxygen saturation target range during the first postnatal 72 h was 84-100% in study period 1 and 85-92% in period 2. Eighty-two infants were included in period 1, and 61 were included in period 2. The lower oxygen saturation target range increased the occurrence of hypoxemia during the first postnatal 72 h. Prevalence of DA closure failure in period 2 (21%) was significantly higher than that in period 1 (1%). On multivariate logistic regression analysis, the lower oxygen saturation target range was an independent risk factor for DA closure failure. Lower early postnatal oxygen saturation target range increases the risk of DA closure failure. © 2016 Japan Pediatric Society.

Quantitative Risk Analysis on the Transport of Dangerous Goods Through a Bi-Directional Road Tunnel.

PubMed

Caliendo, Ciro; De Guglielmo, Maria Luisa

2017-01-01

A quantitative risk analysis (QRA) regarding dangerous goods vehicles (DGVs) running through road tunnels was set up. Peak hourly traffic volumes (VHP), percentage of heavy goods vehicles (HGVs), and failure of the emergency ventilation system were investigated in order to assess their impact on the risk level. The risk associated with an alternative route running completely in the open air and passing through a highly populated urban area was also evaluated. The results in terms of social risk, as F/N curves, show an increased risk level with an increase the VHP, the percentage of HGVs, and a failure of the emergency ventilation system. The risk curves of the tunnel investigated were found to lie both above and below those of the alternative route running in the open air depending on the type of dangerous goods transported. In particular, risk was found to be greater in the tunnel for two fire scenarios (no explosion). In contrast, the risk level for the exposed population was found to be greater for the alternative route in three possible accident scenarios associated with explosions and toxic releases. Therefore, one should be wary before stating that for the transport of dangerous products an itinerary running completely in the open air might be used if the latter passes through a populated area. The QRA may help decisionmakers both to implement additional safety measures and to understand whether to allow, forbid, or limit circulation of DGVs. © 2016 Society for Risk Analysis.

Superior Patency of Upper Arm Arteriovenous Fistulae in High Risk Patients

PubMed Central

Chiulli, Larissa C; Vasilas, Penny; Dardik, Alan

2011-01-01

Background Despite an increased propensity to primary failure in forearm arteriovenous fistulae compared to upper arm fistulae, forearm fistulae remain the preferred primary access type for chronic hemodialysis patients. In a high risk patient population with multiple medical comorbidities associated with requirement for intravenous access we compared the rates of access failure in forearm and upper arm fistulae. Materials and Methods The records of all patients having primary native arteriovenous fistulae placed between 2004 and 2009 at the VA Connecticut Healthcare system were reviewed (n=118). Primary and secondary patency of upper arm and forearm fistulae were evaluated using Kaplan-Meier survival analysis. The effects of medical comorbidities on access patency were analyzed with Cox regression. Results The median time to primary failure of the vascular access was 0.288 years in the forearm group compared to 0.940 years in the upper arm group (p=0.028). Secondary patency was 52% at 4.9 years in upper arm fistulae compared to 52% at 1.1 years in the forearm group (p=0.036). There was no significant effect of patient comorbidities on fistula failure; however, there was a trend toward upper arm surgical site as a protective factor for primary fistula patency (Hazard Ratio=0.573, p=0.076). Conclusions In veterans needing hemodialysis, a high risk population with extensive comorbid factors often requiring intravascular access, upper arm fistulae are not only a viable option for primary vascular access, but are likely to be a superior option to classic forearm fistulae. PMID:21571318

First-line endoscopic treatment with over-the-scope clips significantly improves the primary failure and rebleeding rates in high-risk gastrointestinal bleeding: A single-center experience with 100 cases

PubMed Central

Richter-Schrag, Hans-Jürgen; Glatz, Torben; Walker, Christine; Fischer, Andreas; Thimme, Robert

2016-01-01

AIM To evaluate rebleeding, primary failure (PF) and mortality of patients in whom over-the-scope clips (OTSCs) were used as first-line and second-line endoscopic treatment (FLET, SLET) of upper and lower gastrointestinal bleeding (UGIB, LGIB). METHODS A retrospective analysis of a prospectively collected database identified all patients with UGIB and LGIB in a tertiary endoscopic referral center of the University of Freiburg, Germany, from 04-2012 to 05-2016 (n = 93) who underwent FLET and SLET with OTSCs. The complete Rockall risk scores were calculated from patients with UGIB. The scores were categorized as < or ≥ 7 and were compared with the original Rockall data. Differences between FLET and SLET were calculated. Univariate and multivariate analysis were performed to evaluate the factors that influenced rebleeding after OTSC placement. RESULTS Primary hemostasis and clinical success of bleeding lesions (without rebleeding) was achieved in 88/100 (88%) and 78/100 (78%), respectively. PF was significantly lower when OTSCs were applied as FLET compared to SLET (4.9% vs 23%, P = 0.008). In multivariate analysis, patients who had OTSC placement as SLET had a significantly higher rebleeding risk compared to those who had FLET (OR 5.3; P = 0.008). Patients with Rockall risk scores ≥ 7 had a significantly higher in-hospital mortality compared to those with scores < 7 (35% vs 10%, P = 0.034). No significant differences were observed in patients with scores < or ≥ 7 in rebleeding and rebleeding-associated mortality. CONCLUSION Our data show for the first time that FLET with OTSC might be the best predictor to successfully prevent rebleeding of gastrointestinal bleeding compared to SLET. The type of treatment determines the success of primary hemostasis or primary failure. PMID:27895403

An FMEA evaluation of intensity modulated radiation therapy dose delivery failures at tolerance criteria levels.

PubMed

Faught, Jacqueline Tonigan; Balter, Peter A; Johnson, Jennifer L; Kry, Stephen F; Court, Laurence E; Stingo, Francesco C; Followill, David S

2017-11-01

The objective of this work was to assess both the perception of failure modes in Intensity Modulated Radiation Therapy (IMRT) when the linac is operated at the edge of tolerances given in AAPM TG-40 (Kutcher et al.) and TG-142 (Klein et al.) as well as the application of FMEA to this specific section of the IMRT process. An online survey was distributed to approximately 2000 physicists worldwide that participate in quality services provided by the Imaging and Radiation Oncology Core - Houston (IROC-H). The survey briefly described eleven different failure modes covered by basic quality assurance in step-and-shoot IMRT at or near TG-40 (Kutcher et al.) and TG-142 (Klein et al.) tolerance criteria levels. Respondents were asked to estimate the worst case scenario percent dose error that could be caused by each of these failure modes in a head and neck patient as well as the FMEA scores: Occurrence, Detectability, and Severity. Risk probability number (RPN) scores were calculated as the product of these scores. Demographic data were also collected. A total of 181 individual and three group responses were submitted. 84% were from North America. Most (76%) individual respondents performed at least 80% clinical work and 92% were nationally certified. Respondent medical physics experience ranged from 2.5 to 45 yr (average 18 yr). A total of 52% of individual respondents were at least somewhat familiar with FMEA, while 17% were not familiar. Several IMRT techniques, treatment planning systems, and linear accelerator manufacturers were represented. All failure modes received widely varying scores ranging from 1 to 10 for occurrence, at least 1-9 for detectability, and at least 1-7 for severity. Ranking failure modes by RPN scores also resulted in large variability, with each failure mode being ranked both most risky (1st) and least risky (11th) by different respondents. On average MLC modeling had the highest RPN scores. Individual estimated percent dose errors and severity scores positively correlated (P < 0.01) for each FM as expected. No universal correlations were found between the demographic information collected and scoring, percent dose errors or ranking. Failure modes investigated overall were evaluated as low to medium risk, with average RPNs less than 110. The ranking of 11 failure modes was not agreed upon by the community. Large variability in FMEA scoring may be caused by individual interpretation and/or experience, reflecting the subjective nature of the FMEA tool. © 2017 American Association of Physicists in Medicine.

Utility of the Instability Severity Index Score in Predicting Failure After Arthroscopic Anterior Stabilization of the Shoulder.

PubMed

Phadnis, Joideep; Arnold, Christine; Elmorsy, Ahmed; Flannery, Mark

2015-08-01

The redislocation rate after arthroscopic stabilization for anterior glenohumeral instability is up to 30%. The Instability Severity Index Score (ISIS) was developed to preoperatively rationalize the risk of failure, but it has not yet been validated by an independent group. To assess the utility of the ISIS in predicting failure of arthroscopic anterior shoulder stabilization and to identify other preoperative factors for failure. Case-control study; Level of evidence, 3. A case-control study was performed on 141 consecutive patients, comparing those who suffered failure of arthroscopic stabilization with those who had successful arthroscopic stabilization. The mean follow-up time was 47 months (range, 24-132 months). The ISIS was applied retrospectively, and an analysis was performed to establish independent risk factors for failure. A receiver operator coefficient curve was constructed to set a threshold ISIS for considering alternative surgery. Of 141 patients, 19 (13.5%) suffered recurrent instability. The mean ISIS of the failed stabilization group was higher than that of the successful stabilization group (5.1 vs 1.7; P < .001). Independent risk factors for failure were Hill-Sachs lesion (P < .001), glenoid bone loss (P < .001), age <21 years at the time of surgery (P < .001), age at first dislocation (P = .01), competitive-level participation in sports (P < .001), and participation in contact or overhead sports (P = .03). The presence of glenoid bone loss carried the highest risk of failure (70%). There was a 70% risk of failure if the ISIS was ≥4, as opposed to a 4% risk of failure if the ISIS was <4. This is the first completely independent study to confirm that the ISIS is a useful preoperative tool. It is recommended that surgeons consider alternative forms of stabilization if the ISIS is ≥4. © 2015 The Author(s).

A methodology for estimating risks associated with landslides of contaminated soil into rivers.

PubMed

Göransson, Gunnel; Norrman, Jenny; Larson, Magnus; Alén, Claes; Rosén, Lars

2014-02-15

Urban areas adjacent to surface water are exposed to soil movements such as erosion and slope failures (landslides). A landslide is a potential mechanism for mobilisation and spreading of pollutants. This mechanism is in general not included in environmental risk assessments for contaminated sites, and the consequences associated with contamination in the soil are typically not considered in landslide risk assessments. This study suggests a methodology to estimate the environmental risks associated with landslides in contaminated sites adjacent to rivers. The methodology is probabilistic and allows for datasets with large uncertainties and the use of expert judgements, providing quantitative estimates of probabilities for defined failures. The approach is illustrated by a case study along the river Göta Älv, Sweden, where failures are defined and probabilities for those failures are estimated. Failures are defined from a pollution perspective and in terms of exceeding environmental quality standards (EQSs) and acceptable contaminant loads. Models are then suggested to estimate probabilities of these failures. A landslide analysis is carried out to assess landslide probabilities based on data from a recent landslide risk classification study along the river Göta Älv. The suggested methodology is meant to be a supplement to either landslide risk assessment (LRA) or environmental risk assessment (ERA), providing quantitative estimates of the risks associated with landslide in contaminated sites. The proposed methodology can also act as a basis for communication and discussion, thereby contributing to intersectoral management solutions. From the case study it was found that the defined failures are governed primarily by the probability of a landslide occurring. The overall probabilities for failure are low; however, if a landslide occurs the probabilities of exceeding EQS are high and the probability of having at least a 10% increase in the contamination load within one year is also high. Copyright © 2013 Elsevier B.V. All rights reserved.

Derivation of Failure Rates and Probability of Failures for the International Space Station Probabilistic Risk Assessment Study

NASA Technical Reports Server (NTRS)

Vitali, Roberto; Lutomski, Michael G.

2004-01-01

National Aeronautics and Space Administration s (NASA) International Space Station (ISS) Program uses Probabilistic Risk Assessment (PRA) as part of its Continuous Risk Management Process. It is used as a decision and management support tool to not only quantify risk for specific conditions, but more importantly comparing different operational and management options to determine the lowest risk option and provide rationale for management decisions. This paper presents the derivation of the probability distributions used to quantify the failure rates and the probability of failures of the basic events employed in the PRA model of the ISS. The paper will show how a Bayesian approach was used with different sources of data including the actual ISS on orbit failures to enhance the confidence in results of the PRA. As time progresses and more meaningful data is gathered from on orbit failures, an increasingly accurate failure rate probability distribution for the basic events of the ISS PRA model can be obtained. The ISS PRA has been developed by mapping the ISS critical systems such as propulsion, thermal control, or power generation into event sequences diagrams and fault trees. The lowest level of indenture of the fault trees was the orbital replacement units (ORU). The ORU level was chosen consistently with the level of statistically meaningful data that could be obtained from the aerospace industry and from the experts in the field. For example, data was gathered for the solenoid valves present in the propulsion system of the ISS. However valves themselves are composed of parts and the individual failure of these parts was not accounted for in the PRA model. In other words the failure of a spring within a valve was considered a failure of the valve itself.

Probabilistic evaluation of uncertainties and risks in aerospace components

NASA Technical Reports Server (NTRS)

Shah, A. R.; Shiao, M. C.; Nagpal, V. K.; Chamis, C. C.

1992-01-01

This paper summarizes a methodology developed at NASA Lewis Research Center which computationally simulates the structural, material, and load uncertainties associated with Space Shuttle Main Engine (SSME) components. The methodology was applied to evaluate the scatter in static, buckling, dynamic, fatigue, and damage behavior of the SSME turbo pump blade. Also calculated are the probability densities of typical critical blade responses, such as effective stress, natural frequency, damage initiation, most probable damage path, etc. Risk assessments were performed for different failure modes, and the effect of material degradation on the fatigue and damage behaviors of a blade were calculated using a multi-factor interaction equation. Failure probabilities for different fatigue cycles were computed and the uncertainties associated with damage initiation and damage propagation due to different load cycle were quantified. Evaluations on the effects of mistuned blades on a rotor were made; uncertainties in the excitation frequency were found to significantly amplify the blade responses of a mistuned rotor. The effects of the number of blades on a rotor were studied. The autocorrelation function of displacements and the probability density function of the first passage time for deterministic and random barriers for structures subjected to random processes also were computed. A brief discussion was included on the future direction of probabilistic structural analysis.

Peritonitis outcomes in patients with HIV and end-stage renal failure on peritoneal dialysis: a prospective cohort study.

PubMed

Ndlovu, Kwazi C Z; Sibanda, Wilbert; Assounga, Alain

2017-02-03

Few studies have investigated the management of human immunodeficiency virus (HIV)-associated end-stage renal failure particularly in low-resource settings with limited access to renal replacement therapy. We aimed to evaluate the effects of HIV infection on continuous ambulatory peritoneal dialysis (CAPD)-associated peritonitis outcomes and technique failure in highly active antiretroviral therapy (HAART)-treated HIV-positive CAPD populations. We conducted a single-center prospective cohort study of consecutive incident CAPD patients recruited from two hospitals in Durban, South Africa from September 2012-February 2015. Seventy HIV-negative and 70 HIV-positive end-stage renal failure patients were followed monthly for 18 months at a central renal clinic. Primary outcomes of peritonitis and catheter failure were assessed for the first 18 months of CAPD therapy. We assessed risk factors for peritonitis and catheter failure using Cox regression survival analysis. The HIV-positive cohort had a significantly increased rate of peritonitis compared to the HIV-negative cohort (1.86 vs. 0.76 episodes/person-years, respectively; hazard ratio [HR], 2.41; 95% confidence interval [CI], 1.69-3.45, P < 0.001). When the baseline CD4 count was below 200 cells/μL, the peritonitis rate rose to 3.69 episodes/person-years (HR 4.54, 95% CI 2.35-8.76, P < 0.001), while a baseline CD4 count above 350 cells/μL was associated with a peritonitis rate of 1.60 episodes/person-years (HR 2.10, CI 1.39-3.15, P = 0.001). HIV was associated with increased hazards of peritonitis relapse (HR, 3.88; CI, 1.37-10.94; P = 0.010). Independent predictors associated with increased peritonitis risk were HIV (HR, 1.84; CI, 1.07-3.16; P = 0.027), diabetes (HR, 2.09; CI, 1.09-4.03; P = 0.027) and a baseline CD4 count < 200 cells/μL (HR, 3.28; CI, 1.42-7.61; P = 0.006). Catheter failure rates were 0.34 (HIV-positive cohort) and 0.24 (HIV-negative cohort) episodes/person-years (HR, 1.42; 95% CI, 0.73-2.73; P = 0.299). Peritonitis (HR, 14.47; CI, 2.79-75.00; P = 0.001), average hemoglobin concentrations (HR, 0.75; CI, 0.59-0.95; P = 0.016), and average serum C-reactive protein levels were independent predictors of catheter failure. HIV infection in end-stage renal disease patients managed by CAPD was associated with increased peritonitis risk; however, HIV infection did not increase the risk for CAPD catheter failure rate at 18 months.

The role of exogenous risk factors of antituberculosis treatment failure.

PubMed

Lesnic, Evelina; Ustian, Aurelia; Pop, Carmen Monica

2016-01-01

The Republic of Moldova reports the highest incidence of tuberculosis and the lowest treatment success rate among European region countries. In most of the patients the antituberculosis treatment failure is correlated with social risk factors (low socio-economical state, epidemiological danger characteristics) and biological factors (young age, male sex, physiological conditions, associated diseases). Clinical factors (advanced forms of tuberculosis, chronic evolution, immune disturbances), therapeutic factors (treatment errors and interruptions, individualized regimens) and administrative factors (drug interruption in supply, suboptimal treatment quality) prevail in regions with defficient in health care delivery. The association of risk factors has a higher impact than the severity of one risk factor. The risk factor assessment is very important before initiation of the treatment, for establishing the plan of risk reduction measures for increasing the success rate. The aim of the study was to determine the impact of exogenous risk factors on antituberculosis treatment failure. The study was conducted on 201 patients with pulmonary tuberculosis and treatment failure and 105 patients with pulmonary tuberculosis who successfully finished the antituberculosis treatment. Selected cases were investigated according national standards. The treatment failure occurred in patients belonging to socially disadvantaged groups, patients with harmful habits (alcohol abuse, drug use, active smoking), patients from infectious clusters. Migration, homelessness and detention releasing imperil the quality of treatment, thus predisposing to the treatment failure. Social, educational support and the substitutive therapy and withdrawal techniques (tobacco, alcohol, psycho-active substances) must be implemented in the high risk groups in order to diminish the risk of treatment failure and to increase the treatment success rate. The study of exogenous risk factors in vulnerable groups will contribute to the precocious detection of patients predisposed to failing the tuberculosis treatment and will permit the initiation of measures centered on patient that will favor the increase of treatment quality and success rate.

The role of exogenous risk factors of antituberculosis treatment failure

PubMed Central

LESNIC, EVELINA; USTIAN, AURELIA; POP, CARMEN MONICA

2016-01-01

Background and aim The Republic of Moldova reports the highest incidence of tuberculosis and the lowest treatment success rate among European region countries. In most of the patients the antituberculosis treatment failure is correlated with social risk factors (low socio-economical state, epidemiological danger characteristics) and biological factors (young age, male sex, physiological conditions, associated diseases). Clinical factors (advanced forms of tuberculosis, chronic evolution, immune disturbances), therapeutic factors (treatment errors and interruptions, individualized regimens) and administrative factors (drug interruption in supply, suboptimal treatment quality) prevail in regions with defficient in health care delivery. The association of risk factors has a higher impact than the severity of one risk factor. The risk factor assessment is very important before initiation of the treatment, for establishing the plan of risk reduction measures for increasing the success rate. The aim of the study was to determine the impact of exogenous risk factors on antituberculosis treatment failure. Methods The study was conducted on 201 patients with pulmonary tuberculosis and treatment failure and 105 patients with pulmonary tuberculosis who successfully finished the antituberculosis treatment. Selected cases were investigated according national standards. Results The treatment failure occurred in patients belonging to socially disadvantaged groups, patients with harmful habits (alcohol abuse, drug use, active smoking), patients from infectious clusters. Migration, homelessness and detention releasing imperil the quality of treatment, thus predisposing to the treatment failure. Social, educational support and the substitutive therapy and withdrawal techniques (tobacco, alcohol, psycho-active substances) must be implemented in the high risk groups in order to diminish the risk of treatment failure and to increase the treatment success rate. Conclusions The study of exogenous risk factors in vulnerable groups will contribute to the precocious detection of patients predisposed to failing the tuberculosis treatment and will permit the initiation of measures centered on patient that will favor the increase of treatment quality and success rate. PMID:27547060

Effectiveness of Tutoring to Improve Academic Performance in Nursing Students at the University of Seville

ERIC Educational Resources Information Center

Guerra-Martín, María Dolores; Lima-Serrano, Marta; Lima-Rodríguez, Joaquín Salvador

2017-01-01

In response to the increase of Higher Education support provided to tutoring programs, this paper presents the design, implementation and evaluation of a tutoring program to improve the academic performance of at-risk students enrolled in the last year of a nursing degree characterized by academic failure (failed courses). A controlled…

Delivery and Evaluation of Synchronous Online Reading Tutoring to Students At-Risk of Reading Failure

ERIC Educational Resources Information Center

Vasquez, Eleazar, III; Forbush, David E.; Mason, Lee L.; Lockwood, April R.; Gleed, Linsey

2011-01-01

In a technological society, demands for higher literacy are ever increasing, creating grievous consequences for those who fail to meet these demands (National Research Council, 1998). Both legislative mandates, such as NCLB, and developments in the provision of reading instruction, such as RtI, have increased the demand for high quality tutoring…

Prevention of Problem Behavior by Teaching Functional Communication and Self-Control Skills to Preschoolers

ERIC Educational Resources Information Center

Luczynski, Kevin C.; Hanley, Gregory P.

2013-01-01

We evaluated the effects of the preschool life skills program (PLS; Hanley, Heal, Tiger, & Ingvarsson, 2007) on the acquisition and maintenance of functional communication and self-control skills, as well as its effect on problem behavior, of small groups of preschoolers at risk for school failure. Six children were taught to request teacher…

Pitfalls and Precautions When Using Predicted Failure Data for Quantitative Analysis of Safety Risk for Human Rated Launch Vehicles

NASA Technical Reports Server (NTRS)

Hatfield, Glen S.; Hark, Frank; Stott, James

2016-01-01

Launch vehicle reliability analysis is largely dependent upon using predicted failure rates from data sources such as MIL-HDBK-217F. Reliability prediction methodologies based on component data do not take into account system integration risks such as those attributable to manufacturing and assembly. These sources often dominate component level risk. While consequence of failure is often understood, using predicted values in a risk model to estimate the probability of occurrence may underestimate the actual risk. Managers and decision makers use the probability of occurrence to influence the determination whether to accept the risk or require a design modification. The actual risk threshold for acceptance may not be fully understood due to the absence of system level test data or operational data. This paper will establish a method and approach to identify the pitfalls and precautions of accepting risk based solely upon predicted failure data. This approach will provide a set of guidelines that may be useful to arrive at a more realistic quantification of risk prior to acceptance by a program.

Phrenic nerve stimulation for the treatment of central sleep apnea.

PubMed

Abraham, William T; Jagielski, Dariusz; Oldenburg, Olaf; Augostini, Ralph; Krueger, Steven; Kolodziej, Adam; Gutleben, Klaus-Jürgen; Khayat, Rami; Merliss, Andrew; Harsch, Manya R; Holcomb, Richard G; Javaheri, Shahrokh; Ponikowski, Piotr

2015-05-01

The aim of this study was to evaluate chronic, transvenous, unilateral phrenic nerve stimulation to treat central sleep apnea (CSA) in a prospective, multicenter, nonrandomized study. CSA occurs predominantly in patients with heart failure and increases the risk for morbidity and mortality. Established therapies for CSA are lacking, and those available are limited by poor patient adherence. Fifty-seven patients with CSA underwent baseline polysomnography followed by transvenous phrenic nerve stimulation system implantation and follow-up. Feasibility was assessed by implantation success rate and therapy delivery. Safety was evaluated by monitoring of device- and procedure-related adverse events. Efficacy was evaluated by changes in the apnea-hypopnea index at 3 months. Quality of life at 6 months was evaluated using a sleepiness questionnaire, patient global assessment, and, in patients with heart failure at baseline, the Minnesota Living With Heart Failure Questionnaire. The study met its primary end point, demonstrating a 55% reduction in apnea-hypopnea index from baseline to 3 months (49.5 ± 14.6 episodes/h vs. 22.4 ± 13.6 episodes/h of sleep; p < 0.0001; 95% confidence interval for change: -32.3 to -21.9). Central apnea index, oxygenation, and arousals significantly improved. Favorable effects on quality of life and sleepiness were noted. In patients with heart failure, the Minnesota Living With Heart Failure Questionnaire score significantly improved. Device- or procedure-related serious adverse events occurred in 26% of patients through 6 months post therapy initiation, predominantly due to lead repositioning early in the study. Therapy was well tolerated. Efficacy was maintained at 6 months. Transvenous, unilateral phrenic nerve stimulation appears safe and effective for treating CSA. These findings should be confirmed in a prospective, randomized, controlled trial. (Chronic Evaluation of Respicardia Therapy; NCT01124370). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Acute Respiratory Failure in Cardiac Transplant Recipients.

PubMed

Komurcu, Ozgur; Ozdemirkan, Aycan; Camkiran Firat, Aynur; Zeyneloglu, Pinar; Sezgin, Atilla; Pirat, Arash

2015-11-01

This study sought to evaluate the incidence, risk factors, and outcomes of acute respiratory failure in cardiac transplant recipients. Cardiac transplant recipients >15 years of age and readmitted to the intensive care unit after cardiac transplant between 2005 and 2015 were included. Thirty-nine patients were included in the final analyses. Patients with acute respiratory failure and without acute respiratory failure were compared. The most frequent causes of readmission were routine intensive care unit follow-up after endomyocardial biopsy, heart failure, sepsis, and pneumonia. Patients who were readmitted to the intensive care unit were further divided into 2 groups based on presence of acute respiratory failure. Patients' ages and body weights did not differ between groups. The groups were not different in terms of comorbidities. The admission sequential organ failure assessment scores were higher in patients with acute respiratory failure. Patients with acute respiratory failure were more likely to use bronchodilators and n-acetylcysteine before readmission. Mean peak inspiratory pressures were higher in patients in acute respiratory failure. Patients with acute respiratory failure developed sepsis more frequently and they were more likely to have hypotension. Patients with acute respiratory failure had higher values of serum creatinine before admission to intensive care unit and in the first day of intensive care unit. Patients with acute respiratory failure had more frequent bilateral opacities on chest radiographs and positive blood and urine cultures. Duration of intensive care unit and hospital stays were not statistically different between groups. Mortality in patients with acute respiratory failure was 76.5% compared with 0% in patients without acute respiratory failure. A significant number of cardiac transplant recipients were readmitted to the intensive care unit. Patients presenting with acute respiratory failure on readmission more frequently developed sepsis and hypotension, suggesting a poorer prognosis.

Prediction of new brain metastases after radiosurgery: validation and analysis of performance of a multi-institutional nomogram.

PubMed

Ayala-Peacock, Diandra N; Attia, Albert; Braunstein, Steve E; Ahluwalia, Manmeet S; Hepel, Jaroslaw; Chung, Caroline; Contessa, Joseph; McTyre, Emory; Peiffer, Ann M; Lucas, John T; Isom, Scott; Pajewski, Nicholas M; Kotecha, Rupesh; Stavas, Mark J; Page, Brandi R; Kleinberg, Lawrence; Shen, Colette; Taylor, Robert B; Onyeuku, Nasarachi E; Hyde, Andrew T; Gorovets, Daniel; Chao, Samuel T; Corso, Christopher; Ruiz, Jimmy; Watabe, Kounosuke; Tatter, Stephen B; Zadeh, Gelareh; Chiang, Veronica L S; Fiveash, John B; Chan, Michael D

2017-11-01

Stereotactic radiosurgery (SRS) without whole brain radiotherapy (WBRT) for brain metastases can avoid WBRT toxicities, but with risk of subsequent distant brain failure (DBF). Sole use of number of metastases to triage patients may be an unrefined method. Data on 1354 patients treated with SRS monotherapy from 2000 to 2013 for new brain metastases was collected across eight academic centers. The cohort was divided into training and validation datasets and a prognostic model was developed for time to DBF. We then evaluated the discrimination and calibration of the model within the validation dataset, and confirmed its performance with an independent contemporary cohort. Number of metastases (≥8, HR 3.53 p = 0.0001), minimum margin dose (HR 1.07 p = 0.0033), and melanoma histology (HR 1.45, p = 0.0187) were associated with DBF. A prognostic index derived from the training dataset exhibited ability to discriminate patients' DBF risk within the validation dataset (c-index = 0.631) and Heller's explained relative risk (HERR) = 0.173 (SE = 0.048). Absolute number of metastases was evaluated for its ability to predict DBF in the derivation and validation datasets, and was inferior to the nomogram. A nomogram high-risk threshold yielding a 2.1-fold increased need for early WBRT was identified. Nomogram values also correlated to number of brain metastases at time of failure (r = 0.38, p < 0.0001). We present a multi-institutionally validated prognostic model and nomogram to predict risk of DBF and guide risk-stratification of patients who are appropriate candidates for radiosurgery versus upfront WBRT.

A risk-based approach to sanitary sewer pipe asset management.

PubMed

Baah, Kelly; Dubey, Brajesh; Harvey, Richard; McBean, Edward

2015-02-01

Wastewater collection systems are an important component of proper management of wastewater to prevent environmental and human health implications from mismanagement of anthropogenic waste. Due to aging and inadequate asset management practices, the wastewater collection assets of many cities around the globe are in a state of rapid decline and in need of urgent attention. Risk management is a tool which can help prioritize resources to better manage and rehabilitate wastewater collection systems. In this study, a risk matrix and a weighted sum multi-criteria decision-matrix are used to assess the consequence and risk of sewer pipe failure for a mid-sized city, using ArcGIS. The methodology shows that six percent of the uninspected sewer pipe assets of the case study have a high consequence of failure while four percent of the assets have a high risk of failure and hence provide priorities for inspection. A map incorporating risk of sewer pipe failure and consequence is developed to facilitate future planning, rehabilitation and maintenance programs. The consequence of failure assessment also includes a novel failure impact factor which captures the effect of structurally defective stormwater pipes on the failure assessment. The methodology recommended in this study can serve as a basis for future planning and decision making and has the potential to be universally applied by municipal sewer pipe asset managers globally to effectively manage the sanitary sewer pipe infrastructure within their jurisdiction. Copyright © 2014 Elsevier B.V. All rights reserved.

Preoperative anemia versus blood transfusion: Which is the culprit for worse outcomes in cardiac surgery?

PubMed

LaPar, Damien J; Hawkins, Robert B; McMurry, Timothy L; Isbell, James M; Rich, Jeffrey B; Speir, Alan M; Quader, Mohammed A; Kron, Irving L; Kern, John A; Ailawadi, Gorav

2018-04-04

Reducing blood product utilization after cardiac surgery has become a focus of perioperative care as studies have suggested improved outcomes. The relative impact of preoperative anemia versus packed red blood cells (PRBC) transfusion on outcomes remains poorly understood, however. In this study, we investigated the relative association between preoperative hematocrit (Hct) level and PRBC transfusion on postoperative outcomes after coronary artery bypass grafting (CABG) surgery. Patient records for primary, isolated CABG operations performed between January 2007 and December 2017 at 19 cardiac surgery centers were evaluated. Hierarchical logistic regression modeling was used to estimate the relationship between baseline preoperative Hct level as well as PRBC transfusion and the likelihoods of postoperative mortality and morbidity, adjusted for baseline patient risk. Variable and model performance characteristics were compared to determine the relative strength of association between Hct level and PRBC transfusion and primary outcomes. A total of 33,411 patients (median patient age, 65 years; interquartile range [IQR], 57-72 years; 26% females) were evaluated. The median preoperative Hct value was 39% (IQR, 36%-42%), and the mean Society of Thoracic Surgeons (STS) predicted risk of mortality was 1.8 ± 3.1%. Complications included PRBC transfusion in 31% of patients, renal failure in 2.8%, stroke in 1.3%, and operative mortality in 2.0%. A strong association was observed between preoperative Hct value and the likelihood of PRBC transfusion (P < .001). After risk adjustment, PRBC transfusion, but not Hct value, demonstrated stronger associations with postoperative mortality (odds ratio [OR], 4.3; P < .0001), renal failure (OR 6.3; P < .0001), and stroke (OR, 2.4; P < .0001). A 1-point increase in preoperative Hct was associated with decreased probabilities of mortality (OR, 0.97; P = .0001) and renal failure (OR, 0.94; P < .0001). The models with PRBC had superior predictive power, with a larger area under the curve, compared with Hct for all outcomes (all P < .01). Preoperative anemia was associated with up to a 4-fold increase in the probability of PRBC transfusion, a 3-fold increase in renal failure, and almost double the mortality. PRBC transfusion appears to be more closely associated with risk-adjusted morbidity and mortality compared with preoperative Hct level alone, supporting efforts to reduce unnecessary PRBC transfusions. Preoperative anemia independently increases the risk of postoperative morbidity and mortality. These data suggest that preoperative Hct should be included in the STS risk calculators. Finally, efforts to optimize preoperative hematocrit should be investigated as a potentially modifiable risk factor for mortality and morbidity. Copyright © 2018 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Advanced heart failure due to cancer therapy.

PubMed

Shah, Sachin; Nohria, Anju

2015-01-01

Certain chemotherapeutic agents and mediastinal irradiation can be cardiotoxic and place cancer survivors at risk for developing advanced heart failure (HF). Anthracyclines are the prototypical agents associated with left ventricular (LV) dysfunction. Newer agents including trastuzumab and certain tyrosine kinase inhibitors such as sunitinib can also cause cardiomyopathy. Cancer survivors with advanced HF refractory to standard medical management should be considered for advanced therapies, including mechanical circulatory support (MCS) and transplantation. While overall outcomes after MCS and transplantation are similar in cancer survivors compared to other etiologies of HF, patients with radiation-induced restrictive cardiomyopathy have a significantly worse prognosis after transplantation. The increased need for right ventricular (RV) support after MCS in cancer survivors necessitates a careful evaluation for pre-operative RV dysfunction. Special consideration must also be given to the risk for recurrent malignancy, neurocognitive dysfunction, and increased psychological needs in this patient population.

Risk factors for revision surgery following isolated ulnar nerve release at the cubital tunnel: a study of 25,977 cases.

PubMed

Camp, Christopher L; Ryan, Claire B; Degen, Ryan M; Dines, Joshua S; Altchek, David W; Werner, Brian C

2017-04-01

The literature investigating risk factors for failure after decompression of the ulnar nerve at the elbow (cubital tunnel release [CuTR]) is limited. The purpose of this study was to identify risk factors for failure of isolated CuTR, defined as progression to subsequent ipsilateral revision surgery. The 100% Medicare Standard Analytic Files from 2005 to 2012 were queried for patients undergoing CuTR. Patients undergoing any concomitant procedures were excluded. A multivariate binomial logistic regression analysis was used to evaluate patient-related risk factors for ipsilateral revision surgery. Adjusted odds ratios (ORs) and 95% confidence intervals were calculated for each risk factor. A total of 25,977 patients underwent primary CuTR, and 304 (1.4%) of those with ≥2 years of follow-up required revision surgery. Although the rate of primary procedures is on the rise (P = .002), the revision rate remains steady (P = .148). Significant, independent risk factors for revision surgery included age <65 years (OR, 1.5; P < .001), obesity (OR, 1.3; P = .022), morbid obesity (OR, 1.3; P = .044), tobacco use (OR, 2.0; P < .001), diabetes (OR, 1.3; P = .011), hyperlipidemia (OR, 1.2; P = .015), chronic liver disease (OR, 1.6; P = .001), chronic anemia (OR, 1.6; P = .001), and hypercoagulable disorder (OR, 2.1; P = .001). The incidence of failure requiring ipsilateral revision surgery after CuTR remained steadily low (1.4%) during the study period. There are numerous patient-related risk factors that are independently associated with an increased risk for revision surgery, the most significant of which are tobacco use, younger age, hypercoagulable disorder, liver disease, and anemia. Copyright © 2017 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Cost-Effectiveness of Implantable Pulmonary Artery Pressure Monitoring in Chronic Heart Failure.

PubMed

Sandhu, Alexander T; Goldhaber-Fiebert, Jeremy D; Owens, Douglas K; Turakhia, Mintu P; Kaiser, Daniel W; Heidenreich, Paul A

2016-05-01

This study aimed to evaluate the cost-effectiveness of the CardioMEMS (CardioMEMS Heart Failure System, St Jude Medical Inc, Atlanta, Georgia) device in patients with chronic heart failure. The CardioMEMS device, an implantable pulmonary artery pressure monitor, was shown to reduce hospitalizations for heart failure and improve quality of life in the CHAMPION (CardioMEMS Heart Sensor Allows Monitoring of Pressure to Improve Outcomes in NYHA Class III Heart Failure Patients) trial. We developed a Markov model to determine the hospitalization, survival, quality of life, cost, and incremental cost-effectiveness ratio of CardioMEMS implantation compared with usual care among a CHAMPION trial cohort of patients with heart failure. We obtained event rates and utilities from published trial data; we used costs from literature estimates and Medicare reimbursement data. We performed subgroup analyses of preserved and reduced ejection fraction and an exploratory analysis in a lower-risk cohort on the basis of the CHARM (Candesartan in Heart failure: Reduction in Mortality and Morbidity) trials. CardioMEMS reduced lifetime hospitalizations (2.18 vs. 3.12), increased quality-adjusted life-years (QALYs) (2.74 vs. 2.46), and increased costs ($176,648 vs. $156,569), thus yielding a cost of $71,462 per QALY gained and $48,054 per life-year gained. The cost per QALY gained was $82,301 in patients with reduced ejection fraction and $47,768 in those with preserved ejection fraction. In the lower-risk CHARM cohort, the device would need to reduce hospitalizations for heart failure by 41% to cost <$100,000 per QALY gained. The cost-effectiveness was most sensitive to the device's durability. In populations similar to that of the CHAMPION trial, the CardioMEMS device is cost-effective if the trial effectiveness is sustained over long periods. Post-marketing surveillance data on durability will further clarify its value. Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Failure Rates and Patterns of Recurrence in Patients With Resected N1 Non-Small-Cell Lung Cancer

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

Varlotto, John M., E-mail: jvarlotto@hmc.psu.edu; Medford-Davis, Laura Nyshel; Recht, Abram

2011-10-01

Purpose: To examine the local and distant recurrence rates and patterns of failure in patients undergoing potentially curative resection of N1 non-small-cell lung cancer. Methods and Materials: The study included 60 consecutive unirradiated patients treated from 2000 to 2006. Median follow-up was 30 months. Failure rates were calculated by the Kaplan-Meier method. A univariate Cox proportional hazard model was used to assess factors associated with recurrence. Results: Local and distant failure rates (as the first site of failure) at 2, 3, and 5 years were 33%, 33%, and 46%; and 26%, 26%, and 32%, respectively. The most common site ofmore » local failure was in the mediastinum; 12 of 18 local recurrences would have been included within proposed postoperative radiotherapy fields. Patients who received chemotherapy were found to be at increased risk of local failure, whereas those who underwent pneumonectomy or who had more positive nodes had significantly increased risks of distant failure. Conclusions: Patients with resected non-small-cell lung cancer who have N1 disease are at substantial risk of local recurrence as the first site of relapse, which is greater than the risk of distant failure. The role of postoperative radiotherapy in such patients should be revisited in the era of adjuvant chemotherapy.« less

Ventilator Dependence Risk Score for the Prediction of Prolonged Mechanical Ventilation in Patients Who Survive Sepsis/Septic Shock with Respiratory Failure.

PubMed

Chang, Ya-Chun; Huang, Kuo-Tung; Chen, Yu-Mu; Wang, Chin-Chou; Wang, Yi-Hsi; Tseng, Chia-Cheng; Lin, Meng-Chih; Fang, Wen-Feng

2018-04-04

We intended to develop a scoring system to predict mechanical ventilator dependence in patients who survive sepsis/septic shock with respiratory failure. This study evaluated 251 adult patients in medical intensive care units (ICUs) between August 2013 to October 2015, who had survived for over 21 days and received aggressive treatment. The risk factors for ventilator dependence were determined. We then constructed a ventilator dependence (VD) risk score using the identified risk factors. The ventilator dependence risk score was calculated as the sum of the following four variables after being adjusted by proportion to the beta coefficient. We assigned a history of previous stroke, a score of one point, platelet count less than 150,000/μL a score of one point, pH value less than 7.35 a score of two points, and the fraction of inspired oxygen on admission day 7 over 39% as two points. The area under the curve in the derivation group was 0.725 (p < 0.001). We then applied the VD risk score for validation on 175 patients. The area under the curve in the validation group was 0.658 (p = 0.001). VD risk score could be applied to predict prolonged mechanical ventilation in patients who survive sepsis/septic shock.

The association of ghrelin polymorphisms with coronary artery disease and ischemic chronic heart failure in an elderly Chinese population.

PubMed

Zhang, Qin; Huang, Wei-Dong; Lv, Xue-Ying; Yang, Yun-Mei

2011-04-01

To investigate the association of coronary artery disease (CAD) and ischemic heart failure (IHF) with polymorphisms of the ghrelin gene in elderly Chinese patients. Fifty-six patients with ischemic heart failure, sixty patients with coronary artery disease without heart failure, and one hundred healthy control subjects participated in the study. The polymorphisms were evaluated by polymerase chain reaction, sequencing, and fragment length polymorphism analysis. Only one single nucleotide polymorphism (SNP), Leu72Met (408C/A), was observed across all samples. Gene frequencies of CC and allele frequencies of C were significantly greater in the CAD with IHF group than those in the CAD without IHF group (p=0.025, p=0.011). There was no significant association between the Leu72Met SNP with coronary artery disease risk factors. Our results suggest that a C allele at position 408 of the ghrelin gene is associated with genetic susceptibility to ischemic heart failure in Chinese elders. Copyright © 2010 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

WE-B-BRC-01: Current Methodologies in Risk Assessment

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

Rath, F.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-03: Risk in the Context of Medical Imaging

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

Samei, E.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-00: Concepts in Risk-Based Assessment

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

NONE

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less