964 resultados para Commission for Evaluation of Medical Events


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This study evaluated Multidimensional Geriatric Assessment (MGA) as predictor of mortality and major adverse cardiovascular and cerebral events (MACCE) after transcatheter aortic valve implantation (TAVI).

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The efficacy of postgraduate practical training courses is frequently evaluated by self-assessment instruments. The present study analyses the effect of a basic course in laparoscopic surgery on self-assessed medical competencies.

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BACKGROUND Mortality of patients with acute liver failure (ALF) is still unacceptably high. Available liver support systems are still of limited success at improving survival. A new type of albumin dialysis, the Hepa Wash® system, was newly introduced. We evaluated the new liver support system as well as the Molecular Adsorbent Recycling System (MARS) in an ischemic porcine model of ALF. METHODS In the first study animals were randomly allocated to control (n=5) and Hepa Wash (n=6) groups. In a further pilot study, two animals were treated with the MARS-system. All animals received the same medical and surgical procedures. An intraparenchymal intracranial pressure was inserted. Hemodynamic monitoring and goal-directed fluid therapy using the PiCCO system was done. Animals underwent functional end-to-side portacaval shunt and ligation of hepatic arteries. Treatment with albumin dialysis was started after fall of cerebral perfusion pressure to 45 mmHg and continued for 8 h. RESULTS All animals in the Hepa Wash group survived the 13-hour observation period, except for one that died after stopping treatment. Four of the control animals died within this period (p=0.03). Hepa Wash significantly reduced impairment of cerebral perfusion pressure (23±2 vs. 10±3 mmHg, p=0.006) and mean arterial pressure (37±1 vs. 24±2 mmHg, p=0.006) but had no effect on intracranial pressure (14±1 vs. 15±1 mmHg, p=0.72). Hepa Wash also enhanced cardiac index (4.94±0.32 vs. 3.36±0.25 l/min/m2, p=0.006) and renal function (urine production, 1850 ± 570 vs. 420 ± 180 ml, p=0.045) and eliminated water soluble (creatinine, 1.3±0.2 vs. 3.2±0.3 mg/dl, p=0.01; ammonia 562±124 vs. 1382±92 μg/dl, p=0.006) and protein-bound toxins (nitrate/nitrite 5.54±1.57 vs. 49.82±13.27 μmol/l, p=0.01). No adverse events that could be attributed to the Hepa Wash treatment were observed. CONCLUSIONS Hepa Wash was a safe procedure and improved multiorgan system failure in pigs with ALF. The survival benefit could be the result of ameliorating different organ functions in association with the detoxification capacity of water soluble and protein-bound toxins.

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The "EMR Tutorial" is designed to be a bilingual online physician education environment about electronic medical records. After iterative assessment and redesign, the tutorial was tested in two groups: U.S. physicians and Mexican medical students. Split-plot ANOVA revealed significantly different pre-test scores in the two groups, significant cognitive gains for the two groups overall, and no significant difference in the gains made by the two groups. Users rated the module positively on a satisfaction questionnaire.

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The Personal Response System Program at Huffington Center on Aging, Baylor College of Medicine, provides emergency call systems for elderly people living independently in Houston, Texas. The goal of the project was to complete a formative evaluation of the Personal Response System Program. The specific aims of the evaluation were three-fold. One aim was to evaluate participant health status and level of disability. The second aim was to develop a health care cost estimation strategy. Finally, a preliminary cost-effectiveness analysis was completed to evaluate the program's impact on health care costs and health status among the elderly target population. ^ The evaluation was a longitudinal, randomized experimental design. After the screening of 120 volunteers for eligibility, clients were asked to complete a written questionnaire and a monthly health service contact diary. Volunteers were contacted by telephone interviewers to collect health status information from 100 eligible clients (83%) on three occasions during the six months of follow-up. ^ Initially, volunteers were randomized to two experimental groups. The two groups were found to be comparable at the beginning of the study. No significant differences were detected related to health status, level of disability, or history of physician visits at baseline. However, the group with the Personal Response System (PRS) device had more adverse health events, higher IADL scores, more frequent use of walkers, lower average health status scores, and fewer community volunteers hours than the usual care comparison group. ^ The health care costs were estimated based on an algorithm adapted from the American Medical Association guidelines. Average total health care costs for the group with the PRS device ($912) were greater than the usual care group ($464). However, median health care values for the PRS group ($263) were similar to the usual care comparison group ($234). The preliminary findings indicated that the use of the PRS device was not associated with health care cost savings. ^ In the preliminary cost-effectiveness analysis, use of the personal response system was found to be associated with increased mental health status among elderly clients. The cost-effectiveness evaluation indicated that the associated cost for six months was $710 per unit increase in mental component score when the $150 PRS subscription was included. However, clients with the PRS device were found to have a greater decline in physical health status during the six-month follow-up. The beneficial effect on mental health status was found to be in contrast to negative findings associated with changes in physical health status. The implications for future research relate to the need to identify risk factors among geriatric populations to better target groups that would most likely benefit from PRS Program enrollment. ^

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PRINCIPLES Prediction of arrhythmic events (AEs) has gained importance with the availability of implantable cardioverter-defibrillators (ICDs), but is still imprecise. This study evaluated the innovative Wedensky modulation index (WMI) as predictor of AEs. METHODS In this prospective cohort, 179 patients with coronary artery disease (CAD) referred for AE risk assessment underwent baseline evaluation including measurement of R-/T-wave WMI (WMI(RT)) and left ventricular ejection fraction (LVEF). Two endpoints were assessed 3 years after the baseline evaluation: sudden cardiac death or appropriate ICD event (EP1) and any cardiac death or appropriate ICD event (EP2). Associations between baseline predictors (WMI(RT) and LVEF) and endpoints were evaluated in regression models. RESULTS Only three patients were lost to follow-up. EP1 and EP2 occurred in 24 and 27 patients, respectively. WMI(RT) (odds ratio [OR] per 1 point increase for EP1 20.1, 95% confidence interval [CI] 1.8-221.4, p = 0.014, and for EP2 73.3, 95% CI 6.6-817.7, p <0.001) and LVEF (OR per 1% increase for EP1 0.94, 95% CI 0.90-0.99, p = 0.013, and for EP2 0.93, 95% CI 0.89-0.97, p = 0.002) were significantly associated with both endpoints. In bivariable regression controlled for LVEF, WMI(RT) was independently associated with EP1 (p = 0.047) and EP2 (p = 0.007). The combination of WMI(RT) ≥0.60 and LVEF ≤30% resulted in a positive predictive value of 36% for EP1 and 50% for EP2. CONCLUSIONS WMI(RT) is a significant predictor of AEs independent of LVEF and has potential to improve AE risk prediction in CAD patients. However, WMI(RT) should be evaluated in larger and independent samples before recommendations for clinical routine can be made.

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The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.

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REASONS FOR PERFORMING THE STUDY: Racetrack injuries are of welfare concern and prevention of injuries is an important goal in many racing jurisdictions. Over the years this has led to more detailed recording of clinical events on racecourses. However, risk factor analyses of clinical events at race meetings have never been reported for Switzerland OBJECTIVE: To identify discipline-specific factors that influence the occurrence of clinical events during race meetings with the ultimate aim to improve the monitoring and safety on racetracks in Switzerland and optimise racehorse welfare. STUDY DESIGN: Retrospective study of horse race data collected by the Swiss horse racing association. METHODS: All race starts (n = 17,670, including 6,198 flat, 1,257 obstacle and 10,215 trot race starts) recorded over a period of four years (2009-2012) were analysed in multivariable mixed effect logistic regression models including horse and racecourse related data. The models were designed to identify discipline specific factors influencing the occurrence of clinical events on racecourses in Switzerland. RESULTS: Factors influencing the risk of clinical events during races were different for each discipline. The risk of a clinical event in trot racing was lower for racing on a Porphyre-sand track than on grass tracks. Horses whose driver was also their trainer had an approximately two times higher risk for clinical events. In obstacle races, longer distances (2401-3300 m and 3301-5400 m respectively) had a protective effect compared to racing over shorter distances. In flat racing, five racecourses reported significantly less clinical events. In all three disciplines, finishing 8th place or later was associated with clinical events. CONCLUSIONS: Changes in management that aim to improve the safety and welfare of racehorses, such as racetrack adaptations, need to be individualised for each discipline.

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OBJECTIVE To determine the success of medical management of presumptive cervical disk herniation in dogs and variables associated with treatment outcome. DESIGN Retrospective case series. ANIMALS Dogs (n=88) with presumptive cervical disk herniation. METHODS Dogs with presumptive cervical and thoracolumbar disk herniation were identified from medical records at 2 clinics and clients were mailed a questionnaire related to the success of therapy, clinical recurrence of signs, and quality of life (QOL) as interpreted by the owner. Signalment, duration and degree of neurologic dysfunction, and medication administration were determined from medical records. RESULTS Ninety-seven percent of dogs (84/87) with complete information were described as ambulatory at initial evaluation. Successful treatment was reported for 48.9% of dogs with 33% having recurrence of clinical signs and 18.1% having therapeutic failure. Bivariable logistic regression showed that non-steroidal anti-inflammatory drug (NSAID) administration was associated with success (P=.035; odds ratio [OR]=2.52). Duration of cage rest and glucocorticoid administration were not significantly associated with success or QOL. Dogs with less-severe neurologic dysfunction were more likely to have a successful outcome (OR=2.56), but this association was not significant (P=.051). CONCLUSIONS Medical management can lead to an acceptable outcome in many dogs with presumptive cervical disk herniation. Based on these data, NSAIDs should be considered as part of the therapeutic regimen. Cage rest duration and glucocorticoid administration do not appear to benefit these dogs, but this should be interpreted cautiously because of the retrospective data collection and use of client self-administered questionnaire follow-up. CLINICAL RELEVANCE These results provide insight into the success of medical management for presumptive cervical disk herniation in dogs and may allow for refinement of treatment protocols.

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OBJECTIVE To determine the success of medical management of presumptive thoracolumbar disk herniation in dogs and the variables associated with treatment outcome. STUDY DESIGN Retrospective case series. ANIMALS Dogs (n=223) with presumptive thoracolumbar disk herniation. METHODS Medical records from 2 clinics were used to identify affected dogs, and owners were mailed a questionnaire about success of therapy, recurrence of clinical signs, and quality of life (QOL) as interpreted by the owner. Signalment, duration and degree of neurologic dysfunction, and medication administration were determined from medical records. RESULTS Eighty-three percent of dogs (185/223) were ambulatory at initial evaluation. Successful treatment was reported for 54.7% of dogs, with 30.9% having recurrence of clinical signs and 14.4% classified as therapeutic failures. From bivariable logistic regression, glucocorticoid administration was negatively associated with success (P=.008; odds ratio [OR]=.48) and QOL scores (P=.004; OR=.48). The duration of cage rest was not significantly associated with success or QOL. Nonambulatory dogs were more likely to have lower QOL scores (P=.01; OR=2.34). CONCLUSIONS Medical management can lead to an acceptable outcome in many dogs with presumptive thoracolumbar disk herniation. Cage rest duration does not seem to affect outcome and glucocorticoids may negatively impact success and QOL. The conclusions in this report should be interpreted cautiously because of the retrospective data collection and the use of client self-administered questionnaire follow-up. CLINICAL RELEVANCE These results provide an insight into the success of medical management for presumptive thoracolumbar disk herniation in dogs and may allow for refinement of treatment protocols.

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Background. Cardiac risk assessment in cancer patients has not extensively been studied. We evaluated the role of stress myocardial perfusion imaging (MPI) in predicting cardiovascular outcomes in cancer patients undergoing non-cardiac surgery. ^ Methods. A retrospective chart review was performed on 507 patients who had a MPI from 01/2002 - 03/2003 and underwent non-cardiac surgery. Median follow-up duration was 1.5 years. Cox proportional hazard model was used to determine the time-to-first event. End points included total cardiac events (cardiac death, myocardial infarction (MI) and coronary revascularization), cardiac death, and all cause mortality. ^ Results. Of all 507 MPI studies 146 (29%) were abnormal. There were significant differences in risk factors between normal and abnormal MPI groups. Mean age was 66±11 years, with 60% males and a median follow-up duration of 1.8 years (25th quartile=0.8 years, 75th quartile=2.2 years). The majority of patients had an adenosine stress study (53%), with fewer exercise (28%) and dobutamine stress (16%) studies. In the total group there were 39 total cardiac events, 31 cardiac deaths, and 223 all cause mortality events during the study. Univariate predictors of total cardiac events included CAD (p=0.005), previous MI (p=0.005), use of beta blockers (p=0.002), and not receiving chemotherapy (p=0.012). Similarly, the univariate predictors of cardiac death included previous MI (p=0.019) and use of beta blockers (p=0.003). In the multivariate model for total cardiac events, age at surgery (HR 1.04, p=0.030), use of beta blockers (HR 2.46; p=0.011), dobutamine MPI (HR 3.08; p=0.018) and low EF (HR 0.97; p=0.02) were significant predictors of worse outcomes. In the multivariate model for predictors of cardiac death, beta blocker use (HR=2.74; p=0.017) and low EF (HR=0.95; p<0.003) were predictors of cardiac death. The only univariate MPI predictor of total cardiac events was scar severity (p=0.005). While MPI predictors of cardiac death were scar severity (p= 0.001) and ischemia severity (p=0.02). ^ Conclusions. Stress MPI is a useful tool in predicting long term outcomes in cancer patients undergoing surgery. Ejection fraction and severity of myocardial scar are important factors determining long term outcomes in this group.^

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Introduction. Lake Houston serves as a reservoir for both recreational and drinking water for residents of Houston, Texas, and the metropolitan area. The Texas Commission on Environmental Quality (TCEQ) expressed concerns about the water quality and increasing amounts of pathogenic bacteria in Lake Houston (3). The objective of this investigation is to evaluate water quality for the presence of bacteria, nitrates, nitrites, carbon, phosphorus, dissolved oxygen, pH, turbidity, suspended solids, dissolved solids, and chlorine in Cypress Creek. The aims of this project are to analyze samples of water from Cypress Creek and to render a quantitative and graphical representation of the results. The collected information will allow for a better understanding of the aqueous environment in Cypress Creek.^ Methods. Water samples were collected in August 2009 and analyzed in the field and at UTSPH laboratory by spectrophotometry and other methods. Mapping software was utilized to develop novel maps of the sample sites using coordinates attained with the Global Positioning System (GPS). Sample sites and concentrations were mapped using Geographic Information System (GIS) software and correlated with permitted outfalls and other land use characteristic.^ Results. All areas sampled were positive for the presence of total coliform and Escherichia coli (E. coli). The presences of other water contaminants varied at each location in Cypress Creek but were under the maximum allowable limits designated by the Texas Commission on Environmental Quality. However, dissolved oxygen concentrations were elevated above the TCEQ limit of 5.0 mg/L at majority of the sites. One site had near-limit concentration of nitrates at 9.8 mg/L. Land use above this site included farm land, agricultural land, golf course, parks, residential neighborhoods, and nine permitted TCEQ effluent discharge sites within 0.5 miles upstream.^ Significance. Lake Houston and its tributary, Cypress Creek, are used as recreational waters where individuals may become exposed to microbial contamination. Lake Houston also is the source of drinking water for much of Houston/Harris and Galveston Counties. This research identified the presence of microbial contaminates in Cypress Creek above TCEQ regulatory requirements. Other water quality variables measured were in line with TCEQ regulations except for near-limit for nitrate at sample site #10, at Jarvis and Timberlake in Cypress Texas.^

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This research was intended to evaluate an automated ambulatory medical record and chart review system. Chart review as conceptualized in this research is a series of statements that are made by the computer after reviewing the patients entire computer medical record. The actual chart review st