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Sample records for 30-day major adverse

  1. Advancing Age and 30-Day Adverse Outcomes Following Non-Emergent General Surgical Operations

    PubMed Central

    Gajdos, Csaba; Kile, Deidre; Hawn, Mary T.; Finlayson, Emily; Henderson, William G.; Robinson, Thomas N.

    2014-01-01

    Background While some single center studies have demonstrated that major surgical operations are safe to perform in older adults, most multicenter database studies find advancing age to independently predict adverse postoperative outcomes. We hypothesized that thirty-day postoperative mortality, complications, failure to rescue rates and postoperative length of stay will increase with advancing age. Design Retrospective cohort study. Setting Hospitals participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) Participants Patients undergoing non-emergent major general surgical operations between 2005 and 2008 were studied. Measures Postoperative outcomes of interest were complications occurring within 30 days of the index operation, return to OR within 30 days, failure to rescue after a postoperative complication, post-surgical length of stay and 30 day mortality. Results A total of 165,600 patients were studied. The rates of postoperative mortality, overall morbidity, and each type of postoperative complication increased as age increased. The rates of failure to rescue after each type of postoperative complication also increased with age. Mortality rates in patients ≥80 following renal insufficiency (43.3%), stroke (36.5%), myocardial infarction (35.6%), and pulmonary complications (25-39%) were particularly high. Median postoperative length of stay increased with age following surgical site infection, UTI, pneumonia, return to OR, and overall morbidity, but not after venous thromboembolism, stroke, myocardial infarction, renal insufficiency, failure to wean from the ventilator or reintubations. Conclusion Thirty-day mortality, complications and failure to rescue rates increase with advancing age following non-emergent general surgical operations. Patients over 80 years of age have especially high mortality following renal, cardiovascular, and pulmonary complications. As patient age advances, surgeons need to be

  2. The AFFORD Clinical Decision Aid To Identify Emergency Department Patients With Atrial Fibrillation At Low Risk For 30-Day Adverse Events

    PubMed Central

    Barrett, Tyler W.; Storrow, Alan B.; Jenkins, Cathy A.; Abraham, Robert L.; Liu, Dandan; Miller, Karen F.; Moser, Kelly M.; Russ, Stephan; Roden, Dan M.; Harrell, Frank E.; Darbar, Dawood

    2015-01-01

    There is wide variation in the management of emergency department (ED) patients with atrial fibrillation (AF). We aimed to derive and internally validate the first prospective, ED-based clinical decision aid to identify patients with AF at low risk for 30-day adverse events. We performed a prospective cohort study at a university-affiliated, tertiary-care, ED. Patients were enrolled from June 9, 2010 to February 28, 2013 and followed for 30 days. We enrolled a convenience sample of ED patients presenting with symptomatic AF. Candidate predictors were based on ED data available in the first two hours. The decision aid was derived using model approximation (preconditioning) followed by strong bootstrap internal validation. We utilized an ordinal outcome hierarchy defined as the incidence of the most severe adverse event within 30 days of the ED evaluation. Of 497 patients enrolled, stroke and AF-related death occurred in 13 (3%) and 4 (<1%) patients, respectively. The decision aid included the following: age, triage vitals (systolic blood pressure, temperature, respiratory rate, oxygen saturation, supplemental oxygen requirement); medical history (heart failure, home sotalol use, prior percutaneous coronary intervention, electrical cardioversion, cardiac ablation, frequency of AF symptoms); ED data (2 hour heart rate, chest radiograph results, hemoglobin, creatinine, and brain natriuretic peptide). The decision aid’s c-statistic in predicting any 30-day adverse event was 0.7 (95% CI, 0.65, 0.76). In conclusion, among ED patients with AF, AFFORD provides the first evidence based decision aid for identifying patients who are at low risk for 30-day adverse events and candidates for safe discharge. PMID:25633190

  3. 75 FR 27854 - 30-Day Notice of Proposed Information Collection: DS-4048, Projected Sales of Major Weapons in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-18

    ... Notice of Proposed Information Collection: DS-4048, Projected Sales of Major Weapons in Support of... Major Weapons in Support of Section 25(a)(1) of the Arms Export Control Act. OMB Control Number: 1405... annual report to Congress on projected sales of major weapons and weapons-related defense equipment...

  4. Ares I-X 30 Day Report

    NASA Technical Reports Server (NTRS)

    Ess, Bob; Smith, Marshall

    2009-01-01

    This slide presentation represents the 30 day report on the Ares I-X test flight. Included in the review is information on the following areas: (1) Ground Systems, (2) Guidance, Navigation and Control, (3) Roll Response, (4) Vehicle Response, (5) Control System Performance, (6) Structural Damping, (7) Thrust Oscillation, (8) Stage Separation, (9) Connector Assessment, (10) USS Splashdown, (11) Data Recorder and (12) FS Hardware Assessment.

  5. External validation of the Revised Cardiac Risk Index and update of its renal variable to predict 30-day risk of major cardiac complications after non-cardiac surgery: rationale and plan for analyses of the VISION study

    PubMed Central

    Walsh, Michael; Devereaux, P J; MacNeil, S Danielle; Lam, Ngan N; Hildebrand, Ainslie M; Acedillo, Rey R; Mrkobrada, Marko; Chow, Clara K; Lee, Vincent W; Thabane, Lehana; Garg, Amit X

    2017-01-01

    Introduction The Revised Cardiac Risk Index (RCRI) is a popular classification system to estimate patients' risk of postoperative cardiac complications based on preoperative risk factors. Renal impairment, defined as serum creatinine >2.0 mg/dL (177 µmol/L), is a component of the RCRI. The estimated glomerular filtration rate has become accepted as a more accurate indicator of renal function. We will externally validate the RCRI in a modern cohort of patients undergoing non-cardiac surgery and update its renal component. Methods and analysis The Vascular Events in Non-cardiac Surgery Patients Cohort Evaluation (VISION) study is an international prospective cohort study. In this prespecified secondary analysis of VISION, we will test the risk estimation performance of the RCRI in ∼34 000 participants who underwent elective non-cardiac surgery between 2007 and 2013 from 29 hospitals in 15 countries. Using data from the first 20 000 eligible participants (the derivation set), we will derive an optimal threshold for dichotomising preoperative renal function quantified using the Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) glomerular filtration rate estimating equation in a manner that preserves the original structure of the RCRI. We will also develop a continuous risk estimating equation integrating age and CKD-Epi with existing RCRI risk factors. In the remaining (approximately) 14 000 participants, we will compare the risk estimation for cardiac complications of the original RCRI to this modified version. Cardiac complications will include 30-day non-fatal myocardial infarction, non-fatal cardiac arrest and death due to cardiac causes. We have examined an early sample to estimate the number of events and the distribution of predictors and missing data, but have not seen the validation data at the time of writing. Ethics and dissemination The research ethics board at each site approved the VISION protocol prior to recruitment. We will

  6. Circulating Endothelial Cells and Endothelial Function predict Major Adverse Cardiac Events and Early Adverse Left Ventricular Remodeling in Patients with ST-Segment Elevation Myocardial Infarction

    PubMed Central

    Magdy, Abdel Hamid; Bakhoum, Sameh; Sharaf, Yasser; Sabry, Dina; El-Gengehe, Ahmed T; Abdel-Latif, Ahmed

    2016-01-01

    Endothelial progenitor cells (EPCs) and circulating endothelial cells (CECs) are mobilized from the bone marrow and increase in the early phase after ST-elevation myocardial infarction (STEMI). The aim of this study was to assess the prognostic significance of CECs and indices of endothelial dysfunction in patients with STEMI. In 78 patients with acute STEMI, characterization of CD34+/VEGFR2+ CECs, and indices of endothelial damage/dysfunction such as brachial artery flow mediated dilatation (FMD) were determined. Blood samples for CECs assessment and quantification were obtained within 24 hours of admission and FMD was assessed during the index hospitalization. At 30 days follow up, the primary composite end point of major cardiac adverse events (MACE) consisting of all-cause mortality, recurrent non-fatal MI, or heart failure and the secondary endpoint of early adverse left ventricular (LV) remodeling were analyzed. The 17 patients (22%) who developed MACE had significantly higher CEC level (P = 0.004), vWF level (P =0.028), and significantly lower FMD (P = 0.006) compared to the remaining patients. Logistic regression analysis showed that CECs level and LV ejection fraction were independent predictors of MACE. The areas under the receiver operating characteristic curves (ROC) for CEC level, FMD, and the logistic model with both markers were 0.73, 0.75, and 0.82 respectively for prediction of the MACE. The 16 patients who developed the secondary endpoint had significantly higher CEC level compared to remaining patients (p =0.038). In conclusion, increased circulating endothelial cells and endothelial dysfunction predicted the occurrence of major adverse cardiac events and adverse cardiac remodeling in patients with STEMI. PMID:26864952

  7. Vitamin D Status Predicts 30 Day Mortality in Hospitalised Cats

    PubMed Central

    Titmarsh, Helen; Kilpatrick, Scott; Sinclair, Jennifer; Boag, Alisdair; Bode, Elizabeth F.; Lalor, Stephanie M.; Gaylor, Donna; Berry, Jacqueline; Bommer, Nicholas X.; Gunn-Moore, Danielle; Reed, Nikki; Handel, Ian; Mellanby, Richard J.

    2015-01-01

    Vitamin D insufficiency, defined as low serum concentrations of the major circulating form of vitamin D, 25 hydroxyvitamin D (25(OH)D), has been associated with the development of numerous infectious, inflammatory, and neoplastic disorders in humans. In addition, vitamin D insufficiency has been found to be predictive of mortality for many disorders. However, interpretation of human studies is difficult since vitamin D status is influenced by many factors, including diet, season, latitude, and exposure to UV radiation. In contrast, domesticated cats do not produce vitamin D cutaneously, and most cats are fed a commercial diet containing a relatively standard amount of vitamin D. Consequently, domesticated cats are an attractive model system in which to examine the relationship between serum 25(OH)D and health outcomes. The hypothesis of this study was that vitamin D status would predict short term, all-cause mortality in domesticated cats. Serum concentrations of 25(OH)D, together with a wide range of other clinical, hematological, and biochemical parameters, were measured in 99 consecutively hospitalised cats. Cats which died within 30 days of initial assessment had significantly lower serum 25(OH)D concentrations than cats which survived. In a linear regression model including 12 clinical variables, serum 25(OH)D concentration in the lower tertile was significantly predictive of mortality. The odds ratio of mortality within 30 days was 8.27 (95% confidence interval 2.54-31.52) for cats with a serum 25(OH)D concentration in the lower tertile. In conclusion, this study demonstrates that low serum 25(OH)D concentration status is an independent predictor of short term mortality in cats. PMID:25970442

  8. Outpatient Follow-Up versus 30-day Readmission among General and Vascular Surgery Patients: A Case for Redesigning Transitional Care

    PubMed Central

    Saunders, Richard Scott; Fernandes-Taylor, Sara; Rathouz, Paul J.; Saha, Sandeep; Wiseman, Jason T.; Havlena, Jeffrey; Matsumura, Jon; Kent, K. Craig

    2014-01-01

    Background The association between early outpatient follow-up and 30-day readmission has not been evaluated in any surgical population. Our study characterizes the relationship between outpatient follow-up and early readmissions among surgical patients. Methods We queried the medical record at a large, tertiary care institution (July 2008-December 2012) to determine rates of 30-day outpatient follow-up and readmission for general or vascular surgical procedures. Results The majority of discharges for general (84% of 7552) and vascular (75% of 2362) surgery had a follow-up visit before readmission or within 30 days of discharge. General surgery patients who were not readmitted had high rates of follow-up (88%) and received follow-up at approximately 2-weeks post-discharge (median time 11 days after discharge). In contrast, readmitted general surgery patients received first follow-up at one week (a median time of 8 days); 49% had follow-up. Vascular surgery patients showed a similar trend. Over half of patients readmitted after follow-up were readmitted within 24 hours of their most recent outpatient visit. Conclusions Current routine follow-up does not occur early enough to detect adverse events and prevent readmission. Early outpatient care may prevent readmission in some patients, but often serves as a conduit for readmission among patients already experiencing complications. PMID:25239351

  9. Avoidable 30-Day Readmissions Among Patients With Stroke and Other Cerebrovascular Disease

    PubMed Central

    Nahab, Fadi; Takesaka, Jennifer; Mailyan, Eugene; Judd, Lilith; Culler, Steven; Webb, Adam; Frankel, Michael; Choi, Dennis; Helmers, Sandra

    2012-01-01

    Background: There are limited data on factors associated with 30-day readmissions and the frequency of avoidable readmissions among patients with stroke and other cerebrovascular disease. Methods: University HealthSystem Consortium (UHC) database records were used to identify patients discharged with a diagnosis of stroke or other cerebrovascular disease at a university hospital from January 1, 2007 to December 31, 2009 and readmitted within 30 days to the index hospital. Logistic regression models were used to identify patient and clinical characteristics associated with 30-day readmission. Two neurologists performed chart reviews on readmissions to identify avoidable cases. Results: Of 2706 patients discharged during the study period, 174 patients had 178 readmissions (6.4%) within 30 days. The only factor associated with 30-day readmission was the index length of stay >10 days (vs <5 days; odds ratio [OR] 2.3, 95% CI [1.4, 3.7]). Of 174 patients readmitted within 30 days (median time to readmission 10 days), 92 (53%) were considered avoidable readmissions including 38 (41%) readmitted for elective procedures within 30 days of discharge, 27 (29%) readmitted after inadequate outpatient care coordination, 15 (16%) readmitted after incomplete initial evaluations, 8 (9%) readmitted due to delayed palliative care consultation, and 4 (4%) readmitted after being discharged with inadequate discharge instructions. Only 5% of the readmitted patients had outpatient follow-up recommended within 1 week. Conclusions: More than half of the 30-day readmissions were considered avoidable. Coordinated timing of elective procedures and earlier outpatient follow-up may prevent the majority of avoidable readmissions among patients with stroke and other cerebrovascular disease. PMID:23983857

  10. Relationship between platelet count and 30-day clinical outcomes after percutaneous coronary interventions. Pooled analysis of four ISAR trials.

    PubMed

    Iijima, Raisuke; Ndrepepa, Gjin; Mehilli, Julinda; Bruskina, Olga; Schulz, Stefanie; Schömig, Albert; Kastrati, Adnan

    2007-10-01

    Platelets play an important role in the development of major adverse cardiac events (MACE) following percutaneous coronary intervention (PCI). The impact of platelet count on the outcome of patients undergoing PCI after pre-treatment with clopidogrel is unknown. The study included 5,256 patients enrolled in four randomized trials - ISAR-REACT, ISAR-SMART2, ISAR-SWEET, and ISAR-REACT2 - which assessed the value of abciximab in patients with coronary artery disease (CAD) undergoing PCI after pre-treatment with 600 mg of clopidogrel. Platelet count was measured at baseline before PCI. Primary endpoint was the 30-day incidence of MACE, secondary endpoint was mortality. The tertiles of platelet counts were: lower tertile (<198 x 10(9)/L; n = 1,726), middle tertile (198-244 x 10(9)/L; n = 1,750) and upper tertile (>244 x 10(9)/L; n = 1,780). The 30-day incidence of MACE was 6.7% (n = 116) among patients of the lower tertile, 6.3% (n = 111) among patients of the middle tertile, and 7.0% (n = 124) among patients of the upper tertile (P = 0.76). The 30-day mortality was 1.2% (n = 22) among patients of the upper tertile, 0.5% (n = 9) among patients of middle tertile and 0.6% (n = 11) among patients of the lower tertile (P = 0.04). Q-wave myocardial infarction occurred in 1.3% of patients (n = 23) in the upper tertile, 0.7% of patients (n = 13) in the middle tertile and 0.5% of patients (n = 8) in the lower tertile (P = 0.02). Platelet count was an independent correlate of 30-day mortality (hazard ratio 2.69, 95% confidence interval 1.08-6.67; P = 0.033 for the third vs. the first tertile). In conclusion, in patients with CAD undergoing PCI after pre-treatment with 600 mg clopidogrel, baseline platelet count predicts 30-day mortality.

  11. A Study of Adverse Occurrences and Major Functional Impairment Following Surgery

    DTIC Science & Technology

    2005-05-01

    275 A Study of Adverse Occurrences and Major Functional Impairment Following Surgery Mary Rojas, Alan Silver, Christine Llewellyn, Lenora Rances...database. Non- NYPORTS controls were matched for surgery type, hospital, and procedure date. Functional status was assessed before surgery and at...334 as having high functional impairment before surgery . After adjusting for presurgery functional status, age, gender, and perioperative risk, there

  12. 78 FR 29147 - 30-Day Notice and Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-17

    ... SECURITY United States Secret Service 30-Day Notice and Request for Comments SUMMARY: The Department of... United States Secret Service, Department of Homeland Security, and sent via electronic mail to oira... additional information or copies of the form(s) and instructions should be directed to: United States...

  13. 78 FR 18373 - Paperwork Reduction Act; 30-Day Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-26

    ... CONTROL POLICY Paperwork Reduction Act; 30-Day Notice AGENCY: Office of National Drug Control Policy. ] The Office of National Drug Control Policy (ONDCP) proposes the collection of information concerning... of the President, Office of National Drug Control Policy, Research & Data Analysis, Washington,...

  14. 75 FR 160 - Paperwork Reduction Act; 30-Day Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-04

    ... [Federal Register Volume 75, Number 1 (Monday, January 4, 2010)] [Notices] [Page 160] [FR Doc No: E9-31132] OFFICE OF NATIONAL DRUG CONTROL POLICY Paperwork Reduction Act; 30-Day Notice AGENCY: Office of National Drug Control Policy. The Office of National Drug Control Policy (ONDCP) proposes...

  15. Worse Prognosis in Heart Failure Patients with 30-Day Readmission

    PubMed Central

    Tung, Ying-Chang; Chou, Shing-Hsien; Liu, Kuan-Liang; Hsieh, I-Chang; Wu, Lung-Sheng; Lin, Chia-Pin; Wen, Ming-Shien; Chu, Pao-Hsien

    2016-01-01

    Background Heart failure (HF) readmission results in substantial expenditure on HF management. This study aimed to evaluate the readmission rate, outcome, and predictors of HF readmission. Methods Patients with reduced left ventricular ejection fraction (LVEF < 40%) who were admitted for acute decompensation of de novo HF were enrolled to analyze readmission rate, mortality and predictors of readmission. Results A total of 433 de novo HF patients with LVEF < 40% were enrolled during the period August 2013 to December 2014. The in-hospital and 6-month mortality rates were 3.9% and 15.2%, respectively. In those patients surviving the index HF hospitalization, the 30-day and 6-month readmission rates were 10.9% and 27%, respectively. At the end of the 6-month follow-up, the readmission group had higher mortality than the non-readmission group (27.66% vs. 10.36%; p = 0.001). The survivors of the 30-day readmission had similar mortality rates at 6 months, regardless of the cause of readmission (cardiovascular vs. non-cardiovascular: 25% vs. 30.43%, p = 0.677). Among all the parameters, prescription of beta blockers independently reduced the risk of 30-day readmission (odds ratio 0.15; 95% confidence interval 0.02-0.99; p = 0.049). Conclusions Those HF patients who suffered from 30-day readmission had worse prognosis at the 6-month follow-up. Regardless of the readmission causes, the patients surviving the 30-day readmission had similar mortality rates at 6-month follow-up. These results underscored the importance of reducing readmission as a means to improve HF outcome. PMID:27899857

  16. Relationship between obstructive sleep apnea and 30-day mortality among patients with pulmonary embolism

    PubMed Central

    Ghiasi, Farzin; Ahmadpoor, Amin; Amra, Babak

    2015-01-01

    Background: Pulmonary embolism (PE) is the most life-threatening form of venous thrombosis which causes the majority of mortalities in this category. Obstructive sleep apnea (OSA) has been indicated as one of the risk factors for thromboembolism because of hemostatic alterations. The present study was designed to seek for the relationship between OSA and 30-day mortality of patients with PE. Materials and Methods: This prospective cohort study was conducted among 137 consecutive patients referred to hospital with symptoms of PE and preliminary stable hemodynamic. Confirmation of PE was made by multislice computed tomography pulmonary angiography and in the case of contraindication; V/Q lung scan and Doppler sonography were done. A STOP-Bang Questionnaire was used to determine patients with high- and low-risk of OSA. Patients were followed up for 1-month, and their survivals were recorded. Results: This study showed that there was no relationship between OSA and 30-day mortality (P = 0.389). Chronic kidney disease (P = 0.004), hypertension (P = 0.003), main thrombus (P = 0.004), and segmental thrombus (P = 0.022) were associated with 30-day mortality. In the logistic regression analysis, history of chronic kidney disease was diagnosed as a risk factor for 30-day mortality among the PE patients (P = 0.029, odds ratio = 4.93). Conclusion: Results of this study showed 30-day mortality was not affected by OSA directly. In fact, it was affected by complications of OSA such as hypertension and thrombus. Also, positive history of chronic kidney disease increased the risk of 30-day mortality. PMID:26622255

  17. An update on predictive biomarkers for major adverse cardiovascular events in patients undergoing vascular surgery.

    PubMed

    Patelis, Nikolaos; Kouvelos, George N; Koutsoumpelis, Andreas; Moris, Demetrios; Matsagkas, Miltiadis I; Arnaoutoglou, Eleni

    2016-09-01

    Cardiovascular complications signify a major cause of morbidity and mortality in patients undergoing vascular surgery adversely affecting both short- and long-term prognosis. During the last decade, unmet needs for a distinct cardiovascular risk assessment have led to an intensive research for establishment of biomarkers with sufficient predictive value. This literature review aims in examining the value of several biomarkers in predicting the incidence of major adverse cardiac events in vascular surgery patients. We reviewed the English language literature and analyzed the biomarkers as independent predictors or in correlation with other factors. We found several biomarkers showing a significant predictive value for a major adverse cardiovascular event in patients undergoing vascular surgery. These biomarkers can be used in clinical practice as outcome predictors, although sensitivity and specificity varies. Detection of subclinical cardiovascular damage may improve total risk estimation and facilitate clinical assessment of patients at risk for future cardiovascular events. The wide variety of sensitivity and specificity in predicting a MACE of these biomarkers exert the need for future trials in which these markers will be tested as adjunctive tools of cardiovascular risk estimation scoring systems.

  18. Nursing Home Medical Staff Organization and 30-Day Rehospitalizations

    PubMed Central

    Lima, Julie C.; Intrator, Orna; Karuza, Jurgis; Wetle, Terrie; Mor, Vincent; Katz, Paul

    2013-01-01

    Objectives To examine the relationship between features of nursing home (NH) medical staff organization and residents’ 30-day rehospitalizations. Design Cross-sectional study combining primary data collected from a survey of medical directors, NH resident assessment data (minimum data set), Medicare claims, and the Online Survey Certification and Reporting (OSCAR) database. Setting A total of 202 freestanding US nursing homes. Participants Medicare fee-for-service beneficiaries who were hospitalized and subsequently admitted to a study nursing home. Measurements Medical staff organization dimensions derived from the survey, NH residents’ characteristics derived from minimum data set data, hospitalizations obtained from Part A Medicare claims, and NH characteristics from the OSCAR database and from www.ltcfocus.org. Study outcome defined within a 30-day window following an index hospitalization: rehospitalized, otherwise died, otherwise survived and not rehospitalized. Results Thirty-day rehospitalizations occurred for 3788 (20.3%) of the 18,680 initial hospitalizations. Death was observed for 884 (4.7%) of residents who were not rehospitalized. Adjusted by hospitalization, resident, and NH characteristics, nursing homes having a more formal appointment process for physicians were less likely to have 30-day rehospitalization (b = −0.43, SE = 0.17), whereas NHs in which a higher proportion of residents were cared for by a single physician were more likely to have rehospitalizations (b = 0.18, SE = 0.08). Conclusion This is the first study to show a direct relationship between features of NH medical staff organization and resident-level process of care. The relationship of a more strict appointment process and rehospitalizations might be a consequence of more formalized and dedicated medical practice with a sense of ownership and accountability. A higher volume of patients per physician does not appear to improve quality of care. PMID:22682694

  19. BDNF Met66 modulates the cumulative effect of psychosocial childhood adversities on major depression in adolescents

    PubMed Central

    Cruz-Fuentes, Carlos S; Benjet, Corina; Martínez-Levy, Gabriela A; Pérez-Molina, Amado; Briones-Velasco, Magdalena; Suárez-González, Jesús

    2014-01-01

    Background The interplay among lifetime adversities and the genetic background has been previously examined on a variety of measures of depression; however, only few studies have focused on major depression disorder (MDD) in adolescence. Methods Using clinical data and DNA samples from mouthwash gathered from an epidemiological study on the prevalence of mental disorders in youths between 12 and 17 years old, we tested the statistical interaction between a set of psychosocial adversities experienced during childhood (CAs) with two common polymorphisms in the brain-derived neurotrophic factor (BDNF) (Val66Met) and SLC6A4 (L/S) genes on the probability of suffering MDD in adolescence. Results Genotype or allele frequencies for both polymorphisms were similar between groups of comparison (MDD N = 246; controls N = 270). The CAs factors: Abuse, neglect, and family dysfunctions; parental maladjustment, parental death, and to have experienced a life-threatening physical illness were predictors of clinical depression in adolescents. Remarkably, the cumulative number of psychosocial adversities was distinctly associated with an increase in the prevalence of depression but only in those Val/Val BDNF individuals; while the possession of at least a copy of the BDNF Met allele (i.e., Met +) was statistically linked with a “refractory” or resilient phenotype to the noticeable influence of CAs. Conclusion Liability or resilience to develop MDD in adolescence is dependent of a complex interplay between particular environmental exposures and a set of plasticity genes including BDNF. A better understanding of these factors is important for developing better prevention and early intervention measures. PMID:24683520

  20. Influence of second- and third-degree heart block on 30-day outcome following acute myocardial infarction in the drug-eluting stent era.

    PubMed

    Kim, Hack-Lyoung; Kim, Sang-Hyun; Seo, Jae-Bin; Chung, Woo-Young; Zo, Joo-Hee; Kim, Myung-A; Park, Kyung-Woo; Koo, Bon-Kwon; Kim, Hyo-Soo; Chae, In-Ho; Choi, Dong-Ju; Cho, Myeong-Chan; Kim, Young-Jo; Kim, Ju Han; Ahn, Youngkeun; Jeong, Myung Ho

    2014-12-01

    This study was conducted to investigate the prognostic value of heart block among patients with acute myocardial infarction (AMI) treated with drug-eluting stents. A total of 13,862 patients with AMI, registered in the nation-wide AMI database from January 2005 to June 2013, were analyzed. Second- (Mobitz type I or II) and third-degree atrioventricular block were considered as heart block in this study. Thirty-day major adverse cardiac events (MACE) including all causes of death, recurrent myocardial infarction, and revascularization were evaluated. Percutaneous coronary intervention with implantation of drug-eluting stent was performed in 89.8% of the patients. Heart block occurred in 378 patients (2.7%). Thirty-day MACE occurred in 1,144 patients (8.2%). Patients with heart block showed worse clinical parameters at initial admission, and the presence of heart block was associated with 30-day MACE in univariate analyses. However, the prognostic impact of heart block was not significant after adjustment of potential confounders (p = 0.489). Among patients with heart block, patients with a culprit in the left anterior descending (LAD) coronary artery had worse clinical outcomes than those of patients with a culprit in the left circumflex or right coronary artery. LAD culprit was a significant risk factor for 30-day MACE even after controlling for confounders (odds ratio 5.28, 95% confidence interval 1.22 to 22.81, p = 0.026). In conclusion, despite differences in clinical parameters at the initial admission, heart block was not an independent risk factor for 30-day MACE in adjusted analyses. However, a LAD culprit was an independent risk factor for 30-day MACE among patients with heart block.

  1. Risk prediction models for major adverse cardiac event (MACE) following percutaneous coronary intervention (PCI): A review

    NASA Astrophysics Data System (ADS)

    Manan, Norhafizah A.; Abidin, Basir

    2015-02-01

    Five percent of patients who went through Percutaneous Coronary Intervention (PCI) experienced Major Adverse Cardiac Events (MACE) after PCI procedure. Risk prediction of MACE following a PCI procedure therefore is helpful. This work describes a review of such prediction models currently in use. Literature search was done on PubMed and SCOPUS database. Thirty literatures were found but only 4 studies were chosen based on the data used, design, and outcome of the study. Particular emphasis was given and commented on the study design, population, sample size, modeling method, predictors, outcomes, discrimination and calibration of the model. All the models had acceptable discrimination ability (C-statistics >0.7) and good calibration (Hosmer-Lameshow P-value >0.05). Most common model used was multivariate logistic regression and most popular predictor was age.

  2. Negative Emotionality and Disconstraint Influence PTSD Symptom Course via Exposure to New Major Adverse Life Events

    PubMed Central

    Sadeh, Naomi; Miller, Mark W.; Wolf, Erika J.; Harkness, Kate L.

    2015-01-01

    Identifying the factors that influence stability and change in chronic posttraumatic stress disorder (PTSD) is important for improving clinical outcomes. Using a cross-lagged design, we analyzed the reciprocal effects of personality and PTSD symptoms over time and their effects on stress exposure in a sample of 222 trauma-exposed veterans (ages 23 – 68; 90.5% male). Personality functioning and PTSD were measured approximately 4 years apart, and self-reported exposure to major adverse life events during the interim was also assessed. Negative emotionality positively predicted future PTSD symptoms, and this effect was partially mediated by exposure to new events. Constraint (negatively) indirectly affected PTSD via its association with exposure to new events. There were no significant effects of positive emotionality nor did PTSD symptom severity exert influences on personality over time. Results indicate that high negative affect and disconstraint influence the course of PTSD symptoms by increasing exposure to stressful life events. PMID:25659969

  3. Heart rate variables in the Vascular Quality Initiative are not reliable predictors of adverse cardiac outcomes or mortality after major elective vascular surgery

    PubMed Central

    Scali, Salvatore; Bertges, Daniel; Neal, Daniel; Patel, Virendra; Eldrup-Jorgensen, Jens; Cronenwett, Jack; Beck, Adam

    2015-01-01

    Objective Heart rate (HR) parameters are known indicators of cardiovascular complications after cardiac surgery, but there is little evidence of their role in predicting outcome after major vascular surgery. The purpose of this study was to determine whether arrival HR (AHR) and highest intraoperative HR are associated with mortality or major adverse cardiac events (MACEs) after elective vascular surgery in the Vascular Quality Initiative (VQI). Methods Patients undergoing elective lower extremity bypass (LEB), aortofemoral bypass (AFB), and open abdominal aortic aneurysm (AAA) repair in the VQI were analyzed. MACE was defined as any postoperative myocardial infarction, dysrhythmia, or congestive heart failure. Controlled HR was defined as AHR <75 beats/min on operating room arrival. Delta HR (DHR) was defined as highest intraoperative HR – AHR Procedure-specific MACE models were derived for risk stratification, and generalized estimating equations were used to account for clustering of center effects. HR, beta-blocker exposure, cardiac risk, and their interactions were explored to determine association with MACE or 30-day mortality. A Bonferroni correction with P < .004 was used to declare significance. Results There were 13,291 patients reviewed (LEB, n = 8155 [62%]; AFB, n = 2629 [18%]; open AAA, n = 2629 [20%]). Rates of any preoperative beta-blocker exposure were as follows: LEB, 66.5% (n = 5412); AFB, 57% (n = 1342); and open AAA, 74.2% (n = 1949). AHR and DHR outcome association was variable across patients and procedures. AHR <75 beats/min was associated with increased postoperative myocardial infarction risk for LEB patients across all risk strata (odds ratio [OR], 1.4; 95% confidence interval [CI], 1.03–1.9; P = .03), whereas AHR<75 beats/min was associated with decreased dysrhythmia risk (OR, 0.42; 95% CI, 0.28–0.63; P = .0001) and 30-day death (OR, 0.50; 95% CI, 0.33–0.77; P = .001) in patients at moderate and high cardiac risk. These HR

  4. The Knowledge-Integrated Network Biomarkers Discovery for Major Adverse Cardiac Events

    PubMed Central

    Jin, Guangxu; Zhou, Xiaobo; Wang, Honghui; Zhao, Hong; Cui, Kemi; Zhang, Xiang-Sun; Chen, Luonan; Hazen, Stanley L.; Li, King; Wong, Stephen T. C.

    2010-01-01

    The mass spectrometry (MS) technology in clinical proteomics is very promising for discovery of new biomarkers for diseases management. To overcome the obstacles of data noises in MS analysis, we proposed a new approach of knowledge-integrated biomarker discovery using data from Major Adverse Cardiac Events (MACE) patients. We first built up a cardiovascular-related network based on protein information coming from protein annotations in Uniprot, protein–protein interaction (PPI), and signal transduction database. Distinct from the previous machine learning methods in MS data processing, we then used statistical methods to discover biomarkers in cardiovascular-related network. Through the tradeoff between known protein information and data noises in mass spectrometry data, we finally could firmly identify those high-confident biomarkers. Most importantly, aided by protein–protein interaction network, that is, cardiovascular-related network, we proposed a new type of biomarkers, that is, network biomarkers, composed of a set of proteins and the interactions among them. The candidate network biomarkers can classify the two groups of patients more accurately than current single ones without consideration of biological molecular interaction. PMID:18665624

  5. Apollo 15 30-day failure and anomaly listing report

    NASA Technical Reports Server (NTRS)

    1971-01-01

    The significant anomalies that occurred during the Apollo 15 mission are discussed. The five major areas are command and service modules, lunar module, scientific instrument module experiments, Apollo lunar surface experiment package and associated equipment, and government furnished equipment.

  6. 9 CFR 96.12 - Uncertified casings not disinfected in 30 days; disposition.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 30 days; disposition. 96.12 Section 96.12 Animals and Animal Products ANIMAL AND PLANT HEALTH... STATES § 96.12 Uncertified casings not disinfected in 30 days; disposition. Foreign animal casings... period of 30 days after arrival in the United States, subject to the ability of Division inspectors...

  7. 17 CFR 41.12 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... contracts trading for fewer than 30 days. 41.12 Section 41.12 Commodity and Securities Exchanges COMMODITY... underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of sale for... U.S.C. 1a(25)) for the first 30 days of trading, if: (1) Such index would not have been a...

  8. 7 CFR 27.58 - Postponed classification; must be within 30 days.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 7 Agriculture 2 2014-01-01 2014-01-01 false Postponed classification; must be within 30 days. 27... Classification § 27.58 Postponed classification; must be within 30 days. If thereafter the classification of the cotton be desired, notice thereof shall be filed not later than the expiration of 30 days after the...

  9. 17 CFR 41.12 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... contracts trading for fewer than 30 days. 41.12 Section 41.12 Commodity and Securities Exchanges COMMODITY... Indexes underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of... narrow-based security index under section 1a(35) of the Act (7 U.S.C. 1a(35)) for the first 30 days...

  10. 43 CFR 4.1186 - Waiver of the 30-day decision requirement.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Waiver of the 30-day decision requirement... Expedited Review of Section 521(a)(2) Or 521(a)(3) Orders of Cessation § 4.1186 Waiver of the 30-day decision requirement. (a) Any person qualified to receive a 30-day decision may waive that right— (1)...

  11. 7 CFR 27.58 - Postponed classification; must be within 30 days.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 7 Agriculture 2 2011-01-01 2011-01-01 false Postponed classification; must be within 30 days. 27... Classification § 27.58 Postponed classification; must be within 30 days. If thereafter the classification of the cotton be desired, notice thereof shall be filed not later than the expiration of 30 days after the...

  12. 43 CFR 4.1186 - Waiver of the 30-day decision requirement.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ... 43 Public Lands: Interior 1 2013-10-01 2013-10-01 false Waiver of the 30-day decision requirement... Expedited Review of Section 521(a)(2) Or 521(a)(3) Orders of Cessation § 4.1186 Waiver of the 30-day decision requirement. (a) Any person qualified to receive a 30-day decision may waive that right— (1)...

  13. 26 CFR 31.3406(d)-3 - Special 30-day rules for certain reportable payments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 26 Internal Revenue 15 2012-04-01 2012-04-01 false Special 30-day rules for certain reportable... COLLECTION OF INCOME TAX AT SOURCE Collection of Income Tax at Source § 31.3406(d)-3 Special 30-day rules for... certification of notified payee underreporting) within 30 days after the establishment or acquisition...

  14. 43 CFR 4.1186 - Waiver of the 30-day decision requirement.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 43 Public Lands: Interior 1 2014-10-01 2014-10-01 false Waiver of the 30-day decision requirement... Expedited Review of Section 521(a)(2) Or 521(a)(3) Orders of Cessation § 4.1186 Waiver of the 30-day decision requirement. (a) Any person qualified to receive a 30-day decision may waive that right— (1)...

  15. 9 CFR 96.12 - Uncertified casings not disinfected in 30 days; disposition.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 30 days; disposition. 96.12 Section 96.12 Animals and Animal Products ANIMAL AND PLANT HEALTH... STATES § 96.12 Uncertified casings not disinfected in 30 days; disposition. Foreign animal casings... period of 30 days after arrival in the United States, subject to the ability of Division inspectors...

  16. 43 CFR 4.1186 - Waiver of the 30-day decision requirement.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Waiver of the 30-day decision requirement... Expedited Review of Section 521(a)(2) Or 521(a)(3) Orders of Cessation § 4.1186 Waiver of the 30-day decision requirement. (a) Any person qualified to receive a 30-day decision may waive that right— (1)...

  17. 7 CFR 27.58 - Postponed classification; must be within 30 days.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 7 Agriculture 2 2010-01-01 2010-01-01 false Postponed classification; must be within 30 days. 27... Classification § 27.58 Postponed classification; must be within 30 days. If thereafter the classification of the cotton be desired, notice thereof shall be filed not later than the expiration of 30 days after the...

  18. 9 CFR 96.12 - Uncertified casings not disinfected in 30 days; disposition.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 30 days; disposition. 96.12 Section 96.12 Animals and Animal Products ANIMAL AND PLANT HEALTH... STATES § 96.12 Uncertified casings not disinfected in 30 days; disposition. Foreign animal casings... period of 30 days after arrival in the United States, subject to the ability of Division inspectors...

  19. 7 CFR 27.58 - Postponed classification; must be within 30 days.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 7 Agriculture 2 2013-01-01 2013-01-01 false Postponed classification; must be within 30 days. 27... Classification § 27.58 Postponed classification; must be within 30 days. If thereafter the classification of the cotton be desired, notice thereof shall be filed not later than the expiration of 30 days after the...

  20. 43 CFR 4.1186 - Waiver of the 30-day decision requirement.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 1 2012-10-01 2011-10-01 true Waiver of the 30-day decision requirement... Expedited Review of Section 521(a)(2) Or 521(a)(3) Orders of Cessation § 4.1186 Waiver of the 30-day decision requirement. (a) Any person qualified to receive a 30-day decision may waive that right— (1)...

  1. 17 CFR 41.12 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... contracts trading for fewer than 30 days. 41.12 Section 41.12 Commodity and Securities Exchanges COMMODITY... underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of sale for... U.S.C. 1a(25)) for the first 30 days of trading, if: (1) Such index would not have been a...

  2. 7 CFR 27.58 - Postponed classification; must be within 30 days.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 7 Agriculture 2 2012-01-01 2012-01-01 false Postponed classification; must be within 30 days. 27... Classification § 27.58 Postponed classification; must be within 30 days. If thereafter the classification of the cotton be desired, notice thereof shall be filed not later than the expiration of 30 days after the...

  3. 26 CFR 31.3406(d)-3 - Special 30-day rules for certain reportable payments.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 26 Internal Revenue 15 2014-04-01 2014-04-01 false Special 30-day rules for certain reportable... COLLECTION OF INCOME TAX AT SOURCE Collection of Income Tax at Source § 31.3406(d)-3 Special 30-day rules for... certification of notified payee underreporting) within 30 days after the establishment or acquisition...

  4. 9 CFR 96.12 - Uncertified casings not disinfected in 30 days; disposition.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 30 days; disposition. 96.12 Section 96.12 Animals and Animal Products ANIMAL AND PLANT HEALTH... STATES § 96.12 Uncertified casings not disinfected in 30 days; disposition. Foreign animal casings... period of 30 days after arrival in the United States, subject to the ability of Division inspectors...

  5. Hypotension During Hospitalization for Acute Heart Failure Is Independently Associated With 30-Day Mortality: Findings from ASCEND-HF

    PubMed Central

    Patel, Priyesh A.; Heizer, Gretchen; O’Connor, Christopher M.; Schulte, Phillip J.; Dickstein, Kenneth; Ezekowitz, Justin A.; Armstrong, Paul W.; Hasselblad, Vic; Mills, Roger M.; McMurray, John J.; Starling, Randall C.; Wilson Tang, W. H.; Califf, Robert M.; Hernandez, Adrian F.

    2015-01-01

    Background Outcomes associated with episodes of hypotension while hospitalized are not well understood. Methods and Results Using data from ASCEND-HF, we assessed factors associated with inhospital hypotension and subsequent 30-day outcomes. Patients were classified as having symptomatic or asymptomatic hypotension. Multivariable logistic regression was used to determine factors associated with in-hospital hypotension, and Cox proportional hazards models were used to assess the association between hypotension and 30-day outcomes. We also tested for treatment interaction with nesiritide on 30-day outcomes and the association between inhospital hypotension and renal function at hospital discharge. Overall, 1555/7141 (21.8%) patients had an episode of hypotension, of which 73.1% were asymptomatic and 26.9% were symptomatic. Factors strongly associated with in-hospital hypotension included randomization to nesiritide (odds ratio [OR] 1.98, 95% confidence interval [CI] 1.76–2.23; p<0.001), chronic metolazone therapy (OR 1.74, 95% CI 1.17–2.60; p<0.001), and baseline orthopnea (OR 1.31, 95% CI 1.13–1.52; p=0.001) or S3 gallop (OR 1.21, 95% CI 1.06–1.40; p=0.006). In-hospital hypotension was associated with increased hazards of 30-day mortality (hazard ratio [HR] 2.03, 95% CI 1.57–2.61; p<0.001), 30-day heart failure (HF) hospitalization or mortality (HR 1.58, 95% CI 1.34–1.86; p<0.001), and 30-day all-cause hospitalization or mortality (HR 1.40, 95% CI 1.22–1.61; p<0.001). Nesiritide had no interaction on the relationship between hypotension and 30-day outcomes (interaction p=0.874 for death, p=0.908 for death/HF hospitalization, p=0.238 death/all-cause hospitalization). Conclusions Hypotension while hospitalized for acute decompensated HF is an independent risk factor for adverse 30-day outcomes, and its occurrence highlights the need for modified treatment strategies. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT

  6. Etiologies, Trends, and Predictors of 30-Day Readmission in Patients With Heart Failure.

    PubMed

    Arora, Shilpkumar; Patel, Prashant; Lahewala, Sopan; Patel, Nilay; Patel, Nileshkumar J; Thakore, Kosha; Amin, Aditi; Tripathi, Byomesh; Kumar, Varun; Shah, Harshil; Shah, Mahek; Panaich, Sidakpal; Deshmukh, Abhishek; Badheka, Apurva; Gidwani, Umesh; Gopalan, Radha

    2017-03-01

    Heart failure (HF) is the most common discharge diagnosis across the United States, and these patients are particularly vulnerable to readmissions, increasing attention to potential ways to address the problem. The study cohort was derived from the Healthcare Cost and Utilization Project's National Readmission Data 2013, sponsored by the Agency for Healthcare Research and Quality. HF was identified using appropriate International Classification of Diseases, Ninth Revision, Clinical Modification codes. Readmission was defined as a subsequent hospital admission within 30 days after discharge day of index admission. Readmission causes were identified using International Classification of Diseases, Ninth Revision, codes in primary diagnosis filed. The primary outcome was 30-day readmission. Hierarchical 2-level logistic models were used to evaluate study outcomes. From a total 301,892 principal admissions (73.4% age ≥65 years and 50.6% men), 55,857 (18.5%) patients were readmitted with a total of 64,264 readmissions during the study year. Among the etiologies of readmission, cardiac causes (49.8%) were most common (HF being most common followed by coronary artery disease and arrhythmias), whereas pulmonary causes were responsible for 13.1% and renal causes for 8.9% of the readmissions. Significant predictors of increased 30-day readmission included diabetes (odds ratio, 95% confidence interval, p value: 1.06, 1.03 to 1.08, p <0.001), chronic lung disease (1.13, 1.11 to 1.16, p <0.001), renal failure/electrolyte imbalance (1.12, 1.10 to 1.15, p <0.001), discharge to facilities (1.07, 1.04 to 1.09, p <0.001), lengthier hospital stay, and transfusion during index admission. In conclusion, readmission after a hospitalization for HF is common. Although it may be necessary to readmit some patients, the striking rate of readmission demands efforts to further clarify the determinants of readmission and develop strategies in terms of quality of care and care transitions to

  7. 78 FR 52005 - 30-Day Notice of Proposed Information Collection: Multifamily Project Construction Contract...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... August 21, 2013 Part IV Department of Housing and Urban Development 30-Day Notice of Proposed Information...; ] DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Multifamily... Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at...

  8. 77 FR 48160 - Division of Cardiovascular Devices 30-Day Notices and Annual Reports; Public Workshop; Request...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-13

    ... following public workshop entitled ``Division of Cardiovascular Devices 30-Day Notices and Annual Reports... requirements applicable to premarket approval applications (PMAs), 30-day notices and annual reports... periodic (annual) report. This workshop is intended to focus on manufacturing method and procedure...

  9. 43 CFR 4.1187 - Procedure if 30-day decision requirement is not waived.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ... 43 Public Lands: Interior 1 2012-10-01 2011-10-01 true Procedure if 30-day decision requirement is...-day decision requirement is not waived. If the applicant does not waive the 30-day decision... a response to the application for review shall file a written response within 5 working days...

  10. 78 FR 64141 - 30-Day Notice of Proposed Information Collection: Certificate of Housing Counseling...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... October 25, 2013 Part III Department of Housing and Urban Development 30-Day Notice of Proposed... / Notices#0;#0; ] DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Certificate of Housing Counseling: Homeownership and Certificate of Housing Counseling:...

  11. 43 CFR 4.1187 - Procedure if 30-day decision requirement is not waived.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 43 Public Lands: Interior 1 2011-10-01 2011-10-01 false Procedure if 30-day decision requirement...-day decision requirement is not waived. If the applicant does not waive the 30-day decision... a response to the application for review shall file a written response within 5 working days...

  12. 19 CFR 158.42 - Abandonment by importer within 30 days after entry.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 19 Customs Duties 2 2012-04-01 2012-04-01 false Abandonment by importer within 30 days after entry... days after entry. Allowance in duties for merchandise abandoned to the Government in accordance with... which the merchandise being abandoned appears. (b) Application within 30 days. The importer shall...

  13. 43 CFR 4.1187 - Procedure if 30-day decision requirement is not waived.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 43 Public Lands: Interior 1 2010-10-01 2010-10-01 false Procedure if 30-day decision requirement...-day decision requirement is not waived. If the applicant does not waive the 30-day decision... a response to the application for review shall file a written response within 5 working days...

  14. 19 CFR 158.42 - Abandonment by importer within 30 days after entry.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 19 Customs Duties 2 2010-04-01 2010-04-01 false Abandonment by importer within 30 days after entry... days after entry. Allowance in duties for merchandise abandoned to the Government in accordance with... which the merchandise being abandoned appears. (b) Application within 30 days. The importer shall...

  15. 19 CFR 158.42 - Abandonment by importer within 30 days after entry.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 19 Customs Duties 2 2014-04-01 2014-04-01 false Abandonment by importer within 30 days after entry... days after entry. Allowance in duties for merchandise abandoned to the Government in accordance with... which the merchandise being abandoned appears. (b) Application within 30 days. The importer shall...

  16. Adverse Effects of Hydroalcoholic Extracts and the Major Components in the Stems of Impatiens balsamina L. on Caenorhabditis elegans

    PubMed Central

    Zhuang, Zi-Heng; Hou, Bei-Wei; Shi, Bao-Jun; Shu, Cheng-Jie; Chen, Lei

    2017-01-01

    Impatiens balsamina L. (Balsaminaceae), an annual herb found throughout China, has been extensively used in traditional Chinese medicine (TCM). However, our knowledge regarding the adverse effects of I. balsamina in vivo is very limited. In this present study, the nematode Caenorhabditis elegans model was employed to fully assess the adverse effects of hydroalcoholic (EtOH 55%) extracts of I. balsamina stems (HAEIBS) in vivo. After exposure to 10 mg/mL HAEIBS, the major organism-level endpoints of C. elegans of percent survival, frequency of head thrash and body bends, and reproduction had decreased by 24%, 30%, and 25%, respectively. The lifespan of C. elegans was also greatly reduced after HAEIBS exposure compared to the controls. The active compounds in HAEIBS were separated using high speed countercurrent chromatograph (HSCCC) and characterized by high performance liquid chromatography (HPLC) and nuclear magnetic resonance (NMR). Two compounds, lawsone and 2-methoxy-1,4-naphthoquinone (MNQ), and their adverse effects were then more thoroughly detailed in this study. It was found that lawsone is the major toxin in HAEIBS with a higher toxicity than MNQ in terms of negative impact on C. elegans mortality, locomotion, reproduction, and lifespan. Our data also suggests that the C. elegans model may be useful for assessing the possible toxicity of other Chinese medicines, plant extracts, and/or compounds. PMID:28326124

  17. A Protocolised Once a Day Modified Early Warning Score (MEWS) Measurement Is an Appropriate Screening Tool for Major Adverse Events in a General Hospital Population

    PubMed Central

    Ludikhuize, Jeroen; Kramer, Mark H. H.

    2016-01-01

    Background The Modified Early Warning Score (MEWS) was developed to timely recognise clinically deteriorating hospitalised patients. However, the ability of the MEWS in predicting serious adverse events (SAEs) in a general hospital population has not been examined prospectively. The aims were to (1) analyse protocol adherence to a MEWS protocol in a real-life setting and (2) to determine the predictive value of protocolised daily MEWS measurement on SAEs: death, cardiac arrests, ICU-admissions and readmissions. Methods All adult patients admitted to 6 hospital wards in October and November 2015 were included. MEWS were checked each morning by the research team. For each critical score (MEWS ≥ 3), the clinical staff was inquired about the actions performed. 30-day follow-up for SAEs was performed to compare between patients with and without a critical score. Results 1053 patients with 3673 vital parameter measurements were included, 200 (19.0%) had a critical score. The protocol adherence was 89.0%. 18.2% of MEWS were calculated wrongly. Patients with critical scores had significant higher rates of unplanned ICU admissions [7.0% vs 1.3%, p < 0.001], in-hospital mortality [6.0% vs 0.8%, p < 0.001], 30-day readmission rates [18.6% vs 10.8%, p < 0.05], and a longer length of stay [15.65 (SD: 15.7 days) vs 6.09 (SD: 6.9), p < 0.001]. Specificity of MEWS related to composite adverse events was 83% with a negative predicting value of 98.1%. Conclusions Protocol adherence was high, even though one-third of the critical scores were calculated wrongly. Patients with a MEWS ≥ 3 experienced significantly more adverse events. The negative predictive value of early morning MEWS < 3 was 98.1%, indicating the reliability of this score as a screening tool. PMID:27494719

  18. 78 FR 64143 - 30-Day Notice of Proposed Information Collection: Contractor's Requisition-Project Mortgages

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Contractor's Requisition--Project..., 2013. A. Overview of Information Collection Title of Information Collection: Contractor's...

  19. 78 FR 44579 - 30-Day Notice of Proposed Information Collection: Fellowship Placement Pilot Program Evaluation

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-24

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Fellowship Placement Pilot Program.... A. Overview of Information Collection Title of Information Collection: Fellowship Placement Pilot.... Description of the need for the information and proposed use: The Fellowship Placement Program places...

  20. 78 FR 64234 - 30-Day Notice of Proposed Information Collection: Environmental Review Procedures for Entities...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-28

    ... (NEPA), the regulations of the Council on Environmental Quality, related federal environmental laws... compliance with all applicable environmental laws and authorities. HUD (or the State for certain State... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Environmental Review Procedures...

  1. 78 FR 59046 - 30-Day Notice of Proposed Information Collection: Federal Labor Standards Questionnaire(s...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Federal Labor Standards..., Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street...

  2. 78 FR 69103 - 30-Day Notice of Proposed Information Collection: Quality Control for Rental Assistance Subsidy...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Quality Control for Rental... Information Collection: Quality Control for Rental Assistance Subsidy Determinations. OMB Approval Number... Quality Control process involves selecting a nationally representative sample of assisted households...

  3. 78 FR 36561 - 30-Day Notice of Proposed Information Collection: The Housing Counseling Federal Advisory...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: The Housing Counseling Federal... Information Collection: The Housing Counseling Federal Advisory Committee Membership Application. OMB Approval... for the information and proposed use: The Housing Counseling Federal Advisory Committee (HCFAC)...

  4. Effect of feeding in 30-day bioaccumulation assays using Hyalella azteca in fluoranthene-dosed sediment

    SciTech Connect

    Harkey, G.A.; Landrum, P.F.

    1995-12-31

    Current protocols for conducting freshwater sediment bioaccumulation tests require that food be added to exposures. To determine effects of adding food, 30-day bioaccumulation assays were conducted with H. azteca exposed to sediment dosed with four concentrations (0.05 to 1,267 nmol/g dry weight) of fluoranthene. Accumulation was significantly greater in fed versus non-fed animals at all dose levels after 96 and 240 hours of exposure and continued to be greater after 30 days in the low dose levels. At sediment concentrations above 634 nmol/g dw, survival of unfed animals dropped to 34% after 30 days, However, after 30 days, reproduction was observed in fed animals exposed to sediment concentrations > 16 times the expected LC50 calculated for fluoranthene in sediment. These data raise questions concerning the interpretation of standard toxicity and bioaccumulation tests when food is routinely added.

  5. Predictors of 30-day mortality in patients with spontaneous primary intracerebral hemorrhage

    PubMed Central

    Safatli, Diaa A.; Günther, Albrecht; Schlattmann, Peter; Schwarz, Falko; Kalff, Rolf; Ewald, Christian

    2016-01-01

    Background: Intracerebral hemorrhage (ICH) is a life threatening entity, and an early outcome assessment is mandatory for optimizing therapeutic efforts. Methods: We retrospectively analyzed data from 342 patients with spontaneous primary ICH to evaluate possible predictors of 30-day mortality considering clinical, radiological, and therapeutical parameters. We also applied three widely accepted outcome grading scoring systems [(ICH score, FUNC score and intracerebral hemorrhage grading scale (ICH-GS)] on our population to evaluate the correlation of these scores with the 30-day mortality in our study. We also applied three widely accepted outcome grading scoring systems [(ICH score, FUNC score and intracerebral hemorrhage grading scale (ICH-GS)] on our population to evaluate the correlation of these scores with the 30-day mortality in our study. Results: From 342 patients (mean age: 67 years, mean Glasgow Coma Scale [GCS] on admission: 9, mean ICH volume: 62.19 ml, most common hematoma location: basal ganglia [43.9%]), 102 received surgical and 240 conservative treatment. The 30-day mortality was 25.15%. In a multivariate analysis, GCS (Odds ratio [OR] =0.726, 95% confidence interval [CI] =0.661–0.796, P < 0.001), bleeding volume (OR = 1.012 per ml, 95% CI = 1.007 – 1.017, P < 0.001), and infratentorial hematoma location (OR = 5.381, 95% CI = 2.166-13.356, P = 0.009) were significant predictors for the 30-day mortality. After receiver operating characteristics analysis, we defined a “high-risk group” for an unfavorable short-term outcome with GCS <11 and ICH volume >32 ml supratentorially or 21 ml infratentorially. Using Pearson correlation, we found a correlation of 0.986 between ICH score and 30-day mortality (P < 0.001), 0.853 between FUNC score and 30-day mortality (P = 0.001), and 0.924 between ICH-GS and 30-day mortality (P = 0.001). Conclusions: GCS score on admission together with the baseline volume and localization of the hemorrhage are strong

  6. Relationships between in-hospital and 30-day standardized hospital mortality: implications for profiling hospitals.

    PubMed Central

    Rosenthal, G. E.; Baker, D. W.; Norris, D. G.; Way, L. E.; Harper, D. L.; Snow, R. J.

    2000-01-01

    OBJECTIVE: To examine the relationship of in-hospital and 30-day mortality rates and the association between in-hospital mortality and hospital discharge practices. DATA SOURCES/STUDY SETTING: A secondary analysis of data for 13,834 patients with congestive heart failure who were admitted to 30 hospitals in northeast Ohio in 1992-1994. DESIGN: A retrospective cohort study was conducted. DATA COLLECTION: Demographic and clinical data were collected from patients' medical records and were used to develop multivariable models that estimated the risk of in-hospital and 30-day (post-admission) mortality. Standardized mortality ratios (SMRs) for in-hospital and 30-day mortality were determined by dividing observed death rates by predicted death rates. PRINCIPAL FINDINGS: In-hospital SMRs ranged from 0.54 to 1.42, and six hospitals were classified as statistical outliers (p <.05); 30-day SMRs ranged from 0.63 to 1.73, and seven hospitals were outliers. Although the correlation between in-hospital SMRs and 30-day SMRs was substantial (R = 0.78, p < .001), outlier status changed for seven of the 30 hospitals. Nonetheless, changes in outlier status reflected relatively small differences between in-hospital and 30-day SMRs. Rates of discharge to nursing homes or other inpatient facilities varied from 5.4 percent to 34.2 percent across hospitals. However, relationships between discharge rates to such facilities and in-hospital SMRs (R = 0.08; p = .65) and early post-discharge mortality rates (R = 0.23; p = .21) were not significant. CONCLUSIONS: SMRs based on in-hospital and 30-day mortality were relatively similar, although classification of hospitals as statistical outliers often differed. However, there was no evidence that in-hospital SMRs were biased by differences in post-discharge mortality or discharge practices. PMID:10737447

  7. Measuring hospital mortality rates: are 30-day data enough? Ischemic Heart Disease Patient Outcomes Research Team.

    PubMed Central

    Garnick, D W; DeLong, E R; Luft, H S

    1995-01-01

    OBJECTIVE. We compare 30-day and 180-day postadmission hospital mortality rates for all Medicare patients and those in three categories of cardiac care: coronary artery bypass graft surgery, acute myocardial infarction, and congestive heart failure. DATA SOURCES/COLLECTION. Health Care Financing Administration (HCFA) hospital mortality data for FY 1989. STUDY DESIGN. Using hospital level public use files of actual and predicted mortality at 30 and 180 days, we constructed residual mortality measures for each hospital. We ranked hospitals and used receiver operating characteristic (ROC) curves to compare 0-30, 31-180, and 0-180-day postadmission mortality. PRINCIPAL FINDINGS. For the admissions we studied, we found a broad range of hospital performance when we ranked hospitals using the 30-day data; some hospitals had much lower than predicted 30-day mortality rates, while others had much higher than predicted mortality rates. Data from the time period 31-180 days postadmission yield results that corroborate the 0-30 day postadmission data. Moreover, we found evidence that hospital performance on one condition is related to performance on the other conditions, but that the correlation is much weaker in the 31-180-day interval than in the 0-30-day period. Using ROC curves, we found that the 30-day data discriminated the top and bottom fifths of the 180-day data extremely well, especially for AMI outcomes. CONCLUSIONS. Using data on cumulative hospital mortality from 180 days postadmission does not yield a different perspective from using data from 30 days postadmission for the conditions we studied. PMID:7860319

  8. Hyperkalemia is Associated with Increased 30-Day Mortality in Hip Fracture Patients.

    PubMed

    Norring-Agerskov, Debbie; Madsen, Christian Medom; Abrahamsen, Bo; Riis, Troels; Pedersen, Ole B; Jørgensen, Niklas Rye; Bathum, Lise; Lauritzen, Jes Bruun; Jørgensen, Henrik L

    2017-02-17

    Abnormal plasma concentrations of potassium in the form of hyper- and hypokalemia are frequent among hospitalized patients and have been linked to poor outcomes. In this study, we examined the prevalence of hypo- and hyperkalemia in patients admitted with a fractured hip as well as the association with 30-day mortality in these patients. A total of 7293 hip fracture patients (aged 60 years or above) with admission plasma potassium measurements were included. Data on comorbidity, medication, and death was retrieved from national registries. The association between plasma potassium and mortality was examined using Cox proportional hazards models adjusted for age, sex, and comorbidities. The prevalence of hypo- and hyperkalemia on admission was 19.8% and 6.6%, respectively. The 30-day mortality rates were increased for patients with hyperkalemia (21.0%, p < 0.0001) compared to normokalemic patients (9.5%), whereas hypokalemia was not significantly associated with mortality. After adjustment for age, sex, and individual comorbidities, hyperkalemia was still associated with increased risk of death 30 days after admission (HR = 1.93 [1.55-2.40], p < 0.0001). After the same adjustments, hypokalemia remained non-associated with increased risk of 30-day mortality (HR = 1.06 [0.87-1.29], p = 0.6). Hyperkalemia, but not hypokalemia, at admission is associated with increased 30-day mortality after a hip fracture.

  9. Half of 30-Day Hospital Readmissions Among HIV-Infected Patients Are Potentially Preventable

    PubMed Central

    Kitchell, Ellen; Etherton, Sarah Shelby; Duarte, Piper; Halm, Ethan A.; Jain, Mamta K.

    2015-01-01

    Abstract Thirty-day readmission rates, a widely utilized quality metric, are high among HIV-infected individuals. However, it is unknown how many 30-day readmissions are preventable, especially in HIV patients, who have been excluded from prior potentially preventable readmission analyses. We used electronic medical records to identify all readmissions within 30 days of discharge among HIV patients hospitalized at a large urban safety net hospital in 2011. Two independent reviewers assessed whether readmissions were potentially preventable using both published criteria and detailed chart review, how readmissions might have been prevented, and the phase of care deemed suboptimal (inpatient care, discharge planning, post-discharge). Of 1137 index admissions, 213 (19%) resulted in 30-day readmissions. These admissions occurred among 930 unique HIV patients, with 130 individuals (14%) experiencing 30-day readmissions. Of these 130, about half were determined to be potentially preventable using published criteria (53%) or implicit chart review (48%). Not taking antiretroviral therapy (ART) greatly increased the odds of a preventable readmission (OR 5.9, CI:2.4–14.8). Most of the preventable causes of readmission were attributed to suboptimal care during the index hospitalization. Half of 30-day readmission in HIV patients are potentially preventable. Increased focus on early ART initiation, adherence counseling, management of chronic conditions, and appropriate timing of discharge may help reduce readmissions in this vulnerable population. PMID:26154066

  10. Investigation of the relationship between idiopathic microscopic hematuria (in the first and second trimesters) and major adverse outcomes of pregnancy

    PubMed Central

    Shahraki, Azar Danesh; Bardeh, Mahboobeh Esteki; Najarzadegan, Mohammad Reza

    2016-01-01

    Background: The aim of this study was to investigate the relationship between idiopathic microscopic hematuria (in the first and second trimesters) and major adverse outcomes of pregnancy. Materials and Methods: Urinalysis was done for 700 pregnant women before 24 weeks of pregnancy. Those who had 3–5 red blood cells per milliliter in urinalysis were considered positive urinalysis. Then, all individuals were examined for blood pressure and other alarm signs of pregnancy complications in each visit. All mothers were followed for the incidence of preeclampsia, preterm delivery, and pregnancy outcome until the end of pregnancy. Results: The results of this study showed that no significant difference in terms of incident of pregnancy complications between the pregnant women with and without hematuria and the only abortions and neonatal deaths differed between the two groups. Conclusion: These results suggest that further studies are needed to determine whether idiopathic microscopic hematuria can be a predictive value for pregnancy complications or not. PMID:28028526

  11. Emergency department evaluation and 30-day readmission after craniotomy for primary brain tumor resection in New York State.

    PubMed

    Missios, Symeon; Bekelis, Kimon

    2017-01-06

    OBJECTIVE Fragmentation of care has been recognized as a major contributor to 30-day readmissions after surgical procedures. The authors investigated the association of evaluation in the hospital where the original procedure was performed with the rate of 30-day readmissions for patients presenting to the emergency department (ED) after craniotomy for primary brain tumor resection. METHODS A cohort study was conducted, involving patients who were evaluated in the ED within 30 days after discharge following a craniotomy for primary brain tumor resection between 2009 and 2013, and who were registered in the Statewide Planning and Research Cooperative System (SPARCS) database of New York State. A propensity score-adjusted model was used to control for confounding, whereas a mixed-effects model accounted for clustering at the hospital level. RESULTS Of the 610 patients presenting to the ED, 422 (69.2%) were evaluated in a hospital different from the one where the original procedure was performed (28.9% were readmitted), and 188 (30.8%) were evaluated at the original hospital (20.3% were readmitted). In a multivariable analysis, the authors demonstrated that being evaluated in the ED of the original hospital was associated with a decreased rate of 30-day readmission (OR 0.64, 95% CI 0.41-0.98). Similar associations were found in a mixed-effects logistic regression model (OR 0.63, 95% CI 0.40-0.96) and a propensity score-adjusted model (OR 0.64, 95% CI 0.41-0.98). This corresponds to one less readmission per 12 patients evaluated in the hospital where the original procedure was performed. CONCLUSIONS Using a comprehensive all-payer cohort of patients in New York State who were evaluated in the ED after craniotomy for primary brain tumor resection, the authors identified an association of assessment in the hospital where the original procedure was performed with a lower rate of 30-day readmissions. This underscores the potential importance of continuity of care in

  12. Characteristics of older adults rehospitalized within 7 and 30 days of discharge: implications for nursing practice.

    PubMed

    Hain, Debra J; Tappen, Ruth; Diaz, Sanya; Ouslander, Joseph G

    2012-08-01

    Rehospitalization within 30 days consumes a significant portion of health care costs; therefore, interventions aimed at reducing the risk of rehospitalization are needed. A retrospective study was conducted examining rehospitalization rates and diagnoses according to discharge location and comparing characteristics of older adults within 7 and 30 days of discharge from a community hospital. Data on rehospitalization for Medicare fee-for-service patients (75 and older) over a 12-month period were obtained from the information technology department of a not-for-profit community hospital. A total of 6,809 patients were discharged, with 12% rehospitalized within 30 days. Skilled nursing facilities had the highest rehospitalization rates (15%), followed by home with home health care (13%) and then home with self-care (8%). The highest rehospitalization rates were in areas where nursing has a strong presence, suggesting that nurses can play an important role in the development of interventions aimed at reducing rehospitalizations.

  13. Myelinated fibers of the mouse spinal cord after a 30-day space flight.

    PubMed

    Povysheva, T V; Rezvyakov, P N; Shaimardanova, G F; Nikolskii, E E; Islamov, R R; Chelyshev, Yu A; Grygoryev, A I

    2016-07-01

    Myelinated fibers and myelin-forming cells in the spinal cord at the L3-L5 level were studied in C57BL/6N mice that had spent 30 days in space. Signs of destruction of myelin in different areas of white matter, reduction of the thickness of myelin sheath and axon diameter, decreased number of myelin-forming cells were detected in "flight" mice. The stay of mice in space during 30 days had a negative impact on the structure of myelinated fibers and caused reduced expression of the markers myelin-forming cells. These findings can complement the pathogenetic picture of the development of hypogravity motor syndrome.

  14. Spatial Repolarization Heterogeneity Detected by Magnetocardiography Correlates with Cardiac Iron Overload and Adverse Cardiac Events in Beta-Thalassemia Major

    PubMed Central

    Chen, Chun-An; Lu, Meng-Yao; Peng, Shinn-Forng; Lin, Kai-Hsin; Chang, Hsiu-Hao; Yang, Yung-Li; Jou, Shiann-Tarng; Lin, Dong-Tsamn; Liu, Yen-Bin; Horng, Herng-Er; Yang, Hong-Chang; Wang, Jou-Kou; Wu, Mei-Hwan; Wu, Chau-Chung

    2014-01-01

    Background Patients with transfusion-dependent beta-thalassemia major (TM) are at risk for myocardial iron overload and cardiac complications. Spatial repolarization heterogeneity is known to be elevated in patients with certain cardiac diseases, but little is known in TM patients. The purpose of this study was to evaluate spatial repolarization heterogeneity in patients with TM, and to investigate the relationships between spatial repolarization heterogeneity, cardiac iron load, and adverse cardiac events. Methods and Results Fifty patients with TM and 55 control subjects received 64-channel magnetocardiography (MCG) to determine spatial repolarization heterogeneity, which was evaluated by a smoothness index of QTc (SI-QTc), a standard deviation of QTc (SD-QTc), and a QTc dispersion. Left ventricular function and myocardial T2* values were assessed by cardiac magnetic resonance. Patients with TM had significantly greater SI-QTc, SD-QTc, and QTc dispersion compared to the control subjects (all p values<0.001). Spatial repolarization heterogeneity was even more pronounced in patients with significant iron overload (T2*<20 ms, n = 20) compared to those with normal T2* (all p values<0.001). Loge cardiac T2* correlated with SI-QTc (r = −0.609, p<0.001), SD-QTc (r = −0.572, p<0.001), and QTc dispersion (r = −0.622, p<0.001), while all these indices had no relationship with measurements of the left ventricular geometry or function. At the time of study, 10 patients had either heart failure or arrhythmia. All 3 indices of repolarization heterogeneity were related to the presence of adverse cardiac events, with areas under the receiver operating characteristic curves (ranged between 0.79 and 0.86), similar to that of cardiac T2*. Conclusions Multichannel MCG demonstrated that patients with TM had increased spatial repolarization heterogeneity, which is related to myocardial iron load and adverse cardiac events. PMID:24475137

  15. 77 FR 67657 - Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service (IHS...

    Federal Register 2010, 2011, 2012, 2013, 2014

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  16. 77 FR 13128 - Agency Information Collection Request; 30-Day Public Comment Request

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    ...'' campaign is a national Public Service Announcement (PSA) campaign that aims to educate, engage and empower... HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request AGENCY: Office of... Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services,...

  17. 78 FR 49280 - 30-Day Notice of Proposed Information Collection: Third-Party Documentation Facsimile Transmittal...

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    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Third-Party Documentation Facsimile..., Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette...

  18. 78 FR 52008 - 30-Day Notice of Proposed Information Collection: Multifamily Housing Service Coordinator Program

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  19. 78 FR 39002 - 30-Day Notice of Proposed Information Collection: Request for Withdrawals From Replacements...

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    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Request for Withdrawals From..., Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street...

  20. 78 FR 52009 - 30-Day Notice of Proposed Information Collection: Utility Allowance Adjustments

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    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Utility Allowance Adjustments AGENCY... Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at...

  1. 78 FR 39001 - 30-Day Notice of Proposed Information Collection: Uniform Physical Standards and Physical...

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    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Uniform Physical Standards and..., Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street...

  2. 78 FR 52007 - 30-Day Notice of Proposed Information Collection: Management Certification and Management Entity...

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    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Management Certification and... Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street, SW., Washington,...

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    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Financial Statement of Corporate..., Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street,...

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    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Final Endorsement of Credit..., Department of Housing and Urban Development, 451 7th Street, SW., Washington, DC 20410; email Colette...

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    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Standardized Form for Collecting... Information Collection: Standardized Form for Collecting Information Regarding Race and Ethnic Data. OMB... quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden...

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    ... HUMAN SERVICES Agency Information Collection Request--30-Day Public Comment Request AGENCY: Office of... Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is.... Proposed Project: New Comprehensive Communication Campaign on Right To Non-Discrimination in Certain...

  8. Enhanced recovery of Phytophthora ramorum from soil following 30 days storage at 4C

    Technology Transfer Automated Retrieval System (TEKTRAN)

    Chlamydospores of Phytophthora ramorum produced by mixing 20 percent V8 juice broth cultures with sand and incubating over a 30 day period were used to infest field soil at densities ranging from 0.2 to 42 chlamydospores per cubic centimeter of soil. Chlamydospore recovery was determined by baiting...

  9. 77 FR 18820 - Agency Information Collection Request; 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request AGENCY: Office of... Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services,...

  10. 78 FR 38070 - 30-Day Notice of Proposed Information Collection: Affirmative Fair Housing Marketing (AFHM) Plan

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    2013-06-25

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Affirmative Fair Housing Marketing... Marketing (AFHM) Plan. OMB Approval Number: 2529-0013. Type of Request: Extension of a currently approved collection. Form Number: HUD-935.2A Affirmative Fair Housing Marketing (AFHM) Plan (Multifamily),...

  11. 78 FR 1916 - 30-Day Notice of Proposed Information Collection: Smart Traveler Enrollment Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-09

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF STATE 30-Day Notice of Proposed Information Collection: Smart Traveler Enrollment Program ACTION: Notice of request... Information Collection: Smart Traveler Enrollment Program (STEP). OMB Control Number: 1405-0152. Type...

  12. 78 FR 64142 - 30-Day Notice of Proposed Information Collection: Condominium Project Approval Document Collection

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    2013-10-25

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Condominium Project Approval... submitted the proposed information collection requirement described below to the Office of Management and... Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806. Email:...

  13. 78 FR 36560 - 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal, Periodic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: FHA Lender Approval, Annual Renewal...: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th... Title of Information Collection: FHA Lender Approval, Annual Renewal, Periodic Updates and...

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  15. 77 FR 59354 - Removal of 30-Day Residency Requirement for Per Diem Payments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-27

    ... reasons other than hospital care, such as when a veteran travels to visit family members. This proposed... payments, stating: ``We believe that 30 days is a minimal amount of time for demonstrating that a veteran... State home within a specific period of time, or communicates that he or she will not be returning....

  16. 77 FR 59318 - Removal of 30-Day Residency Requirement for Per Diem Payments

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    2012-09-27

    ... reasons other than hospital care, such as when a veteran travels to visit family members. This rule also... 30 days is a minimal amount of time for demonstrating that a veteran intends to be a resident at the... State home within a specific period of time, or communicates that he or she will not be returning....

  17. 78 FR 75366 - 30-Day Notice of Proposed Information Collection: Public Housing Energy Audits and Utility...

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    2013-12-11

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Public Housing Energy Audits and... Audits and Utility Allowances. OMB Approval Number: 2577-062. Type of Request: Reinstatement, with change... information and proposed use: 24 CFR 965.301, Subpart C, Energy Audit and Energy Conservation...

  18. 76 FR 59129 - Agency Information Collection Request; 30-Day Public Comment Request

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  19. 26 CFR 31.3406(d)-3 - Special 30-day rules for certain reportable payments.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 26 Internal Revenue 15 2010-04-01 2010-04-01 false Special 30-day rules for certain reportable payments. 31.3406(d)-3 Section 31.3406(d)-3 Internal Revenue INTERNAL REVENUE SERVICE, DEPARTMENT OF THE... account. (b) Sale of an instrument for a customer by electronic transmission or by mail. The special...

  20. 78 FR 39305 - 30-Day Notice of Proposed Information Collection: OSHC Progress Report Template

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  1. 77 FR 32638 - Agency Information Collection Request. 30-Day Public Comment Request

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    2012-06-01

    ... HUMAN SERVICES Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of... Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is...) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the...

  2. 78 FR 52964 - 30-Day Notice of Proposed Information Collection: Section 8 Management Assessment Program (SEMAP...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... From the Federal Register Online via the Government Publishing Office ] DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Section 8 Management Assessment..., Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street...

  3. 78 FR 65695 - 30-Day Notice of Proposed Information Collection: Technical Processing Requirements for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Technical Processing Requirements..., Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette...

  4. 78 FR 66042 - 30-Day Notice of Proposed Information Collection: Section 3 Business Registry Pilot Program...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

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  5. 75 FR 50791 - 30-Day Notice of Proposed Information Collection: Recording, Reporting, and Data Collection...

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    ... following information collection request to the Office of Management and Budget (OMB) for approval in... Office: Bureau of Educational and Cultural Affairs, Office of Designation, ECA/EC/D. Form Number: Forms...: Submit comments to the Office of Management and Budget (OMB) for up to 30 days from August 17,...

  6. 76 FR 79683 - Agency Information Collection Request. 30-Day Public Comment Request

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    2011-12-22

    ... HUMAN SERVICES Agency Information Collection Request. 30-Day Public Comment Request AGENCY: Office of... Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is... new AIDS cases. As one strategy to address this disparity, the U.S. Department of Health and...

  7. 78 FR 79474 - 30-Day Notice of Proposed Information Collection: Father's Day

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    2013-12-30

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    ...HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public...

  9. 78 FR 75365 - 30-Day Notice of Proposed Information Collection: Assessment of Native American, Alaska Native...

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  10. 78 FR 79703 - Submission for OMB Review; 30-Day Comment Request: Application Process for Clinical Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-31

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  11. 76 FR 6794 - 30-Day Submission Period for Requests for ONC-Approved Accreditor (ONC-AA) Status

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    2011-02-08

    ... HUMAN SERVICES 30-Day Submission Period for Requests for ONC-Approved Accreditor (ONC-AA) Status AGENCY... ONC-Approved Accreditor (ONC-AA) status. Authority: 42 U.S.C. 300jj-11. DATES: The 30-day submission... a notice in the Federal Register to announce the 30-day period during which requests for...

  12. New consensus definition for acute kidney injury accurately predicts 30-day mortality in cirrhosis with infection

    PubMed Central

    Wong, Florence; O’Leary, Jacqueline G; Reddy, K Rajender; Patton, Heather; Kamath, Patrick S; Fallon, Michael B; Garcia-Tsao, Guadalupe; Subramanian, Ram M.; Malik, Raza; Maliakkal, Benedict; Thacker, Leroy R; Bajaj, Jasmohan S

    2015-01-01

    Background & Aims A consensus conference proposed that cirrhosis-associated acute kidney injury (AKI) be defined as an increase in serum creatinine by >50% from the stable baseline value in <6 months or by ≥0.3mg/dL in <48 hrs. We prospectively evaluated the ability of these criteria to predict mortality within 30 days among hospitalized patients with cirrhosis and infection. Methods 337 patients with cirrhosis admitted with or developed an infection in hospital (56% men; 56±10 y old; model for end-stage liver disease score, 20±8) were followed. We compared data on 30-day mortality, hospital length-of-stay, and organ failure between patients with and without AKI. Results 166 (49%) developed AKI during hospitalization, based on the consensus criteria. Patients who developed AKI had higher admission Child-Pugh (11.0±2.1 vs 9.6±2.1; P<.0001), and MELD scores (23±8 vs17±7; P<.0001), and lower mean arterial pressure (81±16mmHg vs 85±15mmHg; P<.01) than those who did not. Also higher amongst patients with AKI were mortality in ≤30 days (34% vs 7%), intensive care unit transfer (46% vs 20%), ventilation requirement (27% vs 6%), and shock (31% vs 8%); AKI patients also had longer hospital stays (17.8±19.8 days vs 13.3±31.8 days) (all P<.001). 56% of AKI episodes were transient, 28% persistent, and 16% resulted in dialysis. Mortality was 80% among those without renal recovery, higher compared to partial (40%) or complete recovery (15%), or AKI-free patients (7%; P<.0001). Conclusions 30-day mortality is 10-fold higher among infected hospitalized cirrhotic patients with irreversible AKI than those without AKI. The consensus definition of AKI accurately predicts 30-day mortality, length of hospital stay, and organ failure. PMID:23999172

  13. Rheumatoid arthritis patients are not at increased risk for 30-day cardiovascular events, infections, or mortality after total joint arthroplasty

    PubMed Central

    2013-01-01

    Introduction Serious infection, cardiovascular disease, and mortality are increased in rheumatoid arthritis (RA). Whether RA affects the risk for these complications after total joint arthroplasty (TJA) is unknown, we hypothesize that it does. We compared the occurrence of 30-day postoperative complications and mortality in a large cohort of RA and osteoarthritis (OA) patients undergoing hip or knee TJA. Methods Analyses included 7-year data from the Veterans Affairs Surgical Quality Improvement Program. The 30-day complications were compared by diagnosis by using logistic regression, and long-term mortality was examined by using Cox proportional hazards regression. All analyses were adjusted for age, sex, and clustering by surgical site. Additional covariates included sociodemographics, comorbidities, health behaviors, and operative risk factors. Results The 34,524 patients (839 RA, 33,685 OA) underwent knee (65.9%) or hip TJA. Patients were 95.7% men with a mean (SD) age of 64.4 (10.7) years and had 3,764 deaths over a mean follow-up of 3.7 (2.3) years. Compared with OA patients, those with RA were significantly more likely to require a return to the operating room (odds ratio (OR), 1.45 (95% CI, 1.08 to 1.94), but had similar rates of 30-day postoperative infection, OR 1.02 (0.72 to 1.47), cardiovascular events, OR 0.69 (0.37 to 1.28), and mortality, OR 0.94 (0.38 to 2.33). RA was associated with a significantly higher long-term mortality; hazard ratio (HR), 1.22 (1.00 to 1.49). Conclusion In this study of US veterans, RA patients were not at an increased risk for short-term mortality or other major complications after TJA, although they returned to the operating room more often and had increased long-term mortality. PMID:24252350

  14. The predictive value of arterial stiffness on major adverse cardiovascular events in individuals with mildly impaired renal function

    PubMed Central

    Han, Jie; Wang, Xiaona; Ye, Ping; Cao, Ruihua; Yang, Xu; Xiao, Wenkai; Zhang, Yun; Bai, Yongyi; Wu, Hongmei

    2016-01-01

    Objectives Despite growing evidence that arterial stiffness has important predictive value for cardiovascular disease in patients with advanced stages of chronic kidney disease, the predictive significance of arterial stiffness in individuals with mildly impaired renal function has not been established. The aim of this study was to evaluate the predictive value of arterial stiffness on cardiovascular disease in this specific population. Materials and methods We analyzed measurements of arterial stiffness (carotid–femoral pulse-wave velocity [cf-PWV]) and the incidence of major adverse cardiovascular events (MACEs) in 1,499 subjects from a 4.8-year longitudinal study. Results A multivariate Cox proportional-hazard regression analysis showed that in individuals with normal renal function (estimated glomerular filtration rate [eGFR] ≥90 mL/min/1.73 m2), the baseline cf-PWV was not associated with occurrence of MACEs (hazard ratio 1.398, 95% confidence interval 0.748–2.613; P=0.293). In individuals with mildly impaired renal function (eGFR <90 mL/min/1.73 m2), a higher baseline cf-PWV level was associated with a higher risk of MACEs (hazard ratio 2.334, 95% confidence interval 1.082–5.036; P=0.031). Conclusion Arterial stiffness is a moderate and independent predictive factor for MACEs in individuals with mildly impaired renal function (eGFR <90 mL/min/1.73 m2). PMID:27621605

  15. Multivariate prediction of major adverse cardiac events after 9914 percutaneous coronary interventions in the north west of England

    PubMed Central

    Grayson, A D; Moore, R K; Jackson, M; Rathore, S; Sastry, S; Gray, T P; Schofield, I; Chauhan, A; Ordoubadi, F F; Prendergast, B; Stables, R H

    2006-01-01

    Objective To develop a multivariate prediction model for major adverse cardiac events (MACE) after percutaneous coronary interventions (PCIs) by using the North West Quality Improvement Programme in Cardiac Interventions (NWQIP) PCI Registry. Setting All NHS centres undertaking adult PCIs in north west England. Methods Retrospective analysis of prospectively collected data on 9914 consecutive patients undergoing adult PCI between 1 August 2001 and 31 December 2003. A multivariate logistic regression analysis was undertaken, with the forward stepwise technique, to identify independent risk factors for MACE. The area under the receiver operating characteristic (ROC) curve and the Hosmer‐Lemeshow goodness of fit statistic were calculated to assess the performance and calibration of the model, respectively. The statistical model was internally validated by using the technique of bootstrap resampling. Main outcome measures MACE, which were in‐hospital mortality, Q wave myocardial infarction, emergency coronary artery bypass graft surgery, and cerebrovascular accidents. Results Independent variables identified with an increased risk of developing MACE were advanced age, female sex, cerebrovascular disease, cardiogenic shock, priority, and treatment of the left main stem or graft lesions during PCI. The ROC curve for the predicted probability of MACE was 0.76, indicating a good discrimination power. The prediction equation was well calibrated, predicting well at all levels of risk. Bootstrapping showed that estimates were stable. Conclusions A contemporaneous multivariate prediction model for MACE after PCI was developed. The NWQIP tool allows calculation of the risk of MACE permitting meaningful risk adjusted comparisons of performance between hospitals and operators. PMID:16159983

  16. 30-Day Survival Probabilities as a Quality Indicator for Norwegian Hospitals: Data Management and Analysis

    PubMed Central

    Hassani, Sahar; Lindman, Anja Schou; Kristoffersen, Doris Tove; Tomic, Oliver; Helgeland, Jon

    2015-01-01

    Background The Norwegian Knowledge Centre for the Health Services (NOKC) reports 30-day survival as a quality indicator for Norwegian hospitals. The indicators have been published annually since 2011 on the website of the Norwegian Directorate of Health (www.helsenorge.no), as part of the Norwegian Quality Indicator System authorized by the Ministry of Health. Openness regarding calculation of quality indicators is important, as it provides the opportunity to critically review and discuss the method. The purpose of this article is to describe the data collection, data pre-processing, and data analyses, as carried out by NOKC, for the calculation of 30-day risk-adjusted survival probability as a quality indicator. Methods and Findings Three diagnosis-specific 30-day survival indicators (first time acute myocardial infarction (AMI), stroke and hip fracture) are estimated based on all-cause deaths, occurring in-hospital or out-of-hospital, within 30 days counting from the first day of hospitalization. Furthermore, a hospital-wide (i.e. overall) 30-day survival indicator is calculated. Patient administrative data from all Norwegian hospitals and information from the Norwegian Population Register are retrieved annually, and linked to datasets for previous years. The outcome (alive/death within 30 days) is attributed to every hospital by the fraction of time spent in each hospital. A logistic regression followed by a hierarchical Bayesian analysis is used for the estimation of risk-adjusted survival probabilities. A multiple testing procedure with a false discovery rate of 5% is used to identify hospitals, hospital trusts and regional health authorities with significantly higher/lower survival than the reference. In addition, estimated risk-adjusted survival probabilities are published per hospital, hospital trust and regional health authority. The variation in risk-adjusted survival probabilities across hospitals for AMI shows a decreasing trend over time: estimated

  17. Morbidity associated with 30-day surgical site infection following nonshunt pediatric neurosurgery.

    PubMed

    Sherrod, Brandon A; Rocque, Brandon G

    2017-04-01

    OBJECTIVE Morbidity associated with surgical site infection (SSI) following nonshunt pediatric neurosurgical procedures is poorly understood. The purpose of this study was to analyze acute morbidity and mortality associated with SSI after nonshunt pediatric neurosurgery using a nationwide cohort. METHODS The authors reviewed data from the American College of Surgeons National Surgical Quality Improvement Program-Pediatric (NSQIP-P) 2012-2014 database, including all neurosurgical procedures performed on pediatric patients. Procedures were categorized by Current Procedural Terminology (CPT) codes. CSF shunts were excluded. Deep and superficial SSIs occurring within 30 days of an index procedure were identified. Deep SSIs included deep wound infections, intracranial abscesses, meningitis, osteomyelitis, and ventriculitis. The following outcomes occurring within 30 days of an index procedure were analyzed, along with postoperative time to complication development: sepsis, wound disruption, length of postoperative stay, readmission, reoperation, and death. RESULTS A total of 251 procedures associated with a 30-day SSI were identified (2.7% of 9296 procedures). Superficial SSIs were more common than deep SSIs (57.4% versus 42.6%). Deep SSIs occurred more frequently after epilepsy or intracranial tumor procedures. Superficial SSIs occurred more frequently after skin lesion, spine, Chiari decompression, craniofacial, and myelomeningocele closure procedures. The mean (± SD) postoperative length of stay for patients with any SSI was 9.6 ± 14.8 days (median 4 days). Post-SSI outcomes significantly associated with previous SSI included wound disruption (12.4%), sepsis (15.5%), readmission (36.7%), and reoperation (43.4%) (p < 0.001 for each). Post-SSI sepsis rates (6.3% vs 28.0% for superficial versus deep SSI, respectively; p < 0.001), wound disruption rates (4.9% vs 22.4%, p < 0.001), and reoperation rates (23.6% vs 70.1%, p < 0.001) were significantly greater for patients

  18. Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

    PubMed Central

    Tendal, Britta; Hróbjartsson, Asbjørn; Lundh, Andreas; Gøtzsche, Peter C

    2014-01-01

    Objective To assess the effects of coding and coding conventions on summaries and tabulations of adverse events data on suicidality within clinical study reports. Design Systematic electronic search for adverse events of suicidality in tables, narratives, and listings of adverse events in individual patients within clinical study reports. Where possible, for each event we extracted the original term reported by the investigator, the term as coded by the medical coding dictionary, medical coding dictionary used, and the patient’s trial identification number. Using the patient’s trial identification number, we attempted to reconcile data on the same event between the different formats for presenting data on adverse events within the clinical study report. Setting 9 randomised placebo controlled trials of duloxetine for major depressive disorder submitted to the European Medicines Agency for marketing approval. Data sources Clinical study reports obtained from the EMA in 2011. Results Six trials used the medical coding dictionary COSTART (Coding Symbols for a Thesaurus of Adverse Reaction Terms) and three used MedDRA (Medical Dictionary for Regulatory Activities). Suicides were clearly identifiable in all formats of adverse event data in clinical study reports. Suicide attempts presented in tables included both definitive and provisional diagnoses. Suicidal ideation and preparatory behaviour were obscured in some tables owing to the lack of specificity of the medical coding dictionary, especially COSTART. Furthermore, we found one event of suicidal ideation described in narrative text that was absent from tables and adverse event listings of individual patients. The reason for this is unclear, but may be due to the coding conventions used. Conclusion Data on adverse events in tables in clinical study reports may not accurately represent the underlying patient data because of the medical dictionaries and coding conventions used. In clinical study reports, the

  19. Psychometric Properties of 7- and 30-Day Versions of the PROMIS Emotional Distress Item Banks in an Australian Adult Sample.

    PubMed

    Batterham, Philip J; Sunderland, Matthew; Carragher, Natacha; Calear, Alison L

    2017-01-01

    This study aimed to examine the psychometric properties of the PROMIS depression, anxiety, and anger item banks in a large Australian population-based sample. The study tested for unidimensionality; evaluated invariance across age, gender, and education; assessed local independence; and tested item bank scores as an indicator for clinical criteria. In addition, equivalence of the 7-day time frame against an alternative 30-day time frame was assessed. A sample of 3,175 Australian adults were recruited into the study through online advertising. All three item banks showed strong evidence of unidimensionality and parsimony, with no items showing local dependence. All items were invariant across age, gender, and education. The item banks were accurate in detecting clinical criteria for major depressive disorder, generalized anxiety disorder, and panic disorder, although legacy measures designed for this purpose sometimes performed marginally better. Responses to the 30-day time frame were highly consistent with the original 7-day time frame. The study provided support for the validity of the PROMIS emotional distress item banks as measures of depression, anxiety, and anger in the Australian population, supporting the generalizability of the measures. The time frame chosen for assessing mental health outcomes using these item banks should be based on pragmatic considerations.

  20. Work capacity during 30 days of bed rest with isotonic and isokinetic exercise training

    NASA Technical Reports Server (NTRS)

    Greenleaf, J. E.; Bernauer, E. M.; Ertl, A. C.; Trowbridge, T. S.; Wade, C. E.

    1989-01-01

    Results are presented from a study to determine whether or not short-term variable intensity isotonic and intermittent high-intensity isokinetic short-duration leg exercise is effective for the maintenance of peak O2 (VO2) uptake and muscular strength and endurance, respectively, during 30 days of -6 deg head-down bed rest deconditioning. The results show no significant changes in leg peak torque, leg mean total work, arm total peak torque, or arm mean total work for members of the isotonic, isokinetic, and controls groups. Changes are observed, however, in peak VO2 levels. The results suggest that near-peak variabile intensity, isotonic leg excercise maintains peak VO2 during 30 days of bed rest, while peak intermittent, isokinetic leg excercise protocol does not.

  1. Analysis of weekend effect on 30-day mortality among patients with acute myocardial infarction

    PubMed Central

    Noad, Rebecca; Stevenson, Michael; Herity, Niall A

    2017-01-01

    Objectives Several publications have demonstrated increased 30-day mortality in patients admitted on Saturdays or Sundays compared with weekdays. We sought to determine whether this was true for two different cohorts of patients admitted with acute myocardial infarction (MI). Methods and results Thirty-day mortality data were obtained for 3757 patients who had been admitted to the Belfast Health and Social Care Trust with acute MI between 2009 and 2015. They were subdivided into those presenting with ST elevation MI (n=2240) and non-ST elevation MI (n= 1517). We observed no excess 30-day mortality in those admitted over weekends. Conclusion Excess mortality in patients admitted at weekends is not a universal finding. This may mean that that there are patient subgroups with proportionately greater weekend hazard and points to the need for more detailed understanding of the weekend effect.

  2. A Comprehensive Analysis of the Causes and Predictors of 30-Day Mortality Following Hip Fracture Surgery

    PubMed Central

    Hossain, Fahad Siddique; Aqil, Adeel; Akinbamijo, Babawande; Mushtaq, Vhaid; Kapoor, Harish

    2017-01-01

    Background A fracture neck of femur is the leading cause of injury-related mortality in the elderly population. The 30-day mortality figure is a well utilised marker of clinical outcome following a fracture neck of femur. Current studies fail to analyse all patient demographic, biochemical and comorbid parameters associated with increased 30-day mortality. We aimed to assess medical risk factors for mortality, which are easily identifiable on admission for patients presenting with a fractured neck of femur. Methods A retrospective review of a prospectively populated database was undertaken to identify all consecutive patients with a fracture neck of femur between October 2008 and March 2011. All factors related to the patient, injury and surgery were identified. The primary outcome of interest was 30-day mortality. Univariate and subsequent multivariate analyses using a backward stepwise likelihood ratio Cox regression model were performed in order to establish all parameters that significantly increased the risk of death. Results A total of 1,356 patients were included in the study. The 30-day mortality was 8.7%. The most common causes of death included pneumonia, sepsis and acute myocardial infarction. Multiple regression analysis revealed male gender, increasing age, admission source other than the patient's own home, admission haemoglobin of less than 10 g/dL, a history of myocardial infarction, concomitant chest infection during admission, increasing Charlson comorbidity score and liver disease to be significant predictors of mortality. Conclusions This study has elucidated risk factors for mortality using clinical and biochemical information which are easily gathered at the point of hospitalization. These results allow for identification of vulnerable patients who may benefit from a prioritisation of resources. PMID:28261422

  3. Incidence, Causes and Predictors of 30-Day Readmission After Shoulder Arthroplasty

    PubMed Central

    Westermann, Robert W; Anthony, Chris A.; Duchman, Kyle R.; Pugely, Andrew J.; Gao, Yubo; Hettrich, Carolyn M.

    2016-01-01

    Background The Center for Medicare and Medicaid Service has identified several quality metrics, including unplanned readmission within 30 days of surgery, to assess and compare surgeons and hospitals. The purpose of this study was to identify the incidence, causes and risk factors for unplanned 30-day readmission after total shoulder arthroplasty. Methods We identified patients undergoing primary elective shoulder arthroplasty performed at American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) participating hospitals in 2013. Cases were stratified by readmission status. Univariate and multivariate analyses were employed to assess patient demographics, comorbidities and operative variables predicting unplanned readmission. Results 2779 patients undergoing shoulder arthroplasty were identified, with 74 (2.66%) requiring unplanned readmissions within 30 days of surgery. The most common surgical causes for unplanned readmission were surgical site infections (18.6%), dislocations (16.3%) and venous thromboembolism (14.0%). Medical causes for readmission were responsible for 51% of unplanned readmissions. Multivariate analysis identified patient age >75 (OR 2.62, 95% CI: 1.27 - 5.41), and ASA class of 3 (OR 1.79, 95% CI: 1.01 - 3.18) or 4 (OR 3.63, 95% CI: 1.31 - 10.08) as independent risk factors for unplanned readmission. Predictive modeling estimated that patients with ASA class of 4 and age >75 are 17.4 times more likely (95% CI 1.77-171.09) to be readmitted within 30 days of shoulder arthroplasty. Conclusion Unplanned readmission after shoulder arthroplasty is infrequent and medical complications account for more than 50% of occurrences. The risk of readmission exponentially increases when age and preoperative comorbidity burden are increased. PMID:27528839

  4. Skeletal muscle adaptations following blood flow-restricted training during 30 days of muscular unloading.

    PubMed

    Cook, Summer B; Brown, Kimberly A; Deruisseau, Keith; Kanaley, Jill A; Ploutz-Snyder, Lori L

    2010-08-01

    This study evaluated the effectiveness of low-load resistance training with a blood flow restriction (LL(BFR)) to attenuate muscle loss and weakness after 30 days of unilateral lower limb suspension (ULLS). Sixteen subjects (ages 18-50 yr) underwent 30 days of ULLS. Measurements of muscle strength, cross-sectional area, and endurance on the knee extensors and plantar flexors were collected before and after ULLS. Plasma concentrations of IGF-1 and IGFBP-3 were also assessed. During ULLS, eight subjects (5 males, 3 females) participated in LL(BFR) three times per week (ULLS + Exercise) while eight subjects (4 males, 4 females) did not exercise (ULLS). The blood flow-restricted exercise consisted of dynamic knee extension at 20% of the subject's isometric maximum voluntary contraction coupled with a suprasystolic blood flow restriction. After 30 days of limb suspension, the ULLS + Exercise group experienced minimal and insignificant losses in knee extensor cross-sectional area and strength (1.2% and 2.0%, respectively; P 0.05). Muscular endurance in the knee extensors improved 31% in the ULLS + Exercise group, while it decreased 24% in the ULLS group (P = 0.01). No changes were seen in hormone concentrations throughout the study. In conclusion, LL(BFR) of the knee extensors is effective in maintaining muscle strength and size during 30 days of ULLS and results in improved knee extensor muscular endurance.

  5. The 10-30-day intraseasonal variation of the East Asian winter monsoon: The temperature mode

    NASA Astrophysics Data System (ADS)

    Yao, Suxiang; Sun, Qingfei; Huang, Qian; Chu, Peng

    2016-09-01

    East Asia is known for its monsoon characteristics, but little research has been performed on the intraseasonal time scale of the East Asian winter monsoon (EAWM). In this paper, the extended reanalysis (ERA)-Interim sub-daily data are used to study the surface air temperature intraseasonal oscillation (ISO) of the EAWM. The results show that the air temperature (2-m level) of the EAWM has a dominant period of 10-30 days. Lake Baikal and south China are the centers of the air temperature ISO. An anomalous low frequency (10-30-day filtered) anticyclone corresponds to the intraseasonal cold air. The 10-30-day filtered cold air spreads from Novaya Zemlya to Lake Baikal and even to South China. The ISO of the Arctic Oscillation (AO) index influences the temperature of the EAWM by stimulating Rossby waves in middle latitude, causing meridional circulation, and eventually leads to the temperature ISO of the EAWM. RegCM4 has good performance for the simulation of the air temperature ISO. The simulated results indicate that the plateau is responsible for the southward propagation of the intraseasonal anticyclone. The anticyclone could not reach South China when there was no plateau in western China and its upper reaches.

  6. Surgeon volume and 30 day mortality for brain tumours in England

    PubMed Central

    Williams, Matt; Treasure, Peter; Greenberg, David; Brodbelt, Andrew; Collins, Peter

    2016-01-01

    Background: There is evidence that surgeons who perform more operations have better outcomes. However, in patients with brain tumours, all of the evidence comes from the USA. Methods: We examined all English patients with an intracranial neoplasm who had an intracranial resection in 2008–2010. We included surgeons who performed at least six operations over 3 years, and at least one operation in the first and last 6 months of the period. Results: The analysis data set comprised 9194 operations, 163 consultant neurosurgeons and 30 centres. Individual surgeon volumes varied widely (7–272; median=46). 72% of operations were on the brain, and 30 day mortality was 3%. A doubling of surgeon load was associated with a 20% relative reduction in mortality. Thirty day mortality varied between centres (0·95–8·62%) but was not related to centre workload. Conclusions: Individual surgeon volumes correlated with patient 30 day mortality. Centres and surgeons in England are busier than surgeons and centres in the USA. There is no relationship between centre volume and 30 day mortality in England. Services in the UK appear to be adequately arranged at a centre level, but would benefit from further surgeon sub-specialisation. PMID:27764843

  7. Discharge to a rehabilitation facility is associated with decreased 30-day readmission in elective spinal surgery.

    PubMed

    Abt, Nicholas B; McCutcheon, Brandon A; Kerezoudis, Panagiotis; Murphy, Meghan; Rinaldo, Lorenzo; Fogelson, Jeremy; Nassr, Ahmad; Currier, Bradford L; Bydon, Mohamad

    2017-02-01

    The aim of our study was to determine independent predictors of discharge disposition to rehabilitation or skilled care (SC) facilities and investigate whether discharge location is associated with unplanned readmission and/or reoperation rates. All elective spinal surgery patients in a national surgical registry were analyzed using between 2011 and 2012. Multivariable logistic regression analysis was used to assess for predictors of discharge to rehabilitation or SC facilities versus home as well as to determine whether discharge disposition was significantly associated with the 30-day unplanned readmission or reoperation. Of 34,023 elective spinal surgery patients, the distribution of discharge locations was as follows: 30,606 (90.0%) discharged home, 1674 (4.9%) discharged to rehabilitation, and 1743 (5.1%) discharged to SC. Patients discharged home were associated with the lowest complication rate relative to rehabilitation and SC facilities. Following multivariable regression analysis, there was a significant increase in the odds of discharge to rehabilitation associated with age, male gender, current smoking, ASA class three and four, history of diabetes, operative time, total hospital length of stay, preoperative neurologic morbidity and having at least one postoperative morbidity event. Moreover, there were 804 (4.06%) 30-day unplanned readmissions and 822 (2.45%) unplanned reoperations. After risk adjustment, discharge to rehabilitation was independently associated with decreased odds of 30-day unplanned readmission (OR=0.41; p=0.008) but not reoperation.

  8. Risk Factors and Indications for 30-Day Readmission After Primary Surgery for Epithelial Ovarian Cancer

    PubMed Central

    AlHilli, Mariam; Langstraat, Carrie; Tran, Christine; Martin, Janice; Weaver, Amy; McGree, Michaela; Mariani, Andrea; Cliby, William; Bakkum-Gamez, Jamie

    2015-01-01

    Background To identify patients at risk for postoperative morbidities, we evaluated indications and factors associated with 30-day readmission after epithelial ovarian cancer surgery. Methods Patients undergoing primary surgery for epithelial ovarian cancer between January 2, 2003, and December 29, 2008, were evaluated. Univariable and multivariable logistic regression models were fit to identify factors associated with 30-day readmission. A parsimonious multivariable model was identified using backward and stepwise variable selection. Results In total, 324 (60.2%) patients were stage III and 91 (16.9%) were stage IV. Of all 538 eligible patients, 104 (19.3%) were readmitted within 30 days. Cytoreduction to no residual disease was achieved in 300 (55.8%) patients, and 167 (31.0%) had measurable disease (≤1 cm residual disease). The most common indications for readmission were surgical site infection (SSI; 21.2%), pleural effusion/ascites management (14.4%), and thromboembolic events (12.5%). Multivariate analysis identified American Society of Anesthesiologists score of 3 or higher (odds ratio, 1.85; 95% confidence interval, 1.18–2.89; P = 0.007), ascites [1.76 (1.11–2.81); P = 0.02], and postoperative complications during initial admission [grade 3–5 vs none, 2.47 (1.19–5.16); grade 1 vs none, 2.19 (0.98–4.85); grade 2 vs none, 1.28 (0.74–2.21); P = 0.048] to be independently associated with 30-day readmission (c-index = 0.625). Chronic obstructive pulmonary disease was the sole predictor of readmission for SSI (odds ratio, 3.92; 95% confidence interval, 1.07–4.33; P = 0.04). Conclusions Clinically significant risk factors for 30-day readmission include American Society of Anesthesiologists score of 3 or higher, ascites and postoperative complications at initial admission. The SSI and pleural effusions/ascites are common indications for readmission. Systems can be developed to predict patients needing outpatient management, improve care, and reduce

  9. ADMA predicts major adverse renal events in patients with mild renal impairment and/or diabetes mellitus undergoing coronary angiography

    PubMed Central

    Heunisch, Fabian; Chaykovska, Lyubov; von Einem, Gina; Alter, Markus; Dschietzig, Thomas; Kretschmer, Axel; Kellner, Karl-Heinz; Hocher, Berthold

    2017-01-01

    Abstract Asymmetric dimethylarginine (ADMA) is a competitive inhibitor of the nitric oxide (NO)-synthase and a biomarker of endothelial dysfunction (ED). ED plays an important role in the pathogenesis of contrast-induced nephropathy (CIN). The aim of our study was to evaluate serum ADMA concentration as a biomarker of an acute renal damage during the follow-up of 90 days after contrast medium (CM) application. Blood samples were obtained from 330 consecutive patients with diabetes mellitus or mild renal impairment immediately before, 24 and 48 hours after the CM application for coronary angiography. The patients were followed for 90 days. The composite endpoints were major adverse renal events (MARE) defined as occurrence of death, initiation of dialysis, or a doubling of serum creatinine concentration. Overall, ADMA concentration in plasma increased after CM application, although, there was no differences between ADMA levels in patients with and without CIN. ADMA concentration 24 hours after the CM application was predictive for dialysis with a specificity of 0.889 and sensitivity of 0.653 at values higher than 0.71 μmol/L (area under the curve: 0.854, 95% confidential interval: 0.767–0.941, P < 0.001). This association remained significant in multivariate Cox regression models adjusted for relevant factors of long-term renal outcome. 24 hours after the CM application, ADMA concentration in plasma was predictive for MARE with a specificity of 0.833 and sensitivity of 0.636 at a value of more than 0.70 μmol/L (area under the curve: 0.750, 95% confidence interval: 0.602–0.897, P = 0.004). Multivariate logistic regression analysis confirmed that ADMA and anemia were significant predictors of MARE. Further analysis revealed that increased ADMA concentration in plasma was highly significant predictor of MARE in patients with CIN. Moreover, patients with CIN and MARE had the highest plasma ADMA levels 24 hours after CM exposure in our study

  10. ADMA predicts major adverse renal events in patients with mild renal impairment and/or diabetes mellitus undergoing coronary angiography.

    PubMed

    Heunisch, Fabian; Chaykovska, Lyubov; von Einem, Gina; Alter, Markus; Dschietzig, Thomas; Kretschmer, Axel; Kellner, Karl-Heinz; Hocher, Berthold

    2017-02-01

    Asymmetric dimethylarginine (ADMA) is a competitive inhibitor of the nitric oxide (NO)-synthase and a biomarker of endothelial dysfunction (ED). ED plays an important role in the pathogenesis of contrast-induced nephropathy (CIN). The aim of our study was to evaluate serum ADMA concentration as a biomarker of an acute renal damage during the follow-up of 90 days after contrast medium (CM) application.Blood samples were obtained from 330 consecutive patients with diabetes mellitus or mild renal impairment immediately before, 24 and 48 hours after the CM application for coronary angiography. The patients were followed for 90 days. The composite endpoints were major adverse renal events (MARE) defined as occurrence of death, initiation of dialysis, or a doubling of serum creatinine concentration.Overall, ADMA concentration in plasma increased after CM application, although, there was no differences between ADMA levels in patients with and without CIN. ADMA concentration 24 hours after the CM application was predictive for dialysis with a specificity of 0.889 and sensitivity of 0.653 at values higher than 0.71 μmol/L (area under the curve: 0.854, 95% confidential interval: 0.767-0.941, P < 0.001). This association remained significant in multivariate Cox regression models adjusted for relevant factors of long-term renal outcome. 24 hours after the CM application, ADMA concentration in plasma was predictive for MARE with a specificity of 0.833 and sensitivity of 0.636 at a value of more than 0.70 μmol/L (area under the curve: 0.750, 95% confidence interval: 0.602-0.897, P = 0.004). Multivariate logistic regression analysis confirmed that ADMA and anemia were significant predictors of MARE. Further analysis revealed that increased ADMA concentration in plasma was highly significant predictor of MARE in patients with CIN. Moreover, patients with CIN and MARE had the highest plasma ADMA levels 24 hours after CM exposure in our study cohort. The impact

  11. 17 CFR 240.3a55-2 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... contracts trading for fewer than 30 days. 240.3a55-2 Section 240.3a55-2 Commodity and Securities Exchanges... Indexes underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of... the Act (15 U.S.C. 78c(a)(55)) for the first 30 days of trading, if: (1) Such index would not...

  12. 17 CFR 240.3a55-2 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... contracts trading for fewer than 30 days. 240.3a55-2 Section 240.3a55-2 Commodity and Securities Exchanges... Indexes underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of... the Act (15 U.S.C. 78c(a)(55)) for the first 30 days of trading, if: (1) Such index would not...

  13. 17 CFR 240.3a55-2 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... contracts trading for fewer than 30 days. 240.3a55-2 Section 240.3a55-2 Commodity and Securities Exchanges... Indexes underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of... the Act (15 U.S.C. 78c(a)(55)) for the first 30 days of trading, if: (1) Such index would not...

  14. 17 CFR 240.3a55-2 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... contracts trading for fewer than 30 days. 240.3a55-2 Section 240.3a55-2 Commodity and Securities Exchanges... Indexes underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of... the Act (15 U.S.C. 78c(a)(55)) for the first 30 days of trading, if: (1) Such index would not...

  15. 17 CFR 240.3a55-2 - Indexes underlying futures contracts trading for fewer than 30 days.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... contracts trading for fewer than 30 days. 240.3a55-2 Section 240.3a55-2 Commodity and Securities Exchanges... Indexes underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of... the Act (15 U.S.C. 78c(a)(55)) for the first 30 days of trading, if: (1) Such index would not...

  16. Rat brain pro-oxidant effects of peripherally administered 5 nm ceria 30 days after exposure.

    PubMed

    Hardas, Sarita S; Sultana, Rukhsana; Warrier, Govind; Dan, Mo; Florence, Rebecca L; Wu, Peng; Grulke, Eric A; Tseng, Michael T; Unrine, Jason M; Graham, Uschi M; Yokel, Robert A; Butterfield, D Allan

    2012-10-01

    The objective of this study was to determine the residual pro-or anti-oxidant effects in rat brain 30 days after systemic administration of a 5 nm citrate-stabilized ceria dispersion. A ∼4% aqueous ceria dispersion was iv-infused (0 or 85 mg/kg) into rats which were terminated 30 days later. Ceria concentration, localization, and chemical speciation in the brain was assessed by inductively coupled plasma mass spectrometry (ICP-MS), light and electron microscopy (EM), and electron energy loss spectroscopy (EELS), respectively. Pro- or anti-oxidant effects were evaluated by measuring levels of protein carbonyls (PC), 3-nitrotyrosine (3NT), and protein-bound-4-hydroxy-2-trans-nonenal (HNE) in the hippocampus, cortex, and cerebellum. Glutathione reductase (GR), glutathione peroxidase (GPx), superoxide dismutase (SOD), and catalase levels and activity were measured in addition to levels of inducible nitric oxide (iNOS), and heat shock protein-70 (Hsp70). The blood brain barrier (BBB) was visibly intact and no ceria was seen in the brain cells. Ceria elevated PC and Hsp70 levels in hippocampus and cerebellum, while 3NT and iNOS levels were elevated in the cortex. Whereas glutathione peroxidase and catalase activity were decreased in the hippocampus, GR levels were decreased in the cortex, and GPx and catalase levels were decreased in the cerebellum. The GSH:GSSG ratio, an index of cellular redox status, was decreased in the hippocampus and cerebellum. The results are in accordance with the observation that this nanoscale material remains in this mammal model up to 30 days after its administration and the hypothesis that it exerts pro-oxidant effects on the brain without crossing the BBB. These results have important implications on the potential use of ceria ENM as therapeutic agents.

  17. Derivation and validation of a 30-day heart failure readmission model.

    PubMed

    Fleming, Lisa M; Gavin, Michael; Piatkowski, Gail; Chang, James D; Mukamal, Kenneth J

    2014-11-01

    In 2006, there were >1 million hospital admissions for heart failure (HF), and the estimated cost to the United States in 2009 was >$37.2 billion. Better models to target aggressive therapy to patients at the highest risk for readmission are clearly needed. We studied 3,413 consecutive admissions for HF based on discharge diagnosis codes from October 2007 to August 2011 from a single academic center. We randomly generated derivation and validation sets in a 3:1 ratio. We used generalized estimating equations to develop our models, accounting for repeated hospitalizations and the Hosmer-Lemeshow test to examine model calibration. The 30-day readmission rate was 24.2% in the derivation set. Of 25 candidate variables, the best fitting model included creatinine, troponin, hematocrit, and hyponatremia at discharge; race; zip code of residence; discharge hour; and number of hospitalizations in the previous year. Insignificant variables included intravenous diuretic use on day of discharge, discharge service, diabetes, atrial fibrillation, age, and gender. The risk of 30-day readmission increased with increasing decile of predicted risk in both the validation and derivation cohorts. The area under the receiver operating characteristic curve for the model was 0.69 in the derivation set and 0.66 in the validation set. In conclusion, we derived and validated a simple model relating discharge-specific characteristics at risk of 30-day readmission. Application of this approach may facilitate targeted intervention to reduce the burden of rehospitalization in patients with HF, but our results suggest that the best readmission models may require incorporation of both clinical and local system factors for optimal prediction.

  18. Changes in size and compliance of the calf after 30 days of simulated microgravity

    NASA Technical Reports Server (NTRS)

    Convertino, Victor A.; Doerr, Donald F.; Stein, Stewart L.

    1989-01-01

    The hypothesis that reducing muscle compartment by a long-term exposure to microgravity would cause increased leg venous compliance was tested in eight men who were assessed for vascular compliance and for serial circumferences of the calf before and after 30 days of continuous 6-deg head-down bed rest. It was found that head-down bed rest caused decreases in the calculated calf volume and the calf-muscle compartment, as well as increases in calf compliance. The percent increases in calf compliance correlated significantly with decreases in calf muscle compartment.

  19. Race, Rehabilitation, and 30-Day Readmission After Elective Total Knee Arthroplasty

    PubMed Central

    Jorgenson, Erik S.; Richardson, Diane M.; Thomasson, Arwin M.; Nelson, Charles L.

    2015-01-01

    Introduction: To examine racial variations in access to postacute care (PAC) and rehabilitation (Rehab) services following elective total knee arthroplasty and whether where patients go after surgery for PAC/Rehab is associated with 30-day readmission to acute care facility. Materials and Methods: Sample consisted of 129 522 patients discharged from 169 hospitals in the State of Pennsylvania between fiscal years 2008 and 2012. We used multinomial regression models to assess the relationship between patient race and discharge destination after surgery, for patients aged 18 to 64 years and for those aged 65 and older. We used multivariable (MV) regression and propensity score (PS) approaches to examine the relationship between patient discharge destination after surgery for PAC/Rehab and 30-day readmission, controlling for key individual- and facility-level factors. Results: Lower proportions of younger patients compared to those older than 65 were discharged to inpatient rehabilitation facilities (IRFs; 5.8% vs 12.6%, respectively) and skilled nursing facilities (SNFs; 15.2% vs 32.7%, respectively) compared to home-based Rehab (self-care; 23.3% vs 14.2%, respectively). Compared to whites, African American patients had significantly higher odds of discharge to IRF (age < 65, odds ratio = 2.04; age ≥ 65, odds ratio = 1.64) and to SNF (age < 65, odds ratio = 2.86; age ≥ 65, odds ratio = 2.19) and discharge to home care in patients younger than 65 years (odds ratio = 1.31). The odds of 30-day readmission among patients discharged to an IRF (MV odds ratio = 7.76; PS odds ratio = 8.34) and SNF (MV odds ratio = 2.01; PS odds ratio = 1.83) were significantly higher in comparison to patients discharged home with self-care. Conclusion: African American patients with knee replacement are more likely to be discharged to inpatient Rehab settings following surgery. Inpatient Rehab is significantly associated with 30-day readmission to acute care facility. PMID:26623166

  20. Development and implementation of a real-time 30-day readmission predictive model.

    PubMed

    Cronin, Patrick R; Greenwald, Jeffrey L; Crevensten, Gwen C; Chueh, Henry C; Zai, Adrian H

    2014-01-01

    Hospitals are under great pressure to reduce readmissions of patients. Being able to reliably predict patients at increased risk for rehospitalization would allow for tailored interventions to be offered to them. This requires the creation of a functional predictive model specifically designed to support real-time clinical operations. A predictive model for readmissions within 30 days of discharge was developed using retrospective data from 45,924 MGH admissions between 2/1/2012 and 1/31/2013 only including factors that would be available by the day after admission. It was then validated prospectively in a real-time implementation for 3,074 MGH admissions between 10/1/2013 and 10/31/2013. The model developed retrospectively had an AUC of 0.705 with good calibration. The real-time implementation had an AUC of 0.671 although the model was overestimating readmission risk. A moderately discriminative real-time 30-day readmission predictive model can be developed and implemented in a large academic hospital.

  1. The Relationship Between Nurse Staffing and 30-Day Readmission for Adults With Heart Failure

    PubMed Central

    Giuliano, Karen K.; Danesh, Valerie; Funk, Marjorie

    2016-01-01

    OBJECTIVE The purpose of this study was to better understand the relationship between nurse staffing and 30-day excess readmission ratios for patients with heart failure in the top US adult cardiology and heart surgery hospitals. BACKGROUND Heart failure is the most common cause of hospitalization for patients older than 65 years and is the most frequent diagnosis associated with 30-day hospital readmission in the United States. METHODS A secondary data analysis was conducted using nurse staffing data from 661 cardiology and heart surgery hospitals from the 2013 US News & World Report “Best Hospitals” survey. These data were combined with excess readmission ratios from the Centers for Medicare & Medicaid Services Hospital Compare database from 2013. An independent-samples t test was used to compare staffing (low/high) and excess hospital readmissions rates. RESULTS A significant difference (P = .021) was found between the low nurse staffing group (n = 358) and the high nurse staffing group (n = 303). Hospitals with a lower nurse staffing index had a significantly higher excess readmission rate. CONCLUSION These data provide further support to the body of research showing a positive relationship between nurse staffing and positive outcomes. PMID:26579974

  2. 78 FR 70958 - 30-Day Notice of Proposed Information Collection: Recordkeeping for HUD's Continuum of Care Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Recordkeeping for HUD's Continuum of Care Program AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: HUD has... allow for an additional 30 days of public comment. DATES: Comments Due Date: December 27,...

  3. Early inpatient calculation of laboratory-based 30-day readmission risk scores empowers clinical risk modification during index hospitalization.

    PubMed

    Horne, Benjamin D; Budge, Deborah; Masica, Andrew L; Savitz, Lucy A; Benuzillo, José; Cantu, Gabriela; Bradshaw, Alejandra; McCubrey, Raymond O; Bair, Tami L; Roberts, Colleen A; Rasmusson, Kismet D; Alharethi, Rami; Kfoury, Abdallah G; James, Brent C; Lappé, Donald L

    2017-03-01

    Improving 30-day readmission continues to be problematic for most hospitals. This study reports the creation and validation of sex-specific inpatient (i) heart failure (HF) risk scores using electronic data from the beginning of inpatient care for effective and efficient prediction of 30-day readmission risk.

  4. Tropical 40-50- and 25-30-day oscillations appearing in realistic and idealized GFDL climate models and the ECMWF dataset

    SciTech Connect

    Hayashi, Y.; Golder, D.G. )

    1993-02-01

    To clarify differences between the tropical 40-50- and 25-30-day oscillations and to evaluate simulations and various theories, space-time spectrum and filter analyses were performed on a nine-year dataset taken from the nine-level R30 spectral general circulation model and the nine-year (1979-1987) ECMWF four-dimensional analysis dataset. The 40-level SKYHI model was analyzed to examine the effect of increased vertical resolution, while an ocean-surface perpetual January R30 model was analyzed to examine the effects of the absence of geographical and seasonal variations. The R30 model results indicate that the relative amplitude of the wavenumber-one component of the 40-50- and 25-30-day oscillations varies greatly from year to year. The SKYHI model indicates that 25-30-day oscillations still appear too strong, although this model reveals a longer vertical wavelength, a higher penetration of the 25-30-day amplitude above the level of convective heating, and a slightly greater height of the convective-heating amplitude, which cannot be detected in the R30 model. The ocean-surface perpetual January R30 model indicates that not only the 25-30-day mode but also the 40-50-day mode can be simulated in the absence of geographical and seasonal modulations, while the wave-CISK and evaporation-wind feedback theories cannot explain the 40-50-day mode. Both R30 models indicate that daily precipitation is usuallys associated with upward motion. A comparison between the two R30 models suggests that the sea surface temperature geographically modules the intrinsically eastward-moving wavenumber-one precipitation oscillations, resulting in their major Pacific and minor Atlantic local amplitudes. This causes planetary-scale eastward-moving zonal-velocity oscillations and standing geopotential oscillations. 121 refs., 26 figs.

  5. Correspondence between hair cortisol concentrations and 30-day integrated daily salivary and weekly urinary cortisol measures.

    PubMed

    Short, Sarah J; Stalder, Tobias; Marceau, Kristine; Entringer, Sonja; Moog, Nora K; Shirtcliff, Elizabeth A; Wadhwa, Pathik D; Buss, Claudia

    2016-09-01

    Characterization of cortisol production, regulation and function is of considerable interest and relevance given its ubiquitous role in virtually all aspects of physiology, health and disease risk. The quantification of cortisol concentration in hair has been proposed as a promising approach for the retrospective assessment of integrated, long-term cortisol production. However, human research is still needed to directly test and validate current assumptions about which aspects of cortisol production and regulation are reflected in hair cortisol concentrations (HCC). Here, we report findings from a validation study in a sample of 17 healthy adults (mean±SD age: 34±8.6 yrs). To determine the extent to which HCC captures cumulative cortisol production, we examined the correspondence of HCC, obtained from the first 1cm scalp-near hair segment, assumed to retrospectively reflect 1-month integrated cortisol secretion, with 30-day average salivary cortisol area-under-the curve (AUC) based on 3 samples collected per day (on awakening, +30min, at bedtime) and the average of 4 weekly 24-h urinary free cortisol (UFC) assessments. To further address which aspects of cortisol production and regulation are best reflected in the HCC measure, we also examined components of the salivary measures that represent: (1) production in response to the challenge of awakening (using the cortisol awakening response [CAR]), and (2) chronobiological regulation of cortisol production (using diurnal slope). Finally, we evaluated the test-retest stability of each cortisol measure. Results indicate that HCC was most strongly associated with the prior 30-day integrated cortisol production measure (average salivary cortisol AUC) (r=0.61, p=0.01). There were no significant associations between HCC and the 30-day summary measures using CAR or diurnal slope. The relationship between 1-month integrated 24-h UFC and HCC did not reach statistical significance (r=0.30, p=0.28). Lastly, of all cortisol

  6. Incidence And Risk Factors For 30-Day Readmissions After Hip Fracture Surgery

    PubMed Central

    Martin, Christopher T; Gao, Yubo; Pugely, Andrew J.

    2016-01-01

    Background Unplanned hospital readmission following orthopedic procedures results in significant expenditures for the Medicare population. In order to reduce expenditures, hospital readmission has become an important quality metric for Medicare patients. The purpose of the present study is to determine the incidence and risk factors for 30-day readmissions after hip fracture surgery. Methods Patients over the age of 18 years who underwent hip fracture surgery, including open reduction internal fixation (ORIF), intramedullary nailing, hemi-arthroplasty, or total hip arthroplasty, between the years 2012 and 2013 were identified from the American College of Surgeons National Surgical Quality improvement Program (NSQIP) database. Overall, 17,765 patients were identified. Univariate and multivariate analyses were performed in order to determine patient and surgical factors associated with 30-day readmission. Results There were 1503 patients (8.4%) readmitted within 30-days of their index procedure. Of the patients with a reason listed for readmission, 27.4% were for procedurally related reasons, including wound complications (16%), peri-prosthetic fractures (4.5%) and prosthetic dislocations (6%). 72.6% of readmissions were for medical reasons, including sepsis (7%), pneumonia (14%), urinary tract infection (6.3%), myocardial infarction (2.7%), renal failure (2.7%), and stroke (2.3%). In the subsequent multivariate analysis, pre-operative dyspnea, COPD, hypertension, disseminated cancer, a bleeding disorder, pre-operative hematocrit of <36, pre-operative creatinine of >1.2, an ASA class of 3 or 4, and the operative procedure type were each independently associated with readmissions risk (p<0.05 for each). Conclusions The overall rate of readmission following hip fracture surgery was moderate. Surgeons should consider discharge optimization in the at risk cohorts identified here, particularly patients with multiple medical comorbidities or an elevated ASA class, and

  7. [Adverse perinatal and infant outcomes among children born to mothers with major mental disorders in a psychiatric hospital in Rio de Janeiro, Brazil].

    PubMed

    Pereira, Priscila Krauss; Vieira, Cláudia Lima; Santos, Jacqueline Fernandes de Cintra; Lima, Lúcia Abelha; Legay, Letícia Fortes; Lovisi, Giovanni Marcos

    2014-08-01

    Adverse perinatal and infant outcomes are the leading causes of infant morbidity and mortality in developing countries like Brazil. Among the risk factors are maternal mental disorders. A retrospective longitudinal study was conducted based on passive follow-up using probabilistic record linkage to estimate the prevalence of adverse perinatal and infant outcomes in children of women admitted to a public psychiatric hospital in Rio de Janeiro, Brazil, and who gave birth from 1999 to 2009. Prevalence rates were: low birth weight (27.6%), prematurity (17.4%), malformations (2.5%), stillbirths (4.8%), and neonatal deaths (3.7%). Associated factors were deficient prenatal care, schizophrenia, and low income. The results corroborate the high prevalence of adverse perinatal and infant outcomes in mothers with major mental disorders, and that screening of psychiatric symptoms and specialized care by mental health professionals are essential throughout prenatal and postpartum care.

  8. Assessing Risk and Preventing 30-Day Readmissions in Decompensated Heart Failure: Opportunity to Intervene?

    PubMed

    Dunbar-Yaffe, Richard; Stitt, Audra; Lee, Joseph J; Mohamed, Shanas; Lee, Douglas S

    2015-10-01

    Heart failure (HF) patients are at high risk of hospital readmission, which contributes to substantial health care costs. There is great interest in strategies to reduce rehospitalization for HF. However, many readmissions occur within 30 days of initial hospital discharge, presenting a challenge for interventions to be instituted in a short time frame. Potential strategies to reduce readmissions for HF can be classified into three different forms. First, patients who are at high risk of readmission can be identified even before their initial index hospital discharge. Second, ambulatory remote monitoring strategies may be instituted to identify early warning signs before acute decompensation of HF occurs. Finally, strategies may be employed in the emergency department to identify low-risk patients who may not need hospital readmission. If symptoms improve with initial therapy, low-risk patients could be referred to specialized, rapid outpatient follow-up care where investigations and therapy can occur in an outpatient setting.

  9. The Gravity of LBNP Exercise: Lessons Learned from Identical Twins in Bed for 30 Days

    NASA Technical Reports Server (NTRS)

    Hargens, Alan R.; Groppo, Eli R.; Lee, Stuart M. C.; Watenpaugh, Donald; Schneider, Suzanne; O'Leary, Deborah; Smith, Scott M.; Steinbach, Gregory C.; Tanaka, Kunihiko; Kimura, Shinji; Meyer, R. Scott

    2002-01-01

    Microgravity leads to cardiovascular deconditioning in humans, which is manifested by post-flight reduction of orthostatic tolerance and upright exercise capacity. During upright posture on Earth, blood pressures are greater in the feet than at heart or head levels due to gravity's effects on columns of blood in the body. During exposure to Microgravity, all gravitational blood pressures disappear. Presently, there is no exercise hardware available for space flight to provide gravitational blood pressures to tissues of the lower body. We hypothesized that 40 minutes of supine treadmill running per day in a LBNP chamber at 1.0 to 1.2 body weight (approximately 50 - 60 mm Hg LBNP) with a 5 min resting, nonexercise LBNP exposure at 50 mm Hg after the exercise session will maintain aerobic fitness orthostatic tolerance, and selected parameters of musculoskeletal function during 30 days of bed rest (simulated microgravity). This paper is an interim report of some of our findings on 16 subjects.

  10. Development of Lightweight Material Composites to Insulate Cryogenic Tanks for 30-Day Storage in Outer Space

    NASA Technical Reports Server (NTRS)

    Krause, D. R.

    1972-01-01

    A conceptual design was developed for an MLI system which will meet the design constraints of an ILRV used for 7- to 30-day missions. The ten tasks are briefly described: (1) material survey and procurement, material property tests, and selection of composites to be considered; (2) definition of environmental parameters and tooling requirements, and thermal and structural design verification test definition; (3) definition of tanks and associated hardware to be used, and definition of MLI concepts to be considered; (4) thermal analyses, including purge, evacuation, and reentry repressurization analyses; (5) structural analyses (6) thermal degradation tests of composite and structural tests of fastener; (7) selection of MLI materials and system; (8) definition of a conceptual MLI system design; (9) evaluation of nondestructive inspection techniques and definition of procedures for repair of damaged areas; and (10) preparation of preliminary specifications.

  11. Structural and metabolic characteristics of human skeletal muscle following 30 days of simulated microgravity

    NASA Technical Reports Server (NTRS)

    Hikida, Robert S.; Gollnick, Philip D.; Dudley, Gary A.; Convertino, Victor A.; Buchanan, Paul

    1989-01-01

    The effects of simulated microgravity (30 days of continuous 6-deg headdown bedrest, BR) on the structural and metabolic characteristics of human skeletal muscle were determined. Percutaneous needle biopsy samples obtained from the vastus lateralis and soleus muscles before and after the headdown BR were analyzed for histochemical, biochemical and ultrastructual changes. It was found that headdown BR led to decreases in both fast-twitch and slow-twitch fiber areas in both muscles, and there was evidence of remodeling of the ultrastructure in both muscles. The activities of beta-hydroxyacyl-CoA dehydrogenase and citrate synthase were reduced during BR, but phosphofructokinase and lactate dehydrogenase activities did not change. The results indicate that 30-d exposure to simulated microgravity decreased the capacity for aerobic energy supply of human skeletal muscle and led to a disorganization of the contractile machinery.

  12. Continuous 30-day measurements utilizing the monkey metabolism pod. [study of weightlessness effects

    NASA Technical Reports Server (NTRS)

    Pace, N.; Kodama, A. M.; Mains, R. C.; Rahlmann, D. F.; Grunbaum, B. W.

    1977-01-01

    A fiberglass system was previously described, using which quantitative physiological measurements could be made to study the effects of weightlessness on 10 to 14 kg adult monkeys maintained in comfortable restraint under space flight conditions. Recent improvements in the system have made it possible to obtain continuous measurements of respiratory gas exchange, cardiovascular function, and mineral balance for periods of up to 30 days on pig-tailed monkeys. It has also been possible to operate two pods which share one set of instrumentation, thereby permitting simultaneous measurements to be made on two animals by commutating signal outputs from the pods. In principle, more than two pods could be operated in this fashion. The system is compatible with Spacelab design. Representative physiological data from ground tests of the system are presented.

  13. Bone metabolism and nutritional status during 30-day head-down-tilt bed rest.

    PubMed

    Morgan, Jennifer L L; Zwart, Sara R; Heer, Martina; Ploutz-Snyder, Robert; Ericson, Karen; Smith, Scott M

    2012-11-01

    Bed rest studies provide an important tool for modeling physiological changes that occur during spaceflight. Markers of bone metabolism and nutritional status were evaluated in 12 subjects (8 men, 4 women; ages 25-49 yr) who participated in a 30-day -6° head-down-tilt diet-controlled bed rest study. Blood and urine samples were collected twice before, once a week during, and twice after bed rest. Data were analyzed using a mixed-effects linear regression with a priori contrasts comparing all days to the second week of the pre-bed rest acclimation period. During bed rest, all urinary markers of bone resorption increased ~20% (P < 0.001), and serum parathyroid hormone decreased ~25% (P < 0.001). Unlike longer (>60 days) bed rest studies, neither markers of oxidative damage nor iron status indexes changed over the 30 days of bed rest. Urinary oxalate excretion decreased ~20% during bed rest (P < 0.001) and correlated inversely with urinary calcium (R = -0.18, P < 0.02). These data provide a broad overview of the biochemistry associated with short-duration bed rest studies and provide an impetus for using shorter studies to save time and costs wherever possible. For some effects related to bone biochemistry, short-duration bed rest will fulfill the scientific requirements to simulate spaceflight, but other effects (antioxidants/oxidative damage, iron status) do not manifest until subjects are in bed longer, in which case longer studies or other analogs may be needed. Regardless, maximizing research funding and opportunities will be critical to enable the next steps in space exploration.

  14. Integrated systems of stroke care and reduction in 30-day mortality

    PubMed Central

    Ganesh, Aravind; Lindsay, Patrice; Fang, Jiming; Kapral, Moira K.; Côté, Robert; Joiner, Ian; Hakim, Antoine M.

    2016-01-01

    Objective: To evaluate the association between the presence of integrated systems of stroke care and stroke case-fatality across Canada. Methods: We used the Canadian Institute of Health Information's Discharge Abstract Database to retrospectively identify a cohort of stroke/TIA patients admitted to all acute care hospitals, excluding the province of Quebec, in 11 fiscal years from 2003/2004 to 2013/2014. We used a modified Poisson regression model to compute the adjusted incidence rate ratio (aIRR) of 30-day in-hospital mortality across time for provinces with stroke systems compared to those without, controlling for age, sex, stroke type, comorbidities, and discharge year. We conducted surveys of stroke care resources in Canadian hospitals in 2009 and 2013, and compared resources in provinces with integrated systems to those without. Results: A total of 319,972 patients were hospitalized for stroke/TIA. The crude 30-day mortality rate decreased from 15.8% in 2003/2004 to 12.7% in 2012/2013 in provinces with stroke systems, while remaining 14.5% in provinces without such systems. Starting with the fiscal year 2009/2010, there was a clear reduction in relative mortality in provinces with stroke systems vs those without, sustained at aIRR of 0.85 (95% confidence interval 0.79–0.92) in the 2011/2012, 2012/2013, and 2013/2014 fiscal years. The surveys indicated that facilities in provinces with such systems were more likely to care for patients on a stroke unit, and have timely access to a stroke prevention clinic and telestroke services. Conclusion: In this retrospective study, the implementation of integrated systems of stroke care was associated with a population-wide reduction in mortality after stroke. PMID:26850979

  15. Bone metabolism and nutritional status during 30-day head-down-tilt bed rest

    PubMed Central

    Morgan, Jennifer L. L.; Zwart, Sara R.; Heer, Martina; Ploutz-Snyder, Robert; Ericson, Karen

    2012-01-01

    Bed rest studies provide an important tool for modeling physiological changes that occur during spaceflight. Markers of bone metabolism and nutritional status were evaluated in 12 subjects (8 men, 4 women; ages 25–49 yr) who participated in a 30-day −6° head-down-tilt diet-controlled bed rest study. Blood and urine samples were collected twice before, once a week during, and twice after bed rest. Data were analyzed using a mixed-effects linear regression with a priori contrasts comparing all days to the second week of the pre-bed rest acclimation period. During bed rest, all urinary markers of bone resorption increased ∼20% (P < 0.001), and serum parathyroid hormone decreased ∼25% (P < 0.001). Unlike longer (>60 days) bed rest studies, neither markers of oxidative damage nor iron status indexes changed over the 30 days of bed rest. Urinary oxalate excretion decreased ∼20% during bed rest (P < 0.001) and correlated inversely with urinary calcium (R = −0.18, P < 0.02). These data provide a broad overview of the biochemistry associated with short-duration bed rest studies and provide an impetus for using shorter studies to save time and costs wherever possible. For some effects related to bone biochemistry, short-duration bed rest will fulfill the scientific requirements to simulate spaceflight, but other effects (antioxidants/oxidative damage, iron status) do not manifest until subjects are in bed longer, in which case longer studies or other analogs may be needed. Regardless, maximizing research funding and opportunities will be critical to enable the next steps in space exploration. PMID:22995395

  16. Prognostic Value of Combined CT Angiography and Myocardial Perfusion Imaging versus Invasive Coronary Angiography and Nuclear Stress Perfusion Imaging in the Prediction of Major Adverse Cardiovascular Events: The CORE320 Multicenter Study.

    PubMed

    Chen, Marcus Y; Rochitte, Carlos E; Arbab-Zadeh, Armin; Dewey, Marc; George, Richard T; Miller, Julie M; Niinuma, Hiroyuki; Yoshioka, Kunihiro; Kitagawa, Kakuya; Sakuma, Hajime; Laham, Roger; Vavere, Andrea L; Cerci, Rodrigo J; Mehra, Vishal C; Nomura, Cesar; Kofoed, Klaus F; Jinzaki, Masahiro; Kuribayashi, Sachio; Scholte, Arthur J; Laule, Michael; Tan, Swee Yaw; Hoe, John; Paul, Narinder; Rybicki, Frank J; Brinker, Jeffrey A; Arai, Andrew E; Matheson, Matthew B; Cox, Christopher; Clouse, Melvin E; Di Carli, Marcelo F; Lima, João A C

    2017-03-14

    Purpose To compare the prognostic importance (time to major adverse cardiovascular event [MACE]) of combined computed tomography (CT) angiography and CT myocardial stress perfusion imaging with that of combined invasive coronary angiography (ICA) and stress single photon emission CT myocardial perfusion imaging. Materials and Methods This study was approved by all institutional review boards, and written informed consent was obtained. Between November 2009 and July 2011, 381 participants clinically referred for ICA and aged 45-85 years were enrolled in the Combined Noninvasive Coronary Angiography and Myocardial Perfusion Imaging Using 320-Detector Row Computed Tomography (CORE320) prospective multicenter diagnostic study. All images were analyzed in blinded independent core laboratories, and a panel of physicians adjudicated all adverse events. MACE was defined as revascularization (>30 days after index ICA), myocardial infarction, or cardiac death; hospitalization for chest pain or congestive heart failure; or arrhythmia. Late MACE was defined similarly, except for patients who underwent revascularization within the first 182 days after ICA, who were excluded. Comparisons of 2-year survival (time to MACE) used standard Kaplan-Meier curves and restricted mean survival times bootstrapped with 2000 replicates. Results An MACE (49 revascularizations, five myocardial infarctions, one cardiac death, nine hospitalizations for chest pain or congestive heart failure, and one arrhythmia) occurred in 51 of 379 patients (13.5%). The 2-year MACE-free rates for combined CT angiography and CT perfusion findings were 94% negative for coronary artery disease (CAD) versus 82% positive for CAD and were similar to combined ICA and single photon emission CT findings (93% negative for CAD vs 77% positive for CAD, P < .001 for both). Event-free rates for CT angiography and CT perfusion versus ICA and single photon emission CT for either positive or negative results were not

  17. 30-Day Mortality and Late Survival with Reinterventions and Readmissions after Open and Endovascular Aortic Aneurysm Repair in Medicare Beneficiaries

    PubMed Central

    Giles, Kristina A; Landon, Bruce E; Cotterill, Philip; O'Malley, A. James; Pomposelli, Frank B; Schermerhorn, Marc L

    2010-01-01

    Objectives Late survival is similar after EVAR and open AAA repair despite a perioperative benefit with EVAR. AAA-related reinterventions are more common after EVAR while laparotomy related reinterventions are more common after open repair. The impact of reinterventions on survival, however, is unknown. We therefore evaluate the rate of reinterventions and readmission after initial AAA repair along with 30-day mortality and the effect upon long term survival. Methods We identified AAA and laparotomy-related reinterventions for propensity score matched cohorts of Medicare beneficiaries (n=45,652) undergoing EVAR and open repair from 2001-2004. Follow-up was up to 6 years. Hospitalizations for ruptured AAA without repair and for bowel obstruction or ventral hernia without abdominal surgery were also recorded. Event rates were calculated per year and are also presented through 6 years of follow-up as events per 100 person years. Thirty day mortality was calculated for each reintervention or readmission. Results Through 6 years, overall reinterventions or readmissions were similar between repair methods but slightly more common after EVAR (7.6 vs. 7.0 per 100 person years, RR 1.1, P < .001). Overall 30 day mortality with any reintervention or readmission was 9.1%. EVAR patients had more ruptures (0.50 vs. 0.09, RR 5.7, P < .001) with a mortality of 28%, but these were uncommon. EVAR patients also had more AAA-related reinterventions through 6 years (3.7 vs. 0.9, RR 4.0, P < .001) (mortality 5.6%), the majority of which were minor endovascular reinterventions (2.4 vs. 0.2, RR 11.4, P < .001) with a 30 day mortality of 3.0%. However, minor open (0.8 vs. 0.5, RR 1.4, P < .001) (mortality 6.9%) and major reinterventions (0.4 vs. 0.2, RR 2.4, P < .001) (mortality 12.1%) were also more common after EVAR than open repair. Conversely, EVAR patients had fewer laparotomy related reinterventions than open patients (1.4 vs. 3.0, RR 0.5, P < .001) (mortality 8.1%) and readmissions

  18. Low serum albumin and total lymphocyte count as predictors of 30 day hospital readmission in patients 65 years of age or older.

    PubMed

    Robinson, Robert

    2015-01-01

    Introduction. Hospital readmission within 30 days of discharge is a target for health care cost savings through the medicare Value Based Purchasing initiative. Because of this focus, hospitals and health systems are investing considerable resources into the identification of patients at risk of hospital readmission and designing interventions to reduce the rate of hospital readmission. Malnutrition is a known risk factor for hospital readmission. Materials and Methods. All medical patients 65 years of age or older discharged from Memorial Medical Center from January 1, 2012 to March 31, 2012 who had a determination of serum albumin level and total lymphocyte count on hospital admission were studied retrospectively. Admission serum albumin levels and total lymphocyte counts were used to classify the nutritional status of all patients in the study. Patients with a serum albumin less than 3.5 grams/dL and/or a TLC less than 1,500 cells per mm3 were classified as having protein energy malnutrition. The primary outcome investigated in this study was hospital readmission for any reason within 30 days of discharge. Results. The study population included 1,683 hospital discharges with an average age of 79 years. The majority of the patients were female (55.9%) and had a DRG weight of 1.22 (0.68). 219 patients (13%) were readmitted within 30 days of hospital discharge. Protein energy malnutrition was common in this population. Low albumin was found in 973 (58%) patients and a low TLC was found in 1,152 (68%) patients. Low albumin and low TLC was found in 709 (42%) of patients. Kaplan-Meier analysis shows any laboratory evidence of PEM is a significant (p < 0.001) predictor of hospital readmission. Low serum albumin (p < 0.001) and TLC (p = 0.018) show similar trends. Cox proportional-hazards regression analysis showed low serum albumin (Hazard Ratio 3.27, 95% CI [2.30-4.63]) and higher DRG weight (Hazard Ratio 1.19, 95% CI [1.03-1.38]) to be significant independent

  19. Low serum albumin and total lymphocyte count as predictors of 30 day hospital readmission in patients 65 years of age or older

    PubMed Central

    2015-01-01

    Introduction. Hospital readmission within 30 days of discharge is a target for health care cost savings through the medicare Value Based Purchasing initiative. Because of this focus, hospitals and health systems are investing considerable resources into the identification of patients at risk of hospital readmission and designing interventions to reduce the rate of hospital readmission. Malnutrition is a known risk factor for hospital readmission. Materials and Methods. All medical patients 65 years of age or older discharged from Memorial Medical Center from January 1, 2012 to March 31, 2012 who had a determination of serum albumin level and total lymphocyte count on hospital admission were studied retrospectively. Admission serum albumin levels and total lymphocyte counts were used to classify the nutritional status of all patients in the study. Patients with a serum albumin less than 3.5 grams/dL and/or a TLC less than 1,500 cells per mm3 were classified as having protein energy malnutrition. The primary outcome investigated in this study was hospital readmission for any reason within 30 days of discharge. Results. The study population included 1,683 hospital discharges with an average age of 79 years. The majority of the patients were female (55.9%) and had a DRG weight of 1.22 (0.68). 219 patients (13%) were readmitted within 30 days of hospital discharge. Protein energy malnutrition was common in this population. Low albumin was found in 973 (58%) patients and a low TLC was found in 1,152 (68%) patients. Low albumin and low TLC was found in 709 (42%) of patients. Kaplan–Meier analysis shows any laboratory evidence of PEM is a significant (p < 0.001) predictor of hospital readmission. Low serum albumin (p < 0.001) and TLC (p = 0.018) show similar trends. Cox proportional-hazards regression analysis showed low serum albumin (Hazard Ratio 3.27, 95% CI [2.30–4.63]) and higher DRG weight (Hazard Ratio 1.19, 95% CI [1.03–1.38]) to be significant independent

  20. 78 FR 65697 - 30-Day Notice of Proposed Information Collection: Public Housing, Contracting With Resident-Owned...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Public Housing, Contracting With...: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451...

  1. 77 FR 73731 - 30-Day Notice of Proposed Information Collection: Application Under the Hague Convention on the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-11

    ... Notice is to allow 30 days for public comment. DATES: Submit comments directly to the Office of Management and Budget (OMB) up to January 10, 2013. ADDRESSES: Direct comments to the Department of...

  2. Analysis of rat testicular proteome following 30-day exposure to 900 MHz electromagnetic field radiation.

    PubMed

    Sepehrimanesh, Masood; Kazemipour, Nasrin; Saeb, Mehdi; Nazifi, Saeed

    2014-12-01

    The use of electromagnetic field (EMF) generating apparatuses such as cell phones is increasing, and has caused an interest in the investigations of its effects on human health. We analyzed proteome in preparations from the whole testis in adult male Sprague-Dawley rats that were exposed to 900 MHz EMF radiation for 1, 2, or 4 h/day for 30 consecutive days, simulating a range of possible human cell phone use. Subjects were sacrificed immediately after the end of the experiment and testes fractions were solubilized and separated via high-resolution 2D electrophoresis, and gel patterns were scanned, digitized, and processed. Thirteen proteins, which were found only in sham or in exposure groups, were identified by MALDI-TOF/TOF-MS. Among them, heat shock proteins, superoxide dismutase, peroxiredoxin-1, and other proteins related to misfolding of proteins and/or stress were identified. These results demonstrate significant effects of radio frequency modulated EMFs exposure on proteome, particularly in protein species in the rodent testis, and suggest that a 30-day exposure to EMF radiation induces nonthermal stress in testicular tissue. The functional implication of the identified proteins was discussed.

  3. Complications and 30-day Outcomes Associated With Venous Thromboembolism in the Pediatric Orthopaedic Surgical Population

    PubMed Central

    Baker, Dustin; Sherrod, Brandon; McGwin, Gerald; Ponce, Brent; Gilbert, Shawn

    2016-01-01

    Introduction The risk of morbidity associated with venous thromboembolism (VTE) after pediatric orthopaedic surgery remains unclear despite increased use of thromboprophylaxis measures. Methods The American College of Surgeons National Surgical Quality Improvement Program, Pediatric database was queried for patients undergoing an orthopaedic surgical procedure between 2012 and 2013. Upper extremity and skin/subcutaneous surgeries were excluded. Associations between VTE and procedure, demographics, comorbidities, preoperative laboratory values, and 30-day postoperative outcomes were evaluated. Results Of 14,776 cases, 15 patients (0.10%) experienced postoperative VTE. Deep vein thrombosis (DVT) occurred in 13 patients (0.09%), and pulmonary embolism developed in 2 patients (0.01%). The procedure with the highest VTE rate was surgery for infection (1.2%). Patient factors associated with the development of VTE included hyponatremia (P = 0.003), abnormal partial thromboplastin time (P = 0.046), elevated aspartate transaminase level (P = 0.004), and gastrointestinal (P = 0.011), renal (P = 0.016), and hematologic (P = 0.019) disorders. Nearly half (46.2%) of DVTs occurred postdischarge. Complications associated with VTE included prolonged hospitalization (P = <0.001), pneumonia (P = <0.001), unplanned intubation (P = 0.003), urinary tract infection (P = 0.003), and central line-associated bloodstream infection (P = <0.001). Most of the postoperative complications (66.7%) occurred before VTE diagnosis, and no patients with VTE died. Conclusion In the absence of specified risk factors, thromboprophylaxis may be unnecessary for this population. PMID:26855119

  4. [Activity of various oxidases and transaminases in the rat liver in the readaptation period after hypokinesia up to 30 days].

    PubMed

    Potapov, P P

    1990-01-01

    The activity of alpha-ketoglutarate dehydrogenase and succinic dehydrogenase in readaptation after 15-day hypokinesia was within normal limits, whereas following 30-day hypokinesia it was enhanced on days 11-15. Pyruvate dehydrogenase exhibited hyperactivity in the end of readaptation week 2 both in 15- and 30-day hypokinesia which resulted in rat liver hyperactivity of glutamate dehydrogenase and transaminases. Normal levels of the latter were recorded on readaptation day 12-19.

  5. Increased in vivo glucose utilization in 30-day-old obese Zucker rat: Role of white adipose tissue

    SciTech Connect

    Krief, S.; Bazin, R.; Dupuy, F.; Lavau, M. )

    1988-03-01

    In vivo whole-body glucose utilization and uptake in multiple individual tissues were investigated in conscious 30-day-old Zucker rats, which when obese are hyperphagic, hyperinsulinemic, and normoglycemic. Whole-body glucose metabolism (assessed by (3-{sup 3}H)glucose) was 40% higher in obese (fa/fa) than in lean (Fa/fa) rats, suggesting that obese rats were quite responsive to their hyperinsulinemia. In obese compared with lean rats, tissue glucose uptake was increased by 15, 12, and 6 times in dorsal, inguinal, perigonadal white depots, respectively; multiplied by 2.5 in brown adipose tissue; increased by 50% in skin from inguinal region but not in that from cranial, thoracic, or dorsal area; and increased twofold in diaphragm but similar in heart in proximal intestine, and in total muscular mass of limbs. The data establish that in young obese rats the hypertrophied white adipose tissue was a major glucose-utilizing tissue whose capacity for glucose disposal compared with that of half the muscular mass. Adipose tissue could therefore play an important role in the homeostasis of glucose in obese rats in the face of their increased carbohydrate intake.

  6. Unplanned 30-Day Readmissions in a General Internal Medicine Hospitalist Service at a Comprehensive Cancer Center

    PubMed Central

    Manzano, Joanna-Grace M.; Gadiraju, Sahitya; Hiremath, Adarsh; Lin, Heather Yan; Farroni, Jeff; Halm, Josiah

    2015-01-01

    Purpose: Hospital readmissions are considered by the Centers for Medicare and Medicaid as a metric for quality of health care delivery. Robust data on the readmission profile of patients with cancer are currently insufficient to determine whether this measure is applicable to cancer hospitals as well. To address this knowledge gap, we estimated the unplanned readmission rate and identified factors influencing unplanned readmissions in a hospitalist service at a comprehensive cancer center. Methods: We retrospectively analyzed unplanned 30-day readmission of patients discharged from the General Internal Medicine Hospitalist Service at a comprehensive cancer center between April 1, 2012, and September 30, 2012. Multiple independent variables were studied using univariable and multivariable logistic regression models, with generalized estimating equations to identify risk factors associated with readmissions. Results: We observed a readmission rate of 22.6% in our cohort. The median time to unplanned readmission was 10 days. Unplanned readmission was more likely in patients with metastatic cancer and those with three or more comorbidities. Patients discharged to hospice were less likely to be readmitted (all P values < .01). Conclusion: We observed a high unplanned readmission rate among our population of patients with cancer. The risk factors identified appear to be related to severity of illness and open up opportunities for improving coordination with primary care physicians, oncologists, and other specialists to manage comorbidities, or perhaps transition appropriate patients to palliative care. Our findings will be instrumental for developing targeted interventions to help reduce readmissions at our hospital. Our data also provide direction for appropriate application of readmission quality measures in cancer hospitals. PMID:26152375

  7. Monitoring and Modeling the Fluctuations in Apparent Groundwater Age During a 30-Day Pumping Test.

    NASA Astrophysics Data System (ADS)

    Perle, M. E.; Zhang, Y.; Fogg, G. E.

    2004-12-01

    Recent research shows that dispersion due to geologic heterogeneity can cause large (10's to 100's of yrs) variations in actual groundwater age within individual samples drawn from a well, even if well bore mixing is not significant. We hypothesize that the presence of such large ranges in groundwater age may cause the mean apparent age as estimated from environmental tracers such as CFC's, SF&_{6}, and ^{3}H-^{3}He to drift measurably during long-term, continuous pumping. This hypothesis was confirmed by 3-D numerical experiments wherein variation in groundwater ages under high-rate (\\sim0.06 m^{3}/s; 1,000 gpm) long-term pumping was modeled using backward-time random walk particle tracking techniques combined with geostatistical simulations of hydrofacies heterogeneity. Results indicate that the age distribution within a water sample and the mean apparent age implied by environmental tracers is strongly influenced by historical atmospheric concentrations of environmental tracers and subsurface heterogeneity. As a partial implementation of this same experiment in the field, an abandoned well was pumped at a low rate (\\sim0.005 m^{3}/s; 75 gpm) during 53 days. Water samples were collected from the top and bottom of a 25 foot well screen at 12 hour intervals for the first 30 days and were analyzed for CFC's, SF&6, and 3H-3He. The measured tracer ages indicate that 1) CFC-11 apparent ages increased with time within the first five days of pumping and then remained constant for the remainder of the pump test; 2) trends in CFC-12, CFC-113 and SF&_{6}$ indicate a discrepancy in apparent ages with CFC-11, 3) water reaching the top interval is younger than water reaching the bottom interval. Gas samples were collected from the unsaturated zone to investigate possible CFC contamination and tracer concentration spatial variations in the pumping well recharge zone. Potential effects of heterogeneity and local CFC contamination on the monitoring results will be discussed.

  8. Bion M1. Peculiarities of life activities of microbes in 30-day spaceflight

    NASA Astrophysics Data System (ADS)

    Viacheslav, Ilyin; Korshunov, Denis; Morozova, Julia; Voeikova, Tatiana; Tyaglov, Boris; Novikova, Liudmila; Krestyanova, Irina; Emelyanova, Lydia

    The aim of this work was to analyze the influence of space flight factors ( SFF) to microorganism strains , exposed inside unmanned spacecraft Bion M-1 during the 30- day space flight. Objectives of the work - the study of the influence of the SFF exchange chromosomal DNA in crosses microorganisms of the genus Streptomyces; the level of spontaneous phage induction of lysogenic strains fS31 from Streptomyces lividans 66 and Streptomyces coelicolor A3 ( 2 ) on the biosynthesis of the antibiotic tylosin strain of Streptomyces fradiae; survival electrogenic bacteria Shewanella oneidensis MR- 1 is used in the microbial fuel cell As a result of this work it was found that the SFF affect the exchange of chromosomal DNA by crossing strains of Streptomyces. Was detected polarity crossing , expressed in an advantageous contribution chromosome fragment of one of the parent strains in recombinant offspring. This fact may indicate a more prolonged exposure of cells in microgravity and , as a consequence, the transfer of longer fragments of chromosomal DNA This feature is the transfer of genetic material in microgravity could lead to wider dissemination and horizontal transfer of chromosomal and plasmid DNA of symbiotic microflora astronauts and other strains present in the spacecraft. It was shown no effect on the frequency of recombination PCF and the level of mutation model reversion of auxotrophic markers to prototrophy It was demonstrated that PCF increase the level of induction of cell actinophage fS31 lysogenic strain of S. lividans 66, but did not affect the level of induction of this phage cells S. coelicolor A3 ( 2). It is shown that the lower the level of synthesis PCF antibiotic aktinorodina (actinorhodin) in lysogenic strain S. coelicolor A3 ( 2). 66 Strains of S. lividans and S. coelicolor A3 ( 2 ) can be used as a biosensor for studying the effect on microorganisms PCF It is shown that the effect of the PCF reduces synthesis of tylosin and desmicosyn S. fradiae at

  9. [Causal analysis and management strategies of 30-day unplanned revision surgery following single-stage posterior vertebral column resection for severe spinal deformity].

    PubMed

    Tao, Y P; Wu, J G; Ma, H S; Shao, S L; Zhang, L L; Gao, B; Li, H X

    2017-03-01

    Objective: To investigate the causes of 30-day unplanned revision surgery following one-stage posterior vertebral column resection (PVCR) for severe spinal deformity and the methods of prevention and management. Methods: A total of 112 severe deformity patients underwent one-stage PVCR for surgical treatment in the 306(th) Hospital of People's Liberation Army from May 2010 to December 2015 were retrospectively reviewed. Six patients required reoperation within 30 days after PVCR, including 2 males and 4 females with average age of 21 years (ranging from 12 to 38 years). Four cases were congenital kyphoscoliosis, 1 was post-laminectomy kyphoscoliosis and 1 was post-tuberculous angular kyphosis. Three cases associated with preoperative neurologic deficit (Frankel C in 1 patient and D in 2 patients). The causes, management and outcomes of unplanned revision surgery within 30 days after PVCR were recorded. Results: The total incidence of unplanned revision surgery within 30 days following PVCR was 5.4% (6/112). There was 1 case due to cerebrospinal fluid leak, 5 cases with varying degrees of new neurologic deficits, the causes were as followed: dural buckling in 1 case, residual bone compression in 1 case, epidural hematoma compression in 2 cases, spinal subdural hematoma in 1 case. All the 6 cases underwent surgical exploration again, including further dural repair, decompression and hematoma clearance. After unplanned reoperation, 6 cases recovered completely. The average follow-up time after surgery was 30.8 months (ranging from 10 to 60 months). The major curve at coronal plane was improved from preoperative 87.7° to 34.2°, with a mean correction of 61.0% at final follow-up; the sagittal kyphosis curve was improved from preoperative 119.5° to 45.5°, with a mean correction of 61.9% at final follow-up. Two patients' neurological status improved from Frankel D to Frankel E, one patient's neurological status improved from Frankel C to Frankel E. Conclusions: One

  10. Tumor Epression of Major Vault Protein is an Adverse Prognostic Factor for Radiotherapy Outcome in Oropharyngeal Carcinoma

    SciTech Connect

    Silva, Priyamal; West, Catharine M.; Slevin, Nick F.R.C.R.; Valentine, Helen; Ryder, W. David J. Grad. I.S.; Hampson, Lynne; Bibi, Rufzan; Sloan, Philip; Thakker, Nalin; Homer, Jarrod; Hampson, Ian

    2007-09-01

    Purpose: Vaults are multi-subunit structures that may be involved in nucleo-cytoplasmic transport, with the major vault protein (MVP or lung resistance-related protein [LRP]) being the main component. The MVP gene is located on chromosome 16 close to the multidrug resistance-associated protein and protein kinase c-{beta} genes. The role of MVP in cancer drug resistance has been demonstrated in various cell lines as well as in ovarian carcinomas and acute myeloid leukemia, but nothing is known about its possible role in radiation resistance. Our aim was to examine this in head-and-neck squamous cell carcinoma (HNSCC). Methods and Materials: Archived biopsy material was obtained for 78 patients with squamous cell carcinoma of the oropharynx who received primary radiotherapy with curative intent. Immunohistochemistry was used to detect MVP expression. Locoregional failure and cancer-specific survival were estimated using cumulative incidence and Cox multivariate analyses. Results: In a univariate and multivariate analysis, MVP expression was strongly associated with both locoregional failure and cancer-specific survival. After adjustment for disease site, stage, grade, anemia, smoking, alcohol, gender, and age, the estimated hazard ratio for high MVP (2/3) compared with low (0/1) was 4.98 (95% confidence interval, 2.17-11.42; p 0.0002) for locoregional failure and 4.28 (95% confidence interval, 1.85-9.95; p = 0.001) for cancer-specific mortality. Conclusion: These data are the first to show that MVP may be a useful prognostic marker associated with radiotherapy resistance in a subgroup of patients with HNSCC.

  11. Low TLR7 gene expression in atherosclerotic plaques is associated with major adverse cardio- and cerebrovascular events

    PubMed Central

    Karadimou, Glykeria; Folkersen, Lasse; Berg, Martin; Perisic, Ljubica; Discacciati, Andrea; Roy, Joy; Hansson, Göran K.; Persson, Jonas; Paulsson-Berne, Gabrielle

    2017-01-01

    Aims Processes in the development of atherosclerotic lesions can lead to plaque rupture or erosion, which can in turn elicit myocardial infarction or ischaemic stroke. The aims of this study were to determine whether Toll-like receptor 7 (TLR7) gene expression levels influence patient outcome and to explore the mechanisms linked to TLR7 expression in atherosclerosis. Methods and results Atherosclerotic plaques were removed by carotid endarterectomy (CEA) and subjected to gene array expression analysis (n = 123). Increased levels of TLR7 transcript in the plaques were associated with better outcome in a follow-up study over a maximum of 8 years. Patients with higher TLR7 transcript levels had a lower risk of experiencing major cardiovascular and cerebrovascular events (MACCE) during the follow-up period after CEA (hazard ratio: 2.38, P = 0.012, 95% CI 1.21–4.67). TLR7 was expressed in all plaques by T cells, macrophages and endothelial cells in capillaries, as shown by immunohistochemistry. In short-term tissue cultures, ex vivo treatment of plaques with the TLR7 ligand imiquimod elicited dose-dependent secretion of IL-10, TNF-α, GM-CSF, and IL-12/IL-23p40. This secretion was blocked with a TLR7 inhibitor. Immunofluorescent tissue analysis after TLR7 stimulation showed IL-10 expression in T cells, macrophages and vascular smooth muscle cells. TLR7 mRNA levels in the plaques were correlated with IL-10 receptor (r = 0.4031, P < 0.0001) and GM-CSF receptor A (r = 0.4354, P < 0.0001) transcripts. Conclusion These findings demonstrate that TLR7 is abundantly expressed in human atherosclerotic plaques. TLR7 ligation elicits the secretion of pro-inflammatory and anti-inflammatory cytokines, and high TLR7 expression in plaques is associated with better patient outcome, suggesting that TLR7 is a potential therapeutic target for prevention of complications of atherosclerosis. PMID:27864310

  12. Predictors of 30-day mortality and the risk of recurrent systemic thromboembolism in cancer patients suffering acute ischemic stroke

    PubMed Central

    Kim, Tae Jung; An, Sang Joon; Oh, Kyungmi; Mo, Heejung; Kang, Min Kyoung; Han, Moon-Ku; Demchuk, Andrew M.; Ko, Sang-Bae; Yoon, Byung-Woo

    2017-01-01

    Background Stroke in cancer patients is not rare but is a devastating event with high mortality. However, the predictors of mortality in stroke patients with cancer have not been well addressed. D-dimer could be a useful predictor because it can reflect both thromboembolic events and advanced stages of cancer. Aim In this study, we evaluate the possibility of D-dimer as a predictor of 30-day mortality in stroke patients with active cancer. Methods We included 210 ischemic stroke patients with active cancer. The 30-day mortality data were collected by reviewing medical records. We also collected follow-up D-dimer levels in 106 (50%) participants to evaluate the effects of treatment response on D-dimer levels. Results Of the 210 participants, 30-day mortality occurred in 28 (13%) patients. Higher initial NIHSS scores, D-dimer levels, and CRP levels as well as frequent cryptogenic mechanism, systemic metastasis, multiple vascular territory lesion, hemorrhagic transformation, and larger infarct volume were related to 30-day mortality. In the multivariate analysis, D-dimer [adjusted OR (aOR) = 2.19; 95% CI, 1.46–3.28, P < 0.001] predicted 30-day mortality after adjusting for confounders. The initial NIHSS score (aOR = 1.07; 95% CI, 1.00–1.14, P = 0.043) and hemorrhagic transformation (aOR = 3.02; 95% CI, 1.10–8.29, P = 0.032) were also significant independent of D-dimer levels. In the analysis of D-dimer changes after treatment, the mortality group showed no significant decrease in D-dimer levels, despite treatment, while the survivor group showed the opposite response. Conclusions D-dimer levels may predict 30-day mortality in acute ischemic stroke patients with active cancer. PMID:28282388

  13. Immunotoxicological Evaluation of Corn Genetically Modified with Bacillus thuringiensis Cry1Ah Gene by a 30-Day Feeding Study in BALB/c Mice

    PubMed Central

    Song, Yan; Liang, Chunlai; Wang, Wei; Fang, Jin; Sun, Nana; Jia, Xudong; Li, Ning

    2014-01-01

    This study was to investigate the immunotoxicological potential of corn genetically modified (GM) with Bacillus thuringiensis (Bt) Cry1Ah gene in BALB/c mice. Female BALB/c mice were randomly assigned to one of the four groups: the negative control group, the parental corn group, the GM corn group and the positive control group with 10 mice per group. Mice in the GM corn group and the parental corn group were fed with diets containing 70% corresponding corn for 30 days. Mice in the negative control group and the positive control group were fed with AIN93G diet, administered with saline or 200 mg/kg of cyclophosphamide (CY) via intraperitoneal injection 24 h before the termination of the study, respectively. At the end of the study, the immunotoxicological effects of the GM corn were evaluated through immunopathology parameters including body and organ weights, hematology and clinical chemistry parameters, histological examination, peripheral blood lymphocytes phenotype; humoral immunity including antibody plaque-forming cell, serum immunoglobulin, cytokine and half hemolysis value; cellular immunity such as mitogen-induced splenocyte proliferation, cytotoxic T-lymphocyte reaction, delayed-type hypersensitivity reaction; non-specific immunity including phagocytic activities of phagocytes, natural killer cell activity. A single dose of cyclophosphamide (200 mg/kg bw) was found to have significant adverse effects on immunopathology, cellular immunity, and humoral immunity in mice. The corn genetically modified with Bt Cry1Ah gene is considered consistent with the parental corn in terms of immunopathology, humoral immunity, cellular immunity and non-specific immunity. No adverse immunotoxicological effects of GM corn with Bt Cry1Ah gene were found when feeding mice for 30 days. PMID:24520311

  14. Immunotoxicological evaluation of corn genetically modified with Bacillus thuringiensis Cry1Ah gene by a 30-day feeding study in BALB/c mice.

    PubMed

    Song, Yan; Liang, Chunlai; Wang, Wei; Fang, Jin; Sun, Nana; Jia, Xudong; Li, Ning

    2014-01-01

    This study was to investigate the immunotoxicological potential of corn genetically modified (GM) with Bacillus thuringiensis (Bt) Cry1Ah gene in BALB/c mice. Female BALB/c mice were randomly assigned to one of the four groups: the negative control group, the parental corn group, the GM corn group and the positive control group with 10 mice per group. Mice in the GM corn group and the parental corn group were fed with diets containing 70% corresponding corn for 30 days. Mice in the negative control group and the positive control group were fed with AIN93G diet, administered with saline or 200 mg/kg of cyclophosphamide (CY) via intraperitoneal injection 24 h before the termination of the study, respectively. At the end of the study, the immunotoxicological effects of the GM corn were evaluated through immunopathology parameters including body and organ weights, hematology and clinical chemistry parameters, histological examination, peripheral blood lymphocytes phenotype; humoral immunity including antibody plaque-forming cell, serum immunoglobulin, cytokine and half hemolysis value; cellular immunity such as mitogen-induced splenocyte proliferation, cytotoxic T-lymphocyte reaction, delayed-type hypersensitivity reaction; non-specific immunity including phagocytic activities of phagocytes, natural killer cell activity. A single dose of cyclophosphamide (200 mg/kg bw) was found to have significant adverse effects on immunopathology, cellular immunity, and humoral immunity in mice. The corn genetically modified with Bt Cry1Ah gene is considered consistent with the parental corn in terms of immunopathology, humoral immunity, cellular immunity and non-specific immunity. No adverse immunotoxicological effects of GM corn with Bt Cry1Ah gene were found when feeding mice for 30 days.

  15. Impact of Inpatient Versus Outpatient Total Joint Arthroplasty on 30-Day Hospital Readmission Rates and Unplanned Episodes of Care.

    PubMed

    Springer, Bryan D; Odum, Susan M; Vegari, David N; Mokris, Jeffrey G; Beaver, Walter B

    2017-01-01

    This article describes a study comparing 30-day readmission rates between patients undergoing outpatient versus inpatient total hip (THA) and knee (TKA) arthroplasty. A retrospective review of 137 patients undergoing outpatient total joint arthroplasty (TJA) and 106 patients undergoing inpatient (minimum 2-day hospital stay) TJA was conducted. Unplanned hospital readmissions and unplanned episodes of care were recorded. All patients completed a telephone survey. Seven inpatients and 16 outpatients required hospital readmission or an unplanned episode of care following hospital discharge. Readmission rates were higher for TKA than THA. The authors found no statistical differences in 30-day readmission or unplanned care episodes.

  16. The Personality and Psychological Stress Predict Major Adverse Cardiovascular Events in Patients With Coronary Heart Disease After Percutaneous Coronary Intervention for Five Years.

    PubMed

    Du, Jinling; Zhang, Danyang; Yin, Yue; Zhang, Xiaofei; Li, Jifu; Liu, Dexiang; Pan, Fang; Chen, Wenqiang

    2016-04-01

    To investigate the effects of personality type and psychological stress on the occurrence of major adverse cardiovascular events (MACEs) at 5 years in patients with coronary artery disease (CAD) after percutaneous coronary intervention (PCI). Two hundred twenty patients with stable angina (SA) or non-ST segment elevation acute coronary syndrome (NSTE-ACS) treated with PCI completed type A behavioral questionnaire, type D personality questionnaire, Self-Rating Depression Scale (SDS), Self-Rating Anxiety Scale (SAS), Trait Coping Style Questionnaire (TCSQ), and Symptom Checklist 90 (SCL-90) at 3 days after PCI operation. Meanwhile, biomedical markers (cTnI, CK-MB, LDH, LDH1) were assayed. MACEs were monitored over a 5-year follow-up. NSTE-ACS group had higher ratio of type A behavior, type A/D behavior, and higher single factor scores of type A personality and type D personality than control group and SAP group. NSTE-ACS patients had more anxiety, depression, lower level of mental health (P < 0.05; P < 0.01), more negative coping styles and less positive coping styles. The plasma levels of biomedical predictors had positive relation with anxiety, depression, and lower level of mental health. Type D patients were at a cumulative increased risk of adverse outcome compared with non-type D patients (P < 0.05). Patients treated with PCI were more likely to have type A and type D personality and this tendency was associated with myocardial injury. They also had obvious anxiety, depression emotion, and lower level of mental health, which were related to personality and coping style. Type D personality was an independent predictor of adverse events.

  17. Superfund reform: US Environmental Protection Agency`s 30-day study and its implication for the US Department of Energy

    SciTech Connect

    Siegel, M.R.; Friedman, J.R.; Neff, R.W.

    1993-03-01

    As part of an ongoing effort to reform and restructure the US Environmental Protection Agency`s (EPAS) Superfund program, the EPA Administrator on October 21, 1991, announced several key programmatic reforms. These reforms are a result of the Superfund 30-Day Task Force Report (30-Day Study, EPA 1991a), an effort carried out by EPAs office of Solid Waste and Emergency Response (OSWER). The EPA OSWER oversees environmental cleanup activities under a number of statutory authorities, including the Comprehensive Environmental response, Compensation, and Liability Act (CERCLA, also known as Superfund). CERCLA and its implementing regulation, the National Contingency Plan (NCP), establish a regulatory framework to govern the cleanup of existing, and often abandoned, hazardous waste sites. The purposes of this report are to (1) review the background and recommendations of EPNs 30-Day Study, (2) identify and discuss the initiatives from the 30-Day Study that may impact DOE`s environmental restoration mission, (3) report on EPAs progress in implementing the selected priority initiatives, and (4) describe potentially related DOE activities.

  18. 31 CFR 538.506 - 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ...-November 4, 1997 trade contracts involving Sudan. 538.506 Section 538.506 Money and Finance: Treasury....506 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan. (a) Pre... of Sudanese origin or owned or controlled by the Government of Sudan, importations under the...

  19. 31 CFR 538.506 - 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...-November 4, 1997 trade contracts involving Sudan. 538.506 Section 538.506 Money and Finance: Treasury....506 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan. (a) Pre... of Sudanese origin or owned or controlled by the Government of Sudan, importations under the...

  20. 31 CFR 538.506 - 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-November 4, 1997 trade contracts involving Sudan. 538.506 Section 538.506 Money and Finance: Treasury....506 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan. (a) Pre... of Sudanese origin or owned or controlled by the Government of Sudan, importations under the...

  1. 31 CFR 538.506 - 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ...-November 4, 1997 trade contracts involving Sudan. 538.506 Section 538.506 Money and Finance: Treasury....506 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan. (a) Pre... of Sudanese origin or owned or controlled by the Government of Sudan, importations under the...

  2. 31 CFR 538.506 - 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-November 4, 1997 trade contracts involving Sudan. 538.506 Section 538.506 Money and Finance: Treasury....506 30-day delayed effective date for pre-November 4, 1997 trade contracts involving Sudan. (a) Pre... of Sudanese origin or owned or controlled by the Government of Sudan, importations under the...

  3. 31 CFR 560.515 - 30-day delayed effective date for pre-May 7, 1995 trade contracts involving Iran.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...-May 7, 1995 trade contracts involving Iran. 560.515 Section 560.515 Money and Finance: Treasury....515 30-day delayed effective date for pre-May 7, 1995 trade contracts involving Iran. (a) All... involving Iran (a pre-existing trade contract), including the exportation of goods, services...

  4. 31 CFR 560.515 - 30-day delayed effective date for pre-May 7, 1995 trade contracts involving Iran.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ...-May 7, 1995 trade contracts involving Iran. 560.515 Section 560.515 Money and Finance: Treasury....515 30-day delayed effective date for pre-May 7, 1995 trade contracts involving Iran. (a) All... involving Iran (a pre-existing trade contract), including the exportation of goods, services...

  5. 31 CFR 560.515 - 30-day delayed effective date for pre-May 7, 1995 trade contracts involving Iran.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ...-May 7, 1995 trade contracts involving Iran. 560.515 Section 560.515 Money and Finance: Treasury....515 30-day delayed effective date for pre-May 7, 1995 trade contracts involving Iran. (a) All... involving Iran (a pre-existing trade contract), including the exportation of goods, services...

  6. Predicting 30-Day Readmissions: Performance of the LACE Index Compared with a Regression Model among General Medicine Patients in Singapore

    PubMed Central

    Low, Lian Leng; Lee, Kheng Hock; Hock Ong, Marcus Eng; Wang, Sijia; Tan, Shu Yun; Thumboo, Julian; Liu, Nan

    2015-01-01

    The LACE index (length of stay, acuity of admission, Charlson comorbidity index, CCI, and number of emergency department visits in preceding 6 months) derived in Canada is simple and may have clinical utility in Singapore to predict readmission risk. We compared the performance of the LACE index with a derived model in identifying 30-day readmissions from a population of general medicine patients in Singapore. Additional variables include patient demographics, comorbidities, clinical and laboratory variables during the index admission, and prior healthcare utilization in the preceding year. 5,862 patients were analysed and 572 patients (9.8%) were readmitted in the 30 days following discharge. Age, CCI, count of surgical procedures during index admission, white cell count, serum albumin, and number of emergency department visits in previous 6 months were significantly associated with 30-day readmission risk. The final logistic regression model had fair discriminative ability c-statistic of 0.650 while the LACE index achieved c-statistic of 0.628 in predicting 30-day readmissions. Our derived model has the advantage of being available early in the admission to identify patients at high risk of readmission for interventions. Additional factors predicting readmission risk and machine learning techniques should be considered to improve model performance. PMID:26682212

  7. 76 FR 17734 - 30-Day Notice of Proposed Information Collection: Form DS-1998E, Foreign Service Officer Test...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-30

    .... Originating Office: Human Resources, HR/REE/BEX. Form Number: DS-1998E. Respondents: Registrants for the... information collection request to the Office of Management and Budget (OMB) for ] approval in accordance with... Office of Management and Budget (OMB) for up to 30 days from March 30, 2011. ADDRESSES: Direct...

  8. 78 FR 31999 - 30-Day Notice of Proposed Information Collection: Young Turkey/Young America Evaluation (YTYA...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-05-28

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 30-Day Notice of Proposed Information Collection: Young Turkey/ Young America Evaluation (YTYA) Survey ACTION... Collection: Young Turkey/Young America Evaluation (YTYA) Survey. OMB Control Number: None. Type of...

  9. 78 FR 36562 - 30-Day Notice of Proposed Information Collection: Application and Re-certification Packages for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ...HUD has submitted the proposed information collection requirement described below to the Office of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The purpose of this notice is to allow for an additional 30 days of public...

  10. 78 FR 66040 - 30-Day Notice of Proposed Information Collection: HUD-Owned Real Estate-Sales Contract and Addendums

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-04

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: HUD-Owned Real Estate--Sales... collection entitled HUD-Owned Real Estate-Sales Contract and Addendums (2502-0306). HUD will republish...

  11. 77 FR 62518 - Submission for OMB Review; Comment Request (30-Day FRN); Prostate, Lung, Colorectal and Ovarian...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-15

    ... their full effect if received within 30 days of the date of this publication. Proposed Collection... ovarian cancer can reduce mortality from these cancers which currently cause an estimated 255,700 deaths... term effects of the screening on cancer incidence and mortality for the four targeted cancers....

  12. 78 FR 59047 - 30-Day Notice of Proposed Information Collection: Semi-Annual Labor Standards Enforcement Report...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-25

    ... Title of Information Collection: Semi-annual Labor Standards Enforcement Report--Local Contracting... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Semi-Annual Labor Standards Enforcement Report--Local Contracting Agencies (HUD Programs) AGENCY: Office of the Chief Information...

  13. 76 FR 58074 - 30-Day Notice of Proposed Information Collection: DS-7001 and DS-7005, DOS-Sponsored Academic...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... information collection request to the Office of Management and Budget (OMB) for approval in accordance with... Collection. Originating Office: Bureau of Educational and Cultural Affairs, ECA/A/E/EUR. Form Number: DS-7001... to the Office of Management and Budget (OMB) for up to 30 days from September 19, 2011....

  14. 77 FR 47690 - 30-Day Notice of Proposed Information Collection: Civilian Response Corps Database In-Processing...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 30-Day Notice of Proposed Information Collection: Civilian Response Corps Database In-Processing Electronic Form... Database In-Processing Electronic Form. OMB Control Number: 1405-0168. Type of Request: Extension of...

  15. 75 FR 32961 - 30-Day Federal Register Notice of Intention To Request Clearance of Collection of Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-10

    ... collection Office of Management and Budget (OMB) Control 1024-0231. The OMB has up to 60 days to approve or... consideration, OMB should receive public comments within 30 days of the date on which this notice is published... were received on this notice. DATES: Public comments on the proposed Information Collection...

  16. 78 FR 15799 - 30-Day Notice of Proposed Information Collection: Statement Regarding a Lost or Stolen U.S...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 30-Day Notice of Proposed Information Collection: Statement Regarding a Lost or Stolen U.S. Passport Book and/or... INFORMATION: Title of Information Collection: Statement Regarding a Lost or Stolen U.S. Passport Book...

  17. 78 FR 64145 - 30-Day Notice of Proposed Information Collection: Housing Finance Agency Risk-Sharing Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Housing Finance Agency Risk-Sharing..., 2013. A. Overview of Information Collection Title of Information Collection: Housing Finance Agency... Secretary to implement risk sharing with State and local housing finance agencies (HFAs). Under this...

  18. 78 FR 65696 - 30-Day Notice of Proposed Information Collection: Housing Finance Agency Risk-Sharing Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Housing Finance Agency Risk-Sharing... Collection Title of Information Collection: Housing Finance Agency Risk- Sharing Program. OMB Approval Number... with State and local housing finance agencies (HFAs). Under this program, HUD provides full...

  19. 78 FR 35040 - Submission for OMB Review; 30-day Comment Request; Web-Based Media Literacy Parent Training for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-11

    ... HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request; Web-Based Media Literacy Parent Training for Substance Use Prevention in Rural Locations SUMMARY: Under the... Branch, Division of Epidemiology, Services, and Prevention Research, NIDA, NIH, 6001 Executive...

  20. Relationship between Early Physician Follow-Up and 30-Day Readmission after Acute Myocardial Infarction and Heart Failure

    PubMed Central

    Tung, Yu-Chi; Chang, Guann-Ming; Chang, Hsien-Yen

    2017-01-01

    Background Thirty-day readmission rates after acute myocardial infarction (AMI) and heart failure are important patient outcome metrics. Early post-discharge physician follow-up has been promoted as a method of reducing 30-day readmission rates. However, the relationships between early post-discharge follow-up and 30-day readmission for AMI and heart failure are inconclusive. We used nationwide population-based data to examine associations between 7-day physician follow-up and 30-day readmission, and further associations of 7-day same physician (during the index hospitalization and at follow-up) and cardiologist follow-up with 30-day readmission for non-ST-segment-elevation myocardial infarction (NSTEMI) or heart failure. Methods We analyzed all patients 18 years or older with NSTEMI and heart failure and discharged from hospitals in 2010 in Taiwan through Taiwan’s National Health Insurance Research Database. Cox proportional hazard models with robust sandwich variance estimates and propensity score weighting were performed after adjustment for patient and hospital characteristics to test associations between 7-day physician follow-up and 30-day readmission. Results The study population for NSTEMI and heart failure included 5,008 and 13,577 patients, respectively. Early physician follow-up was associated with a lower hazard ratio of readmission compared with no early physician follow-up for patients with NSTEMI (hazard ratio [HR], 0.47; 95% confidence interval [CI], 0.39–0.57), and for patients with heart failure (HR, 0.54; 95% CI, 0.48–0.60). Same physician follow-up was associated with a reduced hazard ratio of readmission compared with different physician follow-up for patients with NSTEMI (HR, 0.56; 95% CI, 0.48–0.65), and for patients with heart failure (HR, 0.69; 95% CI, 0.62–0.76). Conclusions For each condition, patients who have an outpatient visit with a physician within 7 days of discharge have a lower risk of 30-day readmission. Moreover

  1. Sex Differences in the Rate, Timing and Principal Diagnoses of 30-Day Readmissions in Younger Patients with Acute Myocardial Infarction

    PubMed Central

    Dreyer, Rachel P.; Ranasinghe, Isuru; Wang, Yongfei; Dharmarajan, Kumar; Murugiah, Karthik; Nuti, Sudhakar V.; Hsieh, Angela F.; Spertus, John A.; Krumholz, Harlan M.

    2016-01-01

    Background Young women (<65 years) experience a 2–3-fold greater mortality risk than younger men after acute myocardial infarction (AMI). However, it is unknown whether they are at higher risk for 30-day readmission, and if this association varies by age. We examined sex differences in the rate, timing and principal diagnoses of 30-day readmissions, including the independent effect of sex following adjustment for confounders. Methods and Results We included patients aged 18–64 years with a principal diagnosis of AMI. Data was utilized from the Healthcare Cost and Utilization Project-State Inpatient Database for California (07–09). Readmission diagnoses were categorized using an aggregated version of the Centers for Medicare and Medicaid Services’ Condition Categories, and readmission timing was determined from the day after discharge. Of 42,518 younger patients with AMI (26.4% female), 4,775 (11.2%) had at least one readmission. The 30-day all-cause readmission rate was higher for women (15.5% vs. 9.7%, P<0.0001). For both sexes, readmission risk was highest on days 2–4 after discharge and declined thereafter, and women were more likely to present with non-cardiac diagnoses (44.4% vs. 40.6%, P=0.01). Female sex was associated with a higher rate of 30-day readmission, which persisted after adjustment (HR=1.22, 95% CI 1.15, 1.30). There was no significant interaction between age and sex on readmission. Conclusions Compared with men, younger women have a higher risk for readmission, even after adjustment for confounders. The timing of 30-day readmission was similar in women and men, and both sexes were susceptible to a wide range of causes for readmission. PMID:26085455

  2. Preadmission use of SSRIs alone or in combination with NSAIDs and 30-day mortality after peptic ulcer bleeding.

    PubMed

    Gasse, Christiane; Christensen, Steffen; Riis, Anders; Mortensen, Preben B; Adamsen, Sven; Thomsen, Reimar W

    2009-01-01

    OBJECTIVE. Use of selective serotonin reuptake inhibitors (SSRIs) increases the risk of upper gastrointestinal bleeding and this risk is amplified by concomitant use of non-steroidal anti-inflammatory drugs (NSAIDs). The aim of the study was to examine the impact of SSRI use alone or in combination with NSAIDs on 30-day mortality after peptic ulcer bleeding (PUB). MATERIAL AND METHODS. A population-based cohort study of patients with a first hospitalization with PUB in three Danish counties was carried out between 1991 and 2005 using medical databases. We calculated 30-day mortality rate ratios (MRRs) associated with the use of SSRIs, alone or in combination with NSAIDs, adjusted for important covariates. RESULTS. Of 7415 patients admitted with PUB, 5.9% used SSRIs only, and 3.8% used SSRIs in combination with NSAIDs, with a 30-day mortality of 11.8% and 11.3%, respectively. Compared with patients who used neither SSRIs nor NSAIDs, the adjusted 30-day MRR was 1.02 (95% CI: 0.76-1.36) for current users of SSRIs and 0.89 (0.62-1.28) for the combined use of SSRIs with NSAIDs. There was a 2.11-fold (95% CI 1.35-3.30) increased risk of death associated with SSRI use starting within 60 days of admission; for those younger than 80 years, the adjusted MRR was 1.54 (0.72-3.29), and 2.57 (1.47-4.49) for those older than 80 years. CONCLUSIONS. Use of SSRIs, alone or in combination with NSAIDs, was not associated with increased 30-day mortality following PUB. However, increased mortality was found in patients who started SSRI therapy, particularly among those older than 80 years. We can only speculate on whether this finding is due to pharmacological action or confounding factors.

  3. 76 FR 45574 - Agency Information Collection Request: 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ..., consisting of a survey of a national sample of health insurers to learn about the effects of various recent.... The survey instrument will be a one-time, self-administered web survey sent to eight of the 12 largest insurers in each state plus the District of Columbia based on total 2009 comprehensive major...

  4. Impact of Peri-Operative Acute Kidney Injury as a Severity Index for 30-day Readmission After Cardiac Surgery

    PubMed Central

    Brown, Jeremiah R.; Parikh, Chirag R.; Ross, Cathy S.; Kramer, Robert S.; Magnus, Patrick C.; Chaisson, Kristine; Boss, Richard A.; Helm, Robert E.; Horton, Susan R.; Hofmaster, Patricia; Desaulniers, Helen; Blajda, Pamela; Westbrook, Benjamin M.; Duquette, Dennis; LeBlond, Kelly; Quinn, Reed D.; Jones, Cheryl; DiScipio, Anthony W.; Malenka, David J.

    2014-01-01

    Background Of patients undergoing cardiac surgery in the United States, 15–20% are re-hospitalized within 30-days. Current models to predict readmission have not evaluated the association between severity of post-operative acute kidney injury (AKI) and 30-day readmissions. Methods We collected data from 2,209 consecutive patients who underwent either coronary artery bypass (CABG) or valve surgery at seven member hospitals of the Northern New England Cardiovascular Disease Study Group Cardiac Surgery Registry (NNE) between July 2008 and December 2010. Administrative data at each hospital was searched to identify all patients readmitted to the index hospital within 30 days of discharge. We defined AKI Stages by the AKI Network definition of 0.3 or 50% increase (Stage 1), 2-fold increase (stage 2) and a 3-fold or 0.5 increase if the baseline serum creatinine was at least 4.0 (mg/dL) or new dialysis (stage 3). We evaluate the association between stages of AKI and 30-day readmission using multivariate logistic regression. Results There were 260 patients readmitted within 30-days (12.1%). The median time to readmission was 9 (IQR 4–16) days. Patients not developing AKI following cardiac surgery had a 30-day readmission rate of 9.3% compared to patients developing AKI stage 1 (16.1%), AKI stage 2 (21.8%) and AKI stage 3 (28.6%, p <0.001). Adjusted odds ratios for AKI stage 1 (1.81; 1.35, 2.44), stage 2 (2.39; 1.38, 4.14) and stage 3 (3.47; 1.85–6.50). Models to predict readmission were significantly improved with the addition of AKI stage (c-statistic 0.65, p = 0.001) and net reclassification rate of 14.6% (95%CI: 5.05% to 24.14%, p = .003). Conclusions In addition to more traditional patient characteristics, the severity of post-operative AKI should be used when assessing a patient’s risk for readmission. PMID:24119985

  5. 30 Days Wild: Development and Evaluation of a Large-Scale Nature Engagement Campaign to Improve Well-Being.

    PubMed

    Richardson, Miles; Cormack, Adam; McRobert, Lucy; Underhill, Ralph

    2016-01-01

    There is a need to increase people's engagement with and connection to nature, both for human well-being and the conservation of nature itself. In order to suggest ways for people to engage with nature and create a wider social context to normalise nature engagement, The Wildlife Trusts developed a mass engagement campaign, 30 Days Wild. The campaign asked people to engage with nature every day for a month. 12,400 people signed up for 30 Days Wild via an online sign-up with an estimated 18,500 taking part overall, resulting in an estimated 300,000 engagements with nature by participants. Samples of those taking part were found to have sustained increases in happiness, health, connection to nature and pro-nature behaviours. With the improvement in health being predicted by the improvement in happiness, this relationship was mediated by the change in connection to nature.

  6. African Easterly Waves in 30-day High-Resolution Global Simulations: A Case Study During the 2006 NAMMA Period

    NASA Technical Reports Server (NTRS)

    Shen, Bo-Wen; Tao, Wei-Kuo; Wu, Man-Li C.

    2010-01-01

    In this study, extended -range (30 -day) high-resolution simulations with the NASA global mesoscale model are conducted to simulate the initiation and propagation of six consecutive African easterly waves (AEWs) from late August to September 2006 and their association with hurricane formation. It is shown that the statistical characteristics of individual AEWs are realistically simulated with larger errors in the 5th and 6th AEWs. Remarkable simulations of a mean African easterly jet (AEJ) are also obtained. Nine additional 30 -day experiments suggest that although land surface processes might contribute to the predictability of the AEJ and AEWs, the initiation and detailed evolution of AEWs still depend on the accurate representation of dynamic and land surface initial conditions and their time -varying nonlinear interactions. Of interest is the potential to extend the lead time for predicting hurricane formation (e.g., a lead time of up to 22 days) as the 4th AEW is realistically simulated.

  7. No evidence for race and socioeconomic status as independent predictors of 30-day readmission rates following orthopedic surgery.

    PubMed

    Hunter, Tracey; Yoon, Richard S; Hutzler, Lorraine; Band, Philip; Liublinksa, Victoria; Slover, James; Bosco, Joseph A

    2015-01-01

    The Centers for Medicare & Medicaid Services considers readmissions within 30 days of discharge to be a quality indicator. Hospitals' and eventually physicians' readmission rates will be used to determine payment for services. It is imperative that health care providers understand which patients are at risk for readmission so that they can apply the appropriate preventive interventions. The research team analyzed all orthopedic admissions and readmissions at their institution from September 2008 to April 2011 in this study. Preparing for the next stage in health care reform, identifying any preoperative factors that may place certain patients into a "high-risk" category for readmission following an orthopedic procedure is of paramount importance. This data analysis of more than 13 000 patients noted that race-based and income-based risk factors did not translate into significant risk factors or predictors of 30-day readmission following orthopedic admission.

  8. 30 Days Wild: Development and Evaluation of a Large-Scale Nature Engagement Campaign to Improve Well-Being

    PubMed Central

    Richardson, Miles; Cormack, Adam; McRobert, Lucy; Underhill, Ralph

    2016-01-01

    There is a need to increase people’s engagement with and connection to nature, both for human well-being and the conservation of nature itself. In order to suggest ways for people to engage with nature and create a wider social context to normalise nature engagement, The Wildlife Trusts developed a mass engagement campaign, 30 Days Wild. The campaign asked people to engage with nature every day for a month. 12,400 people signed up for 30 Days Wild via an online sign-up with an estimated 18,500 taking part overall, resulting in an estimated 300,000 engagements with nature by participants. Samples of those taking part were found to have sustained increases in happiness, health, connection to nature and pro-nature behaviours. With the improvement in health being predicted by the improvement in happiness, this relationship was mediated by the change in connection to nature. PMID:26890891

  9. Predicting 30-Day Readmissions in an Asian Population: Building a Predictive Model by Incorporating Markers of Hospitalization Severity

    PubMed Central

    Low, Lian Leng; Liu, Nan; Wang, Sijia; Thumboo, Julian; Ong, Marcus Eng Hock; Lee, Kheng Hock

    2016-01-01

    Background To reduce readmissions, it may be cost-effective to consider risk stratification, with targeting intervention programs to patients at high risk of readmissions. In this study, we aimed to derive and validate a prediction model including several novel markers of hospitalization severity, and compare the model with the LACE index (Length of stay, Acuity of admission, Charlson comorbidity index, Emergency department visits in past 6 months), an established risk stratification tool. Method This was a retrospective cohort study of all patients ≥ 21 years of age, who were admitted to a tertiary hospital in Singapore from January 1, 2013 through May 31, 2015. Data were extracted from the hospital’s electronic health records. The outcome was defined as unplanned readmissions within 30 days of discharge from the index hospitalization. Candidate predictive variables were broadly grouped into five categories: Patient demographics, social determinants of health, past healthcare utilization, medical comorbidities, and markers of hospitalization severity. Multivariable logistic regression was used to predict the outcome, and receiver operating characteristic analysis was performed to compare our model with the LACE index. Results 74,102 cases were enrolled for analysis. Of these, 11,492 patient cases (15.5%) were readmitted within 30 days of discharge. A total of fifteen predictive variables were strongly associated with the risk of 30-day readmissions, including number of emergency department visits in the past 6 months, Charlson Comorbidity Index, markers of hospitalization severity such as ‘requiring inpatient dialysis during index admission, and ‘treatment with intravenous furosemide 40 milligrams or more’ during index admission. Our predictive model outperformed the LACE index by achieving larger area under the curve values: 0.78 (95% confidence interval [CI]: 0.77–0.79) versus 0.70 (95% CI: 0.69–0.71). Conclusion Several factors are important for

  10. International Validity of the “HOSPITAL” Score to Predict 30-day Potentially Avoidable Readmissions in Medical Patients

    PubMed Central

    Donzé, Jacques D.; Williams, Mark V.; Robinson, Edmondo J.; Zimlichman, Eyal; Aujesky, Drahomir; Vasilevskis, Eduard E.; Kripalani, Sunil; Metlay, Joshua P.; Wallington, Tamara; Fletcher, Grant S.; Auerbach, Andrew D.; Schnipper, Jeffrey L.

    2016-01-01

    IMPORTANCE Identification of patients at high risk of potentially avoidable readmission allows hospitals to efficiently direct additional care transitions services to the patients most likely to benefit. OBJECTIVE To externally validate the “HOSPITAL” score in an international multicenter study to assess its generalizability. DESIGN International multicenter retrospective cohort study. SETTING 9 large hospitals across 4 different countries. PARTICIPANTS All adult patients consecutively discharged alive from a medical department between January and December, 2011 (117,065 participants). Patients transferred to another acute care facility were excluded. EXPOSURES The “HOSPITAL” score includes the following predictors at discharge: Hemoglobin, discharge from an Oncology service, Sodium level, Procedure during the index admission, Index Type of admission (urgent), number of Admissions during the last 12 months, and Length of stay. MAIN OUTCOMES AND MEASURES 30-day potentially avoidable readmission to the index hospital using the SQLape algorithm. RESULTS Of all medical discharges, 14.5% (n=16,992) were followed by a 30-day readmission, and 9.7% (n=11,307) were followed by a 30-day potentially avoidable readmission. The discriminatory power of the “HOSPITAL” score to predict potentially avoidable readmission was good with a C-statistic of 0.72 (95% CI 0.72-0.72). As in the derivation study, patients were classified into 3 risk categories: low (62%), intermediate (24%), and high risk (14%). The estimated proportions of potentially avoidable readmission for each risk category matched the observed proportion, resulting in an excellent calibration (Pearson goodness of fit test P=0.89). CONCLUSIONS AND RELEVANCE The “HOSPITAL” score identified patients at high risk of 30-day potentially avoidable readmission with moderately high discrimination and excellent calibration when applied to a large international multicenter cohort of medical patients. This score

  11. Factors associated with 30-day mortality in elderly inpatients with community acquired pneumonia during 2 influenza seasons.

    PubMed

    Torner, Núria; Izquierdo, Conchita; Soldevila, Núria; Toledo, Diana; Chamorro, Judith; Espejo, Elena; Fernández-Sierra, Amelia; Domínguez, Angela

    2017-02-01

    Community-acquired pneumonia (CAP) refers to pneumonia unrelated to hospitals or extended-care facilities. The aim of this study was to determine factors associated with 30-day mortality in patients with CAP aged ≥ 65 y admitted to 20 hospitals in 7 Spanish regions during the 2013-14 and 2014-15 influenza seasons. Logistic regression was used to identify factors associated with 30-day mortality. The adjusted model included variables selected by backward elimination with a cut off of < 0.02. A total of 1928 CAP cases were recorded; 60.7% were male, 46.67% were aged 75-84 years, and 30-day mortality was 7.6% (n = 146). Pneumococcal vaccination had a significant protective effect (OR 0.68, 95% CI, 0.48-0.96; p = 0.03) and influenza vaccination in any 3 preceding seasons slight protective effect against CAP (OR 0.72, 95% CI, 0.51-1.02;p = 0.06). Factors significantly associated with 30-day mortality were having a degree of dependence (aOR 3.67, 95% CI, 2.34-5.75; p < 0,001); age ≥ 85 y (OR 3.01, 95% CI, 1.71-5.30; p < 0.001), liver impairment (aOR 2.41, 95% CI, 1.10-5.31; p = 0.03); solid organ neoplasm (aOR 2.24, 95% CI, 1.46-3.45; p < 0.001), impaired cognitive function (aOR 1.93, 95% CI, 1.22-3.05; p = 0.005), and ICU admittance (aOR2.56, 95% CI, 1.27-5.16; p = 0.009); length of stay (aOR 1.56, 95% CI, 1.02 - 2.40; p = 0.04) and cardio-respiratory resuscitation (aOR 7.75, 95% CI, 1.20 - 49.98; p = 0.03). No association was observed for other comorbidities such as chronic pulmonary obstructive disease (COPD) or heart conditions in the adjusted model. Offering both pneumococcal and influenza vaccination to the elderly may improve 30-day mortality in patients with CAP.

  12. Comparison of frequency of major adverse events in patients with atrial fibrillation receiving bare-metal versus drug-eluting stents in their coronary arteries.

    PubMed

    Fauchier, Laurent; Pellegrin, Céline; Bernard, Anne; Clementy, Nicolas; Angoulvant, Denis; Lip, Gregory Y H; Babuty, Dominique

    2012-07-01

    In patients with atrial fibrillation (AF) undergoing percutaneous coronary intervention with drug-eluting stent (DES) implantation, the available evidence from clinical trial data are inconclusive. We evaluated the safety and efficacy of the use of DESs versus bare-metal stents (BMSs) in a consecutive real-world cohort of patients with AF. Of 8,962 unselected patients with AF seen in our institution from 2000 through 2010, 833 (9%) had undergone percutaneous coronary intervention with stent implantation. BMSs were used for 678 patients (81%) and DESs for 155 (19%). During follow-up (median 688 days, interquartile range 1,114), all bleeding episodes, thromboembolism, and major adverse cardiac events (MACEs; i.e., death, acute myocardial infarction, target lesion revascularization) were recorded. Incidence of MACEs was similar in the 2 groups as was incidence of all-cause mortality. Results remained similar even after adjustment for age and other confounding factors. Factors independently associated with an increased risk of MACEs were older age (hazard ratio 1.024, 95% confidence interval 1.004 to 1.044, p = 0.02), implantation of stent during acute ST-segment elevation myocardial infarction (hazard ratio 1.81, 95% confidence interval 1.10 to 2.99, p = 0.02), and stent diameter (hazard ratio 1.09, 95% confidence interval 1.01 to 1.18, p = 0.03). Implantation of DESs was not significantly associated with a higher risk of major bleeding and we observed a similar ratio of serious events at follow-up after DES compared to BMS implantation. In conclusion, in our cohort, systematic use of DESs does not seem to be justified in most patients with AF because it was not associated with any clear advantage compared to BMSs.

  13. Effects of leg strength and bicycle ergometry exercise on cardiovascular deconditioning after 30-day head-down bed rest

    NASA Astrophysics Data System (ADS)

    Wu, Bin; Liu, Yusheng; Sun, Hongyi; Zhao, Dongming; Wang, Yue; Wu, Ping; Ni, Chengzhi

    2010-10-01

    The purpose of this study is to determine if the intermittent leg muscular strength exercise and bicycle ergometry exercise could attenuate cardiovascular deconditioning induced by prolonged -6° head-down bed rest (HDBR). Fifteen male subjects were randomly allocated into group A ( n=5, 30 days HDBR without exercise), group B ( n=5, 30 days HDBR with leg muscular strength exercise) and group C ( n=5, 30 days HDBR with bicycle ergometry exercise). The orthostatic tolerance (OT) was determined by +75°/20 min head-up tilt (HUT) test and the submaximal exercise capacity was determined by bicycle ergometry before and after HDBR. The results were as follows: (1) Compared with that before HDBR, OT time decreased dramatically by 57.6% ( p<0.001) after HDBR in group A, while it decreased by 36.4% ( p=0.084) in group B and by 34.7% ( p=0.062) in group C. (2) Compared with that before HDBR, the submaximal exercise time decreased significantly by 17.7% ( p<0.05) and 21.1% ( p<0.05) in groups A and B, respectively, after HDBR. However, it had no change (+1.3%, p>0.77) in group C. (3) compared with that before HDBR, the changes of heart rate (HR) and blood pressure were slightly improved in group B and C, while deteriorated in group A during orthostatic test and exercise test after HDBR. The results indicate that leg muscular strength exercise and bicycle ergometry exercise could partially attenuate the cardiovascular deconditioning induced by 30 d HDBR, and the latter exercise training could fully provide the protection for the loss of exercise capacity.

  14. Hospital Nursing and 30-Day Readmissions among Medicare Patients with Heart Failure, Acute Myocardial Infarction, and Pneumonia

    PubMed Central

    McHugh, Matthew D.; Ma, Chenjuan

    2013-01-01

    Background Provisions of the Affordable Care Act that increase hospitals’ financial accountability for preventable readmissions have heightened interest in identifying system-level interventions to reduce readmissions. Objectives To determine the relationship between hospital nursing; i.e. nurse work environment, nurse staffing levels, and nurse education, and 30-day readmissions among Medicare patients with heart failure, acute myocardial infarction, and pneumonia. Method and Design Analysis of linked data from California, New Jersey, and Pennsylvania that included information on the organization of hospital nursing (i.e., work environment, patient-to-nurse ratios, and proportion of nurses holding a BSN degree) from a survey of nurses, as well as patient discharge data, and American Hospital Association Annual Survey data. Robust logistic regression was used to estimate the relationship between nursing factors and 30-day readmission. Results Nearly one-quarter of heart failure index admissions (23.3% [n=39,954]); 19.1% (n=12,131) of myocardial infarction admissions; and 17.8% (n=25,169) of pneumonia admissions were readmitted within 30-days. Each additional patient per nurse in the average nurse’s workload was associated with a 7% higher odds of readmission for heart failure (OR=1.07, [1.05–1.09]), 6% for pneumonia patients (OR=1.06, [1.03–1.09]), and 9% for myocardial infarction patients (OR=1.09, [1.05–1.13]). Care in a hospital with a good versus poor work environment was associated with odds of readmission that were 7% lower for heart failure (OR = 0.93, [0.89–0.97]); 6% lower for myocardial infarction (OR = 0.94, [0.88–0.98]); and 10% lower for pneumonia (OR = 0.90, [0.85–0.96]) patients. Conclusions Improving nurses’ work environments and staffing may be effective interventions for preventing readmissions. PMID:23151591

  15. Effects of Cardiopulmonary Support With a Novel Pediatric Pump-Lung in a 30-Day Ovine Animal Model.

    PubMed

    Liu, Yang; Sanchez, Pablo G; Wei, Xufeng; Watkins, Amelia C; Niu, Shuqiong; Wu, Zhongjun J; Griffith, Bartley P

    2015-12-01

    The scarcity of donor organs has led to the development of devices that provide optimal long-term respiratory or cardiopulmonary support to bridge recipients as they wait for lung and/or heart transplantation. This study was designed to evaluate the 30-day in vivo performance of the newly developed pediatric pump-lung (PediPL) for cardiopulmonary support using a juvenile sheep model. The PediPL device was placed surgically between the right atrium and descending aorta in eight sheep (25.4-31.2 kg) and evaluated for 30 days. Anticoagulation was maintained with continuous heparin infusion (activated clotting time 150-200 s). The flow rate was measured continually, and gas transfer was measured daily. Plasma free hemoglobin, platelet activation, hematologic data, and blood biochemistry were assessed twice a week. Sheep were euthanized after 30 days. The explanted devices were examined for gross thrombosis. Six sheep survived for 30-32 days. During the study, the oxygen transfer rate of the devices was 54.9 ± 13.2 mL/min at a mean flow rate of 1.14 ± 0.46 L/min with blood oxygen saturation of 95.4% ± 1.7%. Plasma free hemoglobin was 8.2 ± 3.7 mg/dL. Platelet activation was 5.35 ± 2.65%. The animals had normal organ chemistries except for surgery-related transient alterations in kidney and liver function. Although we found some scattered thrombi on the membrane surfaces of some explanted devices during the necropsy, the device function and performance did not degrade. The PediPL device was capable of providing cardiopulmonary support with long-term reliability and good biocompatibility over the 30-day duration and offers the potential option for bridging pediatric patients with end-stage heart or lung disease to heart and/or lung transplantation.

  16. A space maintainability experiment aboard the Ben Franklin submersible during the 30-day Gulf Stream drift mission.

    NASA Technical Reports Server (NTRS)

    Kappler, J. R.; May, C. B.

    1972-01-01

    In the summer of 1969, a deep submersible drifted for 30 days below the surface of the Gulf Stream, while operated by a six man crew. The main purpose of the mission was oceanographic research. The crew's activities and completely self-contained environment resembled those of a space station such as Skylab. Because of these similarities aspects of onboard vehicle maintenance during the actual conduct of a scientific mission were investigated. The maintainability study was accomplished in six distinct phases. Two useful plots of manpower distribution were developed. A maintenance action summary is presented in a table.

  17. Long-acting bronchodilators with or without inhaled corticosteroids and 30-day readmission in patients hospitalized for COPD

    PubMed Central

    Bishwakarma, Raju; Zhang, Wei; Kuo, Yong-Fang; Sharma, Gulshan

    2017-01-01

    Background The ability of a long-acting muscarinic antagonist (LAMA) and long-acting beta 2 agonists (LABAs; long-acting bronchodilators, LABDs) with or without inhaled corticosteroids (ICSs) to reduce early readmission in hospitalized patients with COPD is unknown. Methods We studied a 5% sample of Medicare beneficiaries enrolled in Medicare parts A, B and D and hospitalized for COPD in 2011. We examined prescriptions filled for LABDs with or without ICSs (LABDs±ICSs) within 90 days prior to and 30 days after hospitalization. Primary outcome was the 30-day readmission rate between “users” and “nonusers” of LABDs±ICSs. Propensity score matching and sensitivity analysis were performed by limiting analysis to patients hospitalized for acute exacerbation of COPD (AECOPD). Among 6,066 patients hospitalized for COPD, 3,747 (61.8%) used LABDs±ICSs during the specified period. The “user” and “nonuser” groups had similar rates of all-cause emergency room (ER) visits and readmissions within 30 days of discharge date (22.4% vs 20.7%, P-value 0.11; 18.0% vs 17.8%, P-value 0.85, respectively). However, the “users” had higher rates of COPD-related ER visits (5.3% vs 3.4%, P-value 0.0006), higher adjusted odds ratio (aOR) 1.47 (95% CI, 1.11–1.93) and readmission (7.8% vs 5.0%, P-value <0.0001 and aOR 1.48 [95% CI, 1.18–1.86]) than “nonusers”. After propensity score matching, the aOR of COPD-related ER visits was 1.45 (95% CI, 1.07–1.96) and that of readmission was 1.34 (95% CI, 1.04–1.73). The results were similar when restricted to patients hospitalized for AECOPD. Conclusion Use of LABDs±ICSs did not reduce 30-day readmissions in patients hospitalized for COPD. PMID:28203071

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

    PubMed Central

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

    2017-01-01

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

  19. Resting heart rate associates with one-year risk of major adverse cardiovascular events in patients with acute coronary syndrome after percutaneous coronary intervention.

    PubMed

    Wang, Shao-Li; Wang, Cheng-Long; Wang, Pei-Li; Xu, Hao; Du, Jian-Peng; Zhang, Da-Wu; Gao, Zhu-Ye; Zhang, Lei; Fu, Chang-Geng; Chen, Ke-Ji; Shi, Da-Zhuo

    2016-03-01

    The study was to access the association between resting heart rate (RHR) and one-year risk of major adverse cardiovascular events (MACE) in acute coronary syndrome (ACS) patients after percutaneous coronary intervention (PCI). Patients with ACS after PCI (n = 808) were prospectively followed-up for MACE. RHR was obtained from electrocardiogram. MACE was defined as a composite of cardiac death, nonfatal recurrent myocardial infarction, ischemic-driven revascularization, and ischemic stroke. The association between RHR and one-year risk of MACE was assessed using Cox proportional hazards regression model. Compared with patients with RHR >76 bpm, the adjusted hazard ratio (AHR) was 0.51 (95% confidence intervals [CI]: 0.23-1.14; P = 0.100) for patients with RHR < 61 bpm, and 0.44 (95%CI: 0.23-0.85; P = 0.014) for those with RHR 61-76 bpm. For patients with RHR ≥ 61 bpm, an increase of 10 bpm in RHR was associated with an increase by 38.0% in the risk of MACE (AHR: 1.38; 95% CI: 1.04-1.83; P = 0.026). ACS patients after PCI with RHR >76 bpm were at higher risk of MACE during one-year follow-up compared with patients with RHR 61-76 bpm. An elevated RHR ≥ 61 bpm was associated with increased risk of one-year MACE in ACS patients.

  20. Troponin T in Prediction of Culprit Lesion Coronary Artery Disease and 1-Year Major Adverse Cerebral and Cardiovascular Events in Patients with Acute Stroke.

    PubMed

    Zeus, Tobias; Ketterer, Ulrike; Leuf, Daniela; Dannenberg, Lisa; Wagstaff, Rabea; Bönner, Florian; Gliem, Michael; Jander, Sebastian; Kelm, Malte; Polzin, Amin

    2016-06-01

    Troponin T (TnT) elevation above the 99th percentile upper reference limit (URL) is considered diagnostic of acute myocardial infarction (MI). Non-specific increases of TnT are frequent in acute stroke patients. However, in these patients, correct diagnosis of MI is crucial because the antithrombotic medications used to treat acute MI might be harmful and produce intracranial bleeding. In this study, we aimed to associate enhanced TnT levels defined by different cutoff values with occurrence of culprit lesion coronary artery disease (CAD) as well as 1-year major adverse cerebral and cardiovascular events (MACCEs). In this cohort study, we investigated 84 consecutive patients with acute ischemic stroke and concomitant MI. TnT levels were measured using a fourth-generation TnT assay. The incidence of culprit lesion CAD was determined by coronary angiography. MACCEs were recorded during 1-year follow-up. Culprit lesion CAD occurred in 55 % of patients, and 1-year MACCE in 37 %. TnT levels above the manufacturers' provided 99th URL (TnT > 0.01) were not associated with culprit lesion CAD (relative risk [RR], 1.3; 95 % confidence interval [CI] 0.96-1.8; P = 0.09). Slightly increased cutoff level (TnT > 0.03) increased specificity and was associated with culprit lesion CAD without decreasing sensitivity (RR, 1.5; 95 % CI 1.1-2.2; P = 0.021) and 1-year MACCE (RR, 1.7; 95 % CI 1.3-2.3; P < 0.001). Slightly increasement of the TnT cutoff level predicted MACCEs and is superior in prediction of culprit lesion CAD in stroke patients without being less sensitive. This finding has to be confirmed in large-scale clinical trials.

  1. Syntax Score and Major Adverse Cardiac Events in Patients with Suspected Coronary Artery Disease: Results from a Cohort Study in a University-Affiliated Hospital in Southern Brazil

    PubMed Central

    Fuchs, Felipe C.; Ribeiro, Jorge P.; Fuchs, Flávio D.; Wainstein, Marco V.; Bergoli, Luis C.; Wainstein, Rodrigo V.; Zen, Vanessa; Kerkhoff, Alessandra C.; Moreira, Leila B.; Fuchs, Sandra C.

    2016-01-01

    Background: The importance of coronary anatomy in predicting cardiovascular events is well known. The use of traditional anatomical scores in routine angiography, however, has not been incorporated to clinical practice. SYNTAX score (SXscore) is a scoring system that estimates the anatomical extent of coronary artery disease (CAD). Its ability to predict outcomes based on a baseline diagnostic angiography has not been tested to date. Objective: To evaluate the performance of the SXscore in predicting major adverse cardiac events (MACE) in patients referred for diagnostic angiography. Methods: Prospective cohort of 895 patients with suspected CAD referred for elective diagnostic coronary angiography from 2008 to 2011, at a university-affiliated hospital in Brazil. They had their SXscores calculated and were stratified in three categories: no significant CAD (n = 495), SXscoreLOW-INTERMEDIATE: < 23 (n = 346), and SXscoreHIGH: ≥ 23 (n = 54). Primary outcome was a composite of cardiac death, myocardial infarction, and late revascularization. Secondary endpoints were the components of MACE and death from any cause. Results: On average, patients were followed up for 1.8 ± 1.4 years. The primary outcome occurred in 2.2%, 15.3%, and 20.4% in groups with no significant CAD, SXscoreLOW-INTERMEDIATE, and SXscoreHIGH, respectively (p < 0.001). All-cause death was significantly higher in the SXscoreHIGH compared with the 'no significant CAD' group, 16.7% and 3.8% (p < 0.001), respectively. After adjustment for confounding factors, all outcomes remained associated with the SXscore. Conclusions: SXscore independently predicts MACE in patients submitted to diagnostic coronary angiography. Its routine use in this setting could identify patients with worse prognosis. PMID:27509092

  2. Dietary patterns and the risk of major adverse cardiovascular events in a global study of high-risk patients with stable coronary heart disease

    PubMed Central

    Stewart, Ralph A. H.; Wallentin, Lars; Benatar, Jocelyne; Danchin, Nicolas; Hagström, Emil; Held, Claes; Husted, Steen; Lonn, Eva; Stebbins, Amanda; Chiswell, Karen; Vedin, Ola; Watson, David; White, Harvey D.

    2016-01-01

    Objectives To determine whether dietary pattern assessed by a simple self-administered food frequency questionnaire is associated with major adverse cardiovascular events (MACE) in high-risk patients with stable coronary artery disease. Background A Mediterranean dietary pattern has been associated with lower cardiovascular (CV) mortality. It is less certain whether foods common in western diets are associated with CV risk. Methods At baseline, 15 482 (97.8%) patients (mean age 67 ± 9 years) with stable coronary heart disease from 39 countries who participated in the Stabilisation of atherosclerotic plaque by initiation of darapladib therapy (STABILITY) trial completed a life style questionnaire which included questions on common foods. A Mediterranean diet score (MDS) was calculated for increasing consumption of whole grains, fruits, vegetables, legumes, fish, and alcohol, and for less meat, and a ‘Western diet score’ (WDS) for increasing consumption of refined grains, sweets and deserts, sugared drinks, and deep fried foods. A multi-variable Cox proportional hazards models assessed associations between MDS or WDS and MACE, defined as CV death, non-fatal myocardial infarction, or non-fatal stroke. Results After a median follow-up of 3.7 years MACE occurred in 7.3% of 2885 subjects with an MDS ≥15, 10.5% of 4018 subjects with an MDS of 13–14, and 10.8% of 8579 subjects with an MDS ≤12. A one unit increase in MDS >12 was associated with lower MACE after adjusting for all covariates (+1 category HR 0.95, 95% CI 0.91, 0.98, P = 0.002). There was no association between WDS (adjusted model +1 category HR 0.99, 95% CI 0.97, 1.01) and MACE. Conclusion Greater consumption of healthy foods may be more important for secondary prevention of coronary artery disease than avoidance of less healthy foods typical of Western diets. PMID:27109584

  3. Association Between Vascular Access Dysfunction and Subsequent Major Adverse Cardiovascular Events in Patients on Hemodialysis: A Population-Based Nested Case-Control Study.

    PubMed

    Kuo, Te-Hui; Tseng, Chien-Tzu; Lin, Wei-Hung; Chao, Jo-Yen; Wang, Wei-Ming; Li, Chung-Yi; Wang, Ming-Cheng

    2015-07-01

    The association between dialysis vascular access dysfunction and the risk of developing major adverse cardiovascular events (MACE) in hemodialysis patients is unclear and has not yet been investigated. We analyzed data from the National Health Insurance Research Database of Taiwan to quantify this association. Adopting a case-control design nested within a cohort of patients who received hemodialysis from 2001 to 2010, we identified 9711 incident cases of MACE during the stage of stable maintenance dialysis and 19,422 randomly selected controls matched to cases on age, gender, and duration of dialysis. Events of vascular access dysfunction in the 6-month period before the date of MACE onset (ie, index date) for cases and before index dates for controls were evaluated retrospectively. The presence of vascular access dysfunction was associated with a 1.385-fold higher odds of developing MACE as estimated from the logistic regression analysis. This represents a significantly increased adjusted odds ratio (OR) at 1.268 (95% confidence interval [CI] = 1.186-1.355) after adjustment for comorbidities and calendar years of initiating dialysis. We also noted a significant exposure-response trend (P < 0.001) between the frequency of vascular access dysfunction and MACE, with the greatest risk (adjusted OR = 1.840, 95% CI = 1.549-2.186) noted in patients with ≥3 vascular access events. We concluded that dialysis vascular access dysfunction was significantly associated with an increased risk of MACE. Hence, vascular access failure can be an early sign for MACE in patients receiving maintenance hemodialysis. Active monitoring and treatment of cardiovascular risk factors and related diseases, not merely managing vascular access dysfunction, would be required to reduce the risk of MACE.

  4. Pharmacokinetic and Genomic Effects of Arsenite in Drinking Water on Mouse Lung in a 30-Day Exposure.

    PubMed

    Chilakapati, Jaya; Wallace, Kathleen; Hernandez-Zavala, Araceli; Moore, Tanya; Ren, Hongzu; Kitchin, Kirk T

    2015-01-01

    The 2 objectives of this subchronic study were to determine the arsenite drinking water exposure dependent increases in female C3H mouse liver and lung tissue arsenicals and to characterize the dose response (to 0, 0.05, 0.25, 1, 10, and 85 ppm arsenite in drinking water for 30 days and a purified AIN-93M diet) for genomic mouse lung expression patterns. Mouse lungs were analyzed for inorganic arsenic, monomethylated, and dimethylated arsenicals by hydride generation atomic absorption spectroscopy. The total lung mean arsenical levels were 1.4, 22.5, 30.1, 50.9, 105.3, and 316.4 ng/g lung tissue after 0, 0.05, 0.25, 1, 10, and 85 ppm, respectively. At 85 ppm, the total mean lung arsenical levels increased 14-fold and 131-fold when compared to either the lowest noncontrol dose (0.05 ppm) or the control dose, respectively. We found that arsenic exposure elicited minimal numbers of differentially expressed genes (DEGs; 77, 38, 90, 87, and 87 DEGs) after 0.05, 0.25, 1, 10, and 85 ppm, respectively, which were associated with cardiovascular disease, development, differentiation, apoptosis, proliferation, and stress response. After 30 days of arsenite exposure, this study showed monotonic increases in mouse lung arsenical (total arsenic and dimethylarsinic acid) concentrations but no clear dose-related increases in DEG numbers.

  5. Kansas City Cardiomyopathy Questionnaire Utility in Prediction of 30-Day Readmission Rate in Patients with Chronic Heart Failure

    PubMed Central

    Gui, Junhong; Zhu, Xiang; Malhotra, Divyanshu; Li, Shenjing; Virkram, Fnu; Chada, Aditya; Jiang, Haibing

    2016-01-01

    Background. Heart failure (HF) is one of the most common diagnoses associated with hospital readmission. We designed this prospective study to evaluate whether Kansas City Cardiomyopathy Questionnaire (KCCQ) score is associated with 30-day readmission in patients hospitalized with decompensated HF. Methods and Results. We enrolled 240 patients who met the study criteria. Forty-eight (20%) patients were readmitted for decompensated HF within thirty days of hospital discharge, and 192 (80%) patients were not readmitted. Compared to readmitted patients, nonreadmitted patients had a higher average KCCQ score (40.8 versus 32.6, P = 0.019) before discharge. Multivariate analyses showed that a high KCCQ score was associated with low HF readmission rate (adjusted OR = 0.566, P = 0.022). The c-statistic for the base model (age + gender) was 0.617. The combination of home medication and lab tests on the base model resulted in an integrated discrimination improvement (IDI) increase of 3.9%. On that basis, the KCQQ further increased IDI of 2.7%. Conclusions. The KCCQ score determined before hospital discharge was significantly associated with 30-day readmission rate in patients with HF, which may provide a clinically useful measure and could significantly improve readmission prediction reliability when combined with other clinical components. PMID:27872790

  6. Readmission for Acute Exacerbation within 30 Days of Discharge Is Associated with a Subsequent Progressive Increase in Mortality Risk in COPD Patients: A Long-Term Observational Study

    PubMed Central

    Guerrero, Mónica; Crisafulli, Ernesto; Liapikou, Adamantia; Huerta, Arturo; Gabarrús, Albert; Chetta, Alfredo; Soler, Nestor; Torres, Antoni

    2016-01-01

    Background and Objective Twenty per cent of chronic obstructive pulmonary disease (COPD) patients are readmitted for acute exacerbation (AECOPD) within 30 days of discharge. The prognostic significance of early readmission is not fully understood. The objective of our study was to estimate the mortality risk associated with readmission for acute exacerbation within 30 days of discharge in COPD patients. Methods The cohort (n = 378) was divided into patients readmitted (n = 68) and not readmitted (n = 310) within 30 days of discharge. Clinical, laboratory, microbiological, and severity data were evaluated at admission and during hospital stay, and mortality data were recorded at four time points during follow-up: 30 days, 6 months, 1 year and 3 years. Results Patients readmitted within 30 days had poorer lung function, worse dyspnea perception and higher clinical severity. Two or more prior AECOPD (HR, 2.47; 95% CI, 1.51–4.05) was the only variable independently associated with 30-day readmission. The mortality risk during the follow-up period showed a progressive increase in patients readmitted within 30 days in comparison to patients not readmitted; moreover, 30-day readmission was an independent risk factor for mortality at 1 year (HR, 2.48; 95% CI, 1.10–5.59). In patients readmitted within 30 days, the estimated absolute increase in the mortality risk was 4% at 30 days (number needed to harm NNH, 25), 17% at 6-months (NNH, 6), 19% at 1-year (NNH, 6) and 24% at 3 years (NNH, 5). Conclusion In conclusion a readmission for AECOPD within 30 days is associated with a progressive increased long-term risk of death. PMID:26943928

  7. [Effect of 30-day space flight and subsequent readaptation on the signaling processes in m. longissimus dorsi of mice].

    PubMed

    Mirzoev, T M; Vil'chinskaia, N A; Lomonosova, Iu N; Nemirovskaia, T L; Shenkman, B S

    2014-01-01

    Some steps of anabolic and catabolic signaling pathways were investigated in postural/tonic m. longissimus dorsi of mice following the 30-day orbital flight of biosatellite "Bion-M1" and 8-day recovery. Western blotting was used for determining insulin receptor substrate 1 (IRS-1) and AMR-activated protein kinase (AMPK) involved in reciprocal regulation of anabolic and catabolic pathways, as well as E3-ligase MURF-1, and elongation factor eEF2. Functioning of the IGF-1-dependent IRS-1 signaling pathway was activated in the recovery period only. Though the content of ubiquitinligase MURF-1 showed an increase after flight, on completion of the recovery period it did not exceed the pre-flight level unambiguously.

  8. Hip Fractures: What Information Does the Evidence Show That Patients and Families Need to Decrease 30-Day Readmission?

    PubMed

    Gardner, Kristin OʼMara

    2015-01-01

    The current bundled payment reimbursement from the Centers for Medicare & Medicaid Services will not cover the additional cost of hospital readmission for the same diagnosis, and patients with hip fractures have one of the highest cost-saving opportunities when compared with other admission reasons. Common reasons for readmission to the hospital after hip fracture include pneumonia, dehydration, and mobility issues. The learning modalities including visual, aural, read/write, and kinesthetic were used to make recommendations on how the education can be incorporated into the instruction of patients with hip fractures and their families. These learning techniques can be used to develop education to decrease possibility of 30-day readmission after hip fracture. Nurses must focus their education to meet the needs of each individual patient, adapting to different types of adult learners to increase the health literacy of patients with hip fractures and their families.

  9. Adding Laboratory Data to Hospital Claims Data to Improve Risk Adjustment of Inpatient/30-Day Postdischarge Outcomes.

    PubMed

    Pine, Michael; Fry, Donald E; Hannan, Edward L; Naessens, James M; Whitman, Kay; Reband, Agnes; Qian, Feng; Schindler, Joseph; Sonneborn, Mark; Roland, Jaclyn; Hyde, Linda; Dennison, Barbara A

    Numerical laboratory data at admission have been proposed for enhancement of inpatient predictive modeling from administrative claims. In this study, predictive models for inpatient/30-day postdischarge mortality and for risk-adjusted prolonged length of stay, as a surrogate for severe inpatient complications of care, were designed with administrative data only and with administrative data plus numerical laboratory variables. A comparison of resulting inpatient models for acute myocardial infarction, congestive heart failure, coronary artery bypass grafting, and percutaneous cardiac interventions demonstrated improved discrimination and calibration with administrative data plus laboratory values compared to administrative data only for both mortality and prolonged length of stay. Improved goodness of fit was most apparent in acute myocardial infarction and percutaneous cardiac intervention. The emergence of electronic medical records should make the addition of laboratory variables to administrative data an efficient and practical method to clinically enhance predictive modeling of inpatient outcomes of care.

  10. Effect of a 30-day isolation stress on calcium, phosphorus and other excretory products in an unrestrained chimpanzee.

    NASA Technical Reports Server (NTRS)

    Sabbot, I. M.; Mcnew, J. J.; Hoshizaki, T.; Sedgwick, C. J.; Adey, W. R.

    1972-01-01

    An unrestrained chimpanzee was studied in an isolation chamber and in his home cage environment. The study consisted of 49 urine collection days (14 days pre-, 5 days post- and 30 days of isolation), and then of 10 days in the home cage. Dietary intake, urine and fecal data were obtained. The effect of isolation on various excretory parameters was studied. Urine samples were analyzed for volume, osmolarity, creatinine, creatine, urea-N, 17-hydroxy corticosteroids, VMA, calcium and inorganic phosphorus. One way analyses of variance performed on the urinary excretion parameters showed all except creatinine excretion to vary significantly during periods of the study. The changes observed in calcium and phosphorus were highly significant. The data suggests that the calcium to phosphorus excretion ratio might serve as a physiological stress indicator of Selye's adaptation syndrome (period of resistance).

  11. Community Level Association between Home Health and Nursing Home Performance on Quality and Hospital 30-day Readmissions for Medicare Patients.

    PubMed

    Wang, Yun; Pandolfi, Michelle M; Fine, Jonathan; Metersky, Mark L; Wang, Changqin; Ho, Shih-Yieh; Galusha, Deron; Nuti, Sudhakar V; Murugiah, Karthik; Spenard, Ann; Elwell, Timothy; Krumholz, Harlan M

    2016-11-01

    We evaluated whether community-level home health agencies and nursing home performance is associated with community-level hospital 30-day all-cause risk-standardized readmission rates for Medicare patients used data from the Centers for Medicare & Medicaid Service from 2010 to 2012. Our final sample included 2,855 communities that covered 4,140 hospitals with 6,751,713 patients, 13,060 nursing homes with 1,250,648 residents, and 7,613 home health agencies providing services to 35,660 zipcodes. Based on a mixed effect model, we found that increasing nursing home performance by one star for all of its 4 measures and home health performance by 10 points for all of its 6 measures is associated with decreases of 0.25% (95% CI 0.17-0.34) and 0.60% (95% CI 0.33-0.83), respectively, in community-level risk-standardized readmission rates.

  12. Sex-Specific Associations Between Coronary Artery Plaque Extent and Risk of Major Adverse Cardiovascular Events: from the CONFIRM Long-Term Registry

    PubMed Central

    Gransar, Heidi; Lin, Fay; Valenti, Valentina; Cho, Iksung; Berman, Daniel; Callister, Tracy; DeLago, Augustin; Hadamitzky, Martin; Hausleiter, Joerg; Al-Mallah, Mouaz; Budoff, Matthew; Kaufmann, Philipp; Achenbach, Stephan; Raff, Gilbert; Chinnaiyan, Kavitha; Cademartiri, Filippo; Maffei, Erica; Villines, Todd; Kim, Yong-Jin; Leipsic, Jonathon; Feuchtner, Gudrun; Rubinshtein, Ronen; Pontone, Gianluca; Andreini, Daniele; Marques, Hugo; Shaw, Leslee; Min, James K.

    2016-01-01

    Objective To examine sex-specific associations, if any, between per-vessel CAD extent and the risk of major adverse cardiovascular events (MACE) over a five-year study duration. Background The presence and extent of coronary artery disease (CAD) diagnosed by coronary computed tomography angiography (CCTA) is associated with increased short-term mortality and MACE. Nevertheless, some uncertainty remains regarding the influence of gender on these findings. Methods 5,632 patients (mean age 60.2 + 11.8 years, 36.5% female) from the CONFIRM (COronary CT Angiography EvaluatioN For Clinical Outcomes: An InteRnational Multicenter) registry were followed over the course of 5 years. Obstructive CAD was defined as ≥50% luminal stenosis in a coronary vessel. Using Cox proportional-hazards models, we calculated the hazard ratio (HR) for incident MACE among women and men, defined as death or myocardial infarction (MI). Results Obstructive CAD was more prevalent in men (42% vs. 26%, p<0.001) whereas women were more likely to have normal coronary arteries (43% vs. 27%, p<0.001). There were a total of 798 incident MACE events. After adjustment, there was a strong association between increased MACE risk and non-obstructive CAD (HR 2.16 for women, 2.56 for men, p<0.001 for both), obstructive one-vessel CAD (HR 3.69 and 2.66, p<0.001), two-vessel CAD (HR 3.92 and 3.55, p<0.001) and three-vessel/left-main CAD (HR 5.94 and 4.44, p<0.001). Further exploratory analyses of atherosclerotic burden did not identify gender-specific patterns predictive of MACE. Conclusion In a large prospective CCTA cohort followed long-term, we did not observe an interaction of gender for the association between MACE risk and increased per-vessel extent of obstructive CAD. These findings highlight the persistent prognostic significance of anatomic CAD subsets as detected by CCTA for the risk of MACE in both women and men. PMID:27056154

  13. Red blood cell distribution width independently predicts medium-term mortality and major adverse cardiac events after an acute coronary syndrome

    PubMed Central

    Turcato, Gianni; Serafini, Valentina; Dilda, Alice; Bovo, Chiara; Caruso, Beatrice; Ricci, Giorgio

    2016-01-01

    Background The value of red blood cell distribution width (RDW), a simple and inexpensive measure of anisocytosis, has been associated with the outcome of many human chronic disorders. Therefore, this retrospective study was aimed to investigate whether RDW may be associated with medium-term mortality and major adverse cardiac events (MACE) after an acute coronary syndrome (ACS). Methods A total number of 979 patients diagnosed with ACS were enrolled from June 2014 to November 2014, and followed-up until June 2015. Results The RDW value in patients with 3-month MACE and in those who died was significantly higher than that of patients without 3-month MACE (13.3% vs. 14.0%; P<0.001) and those who were still alive at the end of follow-up (13.4% vs. 14.4%; P<0.001). In univariate analysis, RDW was found to be associated with 3-month MACE [odds ratio (OR), 1.70; 95% CI, 1.44–2.00, P<0.001]. In multivariate analysis, RDW remained independently associated with 3-month MACE (adjusted OR, 1.36; 95% CI, 1.19–1.55; P<0.001) and death (adjusted OR, 1.34; 95% CI, 1.05–1.71; P=0.020). The accuracy of RDW for predicting 3-month MACE was 0.67 (95% CI, 0.66–0.72; P<0.001). The most efficient discriminatory RDW value was 14.8%, which was associated with 3.8 (95% CI, 2.6–5.7; P<0.001) higher risk of 3-month MACE. Patients with RDW >14.8% exhibited a significantly short survival than those with RDW ≤14.8% (331 vs. 465 days; P<0.001). Conclusions The results of this study confirm that RDW may be a valuable, easy and inexpensive parameter for stratifying the medium-term risk in patients with ACS. PMID:27500155

  14. Effect of Smoking on Infarct Size and Major Adverse Cardiac Events in Patients With Large Anterior ST-Elevation Myocardial Infarction (from the INFUSE-AMI Trial).

    PubMed

    Gennaro, Giustino; Brener, Sorin J; Redfors, Björn; Kirtane, Ajay J; Généreux, Philippe; Maehara, Akiko; Neunteufl, Thomas; Metzger, D Christopher; Mehran, Roxana; Gibson, C Michael; Stone, Gregg W

    2016-10-15

    We sought to investigate the effect of smoking on infarct size (IS) and major adverse cardiac events (MACE) in patients with large anterior ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention. Participants from the Intracoronary Abciximab and Aspiration Thrombectomy in Patients with Large Anterior Myocardial Infarction study were categorized according to smoking status (current or previous smoking vs no history of smoking). The primary imaging outcome was cardiac magnetic resonance imaging-assessed IS of left ventricular mass (%) at 30 days. The primary clinical outcome was the rate of MACE at 30 days and 1 year, defined as the composite of death, reinfarction, new-onset heart failure, or rehospitalization. Of 447 patients enrolled in Intracoronary Abciximab and Aspiration Thrombectomy in Patients with Large Anterior Myocardial Infarction, 271 (60.6%) were current or past smokers. Compared with nonsmokers, smokers were almost 10 years younger and had a lower prevalence of clinical co-morbidities. Smokers had better procedural success and angiographic reperfusion compared with nonsmokers. At 30 days, there were no differences between smokers and nonsmokers in median IS (16.8% vs 17.4%, p = 0.67) or metrics of left ventricular function. By multivariable linear regression analysis, smoking was not significantly associated with IS at 30 days (beta coefficient: 0.83, p = 0.42). At 1 year, smokers had lower crude rates of MACE (7.6% vs 15%, p = 0.01). After multivariable adjustment, there were no significant differences in 1-year MACE between smokers and nonsmokers (adjusted hazard ratio 0.73, 95% CI 0.40 to 1.33, p = 0.30). In conclusion, smoking history had no significant effect on IS at 30 days. Although current or previous smokers had lower rates of 1-year MACE than those with no history of smoking, adjustment for baseline characteristics rendered this association nonsignificant. These findings support the hypothesis

  15. Classifying emergency 30-day readmissions in England using routine hospital data 2004–2010: what is the scope for reduction?

    PubMed Central

    Blunt, Ian; Bardsley, Martin; Grove, Amy; Clarke, Aileen

    2015-01-01

    Background Many health systems across the globe have introduced arrangements to deny payment for patients readmitted to hospital as an emergency. The purpose of this study was to develop an exploratory categorisation based on likely causes of readmission, and then to assess the prevalence of these different types. Methods Retrospective analysis of 82 million routinely collected National Health Service hospital records in England (2004–2010) was undertaken using anonymised linkage of records at person-level. Numbers of 30-day readmissions were calculated. Exploratory categorisation of readmissions was applied using simple rules relating to International Classification of Diseases (ICD) diagnostic codes for both admission and readmission. Results There were 5 804 472 emergency 30-day readmissions over a 6-year period, equivalent to 7.0% of hospital discharges. Readmissions were grouped into hierarchically exclusive categories: potentially preventable readmission (1 739 519 (30.0% of readmissions)); anticipated but unpredictable readmission (patients with chronic disease or likely to need long-term care; 1 141 987 (19.7%)); preference-related readmission (53 718 (0.9%)); artefact of data collection (16 062 (0.3%)); readmission as a result of accident, coincidence or related to a different body system (1 101 818 (19.0%)); broadly related readmission (readmission related to the same body system (1 751 368 (30.2%)). Conclusions In this exploratory categorisation, a large minority of emergency readmissions (eg, those that are potentially preventable or due to data artefacts) fell into groups potentially amenable to immediate reduction. For other categories, a hospital's ability to reduce emergency readmission is less clear. Reduction strategies and payment incentives must be carefully tailored to achieve stated aims. PMID:24668396

  16. Anabolic and Catabolic Signaling Pathways in mouse Longissimus Dorsi after 30-day BION-M1 Spaceflight and Subsequent Recovery

    NASA Astrophysics Data System (ADS)

    Mirzoev, Timur; Blottner, Dieter; Shenkman, Boris; Lomonosova, Yulia; Vilchinskaya, Natalia; Nemirovskaya, Tatiana; Salanova, Michele

    The aim of the study was to analyze some of the key markers regulating anabolic and catabolic processes in mouse m. longissimus dorsi, an important back muscle system for trunk stabilization, following 30-day spaceflight and 8-day recovery period. C57/black mice were divided into 3 groups: 1) Vivarium Control (n=7), 2) Flight (n=5), 3) Recovery (n=5). The experiment was carried out in accordance with the rules of biomedical ethics certified by the Russian Academy of Sciences Committee on Bioethics. Using Western-blotting analysis we determined the content of IRS-1, p-AMPK, MURF-1 and eEF2 in m. longissimus dorsi. The content of IRS-1 in mice m. longissimus dorsi after the 30-day flight did not differ from the control group, however, in the Recovery group IRS-1 level was 80% higher (p<0.05) as compared to Control. Phospho-AMPK content remained unchanged. In the Recovery group there was an increase of eEF2 by 75% compared to the Control (p<0.05). After spaceflight MuRF-1 content was increased more than 2 times compared to the control animals. Thus, our findings showed that the work of the IRS-1 - dependent signaling pathway is only active in the recovery period. The content of the ubiquitin-ligase MURF-1 that takes parts in degrading myosin heavy chain was increased after the spaceflight, however, after 8-day recovery period MURF-1 level did not exceed the control indicating normalization of protein degradation in m. longissimus dorsi. The work was supported by the program of basic research of RAS and Federal Space Program of Russia for the period of 2006-2015.

  17. Prior chronic clopidogrel therapy is associated with increased adverse events and early stent thrombosis.

    PubMed

    Asher, Elad; Fefer, Paul; Sabbag, Avi; Herscovici, Romana; Regev, Ehud; Mazin, Israel; Shlomo, Nir; Zahger, Doron; Atar, Shaul; Hammerman, Haim; Polak, Arthur; Beigel, Roy; Matetzky, Shlomi

    2016-01-01

    Despite the growing use of clopidogrel, limited data exist regarding the prognostic significance of chronic clopidogrel therapy in patients sustaining acute coronary syndrome (ACS). Our aim was to determine whether patients sustaining ACS while on chronic clopidogrel therapy have a worse prognosis than clopidogrel-naïve patients. A total of 5,386 consecutive ACS patients were prospectively characterised and followed-up for 30 days. Of them, 680 (13%) were treated with clopidogrel prior to the index ACS. Major adverse cardiovascular events (MACE) were defined as death, recurrent ACS, stroke and/or stent thrombosis. Compared with clopidogrel-naïve, chronic clopidogrel-treated patients were older (66 ± 12 vs 63 ± 13, respectively; p<0.01), suffered more from diabetes mellitus, hypertension, dyslipidaemia, prior cardiovascular history, including prior myocardial infarction, revascularisation, coronary artery bypass graft and stroke (p<0.01 for all), and were less likely to present with ST-elevation myocardial infarction (21% vs 45%; respectively; p < 0.001). Prior clopidogrel therapy was associated with a two-fold increase in in-hospital (1.6% vs 0.6%, respectively; p =0.006) as well as 30-day stent thrombosis (2.2% vs 1.0%, respectively; p=0.007). MACE at 30 days was also higher among chronic clopidogrel-treated compared with clopidogrel-naïve patients [12.3% vs 9.4%, respectively; p<0.01]. In multivariate log regression analysis chronic clopidogrel treatment was an independent predictor of stent thrombosis [OR=2.6 (95%CI 1.2-5.6), p=0.001]. Patients sustaining ACS while on chronic clopidogrel treatment are at higher risk for in-hospital and 30-day adverse outcomes, including stent thrombosis.

  18. Effect of 30-day orbital flight BION M1 on excretion of expired endogenous CO in mice

    NASA Astrophysics Data System (ADS)

    Shulagin, Yury; Tatarkin, Sergey; Dyachenko, Alexander

    It is known that increased destruction of hem structures is accompanied by increase of the endogenous carbon monoxide excretion rate with respiration (VCO). Changes VCO preceded the observed changes in the blood composition [D’yachenko A. et al., 2010]. Changes in blood composition, i.e. rise of red blood cells content and reduction of reticulocytes content was detected after a 12-day orbital flight (OF) in mice C57BL/6 [Gridley D.et al., 2003]. The purpose of this study was to investigate the effect of 30-day OF on excretion of endogenous CO. The method and apparatus for simultaneous measurement of VCO, and O2 and CO2 exchange were developed. The research consisted of three parts: 1). Measurement of VCO in five C57BL/6 mice after 30-day OF on the Russian satellite BION M1. 2). Measurement of VCO in six C57BL/6 mice after 30-day ground-based experiment (GBE) with simulated flight telemetry environment of BION M1. 3). Measurement of VCO in seven C57BL/6 mice in vivarium The results: Mice weight after OF was 24.3+-3.3 (mean +-SD) with minimal weight 18.1 g, and maximal weight 29.9 g. Vivarium mice weight was 27.0+-1.8 g. KGE mice weight was 25.0+-1.3 g. Mice age in all three groups was the same. We measured and estimated VCO and total CO excretion (MCO) for two gas mixtures ventilated mouse camera: atmospheric CO-contained air and then CO-free air(30 min). The results showed that the average MCO allocated GBE and vivarium mice did not significantly differ. Average MCO in mice after OF was significantly higher then in vivarium group (T=-2,74; p=0.02). MCO after GBE was between the vivarium and OF groups. MCO in OF and KGE groups did not differ ( T=-1,93; p=0,085). Blood tests in mice after OF was not carried out, because the recovery after the OF was studied in this group. The largest excretion of CO was observed in a mouse N39 after the OF. The weight of this mouse was only 18.1 g, i.e. much less than mean weight. Increase of VCO in food-restricted animal is known

  19. Incremental prognostic value of coronary computed tomographic angiography over coronary artery calcium score for risk prediction of major adverse cardiac events in asymptomatic diabetic individuals

    PubMed Central

    Min, James K.; Labounty, Troy M.; Gomez, Millie J.; Achenbach, Stephan; Al-Mallah, Mouaz; Budoff, Matthew J.; Cademartiri, Filippo; Callister, Tracy Q.; Chang, Hyuk-Jae; Cheng, Victor; Chinnaiyan, Kavitha M.; Chow, Benjamin; Cury, Ricardo; Delago, Augustin; Dunning, Allison; Feuchtner, Gudrun; Hadamitzky, Martin; Hausleiter, Jorg; Kaufmann, Philipp; Kim, Yong-Jin; Leipsic, Jonathon; Lin, Fay Y.; Maffei, Erica; Raff, Gilbert; Shaw, Leslee J.; Villines, Todd C.; Berman, Daniel S.

    2015-01-01

    Background Coronary artery disease (CAD) diagnosis by coronary computed tomographic angiography (CCTA) is useful for identification of symptomatic diabetic individuals at heightened risk for death. Whether CCTA-detected CAD enables improved risk assessment of asymptomatic diabetic individuals beyond clinical risk factors and coronary artery calcium scoring (CACS) remains unexplored. Methods From a prospective 12-center international registry of 27,125 individuals undergoing CCTA, we identified 400 asymptomatic diabetic individuals without known CAD. Coronary stenosis by CCTA was graded as 0%, 1–49%, 50–69%, and ≥70%. CAD was judged on a per-patient, per-vessel and per-segment basis as maximal stenosis severity, number of vessels with ≥50% stenosis, and coronary segments weighted for stenosis severity (segment stenosis score), respectively. We assessed major adverse cardiovascular events (MACE) – inclusive of mortality, nonfatal myocardial infarction (MI), and late target vessel revascularization ≥90 days (REV) – and evaluated the incremental utility of CCTA for risk prediction, discrimination and reclassification. Results Mean age was 60.4 ± 9.9 years; 65.0% were male. At a mean follow-up 2.4 ± 1.1 years, 33 MACE occurred (13 deaths, 8 MI, 12 REV) [8.25%; annualized rate 3.4%]. By univariate analysis, per-patient maximal stenosis [hazards ratio (HR) 2.24 per stenosis grade, 95% confidence interval (CI) 1.61–3.10, p < 0.001], increasing numbers of obstructive vessels (HR 2.30 per vessel, 95% CI 1.75–3.03, p < 0.001) and segment stenosis score (HR 1.14 per segment, 95% CI 1.09–1.19, p < 0.001) were associated with increased MACE. After adjustment for CAD risk factors and CACS, maximal stenosis (HR 1.80 per grade, 95% CI 1.18–2.75, p = 0.006), number of obstructive vessels (HR 1.85 per vessel, 95% CI 1.29–2.65, p < 0.001) and segment stenosis score (HR 1.11 per segment, 95% CI 1.05–1.18, p < 0.001) were associated with increased risk of

  20. Utility of models to predict 28-day or 30-day unplanned hospital readmissions: an updated systematic review

    PubMed Central

    Zhou, Huaqiong; Della, Phillip R; Roberts, Pamela; Goh, Louise; Dhaliwal, Satvinder S

    2016-01-01

    Objective To update previous systematic review of predictive models for 28-day or 30-day unplanned hospital readmissions. Design Systematic review. Setting/data source CINAHL, Embase, MEDLINE from 2011 to 2015. Participants All studies of 28-day and 30-day readmission predictive model. Outcome measures Characteristics of the included studies, performance of the identified predictive models and key predictive variables included in the models. Results Of 7310 records, a total of 60 studies with 73 unique predictive models met the inclusion criteria. The utilisation outcome of the models included all-cause readmissions, cardiovascular disease including pneumonia, medical conditions, surgical conditions and mental health condition-related readmissions. Overall, a wide-range C-statistic was reported in 56/60 studies (0.21–0.88). 11 of 13 predictive models for medical condition-related readmissions were found to have consistent moderate discrimination ability (C-statistic ≥0.7). Only two models were designed for the potentially preventable/avoidable readmissions and had C-statistic >0.8. The variables ‘comorbidities’, ‘length of stay’ and ‘previous admissions’ were frequently cited across 73 models. The variables ‘laboratory tests’ and ‘medication’ had more weight in the models for cardiovascular disease and medical condition-related readmissions. Conclusions The predictive models which focused on general medical condition-related unplanned hospital readmissions reported moderate discriminative ability. Two models for potentially preventable/avoidable readmissions showed high discriminative ability. This updated systematic review, however, found inconsistent performance across the included unique 73 risk predictive models. It is critical to define clearly the utilisation outcomes and the type of accessible data source before the selection of the predictive model. Rigorous validation of the predictive models with moderate-to-high discriminative

  1. Immunohistochemical study of motoneurons in lumbar spinal cord of c57black/6 mice after 30-days space flight

    NASA Astrophysics Data System (ADS)

    Tyapkina, Oksana; Islamov, Rustem; Nurullin, Leniz; Petrov, Konstantin.; Rezvyakov, Pavel; Nikolsky, Evgeny

    To investigate mechanisms of hypogravity motor syndrome development the immunoexpression of heat shock proteins (Hsp27 and Hsp70), proteins of synaptic transmission (Synaptophysin and PSD95) and neuroprotective proteins (VEGF and Flt-1) in motoneurons of lumbar spinal cord in c57black/6 control mice (n=2) and after 30-days space flight (n=2) was studied. For a quantitative assessment of target proteins level in motoneurons frozen cross sections of lumbar spinal cord were underwent to immunohistochemical staining. Primary antibodies against VEGF, Flt-1, Hsp27 and Hsp70 (SantaCruz Biotechnology, inc. USA), against Synaptophysin and PSD95 (Abcam plc, UK) were visualized by streptavidin-biotin method. Images of spinal cords were received using OlympusBX51WI microscope with AxioCamMRm camera (CarlZeiss, Germany) and the AxioVisionRel. 4.6.3 software (CarlZeiss, Germany). The digitized data were analyzed using ImageJ 1.43 software (NIH, the USA). Quantitively, protein level in motoneurons was estimated by the density of immunoprecipitation. Results of research have not revealed any reliable changes in the immunnoexpression of vascular endothelial growth factor (VEGF) and its Flt-1 receptor in motoneurons of lumbar spinal cord in control and in mice after 30-day space flight. Studying of heat shock proteins, such as Hsp27 and Hsp70, revealed the decrease in level of these proteins immunoexpression in motoneurons of mice from flight group by 15% and 10%, respectively. Some decrease in level of immunnoexpression of presynaptic membrane proteins (synaptophysin, by 21%) and proteins of postsynaptic area (PSD95, by 55%) was observed after space flight. The data obtained testify to possible changes in a functional state (synaptic activity and stress resistance) of motoneurons of lumbar spinal cord in mice after space flight. Thus, we obtained new data on involvement of motoneurons innervating skeletal muscles in development of hypogravity motor syndrome. Research was supported

  2. Effects of 30 day simulated microgravity and recovery on fluid homeostasis and renal function in the rat

    NASA Technical Reports Server (NTRS)

    Tucker, Bryan J.; Mendonca, Margarida M.

    1995-01-01

    Transition from a normal gravitational environment to that of microgravity eventually results in decreased plasma and blood volumes, increasing with duration of exposure to microgravity. This loss of vascular fluid is presumably due to negative fluid and electrolyte balance and most likely contributes to the orthostatic intolerance associated with the return to gravity. The decrease in plasma volume is presumed to be a reflection of a concurrent decrease in extracellular fluid volume with maintenance of normal plasma-interstitial fluid balance. In addition, the specific alterations in renal function contributing to these changes in fluid and electrolyte homeostasis are potentially responding to neuro-humoral signals that are not consistent with systemic fluid volume status. We have previously demonstrated an early increase in both glomerular filtration rate and extracellular fluid volume and that this decreases towards control values by 7 days of simulated microgravity. However, longer duration studies relating these changes to plasma volume alterations and the response to return to orthostasis have not been fully addressed. Male Wistar rats were chronically cannulated, submitted to 30 days heat-down tilt (HDT) and followed for 7 days after return to orthostasis from HDT. Measurements of renal function and extracellular and blood volumes were performed in the awake rat.

  3. Factors associated with moderate or severe left atrioventricular valve regurgitation within 30 days of repair of complete atrioventricular septal defect

    PubMed Central

    Kozak, Marcelo Felipe; Kozak, Ana Carolina Leiroz Ferreira Botelho Maisano; Marchi, Carlos Henrique De; Hassem Sobrinho Junior, Sirio; Croti, Ulisses Alexandre; Moscardini, Airton Camacho

    2015-01-01

    Introduction Left atrioventricular valve regurgitation is the most concerning residual lesion after surgical correction of atrioventricular septal defects. Objective To determine factors associated with moderate or severe left atrioventricular valve regurgitation within 30 days of surgical repair of complete atrioventricular septal defect. Methods We assessed the results of 53 consecutive patients 3 years-old and younger presenting with complete atrioventricular septal defect that were operated on at our practice between 2002 and 2010. The following variables were considered: age, weight, absence of Down syndrome, grade of preoperative atrioventricular valve regurgitation, abnormalities on the left atrioventricular valve and the use of annuloplasty. Median age was 6.7 months; median weight was 5.3 Kg; 86.8% had Down syndrome. At the time of preoperative evaluation, there were 26 cases with moderate or severe left atrioventricular valve regurgitation (49.1%). Abnormalities on the left atrioventricular valve were found in 11.3%; annuloplasty was performed in 34% of the patients. Results At the time of postoperative evaluation, there were 21 cases with moderate or severe left atrioventricular valve regurgitation (39.6%). After performing a multivariate analysis, the only significant factor associated with moderate or severe left atrioventricular valve regurgitation was the absence of Down syndrome (P=0.03). Conclusion Absence of Down syndrome was associated with moderate or severe postoperative left atrioventricular valve regurgitation after surgical repair of complete atrioventricular septal defect at our practice. PMID:26313720

  4. Human performance profiles for planetary analog extra-vehicular activities: 120 day and 30 day analog missions

    NASA Astrophysics Data System (ADS)

    Swarmer, Tiffany M.

    Understanding performance factors for future planetary missions is critical for ensuring safe and successful planetary extra-vehicular activities (EVAs). The goal of this study was to gain operational knowledge of analog EVAs and develop biometric profiles for specific EVA types. Data was collected for a 120 and 30 day analog planetary exploration simulation focusing on EVA type, pre and post EVA conditions, and performance ratings. From this five main types of EVAs were performed: maintenance, science, survey/exploratory, public relations, and emergency. Each EVA type has unique characteristics and performance ratings showing specific factors in chronological components, environmental conditions, and EVA systems that have an impact on performance. Pre and post biometrics were collected to heart rate, blood pressure, and SpO2. Additional data about issues and specific EVA difficulties provide some EVA trends illustrating how tasks and suit comfort can negatively affect performance ratings. Performance decreases were noted for 1st quarter and 3rd quarter EVAs, survey/exploratory type EVAs, and EVAs requiring increased fine and gross motor function. Stress during the simulation is typically higher before the EVA and decreases once the crew has returned to the habitat. Stress also decreases as the simulation nears the end with the 3rd and 4th quarters showing a decrease in stress levels. Operational components and studies have numerous variable and components that effect overall performance, by increasing the knowledge available we may be able to better prepare future crews for the extreme environments and exploration of another planet.

  5. The migraine generator revisited: continuous scanning of the migraine cycle over 30 days and three spontaneous attacks.

    PubMed

    Schulte, Laura H; May, Arne

    2016-07-01

    Functional imaging using positron emission tomography and later functional magnetic resonance imaging revealed a particular brainstem area that is believed to be specifically activated in migraine during, but not outside of the attack, and consequently has been coined the 'migraine generator'. However, the pathophysiological concept behind this term is not undisputed and typical migraine premonitory symptoms such as fatigue and yawning, but also a typical association of attacks to circadian and menstrual cycles, all make the hypothalamus a possible regulating region of migraine attacks. Neuroimaging studies investigating native human migraine attacks however are scarce and for methodological but also clinical reasons there are currently no studies investigating the last 24 h before headache onset. Here we report a migraine patient who had magnetic resonance imaging every day for 30 days, always in the morning, to cover, using functional imaging, a whole month and three complete, untreated migraine attacks. We found that hypothalamic activity as a response to trigeminal nociceptive stimulation is altered during the 24 h prior to pain onset, i.e. increases towards the next migraine attack. More importantly, the hypothalamus shows altered functional coupling with the spinal trigeminal nuclei and the region of the migraine generator, i.e. the dorsal rostral pons during the preictal day and the pain phase of native human migraine attacks. These data suggest that although the brainstem is highly linked to the migraine biology, the real driver of attacks might be the functional changes in hypothalamo-brainstem connectivity.

  6. Gene Expression Profiling in Slow-Type Calf Soleus Muscle of 30 Days Space-Flown Mice.

    PubMed

    Gambara, Guido; Salanova, Michele; Ciciliot, Stefano; Furlan, Sandra; Gutsmann, Martina; Schiffl, Gudrun; Ungethuem, Ute; Volpe, Pompeo; Gunga, Hanns-Christian; Blottner, Dieter

    2017-01-01

    Microgravity exposure as well as chronic disuse are two main causes of skeletal muscle atrophy in animals and humans. The antigravity calf soleus is a reference postural muscle to investigate the mechanism of disuse-induced maladaptation and plasticity of human and rodent (rats or mice) skeletal musculature. Here, we report microgravity-induced global gene expression changes in space-flown mouse skeletal muscle and the identification of yet unknown disuse susceptible transcripts found in soleus (a mainly slow phenotype) but not in extensor digitorum longus (a mainly fast phenotype dorsiflexor as functional counterpart to soleus). Adult C57Bl/N6 male mice (n = 5) flew aboard a biosatellite for 30 days on orbit (BION-M1 mission, 2013), a sex and age-matched cohort were housed in standard vivarium cages (n = 5), or in a replicate flight habitat as ground control (n = 5). Next to disuse atrophy signs (reduced size and myofiber phenotype I to II type shift) as much as 680 differentially expressed genes were found in the space-flown soleus, and only 72 in extensor digitorum longus (only 24 genes in common) compared to ground controls. Altered expression of gene transcripts matched key biological processes (contractile machinery, calcium homeostasis, muscle development, cell metabolism, inflammatory and oxidative stress response). Some transcripts (Fzd9, Casq2, Kcnma1, Ppara, Myf6) were further validated by quantitative real-time PCR (qRT-PCR). Besides previous reports on other leg muscle types we put forth for the first time a complete set of microgravity susceptible gene transcripts in soleus of mice as promising new biomarkers or targets for optimization of physical countermeasures and rehabilitation protocols to overcome disuse atrophy conditions in different clinical settings, rehabilitation and spaceflight.

  7. Gene Expression Profiling in Slow-Type Calf Soleus Muscle of 30 Days Space-Flown Mice

    PubMed Central

    Gambara, Guido; Salanova, Michele; Ciciliot, Stefano; Furlan, Sandra; Gutsmann, Martina; Schiffl, Gudrun; Ungethuem, Ute; Volpe, Pompeo; Gunga, Hanns-Christian; Blottner, Dieter

    2017-01-01

    Microgravity exposure as well as chronic disuse are two main causes of skeletal muscle atrophy in animals and humans. The antigravity calf soleus is a reference postural muscle to investigate the mechanism of disuse-induced maladaptation and plasticity of human and rodent (rats or mice) skeletal musculature. Here, we report microgravity-induced global gene expression changes in space-flown mouse skeletal muscle and the identification of yet unknown disuse susceptible transcripts found in soleus (a mainly slow phenotype) but not in extensor digitorum longus (a mainly fast phenotype dorsiflexor as functional counterpart to soleus). Adult C57Bl/N6 male mice (n = 5) flew aboard a biosatellite for 30 days on orbit (BION-M1 mission, 2013), a sex and age-matched cohort were housed in standard vivarium cages (n = 5), or in a replicate flight habitat as ground control (n = 5). Next to disuse atrophy signs (reduced size and myofiber phenotype I to II type shift) as much as 680 differentially expressed genes were found in the space-flown soleus, and only 72 in extensor digitorum longus (only 24 genes in common) compared to ground controls. Altered expression of gene transcripts matched key biological processes (contractile machinery, calcium homeostasis, muscle development, cell metabolism, inflammatory and oxidative stress response). Some transcripts (Fzd9, Casq2, Kcnma1, Ppara, Myf6) were further validated by quantitative real-time PCR (qRT-PCR). Besides previous reports on other leg muscle types we put forth for the first time a complete set of microgravity susceptible gene transcripts in soleus of mice as promising new biomarkers or targets for optimization of physical countermeasures and rehabilitation protocols to overcome disuse atrophy conditions in different clinical settings, rehabilitation and spaceflight. PMID:28076365

  8. A contemporary risk model for predicting 30-day mortality following percutaneous coronary intervention in England and Wales

    PubMed Central

    McAllister, Katherine S.L.; Ludman, Peter F.; Hulme, William; de Belder, Mark A.; Stables, Rodney; Chowdhary, Saqib; Mamas, Mamas A.; Sperrin, Matthew; Buchan, Iain E.

    2016-01-01

    Background The current risk model for percutaneous coronary intervention (PCI) in the UK is based on outcomes of patients treated in a different era of interventional cardiology. This study aimed to create a new model, based on a contemporary cohort of PCI treated patients, which would: predict 30 day mortality; provide good discrimination; and be well calibrated across a broad risk-spectrum. Methods and results The model was derived from a training dataset of 336,433 PCI cases carried out between 2007 and 2011 in England and Wales, with 30 day mortality provided by record linkage. Candidate variables were selected on the basis of clinical consensus and data quality. Procedures in 2012 were used to perform temporal validation of the model. The strongest predictors of 30-day mortality were: cardiogenic shock; dialysis; and the indication for PCI and the degree of urgency with which it was performed. The model had an area under the receiver operator characteristic curve of 0.85 on the training data and 0.86 on validation. Calibration plots indicated a good model fit on development which was maintained on validation. Conclusion We have created a contemporary model for PCI that encompasses a range of clinical risk, from stable elective PCI to emergency primary PCI and cardiogenic shock. The model is easy to apply and based on data reported in national registries. It has a high degree of discrimination and is well calibrated across the risk spectrum. The examination of key outcomes in PCI audit can be improved with this risk-adjusted model. PMID:26942330

  9. The statistical extended-range (10-30-day) forecast of summer rainfall anomalies over the entire China

    NASA Astrophysics Data System (ADS)

    Zhu, Zhiwei; Li, Tim

    2017-01-01

    The extended-range (10-30-day) rainfall forecast over the entire China was carried out using spatial-temporal projection models (STPMs). Using a rotated empirical orthogonal function analysis of intraseasonal (10-80-day) rainfall anomalies, China is divided into ten sub-regions. Different predictability sources were selected for each of the ten regions. The forecast skills are ranked for each region. Based on temporal correlation coefficient (TCC) and Gerrity skill score, useful skills are found for most parts of China at a 20-25-day lead. The southern China and the mid-lower reaches of Yangtze River Valley show the highest predictive skills, whereas southwestern China and Huang-Huai region have the lowest predictive skills. By combining forecast results from ten regional STPMs, the TCC distribution of 8-year (2003-2010) independent forecast for the entire China is investigated. The combined forecast results from ten STPMs show significantly higher skills than the forecast with just one single STPM for the entire China. Independent forecast examples of summer rainfall anomalies around the period of Beijing Olympic Games in 2008 and Shanghai World Expo in 2010 are presented. The result shows that the current model is able to reproduce the gross pattern of the summer intraseasonal rainfall over China at a 20-day lead. The present study provides, for the first time, a guide on the statistical extended-range forecast of summer rainfall anomalies for the entire China. It is anticipated that the ideas and methods proposed here will facilitate the extended-range forecast in China.

  10. Nonclinical Factors Associated with 30-Day Mortality after Lung Cancer Resection: An Analysis of 215,000 Patients Using the National Cancer Data Base

    PubMed Central

    Melvan, John N; Sancheti, Manu S; Gillespie, Theresa; Nickleach, Dana C; Liu, Yuan; Higgins, Kristin; Ramalingam, Suresh; Lipscomb, Joseph; Fernandez, Felix G

    2015-01-01

    Background Clinical variables associated with 30-day mortality after lung cancer surgery are well known. However, the effects of non-clinical factors, including insurance coverage, household income, education, type of treatment center, and area of residence, on short term survival are less appreciated. We studied the National Cancer Data Base (NCDB), a joint endeavor of the Commission on Cancer of the American College of Surgeons and the American Cancer Society, to identify disparities in 30-day mortality after lung cancer resection based on these non-clinical factors. Study Design We performed a retrospective cohort analysis of patients undergoing lung cancer resection from 2003-2011, using the NCDB. Data were analyzed using a multivariable logistic regression model to identify risk factors for 30-day mortality. Results 215,645 patients underwent lung cancer resection during our study period. We found that clinical variables such as age, gender, comorbidity, cancer stage, preoperative radiation, extent of resection, positive surgical margins, and tumor size were associated with 30-day mortality after resection. Non-clinical factors including living in lower income neighborhoods with a lesser proportion of high school graduates, and receiving cancer care at a non-academic medical center were also independently associated with increased 30-day postoperative mortality. Conclusions This study represents the largest analysis of 30-day mortality for lung cancer resection to date from a generalizable national cohort. Our results demonstrate that, in addition to known clinical risk factors, several non-clinical factors are associated with increased 30-day mortality after lung cancer resection. These disparities require further investigation to improve lung cancer patient outcomes. PMID:26206651

  11. Development, Validation and Deployment of a Real Time 30 Day Hospital Readmission Risk Assessment Tool in the Maine Healthcare Information Exchange

    PubMed Central

    Hao, Shiying; Wang, Yue; Jin, Bo; Shin, Andrew Young; Zhu, Chunqing; Huang, Min; Zheng, Le; Luo, Jin; Hu, Zhongkai; Fu, Changlin; Dai, Dorothy; Wang, Yicheng; Culver, Devore S.; Alfreds, Shaun T.; Rogow, Todd; Stearns, Frank; Sylvester, Karl G.; Widen, Eric; Ling, Xuefeng B.

    2015-01-01

    Objectives Identifying patients at risk of a 30-day readmission can help providers design interventions, and provide targeted care to improve clinical effectiveness. This study developed a risk model to predict a 30-day inpatient hospital readmission for patients in Maine, across all payers, all diseases and all demographic groups. Methods Our objective was to develop a model to determine the risk for inpatient hospital readmission within 30 days post discharge. All patients within the Maine Health Information Exchange (HIE) system were included. The model was retrospectively developed on inpatient encounters between January 1, 2012 to December 31, 2012 from 24 randomly chosen hospitals, and then prospectively validated on inpatient encounters from January 1, 2013 to December 31, 2013 using all HIE patients. Results A risk assessment tool partitioned the entire HIE population into subgroups that corresponded to probability of hospital readmission as determined by a corresponding positive predictive value (PPV). An overall model c-statistic of 0.72 was achieved. The total 30-day readmission rates in low (score of 0–30), intermediate (score of 30–70) and high (score of 70–100) risk groupings were 8.67%, 24.10% and 74.10%, respectively. A time to event analysis revealed the higher risk groups readmitted to a hospital earlier than the lower risk groups. Six high-risk patient subgroup patterns were revealed through unsupervised clustering. Our model was successfully integrated into the statewide HIE to identify patient readmission risk upon admission and daily during hospitalization or for 30 days subsequently, providing daily risk score updates. Conclusions The risk model was validated as an effective tool for predicting 30-day readmissions for patients across all payer, disease and demographic groups within the Maine HIE. Exposing the key clinical, demographic and utilization profiles driving each patient’s risk of readmission score may be useful to providers

  12. Extent of Surgery Does Not Influence 30-Day Mortality in Surgery for Metastatic Bone Disease: An Observational Study of a Historical Cohort.

    PubMed

    Sørensen, Michala Skovlund; Hindsø, Klaus; Hovgaard, Thea Bechmann; Petersen, Michael Mørk

    2016-04-01

    Estimating patient survival has hitherto been the main focus when treating metastatic bone disease (MBD) in the appendicular skeleton. This has been done in an attempt to allocate the patient to a surgical procedure that outlives them. No questions have been addressed as to whether the extent of the surgery and thus the surgical trauma reduces survival in this patient group. We wanted to evaluate if perioperative parameters such as blood loss, extent of bone resection, and duration of surgery were risk factors for 30-day mortality in patients having surgery due to MBD in the appendicular skeleton. We retrospectively identified 270 consecutive patients who underwent joint replacement surgery or intercalary spacing for skeletal metastases in the appendicular skeleton from January 1, 2003 to December 31, 2013. We collected intraoperative (duration of surgery, extent of bone resection, and blood loss), demographic (age, gender, American Society of Anesthesiologist score [ASA score], and Karnofsky score), and disease-specific (primary cancer) variables. An association with 30-day mortality was addressed using univariate and multivariable analyses and calculation of odds ratio (OR). All patients were included in the analysis. ASA score 3 + 4 (OR 4.16 [95% confidence interval, CI, 1.80-10.85], P = 0.002) and Karnofsky performance status below 70 (OR 7.34 [95% CI 3.16-19.20], P < 0.001) were associated with increased 30-day mortality in univariate analysis. This did not change in multivariable analysis. No parameters describing the extent of the surgical trauma were found to be associated with 30-day mortality. The 30-day mortality in patients undergoing surgery for MBD is highly dependent on the general health status of the patients as measured by the ASA score and the Karnofsky performance status. The extent of surgery, measured as duration of surgery, blood loss, and degree of bone resection were not associated with 30-day mortality.

  13. Radiologic Findings and Patient Factors Associated with 30-Day Mortality after Surgical Evacuation of Subdural Hematoma in Patients Less Than 65 Years Old

    PubMed Central

    Han, Myung-Hoon; Ryu, Je Il; Kim, Choong Hyun; Kim, Jae Min; Cheong, Jin Hwan; Yi, Hyeong-Joong

    2017-01-01

    Objective The purpose of this study is to evaluate the associations between 30-day mortality and various radiological and clinical factors in patients with traumatic acute subdural hematoma (SDH). During the 11-year study period, young patients who underwent surgery for SDH were followed for 30 days. Patients who died due to other medical comorbidities or other organ problems were not included in the study population. Methods From January 1, 2004 to December 31, 2014, 318 consecutive surgically-treated traumatic acute SDH patients were registered for the study. The Kaplan–Meier method was used to analyze 30-day survival rates. We also estimated the hazard ratios of various variables in order to identify the independent predictors of 30-day mortality. Results We observed a negative correlation between 30-day mortality and Glasgow coma scale score (per 1-point score increase) (hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.52–0.70; p<0.001). In addition, use of antithrombotics (HR, 2.34; 95% CI, 1.27–4.33; p=0.008), history of diabetes mellitus (HR, 2.28; 95% CI, 1.20–4.32; p=0.015), and accompanying traumatic subarachnoid hemorrhage (hazard ratio, 2.13; 95% CI, 1.27–3.58; p=0.005) were positively associated with 30-day mortality. Conclusion We found significant associations between short-term mortality after surgery for traumatic acute SDH and lower Glasgow Coma Scale scores, use of antithrombotics, history of diabetes mellitus, and accompanying traumatic subarachnoid hemorrhage at admission. We expect these findings to be helpful for selecting patients for surgical treatment of traumatic acute SDH, and for making accurate prognoses. PMID:28264246

  14. 75 FR 77901 - 30-Day Notice of Opportunity for Public Comment on U.S. Nominations to the World Heritage List...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-14

    ... National Park Service 30-Day Notice of Opportunity for Public Comment on U.S. Nominations to the World Heritage List and Potential Additions to the U.S. World Heritage Tentative List AGENCY: National Park... to comment on the next potential U.S. nominations from the U.S. World Heritage Tentative List to...

  15. The association of culling and death rate within 30 days after calving with productivity or reproductive performance in dairy herds in Fukuoka, Southern Japan

    PubMed Central

    GOTO, Akira; NAKADA, Ken; KATAMOTO, Hiromu

    2015-01-01

    The incidence of peripartum disorders in dairy herds negatively influences productivity and reproductive performance. Concrete data from local areas are helpful for explaining the importance of peripartum management to dairy farmers. This study was conducted to clarify the association of culling and death rate within 30 days after calving with productivity or reproductive performance in 179 dairy herds in Fukuoka, Southern Japan. A database was compiled from the records of the Livestock Improvement Association of Japan, the Dairy Cooperative Association and the Federation of Agricultural Mutual Relief Association. In this study, we created a comprehensive database of dairy farm production data for epidemiological analysis and used a general linear mixed model to analyze the association of culling and death rate within 30 days after calving with milk production or reproductive performance. The database can be used to describe, analyze and predict the risk of production. A cross-sectional analysis with contrasts was applied to investigate the association of cows served by AI/all cows, pregnant cows/cows served by AI, days open, milk yield and somatic cell counts with culling and death rate within 30 days after calving. The days open value significantly increased with increasing rate of culling and death within 30 days after calving (P for trend <0.001). No significant differences were found for the other comparisons. Our data suggest that proper feeding and management in the dry period may lead to improved postpartum reproductive performance in this dairy cow cohort. PMID:26666177

  16. 75 FR 55625 - 30-Day Notice of Proposed Information Collection: Form DS-1622, DS-1843, DS-1622P, and DS-1843P...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-13

    .... SUMMARY: The Department of State is seeking Office of Management and Budget (OMB) approval for the... Management and Budget (OMB) for up to 30 days from August 30, 2010. ADDRESSES: You may submit comments by any... maintain the health and fitness of the individual and family members within the Department of State...

  17. The 30-day prognosis of chronic-disease patients after contact with the out-of-hours service in primary healthcare

    PubMed Central

    Carlsen, Anders Helles; Moth, Grete; Christensen, Morten Bondo; Vestergaard, Mogens; Olesen, Frede; Vedsted, Peter

    2014-01-01

    Abstract Objective. Little is known about the prognosis of patients with chronic disease who contact the out-of-hours (OOH) service in primary care. The characteristics of contacts with the Danish out-of-hours service and daytime general practice, hospitalization, and death were studied during a 30-day follow-up period in patients with chronic heart diseases. Design. Cohort study. Setting and subjects. The study was based on data from 11 897 adults aged 18 + years from a Danish survey of OOH contacts, including information on consultation type. Reason for encounter (RFE) was categorized by OOH GPs at triage as either “exacerbation” or “new health problem”. Registry data were used to identify eligible patients, and the cohort was followed for 30 days after OOH contact through nationwide registries on healthcare use and mortality. Main outcome measures. The 30-day prognosis of chronic-disease patients after OOH contact. Results. Included patients with chronic disease had a higher risk of new OOH contact, daytime GP contact, and hospitalization than other patients during the 30-day follow-up period. OOH use was particularly high among patients with severe mental illness. A strong association was seen between chronic disease and risk of dying during follow-up. Conclusion. Patients with chronic disease used both daytime general practice and the out-of-hours service more often than others during the 30-day follow-up period; they were more often hospitalized and had higher risk of dying. The findings call for a proactive approach to future preventive day care and closer follow-up of this group, especially patients with psychiatric disease. PMID:25471829

  18. An investigation of quality improvement initiatives in decreasing the rate of avoidable 30-day, skilled nursing facility-to-hospital readmissions: a systematic review

    PubMed Central

    Mileski, Michael; Topinka, Joseph Baar; Lee, Kimberly; Brooks, Matthew; McNeil, Christopher; Jackson, Jenna

    2017-01-01

    Objectives The main objective was to investigate the applicability and effectiveness of quality improvement initiatives in decreasing the rate of avoidable 30-day, skilled nursing facility (SNF)-to-hospital readmissions. Problem The rate of rehospitalizations from SNF within 30 days of original discharge has increased within the last decade. Setting The research team participants conducted a literature review via Cumulative Index of Nursing and Allied Health Literature and PubMed to collect data about quality improvement implemented in SNFs. Results The most common facilitator was the incorporation of specialized staff. The most cited barriers were quality improvement tracking and implementation. Conclusion These strategy examples can be useful to acute care hospitals attempting to lower bounce back from subacute care providers and long-term care facilities seeking quality improvement initiatives to reduce hospital readmissions. PMID:28182162

  19. Predictors of early dyspnoea relief in acute heart failure and the association with 30-day outcomes: findings from ASCEND-HF

    PubMed Central

    Mentz, Robert J.; Hernandez, Adrian F.; Stebbins, Amanda; Ezekowitz, Justin A.; Felker, G. Michael; Heizer, Gretchen M.; Atar, Dan; Teerlink, John R.; Califf, Robert M.; Massie, Barry M.; Hasselblad, Vic; Starling, Randall C.; O'Connor, Christopher M.; Ponikowski, Piotr

    2013-01-01

    Aims To examine the characteristics associated with early dyspnoea relief during acute heart failure (HF) hospitalization, and its association with 30-day outcomes. Methods and results ASCEND-HF was a randomized trial of nesiritide vs. placebo in 7141 patients hospitalized with acute HF in which dyspnoea relief at 6 h was measured on a 7-point Likert scale. Patients were classified as having early dyspnoea relief if they experienced moderate or marked dyspnoea improvement at 6 h. We analysed the clinical characteristics, geographical variation, and outcomes (mortality, mortality/HF hospitalization, and mortality/hospitalization at 30 days) associated with early dyspnoea relief. Early dyspnoea relief occurred in 2984 patients (43%). In multivariable analyses, predictors of dyspnoea relief included older age and oedema on chest radiograph; higher systolic blood pressure, respiratory rate, and natriuretic peptide level; and lower serum blood urea nitrogen (BUN), sodium, and haemoglobin (model mean C index = 0.590). Dyspnoea relief varied markedly across countries, with patients enrolled from Central Europe having the lowest risk-adjusted likelihood of improvement. Early dyspnoea relief was associated with lower risk-adjusted 30-day mortality/HF hospitalization [hazard ratio (HR) 0.81; 95% confidence interval (CI) 0.68–0.96] and mortality/hospitalization (HR 0.85; 95% CI 0.74–0.99), but similar mortality. Conclusion Clinical characteristics such as respiratory rate, pulmonary oedema, renal function, and natriuretic peptide levels are associated with early dyspnoea relief, and moderate or marked improvement in dyspnoea was associated with a lower risk for 30-day outcomes. PMID:23159547

  20. In vitro study of 24-hour and 30-day shear bond strengths of three resin-glass ionomer cements used to bond orthodontic brackets.

    PubMed

    Lippitz, S J; Staley, R N; Jakobsen, J R

    1998-06-01

    Interest in using composite resin-glass ionomer hybrid cements as orthodontic bracket adhesives has grown because of their potential for fluoride release. The purpose of this pilot study was to compare shear bond strengths of three resin-glass ionomer cements (Advance, Fuji Duet, Fuji Ortho LC) used as bracket adhesives with a composite resin 24 hours and 30 days after bonding. The amount of adhesive remaining on the debonded enamel surface was scored for each adhesive. Mesh-backed stainless-steel brackets were bonded to 100 extracted human premolars, which were stored in artificial saliva at 37 degrees C until being tested to failure in a testing machine. The hybrid cements, with one exception, had bond strengths similar to those of the composite resin at 24 hours and 30 days. Fuji Ortho LC had significantly lower bond strengths (ANOVA p < or = 0.05) than the other adhesives at 24 hours and 30 days when it was bonded to unetched, water-moistened enamel. Adhesive-remnant scores were similar for all cements, except for cement Fuji Ortho LC when it was bonded to unetched enamel. The resin-glass ionomer cements we tested appear to have bond strengths suitable for routine use as orthodontic bracket-bonding adhesives.

  1. The age estimation of blood stains up to 30 days old using visible wavelength hyperspectral image analysis and linear discriminant analysis.

    PubMed

    Li, Bo; Beveridge, Peter; O'Hare, William T; Islam, Meez

    2013-09-01

    A novel application of visible wavelength hyperspectral image analysis has been applied to determine the age of blood stains up to 30 days old. Reflectance spectra from selected locations within the hyperspectral image, obtained from a portable instrument, were subjected to spectral pre-processing. This was followed by the application of a linear discriminant classification model, making estimations possible with an average error of ±0.27days for the first 7 days and an overall average error of ±1.17days up to 30 days. This is also the first reported study of the determination of the age of fresh blood stains (less than one day old) with an error of ±0.09h. The studies have been made under controlled conditions and represent, at this stage, proof of concept results but also are the most accurate age estimation results for measurements between 0 and 30 days reported to date. The results are consistent with well-established kinetic processes suggesting that the pre-processing stages described are revealing spectroscopic changes which are reliably following the time dependent oxidation of HbO2. The potential for parameterisation of environmental factors to make the method generally applicable at crime scenes is discussed, along with the developments required to further improve classification and to make the instrument genuinely portable.

  2. The HOSPITAL score and LACE index as predictors of 30 day readmission in a retrospective study at a university-affiliated community hospital

    PubMed Central

    Hudali, Tamer

    2017-01-01

    Introduction Hospital readmissions are common, expensive, and a key target of the Medicare Value Based Purchasing (VBP) program. Validated risk assessment tools such as the HOSPITAL score and LACE index have been developed to identify patients at high risk of hospital readmission so they can be targeted for interventions aimed at reducing the rate of readmission. This study aims to evaluate the utility of HOSPITAL score and LACE index for predicting hospital readmission within 30 days in a moderate-sized university affiliated hospital in the midwestern United States. Materials and Methods All adult medical patients who underwent one or more ICD-10 defined procedures discharged from the SIU-SOM Hospitalist service from Memorial Medical Center (MMC) from October 15, 2015 to March 16, 2016, were studied retrospectively to determine if the HOSPITAL score and LACE index were a significant predictors of hospital readmission within 30 days. Results During the study period, 463 discharges were recorded for the hospitalist service. The analysis includes data for the 432 discharges. Patients who died during the hospital stay, were transferred to another hospital, or left against medical advice were excluded. Of these patients, 35 (8%) were readmitted to the same hospital within 30 days. A receiver operating characteristic evaluation of the HOSPITAL score for this patient population shows a C statistic of 0.75 (95% CI [0.67–0.83]), indicating good discrimination for hospital readmission. The Brier score for the HOSPITAL score in this setting was 0.069, indicating good overall performance. The Hosmer–Lemeshow goodness of fit test shows a χ2 value of 3.71 with a p value of 0.59. A receiver operating characteristic evaluation of the LACE index for this patient population shows a C statistic of 0.58 (95% CI [0.48–0.68]), indicating poor discrimination for hospital readmission. The Brier score for the LACE index in this setting was 0.082, indicating good overall performance

  3. Analysis of 30-Day Postdischarge Morbidity and Readmission after Radical Gastrectomy for Gastric Carcinoma: A Single-Center Study of 2107 Patients With Prospective Data

    PubMed Central

    Jeong, Oh; Kyu Park, Young; Ran Jung, Mi; Yeop Ryu, Seong

    2015-01-01

    Abstract PD morbidity and readmission pose a substantial clinical and economic burden to the healthcare system. Comprehensive PD complications and readmission data are essential for developing initiatives to improve patient care. No previous studies have extensively investigated PD complications after gastric cancer surgery. We investigated the incidence, types, treatment, and risk factors of 30-day postdischarge (PD) complications after gastric cancer surgery. Between 2010 and 2013, data concerning complications and readmission within 30 days of hospital discharge were prospectively collected in 2107 patients undergoing gastric cancer surgery. In total, 1642 patients (77.9%) underwent distal gastrectomy, 418 (19.8%) total gastrectomy, and 47 (2.3%) other procedures. Postoperative morbidity and mortality were 17.4% and 0.6%, respectively, with a mean 8.8-day hospital stay. Sixty-one patients (2.9%) developed 30-day PD morbidity (58 local and 3 systemic complications), accounting for 16.6% of overall morbidity; 47 (2.2%) were readmitted; and 7 (0.3%) underwent a reoperation. The mean time to PD complications was 9.5 days after index hospital discharge. The most common complication was intra-abdominal abscess (n = 14), followed by wound, ascites, and anastomosis leakage. No mortality occurred resulting from PD complications. In the univariate and multivariate analyses, underlying comorbidity (hypertension and liver cirrhosis) and obesity were independent risk factors for developing PD complications. The early PD period is a vulnerable time for surgical patients with substantial risk of complication and readmission. Tailored discharge plans along with appropriate PD patient support are essential for improving the quality of patient care. PMID:25789945

  4. Predictors of 30-Day Mortality and 90-Day Functional Recovery after Primary Intracerebral Hemorrhage : Hospital Based Multivariate Analysis in 585 Patients

    PubMed Central

    2009-01-01

    Objective The purpose of this study was to identify independent predictors of mortality and functional recovery in patients with primary intracerebral hemorrhage (PICH) and to improve functional outcome in these patients. Methods Data were collected retrospectively on 585 patients with supratentorial PICH admitted to the Stroke Unit at our hospital between 1st January 2004 and the 31st July 2008. Using multivariate logistic regression analysis, the associations between all selected variables and 30-day mortality and 90-day functional recoveries after PICH was evaluated. Results Ninety-day functional recovery was achieved in 29.1% of the 585 patients and 30-day mortality in 15.9%. Age (OR=7.384, p=0.000), limb weakness (OR=6.927, p=0.000), and hematoma volume (OR=5.293, p=0.000) were found to be powerful predictors of 90-day functional recovery. Furthermore, initial consciousness (OR=3.013, p=0.014) hematoma location (lobar, OR=2.653, p=0.003), ventricular extension of blood (OR=2.077, p=0.013), leukocytosis (OR=2.048, p=0.008), alcohol intake (drinker, OR=1.927, p=0.023), and increased serum aminotransferase (OR=1.892, p=0.035) were found to be independent predictors of 90-day functional recovery after PICH. On the other hand, a pupillary abnormality (OR=4.532, p=0.000) and initial unconsciousness (OR=3.362, p=0.000) were found to be independent predictors of 30-day mortality after PICH. Conclusion The predictors of mortality and functional recovery after PICH identified during this analysis may assist during clinical decision-making, when advising patients or family members about the prognosis of PICH and when planning intervention trials. PMID:19609417

  5. Length of stay, wait time to surgery and 30-day mortality for patients with hip fractures after the opening of a dedicated orthopedic weekend trauma room

    PubMed Central

    Taylor, Michel; Hopman, Wilma; Yach, Jeff

    2016-01-01

    Background In September 2011, Kingston General Hospital (KGH) opened a dedicated orthopedic weekend trauma room. Previously, 1 weekend operating room (OR) was used by all surgical services. We assessed the impact this dedicated weekend trauma room had on hospital length of stay (LOS), time to surgery and 30-day mortality for patients with hip fractures. Methods Patients admitted between Oct. 1, 2009, and Sept. 30, 2012, were identified through our trauma registry, representing the 2 years before and 1 year after the opening of the orthopedic weekend trauma room. We documented type of fracture, mode of fixation, age, sex, American Society of Anesthesiologists (ASA) score, time to OR, LOS, discharge disposition and 30-day mortality. We excluded patients with multiple fractures, open fractures and those requiring trauma team activation. Results Our study included 609 patients (405 pre- and 204 post–trauma room opening). Mean LOS decreased from 11.6 to 9.4 days (p = 0.005) and there was a decreasing trend in mean time to OR from 31.5 to 28.5 hours (p = 0.16). There was no difference in 30-day mortality (p = 0.24). The LOS decreased by an average of 2 days following opening of the weekend trauma room (p = 0.031) and by an average of 2.2 additional days if the patient was admitted on the weekend versus during the week (p = 0.024). Conclusion The weekend trauma OR at KGH significantly decreased the LOS and appears to have decreased wait times to surgery. Further analysis is needed to assess the cost-effectiveness of the current strategy, the long-term outcome of this patient population and the impact the additional orthopedic weekend trauma room has had on other surgical services (i.e., general surgery) and their patients. PMID:27668332

  6. Effectiveness of using thyrocalcitonin for the prevention of a calcium metabolic disorder in the mineralized tissues of rabbits with 30 days hypokinesia

    NASA Technical Reports Server (NTRS)

    Volozhin, A. I.; Shashkov, V. S.; Dmitriyev, B. S.; Yegorov, B. B.; Lobachik, V. I.; Brishin, A. I.

    1980-01-01

    A 30 day hypokinesia in rabbits led to a considerable lag in weight gain for the skeletal bones, reduction in Ca45 uptake, and an increase in isotope resorption rate in the rapidly metabolized fraction of extremity bones. On the other hand, Ca45 content in the teeth and maxillae increased, which may be explained by redistribution of isotope among the various mineralized tissues. Injection of thyrocalcitonin (50 IU/day) produced a distinct normalizing effect on Ca45 uptake and resorption in the mineralized tissues of rabbits kept hypokinetic.

  7. Life sciences payload definition and integration study. Volume 4: Appendix, costs, and data management requirements of the dedicated 30-day laboratory. [carry-on laboratory for Spacelab

    NASA Technical Reports Server (NTRS)

    1974-01-01

    The results of the updated 30-day life sciences dedicated laboratory scheduling and costing activities are documented, and the 'low cost' methodology used to establish individual equipment item costs is explained in terms of its allowances for equipment that is commerical off-the-shelf, modified commercial, and laboratory prototype; a method which significantly lowers program costs. The costs generated include estimates for non-recurring development, recurring production, and recurring operations costs. A cost for a biomedical emphasis laboratory and a Delta cost to provide a bioscience and technology laboratory were also generated. All cost reported are commensurate with the design and schedule definitions available.

  8. Using the AHRQ PSIs to Detect Post-Discharge Adverse Events in the Veterans Health Administration

    PubMed Central

    Mull, Hillary J.; Borzecki, Ann M.; Chen, Qi; Shin, Marlena H.; Rosen, Amy K.

    2015-01-01

    Background PSIs use inpatient administrative data to flag cases with potentially preventable adverse events (AEs) attributable to hospital care. We explored how many AEs the PSIs identified in the 30 days post-discharge. Methods We ran the PSI software (version 3.1a) on VA 2003–2007 administrative data for ten recently validated PSIs. Among PSI-eligible index hospitalizations not flagged with an AE, we evaluated how many AEs occurred within 1–14 and 15–30 days post-discharge using inpatient and outpatient administrative data. Results Considering all PSI-eligible index hospitalizations, we identified 11,141 post-discharge AEs, compared to 40,578 inpatient-flagged AEs. More than 60% of post-discharge AEs were detected within 14 days of discharge. The majority of post-discharge AEs were decubitus ulcers and postoperative pulmonary embolisms or deep vein thromboses. Conclusions Extending PSI algorithms to the post-discharge period may provide a more complete picture of hospital quality. Future work should use chart review to validate post-discharge PSI events. PMID:23939485

  9. [The participation of opioids in the antinociceptive effect induced by the stimulation of hypothalamic "pleasure zones" in 20- to 30-day-old rabbits].

    PubMed

    Butkevich, I P; Kassil', V G

    1995-01-01

    The involvement of opioid peptides in the mediation of inhibitory influences of the positive reinforcement system ("reward areas") on the evoked potential (EPs) recorded in the thalamic parafascicular complex (CM-Pf) in response to the nociceptive electrodermal stimulation of the hind paw in 20-30 day rabbits has been studied. Electrical stimulation of "reward areas" identified in the preliminary behavioural experiments inhibited the EPs. The systemic injection of naloxone potentiated the antinociceptive effect of "reward areas" stimulation in 75% of cases under the incomplete inhibition of EPs (the decrease of EPs amplitude) but decreased its inhibitory effect in 87% of cases under the complete inhibition of EPs. Naloxone did not change the inhibitory effect of "reward areas" stimulation suggesting to the relationship of analgesic "reward areas" function with nonopioid mechanisms too. On the basis of the comparison of the present data and the ones obtained before it can be inferred that opioid mechanism in realization of antinociceptive influence of "reward areas" stimulation on EPs in CM-Pf is more important for 20-30 day rabbits compared with 41-60 day ones. The correlation of the phenomenon under investigation with the formation of neurotransmitter systems has been discussed.

  10. External Validation of a Case-Mix Adjustment Model for the Standardized Reporting of 30-Day Stroke Mortality Rates in China

    PubMed Central

    Yu, Ping; Pan, Yuesong; Wang, Yongjun; Wang, Xianwei; Liu, Liping; Ji, Ruijun; Meng, Xia; Jing, Jing; Tong, Xu; Guo, Li; Wang, Yilong

    2016-01-01

    Background and Purpose A case-mix adjustment model has been developed and externally validated, demonstrating promise. However, the model has not been thoroughly tested among populations in China. In our study, we evaluated the performance of the model in Chinese patients with acute stroke. Methods The case-mix adjustment model A includes items on age, presence of atrial fibrillation on admission, National Institutes of Health Stroke Severity Scale (NIHSS) score on admission, and stroke type. Model B is similar to Model A but includes only the consciousness component of the NIHSS score. Both model A and B were evaluated to predict 30-day mortality rates in 13,948 patients with acute stroke from the China National Stroke Registry. The discrimination of the models was quantified by c-statistic. Calibration was assessed using Pearson’s correlation coefficient. Results The c-statistic of model A in our external validation cohort was 0.80 (95% confidence interval, 0.79–0.82), and the c-statistic of model B was 0.82 (95% confidence interval, 0.81–0.84). Excellent calibration was reported in the two models with Pearson’s correlation coefficient (0.892 for model A, p<0.001; 0.927 for model B, p = 0.008). Conclusions The case-mix adjustment model could be used to effectively predict 30-day mortality rates in Chinese patients with acute stroke. PMID:27846282

  11. The ‘all comer’ Coroflex Please drug-eluting stent registry in Europe and Asia – An overall and transcontinental assessment of the 10-month major adverse cardiac events

    PubMed Central

    Leschke, Matthias; Nhan, Vo Thanh; Waliszewski, Matthias; Palacios, Vicente; Horváth, Iván; Ivanov, Vladimir A.; Tresukosol, Damras; Avraamides, Panicos; Schneider, André; Unverdorben, Martin

    2012-01-01

    Background Randomized trials assess the potential of a medical device in well defined indications while “all comer studies” reveal the device performance in the real clinical environment. Aims This ‘all comers’ registry assessed the 10-month outcome of the Coroflex® Please drug-eluting stent in Europe and Asia by clinically driven major adverse cardiac events. Methods The Coroflex® Please Registry was an international, prospective, multicenter registry enrolling patients with symptomatic ischemic heart disease. The primary endpoint was clinically driven target lesion revascularization (TLR) at 9 months. Secondary endpoints were technical success, in-hospital outcomes, definite stent thrombosis and major adverse cardiac events (death, myocardial infarction, or TLR) for subgroup analyses. Results Of the enrolled 1230 patients (63.6 ± 11.2 years, 33.9% diabetics), 339 (27.6%) had an acute coronary syndrome, 148 (12.1%) STEMI and 191 (15.6%) NSTEMI. After 10.5 ± 3.8 months (follow-up rate 92.8%), the target lesion revascularization rate (TLR) was 7.8% overall, 8.3% in STEMI, and 11.3% in NSTEMI patients. Total MACE was 11.1% and significantly higher in ACS with either diabetes mellitus (22.9%, p = 0.017) or age ≥75 years (25.4%, p = 0.026). In European and Asian patients MI rates (5.2% vs 3.1%, p = 0.135) and cardiac death rates (1.6% vs 0.9%, p = 0.414) were similar. The MACE rate was higher in Europe (13.6% vs 4.7%, p < 0.001) driven by a six times higher TLR rate. Conclusions TLR and MACE occurred within the range of previously published data. The incidence of MI and cardiac death were not different between Europe and Asia. MACE were higher in Europe driven by target lesion revascularization. PMID:23102382

  12. Characteristics and preliminary observations of the influence of electromyostimulation on the size and function of human skeletal muscle during 30 days of simulated microgravity

    NASA Technical Reports Server (NTRS)

    Duvoisin, Marc R.; Convertino, Victor A.; Buchanan, Paul; Gollnick, Philip A.; Dudley, Gary A.

    1989-01-01

    The effect of transcutaneous electromyostimulation (EMS) on the development of atrophy and the loss of strength in lower limb musculature in humans exposed to microgravity was determined in three subjects who received EMS twice daily in a 3-d on/1-d off cycle on their dominant leg during 30 days of bedrest. The output waveform from the stimulator was sequenced to the knee extensors, knee flexors, ankle extensors, and ankle flexors, and caused three isometric contractions of each muscle group per minute. It was found that, in the dominant leg, EMS acted to attenuate the changes caused by bedrest, such as reductions in the leg volume, muscle compartment size, cross-sectional area of slow- and fast-twitch fibers, strength, and aerobic enzyme activities, and an increase in leg compliance.

  13. Results of 30-day petroleum Co-Fire test at the Houston Lighting & Power W.A. Parish Station. Final report

    SciTech Connect

    Jones, A.F.; Booth, R.C.; Machtemes, A.P.

    1995-10-01

    As more heavy crude oil is refined, petroleum coke may become cheaper and more available. A 30-day test co-firing of petroleum coke with Western coal was performed on Unit 8 of Houston Lighting & Power`s W.A. Parish Station to address several concerns about the effects of co-firing coke. The test program studied fuel handling and consistency issues, coal mill performance, furnace operation, emissions, baghouse operation, and flue gas desulfurization (FGD) system performance. Results indicated that petroleum coke can be co-fired with Western coal without any significant problems. The limiting factor on how much coke can be in the bend is the ability of the FGD system to meet emission limits for SO{sub 2}.

  14. Myeloid Precursors in the Bone Marrow of Mice after a 30-Day Space Mission on a Bion-M1 Biosatellite.

    PubMed

    Sotnezova, E V; Markina, E A; Andreeva, E R; Buravkova, L B

    2017-02-01

    The content of myeloid stem CFU in bone marrow karyocytes from the tibial bone of C57Bl/6 mice was evaluated after a 30-day Bion-M1 pace flight/ground control experiment and subsequent 7-day recovery period. After the space flight, we observed a significant decrease in the number of erythroid progenitors in the bone marrow, including common myeloid precursor - granulocyte, erythrocyte, monocyte/macrophage, megakaryocyte CFU. After 7-day readaptation, CFU level in flight animals did not recover completely. In the ground control, the count of erythroid burst-forming units was higher than in vivarium animals. Comparison of the changes observed in fight and ground experiments demonstrated effects associated space flight factors and manifesting in suppression of the bone marrow erythropoiesis.

  15. Exposure to microgravity for 30 days onboard Bion M1 caused muscle atrophy and decreased regeneration in the mouse femoral Quadriceps

    NASA Astrophysics Data System (ADS)

    Grigoryan, Eleonora; Radugina, Elena A.; Almeida, Eduardo; Blaber, Elizabeth; Poplinskaya, Valentina; Markitantova, Yulia

    Mechanical unloading of muscle during spaceflight in microgravity is known to cause muscular atrophy, changes in muscle fiber type composition, gene expression, and reductions in regenerative muscle growth. Although limited data exists for long-term effects of microgravity in human muscle, these processes have mostly been studied in rodents for short periods of time, up to two weeks of spaceflight. Here we report on how 30-day, long-term, mechanical unloading in microgravity affects mouse muscle of the femoral Quadriceps group. To conduct these studies we used muscle tissue from 6 mice from the NASA Biospecimen Sharing Program conducted in collaboration with the Institute for Biomedical Problems of the Russian Academy of Sciences, during the Russian Bion M1 biosatellite mission in 2013. Muscle morphology observed in histological sections shows signs of extensive atrophy and regenerative hypoplasia. Specifically, we observed a two-fold decrease in the number of myonuclei and low density of myofibrils, their separation and fragmentation. Despite obvious atrophy, muscle regeneration nevertheless appears to have continued after 30 days in microgravity as evidenced by thin and short newly formed muscle fibers. Many of them however showed evidence of apoptosis and degradation of synthesized fibrils, suggesting long-term unloading in microgravity affects late stages of myofiber differentiation. Ground asynchronous and vivarium control animals showed normal, well-developed tissue structure with sufficient blood and nerve supply and evidence of regenerative formation of new muscle fibers free of apoptotic nuclei. Myofiber nuclei stress responses in spaceflight animals was detected by positive nuclear immunolocalization of c-jun and c-myc proteins. Regenerative activity of satellite cells in muscle was localized with pax-7, MyoD and MCad immunostaining, and did not appear altered in microgravity. In summary, long-term spaceflight in microgravity causes significant atrophy

  16. Role of pre-procedural C-reactive protein level in the prediction of major adverse cardiac events in patients undergoing percutaneous coronary intervention: a meta-analysisof longitudinal studies.

    PubMed

    Bibek, Singh-Baniya; Xie, Yong; Gao, Jia-Jia; Wang, Zhi; Wang, Jing-Feng; Geng, Deng-Feng

    2015-02-01

    Numerous studies have reported the relation between pre-procedural C-reactive protein (CRP) levels and the risk of major adverse cardiac events (MACEs) in patients undergoing percutaneous coronary intervention (PCI). However, the results across the studies were inconsistent. The aim of this study was to evaluate the predictive effect of pre-procedural CRP levels and the risk of MACEs in patients undergoing PCI. Longitudinal studies on the association between pre-procedural CRP levels and MACEs were identified by electronic and manual searches. Summary risk ratios (RRs) and 95 % confidence intervals (CI) were calculated employing an inverse variance random-effects model irrespective of between-study heterogeneity. Thirty-three studies involving 34,367 patients with 4119 MACEs were included in this study. High CRP level was associated with increased incidences of MACEs, all-cause death, myocardial infarction, coronary revascularization, and clinical restenosis, with pooled RRs of 1.97 (95 % CI, 1.65, 2.35), 2.88 (95 % CI, 2.15, 3.86), 1.81 (95 % CI, 1.48, 2.21), 1.31 (95 % CI, 1.11, 1.56), and 1.45 (95 % CI, 1.07, 1.96), respectively. Dose-response analysis showed that every 1 mg/L increment in pre-procedural serum CRP level was associated with a significant 12 % increase in the risk of MACEs. In spite of heterogeneity across the included studies, this meta-analysis suggests that pre-procedural serum CRP level is a valuable predictor of MACEs in patients undergoing PCI.

  17. Effect of Hospital Use of Oral Nutritional Supplementation on Length of Stay, Hospital Cost, and 30-Day Readmissions Among Medicare Patients With COPD

    PubMed Central

    Snider, Julia Thornton; Linthicum, Mark T.; Hegazi, Refaat A.; Partridge, Jamie S.; LaVallee, Chris; Lakdawalla, Darius N.; Wischmeyer, Paul E.

    2015-01-01

    BACKGROUND: COPD is a leading cause of death and disability in the United States. Patients with COPD are at a high risk of nutritional deficiency, which is associated with declines in respiratory function, lean body mass and strength, and immune function. Although oral nutritional supplementation (ONS) has been associated with improvements in some of these domains, the impact of hospital ONS on readmission risk, length of stay (LOS), and cost among hospitalized patients is unknown. METHODS: Using the Premier Research Database, we first identified Medicare patients aged ≥ 65 years hospitalized with a primary diagnosis of COPD. We then identified hospitalizations in which ONS was provided, and used propensity-score matching to compare LOS, hospitalization cost, and 30-day readmission rates in a one-to-one matched sample of ONS and non-ONS hospitalizations. To further address selection bias among patients prescribed ONS, we also used instrumental variables analysis to study the association of ONS with study outcomes. Model covariates included patient and provider characteristics and a time trend. RESULTS: Out of 10,322 ONS hospitalizations and 368,097 non-ONS hospitalizations, a one-to-one matched sample was created (N = 14,326). In unadjusted comparisons in the matched sample, ONS use was associated with longer LOS (8.7 days vs 6.9 days, P < .0001), higher hospitalization cost ($14,223 vs $9,340, P < .0001), and lower readmission rates (24.8% vs 26.6%, P = .0116). However, in instrumental variables analysis, ONS use was associated with a 1.9-day (21.5%) decrease in LOS, from 8.8 to 6.9 days (P < .01); a hospitalization cost reduction of $1,570 (12.5%), from $12,523 to $10,953 (P < .01); and a 13.1% decrease in probability of 30-day readmission, from 0.34 to 0.29 (P < .01). CONCLUSIONS: ONS may be associated with reduced LOS, hospitalization cost, and readmission risk in hospitalized Medicare patients with COPD. PMID:25357165

  18. Adverse reactions to vaccines.

    PubMed

    Martin, Bryan L; Nelson, Michael R; Hershey, Joyce N; Engler, Renata J M

    2003-06-01

    (The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense.) Immunization healthcare is becoming increasingly complex as the number and types of vaccines have continued to expand. Like all prescription drugs, vaccines may be associated with adverse events. The majority of these reactions are self-limited and not associated with prolonged disability. The media, Internet and public advocacy groups have focused on potentially serious vaccine-associated adverse events with questions raised about causal linkages to increasing frequencies of diseases such as autism and asthma. Despite a lack of evidence of a causal relationship to a variety of vaccine safety concerns, including extensive reviews by the Institute of Medicine, questions regarding vaccine safety continue to threaten the success of immunization programs. Risk communication arid individual risk assessment is further challenged by the public health success of vaccine programs creating the perception that certain vaccines are no longer necessary or justified because of the rare reaction risk. There is a need for improved understanding of true vaccine contraindications and precautions as well as host factors and disease threat in order to develop a patient specific balanced risk communication intervention. When they occur, vaccine related adverse events must be treated, documented and reported through the VAERS system. The increasing complexity of vaccination health care has led the Center of Disease Control and Prevention (CDC) to identify Vaccine Safety Assessment and Evaluation as a potential new specialty.

  19. [Desmin content and transversal stiffness of the left ventricle mouse cardiomyocytes and skeletal muscle fibers after a 30-day space flight on board "BION-M1" biosatellite].

    PubMed

    Ogneva, I V; Maximova, M V; Larina, I M

    2014-01-01

    The aim of this study was to determine the transversal stiffness of the cortical cytoskeleton and the cytoskeletal protein desmin content in the left ventricle cardiomyocytes, fibers of the mouse soleus and tibialis anterior muscle after a 30-day space flight on board the "BION-M1" biosatellite (Russia, 2013). The dissection was made after 13-16.5 h after landing. The transversal stiffness was measured in relaxed and calcium activated state by, atomic force microscopy. The desmin content was estimated by western blotting, and the expression level of desmin-coding gene was detected using real-time PCR. The results indicate that, the transversal stiffness of the left ventricle cardiomyocytes and fibers of the soleus muscle in relaxed and activated states did not differ from the control. The transversal stiffness of the tibialis muscle fibers in relaxed and activated state was increased in the mice group after space flight. At the same time, in all types of studied tissues the desmin content and the expression level of desmin-coding gene did not differ from the control level.

  20. Isoform composition and gene expression of thick and thin filament proteins in striated muscles of mice after 30-day space flight.

    PubMed

    Ulanova, Anna; Gritsyna, Yulia; Vikhlyantsev, Ivan; Salmov, Nikolay; Bobylev, Alexander; Abdusalamova, Zarema; Rogachevsky, Vadim; Shenkman, Boris; Podlubnaya, Zoya

    2015-01-01

    Changes in isoform composition, gene expression of titin and nebulin, and isoform composition of myosin heavy chains as well as changes in titin phosphorylation level in skeletal (m. gastrocnemius, m. tibialis anterior, and m. psoas) and cardiac muscles of mice were studied after a 30-day-long space flight onboard the Russian spacecraft "BION-M" number 1. A muscle fibre-type shift from slow-to-fast and a decrease in the content of titin and nebulin in the skeletal muscles of animals from "Flight" group was found. Using Pro-Q Diamond staining, an ~3-fold increase in the phosphorylation level of titin in m. gastrocnemius of mice from the "Flight" group was detected. The content of titin and its phosphorylation level in the cardiac muscle of mice from "Flight" and "Control" groups did not differ; nevertheless an increase (2.2 times) in titin gene expression in the myocardium of flight animals was found. The observed changes are discussed in the context of their role in the contractile activity of striated muscles of mice under conditions of weightlessness.

  1. The 2013 German-Russian BION-M1 Joint Flight Project: Skeletal Muscle and Neuromuscular Changes in Mice Housed for 30 Days in a Biosatellite on Orbit

    NASA Astrophysics Data System (ADS)

    Blottner, Dieter; Shenkman, Boris; Salanova, Michele

    Exposure to microgravity results in various structural, biochemical and molecular changes of the skeletal neuromuscular system. The BION Joint Flight Proposal between the Charité Berlin Center of Space Medicine (www.zwmb.de) in Berlin, and the Institute of Biomedical Problem (IMBP) in Moscow, provided an exciting opportunity for a more detailed analysis of neuromuscular changes in mice (C57/bl6) exposed to real microgravity housed for 30 days in a BION M1 biosatellite on orbit. The mice from the BION flight group (n=5) were compared to three different on-ground control groups (Flight control, BION-ground and Vivarium, each n=5 mice). We started to analyse various skeletal muscles from the hind limbs or trunk. Apart from routine structural and biochemical analysis (fiber size and type distribution, slow/fastMyHC) we test the hypothesis for the presence of a microgravity-induced sarcolemma-cytosolic protein shift of nitric oxide synthase (NOS) and partial loss in neuromuscular synapse scaffold protein (Homer) immunoexpression known to be prone to disuse in mice or humans (hind limb unloading, bed rest) as previously shown (Sandonà D et al., PLoS One, 2012, Salanova M et al., FASEB J, 2011). National Sponsors: Federal Ministry of Economics and Technology (BMWi) via the German AeroSpace Board, DLR e.V., Bonn-Oberkassel, Germany (#50WB1121); Contract RAS-IMBP/Charité Berlin # Bion-M1/2013

  2. Isoform Composition and Gene Expression of Thick and Thin Filament Proteins in Striated Muscles of Mice after 30-Day Space Flight

    PubMed Central

    Ulanova, Anna; Gritsyna, Yulia; Vikhlyantsev, Ivan; Salmov, Nikolay; Bobylev, Alexander; Abdusalamova, Zarema; Rogachevsky, Vadim; Shenkman, Boris; Podlubnaya, Zoya

    2015-01-01

    Changes in isoform composition, gene expression of titin and nebulin, and isoform composition of myosin heavy chains as well as changes in titin phosphorylation level in skeletal (m. gastrocnemius, m. tibialis anterior, and m. psoas) and cardiac muscles of mice were studied after a 30-day-long space flight onboard the Russian spacecraft “BION-M” number 1. A muscle fibre-type shift from slow-to-fast and a decrease in the content of titin and nebulin in the skeletal muscles of animals from “Flight” group was found. Using Pro-Q Diamond staining, an ~3-fold increase in the phosphorylation level of titin in m. gastrocnemius of mice from the “Flight” group was detected. The content of titin and its phosphorylation level in the cardiac muscle of mice from “Flight” and “Control” groups did not differ; nevertheless an increase (2.2 times) in titin gene expression in the myocardium of flight animals was found. The observed changes are discussed in the context of their role in the contractile activity of striated muscles of mice under conditions of weightlessness. PMID:25664316

  3. Nutritional Status and Physical and Mental Performance of Special Operations Soldiers Consuming the Ration, Lightweight, or the Meal, Ready-to-Eat Military Field Ration during a 30-Day Field Training Exercise

    DTIC Science & Technology

    1987-03-23

    reverse if necessary and identify by block number) A 2000 kcal lightweight ration (RLW-30) was tested as the sole source of food for 30 continuous days...after the 30-day FTX. Food and water intakes were recorded daily and nutritional and hydration status were evaluated. Medical examinations were...sole source of food for 30 days, can be expected to cause some uncomfortable physical symptoms and a small to moderate decrement in physical

  4. Age-related risk of major adverse cardiac event risk and coronary artery disease extent and severity by coronary CT angiography: results from 15 187 patients from the International Multisite CONFIRM Study

    PubMed Central

    Nakazato, Ryo; Arsanjani, Reza; Achenbach, Stephan; Gransar, Heidi; Cheng, Victor Y.; Dunning, Allison; Lin, Fay Y.; Al-Mallah, Mouaz; Budoff, Matthew J.; Callister, Tracy Q.; Chang, Hyuk-Jae; Cademartiri, Filippo; Chinnaiyan, Kavitha; Chow, Benjamin J.W.; DeLago, Augustin; Hadamitzky, Martin; Hausleiter, Joerg; Kaufmann, Philipp; Raff, Gilbert; Shaw, Leslee J.; Villines, Todd; Cury, Ricardo C.; Feuchtner, Gudrun; Kim, Yong-Jin; Leipsic, Jonathon; Berman, Daniel S.; Min, James K.

    2014-01-01

    Aims Prior studies evaluating the prognostic utility of cardiac CT angiography (CCTA) have been largely constrained to an all-cause mortality endpoint, with other cardiac endpoints generally not reported. To this end, we sought to determine the relationship of extent and severity of coronary artery disease (CAD) by CCTA to risk of incident major adverse cardiac events (MACEs) (defined as death, myocardial infarction, and late revascularization). Methods and results We identified subjects without prior known CAD who underwent CCTA and were followed for MACE. CAD by CCTA was defined as none (0% luminal stenosis), mild (1–49% luminal stenosis), moderate (50–69% luminal stenosis), or severe (≥70% luminal stenosis), and ≥50% luminal stenosis was considered as obstructive. CAD severity was judged on per-patient, per-vessel, and per-segment basis. Time to MACE was estimated using univariable and multivariable Cox proportional hazards models. Among 15 187 patients (57 ± 12 years, 55% male), 595 MACE events (3.9%) occurred at a 2.4 ± 1.2 year follow-up. In multivariable analyses, an increased risk of MACE was observed for both non-obstructive [hazard ratio (HR) 2.43, P < 0.001] and obstructive CAD (HR: 11.21, P < 0.001) when compared with patients with normal CCTA. Risk-adjusted MACE increased in a dose–response relationship based on the number of vessels with obstructive CAD ≥50%, with increasing hazards observed for non-obstructive (HR: 2.54, P < 0.001), obstructive one-vessel (HR: 9.15, P < 0.001), two-vessel (HR: 15.00, P < 0.001), or three-vessel or left main (HR: 24.53, P < 0.001) CAD. Among patients stratified by age <65 vs. ≥65 years, older individuals experienced higher risk-adjusted hazards for MACE for non-obstructive, one-, and two-vessel, with similar event rates for three-vessel or left main (P < 0.001 for all) compared with normal individuals age <65. Finally, there was a dose relationship of CAD findings by CCTA and MACE event rates with each

  5. Vaccine Adverse Events

    MedlinePlus

    ... Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products Vaccines, Blood & Biologics Home Vaccines, Blood & Biologics Safety & Availability ( ... Center for Biologics Evaluation & Research Vaccine Adverse Events Vaccine Adverse Events Share Tweet Linkedin Pin it More ...

  6. Uptake of a Consumer-Focused mHealth Application for the Assessment and Prevention of Heart Disease: The <30 Days Study

    PubMed Central

    Morita, Plinio P; Picton, Peter; Seto, Emily; Zbib, Ahmad; Cafazzo, Joseph A

    2016-01-01

    Background Lifestyle behavior modification can reduce the risk of cardiovascular disease, one of the leading causes of death worldwide, by up to 80%. We hypothesized that a dynamic risk assessment and behavior change tool delivered as a mobile app, hosted by a reputable nonprofit organization, would promote uptake among community members. We also predicted that the uptake would be influenced by incentives offered for downloading the mobile app. Objective The primary objective of our study was to evaluate the engagement levels of participants using the novel risk management app. The secondary aim was to assess the effect of incentives on the overall uptake and usage behaviors. Methods We publicly launched the app through the iTunes App Store and collected usage data over 5 months. Aggregate information included population-level data on download rates, use, risk factors, and user demographics. We used descriptive statistics to identify usage patterns, t tests, and analysis of variance to compare group means. Correlation and regression analyses determined the relationship between usage and demographic variables. Results We captured detailed mobile usage data from 69,952 users over a 5-month period, of whom 23,727 (33.92%) were registered during a 1-month AIR MILES promotion. Of those who completed the risk assessment, 73.92% (42,380/57,330) were female, and 59.38% (34,042/57,330) were <30 years old. While the older demographic had significantly lower uptake than the younger demographic, with only 8.97% of users aged ≥51 years old downloading the app, the older demographic completed more challenges than their younger counterparts (F 8, 52,422 = 55.10, P<.001). In terms of engagement levels, 84.94% (44,537/52,431) of users completed 1–14 challenges over a 30-day period, and 10.03% (5,259/52,431) of users completed >22 challenges. On average, users in the incentives group completed slightly more challenges during the first 30 days of the intervention (mean 7.9, SD 0

  7. Early processing variations in selective attention to the color and direction of moving stimuli during 30 days head-down bed rest

    NASA Astrophysics Data System (ADS)

    Wang, Lin-Jie; He, Si-Yang; Niu, Dong-Bin; Guo, Jian-Ping; Xu, Yun-Long; Wang, De-Sheng; Cao, Yi; Zhao, Qi; Tan, Cheng; Li, Zhi-Li; Tang, Guo-Hua; Li, Yin-Hui; Bai, Yan-Qiang

    2013-11-01

    Dynamic variations in early selective attention to the color and direction of moving stimuli were explored during a 30 days period of head-down bed rest. Event-related potentials (ERPs) were recorded at F5, F6, P5, P6 scalp locations in seven male subjects who attended to pairs of bicolored light emitting diodes that flashed sequentially to produce a perception of movement. Subjects were required to attend selectively to a critical feature of the moving target, e.g., color or direction. The tasks included: a no response task, a color selective response task, a moving direction selective response task, and a combined color-direction selective response task. Subjects were asked to perform these four tasks on: the 3rd day before bed rest; the 3rd, 15th and 30th day during the bed rest; and the 5th day after bed rest. Subjects responded quickly to the color than moving direction and combined color-direction response. And they had a longer reaction time during bed rest on the 15th and 30th day during bed rest after a relatively quicker response on the 3rd day. Using brain event-related potentials technique, we found that in the color selective response task, the mean amplitudes of P1 and N1 for target ERPs decreased in the 3rd day during bed rest and 5th day after bed rest in comparison with pre-bed rest, 15th day and 30th day during bed rest. In the combined color-direction selective response task, the P1 latencies for target ERPs on the 3rd and 30th day during bed rest were longer than on the 15th day during bed rest. As 3rd day during bed rest was in the acute adaptation period and 30th day during bed rest was in the relatively adaptation stage of head-down bed rest, the results help to clarify the effects of bed rest on different task loads and patterns of attention. It was suggested that subjects expended more time to give correct decision in the head-down tilt bed rest state. A difficulty in the recruitment of brain resources was found in feature selection task

  8. Structure of cortical cytoskeleton in fibers of mouse muscle cells after being exposed to a 30-day space flight on board the BION-M1 biosatellite.

    PubMed

    Ogneva, I V; Maximova, M V; Larina, I M

    2014-05-15

    The aim of the work was to analyze changes in the organization of the cortical cytoskeleton in fibers of the mouse soleus muscle, tibialis anterior muscle and left ventricular cardiomyocytes after completion of a 30-day space flight on board the BION-M1 biosatellite (Russia, 2013). The transversal stiffness of the cortical cytoskeleton of the cardiomyocytes and fibers of the skeletal muscles did not differ significantly within the study groups compared with the vivarium control group. The content of beta- and gamma-actin in the membranous fraction of proteins in the left ventricular cardiomyocytes did not differ significantly within all study groups and correlated with the transversal stiffness. A similar situation was revealed in fibers of the soleus muscle and tibialis anterior muscle. At the same time, the content of beta-actin in the cytoplasmic fraction of proteins was found to be decreased in all types of studied tissues compared with the control levels in the postflight group, with lowered beta-actin gene expression rates in the postflight group. After completion of the space flight, the content of alpha-actinin-4 was found to be reduced in the membranous fraction of proteins from the mouse cardiomyocytes, while its content in the cytoplasmic fraction of proteins did not change significantly. Furthermore, gene expression rates of this protein were decreased at the time of dissection (it was started after 13 h after landing). At the same time, the content of alpha-actinin-1 decreased in the membranous fraction and increased in the cytoplasmic fraction of proteins from the soleus muscle fibers.

  9. The Risk of Acute Kidney Injury and Its Impact on 30-Day and Long-Term Mortality after Transcatheter Aortic Valve Implantation

    PubMed Central

    Gebauer, Katrin; Diller, Gerhard-Paul; Kaleschke, Gerrit; Kerckhoff, Gregor; Malyar, Nasser; Meyborg, Matthias; Reinecke, Holger; Baumgartner, Helmut

    2012-01-01

    Background. Transcatheter aortic valve implantation (TAVI) is widely used in high risk patients (pts) with aortic stenosis. Underlying chronic kidney disease implicates a high risk of postprocedural acute kidney injury (AKI). We analyzed its occurrence, impact on hospital stay, and mortality. Methods. 150 consecutive pts underwent TAVI in our institution (mean age 81 ± 7 years; logistic EuroSCORE 24 ± 15%). AKI definition was a creatinine rise of 26.5 μmol/L or more within 48 hours postprocedural. Ten patients on chronic hemodialysis were excluded. Results. AKI occurred in 28 pts (20%). Baseline creatinine was higher in AKI pts (126.4 ± 59.2 μmol/L versus 108.7 ± 45.1 μmol/L, P = 0.09). Contrast media use was distributed evenly. Both, 30-day mortality (29% versus 7%, P < 0.0001) and long-term mortality (43% versus 18%, P < 0.0001) were higher; hospital stay was longer in AKI pts (20 ± 12 versus 15 ± 10 days, P = 0.03). Predicted renal failure calculated STS Score was similar (8.0 ± 5.0% [AKI] versus 7.1 ± 4.0% [non-AKI], P = 0.32) and estimated lower renal failure rates than observed. Conclusion. AKI remains a frequent complication with increased mortality in TAVI pts. Careful identification of risk factors and development of more suitable risk scores are essential. PMID:23365748

  10. Coat and claws as new matrices for noninvasive long-term cortisol assessment in dogs from birth up to 30 days of age.

    PubMed

    Veronesi, M C; Comin, A; Meloni, T; Faustini, M; Rota, A; Prandi, A

    2015-09-15

    The last stage of fetal development and the neonatal period represent the most critical phases for the mammals' offspring. In the dog, the knowledge about the final intrauterine fetal development and biology, as well as about the neonatal physiology, remains scarce. Hormonal changes occurring in the last intrauterine fetal phase and during the early neonatal age are still not completely clear, probably because of the invasiveness related to the collection of the more common biological matrix, represented by circulating blood. Toward term of pregnancy, during parturition, and after birth, the hypothalamic-pituitary-adrenal axis is a key system regulating several physiological processes, and its activity was previously investigated by blood analysis, considered an invasive procedure providing a single-point measurement. In respect to animal welfare, and for a more correct long-term retrospective investigation, noninvasive hormonal studies were performed firstly on the hair of humans and coat of animals and, more recently, in the nails of human beings. This study was aimed to assess cortisol (COR) in coat and claws of newborn puppies and to evaluate the possible influence of the newborn gender, breed body size, and age on coat and claws COR concentrations. The results obtained from 165 newborn puppies evidenced that coat and claws COR levels were highly correlated each other (P < 0.0001), although the COR accumulation in the two matrices was different in relation to the class of age. Moreover, the puppies age influenced both coat and claws COR concentrations (P < 0.05), with premature puppies showing higher values when compared to term born-dead puppies or puppies dead between 1 and 30 days of age. The present study reported that COR is quantifiable in coat and claws of newborn dogs. Moreover, both matrices appear as useful tools for new, noninvasive, long-term perinatal and neonatal researches also in canine species.

  11. Characteristics and Preliminary Observations of the Influence of Electromyostimulation on the Size and Function of Human Skeletal Muscle During 30 Days of Simulated Microgravity

    NASA Technical Reports Server (NTRS)

    Duvoisin, Marc R.; Convertino, Victor A; Buchanan, Paul; Gollinick, Philip D.; Dudley, Gary A.

    1989-01-01

    During 30 days (d) of bedrest, the practicality of using Elec- troMyoStimulation (EMS) as a deterrent to atrophy and strength loss of lower limb musculature was examined. An EMS system was developed that provided variable but quantifiable levels of EMS, and measured torque. The dominant log of three male subjects was stimulated twice daily in a 3-d on/1-d off cycle during bedrest. The non-dominant leg of each subject acted as a control. A stimulator, using a 0.3 ms monophasic 60 Hz pulse waveform, activated muscle tissue for 4 s. The output waveform from the stimulator was sequenced to the Knee Extensors (KE), Knee Flex- ors (KF), Ankle Extensors (AE), and Ankle Flexors (AF), and caused three isometric contractions of each muscle group per minute. Subject tolerance determined EMS Intensity. Each muscle group received four 5-min bouts of EMS each session with a 10 -min rest between bouts. EMS and torque levels for each muscle action were recorded directly an a computer. Overall average EMS Intensity was 197, 197, 195, and 188 mA for the KE, KF, AF, and AE, respectively. Overall average torque development for these muscle groups was 70, 16, 12, and 27 Nm, respectively. EMS intensity doubled during the study, and average torque increased 2.5 times. Average maximum torque throughout a session reached 54% of maximal voluntary for the KE and 29% for the KF. Reductions in leg volume, muscle compartment size, cross-sectional area of slow and fast-twitch fibers, strength, and aerobic enzyme activities, and increased log compliance were attenuated in the legs which received EMS during bedrest. These results indicate that similar EMS levels induce different torques among different muscle groups and that repeated exposure to EMS increases tolerance and torque development. Longer orien- tation periods, therefore, may enhance its effectiveness. Our preliminary data suggest that the efficacy of EMS as an effective countermeasure for muscle atrophy and strength loss during long

  12. Mechanical properties of non-sarcomeric cytoskeleton of mice cardiomyocytes and skeletal muscle fibers after 30-day spaceflight biosatellite BION-M1

    NASA Astrophysics Data System (ADS)

    Ogneva, Irina; Maximova, Maria; Larina, Irina

    The aim of this study was to determine transversal stiffness of the cortical cytoskeleton and cytoskeletal protein desmin content of the left ventricle cardiomyocytes, soleus and tibialis anterior muscle fibers of the mice after 30-days space flight biosatellite «BION-M1» (Russia, 2013). The dissection was made after 13-16.5 hours after landing. Transversal stiffness was measured in relaxed and calcium activated state by atomic force microscope. Desmin content was estimated by using western-blot, expression level of the gene, coding desmin, - by real time PCR. The transversal stiffness of the cortical cytoskeleton of the cardiomyocytes and fibers of the skeletal muscles (as measured using the atomic force microscopy) did not differ significantly within the study groups in comparison to the vivarium control group, except for its slight increase in tibialis anterior fibers muscle in the post-flight group of animals. The content of beta- and gamma-actin in the membranous fraction of proteins in the left ventricular cardiomyocytes (as detected using the western blot technique) did not differ significantly within all study groups and correlated with the transversal stiffness. Similar situation was revealed in fibers of the soleus muscle and tibialis anterior muscle, as well as correlation with the transversal stiffness of their cortical cytoskeleton was noted. At the same time, the content of beta-actin in the cytoplasmic fraction of proteins was found to be decreased in all types of studied tissues in comparison to the control levels in the post-flight group, as well as lowered beta-actin gene expression rates in the post-flight group of animals (as detected using the RT-PCR technique). After completion of the space flight, content of alpha-actinin-4 was found to be reduced in the membranous fraction of proteins of mouse cardiomyocytes, while its content in the cytoplasmic fraction of proteins did not change significantly. Furthermore, gene expression rates of this

  13. Intraoperative transfusion of packed red blood cells in microvascular free tissue transfer patients: assessment of 30-day morbidity using the NSQIP dataset.

    PubMed

    Kim, Bobby D; Ver Halen, Jon P; Mlodinow, Alexei S; Kim, John Y S

    2014-02-01

    Although often a life-saving therapeutic maneuver, there is minimal data available that details the effects of intraoperative packed red blood cell transfusion (IOT) after microvascular free tissue transfer. The National Surgical Quality Improvement Program database was queried to identify all patients who underwent microvascular free tissue transfer between 2006 and 2010. Multivariate logistic regression models were used to determine the association between intraoperative transfusion and outcomes. Upon bivariate and multivariate analyses, IOT was significantly associated with higher rates of overall complications (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.12-3.63), medical complications (OR, 3.35; 95% CI, 1.75-6.42), postoperative transfusion (OR, 6.02; 95% CI, 2.02-17.97), and reoperation (OR, 2.24; 95% CI, 1.24-4.04). IOT was not associated with either surgical complications or free flap loss. IOT significantly increases risk for adverse overall and medical complications. However, IOT was not associated with surgical complications or free flap loss. Transfusion practices in the operating room should be reevaluated to improve overall outcomes.

  14. Post-operative delirium is an independent predictor of 30-day hospital readmission after spine surgery in the elderly (≥65years old): A study of 453 consecutive elderly spine surgery patients.

    PubMed

    Elsamadicy, Aladine A; Wang, Timothy Y; Back, Adam G; Lydon, Emily; Reddy, Gireesh B; Karikari, Isaac O; Gottfried, Oren N

    2017-03-02

    In the last decade, costs of U.S. healthcare expenditures have been soaring, with billions of dollars spent on hospital readmissions. Identifying causes and risk factors can reduce soaring readmission rates and help lower healthcare costs. The aim of this is to determine if post-operative delirium in the elderly is an independent risk factor for 30-day hospital readmission after spine surgery. The medical records of 453 consecutive elderly (≥65years old) patients undergoing spine surgery at Duke University Medical Center from 2008 to 2010 were reviewed. We identified 17 (3.75%) patients who experienced post-operative delirium according to DSM-V criteria. Patient demographics, comorbidities, and post-operative complication rates were collected for each patient. Elderly patients experiencing post-operative delirium had an increased length of hospital stay (10.47days vs. 5.70days, p=0.009). Complication rates were similar between the cohorts with the post-operative delirium patients having increased UTI and superficial surgical site infections. In total, 12.14% of patients were re-admitted within 30-days of discharge, with post-operative delirium patients experiencing approximately a 4-fold increase in 30-day readmission rates (Delirium: 41.18% vs. No Delirium: 11.01%, p=0.002). In a multivariate logistic regression analysis, post-operative delirium is an independent predictor of 30-day readmission after spine surgery in the elderly (p=0.03). Elderly patients experiencing post-operative delirium after spine surgery is an independent risk factor for unplanned readmission within 30-days of discharge. Preventable measures and early awareness of post-operative delirium in the elderly may help reduce readmission rates.

  15. Hospital deaths and adverse events in Brazil

    PubMed Central

    2011-01-01

    Background Adverse events are considered a major international problem related to the performance of health systems. Evaluating the occurrence of adverse events involves, as any other outcome measure, determining the extent to which the observed differences can be attributed to the patient's risk factors or to variations in the treatment process, and this in turn highlights the importance of measuring differences in the severity of the cases. The current study aims to evaluate the association between deaths and adverse events, adjusted according to patient risk factors. Methods The study is based on a random sample of 1103 patient charts from hospitalizations in the year 2003 in 3 teaching hospitals in the state of Rio de Janeiro, Brazil. The methodology involved a retrospective review of patient charts in two stages - screening phase and evaluation phase. Logistic regression was used to evaluate the relationship between hospital deaths and adverse events. Results The overall mortality rate was 8.5%, while the rate related to the occurrence of an adverse event was 2.9% (32/1103) and that related to preventable adverse events was 2.3% (25/1103). Among the 94 deaths analyzed, 34% were related to cases involving adverse events, and 26.6% of deaths occurred in cases whose adverse events were considered preventable. The models tested showed good discriminatory capacity. The unadjusted odds ratio (OR 11.43) and the odds ratio adjusted for patient risk factors (OR 8.23) between death and preventable adverse event were high. Conclusions Despite discussions in the literature regarding the limitations of evaluating preventable adverse events based on peer review, the results presented here emphasize that adverse events are not only prevalent, but are associated with serious harm and even death. These results also highlight the importance of risk adjustment and multivariate models in the study of adverse events. PMID:21929810

  16. The effect of periconceptional undernutrition of sheep on the cognitive/emotional response and oocyte quality of offspring at 30 days of age.

    PubMed

    Abecia, J A; Casao, A; Pascual-Alonso, M; Lobón, S; Aguayo-Ulloa, L A; Meikle, A; Forcada, F; Sosa, C; Marín, R H; Silva, M A; Maria, G A

    2014-04-01

    Maternal periconceptional undernutrition is associated with altered development and increased risks of adverse outcomes in the offspring. This circumstance is normal in flocks under extensive farming systems, which depend on natural forage resources. The aim of this study was to determine the effect of periconceptional undernutrition in sheep on behavioral and reproductive aspects of the offspring. Eighty ewes were synchronized in estrus and allocated to two groups (n=40) to be fed diets that provided 1.5 (C) or 0.5 (L) times the requirements for maintenance. Ewes were mated and 7 days later fed the control diet until lambing. One month after lambing, 32 lambs were exposed to tests to determine their cognitive and emotional responses. Six ewe lambs were euthanized and in vitro maturation and fertilization procedures were performed. L ewes presented a significant reduction in prolificacy and fecundity (P<0.05) in comparison with C ewes. Mean LW at lambing of L lambs was significantly higher than C lambs (C: 3.80 ± 0.11; L: 4.24 ± 0.15 kg, P<0.05). Lambs born from C ewes spent more time walking than L lambs (P<0.05) in the isolation test, revealing a decrease in the locomotor activity of lambs born from undernourished ewes around conception. Ewe lambs from the undernourished ewes presented a total population of oocytes 2.3 times higher than ovaries from control ewe lambs (60.0 ± 7.8 v. 140.0 ± 18.5 oocytes; P<0.05). In conclusion, periconceptional undernutrition is able to produce an increment in the body weight and the oocyte population, and an alteration of the locomotor activity of the offspring.

  17. Thiocolchicoside: review of adverse effects.

    PubMed

    2016-02-01

    Thiocolchicoside has long been used as a muscle relaxant, despite a lack of proven efficacy beyond the placebo effect. Its chemical structure consists of colchicine, a sugar (ose) and a sulphur-containing radical (thio), and its adverse effects are therefore likely to be similar to those of colchicine. Using the standard Prescrire methodology, we reviewed the available data on the adverse effects of thiocolchicoside. Liver injury, pancreatitis, seizures, blood cell disorders, severe cutaneous disorders, rhabdomyolysis and reproductive disorders have all been recorded in the French and European pharmacovigilance databases and in the periodic updates that the companies concerned submit to regulatory agencies. These data do not specify the frequency of the disorders nor do they identify the most susceptible patient populations. Thiocolchicoside is teratogenic in experimental animals and also damages chromosomes. Human data are limited to a follow-up of about 30 pregnant women (no major malformations) and reports of altered spermatogenesis, including cases of azoospermia. In practice, there is no justification for exposing patients to the adverse effects of thiocolchicoside. It is better to use an effective, well-known analgesic for patients complaining of muscle pain, starting with paracetamol.

  18. TRICARE: changes included in the National Defense Authorization Act for Fiscal Year 2010; enhancement of transitional dental care for members of the Reserve Component on active duty for more than 30 days in support of a contingency operation. Final rule.

    PubMed

    2011-12-28

    The Department is publishing this final rule to implement section 703 of the National Defense Authorization Act for Fiscal Year 2010 (NDAA for FY10). Specifically, that legislation amends the transitional health care dental benefits for Reserve Component members on active duty for more than 30 days in support of a contingency operation. The legislation entitles these Reserve Component members to dental care in the same manner as a member of the uniformed services on active duty for more than 30 days, thus providing care to the Reserve member in both military dental treatment facilities and authorized private sector dental care. This final rule does not eliminate any medical or dental care that is currently covered as transitional health care for the member.

  19. Variation between Hospitals with Regard to Diagnostic Practice, Coding Accuracy, and Case-Mix. A Retrospective Validation Study of Administrative Data versus Medical Records for Estimating 30-Day Mortality after Hip Fracture

    PubMed Central

    Kristoffersen, Doris Tove; Skyrud, Katrine Damgaard; Lindman, Anja Schou

    2016-01-01

    Background The purpose of this study was to assess the validity of patient administrative data (PAS) for calculating 30-day mortality after hip fracture as a quality indicator, by a retrospective study of medical records. Methods We used PAS data from all Norwegian hospitals (2005–2009), merged with vital status from the National Registry, to calculate 30-day case-mix adjusted mortality for each hospital (n = 51). We used stratified sampling to establish a representative sample of both hospitals and cases. The hospitals were stratified according to high, low and medium mortality of which 4, 3, and 5 hospitals were sampled, respectively. Within hospitals, cases were sampled stratified according to year of admission, age, length of stay, and vital 30-day status (alive/dead). The final study sample included 1043 cases from 11 hospitals. Clinical information was abstracted from the medical records. Diagnostic and clinical information from the medical records and PAS were used to define definite and probable hip fracture. We used logistic regression analysis in order to estimate systematic between-hospital variation in unmeasured confounding. Finally, to study the consequences of unmeasured confounding for identifying mortality outlier hospitals, a sensitivity analysis was performed. Results The estimated overall positive predictive value was 95.9% for definite and 99.7% for definite or probable hip fracture, with no statistically significant differences between hospitals. The standard deviation of the additional, systematic hospital bias in mortality estimates was 0.044 on the logistic scale. The effect of unmeasured confounding on outlier detection was small to moderate, noticeable only for large hospital volumes. Conclusions This study showed that PAS data are adequate for identifying cases of hip fracture, and the effect of unmeasured case mix variation was small. In conclusion, PAS data are adequate for calculating 30-day mortality after hip-fracture as a quality

  20. Distribution and biomarkers of Carbon-14 labeled fullerene C60 ([14C(U)]C60) in female rats and mice for up to 30 days after intravenous exposure

    PubMed Central

    Sumner, Susan C. J.; Snyder, Rodney W.; Wingard, Christopher; Mortensen, Ninell P.; Holland, Nathan A.; Shannahan, Jonathan H.; Dhungana, Suraj; Pathmasiri, Wimal; Han, Li; Lewin, Anita H.; Fennell, Timothy R.

    2016-01-01

    A comprehensive distribution study was conducted in female rats and mice exposed to a suspension of uniformly carbon-14 labeled C60 ([14C(U)]C60). Rodents were administered [14C(U)]C60 (~0.9 mg /kg body weight) or 5% PVP-saline vehicle alone via a single tail vein injection. Tissues were collected at 1 hour, 1, 7, 14 and 30 days after administration. A separate group of rodents received 5 daily injections of suspensions of either [14C(U)]C60 or vehicle with tissue collection 14 days post exposure. Radioactivity was detected in over 20 tissues at all time period. The highest concentration of radioactivity in rodents at each time point was in liver, lungs and spleen. Elimination of [14C(U)]C60 was <2% in urine and feces at any 24 hour time points. [14C(U)]C60 and [14C(U)]C60-retinol were detected in liver of rats and together accounted for ~99% and ~56% of the total recovered at 1 and 30 days post exposure, respectively. The blood radioactivity at 1 hour after [14C(U)]C60 exposure was four-fold higher in rats than in mice; blood radioactivity was still in circulation at 30 days post [14C(U)]C60 exposure in both species (<1%). Levels of oxidative stress markers increased by 5 days after exposure and remained elevated, while levels of inflammation markers initially increased and then returned to control values. The level of cardiovascular marker vWF, increased in rats, but remained at control levels in mice. This study demonstrates that [14C(U)]C60 is retained in female rodents with little elimination by 30 days after i.v. exposure, and leads to systemic oxidative stress. PMID:25727383

  1. Distribution and biomarkers of carbon-14-labeled fullerene C60 ([(14) C(U)]C60 ) in female rats and mice for up to 30 days after intravenous exposure.

    PubMed

    Sumner, Susan C J; Snyder, Rodney W; Wingard, Christopher; Mortensen, Ninell P; Holland, Nathan A; Shannahan, Jonathan H; Dhungana, Suraj; Pathmasiri, Wimal; Han, Li; Lewin, Anita H; Fennell, Timothy R

    2015-12-01

    A comprehensive distribution study was conducted in female rats and mice exposed to a suspension of uniformly carbon-14-labeled C60 ([(14) C(U)]C60 ). Rodents were administered [(14) C(U)]C60 (~0.9 mg kg(-1) body weight) or 5% polyvinylpyrrolidone-saline vehicle alone via a single tail vein injection. Tissues were collected at 1 h and 1, 7, 14 and 30 days after administration. A separate group of rodents received five daily injections of suspensions of either [(14) C(U)]C60 or vehicle with tissue collection 14 days post exposure. Radioactivity was detected in over 20 tissues at all time points. The highest concentration of radioactivity in rodents at each time point was in liver, lungs and spleen. Elimination of [(14) C(U)]C60 was < 2% in urine and feces at any 24 h time points. [(14) C(U)]C60 and [(14) C(U)]C60 -retinol were detected in liver of rats and together accounted for ~99% and ~56% of the total recovered at 1 and 30 days postexposure, respectively. The blood radioactivity at 1 h after [(14) C(U)]C60 exposure was fourfold higher in rats than in mice; blood radioactivity was still in circulation at 30 days post [(14) C(U)]C60 exposure in both species (<1%). Levels of oxidative stress markers increased by 5 days after exposure and remained elevated, while levels of inflammation markers initially increased and then returned to control values. The level of cardiovascular marker von Willebrand factor, increased in rats, but remained at control levels in mice. This study demonstrates that [(14) C(U)]C60 is retained in female rodents with little elimination by 30 days after i.v. exposure, and leads to systemic oxidative stress.

  2. Scientists Trace Adversity's Toll

    ERIC Educational Resources Information Center

    Sparks, Sarah D.

    2012-01-01

    The stress of a spelling bee or a challenging science project can enhance a student's focus and promote learning. But the stress of a dysfunctional or unstable home life can poison a child's cognitive ability for a lifetime, according to new research. Those studies show that stress forms the link between childhood adversity and poor academic…

  3. Adverse drug reactions.

    PubMed

    O'Reilly-Foley, Georgina

    2017-04-05

    What was the nature of the CPD activity, practice-related feedback and/or event and/or experience in your practice? The CPD article defined the different types of adverse drug reactions (ADRs) and explored when they can occur. It emphasised the importance of being knowledgeable about medications, considering patient safety when patients are taking medications, being alert to the possibility of ADRs, and recognising and responding to suspected ADRs.

  4. Shuttle flight experiment 30-day summary report

    NASA Technical Reports Server (NTRS)

    1985-01-01

    A total of 12 AFT training sessions were administered to SL 3 Payload Specialists over a 7 month period. Nine of these sessions were 2 hours in duration and three were 3 hours in duration. A total of three rotating chair tests were conducted in this time frame with four subjects. The performance of these crewmen across tests is shown. Test 1, a baseline motion sickness test, was conducted approximately 10 months prior to the mission, before any AFT was administered. Test 2 was administered after 2 hours of AFT, test 3 after 4 hours and test 4 after 6 hours (total) of training in symptom control. Improvement in performance is reflected by a subject's ability to tolerate a greater number of rotations across tests. Additional training for crewman was not possible within the constraints of the mission. Results of the mission indicate that, as predicted preflight, subject #32 was relatively symptom free inflight while subject #33 was not. Other preflight and postflight tests and analyses are reported.

  5. Adverse effects of cannabis.

    PubMed

    2011-01-01

    Cannabis, Cannabis sativa L., is used to produce a resin that contains high levels of cannabinoids, particularly delta9-tetrahydrocannabinol (THC), which are psychoactive substances. Although cannabis use is illegal in France and in many other countries, it is widely used for its relaxing or euphoric effects, especially by adolescents and young adults. What are the adverse effects of cannabis on health? During consumption? And in the long term? Does cannabis predispose users to the development of psychotic disorders? To answer these questions, we reviewed the available evidence using the standard Prescrire methodology. The long-term adverse effects of cannabis are difficult to evaluate. Since and associated substances, with or without the user's knowledge. Tobacco and alcohol consumption, and particular lifestyles and behaviours are often associated with cannabis use. Some traits predispose individuals to the use of psychoactive substances in general. The effects of cannabis are dosedependent.The most frequently report-ed adverse effects are mental slowness, impaired reaction times, and sometimes accentuation of anxiety. Serious psychological disorders have been reported with high levels of intoxication. The relationship between poor school performance and early, regular, and frequent cannabis use seems to be a vicious circle, in which each sustains the other. Many studies have focused on the long-term effects of cannabis on memory, but their results have been inconclusive. There do not * About fifteen longitudinal cohort studies that examined the influence of cannabis on depressive thoughts or suicidal ideation have yielded conflicting results and are inconclusive. Several longitudinal cohort studies have shown a statistical association between psychotic illness and self-reported cannabis use. However, the results are difficult to interpret due to methodological problems, particularly the unknown reliability of self-reported data. It has not been possible to

  6. Low Prevalance of Major Events Adverse to Exercise Stress Echocardiography

    PubMed Central

    Andrade, Stephanie Macedo; Telino, Caio José Coutinho Leal; Sousa, Antônio Carlos Sobral; de Melo, Enaldo Vieira; Teixeira, Carla Carolina Cardoso; Teixeira, Clarissa Karine Cardoso; Santana, Jaquiele Santos; Mota, Igor Larchert; de Matos, Carlos José Oliveira; Oliveira, Joselina Luzia Menezes

    2016-01-01

    Background: Stress echocardiography is well validated for diagnosis and risk stratification of coronary artery disease. Exercise stress echocardiography (ESE) has been shown to be the most physiological among the modalities of stress, but its safety is not well established. Objective: To study the complications related to ESE and clinical and echocardiographic variables most commonly associated with their occurrence. Methods: Cross-sectional study consisting of 10250 patients submitted to ESE for convenience, from January 2000 to June 2014. Cardiac Arrhythmias (CA) were the most frequent complications observed during the examination. The volunteers were divided into two groups according to the occurrence of CA during ESE: G1 group, composed of patients who have CA, and G2 formed by individuals who did not show such complication. Results: Group G1, consisting of 2843 patients (27.7%), and Group G2 consisting of 7407 patients (72.3%). There was no death, acute myocardial infarction, ventricular fibrillation or asystole. Predominant CAs were: supraventricular extrasystoles (13.7%), and ventricular extrasystoles (11.5%). G1 group had a higher mean age, higher frequency of hypertension and smoking, larger aortic roots and left atrium (LA) and lower ejection fraction than G2. G1 group also had more ischemic changes (p < 0.001). The predictor variables were age (RR 1.04; [CI] 95% from 1.038 to 1.049) and LA (RR 1.64; [CI] 95% from 1.448 to 1.872). Conclusion: ESE proved to be a safe modality of stress, with non-fatal complications only. Advanced age and enlargement of the left atrium are predictive of cardiac arrhythmias. PMID:27355587

  7. [Cutaneous adverse drug reactions].

    PubMed

    Lebrun-Vignes, B; Valeyrie-Allanore, L

    2015-04-01

    Cutaneous adverse drug reactions (CADR) represent a heterogeneous field including various clinical patterns without specific features suggesting drug causality. Exanthematous eruptions, urticaria and vasculitis are the most common forms of CADR. Fixed eruption is uncommon in western countries. Serious reactions (fatal outcome, sequelae) represent 2% of CADR: bullous reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), DRESS (drug reaction with eosinophilia and systemic symptoms or drug-induced hypersensitivity syndrome) and acute generalized exanthematous pustulosis (AGEP). These forms must be quickly diagnosed to guide their management. The main risk factors are immunosuppression, autoimmunity and some HLA alleles in bullous reactions and DRESS. Most systemic drugs may induce cutaneous adverse reactions, especially antibiotics, anticonvulsivants, antineoplastic drugs, non-steroidal anti-inflammatory drugs, allopurinol and contrast media. Pathogenesis includes immediate or delayed immunologic mechanism, usually not related to dose, and pharmacologic/toxic mechanism, commonly dose-dependent or time-dependent. In case of immunologic mechanism, allergologic exploration is possible to clarify drug causality, with a variable sensitivity according to the drug and to the CADR type. It includes epicutaneous patch testing, prick test and intradermal test. However, no in vivo or in vitro test can confirm the drug causality. To determine the cause of the eruption, a logical approach based on clinical characteristics, chronologic factors and elimination of differential diagnosis is required, completed with a literature search. A reporting to pharmacovigilance network is essential in case of a serious CADR whatever the suspected drug and in any case if the involved drug is a newly marketed one or unusually related to cutaneous reactions.

  8. Development of the Canadian Syncope Risk Score to predict serious adverse events after emergency department assessment of syncope

    PubMed Central

    Thiruganasambandamoorthy, Venkatesh; Kwong, Kenneth; Wells, George A.; Sivilotti, Marco L.A.; Mukarram, Muhammad; Rowe, Brian H.; Lang, Eddy; Perry, Jeffrey J.; Sheldon, Robert; Stiell, Ian G.; Taljaard, Monica

    2016-01-01

    Background: Syncope can be caused by serious conditions not evident during initial evaluation, which can lead to serious adverse events, including death, after disposition from the emergency department. We sought to develop a clinical decision tool to identify adult patients with syncope who are at risk of a serious adverse event within 30 days after disposition from the emergency department. Methods: We prospectively enrolled adults (age ≥ 16 yr) with syncope who presented within 24 hours after the event to 1 of 6 large emergency departments from Sept. 29, 2010, to Feb. 27, 2014. We collected standardized variables at index presentation from clinical evaluation and investigations. Adjudicated serious adverse events included death, myocardial infarction, arrhythmia, structural heart disease, pulmonary embolism, serious hemorrhage and procedural interventions within 30 days. Results: We enrolled 4030 patients with syncope; the mean age was 53.6 years, 55.5% were women, and 9.5% were admitted to hospital. Serious adverse events occurred in 147 (3.6%) of the patients within 30 days after disposition from the emergency department. Of 43 candidate predictors examined, we included 9 in the final model: predisposition to vasovagal syncope, heart disease, any systolic pressure reading in the emergency department < 90 or > 180 mm Hg, troponin level above 99th percentile for the normal population, abnormal QRS axis (< −30° or > 100°), QRS duration longer than 130 ms, QTc interval longer than 480 ms, emergency department diagnosis of cardiac syncope and emergency department diagnosis of vasovagal syncope (C statistic 0.88, 95% confidence interval [CI] 0.85–0.90; optimism 0.015; goodness-of-fit p = 0.11). The risk of a serious adverse event within 30 days ranged from 0.4% for a score of −3 to 83.6% for a score of 11. The sensitivity was 99.2% (95% CI 95.9%–100%) for a threshold score of −2 or higher and 97.7% (95% CI 93.5%–99.5%) for a threshold score of −1

  9. Predictive value of NT-proBNP for 30-day mortality in patients with non-ST-elevation acute coronary syndromes: a comparison with the GRACE and TIMI risk scores

    PubMed Central

    Schellings, Dirk AAM; Adiyaman, Ahmet; Dambrink, Jan-Henk E; Gosselink, AT Marcel; Kedhi, Elvin; Roolvink, Vincent; Ottervanger, Jan Paul; van’t Hof, Arnoud WJ

    2016-01-01

    Background The biomarker N-terminal pro-brain natriuretic peptide (NT-proBNP) predicts outcome in patients with non-ST-elevation acute coronary syndromes (NSTE-ACS). Whether NT-proBNP has incremental prognostic value beyond established risk strategies is still questionable. Purpose To evaluate the predictive value of NT-proBNP for 30-day mortality over and beyond the Global Registry of Acute Coronary Events (GRACE) and Thrombolysis In Myocardial Infarction (TIMI) risk scores in patients with NSTE-ACS. Methods Patients included in our ACS registry were candidates. NT-proBNP levels on admission were measured and the GRACE and TIMI risk scores were assessed. We compared the predictive value of NT-proBNP to both risk scores and evaluated whether NT-proBNP improves prognostication by using receiver operator curves and measures of discrimination improvement. Results A total of 1324 patients were included and 50 patients died during follow-up. On logistic regression analysis NT-proBNP and the GRACE risk score (but not the TIMI risk score) both independently predicted mortality at 30 days. The predictive value of NT-proBNP did not differ significantly compared to the GRACE risk score (area under the curve [AUC]) 0.85 vs 0.87 p=0.67) but was considerably higher in comparison to the TIMI risk score (AUC 0.60 p<0.001). Adjustment of the GRACE risk score by adding NT-proBNP did not improve prognostication: AUC 0.86 (p=0.57), integrated discrimination improvement 0.04 (p=0.003), net reclassification improvement 0.12 (p=0.21). Conclusion In patients with NSTE-ACS, NT-proBNP and the GRACE risk score (but not the TIMI risk score) both have good and comparable predictive value for 30-day mortality. However, incremental prognostic value of NT-proBNP beyond the GRACE risk score could not be demonstrated. PMID:27920547

  10. Environmental adversity and uncertainty favour cooperation

    PubMed Central

    Andras, Peter; Lazarus, John; Roberts, Gilbert

    2007-01-01

    Background A major cornerstone of evolutionary biology theory is the explanation of the emergence of cooperation in communities of selfish individuals. There is an unexplained tendency in the plant and animal world – with examples from alpine plants, worms, fish, mole-rats, monkeys and humans – for cooperation to flourish where the environment is more adverse (harsher) or more unpredictable. Results Using mathematical arguments and computer simulations we show that in more adverse environments individuals perceive their resources to be more unpredictable, and that this unpredictability favours cooperation. First we show analytically that in a more adverse environment the individual experiences greater perceived uncertainty. Second we show through a simulation study that more perceived uncertainty implies higher level of cooperation in communities of selfish individuals. Conclusion This study captures the essential features of the natural examples: the positive impact of resource adversity or uncertainty on cooperation. These newly discovered connections between environmental adversity, uncertainty and cooperation help to explain the emergence and evolution of cooperation in animal and human societies. PMID:18053138

  11. Adverse cutaneous drug reaction.

    PubMed

    Nayak, Surajit; Acharjya, Basanti

    2008-01-01

    In everyday clinical practice, almost all physicians come across many instances of suspected adverse cutaneous drug reactions (ACDR) in different forms. Although such cutaneous reactions are common, comprehensive information regarding their incidence, severity and ultimate health effects are often not available as many cases go unreported. It is also a fact that in the present world, almost everyday a new drug enters market; therefore, a chance of a new drug reaction manifesting somewhere in some form in any corner of world is unknown or unreported. Although many a times, presentation is too trivial and benign, the early identification of the condition and identifying the culprit drug and omit it at earliest holds the keystone in management and prevention of a more severe drug rash. Therefore, not only the dermatologists, but all practicing physicians should be familiar with these conditions to diagnose them early and to be prepared to handle them adequately. However, we all know it is most challenging and practically difficult when patient is on multiple medicines because of myriad clinical symptoms, poorly understood multiple mechanisms of drug-host interaction, relative paucity of laboratory testing that is available for any definitive and confirmatory drug-specific testing. Therefore, in practice, the diagnosis of ACDR is purely based on clinical judgment. In this discussion, we will be primarily focusing on pathomechanism and approach to reach a diagnosis, which is the vital pillar to manage any case of ACDR.

  12. Adverse inpatient outcomes during the transition to a new electronic health record system: observational study

    PubMed Central

    Barnett, Michael L; Mehrotra, Ateev

    2016-01-01

    Objective To assess the short term association of inpatient implementation of electronic health records (EHRs) with patient outcomes of mortality, readmissions, and adverse safety events. Design Observational study with difference-in-differences analysis. Setting Medicare, 2011-12. Participants Patients admitted to 17 study hospitals with a verifiable “go live” date for implementation of inpatient EHRs during 2011-12, and 399 control hospitals in the same hospital referral region. Main outcome measures All cause readmission within 30 days of discharge, all cause mortality within 30 days of admission, and adverse safety events as defined by the patient safety for selected indicators (PSI)-90 composite measure among Medicare beneficiaries admitted to one of these hospitals 90 days before and 90 days after implementation of the EHRs (n=28 235 and 26 453 admissions), compared with the control group of all contemporaneous admissions to hospitals in the same hospital referral region (n=284 632 and 276 513 admissions). Analyses were adjusted for beneficiaries’ sociodemographic and clinical characteristics. Results Before and after implementation, characteristics of admissions were similar in both study and control hospitals. Among study hospitals, unadjusted 30 day mortality (6.74% to 7.15%, P=0.06) and adverse safety event rates (10.5 to 11.4 events per 1000 admissions, P=0.34) did not significantly change after implementation of EHRs. There was an unadjusted decrease in 30 day readmission rates, from 19.9% to 19.0% post-implementation (P=0.02). In difference-in-differences analysis, however, there was no significant change in any outcome between pre-implementation and post-implementation periods (all P≥0.13). Conclusions Despite concerns that implementation of EHRs might adversely impact patient care during the acute transition period, we found no overall negative association of such implementation on short term inpatient mortality, adverse safety

  13. Telithromycin: review of adverse effects.

    PubMed

    2014-11-01

    Telithromycin is a macrolide antibiotic that has been marketed since the early 2000s. It has not been shown to be more effective against any bacteria than other macrolide antibiotics. Its antibacterial activity is in no way remarkable. In early 2014, we reviewed its adverse effect profile using data from periodic safety update reports, drug regulatory agencies, and detailed published case reports. In addition to the adverse effect profile telithromycin shares with the other macrolides, it provokes several specific adverse effects: visual disturbances due to impaired accommodation; taste and smell disorders; severe liver damage; worsening of myasthenia gravis; rhabdomyolysis; and loss of consciousness. Prolongation of the QT interval with standard oral doses is a worrisome adverse effect. In practice, it is better not to use telithromycin as it exposes patients to disproportionate, serious adverse effects. When treatment with a macrolide antibiotic appears necessary, it is prudent to choose a different macrolide, such as spiramycin or azithromycin, which have fewer adverse effects.

  14. Childhood adversity impacts on brain subcortical structures relevant to depression.

    PubMed

    Frodl, Thomas; Janowitz, Deborah; Schmaal, Lianne; Tozzi, Leonardo; Dobrowolny, Henrik; Stein, Dan J; Veltman, Dick J; Wittfeld, Katharina; van Erp, Theo G M; Jahanshad, Neda; Block, Andrea; Hegenscheid, Katrin; Völzke, Henry; Lagopoulos, Jim; Hatton, Sean N; Hickie, Ian B; Frey, Eva Maria; Carballedo, Angela; Brooks, Samantha J; Vuletic, Daniella; Uhlmann, Anne; Veer, Ilya M; Walter, Henrik; Schnell, Knut; Grotegerd, Dominik; Arolt, Volker; Kugel, Harald; Schramm, Elisabeth; Konrad, Carsten; Zurowski, Bartosz; Baune, Bernhard T; van der Wee, Nic J A; van Tol, Marie-Jose; Penninx, Brenda W J H; Thompson, Paul M; Hibar, Derrek P; Dannlowski, Udo; Grabe, Hans J

    2017-03-01

    Childhood adversity plays an important role for development of major depressive disorder (MDD). There are differences in subcortical brain structures between patients with MDD and healthy controls, but the specific impact of childhood adversity on such structures in MDD remains unclear. Thus, aim of the present study was to investigate whether childhood adversity is associated with subcortical volumes and how it interacts with a diagnosis of MDD and sex. Within the ENIGMA-MDD network, nine university partner sites, which assessed childhood adversity and magnetic resonance imaging in patients with MDD and controls, took part in the current joint mega-analysis. In this largest effort world-wide to identify subcortical brain structure differences related to childhood adversity, 3036 participants were analyzed for subcortical brain volumes using FreeSurfer. A significant interaction was evident between childhood adversity, MDD diagnosis, sex, and region. Increased exposure to childhood adversity was associated with smaller caudate volumes in females independent of MDD. All subcategories of childhood adversity were negatively associated with caudate volumes in females - in particular emotional neglect and physical neglect (independently from age, ICV, imaging site and MDD diagnosis). There was no interaction effect between childhood adversity and MDD diagnosis on subcortical brain volumes. Childhood adversity is one of the contributors to brain structural abnormalities. It is associated with subcortical brain abnormalities that are relevant to psychiatric disorders such as depression.

  15. Adverse Reactions to Hallucinogenic Drugs.

    ERIC Educational Resources Information Center

    Meyer, Roger E. , Ed.

    This reports a conference of psychologists, psychiatrists, geneticists and others concerned with the biological and psychological effects of lysergic acid diethylamide and other hallucinogenic drugs. Clinical data are presented on adverse drug reactions. The difficulty of determining the causes of adverse reactions is discussed, as are different…

  16. Comparative evaluation of honey, chlorhexidine gluconate (0.2%) and combination of xylitol and chlorhexidine mouthwash (0.2%) on the clinical level of dental plaque: A 30 days randomized control trial

    PubMed Central

    Jain, Ankita; Bhaskar, Dara John; Gupta, Devanand; Agali, Chandan; Gupta, Vipul; Gupta, Rajendra Kumar; Yadav, Priyanka; Lavate, Akash B.; Chaturvedi, Mudita

    2015-01-01

    Aim: To compare the effect of honey, chlorhexidine mouthwash and combination of xylitol chewing gum and chlorhexidine mouthwash on the dental plaque level. Materials and Methods: Ninety healthy dental students, both male and female, aged between 21 to 25 years participated in the study. The subjects were randomly divided into three groups, i.e. the honey group, the chlorhexidine gluconate mouthwash group and the combination of xylitol chewing gum and chlorhexidine (CHX) mouthwash group. The data was collected at the baseline, 15th day and 30th day; the plaque was disclosed using disclosing solution and their scores were recorded at six sites per tooth using the Quigley and Hein plaque index modified by Turesky-Gilmore-Glickman. Statistical analysis was carried out later to compare the effect of all the three groups. P ≤ 0.05 was considered as statistically significant. Results: Our result showed that all the three groups were effective in reducing the plaque but post-hoc LSD (Least Significant Difference) showed that honey group and chlorhexidine + xylitol group were more effective than chlorhexidine group alone. The results demonstrated a significant reduction of plaque indices in honey group and chlorhexidine + xylitol group over a period of 15 and 30 days as compared to chlorhexidine. PMID:25657903

  17. Major depression

    MedlinePlus

    Depression - major; Depression - clinical; Clinical depression; Unipolar depression; Major depressive disorder ... providers do not know the exact causes of depression. It is believed that chemical changes in the ...

  18. Adverse consequences of immunostimulation.

    PubMed

    Ponce, Rafael

    2008-01-01

    The therapeutic uses of immunostimulatory agents are generally in the treatments of infections or cancer. The traditional example of vaccination is one form of immunostimulation used in the prevention of pathogenic infections or cancer (e.g., human papillomavirus vaccine). Recombinant cytokines are increasingly used to stimulate immune system function. For example, interferon-alpha (IFNalpha) and interleukin (IL)-2 have been used to treat chronic hepatitis C virus infection and metastatic melanoma, respectively. In contrast, monoclonal antibodies are used to target malignant cells for elimination via antibody-dependent cytotoxicity mechanisms or apoptosis, including the anti-CD20 monoclonal antibody rituximab and the anti-CD56 monoclonal antibody alemtuzumab used in the treatment of B-cell malignancies, and the anti-erb2 receptor antibody trastuzumab used in the treatment of breast cancer. Finally, immunostimulation may develop via modulation of pathways involved in immune system regulation. For example, the anti-CD28 monoclonal antibody TGN1412 was developed as an agonist of regulatory T-cells for treatment of T-cell-mediated chronic inflammatory diseases or leukemias. A panel was convened to discuss potential toxicities associated with immunostimulation. At the Immunotoxicology IV meeting in 2006, a panel, moderated by Dr. Robert House (Dynport Vaccine Co., Frederick, MD), included Drs. Gary Burleson (Burleson Research Technologies, Inc., Raleigh, NC), Kenneth Hastings (US FDA, Center for Drug Evaluation and Research [CDER], Rockville, MD), Barbara Mounho (Amgen, Thousand Oaks, CA), Rafael Ponce (ZymoGenetics, Inc., Seattle, WA), Mark Wing (Huntington Life Sciences, Cambridgeshire, United Kingdom), Lauren Black (Navigators Consulting, Sparks, NV) and Anne Pilaro (US FDA, CDER, Rockville, MD). This paper reviews the major identified toxicities associated with immunostimulation, including the acute phase response, cell and tissue abnormalities/injury, cytokine

  19. The association of subclinical hypocalcemia, negative energy balance and disease with bodyweight change during the first 30 days post-partum in dairy cows milked with automatic milking systems.

    PubMed

    Caixeta, L S; Ospina, P A; Capel, M B; Nydam, D V

    2015-05-01

    In a prospective cohort study, the daily bodyweight (BW) and milk production of 92 cows were recorded using automatic milking systems. The objectives were to characterize calcium serum concentration variability on days 1-3 post-partum and to evaluate the association between subclinical hypocalcemia (SHPC) and change in BW over the first 30 days in milk (DIM) in Holstein dairy cows, while controlling for concurrent disease and negative energy balance (NEB). SHPC was defined as total serum calcium concentration between 6 and 8 mg/dL, NEB was defined as non-esterified fatty acids (NEFA) > 0.7 mEq/L or β-hydroxybutyrate (BHB) ≥ 1.2 mmol/L. The peak incidence of SHPC was at 1 DIM for all groups (11%, 42% and 60% for parities 1, 2, and ≥3, respectively). All parity groups lost weight (21, 33, and 34 kg) during the first 30 DIM. Parity 1 animals with disease compared with those without disease lost the most weight (2.6 kg/day BW loss vs. <1.9 kg/day, respectively). Normocalcemic parity 2 animals with either NEB or disease lost the most weight (>5 kg/day) compared with those in the SHPC group (≤4.5 kg/day). In parity ≥ 3 animals, SHPC was an important factor for BW loss; SHPC animals lost the most weight (>3.7 kg/day) vs. normocalcemic cows (≤3.3 kg/day) regardless of NEB or disease status. Even though all animals lost weight during early lactation the effect of disease, NEB, and SHPC on BW loss was different in each parity group.

  20. The 2013 German-Russian Bion-M1 Joint Flight Project: Altered cAMP/PKA Signaling Pathway in Skeletal Muscle during Exposure to Real Microgravity in Mice Housed for 30 Days in a Biosatellite on Orbit

    NASA Astrophysics Data System (ADS)

    Salanova, Michele; Blottner, Dieter; Shenkman, Boris S.; Lomonosova, Yulia

    Exposure to real microgravity (muG) results in an impaired skeletal muscle structure and function. We here hypothesized that the cAMP/PKA cell signaling pathway, which triggers a multitude of intracellular effects in response to a variety of extracellular stimuli and which further promote muscle growth, play an important role during Spaceflight- induced disuse atrophy. Particularly, we hypothesized that different effectors of the cAMP-PKA signaling machinery, which are highly compartmentalized into subcellular functional microdomains in order to guarantee signal specificity, are altered after long term exposure to real µG. Taking advantage of the Bion-M1 Spaceflight program which provided us an excellent opportunity to explore mice skeletal muscle exposed for 30 days to real µG, by investigating at the cAMP-dependent protein kinase A (PKA) subcellular localization we compared muscle soleus (SOL) and extensor digitorum longus (EDL) of C57/black mice of a Bion-flight (n=5) group with a Bion-ground control (n=5) group and a ground control (n=5) group which was housed in a standard cage considered as vivarium control. Preliminary results of our experiments showed that different cAMP-PKA micro pools were normally detectable using high-resolution images of immunofluorescence experiments in different subcellular compartments of both SOL and EDL of Bion-ground and ground control groups which were not any longer detectable in Bion-flight group. In summary, our data indicate that an efficient organization in microdomains of the cAMP/PKA pathway may exist in skeletal muscle on ground and that such compartmentalization may be altered in response to prolonged exposure to real muG. National Sponsors: Federal Ministry of Economics and Technology (BMWi) via the German AeroSpace Board, DLR e.V., Bonn-Oberkassel, Germany (#50WB1121 to DB); Contract RAS-IMPB/Charité Berlin # Bion-M1/2013

  1. Cutaneous adverse reactions to lenalidomide.

    PubMed

    Imbesi, S; Allegra, A; Calapai, G; Musolino, C; Gangemi, S

    2015-01-01

    Lenalidomide is an immunomodulatory drug (IMiD) used principally in the treatment of multiple myeloma (MM), myelodysplastic syndromes (MS) and amyloidosis. Adverse reactions related to lenalidomide include myelosuppression (mainly neutropenia but also thrombocytopenia), gastrointestinal problems, skin eruption, atrial fibrillation and asthenia, decreased peripheral blood stem cell yield during stem cell collection, venous thromboembolism, and secondary malignances. In this review we focused our attention on the cutaneous adverse reactions to lenalidomide.

  2. Reverse Engineering Adverse Outcome Pathways

    SciTech Connect

    Perkins, Edward; Chipman, J.K.; Edwards, Stephen; Habib, Tanwir; Falciani, Francesco; Taylor, Ronald C.; Van Aggelen, Graham; Vulpe, Chris; Antczak, Philipp; Loguinov, Alexandre

    2011-01-30

    The toxicological effects of many stressors are mediated through unknown, or poorly characterized, mechanisms of action. We describe the application of reverse engineering complex interaction networks from high dimensional omics data (gene, protein, metabolic, signaling) to characterize adverse outcome pathways (AOPs) for chemicals that disrupt the hypothalamus-pituitary-gonadal endocrine axis in fathead minnows. Gene expression changes in fathead minnow ovaries in response to 7 different chemicals, over different times, doses, and in vivo versus in vitro conditions were captured in a large data set of 868 arrays. We examined potential AOPs of the antiandrogen flutamide using two mutual information theory methods, ARACNE and CLR to infer gene regulatory networks and potential adverse outcome pathways. Representative networks from these studies were used to predict a network path from stressor to adverse outcome as a candidate AOP. The relationship of individual chemicals to an adverse outcome can be determined by following perturbations through the network in response to chemical treatment leading to the nodes associated with the adverse outcome. Identification of candidate pathways allows for formation of testable hypotheses about key biologic processes, biomarkers or alternative endpoints, which could be used to monitor an adverse outcome pathway. Finally, we identify the unique challenges facing the application of this approach in ecotoxicology, and attempt to provide a road map for the utilization of these tools. Key Words: mechanism of action, toxicology, microarray, network inference

  3. Learning Lessons from Adverse Drug Reactions in Children

    PubMed Central

    Sammons, Helen M.; Choonara, Imti

    2016-01-01

    Drug toxicity is, unfortunately, a significant problem in children both in the hospital and in the community. Drug toxicity in children is different to that seen in adults. At least one in 500 children will experience an adverse drug reaction each year. For children in hospital, the risk is far greater (one in ten). Additionally, different and sometimes unique adverse drug reactions are seen in the paediatric age groups. Some of the major cases of drug toxicity historically have occurred in neonates. It is important that we understand the mechanism of action of adverse drug reactions. Greater understanding alongside rational prescribing should hopefully reduce drug toxicity in children in the future. PMID:27417239

  4. Statin-Associated Muscle Adverse Events

    PubMed Central

    Al-Mohaissen, Maha A.; Ignaszewski, Martha J.; Frohlich, Jiri; Ignaszewski, Andrew P.

    2016-01-01

    Statins are potent medications which reduce low-density lipoprotein cholesterol (LDL-C) levels. Their efficacy in cardiovascular risk reduction is well established and indications for their use are expanding. While statins are generally well tolerated and safe, adverse events are relatively common, particularly statin-associated muscle adverse events (SaMAEs), which are the most frequently encountered type of adverse event. Recent guidelines and guideline updates on SaMAEs and statin intolerance have included revised definitions of SaMAEs, incorporating new evidence on their pathogenesis and management. As SaMAEs emerge as a therapeutic challenge, it is important for physicians to be aware of updates on management strategies to ensure better patient outcomes. The majority of patients who are considered statin-intolerant can nevertheless tolerate some forms of statin therapy and successfully achieve optimal LDL-C levels. This review article discusses the recent classification of SaMAEs with emphasis on pathogenesis and management strategies. PMID:28003885

  5. Forecasting Flooding in the Brahmaputra and Ganges Delta of Bangladesh on Short (1-10 days), Medium (20-30 days) and Seasonal Time Scales (1-6 months)

    NASA Astrophysics Data System (ADS)

    Webster, P. J.; Hoyos, C. D.; Hopson, T. M.; Chang, H.; Jian, J.

    2007-12-01

    Following the devastating flood years of 1998 during which 60% of Bangladesh was under water for a period of 3 months, the Climate Forecast Applications in Bangladesh (CFAB) project was formed with funding by USAID and NSF which eventually resulted in a joint project with the European Centre for Medium Range Weather Forecasting (ECMWF), the Asian Disaster Preparedness Centre (ADPC) and the Bangladesh Flood Forecasting and Warning Centre. The project was organized and developed through the Georgia Institute of Technology. The aim of CFAB was to develop innovative methods of extending the warning of flooding in Bangladesh noting that there was a unique problem: India provided no upstream discharge data to Bangladesh so that before CFAB the maximum lead time of a forecast was that given by measuring river discharge at the India-Bangladesh border: no lead-time at the border and 2 days in the southern parts of the country. Given that the Brahmaputra and Ganges catchment areas had to be regarded as essentially unguaged, it was clear that innovative techniques had to be developed. On of the basic criterion was that the system should provide probabilistic forecasts in order for the Bangladeshis to assess risk. A three-tier system was developed to allow strategic and tactical decisions to be made for agricultural purposes and disaster mitigation: seasonal (1-6 months: strategic), medium range (20-30 days: strategic/tactical) and short range (1-10 days: tactical). The system that has been developed brings together for the first time operational meteorological forecasts (ensemble forecasts from ECMWF), with satellite and discharge data and a suite of hydrological models. In addition, with ADPC and FFWC we have developed an in-country forecast dispersion system that allows a rapid dissemination. The system has proven to be rather successful, especially in the short range. The flooding events of 2004 were forecast with all forecasting tiers at the respective lead time. In

  6. Adverse Childhood Experiences and Hallucinations

    ERIC Educational Resources Information Center

    Whitfield, C.L.; Dube, S.R.; Felitti, V.J.; Anda, R.F.

    2005-01-01

    Objective:: Little information is available about the contribution of multiple adverse childhood experiences (ACEs) to the likelihood of reporting hallucinations. We used data from the ACE study to assess this relationship. Methods:: We conducted a survey about childhood abuse and household dysfunction while growing up, with questions about health…

  7. Adverse ocular reactions to drugs.

    PubMed Central

    Spiteri, M. A.; James, D. G.

    1983-01-01

    Drugs acting on various parts of the body may also affect the eye insidiously. Increased awareness of such drug toxicity by the prescribing doctor should encourage him to consider effects on the cornea, lens, retina, optic nerve and elsewhere when checking the patient's progress. The following review concerns adverse ocular effects of systemic drug administration. PMID:6356101

  8. Urbanicity, social adversity and psychosis

    PubMed Central

    Heinz, Andreas; Deserno, Lorenz; Reininghaus, Ulrich

    2013-01-01

    In recent years, there has been increasing interest in research on geographical variation in the incidence of schizophrenia and other psychoses. In this paper, we review the evidence on variation in incidence of schizophrenia and other psychoses in terms of place, as well as the individual- and area-level factors that account for this variation. We further review findings on potential mechanisms that link adverse urban environment and psychosis. There is evidence from earlier and more recent studies that urbanicity is associated with an increased incidence of schizophrenia and non-affective psychosis. In addition, considerable variation in incidence across neighbourhoods has been observed for these disorders. Findings suggest it is unlikely that social drift alone can fully account for geographical variation in incidence. Evidence further suggests that the impact of adverse social contexts – indexed by area-level exposures such as population density, social fragmentation and deprivation – on risk of psychosis is explained (confounding) or modified (interaction) by environmental exposures at the individual level (i.e., cannabis use, social adversity, exclusion and discrimination). On a neurobiological level, several studies suggest a close link between social adversity, isolation and stress on the one hand, and monoamine dysfunction on the other, which resembles findings in schizophrenia patients. However, studies directly assessing correlations between urban stress or discrimination and neurobiological alterations in schizophrenia are lacking to date. PMID:24096775

  9. Reverse engineering adverse outcome pathways.

    PubMed

    Perkins, Edward J; Chipman, J Kevin; Edwards, Stephen; Habib, Tanwir; Falciani, Francesco; Taylor, Ronald; Van Aggelen, Graham; Vulpe, Chris; Antczak, Philipp; Loguinov, Alexandre

    2011-01-01

    The toxicological effects of many stressors are mediated through unknown, or incompletely characterized, mechanisms of action. The application of reverse engineering complex interaction networks from high dimensional omics data (gene, protein, metabolic, signaling) can be used to overcome these limitations. This approach was used to characterize adverse outcome pathways (AOPs) for chemicals that disrupt the hypothalamus-pituitary-gonadal endocrine axis in fathead minnows (FHM, Pimephales promelas). Gene expression changes in FHM ovaries in response to seven different chemicals, over different times, doses, and in vivo versus in vitro conditions, were captured in a large data set of 868 arrays. Potential AOPs of the antiandrogen flutamide were examined using two mutual information-based methods to infer gene regulatory networks and potential AOPs. Representative networks from these studies were used to predict network paths from stressor to adverse outcome as candidate AOPs. The relationship of individual chemicals to an adverse outcome can be determined by following perturbations through the network in response to chemical treatment, thus leading to the nodes associated with the adverse outcome. Identification of candidate pathways allows for formation of testable hypotheses about key biological processes, biomarkers, or alternative endpoints that can be used to monitor an AOP. Finally, the unique challenges facing the application of this approach in ecotoxicology were identified and a road map for the utilization of these tools presented.

  10. Major Links.

    ERIC Educational Resources Information Center

    Henderson, Tona

    1995-01-01

    Provides electronic mail addresses for resources and discussion groups related to the following academic majors: art, biology, business, chemistry, computer science, economics, health sciences, history, literature, math, music, philosophy, political science, psychology, sociology, and theater. (AEF)

  11. FDI report on adverse reactions to resin-based materials.

    PubMed

    Fan, P L; Meyer, D M

    2007-02-01

    Resin-based restorative materials are considered safe for the vast majority of dental patients. Although constituent chemicals such as monomers, accelerators and initiators can potentially leach out of cured resin-based materials after placement, adverse reactions to these chemicals are rare and reaction symptoms commonly subside after removal of the materials. Dentists should be aware of the rare possibility that patients could have adverse reactions to constituents of resin-based materials and be vigilant in observing any adverse reactions after restoration placement. Dentists should also be cognisant of patient complaints about adverse reactions that may result from components of resin-based materials. To minimise monomer leaching and any potential risk of dermatological reactions, resin-based materials should be adequately cured. Dental health care workers should avoid direct skin contact with uncured resin-based materials. Latex and vinyl gloves do not provide adequate barrier protection to the monomers in resin-based materials.

  12. Adverse drug reactions: part II.

    PubMed

    Wooten, James M

    2010-11-01

    Pharmacovigilance is the process of identifying, monitoring, and effectively reducing adverse drug reactions. Adverse drug reactions (ADRs) are an important consideration when assessing a patient's health. The proliferation of new pharmaceuticals means that the incidence of ADRs is increasing. The goal for all health care providers must be to minimize the risk of ADRs as much as possible. Steps to achieve this include understanding the pharmacology for all drugs prescribed and proactively assessing and monitoring those patients at greatest risk for developing an ADR. Groups at greatest risk for developing ADRs include the elderly, children, and pregnant patients, as well as others. Pharmacovigilance must be effectively practiced by all health care providers in order to avoid ADRs.

  13. Adverse drug reactions: Part I.

    PubMed

    Wooten, James M

    2010-10-01

    Pharmacovigilance is the process of identifying, monitoring, and effectively reducing adverse drug reactions. Adverse drug reactions (ADRs) are an important consideration when assessing a patient's health. The proliferation of new pharmaceuticals means that the incidence of ADRs is increasing. The goal for all health care providers must be to minimize the risk of ADRs as much as possible. Steps to achieve this include understanding the pharmacology for all drugs prescribed and proactively assessing and monitoring those patients at greatest risk for developing an ADR. Groups at greatest risk for developing ADRs include the elderly, children, and pregnant patients, as well as others. Pharmacovigilance must effectively be practiced by all health providers in order to avoid ADRs.

  14. [Finasteride adverse effects: An update].

    PubMed

    Carreño-Orellana, Néstor; Moll-Manzur, Catherina; Carrasco-Zuber, Juan Eduardo; Álvarez-Véliz, Sergio; Berroeta-Mauriziano, Daniela; Porras-Kusmanic, Ninoska

    2016-12-01

    Finasteride is a 5-α reductase inhibitor that is widely used in the management of benign prostate hyperplasia and male pattern hair loss. It is well known that these agents improve the quality of life in men suffering from these conditions. However, they are associated with some transient and even permanent adverse effects. The aim of this article is to clarify the controversies about the safety of finasteride by analyzing the evidence available in the literature.

  15. [Pain as adverse drug reaction].

    PubMed

    Böhmdorfer, Birgit; Schaffarzick, Daniel; Nagano, Marietta; Janowitz, Susanne Melitta; Schweitzer, Ekkehard

    2012-09-01

    We present a multidisciplinary (anaesthesiology--clinical pharmacy--bioinformatics) analysis of pain as possible adverse drug reaction taking different manifestations of pain, indication groups, relevance to the Austrian drug market and possible mechanistic influence of drugs on development and apprehension of pain into consideration.We designed an overview that shows how transmitters that play a part in nociception and antinociception can be influenced by drugs. This allows conclusions to the dolorigene potential of therapeutics.

  16. Adverse food-drug interactions.

    PubMed

    de Boer, Alie; van Hunsel, Florence; Bast, Aalt

    2015-12-01

    Food supplements and herbal products are increasingly popular amongst consumers. This leads to increased risks of interactions between prescribed drugs and these products containing bioactive ingredients. From 1991 up to 2014, 55 cases of suspected adverse drug reactions due to concomitant intake of health-enhancing products and drugs were reported to Lareb, the Netherlands Pharmacovigilance Centre. An overview of these suspected interactions is presented and their potential mechanisms of action are described. Mainly during the metabolism of xenobiotics and due to the pharmacodynamics effects interactions seem to occur, which may result in adverse drug reactions. Where legislation is seen to distinct food and medicine, legislation concerning these different bioactive products is less clear-cut. This can only be resolved by increasing the molecular knowledge on bioactive substances and their potential interactions. Thereby potential interactions can be better understood and prevented on an individual level. By considering the dietary pattern and use of bioactive substances with prescribed medication, both health professionals and consumers will be increasingly aware of interactions and these interactive adverse effects can be prevented.

  17. Vitamin D Deficiency Strongly Predicts Adverse Medical Outcome Across Different Medical Inpatient Populations

    PubMed Central

    Graedel, Lena; Merker, Meret; Felder, Susan; Kutz, Alexander; Haubitz, Sebastian; Faessler, Lukas; Kaeslin, Martha; Huber, Andreas; Mueller, Beat; Schuetz, Philipp

    2016-01-01

    Abstract Vitamin D deficiency has been associated with several adverse outcomes mainly in the outpatient setting. The objective of this study was to examine the prevalence of vitamin D deficiency and its association with risk of adverse clinical outcomes in a large prospective cohort of medical inpatients. We collected clinical data and measured 25(OH)D levels in adult medical patients upon hospital admission and followed them for 30 days. Regression analyses adjusted for age, gender, comorbidities, and main medical diagnosis were performed to study the effect of vitamin D deficiency on several hospital outcomes. Of 4257 included patients, 1510 (35.47%) had 25(OH)D levels of 25 to 50 nmol/L (vitamin D insufficiency) and 797 (18.72%) had levels of <25nmol/L (severe deficiency). Vitamin D insufficiency and severe deficiency were associated (OR/HR, 95%CI) with an increased risk of 30-day mortality (OR 1.70, 1.22–2.36 and 2.70, 1.22–2.36) and increased length of stay (HR 0.88, 0.81–0.97 and 0.72, 0.65–0.81). Severe deficiency was associated with risk of falls (OR 1.77, 1.18–2.63), impaired Barthel index (OR 1.80, 1.42–2.28), and impairment in quality of life. Most associations remained robust after multivariate adjustment and in subgroups stratified by gender, age, comorbidities, and main diagnoses (P for interaction >0.05). In this comprehensive and large medical inpatient cohort, vitamin D deficiency was highly prevalent and strongly associated with adverse clinical outcome. Interventional research is urgently needed to prove the effect of vitamin D supplementation on these outcomes. PMID:27175650

  18. Associations between Anticholinergic Burden and Adverse Health Outcomes in Parkinson Disease

    PubMed Central

    Crispo, James A. G.; Willis, Allison W.; Thibault, Dylan P.; Fortin, Yannick; Hays, Harlen D.; McNair, Douglas S.; Bjerre, Lise M.; Kohen, Dafna E.; Perez-Lloret, Santiago; Mattison, Donald R.; Krewski, Daniel

    2016-01-01

    Background Elderly adults should avoid medications with anticholinergic effects since they may increase the risk of adverse events, including falls, delirium, and cognitive impairment. However, data on anticholinergic burden are limited in subpopulations, such as individuals with Parkinson disease (PD). The objective of this study was to determine whether anticholinergic burden was associated with adverse outcomes in a PD inpatient population. Methods Using the Cerner Health Facts® database, we retrospectively examined anticholinergic medication use, diagnoses, and hospital revisits within a cohort of 16,302 PD inpatients admitted to a Cerner hospital between 2000 and 2011. Anticholinergic burden was computed using the Anticholinergic Risk Scale (ARS). Primary outcomes were associations between ARS score and diagnosis of fracture and delirium. Secondary outcomes included associations between ARS score and 30-day hospital revisits. Results Many individuals (57.8%) were prescribed non-PD medications with moderate to very strong anticholinergic potential. Individuals with the greatest ARS score (≥4) were more likely to be diagnosed with fractures (adjusted odds ratio (AOR): 1.56, 95% CI: 1.29–1.88) and delirium (AOR: 1.61, 95% CI: 1.08–2.40) relative to those with no anticholinergic burden. Similarly, inpatients with the greatest ARS score were more likely to visit the emergency department (adjusted hazard ratio (AHR): 1.32, 95% CI: 1.10–1.58) and be readmitted (AHR: 1.16, 95% CI: 1.01–1.33) within 30-days of discharge. Conclusions We found a positive association between increased anticholinergic burden and adverse outcomes among individuals with PD. Additional pharmacovigilance studies are needed to better understand risks associated with anticholinergic medication use in PD. PMID:26939130

  19. Major depression.

    PubMed

    Bentley, Susan M; Pagalilauan, Genevieve L; Simpson, Scott A

    2014-09-01

    Major depression is a common, disabling condition seen frequently in primary care practices. Non-psychiatrist ambulatory providers are increasingly responsible for diagnosing, and primarily managing patients suffering from major depressive disorder (MDD). The goal of this review is to help primary care providers to understand the natural history of MDD, identify practical tools for screening, and a thoughtful approach to management. Clinically challenging topics like co-morbid conditions, treatment resistant depression and pharmacotherapy selection with consideration to side effects and medication interactions, are also covered.

  20. Major Andre

    ERIC Educational Resources Information Center

    Henisch, B. A.; Henisch, H. K.

    1976-01-01

    If most Revolutionary era people seem two-dimensional their lives simpler to understand than ours, it may be only that history, with the benefit of hindsight, clarifies. Examines a profile of Major John Andre, the British liaison officer in Benedict Arnold's plan to surrender West Point, as both hero and villain to show the complexity of early…

  1. In-hospital versus post discharge adverse events following carotid endarterectomy

    PubMed Central

    Fokkema, M; Bensley, RP; Lo, RC; Hamdan, AD; Wyers, MC; Moll, FL; de Borst, GJ; Schermerhorn, ML

    2013-01-01

    Introduction and objectives Most studies based on state and nation-wide registries evaluating perioperative outcome after carotid endarterectomy (CEA) rely on hospital discharge data only. Therefore, the true 30-day complication risk after carotid revascularization may be underestimated. Methods We used the National Surgical Quality Improvement Program (NSQIP) database 2005–2010 to assess the in-hospital and post discharge rate of any stroke, death, cardiac event (new Q-wave MI or cardiac arrest), combined stroke/death and combined adverse outcome (S/D/CE) at 30 days following CEA. Multivariable analyses were used to identify predictors for in-hospital and post discharge events separately, and in particular, those that predict post discharge events distinctly. Results A total of 35,916 patients who underwent CEA during 2005–2010 were identified in the NSQIP database. 59% were male (median age 72 years) and 44% had a previous neurologic event. Thirty-day stroke rate was 1.6% (n=591), death rate was 0.8% (n=272), cardiac event rate was 1.0% (n=350), stroke or death rate was 2.2% (n=794) and combined S/D/CE rate was 2.9% (n=1043). 33% of strokes, 53% of deaths, 32% of cardiac events, 40% of combined stroke/death and 38% of combined S/D/CE took place after hospital discharge. Patients with a prior stroke or TIA had similar proportions of post discharge events as compared to patients without prior symptoms. Independent predictors for post discharge events, but not for in-hospital events were female gender (stroke [OR 1.6, 95% CI 1.2–2.1] and stroke/death [OR 1.4, 95% CI 1.1–1.7]), renal failure (stroke [OR 3.0, 95% CI 1.4–6.2]) and COPD (stroke/death [OR 1.8, 95% CI 1.4–2.4] and S/D/CE [OR 1.8, 95% CI 1.4–2.3]). Conclusions With 38% of perioperative adverse events after CEA happening post hospitalization, regardless of symptoms status, we need to be alert to the ongoing risks after discharge particularly in women, patients with renal failure, or a history

  2. 75 FR 44802 - Nebraska; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-29

    ... determinations. DATES: Effective Date: July 15, 2010. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Recovery... of Nebraska have been designated as adversely affected by this major disaster: Antelope,...

  3. 75 FR 25873 - West Virginia; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-10

    ... adversely affected by this major disaster: The counties of Berkeley, Brooke, Doddridge, Hampshire, Hancock... Wetzel for Public Assistance. Berkeley, Hampshire, Hardy, Jefferson, Morgan, and Pocahontas Counties...

  4. 76 FR 32983 - Tennessee; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-07

    ... State of Tennessee have been designated as adversely affected by this declared major disaster: Bradley, Greene, Hamilton, and Washington Counties for Individual Assistance. Bradley, Greene, Hamilton,...

  5. Adverse responses to local anaesthetics.

    PubMed

    Fisher, M M; Graham, R

    1984-11-01

    Progressive challenge was used to investigate twenty-seven patients with a history of an adverse response to local anaesthesia. True allergy was detected in only one patient. The method does not exclude reactions to additives and preservatives in local anaesthetics. If preservative-free local anaesthetics are used for subsequent exposure in patients with no response to progressive challenge, subsequent exposure is safe. The possibility that some of these patients may be reacting to preservatives in the solutions cannot be excluded by such testing. Where possible preservative-free local anaesthetic preparations should be used for subsequent anaesthesia.

  6. Adverse Outcomes in Group Psychotherapy

    PubMed Central

    Roback, Howard B.

    2000-01-01

    Group forms of therapy have been growing at a rapid rate, in part because of their documented effectiveness and economic considerations such as managed care. It is therefore becoming increasingly important to assess the psychological risks of these interventions. The author provides an overview of the published literature and conference presentations on negative effects in adult outpatient groups. Although much of the literature on adverse outcomes in group therapy focuses on single risk factors (e.g., negative leader, group process, or patient characteristics), the author argues that an interactional model should be encouraged. Means of reducing casualties are also discussed, as well as methodological issues and research directions. PMID:10896735

  7. Adverse effects of isolation in hospitalised patients: a systematic review.

    PubMed

    Abad, C; Fearday, A; Safdar, N

    2010-10-01

    The use of transmission precautions such as contact isolation in patients known to be colonised or infected with multidrug-resistant organisms is recommended in healthcare institutions. Although essential for infection control, contact isolation has recently been associated with adverse effects in patients. We undertook a systematic review to determine whether contact isolation leads to psychological or physical problems for patients. Studies were included if (1) hospitalised patients were placed under isolation precautions for an underlying medical indication, and (2) any adverse events related to the isolation were evaluated. We found 16 studies that reported data regarding the impact of isolation on patient mental well-being, patient satisfaction, patient safety or time spent by healthcare workers in direct patient care. The majority showed a negative impact on patient mental well-being and behaviour, including higher scores for depression, anxiety and anger among isolated patients. A few studies also found that healthcare workers spent less time with patients in isolation. Patient satisfaction was adversely affected by isolation if patients were kept uninformed of their healthcare. Patient safety was also negatively affected, leading to an eight-fold increase in adverse events related to supportive care failures. We found that contact isolation may negatively impact several dimensions of patient care. Well-validated tools are necessary to investigate these results further. Large studies examining a number of safety indicators to assess the adverse effects of isolation are needed. Patient education may be an important step to mitigate the adverse psychological effects of isolation and is recommended.

  8. Adverse weather impacts on arable cropping systems

    NASA Astrophysics Data System (ADS)

    Gobin, Anne

    2016-04-01

    Damages due to extreme or adverse weather strongly depend on crop type, crop stage, soil conditions and management. The impact is largest during the sensitive periods of the farming calendar, and requires a modelling approach to capture the interactions between the crop, its environment and the occurrence of the meteorological event. The hypothesis is that extreme and adverse weather events can be quantified and subsequently incorporated in current crop models. Since crop development is driven by thermal time and photoperiod, a regional crop model was used to examine the likely frequency, magnitude and impacts of frost, drought, heat stress and waterlogging in relation to the cropping season and crop sensitive stages. Risk profiles and associated return levels were obtained by fitting generalized extreme value distributions to block maxima for air humidity, water balance and temperature variables. The risk profiles were subsequently confronted with yields and yield losses for the major arable crops in Belgium, notably winter wheat, winter barley, winter oilseed rape, sugar beet, potato and maize at the field (farm records) to regional scale (statistics). The average daily vapour pressure deficit (VPD) and reference evapotranspiration (ET0) during the growing season is significantly lower (p < 0.001) and has a higher variability before 1988 than after 1988. Distribution patterns of VPD and ET0 have relevant impacts on crop yields. The response to rising temperatures depends on the crop's capability to condition its microenvironment. Crops short of water close their stomata, lose their evaporative cooling potential and ultimately become susceptible to heat stress. Effects of heat stress therefore have to be combined with moisture availability such as the precipitation deficit or the soil water balance. Risks of combined heat and moisture deficit stress appear during the summer. These risks are subsequently related to crop damage. The methodology of defining

  9. "Adversative Conjunction": The Poetics of Linguistic Opposition.

    ERIC Educational Resources Information Center

    Wallerstein, Nicholas

    1992-01-01

    The general use of adversative conjunction in (primarily) English and U.S. poetry is outlined. The contention is that the adversative is not merely a grammatical convenience but sometimes a highly functional tool of rhetorical strategy. (36 references) (LB)

  10. The international serious adverse events consortium.

    PubMed

    Holden, Arthur L; Contreras, Jorge L; John, Sally; Nelson, Matthew R

    2014-11-01

    The International Serious Adverse Events Consortium is generating novel insights into the genetics and biology of drug-induced serious adverse events, and thereby improving pharmaceutical product development and decision-making.

  11. Syrtis Major

    NASA Technical Reports Server (NTRS)

    2002-01-01

    (Released 1 May 2002) The Science This image is from the region of Syrtis Major, which is dominated by a low-relief shield volcano. This area is believed to be an area of vigorous aeolian activity with strong winds in the east-west direction. The effects of these winds are observed as relatively bright streaks across the image, extending from topographic features such as craters. The brighter surface material probably indicates a smaller relative particle size in these areas, as finer particles have a higher albedo. The bright streaks seen off of craters are believed to have formed during dust storms. A raised crater rim can cause a reduction in the wind velocity directly behind it, which results in finer particles being preferentially deposited in this location. In the top half of the image, there is a large bright streak that crosses the entire image. There is no obvious topographic obstacle, therefore it is unclear whether it was formed in the same manner as described above. This image is located northwest of Nili Patera, a large caldera in Syrtis Major. Different flows from the caldera eruptions can be recognized as raised ridges, representing the edge of a flow lobe. The Story In the 17th century, Holland was in its Golden Age, a time of cultural greatness and immense political and economic influence in the world. In that time, lived a inquisitive person named Christian Huygens. As a boy, he loved to draw and to figure out problems in mathematics. As a man, he used these talents to make the first detailed drawings of the Martian surface - - only 50 years or so after Galileo first turned his telescope on Mars. Mars suddenly became something other than a small red dot in the sky. One of the drawings Huygens made was of a dark marking on the red planet's surface named Syrtis Major. Almost 350 years later, here we are with an orbiter that can show us this place in detail. Exploration lives! It's great we can study this area up close. In earlier periods of history

  12. Adverse reactions to drug additives.

    PubMed

    Simon, R A

    1984-10-01

    There is a long list of additives used by the pharmaceutical industry. Most of the agents used have not been implicated in hypersensitivity reactions. Among those that have, only reactions to parabens and sulfites have been well established. Parabens have been shown to be responsible for rare immunoglobulin E-mediated reactions that occur after the use of local anesthetics. Sulfites, which are present in many drugs, including agents commonly used to treat asthma, have been shown to provoke severe asthmatic attacks in sensitive individuals. Recent studies indicate that additives do not play a significant role in "hyperactivity." The role of additives in urticaria is not well established and therefore the incidence of adverse reactions in this patient population is simply not known. In double-blind, placebo-controlled studies, reactions to tartrazine or additives other than sulfites, if they occur at all, are indeed quite rare for the asthmatic population, even for the aspirin-sensitive subpopulation.

  13. Syrtis Major

    NASA Technical Reports Server (NTRS)

    2002-01-01

    (Released 6 June 2002) The Science This image, located near the equator and 288W (72E), is near the southern edge of a low, broad volcanic feature called Syrtis Major. A close look at this image reveals a wrinkly texture that indicates a very rough surface that is associated with the lava flows that cover this region. On a larger scale, there are numerous bright streaks that trail topographic features such as craters. These bright streaks are in the wind shadows of the craters where dust that settles onto the surface is not as easily scoured away. It is important to note that these streaks are only bright in a relative sense to the surrounding image. Syrtis Major is one of the darkest regions on Mars and it is as dark as fresh basalt flows or dunes are on Earth. The Story Cool! It almost looks as if nature has 'painted' comets on the surface of Mars, using craters as comet cores and dust as streaky tails. Of course, that's just an illusion. As in many areas of Mars, the wind is behind the creation of such fantastic landforms. The natural phenomenon seen here gives this particular surface of Mars a very dynamic, fast-moving, almost luminous 'cosmic personality.' The bright, powdery-looking streaks of dust are in the 'wind shadows' of craters, where dust that settles onto the surface is not as easily scoured away. That's because the wind moves across the land in a particular direction, and a raised surface like the rim of a crater 'protects' dust from being completely blown away on the other side. The raised landforms basically act as a buffer. From the streaks seen above, you can tell the wind was blowing in a northeast to southwest direction. Why are the streaks so bright? Because they contrast with the really dark underlying terrain in this volcanic area of Mars. Syrtis Major is one of the darkest regions on Mars because it is made of basalt. Basalt is typically dark gray or black, and forms when a certain type of molten lava cools. The meaning of the word basalt

  14. Adverse events in healthcare: learning from mistakes.

    PubMed

    Rafter, N; Hickey, A; Condell, S; Conroy, R; O'Connor, P; Vaughan, D; Williams, D

    2015-04-01

    Large national reviews of patient charts estimate that approximately 10% of hospital admissions are associated with an adverse event (defined as an injury resulting in prolonged hospitalization, disability or death, caused by healthcare management). Apart from having a significant impact on patient morbidity and mortality, adverse events also result in increased healthcare costs due to longer hospital stays. Furthermore, a substantial proportion of adverse events are preventable. Through identifying the nature and rate of adverse events, initiatives to improve care can be developed. A variety of methods exist to gather adverse event data both retrospectively and prospectively but these do not necessarily capture the same events and there is variability in the definition of an adverse event. For example, hospital incident reporting collects only a very small fraction of the adverse events found in retrospective chart reviews. Until there are systematic methods to identify adverse events, progress in patient safety cannot be reliably measured. This review aims to discuss the need for a safety culture that can learn from adverse events, describe ways to measure adverse events, and comment on why current adverse event monitoring is unable to demonstrate trends in patient safety.

  15. Adverse effects of oral antiviral therapy in chronic hepatitis B

    PubMed Central

    Kayaaslan, Bircan; Guner, Rahmet

    2017-01-01

    Oral nucleoside/nucleotide analogues (NAs) are currently the backbone of chronic hepatitis B (CHB) infection treatment. They are generally well-tolerated by patients and safe to use. To date, a significant number of patients have been treated with NAs. Safety data has accumulated over the years. The aim of this article is to review and update the adverse effects of oral NAs. NAs can cause class adverse effects (i.e., myopathy, neuropathy, lactic acidosis) and dissimilar adverse effects. All NAs carry a “Black Box” warning because of the potential risk for mitochondrial dysfunction. However, these adverse effects are rarely reported. The majority of cases are associated with lamivudine and telbivudine. Adefovir can lead to dose- and time-dependent nephrotoxicity, even at low doses. Tenofovir has significant renal and bone toxicity in patients with human immunodeficiency virus (HIV) infection. However, bone and renal toxicity in patients with CHB are not as prominent as in HIV infection. Entecavir and lamivudine are not generally associated with renal adverse events. Entecavir has been claimed to increase the risk of lactic acidosis in decompensated liver disease and high Model for End-Stage Liver Disease scores. However, current studies reported that entecavir could be safely used in decompensated cirrhosis. An increase in fetal adverse events has not been reported with lamivudine, telbivudine and tenofovir use in pregnant women, while there is no adequate data regarding entecavir and adefovir. Further long-term experience is required to highlight the adverse effects of NAs, especially in special patient populations, including pregnant women, elderly and patients with renal impairment. PMID:28261380

  16. 75 FR 65501 - New York; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-25

    ... declaration of a major disaster for the State of New York (FEMA-1943-DR), dated October 14, 2010, and related... State of New York have been designated as adversely affected by this major disaster: Kings, Queens,...

  17. 76 FR 44032 - Montana; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-22

    ... beginning on April 4, 2011, and continuing, is of sufficient severity and magnitude to warrant a major... Montana have been designated as adversely affected by this major disaster: Big Horn, Blaine,...

  18. Acute adverse event signalling scheme using the Saskatchewan Administrative health care utilization datafiles: results for two benzodiazepines.

    PubMed

    Rawson, N S; Rawson, M J

    1999-01-01

    Linked administrative health care utilization databases offer potential benefits for postmarketing surveillance. The value of the Saskatchewan datafiles in an acute adverse event signalling scheme has been evaluated using two benzodiazepines. The first 20,000 patients dispensed lorazepam and the first 8525 patients dispensed alprazolam were followed through the datafiles over the year after their initial prescription of the relevant drug, and all medical services occurring during treatment were recorded. The most frequent adverse drug reactions to benzodiazepines are drowsiness, depression, impaired intellectual function and memory, lethargy, impaired coordination, dizziness, nausea and/or vomiting, skin rash, and respiratory disturbance. Data from our study showed that sleep disorders, depressive disorders, dizziness and/or vertigo, respiratory symptoms, esophagus and stomach disorders, and inflammatory skin conditions occurred significantly more often in the first 30 days after the initial prescription than in the succeeding six months in both drug groups, indicating that they are important adverse events. There are several limitations to the methodology; however, the results of the analysis indicate that the use of administrative health care utilization datafiles in a systematic assessment to signal potential acute adverse drug reactions is a feasible proposition, but further studies are required to assess whether events are real adverse reactions.

  19. Adverse effects of thyroid hormone preparations and antithyroid drugs.

    PubMed

    Bartalena, L; Bogazzi, F; Martino, E

    1996-07-01

    Thyroid hormone preparations, especially thyroxine, are widely used either at replacement doses to correct hypothyroidism or at suppressive doses to abolish thyrotropin (thyroid-stimulating hormone) secretion in patients with differentiated thyroid carcinoma after total thyroidectomy or with diffuse/ nodular nontoxic goitre. In order to suppress thyrotropin secretion, it is necessary to administer slightly supraphysiological doses of thyroxine. Possible adverse effects of this therapy include cardiovascular changes (shortening of systolic time intervals, increased frequency of atrial premature beats and, possibly, left ventricular hypertrophy) and bone changes (reduced bone density and bone mass), but the risk of these adverse effects can be minimised by carefully monitoring serum free thyroxine and free liothyronine (triiodothyronine) measurements and adjusting the dosage accordingly. Thionamides [thiamazole (methimazole), carbimazole, propylthiouracil] are the most widely used antithyroid drugs. They are given for long periods of time and cause adverse effects in 3 to 5% of patients. In most cases, adverse effects are minor and transient (e.g. skin rash, itching, mild leucopenia). The most dangerous effect is agranulocytosis, which occurs in 0.1 to 0.5% of patients. This life-threatening condition can now be effectively treated by granulocyte colony-stimulating factor administration. Other major adverse effects (aplastic anaemia, thrombocytopenia, lupus erythematosus-like syndrome, vasculitis) are exceedingly rare.

  20. Adverse effects of antihypertensive drugs.

    PubMed

    Husserl, F E; Messerli, F H

    1981-09-01

    Early essential hypertension is asymptomatic and should remain so throughout treatment. In view of the increasing number of available antihypertensive agents, clinicians need to become familiar with the potential side effects of these drugs. By placing more emphasis on non-pharmacological treatment (sodium restriction, weight loss, exercise) and thoroughly evaluating each case in particular, the pharmacological regimen can be optimally tailored to the patient's needs. Potential side effects should be predicted and can often be avoided; if they become clinically significant they should be rapidly recognised and corrected. These side effects can be easily remembered in most instances, as they fall into 3 broad categories: (a) those caused by an exaggerated therapeutic effect; (b) those due to a non-therapeutic pharmacological effect; and (c) those caused by a non-therapeutic, non-pharmacological effect probably representing idiosyncratic reactions. This review focuses mainly on adverse effects of the second and third kind. Each group of drugs in general shares the common side effects of the first two categories, while each individual drug has its own idiosyncratic side effects.

  1. Rethinking the Measurement of Adversity.

    PubMed

    Mersky, Joshua P; Janczewski, Colleen E; Topitzes, James

    2017-02-01

    Research on adverse childhood experiences (ACEs) has unified the study of interrelated risks and generated insights into the origins of disorder and disease. Ten indicators of child maltreatment and household dysfunction are widely accepted as ACEs, but further progress requires a more systematic approach to conceptualizing and measuring ACEs. Using data from a diverse, low-income sample of women who received home visiting services in Wisconsin ( N = 1,241), this study assessed the prevalence of and interrelations among 10 conventional ACEs and 7 potential ACEs: family financial problems, food insecurity, homelessness, parental absence, parent/sibling death, bullying, and violent crime. Associations between ACEs and two outcomes, perceived stress and smoking, were examined. The factor structure and test-retest reliability of ACEs was also explored. As expected, prevalence rates were high compared to studies of more representative samples. Except for parent/sibling death, all ACEs were intercorrelated and associated at the bivariate level with perceived stress and smoking. Exploratory factor analysis confirmed that conventional ACEs loaded on two factors, child maltreatment and household dysfunction, though a more complex four-factor solution emerged once new ACEs were introduced. All ACEs demonstrated acceptable test-retest reliability. Implications and future directions toward a second generation of ACE research are discussed.

  2. OAE: The Ontology of Adverse Events

    PubMed Central

    2014-01-01

    Background A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health. Description The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. For example, using the data extracted from the Vaccine Adverse Event Reporting System (VAERS), OAE was used to analyse vaccine adverse events associated with the administrations of different types of influenza vaccines. OAE has also been used to represent and classify the vaccine adverse events cited in package inserts of FDA-licensed human vaccines in the USA. Conclusion OAE is a biomedical ontology that logically defines and classifies various adverse events occurring after medical interventions. OAE has successfully been applied in several adverse event studies. The OAE ontological framework provides a platform for systematic representation and analysis of

  3. Serenoa repens (saw palmetto): a systematic review of adverse events.

    PubMed

    Agbabiaka, Taofikat B; Pittler, Max H; Wider, Barbara; Ernst, Edzard

    2009-01-01

    associated with serious adverse events. The majority of adverse events are mild, infrequent and reversible, and include abdominal pain, diarrhoea, nausea and fatigue, headache, decreased libido and rhinitis. We found no evidence for drug interactions with S. repens. However, higher quality reporting of adverse events is essential if safety assessments are to be improved in future.

  4. Characterizing "Adversity" of Pathology Findings in ...

    EPA Pesticide Factsheets

    The identification of adverse health effects has a central role in the development and risk/safety assessment of chemical entities and pharmaceuticals. There is currently a need for better alignment in the toxicologic pathology community regarding how nonclinical adversity is determined and characterized. The European Society of Toxicologic Pathology (ESTP) therefore coordinated a workshop in June 2015 to review available definitions of adversity, weigh determining and qualifying factors of adversity based on case examples, and recommend a practical approach to define and characterize adversity in toxicology reports. The international group of expert pathologists and toxicologists emphasized that a holistic, weight-of-evidence, case-specific approach should be followed for each adversity assessment. It was recommended that nonclinical adversity should typically be determined at a morphological level (most often the organ) in the pathology report and should refer specifically to the test species. Final adversity calls, integration of target pharmacology/pathway information, and consideration of human translation should generally be made in toxicology overview reports. Differences in interpretation and implications of adversity calls between (agro)chemical and pharmaceutical industries and among world regions were highlighted. The results of this workshop should serve a valuable prerequisite for future organ- or lesion-specific workshops planned by the ESTP. This

  5. Idiosyncratic Adverse Drug Reactions: Current Concepts

    PubMed Central

    Naisbitt, Dean J.

    2013-01-01

    Idiosyncratic drug reactions are a significant cause of morbidity and mortality for patients; they also markedly increase the uncertainty of drug development. The major targets are skin, liver, and bone marrow. Clinical characteristics suggest that IDRs are immune mediated, and there is substantive evidence that most, but not all, IDRs are caused by chemically reactive species. However, rigorous mechanistic studies are very difficult to perform, especially in the absence of valid animal models. Models to explain how drugs or reactive metabolites interact with the MHC/T-cell receptor complex include the hapten and P-I models, and most recently it was found that abacavir can interact reversibly with MHC to alter the endogenous peptides that are presented to T cells. The discovery of HLA molecules as important risk factors for some IDRs has also significantly contributed to our understanding of these adverse reactions, but it is not yet clear what fraction of IDRs have a strong HLA dependence. In addition, with the exception of abacavir, most patients who have the HLA that confers a higher IDR risk with a specific drug will not have an IDR when treated with that drug. Interindividual differences in T-cell receptors and other factors also presumably play a role in determining which patients will have an IDR. The immune response represents a delicate balance, and immune tolerance may be the dominant response to a drug that can cause IDRs. PMID:23476052

  6. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William; Arellano, Felix; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph; Fernandez, Alina; Freedman, Stephen; Goldsmith, David; Huang, Kui; Jones, Judith; McLeay, Rachel; Moore, Nicholas; Stather, Rosie; Trenque, Thierry; Troutman, William; van Puijenbroek, Eugène; Williams, Frank; Wise, Robert

    2009-01-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation and reporting of suspected drug or other medical product adverse events.

  7. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William N; Arellano, Felix M; Barnes, Joanne; Bergman, Ulf; Edwards, I Ralph; Fernandez, Alina M; Freedman, Stephen B; Goldsmith, David I; Huang, Kui; Jones, Judith K; McLeay, Rachel; Moore, Nicholas; Stather, Rosie H; Trenque, Thierry; Troutman, William G; van Puijenbroek, Eugene; Williams, Frank; Wise, Robert P

    2007-05-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide sufficient details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' web sites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

  8. Guidelines for submitting adverse event reports for publication.

    PubMed

    Kelly, William N; Arellano, Felix M; Barnes, Joanne; Bergman, Ulf; Edwards, Ralph I; Fernandez, Alina M; Freedman, Stephen B; Goldsmith, David I; Huang, Kui A; Jones, Judith K; McLeay, Rachel; Moore, Nicholas; Stather, Rosie H; Trenque, Thierry; Troutman, William G; van Puijenbroek, Eugene; Williams, Frank; Wise, Robert P

    2007-01-01

    Publication of case reports describing suspected adverse effects of drugs and medical products that include herbal and complementary medicines, vaccines, and other biologicals and devices is important for postmarketing surveillance. Publication lends credence to important signals raised in these adverse event reports. Unfortunately, deficiencies in vital information in published cases can often limit the value of such reports by failing to provide enough details for either (i) a differential diagnosis or provisional assessment of cause-effect association, or (ii) a reasonable pharmacological or biological explanation. Properly described, a published report of one or more adverse events can provide a useful signal of possible risks associated with the use of a drug or medical product which might warrant further exploration. A review conducted by the Task Force authors found that many major journals have minimal requirements for publishing adverse event reports, and some have none at all. Based on a literature review and our collective experience in reviewing adverse event case reports in regulatory, academic, and industry settings, we have identified information that we propose should always be considered for inclusion in a report submitted for publication. These guidelines have been endorsed by the International Society for Pharmacoepidemiology (ISPE) and the International Society of Pharmacovigilance (ISoP) and are freely available on the societies' websites. Their widespread distribution is encouraged. ISPE and ISoP urge biomedical journals to adopt these guidelines and apply them to case reports submitted for publication. They also encourage schools of medicine, pharmacy, and nursing to incorporate them into the relevant curricula that address the detection, evaluation, and reporting of suspected drug or other medical product adverse events.

  9. Social Involvement Modulates the Response to Novel and Adverse Life Events in Mice

    PubMed Central

    Colnaghi, Luca; Clemenza, Kelly; Groleau, Sarah E.; Weiss, Shira; Snyder, Anna M.; Lopez-Rosas, Mariana; Levine, Amir A.

    2016-01-01

    Epidemiological findings suggest that social involvement plays a major role in establishing resilience to adversity, however, the neurobiology by which social involvement confers protection is not well understood. Hypothesizing that social involvement confers resilience by changing the way adverse life events are encoded, we designed a series of behavioral tests in mice that utilize the presence or absence of conspecific cage mates in measuring response to novel and adverse events. We found that the presence of cage mates increased movement after exposure to a novel environment, increased time spent in the open arms of the elevated plus maze, and decreased freezing time after a foot shock as well as expedited fear extinction, therefore significantly changing the response to adversity. This is a first description of a mouse model for the effects of social involvement on adverse life events. Understanding how social involvement provides resilience to adversity may contribute to the future treatment and prevention of mental and physical illness. PMID:27632422

  10. Understanding adverse events: human factors.

    PubMed Central

    Reason, J

    1995-01-01

    (1) Human rather than technical failures now represent the greatest threat to complex and potentially hazardous systems. This includes healthcare systems. (2) Managing the human risks will never be 100% effective. Human fallibility can be moderated, but it cannot be eliminated. (3) Different error types have different underlying mechanisms, occur in different parts of the organisation, and require different methods of risk management. The basic distinctions are between: Slips, lapses, trips, and fumbles (execution failures) and mistakes (planning or problem solving failures). Mistakes are divided into rule based mistakes and knowledge based mistakes. Errors (information-handling problems) and violations (motivational problems) Active versus latent failures. Active failures are committed by those in direct contact with the patient, latent failures arise in organisational and managerial spheres and their adverse effects may take a long time to become evident. (4) Safety significant errors occur at all levels of the system, not just at the sharp end. Decisions made in the upper echelons of the organisation create the conditions in the workplace that subsequently promote individual errors and violations. Latent failures are present long before an accident and are hence prime candidates for principled risk management. (5) Measures that involve sanctions and exhortations (that is, moralistic measures directed to those at the sharp end) have only very limited effectiveness, especially so in the case of highly trained professionals. (6) Human factors problems are a product of a chain of causes in which the individual psychological factors (that is, momentary inattention, forgetting, etc) are the last and least manageable links. Attentional "capture" (preoccupation or distraction) is a necessary condition for the commission of slips and lapses. Yet, its occurrence is almost impossible to predict or control effectively. The same is true of the factors associated with

  11. Strategic approaches to adverse outcome pathway development

    EPA Science Inventory

    Adverse outcome pathways (AOPs) are conceptual frameworks for organizing biological and toxicological knowledge in a manner that supports extrapolation of data pertaining to the initiation or early progression of toxicity to an apical adverse outcome that occurs at a level of org...

  12. 78 FR 17283 - 30-Day Notice and Request for Comments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-20

    ... reduce paperwork burdens, and as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501- 3519... Management and Budget (OMB) approval of the information collection--System Diagram Maps--further described...'s request for OMB approval. Description of Collection Title: System Diagram Maps (or, in the case...

  13. Operation Borderstar Field Evaluation of the Ration, Lightweight, 30-Day

    DTIC Science & Technology

    1985-05-01

    Cinnamon Blueberry Pecan Chocolate Chip Chocolate Halva Chocolate Bar* Patrols 7.2 (1.7) 7.6 (1.1) 8.0 (1.0) 8.3 (1.3) 6.2 (2,0) 6.9 (2.0...Escalloped Potatoes Beef £1 Vegetables Chicken a la King Dessert Bars Oatmeal Granola Fig Bar Chocolate Pudding Vanilla Pudding Beverages...Orange Beverage Beef Jerky Pepperoni Chocolate Bar Patrols Command & Control/Radio Corabined 5.8 (0.9) 6.S (1.2) 6.1 (1.1) 6.4 (1.7) 6.2 (1.9

  14. Did the Preflood Earth Have a 30-Day Lunar Month

    DTIC Science & Technology

    2015-01-01

    and it was so. And God made the two great lights, the greater light [the Sun] to govern the day, and the lesser light [the Moon ] to govern the...also caused the Moon to undergo a “serious perturbation,” and “the period of lunation was very probably changed.”7 Why did so many early cultures...Earth impacted the Moon recently, which could have caused the “serious perturbation” that early Vedic and Sanskrit texts claimed altered “the period of

  15. 78 FR 21160 - Paperwork Reduction Act; 30-Day Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... Campaign. Type of Collections: OMB 3201-0011-Qualitative Research--Focus groups; OMB 3201-0006--Copy... Collections: See above. Frequency: OMB 3201-0011--Qualitative Research--Quarterly; OMB 3201-0006--Copy testing... teenagers. Estimated Burden: OMB 3201-0011--Qualitative Research--$19,800; OMB 3201-0006--Copy...

  16. Childhood Adversities and Adult Headache in Poland and Germany

    PubMed Central

    Reuchlein, Bettina; Henn, Lea; Brian, Tamara; Schier, Katarzyna; Hardt, Jochen

    2016-01-01

    Objective Various childhood adversities have been found to be associated with chronic pain in adulthood. However, associations were moderate in most studies, i.e. odds ratios (OR) were between one and two. Method An internet survey was performed in 508 Polish and 500 German subjects. A total of 19 childhood adversities were selected and their associations with headaches explored. Age, gender and country were included as potential confounders, as well as their two-way interaction with the risk factors. Results Two strong risk factors were identified. (1) A combined score for physical and emotional neglect showed an odds ratio (OR) of 2.78 (p < .002) to the frequency of headache in adulthood as a main effect. (2) Father having had chronic pain showed an OR of 4.36 (p < .001) with headache in adulthood for women, but not for men (OR = 0.86, p < .556). The majority of the examined childhood adversities were not associated with adult headache, neither when tested individually nor as a sum score. Conclusion This study confirms results from previous ones that childhood adversities may play a role in the development of adult headache, but it is a rather minor one. Contrary to other studies, neglect turned out to be one of the strongest predictors. PMID:26859500

  17. Synergistic childhood adversities and complex adult psychopathology.

    PubMed

    Putnam, Karen T; Harris, William W; Putnam, Frank W

    2013-08-01

    Numerous studies find a cumulative effect of different types of childhood adversities on increasing risk for serious adult mental and medical outcomes. This study uses the National Comorbidity Survey-Replication sample to investigate the cumulative impact of 8 childhood adversities on complex adult psychopathology as indexed by (a) number of lifetime diagnoses according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed., DSM-IV; American Psychiatric Association, 1994); (b) number of 4 DSM-IV disorder categories (mood, anxiety, impulse control, and substance abuse disorders); and (c) coexistence of internalizing and externalizing disorders. Seven of the 8 childhood adversities were significantly associated with complex adult psychopathology. Individuals with 4 or more childhood adversities had an odds ratio of 7.3, 95% confidence interval [4.7, 11.7] for 4 disorder categories. Additive and multiplicative synergistic effects increasing adult psychopathology were found for specific pairwise combinations of childhood adversities. Synergistic patterns differed by gender suggesting that women are more impacted by sexual abuse and men by economic hardship. The absence of childhood adversities was protective, in that it significantly decreased an individual's risk for subsequent adult mental illness. The results support the clinical impression that increased childhood adversity is associated with more complex adult psychopathology.

  18. The adverse effects of kava.

    PubMed

    Kava, R

    2001-03-01

    In Fiji, kava is also known as yaqona or grog. A convenient sample of 300 kava drinkers in Nadi, Lautoka, Ba and Sigatoka were studied to see whether local people in Fiji experienced side effects of kava use. Because males usually consume kava in Fiji, we approached specific groups of people and asked them to participate in the survey. To evaluate the side effects of kava consumption, we interviewed housewives of male kava drinkers regarding specific effects of kava. We interviewed these housewives during kava drinking sessions since they were usually not taking part in the kava drinking. We also interviewed employers of these kava drinkers and the market vendors in Nadi Town since they were closely involved with kava drinkers. Wives of kava users felt deprived of basic family needs due to the amount of money spent on kava. In Urban schools, 64% males and 46.2% had tried kava. The present study aims to assess the prevalence of side effects of kava usage among a community sample of kava drinkers in Fiji and to compare the result with some of the side effects provided by other studies. The questionnaire also asked how much kava was consumed and the reasons. Since kava use is very much part of our everyday culture and existence, convincing people to change their behavior and kava consumption is a major tasks. I hope that this study would emphasize the need at a national level to educate people on the harmful effects of kava and the need for the health ministry to view very heavy kava intake as contributing to morbidity in Fiji.

  19. Mechanisms of adverse drug reactions to biologics.

    PubMed

    Clarke, Janet B

    2010-01-01

    Biologics encompass a broad range of therapeutics that include proteins and other products derived from living systems. Although the multiplicity of target organs often seen with new chemical entities is generally not seen with biologics, they can produce significant adverse reactions. Examples include IL-12 and an anti-CD28 antibody that resulted in patient deaths and/or long stays in intensive care units. Mechanisms of toxicities can be categorized as pharmacological or nonpharmacological, with most, excepting hypersensitivity reactions, associated with the interaction of the agent with its planned target. Unexpected toxicities generally arise as a result of previously unknown biology. Manufacturing quality is a significant issue relative to the toxicity of biologics. The development of recombinant technology represented the single biggest advance leading to humanized products with minimal or no contaminants in comparison to products purified from animal tissues. Nevertheless, the type of manufacturing process including choice of cell type, culture medium, and purification method can result in changes to the protein. For example, a change to the closure system for erythropoietin led to an increase in aplastic anemia as a result of changing the immunogenicity characteristics of the protein. Monoclonal antibodies represent a major class of successful biologics. Toxicities associated with these agents include those associated with the binding of the complementary determining region (CDR) with the target. First dose reactions or infusion reactions are generally thought to be mediated via the Fc region of the antibody activating cytokine release, and have been observed with several antibodies. Usually, these effects (flu-like symptoms, etc.) are transient with subsequent dosing. Although biologics can have nonpharmacologic toxicities, these are less common than with small molecule drugs.

  20. Adverse effects of extra-articular corticosteroid injections: a systematic review

    PubMed Central

    2010-01-01

    Background To estimate the occurrence and type of adverse effects after application of an extra-articular (soft tissue) corticosteroid injection. Methods A systematic review of the literature was made based on a PubMed and Embase search covering the period 1956 to January 2010. Case reports were included, as were prospective and retrospective studies that reported adverse events of corticosteroid injection. All clinical trials which used extra-articular corticosteroid injections were examined. We divided the reported adverse events into major (defined as those needing intervention or not disappearing) and minor ones (transient, not requiring intervention). Results The search yielded 87 relevant studies:44 case reports, 37 prospective studies and 6 retrospective studies. The major adverse events included osteomyelitis and protothecosis; one fatal necrotizing fasciitis; cellulitis and ecchymosis; tendon ruptures; atrophy of the plantar fat was described after injecting a neuroma; and local skin effects appeared as atrophy, hypopigmentation or as skin defect. The minor adverse events effects ranged from skin rash to flushing and disturbed menstrual pattern. Increased pain or steroid flare after injection was reported in 19 studies. After extra-articular injection, the incidence of major adverse events ranged from 0-5.8% and that of minor adverse events from 0-81%. It was not feasible to pool the risk for adverse effects due to heterogeneity of study populations and difference in interventions and variance in reporting. Conclusion In this literature review it was difficult to accurately quantify the incidence of adverse effects after extra-articular corticosteroid injection. The reported adverse events were relatively mild, although one fatal reaction was reported. PMID:20836867

  1. Construing benefits from adversity: adaptational significance and dispositional underpinnings.

    PubMed

    Affleck, G; Tennen, H

    1996-12-01

    The discovery of benefits from living with adversity has been implicated in psychological well-being in numerous investigations, is pivotal to several prominent theories of cognitive adaptation to threat, and can be predicted by personality differences. This article summarizes the prevalence and adaptive significance of finding benefits from major medical problems, locates the place of benefit-finding in stress and coping theories, and examines how it may be shaped by specific psychological dispositions such as optimism and hope and by broader personality traits such as Extraversion and Openness to Experience. The distinction between beliefs about benefits from adversity (benefit-finding) and the use of such knowledge as a deliberate strategy of coping with the problem (benefit-reminding) is underscored and illustrated by daily process research on coping with chronic pain.

  2. [Cardiovascular pharmacotherapy. Risks and adverse effects].

    PubMed

    Voigt, N; Heijman, J; Dobrev, D

    2014-03-01

    Adverse side effects of drugs are a significantly underestimated problem in modern medicine. In this review article, we summarize common adverse side effects of cardiovascular drugs. In particular, we highlight the factors promoting these adverse side effects in patients, including reduced hepatic or renal clearance in elderly patients that often requires dosage adjustment. Pharmacodynamic and pharmacokinetic interactions between drugs (e.g. through the cytochrome P450 system or P-glycoproteins) can modify the plasma concentration of many compounds, thereby also increasing the likelihood of unwanted side effects. The most prominent cardiac side effects include arrhythmias, e.g. atrioventricular (AV) block, drug-induced long-QT syndrome and torsade de pointes and altered inotropy. Non-cardiac side effects are subsequently discussed grouped by drug class. A better understanding of the risks and side effects of cardiovascular drugs is expected to reduce the mortality and morbidity associated with adverse side effects.

  3. Childhood adversities and psychosis: evidence, challenges, implications

    PubMed Central

    Morgan, Craig; Gayer‐Anderson, Charlotte

    2016-01-01

    There is a substantial body of research reporting evidence of associations between various forms of childhood adversity and psychosis, across the spectrum from experiences to disorder. This has been extended, more recently, to include studies of cumulative effects, of interactions with other factors, of specific effects, and of putative biological and psychological mechanisms. In this paper we evaluate this research and highlight the remaining methodological issues and gaps that temper, but do not dismiss, conclusions about the causal role of childhood adversity. We also consider the emerging work on cumulative, synergistic, and specific effects and on mechanisms; and discuss the broader implications of this line of research for our understanding of psychosis. We conclude that the current balance of evidence is that childhood adversities – particularly exposure to multiple adversities involving hostility and threat – do, in some people, contribute to the onset of psychotic experiences and psychotic disorders. PMID:27265690

  4. Childhood adversity: a review of measurement instruments.

    PubMed

    Burgermeister, Diane

    2007-01-01

    Measurement instruments are needed to stimulate research on the long-term outcomes of childhood adversity. Therefore, the purpose of this review was to locate, describe, and assess instruments to measure retrospective perceptions of childhood adversity. An electronic search of instruments was conducted using a combination of keywords that included child maltreatment, child trauma, and childhood stressful events. Nine instruments were located and described according to format, definition of childhood adversity as measured by the instrument, characteristics of the sample used in development and testing, reliability and validity evidence, and feasibility for use. Six out of the nine instruments were suitable for investigators who require a comprehensive measure of childhood adversity. Corroboration with independent sources and use of randomized samples are needed to improve upon reports of validity.

  5. RACIAL RESIDENTIAL SEGREGATION AND ADVERSE BIRTH OUTCOMES

    EPA Science Inventory

    INTRODUCTION. The disparity between black and white women's adverse birth outcomes has been subject to much investigation, yet the factors underlying its persistence remain elusive, which has encouraged research on neighborhood-level influences, including racial residential segr...

  6. Adverse Outcome Pathways: From Definition to Application

    EPA Science Inventory

    A challenge for both human health and ecological toxicologists is the transparent application of mechanistic (e.g., molecular, biochemical, histological) data to risk assessments. The adverse outcome pathway (AOP) is a conceptual framework designed to meet this need. Specifical...

  7. [Management of adverse effects with antituberculosis chemotherapy].

    PubMed

    Tsuyuguchi, Kazunari; Wada, Masako

    2011-02-01

    Tuberculosis has now become a curable disease with chemotherapy. So it is natural that the present issues in tuberculosis management are focused on how to complete standard chemotherapy. In this context, management of adverse effects constitutes an essential part of antituberculosis chemotherapy, as well as directly observed therapy. In this symposium, discussions were held about three major subjects on this issue. First, hepatotoxicity develops frequently and has sometimes fatal outcome, which makes it the most problematic adverse effect. "Management of hepatotoxicity during antituberculosis chemotherapy" was published by the Japanese Society for Tuberculosis (JST) in 2006. Dr. Shinsho Yoshiba evaluated this recommendation and pointed out that the criteria for discontinuation of drug based on AST, ALT and bilirubin levels is too sensitive and the concept of predicting fulminant hepatic failure (FHF) is lacking. He stressed the importance of monitoring serum prothrombin time for predicting FHF. Next, allergic drug reaction such as fever or skin rash often causes distress, although rarely fatal. As isoniazid (INH) and rifampicin (RFP) are key drugs for the cure, readministration of these drugs is often attempted by desensitization therapy. "Recommendation about desensitization therapy of antituberculosis drugs" was also published by JST in 1997. Dr. Yoshihiro Kobashi reported high success rates of 79 percent for INH and 75 percent for RFP according to this recommendation. He also reported correlated factor with the success, such as the longer period from the discontinuation to the desensitization therapy and lower doses of drugs at starting desensitization. Finally, we sometimes experience transient worsening of radiographical findings and general symptoms during antituberculosis chemotherapy. This is presumed to be due to allergic reaction to dead bacilli without requiring discontinuation of the drug. Differential diagnosis includes drug-induced pneumonia requring

  8. Design of Adverse Drug Events-Scorecards.

    PubMed

    Marcilly, Romaric; Chazard, Emmanuel; Beuscart-Zéphir, Marie-Catherine; Hackl, Werner; Băceanu, Adrian; Kushniruk, Andre; Borycki, Elizabeth M

    2011-01-01

    This paper presents the design of Adverse Drug Event-Scorecards. The scorecards described are innovative and novel, not having previously been reported in the literature. The Scorecards provide organizations (e.g. hospitals) with summary information about Adverse Drug Events (ADEs) using a Web-based platform. The data used in the Scorecards are routinely updated and report on ADEs detected through data mining processes. The development of the ADE Scorecards is ongoing and they are currently undergoing clinical testing.

  9. [Allergies and adverse events associated with fluoroquinolones].

    PubMed

    Muller, Y; Andrey, D; Emonet, S; Harr, T; Spoerl, D

    2015-04-08

    The prescription ot fluoroquinolones has been constantly increasing over the past decade. consequently, an increasing number of hyper-sensitivity reactions and adverse events have been reported. The aim of the review is to discuss the incidence of hypersensitivity reactions either IgE (immediate) or T cells mediated (delayed). We will make an overview ofthe diagnostic tools available to detect such hypersensitivity reactions. Finally, the specific adverse events associated with fluoroquinolones, including tendinopathy, chondrotoxicity, peripheral neuropathy or retinal detachment will be discussed.

  10. Childhood adversity and frequent medical consultations.

    PubMed

    Fiddler, Maggie; Jackson, Judy; Kapur, Navneet; Wells, Adrian; Creed, Francis

    2004-01-01

    We assessed possible psychological mediators of the relationship between childhood adversity and frequent medical consultations among new outpatients at neurology, cardiology, and gastroenterology clinics. We assessed whether these differed in patients with and without organic disease that explained their symptoms. At first clinic visit we recorded Hospital Anxiety and Depression scale (HADS--anxiety and depression subscale scores), Illness Perception Questionnaire (IPQ--four subscales: consequences, cure, identity, timeline), Health Anxiety Questionnaire (total score), and Symptom Amplification Scale (total score). Subjects were divided into two groups according to whether they had experienced any type of childhood adversity using the Childhood Experience of Care and Abuse Schedule. Outcome was the (log) number of medical consultations for 12 months before and 6 months after the index clinic visits. Multiple regression analysis was used to determine mediators; this was performed separately for patients with symptoms explained and not explained by organic disease. One-hundred and twenty-nine patients (61% response) were interviewed. Fifty-two (40.3%) had experienced childhood adversity; they made a median of 16 doctor visits compared with 10 for those without adversity (adjusted P=.026). IPQ identity score (number of symptoms attributed to the illness) and HAD depression scores were significantly associated with both childhood adversity and number of medical consultations and these variables acted as mediators between childhood adversity and frequency of consultation in the multiple regression analyses. This association was limited to patients with medically unexplained symptoms and was mediated by IPQ Identity Score (number of symptoms attributed to the patient's illness) and HAD depression score. Sexual abuse and overt neglect were the adversities most closely associated with frequent consultations. In patients with medically unexplained symptoms the association

  11. Adverse drug reactions in hospitalized Colombian children

    PubMed Central

    Díaz-Agudelo, Daniela; Burgos-Flórez, Francisco Javier; Vaca, Claudia; Serrano-Meriño, Dolores Vanessa

    2016-01-01

    Introduction: The occurrence of adverse drug reactions is an important issue due to the lack of drug safety data in children. Objective: To describe the Adverse Drug Reactions in inpatient children under 6 years of age in two general pediatrics wards located in Barranquilla, Colombia. Methods: A prospective cohort study based on intensive pharmacovigilance was conducted during six months in order to monitor the emergence of Adverse Drug Reactions in inpatients children under 6 years of age with at least one medication prescribed. The study was conducted in two pediatric wards of two hospitals located in Barranquilla, Colombia. Naranjo´s Algorithm was used to evaluate imputability, the modified Hartwig and Siegel assessment scale to establish severity and the Schumock and Thornton criteria to determine preventability. Results: Of a total of 772 monitored patients, 156 Adverse Drug Reactions were detected on 147 children. The cumulative incidence of Adverse Drug Reactions was 19.0% (147/772); the incidence density was 37.6 Adverse Drug Reactions per 1,000 patients-days (147/3,913). The frequency was higher in children under 2 years of age (12.7%). Emergence of Adverse Drug Reactions was higher in male patients (RR= 1.66; 95% CI= 1.22-2.22, p= 0.001) and in those who used systemic antibiotics (RR= 1.82; 95% CI= 1.17-2.82, p= 0.005). Conclusions: Adverse Drug Reactions are common among hospitalized children and represent an additional burden of morbidity and risk, particularly in those who used several medicines, including antibiotics. PMID:27821893

  12. Recognizing and reporting adverse drug reactions.

    PubMed Central

    Lucas, L. M.; Colley, C. A.

    1992-01-01

    Although physicians in practice are most likely to see patients with adverse drug reactions, they may fail to recognize an adverse effect or to attribute it to a drug effect and, when recognized, they may fail to report serious reactions to the US Food and Drug Administration (FDA). To recognize and attribute an adverse event to a drug effect, physicians should review the patient's clinical course, looking at patient risk factors, the known adverse reactions to the suspected drug, and the likelihood of a causal relationship between the drug and the adverse event-based on the temporal relationship, response to stopping or restarting the drug, and whether other factors could explain the reaction. Once an adverse drug reaction has been identified, the patient should be informed and appropriate documentation made in the patient's medical record. Serious known reactions and all reactions to newly released drugs or those not previously known to occur (even if the certainty is low) should be reported to the FDA. PMID:1536067

  13. Smallpox vaccination and adverse reactions. Guidance for clinicians.

    PubMed

    Cono, Joanne; Casey, Christine G; Bell, David M

    2003-02-21

    The guidance in this report is for evaluation and treatment of patients with complications from smallpox vaccination in the preoutbreak setting. Information is also included related to reporting adverse events and seeking specialized consultation and therapies for these events. The frequencies of smallpox vaccine-associated adverse events were identified in studies of the 1960s. Because of the unknown prevalence of risk factors among today's population, precise predictions of adverse reaction rates after smallpox vaccination are unavailable. The majority of adverse events are minor, but the less-frequent serious adverse reactions require immediate evaluation for diagnosis and treatment. Agents for treatment of certain vaccine-associated severe adverse reactions are vaccinia immune globulin (VIG), the first-line therapy, and cidofovir, the second-line therapy. These agents will be available under Investigational New Drug (IND) protocols from CDC and the U.S. Department of Defense (DoD). Smallpox vaccination in the preoutbreak setting is contraindicated for persons who have the following conditions or have a close contact with the following conditions: 1) a history of atopic dermatitis (commonly referred to as eczema), irrespective of disease severity or activity; 2) active acute, chronic, or exfoliative skin conditions that disrupt the epidermis; 3) pregnant women or women who desire to become pregnant in the 28 days after vaccination; and 4) persons who are immunocompromised as a result of human immunodeficiency virus or acquired immunodeficiency syndrome, autoimmune conditions, cancer, radiation treatment, immunosuppressive medications, or other immunodeficiencies. Additional contraindications that apply only to vaccination candidates but do not include their close contacts are persons with smallpox vaccine-component allergies, women who are breastfeeding, those taking topical ocular steroid medications, those with moderate-to-severe intercurrent illness, and

  14. Life adverse experiences in relation with obesity and binge eating disorder: A systematic review.

    PubMed

    Palmisano, Giovanni Luca; Innamorati, Marco; Vanderlinden, Johan

    2016-03-01

    Background and aims Several studies report a positive association between adverse life experiences and adult obesity. Despite the high comorbidity between binge eating disorder (BED) and obesity, few authors have studied the link between trauma and BED. In this review the association between exposure to adverse life experiences and a risk for the development of obesity and BED in adulthood is explored. Methods Based on a scientific literature review in Medline, PubMed and PsycInfo databases, the results of 70 studies (N = 306,583 participants) were evaluated including 53 studies on relationship between adverse life experiences and obesity, 7 studies on post-traumatic stress disorder (PTSD) symptoms in relation to obesity, and 10 studies on the association between adverse life experiences and BED. In addition, mediating factors between the association of adverse life experiences, obesity and BED were examined. Results The majority of studies (87%) report that adverse life experiences are a risk factor for developing obesity and BED. More precisely a positive association between traumatic experiences and obesity and PTSD and obesity were found, respectively, in 85% and 86% of studies. Finally, the great majority of studies (90%) between trauma and the development of BED in adulthood strongly support this association. Meanwhile, different factors mediating between the trauma and obesity link were identified. Discussion and conclusions Although research data show a strong association between life adverse experiences and the development of obesity and BED, more research is needed to explain this association.

  15. Life adverse experiences in relation with obesity and binge eating disorder: A systematic review

    PubMed Central

    Palmisano, Giovanni Luca; Innamorati, Marco; Vanderlinden, Johan

    2016-01-01

    Background and aims Several studies report a positive association between adverse life experiences and adult obesity. Despite the high comorbidity between binge eating disorder (BED) and obesity, few authors have studied the link between trauma and BED. In this review the association between exposure to adverse life experiences and a risk for the development of obesity and BED in adulthood is explored. Methods Based on a scientific literature review in Medline, PubMed and PsycInfo databases, the results of 70 studies (N = 306,583 participants) were evaluated including 53 studies on relationship between adverse life experiences and obesity, 7 studies on post-traumatic stress disorder (PTSD) symptoms in relation to obesity, and 10 studies on the association between adverse life experiences and BED. In addition, mediating factors between the association of adverse life experiences, obesity and BED were examined. Results The majority of studies (87%) report that adverse life experiences are a risk factor for developing obesity and BED. More precisely a positive association between traumatic experiences and obesity and PTSD and obesity were found, respectively, in 85% and 86% of studies. Finally, the great majority of studies (90%) between trauma and the development of BED in adulthood strongly support this association. Meanwhile, different factors mediating between the trauma and obesity link were identified. Discussion and conclusions Although research data show a strong association between life adverse experiences and the development of obesity and BED, more research is needed to explain this association. PMID:28092189

  16. 77 FR 50707 - Maryland; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-22

    ... State of Maryland have been designated as adversely affected by this major disaster: Calvert, Charles... Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans;...

  17. 75 FR 30420 - South Dakota; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-01

    ... designated as adversely affected by this major disaster: Aurora, Beadle, Brown, Brule, Buffalo, Charles Mix... Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans;...

  18. 76 FR 64097 - Maryland; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-17

    ... Maryland have been designated as adversely affected by this major disaster: Anne Arundel, Cecil, Charles... and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032,...

  19. 75 FR 39959 - Minnesota; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-13

    ... Minnesota have been designated as adversely affected by this major disaster: Faribault, Freeborn, Olmsted, Otter Tail, Polk, Steele, and Wadena Counties for Public Assistance. All counties within the State...

  20. 75 FR 23792 - Minnesota; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-04

    ... Minnesota have been designated as adversely affected by this major disaster: Big Stone, Blue Earth, Brown..., Traverse, Wilkin, and Yellow Medicine Counties and the Tribal Nation of the Upper Sioux Community...

  1. 76 FR 61731 - Iowa; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-05

    ..., under Executive Order 12148, as amended, Michael R. Scott, of FEMA is appointed to act as the Federal... adversely affected by this major disaster: Dubuque and Jackson Counties for Public Assistance. All...

  2. Adverse events temporally associated with meningococcal vaccines.

    PubMed Central

    Yergeau, A; Alain, L; Pless, R; Robert, Y

    1996-01-01

    OBJECTIVE: To determine the incidence of severe adverse events temporally associated with meningococcal vaccines administered as part of a mass vaccination program. DESIGN: Retrospective descriptive study of events reported to a passive provincial surveillance system. SETTING: The province of Quebec. PARTICIPANTS: The 1,198,751 individuals aged 6 months to 20 years who were vaccinated against meningococcal disease between Dec. 27, 1992, and Mar. 31, 1993. OUTCOME MEASURES: Total numbers and rates of severe adverse events, including allergic reactions, anaphylactic reactions, neurological events (other than abnormal crying and screaming) and other serious or unusual events. RESULTS: A total of 118 reports of severe adverse events were selected from the surveillance system. The most frequent were allergic reactions (9.2 per 100,000 doses). Few anaphylactic or neurologic reactions were reported (0.1 and 0.5 per 100,000 doses respectively). There were no reports of sequelae or of encephalopathy, meningitis or encephalitis. CONCLUSION: Meningococcal vaccines seem to be associated with fewer adverse events than have previously been reported. Existing surveillance programs are useful for determining the incidence of adverse events temporally associated with vaccines. PMID:8630839

  3. Putative adverse outcome pathways relevant to neurotoxicity

    PubMed Central

    Bal-Price, Anna; Crofton, Kevin M.; Sachana, Magdalini; Shafer, Timothy J.; Behl, Mamta; Forsby, Anna; Hargreaves, Alan; Landesmann, Brigitte; Lein, Pamela J.; Louisse, Jochem; Monnet-Tschudi, Florianne; Paini, Alicia; Rolaki, Alexandra; Schrattenholz, André; Suñol, Cristina; van Thriel, Christoph; Whelan, Maurice; Fritsche, Ellen

    2016-01-01

    The Adverse Outcome Pathway (AOP) framework provides a template that facilitates understanding of complex biological systems and the pathways of toxicity that result in adverse outcomes (AOs). The AOP starts with an molecular initiating event (MIE) in which a chemical interacts with a biological target(s), followed by a sequential series of KEs, which are cellular, anatomical, and/or functional changes in biological processes, that ultimately result in an AO manifest in individual organisms and populations. It has been developed as a tool for a knowledge-based safety assessment that relies on understanding mechanisms of toxicity, rather than simply observing its adverse outcome. A large number of cellular and molecular processes are known to be crucial to proper development and function of the central (CNS) and peripheral nervous systems (PNS). However, there are relatively few examples of well-documented pathways that include causally linked MIEs and KEs that result in adverse outcomes in the CNS or PNS. As a first step in applying the AOP framework to adverse health outcomes associated with exposure to exogenous neurotoxic substances, the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) organized a workshop (March 2013, Ispra, Italy) to identify potential AOPs relevant to neurotoxic and developmental neurotoxic outcomes. Although the AOPs outlined during the workshop are not fully described, they could serve as a basis for further, more detailed AOP development and evaluation that could be useful to support human health risk assessment in a variety of ways. PMID:25605028

  4. The Complement System and Adverse Pregnancy Outcomes

    PubMed Central

    Regal, Jean F.; Gilbert, Jeffrey S.; Burwick, Richard M.

    2015-01-01

    Adverse pregnancy outcomes significantly contribute to morbidity and mortality for mother and child, with lifelong health consequences for both. The innate and adaptive immune system must be regulated to insure survival of the feta allograft, and the complement system is no exception. An intact complement system optimizes placental development and function and is essential to maintain host defense and fetal survival. Complement regulation is apparent at the placental interface from early pregnancy with some degree of complement activation occurring normally throughout gestation. However, a number of pregnancy complications including early pregnancy loss, fetal growth restriction, hypertensive disorders of pregnancy and preterm birth are associated with excessive or misdirected complement activation, and are more frequent in women with inherited or acquired complement system disorders or complement gene mutations. Clinical studies employing complement biomarkers in plasma and urine implicate dysregulated complement activation in components of each of the adverse pregnancy outcomes. In addition, mechanistic studies in rat and mouse models of adverse pregnancy outcomes address the complement pathways or activation products of importance and allow critical analysis of the pathophysiology. Targeted complement therapeutics are already in use to control adverse pregnancy outcomes in select situations. A clearer understanding of the role of the complement system in both normal pregnancy and complicated or failed pregnancy will allow a rational approach to future therapeutic strategies for manipulating complement with the goal of mitigating adverse pregnancy outcomes, preserving host defense, and improving long term outcomes for both mother and child. PMID:25802092

  5. Is It Adverse, Nonadverse, Adaptive, or Artifact?

    PubMed

    Pandiri, Arun R; Kerlin, Roy L; Mann, Peter C; Everds, Nancy E; Sharma, Alok K; Myers, L Peyton; Steinbach, Thomas J

    2017-01-01

    One of the principal challenges facing a toxicologic pathologist is to determine and differentiate a true adverse effect from a nonadverse or an adaptive response. Recent publications from the Society of Toxicologic Pathology (STP) and the European STP provide guidance for determining and communicating adversity in nonclinical toxicology studies. In order to provide a forum to inform and engage in a discussion on this important topic, a continuing education (CE) course was held during the 2016 STP Annual meeting in San Diego, CA. The lectures at this course provided guidance on determining and communicating adversity using case studies involving both clinical pathology and anatomic pathology. In addition, one talk also focused on data quality, study design, and interpretation of artifacts that could hinder the determination of adversity. The CE course ended with a talk on understanding adversity in preclinical studies and engaging the regulatory agencies in the decision-making process. This manuscript is designed to provide brief summaries of all the talks in this well-received CE course.

  6. Mismatch or allostatic load? Timing of life adversity differentially shapes gray matter volume and anxious temperament.

    PubMed

    Kuhn, Manuel; Scharfenort, Robert; Schümann, Dirk; Schiele, Miriam A; Münsterkötter, Anna L; Deckert, Jürgen; Domschke, Katharina; Haaker, Jan; Kalisch, Raffael; Pauli, Paul; Reif, Andreas; Romanos, Marcel; Zwanzger, Peter; Lonsdorf, Tina B

    2016-04-01

    Traditionally, adversity was defined as the accumulation of environmental events (allostatic load). Recently however, a mismatch between the early and the later (adult) environment (mismatch) has been hypothesized to be critical for disease development, a hypothesis that has not yet been tested explicitly in humans. We explored the impact of timing of life adversity (childhood and past year) on anxiety and depression levels (N = 833) and brain morphology (N = 129). Both remote (childhood) and proximal (recent) adversities were differentially mirrored in morphometric changes in areas critically involved in emotional processing (i.e. amygdala/hippocampus, dorsal anterior cingulate cortex, respectively). The effect of adversity on affect acted in an additive way with no evidence for interactions (mismatch). Structural equation modeling demonstrated a direct effect of adversity on morphometric estimates and anxiety/depression without evidence of brain morphology functioning as a mediator. Our results highlight that adversity manifests as pronounced changes in brain morphometric and affective temperament even though these seem to represent distinct mechanistic pathways. A major goal of future studies should be to define critical time periods for the impact of adversity and strategies for intervening to prevent or reverse the effects of adverse childhood life experiences.

  7. Mismatch or allostatic load? Timing of life adversity differentially shapes gray matter volume and anxious temperament

    PubMed Central

    Kuhn, Manuel; Scharfenort, Robert; Schümann, Dirk; Schiele, Miriam A.; Münsterkötter, Anna L.; Deckert, Jürgen; Domschke, Katharina; Haaker, Jan; Kalisch, Raffael; Pauli, Paul; Reif, Andreas; Romanos, Marcel; Zwanzger, Peter

    2016-01-01

    Traditionally, adversity was defined as the accumulation of environmental events (allostatic load). Recently however, a mismatch between the early and the later (adult) environment (mismatch) has been hypothesized to be critical for disease development, a hypothesis that has not yet been tested explicitly in humans. We explored the impact of timing of life adversity (childhood and past year) on anxiety and depression levels (N = 833) and brain morphology (N = 129). Both remote (childhood) and proximal (recent) adversities were differentially mirrored in morphometric changes in areas critically involved in emotional processing (i.e. amygdala/hippocampus, dorsal anterior cingulate cortex, respectively). The effect of adversity on affect acted in an additive way with no evidence for interactions (mismatch). Structural equation modeling demonstrated a direct effect of adversity on morphometric estimates and anxiety/depression without evidence of brain morphology functioning as a mediator. Our results highlight that adversity manifests as pronounced changes in brain morphometric and affective temperament even though these seem to represent distinct mechanistic pathways. A major goal of future studies should be to define critical time periods for the impact of adversity and strategies for intervening to prevent or reverse the effects of adverse childhood life experiences. PMID:26568620

  8. 75 FR 11900 - North Dakota; Major Disaster and Related Determinations

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-03-12

    ... February 26, 2010, the President issued a major disaster declaration under the authority of the Robert T... warrant a major disaster declaration under the Robert T. Stafford Disaster Relief and Emergency Assistance... State of North Dakota have been designated as adversely affected by this major disaster: Adams,...

  9. Adverse health consequences of the Iraq War.

    PubMed

    Levy, Barry S; Sidel, Victor W

    2013-03-16

    The adverse health consequences of the Iraq War (2003-11) were profound. We conclude that at least 116,903 Iraqi non-combatants and more than 4800 coalition military personnel died over the 8-year course. Many Iraqi civilians were injured or became ill because of damage to the health-supporting infrastructure of the country, and about 5 million were displaced. More than 31,000 US military personnel were injured and a substantial percentage of those deployed suffered post-traumatic stress disorder, traumatic brain injury, and other neuropsychological disorders and their concomitant psychosocial problems. Many family members of military personnel had psychological problems. Further review of the adverse health consequences of this war could help to minimise the adverse health consequences of, and help to prevent, future wars.

  10. Standardizing drug adverse event reporting data.

    PubMed

    Wang, Liwei; Jiang, Guoqian; Li, Dingcheng; Liu, Hongfang

    2013-01-01

    Normalizing data in the Adverse Event Reporting System (AERS), an FDA database, would improve the mining capacity of AERS for drug safety signal detection. In this study, we aim to normalize AERS and build a publicly available normalized Adverse drug events (ADE) data source.he drug information in AERS is normalized to RxNorm, a standard terminology source for medication. Drug class information is then obtained from the National Drug File - Reference Terminology (NDF-RT). Adverse drug events (ADE) are aggregated through mapping with the PT (Preferred Term) and SOC (System Organ Class) codes of MedDRA. Our study yields an aggregated knowledge-enhanced AERS data mining set (AERS-DM). The AERS-DM could provide more perspectives to mine AERS database for drug safety signal detection and could be used by research community in the data mining field.

  11. [Adverse reaction to not iodinated contrast].

    PubMed

    Palma-Gómez, Samuel; González-Díaz, Sandra Nora; Arias-Cruz, Alfredo; Macías-Weinmann, Alejandra; Amaro-Vivian, Laura Elizabeth; Pérez-Vanzzini, Rafael; Gutiérrez-Mujica, José Julio; Yong-Rodríguez, Adrián

    2014-01-01

    Adverse reactions to drugs are relatively frequent in clinical practice, and some of them can be life threatening. Reactions to contrast material (CM) represent an important percentage of these adverse reactions. It has been found that 70% of reactions to contrast material happen within the first five minutes of their administration. Despite the fact that hypersensitivity reactions are traditionally classified as non-allergic, in recent years investigators have reported positive skin prick tests in patients with immediate and late reactions to contrast material. This paper reports the case of a female patient with non-Hodgkin lymphoma that has presented on two distinct occasions adverse reactions to contrast material. We discuss on the type of reaction, severity, suggested prophylaxis, prognosis and recommendations, keeping in mind the underlying disease and the need to have further image studies performed.

  12. Adverse events related to blood transfusion.

    PubMed

    Sahu, Sandeep; Hemlata; Verma, Anupam

    2014-09-01

    The acute blood transfusion reactions are responsible for causing most serious adverse events. Awareness about various clinical features of acute and delayed transfusion reactions with an ability to assess the serious reactions on time can lead to a better prognosis. Evidence-based medicine has changed today's scenario of clinical practice to decrease adverse transfusion reactions. New evidence-based algorithms of transfusion and improved haemovigilance lead to avoidance of unnecessary transfusions perioperatively. The recognition of adverse events under anaesthesia is always challenging. The unnecessary blood transfusions can be avoided with better blood conservation techniques during surgery and with anaesthesia techniques that reduce blood loss. Better and newer blood screening methods have decreased the infectious complications to almost negligible levels. With universal leukoreduction of red blood cells (RBCs), selection of potential donors such as use of male donors only plasma and restriction of RBC storage, most of the non-infectious complications can be avoided.

  13. Adverse perinatal events associated with ART.

    PubMed

    Skora, Daniel; Frankfurter, David

    2012-04-01

    Since the advent of ART, much research has focused on the potential adverse for resultant harm. Prematurity, low birth-weight, PIH, congenital malformations, and CP are closely tied to multiple gestation. With the increase in elective single embryo transfer, there will be a reduction in adversity related to multiple birth. It is understood that underlying causes of infertility, including advanced maternal age, PCOS, thyroid disease, and uterine fibroids, predispose to adverse outcomes. However, imprinting abnormalities do not appear to stem from multiple births, and thus the need to consider the association between fertility treatment and methylation disorders remains essential. These, as well as risks of multi-fetal gestation, must be discussed with patients when considering using assisted reproduction.

  14. Early Adverse Experiences and the Developing Brain

    PubMed Central

    Bick, Johanna; Nelson, Charles A

    2016-01-01

    Children exposed to various forms of adversity early in life are at increased risk for a broad range of developmental difficulties, affecting both cognitive and emotional adjustment. We review a growing body of evidence suggesting that exposure to adverse circumstances affects the developing brain in ways that increase risk for a myriad of problems. We focus on two forms of adversity, one in which children are exposed to childhood maltreatment in family environments, and another in which children are exposed to extreme psychosocial deprivation in contexts of institutional rearing. We discuss ways in which each of these experiences represent violations of species-expected caregiving conditions, thereby imposing challenges to the developing brain. We also review emerging data pointing to the effectiveness of early intervention in remediating neurodevelopmental consequences associated with maltreatment or institutional rearing. We conclude by discussing implications of this work for public health efforts and highlight important directions for the field. PMID:26334107

  15. Local adverse effects associated with the use of inhaled corticosteroids in patients with moderate or severe asthma*

    PubMed Central

    Pinto, Charleston Ribeiro; Almeida, Natalie Rios; Marques, Thamy Santana; Yamamura, Laira Lorena Lima; Costa, Lindemberg Assunção; Souza-Machado, Adelmir

    2013-01-01

    OBJECTIVE: To describe and characterize local adverse effects (in the oral cavity, pharynx, and larynx) associated with the use of inhaled corticosteroids (ICSs) in patients with moderate or severe asthma. METHODS: This was a cross-sectional study involving a convenience sample of 200 asthma patients followed in the Department of Pharmaceutical Care of the Bahia State Asthma and Allergic Rhinitis Control Program Referral Center, located in the city of Salvador, Brazil. The patients were ≥ 18 years of age and had been using ICSs regularly for at least 6 months. Local adverse effects (irritation, pain, dry throat, throat clearing, hoarseness, reduced vocal intensity, loss of voice, sensation of thirst, cough during ICS use, altered sense of taste, and presence of oral candidiasis) were assessed using a 30-day recall questionnaire. RESULTS: Of the 200 patients studied, 159 (79.5%) were women. The mean age was 50.7 ± 14.4 years. In this sample, 55 patients (27.5%) were using high doses of ICS, with a median treatment duration of 38 months. Regarding the symptoms, 163 patients (81.5%) reported at least one adverse effect, and 131 (65.5%) had a daily perception of at least one symptom. Vocal and pharyngeal symptoms were identified in 57 (28.5%) and 154 (77.0%) of the patients, respectively. The most commonly reported adverse effects were dry throat, throat clearing, sensation of thirst, and hoarseness. CONCLUSIONS: Self-reported adverse effects related to ICS use were common among the asthma patients evaluated here. PMID:24068261

  16. Major Oncologic Surgery at a Community Hospital

    PubMed Central

    Loui, Hollyann; Benyamini, Pouya

    2017-01-01

    There is a national trend to refer patients requiring complex oncologic surgery to tertiary high-volume cancer centers. However, this presents major access challenges to Hawai‘i patients seeking care. The purpose of this study is to demonstrate that complex oncologic surgery can be safely performed at community hospitals like those in Hawai‘i. From July 2007 to December 2014, 136 patients underwent complex oncologic procedures at a community hospital in Hawai'i by a single general surgeon. Cases included esophagogastric, hepatobiliary, pancreatic, rectal, and retroperitoneal resections. A database of patients was created from information extracted from the EPIC database. Complications were evaluated using the Clavien-Dindo grading system. There was 0.7% mortality rate (grade V complication). The major morbidity rate was 12.5%, including 10.3% grade III complications and 2.2% grade IV complications. The median length of stay for all operations was 8 days. The mean estimated blood loss for all operations was 708 cc. There was a 2.9% hospital readmission rate within 30 days of initial discharge, and a 5.1% reoperation rate. Complex oncologic procedures can be safely performed at a low-volume community hospital, with outcomes similar to those from high-volume cancer centers. PMID:28210527

  17. Soluble TWEAK and Major Adverse Cardiovascular Events in Patients with CKD

    PubMed Central

    Fernández-Laso, Valvanera; Sastre, Cristina; Valdivielso, Jose M.; Betriu, Angels; Fernández, Elvira; Egido, Jesús; Martín-Ventura, Jose L.

    2016-01-01

    Background and objectives Soluble TNF–like weak inducer of apoptosis (sTWEAK) is a proinflammatory cytokine belonging to the TNF superfamily. sTWEAK concentrations have been associated with the presence of CKD and cardiovascular disease (CVD). We hypothesized that sTWEAK levels may relate to a higher prevalence of atherosclerotic plaques, vascular calcification, and cardiovascular outcomes observed in patients with CKD. Design, setting, participants, & measurements A 4-year prospective, multicenter, longitudinal study was conducted in 1058 patients with CKD stages 3–5D (mean age =58±13 years old; 665 men) but without any history of CVD from the NEFRONA Study (a study design on the prevalence of surrogate markers of CVD). Ankle-brachial index and B-mode ultrasound were performed to detect the presence of carotid and/or femoral atherosclerotic plaques together with biochemical measurements and sTWEAK assessment. Patients were followed for cardiovascular outcomes (follow-up of 3.13±1.15 years). Results Patients with more advanced CKD had lower sTWEAK levels. sTWEAK concentrations were independently and negatively associated with carotid intima-media thickness. sTWEAK levels were lower in patients with carotid atherosclerotic plaques but not in those with femoral plaques. After adjustment by confounders, the odds ratio (OR) for presenting carotid atherosclerotic plaques in patients in the lowest versus highest tertile of sTWEAK was 4.18 (95% confidence interval [95% CI], 2.89 to 6.08; P<0.001). Furthermore, sTWEAK levels were lower in patients with calcified carotid atherosclerotic plaques. The OR for presenting calcified carotid plaques was 1.77 (95% CI, 1.06 to 2.93; P=0.02) after multivariable adjustment. After the follow-up, 41 fatal and 68 nonfatal cardiovascular events occurred. In a Cox model, after controlling for potential confounding factors, patients in the lowest tertile of sTWEAK concentrations had a higher risk of fatal and nonfatal cardiovascular events (hazard ratio [HR], 2.40; 95% CI, 1.33 to 4.33; P=0.004) and cardiovascular mortality (HR, 2.67; 95% CI, 1.05 to 6.76; P=0.04). Conclusions Low sTWEAK levels were associated with the presence of carotid atherosclerotic plaques in patients with CKD. Additionally, lower sTWEAK levels were associated with a higher risk of cardiovascular morbidity and mortality. PMID:26728587

  18. To provide additional housing assistance for certain individuals and households adversely affected by a major disaster.

    THOMAS, 111th Congress

    Rep. Hinchey, Maurice D. [D-NY-22

    2009-06-26

    06/29/2009 Referred to the Subcommittee on Economic Development, Public Buildings and Emergency Management. (All Actions) Tracker: This bill has the status IntroducedHere are the steps for Status of Legislation:

  19. Enduring psychobiological effects of childhood adversity.

    PubMed

    Ehlert, Ulrike

    2013-09-01

    This mini-review refers to recent findings on psychobiological long-term consequences of childhood trauma and adverse living conditions. The continuum of trauma-provoked aftermath reaches from healthy adaptation with high resilience, to severe maladjustment with co-occurring psychiatric and physical pathologies in children, adolescents and adults. There is increasing evidence of a strong interconnectivity between genetic dispositions, epigenetic processes, stress-related hormonal systems and immune parameters in all forms of (mal)-adjustment to adverse living conditions. Unfavorable constellations of these dispositions and systems, such as low cortisol levels and elevated markers of inflammation in maltreated children, seem to promote the (co)-occurrence of psychiatric and physical pathologies such as posttraumatic stress disorder, obesity, or diabetes. Although findings from prospective study designs support a deepened understanding of causal relations between adverse living conditions, including traumatic experiences, during childhood and its psychobiological effects, so far, little is known about the temporal coincidence of stress-sensitive developmental stages during childhood and adolescence and trauma consequences. Taken together, childhood adversity is a severe risk factor for the onset of psychobiological (mal)-adjustment, which has to be explained under consideration of diverse physiological systems and developmental stages of childhood and adolescence.

  20. Reducing Adverse Impact: One City's Efforts.

    ERIC Educational Resources Information Center

    Prewitt, Jeff

    Following a workshop on "Innovations in Employment Testing that Improve Validity and Reduce Adverse Impact," the City of Louisville (Kentucky) implemented a strategy to develop a comprehensive testing and recruiting program for police recruits. To improve candidate expectations and preparation, the following activities were undertaken:…

  1. Educational Leadership: The Uses of Adversity

    ERIC Educational Resources Information Center

    Culbertson, Jack

    1976-01-01

    Skepticism about the power of education challenges the educational administrator to (1) attain a better understanding of the sources of dissatisfaction and their implications for change, (2) learn to cope with adversity and make constructive use of it, and (3) define the leadership requirements needed to address education's problems. (MB)

  2. The adverse outcome pathway knowledge base

    EPA Science Inventory

    The rapid advancement of the Adverse Outcome Pathway (AOP) framework has been paralleled by the development of tools to store, analyse, and explore AOPs. The AOP Knowledge Base (AOP-KB) project has brought three independently developed platforms (Effectopedia, AOP-Wiki, and AOP-X...

  3. Clinical spectrum of adverse reactions to tartrazine.

    PubMed

    Collins-Williams, C

    1985-01-01

    Tartrazine, a common additive in foods and drugs, often causes adverse reactions such as recurrent urticaria, angioedema, and asthma and is frequently implicated in hyperkinesis. This paper summarizes the recent literature on the subject and outlines a practical approach for the practicing physician to diagnose and treat these patients in an optimal manner.

  4. The Public Health Burden of Early Adversity

    ERIC Educational Resources Information Center

    Schlueter, Lisa J.; Watamura, Sarah Enos

    2017-01-01

    Severe and chronic stress in early childhood has enormous physical and mental health costs across an individual's lifespan. Unfortunately, exposure to early life adversity is common, and costs accrue to individuals and society. This article highlights several promising approaches to buffer children from the negative health consequences associated…

  5. [Analysis of Spontaneously Reported Adverse Events].

    PubMed

    Nakamura, Mitsuhiro

    2016-01-01

    Observational study is necessary for the evaluation of drug effectiveness in clinical practice. In recent years, the use of spontaneous reporting systems (SRS) for adverse drug reactions has increased and they have become an important resource for regulatory science. SRS, being the largest and most well-known databases worldwide, are one of the primary tools used for postmarketing surveillance and pharmacovigilance. To analyze SRS, the US Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report Database (JADER) are reviewed. Authorized pharmacovigilance algorithms were used for signal detection, including the reporting odds ratio. An SRS is a passive reporting database and is therefore subject to numerous sources of selection bias, including overreporting, underreporting, and a lack of a denominator. Despite the inherent limitations of spontaneous reporting, SRS databases are a rich resource and data mining index that provide powerful means of identifying potential associations between drugs and their adverse effects. Our results, which are based on the evaluation of SRS databases, provide essential knowledge that could improve our understanding of clinical issues.

  6. Adverse skin reactions following intravitreal bevacizumab injection

    PubMed Central

    Ameen, S; Entabi, M; Lee, N; Stavrakoglou, A

    2011-01-01

    The authors describe two separate cases of skin eruption following intravitreal bevacizumab injection with evidence to suggest that these were adverse drug reactions to bevacizumab. The authors also discuss how each case was treated and report on the final outcome. PMID:22715260

  7. Due Process in Adverse Personnel Action.

    ERIC Educational Resources Information Center

    Scriven, Michael

    1997-01-01

    A detailed checklist and timeline for ensuring due process are provided for adverse personnel actions, and the need to supplement this with expert, same-jurisdiction legal advice is stressed. This approach emphasizes the importance of treating due process as an ethical as well as a legal requirement. (SLD)

  8. Adverse outcome pathway (AOP) development and evaluation

    EPA Science Inventory

    The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be mea...

  9. [Laser trabeculoplasty: therapeutic options and adverse effects].

    PubMed

    Wacker, T; Eckert, S

    2010-01-01

    Laser trabeculoplasty is a simple method for treating glaucoma and ocular hypertension and has few adverse effects. There are different laser systems for reducing the intraocular pressure of patients with glaucoma and ocular hypertension. Complications include transient intraocular pressure elevation, iritis, and anterior synechiae.

  10. Resilience in the Face of Adversity.

    ERIC Educational Resources Information Center

    Patterson, Jerry

    2001-01-01

    "Resilience" is the capacity for moving ahead under adverse circumstances. School superintendents are advised to stay upbeat and mindful of "both-and" opportunities; stay focused on what they care about; remain flexible and tolerant of ambiguity; be proactive, not reactive; and apply resilience-conserving strategies during…

  11. Adverse drug reactions in special populations – the elderly

    PubMed Central

    Davies, E A; O’Mahony, M S

    2015-01-01

    The International Conference on Harmonization considers older people a ‘special population’, as they differ from younger adults in terms of comorbidity, polypharmacy, pharmacokinetics and greater vulnerability to adverse drug reactions (ADRs). Medical practice is often based on single disease guidelines derived from clinical trials that have not included frail older people or those with multiple morbidities. This presents a challenge caring for older people, as drug doses in trials may not be achievable in real world patients and risks of ADRs are underestimated in clinical trial populations. The majority of ADRs in older people are Type A, potentially avoidable and associated with commonly prescribed medications. Several ADRs are particularly associated with major adverse consequences in the elderly and their reduction is therefore a clinical priority. Falls are strongly associated with benzodiazepines, neuroleptics, antidepressants and antihypertensives. There is good evidence for medication review as part of a multifactorial intervention to reduce falls risk in community dwelling elderly. Multiple medications also contribute to delirium, another multifactorial syndrome resulting in excess mortality particularly in frail older people. Clostridium difficile associated with use of broad spectrum antibiotics mainly affects frail older people and results in prolonged hospital stay with substantial morbidity and mortality. Antipsychotics increase the risk of stroke by more than three-fold in patients with dementia. Inappropriate prescribing can be reduced by adherence to prescribing guidelines, suitable monitoring and regular medication review. Given the heterogeneity within the older population, providing individualized care is pivotal to preventing ADRs. PMID:25619317

  12. Adverse events of intravenous immunoglobulin infusions: a ten-year retrospective study

    PubMed Central

    Kwong, Shirley L.; Padua, Florecita R.

    2013-01-01

    Background Intravenous immunoglobulin (IVIG) is a biological product with adverse effects that appears to vary considerably among different IVIG preparations. Objectives To describe the adverse events of patients given intravenous immunoglobulin infusions. Method Data was collected on all patients receiving IVIG infusion at a tertiary hospital from January 2001 to December 2010. Descriptive statistics was used. Results 77 patients (45 males, 32 females) received IVIG infusions. Thirty two percent (n = 25) experienced adverse reactions. The most common indication was Kawasaki disease (85.7%) followed by immunodeficiency disorders (7.8%). Majority of the patients were children, with the highest frequency of infusions among those aged 2 to 8 years old (52%). 36 infusions were associated with occurrence of adverse effects. Fever was the most common adverse event (n = 11, 30.6%), followed by rash (n = 8, 22.2%) and chills (n = 7, 19.4%). Other adverse events were cyanosis (n = 3, 8.3%), hypotension (n = 2, 5.6%), hypothermia (n = 2, 5.6%), irritability (n = 1, 2.8%), vomiting (n = 1, 2.8%), and chest pain (n = 1, 2.8%). Adverse events were observed to occur most frequently within 1 to 6 h from onset of IVIG infusion. Among the various IVIG preparations available locally (Gammagard, Kiovig, Gamimune, Veno-S & IV Globulin S), Gammagard was the brand frequently used (50.7%). It also has the most number of adverse events, with 17 out of 41 (41.5%) infusions resulting in adverse reactions. Most of the reactions occurred with fast infusion rates, and clinical manifestations subsided when the rate of infusion was reduced. Conclusion In this study, thirty two percent of patients given IVIG infusions experienced adverse events. Fever was the most common manifestation. Symptoms occurred within 1 to 6 h from onset of infusion, were affected by fast infusion rates, and managed by reducing the rate of infusion. PMID:24260730

  13. Serum 25-Hydroxyvitamin D Levels are not Associated with Adverse Outcomes in Clostridium Difficile Infection

    PubMed Central

    Micic, Dejan; Rao, Krishna; Trindade, Bruno Caetano; Walk, Seth T.; Chenoweth, Elizabeth; Jain, Ruchika; Trivedi, Itishree; Santhosh, Kavitha; Young, Vincent B.; Aronoff, David M.

    2015-01-01

    Clostridium difficile infection (CDI) is a significant source of healthcare-associated morbidity and mortality. This study investigated whether serum 25-hydroxyvitamin D is associated with adverse outcomes from CDI. Patients with CDI were prospectively enrolled. Charts were reviewed and serum 25-hydroxyvitamin D was measured. The primary outcome was a composite definition of severe disease: fever (temperature >38°C), acute organ dysfunction, or serum white blood cell count >15,000 cells/µL within 24-48 hours of diagnosis; lack of response to therapy by day 5; and intensive care unit admission; colectomy; or death within 30 days. Sixty-seven patients were included in the final analysis. Mean (±SD) serum 25-hydroxyvitamin D was 26.1 (±18.54) ng/mL. Severe disease, which occurred in 26 (39%) participants, was not associated with serum 25-hydroxyvitamin D [odds ratio (OR) 1.00; 95% confidence interval (CI) 0.96-1.04]. In the adjusted model for severe disease only serum albumin (OR 0.12; 95%CI 0.02-0.64) and diagnosis by detection of stool toxin (OR 5.87; 95%CI 1.09-31.7) remained independent predictors. We conclude that serum 25-hydroxyvitamin D is not associated with the development of severe disease in patients with CDI. PMID:26500740

  14. Molecular signatures of major depression.

    PubMed

    Cai, Na; Chang, Simon; Li, Yihan; Li, Qibin; Hu, Jingchu; Liang, Jieqin; Song, Li; Kretzschmar, Warren; Gan, Xiangchao; Nicod, Jerome; Rivera, Margarita; Deng, Hong; Du, Bo; Li, Keqing; Sang, Wenhu; Gao, Jingfang; Gao, Shugui; Ha, Baowei; Ho, Hung-Yao; Hu, Chunmei; Hu, Jian; Hu, Zhenfei; Huang, Guoping; Jiang, Guoqing; Jiang, Tao; Jin, Wei; Li, Gongying; Li, Kan; Li, Yi; Li, Yingrui; Li, Youhui; Lin, Yu-Ting; Liu, Lanfen; Liu, Tiebang; Liu, Ying; Liu, Yuan; Lu, Yao; Lv, Luxian; Meng, Huaqing; Qian, Puyi; Sang, Hong; Shen, Jianhua; Shi, Jianguo; Sun, Jing; Tao, Ming; Wang, Gang; Wang, Guangbiao; Wang, Jian; Wang, Linmao; Wang, Xueyi; Wang, Xumei; Yang, Huanming; Yang, Lijun; Yin, Ye; Zhang, Jinbei; Zhang, Kerang; Sun, Ning; Zhang, Wei; Zhang, Xiuqing; Zhang, Zhen; Zhong, Hui; Breen, Gerome; Wang, Jun; Marchini, Jonathan; Chen, Yiping; Xu, Qi; Xu, Xun; Mott, Richard; Huang, Guo-Jen; Kendler, Kenneth; Flint, Jonathan

    2015-05-04

    Adversity, particularly in early life, can cause illness. Clues to the responsible mechanisms may lie with the discovery of molecular signatures of stress, some of which include alterations to an individual's somatic genome. Here, using genome sequences from 11,670 women, we observed a highly significant association between a stress-related disease, major depression, and the amount of mtDNA (p = 9.00 × 10(-42), odds ratio 1.33 [95% confidence interval [CI] = 1.29-1.37]) and telomere length (p = 2.84 × 10(-14), odds ratio 0.85 [95% CI = 0.81-0.89]). While both telomere length and mtDNA amount were associated with adverse life events, conditional regression analyses showed the molecular changes were contingent on the depressed state. We tested this hypothesis with experiments in mice, demonstrating that stress causes both molecular changes, which are partly reversible and can be elicited by the administration of corticosterone. Together, these results demonstrate that changes in the amount of mtDNA and telomere length are consequences of stress and entering a depressed state. These findings identify increased amounts of mtDNA as a molecular marker of MD and have important implications for understanding how stress causes the disease.

  15. Molecular Signatures of Major Depression

    PubMed Central

    Cai, Na; Chang, Simon; Li, Yihan; Li, Qibin; Hu, Jingchu; Liang, Jieqin; Song, Li; Kretzschmar, Warren; Gan, Xiangchao; Nicod, Jerome; Rivera, Margarita; Deng, Hong; Du, Bo; Li, Keqing; Sang, Wenhu; Gao, Jingfang; Gao, Shugui; Ha, Baowei; Ho, Hung-Yao; Hu, Chunmei; Hu, Jian; Hu, Zhenfei; Huang, Guoping; Jiang, Guoqing; Jiang, Tao; Jin, Wei; Li, Gongying; Li, Kan; Li, Yi; Li, Yingrui; Li, Youhui; Lin, Yu-Ting; Liu, Lanfen; Liu, Tiebang; Liu, Ying; Liu, Yuan; Lu, Yao; Lv, Luxian; Meng, Huaqing; Qian, Puyi; Sang, Hong; Shen, Jianhua; Shi, Jianguo; Sun, Jing; Tao, Ming; Wang, Gang; Wang, Guangbiao; Wang, Jian; Wang, Linmao; Wang, Xueyi; Wang, Xumei; Yang, Huanming; Yang, Lijun; Yin, Ye; Zhang, Jinbei; Zhang, Kerang; Sun, Ning; Zhang, Wei; Zhang, Xiuqing; Zhang, Zhen; Zhong, Hui; Breen, Gerome; Wang, Jun; Marchini, Jonathan; Chen, Yiping; Xu, Qi; Xu, Xun; Mott, Richard; Huang, Guo-Jen; Kendler, Kenneth; Flint, Jonathan

    2015-01-01

    Summary Adversity, particularly in early life, can cause illness. Clues to the responsible mechanisms may lie with the discovery of molecular signatures of stress, some of which include alterations to an individual’s somatic genome. Here, using genome sequences from 11,670 women, we observed a highly significant association between a stress-related disease, major depression, and the amount of mtDNA (p = 9.00 × 10−42, odds ratio 1.33 [95% confidence interval [CI] = 1.29–1.37]) and telomere length (p = 2.84 × 10−14, odds ratio 0.85 [95% CI = 0.81–0.89]). While both telomere length and mtDNA amount were associated with adverse life events, conditional regression analyses showed the molecular changes were contingent on the depressed state. We tested this hypothesis with experiments in mice, demonstrating that stress causes both molecular changes, which are partly reversible and can be elicited by the administration of corticosterone. Together, these results demonstrate that changes in the amount of mtDNA and telomere length are consequences of stress and entering a depressed state. These findings identify increased amounts of mtDNA as a molecular marker of MD and have important implications for understanding how stress causes the disease. PMID:25913401

  16. It's Major! College Major Selection & Success

    ERIC Educational Resources Information Center

    Byers, Jenny; Mattern, Krista D.; Shaw, Emily J.; Springall, Robert

    2011-01-01

    Presented at the College Board National Forum, October 26, 2011. Choosing a college major is challenging enough, without stopping to consider the impact it has on a student's college experience and career choice. To provide support during this major decision, participants in this session will develop strategies to facilitate students in making an…

  17. Effects of Alcohol-Induced Working Memory Decline on Alcohol Consumption and Adverse Consequences of Use

    PubMed Central

    Lechner, William V.; Day, Anne M.; Metrik, Jane; Leventhal, Adam M.; Kahler, Christopher W.

    2015-01-01

    Rationale Alcohol use appears to decrease executive function acutely in a dose dependent manner, and lower baseline executive function appears to contribute to problematic alcohol use. However, no studies, to our knowledge, have examined the relationship between individual differences in working memory (a subcomponent of executive function) after alcohol consumption and drinking behaviors and consequences. Objectives The current study assessed the relationship between drinking behavior, alcohol-related consequences, and alcohol-induced changes in working memory (as assessed by Trails Making Test-B). Method Participants recruited from the community (n = 41), 57.3% male, mean age 39.2, took part in a three-session, within-subjects, repeated-measures design. Participants were administered a placebo, 0.4 g/kg, or 0.8 g/kg dose of alcohol. Working memory, past 30 day alcohol consumption, and consequences of alcohol use were measured at baseline; working memory was measured again after each beverage administration. Results Poorer working memory after alcohol administration (controlling for baseline working memory) was significantly associated with a greater number of drinks consumed per drinking day. Additionally, we observed a significant indirect relationship between the degree of alcohol-induced working memory decline and adverse consequences of alcohol use, which was mediated through greater average drinks per drinking day. Conclusions It is possible that greater individual susceptibility to alcohol-induced working memory decline may limit one’s ability to moderate alcohol consumption as evidenced by greater drinks per drinking day, and that this results in more adverse consequences of alcohol use. PMID:26407604

  18. Alcohol and cannabis: Comparing their adverse health effects and regulatory regimes.

    PubMed

    Hall, Wayne

    2016-11-28

    The claim that the adverse health effects of cannabis are much less serious than those of alcohol has been central to the case for cannabis legalisation. Regulators in US states that have legalised cannabis have adopted regulatory models based on alcohol. This paper critically examines the claim about adverse health effects and the wisdom of regulating cannabis like alcohol. First, it compares what we know about the adverse health effects of alcohol and cannabis. Second, it discusses the uncertainties about the long term health effects of sustained daily cannabis use. Third, it speculates about how the adverse health effects of cannabis may change after legalisation. Fourth, it questions the assumption that alcohol provides the best regulatory model for a legal cannabis market. Fifth, it outlines the major challenges in regulating cannabis under the liberal alcohol-like regulatory regimes now being introduced.

  19. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 21 Food and Drugs 7 2013-04-01 2013-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  20. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 21 Food and Drugs 7 2014-04-01 2014-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  1. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 21 Food and Drugs 7 2010-04-01 2010-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. (a) Records shall be maintained of any reports of complaints of adverse reactions... thorough investigation of each reported adverse reaction shall be made. A written report of...

  2. Recurrent adverse pregnancy outcome and antiphospholipid antibodies.

    PubMed

    Reece, E A; Gabrielli, S; Cullen, M T; Zheng, X Z; Hobbins, J C; Harris, E N

    1990-07-01

    Antiphospholipid antibodies, which include lupus-like anticoagulant and anticardiolipin antibody, have been linked to a number of adverse pregnancy outcomes, although their exact pathogenic mechanisms remain poorly defined. The relative risk of complications such as intrauterine growth retardation, spontaneous abortions, and stillbirth in patients with antiphospholipid antibodies also remains undetermined. Heightened attention has been focused on the association, leading to investigations into the pathogenesis. Uncontrolled studies have also explored therapeutic regimens such as aspirin, steroids, and heparin, and clinical trials have used various treatment protocols. Although knowledge into the association of antiphospholipid antibodies and recurrent adverse pregnancy outcome is limited and continues to evolve, this association provides new insights into the disease and offers promise for pharmacologic prophylaxis. In this article, current concepts on pathogenesis, diagnosis, and therapy are reviewed and recommendations are made for clinical care of these patients.

  3. An Ss Model with Adverse Selection.

    ERIC Educational Resources Information Center

    House, Christopher L.; Leahy, John V.

    2004-01-01

    We present a model of the market for a used durable in which agents face fixed costs of adjustment, the magnitude of which depends on the degree of adverse selection in the secondary market. We find that, unlike typical models, the sS bands in our model contract as the variance of the shock increases. We also analyze a dynamic version of the model…

  4. Childhood Adversities and Adult Cardiometabolic Health: Does the Quantity, Timing, and Type of Adversity Matter?

    PubMed Central

    Friedman, Esther M.; Montez, Jennifer Karas; Sheehan, Connor McDevitt; Guenewald, Tara L.; Seeman, Teresa E.

    2015-01-01

    Objective Adverse events in childhood can indelibly influence adult health. While evidence for this association has mounted, a fundamental set of questions about how to operationalize adverse events has been understudied. Method We used data from the National Survey of Midlife Development in the United States to examine how quantity, timing, and types of adverse events in childhood are associated with adult cardiometabolic health. Results The best-fitting specification of quantity of events was a linear measure reflecting a dose–response relationship. Timing of event mattered less than repeated exposure to events. Regarding the type of event, academic interruptions and sexual/physical abuse were most important. Adverse childhood events elevated the risk of diabetes and obesity similarly for men and women but had a greater impact on women’s risk of heart disease. Discussion Findings demonstrate the insights that can be gleaned about the early-life origins of adult health by examining operationalization of childhood exposures. PMID:25903978

  5. Utilizing the salutogenic paradigm to investigate well-being among adult survivors of childhood sexual abuse and other adversities.

    PubMed

    Dube, Shanta R; Rishi, Shobhana

    2017-02-26

    The long-term negative consequences of adverse childhood experiences are well documented. However, less is known about salutogenesis (well-being) among adult survivors of childhood adversity. The 2010 Behavioral Risk Factor Surveillance System data were analyzed to assess the contribution of four health promoting factors (physical activity, smoking abstinence, educational level, social-emotional support) with positive health-related quality of life (HRQoL), among adults who retrospectively reported childhood abuse or exposure to other childhood toxic stressors (n=12,032) and separately for adults who reported childhood sexual abuse (CSA). Outcomes examined included positive self-rated health (good/very good/excellent); mentally unhealthy days (MUDS) and physically unhealthy days (PUDS) in the past 30 days. After controlling for demographic characteristics and existing health conditions, physical activity (p<.05), smoking abstinence (p<.05), education of high school or greater (p<.05), and social-emotional support (p<.05) were associated with positive HRQoL outcomes among adult survivors of childhood adversity and adult survivors of CSA. Each unit increase of the health promoting factor score (0-4) resulted in adjusted odds ratio of 2.1 (95% CI: 1.3-2.4) for self-rated health and 1.6 (95%CI: 1.1-2.6) for <14 PUDs among male CSA survivors; among female survivors the adjusted odds ratios were 2.4 (95% CI: 1.8-3.2) for self-rated health, 2.3 (95% CI: 1.7-3.1) for <14 MUDs, and 2.2 (95% CI: 1.6-3.0) for <14 PUDs. The study validates that a large proportion of adults survive childhood adversities and underscores the importance of the salutogenic paradigm to identify strategies that may contribute to well-being.

  6. Adverse Outcome Pathway (AOP) Network Development for ...

    EPA Pesticide Factsheets

    Adverse outcome pathways (AOPs) are descriptive biological sequences that start from a molecular initiating event (MIE) and end with an adverse health outcome. AOPs provide biological context for high throughput chemical testing and further prioritize environmental health risk research. According to the Organization for Economic Co-operation and Development guidelines, AOPs are pathways with one MIE anchored to an adverse outcome (AO) by key events (KEs) and key event relationships (KERs). However, this approach does not always capture the cumulative impacts of multiple MIEs on the AO. For example, hepatic lipid flux due to chemical-induced toxicity initiates from multiple ligand-activated receptors and signaling pathways that cascade across biology to converge upon a common fatty liver (FL, also known as steatosis) outcome. To capture this complexity, a top-down strategy was used to develop a FL AOP network (AOPnet). Literature was queried based on the terms steatosis, fatty liver, cirrhosis, and hepatocellular carcinoma. Search results were analyzed for physiological and pathophysiological organ level, cellular and molecular processes, as well as pathway intermediates, to identify potential KEs and MIEs that are key for hepatic lipid metabolism, maintenance, and dysregulation. The analysis identified four apical KE nodes (hepatic fatty acid uptake, de novo fatty acid and lipid synthesis, fatty acid oxidation, and lipid efflux) juxtaposed to the FL AO. The apic

  7. Serious Adverse Events After Cataract Surgery

    PubMed Central

    Stein, Joshua D.

    2013-01-01

    Purpose Over the past several decades there have been many advances in the equipment, instrumentation and techniques of performing cataract surgery. This review will address the impact of these advances on the safety profile of cataract surgery. Recent Findings Recent studies have demonstrated a decline in the risk of serious postoperative adverse events (endophthalmitis, suprachoroidal hemorrhage, retinal detachment) following cataract surgery. Factors that increase the risk of serious complications from cataract surgery include patient-related factors (male sex, concomitant diabetic retinopathy, same day cataract surgery combined with another intraocular surgery, tamsulosin use) and surgeon-related factors (low surgical volume, limited experience, operating on patients who are most prone to adverse events). Summary Cataract surgery continues to be a very safe surgical procedure with few patients experiencing serious sight-threatening adverse events. Studies in the literature have helped surgeons identify patients who are at high risk for surgical complications and to develop strategies to limit surgical complications when operating on these patients. As multifocal intraocular lenses, femtosecond laser technology, and other surgical innovations continue to gain popularity, it will be interesting in the coming years to determine whether there will be a continued reduction in complications of cataract surgery. PMID:22450221

  8. Metabolic and adverse effects of diuretics.

    PubMed

    Wilcox, C S

    1999-11-01

    Diuretics are among the most frequently prescribed drugs. They enjoy a very high clinical reputation for safety and efficacy. However, more than 3 decades of clinical investigation have disclosed a number of abnormalities in fluid electrolyte handling, metabolism, and other adverse effects that can complicate therapy with diuretic drugs. Some of these complications are a direct extension of the wanted action of the drug. These include extracellular fluid volume depletion, associated orthostatic hypotension, and prerenal azotemia. Others are not a direct action of the diuretic, but can be explained as an intranephronal compensation to the diuretic action. These include hypokalemia, in part to increased potassium secretion secondary to the enhanced tubular fluid flow and aldosterone secretion induced by diuretic administration. Metabolic abnormalities are usually mild. Hyperglycemia and carbohydrate intolerance have been related to diuretic-induced hypokalemia, which inhibits insulin secretion by the beta cells, and reductions in extracellular fluid volume and cardiac output. This is compounded by increases in catecholamines from sympathetic nerve activity which decrease peripheral glucose utilization. A mild increase in serum cholesterol concentration is seen frequently during initiation of diuretic therapy, but during steady state therapy after 6 to 12 months, values usually return to baseline. Knowledge of the more common adverse effects induced by diuretics helps the physician in predicting patients at risk and taking effective steps to anticipate or treat adverse responses.

  9. Neuropsychiatric Adverse Effects of Amphetamine and Methamphetamine.

    PubMed

    Harro, Jaanus

    2015-01-01

    Administration of amphetamine and methamphetamine can elicit psychiatric adverse effects at acute administration, binge use, withdrawal, and chronic use. Most troublesome of these are psychotic states and aggressive behavior, but a large variety of undesirable changes in cognition and affect can be induced. Adverse effects occur more frequently with higher dosages and long-term use. They can subside over time but some persist long-term. Multiple alterations in the gray and white matter of the brain assessed as changes in tissue volume or metabolism, or at molecular level, have been associated with amphetamine and methamphetamine use and the psychiatric adverse effects, but further studies are required to clarify their causal role, specificity, and relationship with preceding states and traits and comorbidities. The latter include other substance use disorders, mood and anxiety disorders, attention deficit hyperactivity disorder, and antisocial personality disorder. Amphetamine- and methamphetamine-related psychosis is similar to schizophrenia in terms of symptomatology and pathogenesis, and these two disorders share predisposing genetic factors.

  10. Combating adverse selection in secondary PC markets.

    PubMed

    Hickey, Stewart W; Fitzpatrick, Colin

    2008-04-15

    Adverse selection is a significant contributor to market failure in secondary personal computer (PC) markets. Signaling can act as a potential solution to adverse selection and facilitate superior remarketing of second-hand PCs. Signaling is a means whereby usage information can be utilized to enhance consumer perception of both value and utility of used PCs and, therefore, promote lifetime extension for these systems. This can help mitigate a large portion of the environmental impact associated with PC system manufacture. In this paper, the computer buying and selling behavior of consumers is characterized via a survey of 270 Irish residential users. Results confirm the existence of adverse selection in the Irish market with 76% of potential buyers being unwilling to purchase and 45% of potential vendors being unwilling to sell a used PC. The so-called "closet affect" is also apparent with 78% of users storing their PC after use has ceased. Results also indicate that consumers place a higher emphasis on specifications when considering a second-hand purchase. This contradicts their application needs which are predominantly Internet and word-processing/spreadsheet/presentation applications, 88% and 60% respectively. Finally, a market solution utilizing self monitoring and reporting technology (SMART) sensors for the purpose of real time usage monitoring is proposed, that can change consumer attitudes with regard to second-hand computer equipment.

  11. Closure of Interatrial Septal Communications: Adverse Events and Lessons Learned

    PubMed Central

    Wagdi, Philipp

    2011-01-01

    Background Percutaneous closure of interatrial septal communications (IASC) is generally being regarded as a safe and straightforward intervention. Reporting and classification of adverse events (AE) as is the case for percutaneous coronary intervention (PCI) is not standardized. Also, the focus of reported larger studies has not been primarily on AE and strategies to avoid them. Methods The data of all 112 consecutive patients undergoing IASC by a single operator were reviewed. In analogy to classification for PCI, an AE was considered to be major if any of the following occurred: death, major or minor stroke, myocardial infarction, the need for an originally unplanned additional surgery or intervention or blood transfusion. Every AE and how it may have been avoided is reviewed in detail. Results Major AE according to the suggested classification occurred in 2.7% of patients, including tamponade in 1 patient necessitating thoracotomy 7 months after IASC, percutaneous retrieval of an embolized device in 1 patient, and ambulatory same day surgical treatment of an arteriovenous fistula in 1 patient. Conclusions The proposed new classification of AE provides a unified and comparable approach for IASC procedures. Retrospectively, two of the 3 major AE could have probably been avoided by more thoughtful patient and material selection.

  12. Severe Cutaneous Adverse Drug Reactions: A Clinicoepidemiological Study

    PubMed Central

    Sasidharanpillai, Sarita; Riyaz, Najeeba; Khader, Anza; Rajan, Uma; Binitha, Manikoth P; Sureshan, Deepthi N

    2015-01-01

    Background: Drug eruptions range from transient erythema to the life threatening severe cutaneous adverse reactions (SCAR) that encompass Stevens–Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms complex (DRESS). Aims and Objectives: To study the clinical and epidemiological aspects of cutaneous adverse drug reactions (CADR). Materials and Methods: Ethical clearance was obtained from the institutional ethics committee. All patients admitted in the Dermatology ward of our tertiary care hospital with CADR (those who fit in the category of probable or possible drug reaction as per WHO casuality assessment) from first September 2011 to 31st August 2012 were included in this cross sectional study after obtaining written informed consent. The drug reaction patterns observed in the study population were determined and the common offending drugs were identified. Results: In the study, population of males outnumbered females and the majority were between 46 and 60 years of age. The commonest reaction pattern observed was SJS- TEN spectrum of illness and aromatic anticonvulsants were the common offending drugs. Prompt withdrawal of the culprit drug and administration of systemic steroids with or without I/V Ig reverted the adverse reaction in all except one. Conclusion: Severe drug reactions predominated as the study population was comprised of inpatients of a tertiary referral centre. Though; previous authors had reported a mortality rate of up to 20% in DRESS, all our patients with this reaction pattern, responded well to treatment. The mortality rate among TEN cases was much lower than the previous reports. Early diagnosis, prompt withdrawal of the suspected drug, careful monitoring for development of complications and immediate intervention can improve the prognosis of CADR. PMID:25657416

  13. Adverse drug reactions in therapeutic hypothermia after cardiac arrest

    PubMed Central

    Witcher, Robert; Dzierba, Amy L.; Kim, Catherine; Smithburger, Pamela L.; Kane-Gill, Sandra L.

    2016-01-01

    Background: Therapeutic hypothermia (TH) improves survival and neurologic function in comatose survivors of cardiac arrest. Many medications used to support TH have altered pharmacokinetics and pharmacodynamics during this treatment. It is unknown if or at what frequency the medications used during TH cause adverse drug reactions (ADRs). Methods: A retrospective chart review was conducted for patients admitted to an intensive care unit (ICU) after cardiac arrest and treated with TH from January 2009 to June 2012 at two urban, university-affiliated, tertiary-care medical centres. Medications commonly used during TH were screened for association with significant ADRs (grade 3 or greater per Common Terminology Criteria for Adverse Events) using three published ADR detection instruments. Results: A total of 229 patients were included, the majority being males with median age of 62 presenting with an out-of-hospital cardiac arrest in pulseless electrical activity or asystole. The most common comorbidities were hypertension, coronary artery disease, and diabetes mellitus. There were 670 possible ADRs and 69 probable ADRs identified. Of the 670 possible ADRs, propofol, fentanyl, and acetaminophen were the most common drugs associated with ADRs. Whereas fentanyl, insulin, and propofol were the most common drugs associated with a probable ADR. Patients were managed with TH for a median of 22 hours, with 38% of patients surviving to hospital discharge. Conclusions: Patients undergoing TH after cardiac arrest frequently experience possible adverse reactions associated with medications and the corresponding laboratory abnormalities are significant. There is a need for judicious use and close monitoring of drugs in the setting of TH until recommendations for dose adjustments are available to help prevent ADRs.

  14. Managing adverse birth outcomes: helping parents and families cope.

    PubMed

    Van Dinter, Maureen C; Graves, Lisa

    2012-05-01

    Unexpected adverse fetal and neonatal outcomes (e.g., stillbirth, birth trauma, congenital anomalies) present a crisis for the family and the medical care team. In cases of stillbirth, the family physician should be flexible in supporting the parents' choices, validate the loss, and work as a team with the nursing staff. Psychosocial support includes offering counseling services, assessing women for postpartum depression and anxiety, and considering the effect of the loss on the entire family. Although infants with birth asphyxia or major anomalies may require transfer to facilities with a neonatal intensive care unit, the physician will usually provide ongoing care for the mother in the postpartum period. A comprehensive assessment can determine the etiology of fetal demise in most cases, which may guide future preconception and maternity care. Women with a previous adverse pregnancy outcome may have increased psychological stress in a subsequent pregnancy. Knowledge of community resources will facilitate care for the mother and her partner or family. Physicians may need to seek peer support to cope with their own feelings of loss.

  15. Racial Discrimination and Adverse Birth Outcomes: An Integrative Review

    PubMed Central

    Alhusen, Jeanne L.; Bower, Kelly; Epstein, Elizabeth; Sharps, Phyllis

    2016-01-01

    Introduction This article presents an integrative review of the literature examining the relationship between racial discrimination and adverse birth outcomes. Methods Searches for research studies published from 2009 to 2015 were conducted using PubMed, CINAHL, Scopus, PsycINFO, Web of Science, and Embase. Articles were assessed for potential inclusion using the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) 2009 framework. Results Fifteen studies met criteria for review. The majority of the studies found a significant relationship between racial discrimination and low birth weight, preterm birth, and small for gestational age. Each of the studies that examined more proximal variables related to birth outcomes such as entry into prenatal care, employment opportunities, neighborhood characteristics, or inflammatory markers found significant associations between the specific variables examined and racial discrimination. Participants in qualitative studies discussed experiences of institutional racism with regard to several components of prenatal care including access and quality of care. Discussion Racial discrimination is a significant risk factor for adverse birth outcomes. To best understand the mechanisms by which racial discrimination impacts birth outcomes, and to inform the development of effective interventions that eliminate its harmful effects on health, longitudinal research that incorporates comprehensive measures of racial discrimination is needed. Health care providers must fully acknowledge and address the psychosocial factors that impact health outcomes in minority racial/ethnic women. PMID:27737504

  16. Adversity in childhood and depression: linked through SIRT1

    PubMed Central

    Lo Iacono, L; Visco-Comandini, F; Valzania, A; Viscomi, M T; Coviello, M; Giampà, A; Roscini, L; Bisicchia, E; Siracusano, A; Troisi, A; Puglisi-Allegra, S; Carola, V

    2015-01-01

    Experiencing an adverse childhood and parental neglect is a risk factor for depression in the adult population. Patients with a history of traumatic childhood develop a subtype of depression that is characterized by earlier onset, poor treatment response and more severe symptoms. The long-lasting molecular mechanisms that are engaged during early traumatic events and determine the risk for depression are poorly understood. In this study, we altered adult depression-like behavior in mice by applying juvenile isolation stress. We found that this behavioral phenotype was associated with a reduction in the levels of the deacetylase sirtuin1 (SIRT1) in the brain and in peripheral blood mononuclear cells. Notably, peripheral blood mRNA expression of SIRT1 predicted the extent of behavioral despair only when depression-like behavior was induced by juvenile—but not adult—stress, implicating SIRT1 in the regulation of adult behavior at early ages. Consistent with this hypothesis, pharmacological modulation of SIRT1 during juvenile age altered the depression-like behavior in naive mice. We also performed a pilot study in humans, in which the blood levels of SIRT1 correlated significantly with the severity of symptoms in major depression patients, especially in those who received less parental care during childhood. On the basis of these novel findings, we propose the involvement of SIRT1 in the long-term consequences of adverse childhood experiences. PMID:26327687

  17. Innate immunity, coagulation and placenta-related adverse pregnancy outcomes.

    PubMed

    Li, Min; Huang, S Joseph

    2009-12-01

    Maternal immunity undergoes subtle adjustment in order to tolerate the semi-allogeneic embryo and maintain the host defense against potential pathogens. Concomitantly, coagulation systems change from an anti-coagulant state to a pro-coagulant state to meet the hemostatic challenge of placentation and delivery. Innate immunity and blood coagulation systems are the first line of defense to protect a host against exogenous challenges, including alloantigens and mechanical insults, and preserve the integrity of an organism. The interactions between coagulation and immune systems have been extensively studied. Immune cells play a pivotal role in the initiation of the coagulation cascade, whereas coagulation proteases display substantial immuno-modulatory effects. Upon exogenous challenges, the immune and coagulation systems are capable of potentiating each other leading to a vicious cycle. Natural killer (NK) cells, macrophages (Mphis) and dendritic cells (DCs) are three major innate immune cells that have been demonstrated to play essential roles in early pregnancy. However, immune maladaptation and hemostatic imbalance have been suggested to be responsible for adverse pregnant outcomes, such as preeclampsia (PE), miscarriage, recurrent spontaneous abortion (RSA) and intrauterine growth restriction (IUGR). In this review, we will summarize the mutual regulation between blood coagulation and innate immune systems as well as their roles in the maintenance of normal pregnancy and in the pathogenesis of adverse pregnancy outcomes.

  18. Building an Evidence-Based Mental Health Program for Children with History of Early Adversity

    ERIC Educational Resources Information Center

    Kroupina, Maria; Vermeulen, Marlous; Moberg, Stephanie

    2015-01-01

    Adoption is a major intervention in a child's life, however internationally adopted (IA) children remain at risk for long-term neurodevelopmental and mental health issues due to the fact that most of them have a history of early adversity prior to their adoption. In the last 20 years, extensive research with this population has increased the…

  19. Academic Buoyancy and Academic Resilience: Exploring "Everyday" and "Classic" Resilience in the Face of Academic Adversity

    ERIC Educational Resources Information Center

    Martin, Andrew J.

    2013-01-01

    Academic buoyancy has been defined as a capacity to overcome setbacks, challenges, and difficulties that are part of everyday academic life. Academic resilience has been defined as a capacity to overcome acute and/or chronic adversity that is seen as a major threat to a student's educational development. This study is the first to examine the…

  20. Adverse effects of statins - myths and reality.

    PubMed

    Šimić, Iveta; Reiner, Željko

    2015-01-01

    Statins reduce cardiovascular mortality and morbidity as well as cardiovascular events in patients with a very high risk of cardiovascular disease (CVD) and also in subjects with high or moderate risk by reducing the levels of low-density lipoprotein cholesterol (LDL-C). Although they are considered to be drugs with a very good safety profile, because of their wide use there are many concerns that their adverse effects might compromise their proven beneficial effects. Therefore this article reviews all the data and provides an evidence- based insight what are the proven adverse effects of statins and what are the "myths" about them. The most important side effects include myopathy and rhabdomyolysis. Another side effect is increased activity of liver tests which occurs occasionally and is reversible. However, recent studies even suggest that statin therapy can improve hepatic steatosis. It is beyond any doubt that statins do slightly increase the incidence of type 2 diabetes mellitus in people with two or more components of metabolic syndrome but the cardiovascular benefits of such a treatment by far exceed this risk. Statin therapy has also been associated with some adverse renal effects, eg. acute renal failure, but recent data suggest even a possible protective effect of these drugs on renal dysfunction. Concerns that statins might increase cancer have not been proven. On the contrary, several studies have indicated a possible benefit of these drugs in patients with different types of cancer. Early concerns about cognitive dysfunction and memory loss associated with statins use could not be proven and most recent data even suggest a possible beneficial effect of statins in the prevention of dementia. Systematic reviews and clinical guidelines suggest that the cardiovascular benefits of statins by far out-weight non-cardiovascular harms in patients with cardiovascular risk.

  1. Determinants of Adverse Events in Vascular Surgery

    PubMed Central

    Hernandez-Boussard, Tina; McDonald, Kathryn; Morton, John; Dalman, Ron L; Bech, Fritz R

    2016-01-01

    Background Patient safety is a national priority. Patient Safety Indicators (PSIs) monitor potential adverse events during hospital stays. Surgical specialty PSI benchmarks do not exist, which are needed to account for differences in the range of procedures performed, reasons for the procedure, and differences in patient characteristics. A comprehensive profile of adverse events in vascular surgery was created. Study Design The Nationwide Inpatient Sample was queried for 8 vascular procedures using ICD-9-CM codes from 2005–2009. Factors associated with PSI development were evaluated in univariate and multivariate analyses. Results A total of 1,412,703 patients underwent a vascular procedure and 5.2% developed a PSI. PSIs were more frequent in female, non-white patients with public payers (p<.01). Patients at mid and low volume hospitals had greater odds of developing a PSI (Odds Ratio [OR], 1.17; 95% Confidence Interval [CI], 1.10–1.23 and OR, 1.69; CI, 1.53–1.87). Amputations had highest PSI risk-adjusted rate (RAR) and carotid endarterectomy and endovascular abdominal aortic aneurysm (AAA) repair had lower RAR (p<.0001). PSI RAR increased linearly by severity of patient indication: claudicants (OR, 0.40, CI, 0.35–0.46), rest pain patients (OR, 0.78, CI 0.69–0.90), ulcer (OR: 1.20, CI: 1.07–1.34) and gangrene patients (OR:1.85, CI: 1.66–2.06). Conclusions Patient safety events in vascular surgery were high and varied by procedure, with amputations and open AAA having substantially more potential adverse events. PSIs were associated with black race, public payer, and procedure indication. It is important to note the overall higher rates of PSIs occurring in vascular patients and appropriately adjust benchmarks for this surgical specialty. PMID:22425449

  2. Ofloxacin Induced Angioedema: A Rare Adverse Drug Reaction

    PubMed Central

    Yadav, Sankalp; Kumar, Raj; Wani, Umar Rasool

    2016-01-01

    The Adverse Drug Reaction (ADR) to a commonly prescribed anti-microbial can pose a major public health problem. The authors report a rare case of 24-year-old young lady who presented with angioedema of lips after ingestion of Ofloxacin, prescribed to her for treatment of loose motions. Fluoroquinolones are widely prescribed antibiotics for various disease conditions. The history, clinical examination and normal laboratory parameters led to the diagnosis of ofloxacin induced hypersensitivity reaction and the patient was successfully treated with corticosteroids and antihistamines. The hypersensitivity reactions to fluoroquinolones are rare with an incidence of 0.4% to 2%. The pharmacovigilance program and self-reporting of all the ADR’s by the health care workers can help in ensuring the judicious use of the drug, drug safety and thus decrease the associated morbidity and mortality. PMID:28050397

  3. A time-indexed reference standard of adverse drug reactions.

    PubMed

    Harpaz, Rave; Odgers, David; Gaskin, Greg; DuMouchel, William; Winnenburg, Rainer; Bodenreider, Olivier; Ripple, Anna; Szarfman, Ana; Sorbello, Alfred; Horvitz, Eric; White, Ryen W; Shah, Nigam H

    2014-11-11

    Undetected adverse drug reactions (ADRs) pose a major burden on the health system. Data mining methodologies designed to identify signals of novel ADRs are of deep importance for drug safety surveillance. The development and evaluation of these methodologies requires proper reference benchmarks. While progress has recently been made in developing such benchmarks, our understanding of the performance characteristics of the data mining methodologies is limited because existing benchmarks do not support prospective performance evaluations. We address this shortcoming by providing a reference standard to support prospective performance evaluations. The reference standard was systematically curated from drug labeling revisions, such as new warnings, which were issued and communicated by the US Food and Drug Administration in 2013. The reference standard includes 62 positive test cases and 75 negative controls, and covers 44 drugs and 38 events. We provide usage guidance and empirical support for the reference standard by applying it to analyze two data sources commonly mined for drug safety surveillance.

  4. Sexual behaviour: related adverse health burden in the United States

    PubMed Central

    Ebrahim, S; McKenna, M; Marks, J

    2005-01-01

    As part of an analysis of the burden of disease and injury in the United States, we identified and quantified the incidence of adverse health events, deaths, and disability adjusted life years (DALY) attributed to sexual behaviour. In 1998, about 20 million such events (7532/100 000 people) and 29 782 such deaths (1.3% of all US deaths) occurred, contributing to 2 161 417 DALYs (6.2% of all US DALYs). The majority of incident health events (62%) and DALYs (57%) related to sexual behaviour were among females, and curable infections and their sequelae contributed to over half of these. Viral infections and their sequelae accounted for nearly all sexual behaviour related deaths—mostly HIV/AIDS. Sexual behaviour attributed DALYs in the United States are threefold higher than that in overall established market economies. PMID:15681721

  5. Agomelatine: a review of adverse effects.

    PubMed

    2013-03-01

    More pharmacovigilance data on agomelatine became available in 2012. The main sources of information were surveillance data from the French national monitoring system, EU periodic safety update reports (PSURs), and the European pharmacovigilance database. The principal adverse effects of agomelatine consist of hepatic, pancreatic, neuropsychiatric, muscular and cutaneous disorders. The harms associated with agomelatine, which has no proven efficacy in depression, clearly outweigh the benefits. Until regulatory agencies decide to withdraw agomelatine from the market, it is up to healthcare professionals to protect patients from this unnecessarily dangerous drug.

  6. Joint Commission suspends 'auto' adverse decision.

    PubMed

    2010-08-01

    The Joint Commission's revision of its policy on root cause analysis puts greater attention of something that, quite frankly, some ED managers might not have been aware of. The ED manager plays an important role when events occur in the department, such as: knowing who the main Joint Commission contact is in the hospital, and making them aware of a potential adverse or sentinel event that has occurred; participating in the root cause analysis to identify what ED processes might need improvement; making sure the remedial activities recommended can be measured, so The Joint Commission can see an active attempt is being made to improve.

  7. Environmental Perchlorate Exposure: Potential Adverse Thyroid Effects

    PubMed Central

    Leung, Angela M.; Pearce, Elizabeth N.; Braverman, Lewis E.

    2014-01-01

    Purpose of review This review will present a general overview of the sources, human studies, and proposed regulatory action regarding environmental perchlorate exposure. Recent findings Some recent studies have reported significant associations between urinary perchlorate concentrations, thyroid dysfunction, and decreased infant IQ in groups who would be particularly susceptible to perchlorate effects. An update regarding the recent proposed regulatory actions and potential costs surrounding amelioration of perchlorate contamination is provided. Summary The potential adverse thyroidal effects of environmental perchlorate exposure remain controversial, and further research is needed to further define its relationship to human health among pregnant and lactating women and their infants. PMID:25106002

  8. [Adverse drug effects in the community pharmacy].

    PubMed

    Arnet, Isabelle; Seidling, Hanna M; Hersberger, Kurt E

    2015-12-01

    Community pharmacists represent an important pillar for the identification and the reporting of adverse drug effects (ADE}. Thanks to their broad view on the pharmacotherapy, over-the-counter medication included, they contribute greatly to the improvement of drug safety. In principle, the community pharmacy will face three groups of ADE which require specific attention. This article deals with these specific ADE groups and presents some illustrative examples from daily practice. Furthermore, we suggest some solutions to identify potential relevant interactions - including herbal-drug interactions - and give tips for daily practice, along with some often overseen cutaneous ADE.

  9. Mitigation of adverse environmental and unavoidable impacts

    SciTech Connect

    1995-10-01

    This portion of the Energy Vision 2020 draft report is a broad scope discussion of the mitigation of adverse environmental and unavoidable impacts. TVA will mitigate site specific environmental impacts from the construction and operation of new power facilities through a combination of planning, pollution prevention, and environmental controls. However, one of the most important mitigative measures associated with Energy Vision 2020 is the multi-attribute tradeoff method used for the evaluation. This method allowed proposed strategies to be reformated in order to reduce potential impacts.

  10. Adverse environments and children's creativity development: transforming the notion of "success in adversity" in China.

    PubMed

    Cheng, Li; Tan, Mei; Liu, Zhengkui

    2015-01-01

    China has been undergoing great social change due to its new focus on urbanization and globalization. Such change has had a tremendous adverse impact on the living conditions of millions of young children, simultaneously generating new interest in children's creativity development. The intersection of these two issues has important implications for China's future as it brings together one of China's core cultural values-"success in adversity"-the importance of creativity, and very real social and economic needs. "Success in adversity" reflects the strongly held belief that individuals who suffer adverse environments can rise to excellence and success through persistence, effort, and creativity. In this article, we briefly explore the historical sources of this belief and how it is closely related to the Chinese conception of creativity. We then present some studies on the creativity of some of China's migrant children. Findings show that while migrant children as a group may not generally exhibit higher creativity than their urban peers as hypothesized, indications of resilience and creative potential suggest that the notion of success in adversity may contribute to the positive development of China's migrant children more substantially when it is informed by research and augmented by research-supported policy.

  11. Adverse Effects of Psychotropic Medications: A Call to Action.

    PubMed

    Mago, Rajnish

    2016-09-01

    Adverse effects are common, bothersome, and a leading cause of discontinuation of treatment. The methodology for evaluating adverse effects of medications has been greatly neglected, however, especially in comparison to the methodology for assessment of efficacy of medications. Existing methods for assessment and reporting of adverse effects have important limitations leading to lack of much-needed data related to adverse effects. Lastly, there is little systematic research into management of most adverse effects. A series of recommendations are made in this article about how to improve identification, assessment, reporting, and management of adverse effects.

  12. Attributable Risk Estimate of Severe Psoriasis on Major Cardiovascular Events

    PubMed Central

    Mehta, Nehal N.; Yu, YiDing; Pinnelas, Rebecca; Krishnamoorthy, Parasuram; Shin, Daniel B.; Troxel, Andrea B.; Gelfand, Joel M.

    2011-01-01

    Background Recent studies suggest that psoriasis, particularly if severe, may be a risk factor for major adverse cardiac events such as myocardial infarction, stroke, and mortality from cardiovascular disease. We compared the risk of major adverse cardiac events between patients with psoriasis and the general population and estimated the attributable risk of severe psoriasis. Methods We performed a cohort study in the General Practice Research Database. Severe psoriasis was defined as receiving a psoriasis diagnosis and systemic therapy (N=3,603). Up to 4 patients without psoriasis were selected from the same practices and start dates for each patient with psoriasis (N=14,330). Results Severe psoriasis was a risk factor for major adverse cardiac events (hazard ratio 1.53; 95% confidence interval 1.26, 1.85) after adjusting for age, gender, diabetes, hypertension, tobacco use and hyperlipidemia. After fully adjusted analysis, severe psoriasis conferred an additional 6.2% absolute risk of 10-year major adverse cardiac events. Conclusions Severe psoriasis confers an additional 6.2% absolute risk of 10-year rate of major adverse cardiac events compared to the general population. This potentially has important therapeutic implications for cardiovascular risk stratification and prevention in patients with severe psoriasis. Future prospective studies are needed to validate these findings. PMID:21787906

  13. Urinary calprotectin, kidney injury molecule-1, and neutrophil gelatinase-associated lipocalin for the prediction of adverse outcome in pediatric acute kidney injury.

    PubMed

    Westhoff, Jens H; Seibert, Felix S; Waldherr, Sina; Bauer, Frederic; Tönshoff, Burkhard; Fichtner, Alexander; Westhoff, Timm H

    2017-04-14

    Early identification of patients with acute kidney injury (AKI) being at high risk for adverse outcome can influence medical treatment. This study compares urinary calprotectin, kidney injury molecule-1 (KIM-1), and neutrophil gelatinase-associated lipocalin (NGAL) for their performance in predicting mortality and need for renal replacement therapy (RRT) in pediatric AKI patients. Urinary biomarker concentrations were assessed prospectively in 141 subjects aged 0-18 years including 55 patients with established AKI according to pediatric Risk, Injury, Failure, Loss, and End-stage kidney disease (pRIFLE) criteria, 27 patients without AKI, and 59 healthy children. Within the AKI group, receiver operating characteristic (ROC) curve analysis revealed moderate to poor performance of calprotectin and KIM-1 in the prediction of 30-day mortality (calprotectin area under the curve (AUC) 0.55; KIM-1 AUC 0.55) and 3-month mortality (calprotectin AUC 0.61; KIM-1 AUC 0.60) and fair performance in the prediction of RRT requirement (calprotectin AUC 0.72; KIM-1 AUC 0.71). Urinary NGAL showed good performance in predicting 30-day (AUC 0.79) and 3-month (AUC 0.81) mortality and moderate performance in predicting RRT (AUC 0.61).

  14. Long-term antidepressant use: patient perspectives of benefits and adverse effects

    PubMed Central

    Cartwright, Claire; Gibson, Kerry; Read, John; Cowan, Ondria; Dehar, Tamsin

    2016-01-01

    Long-term antidepressant treatment has increased and there is evidence of adverse effects; however, little is known about patients’ experiences and views of this form of treatment. This study used mixed methods to examine patients’ views and experiences of long-term antidepressant treatment, including benefits and concerns. Data from 180 patients, who were long-term users of antidepressants (3–15 years), were extracted from an anonymous online survey of patients’ experiences of antidepressants in New Zealand. Participants had completed rating scales about the effectiveness of antidepressants, levels of depression before and during antidepressant use, quality of life, and perceived adverse effects. Two open-ended questions allowed participants to comment on personal experiences. The majority (89.4%) reported that antidepressants had improved their depression although 30% reported moderate-to-severe depression on antidepressants. Common adverse effects included withdrawal effects (73.5%), sexual problems (71.8%), and weight gain (65.3%). Adverse emotional effects, such as feeling emotionally numb (64.5%) and addicted (43%), were also common. While the majority of patients were pleased with the benefits of antidepressant treatment, many were concerned about these adverse effects. Some expressed a need for more information about long-term risks and increased information and support to discontinue. PMID:27528803

  15. Adverse outcome pathway development II: best practices.

    PubMed

    Villeneuve, Daniel L; Crump, Doug; Garcia-Reyero, Natàlia; Hecker, Markus; Hutchinson, Thomas H; LaLone, Carlie A; Landesmann, Brigitte; Lettieri, Teresa; Munn, Sharon; Nepelska, Malgorzata; Ottinger, Mary Ann; Vergauwen, Lucia; Whelan, Maurice

    2014-12-01

    Organization of existing and emerging toxicological knowledge into adverse outcome pathway (AOP) descriptions can facilitate greater application of mechanistic data, including those derived through high-throughput in vitro, high content omics and imaging, and biomarker approaches, in risk-based decision making. The previously ad hoc process of AOP development is being formalized through development of internationally harmonized guidance and principles. The goal of this article was to outline the information content desired for formal AOP description and some rules of thumb and best practices intended to facilitate reuse and connectivity of elements of an AOP description in a knowledgebase and network context. For example, key events (KEs) are measurements of change in biological state that are indicative of progression of a perturbation toward a specified adverse outcome. Best practices for KE description suggest that each KE should be defined as an independent measurement made at a particular level of biological organization. The concept of "functional equivalence" can help guide both decisions about how many KEs to include in an AOP and the specificity with which they are defined. Likewise, in describing both KEs and evidence that supports a causal linkage or statistical association between them (ie, a key event relationship; KER), best practice is to build from and contribute to existing KE or KER descriptions in the AOP knowledgebase rather than creating redundant descriptions. The best practices proposed address many of the challenges and uncertainties related to AOP development and help promote a consistent and reliable, yet flexible approach.

  16. Adverse outcome pathway (AOP) development and evaluation ...

    EPA Pesticide Factsheets

    The Adverse Outcome Pathway provides a construct for assembling mechanistic information at different levels of biological organization in a form designed to support regulatory decision making. In particular, it frames the link between molecular and cellular events that can be measured in high throughput toxicity testing and the organism or population-level events that are commonly relevant in defining risk. Recognizing the importance of this emerging framework, the Organisation for Economic Co-operation and Development (OECD) launched a program to support the development, documentation and consideration of AOPs by the international community in 2012 (http://www.oecd.org/chemicalsafety/testing/adverse-outcome-pathways-molecular-screening-and-toxicogenomics.htm). In 2014, a handbook (https://aopkb.org/common/AOP_Handbook.pdf) was developed to guide users in the documentation and evaluation of AOPs and their entry into an official knowledgebase. The handbook draws on longstanding experience in consideration of mechanistic data (e.g., mode of action analysis) to inform risk assessment. To further assist users, a training program was developed by members of the OECD Extended Advisory Group to teach users the basic principles of AOP development and the best practices as outlined in the OECD AOP handbook. Training sessions began in early 2015, and this course will provide training for interested SOT scientists. Following this course, all participants will be familiar w

  17. [Adverse events of immune checkpoint inhibitors].

    PubMed

    Foller, S; Oppel-Heuchel, H; Fetter, I; Winkler, Y; Grimm, M-O

    2017-04-01

    After immune checkpoint inhibitor therapy was approved for renal cell carcinoma last year, this new immune therapy has spread to urology. Further approvals (atezolizumab, nivolumab, pembrolizumab) are expected in 2017 for metastatic urothelial carcinoma that has progressed following treatment with platinum-based chemotherapy. With expanding use of immune checkpoint inhibitors, experience in diagnosing and managing immune-mediated adverse events increases. Although of low incidence, grade 3/4 toxicities play a central role. Organs most common for immune-mediated adverse events are skin, liver (hepatitis), kidneys (nephritis), gastrointestinal tract (diarrhea and colitis), lungs (pneumonitis), and endocrine organs (hyper-, hypothyroidism and hypophysitis). Diagnostic workup includes routine laboratory tests (including liver function tests) and may be supplemented with hormone values. In cases of pneumonitis or hypophysitis, imaging (high-resolution CT, MRI) can confirm diagnoses. Immune-mediated toxicities are treated with therapy interruption and administration of corticosteroids (and in individual cases additional immunosuppression). Dose modification is not intended!

  18. Adverse effects of new antiepileptic drugs.

    PubMed

    Onat, Filiz; Ozkara, Cigdem

    2004-04-01

    Starting with phenobarbital in the 1900s, it took almost 70-80 years to introduce old-generation agents for the treatment of epilepsy. Then, in eleven years, nine more new antiepileptic drugs were added to the armamentarium. These drugs produce a nearly 40-50% decrease in seizure incidence in refractory patients, but few patients have been able to achieve complete freedom from seizures. So the search for more effective drugs with minimal adverse effect profiles will continue. Although the new antiepileptic drugs do not demonstrate a superior efficacy compared to the older ones, they do offer some advantages in terms of tolerability, fewer drug interactions and simpler pharmacokinetics. However, our knowledge concerning their safety profiles can not yet be considered adequate due to the relatively short time these drugs have been on the market and to the limited number of patients exposed to them. The fact that the serious side effects of felbamate and vigabatrine appeared late after marketing should be taken as an important lesson because it implies the potential for unknown side effects at any time during treatment. Antiepileptic drug treatment should begin with diagnosis of the seizure and epileptic syndrome, followed by selection of the drug most appropriate for treatment of the individual patient, and continued with monitoring of not only the seizures but the adverse effect profile as well.

  19. Immunomodulatory drugs: Oral and systemic adverse effects

    PubMed Central

    Mattila, Riikka; Gomez-Font, Rafael; Meurman, Jukka H.

    2014-01-01

    Objectives: The main objectives are to present the different adverses effects of the immunomodulatory drugs that can impair the quality of life of the immunosupressed patients and study the impact of immunomodualtion on oral diseases. Immunomodulatory drugs have changed the treatment protocols of many diseases where immune functions play a central role, such as rheumatic diseases. Their effect on oral health has not been systematically investigated, however. Study Design: We review current data on the new immunomodulatory drugs from the oral health perspective based on open literature search of the topic. Results: These target specific drugs appear to have less drug interactions than earlier immunomodulating medicines but have nevertheless potential side effects such as activating latent infections. There are some data showing that the new immunomodulatory drugs may also have a role in the treatment of certain oral diseases such as lichen planus or ameliorating symptoms in Sjögren´s syndrome, but the results have not been overly promising. Conclusions: In general, data are sparse of the effect of these new drugs vs. oral diseases and there are no properly powered randomized controlled trials published on this topic. Key words:Immunomodulatory drugs, oral diseases, adverse effects, therapeutic action. PMID:23986016

  20. Hyperinsulinemia adversely affects lung structure and function.

    PubMed

    Singh, Suchita; Bodas, Manish; Bhatraju, Naveen K; Pattnaik, Bijay; Gheware, Atish; Parameswaran, Praveen Kolumam; Thompson, Michael; Freeman, Michelle; Mabalirajan, Ulaganathan; Gosens, Reinoud; Ghosh, Balaram; Pabelick, Christina; Linneberg, Allan; Prakash, Y S; Agrawal, Anurag

    2016-05-01

    There is limited knowledge regarding the consequences of hyperinsulinemia on the lung. Given the increasing prevalence of obesity, insulin resistance, and epidemiological associations with asthma, this is a critical lacuna, more so with inhaled insulin on the horizon. Here, we demonstrate that insulin can adversely affect respiratory health. Insulin treatment (1 μg/ml) significantly (P < 0.05) increased the proliferation of primary human airway smooth muscle (ASM) cells and induced collagen release. Additionally, ASM cells showed a significant increase in calcium response and mitochondrial respiration upon insulin exposure. Mice administered intranasal insulin showed increased collagen deposition in the lungs as well as a significant increase in airway hyperresponsiveness. PI3K/Akt mediated activation of β-catenin, a positive regulator of epithelial-mesenchymal transition and fibrosis, was observed in the lungs of insulin-treated mice and lung cells. Our data suggests that hyperinsulinemia may have adverse effects on airway structure and function. Insulin-induced activation of β-catenin in lung tissue and the contractile effects on ASM cells may be causally related to the development of asthma-like phenotype.

  1. Development of a Pediatric Adverse Events Terminology

    PubMed Central

    Gipson, Debbie S.; Kirkendall, Eric S.; Gumbs-Petty, Brenda; Quinn, Theresa; Steen, A.; Hicks, Amanda; McMahon, Ann; Nicholas, Savian; Zhao-Wong, Anna; Taylor-Zapata, Perdita; Turner, Mark; Herreshoff, Emily; Jones, Charlotte; Davis, Jonathan M.; Haber, Margaret; Hirschfeld, Steven

    2017-01-01

    In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute’s Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute’s Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization. PMID:28028203

  2. Development of a Pediatric Adverse Events Terminology.

    PubMed

    Gipson, Debbie S; Kirkendall, Eric S; Gumbs-Petty, Brenda; Quinn, Theresa; Steen, A; Hicks, Amanda; McMahon, Ann; Nicholas, Savian; Zhao-Wong, Anna; Taylor-Zapata, Perdita; Turner, Mark; Herreshoff, Emily; Jones, Charlotte; Davis, Jonathan M; Haber, Margaret; Hirschfeld, Steven

    2017-01-01

    In 2009, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) established the Pediatric Terminology Harmonization Initiative to establish a core library of terms to facilitate the acquisition and sharing of knowledge between pediatric clinical research, practice, and safety reporting. A coalition of partners established a Pediatric Terminology Adverse Event Working Group in 2013 to develop a specific terminology relevant to international pediatric adverse event (AE) reporting. Pediatric specialists with backgrounds in clinical care, research, safety reporting, or informatics, supported by biomedical terminology experts from the National Cancer Institute's Enterprise Vocabulary Services participated. The multinational group developed a working definition of AEs and reviewed concepts (terms, synonyms, and definitions) from 16 pediatric clinical domains. The resulting AE terminology contains >1000 pediatric diseases, disorders, or clinical findings. The terms were tested for proof of concept use in 2 different settings: hospital readmissions and the NICU. The advantages of the AE terminology include ease of adoption due to integration with well-established and internationally accepted biomedical terminologies, a uniquely temporal focus on pediatric health and disease from conception through adolescence, and terms that could be used in both well- and underresourced environments. The AE terminology is available for use without restriction through the National Cancer Institute's Enterprise Vocabulary Services and is fully compatible with, and represented in, the Medical Dictionary for Regulatory Activities. The terminology is intended to mature with use, user feedback, and optimization.

  3. Diagnosis of potential stressors adversely affecting benthic ...

    EPA Pesticide Factsheets

    Greenwich Bay is an urbanized embayment of Narragansett Bay potentially impacted by multiple stressors. The present study identified the important stressors affecting Greenwich Bay benthic fauna. First, existing data and information were used to confirm that the waterbody was impaired. Second, the presence of source, stressor, and effect were established. Then linkages between source, stressor, and effect were developed. This allows identification of probable stressors adversely affecting the waterbody. Three pollutant categories were assessed: chemicals, nutrients, and suspended sediments. This weight of evidence approach indicated that Greenwich Bay was primarily impacted by eutrophication-related stressors. The sediments of Greenwich Bay were carbon enriched and low dissolved oxygen concentrations were commonly seen, especially in the western portions of Greenwich Bay. The benthic community was depauperate, as would be expected under oxygen stress. Although our analysis indicated that contaminant loads in Greenwich Bay were at concentrations where adverse effects might be expected, no toxicity was observed, as a result of high levels of organic carbon in these sediments reducing contaminant bioavailability. Our analysis also indicated that suspended sediment impacts were likely nonexistent for much of the Bay. This analysis demonstrates that the diagnostic procedure was useful to organize and assess the potential stressors impacting the ecological well-being

  4. Consumer reporting of adverse events following immunization

    PubMed Central

    Clothier, Hazel J; Selvaraj, Gowri; Easton, Mee Lee; Lewis, Georgina; Crawford, Nigel W; Buttery, Jim P

    2014-01-01

    Surveillance of adverse events following immunisation (AEFI) is an essential component of vaccine safety monitoring. The most commonly utilized passive surveillance systems rely predominantly on reporting by health care providers (HCP). We reviewed adverse event reports received in Victoria, Australia since surveillance commencement in July 2007, to June 2013 (6 years) to ascertain the contribution of consumer (vaccinee or their parent/guardian) reporting to vaccine safety monitoring and to inform future surveillance system development directions. Categorical data included were: reporter type; serious and non-serious AEFI category; and, vaccinee age group. Chi-square test and 2-sample test of proportions were used to compare categories; trend changes were assessed using linear regression. Consumer reporting increased over the 6 years, reaching 21% of reports received in 2013 (P <0.001), most commonly for children aged less than 7 years. Consumer reports were 5% more likely to describe serious AEFI than HCP (P = 0.018) and 10% more likely to result in specialist clinic attendance (P <0.001). Although online reporting increased to 32% of all report since its introduction in 2010, 85% of consumers continued to report by phone. Consumer reporting of AEFI is a valuable component of vaccine safety surveillance in addition to HCP reporting. Changes are required to AEFI reporting systems to implement efficient consumer AEFI reporting, but may be justified for their potential impact on signal detection sensitivity. PMID:25483686

  5. Accelerating Adverse Outcome Pathway (AOP) development ...

    EPA Pesticide Factsheets

    The Adverse Outcome Pathway (AOP) framework is increasingly being adopted as a tool for organizing and summarizing the mechanistic information connecting molecular perturbations by environmental stressors with adverse outcomes relevant for ecological and human health outcomes. However, the conventional process for assembly of these AOPs is time and resource intensive, and has been a rate limiting step for AOP use and development. Therefore computational approaches to accelerate the process need to be developed. We previously developed a method for generating computationally predicted AOPs (cpAOPs) by association mining and integration of data from publicly available databases. In this work, a cpAOP network of ~21,000 associations was established between 105 phenotypes from TG-GATEs rat liver data from different time points (including microarray, pathological effects and clinical chemistry data), 994 REACTOME pathways, 688 High-throughput assays from ToxCast and 194 chemicals. A second network of 128,536 associations was generated by connecting 255 biological target genes from ToxCast to 4,980 diseases from CTD using either HT screening activity from ToxCast for 286 chemicals or CTD gene expression changes in response to 2,330 chemicals. Both networks were separately evaluated through manual extraction of disease-specific cpAOPs and comparison with expert curation of the relevant literature. By employing data integration strategies that involve the weighting of n

  6. PUTATIVE ADVERSE OUTCOME PATHWAY FOR INHIBITON ...

    EPA Pesticide Factsheets

    The adverse outcome pathway (AOP) provides a framework for organizing knowledge to define links between a molecular initiating event (MIE) and an adverse outcome (AO) occurring at a higher level of biological organization, such as the individual or population. The AOP framework proceeds from a general (e.g., not chemical specific) molecular mode of action, designated as a MIE, through stepwise changes in biological status, defined as key events (KEs), to a final AO that can be used in risk assessment. Because aromatase-inhibiting pharmaceuticals are widely used to treat breast cancer patients, we explored the unintended consequences that might occur in fish exposed to these chemicals through wastewater discharge into the aquatic environment. Unlike mammals, fish have two isoforms of aromatase, one that predominates in the ovary (cyp19a1a) and a second (cyp19a1b) that prevails in the brain. Aromatase activity in fish brain can be 100 to 1000 times that in mammals and is associated with reproduction. We have developed a putative AOP for inhibition of brain aromatase in fish leading to reproductive dysfunction based on review of relevant literature and reproductive experiments with the marine fish cunner (Tautogolabrus adspersus) exposed to aromatase-inhibiting pharmaceuticals in the laboratory. The first KE in this AOP is a decrease in brain aromatase activity due to exposure to an aromatase inhibitor. KEs then progress through subsequent steps including decreas

  7. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  8. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  9. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  10. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  11. 19 CFR 181.116 - Petition regarding adverse marking decision.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... for NAFTA Review of Adverse Marking Decision” and shall be signed by the exporter, producer or his... other than the principal. (c) Content. The Petition for NAFTA Review of Adverse Marking Decision...

  12. Adverse Outcome Pathways – Tailoring Development to Support Use

    EPA Science Inventory

    Adverse Outcome Pathways (AOPs) represent an ideal framework for connecting high-throughput screening (HTS) data and other toxicity testing results to adverse outcomes of regulatory importance. The AOP Knowledgebase (AOP-KB) captures AOP information to facilitate the development,...

  13. Adverse outcome pathway (AOP) development I: Strategies and principles

    EPA Science Inventory

    An adverse outcome pathway (AOP) is a conceptual framework that organizes existing knowledge concerning biologically plausible, and empirically-supported, links between molecular-level perturbation of a biological system and an adverse outcome at a level of biological organizatio...

  14. Adverse Outcome Pathway (AOP) Network Development for Fatty Liver

    EPA Science Inventory

    Adverse outcome pathways (AOPs) are descriptive biological sequences that start from a molecular initiating event (MIE) and end with an adverse health outcome. AOPs provide biological context for high throughput chemical testing and further prioritize environmental health risk re...

  15. Patient stratification and identification of adverse event correlations in the space of 1190 drug related adverse events

    PubMed Central

    Roitmann, Eva; Eriksson, Robert; Brunak, Søren

    2014-01-01

    Purpose: New pharmacovigilance methods are needed as a consequence of the morbidity caused by drugs. We exploit fine-grained drug related adverse event information extracted by text mining from electronic medical records (EMRs) to stratify patients based on their adverse events and to determine adverse event co-occurrences. Methods: We analyzed the similarity of adverse event profiles of 2347 patients extracted from EMRs from a mental health center in Denmark. The patients were clustered based on their adverse event profiles and the similarities were presented as a network. The set of adverse events in each main patient cluster was evaluated. Co-occurrences of adverse events in patients (p-value < 0.01) were identified and presented as well. Results: We found that each cluster of patients typically had a most distinguishing adverse event. Examination of the co-occurrences of adverse events in patients led to the identification of potentially interesting adverse event correlations that may be further investigated as well as provide further patient stratification opportunities. Conclusions: We have demonstrated the feasibility of a novel approach in pharmacovigilance to stratify patients based on fine-grained adverse event profiles, which also makes it possible to identify adverse event correlations. Used on larger data sets, this data-driven method has the potential to reveal unknown patterns concerning adverse event occurrences. PMID:25249979

  16. Depicting adverse events in cardiac theatre: the preliminary conception of the RECORD model

    PubMed Central

    2013-01-01

    Human error is a byproduct of the human activity and may results in random unintended events; they may have major consequences when it comes to delivery of medicine. Furthermore the causes of error in surgical practice are multifaceted and complex. This article aims to raise awareness for safety measures in the cardiac surgical room and briefly “touch upon” the human factors that could lead to adverse outcomes. Finally, we describe a model that would enable us to depict and study adverse events in the operating theatre. PMID:23510398

  17. Is there evidence that recent consolidation in the health insurance industry has adversely affected premiums?

    PubMed

    Kopit, William G

    2004-01-01

    James Robinson suggests that recent consolidation in the insurance market has been a cause of higher health insurance prices (premiums). Although the recent consolidation among health insurers and rising premiums are indisputable, it is unlikely that consolidation has had any adverse effect on premiums nationwide, and Robinson provides no data that suggest otherwise. Specifically, he does not present data showing an increase in concentration in any relevant market during the past few years, let alone any resulting increase in premiums. Health insurance consolidation in certain local markets could adversely affect premiums, but it seems clear that it is not a major national antitrust issue.

  18. Adversity and Resilience: A Synthesis of International Research

    ERIC Educational Resources Information Center

    Noltemeyer, Amity L.; Bush, Kevin R.

    2013-01-01

    Children and adolescents worldwide experience a variety of adversities that have the potential to disrupt typical development. However, some of these individuals exhibit resilience, evidencing normal development in the face of adversity. Here we review research on these constructs of risk, adversity, and resilience; synthesize international…

  19. 36 CFR 800.5 - Assessment of adverse effects.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 36 Parks, Forests, and Public Property 3 2010-07-01 2010-07-01 false Assessment of adverse effects... PROTECTION OF HISTORIC PROPERTIES The section 106 Process § 800.5 Assessment of adverse effects. (a) Apply criteria of adverse effect. In consultation with the SHPO/THPO and any Indian tribe or Native...

  20. 21 CFR 606.170 - Adverse reaction file.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 21 Food and Drugs 7 2012-04-01 2012-04-01 false Adverse reaction file. 606.170 Section 606.170... Adverse reaction file. Link to an amendment published at 77 FR 18, Jan. 3, 2012. (a) Records shall be maintained of any reports of complaints of adverse reactions regarding each unit of blood or blood...