Science.gov

Sample records for 30-day clinical outcomes

  1. Discharge Outcomes in Seniors Hospitalized for More than 30 Days

    ERIC Educational Resources Information Center

    Kozyrskyj, Anita; Black, Charlyn; Chateau, Dan; Steinbach, Carmen

    2005-01-01

    Hospitalization is a sentinel event that leads to loss of independence for many seniors. This study of long-stay hospitalizations (more than 30 days) in seniors was undertaken to identify risk factors for not going home, to characterize patients with risk factors who did go home and to describe one year outcomes following home discharge. Using…

  2. Utility of Socioeconomic Status in Predicting 30-Day Outcomes After Heart Failure Hospitalization

    PubMed Central

    Eapen, Zubin J.; McCoy, Lisa A.; Fonarow, Gregg C.; Yancy, Clyde W.; Miranda, Marie Lynn; Peterson, Eric D.; Califf, Robert M.; Hernandez, Adrian F.

    2015-01-01

    Background An individual's socioeconomic status (SES) is associated with health outcomes and mortality, yet it is unknown whether accounting for SES can improve risk-adjustment models for 30-day outcomes among Centers for Medicare & Medicaid Services (CMS) beneficiaries hospitalized with heart failure (HF). Methods and Results We linked clinical data on hospitalized HF patients in the Get With The Guidelines®-HF™ database (01/2005–12/2011) with CMS claims and county-level SES data from the 2012 Area Health Resources Files. We compared the discriminatory capabilities of multivariable models that adjusted for SES, patient, and/or hospital characteristics to determine whether county-level SES data improved prediction or changed hospital rankings for 30-day all-cause mortality and rehospitalization. After adjusting for patient and hospital characteristics, median household income (per $5,000 increase) was inversely associated with odds of 30-day mortality (OR 0.97, 95% CI 0.95–1.00, p=0.032), and the percentage of persons with at least a high school diploma (per 5 unit increase) was associated with lower odds of 30-day rehospitalization (OR 0.95, 95% CI 0.91–0.99).After adjustment for county-level SES data, relative to whites, Hispanic ethnicity (OR 0.70, 95% CI 0.58, 0.83) and black race (OR 0.57, 95% CI: 0.50–0.65) remained significantly associated with lower 30-day mortality, but had similar 30-day rehospitalization. County-level SES did not improve risk adjustment or change hospital rankings for 30-day mortality or rehospitalization. Conclusions County-level SES data are modestly associated with 30-day outcomes for CMS beneficiaries hospitalized with HF, but do not improve risk adjustment models based on patient characteristics alone. PMID:25747700

  3. READMIT: a clinical risk index to predict 30-day readmission after discharge from acute psychiatric units.

    PubMed

    Vigod, Simone N; Kurdyak, Paul A; Seitz, Dallas; Herrmann, Nathan; Fung, Kinwah; Lin, Elizabeth; Perlman, Christopher; Taylor, Valerie H; Rochon, Paula A; Gruneir, Andrea

    2015-02-01

    Our aim was to create a clinically useful risk index, administered prior to discharge, for determining the probability of psychiatric readmission within 30 days of hospital discharge for general psychiatric inpatients. We used population-level sociodemographic and health administrative data to develop a predictive model for 30-day readmission among adults discharged from an acute psychiatric unit in Ontario, Canada (2008-2011), and converted the final model into a risk index system. We derived the predictive model in one-half of the sample (n = 32,749) and validated it in the other half of the sample (n = 32,750). Variables independently associated with 30-day readmission (forming the mnemonic READMIT) were: (R) Repeat admissions; (E) Emergent admissions (i.e. harm to self/others); (D) Diagnoses (psychosis, bipolar and/or personality disorder), and unplanned Discharge; (M) Medical comorbidity; (I) prior service use Intensity; and (T) Time in hospital. Each 1-point increase in READMIT score (range 0-41) increased the odds of 30-day readmission by 11% (odds ratio 1.11, 95% CI 1.10-1.12). The index had moderate discriminative capacity in both derivation (C-statistic = 0.631) and validation (C-statistic = 0.630) datasets. Determining risk of psychiatric readmission for individual patients is a critical step in efforts to address the potentially avoidable high rate of this negative outcome. The READMIT index provides a framework for identifying patients at high risk of 30-day readmission prior to discharge, and for the development, evaluation and delivery of interventions that can assist with optimizing the transition to community care for patients following psychiatric discharge.

  4. 30-Day Mortality in Acute Pulmonary Embolism: Prognostic Value of Clinical Scores and Anamnestic Features

    PubMed Central

    Bach, Andreas Gunter; Taute, Bettina-Maria; Baasai, Nansalmaa; Wienke, Andreas; Meyer, Hans Jonas; Schramm, Dominik; Surov, Alexey

    2016-01-01

    Purpose Identification of high-risk patients with pulmonary embolism is vital. The aim of the present study was to examine clinical scores, their single items, and anamnestic features in their ability to predict 30-day mortality. Materials and Methods A retrospective, single-center study from 06/2005 to 01/2010 was performed. Inclusion criteria were presence of pulmonary embolism, availability of patient records and 30-day follow-up. The following clinical scores were calculated: Acute Physiology and Chronic Health Evaluation II, original and simplified pulmonary embolism severity index, Glasgow Coma Scale, and euroSCORE II. Results In the study group of 365 patients 39 patients (10.7%) died within 30 days due to pulmonary embolism. From all examined scores and parameters the best predictor of 30-day mortality were the Glasgow Coma scale (≤ 10) and parameters of the circulatory system including presence of mechanical ventilation, arterial pH (< 7.335), and systolic blood pressure (< 99 mm Hg). Conclusions Easy to ascertain circulatory parameters have the same or higher prognostic value than the clinical scores that were applied in this study. From all clinical scores studied the Glasgow Coma Scale was the most time- and cost-efficient one. PMID:26866472

  5. Examination of hospital characteristics and patient quality outcomes using four inpatient quality indicators and 30-day all-cause mortality.

    PubMed

    Carretta, Henry J; Chukmaitov, Askar; Tang, Anqi; Shin, Jihyung

    2013-01-01

    The study objective was to examine hospital mortality outcomes and structure using 2008 patient-level discharges from general community hospitals. Discharges from Florida administrative files were merged to the state mortality registry. A cross-sectional analysis of inpatient mortality was conducted using Inpatient Quality Indicators (IQIs) for acute myocardial infarction (AMI), congestive heart failure (CHF), stroke, pneumonia, and all-payer 30-day postdischarge mortality. Structural characteristics included bed size, volume, ownership, teaching status, and system affiliation. Outcomes were risk adjusted using 3M APR-DRG. Volume was inversely correlated with AMI, CHF, stroke, and 30-day mortality. Similarities and differences in the direction and magnitude of the relationship of structural characteristics to 30-day postdischarge and IQI mortality measures were observed. Hospital volume was inversely correlated with inpatient mortality outcomes. Other hospital characteristics were associated with some mortality outcomes. Further study is needed to understand the relationship between 30-day postdischarge mortality and hospital quality.

  6. Inclusion of Dynamic Clinical Data Improves the Predictive Performance of a 30-Day Readmission Risk Model in Kidney Transplantation

    PubMed Central

    Taber, David J; Palanisamy, Arun P; Srinivas, Titte R; Gebregziabher, Mulugeta; Odeghe, John; Chavin, Kenneth D; Egede, Leonard E; Baliga, Prabhakar K

    2015-01-01

    Background 30-day readmissions (30DRA) are a highly scrutinized measure of healthcare quality and relatively frequent among kidney transplants (KTX). Development of predictive risk models are critical to reducing 30DRA and improving outcomes. Current approaches rely on fixed variables derived from administrative data. These models may not capture clinical evolution that is critical to predicting outcomes. Methods We directed a retrospective analysis towards: 1) developing parsimonious risk models for 30DRA and 2) comparing efficiency of models based on the use of immutable versus dynamic data. Baseline and in-hospital clinical and outcomes data were collected from adult KTX recipients between 2005 – 12. Risk models were developed using backward logistic regression and compared for predictive efficacy using ROC Curves. Results Of 1,147 KTX patients, 123 had 30DRA. Risk factors for 30DRA included recipient comorbidities, transplant factors, and index hospitalization patient level clinical data. The initial fixed variable model included 9 risk factors and was modestly predictive (AUC 0.64, 95% CI 0.58–0.69). The model was parsimoniously reduced to 6 risks, which remained modestly predictive (AUC 0.63, 95% CI 0.58–0.69). The initial predictive model using 13 fixed and dynamic variables was significantly predictive (AUC 0.73, 95% CI 0.67–0.80), with parsimonious reduction to 9 variables maintaining predictive efficacy (AUC 0.73, 95% CI 0.67–0.79). The final model using dynamically evolving clinical data outperformed the model using static variables (p=0.009). Internal validation demonstrated the final model was stable with minimal bias. Conclusion We demonstrate that modeling dynamic clinical data outperformed models utilizing immutable data in predicting 30DRA. PMID:25594549

  7. 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.

  8. Income inequality and 30 day outcomes after acute myocardial infarction, heart failure, and pneumonia: retrospective cohort study

    PubMed Central

    Lagu, Tara; Rothberg, Michael B; Avrunin, Jill; Pekow, Penelope S; Wang, Yongfei; Krumholz, Harlan M

    2013-01-01

    Objectives To examine the association between income inequality and the risk of mortality and readmission within 30 days of hospitalization. Design Retrospective cohort study of Medicare beneficiaries in the United States. Hierarchical, logistic regression models were developed to estimate the association between income inequality (measured at the US state level) and a patient’s risk of mortality and readmission, while sequentially controlling for patient, hospital, other state, and patient socioeconomic characteristics. We considered a 0.05 unit increase in the Gini coefficient as a measure of income inequality. Setting US acute care hospitals. Participants Patients aged 65 years and older, and hospitalized in 2006-08 with a principal diagnosis of acute myocardial infarction, heart failure, or pneumonia. Main outcome measures Risk of death within 30 days of admission or rehospitalization for any cause within 30 days of discharge. The potential number of excess deaths and readmissions associated with higher levels of inequality in US states in the three highest quarters of income inequality were compared with corresponding data in US states in the lowest quarter. Results Mortality analyses included 555 962 admissions (4348 hospitals) for acute myocardial infarction, 1 092 285 (4484) for heart failure, and 1 146 414 (4520); readmission analyses included 553 037 (4262), 1 345 909 (4494), and 1 345 909 (4524) admissions, respectively. In 2006-08, income inequality in US states (as measured by the average Gini coefficient over three years) varied from 0.41 in Utah to 0.50 in New York. Multilevel models showed no significant association between income inequality and mortality within 30 days of admission for patients with acute myocardial infarction, heart failure, or pneumonia. By contrast, income inequality was associated with rehospitalization (acute myocardial infarction, risk ratio 1.09 (95% confidence interval 1.03 to 1.15), heart failure 1

  9. 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

    ... Center (CC), National Institutes of Health, may not conduct or sponsor, and the respondent is not...--Existing collection in use without OMB control number--Clinical Center, National Institutes of Health...

  10. 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

  11. North vs south differences in acute peptic ulcer hemorrhage in Croatia: hospitalization incidence trends, clinical features, and 30-day case fatality

    PubMed Central

    Ljubičić, Neven; Pavić, Tajana; Budimir, Ivan; Puljiz, Željko; Bišćanin, Alen; Bratanić, Andre; Nikolić, Marko; Hrabar, Davor; Troskot, Branko

    2014-01-01

    Aim To assess the seven-year trends of hospitalization incidence due to acute peptic ulcer hemorrhage (APUH) and associated risk factors, and examine the differences in these trends between two regions in Croatia. Methods The study collected sociodemographic, clinical, and endoscopic data on 2204 patients with endoscopically confirmed APUH who were admitted to the Clinical Hospital Center “Sestre Milosrdnice,” Zagreb and Clinical Hospital Center Split between January 1, 2005 and December 31, 2011. We determined hospitalization incidence rates, 30-day case fatality rate, clinical outcomes, and incidence-associated factors. Results No differences were observed in APUH hospitalization incidence rates between the regions. Age-standardized one-year cumulative APUH hospitalization incidence rate calculated using the European Standard Population was significantly higher in Zagreb than in Split region (43.2/100 000 vs 29.2/100,000). A significantly higher APUH hospitalization incidence rates were observed in the above 65 years age group. Overall 30-day case fatality rate was 4.9%. Conclusion The hospitalization incidence of APUH in two populations did not change over the observational period and it was significantly higher in the Zagreb region. The incidence of acute duodenal ulcer hemorrhage also remained unchanged, whereas the incidence of acute gastric ulcer hemorrhage increased. The results of this study allow us to monitor epidemiological indicators of APUH and compare data with other countries. PMID:25559836

  12. Preventing 30-day readmissions.

    PubMed

    Stevens, Sherri

    2015-03-01

    Preventing 30-day readmissions to hospitals is a top priority in the era of health care reform. New regulations will be costly to health care facilities because of payment guidelines. The most frequently readmitted medical conditions are acute myocardial infarction, heart failure, and pneumonia. The transition from the hospital and into the home has been classified as a vulnerable time for many patients. During this time of transition patients may fail to fully understand their discharge instructions. Ineffective communication, low health literacy, and compliance issues contribute to readmissions. Telehealth and the use of technology may be used to prevent some readmissions.

  13. 78 FR 21130 - Submission for OMB Review; 30-day Comment Request: The Clinical Trials Reporting Program (CTRP...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-09

    ... Clinical Trials Reporting Program (CTRP) Database (NCI) SUMMARY: Under the provisions of Section 3507(a)(1... writing. Proposed Collection: The Clinical Trials Reporting Program (CTRP) Database, 0925-0600, Expiration... Health (NIH). Need and Use of Information Collection: The Clinical Trials Reporting Program (CTRP) is...

  14. Prediction of 30-day mortality after hip fracture surgery by the Nottingham Hip Fracture Score and the Surgical Outcome Risk Tool.

    PubMed

    Marufu, T C; White, S M; Griffiths, R; Moonesinghe, S R; Moppett, I K

    2016-05-01

    The care of the elderly with hip fractures and their outcomes might be improved with resources targeted by the accurate calculation of risks of mortality and morbidity. We used a multicentre national dataset to evaluate and recalibrate the Nottingham Hip Fracture Score and Surgical Outcome Risk Tool. We split 9,017 hip fracture cases from the Anaesthesia Sprint Audit of Practice into derivation and validation data sets and used logistic regression to derive new model co-efficients for death at 30 postoperative days. The area (95% CI) under the receiver operator characteristic curve of 0.71 (0.67-0.75) indicated acceptable discrimination by the Nottingham Hip Fracture Score and acceptable calibration fit (Hosmer-Lemeshow test), p = 0.23, with a similar discrimination by the Surgical Outcome Risk Tool, 0.70 (0.66-0.74), which was miscalibrated to the observed data, p = 0.001. We recommend that studies test these scores for patients with hip fractures in other countries. We also recommend these models are compared with case-mix adjustment tools used in the UK.

  15. 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

  16. Prevalence and Impact of Co-morbidity Burden as Defined by the Charlson Co-morbidity Index on 30-Day and 1- and 5-Year Outcomes After Coronary Stent Implantation (from the Nobori-2 Study).

    PubMed

    Mamas, Mamas A; Fath-Ordoubadi, Farzin; Danzi, Gian B; Spaepen, Erik; Kwok, Chun Shing; Buchan, Iain; Peek, Niels; de Belder, Mark A; Ludman, Peter F; Paunovic, Dragica; Urban, Philip

    2015-08-01

    Co-morbidities have typically been considered as prevalent cardiovascular risk factors and cardiovascular diseases rather than systematic measures of general co-morbidity burden in patients who underwent percutaneous coronary intervention (PCI). Charlson co-morbidity index (CCI) is a measure of co-morbidity burden providing a means of quantifying the prognostic impact of 22 co-morbid conditions on the basis of their number and prognostic impact. The study evaluated the impact of the CCI on cardiac mortality and major adverse cardiovascular events (MACE) after PCI through analysis of the Nobori-2 study. The prognostic impact of CCI was studied in 3,067 patients who underwent PCI in 4,479 lesions across 125 centers worldwide on 30-day and 1- and 5-year cardiac mortality and MACE. Data were adjusted for potential confounders using stepwise logistic regression; 2,280 of 3,067 patients (74.4%) had ≥1 co-morbid conditions. CCI (per unit increase) was independently associated with an increase in both cardiac death (odds ratio [OR] 1.47 95% confidence interval [CI] 1.20 to 1.80, p = 0.0002) and MACE (OR 1.29 95% CI 1.14 to 1.47, p ≤0.0011) at 30 days, with similar observations recorded at 1 and 5 years. CCI score ≥2 was independently associated with increased 30-day cardiac death (OR 4.25, 95% CI 1.24 to 14.56, p = 0.02) at 1 month, and this increased risk was also observed at 1 and 5 years. In conclusion, co-morbid burden, as measured using CCI, is an independent predictor of adverse outcomes in the short, medium, and long term. Co-morbidity should be considered in the decision-making process when counseling patients regarding the periprocedural risks associated with PCI, in conjunction with traditional risk factors.

  17. Reducing 30-day Readmission After Joint Replacement.

    PubMed

    Chambers, Monique C; El-Othmani, Mouhanad M; Anoushiravani, Afshin A; Sayeed, Zain; Saleh, Khaled J

    2016-10-01

    Hospital readmission is a focus of quality measures used by the Center for Medicare and Medicaid (CMS) to evaluate quality of care. Policy changes provide incentives and enforce penalties to decrease 30-day hospital readmissions. CMS implemented the Readmission Penalty Program. Readmission rates are being used to determine reimbursement rates for physicians. The need for readmission is deemed an indication for inadequate quality of care subjected to financial penalties. This reviews identifies risk factors that have been significantly associated with higher readmission rates, addresses approaches to minimize 30-day readmission, and discusses the potential future direction within this area as regulations evolve.

  18. Reducing 30-day Readmission After Joint Replacement.

    PubMed

    Chambers, Monique C; El-Othmani, Mouhanad M; Anoushiravani, Afshin A; Sayeed, Zain; Saleh, Khaled J

    2016-10-01

    Hospital readmission is a focus of quality measures used by the Center for Medicare and Medicaid (CMS) to evaluate quality of care. Policy changes provide incentives and enforce penalties to decrease 30-day hospital readmissions. CMS implemented the Readmission Penalty Program. Readmission rates are being used to determine reimbursement rates for physicians. The need for readmission is deemed an indication for inadequate quality of care subjected to financial penalties. This reviews identifies risk factors that have been significantly associated with higher readmission rates, addresses approaches to minimize 30-day readmission, and discusses the potential future direction within this area as regulations evolve. PMID:27637653

  19. Comparison of robotic and laparoscopic colorectal resections with respect to 30-day perioperative morbidity

    PubMed Central

    Feinberg, Adina E.; Elnahas, Ahmad; Bashir, Shaheena; Cleghorn, Michelle C.; Quereshy, Fayez A.

    2016-01-01

    Background Robotic surgery has emerged as a minimally invasive alternative to traditional laparoscopy. Robotic surgery addresses many of the technical and ergonomic limitations of laparoscopic surgery, but the literature regarding clinical outcomes in colorectal surgery is limited. We sought to compare robotic and laparoscopic colorectal resections with respect to 30-day perioperative outcomes. Methods The American College of Surgeons National Surgical Quality Improvement Program database was used to identify all patients who underwent robotic or laparoscopic colorectal surgery in 2013. We performed a logistic regression analysis to compare intraoperative variables and 30-day outcomes. Results There were 8392 patients who underwent laparoscopic colorectal surgery and 472 patients who underwent robotic colorectal surgery. The robotic cohort had a lower incidence of unplanned intraoperative conversion (9.5% v. 13.7%, p = 0.008). There were no significant differences between robotic and laparoscopic surgery with respect to other intraoperative and postoperative outcomes, such as operative duration, length of stay, postoperative ileus, anastomotic leak, venous thromboembolism, wound infection, cardiac complications and pulmonary complications. On multivariable analysis, robotic surgery was protective for unplanned conversion, while male sex, malignancy, Crohn disease and diverticular disease were all associated with open conversion. Conclusion Robotic colorectal surgery has comparable 30-day perioperative morbidity to laparoscopic surgery and may decrease the rate of intraoperative conversion in select patients. PMID:27240135

  20. 75 FR 45121 - Agency Information Collection Request; 30-Day Public Comment Request; 30-Day Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-02

    ... 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; 30-Day Notice... Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human...

  1. 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.

  2. Risk Factors for 30-Day Hospital Readmission among General Surgery Patients

    PubMed Central

    Kassin, Michael T; Owen, Rachel M; Perez, Sebastian; Leeds, Ira; Cox, James C; Schnier, Kurt; Sadiraj, Vjollca; Sweeney, John F

    2012-01-01

    Background Hospital readmission within 30-days of an index hospitalization is receiving increased scrutiny as a marker of poor quality patient care. This study identifies factors associated with 30-day readmission following General Surgery procedures. Study Design Using standard National Surgical Quality Improvement Project (NSQIP) protocol, preoperative, intraoperative, and postoperative outcomes were collected on patients undergoing inpatient General Surgery procedures at a single academic center between 2009 and 2011. Data were merged with our institutional clinical data warehouse to identify unplanned 30-day readmissions. Demographics, comorbidities, type of procedure, postoperative complications, and ICD-9 coding data were reviewed for patients who were readmitted. Univariate and multivariate analysis was utilized to identify risk factors associated with 30-day readmission. Results 1442 General Surgery patients were reviewed. 163 (11.3%) were readmitted within 30 days of discharge. The most common reasons for readmission were gastrointestinal complaint/complication (27.6%), surgical infection (22.1%), and failure to thrive/malnutrition (10.4%). Comorbidities associated with risk of readmission included disseminated cancer, dyspnea, and preoperative open wound (p<0.05 for all variables). Surgical procedures associated with higher rates of readmission included pancreatectomy, colectomy, and liver resection. Postoperative occurrences leading to increased risk of readmission were blood transfusion, postoperative pulmonary complication, wound complication, sepsis/shock, urinary tract infection, and vascular complications. Multivariable analysis demonstrates that the most significant independent risk factor for readmission is the occurrence of any postoperative complication (OR 4.20, 95% CI 2.89–6.13). Conclusions Risk factors for readmission after General Surgery procedures are multi-factorial; however, postoperative complications appear to drive readmissions in

  3. 30-day Mortality after Bariatric Surgery: Independently Adjudicated Causes of Death in the Longitudinal Assessment of Bariatric Surgery

    PubMed Central

    Smith, Mark D.; Patterson, Emma; Wahed, Abdus S.; Belle, Steven H.; Berk, Paul D.; Courcoulas, Anita P.; Dakin, Gregory F.; Flum, David R.; Machado, Laura; Mitchell, James E.; Pender, John; Pomp, Alfons; Pories, Walter; Ramanathan, Ramesh; Schrope, Beth; Staten, Myrlene; Ude, Akuezunkpa; Wolfe, Bruce M.

    2011-01-01

    Purpose Mortality following bariatric surgery is a rare event in contemporary series, making it difficult for any single center to draw meaningful conclusions as to cause of death. Nevertheless, much of the published mortality data come from single center case series and reviews of administrative databases. These sources tend to produce lower mortality estimates than those obtained from controlled clinical trials. Furthermore, information about the causes of death and how they were determined is not always available. The aim of the present report is to describe in detail all deaths occurring within 30-days of surgery in the Longitudinal Assessment of Bariatric Surgery (LABS). Methods LABS is a 10-center observational cohort study of bariatric surgical outcomes. Data were collected prospectively for bariatric surgeries performed between March 2005 and April 2009. All deaths occurring within 30-days of surgery were identified, and cause of death assigned by an independent Adjudication Subcommittee, blinded to operating surgeon and site. Results 6118 patients underwent primary bariatric surgery. 18 deaths (0.3%) occurred within 30-days of surgery. The most common cause of death was sepsis (33% of deaths), followed by cardiac causes (28%) and pulmonary embolism (17%). For one patient cause of death could not be determined despite examination of all available information. Conclusions This study confirms the low 30-day mortality rate following bariatric surgery. The recognized complications of anastomotic leak, cardiac events, and pulmonary emboli accounted for the majority of 30-day deaths. PMID:21866378

  4. 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

  5. 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

  6. Comparing three clinical prediction rules for primarily predicting the 30-day mortality of patients with pulmonary embolism: The “Simplified Revised Geneva Score,” the “Original PESI,” and the “Simplified PESI”

    PubMed Central

    Tamizifar, Babak; Fereyduni, Farid; Esfahani, Morteza Abdar; Kheyri, Saeed

    2016-01-01

    Background: Patients with suspected pulmonary embolism (PE) should be evaluated for the clinical probability of PE using an applicable risk score. The Geneva prognostic score, the PE Severity Index (PESI), and its simplified version (sPESI) are well-known clinical prognostic scores for PE. The purpose of this study was to analyze these clinical scores as prognostic tools. Materials and Methods: A historical cohort study was conducted on patients with acute PE in Al-Zahra Teaching Hospital, Isfahan, Iran, from June 2013 to August 2014. To compare survival in the 1-month follow-up and factor-analyze mortality from the survival graph, Kaplan–Meier, and log-rank logistic regression were applied. Results: Two hundred and twenty four patients were assigned to two “low risk” and “high risk” groups using the three versions of “Simplified PESI, Original PESI, and Simplified Geneva.” They were followed for a period of 1 month after admission. The overall mortality rate within 1 month from diagnosis was about 24% (95% confidence interval, 21.4–27.2). The mortality rate of low risk PE patients was about 4% in the PESI, 17% in the Geneva, and <1% in the simplified PESI scales (P < 0.005). The mortality rate among high risk patients was 33%, 33.5%, and 27.5%, respectively. Conclusions: Among patients with acute PE, the simplified PESI model was able to accurately predict mortality rate for low risk patients. Among high risk patients, however, the difference between the three models in predicting prognosis was not significant. PMID:27656606

  7. Comparing three clinical prediction rules for primarily predicting the 30-day mortality of patients with pulmonary embolism: The “Simplified Revised Geneva Score,” the “Original PESI,” and the “Simplified PESI”

    PubMed Central

    Tamizifar, Babak; Fereyduni, Farid; Esfahani, Morteza Abdar; Kheyri, Saeed

    2016-01-01

    Background: Patients with suspected pulmonary embolism (PE) should be evaluated for the clinical probability of PE using an applicable risk score. The Geneva prognostic score, the PE Severity Index (PESI), and its simplified version (sPESI) are well-known clinical prognostic scores for PE. The purpose of this study was to analyze these clinical scores as prognostic tools. Materials and Methods: A historical cohort study was conducted on patients with acute PE in Al-Zahra Teaching Hospital, Isfahan, Iran, from June 2013 to August 2014. To compare survival in the 1-month follow-up and factor-analyze mortality from the survival graph, Kaplan–Meier, and log-rank logistic regression were applied. Results: Two hundred and twenty four patients were assigned to two “low risk” and “high risk” groups using the three versions of “Simplified PESI, Original PESI, and Simplified Geneva.” They were followed for a period of 1 month after admission. The overall mortality rate within 1 month from diagnosis was about 24% (95% confidence interval, 21.4–27.2). The mortality rate of low risk PE patients was about 4% in the PESI, 17% in the Geneva, and <1% in the simplified PESI scales (P < 0.005). The mortality rate among high risk patients was 33%, 33.5%, and 27.5%, respectively. Conclusions: Among patients with acute PE, the simplified PESI model was able to accurately predict mortality rate for low risk patients. Among high risk patients, however, the difference between the three models in predicting prognosis was not significant.

  8. 30-Day morbidity after augmentation enterocystoplasty and appendicovesicostomy: a NSQIP pediatric analysis

    PubMed Central

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

    2015-01-01

    Summary Introduction Augmentation enterocystoplasty and appendicovesicostomy are complex pediatric urologic procedures. Although there is literature identifying long-term outcomes in these patients, the reporting of short-term postoperative outcomes has been limited by small numbers of cases and lack of prospective data collection. Here we report 30-day outcomes from the first nationally based, prospectively assembled cohort of pediatric patients undergoing these procedures. Objective To determine 30-day complication, readmission and reoperation after augmentation enterocystoplasty and appendicovesicostomy in a large national sample of pediatric patients, and to explore the association between preoperative and intraoperative characteristics and occurrence of any 30-day event. Study design We queried the 2012 and 2013 American College of Surgeons National Surgical Quality Improvement Program Pediatric database (ACS-NSQIPP) for all patients undergoing augmentation enterocystoplasty and/or appendicovesicostomy. Surgical risk score was classified on a linear scale using a validated pediatric-specific comorbidity score. Intraoperative characteristics and postoperative 30-day events were reported from prospectively collected data. A composite measure of complication, readmission and/or reoperation was used as primary outcome for the multivariate logistic regression. Results There were 461 patients included in the analysis: 245 had appendicovesicostomy, 97 had augmentation enterocystoplasty and 119 had both procedures. There were a total of 110 NSQIP complications seen in 87 patients. The most common complication was urinary tract infection(see Table for 30-day outcomes by patient). The composite measure of any 30-day event was seen in 27.8% of the cohort and this was associated with longer operative time, increased number of procedures done at time of primary surgical procedure and higher surgical risk score. Discussion The ACS-NSQIPP provides a tool to examine short

  9. Evaluation of a Pharmacist-Specific Intervention on 30-Day Readmission Rates for High-Risk Patients with Pneumonia

    PubMed Central

    Carroll, Douglas N.; Pinner, Nathan A.

    2015-01-01

    Background: Pharmacist interventions have been shown to have an impact on reducing readmission rates, however further research is necessary to target resources to high-risk populations and determine the most effective bundle of interventions. Objective: To evaluate the effect of a pharmacist-bundled intervention on 30-day readmission rates for high-risk patients with pneumonia. Methods: A pilot study with a historical control conducted at a community, teaching-affiliated medical center. Up to 65 selected subjects were included if they had pneumonia and any of the following high-risk criteria: admission within 6 months, at least 5 scheduled home medications, chronic obstructive pulmonary disease (COPD), or heart failure. A retrospective chart review was conducted to compile the historical control group that received usual care between June and November 2013. Patients admitted from December 2013 through March 2014 were reviewed to receive a bundled intervention. The primary outcome was 30-day readmission rates. Risk factors and reasons for readmission, pharmacist clinical interventions, and the time interval between discharge and readmission were also evaluated. Results: A trend toward a reduced 30-day readmission rate was observed in the intervention group (n = 43) compared to those who received usual care (n = 65) (27.9% vs 40.0%; relative risk [RR], 0.6977; 95% CI, 0.3965–1.2278; P = .2119). The most commonly identified high-risk inclusion criteria were having at least 5 scheduled home medications and COPD. The time interval between discharge and readmission did not considerably differ between groups (10.8 vs 10.6 days). Conclusions: The pharmacist-bundled intervention was associated with a reduced 30-day readmission rate for high-risk patients with pneumonia. PMID:26823619

  10. Utilization of trained volunteers decreases 30-day readmissions for heart failure.

    PubMed

    Sales, Virna L; Ashraf, Muhammad Salman; Lella, Leela K; Huang, Jiaxin; Bhumireddy, Geetha; Lefkowitz, Lance; Feinstein, Mimi; Kamal, Mikail; Caesar, Raqib; Cusick, Elizabeth; Norenberg, Jane; Lee, Jiwon; Brener, Sorin; Sacchi, Terrence J; Heitner, John F

    2014-05-01

    Background: This study evaluated the effectiveness of using trained volunteer staff in reducing 30-day readmissions of congestive heart failure (CHF) patients.Methods: From June 2010 to December 2010, 137 patients (mean age 73 years) hospitalized for CHF were randomly assigned to either: an interventional arm (arm A) receiving dietary and pharmacologic education by a trained volunteer, follow-up telephone calls within 48 hours, and a month of weekly calls; ora control arm (arm B) receiving standard care. Primary outcomes were 30-day readmission rates for CHF and worsening New York Heart Association (NYHA) functional classification; composite and all-cause mortality were secondary outcomes.Results: Arm A patients had decreased 30-day readmissions (7% vs 19%; P ! .05) with a relative risk reduction (RRR) of 63% and an absolute risk reduction (ARR) of 12%. The composite outcome of 30-day readmission, worsening NYHA functional class, and death was decreased in the arm A (24% vs 49%;P ! .05; RRR 51%, ARR 25%). Standard-care treatment and hypertension, age $65 years and hypertension,and cigarette smoking were predictors of increased risk for readmissions, worsening NYHA functional class, and all-cause mortality, respectively, in the multivariable analysis.Conclusions: Utilizing trained volunteer staff to improve patient education and engagement might be an efficient and low-cost intervention to reduce CHF readmissions.

  11. Associations between Depressive Symptoms and 30-day Hospital Readmission among Older Adults

    PubMed Central

    Berges, Ivonne M.; Amr, Sania; Abraham, Danielle S.; Cannon, Dawn L.; Ostir, Glenn V.

    2015-01-01

    Background Hospital readmissions are common and costly. Our goal was to determine the association between depressive symptoms and readmission within 30 days following hospital discharge in older adults. Methods We analyzed data from a study of 789 persons aged 65 years or older admitted to a 20-bed acute care for elders (ACE) hospital unit from May 2009 to July 2011. Depressive symptoms were recorded within 24-hours of admission to the hospital unit, using the Center for Epidemiologic Studies -Depression (CES-D) Scale. The primary outcome was readmission to hospital within 30 days of discharge. Results The mean age was 77 years; 66% were female, 72% were White, and 59% were unmarried. On average, older patients reported 2.6 comorbid conditions. Sixteen percent were classified with high depressive symptoms (CES-D ≥ 16). The readmission rate within 30 days was 15%. Older patients with high depressive symptoms had more than 1.6 times the odds (OR 1.66; 95% CI: 1.01-2.74) of being readmitted within 30-days, as compared to those with low depressive symptoms (CES-D < 16), after adjustment for age, race/ethnicity, sex, marital status and comorbid conditions. Conclusion High depressive symptoms increased the risk of hospital readmission within 30 days of discharge after adjusting for relevant covariates. In-hospital screening for depressive symptoms may identify older persons at risk for recurrent hospital admissions. PMID:27134802

  12. Clinical Outcome of Hypertensive Uveitis

    PubMed Central

    Lewkowicz, Deborah; Willermain, François; Relvas, Lia Judice; Makhoul, Dorine; Janssens, Sarah; Janssens, Xavier; Caspers, Laure

    2015-01-01

    Purpose. To review the clinical outcome of patients with hypertensive uveitis. Methods. Retrospective review of uveitis patients with elevated intraocular pressure (IOP) > 25 mmHg and >1-year follow-up. Data are uveitis type, etiology, viral (VU) and nonviral uveitis (NVU), IOP, and medical and/or surgical treatment. Results. In 61 patients, IOP values are first 32.9 mmHg (SD: 9.0), highest 36.6 mmHg (SD: 9.9), 3 months after the first episode 19.54 mmHg (SD: 9.16), and end of follow-up 15.5 mmHg (SD: 6.24). Patients with VU (n = 25) were older (50.6 y/35.7 y, p = 0.014) and had more unilateral disease (100%/72.22%  p = 0.004) than those with NVU (n = 36). Thirty patients (49.2%) had an elevated IOP before topical corticosteroid treatment. Patients with viral uveitis might have higher first elevated IOP (36.0/27.5 mmHg, p = 0,008) and maximal IOP (40.28/34.06 mmHg, p = 0.0148) but this was not significant when limited to the measurements before the use of topical corticosteroids (p = 0.260 and 0.160). Glaucoma occurred in 15 patients (24.59%) and was suspected in 11 (18.03%) without difference in viral and nonviral groups (p = 0.774). Conclusion. Patients with VU were older and had more unilateral hypertensive uveitis. Glaucoma frequently complicates hypertensive uveitis. Half of the patients had an elevated IOP before topical corticosteroid treatment. PMID:26504598

  13. Clinical Outcome Measures in Chiari I Malformation.

    PubMed

    Yarbrough, Chester K; Greenberg, Jacob K; Park, Tae Sung

    2015-10-01

    Chiari malformation type 1 (CM-I) is a common and often debilitating neurologic disease. Reliable evaluation of treatments has been hampered by inconsistent use of clinical outcome measures. A variety of outcome measurement tools are available, although few have been validated in CM-I. The recent development of the Chicago Chiari Outcome Scale and the Chiari Symptom Profile provides CM-I-specific instruments to measure outcomes in adults and children, although validation and refinement may be necessary.

  14. 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,...

  15. 75 FR 160 - Paperwork Reduction Act; 30-Day Notice

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-04

    ... From the Federal Register Online via the Government Publishing Office 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 the collection of information concerning...

  16. Anastomotic leaks after colorectal anastomosis occurring more than 30 days postoperatively: a single-institution evaluation.

    PubMed

    Tan, Wei Phin; Hong, En Yaw; Phillips, Benjamin; Isenberg, Gerald A; Goldstein, Scott D

    2014-09-01

    National hospital registries only report colorectal anastomotic leaks (ALs) within 30 days postoperatively. The aim of our study was to determine the incidence and significance of ALs that occur beyond 30 days postoperatively. We performed a retrospective review of our prospective database from June 2008 to August 2012. A total of 504 patients were included. These patients were operated on by two surgeons. Any clinical or radiographic abnormalities were considered to be an anastomotic imperfection. A total of 504 patients were reviewed with a total of 18 (3.6%) anastomotic leaks. Six leaks (31.6% of leaks) were diagnosed more than 30 days postoperatively (P < 0.001). Of the 18 leaks, interventional radiology drainage was performed for four cases and 14 patients required reoperation. All six delayed leaks required reoperation. There was one leak that occurred under 30 days, which was discovered on autopsy. The median follow-up was 12 months (range, 1 to 4 months). All the delayed leak patients presented with fistulas, whereas 58 per cent of typical leak patients presented with the triad of leukocytosis, fever, and abdominal pain. Colorectal anastomotic leaks can occur after the 30-day postoperative period. In patients with vague and atypical abdominal findings, anastomotic leak must be suspected. More systematic, prospective studies are required to help us further understand the risk factors and natural history of anastomotic failures in elective colorectal surgery.

  17. Neurocognition: clinical and functional outcomes in schizophrenia.

    PubMed

    Lepage, Martin; Bodnar, Michael; Bowie, Christopher R

    2014-01-01

    Schizophrenia is characterized by significant heterogeneity in outcome. The last decades have witnessed a significant interest in identifying factors that can moderate or influence clinical and functional outcomes in people with schizophrenia. One factor of particular interest is neurocognition, as performance on various measures of cognitive abilities, such as memory, attention, and executive functions, have been consistently related to functional outcome and, to a lesser extent, clinical outcome. This review aims to provide an up-to-date description of recent studies examining the association between neurocognition and clinical and (or) functional outcomes. In the first section, studies examining neurocognitive performance in relation to clinical outcome are examined. When clinical outcome is defined dichotomously (for example, comparing remitted and nonremitted), verbal memory performance consistently exhibits a strong association with clinical status, with the poor outcome group showing the largest deficits. In the second section, studies exploring the relation between neurocognition and various dimensions of functional outcome are reviewed. These dimensions include independent living, social functioning, and vocational functioning, among others. Again, a strong link between neurocognitive deficits and impairments in several aspects of functioning clearly emerges from this review. Finally, several measurement issues are discussed that pertain to the need to standardize definitions of clinical and (or) functional outcomes, the importance of defining cognitive domains consistently across studies, and distinguishing between one's competence to perform tasks and what one actually does in everyday life. Addressing these measurement issues will be key to studies examining the development of effective interventions targeting neurocognitive functions and their impact on clinical and functional outcomes.

  18. Thinking About Clinical Outcomes in Medicaid

    PubMed Central

    Weimar, Dawn; Gray, Jeffrey; Davies, Bud

    2016-01-01

    As Medicaid expands in scope and influence, it is evolving toward being a “purchaser” of quality health care. This commentary discusses measurement and incentivization of clinical outcomes in Medicaid. Advantages and disadvantages of outcome versus process measures are discussed. Distinctions are drawn between the roles of Medicare and Medicaid, including the implications of the growth in Medicaid managed care. Medicaid's influence is particularly notable for obstetric, pediatric, newborn, and long-term care. We provide data on 3 Medicaid outcomes: potentially preventable hospital admissions, readmissions, and complications. The commentary concludes with suggestions for choosing and implementing outcome-oriented value-based purchasing initiatives in Medicaid. PMID:26945295

  19. Thinking About Clinical Outcomes in Medicaid.

    PubMed

    Quinn, Kevin; Weimar, Dawn; Gray, Jeffrey; Davies, Bud

    2016-01-01

    As Medicaid expands in scope and influence, it is evolving toward being a "purchaser" of quality health care. This commentary discusses measurement and incentivization of clinical outcomes in Medicaid. Advantages and disadvantages of outcome versus process measures are discussed. Distinctions are drawn between the roles of Medicare and Medicaid, including the implications of the growth in Medicaid managed care. Medicaid's influence is particularly notable for obstetric, pediatric, newborn, and long-term care. We provide data on 3 Medicaid outcomes: potentially preventable hospital admissions, readmissions, and complications. The commentary concludes with suggestions for choosing and implementing outcome-oriented value-based purchasing initiatives in Medicaid.

  20. Dendritic cell immunotherapy: clinical outcomes

    PubMed Central

    Apostolopoulos, Vasso; Pietersz, Geoffrey A; Tsibanis, Anastasios; Tsikkinis, Annivas; Stojanovska, Lily; McKenzie, Ian FC; Vassilaros, Stamatis

    2014-01-01

    The use of tumour-associated antigens for cancer immunotherapy studies is exacerbated by tolerance to these self-antigens. Tolerance may be broken by using ex vivo monocyte-derived dendritic cells (DCs) pulsed with self-antigens. Targeting tumour-associated antigens directly to DCs in vivo is an alternative and simpler strategy. The identification of cell surface receptors on DCs, and targeting antigens to DC receptors, has become a popular approach for inducing effective immune responses against cancer antigens. Many years ago, we demonstrated that targeting the mannose receptor on macrophages using the carbohydrate mannan to DCs led to appropriate immune responses and tumour protection in animal models. We conducted Phase I, I/II and II, clinical trials demonstrating the effectiveness of oxidised mannan-MUC1 in patients with adenocarcinomas. Here we summarise DC targeting approaches and their efficacy in human clinical trials. PMID:25505969

  1. Liposomal bupivacaine and clinical outcomes.

    PubMed

    Tong, Yi Cai Isaac; Kaye, Alan David; Urman, Richard D

    2014-03-01

    In the multimodal approach to the management of postoperative pain, local infiltration and regional blocks have been increasingly utilized for pain control. One of the limitations of local anesthetics in the postoperative setting is its relatively short duration of action. Multivesicular liposomes containing bupivacaine have been increasingly utilized for their increased duration of action. Compared with bupivacaine HCl, local infiltration of liposomal bupivacaine has shown to have an increase in duration of action and causes delay in peak plasma concentration. In this article, we attempt to review the clinical literature surrounding liposomal bupivacaine and its evolving role in perioperative analgesia. This new bupivacaine formation may have promising implications in postoperative pain control, resulting in increased patient satisfaction and a decrease in both hospital stay and opioid-induced adverse events (AEs). Although more studies are needed, the preliminary clinical trials suggest that liposomal bupivacaine has predictable pharmacokinetics, a similar side effect profile compared with bupivacaine HCl, and is effective in providing increased postoperative pain control.

  2. Cirrhosis is Associated with an Increased 30-Day Mortality After Venous Thromboembolism

    PubMed Central

    Søgaard, Kirstine Kobberøe; Horváth-Puhó, Erzsébet; Montomoli, Jonathan; Vilstrup, Hendrik; Sørensen, Henrik Toft

    2015-01-01

    Objectives: Patients with cirrhosis are at increased risk of venous thromboembolism (VTE), but the impact of cirrhosis on the clinical course following VTE is unclear. In a nationwide cohort study, we examined 30-day mortality among patients with cirrhosis and VTE. Methods: We used Danish population-based health-care databases (1994–2011) to identify patients with incident VTE, i.e., deep venous thrombosis (DVT), pulmonary embolism (PE), and portal vein thrombosis (PVT). Among these, we identified 745 patients with cirrhosis and 3647 patients without cirrhosis (matched on gender, year of birth, calendar year of VTE diagnosis and VTE type). We assessed the 30-day mortality risk among VTE patients with and without cirrhosis, and the mortality rate ratios (MRRs), using an adjusted Cox model with 95% confidence interval. We obtained information on immediate cause of death for patients who died within 30 days after VTE. Results: The 30-day mortality risk for DVT was 7% for patients with cirrhosis and 3% for patients without cirrhosis. Corresponding PE-related mortality risks were 35% and 16%, and PVT-related mortality risks were 19% and 15%, respectively. The adjusted 30-day MRRs were 2.17 (1.24–3.79) for DVT, 1.83 (1.30–2.56) for PE, and 1.30 (0.80–2.13) for PVT. Though overall mortality was higher in patients with cirrhosis than patients without cirrhosis, the proportions of deaths due to PE were similar among patients (25% and 24%, respectively). Conclusions: Cirrhosis is a predictor for increased short-term mortality following VTE, with PE as the most frequent cause of death. PMID:26133110

  3. Assessing clinical ethics consultation: processes and outcomes.

    PubMed

    Batten, Jason

    2013-06-01

    The vast majority of hospitals use clinical ethics consultation (CEC) as a service to address ethical issues in patient care. Both proponents and critics alike recognize a need to evaluate CEC. I review three outcomes of CEC that have been formally evaluated: healthcare cost, clinical indicators in the intensive care unit, and user satisfaction. These outcome indicators cannot be used to evaluate the worth of CEC because they are contingent and outside of the consultant's control. However, the failure of outcomes-based assessment poses no threat to CEC since the service is continually justified by the fundamental necessity of resolving ethical problems in patient care. While outcome indicators can be used as heuristics to investigate quality issues in CEC, process indicators can capture the quality of CEC more directly. Therefore, further research should be directed toward developing process-based conceptual models for CEC and various methods for assessing these processes. PMID:23967789

  4. Pulmonary Embolism in Ischemic Stroke: Clinical Presentation, Risk Factors, and Outcome

    PubMed Central

    Pongmoragot, Jitphapa; Rabinstein, Alejandro A.; Nilanont, Yongchai; Swartz, Richard H.; Zhou, Limei; Saposnik, Gustavo

    2013-01-01

    Background Limited information is available on the frequency of pulmonary embolism (PE) in patients with an acute ischemic stroke (AIS). We evaluated clinical characteristics, predisposing factors, and outcomes in AIS patients with PE. Methods and Results We included all AIS patients admitted to participating institutions in the Registry of the Canadian Stroke Network. Clinically PE was documented by a physician and confirmed by computed tomography pulmonary angiography within 30 days of the stroke case index. The primary outcome was death or disability at discharge. Secondary outcomes included disposition, length of hospital stay, mortality at 3 months and 1 year. Among 11 287 patients with AIS, PE was found in 89 (0.78%) patients. History of cancer, deep vein thrombosis (DVT)/PE, and DVT during the hospitalization were associated with PE. PE was associated with higher risk of death at 30 days (25.8% versus 13.6%; P<0.001), at 1 year (47.2% versus 24.6%; P<0.001), and disability at discharge (85.4% versus 63.6%; P<0.001). Mean length of stay was longer in stroke patients with PE (36 versus 16 days; P=0.001). After adjusting for age, sex, and stroke severity, PE remained associated with lower survival at 30 days and 1 year, and death or disability at discharge (OR 3.02; 95% CI 1.56 to 5.83). Conclusions In this large cohort study, PE occurred in nearly 1% of AIS patients. PE was more common in patients with severe stroke, history of cancer, previous DVT/PE or acute DVT and associated with lower short‐ and long‐term survival, greater disability, and longer length of stay. PMID:24275627

  5. Predicting Clinical Outcomes Using Molecular Biomarkers

    PubMed Central

    Burke, Harry B.

    2016-01-01

    Over the past 20 years, there has been an exponential increase in the number of biomarkers. At the last count, there were 768,259 papers indexed in PubMed.gov directly related to biomarkers. Although many of these papers claim to report clinically useful molecular biomarkers, embarrassingly few are currently in clinical use. It is suggested that a failure to properly understand, clinically assess, and utilize molecular biomarkers has prevented their widespread adoption in treatment, in comparative benefit analyses, and their integration into individualized patient outcome predictions for clinical decision-making and therapy. A straightforward, general approach to understanding how to predict clinical outcomes using risk, diagnostic, and prognostic molecular biomarkers is presented. In the future, molecular biomarkers will drive advances in risk, diagnosis, and prognosis, they will be the targets of powerful molecular therapies, and they will individualize and optimize therapy. Furthermore, clinical predictions based on molecular biomarkers will be displayed on the clinician’s screen during the physician–patient interaction, they will be an integral part of physician–patient-shared decision-making, and they will improve clinical care and patient outcomes. PMID:27279751

  6. Clinical and fiscal outcomes of utilization review.

    PubMed

    Murray, Mary Ellen; Darmody, Julie V

    2004-01-01

    Concurrent utilization review (UR) is both a quality improvement tool and a cost containment strategy used by managed care organizations. The UR process requires that providers (hospital staff) communicate clinical information about hospitalized patients to payers who evaluate the appropriateness and medical necessity of the planned care. Payers then make a decision whether to certify the care for reimbursement. This study provides data to indicate that denials of certification have little impact on clinical and fiscal outcomes of patient care. PMID:14740580

  7. Carbapenem Breakpoints for Acinetobacter baumannii Group: Supporting Clinical Outcome Data from Patients with Bacteremia.

    PubMed

    Lee, Yi-Tzu; Chiang, Mei-Chun; Kuo, Shu-Chen; Wang, Yung-Chih; Lee, I-Hsin; Chen, Te-Li; Yang, Ya-Sung

    2016-01-01

    The carbapenem breakpoints set by different organizations for Acinetobacter are discordant, but supporting clinical data are lacking. This study aimed to provide the first clinical outcome data to support the carbapenem breakpoints for Acinetobacter baumannii (Ab) group in patients with bacteremia. This study included 117 adults who received carbapenems for treatment of Ab group bacteremia in Taipei Veterans General Hospital over an 8-year period. We analyzed 30-day mortality rates among patient groups acquiring isolates with different carbapenem minimal inhibitory concentrations (MICs). The carbapenem MIC breakpoint derived from classification and regression tree (CART) analysis to delineate the risk of 30-day mortality was between MICs of ≤ 4 mg/L and ≥ 8 mg/L. Mortality rate was higher in patients acquiring isolates with carbapenem MIC ≥ 8 mg/L than ≤ 4 mg/L, by bivariate (54.9% [28/51] vs 25.8% [17/66]; P = 0.003) and survival analysis (P = 0.001 by log-rank test). Multivariate analysis using logistic regression and Cox regression models including severity of illness indices demonstrated that treating patients with Ab group bacteremia caused by isolates with a carbapenem MIC ≥ 8 mg/L with carbapenem was an independent predictor of 30-day mortality (odds ratio, 5.125; 95% confidence interval [CI], 1.946-13.498; P = 0.001, and hazard ratio, 2.630; 95% CI, 1.431-4.834; P = 0.002, respectively). The clinical outcome data confirmed that isolates with MIC ≤ 4 mg/L were susceptible to carbapenem, and those with MIC ≥ 8 mg/L were resistant in patients with Ab group bacteremia. PMID:27644087

  8. Carbapenem Breakpoints for Acinetobacter baumannii Group: Supporting Clinical Outcome Data from Patients with Bacteremia

    PubMed Central

    Lee, Yi-Tzu; Chiang, Mei-Chun; Kuo, Shu-Chen; Wang, Yung-Chih; Lee, I-Hsin; Chen, Te-Li; Yang, Ya-Sung

    2016-01-01

    The carbapenem breakpoints set by different organizations for Acinetobacter are discordant, but supporting clinical data are lacking. This study aimed to provide the first clinical outcome data to support the carbapenem breakpoints for Acinetobacter baumannii (Ab) group in patients with bacteremia. This study included 117 adults who received carbapenems for treatment of Ab group bacteremia in Taipei Veterans General Hospital over an 8-year period. We analyzed 30-day mortality rates among patient groups acquiring isolates with different carbapenem minimal inhibitory concentrations (MICs). The carbapenem MIC breakpoint derived from classification and regression tree (CART) analysis to delineate the risk of 30-day mortality was between MICs of ≤ 4 mg/L and ≥ 8 mg/L. Mortality rate was higher in patients acquiring isolates with carbapenem MIC ≥ 8 mg/L than ≤ 4 mg/L, by bivariate (54.9% [28/51] vs 25.8% [17/66]; P = 0.003) and survival analysis (P = 0.001 by log-rank test). Multivariate analysis using logistic regression and Cox regression models including severity of illness indices demonstrated that treating patients with Ab group bacteremia caused by isolates with a carbapenem MIC ≥ 8 mg/L with carbapenem was an independent predictor of 30-day mortality (odds ratio, 5.125; 95% confidence interval [CI], 1.946–13.498; P = 0.001, and hazard ratio, 2.630; 95% CI, 1.431–4.834; P = 0.002, respectively). The clinical outcome data confirmed that isolates with MIC ≤ 4 mg/L were susceptible to carbapenem, and those with MIC ≥ 8 mg/L were resistant in patients with Ab group bacteremia. PMID:27644087

  9. Impact of periprocedural atrial fibrillation on short-term clinical outcomes following percutaneous coronary intervention.

    PubMed

    Chan, William; Ajani, Andrew E; Clark, David J; Stub, Dion; Andrianopoulos, Nick; Brennan, Angela L; New, Gishel; Sebastian, Martin; Johnston, Rozanne; Walton, Antony; Reid, Christopher M; Dart, Anthony M; Duffy, Stephen J

    2012-02-15

    There are few data on the incidence and clinical outcomes of patients with atrial fibrillation (AF) treated in the era of percutaneous coronary intervention (PCI). We analyzed 30-day clinical outcomes in 3,307 consecutive patients with and without AF (sinus rhythm) undergoing PCI from January 2007 through December 2008 enrolled in a multicenter Australian registry. Periprocedural AF was present in 162 patients (4.9%). AF was associated with older age (74.1 ± 8.9 vs 63.9 ± 11.9 years, p <0.001), higher baseline serum creatinine (0.13 ± 0.14 vs 0.10 ± 0.13 mmol/L, p = 0.01), and lower left ventricular ejection fraction (49.5 ± 13.2% vs 53.4% ± 11.6%, p <0.001). Significantly more patients with AF had a history of heart failure and cerebrovascular and peripheral arterial diseases (p ≤0.01 for all comparisons). Periprocedural glycoprotein IIb/IIIa inhibitor (31.5% vs 31.4%, p = 0.98) and antithrombin use were not different between groups, but in-hospital bleeding complications were higher in patients with AF (5.0% vs 2.1%, p = 0.015). Fewer patients with AF received drug-eluting stents (p = 0.004). AF was associated with a greater than fourfold increase in 30-day mortality (9.9% vs 2.2%, p <0.0001) and readmission rates at 30 days (p = 0.01). Fewer patients with AF were on dual antiplatelet therapy at 30 days (86.3% vs 94.3%, p <0.0001), although 28.1% of patients with AF were on triple therapy (dual antiplatelet therapy plus oral anticoagulation). In conclusion, patients with periprocedural AF represent a very high-risk group. Excess 30-day morbidity and mortality after PCI may be due to the higher incidence of co-morbidities, bleeding complications, and suboptimal antiplatelet therapy.

  10. Influence of psychiatric comorbidity on 30-day readmissions for heart failure, myocardial infarction, and pneumonia

    PubMed Central

    Ahmedani, Brian K.; Solberg, Leif I.; Copeland, Laurel; Fang, Ying; Stewart, Christine; Hu, Jianhui; Nerenz, David R.; Williams, L. Keoki; Cassidy-Bushrow, Andrea E.; Waxmonsky, Jeanette; Lu, Christine Y.; Waitzfelder, Beth E.; Owen-Smith, Ashli A.; Coleman, Karen J.; Lynch, Frances L.; Ahmed, Ameena T.; Beck, Arne L.; Rossom, Rebecca C.; Simon, Gregory E.

    2014-01-01

    Objective The Centers for Medicare and Medicaid Services (CMS) implemented a policy in 2012 that penalizes hospitals for ‘excessive’ all-cause hospital readmissions within 30 days after discharge for heart failure (HF), acute myocardial infarction (AMI), and pneumonia. The aim of this study is to investigate the influence of psychiatric comorbidities on 30-day all-cause readmissions for heart failure, acute myocardial infarction, and pneumonia. Methods Longitudinal study from 2009-2011 within 11 Mental Health Research Network (MHRN) affiliated health systems. Data were derived from the HMO Research Network Virtual Data Warehouse. Participants were individuals admitted to the hospital for HF, AMI, and pneumonia. All index inpatient hospitalizations for HF, AMI and pneumonia were captured (n=160,169 patient index admissions). Psychiatric diagnoses were measured for the year prior to admission. All-cause readmissions within 30 days of discharge were the outcome variable. Results Approximately 18% of all individuals with these conditions were readmitted within 30-days. The rate was 5% greater for individuals with a past-year psychiatric comorbidity (21.7%) than for those without (16.5%; p<.001). Depression, anxiety, and dementia were associated with more readmissions for those with index hospitalizations for all three conditions independently and combined (p<.05). Substance use and bipolar disorders were linked with higher readmissions for those with initial HF and pneumonia hospitalizations (p<.05). Readmission rates declined overall from 2009-2011. Conclusions Individuals with HF, AMI, and pneumonia experience high rates of readmission, but psychiatric comorbidities appear to increase that risk. Future readmission interventions should consider adding mental health components. PMID:25642610

  11. Risk factors for 30-day readmission following hypoglycemia-related emergency room and inpatient admissions

    PubMed Central

    Emons, M F; Bae, J P; Hoogwerf, B J; Kindermann, S L; Taylor, R J; Nathanson, B H

    2016-01-01

    Objective Hypoglycemia is a serious complication of diabetes treatment. This retrospective observational study characterized hypoglycemia-related hospital emergency room (ER) and inpatient (in-pt) admissions and identified risk factors for 30-day all-cause and hypoglycemia-related readmission. Research design and methods 4476 hypoglycemia-related ER and in-pt encounters with discharge dates from 1/1/2009 to 3/31/2014 were identified in a large, multicenter electronic health record database. Outcomes were 30-day all-cause ER/hospital readmission and hypoglycemia-related readmission. Multivariable logistic regression methods identified risk factors for both outcomes. Results 1095 (24.5%) encounters had ER/hospital all-cause readmission within 30 days and 158 (14.4%) of these were hypoglycemia-related. Predictors of all-cause 30-day readmission included recent exposure to a hospital/nursing home (NH)/skilled nursing facility (SNF; OR 1.985, p<0.001); age 25–34 and 35–44 (OR 2.334 and 1.996, respectively, compared with age 65–74, both p<0.001); and African-American (AA) race versus all other race categories (OR 1.427, p=0.011). Other factors positively associated with readmission include chronic obstructive pulmonary disease, cerebrovascular disease, cardiac dysrhythmias, congestive heart disease, hypertension, and mood disorders. Predictors of readmissions attributable to hypoglycemia included recent exposure to a hospital/NH/SNF (OR 2.299, p<0.001), AA race (OR 1.722, p=0.002), age 35–44 (OR 3.484, compared with age 65–74, p<0.001), hypertension (OR 1.891, p=0.019), and delirium/dementia and other cognitive disorders (OR 1.794, p=0.038). Obesity was protective against 30-day hypoglycemia-related readmission (OR 0.505, p=0.017). Conclusions Factors associated with 30-day all-cause and hypoglycemia-related readmission among patients with diabetic hypoglycemia include recent exposure to hospital/SNF/NH, adults <45 years, AAs, and several cardiovascular and

  12. Clinical outcome measures for Cutaneous Lupus Erythematosus

    PubMed Central

    Albrecht, Joerg; Werth, Victoria P.

    2011-01-01

    Cutaneous lupus erythematosus is a clinically heterogeneous group of rare skin diseases that only rarely have been subjected to controlled clinical trials. This may be have been partly due to a lack of suitable validated outcome instruments. Recently the FDA mandated that organ specific trials for lupus erythematosus need to use a combination of different outcome measures. The patient’s condition needs to be assessed in terms of quality of life, the patient’s global response and organ specific instruments that measure activity of the disease as well as damage due to the disease. For the skin the only formally validated and published instrument is currently the Cutaneous Lupus Erythematosis Disease Area and Severity Index (CLASI). This paper discusses the background of the development of the CLASI as well as issues related to its use and interpretation in the context of clinical research of CLE. PMID:20693208

  13. Fundamentals of Clinical Outcomes Assessment for Spinal Disorders: Clinical Outcome Instruments and Applications

    PubMed Central

    Vavken, Patrick; Ganal-Antonio, Anne Kathleen B.; Quidde, Julia; Shen, Francis H.; Chapman, Jens R.; Samartzis, Dino

    2015-01-01

    Study Design A broad narrative review. Objectives Outcome assessment in spinal disorders is imperative to help monitor the safety and efficacy of the treatment in an effort to change the clinical practice and improve patient outcomes. The following article, part two of a two-part series, discusses the various outcome tools and instruments utilized to address spinal disorders and their management. Methods A thorough review of the peer-reviewed literature was performed, irrespective of language, addressing outcome research, instruments and tools, and applications. Results Numerous articles addressing the development and implementation of health-related quality-of-life, neck and low back pain, overall pain, spinal deformity, and other condition-specific outcome instruments have been reported. Their applications in the context of the clinical trial studies, the economic analyses, and overall evidence-based orthopedics have been noted. Additional issues regarding the problems and potential sources of bias utilizing outcomes scales and the concept of minimally clinically important difference were discussed. Conclusion Continuing research needs to assess the outcome instruments and tools used in the clinical outcome assessment for spinal disorders. Understanding the fundamental principles in spinal outcome assessment may also advance the field of “personalized spine care.” PMID:26225283

  14. Usefulness of transient and persistent no reflow to predict adverse clinical outcomes following percutaneous coronary intervention.

    PubMed

    Chan, William; Stub, Dion; Clark, David J; Ajani, Andrew E; Andrianopoulos, Nick; Brennan, Angela L; New, Gishel; Black, Alexander; Shaw, James A; Reid, Christopher M; Dart, Anthony M; Duffy, Stephen J

    2012-02-15

    The no reflow phenomenon is reported to occur in >2% of all percutaneous coronary interventions (PCIs) and portends a poor prognosis. We analyzed data from 5,286 consecutive patients who underwent PCI from the Melbourne Interventional Group (MIG) registry from April 2004 through January 2008 who had 30-day follow-up completed. Patients without no reflow (normal reflow, n = 5,031) were compared to 255 (4.8%) with no reflow (n = 217 for transient no reflow, n = 38 for persistent no reflow). Patients with transient or persistent no reflow were more likely to present with ST-elevation myocardial infarction (MI) or cardiogenic shock (p <0.0001 for the 2 comparisons). They were also more likely to have complex lesions (American College of Cardiology/American Heart Association type B2/C), have lesions within a bypass graft, require an intra-aortic balloon pump, receive glycoprotein IIb/IIIa inhibition, and have a longer mean stent length (p <0.0001 for all comparisons). In-hospital outcomes were significantly worse in those patients with transient or persistent no reflow, with increased death, periprocedural MI, renal impairment, and major adverse cardiac events (p <0.0001 for all comparisons). Similarly, transient and persistent no reflow portended worse 30-day clinical outcomes, with a progressive increase in mortality (normal reflow 1.7% vs transient no reflow 5.5% vs persistent no reflow 13.2%, p <0.0001), MI, target vessel revascularization, and major adverse cardiac events (p <0.0001 for all comparisons) compared to patients with normal flow. In conclusion, transient or persistent no reflow complicates approximately 1 in 20 PCIs and results in stepwise increases in in-hospital and 30-day adverse outcomes.

  15. Carotid baroreflex response following 30 days exposure to simulated microgravity

    NASA Technical Reports Server (NTRS)

    Convertino, V. A.; Doerr, D. F.; Eckberg, D. L.; Fritsch, J. M.; Vernikos-Danellis, J.

    1989-01-01

    The mechanism of the carotid-baroreflex response to weightlessness was investigated in human subjects exposed to simulated microgravity (30 days of 6-day head-down bed rest followed by 5 days of recovery). Baroreceptor-cardiac reflex responses were elicited by a complex sequence of pressure changes delivered to a neck chamber device. The shape of the sigmoid baroreceptor-cardiac response curve was examined for alterations and the occurrence of resetting, as well as for a possible association of the impaired baroreflex function with hypotension during the postexposure orthostatic stress. It was found that the exposure to head-down bed rest caused a significant shift on the R-R interval axis, which paralleled reductions and elevations in baseline HR such that the baseline R-R (operational point) remained in the same position on the response curve. This shift in the location of the reflex relation indicates a significant resetting of the carotid baroreceptors, which may represent an appropriate adaptation which contributes to the maintenance of a constant resting arterial blood pressure before, during, and after bed rest, observed in these study.

  16. Clinical outcome of transcatheter arterial embolization with N-butyl-2-cyanoacrylate for control of acute gastrointestinal tract bleeding.

    PubMed

    Koo, Hyun Jung; Shin, Ji Hoon; Kim, Hwa Jung; Kim, Jinoo; Yoon, Hyun-Ki; Ko, Gi-Young; Gwon, Dong Il

    2015-03-01

    OBJECTIVE. The purpose of this article is to evaluate the clinical effectiveness of trans-catheter arterial embolization (TAE) with N-butyl-2-cyanoacrylate (NBCA), with or without other embolic materials for acute nonvariceal gastrointestinal tract bleeding, and to determine the factors associated with clinical outcomes. MATERIALS AND METHODS. TAE using NBCA only or in conjunction with other materials was performed for 102 patients (80 male and 22 female patients; mean age, 61.3 years) with acute nonvariceal gastrointestinal tract bleeding. Technical success, clinical success, and clinical factors, including age, sex, bleeding tendency, endoscopic attempts at hemostasis, number of transfusions, and bleeding causes (i.e., cancer vs noncancer), were retrospectively evaluated. Univariate and multivariable logistic regression analyses were performed to evaluate clinical factors and their ability to predict patient outcomes. Survival curves were obtained using Kaplan-Meier analyses and log-rank tests. RESULTS. There were 36 patients with cancer-related bleeding and 66 with non-cancer-related bleeding. Overall technical and clinical success rates were 100% (102/102) and 76.5% (78/102), respectively. Procedure-related complications included bowel infarction, which was noted in two patients. Recurrent bleeding and bleeding-related 30-day mortality rates were 15.7% (16/102) and 8.8% (9/102), respectively. Cancer-related bleeding increased clinical failure significantly (p = 0.003) and bleeding-related 30-day mortality with marginal significance (p = 0.05). Overall survival was poorer in patients with cancer-related bleeding. CONCLUSION. TAE with NBCA with or without other embolic agents showed high technical and clinical effectiveness in the management of acute nonvariceal gastrointestinal tract bleeding. Cancer-related bleeding was the only factor related to clinical failure, and possibly related to bleeding-related 30-day mortality.

  17. Residential treatment for homeless female veterans with psychiatric and substance use disorders: effect on 1-year clinical outcomes.

    PubMed

    Harpaz-Rotem, Ilan; Rosenheck, Robert A; Desai, Rani

    2011-01-01

    Limited evidence shows that time-limited residential treatment (RT) is beneficial for homeless people with serious mental illness. The Department of Veterans Affairs has established 11 specialty programs for homeless female veterans. We present data comparing 1-year clinical outcomes in a group of veterans who did and did not receive at least 30 days of RT. Clients of the Homeless Women Veterans Programs were invited to participate in a follow-up study. They were interviewed every 3 months for 1 year. Those who received at least 30 days of RT in the 3 months after program entry (RT group) were compared with other program participants (no or <30 days RT [NRT] group) on measures of community functioning, psychiatric symptoms, and drug and alcohol use during the follow-up. The RT group had better outcomes on employment, social support, housing status, and psychiatric symptoms. They also had significantly increased use of drugs and alcohol compared with the NRT group. Data suggest that RT may have a beneficial effect on mental health outcomes in homeless women. This study, in conjunction with others, suggests that provision of stable housing may be an important element of recovery for homeless women with psychiatric problems, excluding substance use.

  18. Clinical Outcomes After Anterior Cruciate Ligament Reconstruction

    PubMed Central

    Tibor, Lisa M.; Long, Joy L.; Schilling, Peter L.; Lilly, Ryan J.; Carpenter, James E.; Miller, Bruce S.

    2010-01-01

    Background: Clinical outcomes of autograft and allograft anterior cruciate ligament (ACL) reconstructions are mixed, with some reports of excellent to good outcomes and other reports of early graft failure or significant donor site morbidity. Objective: To determine if there is a difference in functional outcomes, failure rates, and stability between autograft and allograft ACL reconstructions. Data Sources: Medline, Cochrane Central Register of Controlled Trials (Evidence Based Medicine Reviews Collection), Cochrane Database of Systematic Reviews, Web of Science, CINAHL, and SPORTDiscus were searched for articles on ACL reconstruction. Abstracts from annual meetings of the American Academy of Orthopaedic Surgeons, American Orthopaedic Society for Sports Medicine, and Arthroscopy Association of North America were searched for relevant studies. Study Selection: Inclusion criteria for studies were as follows: primary unilateral ACL injuries, mean patient age less than 41 years, and follow-up for at least 24 months postreconstruction. Exclusion criteria for studies included the following: skeletally immature patients, multiligament injuries, and publication dates before 1990. Data Extraction: Joint stability measures included Lachman test, pivot-shift test, KT-1000 arthrometer assessment, and frequency of graft failures. Functional outcome measures included Tegner activity scores, Cincinnati knee scores, Lysholm scores, and IKDC (International Knee Documentation Committee) total scores. Results: More than 5000 studies were identified. After full text review of 576 studies, 56 were included, of which only 1 directly compared autograft and allograft reconstruction. Allograft ACL reconstructions were more lax when assessed by the KT-1000 arthrometer. For all other outcome measures, there was no statistically significant difference between autograft and allograft ACL reconstruction. For all outcome measures, there was strong evidence of statistical heterogeneity between

  19. 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

  20. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.

    2016-01-01

    Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design. PMID:27602406

  1. The Clinical Outcome Study for dysferlinopathy

    PubMed Central

    Harris, Elizabeth; Bladen, Catherine L.; Mayhew, Anna; James, Meredith; Bettinson, Karen; Moore, Ursula; Smith, Fiona E.; Rufibach, Laura; Cnaan, Avital; Bharucha-Goebel, Diana X.; Blamire, Andrew M.; Bravver, Elena; Carlier, Pierre G.; Day, John W.; Díaz-Manera, Jordi; Eagle, Michelle; Grieben, Ulrike; Harms, Matthew; Jones, Kristi J.; Lochmüller, Hanns; Mendell, Jerry R.; Mori-Yoshimura, Madoka; Paradas, Carmen; Pegoraro, Elena; Pestronk, Alan; Salort-Campana, Emmanuelle; Schreiber-Katz, Olivia; Semplicini, Claudio; Spuler, Simone; Stojkovic, Tanya; Straub, Volker; Takeda, Shin'ich; Rocha, Carolina Tesi; Walter, M.C.

    2016-01-01

    Objective: To describe the baseline clinical and functional characteristics of an international cohort of 193 patients with dysferlinopathy. Methods: The Clinical Outcome Study for dysferlinopathy (COS) is an international multicenter study of this disease, evaluating patients with genetically confirmed dysferlinopathy over 3 years. We present a cross-sectional analysis of 193 patients derived from their baseline clinical and functional assessments. Results: There is a high degree of variability in disease onset, pattern of weakness, and rate of progression. No factor, such as mutation class, protein expression, or age at onset, accounted for this variability. Among patients with clinical diagnoses of Miyoshi myopathy or limb-girdle muscular dystrophy, clinical presentation and examination was not strikingly different. Respiratory impairment and cardiac dysfunction were observed in a minority of patients. A substantial delay in diagnosis was previously common but has been steadily reducing, suggesting increasing awareness of dysferlinopathies. Conclusions: These findings highlight crucial issues to be addressed for both optimizing clinical care and planning therapeutic trials in dysferlinopathy. This ongoing longitudinal study will provide an opportunity to further understand patterns and variability in disease progression and form the basis for trial design.

  2. Vomiting and Hyponatremia Are Risk Factors for Worse Clinical Outcomes Among Patients Hospitalized Due to Nonsurgical Abdominal Pain

    PubMed Central

    Goren, Idan; Israel, Ariel; Carmel-neiderman, Narin n.; Kliers, Iris; Gringauz, Irina; Dagan, Amir; Lavi, Bruno; Segal, Omer; Segal, Gad

    2016-01-01

    Abstract After initial evaluation in the Emergency Department (ED), many patients complaining of abdominal pain are classified as suffering from nonsurgical abdominal pain (NSAP). Clinical characteristics and risk factors for worse prognosis were not published elsewhere. Characterizing the clinical profile of patients hospitalized due to NSAP and identifying predictor variables for worse clinical outcomes. We made a retrospective cohort analysis of patients hospitalized due to NSAP compared to matched control patients (for age, gender, and Charlson comorbidity index) hospitalized due to other, nonsurgical reasons in a ratio of 1 to 10. We further performed in-group analysis of patients admitted due to NSAP in order to appreciate variables (clinical and laboratory parameters) potentially associated with worse clinical outcomes. Overall 23,584 patients were included, of which 2144 were admitted due to NSAP and 21,440 were matched controls. Patients admitted due to NSAP had overall better clinical outcomes: they had lower rates of in-hospital and 30-days mortality (2.8% vs 5.5% and 7.9% vs 10.4% respectively, P < 0.001 for both comparisons). They also had a significantly shorter length of hospital stay (3.9 vs 6.2 days, P < 0.001). Rates of re-hospitalization within 30-days were not significantly different between study groups. Among patients hospitalized due to NSAP, we found that vomiting or hyponatremia at presentation or during hospital stay were associated with worse clinical outcomes. Compared to patients hospitalized due to other, nonsurgical reasons, the overall prognosis of patients admitted due to NSAP is favorable. The combination of NSAP with vomiting and hyponatremia is associated with worse clinical outcomes. PMID:27057886

  3. Creating clinical trial designs that incorporate clinical outcome assessments.

    PubMed

    Gilbert, Mark R; Rubinstein, Lawrence; Lesser, Glenn

    2016-03-01

    Clinical outcome assessments (COAs) are increasingly being used in determining the efficacy of new treatment regimens. This was typified in the recent use of a symptom-based instrument combined with an organ-based measure of response for the approval of ruxolitinib in myelofibrosis. There are challenges in incorporating these COAs into clinical trials, including designating the level of priority, incorporating these measures into a combined or composite endpoint, and dealing with issues related to compliance and interpretation of results accounting for missing data. This article describes the results of a recent panel discussion that attempted to address these issues and provide guidance to the incorporation of COAs into clinical trials, including novel statistical designs, so that the testing of new treatments in patients with cancers of the central nervous system can incorporate these important clinical endpoints. PMID:26989129

  4. Clinical Outcomes Following Revision Anterior Shoulder Stabilization

    PubMed Central

    Frank, Rachel M.; Mellano, Chris; Shin, Jason J.; Feldheim, Terrence F.; Mascarenhas, Randhir; Yanke, Adam Blair; Cole, Brian J.; Nicholson, Gregory P.; Romeo, Anthony A.; Verma, Nikhil N.

    2015-01-01

    Objectives: The purpose of this study was to determine the clinical outcomes following revision anterior shoulder stabilization performed either via all-arthroscopic soft tissue repair or via Latarjet coracoid transfer. Methods: A retrospective review of prospectively collected data on 91 shoulders undergoing revision anterior shoulder stabilization was performed. All patients underwent prior soft tissue stabilization; those with prior open bone grafting procedures were excluded. For patients with 25% glenoid bone loss, Latarjet was performed (n=28). Patients were queried regarding recurrent instability (subluxation or dislocation). Clinical outcomes were evaluated using validated patient reported outcome questionnaires including the American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), visual analog scale (VAS) for pain, and Western Ontario Shoulder Instability Index (WOSI). Results: A total of 63 shoulders in 62 patients (46 males, 16 females) with an average age of 23.2 ± 6.9 years were included in the revision arthroscopy group. At an average follow-up of 46.9 ± 16.8 months (range, 15 to 78), the mean WOSI score was 80.1 (range, 15.0 to 100), and there were significant improvements (p<0.001) in ASES (63.7 to 85.1), SST (6.2 to 9.1), and VAS pain scores (2.89 to 0.81). Recurrent instability occurred in 12 of 63 shoulders (19%); the number of prior surgeries and baseline hyperlaxity were significant risk factors for failure (p<0.001 and p=0.04, respectively). No patients developed clinical or radiographic evidence of arthritis. A total of 28 shoulders in 28 patients (21 male, 7 female) with an average age of 27.5 years (range 14 to 45) were included in the Latarjet group. Thirteen (46%) had more than one previous stabilization attempt. ), the average WOSI score was 71.9, and there were significant improvements (p<0.001) in ASES (65.7 to 87.0), SST (7.2 to 10.3), and VAS (3.1 to 1.1). Recurrent instability occurred in 2 of 28 shoulders

  5. Neighborhood Socioeconomic Disadvantage and 30 Day Rehospitalizations: An Analysis of Medicare Data

    PubMed Central

    Kind, Amy JH; Jencks, Steve; Brock, Jane; Yu, Menggang; Bartels, Christie; Ehlenbach, William; Greenberg, Caprice; Smith, Maureen

    2014-01-01

    Background Measures of socioeconomic disadvantage may enable improved targeting of programs to prevent rehospitalizations, but obtaining such information directly from patients can be difficult. Measures of US neighborhood socioeconomic disadvantage are more readily available, although rarely employed clinically. Objective To evaluate the association between neighborhood socioeconomic disadvantage at the census block-group level, as measured by Singh’s validated Area Deprivation Index (ADI), and 30-day rehospitalization. Design Retrospective cohort study Setting United States Patients Random 5% national sample of fee-for-service Medicare patients discharged with congestive heart failure, pneumonia or myocardial infarction, 2004–2009 (N = 255,744) Measurements 30-day rehospitalizations. Medicare data were linked to 2000 Census data to construct an ADI for each patient’s census block-group, which were then sorted into percentiles by increasing ADI. Relationships between neighborhood ADI grouping and rehospitalization were evaluated using multivariate logistic regression models, controlling for patient sociodemographics, comorbidities/severity, and index hospital characteristics. Results The 30-day rehospitalization rate did not vary significantly across the least disadvantaged 85% of neighborhoods, which had an average rehospitalization rate=21%. However, within the most disadvantaged 15% of neighborhoods, rehospitalization rates rose from 22% to 27% with worsening ADI. This relationship persisted after full adjustment, with the most disadvantaged neighborhoods having a rehospitalization risk (adjusted risk ratio = 1.09, confidence interval 1.05–1.12) similar to that of chronic pulmonary disease (1.06, 1.04–1.08) and greater than that of diabetes (0.95, 0.94–0.97). Limitations No direct markers of care quality, access Conclusions Residence within a disadvantaged US neighborhood is a rehospitalization predictor of magnitude similar to chronic pulmonary

  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. Pediatric multiple sclerosis: Clinical features and outcome.

    PubMed

    Waldman, Amy; Ness, Jayne; Pohl, Daniela; Simone, Isabella Laura; Anlar, Banu; Amato, Maria Pia; Ghezzi, Angelo

    2016-08-30

    Multiple sclerosis (MS) in children manifests with a relapsing-remitting MS (RRMS) disease course. Acute relapses consist of new neurologic deficits persisting greater than 24 hours, in the absence of intercurrent illness, and occur with a higher frequency early in the disease as compared to adult-onset RRMS. Most pediatric patients with MS recover well from these early relapses, and cumulative physical disability is rare in the first 10 years of disease. Brainstem attacks, poor recovery from a single attack, and a higher frequency of attacks portend a greater likelihood of future disability. Although prospective pediatric-onset MS cohorts have been established in recent years, there remains very limited prospective data detailing the longer-term clinical outcome of pediatric-onset MS into adulthood. Whether the advent of MS therapies, and the largely off-label access to such therapies in pediatric MS, has improved prognosis is unknown. MS onset during the key formative academic years, concurrent with active cognitive maturation, is an important determinant of long-term outcome, and is discussed in detail in another article in this supplement. Finally, increasing recognition of pediatric MS worldwide, recent launch of phase III trials for new agents in the pediatric MS population, and the clear imperative to more fully appreciate health-related quality of life in pediatric MS through adulthood highlight the need for standardized, validated, and robust outcome measures. PMID:27572865

  8. Clinical outcomes of acute myocarditis in childhood

    PubMed Central

    Lee, K; McCrindle, B; Bohn, D; Wilson, G; Taylor, G; Freedom, R; Smallhorn, J; Benson, L

    1999-01-01

    OBJECTIVE—To describe clinical outcomes of a paediatric population with histologically confirmed lymphocytic myocarditis.
DESIGN—A retrospective review between November 1984 and February 1998.
SETTING—A major paediatric tertiary care hospital.
PATIENTS—36 patients with histologically confirmed lymphocytic myocarditis.
MAIN OUTCOME MEASURES—Survival, cardiac transplantation, recovery of ventricular function, and persistence of dysrhythmias.
RESULTS—Freedom from death or cardiac transplantation was 86% at one month and 79% after two years. Five deaths occurred within 72 hours of admission, and one late death at 1.9 years. Extracorporeal membrane oxygenation support was used in four patients, and three patients underwent heart replacement. 34 patients were treated with intravenous corticosteroids. In the survivor/non-cardiac transplantation group (n = 29), the median follow up was 19 months (range 1.2-131.6 months), and the median period for recovery of a left ventricular ejection fraction to > 55% was 2.8 months (range 0-28 months). The mean (SD) final left ventricular ejection and shortening fractions were 66 (9)% and 34 (8)%, respectively. Two patients had residual ventricular dysfunction. No patient required antiarrhythmic treatment. All survivors reported no cardiac symptoms or restrictions in physical activity.
CONCLUSIONS—Our experience documents good outcomes in paediatric patients presenting with acute heart failure secondary to acute lymphocytic myocarditis treated with immunosuppression. Excellent survival and recovery of ventricular function, with the absence of significant arrhythmias, continued cardiac medications, or restrictions in physical activity were the normal outcomes.


Keywords: myocarditis; paediatric cardiology; immunosuppression PMID:10409542

  9. 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

  10. Endoscopic ultrasonic dacryocystorhinostomy: clinical profile and outcomes.

    PubMed

    Ali, Mohammad Javed; Singh, Manpreet; Chisty, Naja; Kamal, Saurabh; Naik, Milind N

    2016-07-01

    Ultrasonic endoscopic dacryocystorhinostomy (UEnDCR) is emerging alternative modality of managing nasolacrimal duct obstructions. The aim of this study was to report the clinical profile and outcomes with a UEnDCR with mitomycin C and silicone intubation. Prospective interventional case series performed on all consecutive patients undergoing an ultrasonic endoscopic dacryocystorhinostomy over a 1-year period from September 2013 to October 2014. All surgeries were performed by a single surgeon (MJA). Data collected include demographics, presentation, indications for surgery, past interventions, intraoperative and post-operative complications and outcomes. The main outcome measures were anatomical and functional success of the surgery. 44 procedures were performed in 41 patients. The mean age was 31.6 years. Children with complex congenital nasolacrimal duct obstructions refractory to probing and intubation accounted for 17 % (7/41) of the cohort. Past history of acute dacryocystitis was noted in 35.6 % (15/41). Two patients (4.9 %, 2/41) had failed external DCR. A minimal follow-up of 6 months following surgery was taken for final analysis. Complications included intraoperative focal epithelial burn in one patient that healed spontaneously and post-operative ostium granulomas in 15.9 % (7/44) of the ostia. At the 6-month follow-up, anatomical and functional successes were noted in 93.1 % (41/44) and 88.6 % (39/44), respectively. Ultrasonic dacryocystorhinostomy is a safe and effective alternative modality in the management of nasolacrimal duct obstructions in pediatric and adult age groups. Setup was easy and no additional technical difficulties were observed. PMID:26530294

  11. Clinical characteristics and outcomes in biclonal gammopathies.

    PubMed

    Mullikin, Trey C; Rajkumar, S Vincent; Dispenzieri, Angela; Buadi, Francis K; Lacy, Martha Q; Lin, Yi; Dingli, David; Go, Ronald S; Hayman, Suzanne R; Zeldenrust, Steven R; Russell, Stephen J; Lust, John A; Leung, Nelson; Kapoor, Prashant; Kyle, Robert A; Gertz, Morie A; Kumar, Shaji K

    2016-05-01

    A single monoclonal protein typically characterizes monoclonal gammopathies, but a small proportion may have more than one M protein identifiable. In the setting of symptomatic multiple myeloma (MM), the development of a new monoclonal protein following therapy is associated with better outcomes. As for the precursor conditions, monoclonal gammopathy undetermined significance (MGUS) and smoldering multiple myeloma (SMM), there is limited information on the impact of a second monoclonal protein on the disease course, including progression and response to treatment. The outcomes of patients with MGUS and SMM with more than one monoclonal protein, after identifying 539 patients with biclonal proteins on electrophoresis and/or immunofixation, were reported. About 22 of 393 patients with MGUS/biclonal gammopathy of undetermined significance (BGUS) progressed to SMM (6), MM (11), AL (3), or WM (2), and 5 of 16 patients with biclonal SMM progressed to MM. The rate of progression for BGUS was approximately 1% per year, which is similar to MGUS with one monoclonal protein. The median estimated time of progression of biclonal SMM was 2.6 years; similar to monoclonal SMM. For patients with biclonal MM, both M spikes responded to treatment and, upon relapse, the original dominant M protein remained dominant as the disease progressed. In conclusion, the presence of a second monoclonal protein does not appear to affect the progression of precursor states and suggests multiple monoclonal proteins do not clinically impact one another in the course of the disease. PMID:26840395

  12. Inpatient Readmissions and Emergency Department Visits within 30 Days of a Hospital Admission

    PubMed Central

    Brennan, Jesse J.; Chan, Theodore C.; Killeen, James P.; Castillo, Edward M.

    2015-01-01

    Introduction Inpatient hospital readmissions have become a focus for healthcare reform and cost-containment efforts. Initiatives targeting unanticipated readmissions have included care coordination for specific high readmission diseases and patients and health coaching during the post-discharge transition period. However, little research has focused on emergency department (ED) visits following an inpatient admission. The objective of this study was to assess 30-day ED utilization and all-cause readmissions following a hospital admission. Methods This was a retrospective study using inpatient and ED utilization data from two hospitals with a shared patient population in 2011. We assessed the 30-day ED visit rate and 30-day readmission rate and compared patient characteristics among individuals with 30-day inpatient readmissions, 30-day ED discharges, and no 30-day visits. Results There were 13,449 patients who met the criteria of an index visit. Overall, 2,453 (18.2%) patients had an ED visit within 30 days of an inpatient stay. However, only 55.6% (n=1,363) of these patients were admitted at one of these 30-day visits, resulting in a 30-day all-cause readmission rate of 10.1%. Conclusion Approximately one in five patients presented to the ED within 30 days of an inpatient hospitalization and over half of these patients were readmitted. Readmission measures that incorporate ED visits following an inpatient stay might better inform interventions to reduce avoidable readmissions. PMID:26759647

  13. The National Anesthesia Clinical Outcomes Registry.

    PubMed

    Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P

    2015-12-01

    The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses. PMID:26579661

  14. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-08-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem. PMID:24165457

  15. Controlled outcome studies of child clinical hypnosis.

    PubMed

    Adinolfi, Barbara; Gava, Nicoletta

    2013-09-01

    Background Hypnosis is defined as "as an interaction in which the hypnotist uses suggested scenarios ("suggestions") to encourage a person's focus of attention to shift towards inner experiences". Aim of the work The focus of this review is to summarize the findings of controlled outcome studies investigating the potential of clinical hypnosis in pediatric populations. We will examine the following themes: anesthesia, acute and chronic pain, chemotherapy-related distress, along with other specific medical issues. Results Hypnosis is an effective method to reduce pain and anxiety before, during and after the administration of anesthetics, during local dental treatments, invasive medical procedures and in burn children. Hypnosis can be successfully used to manage recurrent headaches, abdominal pain, irritable bowel syndrome and chemotherapy-related distress. Hypnosis has an important role in managing symptoms and improving the quality of life of children suffering from asthma and cystic fibrosis and in facilitating the treatment of insomnia in school-age children. Finally, hypnosis can be effectively used for the treatment of some habitual disorders such as nocturnal enuresis and dermatologic conditions, including atopic dermatitis and chronic eczema Conclusions Clinical hypnosis seems to be a useful, cheap and side-effects free tool to manage fear, pain and several kinds of stressful experiences in pediatric populations. Children who receive self-hypnosis trainings achieve significantly greater improvements in their physical health, quality of life, and self-esteem.

  16. The National Anesthesia Clinical Outcomes Registry.

    PubMed

    Liau, Adrian; Havidich, Jeana E; Onega, Tracy; Dutton, Richard P

    2015-12-01

    The Anesthesia Quality Institute (AQI) was chartered in 2008 by the American Society of Anesthesiologists to develop the National Anesthesia Clinical Outcomes Registry (NACOR). In this Technical Communication, we will describe how data enter NACOR, how they are authenticated, and how they are analyzed and reported. NACOR accepts case-level administrative, clinical, and quality capture data from voluntarily participating anesthesia practices and health care facilities in the United States. All data are transmitted to the AQI in summary electronic files generated by billing, quality capture, and electronic health care record software, typically on a monthly basis. All data elements are mapped to fields in the NACOR schema in accordance with a publicly available data dictionary. Incoming data are loaded into NACOR by AQI technologists and are subject to both manual and automated review to identify systematically missing elements, miscoding, and inadvertent corruption. Data are deidentified in compliance with Health Insurance Portability and Accountability Act regulations. The database server of AQI, which houses the NACOR database, is protected by 2 firewalls within the American Society of Anesthesiologists' network infrastructure; this system has not been breached. The NACOR Participant User File, a deidentified case-level dataset of information from NACOR, is available to researchers at participating institutions. NACOR architecture and the nature of the Participant User File include both strengths and weaknesses.

  17. Core Practice Outcomes for Clinical Nurse Specialists: A Revalidation Study.

    PubMed

    Fulton, Janet S; Mayo, Ann M; Walker, Jane A; Urden, Linda D

    2016-01-01

    Measuring outcomes of clinical nurse specialist (CNS) practice is essential for demonstrating accountability. Literature is limited with respect to the scope of reported CNS outcomes. The National Association of Clinical Nurse Specialists' (NACNS) published listing of CNS outcomes could serve as an outcome measurement framework. Revalidation of these outcomes is an important step in creating a structured outcome measurement approach. The purpose of this descriptive study was to assess CNSs' perceptions of the ongoing validity of NACNS published outcomes. A Web-based survey asked participants to describe, for each of 42 outcomes, the frequency of outcome accountability, importance to practice, and frequency of monitoring. Of the 427 surveys returned, 347 (81%) were included in analysis. Findings demonstrated concordance between identified outcomes and actual CNS practice. When job descriptions included the CNS outcomes, more CNSs reported using the outcomes in practice. Both accountability and importance predicted the monitoring of outcomes (p < .001). This study demonstrated the ongoing validity of NACNS outcomes. Nurse educators must ensure that CNS program curricula are based on the NACNS framework and that successful achievement of program outcomes are congruent with the framework. These outcomes have potential for use as a conceptual framework for guiding future CNS outcome investigations and ongoing monitoring systems. Finally, the findings of this study give voice to CNS practice and provide knowledge about expectations for practice outcomes. PMID:27424927

  18. Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency

    PubMed Central

    Lunardi, Mattia; Pesarini, Gabriele; Zivelonghi, Carlo; Piccoli, Anna; Geremia, Giulia; Ariotti, Sara; Rossi, Andrea; Gambaro, Alessia; Gottin, Leonardo; Faggian, Giuseppe; Vassanelli, Corrado; Ribichini, Flavio

    2016-01-01

    Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity.

  19. Clinical outcomes of transcatheter aortic valve implantation: from learning curve to proficiency

    PubMed Central

    Lunardi, Mattia; Pesarini, Gabriele; Zivelonghi, Carlo; Piccoli, Anna; Geremia, Giulia; Ariotti, Sara; Rossi, Andrea; Gambaro, Alessia; Gottin, Leonardo; Faggian, Giuseppe; Vassanelli, Corrado; Ribichini, Flavio

    2016-01-01

    Objective The use of transcatheter aortic valve implantation (TAVI) is growing rapidly in countries with a predominantly elderly population, posing a huge challenge to healthcare systems worldwide. The increment of human and economic resource consumption imposes a careful monitoring of clinical outcomes and cost-benefit balance, and this article is aimed at analysing clinical outcomes related to the TAVI learning curve. Methods Outcomes of 177 consecutive transfemoral TAVI procedures performed in 5 years by a single team were analysed by the Cumulative Sum of failures method (CUSUM) according to the clinical events comprised in the Valve Academic Research Consortium (VARC-2) safety end point and the VARC-2 definition of device success. Margins for events acceptance were extrapolated from landmark trials that tested both balloon or self-expandable percutaneous valves. Results 30-day and 1-year survival rates were 97.2% and 89.9%, respectively. Achievement of the primary end point (number of cases needed to provide the acceptable margin of the composite end point of any death, stroke, myocardial infarction, life-threatening bleeding, major vascular complications, stage 2–3 acute kidney injury and valve-related dysfunction requiring a repeat procedure) required the performance of 54 cases, while the learning curve to achieve ‘device success’ identified 32 cases to reach the expected proficiency. In this experience, the baseline clinical risk as assessed by the Society of Thoracic Surgeons (STS) score determined the long-term survival rather than the adverse events related to the learning curve. Conclusions A relatively large number of cases are required to achieve clinical outcomes comparable to those reported in high-volume centres and controlled trials. According to our national workload standards, this represents more than 2 years of continuous activity. PMID:27621826

  20. Prediction of Hospital Acute Myocardial Infarction and Heart Failure 30-Day Mortality Rates Using Publicly Reported Performance Measures

    PubMed Central

    Aaronson, David S.; Bardach, Naomi S.; Lin, Grace A.; Chattopadhyay, Arpita; Goldman, L. Elizabeth; Dudley, R. Adams

    2014-01-01

    Objective To identify an approach to summarizing publicly reported hospital performance data for acute myocardial infarction (AMI) or heart failure (HF) that best predicts current year hospital mortality rates. Setting A total of 1,868 U.S. hospitals reporting process and outcome measures for AMI and HF to the Centers for Medicare and Medicaid Services (CMS) from July 2005 to June 2006 (Year 0) and July 2006 to June 2007 (Year 1). Design Observational cohort study measuring the percentage variation in Year 1 hospital 30-day risk-adjusted mortality rate explained by denominator-based weighted composite scores summarizing hospital Year 0 performance. Data Collection Data were prospectively collected from hospitalcompare.gov. Results Percentage variation in Year 1 mortality was best explained by mortality rate alone in Year 0 over other composites including process performance. If only Year 0 mortality rates were reported, and consumers using hospitals in the highest decile of mortality instead chose hospitals in the lowest decile of mortality rate, the number of deaths at 30 days that potentially could have been avoided was 1.31 per 100 patients for AMI and 2.12 for HF (p < .001). Conclusion Public reports focused on 30-day risk-adjusted mortality rate may more directly address policymakers’ goals of facilitating consumer identification of hospitals with better outcomes. PMID:22093186

  1. Severe bacterial endophthalmitis: towards improving clinical outcomes

    PubMed Central

    Novosad, Billy D; Callegan, Michelle C

    2011-01-01

    Endophthalmitis is an infection and inflammation of the interior of the eye that can result in significant vision loss. This infection occurs as a result of the seeding of organisms into the interior of the eye following surgery (postoperative), trauma (post-traumatic) or an infection in another site in the body (endogenous). The general rate of endophthalmitis has remained steady over the past several years. However, the increased use of intraocular injections to treat various degenerative and inflammatory ocular diseases, in addition to the already large and growing number of invasive ocular surgeries, may increase the opportunities in which organisms can gain access to the eye. In most cases of endophthalmitis, useful vision can be retained if proper treatment is instituted. However, in severe cases of bacterial endophthalmitis, blindness often occurs despite treatment. This article summarizes information on endophthalmitis epidemiology, treatment issues and current regimens, and recent experimental and clinical efforts to improve the outcome of severe and blinding forms of bacterial endophthalmitis. PMID:21572565

  2. The primary outcome measure and its importance in clinical trials.

    PubMed

    Andrade, Chittaranjan

    2015-10-01

    The primary outcome measure is the outcome that an investigator considers to be the most important among the many outcomes that are to be examined in the study. The primary outcome needs to be defined at the time the study is designed. There are 2 reasons for this: it reduces the risk of false-positive errors resulting from the statistical testing of many outcomes, and it reduces the risk of a false-negative error by providing the basis for the estimation of the sample size necessary for an adequately powered study. This article discusses the setting of the primary outcome measure, the need for it, the increased risk of false-positive and false-negative errors in secondary outcome results, how to regard articles that do not state the primary outcome, how to interpret results when secondary outcomes are statistically significant but not the primary outcome, and limitations of the concept of a primary outcome measure in clinical trial research.

  3. Cervical Scoliosis: Clinical and Radiographic Outcomes

    PubMed Central

    Mesfin, Addisu; Bakhsh, Wajeeh R.; Chuntarapas, Tapanut; Riew, K. Daniel

    2015-01-01

    Study Design Retrospective study. Objective Cervical scoliosis is a rare condition that can arise from various etiologies. Few reports on the surgical management of cervical scoliosis exist. Our objective was to evaluate clinical and radiographic outcomes following surgical management of cervical scoliosis. Methods We evaluated our cervical spine surgical database for patients with cervical scoliosis (Cobb angle > 10 degrees) from 2005 to 2010. Demographic data including age, gender, diagnoses, and primary versus revision surgery was collected. Surgical data including procedure (anterior versus posterior), estimated blood loss (EBL), length of surgery, length of hospitalization, and complications was recorded. Preoperative and postoperative Cobb angle measurements and Neck Disability Index (NDI) scores were recorded. Results Cervical scoliosis was identified in 18 patients. We excluded 5, leaving 5 men and 8 women with an average age of 50.7 (median 52, range 25 to 65). The average follow-up was 40 months (median 36.5, range 5 to 87). An anterior-only approach was used in 6 cases (average 4 levels fused), 5 cases were posterior-only approach (average 8.7 levels fused), and 2 cases were combined anterior-posterior approach. The EBL was an average of 286 mL (median 150, range 50 to 900), the average surgical time was 266 minutes (median 239, range 136 to 508), and the average hospital stay was 2.7 days (median 2, range 1 to 7). Complications occurred in 7 patients, and 2 developed adjacent segment pathology. The average coronal Cobb angle preoperatively was 35.1 degrees (median 31, range 13 to 63) and corrected was 15.7 degrees (median 10.5, range 2 to 59) postoperatively (p < 0.005). The average NDI preoperatively was 24.9 (median 26, range 6 to 37) and was reduced to 17.8 (median 18, range 7 to 30) postoperatively (p < 0.02). Conclusion Surgical management of cervical scoliosis can result in deformity correction and improvement in patient

  4. 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 FUTURES TRADING COMMISSION SECURITY FUTURES PRODUCTS Narrow-Based Security Indexes § 41.12 Indexes underlying futures contracts trading for fewer than 30 days. (a) An index on which a contract of sale...

  5. 78 FR 65695 - 30-Day Notice of Proposed Information Collection: Technical Processing Requirements for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-01

    .... ACTION: Correction, notice. SUMMARY: On October 25, 2013 at 78 FR 64146 HUD published a 30 day notice of... 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...

  6. 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..., OR EXPORTED Destroyed, Abandoned, or Exported Merchandise § 158.42 Abandonment by importer within 30... written notice of abandonment with the director of the port where the entry was filed within 30 days...

  7. 19 CFR 158.42 - Abandonment by importer within 30 days after entry.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 19 Customs Duties 2 2011-04-01 2011-04-01 false Abandonment by importer within 30 days after entry..., OR EXPORTED Destroyed, Abandoned, or Exported Merchandise § 158.42 Abandonment by importer within 30... written notice of abandonment with the director of the port where the entry was filed within 30 days...

  8. 19 CFR 158.42 - Abandonment by importer within 30 days after entry.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 19 Customs Duties 2 2013-04-01 2013-04-01 false Abandonment by importer within 30 days after entry..., OR EXPORTED Destroyed, Abandoned, or Exported Merchandise § 158.42 Abandonment by importer within 30... written notice of abandonment with the director of the port where the entry was filed within 30 days...

  9. 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..., OR EXPORTED Destroyed, Abandoned, or Exported Merchandise § 158.42 Abandonment by importer within 30... written notice of abandonment with the director of the port where the entry was filed within 30 days...

  10. 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..., OR EXPORTED Destroyed, Abandoned, or Exported Merchandise § 158.42 Abandonment by importer within 30... which the merchandise being abandoned appears. (b) Application within 30 days. The importer shall...

  11. 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

    ... HUMAN SERVICES Food and Drug Administration Division of Cardiovascular Devices 30-Day Notices and Annual... following public workshop entitled ``Division of Cardiovascular Devices 30-Day Notices and Annual Reports..., specifically for cardiovascular devices. DATES: Date and Time: The public workshop will be held on August...

  12. Clinical Outcomes of Characterized Chondrocyte Implantation

    PubMed Central

    Huylebroek, José; Van Der Bauwhede, Jan; Saris, Daniël; Veeckman, Geert; Bobic, Vladimir; Victor, Jan; Almqvist, Karl Fredrik; Verdonk, Peter; Fortems, Yves; Van Lommel, Nel; Haazen, Ludo

    2012-01-01

    Objective: To assess the clinical outcome of patients treated with autologous chondrocyte implantation using ChondroCelect in daily practice. Methods: The study is a cross-sectional analysis of an open-label, noninterventional cohort. The setting was a compassionate use program, involving 43 orthopaedic centers in 7 European countries. The participants were patients treated with ChondroCelect between October 13, 2004 and July 2, 2008. The measurements used were Clinical Global Impression–Improvement and –Efficacy and solicited adverse event reports. Results: Safety data were collected from 334 patients (90.3%), and effectiveness data were from 282 (76.2%) of the 370 patients treated. Mean age at baseline was 33.6 years (range, 12-57 years), 57% were male, and mean body mass index was 25 kg/m2. Mean follow-up was 2.2 years (range, 0.4-4.1 years). A femoral condyle lesion was reported in 66% (288/379) and a patellar lesion in 19% (84/379). Mean lesion size was 3.5 cm2; a collagen membrane was used in 92.4% (328/355). A therapeutic effect was reported in 89% (234/264) of patients overall and in 87% (40/46) of patellar lesion patients. Rates of much or very much improved patients were similar in patients with short- (<18 months: 71% [115/163]) and long-term follow-up (>18 months: 68% [70/103]) (P = 0.68) and were independent of lesion size (>4 cm2: 75.5% [37/49]; ≤4 cm2: 67.7% [111/164]) (P = 0.38). Adverse events were similar to those reported in the randomized trial with the same product, with more arthrofibrosis, more reduced joint mobility, and more crepitations reported in patellar lesions. Overall, less cartilage hypertrophy was noted, probably due to the use of a biological membrane cover. Conclusions: Implantation of ChondroCelect appeared to result in a positive benefit/risk ratio when used in an unselected heterogenous population, irrespective of the follow-up period, lesion size, and type of lesion treated. PMID:26069630

  13. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M,; Foy, M. H.; Dulchavsky, S. A.; Gibson, C. R.

    2015-01-01

    The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capabilities (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-flight Medical Capabilities". Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes.

  14. Evaluation of nonlinear frequency compression: Clinical outcomes

    PubMed Central

    Glista, Danielle; Scollie, Susan; Bagatto, Marlene; Seewald, Richard; Parsa, Vijay; Johnson, Andrew

    2009-01-01

    This study evaluated prototype multichannel nonlinear frequency compression (NFC) signal processing on listeners with high-frequency hearing loss. This signal processor applies NFC above a cut-off frequency. The participants were hearing-impaired adults (13) and children (11) with sloping, high-frequency hearing loss. Multiple outcome measures were repeated using a modified withdrawal design. These included speech sound detection, speech recognition, and self-reported preference measures. Group level results provide evidence of significant improvement of consonant and plural recognition when NFC was enabled. Vowel recognition did not change significantly. Analysis of individual results allowed for exploration of individual factors contributing to benefit received from NFC processing. Findings suggest that NFC processing can improve high frequency speech detection and speech recognition ability for adult and child listeners. Variability in individual outcomes related to factors such as degree and configuration of hearing loss, age of participant, and type of outcome measure. PMID:19504379

  15. 78 FR 52007 - 30-Day Notice of Proposed Information Collection: Financial Statement of Corporate Applicant for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Financial Statement of Corporate... Information Collection: Financial Statement of Corporate Applicant for Cooperative Housing Mortgage. OMB... information to determine feasibility, mortgagor/contractor acceptability as well as the financial data,...

  16. 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.

  17. 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)...

  18. 78 FR 40314 - 30-Day Notice of Proposed Information Collection: Fair Housing Initiatives Program Grant

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Fair Housing Initiatives Program..., 2012. A. Overview of Information Collection Title of Information Collection: Fair Housing Initiatives... approved information collection used to select applicants for the Fair Housing Initiatives Program...

  19. 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...

  20. 78 FR 39001 - 30-Day Notice of Proposed Information Collection: Uniform Physical Standards and Physical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-28

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Uniform Physical Standards and Physical Inspection Requirements AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice... Information Collection: Uniform Physical Standards and Physical Inspection Requirements. OMB Approval...

  1. 78 FR 54267 - 30-Day Notice of Proposed Information Collection: Disaster Recovery Grant Reporting System

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-03

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Disaster Recovery Grant Reporting..., 2013. A. Overview of Information Collection Title of Information Collection: Disaster Recovery Grant... information and proposed use: The Disaster Recovery Grant Reporting (DRGR) System is a grants...

  2. 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...

  3. Patient-centered community health worker intervention to improve posthospital outcomes: a randomized clinical trial.

    PubMed

    Kangovi, Shreya; Mitra, Nandita; Grande, David; White, Mary L; McCollum, Sharon; Sellman, Jeffrey; Shannon, Richard P; Long, Judith A

    2014-04-01

    IMPORTANCE Socioeconomic and behavioral factors can negatively influence posthospital outcomes among patients of low socioeconomic status (SES). Traditional hospital personnel often lack the time, skills, and community linkages required to address these factors. OBJECTIVE To determine whether a tailored community health worker (CHW) intervention would improve posthospital outcomes among low-SES patients. DESIGN, SETTING, AND PARTICIPANTS A 2-armed, single-blind, randomized clinical trial was conducted between April 10, 2011, and October 30, 2012, at 2 urban, academically affiliated hospitals. Of 683 eligible general medical inpatients (ie, low-income, uninsured, or Medicaid) that we screened, 237 individuals (34.7%) declined to participate. The remaining 446 patients (65.3%) were enrolled and randomly assigned to study arms. Nearly equal percentages of control and intervention group patients completed the follow-up interview (86.6% vs 86.9%). INTERVENTIONS During hospital admission, CHWs worked with patients to create individualized action plans for achieving patients' stated goals for recovery. The CHWs provided support tailored to patient goals for a minimum of 2 weeks. MAIN OUTCOMES AND MEASURES The prespecified primary outcome was completion of primary care follow-up within 14 days of discharge. Prespecified secondary outcomes were quality of discharge communication, self-rated health, satisfaction, patient activation, medication adherence, and 30-day readmission rates. RESULTS Using intention-to-treat analysis, we found that intervention patients were more likely to obtain timely posthospital primary care (60.0% vs 47.9%; P = .02; adjusted odds ratio [OR], 1.52; 95% CI, 1.03-2.23), to report high-quality discharge communication (91.3% vs 78.7%; P = .002; adjusted OR, 2.94; 95% CI, 1.5-5.8), and to show greater improvements in mental health (6.7 vs 4.5; P = .02) and patient activation (3.4 vs 1.6; P = .05). There were no significant differences

  4. Combining clinical variables to optimize prediction of antidepressant treatment outcomes.

    PubMed

    Iniesta, Raquel; Malki, Karim; Maier, Wolfgang; Rietschel, Marcella; Mors, Ole; Hauser, Joanna; Henigsberg, Neven; Dernovsek, Mojca Zvezdana; Souery, Daniel; Stahl, Daniel; Dobson, Richard; Aitchison, Katherine J; Farmer, Anne; Lewis, Cathryn M; McGuffin, Peter; Uher, Rudolf

    2016-07-01

    The outcome of treatment with antidepressants varies markedly across people with the same diagnosis. A clinically significant prediction of outcomes could spare the frustration of trial and error approach and improve the outcomes of major depressive disorder through individualized treatment selection. It is likely that a combination of multiple predictors is needed to achieve such prediction. We used elastic net regularized regression to optimize prediction of symptom improvement and remission during treatment with escitalopram or nortriptyline and to identify contributing predictors from a range of demographic and clinical variables in 793 adults with major depressive disorder. A combination of demographic and clinical variables, with strong contributions from symptoms of depressed mood, reduced interest, decreased activity, indecisiveness, pessimism and anxiety significantly predicted treatment outcomes, explaining 5-10% of variance in symptom improvement with escitalopram. Similar combinations of variables predicted remission with area under the curve 0.72, explaining approximately 15% of variance (pseudo R(2)) in who achieves remission, with strong contributions from body mass index, appetite, interest-activity symptom dimension and anxious-somatizing depression subtype. Escitalopram-specific outcome prediction was more accurate than generic outcome prediction, and reached effect sizes that were near or above a previously established benchmark for clinical significance. Outcome prediction on the nortriptyline arm did not significantly differ from chance. These results suggest that easily obtained demographic and clinical variables can predict therapeutic response to escitalopram with clinically meaningful accuracy, suggesting a potential for individualized prescription of this antidepressant drug. PMID:27089522

  5. Transcatheter Aortic Valve Implantation: First Applications and Short Term Outcomes in Our Clinic

    PubMed Central

    Aksoy, Mehmet; Ince, Ilker; Ahiskalioglu, Ali; Dogan, Nazim; Colak, Abdurrahim; Sevimli, Serdar

    2015-01-01

    Objective: The objective of this study is to evaluate the first applications and short term outcomes of transcatheter aortic valve implantation (TAVI) in our clinic, which is a new technology for the patients with high risk for surgical aortic valve replacement (SAVR). Materials and Methods: Between January 2010 and December 2012, twenty five patients (16 males, 9 females; mean age 74.04±8.86 years) diagnosed with severe aortic stenosis, who were at high risk for surgery (EuroSCORE II: 5.58±4.20) and underwent TAVI in our clinic, were evaluated. The demographic and clinical characteristics of patients, anaesthetic management, complications during pre- and post-operative periods and the mortality rate in the first 30 days and six months were recorded. Results: Edwards SAPIEN Valve prostheses were implanted by transfemoral approach (percutaneously in 10 patients and surgically in 15 patients) in all patients. The TAVI procedure was performed under general anaesthesia. The success rate of the TAVI procedure was 100%. Three patients had limited dissection of the femoral artery; however, intervention was not needed due to good distal perfusion rate. Permanent pacemaker was implanted to four patients because of long-term atrioventricular blockage. After the procedure, all patients were transferred to the Intensive Care Unit (ICU) and all patients were extubated in the ICU. The mean mechanical ventilation duration (minutes) was 166.20±39.32, the mean critical care unit stay (day) was 5.64±2.99 and the mean hospital stay (day) was 11.92±5.54. Acute renal failure was observed in one patient and stroke was observed in two patients on the first postoperative day. The mortality rate in the first 30 days and 6 months was found to be 4% and 16%, respectively. Conclusion: Transcatheter aortic valve implantation is a great option for patients with severe aortic stenosis who are at high risk for SAVR. In our institute, procedural success and short term outcomes for patients

  6. Clinical manifestations, response to treatment, and clinical outcome for Weimaraners with hypertrophic osteodystrophy: 53 cases (2009–2011)

    PubMed Central

    Safra, Noa; Johnson, Eric G.; Lit, Lisa; Foreman, Oded; Wolf, Zena T.; Aguilar, Miriam; Karmi, Nili; Finno, Carrie J.; Bannasch, Danika L.

    2014-01-01

    Objective To evaluate clinical manifestations, response to treatment, and outcome for Weimaraners with hypertrophic osteodystrophy (HOD). Design Retrospective case series. Animals 53 dogs. Procedures Medical records were reviewed for signalment, vaccination history, clinical signs, laboratory test results, response to treatment, and relapses. Radiographs were reviewed. Results Clinical signs included pyrexia, lethargy, and ostealgia; signs involving the gastrointestinal, ocular, or cutaneous systems were detected. Of the 53 dogs, 28 (52.8%) had HOD-affected littermates. Dogs with HOD-affected littermates were more likely to relapse, compared with the likelihood of relapse for dogs with no HOD-affected littermates. All 53 dogs had been vaccinated 1 to 30 days before HOD onset; no difference was found between the number of dogs with a history of vaccination with a recombinant vaccine (n = 21) versus a nonrecombinant vaccine (32). Fifty (94.3%) dogs had radiographic lesions compatible with HOD at disease onset, and the other 3 (5.7%) had HOD lesions 48 to 72 hours after the onset of clinical signs. Twelve of 22 (54.5%) dogs treated with NSAIDs did not achieve remission by 7 days after initiation of treatment. All dogs treated initially with corticosteroids achieved remission within 8 to 48 hours. Of the 33 dogs that reached adulthood, 28 (84.8%) were healthy and 5 (15.2%) had episodes of pyrexia and malaise. Conclusions and Clinical Relevance Treatment with corticosteroids was superior to treatment with NSAIDs in Weimaraners with HOD. It may be necessary to evaluate repeated radiographs to establish a diagnosis of HOD. Most HOD-affected Weimaraners had resolution of the condition with physeal closure. PMID:23600784

  7. Impact of penicillin nonsusceptibility on clinical outcomes of patients with nonmeningeal Streptococcus pneumoniae bacteremia in the era of the 2008 clinical and laboratory standards institute penicillin breakpoints.

    PubMed

    Choi, Seong-Ho; Chung, Jin-Won; Sung, Heungsup; Kim, Mi-Na; Kim, Sung-Han; Lee, Sang-Oh; Kim, Yang Soo; Woo, Jun Hee; Choi, Sang-Ho

    2012-09-01

    To investigate the impact of penicillin nonsusceptibility on clinical outcomes of patients with nonmeningeal Streptococcus pneumoniae bacteremia (SPB), a retrospective cohort study was performed. The characteristics of 39 patients with penicillin-nonsusceptible SPB (PNSPB) were compared to those of a group of age- and sex-matched patients (n = 78) with penicillin-susceptible SPB (PSSPB). Susceptibility to penicillin was redetermined by using the revised Clinical and Laboratory Standards Institute (CLSI) penicillin breakpoints in CLSI document M100-S18. Although the PNSPB group tended to have more serious initial manifestations than the PSSPB group, the two groups did not differ significantly in terms of their 30-day mortality rates (30.8% versus 23.1%; P = 0.37) or the duration of hospital stay (median number of days, 14 versus 12; P = 0.89). Broad-spectrum antimicrobial agents, such as extended-spectrum cephalosporins, vancomycin, and carbapenem, were frequently used in both the PNSPB and PSSPB groups. Multivariate analysis revealed that ceftriaxone nonsusceptibility (adjusted odds ratio [aOR] = 4.88; 95% confidence interval [CI] = 1.07 to 22.27; P = 0.041) was one of the independent risk factors for 30-day mortality. Thus, when the 2008 CLSI penicillin breakpoints are applied and the current clinical practice of using wide-spectrum empirical antimicrobial agents is pursued, fatal outcomes in patients with nonmeningeal SPB that can be attributed to penicillin nonsusceptibility are likely to be rare. Further studies that examine the clinical impact of ceftriaxone nonsusceptibility in nonmningeal SPB may be warranted.

  8. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, Doug; Byrne, Vicky; Cole, Richard; Dulchavsky, Scott; Foy, Millennia; Garcia, Kathleen; Gibson, Robert; Ham, David; Hurst, Victor; Kerstman, Eric; McGuire, Kerry; Sargsyan, Ashot

    2015-01-01

    The objective of this research is to develop and use clinical outcome metrics and training tools to quantify the differences in performance of a physician vs non-physician crew medical officer (CMO) analogues during simulations.

  9. Development and Clinical Outcomes of a Dialectical Behavior Therapy Clinic

    ERIC Educational Resources Information Center

    Lajoie, Travis; Sonkiss, Joshua; Rich, Anne

    2011-01-01

    Objective: The authors describe the first 6 months of a dialectical behavior therapy (DBT) clinic operated by trainees in a general adult psychiatry residency program. The purpose of this report is to provide a model for the creation and maintenance of a formalized resident DBT clinic. Methods: Residents participated in the DBT clinic, attended a…

  10. Clinical features and outcome of acute exacerbation of interstitial pneumonia associated with connective tissue disease.

    PubMed

    Toyoda, Yuko; Hanibuchi, Masaki; Kishi, Jun; Kawano, Hiroshi; Morizumi, Shun; Sato, Seidai; Kondo, Mayo; Takikura, Terumi; Tezuka, Toshifumi; Goto, Hisatsugu; Nishioka, Yasuhiko

    2016-01-01

    Acute exacerbation (AE) of interstitial lung disease is reported to be developed in not only idiopathic pulmonary fibrosis but also connective tissue disease-associated interstitial pneumonia (CTD-IP). As the significance of AE of CTD-IP has not been so widely recognized, its clinical feature is not fully elucidated. In the present study, we investigated the incidence, clinical features and outcome of AE of CTD-IP. We retrospectively reviewed admitted cases in our department with medical record from 2011 to 2015. Among 155 patients with CTD-IP, 10 (6.5%) cases developed AE (6 rheumatoid arthritis, 2 polymyositis/dermatomyositis, 1 systemic lupus erythematosus, 1 Sjögren syndrome), and one died of AE within 30 days. Median survival time after the onset of AE was 169 days in all 10 patients. The treatment with immunosuppressant just before AE onset might improve the prognosis of AE. The median survival time after the onset of AE was significantly longer in patients showing good response to corticosteroid compared with those with poor response to corticosteroid (805 days and 45 days, respectively) (p <0.05), suggesting that there are some cases in CTD-IP, showing the good response to corticosteroid even when AE was complicated. J. Med. Invest. 63: 294-299, August, 2016. PMID:27644575

  11. Single Case Research Results as Clinical Outcomes

    ERIC Educational Resources Information Center

    Parker, Richard I.; Hagan-Burke, Shanna

    2007-01-01

    The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, "proportion of variance" ("R"[superscript 2],…

  12. 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

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

    PubMed

    Nijhawan, Ank E; Kitchell, Ellen; Etherton, Sarah Shelby; Duarte, Piper; Halm, Ethan A; Jain, Mamta K

    2015-09-01

    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.

  14. Using data linkage to generate 30-day crash-fatality adjustment factors for Taiwan.

    PubMed

    Lai, Ching-Huei; Huang, Wei-Shin; Chang, Kai-Kuo; Jeng, Ming-Chang; Doong, Ji-Liang

    2006-07-01

    Different countries have their own police reporting time standards for counting the number of fatalities in reported crashes. A rapid estimation method (such as adjustment factor) for the comparison is important. The data-linkage technique was used to combine police-reported crash data and vital registration data, in order to generate 30-day fatality adjustment factors for various reporting time standards, which could also shed light on the fatal injury trend over time. The major findings were as follows. Firstly, a conservative 30-day fatality adjustment factor for the first day (or 24 h) would be 1.54 (or 1.35) in an area with a large motorcycle population, like Taiwan. This produced 20-40% higher 30-day fatalities than UK Transport Research Laboratory predicted, and 15-25% higher fatalities than those in Europe/Japan. Secondly, after excluding motorcycle impacts, the Taiwanese factors suggested 8-14% higher fatalities within 30 days than those in Europe/Japan. Third, motorcycle fatalities influenced the overall 30-day fatality trend within 3 days. In the future, both the police under-reporting problem and the motorcycle/overall fatal injury pattern within 3 days after crashing in developing countries like Taiwan merit further investigation. PMID:16430844

  15. A Five-Phase Model for Clinical-Outcome Research

    ERIC Educational Resources Information Center

    Robey, Randall R.

    2004-01-01

    Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…

  16. Comparing clinical outcomes in HIV-infected and uninfected older men hospitalized with community-acquired pneumonia

    PubMed Central

    Barakat, LA; Juthani-Mehta, M; Allore, H; Trentalange, M; Tate, J; Rimland, D; Pisani, M; Akgün, KM; Goetz, MB; Butt, AA; Rodriguez-Barradas, M; Duggal, M; Crothers, K; Justice, AC; Quagliarello, VJ

    2016-01-01

    Objectives Outcomes of community–acquired pneumonia (CAP) among HIV-infected older adults are unclear. Methods Associations between HIV infection and three CAP outcomes (30-day mortality, readmission within 30 days post-discharge, and hospital length of stay [LOS]) were examined in the Veterans Aging Cohort Study (VACS) of male Veterans, age ≥ 50 years, hospitalized for CAP from 10/1/2002 through 08/31/2010. Associations between the VACS Index and CAP outcomes were assessed in multivariable models. Results Among 117 557 Veterans (36 922 HIV-infected and 80 635 uninfected), 1203 met our eligibility criteria. The 30-day mortality rate was 5.3%, the mean LOS was 7.3 days, and 13.2% were readmitted within 30 days of discharge. In unadjusted analyses, there were no significant differences between HIV-infected and uninfected participants regarding the three CAP outcomes (P > 0.2). A higher VACS Index was associated with increased 30-day mortality, readmission, and LOS in both HIV-infected and uninfected groups. Generic organ system components of the VACS Index were associated with adverse CAP outcomes; HIV-specific components were not. Among HIV-infected participants, those not on antiretroviral therapy (ART) had a higher 30-day mortality (HR 2.94 [95% CI 1.51, 5.72]; P = 0.002) and a longer LOS (slope 2.69 days [95% CI 0.65, 4.73]; P = 0.008), after accounting for VACS Index. Readmission was not associated with ART use (OR 1.12 [95% CI 0.62, 2.00] P = 0.714). Conclusion Among HIV-infected and uninfected older adults hospitalized for CAP, organ system components of the VACS Index were associated with adverse CAP outcomes. Among HIV-infected individuals, ART was associated with decreased 30-day mortality and LOS. PMID:25959543

  17. Initial weather regimes as predictors of numerical 30-day mean forecast accuracy

    NASA Technical Reports Server (NTRS)

    Colucci, Stephen J.; Baumhefner, David P.

    1992-01-01

    Thirty 30-day mean 500-mb-height anomaly forecasts generated by the NCAR Community Climate Model (CCM) for the year 1978 are examined in order to determine if the forecast accuracy can be estimated with the initial conditions. The initial weather regimes were defined in such a way that the regimes could discriminate between the best and the worst 30-day mean forecasts run from the initial fields in this data set. On the basis of the CCM experiments, it is suggested that the accuracy of numerical 30-day mean forecasts may depend upon the accuracy with which the cyclones and their interactions with the planetary scale are predicted early in the forecast cycle, and that this accuracy may depend upon the initial conditions.

  18. Marked Improvement in 30-Day Mortality among Elderly Inpatients and Outpatients with Community-Acquired Pneumonia

    PubMed Central

    Ruhnke, Gregory W.; Coca-Perraillon, Marcelo; Kitch, Barrett T.; Cutler, David M.

    2011-01-01

    BACKGROUND Community-acquired pneumonia is the most common infectious cause of death in the United States. Over the last two decades, patient characteristics and clinical care have changed. To understand the impact of these changes, we quantified incidence and mortality trends among elderly adults. METHODS We used Medicare claims to identify episodes of pneumonia, based on a validated combination of diagnosis codes. Comorbidities were ascertained using the diagnosis codes located on a one-year look back. Trends in patient characteristics and site of care were compared. The association between year of pneumonia episode and 30-day mortality was then evaluated by logistic regression, with adjustment for age, sex, and comorbidities. RESULTS We identified 2,654,955 cases of pneumonia from 1987–2005. During this period, the proportion treated as inpatients decreased, the proportion aged >= 80 increased, and the frequency of many comorbidities rose. Adjusted incidence increased to 3096 episodes per 100,000 population in 1999, with some decline thereafter. Age/sex-adjusted mortality decreased from 13.5% to 9.7%, a relative reduction of 28.1%. Compared to 1987, the risk of mortality declined through 2005 (adjusted odds ratio, 0.46; 95% confidence interval, 0.44 to 0.47). This result was robust to a restriction on comorbid diagnoses assessing for the results' sensitivity to increased coding. CONCLUSIONS These findings show a marked mortality reduction over time in community-acquired pneumonia patients. We hypothesize that increased pneumococcal and influenza vaccination rates as well as wider use of guideline-concordant antibiotics explain a large portion of this trend. PMID:21295197

  19. 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

  20. Extent of Surgery Does Not Influence 30-Day Mortality in Surgery for Metastatic Bone Disease

    PubMed Central

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

    2016-01-01

    Abstract 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. PMID:27082592

  1. A 30-day forecast experiment with the GISS model and updated sea surface temperatures

    NASA Technical Reports Server (NTRS)

    Spar, J.; Atlas, R.; Kuo, E.

    1975-01-01

    The GISS model was used to compute two parallel global 30-day forecasts for the month January 1974. In one forecast, climatological January sea surface temperatures were used, while in the other observed sea temperatures were inserted and updated daily. A comparison of the two forecasts indicated no clear-cut beneficial effect of daily updating of sea surface temperatures. Despite the rapid decay of daily predictability, the model produced a 30-day mean forecast for January 1974 that was generally superior to persistence and climatology when evaluated over either the globe or the Northern Hemisphere, but not over smaller regions.

  2. 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.

  3. 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. PMID:27595822

  4. Incidence and Predictors of 30-Day Readmission Among Patients Hospitalized for Advanced Liver Disease

    PubMed Central

    BERMAN, KENNETH; TANDRA, SWETA; FORSSELL, KATE; VUPPALANCHI, RAJ; BURTON, JAMES R.; NGUYEN, JAMES; MULLIS, DEVONNE; KWO, PAUL; CHALASANI, NAGA

    2011-01-01

    BACKGROUND & AIMS The rate of readmission to the hospital 30 days after discharge (30-day readmission rate) is used as a quality measure for hospitalized patients, but it has not been studied adequately for patients with advanced liver disease. We investigated the incidence and factors that predict this rate and its relationship with mortality at 90 days. METHODS We analyzed data from patients with advanced liver disease who were hospitalized to an inpatient hepatology service at 2 large academic medical centers in 2008. Patients with elective admission and recipients of liver transplants were not included. During the study period, there were 447 patients and a total of 554 eligible admissions. Multivariate analyses were performed to identify variables associated with 30-day readmission and to examine its relationship with mortality at 90 days. RESULTS The 30-day readmission rate was 20%. After adjusting for multiple covariates, readmission within 30 days was associated independently with model for end-stage liver disease scores at discharge (odds ratio [OR], 1.06; 95% confidence interval [CI], 1.02–1.09; P = .002), the presence of diabetes (OR, 1.78; 95% CI, 1.07–2.95; P = .027), and male sex (OR, 1.73; 95% CI, 1.03–2.89; P = .038). After adjusting for age, sex, and model for end-stage liver disease score at discharge, the 90-day mortality rate was significantly higher among patients who were readmitted to the hospital within 30 days than those who were not (26.8% vs 9.8%; OR, 2.6; 95% CI, 1.36 –5.02; P = .004). CONCLUSIONS Patients with advanced liver disease frequently are readmitted to the hospital within 30 days after discharge; these patients have a higher 90-day mortality rate than those who are not readmitted in 30 days. These data might be used to develop strategies to reduce early readmission of hospitalized patients with cirrhosis. PMID:21092762

  5. Impact of the Development of a Regional Collaborative to Reduce 30-Day Heart Failure Readmissions.

    PubMed

    Pollard, Joy; Oliver-McNeil, Sandra; Patel, Shilpa; Mason, Lisa; Baker, Harolyn

    2015-01-01

    Thirty-day heart failure readmissions can be reduced if multiple interventions, such as 7-day postdischarge follow-up, are implemented, but this task is challenging for health systems. Ten hospitals participated in a multisystem collaborative implementing evidence-based strategies. The overall 30-day readmission rate was reduced more in the collaborating hospitals than in the noncollaborating hospitals (from 29.32% to 27.66% vs from 27.66% to 26.03%, P = .008). Regional collaboration between health care systems within a quality improvement project was associated with reduced 30-day readmission.

  6. Nutrition and Chronic Wounds: Improving Clinical Outcomes.

    PubMed

    Molnar, Joseph A; Vlad, Lucian G; Gumus, Tuna

    2016-09-01

    There is increasing awareness that chronic wound healing is very dependent on the patient's nutritional status, but there are no clearly established and accepted assessment protocols or interventions in clinical practice. Much of the data used as guidelines for chronic wound patients are extrapolated from acutely wounded trauma patients, but the 2 groups are very different patient populations. While most trauma patients are young, healthy, and well-nourished before injury, the chronic wound patient is usually old, with comorbidities and frequently malnourished. We suggest the assumption that all geriatric wound patients are malnourished until proved otherwise. Evaluation should include complete history and physical and a formal nutritional evaluation should be obtained. Laboratory studies can be used in conjunction with this clinical information to confirm the assessment. While extensive studies are available in relation to prevention and treatment of pressure ulcers and perioperative nutrition, less is known of the effect of nutritional deficits and supplementation of the diabetic foot ulcer and venous stasis ulcer patient. This does not necessarily mean that nutritional support of these patients is not helpful. In the pursuit of wound healing, we provide systemic support of cardiac and pulmonary function and cessation of smoking, improve vascular inflow, improve venous outflow, decrease edema, and treat with hyperbaric oxygen. If we address all of these other conditions, why would we not wish to support the most basic of organismal needs in the form of nutrition? PMID:27556777

  7. A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.

    PubMed

    Muresanu, Dafin F; Ciurea, Alexandru V; Gorgan, Radu M; Gheorghita, Eva; Florian, Stefan I; Stan, Horatiu; Blaga, Alin; Ianovici, Nicolai; Iencean, Stefan M; Turliuc, Dana; Davidescu, Horia B; Mihalache, Cornel; Brehar, Felix M; Mihaescu, Anca S; Mardare, Dinu C; Anghelescu, Aurelian; Chiparus, Carmen; Lapadat, Magdalena; Pruna, Viorel; Mohan, Dumitru; Costea, Constantin; Costea, Daniel; Palade, Claudiu; Bucur, Narcisa; Figueroa, Jesus; Alvarez, Anton

    2015-01-01

    Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day) of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within 48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion, the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved TBI outcome.

  8. Levothyroxine Poisoning - Symptoms and Clinical Outcome.

    PubMed

    Nygaard, Birgitte; Saedder, Eva A; Dalhoff, Kim; Wikkelsoe, Mette; Jürgens, Gesche

    2015-10-01

    Levothyroxine (LT), T4, poisoning is rarely associated with a severe outcome. However, cases with significant complications have been reported. The aim of this study was to identify factors associated with symptoms of poisoning including late-onset symptoms. All enquiries to the Danish Poison Information Centre (DPIC) concerning LT poisoning between March 2007 and September 2012 were reviewed and the following parameters were recorded: age, dose, time from ingestion, multiple drug intake and symptoms. To evaluate the frequency of late-onset symptoms, a subgroup of patients without initial symptoms were contacted. A total of 181 patients were registered (112 children). Ingested LT dose ranged from 10 to 9000 mcg (median 275 mcg). A total of 29 of 181 (16%) patients were symptomatic at the time of enquiry, and there was no difference in ingested LT dose between asymptomatic and symptomatic patients, neither in children nor in adults (age 16-92 years) (p < 0.68 and p < 0.47, respectively). In total, 153 of 181 (85%) patients did not have symptoms of poisoning at the time of enquiry; however, in 9 of 21 (43%) patients, we were able to contact, late-onset symptoms existed. In none of the cases, hospital contact was needed and there were no reports of long-term sequelae. Acute LT poisoning often follows a benign course. The occurrence of symptoms appears not to be dose dependent. Late-onset symptoms seem to be common. However, all symptoms resolved spontaneously without need of medical care.

  9. The Clinical Outcomes Assessment Toolkit: A Framework to Support Automated Clinical Records–based Outcomes Assessment and Performance Measurement Research

    PubMed Central

    D'Avolio, Leonard W.; Bui, Alex A.T.

    2008-01-01

    The Clinical Outcomes Assessment Toolkit (COAT) was created through a collaboration between the University of California, Los Angeles and Brigham and Women's Hospital to address the challenge of gathering, formatting, and abstracting data for clinical outcomes and performance measurement research. COAT provides a framework for the development of information pipelines to transform clinical data from its original structured, semi-structured, and unstructured forms to a standardized format amenable to statistical analysis. This system includes a collection of clinical data structures, reusable utilities for information analysis and transformation, and a graphical user interface through which pipelines can be controlled and their results audited by nontechnical users. The COAT architecture is presented, as well as two case studies of current implementations in the domain of prostate cancer outcomes assessment. PMID:18308990

  10. Bioplastique at 6 years: clinical outcome studies.

    PubMed

    Ersek, R A; Gregory, S R; Salisbury, A V

    1997-11-01

    Bioplastique is a biphasic polymer for the permanent augmentation of some soft tissues. It was developed in 1987, and clinical studies at this institution were begun in 1990. The combination of low molecular weight polyvinylpyrrolidone and solid polymer particles allows the implantation of permanent polymer spheres through a small needle under local anesthesia. In this study 127 cases are reviewed of consecutive patients who have received Bioplastique for scar revision, wrinkles, and augmentation for soft-tissue defects at 6 years after application. All patients who had not been in for follow-up recently were contacted by mail and questioned on the permanence of augmentation and migration of particles. About 30 percent of the patients were unreachable and had their charts reviewed for permanence and migration of particles. In eight of these cases, Bioplastique was removed because of overcorrection, two of them may have had infection. Bioplastique has gained wide use throughout the world and although some complications have been reported, in general, it functions quite well when used in selected cases.

  11. Clinical outcome of patients with refractory Kawasaki disease based on treatment modalities

    PubMed Central

    Kim, Hyun Jung; Lee, Hyo Eun; Yu, Jae Won

    2016-01-01

    Purpose Although a significant number of reports on new therapeutic options for refractory Kawasaki disease (KD) such as steroid, infliximab, or repeated intravenous immunoglobulin (IVIG) are available, their effectiveness in reducing the prevalence of coronary artery lesions (CAL) remains controversial. This study aimed to define the clinical characteristics of patients with refractory KD and to assess the effects of adjuvant therapy on patient outcomes. Methods We performed a retrospective study of 38 refractory KD patients from January 2012 to March 2015. We divided these patients into 2 groups: group 1 received more than 3 IVIG administration+ steroid therapy, (n=7, 18.4%), and group 2 patients were unresponsive to initial IVIG and required steroid therapy or second IVIG (n=31, 81.6%). We compared the clinical manifestations, laboratory results, and echocardiographic findings between the groups and examined the clinical utility of additional therapies in both groups. Results A significant difference was found in the total duration of fever between the groups (13.0±4.04 days in group 1 vs. 8.87±2.30 days in group 2; P=0.035). At the end of the follow-up, all cases in group 1 showed suppressed CAL. In group 2, coronary artery aneurysm occurred in 2 patients (6.4 %). All the patients treated with intravenous corticosteroids without additional IVIG developed CALs including coronary artery aneurysms. Conclusion No statistical difference was found in the development of CAL between the groups. Prospective, randomized, clinical studies are needed to elucidate the effects of adjunctive therapy in refractory KD patients. PMID:27610181

  12. Clinical outcome of patients with refractory Kawasaki disease based on treatment modalities

    PubMed Central

    Kim, Hyun Jung; Lee, Hyo Eun; Yu, Jae Won

    2016-01-01

    Purpose Although a significant number of reports on new therapeutic options for refractory Kawasaki disease (KD) such as steroid, infliximab, or repeated intravenous immunoglobulin (IVIG) are available, their effectiveness in reducing the prevalence of coronary artery lesions (CAL) remains controversial. This study aimed to define the clinical characteristics of patients with refractory KD and to assess the effects of adjuvant therapy on patient outcomes. Methods We performed a retrospective study of 38 refractory KD patients from January 2012 to March 2015. We divided these patients into 2 groups: group 1 received more than 3 IVIG administration+ steroid therapy, (n=7, 18.4%), and group 2 patients were unresponsive to initial IVIG and required steroid therapy or second IVIG (n=31, 81.6%). We compared the clinical manifestations, laboratory results, and echocardiographic findings between the groups and examined the clinical utility of additional therapies in both groups. Results A significant difference was found in the total duration of fever between the groups (13.0±4.04 days in group 1 vs. 8.87±2.30 days in group 2; P=0.035). At the end of the follow-up, all cases in group 1 showed suppressed CAL. In group 2, coronary artery aneurysm occurred in 2 patients (6.4 %). All the patients treated with intravenous corticosteroids without additional IVIG developed CALs including coronary artery aneurysms. Conclusion No statistical difference was found in the development of CAL between the groups. Prospective, randomized, clinical studies are needed to elucidate the effects of adjunctive therapy in refractory KD patients.

  13. 77 FR 37706 - Agency Information Collection Activities: 30-Day Notice of Intention To Request Clearance of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR National Park Service Agency Information Collection Activities: 30-Day Notice of Intention To Request Clearance of Collection of Information; Opportunity for Public Comment AGENCY: National Park Service,...

  14. 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. 27.58 Section 27.58 Agriculture Regulations of the Department of Agriculture AGRICULTURAL MARKETING SERVICE (Standards, Inspections, Marketing Practices), DEPARTMENT OF AGRICULTURE COMMODITY STANDARDS...

  15. 77 FR 47702 - 30-Day Notice of Request for Approval: Statutory Authority To Preserve Rail Service

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-09

    ... this collection in the Federal Register on February 10, 2012, at 77 FR 7236-37 (60-day notice). That... Surface Transportation Board 30-Day Notice of Request for Approval: Statutory Authority To Preserve Rail Service AGENCY: Surface Transportation Board, DOT. ACTION: Notice and request for comments. SUMMARY:...

  16. 78 FR 49280 - 30-Day Notice of Proposed Information Collection: Third-Party Documentation Facsimile Transmittal...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-13

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Third-Party Documentation Facsimile..., 2013. A. Overview of Information Collection Title of Information Collection: Third-Party Documentation... of the need for the information and proposed use: The use of the Third-Party Documentation...

  17. 78 FR 7436 - Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-01

    ... in the Federal Register (77 FR 69865) on November 21, 2012, and allowed 60 days for public comment... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Indian Health Service Request for Public Comment: 30-Day Proposed Information...

  18. 78 FR 79474 - 30-Day Notice of Proposed Information Collection: Father's Day

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ...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...

  19. 78 FR 36198 - Request for Public Comment: 30-Day Proposed Information Collection: Indian Health Service Medical...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-17

    ... process has been streamlined and is using information technology to make the application electronically... information technology. Send Requests for Further Information: For the proposed collection, or requests to... HUMAN SERVICES Indian Health Service Request for Public Comment: 30-Day Proposed Information...

  20. Heart failure performance measures: do they have an impact on 30-day readmission rates?

    PubMed

    Mazimba, Sula; Grant, Nakash; Parikh, Analkumar; Mwandia, George; Makola, Diklar; Chilomo, Christine; Redko, Cristina; Hahn, Harvey S

    2013-01-01

    Congestive heart failure (CHF) accounts for more health care costs than any other diagnosis. Readmissions contribute to this expenditure. The authors evaluated the relationship between adherence to performance metrics and 30-day readmissions. This was a retrospective study of 6063 patients with CHF between 2001 and 2008. Data were collected for 30-day readmissions and compliance with CHF performance measures at discharge. Rates of readmission for CHF increased from 16.8% in 2002 to 24.8% in 2008. Adherence to performance measures increased concurrently from 95.8% to 99.9%. Except for left ventricular function (LVF) assessment, the 30-day readmission rate was not associated with adherence to performance measures. Readmitted patients had twice the odds of not having their LVF assessed (odds ratio = 2.0; P < .00005; 95% confidence interval = 1.45-2.63). CHF performance measures, except for the LVF assessment, have little relationship to 30-day readmissions. Further studies are needed to identify performance measures that correlate with quality of care. PMID:23110998

  1. 76 FR 10035 - Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... HUMAN SERVICES Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov AGENCY..., OMB number, to Ed.Calimag@hhs.gov , or call the Reports Clearance Office on (202) 205- 1193. Send... notice directly to the Grants.gov OMB Desk Officer; faxed to OMB at 202-395-6974. Proposed Project:...

  2. 76 FR 10036 - Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... HUMAN SERVICES Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov AGENCY..., OMB number, to Ed.Calimag@hhs.gov , or call the Reports Clearance Office on (202) 205- 1193. Send... notice directly to the Grants.gov OMB Desk Officer; faxed to OMB at 202-395-6974. Proposed Project:...

  3. 76 FR 10034 - Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... HUMAN SERVICES Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov AGENCY..., OMB number, to Ed.Calimag@hhs.gov , or call the Reports Clearance Office on (202) 205- 1193. Send... notice directly to the Grants.gov OMB Desk Officer; faxed to OMB at 202-395-6974. Proposed Project:...

  4. 76 FR 10364 - Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-24

    ... HUMAN SERVICES Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov AGENCY..., OMB number, to Ed.Calimag@hhs.gov , or call the Reports Clearance Office on (202) 205- 1193. Send... notice directly to the Grants.gov OMB Desk Officer; faxed to OMB at 202-395-6974. Proposed Project:...

  5. 76 FR 10033 - Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... HUMAN SERVICES Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov AGENCY..., OMB number, to Ed.Calimag@hhs.gov , or call the Reports Clearance Office on (202) 690- 7569. Send... notice directly to the Grants.gov OMB Desk Officer; faxed to OMB at 202-395-6974. Proposed Project:...

  6. 78 FR 48178 - Submission for OMB Review; 30-day Comment Request: Autism Spectrum Disorder Research Portfolio...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-07

    ... HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request: Autism... any data that is collected on autism projects that are funded. This comment was considered, but it did..., contact: The Office of Autism Research Coordination, NIMH, NIH, Neuroscience Center, 6001 Executive...

  7. 78 FR 1916 - 30-Day Notice of Proposed Information Collection: Smart Traveler Enrollment Program

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-01-09

    ...The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public...

  8. 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

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Section 3 Business Registry Pilot..., Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street...

  9. 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

    ...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 19496 - Submission for OMB Review; 30-day Comment Request; The National Cancer Institute (NCI...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-01

    ... of eHealth/ mHealth tobacco cessation intervention programs. SmokefreeTXT has been developed (and is... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request;...

  11. 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...

  12. 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

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Section 8 Management Assessment... of Management and Budget (OMB) for review, in accordance with the Paperwork Reduction Act. The... Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax:...

  13. 78 FR 70956 - 30-Day Notice of Proposed Information Collection: Assessment of Native American, Alaska Native...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-27

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Assessment of Native American... Title of Information Collection: Assessment of Native American, Alaska Native and Native Hawaiian... American and Alaskan Native populations, most notably through the Indian Housing Block Grant. The level...

  14. 76 FR 28987 - Agency Information Collection Request; 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-19

    ... 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 the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary...

  15. 78 FR 78369 - Submission for OMB Review; 30-Day Comment Request: Early Career Reviewer Program Online...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-26

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Early.... Currently, the application process involves repeated email interactions with potential applicants and...

  16. 75 FR 48970 - Agency Information Collection Request; 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Office of the Secretary Agency Information Collection Request; 30-Day Public Comment... Human Services, is publishing the following summary of a proposed collection for public...

  17. 75 FR 48969 - Agency Information Collection Request. 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-12

    ... 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,...

  18. 78 FR 36564 - 30-Day Notice of Proposed Information Collection: Multifamily Default Status Report

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Multifamily Default Status Report..., Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard... Report. OMB Approval Number: 2502-0041. Type of Request: Extension of a currently approved...

  19. 78 FR 39305 - 30-Day Notice of Proposed Information Collection: OSHC Progress Report Template

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-01

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: OSHC Progress Report Template AGENCY... Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at Colette.Pollard... Information Collection Title of Information Collection: OSHC Progress Report Template. OMB Approval...

  20. 78 FR 38070 - 30-Day Notice of Proposed Information Collection: Affirmative Fair Housing Marketing (AFHM) Plan

    Federal Register 2010, 2011, 2012, 2013, 2014

    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),...

  1. [Separate birth 30 days after a premature delivery in a twin pregnancy. A case report].

    PubMed

    Kisoka, R

    1994-01-01

    The author reports an exceptional observation concerning a delayed delivery of a second twin born at 34 weeks' gestation. The first infant was born 30 days before. The "fetal retention" of the second twin seems to improve its vital prognostic, 12 months later, the infant was in full growth and showing a good health. PMID:7995920

  2. 76 FR 40913 - Agency Information Collection Request; 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-12

    ... respondent (in hours) hours Survey Human Resource Manager 3,000 1 30/60 1,500 Focus Group Protocol Employees in All 48 1 1.5 72 Occupations Key Informant Interview Script...... Human Resource Manager 20 1 45/60... HUMAN SERVICES Agency Information Collection Request; 30-Day Public Comment Request AGENCY: Office...

  3. 78 FR 79475 - 30-Day Notice of Proposed Information Collection: The Impact of Housing and Services...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-30

    ...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...

  4. 78 FR 56908 - 30-Day Notice of Proposed Information Collection: Training Evaluation Form

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-16

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Training Evaluation Form AGENCY... Information Collection Title of Information Collection: Training Evaluation Form. OMB Approval Number: 2577... Evaluation Form is currently being used and will be used are: On-site Core Curriculum training in...

  5. 78 FR 36563 - 30-Day Notice of Proposed Information Collection: Single Family Premium Collection Subsystem...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-06-18

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Single Family Premium Collection..., 2013. A. Overview of Information Collection Title of Information Collection: Single Family Premium... use: The Single Family Premium Collection Subsystem-Upfront (SFPCS-U) allows the lenders to remit...

  6. 78 FR 75366 - 30-Day Notice of Proposed Information Collection: Public Housing Energy Audits and Utility...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  7. 77 FR 39318 - 30-Day Notice of Proposed Information Collection: DS-5513, Supplemental Questionnaire To...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-02

    ..., Office of Project Management and Operational Support, Program Coordination (CA/PPT/PMO/PC) Form Number... information collection request to the Office of Management and Budget (OMB) for approval in accordance with... to the Office of Management and Budget (OMB) for up to 30 days from July 2, 2012. ADDRESSES:...

  8. 77 FR 29348 - Agency Information Collection Request; 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-17

    ... 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 the Secretary, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary...

  9. 76 FR 32008 - 30-Day Notice of Proposed Information Collections: RPPR Public Diplomacy Surveys

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-02

    ... forms of social media and similar collaborative technologies to interact on Public Diplomacy themes in... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 30-Day Notice of Proposed Information Collections: RPPR Public Diplomacy Surveys ACTION: Notice of request...

  10. 77 FR 13128 - Agency Information Collection Request; 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-05

    ... social media PSA. This study will collect information on awareness of the ``Make the Call--Don't Miss a... 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...

  11. 78 FR 52009 - 30-Day Notice of Proposed Information Collection: Utility Allowance Adjustments

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-21

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Utility Allowance Adjustments AGENCY... Information Collection Title of Information Collection: Utility Allowance Adjustments. OMB Approval Number... advise the Secretary of the need for and request approval of a new utility allowance for...

  12. 78 FR 36565 - 30-Day Notice of Proposed Information Collection: Standardized Form for Collecting Information...

    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...

  13. 76 FR 10037 - Agency Information Collection Request. 30-Day Public Comment Request, Grants.gov

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-23

    ... written comments and recommendations for the proposed information collections within 30 days of this... ``General Instructions'' section, the following sentence is added as the last sentence: ``In ALL cases total... B Budget Categories'' section, the last sentence is revised as follows: ``For each program,...

  14. Clinical Outcome Metrics for Optimization of Robust Training

    NASA Technical Reports Server (NTRS)

    Ebert, D.; Byrne, V. E.; McGuire, K. M.; Hurst, V. W., IV; Kerstman, E. L.; Cole, R. W.; Sargsyan, A. E.; Garcia, K. M.; Reyes, D.; Young, M.

    2016-01-01

    Introduction: The emphasis of this research is on the Human Research Program (HRP) Exploration Medical Capability's (ExMC) "Risk of Unacceptable Health and Mission Outcomes Due to Limitations of In-Flight Medical Capabilities." Specifically, this project aims to contribute to the closure of gap ExMC 2.02: We do not know how the inclusion of a physician crew medical officer quantitatively impacts clinical outcomes during exploration missions. The experiments are specifically designed to address clinical outcome differences between physician and non-physician cohorts in both near-term and longer-term (mission impacting) outcomes. Methods: Medical simulations will systematically compare success of individual diagnostic and therapeutic procedure simulations performed by physician and non-physician crew medical officer (CMO) analogs using clearly defined short-term (individual procedure) outcome metrics. In the subsequent step of the project, the procedure simulation outcomes will be used as input to a modified version of the NASA Integrated Medical Model (IMM) to analyze the effect of the outcome (degree of success) of individual procedures (including successful, imperfectly performed, and failed procedures) on overall long-term clinical outcomes and the consequent mission impacts. The procedures to be simulated are endotracheal intubation, fundoscopic examination, kidney/urinary ultrasound, ultrasound-guided intravenous catheter insertion, and a differential diagnosis exercise. Multiple assessment techniques will be used, centered on medical procedure simulation studies occurring at 3, 6, and 12 months after initial training (as depicted in the following flow diagram of the experiment design). Discussion: Analysis of procedure outcomes in the physician and non-physician groups and their subsets (tested at different elapsed times post training) will allow the team to 1) define differences between physician and non-physician CMOs in terms of both procedure performance

  15. Clinical outcomes for Conduits and Scaffolds in peripheral nerve repair

    PubMed Central

    Gerth, David J; Tashiro, Jun; Thaller, Seth R

    2015-01-01

    The gold standard of peripheral nerve repair is nerve autograft when tensionless repair is not possible. Use of nerve autograft has several shortcomings, however. These include limited availability of donor tissue, sacrifice of a functional nerve, and possible neuroma formation. In order to address these deficiencies, researchers have developed a variety of biomaterials available for repair of peripheral nerve gaps. We review the clinical studies published in the English literature detailing outcomes and reconstructive options. Regardless of the material used or the type of nerve repaired, outcomes are generally similar to nerve autograft in gaps less than 3 cm. New biomaterials currently under preclinical evaluation may provide improvements in outcomes. PMID:25685760

  16. Early clinical outcomes following laparoscopic inguinal hernia repair.

    PubMed

    Tolver, Mette Astrup

    2013-07-01

    Laparoscopic inguinal hernia repair (TAPP) has gained increasing popularity because of less post-operative pain and a shorter duration of convalescence compared with open hernia repair technique (Lichtenstein). However, investigation of duration of convalescence with non-restrictive recommendations, and a procedure-specific characterization of the early clinical outcomes after TAPP was lacking. Furthermore, optimization of the post-operative period with fibrin sealant versus tacks for fixation of mesh, and the glucocorticoid dexamethasone versus placebo needed to be investigated in randomized clinical trials. The objective of this PhD thesis was to characterize the early clinical outcomes after TAPP and optimize the post-operative period. The four studies included in this thesis have investigated duration of convalescence and procedure-specific post-operative pain and other early clinical outcomes after TAPP. Furthermore, it has been shown that fibrin sealant can improve the early post-operative period compared with tacks, while dexamethasone showed no advantages apart from reduced use of antiemetics compared with placebo. Based on these findings, and the existing knowledge, 3-5 days of convalescence should be expected when 1 day of convalescence is recommended and future studies should focus on reducing intraabdominal pain after TAPP. Fibrin sealant can optimize the early clinical outcomes but the risk of hernia recurrence and chronic pain needs to be evaluated. Dexamethasone should be investigated in higher doses. PMID:23809977

  17. Campus Clinical: simulation-based curriculum designed to meet clinical course learning outcomes.

    PubMed

    Jarvis, Michelle; Rivers, Julie

    2014-01-01

    Campus Clinical is a simulation-based curriculum designed to meet the challenge of decreasing clinical spaces in maternal-child units. The curriculum framework is situated in a constructivist, experiential learning context, integrating Chickering and Gamson's principles for good practice in education. This innovative approach to meeting clinical course learning outcomes is transferable to a variety of settings.

  18. Psychometric properties of the Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure

    PubMed Central

    Trujillo, Adriana; Feixas, Guillem; Bados, Arturo; García-Grau, Eugeni; Salla, Marta; Medina, Joan Carles; Montesano, Adrián; Soriano, José; Medeiros-Ferreira, Leticia; Cañete, Josep; Corbella, Sergi; Grau, Antoni; Lana, Fernando; Evans, Chris

    2016-01-01

    Objective The objective of this paper is to assess the reliability and validity of the Spanish translation of the Clinical Outcomes in Routine Evaluation – Outcome Measure, a 34-item self-report questionnaire that measures the client’s status in the domains of Subjective well-being, Problems/Symptoms, Life functioning, and Risk. Method Six hundred and forty-four adult participants were included in two samples: the clinical sample (n=192) from different mental health and primary care centers; and the nonclinical sample (n=452), which included a student and a community sample. Results The questionnaire showed good acceptability and internal consistency, appropriate test–retest reliability, and acceptable convergent validity. Strong differentiation between clinical and nonclinical samples was found. As expected, the Risk domain had different characteristics than other domains, but all findings were comparable with the UK referential data. Cutoff scores were calculated for clinical significant change assessment. Conclusion The Spanish version of the Clinical Outcomes in Routine Evaluation – Outcome Measure showed acceptable psychometric properties, providing support for using the questionnaire for monitoring the progress of Spanish-speaking psychotherapy clients. PMID:27382288

  19. Multisystemic Therapy(®) : Clinical Overview, Outcomes, and Implementation Research.

    PubMed

    Henggeler, Scott W; Schaeffer, Cindy M

    2016-09-01

    Multisystemic therapy (MST) is an evidence-based treatment originally developed for youth with serious antisocial behavior who are at high risk for out-of-home placement and their families; and subsequently adapted to address other challenging clinical problems experience by youths and their families. The social-ecological theoretical framework of MST is presented as well as its home-based model of treatment delivery, defining clinical intervention strategies, and ongoing quality assurance/quality improvement system. With more than 100 peer-reviewed outcome and implementation journal articles published as of January 2016, the majority by independent investigators, MST is one of the most extensively evaluated family based treatments. Outcome research has yielded almost uniformly favorable results for youths and families, and implementation research has demonstrated the importance of treatment and program fidelity in achieving such outcomes. PMID:27370172

  20. Clinical profile and outcome of Dengue fever cases.

    PubMed

    Ratageri, Vinod H; Shepur, T A; Wari, P K; Chavan, S C; Mujahid, I B; Yergolkar, P N

    2005-08-01

    Dengue fever is on rise globally. In India, Dengue epidemics are expanding geographically, even into the rural areas. Dengue can present with varied manifestations. The mortality rate has been brought down with high index of suspicion, strict monitoring and proper fluid resuscitation. Herewith, we are presenting clinical features and outcome of Dengue cases seen in and around Hubli (North Karnataka).

  1. 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.

  2. Long-term (30 days) toxicity of NiO nanoparticles for adult zebrafish Danio rerio

    PubMed Central

    Kovrižnych, Jevgenij A.; Zeljenková, Dagmar; Rollerová, Eva; Szabová, Elena

    2014-01-01

    Nickel oxide in the form of nanoparticles (NiO NPs) is extensively used in different industrial branches. In a test on adult zebrafish, the acute toxicity of NiO NPs was shown to be low, however longlasting contact with this compound can lead to its accumulation in the tissues and to increased toxicity. In this work we determined the 30-day toxicity of NiO NPs using a static test for zebrafish Danio rerio. We found the 30-day LC50 value to be 45.0 mg/L, LC100 (minimum concentration causing 100% mortality) was 100.0 mg/L, and LC0 (maximum concentration causing no mortality) was 6.25 mg/L for adult individuals of zebrafish. Considering a broad use of Ni in the industry, NiO NPs chronic toxicity may have a negative impact on the population of aquatic organisms and on food web dynamics in aquatic systems. PMID:26038672

  3. Clinical Outcome Following Infra-Inguinal Percutaneous Transluminal Angioplasy for Critical Limb Ischemia

    SciTech Connect

    Matsagas, Miltiadis I.; Rivera, Marco A.; Tran, Tan; Mitchell, Adam; Robless, Peter; Davies, Alun H.; Geroulakos, George

    2003-06-15

    Objective: The aim of this study was to assess the efficacy and durability of infra-inguinal PTA in patients with CLI, in terms of clinical outcome. Design:Retrospective study of 50 consecutive patients with CLI that were exclusively treated by infra-inguinal PTA. Methods: The indications for intervention were rest pain in seven (14%) patients,non-healing ulcers in 27 (54%), and gangrenous lesions in 16 (32%).Thirty-three (66%) of these patients presented with a single arterial lesion, and the remaining 17 (34%) with multilevel arterial lesions.Kaplan-Meier analysis was used to assess survival, patency,limb-salvage rates, and amputation-free survival. Results: A total of 67 endovascular procedures were performed and 59 (88.1%) of them were considered to be technically successful. The median follow-up period was 12 months (interquartilerange: 17 months). The 30-day mortality was 4%, while the cumulative survival rates at 12, 24, and 36 months were 73%, 67%, and 59%,respectively. The cumulative primary patency rates at 12 and 24 months were 63% and 52%, respectively, and remained unchanged thereafter.The estimated secondary patency rate was 72% at 36 months. There was only one below-knee amputation in the patients that were treated exclusively with infra-inguinal PTA. The cumulative amputation-free survival at the same period was estimated at 60%. Conclusions: Infra-inguinal PTA had a good early and late outcome in this series of patients with a limited life expectancy.These results are comparable to historical results of surgical revascularization in the treatment of CLI. There is need for a randomized study to determine the primary optimal interventional approach for patients with CLI.

  4. A quality improvement plan to reduce 30-day readmissions of heart failure patients.

    PubMed

    Simpson, Monica

    2014-01-01

    An evidence-based quality initiative to decrease heart failure 30-day readmissions was implemented at a hospital in Florida. Heart failure education and postdischarge telephone contact were provided to patients determined to be at high risk of readmission using risk stratification tools. The rate during the project decreased 13% as compared to the same time period in the previous year and 8.5% from the 2012 year to date rate.

  5. 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

  6. Coronary Stents: The Impact of Technological Advances on Clinical Outcomes.

    PubMed

    Mennuni, Marco G; Pagnotta, Paolo A; Stefanini, Giulio G

    2016-02-01

    Percutaneous coronary interventions (PCI) were proposed in the late 1970s as an alternative to surgical coronary artery bypass grafting for the treatment of coronary artery disease. Important technological progress has been made since. Balloon angioplasty was replaced by bare metal stents, which allowed to permanently scaffold the coronary vessel avoiding acute recoil and abrupt occlusion. Thereafter, the introduction of early generation drug-eluting stents (DES) has significantly improved clinical outcomes, primarily by markedly reducing the risk of restenosis. New generation DES with thinner stent struts, novel durable or biodegradable polymer coatings, and new limus antiproliferative agents, have further improved upon the safety and efficacy profile of early generation DES. The present article aims to review the impact of technological advances on clinical outcomes in the field of PCI with coronary stents, and to provide a brief overview on clinical margins of improvement and unmet needs of available DES.

  7. Women are less likely to be admitted to substance abuse treatment within 30 days of assessment.

    PubMed

    Arfken, Cynthia L; Borisova, Natalie; Klein, Chris; di Menza, Salvatore; Schuster, Charles R

    2002-01-01

    The information gathered in a centralized intake unit (CIU) allows payers and administrators to examine if there are access issues for their population. For this study, the authors examined whether there were gender differences in the rate at which people are admitted to treatment within 30 days of assessment. Of the 5,004 individuals seeking publicly-funded substance abuse treatment in Detroit for the years 1996-97, 50.3% of those assessed at the CIU actually entered treatment. Women (31% of the people assessed) had a lower rate of admission (45% for women versus 53% for men) a difference that was maintained even after controlling for known risk factors. Women who were given priority for admission (i.e., those who were pregnant, had children, or injected drugs) had a higher rate of admission than other women (73% versus 39%), but only 17% of the women presenting were included in the priority groups. Men who were injecting drugs (a priority group) also had a higher rate of admission than other men (83% versus 49%). In multivariate analysis controlling for priority groups and known risk factors, women were still less likely to be admitted to treatment within 30 days of admission than men. Establishing priorities improves the rate of admission within 30 days of assessment for those groups, but more needs to be done to improve the admission rate for women. These results demonstrate that a CIU allows administrators to monitor for access issues.

  8. 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.

  9. Surgical management and outcomes of type A dissection—the Mayo Clinic experience

    PubMed Central

    Cabasa, Alduz

    2016-01-01

    Background Type A aortic dissection (TAAD) is a complex cardiovascular disease that is associated with high perioperative morbidity and mortality. The most effective approach is still being debated—such as the best cannulation technique, and conservative versus extensive initial surgery. We reviewed our experience over the last 20 years and examined for variables that correlated with observed outcomes. Methods All patients who underwent TAAD repair were reviewed. Chi-Square tests, Fisher Exact tests and Wilcoxon tests were performed where appropriate. Survival and freedom from reoperations were analyzed with the Kaplan-Meier actuarial method. Results Acute TAAD was associated with a higher incidence of permanent stroke (P=0.010), renal failure (P=0.025), prolonged mechanical ventilator support (P=0.004), higher operative mortality (P=0.039) and higher 30-day mortality (P=0.003) compared to chronic TAAD. There was a trend towards higher risk for transient neurologic events among patients who were reoperated on (P=0.057). Extensive proximal repair led to longer perfusion and cross clamp times (P<0.001) and the need for temporary mechanical support post-operatively (P=0.011). More patients that had extensive distal repair underwent circulatory arrest (P=0.009) with no significant differences in the incidence of peri-operative complications, early, middle and long-term survival compared to the conservative management group. Overall survival in our series was 66.73% and 46.30% at 5 and 10 years respectively (median survival time: 9.38 years). There was a significant improvement in operative mortality (P=0.002) and 30-day mortality (P=0.033) in the second decade of our study. Discussion TAAD is a complex disease with several options for its surgical management. Each technique has its own advantages and complications and surgical management should be individualized depending on the clinical presentation. We propose our present approach to maximize benefits in both the

  10. Possible clinical outcome measures for clinical trials in patients with multiple sclerosis

    PubMed Central

    Goldman, Myla D.; Motl, Robert W.; Rudick, Richard A.

    2010-01-01

    Multiple sclerosis (MS) is a chronic inflammatory and neurodegenerative disease with both clinical and pathological heterogeneity. The complexity of the MS population has offered challenges to the measurement of MS disease progression in therapeutic trials. The current standard clinical outcome measures are relapse rate, Expanded Disability Severity Scale (EDSS), and the MS Functional Composite (MSFC). These measures each have strengths and some weakness. Two additional measures, the six-minute walk and accelerometry, show promise in augmenting current measures. MS therapeutics is a quickly advancing field which requires sensitive clinical outcome measures that can detect small changes in disability that reliably reflect long-term changes in sustained disease progression in a complex population. A single clinical outcome measure of sustained disease progression may remain elusive. Rather, an integration of current and new outcome measures may be most appropriate and utilization of different measures depending on the MS population and stage of the disease may be preferred. PMID:21179614

  11. Novel methods of measuring clinical outcomes from psoriasis and psoriatic arthritis clinical trials.

    PubMed

    Villacorta, Reginald; Hay, Joel W; Messali, Andrew

    2014-08-01

    Numerous instruments exist that measure the clinical and health related quality of life impact of psoriasis and psoriatic arthritis (PsA) in clinical trials. However, many of these instruments are not typically used in economic evaluations to inform decision problems facing health care decision makers. This study reviews the current state of psoriasis and PsA health outcome measures and evaluates their limitations in cost-effectiveness analyses (CEAs). We highlight the health related quality of life and clinical outcome measures that are typically used in CEAs, with special focus on studies with quality adjusted life years as a primary outcome measure. Despite the high prevalence of psoriasis and PsA health outcome measures in clinical trials, only a few are used in CEAs. The methods by which utilities are estimated from these measures vary across cost-effectiveness studies. These differences should be considered when conducting cost-effectiveness research in psoriasis and PsA.

  12. Beyond the Basics of Clinical Outcomes Assessment: Selecting Appropriate Patient-Rated Outcomes Instruments for Patient Care

    ERIC Educational Resources Information Center

    Valier, Alison R.; Lam, Kenneth C.

    2015-01-01

    The fifth edition of the "Athletic Training Education Competencies" emphasizes the concepts of clinical outcomes assessment. In athletic training, clinical outcomes assessment, especially as it relates to patient-rated outcomes (PRO) instruments, is new, which produces uncertainty with regard to how to integrate PROs into athletic…

  13. Increased 30-Day Emergency Department Revisits Among Homeless Patients with Mental Health Conditions

    PubMed Central

    Lam, Chun Nok; Arora, Sanjay; Menchine, Michael

    2016-01-01

    Introduction Patients with mental health conditions frequently use emergency medical services. Many suffer from substance use and homelessness. If they use the emergency department (ED) as their primary source of care, potentially preventable frequent ED revisits and hospital readmissions can worsen an already crowded healthcare system. However, the magnitude to which homelessness affects health service utilization among patients with mental health conditions remains unclear in the medical community. This study assessed the impact of homelessness on 30-day ED revisits and hospital readmissions among patients presenting with mental health conditions in an urban, safety-net hospital. Methods We conducted a secondary analysis of administrative data on all adult ED visits in 2012 in an urban safety-net hospital. Patient demographics, mental health status, homelessness, insurance coverage, level of acuity, and ED disposition per ED visit were analyzed using multilevel modeling to control for multiple visits nested within patients. We performed multivariate logistic regressions to evaluate if homelessness moderated the likelihood of mental health patients’ 30-day ED revisits and hospital readmissions. Results Study included 139,414 adult ED visits from 92,307 unique patients (43.5±15.1 years, 51.3% male, 68.2% Hispanic/Latino). Nearly 8% of patients presented with mental health conditions, while 4.6% were homeless at any time during the study period. Among patients with mental health conditions, being homeless contributed to an additional 28.0% increase in likelihood (4.28 to 5.48 odds) of 30-day ED revisits and 38.2% increase in likelihood (2.04 to 2.82 odds) of hospital readmission, compared to non-homeless, non-mental health (NHNM) patients as the base category. Adjusted predicted probabilities showed that homeless patients presenting with mental health conditions have a 31.1% chance of returning to the ED within 30-day post discharge and a 3.7% chance of hospital

  14. Increased 30-Day Emergency Department Revisits Among Homeless Patients with Mental Health Conditions

    PubMed Central

    Lam, Chun Nok; Arora, Sanjay; Menchine, Michael

    2016-01-01

    Introduction Patients with mental health conditions frequently use emergency medical services. Many suffer from substance use and homelessness. If they use the emergency department (ED) as their primary source of care, potentially preventable frequent ED revisits and hospital readmissions can worsen an already crowded healthcare system. However, the magnitude to which homelessness affects health service utilization among patients with mental health conditions remains unclear in the medical community. This study assessed the impact of homelessness on 30-day ED revisits and hospital readmissions among patients presenting with mental health conditions in an urban, safety-net hospital. Methods We conducted a secondary analysis of administrative data on all adult ED visits in 2012 in an urban safety-net hospital. Patient demographics, mental health status, homelessness, insurance coverage, level of acuity, and ED disposition per ED visit were analyzed using multilevel modeling to control for multiple visits nested within patients. We performed multivariate logistic regressions to evaluate if homelessness moderated the likelihood of mental health patients’ 30-day ED revisits and hospital readmissions. Results Study included 139,414 adult ED visits from 92,307 unique patients (43.5±15.1 years, 51.3% male, 68.2% Hispanic/Latino). Nearly 8% of patients presented with mental health conditions, while 4.6% were homeless at any time during the study period. Among patients with mental health conditions, being homeless contributed to an additional 28.0% increase in likelihood (4.28 to 5.48 odds) of 30-day ED revisits and 38.2% increase in likelihood (2.04 to 2.82 odds) of hospital readmission, compared to non-homeless, non-mental health (NHNM) patients as the base category. Adjusted predicted probabilities showed that homeless patients presenting with mental health conditions have a 31.1% chance of returning to the ED within 30-day post discharge and a 3.7% chance of hospital

  15. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report.

    PubMed

    Pimentel, Welson; Teixeira, Marcelo Lucchesi; Costa, Priscila Paganini; Jorge, Mônica Zacharias; Tiossi, Rodrigo

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome. PMID:26633080

  16. Predictable Outcomes with Porcelain Laminate Veneers: A Clinical Report.

    PubMed

    Pimentel, Welson; Teixeira, Marcelo Lucchesi; Costa, Priscila Paganini; Jorge, Mônica Zacharias; Tiossi, Rodrigo

    2016-06-01

    This clinical report describes how to achieve predictable outcomes for anterior teeth esthetic restorations with porcelain laminate veneers by associating the digital planning and design of the restoration with interim restorations. The previous digital smile design of the restoration eliminates the communication barrier with the patient and assists the clinician throughout patient treatment. Interim restorations (diagnostic mock-ups) further enhance communication with the patient and prevent unnecessary tooth reduction for conservative tooth preparation. Adequate communication between patient and clinician contributes to successful definitive restorations and patient satisfaction with the final esthetic outcome.

  17. Clinical validity of outcome pain measures in naturally occurring canine osteoarthritis

    PubMed Central

    2012-01-01

    Background The conceptual validity of kinetic gait analysis and disability outcome assessment methods has guided their use in the assessment of pain caused by osteoarthritis (OA). No consensus on the best clinical methods for pain evaluation in canine OA exists, particularly, when evaluating treatments where a smaller treatment effect is anticipated than with pharmacological pain killers. This study thus aimed at determining the technical validity of some clinical endpoints on OA pain in dogs using the green-lipped mussel (GLM)-enriched diet. Twenty-three adult dogs with clinical OA completed the prospective controlled study. All the dogs were fed a balanced diet over a 30-day control period followed by a GLM-enriched diet over a 60-day period. The kinetic gait analysis parameter (PVFBW, peak vertical force adjusted for body weight change), electrodermal activity (EDA), and a standardized multifactorial pain questionnaire (MFQ) were performed on day (D) 0 (inclusion), D30 (start) and D90 (end). The owners completed a client-specific outcome measures (CSOM) instrument twice a week. Motor activity (MA) was continuously recorded in seven dogs using telemetered accelerometric counts. We hypothesized that these methods would produce convergent results related to diet changes. A Type I error of 0.05 was adjusted to correct for the multiplicity of the primary clinical endpoints. Results Neither the EDA nor the MFQ were found reliable or could be validated. Changes in the PVFBW (Padj = 0.0004), the CSOM (Padj = 0.006) and the MA intensity (Padj = 0.02) from D0 to D90 suggested an effect of diet(s). Only the PVFBW clearly increased after the GLM-diet (Padj = 0.003). The CSOM exhibited a negative relationship with the PVFBW (P = 0.02) and MA duration (P = 0.02). Conclusions The PVFBW exhibited the best technical validity for the characterization of the beneficial effect of a GLM-enriched diet. The CSOM and MA appeared less responsive following a GLM

  18. The HOSPITAL score as a predictor of 30 day readmission in a retrospective study at a university affiliated community hospital

    PubMed Central

    2016-01-01

    Introduction Hospital readmissions are common, expensive, and a key target of the Medicare Value Based Purchasing (VBP) program. Risk assessment tools 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. One such tool is the HOSPITAL score that uses seven readily available clinical variables to predict the risk of readmission within 30 days of discharge. The HOSPITAL score has been internationally validated in large academic medical centers. This study aims to determine if the HOSPITAL score is similarly useful in a moderate sized university affiliated hospital in the midwestern United States. Materials and Methods All adult medical patients 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 was a significant predictor of hospital readmission within 30 days. Results During the study period, 998 discharges were recorded for the hospitalist service. The analysis includes data for the 931 discharges. Patients who died during the hospital stay, were transferred to another hospital, or left against medical advice were excluded. Of these patients, 109 (12%) were readmitted to the same hospital within 30 days. The patients who were readmitted were more likely to have a length of stay greater than or equal to 5 days (55% vs. 41%, p = 0.005) and were more likely to have been admitted more than once to the hospital within the last year (100% vs. 49%, p < 0.001). A receiver operating characteristic evaluation of the HOSPITAL score for this patient population shows a C statistic of 0.77 (95% CI [0.73–0.81]), indicating good discrimination for hospital readmission. The Brier score for the HOSPITAL score in this setting was 0.10, indicating good overall performance. The Hosmer–Lemeshow goodness of fit test shows a χ2 value of 1

  19. The HOSPITAL score as a predictor of 30 day readmission in a retrospective study at a university affiliated community hospital

    PubMed Central

    2016-01-01

    Introduction Hospital readmissions are common, expensive, and a key target of the Medicare Value Based Purchasing (VBP) program. Risk assessment tools 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. One such tool is the HOSPITAL score that uses seven readily available clinical variables to predict the risk of readmission within 30 days of discharge. The HOSPITAL score has been internationally validated in large academic medical centers. This study aims to determine if the HOSPITAL score is similarly useful in a moderate sized university affiliated hospital in the midwestern United States. Materials and Methods All adult medical patients 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 was a significant predictor of hospital readmission within 30 days. Results During the study period, 998 discharges were recorded for the hospitalist service. The analysis includes data for the 931 discharges. Patients who died during the hospital stay, were transferred to another hospital, or left against medical advice were excluded. Of these patients, 109 (12%) were readmitted to the same hospital within 30 days. The patients who were readmitted were more likely to have a length of stay greater than or equal to 5 days (55% vs. 41%, p = 0.005) and were more likely to have been admitted more than once to the hospital within the last year (100% vs. 49%, p < 0.001). A receiver operating characteristic evaluation of the HOSPITAL score for this patient population shows a C statistic of 0.77 (95% CI [0.73–0.81]), indicating good discrimination for hospital readmission. The Brier score for the HOSPITAL score in this setting was 0.10, indicating good overall performance. The Hosmer–Lemeshow goodness of fit test shows a χ2 value of 1

  20. The CD14 rs2569190 TT Genotype Is Associated with an Improved 30-Day Survival in Patients with Sepsis: A Prospective Observational Cohort Study

    PubMed Central

    Mansur, Ashham; Liese, Benjamin; Steinau, Maximilian; Ghadimi, Michael; Bergmann, Ingo; Tzvetkov, Mladen; Popov, Aron Frederik; Beissbarth, Tim; Bauer, Martin; Hinz, José

    2015-01-01

    According to previous investigations, CD14 is suggested to play a pivotal role in initiating and perpetuating the pro-inflammatory response during sepsis. A functional polymorphism within the CD14 gene, rs2569190, has been shown to impact the pro-inflammatory response upon stimulation with lipopolysaccharide, a central mediator of inflammation in sepsis. In this study, we hypothesized that the strong pro-inflammatory response induced by the TT genotype of CD14 rs2569190 may have a beneficial effect on survival (30-day) in patients with sepsis. A total of 417 adult patients with sepsis (and of western European descent) were enrolled into this observational study. Blood samples were collected for rs2569190 genotyping. Patients were followed over the course of their stay in the ICU, and the 30-day mortality risk was recorded as the primary outcome parameter. Sepsis-related organ failure assessment (SOFA) scores were quantified at sepsis onset and throughout the observational period to monitor organ failure as a secondary variable. Moreover, organ support-free days were evaluated as a secondary outcome parameter. TT-homozygous patients were compared to C-allele carriers. Kaplan-Meier survival analysis revealed a higher 30-day mortality risk among C-allele carriers compared with T homozygotes (p = 0.0261). To exclude the effect of potential confounders (age, gender, BMI and type of infection) and covariates that varied at baseline with a p-value < 0.2 (e.g., comorbidities), we performed multivariate Cox regression analysis to examine the survival time. The CD14 rs2569190 C allele remained a significant covariate for the 30-day mortality risk in the multivariate analysis (hazard ratio, 2.11; 95% CI, 1.08-4.12; p = 0.0282). The 30-day mortality rate among C allele carriers was 23%, whereas the T homozygotes had a mortality rate of 13%. Additionally, an analysis of organ-specific SOFA scores revealed a significantly higher SOFA-Central nervous system score among patients

  1. Outcome Measures for Artificial Pancreas Clinical Trials: A Consensus Report.

    PubMed

    Maahs, David M; Buckingham, Bruce A; Castle, Jessica R; Cinar, Ali; Damiano, Edward R; Dassau, Eyal; DeVries, J Hans; Doyle, Francis J; Griffen, Steven C; Haidar, Ahmad; Heinemann, Lutz; Hovorka, Roman; Jones, Timothy W; Kollman, Craig; Kovatchev, Boris; Levy, Brian L; Nimri, Revital; O'Neal, David N; Philip, Moshe; Renard, Eric; Russell, Steven J; Weinzimer, Stuart A; Zisser, Howard; Lum, John W

    2016-07-01

    Research on and commercial development of the artificial pancreas (AP) continue to progress rapidly, and the AP promises to become a part of clinical care. In this report, members of the JDRF Artificial Pancreas Project Consortium in collaboration with the wider AP community 1) advocate for the use of continuous glucose monitoring glucose metrics as outcome measures in AP trials, in addition to HbA1c, and 2) identify a short set of basic, easily interpreted outcome measures to be reported in AP studies whenever feasible. Consensus on a broader range of measures remains challenging; therefore, reporting of additional metrics is encouraged as appropriate for individual AP studies or study groups. Greater consistency in reporting of basic outcome measures may facilitate the interpretation of study results by investigators, regulatory bodies, health care providers, payers, and patients themselves, thereby accelerating the widespread adoption of AP technology to improve the lives of people with type 1 diabetes. PMID:27330126

  2. Novel Outcome Measures for Clinical Trials in Cystic Fibrosis

    PubMed Central

    Tiddens, Harm AWM; Puderbach, Michael; Venegas, Jose G; Ratjen, Felix; Donaldson, Scott H; Davis, Stephanie D; Rowe, Steven M; Sagel, Scott D; Higgins, Mark; Waltz, David A

    2015-01-01

    Cystic fibrosis (CF) is a common inherited condition caused by mutations in the gene encoding the CF transmembrane regulator protein. With increased understanding of the molecular mechanisms underlying CF and the development of new therapies there comes the need to develop new outcome measures to assess the disease, its progression and response to treatment. As there are limitations to the current endpoints accepted for regulatory purposes, a workshop to discuss novel endpoints for clinical trials in CF was held in Anaheim, California in November 2011. The pros and cons of novel outcome measures with potential utility for evaluation of novel treatments in CF were critically evaluated. The highlights of the 2011 workshop and subsequent advances in technologies and techniques that could be used to inform the development of clinical trial endpoints are summarized in this review. Pediatr Pulmonol. © 2014 The Authors. Pediatric Pulmonology published by Wiley Periodicals, Inc. PMID:25641878

  3. Midterm clinical outcomes following arthroscopic transosseous rotator cuff repair

    PubMed Central

    Flanagin, Brody A.; Garofalo, Raffaele; Lo, Eddie Y.; Feher, LeeAnne; Castagna, Alessandro; Qin, Huanying; Krishnan, Sumant G.

    2016-01-01

    Purpose: Arthroscopic transosseous (TO) rotator cuff repair has recently emerged as a new option for surgical treatment of symptomatic rotator cuff tears. Limited data is available regarding outcomes using this technique. This study evaluated midterm clinical outcomes following a novel arthroscopic TO (anchorless) rotator cuff repair technique. Materials and Methods: A consecutive series of 107 patients and 109 shoulders underwent arthroscopic TO (anchorless) rotator cuff repair for a symptomatic full-thickness tear. Pre and postoperative range of motion (ROM) was compared at an average of 11.8 months. Postoperative outcome scores were obtained at an average of 38.0 months. Statistical analysis was performed to compare pre and postoperative ROM data. Univariate analysis was performed using Student's t-test to compare the effect of other clinical characteristics on final outcome. Results: Statistically significant improvements were noted in forward flexion, external rotation and internal rotation (P < 0.0001). Average postoperative subjective shoulder value was 93.7, simple shoulder test 11.6, and American Shoulder and Elbow Surgeons (ASES) score 94.6. According to ASES scores, results for the 109 shoulders available for final follow-up were excellent in 95 (87.1%), good in 8 (7.3%), fair in 3 (2.8%), and poor in 3 (2.8%). There was no difference in ROM or outcome scores in patients who underwent a concomitant biceps procedure (tenodesis or tenotomy) compared with those who did not. Furthermore, there was no significant difference in outcome between patients who underwent either biceps tenodesis or tenotomy. Age, history of injury preceding the onset of pain, tear size, number of TO tunnels required to perform the repair, and presence of fatty infiltration did not correlate with postoperative ROM or subjective outcome measures at final follow-up. Two complications and four failures were noted. Conclusions: Arthroscopic TO rotator cuff repair technique leads to

  4. Effects of a New Metabolic Conditioning Supplement on Perioperative Metabolic Stress and Clinical Outcomes: A Randomized, Placebo-Controlled Trial

    PubMed Central

    Akbarzadeh, Marzieh; Eftekhari, Mohammad Hassan; Shafa, Masih; Alipour, Shohreh; Hassanzadeh, Jafar

    2016-01-01

    Background: Insulin resistance is a measure of metabolic stress in the perioperative period. Before now, no clinical trial has determined the summative effects of glutamine, L-carnitine, and antioxidants as metabolic conditioning supplements in the perioperative period. Objectives: The purpose of this study was to determine the effects of a new conditioning supplement on perioperative metabolic stress and clinical outcomes in non-diabetic patients. Patients and Methods: In this randomized controlled trial, 89 non-diabetic patients scheduled for coronary artery bypass grafting, with ejection fractions above 30%, were selected. Using the balanced block randomization method, the patients were allocated to one of four study arms: 1) SP (supplement/placebo): supplement seven days before and placebo 30 days after the surgery; 2) PS: placebo before and supplement after the surgery; 3) SS: supplement before and after the surgery; and 4) PP: placebo before and after the surgery. The supplement was composed of glutamine, L-carnitine, vitamin C, vitamin E, and selenium, which was manufactured for the first time by this research team. Five blood samples were drawn: seven days preoperatively, at the entrance to the operating room, while leaving the operating room, seven days postoperatively, and 30 days postoperatively. Levels of glucose, insulin, and HbA1c were measured in blood samples. Insulin resistance and sensitivity were calculated using a formula. Surgical complications were assessed 30 days postoperatively. Data analysis was done using one-way ANOVA, the Chi-square test, and a general linear model repeated-measures analysis with Bonferroni adjustment. Results: Blood glucose levels were increased postoperatively in the four groups (< 0.001), but a significantly higher increase occurred in the PP group compared to the SP (0.027), PS (0.026), and SS (0.004) groups. The superficial wound infection rate was significantly different between the four groups (0.021): 26.08% in

  5. 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

  6. Candida Virulence Properties and Adverse Clinical Outcomes in Neonatal Candidiasis

    PubMed Central

    Bliss, Joseph M.; Wong, Angela Y.; Bhak, Grace; Laforce-Nesbitt, Sonia S.; Taylor, Sarah; Tan, Sylvia; Stoll, Barbara J.; Higgins, Rosemary D.; Shankaran, Seetha; Benjamin, Daniel K.

    2012-01-01

    Objective To determine if premature infants with invasive Candida infection caused by strains with increased virulence properties have worse clinical outcomes than those infected with less virulent strains. Study design Clinical isolates were studied from 2 populations; premature infants colonized with Candida (commensal, n=27), and those with invasive candidiasis (n=81). Individual isolates of C. albicans and C. parapsilosis were tested for virulence in each of 3 assays: phenotypic switching, adhesion, and cytotoxicity. Invasive isolates were considered to have enhanced virulence if they measured more than 1 SD above the mean for the commensal isolates in at least 1 assay. Outcomes of patients with invasive isolates with enhanced virulence were compared with those with invasive isolates lacking enhanced virulence characteristics. Results 61% of invasive isolates of C. albicans and 42% of invasive isolates of C. parapsilosis had enhanced virulence. All C. albicans cerebrospinal fluid (CSF) isolates (n=6) and 90% of urine isolates (n=10) had enhanced virulence, compared with 48% of blood isolates (n=40). Infants with more virulent isolates were younger at the time of positive culture and had higher serum creatinine. Conclusions Individual isolates of Candida species vary in their virulence properties. Strains with higher virulence are associated with certain clinical outcomes. PMID:22504098

  7. 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.

  8. Rehabilitation Predictors of Clinical Outcome following Revision ACL Reconstruction

    PubMed Central

    Wright, Rick W.; Group, Mars

    2016-01-01

    Objectives: Revision ACL reconstruction has been documented to have worse outcomes compared with primary ACL reconstructions. The reasons why remain unknown. The purpose of this study was to determine whether rehabilitation-related factors prescribed at the time of ACL revision reconstruction significantly influence two year outcomes, as well as the incidence of incurring a subsequent re-operation. Our hypothesis was that immediate versus passive, active range of motion (ROM) and weightbearing will result in improved outcomes without incidence of subsequent surgery. Use of postoperative and functional return to sport braces will not improve return to sports function. Methods: Revision ACL reconstruction patients were identified and prospectively enrolled between 2006 and 2011. Data collected included baseline demographics, surgical technique and pathology, prescribed post-op and rehabilitation instructions (ie. timing of weightbearing, timing of passive and active ROM, use of postoperative and return to sport braces) and a series of validated patient reported outcome instruments (IKDC, KOOS, and Marx activity rating score). Patients were followed up for 2 years, and asked to complete the identical set of outcome instruments. Because meniscal repair, meniscal transplants, HTOs, concurrent ligamentous reconstructions, and certain chondral treatments (ie. microfracture, abrasion arthroplasty, mosiacplasty, etc) are known to affect prescribed rehab treatments, patients with these pathologies were excluded from the analyses. Regression analysis was used to control for age, gender, activity level, baseline outcome scores, and the above-mentioned rehabilitation-related variables, in order to assess the risk factors for clinical outcomes 2 years after revision ACL reconstruction. Results: A total of 843 patients met the inclusion criteria and were successfully enrolled. 482 (57%) were males, with a median cohort age of 27 years. Baseline characteristics of the cohort are

  9. Clinical and outcome research in oncology. The need for integration.

    PubMed

    Apolone, Giovanni

    2003-01-01

    Cancer is one of the main healthcare problems in Europe. Although significant progress has recently been made, long-term survival is still disappointing for most common solid tumours. The explosion of information has strengthened the need to create and sustain coordinated interaction between technology, biology, clinical research, clinical practice and health policy. A simple process based on automatic and passive translation from bench to clinical research and eventually to the bed side is usually assumed but cannot be taken for granted. A critical role might be played by Outcome Research (OR), defined as the discipline that describes, interprets, and predicts the impact of various influences, especially interventions, on final endpoints (from survival to satisfaction with care) that matter to decision makers (from patients to society at large), with special emphasis on the use of patient-reported outcomes (PRO). Recently, under pressure from several parts of society, the FDA, recognizing the need for faster drug approval, has modified existing regulations and created new rules to allow anti-cancer drugs to be approved more quickly and, in certain but quite common circumstances, single arm trials and surrogate endpoints to be used as measures of clinical benefit. In this context, the faster approval process may lead to drugs being marketed without there being a complete picture of how effective or safe they are. The FDA move to speed up drug approval, together with the use of not fully validated surrogate endpoints, give OR the unique opportunity to help understand the value of drugs that have received accelerated approval. Despite this opportunity, OR has yet to demonstrate its role in this specific setting and provide proof of the validity, reliability and added value of its primary endpoint measures when evaluated in a broader context. The implementation of lines of OR in the development and evaluation of anti-cancer drugs hinges upon the availability of

  10. Clinical Coronary In-Stent Restenosis Follow-Up after Treatment and Analyses of Clinical Outcomes

    PubMed Central

    Marino, Barbara Campos Abreu; Nascimento, Guilherme Abreu; Rabelo, Walter; Marino, Marcos Antônio; Marino, Roberto Luiz; Ribeiro, Antonio Luiz Pinho

    2015-01-01

    Background Clinical in-stent restenosis (CISR) is the main limitation of coronary angioplasty with stent implantation. Objective Describe the clinical and angiographic characteristics of CISR and the outcomes over a minimum follow-up of 12 months after its diagnosis and treatment. Methods We analyzed in 110 consecutive patients with CISR the clinical presentation, angiographic characteristics, treatment and combined primary outcomes (cardiovascular death, nonfatal acute myocardial infarction [AMI]) and combined secondary (unstable angina with hospitalization, target vessel revascularization and target lesion revascularization) during a minimal follow-up of one year. Results Mean age was 61 ± 11 years (68.2% males). Clinical presentations included acute coronary syndrome (ACS) in 62.7% and proliferative ISR in 34.5%. CISR was treated with implantation of drug-eluting stents (DES) in 36.4%, Bare Metal Stent (BMS) in 23.6%, myocardial revascularization surgery in 18.2%, balloon angioplasty in 15.5% and clinical treatment in 6.4%. During a median follow-up of 19.7 months, the primary outcome occurred in 18 patients, including 6 (5.5%) deaths and 13 (11.8%) AMI events. Twenty-four patients presented a secondary outcome. Predictors of the primary outcome were CISR with DES (HR = 4.36 [1.44–12.85]; p = 0.009) and clinical treatment for CISR (HR = 10.66 [2.53–44.87]; p = 0.001). Treatment of CISR with BMS (HR = 4.08 [1.75–9.48]; p = 0.001) and clinical therapy (HR = 6.29 [1.35–29.38]; p = 0.019) emerged as predictors of a secondary outcome. Conclusion Patients with CISR present in most cases with ACS and with a high frequency of adverse events during a medium-term follow-up. PMID:25651344

  11. ADCOMS: a composite clinical outcome for prodromal Alzheimer's disease trials

    PubMed Central

    Wang, Jinping; Logovinsky, Veronika; Hendrix, Suzanne B; Stanworth, Stephanie H; Perdomo, Carlos; Xu, Lu; Dhadda, Shobha; Do, Ira; Rabe, Martin; Luthman, Johan; Cummings, Jeffrey; Satlin, Andrew

    2016-01-01

    Background Development of new therapies for Alzheimer's disease (AD) is increasingly focused on more mildly affected populations, and requires new assessment and outcome strategies. Patients in early stages of AD have mild cognitive decline and no, or limited, functional impairment. To respond to these assessment challenges, we developed a measurement approach based on established scale items that exhibited change in previous amnestic Mild Cognitive Impairment (aMCI) trials. Methods Partial least squares regression with a longitudinal clinical decline model identified items from commonly used clinical scales with the highest combined sensitivity to change over time in aMCI and weighted these items according to their relative contribution to detecting clinical progression in patients’ early stages of AD. The resultant AD Composite Score (ADCOMS) was assessed for its ability to detect treatment effect in aMCI/prodromal AD (pAD) clinical trial populations. Results ADCOMS consists of 4 Alzheimer's Disease Assessment Scale–cognitive subscale items, 2 Mini-Mental State Examination items, and all 6 Clinical Dementia Rating—Sum of Boxes items. ADCOMS demonstrated improved sensitivity to clinical decline over individual scales in pAD, aMCI and in mild AD dementia. ADCOMS also detected treatment effects associated with the use of cholinesterase inhibitors in these populations. Improved sensitivity predicts smaller sample size requirements when ADCOMS is used in early AD trials. Conclusions ADCOMS is proposed as new standard outcome for pAD and mild AD dementia trials, and is progressing in a CAMD-sponsored qualification process for use in registration trials of pAD. PMID:27010616

  12. Breast Cancer EDGE Task Force Outcomes: Clinical Measures of Pain

    PubMed Central

    Harrington, Shana; Gilchrist, Laura; Sander, Antoinette

    2014-01-01

    Background Pain is one of the most commonly reported impairments after breast cancer treatment affecting anywhere from 16-73% of breast cancer survivors Despite the high reported incidence of pain from cancer and its treatments, the ability to evaluate cancer pain continues to be difficult due to the complexity of the disease and the subjective experience of pain. The Oncology Section Breast Cancer EDGE Task Force was created to evaluate the evidence behind clinical outcome measures of pain in women diagnosed with breast cancer. Methods The authors systematically reviewed the literature for pain outcome measures published in the research involving women diagnosed with breast cancer. The goal was to examine the reported psychometric properties that are reported in the literature in order to determine clinical utility. Results Visual Analog Scale, Numeric Rating Scale, Pressure Pain Threshold, McGill Pain Questionnaire, McGill Pain Questionnaire – Short Form, Brief Pain Inventory and Brief Pain Inventory – Short Form were highly recommended by the Task Force. The Task Force was unable to recommend two measures for use in the breast cancer population at the present time. Conclusions A variety of outcome measures were used to measure pain in women diagnosed with breast cancer. When assessing pain in women with breast cancer, researchers and clinicians need to determine whether a unidimensional or multidimensional tool is most appropriate as well as whether the tool has strong psychometric properties. PMID:25346950

  13. 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 sale for future delivery is trading on a designated contract market, registered derivatives...

  14. 78 FR 69428 - Submission for OMB Review; 30-Day Comment Request: Cancer Trials Support Unit (CTSU) (NCI)

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-19

    ... HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Cancer... and Budget (OMB) a request for review and approval of the information collection listed below. This... of this notice is to allow an additional 30 days for public comment. The National Cancer...

  15. 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

    ... October 25, 2013 at 78 FR 64145 HUD published a 30 day notice of proposed information collection. This... 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...

  16. 76 FR 6794 - 30-Day Submission Period for Requests for ONC-Approved Accreditor (ONC-AA) Status

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-02-08

    ... Program for Health Information Technology, 76 FR 1262 (Jan. 7, 2011) (the ``Permanent Certification... 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...

  17. 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

    ... October 25, 2013 at 78 FR 64145, HUD inadvertently published a 30 day notice of proposed information... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: HUD-Owned Real Estate--Sales... Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email Colette Pollard at...

  18. Electronic patient-reported outcome systems in oncology clinical practice.

    PubMed

    Bennett, Antonia V; Jensen, Roxanne E; Basch, Ethan

    2012-01-01

    Patient-reported outcome (PRO) questionnaires assess topics a patient can report about his or her own health. This includes symptoms (eg, nausea, fatigue, diarrhea, pain, or frequent urination), physical functioning (eg, difficulty climbing stairs or difficulty fastening buttons), and mental health (eg, anxiety, fear, or worry). Electronic PRO (ePRO) systems are used in oncology clinical care because of 1) their ability to enhance clinical care by flagging important symptoms and saving clinicians time; 2) the availability of standardized methods for creating and implementing PROs in clinics; and 3) the existence of user-friendly platforms for patient self-reporting like tablet computers and automated telephone surveys. Many ePRO systems can provide actionable links to clinical care such as summary reports in a patient's electronic medical record and real-time e-mail alerts to providers when patients report acute needs. This review presents 5 examples of ePRO systems currently in use in oncology practice. These systems support multiple clinical activities, including assessment of symptoms and toxicities related to chemotherapy and radiation, postoperative surveillance, and symptom management during palliative care and hospice. Patient self-reporting is possible both at clinical visits and between visits over the Internet or by telephone. The implementation of an ePRO system requires significant resources and expertise, as well as user training. ePRO systems enable regular monitoring of patient symptoms, function, and needs, and can enhance the efficiency and quality of care as well as communication with patients.

  19. Clinical course and outcome in class IC antiarrhythmic overdose.

    PubMed

    Köppel, C; Oberdisse, U; Heinemeyer, G

    1990-01-01

    120 cases of class IC antiarrhythmic overdose, including propafenone, flecainide, ajmaline and prajmaline overdose, were evaluated with respect to clinical course, therapy and outcome. Whereas drug overdose in general has an overall mortality of less than 1%, intoxication with antiarrhythmic drugs of class IC was associated with a mean mortality of 22.5%. Nausea, which occurred within the first 30 minutes after ingestion, was the earliest symptom. Spontaneous vomiting probably led to self-detoxication in about half the patients. Cardiac symptoms including bradycardia and, less frequently, tachyrhythmia occurred after about 30 minutes to 2 hours. Therapeutic measures included administration of activated charcoal, gastric lavage and a saline laxative, catecholamines, and in some patients, hypertonic sodium bicarbonate, insertion of a transvenous pacemaker and hemoperfusion. Fatal outcome was mainly due to cardiac conduction disturbances progressing to electromechanical dissociation or asystolia. Resuscitation, which had to be performed in 29 patients, was successful in only two of them. No correlation was found between fatal outcome, the type of antiarrhythmic, and ingested dose. Since a specific treatment is not available and resuscitive procedures including sodium bicarbonate and insertion of a pacemaker are of limited therapeutic value, early diagnosis and primary detoxification are most important for prevention of fatal outcome. PMID:2176700

  20. Role of α-II-spectrin breakdown products in the prediction of the severity and clinical outcome of acute traumatic brain injury

    PubMed Central

    CHEN, SHANGYU; SHI, QIANKUN; ZHENG, SHUYUN; LUO, LIANGSHEN; YUAN, SHOUTAO; WANG, XIANG; CHENG, ZIHAO; ZHANG, WENHAO

    2016-01-01

    αII-spectrin breakdown products are regarded as potential biomarkers for traumatic brain injury (TBI). The aim of the present study was to further evaluate these biomarkers by assessing their clinical utility in predicting the severity of injury and clinical outcome of patients with TBI. Eligible patients with acute TBI (n=17), defined by a Glasgow Coma Scale (GCS) score of ≤8, were enrolled. Ventricular cerebrospinal fluid (CSF) was sampled from each patient at 24, 72 and 120 h following TBI. An immunoblot assay was used to determine the concentrations of SBDPs in the CSF samples. The concentrations of SBDPs combined with the GCS score at 24 h after injury and the Glasgow Outcome Score (GOS) at 30 days after injury were compared and analyzed. The levels of SBDPs in CSF were markedly increased following acute TBI in comparison with those in the control group. In the early period after TBI, the levels of SBDPs were closely associated with GCS score. Comparisons of the SBDP levels with the severity of injury revealed significant differences between patients with the most severe brain injury and patients with severe brain injury in the first 24 h post-injury (P<0.05). The levels and dynamic changes of SBDPs in CSF exhibited a close association with GOS at 30 days after injury. The levels of SBDPs differed significantly between patients grouped according to prognosis (P<0.05). These results suggest that in the early period after TBI, the levels and dynamic changes of SBDPs in CSF can be useful in the prediction of the severity of injury and clinical outcome of patients. PMID:27168849

  1. 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

  2. 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

  3. 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

  4. Postoperative Morbidity by Procedure and Patient Factors Influencing Major Complications Within 30 Days Following Shoulder Surgery

    PubMed Central

    Shields, Edward; Iannuzzi, James C.; Thorsness, Robert; Noyes, Katia; Voloshin, Ilya

    2014-01-01

    Background: Little data are available to prioritize quality improvement initiatives in shoulder surgery. Purpose: To stratify the risk for 30-day postoperative morbidity in commonly performed surgical procedures about the shoulder completed in a hospital setting and to determine patient factors associated with major complications. Study Design: Cohort study; Level of evidence, 3. Methods: This retrospective study utilized the National Surgical Quality Improvement Program (NSQIP) database from the years 2005 to 2010. Using Current Procedural Terminology codes, the database was queried for shoulder cases that were divided into 7 groups: arthroscopy without repair; arthroscopy with repair; arthroplasty; clavicle/acromioclavicular joint (AC) open reduction and internal fixation (ORIF)/repair; ORIF of proximal humeral fracture; open tendon release/repair; and open shoulder stabilization. The primary end point was any major complication, with secondary end points of incisional infection, return to the operating room, and venothromboembolism (VTE), all within 30 days of surgery. Results: Overall, 11,086 cases were analyzed. The overall major complication rate was 2.1% (n = 234). Factors associated with major complications on multivariate analysis included: procedure performed (P < .001), emergency case (P < .001), pulmonary comorbidity (P < .001), preoperative blood transfusion (P = .033), transfer from an outside institution (P = .03), American Society of Anesthesiologists (ASA) score (P = .006), wound class (P < .001), dependent functional status (P = .027), and age older than 60 years (P = .01). After risk adjustment, open shoulder stabilization was associated with the greatest risk of major complications relative to arthroscopy without repair (odds ratio [OR], 5.56; P = .001), followed by ORIF of proximal humerus fracture (OR, 4.90; P < .001) and arthroplasty (OR, 4.40; P < .001). These 3 groups generated over 60% of all major complications. Open shoulder

  5. Clinical Outcomes Associated with Home Mechanical Ventilation: A Systematic Review.

    PubMed

    MacIntyre, Erika J; Asadi, Leyla; Mckim, Doug A; Bagshaw, Sean M

    2016-01-01

    Background. The prevalence of patients supported with home mechanical ventilation (HMV) for chronic respiratory failure has increased. However, the clinical outcomes associated with HMV are largely unknown. Methods. We performed a systematic review of studies evaluating patients receiving HMV for indications other than obstructive lung disease, reporting at least one clinically relevant outcome including health-related quality of life (HRQL) measured by validated tools; hospitalization requirements; caregiver burden; and health service utilization. We searched MEDLINE, EMBASE, CINAHL, the Cochrane library, clinical trial registries, proceedings from selected scientific meetings, and bibliographies of retrieved citations. Results. We included 1 randomized control trial (RCT) and 25 observational studies of mixed methodological quality involving 4425 patients; neuromuscular disorders (NMD) (n = 1687); restrictive thoracic diseases (RTD) (n = 481); obesity hypoventilation syndrome (OHS) (n = 293); and others (n = 748). HRQL was generally described as good for HMV users. Mental rather than physical HRQL domains were rated higher, particularly where physical assessment was limited. Hospitalization rates and days in hospital appear to decrease with implementation of HMV. Caregiver burden associated with HMV was generally high; however, it is poorly described. Conclusion. HRQL and need for hospitalization may improve after establishment of HMV. These inferences are based on relatively few studies of marked heterogeneity and variable quality. PMID:27445559

  6. Outcomes of clinical trial: tinnitus masking versus tinnitus retraining therapy.

    PubMed

    Henry, James A; Schechter, Martin A; Zaugg, Tara L; Griest, Susan; Jastreboff, Pawel J; Vernon, Jack A; Kaelin, Christine; Meikle, Mary B; Lyons, Karen S; Stewart, Barbara J

    2006-02-01

    A controlled clinical study was conducted to evaluate prospectively the clinical efficacy of tinnitus masking (TM) and tinnitus retraining therapy (TRT) in military veterans having clinically significant tinnitus. Qualifying patients were placed into the two groups in an alternating manner (to avoid selection bias), and treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index) and the verbally administered TRT interview forms. Findings are presented from the three written questionnaires, and from two of the interview questions (percentage time aware of, and annoyed by, tinnitus). Outcomes were analyzed on an intent-to-treat basis, using a multilevel modeling approach. Of the 123 patients enrolled, 118 were included in the analysis. Both groups showed significant declines (improvements) on these measures, with the TRT decline being significantly greater than for TM. The greater declines in TRT compared to TM occurred most strongly in patients who began treatment with a "very big" tinnitus problem. When patients began treatment with a "moderate" tinnitus problem, the benefits of TRT compared to TM were more modest. PMID:16640064

  7. Spontaneous primary intraventricular hemorrhage: clinical features and early outcome.

    PubMed

    Arboix, Adrià; García-Eroles, Luis; Vicens, Adela; Oliveres, Montserrat; Massons, Joan

    2012-01-01

    Purpose. Primary hemorrhage in the ventricular system without a recognizable parenchymal component is very rare. This single-center retrospective study aimed to further characterize the clinical characteristics and early outcome of this stroke subtype. Methods. All patients with primary intraventricular hemorrhage included in a prospective hospital-based stroke registry over a 19-year period were assessed. A standardized protocol with 161 items, including demographics, risk factors, clinical data, neuroimaging findings, and outcome, was used for data collection. A comparison was made between the groups of primary intraventricular hemorrhage and subcortical intracerebral hemorrhage. Predictors of primary intraventricular hemorrhage were identified by logistic regression analysis. Results. There were 12 patients with primary intraventricular hemorrhage (0.31% of all cases of stroke included in the database) and 133 in the cohort of subcortical hemorrhage. Very old age (≥85 years) (odds ratio (OR) 9.89), atrial fibrillation (OR 8.92), headache (OR 6.89), and altered consciousness (OR 4.36) were independent predictors of intraventricular hemorrhage. The overall in-hospital mortality rate was 41.7% (5/12) but increased to 60% (3/5) in patients aged 85 years or older. Conclusion. Although primary intraventricular hemorrhage is uncommon, it is a severe clinical condition with a high early mortality. The prognosis is particularly poor in very old patients.

  8. Spontaneous Primary Intraventricular Hemorrhage: Clinical Features and Early Outcome

    PubMed Central

    Arboix, Adrià; García-Eroles, Luis; Vicens, Adela; Oliveres, Montserrat; Massons, Joan

    2012-01-01

    Purpose. Primary hemorrhage in the ventricular system without a recognizable parenchymal component is very rare. This single-center retrospective study aimed to further characterize the clinical characteristics and early outcome of this stroke subtype. Methods. All patients with primary intraventricular hemorrhage included in a prospective hospital-based stroke registry over a 19-year period were assessed. A standardized protocol with 161 items, including demographics, risk factors, clinical data, neuroimaging findings, and outcome, was used for data collection. A comparison was made between the groups of primary intraventricular hemorrhage and subcortical intracerebral hemorrhage. Predictors of primary intraventricular hemorrhage were identified by logistic regression analysis. Results. There were 12 patients with primary intraventricular hemorrhage (0.31% of all cases of stroke included in the database) and 133 in the cohort of subcortical hemorrhage. Very old age (≥85 years) (odds ratio (OR) 9.89), atrial fibrillation (OR 8.92), headache (OR 6.89), and altered consciousness (OR 4.36) were independent predictors of intraventricular hemorrhage. The overall in-hospital mortality rate was 41.7% (5/12) but increased to 60% (3/5) in patients aged 85 years or older. Conclusion. Although primary intraventricular hemorrhage is uncommon, it is a severe clinical condition with a high early mortality. The prognosis is particularly poor in very old patients. PMID:22966468

  9. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    PubMed

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  10. Clinical Outcome Assessments: Conceptual Foundation-Report of the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force.

    PubMed

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald; Marquis, Patrick; Vamvakas, Spiros; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan; Burke, Laurie B

    2015-09-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient's health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation. COAs must be well-defined and possess adequate measurement properties to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment - Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment's benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is on the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a COA is to

  11. The clinical outcomes of chronic hepatitis C in South Korea

    PubMed Central

    Ok, Kyeong Sam; Jeong, Sook-Hyang; Jang, Eun Sun; Kim, Young Seok; Lee, Youn Jae; Kim, In Hee; Cho, Sung Bum; Bae, Si Hyun; Lee, Han Chu

    2016-01-01

    Abstract This prospective cohort study aimed to elucidate the clinical outcome and its related factors of chronic hepatitis C in a hepatitis B-dominant Asian region. From January 2007 to October 2012, 382 patients with chronic hepatitis C without liver cirrhosis were prospectively enrolled at 6 university hospitals, and regularly followed until Apr 2014 to identify the development of liver cirrhosis, decompensated cirrhosis, hepatocellular carcinoma (HCC), and overall survival. During the median follow-up of 39.0 months (range 18.0–81.0 months), liver cirrhosis, hepatic decompensation, and HCC developed in 42 patients (11.0%), 4 patients (1.0%), and 12 patients (3.1%), respectively. The cumulative probability of development of cirrhosis at 3 years and at 5 years was 9.6% and 16.7%, respectively. That of HCC at 3 and 5 years was 1.6% and 4.5%, respectively. The 3-year and 5-year overall survival rate was 99.7% and 96.0%, respectively. Pegylated interferon-based antiviral therapy was undertaken in 237 patients (62.0%) with a sustained virologic response (SVR) rate of 74.3%. The factors related to the overall clinical outcomes were age ≥55 years (HR 2.924, P = 0.016), platelet counts <150  × 109/L (HR 3.195, P = 0.007), and the achievement of SVR (HR 0.254, P = 0.002). The clinical outcomes of this Korean chronic hepatitis C cohort were modest with minimal mortality, but significant disease progression occurred in the patients with old age, low platelet, and non-SVR after interferon-based antiviral treatment or no treatment, suggesting priority for direct acting antiviral therapy. PMID:27583874

  12. 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.

  13. 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.

  14. 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.

  15. [Clinical Outcomes of Cardiovascular Surgery in Jehovah's Witness Patients].

    PubMed

    Mukaihara, Kosuke; Yamashita, Masafumi; Toyohira, Hitoshi; Yotsumoto, Goichi; Fukumoto, Yoshihiro; Ueno, Takayuki; Matsumoto, Kazuhisa; Moriyama, Yukinori; Imoto, Yutaka

    2016-03-01

    Cardiovascular surgery in Jehovah's Witness is challenging for surgeons on the ground that they refuse blood transfusion. We report 11 cases of cardiovascular surgery. All of the patients underwent elective surgery with cardiopulmonary bypass. Two cases underwent minimally invasive procedures. The mean preoperative hemoglobin level was 13.0 g/dl, and hematopoietic medicines were preoperatively administrated in 4 patients. Although 10 patients recovered satisfactory without blood transfusion, 1 surgical case was lost due to uncontrollable postoperative bleeding. The clinical outcomes of the Jehovah's Witness patients are considered to be satisfactory. However, careful indication is recommended in high risk cases. PMID:27075280

  16. 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. PMID:22995395

  17. Clinical Features and Treatment Outcomes of Bloodstream Infections Caused by Extended-Spectrum β-Lactamase-Producing Escherichia coli Sequence Type 131.

    PubMed

    Cho, Sun Young; Kang, Cheol-In; Cha, Min Kyeong; Wi, Yu Mi; Ha, Young Eun; Chung, Doo Ryeon; Lee, Nam Yong; Peck, Kyong Ran; Song, Jae-Hoon

    2015-08-01

    Despite the remarkable emergence of extended-spectrum β-lactamase (ESBL)-producing Escherichia coli sequence type 131 (ST131), the clinical features and outcomes of infections caused by ST131 remain poorly described. From 2011 to 2012, we collected ESBL-producing E. coli isolates from patients with bloodstream infections in 13 hospitals in Korea and compared clinical characteristics and outcomes between ST131 and non-ST131 clones. Of the 110 ESBL-producing isolates, the most common ST was ST131 (30.9%). Multivariate analysis showed that recent operation was the only variable associated with the ST131 clone; other comorbid conditions and clinical features were similar between ST131 and non-ST131 clones. CTX-M-14 and CTX-M-15 were the predominant types of ESBLs, and CTX-M-15 was significantly associated with ST131. The rate of nonsusceptibility to ciprofloxacin was higher in ST131 than in non-ST131 clones (94.1% vs. 75.0%). No significant differences in 30-day mortality rates were found between ST131 and non-ST131 clones. Multivariate analysis revealed that older age (odds ratio [OR]=5.39, 95% confidence interval [CI] 1.22-23.89; p=0.027), nosocomial infection (OR=4.81, 95% CI 1.15-20.15; p=0.032), and higher Pitt bacteremia score (OR=7.26, 95% CI 1.41-37.42; p=0.018) were independent risk factors for 30-day mortality. The ESBL-producing E. coli ST131 clone has emerged and disseminated in Korea. Our findings reveal similarities in clinical and demographic characteristics between ST131 and non-ST131 clones. Although a more resistant profile has been detected in ST131, patients with the ST131 clone did not exhibit a higher mortality rate.

  18. Portal hypertension due to portal venous thrombosis: Etiology, clinical outcomes

    PubMed Central

    Harmanci, Ozgur; Bayraktar, Yusuf

    2007-01-01

    The thrombophilia in adult life has major implications in the hepatic vessels. The resulting portal vein thrombosis has various outcomes and complications. Esophageal varices, portal gastropathy, ascites, severe hypersplenism and liver failure needing liver transplantation are known well. The newly formed collateral venous circulation showing itself as pseudocholangicarcinoma sign and its possible clinical reflection as cholestasis are also known from a long time. The management strategies for these complications of portal vein thrombosis are not different from their counterpart which is cirrhotic portal hypertension, but the prognosis is unquestionably better in former cases. In this review we present and discuss the portal vein thrombosis, etiology and the resulting clinical pictures. There are controversial issues in nomenclature, management (including anticoagulation problems), follow up strategies and liver transplantation. In the light of the current knowledge, we discuss some controversial issues in literature and present our experience and our proposals about this group of patients. PMID:17552000

  19. Effects on groundwater microbial communities of an engineered 30-day in situ exposure to the antibiotic sulfamethoxazole.

    PubMed

    Haack, Sheridan K; Metge, David W; Fogarty, Lisa R; Meyer, Michael T; Barber, Larry B; Harvey, Ronald W; Leblanc, Denis R; Kolpin, Dana W

    2012-07-17

    Effects upon microbial communities from environmental exposure to concentrations of antibiotics in the μg L(-1) range remain poorly understood. Microbial communities from an oligotrophic aquifer (estimated doubling rates of only once per week) that were previously acclimated (AC) or unacclimated (UAC) to historical sulfamethoxazole (SMX) contamination, and a laboratory-grown Pseudomonas stutzeri strain, were exposed to 240-520 μg L(-1) SMX for 30 days in situ using filter chambers allowing exposure to ambient groundwater, but not to ambient microorganisms. SMX-exposed UAC bacterial communities displayed the greatest mortality and impairment (viable stain assays), the greatest change in sensitivity to SMX (dose-response assays), and the greatest change in community composition (Terminal Restriction Fragment Length Polymorphism; T-RFLP). The sul1 gene, encoding resistance to SMX at clinically relevant levels, and an element of Class I integrons, was not detected in any community. Changes in microbial community structure and SMX resistance over a short experimental period in previously nonexposed, slow-growing aquifer communities suggest concentrations of antibiotics 2-3 orders of magnitude less than those used in clinical applications may influence ecological function through changes in community composition, and could promote antibiotic resistance through selection of naturally resistant bacteria.

  20. CLINICAL OUTCOME AFTER INFECTED TOTAL KNEE AND TOTAL HIP ARTHROPLASTY

    PubMed Central

    Mittag, Falk; Leichtle, Carmen Ina; Schlumberger, Michael; Leichtle, Ulf Gunther; Wünschel, Markus

    2016-01-01

    ABSTRACT Objective: Infection after total hip (THA) and knee arthroplasty (TKA) is a serious complication which typically leads to a long lasting and intensive surgical and medicamentous treatment. The aim of this study was to identify factors that influence outcome after revision surgery caused by prosthetic infection. Methods: We retrospectively analyzed 64 patients who had revision surgery between 1989 and 2009 due to periprosthetic infection. We examined a total of 69 joints (TKA: 36%, THA: 64%), follow-up 5.1 years (0.5-21 years) after the initial surgical intervention. The mean patient age at time of surgery was 67 years old (43-79 years old). Clinical data and scores including the Western Ontario and McMaster Universities (WOMAC)-Index, the Harris Hip Score (HHS) and the Hospital for Special Surgery Score (HSS) were surveyed. Results: There was no difference in clinical scores regarding treatment between a single and a multiple stage treatment regime. Infections with multiple microorganisms and Enterococcus spp. lead to a significantly higher number of interventions. Using a modified Tsukayama system we classified 24% as type I, 34% type II and 42% type III- infections, with no differences in clinical outcome. Overweight patients had a significantly lower HHS and WOMAC-score. Immunosuppression leads to a worse WOMAC and HSS-Score. An increased number of procedures was associated to a limping gait. Conclusion: Thorough surgical technique leads to good clinical results independent of infection-type and treatment philosophy. Level of Evidence III, Case Control Study. PMID:26997914

  1. Clinical characteristics and outcome of clinically diagnosed viral encephalitis in southwest China.

    PubMed

    Zhao, Lei; Zhou, Muke; Wang, Bin; Guo, Jian; Chen, Ning; He, Li

    2015-12-01

    Patients with viral encephalitis have a high incidence of morbidity and mortality. We analyze the clinical characteristics and outcome of patients with clinically diagnosed viral encephalitis to investigate possible predictors of prognosis. We retrospectively evaluated 1107 patients diagnosed with viral encephalitis in southwest China from 2009 to 2012 by evaluating their outcomes using the Glasgow Outcome Scale. We compared patient outcome at hospital discharge with long-term follow-up visits, and evaluated the prognostic indicators of the outcome. At hospital discharge, 375 (33.9 %) of the 1107 patients who survived made a full recovery, while 399 (36.0 %), 160 (14.5 %), and 145 (13.1 %) had mild, moderate or severe neurologic sequelae, respectively. Twenty-eight (2.5 %) of the patients died prior to discharge from the hospital. Of the 1027 patients who had follow-up assessments, 658 (64.1 %) made a full recovery, while 213 (20.7 %), 103 (10.0 %), and 19 (1.8 %) had mild, moderate or severe neurologic sequelae, respectively. Six (0.6 %) of the patients died after discharge from the hospital. Use of mechanical ventilation, lower Glasgow coma score, and concurrent seizures are predictors for a poor outcome in patients both at hospital discharge and at long-term follow-up visits. PMID:26205533

  2. Congenital Aural Stenosis: Clinical Features and Long-term Outcomes

    PubMed Central

    Li, Chen-long; Chen, Ying; Chen, Yong-zheng; Fu, Yao-yao; Zhang, Tian-yu

    2016-01-01

    The aim of the present study was to comprehensively evaluate the clinical features and long-term outcomes of congenital aural stenosis (CAS). This study presents a retrospective review of patients who underwent meatoplasty for CAS at a tertiary referral hospital from 2008 to 2015. A total of 246 meatoplasty procedures were performed on 232 patients in the present study. We performed multivariate regression analysis. Except in the age < 6 years group, no significant difference was observed among different age groups for cholesteatoma formation, p > 0.05. Except for the stenosis of the external auditory canal (EAC) (>4 mm) group, the other stenosis of EAC groups were not associated with cholesteatoma formation, p > 0.05. Postoperative air-bone gaps (ABG) less than 30 dB occurred in 77.3% (99/128) of the patients, and the Jahrsdoerfer score was associated with postoperative ABG, p < 0.001. The complication rate of CAS was 13.8% (20/144), and males showed a higher risk for postoperative complications (OR, 6.563; 95% CI, 1.268–33.966, p = 0.025). These results indicate that meatoplasty was an effective surgical intervention for CAS, showing a stable hearing outcome with prolonged follow-up. There was no significant difference between the cholesteatoma and no cholesteatoma groups for hearing outcomes, p > 0.05. PMID:27257165

  3. A clinically meaningful theory of outcome measures in rehabilitation medicine.

    PubMed

    Massof, Robert W

    2010-01-01

    Comparative effectiveness research in rehabilitation medicine requires the development and validation of clinically meaningful and scientifically rigorous measurements of patient states and theories that explain and predict outcomes of intervention. Patient traits are latent (unobservable) variables that can be measured only by inference from observations of surrogate manifest (observable) variables. In the behavioral sciences, latent variables are analogous to intensive physical variables such as temperature and manifest variables are analogous to extensive physical variables such as distance. Although only one variable at a time can be measured, the variable can have a multidimensional structure that must be understood in order to explain disagreements among different measures of the same variable. The use of Rasch theory to measure latent trait variables can be illustrated with a balance scale metaphor that has randomly added variability in the weights of the objects being measured. Knowledge of the distribution of the randomly added variability provides the theoretical structure for estimating measures from ordinal observation scores (e.g., performance measures or rating scales) using statistical inference. In rehabilitation medicine, the latent variable of primary interest is the patient's functional ability. Functional ability can be estimated from observations of surrogate performance measures (e.g., speed and accuracy) or self-report of the difficulty the patient experiences performing specific activities. A theoretical framework borrowed from project management, called the Activity Breakdown Structure (ABS), guides the choice of activities for assessment, based on the patient's value judgments, to make the observations clinically meaningful. In the case of low vision, the functional ability measure estimated from Rasch analysis of activity difficulty ratings was discovered to be a two-dimensional variable. The two visual function dimensions are independent

  4. Impact of routine bedside infectious disease consultation on clinical management and outcome of Staphylococcus aureus bacteraemia in adults

    PubMed Central

    Saunderson, R.B.; Gouliouris, T.; Nickerson, E.K.; Cartwright, E.J.P.; Kidney, A.; Aliyu, S.H.; Brown, N.M.; Limmathurotsakul, D.; Peacock, S.J.; Török, M.E.

    2015-01-01

    Staphylococcus aureus bacteraemia (SAB) is a common, serious infection that is associated with high rates of morbidity and mortality. Evidence suggests that infectious disease consultation (IDC) improves clinical management in patients with SAB. We examined whether the introduction of a routine bedside IDC service for adults with SAB improved clinical management and outcomes compared to telephone consultation. We conducted an observational cohort study of 571 adults with SAB at a teaching hospital in the United Kingdom between July 2006 and December 2012. A telephone consultation was provided on the day of positive blood culture in all cases, but an additional bedside IDC was provided after November 2009 (routine IDC group). Compared to patients in the pre-IDC group, those in the routine IDC group were more likely to have a removable focus of infection identified, echocardiography performed and follow-up blood cultures performed. They also received longer courses of antimicrobial therapy, were more likely to receive combination antimicrobial therapy and were more likely to have SAB recorded in the hospital discharge summary. There was a trend towards lower mortality at 30 days in the routine IDC group compared to the pre-IDC group (12% vs. 22%, p 0.07). Our findings suggest that routine bedside IDC should become the standard of care for adults with SAB. PMID:26033668

  5. Outcome measures for clinical drug trials in autism.

    PubMed

    Aman, Michael G; Novotny, Sherie; Samango-Sprouse, Carole; Lecavalier, Luc; Leonard, Elizabeth; Gadow, Kenneth D; King, Bryan H; Pearson, Deborah A; Gernsbacher, Morton Ann; Chez, Michael

    2004-01-01

    This paper identifies instruments and measures that may be appropriate for randomized clinical trials in participants with autism spectrum disorders (ASDs). The Clinical Global Impressions scale was recommended for all randomized clinical trials. At this point, however, there is no "perfect" choice of outcome measure for core features of autism, although we will discuss five measures of potential utility. Several communication instruments are recommended, based in part on suitability across the age range. In trials where the intention is to alter core features of ASDs, adaptive behavior scales are also worthy of consideration. Several "behavior complexes" common to ASDs are identified, and instruments are recommended for assessment of these. Given the prevalence of cognitive impairment in ASDs, it is important to assess any cognitive effects, although cognitive data from ASD randomized clinical trials, thus far, are minimal. Guidance from trials in related pharmacologic areas and behavioral pharmacology may be helpful. We recommend routine elicitation of side effects, height and weight, vital signs, and (in the case of antipsychotics) extrapyramidal side-effects assessment. It is often appropriate to include laboratory tests and assessments for continence and sleep pattern.

  6. How customer satisfaction can influence clinical outcome in a back specialty clinic.

    PubMed

    Reznik, B

    1994-01-01

    Determining what defines quality is the aim of the study produced at the Texas Back Institute. Bob Reznik, M.B.A., vice president of the institute, presents a methodology for measuring the outcomes of clinical care and relating it to physician performance on a variety of levels. PMID:10131360

  7. How customer satisfaction can influence clinical outcome in a back specialty clinic.

    PubMed

    Reznik, B

    1994-01-01

    Determining what defines quality is the aim of the study produced at the Texas Back Institute. Bob Reznik, M.B.A., vice president of the institute, presents a methodology for measuring the outcomes of clinical care and relating it to physician performance on a variety of levels.

  8. Clinical and functional outcomes of acute lower extremity compartment syndrome at a Major Trauma Hospital

    PubMed Central

    Lollo, Loreto; Grabinsky, Andreas

    2016-01-01

    Background: Acute lower extremity compartment syndrome (CS) is a condition that untreated causes irreversible nerve and muscle ischemia. Treatment by decompression fasciotomy without delay prevents permanent disability. The use of intracompartmental pressure (iCP) measurement in uncertain situations aids in diagnosis of severe leg pain. As an infrequent complication of lower extremity trauma, consequences of CS include chronic pain, nerve injury, and contractures. The purpose of this study was to observe the clinical and functional outcomes for patients with lower extremity CS after fasciotomy. Methods: Retrospective chart analysis for patients with a discharge diagnosis of CS was performed. Physical demographics, employment status, activity at time of injury, injury severity score, fracture types, pain scores, hours to fasciotomy, iCP, serum creatine kinase levels, wound treatment regimen, length of hospital stay, and discharge facility were collected. Lower extremity neurologic examination, pain scores, orthopedic complications, and employment status at 30 days and 12 months after discharge were noted. Results: One hundred twenty-four patients were enrolled in this study. One hundred and eight patients were assessed at 12 months. Eighty-one percent were male. Motorized vehicles caused 51% of injuries in males. Forty-one percent of injuries were tibia fractures. Acute kidney injury occurred in 2.4%. Mean peak serum creatine kinase levels were 58,600 units/ml. Gauze dressing was used in 78.9% of nonfracture patients and negative pressure wound vacuum therapy in 78.2% of fracture patients. About 21.6% of patients with CS had prior surgery. Nearly 12.9% of patients required leg amputation. Around 81.8% of amputees were male. Sixty-seven percent of amputees had associated vascular injuries. Foot numbness occurred in 20.5% of patients and drop foot palsy in 18.2%. Osteomyelitis developed in 10.2% of patients and fracture nonunion in 6.8%. About 14.7% of patients

  9. A UK general practice population cohort study investigating the association between lipid lowering drugs and 30-day mortality following medically attended acute respiratory illness

    PubMed Central

    Joshi, Roshni; Myles, Puja R.

    2016-01-01

    Background. Cholesterol lowering drugs HMG-CoA reductase inhibitors (statins) and PPARα activators (fibrates) have been shown to reduce host inflammation via non-disease specific immunomodulatory mechanisms. Recent studies suggest that commonly prescribed drugs in general practice, statins and fibrates, may be beneficial in influenza-like illness related mortality. This retrospective cohort study examines the association between two lipid lowering drugs, statins and fibrates, and all-cause 30-day mortality following a medically attended acute respiratory illness (MAARI). Methods. Primary care patient data were retrospectively extracted from the UK Clinical Practice Research Datalink (CPRD) database. The sample comprised 201,179 adults aged 30 years or older experiencing a MAARI episode. Patient exposure to statins or fibrates was coded as separate dichotomous variables and deemed current if the most recent GP prescription was issued in the 30 days prior to MAARI diagnosis. Multivariable logistic regression and Cox regression were used for analyses. Adjustment was carried out for chronic lung disease, heart failure, metformin and glitazones, comorbidity burden, socio-demographic and lifestyle variables such as smoking status and body mass index (BMI). Statistical interaction tests were carried out to check for effect modification by gender, body mass index, smoking status and comorbidity. Results. A total of 1,096 (5%) patients died within the 30-day follow up period. Of this group, 213 (19.4%) were statin users and 4 (0.4%) were fibrate users. After adjustment, a significant 35% reduction in odds [adj OR; 0.65 (95% CI [0.52–0.80])] and a 33% reduction in the hazard [adj HR: 0.67 (95% CI [0.55–0.83])] of all-cause 30-day mortality following MAARI was observed in statin users. A significant effect modification by comorbidity burden was observed for the association between statin use and MAARI-related mortality. Fibrate use was associated with a non

  10. A UK general practice population cohort study investigating the association between lipid lowering drugs and 30-day mortality following medically attended acute respiratory illness.

    PubMed

    Joshi, Roshni; Venkatesan, Sudhir; Myles, Puja R

    2016-01-01

    Background. Cholesterol lowering drugs HMG-CoA reductase inhibitors (statins) and PPARα activators (fibrates) have been shown to reduce host inflammation via non-disease specific immunomodulatory mechanisms. Recent studies suggest that commonly prescribed drugs in general practice, statins and fibrates, may be beneficial in influenza-like illness related mortality. This retrospective cohort study examines the association between two lipid lowering drugs, statins and fibrates, and all-cause 30-day mortality following a medically attended acute respiratory illness (MAARI). Methods. Primary care patient data were retrospectively extracted from the UK Clinical Practice Research Datalink (CPRD) database. The sample comprised 201,179 adults aged 30 years or older experiencing a MAARI episode. Patient exposure to statins or fibrates was coded as separate dichotomous variables and deemed current if the most recent GP prescription was issued in the 30 days prior to MAARI diagnosis. Multivariable logistic regression and Cox regression were used for analyses. Adjustment was carried out for chronic lung disease, heart failure, metformin and glitazones, comorbidity burden, socio-demographic and lifestyle variables such as smoking status and body mass index (BMI). Statistical interaction tests were carried out to check for effect modification by gender, body mass index, smoking status and comorbidity. Results. A total of 1,096 (5%) patients died within the 30-day follow up period. Of this group, 213 (19.4%) were statin users and 4 (0.4%) were fibrate users. After adjustment, a significant 35% reduction in odds [adj OR; 0.65 (95% CI [0.52-0.80])] and a 33% reduction in the hazard [adj HR: 0.67 (95% CI [0.55-0.83])] of all-cause 30-day mortality following MAARI was observed in statin users. A significant effect modification by comorbidity burden was observed for the association between statin use and MAARI-related mortality. Fibrate use was associated with a non

  11. Urine Creatinine Excretion and Clinical Outcomes in CKD

    PubMed Central

    Di Micco, Lucia; Quinn, Robert Ross; Ronksley, Paul Everett; Bellizzi, Vincenzo; Lewin, Adriane Marlene; Cianciaruso, Bruno

    2013-01-01

    Summary Background and objectives Twenty-four–hour urine creatinine excretion is a reliable approximation of muscle mass. Whether changes in urine creatinine predict clinical outcomes in persons with CKD is unknown. This work studied the relationship between urine creatinine and patient and renal survival in people with CKD not requiring renal replacement therapy. Design, setting, participants, & measurements This longitudinal cohort study included incident stages 3–5 CKD patients referred to the renal clinic at the University Federico II in Naples between January of 1995 and December of 2005. Clinical data and urine creatinine were updated at each visit. Main outcomes were all-cause mortality and kidney failure requiring dialysis. Results This study enrolled 525 individuals and followed them for a median of 6 years (range of 4 months to 15 years). Urine creatinine excretion declined by 16 mg/d per year (95% confidence interval, 14 to 19) in participants with CKD stages 3a, 3b, and 4, and it remained stable in participants with stage 5 CKD. Per each 20 mg/d decline in urine creatinine, mortality increased by 3% (adjusted hazard ratio, 1.03; 95% confidence interval, 1.01 to 1.05), and the risk of initiating dialysis increased by 2% (adjusted hazard ratio, 1.02; 95% confidence interval, 1.01 to 1.03). These associations were independent of body mass index and GFR. Conclusions In persons with CKD stages 3 and 4, urine creatinine declines at a rate of 16 mg/d per year. Lower urine creatinine excretion predicts greater risk of kidney failure and patient mortality. PMID:24158796

  12. Repair Integrity and Clinical Outcomes Following Arthroscopic Rotator Cuff Repair

    PubMed Central

    Williams, Ariel A.; Mark, P.; DiVenere, Jessica Megan; Klinge, Stephen Austin; Arciero, Robert A.; Mazzocca, Augustus D.

    2016-01-01

    Objectives: To prospectively evaluate the effect of early versus delayed motion on repair integrity on 6-month postoperative magnetic resonance imaging (MRI) scans following rotator cuff repair, and to correlate repair integrity with clinical and functional outcomes. We hypothesized that repair integrity would differ between the early and delayed groups and that patients with repair failures would have worse clinical and functional outcomes. Methods: This was a prospective, randomized, single blinded clinical trial comparing an early motion (post-op day 2-3) to a delayed motion (post-op day 28) rehabilitation protocol following arthroscopic repair of isolated supraspinatus tears. All patients underwent MRI at 6 months post-operatively as part of the study protocol. A blinded board-certified and fellowship-trained orthopaedic surgeon (not part of the surgical team) reviewed operative photos and video to confirm the presence of a full thickness supraspinatus tear and to ensure an adequate and consistent repair. The same surgeon along with a blinded sports medicine fellowship-trained musculoskeletal radiologist independently reviewed all MRIs to determine whether the repair was intact at 6 months. Outcome measures were collected by independent evaluators who were also blinded to group assignment. These included the Western Ontario Rotator Cuff (WORC) index, Single Assessment Numeric Evaluation (SANE) ratings, pain scores, sling use, and physical exam data. Enrolled patients were followed at 6 weeks, 6 months, and 1 year. Results: From October 2008 to April 2012, 73 patients met all inclusion criteria and were willing to participate. 36 patients were randomized to delayed motion and 37 were randomized to early motion. The final study group at 6 months consisted of 58 study participants. Postoperative MRIs were obtained on all of these patients at 6 months regardless of whether or not they were progressing as expected. These MRIs demonstrated an overall failure rate of

  13. Homogeneity and the outcome of clinical trials: An appraisal of the outcome of recent clinical trials on endovascular intervention in acute ischemic stroke

    PubMed Central

    Husain, Shakir; Srijithesh, PR

    2016-01-01

    Clinical trials that allow significant heterogeneity of population or interventions often result in uncertain outcomes. In this paper, we review the outcomes of five recent trials of endovascular interventions in acute ischemic stroke in the context of the neutral results of previous large clinical trials on the subject. PMID:27011623

  14. 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

    ... organizations. The purpose of this 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...

  15. 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...

  16. 78 FR 59943 - Submission for OMB Review; 30-Day Comment Request; Interactive Informed Consent for Pediatric...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-30

    ...; Interactive Informed Consent for Pediatric Clinical Trials SUMMARY: In compliance with the requirement of... information on the proposed project contact: Victoria Pemberton, Clinical Trials Specialist, NHLBI, 6701... for Pediatric Clinical Trials, 0925-New, National Heart, Lung, and Blood Institute (NHLBI),...

  17. 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.

  18. 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.

  19. The factor structure and psychometric properties of the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) in Norwegian clinical and non-clinical samples

    PubMed Central

    2013-01-01

    Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical

  20. Predictive model for patients with poor-grade subarachnoid haemorrhage in 30-day observation: a 9-year cohort study

    PubMed Central

    Szklener, Sebastian; Melges, Anna; Korchut, Agnieszka; Zaluska, Wojciech; Trojanowski, Tomasz; Rejdak, Robert; Rejdak, Konrad

    2015-01-01

    Objective The purpose of this study was to identify prognostic factors and build the predictive model based on poor-grade subarachnoid haemorrhage (SAH) population received only supportive symptomatic treatment. Design Prospective observational cohort study. Setting Intensive care unit at the Clinical Department of Neurology. Participants A total of 101 patients with spontaneous SAH disqualified from neurosurgical operative treatment due to poor clinical condition. Data were collected over a 9-year period. Outcome measures Unfavourable outcome was defined as a modified Rankin Score ≥5 at 30 days of observation. Results Multivariable logistic regression analysis indicated the World Federation of Neurosurgical Societies Scale score, increasing age, Fisher grade and admission leucocytosis as independent predictive factors. The proposed scale subdivides the study population into four prognostic groups with significantly different outcomes: grade I: probability of favourable outcome 89.9%; grade II: 47.5%; grade III: 4.2%; grade IV: 0%. The receiver operating characteristic (ROC) curve for the prediction of outcome performed by the new scale had an area under the curve (AUC)=0.910 (excellent accuracy). Conclusions Unfavourable outcome in non-operated patients with poor-grade SAH is strongly predicted by traditional unmodifiable factors such as age, amount of bleeding in CT, level of consciousness as well as leucocytosis. A new predictive scale based on the above parameters seems to reliably predict the outcome and may contribute to more effective planning of therapeutic management in patients with poor-grade SAH. PMID:26070797

  1. Clinical Outcomes After Suture Anchor Repair of Recalcitrant Medial Epicondylitis.

    PubMed

    Grawe, Brian M; Fabricant, Peter D; Chin, Christopher S; Allen, Answorth A; DePalma, Brian J; Dines, David M; Altchek, David W; Dines, Joshua S

    2016-01-01

    This study evaluated clinical and patient-reported outcomes and return to sport after surgical treatment of medial epicondylitis with suture anchor fixation. Consecutive patients were evaluated after undergoing debridement and suture anchor repair of the flexor-pronator mass for the treatment of medial epicondylitis. Demographic variables, a short version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH) score, Oxford Elbow Score (OES), and 10-point pain and satisfaction scales were collected. Ability and time to return to sport after surgery were evaluated, and the relationship between predictor variables and both elbow function and return to sport was investigated. Median age at the time of surgery was 55 years (range, 29-65 years), with median follow-up of 40 months (range, 12-67 months). Median QuickDASH score and OES at final follow-up were 2.3 (range, 0-38.6) and 45 (range, 22-48), respectively. Most patients returned to premorbid sporting activities at a median of 4.5 months (range, 2.5-12 months), whereas 4 patients (14%) reported significant limitations at final follow-up. Older age at the time of surgery was predictive of better QuickDASH score and OES (P=.05 and P=.02, respectively). Patients who underwent surgery after a shorter duration of symptoms had better outcomes, but the difference did not reach statistical significance (QuickDASH, P=.09; OES, P=.10). Surgical treatment of recalcitrant medial epicondylitis with suture anchor fixation offers good pain relief and patient satisfaction, with little residual disability. Older age at the time of surgery predicts a better outcome.

  2. Graft rejection in pediatric penetrating keratoplasty: Clinical features and outcomes

    PubMed Central

    Kusumesh, Rakhi; Vanathi, Murugesan

    2015-01-01

    Purpose: Early presentation of rejection facilitates early initiation of treatment which can favor a reversible rejection and better outcome. We analyzed the incidence, clinical features including rejection-treatment period and outcomes following graft rejection in our series of pediatric corneal graft. Materials and Methods: Case records of pediatric penetrating keratoplasty (PK) were reviewed retrospectively, and parameters noted demographic profile, indication of surgery, surgery-rejection period, rejection-treatment interval, graft outcome, and complications. Results: PK was performed in 66 eyes of 66 children <12 years, with an average follow-up of 21.12 ± 11.36 months (range 4-48 month). The median age at the time of surgery was 4.0 years (range 2 months to 12 years). Most of the children belonged to rural background. Scarring after keratitis (22, 33.4%) was the most common indication. Graft rejection occurred in eight eyes (12.12%) (acquired nontraumatic - 3, congenital hereditary endothelial dystrophy [CHED] - 2, nonCHED - 1, congenital glaucoma - 1, regraft - 1). The mean surgery-rejection period was 10.5 ± 7.3 months and mean rejection-treatment interval was 10.9 ± 7.02 days. Conclusion: This study showed irreversible graft rejection was the leading cause of graft failure of pediatric PK. Though, the incidence (12.1%) of graft rejection in current study was not high, but the percentage of reversal (25%) was one of the lowest in literature because of delayed presentation and longer interval between corneal graft rejection and treatment. In addition, categorization of the type of graft rejection was very difficult and cumbersome in pediatric patients. PMID:25709272

  3. Preterm birth in twin pregnancies: Clinical outcomes and predictive parameters

    PubMed Central

    Dolgun, Zehra Nihal; Inan, Cihan; Altintas, Ahmet Salih; Okten, Sabri Berkem; Sayin, Niyazi Cenk

    2016-01-01

    Objective: To document the neonatal outcomes of preterm birth in twin pregnancies and to investigate whether perinatal and obstetric parameters are associated with clinical outcomes. Methods: This retrospective trial was conducted on data gathered from 176 preterm twins delivered in the obstetrics and gynecology department of our tertiary care center. Data extracted from medical files of 88 pregnant women who gave preterm birth (at 260/7 to 366/7 gestational weeks) to twins were analyzed. Maternal/fetal descriptive and obstetric parameters, sonographic data, route of delivery, indication for cesarean section, birth weight, Apgar scores, head circumference, umbilical cord length and placental weight were noted. Results: The average age of the pregnant women was 28.8±6.4 years and ultrasonographic gestational age was 31.9±2.6 weeks. Apgar scores at 1st minute were affected significantly by fetal body weight (p=0.001), gestational age (p=0.001), height (p=0.004) and head circumference (p=0.011). None of these variables exhibited a noteworthy effect on Apgar scores at 5th minute. Conclusion: Efforts must be made to achieve advancement of gestational age until delivery in the follow-up preterm of twins. A well-established algorithm with special emphasis to risk factors is necessary to standardize and popularize the appropriate management strategy.

  4. Update on transcobalamin deficiency: clinical presentation, treatment and outcome.

    PubMed

    Trakadis, Y J; Alfares, A; Bodamer, O A; Buyukavci, M; Christodoulou, J; Connor, P; Glamuzina, E; Gonzalez-Fernandez, F; Bibi, H; Echenne, B; Manoli, I; Mitchell, J; Nordwall, M; Prasad, C; Scaglia, F; Schiff, M; Schrewe, B; Touati, G; Tchan, M C; Varet, B; Venditti, C P; Zafeiriou, D; Rupar, C A; Rosenblatt, D S; Watkins, D; Braverman, N

    2014-05-01

    Transcobalamin (TC) transports cobalamin from blood into cells. TC deficiency is a rare autosomal recessive disorder usually presenting in early infancy with failure to thrive, weakness, diarrhoea, pallor, anemia, and pancytopenia or agammaglobulinemia. It can sometimes resemble neonatal leukemia or severe combined immunodeficiency disease. Diagnosis of TC deficiency is suspected based on megaloblastic anemia, elevation of total plasma homocysteine, and blood or urine methylmalonic acid. It is confirmed by studying the synthesis of TC in cultured fibroblasts, or by molecular analysis of the TCN2 gene. TC deficiency is treatable with supplemental cobalamin, but the optimal type, route and frequency of cobalamin administration and long term patient outcomes are unknown. Here we present a series of 30 patients with TC deficiency, including an update on multiple previously published patients, in order to evaluate the different treatment strategies and provide information about long term outcome. Based on the data presented, current practice appears to favour treatment of individuals with TC deficiency by intramuscular injections of hydroxy- or cyanocobalamin. In most cases presented, at least weekly injections (1 mg IM) were necessary to ensure optimal treatment. Most centres adjusted the treatment regimen based on monitoring CBC, total plasma homocysteine, plasma and urine methylmalonic acid, as well as, clinical status. Finally, continuing IM treatment into adulthood appears to be beneficial. PMID:24305960

  5. Preterm birth in twin pregnancies: Clinical outcomes and predictive parameters

    PubMed Central

    Dolgun, Zehra Nihal; Inan, Cihan; Altintas, Ahmet Salih; Okten, Sabri Berkem; Sayin, Niyazi Cenk

    2016-01-01

    Objective: To document the neonatal outcomes of preterm birth in twin pregnancies and to investigate whether perinatal and obstetric parameters are associated with clinical outcomes. Methods: This retrospective trial was conducted on data gathered from 176 preterm twins delivered in the obstetrics and gynecology department of our tertiary care center. Data extracted from medical files of 88 pregnant women who gave preterm birth (at 260/7 to 366/7 gestational weeks) to twins were analyzed. Maternal/fetal descriptive and obstetric parameters, sonographic data, route of delivery, indication for cesarean section, birth weight, Apgar scores, head circumference, umbilical cord length and placental weight were noted. Results: The average age of the pregnant women was 28.8±6.4 years and ultrasonographic gestational age was 31.9±2.6 weeks. Apgar scores at 1st minute were affected significantly by fetal body weight (p=0.001), gestational age (p=0.001), height (p=0.004) and head circumference (p=0.011). None of these variables exhibited a noteworthy effect on Apgar scores at 5th minute. Conclusion: Efforts must be made to achieve advancement of gestational age until delivery in the follow-up preterm of twins. A well-established algorithm with special emphasis to risk factors is necessary to standardize and popularize the appropriate management strategy. PMID:27648040

  6. Prognostic factors for clinical outcomes after rotator cuff repair

    PubMed Central

    Pécora, José Otávio Reggi; Malavolta, Eduardo Angeli; Assunção, Jorge Henrique; Gracitelli, Mauro Emílio Conforto; Martins, João Paulo Sobreiro; Ferreira, Arnaldo Amado

    2015-01-01

    OBJECTIVE: To identify prognostic factors of postoperative functional outcomes. METHODS: Retrospective case series evaluating patients undergoing rotator cuff repair, analyzed by the UCLA score (pre and 12-month postoperative) and Magnetic Resonance Imaging (preoperative). Patients' intrinsic variables related to the injury and intervention were evaluated. Multivariate linear regression analysis was performed to determine variables impact on postoperative functional assessment. RESULTS: 131 patients were included. The mean UCLA score increased from 13.17 ± 3.77 to 28.73 ± 6.09 (p<0,001). We obtained 65.7% of good and excellent results. Age (r= 0.232, p= 0.004) and reparability of posterosuperior injuries (r= 0.151, p= 0.043) correlated with the functional assessment at 12 months. After multivariate linear regression analysis, only age was associated (p = 0.008). CONCLUSIONS: The surgical treatment of rotator cuff tears lead to good and excellent results in 65.6% of patients. Age was an independent predictor factor with better clinical outcomes by UCLA score in older patients. Level of Evidence IV, Case Series. PMID:26207092

  7. Clinical Outcome after Colonic Resection in Women with Endometriosis

    PubMed Central

    Klugsberger, Bettina; Shamiyeh, Andreas; Oppelt, Peter; Jabkowski, Christina; Schimetta, Wolfgang; Haas, Dietmar

    2015-01-01

    Background. In severe forms of endometriosis, the colon or rectum may be involved. This study evaluated the functional results and long-term outcome after laparoscopic colonic resection for endometriosis. Patients and Methods. Questionnaire survey with 24 women who had experienced typical symptoms, including pelvic pain, infertility, and endometriotic lesions in the bowel and undergone laparoscopic surgery, including low anterior resection, from 2009 to 2012, was conducted. Results. Information about the postoperative outcome was obtained from 22 women and was analyzed statistically. Twenty-one had undergone low anterior resection; one patient required a primary Hartmann procedure due to a rectovaginal fistula. The conversion rate was 4.5%. Major complications occurred in one patient, including an anastomotic leakage, and a Hartmann procedure was carried out subsequently in this patient. The symptoms of pain during defecation, pelvic pain, dyspareunia, dysmenorrhea, and hematochezia showed clear improvement one year after the operation and at the time of the questionnaire. Conclusion. Laparoscopic low anterior resection for deeply infiltrative endometriosis is technically demanding but feasible and safe, and it improves the clinical symptoms of endometriosis in the bowel. PMID:26258139

  8. Using patient outcomes to screen for clinical laboratory errors.

    PubMed

    Winkelman, J W; Mennemeyer, S T

    1996-01-01

    How to measure the quality of laboratory testing has long been a challenging problem for laboratory managers and accrediting agencies. Traditionally, laboratory quality has been assessed by direct inspection, proficiency testing, and the credentials of staff. None of these methods is entirely satisfactory at answering a fundamental question: does the laboratory give technically accurate and clinically meaningful information for each patient that it tests? This paper discusses how information on patient outcomes can be used to screen for laboratories that may be making frequent random or systematic errors. This approach is called downstream event monitoring (DEM). The basic idea is to look at what happens to a laboratory's patients in a critical window of time after they have been tested. The approach carries out a basic adage of quality management: follow up with your customers to see if your product has met their needs. The main idea of DEM is that if a laboratory has not conveyed accurate information, the clinician may take actions that fail to help, or maybe even harm, the patient. If a laboratory's patients have an unusually high rate of adverse events that happen within a window of time when the laboratory test would have played a critical role, the laboratory should be further examined to see if it is the cause of the problem. Right now, DEM is a technique under development. It needs a clinical logic to relate a patient's outcomes back to a laboratory test, and it needs good data to compare laboratories. This paper discusses how the prothrombin time test and the serum digoxin test have been examined for Medicare patients to see if certain laboratory characteristics are associated with unusually high occurrences of adverse events after testing. The need for future validation studies is also discussed. PMID:10172598

  9. Clinical Features and Outcomes of Pasteurella multocida Infection

    PubMed Central

    Giordano, Antonio; Dincman, Toros; Clyburn, Benjamin E.; Steed, Lisa L.; Rockey, Don C.

    2015-01-01

    Abstract Pasteurella multocida, a zoonotic infectious organism, has most often been described in patients after an animal bite. Here, we characterize the clinical features and outcomes of P multocida infection in a large cohort of patients according to the presence or absence of an animal bite. We retrospectively searched MUSC's laboratory information system for all patients with positive P multocida cultures from 2000 to 2014. Extensive data were abstracted, including clinical and outcome data. The Charlson comorbidity index (CCI) was used to assess comorbidities among patients. We identified 44 patients with P multocida infections, including 25 with an animal bite. The average age was 64 years and the majority of patients were women (N = 30). There was no difference in age and sex distribution among those with and without a bite (P = 0.38 and 0.75, respectively). A CCI ≥1 was significantly associated with the absence of a bite (P = 0.006). Patients presenting without a bite were more frequently bacteremic (37% vs 4%, respectively, P = 0.001), and were hospitalized more often (84% vs 44%, respectively, P = 0.012). Of the 8 patients who required intensive care unit (ICU)-based care, 7 were non-bite-related. There were 4 deaths, all occurring in patients not bitten. P multocida infections not associated with an animal bite were often associated with bacteremia, severe comorbidity(ies), immune-incompetent states, the need for ICU management, and were associated with substantial mortality. PMID:26356688

  10. Different Placebos, Different Mechanisms, Different Outcomes: Lessons for Clinical Trials

    PubMed Central

    Benedetti, Fabrizio; Dogue, Sara

    2015-01-01

    Clinical trials use placebos with the assumption that they are inert, thus all placebos are considered to be equal. Here we show that this assumption is wrong and that different placebo procedures are associated to different therapeutic rituals which, in turn, trigger different mechanisms and produce different therapeutic outcomes. We studied high altitude, or hypobaric hypoxia, headache, in which two different placebos were administered. The first was placebo oxygen inhaled through a mask, whereas the second was placebo aspirin swallowed with a pill. Both placebos were given after a conditioning procedure, whereby either real oxygen or real aspirin was administered for three consecutive sessions to reduce headache pain. We found that after real oxygen conditioning, placebo oxygen induced pain relief along with a reduction in ventilation, blood alkalosis and salivary prostaglandin (PG)E2, yet without any increase in blood oxygen saturation (SO2). By contrast, after real aspirin conditioning, placebo aspirin induced pain relief through the inhibition of all the products of cyclooxygenase, that is, PGD2, PGE2, PGF2, PGI2, thromboxane (TX)A2, without affecting ventilation and blood alkalosis. Therefore, two different placebos, associated to two different therapeutic rituals, used two different pathways to reduce headache pain. The analgesic effect following placebo oxygen was superior to placebo aspirin. These findings show that different placebos may use different mechanisms to reduce high altitude headache, depending on the therapeutic ritual and the route of administration. In clinical trials, placebos and outcome measures should be selected very carefully in order not to incur in wrong interpretations. PMID:26536471

  11. Spinal Cord Hemangioblastoma : Diagnosis and Clinical Outcome after Surgical Treatment

    PubMed Central

    Na, Joon Ho; Kim, Hyeong Soo; Eoh, Whan; Kim, Jong Hyun; Kim, Jong Soo

    2007-01-01

    Objective Spinal cord hemangioblastoma is an uncommon vascular neoplasm with a benign nature and is associated with von Hippel-Lindau (VHL) disease in 20-30% of patients. Total removal of these tumors without significant neurological deficit remains a great challenge. The purpose of this study was to investigate the efficacy of VHL mutation analysis and to evaluate surgical outcome of patients with spinal cord hemangioblastomas. Methods This study included nine patients treated for spinal cord hemangioblastomas at our institute between December 1994 and March 2006. There were four male and five female patients. Mean age was 37.8 years. The mean follow-up period was 22.4 months. Magnetic resonance imaging (MRI) of the complete neuraxis was done in all cases and VHL mutation analysis was performed in three cases for a definite diagnosis. Results Six patients had intramedullary tumor, and the remaining patients had intradural extramedullary lesions. Five patients were associated with VHL disease. The von Hippel-Lindau mutation analysis was done in three patients and two of them showed VHL gene abnormality. Tumors were located in the cervical cord in five cases and in the thoracic cord in four cases. All patients underwent surgical intervention, and total removal was achieved in six cases. All patients showed improvement or, at least, clinically stationary state. Surgical complications did not develop in any cases. Conclusion Spinal hemangioblastoma in this series has been safely and effectively removed via a posterior approach. Postoperatively, clinical outcome was excellent in the majority of cases. The VHL mutation analysis was useful in patients with family history and in those with multiple hemangioblastomas. PMID:19096585

  12. Atrial Fibrillation Ablation in Systolic Dysfunction: Clinical and Echocardiographic Outcomes

    PubMed Central

    Lobo, Tasso Julio; Pachon, Carlos Thiene; Pachon, Jose Carlos; Pachon, Enrique Indalecio; Pachon, Maria Zelia; Pachon, Juan Carlos; Santillana, Tomas Guillermo; Zerpa, Juan Carlos; Albornoz, Remy Nelson; Jatene, Adib Domingos

    2015-01-01

    Background Heart failure and atrial fibrillation (AF) often coexist in a deleterious cycle. Objective To evaluate the clinical and echocardiographic outcomes of patients with ventricular systolic dysfunction and AF treated with radiofrequency (RF) ablation. Methods Patients with ventricular systolic dysfunction [ejection fraction (EF) <50%] and AF refractory to drug therapy underwent stepwise RF ablation in the same session with pulmonary vein isolation, ablation of AF nests and of residual atrial tachycardia, named "background tachycardia". Clinical (NYHA functional class) and echocardiographic (EF, left atrial diameter) data were compared (McNemar test and t test) before and after ablation. Results 31 patients (6 women, 25 men), aged 37 to 77 years (mean, 59.8±10.6), underwent RF ablation. The etiology was mainly idiopathic (19 p, 61%). During a mean follow-up of 20.3±17 months, 24 patients (77%) were in sinus rhythm, 11 (35%) being on amiodarone. Eight patients (26%) underwent more than one procedure (6 underwent 2 procedures, and 2 underwent 3 procedures). Significant NYHA functional class improvement was observed (pre-ablation: 2.23±0.56; postablation: 1.13±0.35; p<0.0001). The echocardiographic outcome also showed significant ventricular function improvement (EF pre: 44.68%±6.02%, post: 59%±13.2%, p=0.0005) and a significant left atrial diameter reduction (pre: 46.61±7.3 mm; post: 43.59±6.6 mm; p=0.026). No major complications occurred. Conclusion Our findings suggest that AF ablation in patients with ventricular systolic dysfunction is a safe and highly effective procedure. Arrhythmia control has a great impact on ventricular function recovery and functional class improvement. PMID:25387404

  13. 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

  14. Targeting bone metastases in prostate cancer: improving clinical outcome.

    PubMed

    Body, Jean-Jacques; Casimiro, Sandra; Costa, Luís

    2015-06-01

    Bone metastases develop in most patients with metastatic castration-resistant prostate cancer (mCRPC). They affect the structural integrity of bone, manifesting as pain and skeletal-related events (SREs), and are the primary cause of patient disability, reduced quality of life (QOL) and death. Understanding the pathophysiology of bone metastases resulted in the development of agents that improve clinical outcome, suggesting that managing both the systemic disease and associated bone events is important. Historically, the treatment of CRPC bone metastases with early radiopharmaceuticals and external beam radiation therapy was largely supportive; however, now, zoledronic acid and denosumab are integral to the therapeutic strategy for mCRPC. These agents substantially reduce skeletal morbidity and improve patient QOL. Radium-223 dichloride is the first bone-targeting agent to show improved survival and reduced pain and symptomatic skeletal events in patients with mCRPC without visceral disease. Five other systemic agents are currently approved for use in mCRPC based on their ability to improve survival. These include the cytotoxic drugs docetaxel and cabazitaxel, the hormone-based therapies, abiraterone and enzalutamide, and the immunotherapeutic vaccine sipuleucel-T. Abiraterone and enzalutamide are able to reduce SREs and improve survival in this setting. Novel agents targeting tumour and bone cells are under clinical development. PMID:26119830

  15. Ebola in children: epidemiology, clinical features, diagnosis and outcomes.

    PubMed

    Olupot-Olupot, Peter

    2015-03-01

    Ebola virus disease is caused by a highly contagious and pathogenic threadlike RNA virus of the Filoviridae family. The index human case is usually a zoonosis that launches human-to-human transmission interface with varying levels of sustainability of the epidemic depending on the level of public health preparedness of the affected country and the Ebola virus strain. The disease affects all age groups in the population. Clinical diagnosis is challenging in index cases especially in the early stages of the disease when the presenting features are usually nonspecific and only similar to a flu-like illness. However, in the agonal stages, hemorrhage frequently occurs in a high proportion of cases. The diagnostic gold standard is by detecting the antigen using reverse transcription-polymerase chain reaction. Mortality rates in the past 28 outbreaks since 1976 have ranged from 30% to 100% in different settings among adults, but lower mortality rates have been documented in children. This review aims to describe Ebola virus infection, clinical presentation, diagnosis and outcomes in children.

  16. COMPASS identifies T-cell subsets correlated with clinical outcomes

    PubMed Central

    Lin, Lin; Finak, Greg; Ushey, Kevin; Seshadri, Chetan; Hawn, Thomas R.; Frahm, Nicole; Scriba, Thomas J.; Mahomed, Hassan; Hanekom, Willem; Bart, Pierre-Alexandre; Pantaleo, Giuseppe; Tomaras, Georgia D.; Rerks-Ngarm, Supachai; Kaewkungwal, Jaranit; Nitayaphan, Sorachai; Pitisuttithum, Punnee; Michael, Nelson L.; Kim, Jerome H.; Robb, Merlin L.; O’Connell, Robert J.; Karasavvas, Nicos; Gilbert, Peter; DeRosa, Stephen; McElrath, M. Juliana

    2015-01-01

    Advances in flow cytometry and other single-cell technologies have enabled high-dimensional, high-throughput measurements of individual cells and allowed interrogation of cell population heterogeneity. Computational tools to take full advantage of these technologies are lacking. Here, we present COMPASS, a computational framework for unbiased polyfunctionality analysis of antigen-specific T-cell subsets. COMPASS uses a Bayesian hierarchical framework to model all observed functional cell subsets and select those most likely to exhibit antigen-specific responses. Cell-subset responses are quantified by posterior probabilities, while subject-level responses are quantified by two novel summary statistics that can be correlated directly with clinical outcome, and describe the quality of an individual’s (poly)functional response. Using three clinical datasets of cytokine production we demonstrate how COMPASS improves characterization of antigen-specific T cells and reveals novel cellular correlates of protection in the RV144 HIV vaccine efficacy trial that are missed by other methods. COMPASS is available as open-source software. PMID:26006008

  17. A Public-Private Partnership Develops and Externally Validates a 30-Day Hospital Readmission Risk Prediction Model

    PubMed Central

    Choudhry, Shahid A.; Li, Jing; Davis, Darcy; Erdmann, Cole; Sikka, Rishi; Sutariya, Bharat

    2013-01-01

    Introduction: Preventing the occurrence of hospital readmissions is needed to improve quality of care and foster population health across the care continuum. Hospitals are being held accountable for improving transitions of care to avert unnecessary readmissions. Advocate Health Care in Chicago and Cerner (ACC) collaborated to develop all-cause, 30-day hospital readmission risk prediction models to identify patients that need interventional resources. Ideally, prediction models should encompass several qualities: they should have high predictive ability; use reliable and clinically relevant data; use vigorous performance metrics to assess the models; be validated in populations where they are applied; and be scalable in heterogeneous populations. However, a systematic review of prediction models for hospital readmission risk determined that most performed poorly (average C-statistic of 0.66) and efforts to improve their performance are needed for widespread usage. Methods: The ACC team incorporated electronic health record data, utilized a mixed-method approach to evaluate risk factors, and externally validated their prediction models for generalizability. Inclusion and exclusion criteria were applied on the patient cohort and then split for derivation and internal validation. Stepwise logistic regression was performed to develop two predictive models: one for admission and one for discharge. The prediction models were assessed for discrimination ability, calibration, overall performance, and then externally validated. Results: The ACC Admission and Discharge Models demonstrated modest discrimination ability during derivation, internal and external validation post-recalibration (C-statistic of 0.76 and 0.78, respectively), and reasonable model fit during external validation for utility in heterogeneous populations. Conclusions: The ACC Admission and Discharge Models embody the design qualities of ideal prediction models. The ACC plans to continue its partnership to

  18. AB129. Osteogenesis imperfecta: clinical features and bisphosphonate treatment outcome

    PubMed Central

    Can, Ngoc Thi Bich; Vu, Dung Chi; Bui, Thao Phuong; Nguyen, Khanh Ngoc

    2015-01-01

    Background and objective Osteogenesis imperfecta (OI) comprises a group of disorders principally affecting type I collagen which result in increased bone fragility. Children with severe OI suffer recurrent fractures, resulting in severe deformity and growth stunting in many cases, with loss of independent ambulation by the teenage years in over 50% of cases. Recently, cyclical intravenous treatment with pamidronate has proven of benefit to children with severe forms of OI. This article aims to describle clinical features and laboratory manifestations of patient with OI and evaluate outcome of bisphosphonate management. Methods Clinical features, biochemical finding, and management outcome of 104 cases were study. The patients were classified into four major subtypes of Sillience et al. 1979. Patients with severe types were treatment with pamidronate (Aredia) used Rauch protocol 2003. Results Now we have 196 patients (87 females and 109 males) but we studied focus on 104 patients from 98 families (60 males, 44 females) onset at 2.1±3.0 years (median 0.35) with the average fracture bone of 5.9±4.4 times. In there, 17% type I, 8% type II, 63% type III, and 12% type IV. Clinical features include of intrauterine fracture visible on ultrasound 35%, bone deformation after birth 68%, triangle face 76%, long bone deformation 91%, chest deformation 46%, scoliosis 27%, short status 90%, blue sclera 83%, dentinogenesis imperfecta 20%, hearing loss 6%. Thirty patients have been treated with pamidronate at 3.2±3.7 years (4 months to 8 years) during 13±0.8 months (6-30 months). Fourteen patients had fracture bone after 6 months of treatment but no patients had fracture bone after 12 months. Seven patients had been treatment after 1.6±0.5 years, BMD increase from 0.39±0.311 to 0.79±0.105 g/cm2 (P<0.05). One patient had fever reaction after first pamidronate infusion but controlled with standard antipyretic therapy, and do not recur in later treatments. Conclusions OI has

  19. Are weekend inpatient rehabilitation services value for money? An economic evaluation alongside a randomized controlled trial with a 30 day follow up

    PubMed Central

    2014-01-01

    Background Providing additional Saturday rehabilitation can improve functional independence and health related quality of life at discharge and it may reduce patient length of stay, yet the economic implications are not known. The aim of this study was to determine from a health service perspective if the provision of rehabilitation to inpatients on a Saturday in addition to Monday to Friday was cost effective compared to Monday to Friday rehabilitation alone. Methods Cost utility and cost effectiveness analyses were undertaken alongside a multi-center, single-blind randomized controlled trial with a 30-day follow up after discharge. Participants were adults admitted for inpatient rehabilitation in two publicly funded metropolitan rehabilitation facilities. The control group received usual care rehabilitation services from Monday to Friday and the intervention group received usual care plus an additional rehabilitation service on Saturday. Incremental cost utility ratio was reported as cost per quality adjusted life year (QALY) gained and an incremental cost effectiveness ratio (ICER) was reported as cost for a minimal clinically important difference (MCID) in functional independence. Results 996 patients (mean age 74 (standard deviation 13) years) were randomly assigned to the intervention (n = 496) or the control group (n = 500). Mean difference in cost of AUD$1,673 (95% confidence interval (CI) -271 to 3,618) was a saving in favor of the intervention group. The incremental cost utility ratio found a saving of AUD$41,825 (95% CI -2,817 to 74,620) per QALY gained for the intervention group. The ICER found a saving of AUD$16,003 (95% CI -3,074 to 87,361) in achieving a MCID in functional independence for the intervention group. If the willingness to pay per QALY gained or for a MCID in functional independence was zero dollars the probability of the intervention being cost effective was 96% and 95%, respectively. A sensitivity analysis removing Saturday

  20. 78 FR 76311 - Submission for OMB Review; 30-Day Comment Request: Outcomes Evaluation of the National Cancer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-17

    ... previously published in the Federal Register on August 12, 2013, (Vol. 78 FR p. 48879) and allowed 60 days... Evaluation of the National Cancer Institute (NCI) Cancer Prevention Fellowship Program (CPFP) SUMMARY: Under...: Jessica Faupel-Badger, Ph.D., MPH, Cancer Prevention Fellowship Program, National Cancer Institute,...

  1. Clinical outcomes and adverse effect monitoring in allergic rhinitis.

    PubMed

    Juniper, Elizabeth F; Ståhl, Elisabeth; Doty, Richard L; Simons, F Estelle R; Allen, David B; Howarth, Peter H

    2005-03-01

    The subjective recording in diary cards of symptoms of itch, sneeze, nose running, and blockage, with the use of a rating scale to indicate the level of severity, is usual for clinical trials in allergic rhinitis. The primary outcome measure is usually a composite score that enables a single total symptoms score endpoint. It is appreciated, however, that rhinitis has a greater effect on the individual than is reflected purely by the recording of anterior nasal symptoms. Nasal obstruction is troublesome and may lead to sleep disturbance in addition to impaired daytime concentration and daytime sleepiness. These impairments affect school and work performance. Individuals with rhinitis find it socially embarrassing to be seen sneezing, sniffing, or blowing their nose. To capture these and other aspects of the disease-specific health-related quality of life, questionnaires such as the Rhinoconjunctivitis Quality of Life Questionnaire have been developed and validated for clinical trial use. The adoption of health-related quality of life questionnaires into clinical trials broadens the information obtained regarding the effect of the therapeutic intervention and helps focus on issues relevant to the individual patient. It must be appreciated that it is not only the disease that may adversely affect health-related quality of life; administered therapy, although intended to be beneficial, may also cause health impairment. Adverse-event monitoring is thus essential in clinical trials. The first-generation H 1 -histamines, because of their effect on central H 1 -receptors, are classically associated with central nervous system (CNS) effects such as sedation. Although this is not always perceived by the patient, it is clearly evident with objective performance testing, and positron emission tomography scanning has directly demonstrated the central H 1 -receptor occupancy. The second-generation H 1 -antihistamines have reduced central H 1 -receptor occupancy and considerably

  2. Bilateral Vitreous Hemorrhage in Children: Clinical Features and Outcomes

    PubMed Central

    Sudhalkar, Aditya; Chhablani, Jay; Rani, Padmaja Kumari; Jalali, Subhadra; Balakrishnan, Divya; Tyagi, Mudit

    2015-01-01

    Purpose: To determine the etiology, clinical features and outcomes of bilateral vitreous hemorrhage (VH) in children. Methods: This retrospective chart review was performed on patients with bilateral VH under the age of 18 at a tertiary eye care center in India. Data included demographics, details of history and ocular examination, reports of investigations, surgeries or other interventions performed, and final anatomical and visual outcomes. Patients were divided into two groups i.e., traumatic and non-traumatic (spontaneous). Results: The traumatic group was comprised of 37 patients including 27 male and 10 female subjects with mean age of 13.47 ± 5.31 years, the most common complaint was decreased vision (96.45%) and the most prevalent etiology was firecracker injury in 16 (43.2%) patients. Mean baseline visual acuity (VA) was 2.34 ± 1.31 logMAR which was significantly improved to 1.08 ± 0.23 logMAR (P = 0.042). The mean number of surgeries was 2.72 ± 1.43 in the traumatic VH and mean follow up period was 23.14 ± 6.54 months. The spontaneous group included 48 subjects comprised of 27 male and 21 female cases with mean age of 14.48 ± 2.03 years. The most common cause was vasculitis in 21 (43.75%) subjects including four patients with tuberculosis. Mean baseline VA was 1.97 ± 1.13 logMAR which showed a significant improvement to 0.82 ± 0.24 logMAR (P = 0.012) after mean follow up of 34.2 ± 11.2 months. Eleven patients required at least one major surgery. Conclusion: Vasculitis was the most common cause of spontaneous bilateral VH; traumatic VH most prevalently occurred due to firecracker injury. Final VA was better in the spontaneous group. PMID:26425315

  3. Paravalvular Regurgitation: Clinical Outcomes in Surgical and Percutaneous Treatments

    PubMed Central

    Pinheiro, Carlos Passos; Rezek, Daniele; Costa, Eduardo Paiva; de Carvalho, Edvagner Sergio Leite; Moscoso, Freddy Antonio Brito; Taborga, Percy Richard Chavez; Jeronimo, Andreia Dias; Abizaid, Alexandre Antonio Cunha; Ramos, Auristela Isabel de Oliveira

    2016-01-01

    Background Paravalvular regurgitation (paravalvular leak) is a serious and rare complication associated with valve replacement surgery. Studies have shown a 3% to 6% incidence of paravalvular regurgitation with hemodynamic repercussion. Few studies have compared surgical and percutaneous approaches for repair. Objectives To compare the surgical and percutaneous approaches for paravalvular regurgitation repair regarding clinical outcomes during hospitalization and one year after the procedure. Methods This is a retrospective, descriptive and observational study that included 35 patients with paravalvular leak, requiring repair, and followed up at the Dante Pazzanese Institute of Cardiology between January 2011 and December 2013. Patients were divided into groups according to the established treatment and followed up for 1 year after the procedure. Results The group submitted to percutaneous treatment was considered to be at higher risk for complications because of the older age of patients, higher prevalence of diabetes, greater number of previous valve surgeries and lower mean creatinine clearance value. During hospitalization, both groups had a large number of complications (74.3% of cases), with no statistical difference in the analyzed outcomes. After 1 year, the percutaneous group had a greater number of re-interventions (8.7% vs 20%, p = 0.57) and a higher mortality rate (0% vs. 20%, p = 0.08). A high incidence of residual mitral leak was observed after the percutaneous procedure (8.7% vs. 50%, p = 0.08). Conclusion Surgery is the treatment of choice for paravalvular regurgitation. The percutaneous approach can be an alternative for patients at high surgical risk. PMID:27305109

  4. Clinical attributes and surgical outcomes of angiocentric gliomas.

    PubMed

    Ampie, Leonel; Choy, Winward; DiDomenico, Joseph D; Lamano, Jonathan B; Williams, Christopher Kazu; Kesavabhotla, Kartik; Mao, Qinwen; Bloch, Orin

    2016-06-01

    Angiocentric gliomas (AG) are exceedingly rare low-grade neoplasms which often present in the form of intractable epilepsy within younger patients. The current study extensively reviews all reported cases which were pathologically verified as AG in the literature to analyze clinical attributes and surgical outcomes of this neoplasm. There were 88 patients with AG reported in the literature consisting mostly of pediatric cases. The sex distribution consisted of 45 males and 36 females with the remaining seven cases not documenting sex. The average age of initial diagnosis was 16years with almost half of all diagnosed patients being within the first decade of life. In cases where extent of resection was reported, gross total resection (GTR) was achieved in 54 patients, subtotal resection (STR) in 16, and biopsy only in three. Post-operative complications were transient and only occurred in three patients with no reports of death following surgery. Only five cases reported tumor recurrence on follow-up. Eight patients had seizure recurrence post-operatively and GTR offered improved rates of seizure control when compared to STR (p=0.0005). Nearly half of the cases of AG are diagnosed within the first decade of life and they usually manifest with intractable seizures. GTR appears to offer better seizure control in the post-operative period. Surgical resection is the mainstay therapy for AG as post-operative complications and tumor recurrence remain uncommon. Since the number of reported cases is limited, future studies with longer follow-up periods will help elaborate more long-term outcomes.

  5. Snoezelen Room and Childbirth Outcome: A Randomized Clinical Trial

    PubMed Central

    Jamshidi Manesh, Mansoureh; Kalati, Mahnaz; Hosseini, Fatemeh

    2015-01-01

    Background: One of the strategies for a good outcome and pain free childbearing is to design the delivery room. Objectives: The aim of this study was to evaluate the effects of snoezelen room on childbearing outcome such as pain intensity, duration of labor, and perinea status in nulliparous women. Patients and Methods: This study was a randomized controlled clinical trial consists of 100 childbearing women. They were randomly divided into 2 groups. The experimental group went to snoezelen room when their cervix dilation was 4 cm, while the control group went to physiologic delivery room with the same cervix dilation. Results: The mean ± SD of VAS (Visual Analogue Scale) pain intensity of the experimental and control groups before the intervention were 5.1 ± 1.95 and 5.58 ± 1.62, respectively (P = 0.13). The mean ± SD of VAS pain intensity scores of the experimental and control groups after 3 hours spending in their assigned rooms were 5.26 ± 0.86 and 9.56 ± 1.48, respectively (P = 0.01). The mean ± SD of the first stage scores of the experimental and control groups were 6.95 ± 0.97 and 8.41 ± 0.67, respectively (P = 0.042). About 92% of participants’ intervention vs. 66% of control participants had perinea laceration (P = 0.041). Conclusions: According to the findings of the present study, distracting senses in snoezelen room decreases mother’s pain intensity, the length of labor, and incidence of episiotomy. PMID:26082849

  6. 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

  7. Nutritional Risk, Micronutrient Status and Clinical Outcomes: A Prospective Observational Study in an Infectious Disease Clinic

    PubMed Central

    Dizdar, Oguzhan Sıtkı; Baspınar, Osman; Kocer, Derya; Dursun, Zehra Bestepe; Avcı, Deniz; Karakükcü, Cigdem; Çelik, İlhami; Gundogan, Kursat

    2016-01-01

    Malnutrition has been associated with increased morbidity and mortality. The objective of this study was to determine the nutritional status and micronutrient levels of hospitalized patients in an infectious disease clinic and investigate their association with adverse clinical outcomes. The nutritional status of the study participants was assessed using the Nutritional Risk Screening 2002 (NRS 2002) and micronutrient levels and routine biochemical parameters were tested within the first 24 h of the patient’s admission. The incidence of zinc, selenium, thiamine, vitamin B6, vitamin B12 deficiency were 66.7% (n = 40), 46.6% (n = 29), 39.7% (n = 27), 35.3% (n = 24), 14.1% (n = 9), respectively. Selenium levels were significantly higher in patients with urinary tract infections, but lower in soft tissue infections. Copper levels were significantly higher in patients with soft tissue infections. In the Cox regression models, lower albumin, higher serum lactate dehydrogenase levels and higher NRS-2002 scores were associated with increased death. Thiamine, selenium, zinc and vitamin B6 deficiencies but not chromium deficiencies are common in infectious disease clinics. New associations were found between micronutrient levels and infection type and their adverse clinical outcomes. Hypoalbuminemia and a high NRS-2002 score had the greatest accuracy in predicting death, systemic inflammatory response syndrome and sepsis on admission. PMID:26938553

  8. Clinical Heterogeneity of Guillain-Barré Syndrome in the Emergency Department: Impact on Clinical Outcome

    PubMed Central

    Markakis, Ioannis

    2016-01-01

    Guillain-Barré syndrome (GBS) is mainly classified into acute inflammatory demyelinating polyneuropathy (AIDP) and acute motor axonal neuropathy (AMAN). Although diagnosis of GBS requires progressive weakness and universal areflexia or hyporeflexia, cases of GBS with preserved or increased deep tendon reflexes (DTRs) have been increasingly recognized. We report three cases of GBS, presenting at a single unit in six months. Our first case presented with pure sensory symptoms. The second case had nonspecific generalized weakness, while the third presented with typical ascending weakness. One of our patients had preserved DTRs, while the other two had increased DTRs. Our two cases with hyperreflexia were found to have a preceding Campylobacter jejuni infection and anti-ganglioside antibodies, and their electrophysiological studies revealed AMAN. The other case had an AIDP. Only one case was offered a diagnosis and treatment from the first emergency department (ED) visit and had a better clinical outcome. Clinical diagnosis of GBS in the ED can be challenging. Delay in diagnosis of GBS in the ED is common due to cases with intact or increased DTRs, atypical pattern of weakness, or pure sensory symptoms. Emergency physicians should be aware of GBS clinical heterogeneity, because early diagnosis and treatment improve clinical outcome. PMID:27761272

  9. Clinical outcomes of microendoscopic decompression surgery for cervical myelopathy

    PubMed Central

    Yoshida, Munehito; Yamada, Hiroshi; Nakagawa, Yukihiro; Maio, Kazuhiro; Kawai, Masaki; Iwasaki, Hiroshi

    2009-01-01

    Retrospective study on the results of microendoscopic decompression surgery for the treatment of cervical myelopathy. The purpose of this study was to describe the microendoscopic laminoplasty (MEL) technique as the surgical method in the treatment of cervical myelopathy, and to document the clinical outcomes for MEL surgery. Endoscopic surgery poses several challenges for the aspiring endoscopic surgeons, the most critical of which is mastering hand–eye coordination. With training in live animal and cadaver surgery, the technical progress has reduced the problem of morbidity following surgery. The authors have performed microendoscopic decompression surgery on more than 2,000 patients for lumbar spinal canal stenosis. Fifty-one patients underwent the posterior decompression surgery using microendoscopy for cervical myelopathy at authors’ institute. The average age was 62.9 years. The criteria for exclusion were cervical myelopathy with tumor, trauma, severe ossification of posterior longitudinal ligament, rheumatoid arthritis, pyogenic spondylitises, destructive spondylo-arthropathies, and other combined spinal lesions. The items evaluated were neurological evaluation, recovery rates; these were calculated following examination using the Hirabayashi’s method with the criteria proposed by the Japanese Orthopaedic Association scoring system (JOA score). The mean follow-up period was 20.3 months. The average of JOA score was 10.1 points at the initial examination and 13.6 points at the final follow-up. The average recovery rate was 52.5%. The recovery rate according to surgical levels was, respectively, 56.5% in one level, 46.3% in two levels and 54.1% in more than three levels. The complications were as follows: one patient sustained a pin-hole-like dura mater injury inflicted by a high-speed air-drill during surgery, one patient developed an epidural hematoma 3 days after surgery, and two patients had the C5 nerve root palsy after surgery. The epidural

  10. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes

    PubMed Central

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin

    2015-01-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and BiodentineTM as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

  11. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes.

    PubMed

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes.

  12. Regenerative Endodontic Treatment: Report of Two Cases with Different Clinical Management and Outcomes.

    PubMed

    Khoshkhounejad, Mehrfam; Shokouhinejad, Noushin; Pirmoazen, Salma

    2015-06-01

    Endodontic intervention in necrotic immature permanent teeth is usually a clinical challenge. With appropriate case selection, regenerative treatment can be effective, providing a desirable outcome. However, there is still no consensus on the optimal disinfection protocol or the method to achieve predictable clinical outcome. This article presents two cases of regenerative treatment in necrotic immature teeth, using mineral trioxide aggregate (MTA) and Biodentine(TM) as coronal barriers and different irrigants, which led to different clinical outcomes. PMID:26884781

  13. Bone marrow necrosis in acute leukemia: Clinical characteristic and outcome.

    PubMed

    Badar, Talha; Shetty, Aditya; Bueso-Ramos, Carlos; Cortes, Jorge; Konopleva, Marina; Borthakur, Gautam; Pierce, Sherry; Huang, Xuelin; Chen, Hsiang-Chun; Kadia, Tapan; Daver, Naval; Dinardo, Courtney; O'Brien, Susan; Garcia-Manero, Guillermo; Kantarjian, Hagop; Ravandi, Farhad

    2015-09-01

    Bone marrow necrosis (BMN) is characterized by infarction of the medullary stroma, leading to marrow necrosis with preserved cortical bone. In reported small series, BMN in hematological malignancies is associated with poor prognosis. We sought to find the impact of BMN on clinical outcome in a relatively larger cohort of patients with acute leukemias. Overall we evaluated 1,691 patients; 1,051 with acute myeloid leukemia (AML) and 640 with acute lymphocytic leukemia referred to our institution between 2002 and 2013. Patients with AML and acute lymphoblastic leukemia (ALL) were evaluated separately to determine the incidence of BMN, associated clinical features and its prognostic significance. At initial diagnosis, BMN was observed in 25 (2.4%) patients with AML and 20 (3.2%) patients with ALL. In AML, BMN was significantly associated with French-American-British AML M5 morphology (32% vs. 10%, P = 0.002). The complete remission (CR) rate in AML with and without BMN was 32% and 59% respectively (P = 0.008). Likewise, CR rate in ALL with BMN was also inferior, 70% vs. 92% (P = 0.005). The median overall survival (OS) in AML with BMN was significantly poorer, 3.7 months compared to 14 months without BMN (P = 0.003). Similarly, the median OS in ALL with and without BMN was 61.7 and 72 months respectively (P = 0.33). BMN is not a rare entity in AML and ALL, but is infrequent. BMN in AML and in ALL is suggestive of inferior response and poor prognosis.

  14. Systematic review of clinical outcomes after prophylactic surgery.

    PubMed

    Davis, C R; Trevatt, Aej; Dixit, A; Datta, V

    2016-07-01

    Introduction Prophylactic appendicectomy is performed prior to military, polar and space expeditions to prevent acute appendicitis in the field. However, the risk-benefit ratio of prophylactic surgery is controversial. This study aimed to systematically review the evidence for prophylactic appendicectomy. It is supplemented by a clinical example of prophylactic surgery resulting in life-threatening complications. Methods A systematic review was performed using MEDLINE(®) and the Cochrane Central Register of Controlled Trials. Keyword variants of 'prophylaxis' and 'appendicectomy' were combined to identify potential papers for inclusion. Papers related to prophylactic appendicectomy risks and benefits were reviewed. Results Overall, 511 papers were identified, with 37 papers satisfying the inclusion criteria. Nine reported outcomes after incidental appendicectomy during concurrent surgical procedures. No papers focused explicitly on prophylactic appendicectomy in asymptomatic patients. The clinical example outlined acute obstruction secondary to adhesions from a prophylactic appendicectomy. Complications after elective appendicectomy versus the natural history of acute appendicitis in scenarios such as polar expeditions or covert operations suggest prophylactic appendicectomy may be appropriate prior to extreme situations. Nevertheless, the long-term risk of adhesion related complications render prophylactic appendicectomy feasible only when the short-term risk of acute appendicitis outweighs the long-term risks of surgery. Conclusions Prophylactic appendicectomy is rarely performed and not without risk. This is the first documented evidence of long-term complications following prophylactic appendicectomy. Surgery should be considered on an individual basis by balancing the risks of acute appendicitis in the field with the potential consequences of an otherwise unnecessary surgical procedure in a healthy patient.

  15. Neurofeedback and biofeedback with 37 migraineurs: a clinical outcome study

    PubMed Central

    2010-01-01

    Background Traditional peripheral biofeedback has grade A evidence for effectively treating migraines. Two newer forms of neurobiofeedback, EEG biofeedback and hemoencephalography biofeedback were combined with thermal handwarming biofeedback to treat 37 migraineurs in a clinical outpatient setting. Methods 37 migraine patients underwent an average of 40 neurofeedback sessions combined with thermal biofeedback in an outpatient biofeedback clinic. All patients were on at least one type of medication for migraine; preventive, abortive or rescue. Patients kept daily headache diaries a minimum of two weeks prior to treatment and throughout treatment showing symptom frequency, severity, duration and medications used. Treatments were conducted an average of three times weekly over an average span of 6 months. Headache diaries were examined after treatment and a formal interview was conducted. After an average of 14.5 months following treatment, a formal interview was conducted in order to ascertain duration of treatment effects. Results Of the 37 migraine patients treated, 26 patients or 70% experienced at least a 50% reduction in the frequency of their headaches which was sustained on average 14.5 months after treatments were discontinued. Conclusions All combined neuro and biofeedback interventions were effective in reducing the frequency of migraines with clients using medication resulting in a more favorable outcome (70% experiencing at least a 50% reduction in headaches) than just medications alone (50% experience a 50% reduction) and that the effect size of our study involving three different types of biofeedback for migraine (1.09) was more robust than effect size of combined studies on thermal biofeedback alone for migraine (.5). These non-invasive interventions may show promise for treating treatment-refractory migraine and for preventing the progression from episodic to chronic migraine. PMID:20205867

  16. Standardized clinical outcome rating scale for depression for use in clinical practice.

    PubMed

    Zimmerman, Mark; Posternak, Michael A; Chelminski, Iwona; Friedman, Michael

    2005-01-01

    The integration of research into clinical practice to conduct effectiveness studies faces multiple obstacles. One obstacle is the burden of completing research measures of outcome. A simple, reliable, and valid measure that could be rated at every visit, incorporated into a clinician's progress note, and reflect the DSM-IV definition of a major depressive episode (including partial and full remission from the episode) would enhance the ability to conduct effectiveness research. The goal of the present study was to examine the reliability and validity of such a measure. Three hundred and three psychiatric outpatients who were being treated for a DSM-IV major depressive episode were rated on the Standardized Clinical Outcome Rating for Depression (SCOR-D), 17-item Hamilton Rating Scale for Depression, Montgomery-Asberg Depression Rating Scale, and the Global Assessment of Functioning. We examined the correlation between the SCOR-D and the other measures, and conducted an analyses of variance to compare mean values on these measures for each rating point on the SCOR-D. The inter-rater reliability of the SCOR-D dimensional ratings and categorical determination of remission were high. The SCOR-D was highly correlated with the other scales, and there were significant differences on the other measures of depression severity between each adjacent rating level of the SCOR-D. The SCOR-D is a brief standardized outcome measure linked to the DSM-IV approach toward defining remission that can be incorporated into routine clinical practice without adding undue burden to the treating clinician with some evidence of reliability and validity. This measure could make it more feasible to conduct effectiveness studies in clinical practice.

  17. Use of mortality within 30 days of a COPD hospitalisation as a measure of COPD care in UK hospitals.

    PubMed

    Walker, P P; Thompson, E; Crone, H; Flatt, G; Holton, K; Hill, S L; Pearson, M G

    2013-10-01

    Mortality rate has been proposed as a metric of hospital chronic obstructive pulmonary disease (COPD) care in light of variation seen in national COPD audits. Using Hospital Episode Statistics (hospital 'coding') we examined 30-day mortality after COPD hospitalisation in 150 UK hospitals during 2006-2007 and 2007-2008. Mean and median 30-day mortalities were similar each year but the coefficient of variation was >20% and hospitals could change from a low or high quartile to the median by chance. We could not detect any reasons for hospitals being at the extremes. 30-day mortality after COPD hospitalisation is a complex variable and unlikely to be useful as a primary annual COPD metric.

  18. 75 FR 75677 - Agency Information Collection Request. 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-06

    ... technical assistance to help implement select MAPPS (Media, Access, Point of Purchase/Promotion, Pricing... and support the National Prevention Media Initiative through co-branding and augmenting HHS-developed media campaigns in communities. The outcome measures that will be collected from funded...

  19. 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

  20. Antibiotic use and clinical outcomes in the acute setting under management by an infectious diseases acute physician versus other clinical teams: a cohort study

    PubMed Central

    Jones, Nicola; Mistry, Vikash; Crook, Derrick; Peto, Tim; Walker, A Sarah

    2016-01-01

    Objectives To assess the magnitude of difference in antibiotic use between clinical teams in the acute setting and assess evidence for any adverse consequences to patient safety or healthcare delivery. Design Prospective cohort study (1 week) and analysis of linked electronic health records (3 years). Setting UK tertiary care centre. Participants All patients admitted sequentially to the acute medical service under an infectious diseases acute physician (IDP) and other medical teams during 1 week in 2013 (n=297), and 3 years 2012–2014 (n=47 585). Primary outcome measure Antibiotic use in days of therapy (DOT): raw group metrics and regression analysis adjusted for case mix. Secondary outcome measures 30-day all-cause mortality, treatment failure and length of stay. Results Antibiotic use was 173 vs 282 DOT/100 admissions in the IDP versus non-IDP group. Using case mix-adjusted zero-inflated Poisson regression, IDP patients were significantly less likely to receive an antibiotic (adjusted OR=0.25 (95% CI 0.07 to 0.84), p=0.03) and received shorter courses (adjusted rate ratio (RR)=0.71 (95% CI 0.54 to 0.93), p=0.01). Clinically stable IDP patients of uncertain diagnosis were more likely to have antibiotics held (87% vs 55%; p=0.02). There was no significant difference in treatment failure or mortality (adjusted p>0.5; also in the 3-year data set), but IDP patients were more likely to be admitted overnight (adjusted OR=3.53 (95% CI 1.24 to 10.03), p=0.03) and have longer length of stay (adjusted RR=1.19 (95% CI 1.05 to 1.36), p=0.007). Conclusions The IDP-led group used 30% less antibiotic therapy with no adverse clinical outcome, suggesting antibiotic use can be reduced safely in the acute setting. This may be achieved in part by holding antibiotics and admitting the patient for observation rather than prescribing, which has implications for costs and hospital occupancy. More information is needed to indicate whether any such longer admission will

  1. 77 FR 37046 - Agency Information Collection Request; 30-Day Public Comment Request

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-20

    ... conducted or supported by HHS, or, in the case of FDA's regulation, each IRB in the United States that reviews clinical investigations regulated by FDA under sections 505(i) or 520(g) of the Federal Food, Drug and Cosmetic Act; and each IRB in the United States that reviews clinical investigations that...

  2. Proton Radiotherapy for Pediatric Ewing's Sarcoma: Initial Clinical Outcomes

    SciTech Connect

    Rombi, Barbara; DeLaney, Thomas F.; MacDonald, Shannon M.; Huang, Mary S.; Ebb, David H.; Liebsch, Norbert J.; Raskin, Kevin A.; Yeap, Beow Y.; Marcus, Karen J.; Tarbell, Nancy J.; Yock, Torunn I.

    2012-03-01

    Purpose: Proton radiotherapy (PT) has been prescribed similarly to photon radiotherapy to achieve comparable disease control rates at comparable doses. The chief advantage of protons in this setting is to reduce acute and late toxicities by decreasing the amount of normal tissue irradiated. We report the preliminary clinical outcomes including late effects on our pediatric Ewing's sarcoma patients treated with PT at the Francis H. Burr Proton Therapy Center at Massachusetts General Hospital (Boston, MA). Methods and Materials: This was a retrospective review of the medical records of 30 children with Ewing's sarcoma who were treated with PT between April 2003 and April 2009. Results: A total of 14 male and 16 female patients with tumors in several anatomic sites were treated with PT at a median age of 10 years. The median dose was 54 Gy (relative biological effectiveness) with a median follow-up of 38.4 months. The 3-year actuarial rates of event-free survival, local control, and overall survival were 60%, 86%, and 89%, respectively. PT was acutely well tolerated, with mostly mild-to-moderate skin reactions. At the time of writing, the only serious late effects have been four hematologic malignancies, which are known risks of topoisomerase and anthracyline exposure. Conclusions: Proton radiotherapy was well tolerated, with few adverse events. Longer follow-up is needed to more fully assess tumor control and late effects, but the preliminary results are encouraging.

  3. Textured surface, nonsilicone gel breast implants: four years' clinical outcome.

    PubMed

    Ersek, R A; Salisbury, A V

    1997-12-01

    Since the development of smooth silicone breast implants in 1962, more than 1 million women throughout the world have opted for breast augmentation surgery. Although initially successful, smooth implants are prone to develop surrounding scar capsules that may harden and contract, resulting in discomfort, weakening of the shell with rupture, asymmetry, and patient dissatisfaction. This phenomenon has been shown to occur in as many as 70 percent of implanted patients over time. We have reviewed all of our patients and the Medical Device Reporting System for Bioplasty, Inc. (Minneapolis, Minn.) for the history of this device. At 18 months, more textured implants remain soft than the smooth group. After an additional 30 months of follow-up, for a total of 48 months maximum and 18 months minimum, most textured implants still remain soft. Since 1990 we have used AU24K, bio-oncotic hydrogel filling material in molecular impact surface textured implants (MISTI) that is similar to breast tissue in color, radiodensity, and viscosity. Complications have been late leaks, infection, and capsular contracture. Several asymptomatic implants were removed because of anxiety over the FDA controversy. Our experience so far indicates that such a breast implant is a reasonable alternative to the prior art. The longer-term performance of these implants must await the availability of further clinical outcome data.

  4. Tuberculosis in African Americans: clinical characteristics and outcome.

    PubMed Central

    Funnyé, A. S.; Ganesan, K.; Yoshikawa, T. T.

    1998-01-01

    This study examined the clinical characteristics and outcome of pulmonary tuberculosis in African Americans hospitalized in a teaching hospital in south-central Los Angeles from May 1992 through April 1994. The charts of 41 African Americans with culture-positive Mycobacterium tuberculosis were reviewed. Predisposing factors for pulmonary tuberculosis were identified in nearly half of cases. Cough and fever were the most common symptoms. Seventy-six percent had positive acid-fast bacilli (AFB) smears. Nine patients were human immunodeficiency virus (HIV)-positive, and 6 of 9 HIV-positive patients had positive AFB smears whereas 17 of 19 HIV-negative patients had positive AFB smears. Radiographic changes were not significantly different between HIV-positive and HIV-negative patients. Drug resistance was identified in nine of 31 patients (29%). Eight of 41 patients (19.5%) died, with 2 being drug resistant. Human immunodeficiency virus infection was a major predisposing factor for tuberculosis, and no statistical differences were found in radiographic features or AFB smear positivity between HIV-positive and HIV-negative patients. Drug resistance and mortality were disproportionately high. These results indicate that HIV infection and drug resistance are major problems that predispose for tuberculosis infection and make its treatment difficult. PMID:9510620

  5. Spinal epidural angiolipomas: Clinical characteristics, management and outcomes

    PubMed Central

    Bouali, Sofiene; Maatar, Nidhal; Bouhoula, Asma; Abderrahmen, Khansa; Said, Imed Ben; Boubaker, Adnen; Kallel, Jalel; Jemel, Hafedh

    2016-01-01

    Purpose: The spinal epidural angiolipomas are rare expansive processes made of mature lipomatous and angiomatous elements. They often have a benign character. Their etiology, pathogenesis remains uncertain, and it is a cause of spinal cord compression. The magnetic resonance imaging is the most important neuroradiological examination. Histological examination is the only examination to confirm the diagnosis. Surgery is the treatment of choice. Methods: A retrospective study of all patients operated on for a spinal epidural angiolipoma at the Department of Neurosurgery at the National Institute of Neurology of Tunis between January 2000 and December 2014 (15 years) was performed. The aim of this study is to describe the clinical, radiological, histological characteristics and the treatment of this tumor. Results: A total of nine patients were operated from January 01, 2000 to November 30, 2014. The average age of our patients was 51 years with ages that ranged from 29 to 65 with a male predominance. The period between onset of symptoms and diagnosis ranged from 24 months with an average 12 months. Posterior localization of the tumor was seen in all patients. Surgical resection was performed for all cases. The postoperative course has been satisfactory, with a complete recovery of neurological functions in all patients. Conclusions: The spinal epidural angiolipomas is rare expansive process causing spinal cord compression. Treatment is exclusively surgical resection. The functional outcome of spinal epidural angiolipomas is particularly favorable with a complete neurological recovery is if the patient was quickly operated. PMID:27695535

  6. Spinal epidural angiolipomas: Clinical characteristics, management and outcomes

    PubMed Central

    Bouali, Sofiene; Maatar, Nidhal; Bouhoula, Asma; Abderrahmen, Khansa; Said, Imed Ben; Boubaker, Adnen; Kallel, Jalel; Jemel, Hafedh

    2016-01-01

    Purpose: The spinal epidural angiolipomas are rare expansive processes made of mature lipomatous and angiomatous elements. They often have a benign character. Their etiology, pathogenesis remains uncertain, and it is a cause of spinal cord compression. The magnetic resonance imaging is the most important neuroradiological examination. Histological examination is the only examination to confirm the diagnosis. Surgery is the treatment of choice. Methods: A retrospective study of all patients operated on for a spinal epidural angiolipoma at the Department of Neurosurgery at the National Institute of Neurology of Tunis between January 2000 and December 2014 (15 years) was performed. The aim of this study is to describe the clinical, radiological, histological characteristics and the treatment of this tumor. Results: A total of nine patients were operated from January 01, 2000 to November 30, 2014. The average age of our patients was 51 years with ages that ranged from 29 to 65 with a male predominance. The period between onset of symptoms and diagnosis ranged from 24 months with an average 12 months. Posterior localization of the tumor was seen in all patients. Surgical resection was performed for all cases. The postoperative course has been satisfactory, with a complete recovery of neurological functions in all patients. Conclusions: The spinal epidural angiolipomas is rare expansive process causing spinal cord compression. Treatment is exclusively surgical resection. The functional outcome of spinal epidural angiolipomas is particularly favorable with a complete neurological recovery is if the patient was quickly operated.

  7. Clinical outcomes and mortality in elderly peritoneal dialysis patients

    PubMed Central

    Sakacı, Tamer; Ahbap, Elbis; Koc, Yener; Basturk, Taner; Ucar, Zuhal Atan; Sınangıl, Ayse; Sevınc, Mustafa; Kara, Ekrem; Akgol, Cuneyt; Kayalar, Arzu Ozdemır; Caglayan, Feyza Bayraktar; Sahutoglu, Tuncay; Ünsal, Abdulkadir

    2015-01-01

    OBJECTIVES: To evaluate the clinical outcomes and identify the predictors of mortality in elderly patients undergoing peritoneal dialysis. METHODS: We conducted a retrospective study including all incident peritoneal dialysis cases in patients ≥65 years of age treated from 2001 to 2014. Demographic and clinical data on the initiation of peritoneal dialysis and the clinical events during the study period were collected. Infectious complications were recorded. Overall and technique survival rates were analyzed. RESULTS: Fifty-eight patients who began peritoneal dialysis during the study period were considered for analysis, and 50 of these patients were included in the final analysis. Peritoneal dialysis exchanges were performed by another person for 65% of the patients, whereas 79.9% of patients preferred to perform the peritoneal dialysis themselves. Peritonitis and catheter exit site/tunnel infection incidences were 20.4±16.3 and 24.6±17.4 patient-months, respectively. During the follow-up period, 40 patients were withdrawn from peritoneal dialysis. Causes of death included peritonitis and/or sepsis (50%) and cardiovascular events (30%). The mean patient survival time was 38.9±4.3 months, and the survival rates were 78.8%, 66.8%, 50.9% and 19.5% at 1, 2, 3 and 4 years after peritoneal dialysis initiation, respectively. Advanced age, the presence of additional diseases, increased episodes of peritonitis, the use of continuous ambulatory peritoneal dialysis, and low albumin levels and daily urine volumes (<100 ml) at the initiation of peritoneal dialysis were predictors of mortality. The mean technique survival duration was 61.7±5.2 months. The technique survival rates were 97.9%, 90.6%, 81.5% and 71% at 1, 2, 3 and 4 years, respectively. None of the factors analyzed were predictors of technique survival. CONCLUSIONS: Mortality was higher in elderly patients. Factors affecting mortality in elderly patients included advanced age, the presence of comorbid

  8. 78 FR 11209 - Submission of OMB Review; Comment Request (30-Day FRN):

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-02-15

    ... clinical trials program. The information collected is used to identify qualified investigators and to... information collection was previously published in the Federal Register on September 20, 2012 (77 FR...

  9. 78 FR 44136 - Submission for OMB review; 30-day Comment Request: National Cancer Institute (NCI) Cancer...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-23

    ... collection plans and instruments or request more information on the proposed project contact: Dorothy Farrell... additional plans and instruments must be requested in writing. Proposed Collection: National Cancer Institute... towards clinical translation and technology commercialization, and education and outreach efforts....

  10. Intra-arterial nimodipine for cerebral vasospasm after subarachnoid haemorrhage: Influence on clinical course and predictors of clinical outcome.

    PubMed

    Bashir, Asma; Andresen, Morten; Bartek, Jiri; Cortsen, Marie; Eskesen, Vagn; Wagner, Aase

    2016-02-01

    Intra-arterial nimodipine (IAN) has shown a promising effect on cerebral vasospasm (CV) after aneurysmal subarachnoid haemorrhage. At our institution, Rigshospitalet, IAN treatment has been used since 2009, but the short- and long-term clinical efficacy of IAN has not yet been assessed. The purpose was to evaluate the efficacy and clinical outcome of IAN treatment of symptomatic CV, and to assess the predictors of clinical outcome. Medical records of 25 patients undergoing a total of 41 IAN treatment sessions were retrospectively reviewed. Data on angiographic results, blood-flow velocities and the clinical condition before and after the IAN treatment were recorded. Predictors of the clinical outcome were assessed with a linear regression model. Positive angiographic response was achieved in 95.1% of 41 IAN treatment sessions. Flow-velocity measurements showed no relationship with angiographic responses of IAN. The immediate clinical improvement was observed in three patients (12%). Five patients (20%) had a favourable outcome at discharge and at three-month follow-up; 10 patients (40%) had a moderate to poor outcome; and the rest (40%) died. Increased number of affected vessels and number of procedures carried out per patient, and a trend toward an increased delay time from symptomatic CV to confirming angiographic CV and thus instituting IAN treatment predicted the poor clinical outcome. IAN treatment appears to be effective in reversing angiographic CV. However, it is not always effective in reversing clinical deterioration, as several other factors including treatment delay affect the clinical course.

  11. Endodontic retreatment. Aspects of decision making and clinical outcome.

    PubMed

    Kvist, T

    2001-01-01

    Epidemiological surveys have reported that 25%-35% of root filled teeth are associated with periapical radiolucencies. Descriptive studies have demonstrated that clinicians' decision making regarding such teeth are subject to substantial variation. A coherent model to explain the observed variation has not been produced. In the present thesis a "Praxis Concept theory" was proposed. The theory suggests that dentists perceive periapical lesions of varying sizes as different stages on a continuous health scale. Interindividual variations can then be regarded as the result of the choice of different cut-off points on the continuum for prescribing retreatment. In the present study experiments among novice and expert decision makers gave evidence in favour of the theory. Data also suggested that the choice of retreatment criterion is affected by values, costs of retreatment and technical quality of original treatment. From a prescriptive point of view, the presence of a persistent periapical radiolucency has often been used as a criterion of endodontic "failure" and as an indication for endodontic retreatment. As an alternative decision strategy, the use of decision analysis has been proposed. Logical display of decision alternatives, values of probabilities, utility values (U-values) of the different outcomes and calculation of optimal decision strategy are features of this theory. The implementation of this approach is impeded by the uncertainty of outcome probabilities and lack of investigations concerning U-values. U-values of two periapical health states in root filled teeth (with and without a periapical lesion respectively) were investigated in a group of 82 dental students and among 16 Swedish endodontists. Two methods were used to elicit U-values: Standard gamble and Visual Analogue Scale. Large interindividual variation for both health states were recorded. The difference in U-values between the two health states was found to be statistically significant

  12. Clinical Outcomes of Medial Meniscus Posterior Root Tears

    PubMed Central

    Krych, Aaron John; Reardon, Patrick J.; Pareek, Ayoosh; Peter, Logan; Dahm, Diane L.; Levy, Bruce A.; Stuart, Michael J.

    2016-01-01

    diagnosis. After initial diagnosis, 59 (58%) underwent subsequent surgical treatment. This included 52 (51%) patients undergoing arthroscopic partial meniscectomy, and 29 (28%) patients undergoing total knee arthroplasty at a mean 38±32 (range 3-107) months after MRI. Kellgren-Lawrence grades worsened from 1.3±0.7 before diagnosis to 2.2±1.0 after (p<0.001), with a mean 44±32 months between radiographs. There was a higher rate of radiographic arthritis (K-L grade 2+) after diagnosis (73%) than before diagnosis (36%) (p<0.001). The presence of meniscal extrusion on MRI was associated with the presence of arthritis on post-diagnosis radiographs (p=0.03). Meniscal extrusion, subchondral edema, and insufficiency fractures were not associated with increased rates of surgical treatment, or time to arthroplasty. Conclusion: Little information is available to guide patients and physicians on the clinical outcomes for MMPRTs. These injuries are associated with a relatively high rate of arthroplasty and worsening arthritis, especially with concomitant meniscal extrusion. More information is needed to determine the efficacy of meniscal root repair in preventing these unfavorable outcomes.

  13. 78 FR 20329 - Submission for OMB review; 30-day Comment Request: A Generic Submission for Formative Research...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-04-04

    ... October 1, 1995, unless it displays a currently valid OMB control number. Direct Comments to OMB: Written... having their full effect if received within 30-days of the date of this publication. FOR FURTHER... be requested in writing. Proposed Collection: A Generic Submission For Formative Research,...

  14. 75 FR 39577 - 30-Day Notice of Intention To Request Clearance of Collection of Information; Opportunity for...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-07-09

    ... comments on these information collection requirements on January 29, 2010 (75 FR 4838). The comment period... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR National Park Service 30-Day Notice of Intention To Request Clearance of Collection of...

  15. 75 FR 8101 - 30-Day Federal Register Notice of Intention To Request Clearance of Collection of Information...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-02-23

    ... Register on Wednesday, November 4, 2009 (74 FR 57188). The comment period closed on January 4, 2010. No... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF THE INTERIOR National Park Service 30-Day Federal Register Notice of Intention To Request Clearance of Collection...

  16. 78 FR 64145 - 30-Day Notice of Proposed Information Collection: HUD-Owned Real Estate-Sales Contract and Addendums

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: HUD-Owned Real Estate--Sales..., Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-5806... Collection: HUD-Owned Real Estate--Sales Contract and Addendums. OMB Approval Number: 2502-0306. Type...

  17. 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... solicit comments on this proposed information collection on April 5, 2010 (75 FR 17152-17153). No...

  18. 78 FR 55264 - Submission for OMB Review; 30-Day Comment Request: Awareness and Beliefs About Cancer Survey...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-Day Comment Request: Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI) SUMMARY: Under the provisions of... submitted to the Office of Management and Budget (OMB) a request to review and approve the...

  19. 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...

  20. 78 FR 69077 - Notice of 30-Day Public Review Period and Availability of Final Environmental Assessment and...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... of No Significant Impact (FONSI) for the Department of Navy's (DoN) transfer of excess property at... VA's implementation and monitoring of the mitigation measures identified in the FONSI, would not have... infrastructure at the former NAS Alameda. The FONSI is available for public review for 30 days before...

  1. 78 FR 55325 - 30-Day Notice of Proposed Information Collection: U.S. Passport Renewal Application for Eligible...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-10

    ... and/or card format) in the exercise of authorities granted to the Secretary of State in 22 United... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 30-Day.... SUMMARY: The Department of State has submitted the information collection described below to......

  2. 78 FR 40313 - 30-Day Notice of Proposed Information Collection: Monthly Report of Excess Income and Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-03

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: Monthly Report of Excess Income and Annual Report of Uses of Excess Income AGENCY: Office of the Chief Information Officer, HUD. ACTION... Information Collection: Monthly Report of Excess Income and Annual Report of Uses of Excess Income....

  3. 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

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

  4. 78 FR 15958 - Submission for OMB Review; 30-day Comment Request: Pediatric Palliative Care Campaign Pilot Survey

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... HUMAN SERVICES National Institutes of Health Submission for OMB Review; 30-day Comment Request: Pediatric Palliative Care Campaign Pilot Survey SUMMARY: Under the provisions of Section 3507(a)(1)(D) of... previously published in the Federal Register on December 26, 2012, page 76053 and allowed 60-days for...

  5. 78 FR 64143 - 30-Day Notice of Proposed Information Collection: FHA-Application for Insurance of Advance of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-25

    ...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...

  6. 78 FR 55083 - Submission for OMB Review; 30-day Comment Request; Genomics and Society Public Surveys in...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... and Society Public Surveys in Conjunction With Smithsonian Museum of Natural History Genome Exhibit... an additional 30 days for public comment. The National Human Genome Research Institute (NHGRI...: Genomics and Society Public Surveys in Conjunction with National Museum of Natural History Genome...

  7. 77 FR 71668 - 30-Day Notice of Proposed Information Collection: Choice of Address and Agent for Immigrant Visa...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-03

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 30-Day Notice of Proposed Information Collection: Choice of Address and Agent for Immigrant Visa Applicants...: Title of Information Collection: Choice of Address and Agent for Immigrant Visa Applicants. OMB...

  8. 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...

  9. 78 FR 42795 - Submission for OMB review; 30-Day Comment Request: Evaluation of the Brain Disorders in the...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-17

    ...: Evaluation of the Brain Disorders in the Developing World Program of the John E. Fogarty International Center... additional 30 days for public comment. The John E. Fogarty International Center (FIC), National Institutes of.... Rachel Sturke, Evaluation Officer, Division of Policy, Planning and Evaluation, FIC, NIH, Building...

  10. 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

    ... following information collection request to the Office of Management and Budget (OMB) for approval in... Currently Approved Collection. Originating Office: Bureau of Conflict and Stabilization Operations (CSO... benefits. DATES: Submit comments to the Office of Management and Budget (OMB) for up to 30 days from...

  11. 77 FR 20687 - 30-Day Notice of Proposed Information Collection: Form DS-3097, Exchange Visitor Program Annual...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-04-05

    ... Visitor Information System (SEVIS) and then printed and signed by a sponsor official, and sent to the... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF STATE 30-Day Notice of Proposed Information Collection: Form DS-3097, Exchange Visitor Program Annual Report,...

  12. 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...

  13. 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...

  14. 78 FR 67385 - 30-Day Notice of Proposed Information Collection: FHA PowerSaver Pilot Program (Title I Property...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-12

    ... URBAN DEVELOPMENT 30-Day Notice of Proposed Information Collection: FHA PowerSaver Pilot Program (Title I Property Improvement and Title II--203(k) Rehabilitation Mortgage Insurance) AGENCY: Office of the... Collection Title of Information Collection: FHA PowerSaver Pilot Program (Title I Property Improvement...

  15. 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...

  16. Long-term suprapubic catheterisation: clinical outcome and satisfaction survey.

    PubMed

    Sheriff, M K; Foley, S; McFarlane, J; Nauth-Misir, R; Craggs, M; Shah, P J

    1998-03-01

    We report on the clinical outcome and satisfaction survey of long-term suprapubic catheterisation in patients with neuropathic bladder dysfunction. Between early 1988 and later 1995, 185 suprapubic catheters were inserted under direct cystoscopic vision. Anti-cholinergic therapy was given to all patients with significant detrusor hyper-reflexia; the catheters clamped daily for two hours and changed every six weeks. Ultrasonography and assessment of the serum creatinine were used to assess the upper renal tracts, and the results of the pre- and post-catheter video-cystometrography was used to evaluate bladder morphology, cystometric capacity, maximum detrusor pressure and the presence of vesico-ureteric reflux. There were equivalent numbers of males and females. The follow-up ranges from 3-68 months. Following catheterisation, there was a 50% reduction in the average maximum detrusor pressure, bladder morphology improved in 85% of the cases; the bladder capacity and upper renal tracts remained unchanged. Vesico-ureteric reflux was abolished in 33% of the cases. Complaints were common consisting of recurrent catheter blockage, persistent urinary leakage and recurrent urinary tract infections. There was a 2.7% incidence of small bowel injury with one fatality. However, the general level of satisfaction was high. It is concluded that suprapubic catheterisation is an effective and well tolerated method of management in selected patients with neuropathic bladder dysfunction for whom only major surgery would otherwise provide a solution to incontinence. We are encouraged to find preservation of renal function with maintained bladder volumes and reduced maximum detrusor pressures thus justifying the policy of catheter clamping and anti-cholinergic therapy in the presence of significant detrusor hyper-reflexia. However, even in expert hands this procedure is not without hazards.

  17. Surgical Treatment and Clinical Outcome of Nonfunctional Pancreatic Neuroendocrine Tumors

    PubMed Central

    Yang, Min; Zeng, Lin; Zhang, Yi; Su, An-ping; Yue, Peng-ju; Tian, Bo-le

    2014-01-01

    Abstract Our primary aim of the present study was to analyze the clinical characteristics and surgical outcome of nonfunctional pancreatic neuroendocrine tumors (non-F-P-NETs), with an emphasis on evaluating the prognostic value of the newly updated 2010 grading classification of the World Health Organization (WHO). Data of 55 consecutive patients who were surgically treated and pathologically diagnosed as non-F-P-NETs in our single institution from January 2000 to December 2013 were retrospectively collected. This entirety comprised of 55 patients (31 males and 24 females), with a mean age of 51.24 ± 12.95 years. Manifestations of non-F-P-NETs were nonspecific. Distal pancreatectomy, pancreaticoduodenectomy, and local resection of pancreatic tumor were the most frequent surgical procedures, while pancreatic fistula was the most common but acceptable complication (30.3%). The overall 5-year survival rate of this entire cohort was 41.0%, with a median survival time of 60.4 months. Patients who underwent R0 resections obtained a better survival than those who did not (P < 0.005). As for the prognostic analysis, tumor size and lymph invasion were only statistically significant in univariate analysis (P = 0.046 and P < 0.05, respectively), whereas the newly updated 2010 grading classification of WHO (G1 and G2 vs G3), distant metastasis, and surgical margin were all meaningful in both univariate and multivariate analysis (P = 0.045, 0.001, and 0.042, respectively). Non-F-P-NETs are a kind of rare neoplasm, with mostly indolent malignancy. Patients with non-F-P-NETs could benefit from the radical resections. The new WHO criteria, distant metastasis and surgical margin, might be independent predictors for the prognosis of non-F-P-NETs. PMID:25396335

  18. Proton Radiotherapy for Parameningeal Rhabdomyosarcoma: Clinical Outcomes and Late Effects

    SciTech Connect

    Childs, Stephanie K.; Kozak, Kevin R.; Friedmann, Alison M.; Yeap, Beow Y.; Adams, Judith; MacDonald, Shannon M.; Liebsch, Norbert J.; Tarbell, Nancy J.; Yock, Torunn I.

    2012-02-01

    Purpose: To report the clinical outcome and late side effect profile of proton radiotherapy in the treatment of children with parameningeal rhabdomyosarcoma (PM-RMS). Methods and Materials: Seventeen consecutive children with PM-RMS were treated with proton radiotherapy at Massachusetts General Hospital between 1996 and 2005. We reviewed the medical records of all patients and asked referring physicians to report specific side effects of interest. Results: Median patient age at diagnosis was 3.4 years (range, 0.4-17.6). Embryonal (n = 11), alveolar (n = 4), and undifferentiated (n = 2) histologies were represented. Ten patients (59%) had intracranial extension. Median prescribed dose was 50.4 cobalt gray equivalents (GyRBE) (range, 50.4-56.0 GyRBE) delivered in 1.8-2.0-GyRBE daily fractions. Median follow-up was 5.0 years for survivors. The 5-year failure-free survival estimate was 59% (95% confidence interval, 33-79%), and overall survival estimate was 64% (95% confidence interval, 37-82%). Among the 7 patients who failed, sites of first recurrence were local only (n = 2), regional only (n = 2), distant only (n = 2), and local and distant (n = 1). Late effects related to proton radiotherapy in the 10 recurrence-free patients (median follow-up, 5 years) include failure to maintain height velocity (n = 3), endocrinopathies (n = 2), mild facial hypoplasia (n = 7), failure of permanent tooth eruption (n = 3), dental caries (n = 5), and chronic nasal/sinus congestion (n = 2). Conclusions: Proton radiotherapy for patients with PM-RMS yields tumor control and survival comparable to that in historical controls with similar poor prognostic factors. Furthermore, rates of late effects from proton radiotherapy compare favorably to published reports of photon-treated cohorts.

  19. Clinical outcomes following salvage Gamma Knife radiosurgery for recurrent glioblastoma

    PubMed Central

    Larson, Erik W; Peterson, Halloran E; Lamoreaux, Wayne T; MacKay, Alexander R; Fairbanks, Robert K; Call, Jason A; Carlson, Jonathan D; Ling, Benjamin C; Demakas, John J; Cooke, Barton S; Lee, Christopher M

    2014-01-01

    Glioblastoma multiforme (GBM) is the most common malignant primary brain tumor with a survival prognosis of 14-16 mo for the highest functioning patients. Despite aggressive, multimodal upfront therapies, the majority of GBMs will recur in approximately six months. Salvage therapy options for recurrent GBM (rGBM) are an area of intense research. This study compares recent survival and quality of life outcomes following Gamma Knife radiosurgery (GKRS) salvage therapy. Following a PubMed search for studies using GKRS as salvage therapy for malignant gliomas, nine articles from 2005 to July 2013 were identified which evaluated rGBM treatment. In this review, we compare Overall survival following diagnosis, Overall survival following salvage treatment, Progression-free survival, Time to recurrence, Local tumor control, and adverse radiation effects. This report discusses results for rGBM patient populations alone, not for mixed populations with other tumor histology grades. All nine studies reported median overall survival rates (from diagnosis, range: 16.7-33.2 mo; from salvage, range: 9-17.9 mo). Three studies identified median progression-free survival (range: 4.6-14.9 mo). Two showed median time to recurrence of GBM. Two discussed local tumor control. Six studies reported adverse radiation effects (range: 0%-46% of patients). The greatest survival advantages were seen in patients who received GKRS salvage along with other treatments, like resection or bevacizumab, suggesting that appropriately tailored multimodal therapy should be considered with each rGBM patient. However, there needs to be a randomized clinical trial to test GKRS for rGBM before the possibility of selection bias can be dismissed. PMID:24829861

  20. Clinical Characteristics and Outcomes Among Individuals With Spinal Implant Infections: A Descriptive Study

    PubMed Central

    Baxi, Sanjiv M.; Robinson, Makeda L.; Grill, Marie F.; Schwartz, Brian S.; Doernberg, Sarah B.; Liu, Catherine

    2016-01-01

    Little is known about the clinical presentation and outcomes associated with spinal implant infections. Here, we describe a single center's experience in a retrospective cohort of 109 individuals with spinal implant infections, including clinical, microbiological, therapeutic, and outcome data. PMID:27704027

  1. Feasibility and Clinical Outcomes of Peripheral Drug-Coated Balloon in High-Risk Patients with Femoropopliteal Disease

    PubMed Central

    Huang, Hsuan-Li; Juang, Jyh-Ming Jimmy; Chou, Hsin-Hua; Tsao, Chueh-Yung; Wu, Tien-Yu; Ko, Yu-Lin

    2015-01-01

    Background Clinical outcomes of the drug-coated balloon (DCB) procedure in high-risk patients with femoropopliteal (FP) disease have not been investigated sufficiently. Methods This retrospective, single-center study analyzed 87 patients (39% dialysis) and 97 affected legs (64% critical limb ischemia [CLI]) that underwent DCB for symptomatic FP disease from March 2013 to September 2014. Risk stratification was based on FeDCLIP (female, diabetes, dialysis, CLI, lesion length >150 mm and poor runoff) score. The DCB outcomes among the different risk groups were compared and factors predicting restenosis were analyzed during follow-up. Results Most of study participants (84%) were moderate to high-risk patients. The procedural success rate was 100% and the 30-day major adverse vascular event rate was 2.1%. The mean lesion length was 178 ± 106 mm and the mean follow-up time was 428 ± 145 (range 50–782) days. The binary restenosis-free and clinically driven target lesion revascularization (CD-TLR)-free rates at 12 months were 77.5% and 84.3%, respectively, for all participants. No significant differences were observed in 1-year binary restenosis and CD-TLR rates in the low-, moderate-, and high-risk groups (60%, 84%, and 73%: p = 0.396; 78%, 89%, and 80%: p = 0.635, respectively). In multivariate analysis, lesion length >150 mm (Hazard ratio [HR]: 8.00, 95% confidence interval (CI) 1.12 to 55.6, p = 0.038) and Rutherford class 6 (HR: 7.09, 95% CI, 1.15 to 43.5, p = 0.034) were identified as independent predictors of binary restenosis. Conclusions Despite general comorbidities and advanced limb ischemia, 1-year outcomes of DCB in high-risk patients with FP disease were effective. The DCB procedure holds promise to improve vessel patency; however, lesion length >150 mm and major tissue loss were independent predictors for binary restenosis after the treatment. PMID:26599128

  2. Transforming the Academic Faculty Perspective in Graduate Medical Education to Better Align Educational and Clinical Outcomes.

    PubMed

    Wong, Brian M; Holmboe, Eric S

    2016-04-01

    The current health care delivery model continues to fall short in achieving the desired patient safety and quality-of-care outcomes for patients. And, until recently, an explicit acknowledgment of the role and influence of the clinical learning environment on professional development had been missing from physician-based competency frameworks. In this Perspective, the authors explore the implications of the insufficient integration of education about patient safety and quality improvement by academic faculty into the clinical learning environment in many graduate medical education (GME) programs, and the important role that academic faculty need to play to better align the educational and clinical contexts to improve both learner and patient outcomes. The authors propose a framework that closely aligns the educational and clinical contexts, such that both educational and clinical outcomes are centered around the patient. This will require a reorganization of academic faculty perspective and educational design of GME training programs that recognizes that (1) the dynamic interplay between the faculty, learner, training program, and clinical microsystem ultimately influences the quality of physician that emerges from the training program and environment, and (2) patient outcomes relate to the quality of education and the success of clinical microsystems. To enable this evolution, there is a need to revisit the core competencies expected of academic faculty, implement innovative faculty development strategies, examine closely faculty's current clinical super vision practices, and establish a training environment that supports bridging from clinician to educator, training program to clinical microsystem, and educational outcomes to clinical outcomes that benefit patients.

  3. Clinical Research of Traditional Chinese Medicine Needs to Develop Its Own System of Core Outcome Sets

    PubMed Central

    Zhang, Li; Zhang, Junhua; Chen, Jing; Xing, Dongmei; Wang, Jiaying

    2013-01-01

    Currently, quality issues concerning clinical research of traditional Chinese medicine (TCM) have come into the spotlight. It has been recognized that poorly-devised research methodology largely restricted the development of clinical research in TCM. The choice of appropriate outcome measurements is key to the success of clinical research; however, the current procedure for outcomes selection in clinical research of TCM is problematic due to the underdevelopment of clinical methodology. Under this circumstance, we propose the introduction to the concept of Core Outcome Set (COS) and discuss the feasibility of developing a COS system that caters for clinical studies in TCM, in the hope that the outcome evaluation system could be up to international standards. PMID:24312133

  4. Individual risk alleles of susceptibility to schizophrenia are associated with poor clinical and social outcomes.

    PubMed

    Sakamoto, Shinji; Takaki, Manabu; Okahisa, Yuko; Mizuki, Yutaka; Inagaki, Masatoshi; Ujike, Hiroshi; Mitsuhashi, Toshiharu; Takao, Soshi; Ikeda, Masashi; Uchitomi, Yosuke; Iwata, Nakao; Yamada, Norihito

    2016-04-01

    Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study. PMID:26674612

  5. Neurobrucellosis: clinical, diagnostic, therapeutic features and outcome. Unusual clinical presentations in an endemic region.

    PubMed

    Ceran, Nurgul; Turkoglu, Recai; Erdem, Ilknur; Inan, Asuman; Engin, Derya; Tireli, Hulya; Goktas, Pasa

    2011-01-01

    Brucellosis is a zoonotic infection and has endemic characteristics. Neurobrucellosis is an uncommon complication of this infection. The aim of this study was to present unusual clinical manifestations and to discuss the management and outcome of a series of 18 neurobrucellosis cases. Initial clinical manifestations consist of pseudotumor cerebri in one case, white matter lesions and demyelinating syndrome in three cases, intracranial granuloma in one case, transverse myelitis in two cases, sagittal sinus thrombosis in one case, spinal arachnoiditis in one case, intracranial vasculitis in one case, in addition to meningitis in all cases. Eleven patients were male and seven were female. The most prevalent symptoms were headache (83%) and fever (44%). All patients were treated with rifampicin, doxycycline plus trimethoprim-sulfamethoxazole or ceftriaxone. Duration of treatment (varied 3-12 months) was determined on basis of the CSF response. In four patients presented with left mild sequelae including aphasia, hearing loss, hemiparesis. In conclusion, although mortality is rare in neurobrucellosis, its sequelae are significant. In neurobrucellosis various clinical and neuroradiologic signs and symptoms can be confused with other neurologic diseases. In inhabitants or visitors of endemic areas, neurobrucellosis should be kept in mind in cases that have unusual neurological manifestations.

  6. Defining Our Clinical Practice: The Identification of Genetic Counseling Outcomes Utilizing the Reciprocal Engagement Model.

    PubMed

    Redlinger-Grosse, Krista; Veach, Patricia McCarthy; Cohen, Stephanie; LeRoy, Bonnie S; MacFarlane, Ian M; Zierhut, Heather

    2016-04-01

    The need for evidence-based medicine, including comparative effectiveness studies and patient-centered outcomes research, has become a major healthcare focus. To date, a comprehensive list of genetic counseling outcomes, as espoused by genetic counselors, has not been established and thus, identification of outcomes unique to genetic counseling services has become a priority for the National Society of Genetic Counselors (NSGC). The purpose of this study was to take a critical first step at identifying a more comprehensive list of genetic counseling outcomes. This paper describes the results of a focus group study using the Reciprocal-Engagement Model (REM) as a framework to characterize patient-centered outcomes of genetic counseling clinical practice. Five focus groups were conducted with 27 peer nominated participants who were clinical genetic counselors, genetic counseling program directors, and/or outcomes researchers in genetic counseling. Members of each focus group were asked to identify genetic counseling outcomes for four to five of the 17 goals of the REM. A theory-driven, thematic analysis of focus group data yielded 194 genetic counseling outcomes across the 17 goals. Participants noted some concerns about how genetic counseling outcomes will be measured and evaluated given varying stakeholders and the long-term nature of genetic concerns. The present results provide a list of outcomes for use in future genetic counseling outcomes research and for empirically-supported clinical interventions.

  7. 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

  8. 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.

  9. 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. PMID:26890891

  10. 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.

  11. How can we improve clinical research in clinical practice with better research outcome?

    PubMed

    Woo, Keng Thye; Wong, Kok Seng; Lee, Evan J C; Chan, Choong Meng

    2011-11-01

    This paper explains some of the difficulties doctors face when taking up a career in research. It describes the efforts by the government and the Ministry of Health (MOH) to nurture the Clinician Scientist Programme. The nature of research and the mindset of clinicians who are passionate about research are explored and the reasons which drive some of them to pursue a research career. It discusses the need to have structured training for research and how continuing research education is necessary for the researcher. The paper discusses the goals for research and how we can achieve better research outcomes and the importance of good mentorship. It suggests ways to engage more doctors in research in the restructured hospitals by overcoming some of the problems they encounter. Finally, it relates the Biomedical Science initiative of the government through the National Research Foundation and the various programmes in Translational Clinical Research available for clinicians who are keen on a research career.

  12. The Readmission Risk Flag: Using the Electronic Health Record to Automatically Identify Patients at Risk for 30-day Readmission

    PubMed Central

    Baillie, Charles A.; VanZandbergen, Christine; Tait, Gordon; Hanish, Asaf; Leas, Brian; French, Benjamin; Hanson, C. William; Behta, Maryam; Umscheid, Craig A.

    2015-01-01

    Background Identification of patients at high risk for readmission is a crucial step toward improving care and reducing readmissions. The adoption of electronic health records (EHR) may prove important to strategies designed to risk stratify patients and introduce targeted interventions. Objective To develop and implement an automated prediction model integrated into our health system’s EHR that identifies on admission patients at high risk for readmission within 30 days of discharge. Design Retrospective and prospective cohort. Setting Healthcare system consisting of three hospitals. Patients All adult patients admitted from August 2009 to September 2012. Interventions An automated readmission risk flag integrated into the EHR. Measures Thirty-day all-cause and 7-day unplanned healthcare system readmissions. Results Using retrospective data, a single risk factor, ≥2 inpatient admissions in the past 12 months, was found to have the best balance of sensitivity (40%), positive predictive value (31%), and proportion of patients flagged (18%), with a c-statistic of 0.62. Sensitivity (39%), positive predictive value (30%), proportion of patients flagged (18%) and c-statistic (0.61) during the 12-month period after implementation of the risk flag were similar. There was no evidence for an effect of the intervention on 30-day all-cause and 7-day unplanned readmission rates in the 12-month period after implementation. Conclusions An automated prediction model was effectively integrated into an existing EHR and identified patients on admission who were at risk for readmission within 30 days of discharge. PMID:24227707

  13. Yoga & cancer interventions: a review of the clinical significance of patient reported outcomes for cancer survivors.

    PubMed

    Culos-Reed, S Nicole; Mackenzie, Michael J; Sohl, Stephanie J; Jesse, Michelle T; Zahavich, Ashley N Ross; Danhauer, Suzanne C

    2012-01-01

    Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004-2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies. PMID:23125870

  14. Yoga & Cancer Interventions: A Review of the Clinical Significance of Patient Reported Outcomes for Cancer Survivors

    PubMed Central

    Culos-Reed, S. Nicole; Mackenzie, Michael J.; Sohl, Stephanie J.; Jesse, Michelle T.; Zahavich, Ashley N. Ross; Danhauer, Suzanne C.

    2012-01-01

    Limited research suggests yoga may be a viable gentle physical activity option with a variety of health-related quality of life, psychosocial and symptom management benefits. The purpose of this review was to determine the clinical significance of patient-reported outcomes from yoga interventions conducted with cancer survivors. A total of 25 published yoga intervention studies for cancer survivors from 2004–2011 had patient-reported outcomes, including quality of life, psychosocial or symptom measures. Thirteen of these studies met the necessary criteria to assess clinical significance. Clinical significance for each of the outcomes of interest was examined based on 1 standard error of the measurement, 0.5 standard deviation, and relative comparative effect sizes and their respective confidence intervals. This review describes in detail these patient-reported outcomes, how they were obtained, their relative clinical significance and implications for both clinical and research settings. Overall, clinically significant changes in patient-reported outcomes suggest that yoga interventions hold promise for improving cancer survivors' well-being. This research overview provides new directions for examining how clinical significance can provide a unique context for describing changes in patient-reported outcomes from yoga interventions. Researchers are encouraged to employ indices of clinical significance in the interpretation and discussion of results from yoga studies. PMID:23125870

  15. Neuropsychological changes after 30-day Ginkgo biloba administration in healthy participants.

    PubMed

    Stough, C; Clarke, J; Lloyd, J; Nathan, P J

    2001-06-01

    Ginkgo biloba extract (EGb) from the world's oldest living tree has been reputed to ameliorate cognitive decline in the elderly and slow cognitive deterioration in patients with dementia of the Alzheimer's type. EGb remains as one of the most popular plant extracts to alleviate symptoms associated with a range of cognitive disorders such as Alzheimer's disease, vascular dementia and age-related amnesic conditions. EGb is known to contain a range of chemically active components that have antagonistic effects on platelet-activating factor, free-radical scavenging activity and direct effects on the cholinergic neurotransmitter system. Recently there has been much speculation, that EGb may act as a 'smart drug' or nootropic agent in the healthy young to improve intelligence. We conducted a 30-d randomized, double-blind, placebo-controlled clinical trial in which 61 participants were administered a battery of validated neuropsychological tests before and after treatment. Statistical analysis indicated significant improvements in speed of information processing working memory and executive processing attributable to the EGb.

  16. Clinical applicability of nursing outcomes in the evolution of orthopedic patients with Impaired Physical Mobility 1

    PubMed Central

    da Silva, Marcos Barragan; Almeida, Miriam de Abreu; Panato, Bruna Paulsen; Siqueira, Ana Paula de Oliveira; da Silva, Mariana Palma; Reisderfer, Letícia

    2015-01-01

    AIM: to evaluate the clinical applicability of outcomes, according to the Nursing Outcomes Classification (NOC) in the evolution of orthopedic patients with Impaired Physical Mobility METHOD: longitudinal study conducted in 2012 in a university hospital, with 21 patients undergoing Total Hip Arthroplasty, evaluated daily by pairs of trained data collectors. Data were collected using an instrument containing five Nursing Outcomes, 16 clinical indicators and a five point Likert scale, and statistically analyzed. RESULTS: The outcomes Body Positioning: self-initiated, Mobility, Knowledge: prescribed activity, and Fall Prevention Behavior presented significant increases in mean scores when comparing the first and final evaluations (p<0.001) and (p=0.035). CONCLUSION: the use of the NOC outcomes makes it possible to demonstrate the clinical progression of orthopedic patients with Impaired Physical Mobility, as well as its applicability in this context. PMID:25806631

  17. How electrodiagnosis predicts clinical outcome of focal peripheral nerve lesions.

    PubMed

    Robinson, Lawrence R

    2015-09-01

    This article reviews the electrodiagnostic (EDX) prognostic factors for focal traumatic and nontraumatic peripheral nerve injuries. Referring physicians and patients often benefit from general and nerve-specific prognostic information from the EDX consultant. Knowing the probable outcome from a nerve injury allows the referring physician to choose the best treatment options for his/her patients. Nerve injuries are variable in their mechanism, location, and pathophysiology. The general effects of the injuries on nerve and muscle are well known, but more research is needed for nerve-specific information. Several factors currently known to influence prognosis include: nature of the nerve trauma, amount of axon loss, recruitment in muscles supplied by the nerve, the extent of demyelination, and the distance to reinnervate functional muscles. This article reviews these general concepts and also nerve-specific EDX measures that predict outcome after focal neuropathies.

  18. Clinical outcomes of pars plicata anterior vitrectomy: 2-year results

    PubMed Central

    Narang, Priya; Agarwal, Amar

    2015-01-01

    Purpose: To demonstrate the safety and outcome of a surgical approach that uses pars plicata site for anterior vitrectomy during phacoemulsification procedure complicated by posterior capsule rupture and residual cortical matter. Design: Single center, retrospective, interventional, noncomparative study. Materials and Methods: Medical records of a consecutive series of 35 eyes of 35 patients who underwent pars plicata anterior vitrectomy (PPAV) were reviewed. The main outcome measures were corrected and uncorrected distance visual acuity (CDVA, UDVA), early and late postoperative complications and intraocular pressure (IOP). Ultrasound biomicroscopic (UBM) evaluation of sclerotomy site and spectral domain optical coherence tomography analysis for central macular thickness (CMT) was performed. The final visual outcome at 2 years was evaluated. Results: At 2 years follow-up, the mean postoperative UDVA (logarithm of the minimum angle of resolution [logMAR]) and CDVA (logMAR) was 0.49 ± 0.26 and 0.19 ± 0.14, respectively. There was no significant change in the IOP (P = 0.061) and the mean CMT at 2 years was 192.5 ± 5.54 μm. The postoperative UBM image of the sclerotomy site at 8 weeks demonstrated a clear wound without any vitreous adhesion or incarceration. Intraoperative hyphema was seen in 1 (2.8%) case and postoperative uveitis was seen in 2 (5.7%) cases, which resolved with medications. No case of an iatrogenic retinal break or retinal detachment was reported. Conclusions: PPAV enables a closed chamber approach, allows thorough cleanup of vitreous in the pupillary plane and anterior chamber and affords better access to the subincisional and retropupillary cortical remnant with a significant visual outcome and an acceptable complication rate. PMID:26632124

  19. Quality training in laparoscopic colorectal surgery: does it improve clinical outcome?

    PubMed

    Pitiakoudis, M; Michailidis, L; Zezos, P; Kouklakis, G; Simopoulos, C

    2011-10-01

    Laparoscopic colorectal surgery (LCRS) is a safe, effective and cost-efficient option for the treatment of various benign and malignant conditions. However, its implementation to surgical practice is still limited. That is mainly due to its association with a steep learning curve. We performed a review of the literature to determine whether quality training in LCRS can reduce that learning curve and lead to better clinical outcomes. We concluded that a structured training program with pre-clinical phase focused on basic skill acquisition and a clinical phase focused on mentoring from experts can shorten the learning curve and improve clinical outcomes. PMID:21887564

  20. Impact of preoperative serum albumin on 30-day mortality following surgery for colorectal cancer: a population-based cohort study

    PubMed Central

    Montomoli, Jonathan; Erichsen, Rune; Antonsen, Sussie; Nilsson, Tove; Sørensen, Henrik Toft

    2015-01-01

    Objective Surgery is the only potentially curable treatment for colorectal cancer (CRC), but it is hampered by high mortality. Human serum albumin (HSA) below 35 g/L is associated with poor overall prognosis in patients with CRC, but evidence regarding the impact on postoperative mortality is sparse. Methods We performed a population-based cohort study including patients undergoing CRC surgery in North and Central Denmark (1997–2011). We categorised patients according to HSA concentration measured 1–30 days prior to surgery date. We used the Kaplan-Meier method to compute 30-day mortality and Cox regression model to compute HRs as measures of the relative risk of death, controlling for potential confounders. We further stratified patients by preoperative conditions, including cancer stage, comorbidity level, and C reactive protein concentration. Results Of the 9339 patients undergoing first-time CRC surgery with preoperative HSA measurement, 26.4% (n=2464) had HSA below 35 g/L. 30-day mortality increased from 4.9% among patients with HSA 36–40 g/L to 26.9% among patients with HSA equal to or below 25 g/L, compared with 2.0% among patients with HSA above 40 g/L. The corresponding adjusted HRs increased from 1.75 (95% CI 1.25 to 2.45) among patients with HSA 36–40 g/L to 7.59 (95% CI 4.95 to 11.64) among patients with HSA equal to or below 25 g/L, compared with patients with HSA above 40 g/L. The negative impact associated with a decrement of HSA was found in all subgroups. Conclusions A decrement in preoperative HSA concentration was associated with substantial concentration-dependent increased 30-day mortality following CRC surgery. PMID:26462287

  1. 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

  2. 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.

  3. In-patient rehabilitation: clinical outcomes and cost implications

    PubMed Central

    Bunyan, Mel; Ganeshalingam, Yogesh; Morgan, Ehab; Thompson-Boy, Donvé; Wigton, Rebekah; Holloway, Frank; Tracy, Derek K.

    2016-01-01

    Aims and method A retrospective evaluation was undertaken of the clinical and economic effectiveness of three in-patient rehabilitation units across one London National Health Service trust. Information on admission days and costs 2 years before and 2 years after the rehabilitation placement, length of rehabilitation placement and the discharge pathway was collected on 22 service users. Results There were statistically significant reductions in hospital admission days in the 2 years following rehabilitation compared with the 2 years before, further reflected in significantly lower bed costs. Longer length of rehabilitation placement was correlated with fewer admission days after the placement. A substantial proportion of the sample went into more independent living, some with no further admissions at follow-up. Clinical implications The findings suggest that in-patient rehabilitation is both clinically and cost effective: if benefits are sustained they will offset the cost of the rehabilitation placement. PMID:26958355

  4. Quantitative analysis of the impact of total ischemic time on myocardial perfusion and clinical outcome in patients with ST-elevation myocardial infarction.

    PubMed

    Fokkema, Marieke L; Wieringa, Wouter G; van der Horst, Iwan C; Boersma, Eric; Zijlstra, Felix; de Smet, Bart J

    2011-12-01

    Early reperfusion of the infarct-related coronary artery is an important issue in improvement of outcomes after ST-segment elevation myocardial infarction (STEMI). In this study, the clinical significance of total ischemic time on myocardial reperfusion and clinical outcomes was evaluated in patients with STEMI treated with primary percutaneous coronary intervention and thrombus aspiration and additional triple-antiplatelet therapy. Total ischemic time was defined as time from symptom onset to first intracoronary therapy (first balloon inflation or thrombus aspiration). All patients with STEMI treated with primary percutaneous coronary intervention with total ischemic times ≥30 minutes and <24 hours from 2005 to 2008 were selected. Ischemic times were available in 1,383 patients, of whom 18.4% presented with total ischemic times ≤2 hours, 31.2% >2 to 3 hours, 26.8% >3 to 5 hours, and 23.5% >5 hours. Increased ischemic time was associated with age, female gender, hypertension, and diabetes. Patients with total ischemic times <5 hours more often had myocardial blush grade 3 (40% to 45% vs 22%, p <0.001) and complete ST-segment resolution (55% to 60% vs 42%, p = 0.002) than their counterparts with total ischemic times >5 hours. In addition, patients with total ischemic times ≤5 hours had lower 30-day mortality (1.5% vs 4.0%, p = 0.032) than patients with total ischemic times >5 hours. In conclusion, in this contemporary cohort of patients with STEMI treated with primary percutaneous coronary intervention, triple-antiplatelet therapy, and thrombus aspiration, short ischemic time was associated with better myocardial reperfusion and decreased mortality. After a 5-hour period in which outcomes remain relatively stable, myocardial reperfusion becomes suboptimal and mortality increases. PMID:21906710

  5. Evolving systems of care with total clinical outcomes management.

    PubMed

    Lyons, John S; Epstein, Richard A; Jordan, Neil

    2010-02-01

    The current article proposes that further specification of the system of care concept is required. Based on the assertions that the system of care concept (a) refers to an ideal as opposed to an observable phenomenon, and (b) is engaged in offering transformational experiences, the authors propose that the system of care definition must be expanded to include measurement and outcomes monitoring strategies that extend beyond current quality improvement initiatives. The authors propose that communication across multiple levels is essential if the goal of offering transformational experiences to children and families is to be realized.

  6. 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.

  7. Relationship between clozapine dose, serum concentration, and clinical outcome in children and adolescents in clinical practice.

    PubMed

    Wohkittel, Christopher; Gerlach, Manfred; Taurines, Regina; Wewetzer, Christoph; Unterecker, Stefan; Burger, Rainer; Schreck, Diana; Mehler-Wex, Claudia; Romanos, Marcel; Egberts, Karin

    2016-08-01

    Information on dose- and concentration-related clinical effects of clozapine treatment in children and adolescents is scarce. This study aimed to examine the relationship between dose, serum concentration, and clinical outcome as well as the influencing factors thereof in paediatric patients treated with clozapine. Data from a routine Therapeutic Drug Monitoring (TDM) service between 2004 and 2014 were studied in 68 patients, aged 11-18 years. Severity of illness, therapeutic effectiveness and adverse drug reactions (ADRs) were assessed by standardized means. A relationship between the daily dose (mean 319 mg, 4.9 mg/kg) and serum concentration (mean 387 ng/ml) of clozapine was found with the variation in dose explaining 30 % of the variability in clozapine serum concentrations. Also gender contributed to the variability, however, no influence of age or concomitant medications was detected. Furthermore, a significant association was found between clozapine serum concentration and the occurrence of ADRs. Patients without ADRs had a lower mean serum concentration than those with mild (261.4 vs 407.3 ng/ml, P = 0.018) and moderate ADRs (261.4 vs 416.3 ng/ml, P = 0.028). As clozapine was estimated to be effective in lower blood concentrations, guidance on a possibly lower therapeutic range of clozapine serum levels in paediatric patients is provided. With ADRs increasing under higher concentrations, TDM is strongly recommended in paediatric clozapine therapy for individualized dosing. Dose adjustment in females also might be reasonable according to gender-related differences in serum concentrations. However, regarding the limitations of this study results should be validated in larger studies with more standardized designs. PMID:27221285

  8. Transforming the Academic Faculty Perspective in Graduate Medical Education to Better Align Educational and Clinical Outcomes.

    PubMed

    Wong, Brian M; Holmboe, Eric S

    2016-04-01

    The current health care delivery model continues to fall short in achieving the desired patient safety and quality-of-care outcomes for patients. And, until recently, an explicit acknowledgment of the role and influence of the clinical learning environment on professional development had been missing from physician-based competency frameworks. In this Perspective, the authors explore the implications of the insufficient integration of education about patient safety and quality improvement by academic faculty into the clinical learning environment in many graduate medical education (GME) programs, and the important role that academic faculty need to play to better align the educational and clinical contexts to improve both learner and patient outcomes. The authors propose a framework that closely aligns the educational and clinical contexts, such that both educational and clinical outcomes are centered around the patient. This will require a reorganization of academic faculty perspective and educational design of GME training programs that recognizes that (1) the dynamic interplay between the faculty, learner, training program, and clinical microsystem ultimately influences the quality of physician that emerges from the training program and environment, and (2) patient outcomes relate to the quality of education and the success of clinical microsystems. To enable this evolution, there is a need to revisit the core competencies expected of academic faculty, implement innovative faculty development strategies, examine closely faculty's current clinical super vision practices, and establish a training environment that supports bridging from clinician to educator, training program to clinical microsystem, and educational outcomes to clinical outcomes that benefit patients. PMID:26703412

  9. Arterial Stiffening and Clinical Outcomes in Dialysis Patients.

    PubMed

    Kato, Akihiko

    2015-09-01

    Cardiovascular disease (CVD) is an important cause of morbidity and mortality in dialysis patients. Brachial-ankle pulse wave velocity (baPWV) is more efficient to handily assess arteriosclerosis than aortic PWV. The cardio-ankle vascular index (CAVI) is also a novel blood pressure-independent arterial stiffness parameter. In dialysis patients, both baPWV and CAVI are increased compared to general subjects. Several studies have demonstrated that increased baPWV is associated with carotid atherosclerosis and diastolic left ventricular dysfunction in hemodialysis (HD) patients. In addition, higher baPWV is related to all-cause and cardiovascular (CV) mortality. CAVI is similarly associated with CVD. However, baPWV is superior to CAVI as a predictor of CV outcomes in HD patients. Besides these outcomes, a close relationship exists between sarcopenia, abdominal visceral obesity and arterial stiffening. Reduction of thigh muscle mass is inversely correlated with baPWV and CAVI in males. Abdominal fatness is also associated with increased arterial stiffness in females. These observations provide further evidence of higher risk of CV events in HD patients with sarcopenic obesity. In addition, arterial stiffness is associated with cerebral small vessel disease and decreased cognitive function in the elderly. However, it is unknown whether arterial stiffness may be useful as an early indicator of cognitive decline in dialysis patients. Because dialysis patients are at risk of developing dementia, more studies are needed to elucidate the causal link between arterial stiffness and cognitive impairment. PMID:26587457

  10. Very poor outcome schizophrenia: Clinical and neuroimaging aspects

    PubMed Central

    Mitelman, Serge A.; Buchsbaum, Monte S.

    2009-01-01

    In spite of significant advances in treatment of patients with schizophrenia and continued efforts towards their deinstitutionalization, a considerable group of patients remain chronically hospitalized or otherwise dependent on others for basic necessities of life. It has been proposed that these patients belong to a distinct etiopathological subgroup, termed Kraepelinian, whose course of illness may be progressive and resistant to treatment. Indeed, longitudinal studies appear to show that elderly Kraepelinian patients follow a course of rapid cognitive and functional deterioration, commensurate with a dementing process, and that their poor functional status is closely correlated with the cognitive deterioration. Recent neuroimaging studies described a pattern of posteriorization of grey and white matter deficits with poor outcome in schizophrenia, and produced a constellation of findings implicating primary processing of visual and auditory information as central to the impaired functional status in this patient group. These studies are summarized in detail in this review and future directions for neuroimaging assessment of very poor outcome patients with schizophrenia are suggested. PMID:17671868

  11. Clinical Supervision in Treatment Transport: Effects on Adherence and Outcomes

    ERIC Educational Resources Information Center

    Schoenwald, Sonja K.; Sheidow, Ashli J.; Chapman, Jason E.

    2009-01-01

    This nonexperimental study used mixed-effects regression models to examine relations among supervisor adherence to a clinical supervision protocol, therapist adherence, and changes in the behavior and functioning of youths with serious antisocial behavior treated with an empirically supported treatment (i.e., multisystemic therapy [MST]) 1 year…

  12. Outcome measures for clinical trials assessing treatment of cystic fibrosis lung disease

    PubMed Central

    VanDevanter, Donald R; Konstan, Michael W

    2015-01-01

    Cystic fibrosis (CF) is a complex genetic disease characterized by death from loss of lung function. Therapies target pathophysiologic changes associated with pulmonary disease progression. Although therapeutic mechanisms differ, efficacy demonstration is limited to a few accepted outcome measures, each with shortcomings that are becoming more pronounced as CF population health improves. Pulmonary function improvement (as forced expiratory volume in 1 s [FEV1]) and reduction of pulmonary exacerbation risk are commonly used outcomes. Changes in FEV1 decline rate, quality of life, linear growth and/or weight gain are less utilized outcomes. Validated outcomes tend to work best in subjects with more aggressive or advanced lung disease and less so in healthier subjects. Assays of effects on primary therapeutic targets have yet to be validated as surrogate measures of clinical efficacy. As CF population health improves, it will become increasingly difficult to employ current clinical outcome measures to demonstrate efficacy. PMID:26146539

  13. Clinical Outcomes of High Tibial Osteotomy for Knee Instability

    PubMed Central

    Dean, Chase S.; Liechti, Daniel J.; Chahla, Jorge; Moatshe, Gilbert; LaPrade, Robert F.

    2016-01-01

    Background: In recent years there has been an increasing interest in high tibial osteotomy (HTO) to treat patients with chronic knee instability due to posterolateral corner (PLC), posterior cruciate ligament (PCL), and anterior cruciate ligament (ACL) insufficiencies with concurrent malalignment in the coronal and/or sagittal plane. Purpose: To perform a systematic review of the use of HTO for the treatment of knee ligament instability with concurrent malalignment. Study Design: Systematic review; Level of evidence, 4. Methods: A systematic review of the literature was conducted for the treatment of combined knee ligament instability and malalignment with HTO using the Cochrane Central Register of Controlled Trials, PubMed, and MEDLINE (1980 to present); the queries were performed in July 2015. Terms searched included the following: high or proximal tibial osteotomy, unstable, instability, laxity, subluxation, tibial slope, and malalignment, in the knee joint. Inclusion criteria were as follows: HTO to treat instability of the knee joint in the sagittal and/or coronal plane, minimum 2-year follow-up with reported outcomes measures, English language, and human studies. Animal, basic science, and cadaveric studies were excluded as well as editorials, reviews, expert opinions, surveys, special topics, letters to the editor, and correspondence. Results: The search resulted in 460 studies. After applying exclusion criteria and removing duplicates, 13 studies were considered. Of the studies reviewed, knee ligament pathologies, previous surgeries, and measurement of knee stability were heterogeneous. However, all studies reported an improvement in knee stability after HTO. Most studies reported improvement in outcome scores. However, other studies did not provide preoperative scores for comparison. Reported complication rates ranged from 0% to 47%. Conclusion: Although HTO has been highly advocated and used in treating patients with ligamentous knee instability, there

  14. Systematic Review of Outcome Measures Reported in Clinical Canine Osteoarthritis Research

    PubMed Central

    Asher, Lucy; Dean, Rachel S.

    2016-01-01

    Objective To record and categorize the outcome measures used in dogs with naturally occurring osteoarthritis (OA) by systematically reviewing the peer reviewed publications on OA in dogs. Study Design Systematic literature review. Study Population Peer reviewed literature on canine OA. Methods A computer‐based bibliographic search was performed on PubMed and CAB Abstracts in August 2013 to find peer reviewed publications relevant to canine OA. Inclusion and exclusion criteria were applied. The outcome measures reported within each publication were recorded and categorized for comparison. Adequately described outcome measures were assessed for uniqueness and evidence of prior validation. Results Of 3,697 publications identified and screened, 117 were deemed eligible for inclusion. Within eligible publications, outcome measures were used 618 times (median of 4 outcome measures per publication). Outcomes measured were divided into 5 groups containing 65 categories. The most frequently assessed outcomes were lameness assessment with no stated gait/mixed gaits (66 outcomes), radiography (58), and lameness single gait/lateral motion (55). Of 618 outcome measures reported, 491 were assessed for uniqueness and 348 (71%) were unique to a single publication. Ten outcome measures were reported to have been validated. Conclusion Many outcome measures have been used to assess canine OA. There is no consensus on which are the most useful outcomes or by which method they should be assessed. There is a pressing need for agreement on outcomes reporting in canine OA and for validation of outcome measures used for these assessments. Until consensus is reached, we recommend at least one validated outcome measure be used in every clinical study. PMID:27120270

  15. Planning and predictability of clinical outcomes in esthetic rehabilitation.

    PubMed

    Kurbad, A

    2015-01-01

    In esthetic rehabilitation, it is a challenge to meet the needs of patients with growing expectations. Creating predictable results is the key to success. This can be accomplished by performing a comprehensive esthetic diagnosis, elaborating treatment proposals that satisfy today's esthetic standards, and using modern computer-assisted methods. The diagnostic wax-up and mock-up are effective tools that allow patients to visualize treatment proposals without invasive procedures. Once the patient has approved the proposals, they provide the basis for the fabrication of the final restoration. The use of modern ceramic materials makes it possible to achieve a good esthetic outcome, even in restorations with extremely thin layer thicknesses. Esthetic cementation is the final step of restorative treatment.

  16. Planning and predictability of clinical outcomes in esthetic rehabilitation.

    PubMed

    Kurbad, A

    2015-01-01

    In esthetic rehabilitation, it is a challenge to meet the needs of patients with growing expectations. Creating predictable results is the key to success. This can be accomplished by performing a comprehensive esthetic diagnosis, elaborating treatment proposals that satisfy today's esthetic standards, and using modern computer-assisted methods. The diagnostic wax-up and mock-up are effective tools that allow patients to visualize treatment proposals without invasive procedures. Once the patient has approved the proposals, they provide the basis for the fabrication of the final restoration. The use of modern ceramic materials makes it possible to achieve a good esthetic outcome, even in restorations with extremely thin layer thicknesses. Esthetic cementation is the final step of restorative treatment. PMID:25911830

  17. Modulation of HLA-DR in dry eye patients following 30 days of treatment with a lubricant eyedrop solution

    PubMed Central

    Fernandez, Karen B; Epstein, Seth P; Raynor, Geoffrey S; Sheyman, Alan T; Massingale, Morgan L; Dentone, Peter G; Landegger, Lukas D; Asbell, Penny A

    2015-01-01

    Purpose To determine the changes in dry eye disease (DED) severity and the percentage of cells expressing HLA-DR on the ocular surface following treatment with lubricant eyedrops containing polyethylene glycol and propylene glycol (PEG/PG) and the gelling agent hydroxypropyl guar (HP-Guar). Patients and methods Nineteen patients with DED used PEG/PG + HP-Guar eyedrops four times per day for 30 days. Assessments included DED severity (Ocular Surface Disease Index [OSDI], corneal staining, conjunctival staining, tear film break-up time [TFBUT], and Schirmer testing) and impression cytology of the conjunctiva with masked flow cytometry at baseline and at 30 days. Results There was a significant decrease in corneal staining (P<0.01), OSDI (P=0.02), and TFBUT (P<0.01) following treatment with PEG/PG + HP-Guar. Results from flow cytometry revealed a significant decrease in cells expressing HLA-DR (P=0.02). Conclusion Treatment with PEG/PG + HP-Guar eyedrops showed improvement in dry eye severity and reduction in surface inflammation as indicated by a reduction in HLA-DR expression. PMID:26170605

  18. Early-Onset Psychoses: Comparison of Clinical Features and Adult Outcome in 3 Diagnostic Groups

    ERIC Educational Resources Information Center

    Ledda, Maria Giuseppina; Fratta, Anna Lisa; Pintor, Manuela; Zuddas, Alessandro; Cianchetti, Carlo

    2009-01-01

    A comparison of clinical features and adult outcome in adolescents with three types of psychotic disorders: schizophrenic (SPh), schizoaffective (SA) and bipolar with psychotic features (BPP). Subjects (n = 41) were finally diagnosed (DSM-IV criteria) with SPh (n = 17), SA (n = 11) or BPP (n = 13). Clinical evaluation took place at onset and at a…

  19. 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

  20. 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.

  1. [Assessment of individual clinical outcomes: regarding an electroconvulsive therapy case].

    PubMed

    Iraurgi, Ioseba; Gorbeña, Susana; Martínez-Cubillos, Miren-Itxaso; Escribano, Margarita; Gómez-de-Maintenant, Pablo

    2015-01-01

    Evaluation of therapeutic results and of the efficacy and effectiveness of treatments is an area of interest both for clinicians and researchers. In general, randomized controlled trial designs have been used as the methodology of choice in which intergroup comparisons are made having a minimum of participants in each arm of treatment. However, these procedures are seldom used in daily clinical practice. Despite this fact, the evaluation of treatment results for a specific patient is important for the clinician in order to address if therapeutic goals have been accomplished both in terms of statistical significance and clinical meaningfulness. The methodology based on the reliable change index (Jacobson y Truax)1 provides an estimate of these two criteria. The goal of this article is to propose a procedure to apply the methodology with a single case study of a woman diagnosed with major depression and treated with electroconvulsive therapy.

  2. Clinical Outcomes of TP53 Mutations in Cancers.

    PubMed

    Robles, Ana I; Jen, Jin; Harris, Curtis C

    2016-01-01

    High-throughput sequencing of cancer genomes is increasingly becoming an essential tool of clinical oncology that facilitates target identification and targeted therapy within the context of precision medicine. The cumulative profiles of somatic mutations in cancer yielded by comprehensive molecular studies also constitute a fingerprint of historical exposures to exogenous and endogenous mutagens, providing insight into cancer evolution and etiology. Mutational signatures that were first established by inspection of the TP53 gene somatic landscape have now been confirmed and expanded by comprehensive sequencing studies. Further, the degree of granularity achieved by deep sequencing allows detection of low-abundance mutations with clinical relevance. In tumors, they represent the emergence of small aggressive clones; in normal tissues, they signal a mutagenic exposure related to cancer risk; and, in blood, they may soon become effective surveillance tools for diagnostic purposes and for monitoring of cancer prognosis and recurrence. PMID:27449973

  3. Fixation systems of greater trochanteric osteotomies: biomechanical and clinical outcomes.

    PubMed

    Jarit, Gregg J; Sathappan, Sathappan S; Panchal, Anand; Strauss, Eric; Di Cesare, Paul E

    2007-10-01

    The development of cerclage systems for fixation of greater trochanteric osteotomies has progressed from monofilament wires to multifilament cables to cable grip and cable plate systems. Cerclage wires and cables have various clinical indications, including fixation for fractures and for trochanteric osteotomy in hip arthroplasty. To achieve stable fixation and eventual union of the trochanteric osteotomy, the implant must counteract the destabilizing forces associated with pull of the peritrochanteric musculature. The material properties of cables and cable grip systems are superior to those of monofilament wires; however, potential complications with the use of cables include debris generation and third-body polyethylene wear. Nevertheless, the cable grip system provides the strongest fixation and results in lower rates of nonunion and trochanteric migration. Cable plate constructs show promise but require further clinical studies to validate their efficacy and safety.

  4. [Assessment of individual clinical outcomes: regarding an electroconvulsive therapy case].

    PubMed

    Iraurgi, Ioseba; Gorbeña, Susana; Martínez-Cubillos, Miren-Itxaso; Escribano, Margarita; Gómez-de-Maintenant, Pablo

    2015-01-01

    Evaluation of therapeutic results and of the efficacy and effectiveness of treatments is an area of interest both for clinicians and researchers. In general, randomized controlled trial designs have been used as the methodology of choice in which intergroup comparisons are made having a minimum of participants in each arm of treatment. However, these procedures are seldom used in daily clinical practice. Despite this fact, the evaluation of treatment results for a specific patient is important for the clinician in order to address if therapeutic goals have been accomplished both in terms of statistical significance and clinical meaningfulness. The methodology based on the reliable change index (Jacobson y Truax)1 provides an estimate of these two criteria. The goal of this article is to propose a procedure to apply the methodology with a single case study of a woman diagnosed with major depression and treated with electroconvulsive therapy. PMID:25282427

  5. Early clinical outcome with a new monofocal microincision intraocular lens.

    PubMed

    Toygar, Baha; Yabas Kiziloglu, Ozge; Toygar, Okan; Hacimustafaoglu, Ali Murat

    2016-10-01

    The purpose of this study was to evaluate the early visual and refractive outcomes of a new aspheric monofocal microincision intraocular lens (IOL). This retrospective case series included eyes of patients who underwent implantation of a microincision IOL following 1.8 mm manual coaxial microincision cataract surgery and who attended regular postoperative follow-up visits on the first week and first, third, and sixth months. The postoperative uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction and predictability, intraoperative and postoperative complications, posterior capsule opacification (PCO), IOL centration, and surgically induced astigmatism (SIA) were evaluated. Sixty-three eyes of 38 patients ranging in age from 51 to 86 were included in the study. The mean preoperative BCVA was 0.52 ± 0.42 logMAR. At the postoperative sixth month, the mean postoperative UCVA and BCVA were 0.12 ± 0.11 and 0.01 ± 0.03 logMAR, respectively. The mean postoperative spherical equivalent refraction (SER) was -0.30 ± 0.49 D. The SER was within ± 1.00 D of the attempted correction in 95.2 % of the eyes. The mean SIA measured with vector analysis was 0.45 ± 0.28 D. Mild PCO was observed in 9 eyes (14.7 %) with none requiring Nd:Yag laser capsulotomy. On centration analysis, the IOL was found to be 0.26 mm on average to the supero-nasal position. The aspheric microincision IOL was safely implanted and provided satisfactory visual and refractive outcomes in the early postoperative period.

  6. Maternal characteristics and clinical diagnoses influence obstetrical outcomes in Indonesia.

    PubMed

    Adisasmita, Asri; Smith, Carl V; El-Mohandes, Ayman A E; Deviany, Poppy Elvira; Ryon, Judith J; Kiely, Michele; Rogers-Bloch, Quail; Gipson, Reginald F

    2015-07-01

    This Indonesian study evaluates associations between near-miss status/death with maternal demographic, health care characteristics, and obstetrical complications, comparing results using retrospective and prospective data. The main outcome measures were obstetric conditions and socio-economic factors to predict near-miss/death. We abstracted all obstetric admissions (1,358 retrospective and 1,240 prospective) from two district hospitals in East Java, Indonesia between 4/1/2009 and 5/15/2010. Prospective data added socio-economic status, access to care and referral patterns. Reduced logistic models were constructed, and multivariate analyses used to assess association of risk variables to outcome. Using multivariate analysis, variables associated with risk of near-miss/death include postpartum hemorrhage (retrospective AOR 5.41, 95 % CI 2.64-11.08; prospective AOR 10.45, 95 % CI 5.59-19.52) and severe preeclampsia/eclampsia (retrospective AOR 1.94, 95 % CI 1.05-3.57; prospective AOR 3.26, 95 % CI 1.79-5.94). Associations with near-miss/death were seen for antepartum hemorrhage in retrospective data (AOR 9.34, 95 % CI 4.34-20.13), and prospectively for poverty (AOR 2.17, 95 % CI 1.33-3.54) and delivering outside the hospital (AOR 2.04, 95 % CI 1.08-3.82). Postpartum hemorrhage and severe preeclampsia/eclampsia are leading causes of near-miss/death in Indonesia. Poverty and delivery outside the hospital are significant risk factors. Prompt recognition of complications, timely referrals, standardized care protocols, prompt hospital triage, and structured provider education may reduce obstetric mortality and morbidity. Retrospective data were reliable, but prospective data provided valuable information about barriers to care and referral patterns.

  7. Association Between In Vitro Susceptibility to Natamycin and Voriconazole and Clinical Outcomes in Fungal Keratitis

    PubMed Central

    Sun, Catherine Q.; Lalitha, Prajna; Prajna, N. Venkatesh; Karpagam, Rajarathinam; Geetha, Manoharan; O’Brien, Kieran S.; Oldenburg, Catherine E.; Ray, Kathryn J.; McLeod, Stephen D.; Acharya, Nisha R.; Lietman, Thomas M.

    2014-01-01

    Purpose To assess the association between minimum inhibitory concentration (MIC) and clinical outcomes in a fungal keratitis clinical trial. Design Experimental study using data from a randomized comparative trial. Participants Of the 323 patients enrolled in the trial, we were able to obtain MIC values from 221 patients with monocular fungal keratitis. Methods The Mycotic Ulcer Treatment Trial I (MUTT I) was a randomized, double-masked clinical trial comparing clinical outcomes of monotherapy with topical natamycin versus voriconazole for the treatment of fungal keratitis. Speciation and determination of MIC to natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines. The relationship between MIC and clinical outcome was assessed. Main Outcome Measures The primary outcome was 3-month best spectacle-corrected visual acuity. Secondary outcomes included 3-month infiltrate/scar size, corneal perforation and/or therapeutic penetrating keratoplasty (TPK), and time to re-epithelialization. Results A 2-fold increase in MIC was associated with a larger 3-month infiltrate/scar size (0.21 mm, 95% confidence interval [CI] 0.10–0.31, P <0.001) and increased odds of perforation (odds ratio [OR] 1.32, 95% CI 1.04–1.69, P=0.02). No correlation was found between MIC and 3-month visual acuity. For natamycin-treated cases, an association was found between higher natamycin MIC with larger 3-month infiltrate/scar size (0.29 mm, 95% CI 0.15–0.43, P<0.001) and increased perforations (OR 2.41, 95% CI 1.46–3.97, P<0.001). Among voriconazole-treated cases, the voriconazole MIC did not correlate with any of the measured outcomes in the study. Conclusion Decreased susceptibility to natamycin was associated with increased infiltrate/scar size and increased odds of perforation. There was no association between susceptibility to voriconazole and outcome. PMID:24746358

  8. Clinical meaningful outcomes in schizophrenia: remission and recovery.

    PubMed

    Ciudad, Antonio; Bobes, Julio; Alvarez, Enric; San, Luis; Novick, Diego; Gilaberte, Inmaculada

    2011-01-01

    The traditional view of schizophrenia as a disabling and irremediably progressive disease is being reconsidered because of the evidences arising from long-term follow-up studies. On the other hand, recent advances of therapies have yielded significant functional improvements for some patients. Together, these facts are serving to raise treatment prospects, placing the focus on functional recovery. Although the availability of a valid set of consensus remission criteria has been an important step toward the definition of therapeutic objectives and the conceptualization of recovery, remission and recovery still are rare concepts in the setting of routine clinical practice. The present article includes a brief review of these concepts, and presents the results from two observational European studies that provide empirical data about the actual situation of ambulatory patients with schizophrenia in terms of symptomatic remission, and that help in advancing the conceptualization of recovery, contributing to the development of clinical and research definitional criteria. Such results indicate that remission of symptoms constitutes a realistic therapeutic goal in a number of patients, with a considerable temporal stability; on the other hand, recovery definitions should include functional and subjective dimensions. In conclusion, remission is a tenable and clinically valid concept, with a significant contribution to functional improvement. Meanwhile, the recovery construct still requires substantial development.

  9. Neuroendocrine prostate cancer: subtypes, biology, and clinical outcomes.

    PubMed

    Aggarwal, Rahul; Zhang, Tian; Small, Eric J; Armstrong, Andrew J

    2014-05-01

    Neuroendocrine prostate cancer (NEPC) encompasses various clinical contexts, ranging from the de novo presentation of small cell prostatic carcinoma to a treatment-emergent transformed phenotype that arises from typical adenocarcinoma of the prostate. The development of resistance to potent androgen receptor signaling inhibition may be associated with the emergence of aggressive phenotype, advanced castration-resistant NEPC. Clinically, small cell prostate cancer and NEPC are often manifested by the presence of visceral or large soft tissue metastatic disease, a disproportionately low serum prostate-specific antigen level relative to the overall burden of disease, and a limited response to targeting of the androgen signaling axis. These tumors are often characterized by loss of androgen receptor expression, loss of retinoblastoma tumor suppressor copy number or expression, amplification of Aurora kinase A and N-Myc, and activation of the PI3K pathway. However, a consensus phenotype-genotype definition of NEPC has yet to emerge, and molecularly based biomarkers are needed to expand on traditional morphologic and immunohistochemical markers of NEPC to fully define the spectrum of this aggressive, androgen receptor-independent disease. Emerging studies implicate a shared clonal origin with prostatic adenocarcinoma in many cases, with the adaptive emergence of unique cellular programming and gene expression profiles. Ongoing clinical studies are focused on developing novel targeted therapeutic approaches for this high-risk, lethal subset of disease, to improve on the limited durations of response often observed with traditional platinum-based chemotherapy.

  10. Development of a multiple sclerosis functional composite as a clinical trial outcome measure.

    PubMed

    Cutter, G R; Baier, M L; Rudick, R A; Cookfair, D L; Fischer, J S; Petkau, J; Syndulko, K; Weinshenker, B G; Antel, J P; Confavreux, C; Ellison, G W; Lublin, F; Miller, A E; Rao, S M; Reingold, S; Thompson, A; Willoughby, E

    1999-05-01

    The primary clinical outcome measure for evaluating multiple sclerosis in clinical trials has been Kurtzke's expanded disability status scale (EDSS). New therapies appear to favourably impact the course of multiple sclerosis and render continued use of placebo control groups more difficult. Consequently, future trials are likely to compare active treatment groups which will most probably require increased sample sizes in order to detect therapeutic efficacy. Because more responsive outcome measures will be needed for active arm comparison studies, the National Multiple Sclerosis Society's Advisory Committee on Clinical Trials of New Agents in Multiple Sclerosis appointed a Task Force that was charged with developing improved clinical outcome measures. This Task Force acquired contemporary clinical trial and historical multiple sclerosis data for meta-analyses of primary and secondary outcome assessments to provide a basis for recommending a new outcome measure. A composite measure encompassing the major clinical dimensions of arm, leg and cognitive function was identified and termed the multiple sclerosis functional composite (MSFC). The MSFC consists of three objective quantitative tests of neurological function which are easy to administer. Change in this MSFC over the first year of observation predicted subsequent change in the EDSS, suggesting that the MSFC is more sensitive to change than the EDSS. This paper provides details concerning the development and testing of the MSFC.

  11. Caspofungin: Pharmacodynamics, pharmacokinetics, clinical uses and treatment outcomes.

    PubMed

    Song, Jessica C; Stevens, David A

    2016-09-01

    Over the past decade, echinocandins have emerged as first-line antifungal agents for many Candida infections. The echinocandins have a unique mechanism of action, inhibiting the synthesis of β-1,3-d-glucan polymers, key components of the cell wall in pathogenic fungi. Caspofungin was the first echinocandin antifungal agent to become licensed for use. The objectives of this review are to summarize the existing published data on caspofungin, under the subject headings of chemistry and mechanism of action, spectrum of activity, pharmacodynamics, pharmacokinetics, clinical studies, safety, drug interactions, dosing, and an overview of the drug's current place in therapy. PMID:26369708

  12. Clinical Experiences Are Not Predictive of Outcomes on the NATABOC Examination

    PubMed Central

    Turocy, Paula Sammarone; Comfort, Ronald E.; Perrin, David H.; Gieck, Joe H.

    2000-01-01

    Objective: To determine the efficacy of the National Athletic Trainers' Association Board of Certification (NATABOC) clinical experience requirements and individual student characteristics to predict candidate outcomes on the NATABOC certification examination. Design and Setting: For all subjects, we gathered survey information and examination scores. The survey information included age, sex, route to certification, previous athletic training and allied health experience, and clinical education experiences. Subjects: A total of 269 subjects, 22.25% of all first-time candidates for the June and November 1993 NATABOC examinations, were included in this study. Measurements: Data were analyzed for standard descriptive statistics and parametric linear regression and correlational relationships. Results: Total clinical hours, high-risk sport experiences, and previous athletic training experience were not predictive of examination outcomes. Although our results indicated a relationship between previous allied health experience and both outcome on the written section of the examination and age and outcome on the oral/practical section, these characteristics also were not predictive of examination outcomes. Conclusions: Gaining clinical experience hours in excess of 400 hours beyond the 800-or 1500-hour requirement may yield no greater benefit for an entry-level professional than less time. The quality, rather than the quantity, of clinical experiences should be evaluated. More emphasis should be placed on the achievement of an entry level of clinical competency, rather than on total hour collection. Also, because high-risk sport experiences did not predict outcomes on the NATABOC examination, the emphasis of clinical education should be on students' receiving a more structured clinical experience, in which they are progressively required to assume greater responsibilities integrating both cognitive and psychomotor skills, while working under the supervision of a certified

  13. Outcome assessment in cellulitis clinical trials: is telephone follow up sufficient?

    PubMed

    Nambudiri, V E; Dwyer, R C; Camargo, C A; Kupper, T S; Pallin, D J

    2015-07-01

    The US Food and Drug Administration has scrutinized clinical trial methodology in cellulitis, partly because the definition and timing of cure are debatable. We analysed the validity of telephone self-report as a proxy for in-person follow up in a cellulitis treatment trial comparing cephalexin alone with cephalexin-plus-trimethoprim/sulfamethoxazole. Our results demonstrate poor agreement between these two methods of outcome determination and have implications for future cellulitis clinical trial design and clinical management. PMID:25882364

  14. Clinical outcome of surgical treatment for periorbital basal cell carcinoma.

    PubMed

    Kakudo, Natsuko; Ogawa, Yutaka; Suzuki, Kenji; Kushida, Satoshi; Kusumoto, Kenji

    2009-11-01

    Basal cell carcinoma (BCC) has a predilection for the periorbital region, which is a special, prominent, cosmetic, functional area to protect the eyeball. For squamous cell carcinoma and melanoma, extensive resection with reconstruction is performed. In contrast, for BCC, resection is often confined to a small to medium-sized area, necessitating higher-quality reconstructive surgery. We analyze the surgical outcomes of treatment for periorbital BCC, and evaluate reconstruction method after resection. Forty-nine patients with periorbital BCC had surgery in our hospital over 20 years. Age, gender of the patients, and size, localization, and histology of the tumor, and surgical procedures, and their early and late complications were analyzed retrospectively. BCC was most frequently occurred in the lower lid (55%), followed by inner canthus (19%), upper lid (17%), and outer canthus (9%). The histologic classifications were solid (80%), morphea (7%), mix (7%), superficial (2%), keratotic (2%), and adenoid (2%). Recurrence of the tumor was observed in 2 advanced cases in patients treated with resection of the tumor including surrounding tissue 5 mm from the margin. A rotation advancement cheek flap procedure was most frequently applied. Horizontal shift of the skin was most effective to prevent postoperative lagophthalmos. BCC occurred most frequently in the lower lid within the periorbital area. Rotation advancement of cheek flap with horizontal shift of the skin is most effective procedure in both appearance and function of the eyelid. PMID:19801921

  15. Clinical observation and neurological outcomes in "Alice in Wonderland" syndrome.

    PubMed

    Ho, C S; Shen, E Y; Liaw, S B; Huang, F Y

    1992-01-01

    Ten patients, aged from 3 to 10 years, who had either had attacks of perception errors of body schema and objects or had visual hallucination were enrolled from 1987 to 1990. Seven were boys and three, girls. The metamorphopsia or visual hallucination that has been named the "Alice in Wonderland syndrome" (AIWS) were the leading presentations. All the patients had preceding episodes of upper respiratory tract infection (URI) from two days to four weeks previously except for one who had had chickenpox within the immediate three days of being seen. Among these patients, six had received serological studies for Epstein-Barr (EB) virus infection. Two patients were indeed victims of acute EB virus infection as documented by positive IgM antibody against EB virus capsid antigen, the other three patients were highly suspected of having had recent EB virus infection as suggested by positive Heterophil antibody test and high IgG antibody titer against EB virus capsid antigen (1:320X). The duration of perception disorder ranged from four days to three months. All cases recovered completely, without sequelae. It is emphasized that any young children who present as acute episodes of AIWS should undergo examination for EB virus infection. The neurological outcome of AIWS seems to be good. PMID:1325095

  16. Tinnitus Functional Index: Development, validation, outcomes research, and clinical application.

    PubMed

    Henry, James A; Griest, Susan; Thielman, Emily; McMillan, Garnett; Kaelin, Christine; Carlson, Kathleen F

    2016-04-01

    The Tinnitus Research Consortium (TRC) issued a Request for Proposals in 2003 to develop a new tinnitus outcome measure that would: (1) be highly sensitive to treatment effects (validated for "responsiveness"); (2) address all major dimensions of tinnitus impact; and (3) be validated for scaling the negative impact of tinnitus. A grant was received by M. Meikle to conduct the study. In that observational study, all of the TRC objectives were met, with the final 25-item Tinnitus Functional Index (TFI) containing eight subscales. The study was published in 2012, and since then the TFI has received increasing international use and is being translated into at least 14 languages. The present study utilized data from a randomized controlled trial (RCT) that involved testing the efficacy of "telephone tinnitus education" as intervention for bothersome tinnitus. These data were used to confirm results from the original TFI study. Overall, the TFI performed well in the RCT with Cohen's d being 1.23. There were large differences between the eight different subscales, ranging from a mean 13.2-point reduction (for the Auditory subscale) to a mean 26.7-point reduction (for the Relaxation subscale). Comparison of TFI performance was made with the Tinnitus Handicap Inventory. All of the results confirmed sensitivity of the TFI along with its subscales. This article is part of a Special Issue entitled . PMID:26074306

  17. Improving periodontal outcomes: merging clinical and behavioral science.

    PubMed

    Wilder, Rebecca S; Bray, Kimberly S

    2016-06-01

    New data indicate that periodontal diseases are much more prevalent than previously thought, which means that there are large numbers of patients who will need to be diagnosed and treated for periodontal disease in a general dental practice. Oral hygiene procedures performed by patients between office visits are important for gingival health. No particular type of toothbrush has consistently been shown to have superior plaque-removal ability over another. Although studies on powered brushes have shown evidence for efficacy of biofilm removal and increased patient compliance, they are of short duration, making evaluation of long-term effects difficult to achieve. Interdental cleaning with dental floss can be effective but it is technique-sensitive. Interdental brushes have been shown to be superior to floss in plaque index scores, but not in gingival inflammation reduction. A systematic review of oral irrigation reported a beneficial adjunctive effect on bleeding and gingival indices and pocket depth. Antimicrobials in mouthrinses and toothpastes have shown significant reductions in plaque and gingivitis when used correctly. Even though it is considered essential for patients to utilize biofilm-removal techniques on a frequent basis, studies on adherence show that approximately 30-60% of health information is forgotten within 1 h, and 50% of health recommendations are not followed. Incorporating psychosocial aspects of behavioral change, including well-established counseling strategies, such as motivational interviewing, may elicit improved patient outcomes. PMID:27045431

  18. Factors influencing outcomes of clinical information systems implementation: a systematic review.

    PubMed

    Gruber, Dianne; Cummings, Greta G; LeBlanc, Lisa; Smith, Donna L

    2009-01-01

    Healthcare agencies spend significant resources to acquire or develop clinical information systems. However, implementation of clinical information systems often report significant failures. A systematic review of the research literature identified processes and outcomes of clinical information system implementation and factors that influenced success or failure. Of 124 original papers, 18 met the primary inclusion criteria-clinical systems implementation, healthcare facility, and outcome measures. Data extraction elements included study characteristics, outcomes, and implementation risk factors classified according to the Expanded Systems Life Cycle. The quality of each study was also assessed. Forty-nine outcomes of clinical information system implementation were identified. No single implementation strategy proved completely effective. The findings of this synthesis direct the attention of managers and decision makers to the importance of clinical context to successful implementation of clinical information systems. The highest number of factors influencing success or failure was reported during implementation and system "go-live." End-user support or lack thereof was the important factor in both successful and failed implementations, respectively. Following the Expanded Systems Life Cycle management model instead of a traditional project management approach may contribute to greater success over time, by paying particular attention to the underrecognized maintenance phase of implementation. PMID:19411944

  19. Bayesian nonparametric estimation of targeted agent effects on biomarker change to predict clinical outcome.

    PubMed

    Graziani, Rebecca; Guindani, Michele; Thall, Peter F

    2015-03-01

    The effect of a targeted agent on a cancer patient's clinical outcome putatively is mediated through the agent's effect on one or more early biological events. This is motivated by pre-clinical experiments with cells or animals that identify such events, represented by binary or quantitative biomarkers. When evaluating targeted agents in humans, central questions are whether the distribution of a targeted biomarker changes following treatment, the nature and magnitude of this change, and whether it is associated with clinical outcome. Major difficulties in estimating these effects are that a biomarker's distribution may be complex, vary substantially between patients, and have complicated relationships with clinical outcomes. We present a probabilistically coherent framework for modeling and estimation in this setting, including a hierarchical Bayesian nonparametric mixture model for biomarkers that we use to define a functional profile of pre-versus-post-treatment biomarker distribution change. The functional is similar to the receiver operating characteristic used in diagnostic testing. The hierarchical model yields clusters of individual patient biomarker profile functionals, and we use the profile as a covariate in a regression model for clinical outcome. The methodology is illustrated by analysis of a dataset from a clinical trial in prostate cancer using imatinib to target platelet-derived growth factor, with the clinical aim to improve progression-free survival time. PMID:25319212

  20. Bayesian Nonparametric Estimation of Targeted Agent Effects on Biomarker Change to Predict Clinical Outcome

    PubMed Central

    Graziani, Rebecca; Guindani, Michele; Thall, Peter F.

    2015-01-01

    Summary The effect of a targeted agent on a cancer patient's clinical outcome putatively is mediated through the agent's effect on one or more early biological events. This is motivated by pre-clinical experiments with cells or animals that identify such events, represented by binary or quantitative biomarkers. When evaluating targeted agents in humans, central questions are whether the distribution of a targeted biomarker changes following treatment, the nature and magnitude of this change, and whether it is associated with clinical outcome. Major difficulties in estimating these effects are that a biomarker's distribution may be complex, vary substantially between patients, and have complicated relationships with clinical outcomes. We present a probabilistically coherent framework for modeling and estimation in this setting, including a hierarchical Bayesian nonparametric mixture model for biomarkers that we use to define a functional profile of pre-versus-post treatment biomarker distribution change. The functional is similar to the receiver operating characteristic used in diagnostic testing. The hierarchical model yields clusters of individual patient biomarker profile functionals, and we use the profile as a covariate in a regression model for clinical outcome. The methodology is illustrated by analysis of a dataset from a clinical trial in prostate cancer using imatinib to target platelet-derived growth factor, with the clinical aim to improve progression-free survival time. PMID:25319212

  1. Amebic liver abscess: epidemiology, clinical features, and outcome.

    PubMed Central

    Seeto, R K; Rockey, D C

    1999-01-01

    Amebic liver abscess (ALA) is a serious, but readily treatable form of hepatic infection. In order to understand the clinical features of this condition in the United States, we reviewed the medical histories of 56 patients with ALA at two large San Francisco Hospitals from 1979 to 1994. Patients were divided into the following groups based on the presumed manner in which they had acquired ALA: those born or raised in the United States, with a history of travel to an endemic area (Tr-ALA); those from an endemic area, but living in the United States for less than one year (En-ALA); and those neither from nor having traveled to an endemic area (N-ALA). We found distinct clinical patterns in patients from different epidemiological groups. Patients with Tr-ALA were a decade older than those from endemic regions, were more likely to be male, and tended to have an insidious onset. Furthermore, compared to patients with En-ALA, those with Tr-ALA were more likely to have hepatomegaly (P < 0.0001) and large abscesses (ALA > 10 cm; P < 0.01). One third of the patients studied had no associated travel history or endemic origin as risk factors. Of these, 63% had a condition consistent with severe immunosuppression, such as infection with the human immunodeficiency virus (HIV), malnourishment with severe hypoalbuminemia, or chronic infection. In patients with N-ALA, the presence of a presumed immunosuppressed state increased significantly, as compared to patients with endemic or travel risk factors for ALA. During the last five years of the study, one third of all patients diagnosed with ALA were HIV positive (including 2 with a new diagnosis of AIDS), many of whom were discovered to be HIV-infected only after presentation with ALA. We conclude that travel to and origin in an endemic area are important risk factors for the development of ALA, and patients in these different epidemiological groups appear to have distinct clinical features. Further, in the absence of recognized

  2. A comparison of clinical outcomes between healthcare-associated infections due to community-associated methicillin-resistant Staphylococcus aureus strains and healthcare-associated methicillin-resistant S. aureus strains

    PubMed Central

    EELLS, S. J.; MCKINNELL, J.A.; WANG, A. A.; GREEN, N. L.; WHANG, D.; O'HARA, P.; BROWN, M. L.; MILLER, L. G.

    2013-01-01

    SUMMARY There are limited data examining whether outcomes of MRSA healthcare-associated infections (HAIs) are worse when caused by community-associated strains compared to healthcare-associated strains. We reviewed all patient charts at our institution from 1999 to 2009 that had MRSA first isolated only after 72 hours of hospitalization (n=724). Of these, 384 patients had an MRSA-HAI by CDC criteria. Treatment failure was similar in those infected with a phenotypically CA-MRSA strain compared to a phenotypically HA-MRSA strain (23% vs. 15%, P=0.10) as was 30-day mortality (16% vs. 19%, P=0.57). Independent risk factors associated with (p<0.05) treatment failure were higher Charlson Comorbidity Index, higher APACHE II score, and no anti-MRSA treatment. These factors were also associated with 30-day mortality, as were female gender, older age, MRSA bloodstream infection, MRSA pneumonia, and HIV. Our findings suggest that clinical and host factors, not MRSA strain type, predict treatment failure and death in hospitalized patients with MRSA-HAIs. PMID:23217979

  3. Clinical Outcomes of Primary Palatal Surgery in Children with Nonsyndromic Cleft Palate with and without Lip

    PubMed Central

    Ha, Seunghee; Koh, Kyung S.; Moon, Heewon; Jung, Seungeun; Oh, Tae Suk

    2015-01-01

    This study presents clinical outcomes of primary cleft palate surgery, including rate of oronasal fistula development, rate of velopharyngeal insufficiency (VPI) requiring secondary surgery, and speech outcomes. We examined the effect of cleft type on the clinical outcomes. Retrospective analysis was performed using clinical records of all patients who received a primary palatoplasty at the Cleft Palate Clinic at Seoul Asan Medical Center, South Korea, between 2007 and 2012. The study included 292 patients with nonsyndromic overt cleft palate (±cleft lip). The results revealed that the rate of oronasal fistula was 7.9% and the incidence of VPI based on the rate of secondary palatal surgery was 19.2%. The results showed that 50.3% of all the patients had received speech therapy and 28.8% and 51.4% demonstrated significant hypernasality and articulatory deficits, respectively. The results of the rate of VPI and speech outcomes were significantly different in terms of cleft type. Except for the rate of oronasal fistula, patients with cleft palate generally exhibited better clinical outcomes compared to those with bilateral or unilateral cleft lip and palate. This study suggests that several factors, including cleft type, should be identified and comprehensively considered to establish an optimal treatment regimen for patients with cleft palate. PMID:26273593

  4. Clinical outcomes of childhood x-irradiation for lymphoid hyperplasia

    SciTech Connect

    Pottern, L.M.

    1987-01-01

    A prospective study was conducted to explore the relationship between childhood x-irradiation for lymphoid hyperplasia and the subsequent development of thyroid gland and other head and neck disorders. All individuals under 18 years of age who were x-irradiated for lymphoid hyperplasia during the years 1938-69 at Children's Hospital Medical Center, Boston comprised the exposed population. The comparison group consisted of non-exposed, surgically treated individuals. The study included a health questionnaire and a clinical examination component. A history of thyroid cancer was reported by 11 exposed subjects and no non-exposed subjects. Significantly elevated standardized incidence ratios of thyroid cancer were seen for both exposed males and females, 19.9 and 12.1, respectively. The average thyroid radiation dose was 25.8 rads and the mean latency period was 17.3 years.

  5. Clinical Outcomes after Arthroscopic Release for Recalcitrant Frozen Shoulder

    PubMed Central

    Ebrahimzadeh, Mohammad H; Moradi, Ali; Pour, Mostafa Khalili; Moghadam, Mohammad Hallaj; Kachooei, Amir Reza

    2014-01-01

    -term outcomes. PMID:25386586

  6. A novel caveolin-1 biomarker for clinical outcome of sarcopenia.

    PubMed

    Lin, Chih-Hsueh; Lin, Cheng-Chieh; Tsai, Chia-Wen; Chang, Wen-Shin; Yang, Mei-Do; Bau, Da-Tian

    2014-01-01

    Sarcopenia, defined by the European Working Group on Sarcopenia in Older People as leading to significantly decreased muscle mass and function, contributes to increased risk of adverse health outcomes among older people. Caveolin-1 (CAV1) is a main structural protein playing a regulatory role in signaling pathways and muscle normality. However, the role of CAV1 in the development of sarcopenia is largely unknown. In this study, we aimed to investigate the contribution of CAV1 genotype to sarcopenia in a Taiwanese population. We enrolled 175 patients with sarcopenia (56 pre-sarcopenia, 63 sarcopenia and 56 severe sarcopenia) and 327 age- and gender-matched controls in this community-based case control study. The associations of six single nucleotide polymorphisms of the CAV1 gene at C521A (rs1997623), G14713A (rs3807987), G21985A (12672038), T28608A (rs3757733), T29107A (rs7804372), and G32124A (rs3807992) with sarcopenia risk were evaluated. After grouping the sarcopenia patients together, the results showed that there was a significant differential distribution among the cases and controls in their CAV1 G14713A genotype (p=0.0235), and those carrying the AG and AA genotypes had 1.65- and 1.78-fold higher odds ratios for sarcopenia compared to those with the GG genotype (95% confidence interval=1.09-2.49 and 0.96-3.31, respectively). Furthermore, the carriers with CAV1 G14713A AG or AA genotype had a higher risk for sarcopenia and severe sarcopenia, but not pre-sarcopenia, compared to those with the GG genotype. Our findings suggest that Cav1 may play a critical role in the etiology of sarcopenia, and the A allele of Cav1 G14713A may serve as an early marker for detection of sarcopenia and severe sarcopenia.

  7. Congenital toxoplasmosis: Clinical features, outcomes, treatment, and prevention

    PubMed Central

    Singh, Sarman

    2016-01-01

    Toxoplasmosis is caused by a coccidian parasite, Toxoplasma gondii. The parasite is highly prevalent both in humans and in warm-blooded animals. Cat family animals are definitive host, and these animals excrete the infective oocysts in their feces. Humans, though not definitive host, get infection by consuming water or food contaminated with cat feces. Rarely, infection can also take place through transfusing the infected blood, through transplantation of infected organs, or transplacentally from infected mother to fetus. Transplacental infection can cause congenital infection with varied degree of clinical manifestations, which depend on the age of fetus when infection took place. Diagnosis of congenital toxoplasmosis is difficult to establish until it is suspected and laboratory investigations are carried out. In more than 75% of cases, acute infection is missed due to very mild or unnoticeable clinical symptoms and signs. In India, a prevalence rate of 22.4% (8.8-37.3%) has been reported with an overall IgM positivity of 1.43%. It is estimated that approximately between 56,737 and 176,882 children per year are born in India with a possible risk of congenital toxoplasmosis. The diagnosis of congenital toxoplasmosis can be made by serological methods which are most commonly used. The other methods are parasite isolation by culture and molecular methods. Toxoplasmosis is treatable and transplacental transmission can be prevented by spiramycin, which concentrates in the placenta. However, if infection has done any damage to the fetus or the parasite has passed the placenta, spiramycin cannot reverse the damage. Prevention remains the best remedy. PMID:27722099

  8. Predicting MCI outcome with clinically available MRI and CSF biomarkers

    PubMed Central

    Heister, D.; Brewer, J.B.; Magda, S.; Blennow, K.

    2011-01-01

    Objective: To determine the ability of clinically available volumetric MRI (vMRI) and CSF biomarkers, alone or in combination with a quantitative learning measure, to predict conversion to Alzheimer disease (AD) in patients with mild cognitive impairment (MCI). Methods: We stratified 192 MCI participants into positive and negative risk groups on the basis of 1) degree of learning impairment on the Rey Auditory Verbal Learning Test; 2) medial temporal atrophy, quantified from Food and Drug Administration–approved software for automated vMRI analysis; and 3) CSF biomarker levels. We also stratified participants based on combinations of risk factors. We computed Cox proportional hazards models, controlling for age, to assess 3-year risk of converting to AD as a function of risk group and used Kaplan-Meier analyses to determine median survival times. Results: When risk factors were examined separately, individuals testing positive showed significantly higher risk of converting to AD than individuals testing negative (hazard ratios [HR] 1.8–4.1). The joint presence of any 2 risk factors substantially increased risk, with the combination of greater learning impairment and increased atrophy associated with highest risk (HR 29.0): 85% of patients with both risk factors converted to AD within 3 years, vs 5% of those with neither. The presence of medial temporal atrophy was associated with shortest median dementia-free survival (15 months). Conclusions: Incorporating quantitative assessment of learning ability along with vMRI or CSF biomarkers in the clinical workup of MCI can provide critical information on risk of imminent conversion to AD. PMID:21998317

  9. Defining, Valuing, and Teaching Clinical Outcomes Assessment in Professional and Post-Professional Athletic Training Education Programs

    ERIC Educational Resources Information Center

    Snyder, Alison R.; McLeod, Tamara C. Valovich; Sauers, Eric L.

    2007-01-01

    Objective: To provide a basic introduction for athletic training educators about the importance of clinical outcomes measures and to recommend strategies for implementing clinical outcomes assessment education in professional and post-professional athletic training education programs. Background: Outcomes is a frequently used term amongst…

  10. Capturing and Incorporating Patient-Reported Outcomes into Clinical Trials: Practical Considerations for Clinicians.

    PubMed

    Botero, Juliana Perez; Thanarajasingam, Gita; Warsame, Rahma

    2016-10-01

    Patient centeredness as the focus of healthcare delivery requires the incorporation of patient-reported outcomes into clinical trials. Clearly defining measurable outcomes as well as selecting the most appropriate validated collection tool to use is imperative for success. Creating and validating one's own instrument is also possible, albeit more cumbersome. Meticulous data collection to avoid missing data is key, as is limiting the number of data collection points to prevent survey fatigue and using electronic systems to facilitate data gathering and analysis. Working in a multidisciplinary team that includes statisticians with expertise in patient reported outcomes is essential to navigate the complexities of statistical analysis of these variables. Use of available and emerging technologies for data collection and analysis as well as data sharing will greatly facilitate the process of incorporating patient-reported outcomes into trials and routine clinical practice. PMID:27525737

  11. [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.

  12. 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).

  13. Can the American College of Surgeons Risk Calculator Predict 30-Day Complications After Knee and Hip Arthroplasty?

    PubMed

    Edelstein, Adam I; Kwasny, Mary J; Suleiman, Linda I; Khakhkhar, Rishi H; Moore, Michael A; Beal, Matthew D; Manning, David W

    2015-09-01

    Accurate risk stratification of patients undergoing total hip (THA) and knee (TKA) arthroplasty is essential in the highly scrutinized world of pay-for-performance, value-driven healthcare. We assessed the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) surgical risk calculator's ability to predict 30-day complications using 1066 publicly-reported Medicare patients undergoing primary THA or TKA. Risk estimates were significantly associated with complications in the categories of any complication (P = .005), cardiac complication (P < .001), pneumonia (P < .001) and discharge to skilled nursing facility (P < .001). However, predictability of complication occurrence was poor for all complications assessed. To facilitate the equitable provision and reimbursement of patient care, further research is needed to develop accurate risk stratification tools in TKA and THA surgery. PMID:26165953

  14. Alterations of the in vivo torque-velocity relationship of human skeletal muscle following 30 days exposure to simulated microgravity

    NASA Technical Reports Server (NTRS)

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

    1989-01-01

    The effect of a continuous 30-d-long 6-deg headdown bedrest (BR) on the force output ability of skeletal muscles was investigated in human subjects by measuring peak angle specific torque of the knee extensor (KE) and knee flexor (KF) muscle groups of both limbs during unilateral efforts at four speeds (0.52. 1.74, 2.97, and 4.19 rad/sec) during eccentric action. It was found that, for the KE muscle group, the headdown BR resulted in decreases, by 19 percent on the average, of peak angle specific torque; on the other hand, the strength of the KF muscles was not altered significantly. A post-BR recovery for 30 days was found to restore muscle strength of the KE muscle group to about 92 percent of the pre-BR values. Changes of strength were not affected by the type of speed of muscle action.

  15. Intradialytic Hypoxemia and Clinical Outcomes in Patients on Hemodialysis

    PubMed Central

    Meyring-Wösten, Anna; Zhang, Hanjie; Ye, Xiaoling; Fuertinger, Doris H.; Chan, Lili; Kappel, Franz; Artemyev, Mikhail; Ginsberg, Nancy; Wang, Yuedong; Thijssen, Stephan

    2016-01-01

    Background and objectives Intradialytic hypoxemia has been recognized for decades, but its associations with outcomes have not yet been assessed in a large patient cohort. Design, setting, participants, & measurements Our retrospective cohort study was conducted between January of 2012 and January of 2015. We recorded blood oxygen saturation every minute during hemodialysis in patients with arteriovenous access. A 6-month baseline period with at least 10 treatments with oxygen saturation measurements preceded a 12-month follow-up. Patients were stratified by the presence or absence of prolonged intradialytic hypoxemia defined as oxygen saturation <90% for at least one third of the treatment time. Demographic, laboratory, and treatment data and hospitalization and mortality rates were compared between the groups. Multivariate Cox regression analysis was used to assess baseline predictors of all-cause mortality during follow-up. Results In total, 100 (10%) of 983 patients had prolonged intradialytic hypoxemia. These patients were older (+3.6 years; 95% confidence interval, 0.8 to 6.3), had longer dialysis vintage (+1.2 years; 95% confidence interval, 0.3 to 2.1), and had higher prevalence of congestive heart failure (+10.8%; 95% confidence interval, 1.6 to 20.7) and chronic obstructive pulmonary disease (+13%; 95% confidence interval, 5 to 21.2). They also resembled an inflammatory phenotype, with lower serum albumin levels (−0.1 g/dl; 95% confidence interval, −0.2 to 0) and higher neutrophil-to-lymphocyte ratios (+1; 95% confidence interval, 0.5 to 1.6). They had lower hemoglobin levels (−0.2 g/dl; 95% confidence interval, −0.4 to 0) and required more erythropoietin (+1374 U per hemodialysis treatment; 95% confidence interval, 343 to 2405). During follow-up, all-cause hospitalization (1113 hospitalizations; univariate hazard ratio, 1.46; 95% confidence interval, 1.22 to 1.73) and mortality (89 deaths; adjusted hazard ratio, 1.98; 95% confidence interval, 1

  16. Outcomes of laparoscopic adrenalectomy. Clinical experience with 68 patients.

    PubMed

    Pugliese, Raffaele; Boniardi, Marco; Sansonna, Fabio; Maggioni, Dario; De Carli, Stefano; Costanzi, Andrea; Scandroglio, Ildo; Ferrari, Giovanni Carlo; Di Lernia, Stefano; Magistro, Carmelo; Loli, Paola; Grossrubatscher, Erika

    2008-07-01

    The aim of this study was to analyze feasibility and outcomes of laparoscopic adrenalectomy (LA). Pathology, size and bilateral site of lesions were considered. Between December 1998 and May 2007 in our institution a total of 68 patients of mean age of 53 years underwent unilateral (n=57) or bilateral (n=11) LA. Adrenal masses averaged 5.4cm in size (range 1.2-13cm) and 56.7g in weight (range 10-265) including 71 benign and 8 malignant lesions. A total of 79 adrenal glands were resected, 44 right sided and 35 left sided. Removal was complete in 77 cases and partial (sparing adrenalectomy) in 1 patient affected by bilateral pheochomocytoma. Three left adrenalectomies for pheochromocytoma were robot-assisted. The transperitoneal lateral approach was preferred and the posterior retroperitoneal approach was adopted in 5 patients. The mean duration of surgery for each LA was 138+/-90min and 3.8 trocar were used on average (range 3-6). Conversion was needed in 3 cases owing to difficult dissection of large masses. Estimated mean blood loss for each LA was 95+/-30ml and it was greater for bilateral LA. Mortality was nil and morbidity was 5.8%. The average length of hospital stay (LOS) in surgical unit was 4+/-2.4 days (range 2-8). Patients affected by hormone secreting or bilateral lesions, by unilateral or bilateral pheochromocytoma and by bilateral Cushing's disease were transferred to the endocrinological ward so that their overall hospital stay was prolonged to 9+/-2.8 days on average (range 7-17). Mean duration of follow-up of patients was 38 months (range 2-100) and demonstrated acceptable endocrine results. Three primary cortical carcinomas were discovered as chance findings on histologic examination. While long-term results after LA for cortical carcinomas were poor and LA is not recommended in such cases, long-term results after LA for adrenal metastases were encouraging. PMID:17949973

  17. Outcomes of laparoscopic adrenalectomy. Clinical experience with 68 patients.

    PubMed

    Pugliese, Raffaele; Boniardi, Marco; Sansonna, Fabio; Maggioni, Dario; De Carli, Stefano; Costanzi, Andrea; Scandroglio, Ildo; Ferrari, Giovanni Carlo; Di Lernia, Stefano; Magistro, Carmelo; Loli, Paola; Grossrubatscher, Erika

    2008-07-01

    The aim of this study was to analyze feasibility and outcomes of laparoscopic adrenalectomy (LA). Pathology, size and bilateral site of lesions were considered. Between December 1998 and May 2007 in our institution a total of 68 patients of mean age of 53 years underwent unilateral (n=57) or bilateral (n=11) LA. Adrenal masses averaged 5.4cm in size (range 1.2-13cm) and 56.7g in weight (range 10-265) including 71 benign and 8 malignant lesions. A total of 79 adrenal glands were resected, 44 right sided and 35 left sided. Removal was complete in 77 cases and partial (sparing adrenalectomy) in 1 patient affected by bilateral pheochomocytoma. Three left adrenalectomies for pheochromocytoma were robot-assisted. The transperitoneal lateral approach was preferred and the posterior retroperitoneal approach was adopted in 5 patients. The mean duration of surgery for each LA was 138+/-90min and 3.8 trocar were used on average (range 3-6). Conversion was needed in 3 cases owing to difficult dissection of large masses. Estimated mean blood loss for each LA was 95+/-30ml and it was greater for bilateral LA. Mortality was nil and morbidity was 5.8%. The average length of hospital stay (LOS) in surgical unit was 4+/-2.4 days (range 2-8). Patients affected by hormone secreting or bilateral lesions, by unilateral or bilateral pheochromocytoma and by bilateral Cushing's disease were transferred to the endocrinological ward so that their overall hospital stay was prolonged to 9+/-2.8 days on average (range 7-17). Mean duration of follow-up of patients was 38 months (range 2-100) and demonstrated acceptable endocrine results. Three primary cortical carcinomas were discovered as chance findings on histologic examination. While long-term results after LA for cortical carcinomas were poor and LA is not recommended in such cases, long-term results after LA for adrenal metastases were encouraging.

  18. 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

  19. Study on the kinetic characteristics of trace harmful gases for a two-person-30-day integrated CELSS test.

    PubMed

    Guo, Shuangsheng; Ai, Weidang; Fei, Jinxue; Xu, Guoxin; Zeng, Gu; Shen, Yunze

    2015-05-01

    A two-person-30-day controlled ecological life support system (CELSS) integrated test was carried out, and more than 30 kinds of trace harmful gases including formaldehyde, benzene, and ammonia were measured and analyzed dynamically. The results showed that the kinds and quantities of the trace harmful gases presented a continuously fluctuating state during the experimental period, but none of them exceed the spacecraft maximum allowable concentration (SMAC). The results of the Pre-Test (with two persons without plants for 3 days) and the Test (with two persons and four kinds of plants for 30 days) showed that there are some notable differences for the compositions of the trace harmful gases; the volatile organic compounds (VOCs) such as toluene, hexane, and acetamide were searched out in the Pre-Test, but were not found in the Test. Moreover, the concentrations of the trace harmful gases such as acetic benzene, formaldehyde, and ammonia decreased greatly in the Test more than those in the Pre-Test, which means that the plants can purify these gases efficiently. In addition, the VOCs such as carbon monoxide, cyclopentane, and dichloroethylene were checked out in the Test but none in the Pre-Test, which indicates that these materials might be from the crew's metabolites or those devices in the platform. Additionally, the ethylene released specially by plants accumulated in the later period and its concentration reached nearly ten times of 0.05 mg m(-3) (maximum allowed concentration for plant growth, which must have promoted the later withering of plants). We hoped that the work can play a referring function for controlling VOCs effectively so that future more CELSS integrating tests can be implemented smoothly with more crew, longer period, and higher closure. PMID:25483969

  20. Study on the Dynamically Changing Law of Trace Contaminants for the 2-person-30-day Integrated CELSS Test

    NASA Astrophysics Data System (ADS)

    Guo, Shuangsheng

    A 2-person-30-day Integrated CELSS Test was carried out recently, and more than 30 kinds of trace contaminants including formaldehyde, benzene and ammonia were measured and analyzed dynamically. The results showed that the kinds and quantities of trace contaminants presented a continuously fluctuating state during the experimental period, but all of them didn’t exceed the SMAC. The results of the pre-test (with 2 persons without plants for 3 days) and the formal test (with 2 persons and 4 kinds of plants for 30 days) showed that there are some notable differences for the compositions of the trace contaminants; the volatile organic compounds (VOCs) such as toluene, hexane and acetamide were searched out in the pre-test, but couldn’t be found in the formal test. Moreover, the concentrations of the trace gases such as acetic benzene, formaldehyde and ammonia decreased greatly in the formal test more than them in the pre-test, which means that the plants can purified these gases efficiently. In addition, the VOCs such as carbon monoxide, cyclopentane and dichloroethylene were checked out in the formal test but none in the pre-test, which means that these materials might be from cabin facilities or human metabolites. Additionally, the ethylene released specially by plants accumulated in the later period and its concentration reached nearly 10 times of MAC (50ppb), which must have promoted the earlier wane of plants. It’s hoped that the work can play a referring function for future more CELSS integrating test with more persons, longer time and higher material closure.

  1. Study on the kinetic characteristics of trace harmful gases for a two-person-30-day integrated CELSS test.

    PubMed

    Guo, Shuangsheng; Ai, Weidang; Fei, Jinxue; Xu, Guoxin; Zeng, Gu; Shen, Yunze

    2015-05-01

    A two-person-30-day controlled ecological life support system (CELSS) integrated test was carried out, and more than 30 kinds of trace harmful gases including formaldehyde, benzene, and ammonia were measured and analyzed dynamically. The results showed that the kinds and quantities of the trace harmful gases presented a continuously fluctuating state during the experimental period, but none of them exceed the spacecraft maximum allowable concentration (SMAC). The results of the Pre-Test (with two persons without plants for 3 days) and the Test (with two persons and four kinds of plants for 30 days) showed that there are some notable differences for the compositions of the trace harmful gases; the volatile organic compounds (VOCs) such as toluene, hexane, and acetamide were searched out in the Pre-Test, but were not found in the Test. Moreover, the concentrations of the trace harmful gases such as acetic benzene, formaldehyde, and ammonia decreased greatly in the Test more than those in the Pre-Test, which means that the plants can purify these gases efficiently. In addition, the VOCs such as carbon monoxide, cyclopentane, and dichloroethylene were checked out in the Test but none in the Pre-Test, which indicates that these materials might be from the crew's metabolites or those devices in the platform. Additionally, the ethylene released specially by plants accumulated in the later period and its concentration reached nearly ten times of 0.05 mg m(-3) (maximum allowed concentration for plant growth, which must have promoted the later withering of plants). We hoped that the work can play a referring function for controlling VOCs effectively so that future more CELSS integrating tests can be implemented smoothly with more crew, longer period, and higher closure.

  2. LBNP exercise protects aerobic capacity and sprint speed of female twins during 30 days of bed rest.

    PubMed

    Lee, Stuart M C; Schneider, Suzanne M; Boda, Wanda L; Watenpaugh, Donald E; Macias, Brandon R; Meyer, R Scott; Hargens, Alan R

    2009-03-01

    We have shown previously that treadmill exercise within lower body negative pressure (LBNPex) maintains upright exercise capacity (peak oxygen consumption, Vo(2peak)) in men after 5, 15, and 30 days of bed rest (BR). We hypothesized that LBNPex protects treadmill Vo(2peak) and sprint speed in women during a 30-day BR. Seven sets of female monozygous twins volunteered to participate. Within each twin set, one was randomly assigned to a control group (Con) and performed no countermeasures, and the other was assigned to an exercise group (Ex) and performed a 40-min interval (40-80% pre-BR Vo(2peak)) LBNPex (51 +/- 5 mmHg) protocol, plus 5 min of static LBNP, 6 days per week. Before and immediately after BR, subjects completed a 30.5-m sprint test and an upright graded treadmill test to volitional fatigue. These results in women were compared with previously reported reductions in Vo(2peak) and sprint speed in male twins after BR. In women, sprint speed (-8 +/- 2%) and Vo(2peak) (-6 +/- 2%) were not different after BR in the Ex group. In contrast, both sprint speed (-24 +/- 5%) and Vo(2peak) (-16 +/- 3%) were significantly less after BR in the Con group. The effect of BR on sprint speed and Vo(2peak) after BR was not different between women and men. We conclude that treadmill exercise within LBNP protects against BR-induced reductions in Vo(2peak) and sprint speed in women and should prove effective during long-duration spaceflight.

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

    PubMed Central

    Kozak, Marcelo Felipe; Kozak, Ana Carolina Leiroz Ferreira Botelho Maisano; Marchi, Carlos Henrique De; de Godoy, Moacyr Fernandes; 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 defect. Objective To determine factors associated with moderate or greater left atrioventricular valve regurgitation within 30 days of surgical repair of incomplete atrioventricular septal defect. Methods We assessed the results of 51 consecutive patients 14 years-old and younger presenting with incomplete 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 left atrioventricular valve regurgitation, abnormalities on the left atrioventricular valve and the use of annuloplasty. The median age was 4.1 years; the median weight was 13.4 Kg; 37.2% had Down syndrome. At the time of preoperative evaluation, there were 23 cases with moderate or greater left atrioventricular valve regurgitation (45.1%). Abnormalities on the left atrioventricular valve were found in 17.6%; annuloplasty was performed in 21.6%. Results At the time of postoperative evaluation, there were 12 cases with moderate or greater left atrioventricular valve regurgitation (23.5%). The variation between pre- and postoperative grades of left atrioventricular valve regurgitation of patients with atrioventricular valve malformation did not reach significance (P=0.26), unlike patients without such abnormalities (P=0.016). During univariate analysis, only absence of Down syndrome was statistically significant (P=0.02). However, after a multivariate analysis, none of the factors reached significance. Conclusion None of the factors studied was determinant of a moderate or greater left atrioventricular valve regurgitation within the first 30 days of repair of incomplete atrioventricular septal defect in the sample. Patients without abnormalities on the left atrioventricular valve benefit more of the operation. PMID:26107451

  4. 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.

  5. Improving Heart Failure Outcomes: The Role of the Clinical Nurse Specialist.

    PubMed

    Coen, Jennifer; Curry, Kimberly

    2016-01-01

    This article identifies and explains barriers to optimal outcomes of heart failure and the role of the clinical nurse specialist in overcoming these obstacles, improving patient outcomes and quality of life. In recent years, advances in heart failure management have increased survival rates, and as a result, the number of patients requiring services to manage disease progression and the complex array of symptoms associated with end-stage heart disease. Management of the heart failure patient is dependent on the severity of the disease and wide range of available treatment regimens. Disease progression can be unpredictable and treatment regimens increasingly complex. The authors present a typical case of a patient with heart failure, identify the barriers to optimal outcomes in managing heart failure, as well as describe the roles of the clinical nurse specialist in overcoming these barriers within 3 spheres of clinical nurse specialist influence: patient, health care provider, and health care systems. The clinical nurse specialist role is ideally suited to positively affect heart failure outcomes. These positive effects are drawn from the dynamic and unique nature of the clinical nurse specialist role and are perpetrated through the 3 spheres of clinical nurse specialist practice: patient, health care provider, and heath care system. PMID:27575796

  6. St John's wort (Hypericum perforatum): drug interactions and clinical outcomes

    PubMed Central

    Henderson, L; Yue, Q Y; Bergquist, C; Gerden, B; Arlett, P

    2002-01-01

    Aims The aim of this work is to identify the medicines which interact with the herbal remedy St John's wort (SJW), and the mechanisms responsible. Methods A systematic review of all the available evidence, including worldwide published literature and spontaneous case reports provided by healthcare professionals and regulatory authorities within Europe has been undertaken. Results A number of clinically significant interactions have been identified with prescribed medicines including warfarin, phenprocoumon, cyclosporin, HIV protease inhibitors, theophylline, digoxin and oral contraceptives resulting in a decrease in concentration or effect of the medicines. These interactions are probably due to the induction of cytochrome P450 isoenzymes CYP3A4, CYP2C9, CYP1A2 and the transport protein P-glycoprotein by constituent(s) in SJW. The degree of induction is unpredictable due to factors such as the variable quality and quantity of constituent(s) in SJW preparations. In addition, possible pharmacodynamic interactions with selective serotonin re-uptake inhibitors and serotonin (5-HT1d) receptor-agonists such as triptans used to treat migraine were identified. These interactions are associated with an increased risk of adverse reactions. Conclusions In Sweden and the UK the potential risks to patients were judged to be significant and therefore information about the interactions was provided to health care professionals and patients. The product information of the licensed medicines involved has been amended to reflect these newly identified interactions and SJW preparations have been voluntarily labelled with appropriate warnings. PMID:12392581

  7. EMT-induced metabolite signature identifies poor clinical outcome.

    PubMed

    Bhowmik, Salil Kumar; Ramirez-Peña, Esmeralda; Arnold, James Michael; Putluri, Vasanta; Sphyris, Nathalie; Michailidis, George; Putluri, Nagireddy; Ambs, Stefan; Sreekumar, Arun; Mani, Sendurai A

    2015-12-15

    Metabolic reprogramming is a hallmark of cancer. Epithelial-mesenchymal transition (EMT) induces cancer stem cell (CSC) characteristics and promotes tumor invasiveness; however relatively little is known about the metabolic reprogramming in EMT. Here we show that breast epithelial cells undergo metabolic reprogramming following EMT. Relative to control, cell lines expressing EMT transcription factors show ≥1.5-fold accumulation of glutamine, glutamate, beta-alanine and glycylleucine as well as ≥1.5-fold reduction of phosphoenolpyruvate, urate, and deoxycarnitine. Moreover, these metabolic alterations were found to be predictive of overall survival (hazard ratio = 2.3 (95% confidence interval: 1.31-4.2), logrank p-value = 0.03) and define breast cancer molecular subtypes. EMT-associated metabolites are primarily composed of anapleurotic precursors, suggesting that cells undergoing EMT have a shift in energy production. In summary, we describe a unique panel of metabolites associated with EMT and demonstrate that these metabolites have the potential for predicting clinical and biological characteristics associated with patient survival. PMID:26315396

  8. Titanium oral implants: surface characteristics, interface biology and clinical outcome

    PubMed Central

    Palmquist, Anders; Omar, Omar M.; Esposito, Marco; Lausmaa, Jukka; Thomsen, Peter

    2010-01-01

    Bone-anchored titanium implants have revolutionized oral healthcare. Surface properties of oral titanium implants play decisive roles for molecular interactions, cellular response and bone regeneration. Nevertheless, the role of specific surface properties, such as chemical and phase composition and nanoscale features, for the biological in vivo performance remains to be established. Partly, this is due to limited transfer of state-of-the-art preparation techniques to complex three-dimensional geometries, analytical tools and access to minute, intact interfacial layers. As judged by the available results of a few randomized clinical trials, there is no evidence that any particular type of oral implant has superior long-term success. Important insights into the recruitment of mesenchymal stem cells, cell–cell communication at the interface and high-resolution imaging of the interface between the surface oxide and the biological host are prerequisites for the understanding of the mechanisms of osseointegration. Strategies for development of the next generation of material surface modifications for compromised tissue are likely to include time and functionally programmed properties, pharmacological modulation and incorporation of cellular components. PMID:20591849

  9. EMT-induced metabolite signature identifies poor clinical outcome

    PubMed Central

    Putluri, Vasanta; Sphyris, Nathalie; Michailidis, George; Putluri, Nagireddy; Ambs, Stefan; Sreekumar, Arun; Mani, Sendurai A.

    2015-01-01

    Metabolic reprogramming is a hallmark of cancer. Epithelial-mesenchymal transition (EMT) induces cancer stem cell (CSC) characteristics and promotes tumor invasiveness; however relatively little is known about the metabolic reprogramming in EMT. Here we show that breast epithelial cells undergo metabolic reprogramming following EMT. Relative to control, cell lines expressing EMT transcription factors show ≥1.5-fold accumulation of glutamine, glutamate, beta-alanine and glycylleucine as well as ≥1.5-fold reduction of phosphoenolpyruvate, urate, and deoxycarnitine. Moreover, these metabolic alterations were found to be predictive of overall survival (hazard ratio = 2.3 (95% confidence interval: 1.31–4.2), logrank p-value = 0.03) and define breast cancer molecular subtypes. EMT-associated metabolites are primarily composed of anapleurotic precursors, suggesting that cells undergoing EMT have a shift in energy production. In summary, we describe a unique panel of metabolites associated with EMT and demonstrate that these metabolites have the potential for predicting clinical and biological characteristics associated with patient survival. PMID:26315396

  10. Can adventurous training have a role in improving clinical outcomes?

    PubMed

    Mellor, A; Jackson, S; Hardern, R

    2012-06-01

    The aim of military adventurous training (AT) is "to develop, through authorised challenging pursuits and within an outdoor environment, leadership and the qualities necessary to enhance the performance of military personnel during peace and war". An increasing amount of effort is being applied by all three services to increase participation in AT to achieve these, largely immeasurable, aims. Existing guidance to Commanding Officers dictates that, where possible, 20% of a unit strength should undertake some form of AT annually with 5% taking part in an overseas expedition. In a speech in 2008 Alan Johnson, the then Secretary of State for Health, acknowledged that for Armed Forces medical personnel 'just as important as clinical skills are issues such as leadership, communication, adaptability and teamwork." Controlled exposure to risk, discomfort and personal hardship is a common theme for both AT activities and military deployments. Both General Medical Council competencies for all doctors and the Royal College of Anaesthetists military module include elements which can effectively be taught and developed through training in an outdoors environment. These skills include communication skills, leadership, risk assessment and interdisciplinary working. In this review the value of AT in training doctors to develop those attributes is examined. PMID:22860500

  11. Prevalence of Sarcopenia and Associated Outcomes in the Clinical Setting.

    PubMed

    Peterson, Sarah J; Braunschweig, Carol A

    2016-02-01

    Sarcopenia refers to age-associated decrease in muscle mass and function. The condition was originally described in the elderly, but emerging evidence suggests that it is also a concern among the chronically ill nonelderly. Currently there are a number of definitions for diagnosing sarcopenia; however, in the clinical setting, abdominal computed tomography (CT) scans completed for diagnostic purposes can be utilized to identify CT-defined sarcopenia. Recent studies suggest that prevalence of CT-defined sarcopenia is high among chronically ill patients, ranging from 15%-50% in patients with cancer, 30%-45% with liver failure, and 60%-70% for critically ill patients in the intensive care unit. Depleted muscle mass is associated with infectious complications, prolonged duration of mechanical ventilation, longer hospitalization, greater need for rehabilitation care after hospital discharge, and higher mortality. In consideration of the growing population of older adults with multiple comorbidities, more research is needed to identify sarcopenia and develop interventions that are directed at attenuating or reversal muscle loss.

  12. Dietary sodium and clinical outcome in hemodialysis: where do we stand and what is next?

    PubMed

    Rambod, Mehdi; Tolouian, Ramin

    2012-07-01

    The association of dietary sodium and outcome is widely studied in the general population, but less is known in hemodialysis patients. The evidence supporting daily dietary sodium intake of 2 g on hemodialysis is not strong. Mc Causland et al. found that higher dietary sodium intake was marginally associated with a higher ultrafiltration requirement and mortality, but not with blood pressure. Well-designed clinical trials are needed to examine the association of dietary sodium modification and outcomes in hemodialysis patients.

  13. Clinical outcomes and management of inflammatory bowel disease in the older patient.

    PubMed

    Ha, Christina Y; Katz, Seymour

    2013-02-01

    The management of inflammatory bowel disease in the older patient extends beyond the gastrointestinal tract. Pre-existing comorbidities, polypharmacy, functional status and physical reserve can impact disease course, response to therapy and quality of life. Current therapeutic endpoints may not be as immediately applicable to the older IBD patient at higher risk for adverse outcomes. This review focuses on the latest studies addressing the natural history, clinical course and therapeutic outcomes among the older IBD cohort.

  14. Etiology of community-acquired pneumonia in a population-based study: Link between etiology and patients characteristics, process-of-care, clinical evolution and outcomes

    PubMed Central

    2012-01-01

    Background The etiologic profile of community-acquired pneumonia (CAP) for each age group could be similar among inpatients and outpatients. This fact brings up the link between etiology of CAP and its clinical evolution and outcome. Furthermore, the majority of pneumonia etiologic studies are based on hospitalized patients, whereas there have been no recent population-based studies encompassing both inpatients and outpatients. Methods To evaluate the etiology of CAP, and the relationship among the different pathogens of CAP to patients characteristics, process-of-care, clinical evolution and outcomes, a prospective population-based study was conducted in Spain from April 1, 2006, to June 30, 2007. Patients (age >18) with CAP were identified through the family physicians and the hospital area. Results A total of 700 patients with etiologic evaluation were included: 276 hospitalized and 424 ambulatory patients. We were able to define the aetiology of pneumonia in 55.7% (390/700). The most frequently isolated organism was S. pneumoniae (170/390, 43.6%), followed by C. burnetti (72/390, 18.5%), M. pneumoniae (62/390, 15.9%), virus as a group (56/390, 14.4%), Chlamydia species (39/390, 106%), and L. pneumophila (17/390, 4.4%). The atypical pathogens and the S. pneumoniae are present in pneumonias of a wide spectrum of severity and age. Patients infected by conventional bacteria were elderly, had a greater hospitalization rate, and higher mortality within 30 days. Conclusions Our study provides information about the etiology of CAP in the general population. The microbiology of CAP remains stable: infections by conventional bacteria result in higher severity, and the S. pneumoniae remains the most important pathogen. However, atypical pathogens could also infect patients in a wide spectrum of severity and age. PMID:22691449

  15. Effects of Glasgow Outcome Scale Misclassification on Traumatic Brain Injury Clinical Trials

    PubMed Central

    Lu, Juan; Murray, Gordon D.; Steyerberg, Ewout W.; Butcher, Isabella; Mchugh, Gillian S.; Lingsma, Hester; Mushkudiani, Nino; Choi, Sung; Maas, Andrew I.R.

    2008-01-01

    Abstract The Glasgow Outcome Scale (GOS) is the primary endpoint for efficacy analysis of clinical trials in traumatic brain injury (TBI). Accurate and consistent assessment of outcome after TBI is essential to the evaluation of treatment results, particularly in the context of multicenter studies and trials. The inconsistent measurement or interobserver variation on GOS outcome, or for that matter, on any outcome scales, may adversely affect the sensitivity to detect treatment effects in clinical trial. The objective of this study is to examine effects of nondifferential misclassification of the widely used five-category GOS outcome scale and in particular to assess the impact of this misclassification on detecting a treatment effect and statistical power. We followed two approaches. First, outcome differences were analyzed before and after correction for misclassification using a dataset of 860 patients with severe brain injury randomly sampled from two TBI trials with known differences in outcome. Second, the effects of misclassification on outcome distribution and statistical power were analyzed in simulation studies on a hypothetical 800-patient dataset. Three potential patterns of nondifferential misclassification (random, upward and downward) on the dichotomous GOS outcome were analyzed, and the power of finding treatments differences was investigated in detail. All three patterns of misclassification reduce the power of detecting the true treatment effect and therefore lead to a reduced estimation of the true efficacy. The magnitude of such influence not only depends on the size of the misclassification, but also on the magnitude of the treatment effect. In conclusion, nondifferential misclassification directly reduces the power of finding the true treatment effect. An awareness of this procedural error and methods to reduce misclassification should be incorporated in TBI clinical trials. PMID:18578634

  16. Tophus measurement as an outcome measure for clinical trials of chronic gout: progress and research priorities.

    PubMed

    Dalbeth, Nicola; McQueen, Fiona M; Singh, Jasvinder A; MacDonald, Patricia A; Edwards, N Lawrence; Schumacher, H Ralph; Simon, Lee S; Stamp, Lisa K; Neogi, Tuhina; Gaffo, Angelo L; Khanna, Puja P; Becker, Michael A; Taylor, William J

    2011-07-01

    Despite the recognition that tophus regression is an important outcome measure in clinical trials of chronic gout, there is no agreed upon method of tophus measurement. A number of methods have been used in clinical trials of chronic gout, from simple physical measurement techniques to more complex advanced imaging methods. This article summarizes methods of tophus measurement and discusses their properties. Physical measurement using Vernier calipers meets most aspects of the Outcome Measures in Rheumatology (OMERACT) filter. Rigorous testing of the complex methods, particularly with respect to reliability and sensitivity to change, is needed to determine the appropriate use of these methods. Further information is also required regarding which method of physical measurement is best for use in future clinical trials. The need to develop and test a patient-reported outcome measure of tophus burden is also highlighted.

  17. User-centered design in clinical handover: exploring post-implementation outcomes for clinicians.

    PubMed

    Wong, Ming Chao; Cummings, Elizabeth; Turner, Paul

    2013-01-01

    This paper examines the outcomes for clinicians from their involvement in the development of an electronic clinical hand-over tool developed using principles of user-centered design. Conventional e-health post-implementation evaluations tend to emphasize technology-related (mostly positive) outcomes. More recently, unintended (mostly negative) consequences arising from the implementation of e-health technologies have also been reported. There remains limited focus on the post-implementation outcomes for users, particularly those directly involved in e-health design processes. This paper presents detailed analysis and insights into the outcomes experienced post-implementation by a cohort of junior clinicians involved in developing an electronic clinical handover tool in Tasmania, Australia. The qualitative methods used included observations, semi-structured interviews and analysis of clinical handover notes. Significantly, a number of unanticipated flow-on effects were identified that mitigated some of the challenges arising during the design and implementation of the tool. The paper concludes by highlighting the importance of identifying post-implementation user outcomes beyond conventional system adoption and use and also points to the need for more comprehensive evaluative frameworks to encapsulate these broader socio-technical user outcomes.

  18. Collaboration in research: testing the PIPC model on clinical and nonclinical outcomes.

    PubMed

    Lengacher, C A; Mabe, P R; Heinemann, D; VanCott, M L; Kent, K; Swymer, S

    1997-01-01

    This outcomes research used a collaborative framework between a college of nursing and a medical center to test the effects of the Partners in Patient Care delivery model (PIPC) on clinical and nonclinical outcomes. An experimental pretest-postest design was used to compare selected nonclinical outcomes and clinical outcomes of care in two patient units. Results showed that there were significant differences between units in the nonclinical outcomes of nurse satisfaction, salary costs, supply costs, and productivity as measured by documentation time. In addition, there were significant differences in the clinical outcomes of care in terms of patient satisfaction. No significant differences were found in number of falls, medication errors, and intravenous infections; however, when ratios of these indicators were examined in relation to patient days, significant differences in the medication error ratio and the fall ratio were revealed. The results indicate that the PIPC delivery model did have positive effects on patient satisfaction and nurse satisfaction but that there were increased costs and increased time spent in documentation on the pilot unit. PMID:9171689

  19. Academic nursing clinic: impact on health and cost outcomes for vulnerable populations.

    PubMed

    Badger, Terry A; McArthur, Donna Behler

    2003-02-01

    The purpose of this study was to examine selected health and cost outcomes of clients who used an academic nursing clinic (ANC) located in a high-rise public housing facility for low-income citizens. Service use, health promotion and screening, quality of care, satisfaction and costs were examined. Health outcomes were improved. Estimated cost savings were about $36,000 during the first year with reduced paramedic and police calls, hospitalizations, and emergency room visits. Findings show that advanced practice nurses can positively influence health outcomes by providing cost-effective quality health care. PMID:12624864

  20. PREP for Strong Bonds: A review of outcomes from a randomized clinical trial

    PubMed Central

    Allen, Elizabeth; Stanley, Scott; Rhoades, Galena; Markman, Howard

    2015-01-01

    To help address the relationship needs of service members, there have been a number of programs offered within active duty and veteran contexts. One program, offered within the Strong Bonds portfolio delivered by Army Chaplains, is PREP for Strong Bonds (PREP = the Prevention and Relationship Education Program). PREP has a number of empirically based and tested variants. This article reviews the disseminated research regarding results from a large randomized clinical trial designed to test the effectiveness of PREP for Strong Bonds. From a sample of 662 Army couples drawn from two sites, outcome papers have focused on different subsamples, marital outcomes, follow up time points, and moderators. Reviewing these disseminated outcomes, we conclude that PREP for Strong Bonds has significant divorce reduction effects at one site; these divorce effects were found at both one and two years post intervention, and were moderated by factors such as minority status, economic strain, and cohabitation history of the couple. In terms of marital quality outcomes, some modest overall effects were found pre to post intervention, but there were no overall marital quality outcome effects two years post intervention. However, marital quality outcomes are significantly moderated by infidelity and cohabitation history, with couples reporting these risk factors showing greater positive marital quality outcomes. These results to date are discussed in terms of clinical and research implications as well as directions for future work, such as examining longer term preventative effects. PMID:26366041

  1. Correlation of clinical outcome to the estimated radiation dose from Boron Neutron Capture Therapy (BNCT)

    SciTech Connect

    Chadha, M.; Coderre, J.A.; Chanana, A.D.

    1996-12-31

    A phase I/II trial delivering a single fraction of BNCT using p-Boronophenylalanine-Fructose and epithermal neutrons at the the Brookhaven Medical Research Reactor was initiated in September 1994. The primary endpiont of the study was to evaluate the feasibility and safety of a given BNCT dose. The clinical outcome of the disease was a secondary endpoint of the study. The objective of this paper is to evaluate the correlation of the clinical outcome of patients to the estimated radiation dose from BNCT.

  2. The application of Rasch measurement theory to psychiatric clinical outcomes research

    PubMed Central

    Barbic, Skye P.; Cano, Stefan J.

    2016-01-01

    This commentary argues the importance of robust, meaningful assessment of clinical and functional outcomes in psychiatry. Outcome assessments should be fit for the purpose of measuring relevant concepts of interest in specific clinical settings. As well, the measurement model selected to develop and test assessments can be critical for guiding care. Three types of measurement models are presented: classical test theory, item response theory, and Rasch measurement theory. To optimise current diagnostic and treatment practices in psychiatry, careful consideration of these models is warranted.. PMID:27752341

  3. 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

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

    PubMed

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

    2016-09-01

    OBJECTIVE Hospital readmission rate is increasingly used as a quality outcome measure after surgery. The purpose of this study was to establish, using a national database, the baseline readmission rates and risk factors for patient readmission after pediatric neurosurgical procedures. METHODS The American College of Surgeons National Surgical Quality Improvement Program-Pediatric database was queried for pediatric patients treated by a neurosurgeon between 2012 and 2013. Procedures were categorized by current procedural terminology (CPT) code. Patient demographics, comorbidities, preoperative laboratory values, operative variables, and postoperative complications were analyzed via univariate and multivariate techniques to find associations with unplanned readmissions within 30 days of the primary procedure. RESULTS A total of 9799 cases met the inclusion criteria, 1098 (11.2%) of which had an unplanned readmission within 30 days. Readmission occurred 14.0 ± 7.7 days postoperatively (mean ± standard deviation). The 4 procedures with the highest unplanned readmission rates were CSF shunt revision (17.3%; CPT codes 62225 and 62230), repair of myelomeningocele > 5 cm in diameter (15.4%), CSF shunt creation (14.1%), and craniectomy for infratentorial tumor excision (13.9%). The lowest unplanned readmission rates were for spine (6.5%), craniotomy for craniosynostosis (2.1%), and skin lesion (1.0%) procedures. On multivariate regression analysis, the odds of readmission were greatest in patients experiencing postoperative surgical site infection (SSI; deep, organ/space, superficial SSI, and wound disruption: OR > 12 and p < 0.001 for each). Postoperative pneumonia (OR 4.294, p < 0.001), urinary tract infection (OR 4.262, p < 0.001), and sepsis (OR 2.616, p = 0.006) also independently increased the readmission risk. Independent patient risk factors for unplanned readmission included Native American race (OR 2.363, p = 0.019), steroid use > 10 days (OR 1.411, p = 0

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

    PubMed

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

    2016-09-01

    OBJECTIVE Hospital readmission rate is increasingly used as a quality outcome measure after surgery. The purpose of this study was to establish, using a national database, the baseline readmission rates and risk factors for patient readmission after pediatric neurosurgical procedures. METHODS The American College of Surgeons National Surgical Quality Improvement Program-Pediatric database was queried for pediatric patients treated by a neurosurgeon between 2012 and 2013. Procedures were categorized by current procedural terminology (CPT) code. Patient demographics, comorbidities, preoperative laboratory values, operative variables, and postoperative complications were analyzed via univariate and multivariate techniques to find associations with unplanned readmissions within 30 days of the primary procedure. RESULTS A total of 9799 cases met the inclusion criteria, 1098 (11.2%) of which had an unplanned readmission within 30 days. Readmission occurred 14.0 ± 7.7 days postoperatively (mean ± standard deviation). The 4 procedures with the highest unplanned readmission rates were CSF shunt revision (17.3%; CPT codes 62225 and 62230), repair of myelomeningocele > 5 cm in diameter (15.4%), CSF shunt creation (14.1%), and craniectomy for infratentorial tumor excision (13.9%). The lowest unplanned readmission rates were for spine (6.5%), craniotomy for craniosynostosis (2.1%), and skin lesion (1.0%) procedures. On multivariate regression analysis, the odds of readmission were greatest in patients experiencing postoperative surgical site infection (SSI; deep, organ/space, superficial SSI, and wound disruption: OR > 12 and p < 0.001 for each). Postoperative pneumonia (OR 4.294, p < 0.001), urinary tract infection (OR 4.262, p < 0.001), and sepsis (OR 2.616, p = 0.006) also independently increased the readmission risk. Independent patient risk factors for unplanned readmission included Native American race (OR 2.363, p = 0.019), steroid use > 10 days (OR 1.411, p = 0

  6. Thyroid hormones association with depression severity and clinical outcome in patients with major depressive disorder.

    PubMed

    Berent, Dominika; Zboralski, Krzysztof; Orzechowska, Agata; Gałecki, Piotr

    2014-01-01

    The clinical implications of thyroid hormones in depression have been studied extensively and still remains disputable. Supplementation of thyroid hormones is considered to augment and accelerate antidepressant treatment. Studies on the role of thyroid hormones in depression deliver contradictory results. Here we assess theirs impact on depression severity and final clinical outcome in patients with major depression. Thyrotropin, free thyroxine (FT4), and free triiodothyronine (FT3) concentrations were measured with automated quantitative enzyme immunoassay. Depression severity and final clinical outcome were rated with 17-itemic Hamilton Rating Scale for Depression [HDRS(17)] and Clinical Global Impression Scales for severity and for improvement (CGIs, CGIi). FT3 and FT4 concentrations were significantly positively correlated with clinical improvement evaluated with CGIi (R = 0.38, P = 0.012; R = 0.33, P = 0.034, respectively). There was a significant correlation between FT4 concentrations and depression severity assessed in HDRS(17) (R = 0.31, P = 0.047). Male patients presented significantly higher FT3 serum levels (Z = 2.34, P = 0.018) and significantly greater clinical improvement (Z = 2.36, P = 0.018) when compared to female patients. We conclude that free thyroid hormones concentrations are associated with depression severity and have an impact on final clinical outcome. It can be more efficient to augment and accelerate the treatment of major depressive disorder with triiodothyronine instead of levothyroxine because of individual differences in thyroid hormones metabolism.

  7. 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

  8. Clinical outcomes of single versus double blastocyst transfer in fresh and vitrified-warmed cycles

    PubMed Central

    Eum, Jin Hee; Park, Jae Kyun; Kim, So Young; Paek, Soo Kyung; Seok, Hyun Ha; Chang, Eun Mi; Lee, Woo Sik

    2016-01-01

    Objective Assisted reproductive technology has been associated with an increase in multiple pregnancies. The most effective strategy for reducing multiple pregnancies is single embryo transfer. Beginning in October 2015, the National Supporting Program for Infertility in South Korea has limited the number of embryos that can be transferred per in vitro fertilization (IVF) cycle depending on the patient's age. However, little is known regarding the effect of age and number of transferred embryos on the clinical outcomes of Korean patients. Thus, this study was performed to evaluate the effect of the number of transferred blastocysts on clinical outcomes. Methods This study was carried out in the Fertility Center of CHA Gangnam Medical Center from January 2013 to December 2014. The clinical outcomes of 514 women who underwent the transfer of one or two blastocysts on day 5 after IVF and of 721 women who underwent the transfer of one or two vitrified-warmed blastocysts were analyzed retrospectively. Results For both fresh and vitrified-warmed cycles, the clinical pregnancy rate and live birth or ongoing pregnancy rate were not significantly different between patients who underwent elective single blastocyst transfer (eSBT) and patients who underwent double blastocyst transfer (DBT), regardless of age. However, the multiple pregnancy rate was significantly lower in the eSBT group than in the DBT group. Conclusion The clinical outcomes of eSBT and DBT were equivalent, but eSBT had a lower risk of multiple pregnancy and is, therefore, the best option. PMID:27689039

  9. Clinical outcomes of single versus double blastocyst transfer in fresh and vitrified-warmed cycles

    PubMed Central

    Eum, Jin Hee; Park, Jae Kyun; Kim, So Young; Paek, Soo Kyung; Seok, Hyun Ha; Chang, Eun Mi; Lee, Woo Sik

    2016-01-01

    Objective Assisted reproductive technology has been associated with an increase in multiple pregnancies. The most effective strategy for reducing multiple pregnancies is single embryo transfer. Beginning in October 2015, the National Supporting Program for Infertility in South Korea has limited the number of embryos that can be transferred per in vitro fertilization (IVF) cycle depending on the patient's age. However, little is known regarding the effect of age and number of transferred embryos on the clinical outcomes of Korean patients. Thus, this study was performed to evaluate the effect of the number of transferred blastocysts on clinical outcomes. Methods This study was carried out in the Fertility Center of CHA Gangnam Medical Center from January 2013 to December 2014. The clinical outcomes of 514 women who underwent the transfer of one or two blastocysts on day 5 after IVF and of 721 women who underwent the transfer of one or two vitrified-warmed blastocysts were analyzed retrospectively. Results For both fresh and vitrified-warmed cycles, the clinical pregnancy rate and live birth or ongoing pregnancy rate were not significantly different between patients who underwent elective single blastocyst transfer (eSBT) and patients who underwent double blastocyst transfer (DBT), regardless of age. However, the multiple pregnancy rate was significantly lower in the eSBT group than in the DBT group. Conclusion The clinical outcomes of eSBT and DBT were equivalent, but eSBT had a lower risk of multiple pregnancy and is, therefore, the best option.

  10. Plasma C-Reactive Protein and Clinical Outcomes after Acute Ischemic Stroke: A Prospective Observational Study

    PubMed Central

    Matsuo, Ryu; Ago, Tetsuro; Hata, Jun; Wakisaka, Yoshinobu; Kuroda, Junya; Kuwashiro, Takahiro; Kitazono, Takanari; Kamouchi, Masahiro

    2016-01-01

    Background and Purpose Although plasma C-reactive protein (CRP) is elevated in response to inflammation caused by brain infarction, the association of CRP with clinical outcomes after acute ischemic stroke remains uncertain. This study examined whether plasma high-sensitivity CRP (hsCRP) levels at onset were associated with clinical outcomes after acute ischemic stroke independent of conventional risk factors and acute infections after stroke. Methods We prospectively included 3653 patients with first-ever ischemic stroke who had been functionally independent and were hospitalized within 24 h of onset. Plasma hsCRP levels were measured on admission and categorized into quartiles. The association between hsCRP levels and clinical outcomes, including neurological improvement, neurological deterioration, and poor functional outcome (modified Rankin scale ≥3 at 3 months), were investigated using a logistic regression analysis. Results Higher hsCRP levels were significantly associated with unfavorable outcomes after adjusting for age, sex, baseline National Institutes of Health Stroke Scale score, stroke subtype, conventional risk factors, intravenous thrombolysis and endovascular therapy, and acute infections during hospitalization (multivariate-adjusted odds ratios [95% confidence interval] in the highest quartile versus the lowest quartile as a reference: 0.80 [0.65–0.97] for neurological improvement, 1.72 [1.26–2.34] for neurological deterioration, and 2.03 [1.55–2.67] for a poor functional outcome). These associations were unchanged after excluding patients with infectious diseases occurring during hospitalization, or those with stroke recurrence or death. These trends were similar irrespective of stroke subtypes or baseline stroke severity, but more marked in patients aged <70 years (Pheterogeneity = 0.001). Conclusions High plasma hsCRP is independently associated with unfavorable clinical outcomes after acute ischemic stroke. PMID:27258004

  11. Clinical presentation and treatment outcome of retinoblastoma in children of South Western China

    PubMed Central

    Gao, Jingge; Zeng, Jihong; Guo, Bo; He, Weimin; Chen, Jun; Lu, Fang; Chen, Danian

    2016-01-01

    Abstract To study the clinical presentation and treatment outcome among children in South Western China with retinoblastoma (RB) and to determine factors predictive of poor outcome. A retrospective review of children diagnosed with RB from 2006 to 2015 at West China Hospital was undertaken. Demographic and clinical characteristics and treatment outcomes were studied. A total of 253 patients (unilateral 80.2%, bilateral 19.8%) were studied. Twenty six patients (10.3%) were from minority ethnic groups of China. The median onset age was 21 months. Leukocoria was the most common presenting sign (71%). Tumors were intraocular in 91.3% cases, extraocular in 8.7% cases. Extraocular RB patients had a longer median lag period than intraocular patients (9 months vs 2 months, P < 0.0001). In the intraocular group, 89.5% were advanced group D or E diseases. Enucleation was the major treatment for intraocular RB. However, over 10 years, the enucleation rate decreased constantly while more patients received chemotherapy. The Kaplan–Meier survival probability was 87.8%, 81.4%, and 74.8% at 3 years, 5 years, and 10 years, respectively. On Cox regression analysis, extraocular RB (P = 0.0008) and treatment abandonment (P < 0.0001) were associated with poor outcome; bilateral RB (P = 0.0116) and advanced pathological grade pT4 (P = 0.0011) were associated with poor outcome of intraocular RB. Most RB patients from South Western China were diagnosed at advanced clinical stage. Delayed presentation is related to extraocular RB which is a risk factor for poor outcome. Chemotherapy increased the eye salvage but had no effects to overall survival. Education for parents and general physicians for the early signs of RB (such as leukocoria), therapeutic strategy and treatment outcomes of RB may promote early diagnosis, improve the compliance, and outcome. PMID:27759657

  12. Beyond the "acid test": a conceptual review and reformulation of outcome evaluation in clinical supervision.

    PubMed

    Milne, Derek

    2014-01-01

    Theoretical models abound within clinical supervision, but these rarely have been applied to supervision evaluation. Instead, it appears that reviewers and researchers have simply transferred to supervision the conceptual frameworks used within medicine, especially the idea that clinical outcomes are the "acid test" of supervisory effectiveness or quality. Following a careful examination of the key literature, in this paper I argue that this has led to an over-emphasis on clinical outcomes, with the net effect of reducing scientific confidence, understanding, and the effectiveness of supervision. To begin to rectify this bias, an augmented fidelity framework is used to reformulate evaluation, drawing on some of the key concepts guiding evaluation within related fields (i.e. service evaluation; staff development; psychotherapy; applied research). The resulting evaluation model is specific to clinical supervision and can help to increase our understanding, enhance our practice, re-prioritise research, and inspire confidence in supervision.

  13. Beyond the "acid test": a conceptual review and reformulation of outcome evaluation in clinical supervision.

    PubMed

    Milne, Derek

    2014-01-01

    Theoretical models abound within clinical supervision, but these rarely have been applied to supervision evaluation. Instead, it appears that reviewers and researchers have simply transferred to supervision the conceptual frameworks used within medicine, especially the idea that clinical outcomes are the "acid test" of supervisory effectiveness or quality. Following a careful examination of the key literature, in this paper I argue that this has led to an over-emphasis on clinical outcomes, with the net effect of reducing scientific confidence, understanding, and the effectiveness of supervision. To begin to rectify this bias, an augmented fidelity framework is used to reformulate evaluation, drawing on some of the key concepts guiding evaluation within related fields (i.e. service evaluation; staff development; psychotherapy; applied research). The resulting evaluation model is specific to clinical supervision and can help to increase our understanding, enhance our practice, re-prioritise research, and inspire confidence in supervision. PMID:25122986

  14. Severe hypoxaemia can predict unfavourable clinical outcomes in individuals with pulmonary embolism aged over 40 years

    PubMed Central

    Souza, Caio Simoes; Resende, Fernanda Simoes Seabra; Rodrigues, Marcelo Palmeira

    2014-01-01

    INTRODUCTION Acute pulmonary embolism (APE) is an urgent clinical condition that can progress in a wide variety of ways. Therefore, we sought to develop an easy-to-apply algorithm, to be based on readily available clinical indicators, effective in predicting unfavourable outcomes. METHODS This was a retrospective cohort study based on systematically collected data in a database. The study included 102 patients with APE who were admitted to a tertiary care hospital. The following outcomes were defined as unfavourable shock, the need for mechanical ventilation, the use of thrombolytics, and death. Logistic regression analysis was used to explore variables significantly associated with outcome and to calculate post-test probabilities. RESULTS The prevalence of unfavourable outcomes was 25.5% (26 of the 102 patients with APE). The risk of an unfavourable outcome was reduced to 7.0% for patients with APE who were aged ≤ 40 years. In patients with APE who were aged > 40 years, the presence of hypoxaemia (i.e. peripheral oxygen saturation < 90%) alone increased the risk of an unfavourable outcome to 57.0%. A recent history of trauma and the presence of pre-existing lung or heart disease were significantly associated with unfavourable outcomes. The inclusion of those variables in the logistic regression model increased the post-test risk of an unfavourable outcome to 65.0%–86.0%. CONCLUSION Advanced age (i.e. > 40 years), the presence of hypoxaemia, a recent history of trauma and the presence of pre-existing lung or heart disease are risk factors for unfavourable outcome in patients with APE. PMID:25273933

  15. Relationship between Lesion Topology and Clinical Outcome In Anterior Circulation Large Vessel Occlusions

    PubMed Central

    Rangaraju, Srikant; Streib, Christopher; Aghaebrahim, Amin; Jadhav, Ashutosh; Frankel, Michael; Jovin, Tudor G.

    2015-01-01

    Background and purpose Diffusion-weighted imaging (DWI) ASPECTS, a surrogate of infarct volume, predicts outcome in anterior large vessel occlusion (LVO) strokes. We aim to determine whether topological information captured by DWI ASPECTS contributes additional prognostic value. Methods Adults with intracranial ICA, M1 or M2 MCA occlusions who underwent endovascular therapy were included. The primary outcome measure was poor clinical outcome (3-month modified Rankin Scale score 3–6). Prognostic value of the 10 DWI ASPECTS regions in predicting poor outcome was determined by multivariable logistic regression, controlling for final infarct volume, age and laterality. Results 213 patients (mean age 66.1±14.5 years, median NIHSS 15) were included. Inter-rater reliability was good for DWI ASPECTS (Deep regions: Kappa=0.72, Cortical regions: Kappa=0.63). All DWI ASPECTS regions with the exception of the putamen were significant predictors (p<0.05) of poor outcome in univariate analyses. Statistical collinearity among ASPECTS regions was not observed. Using penalized multivariable logistic regression, only M4 (OR=2.82 95%CI 1.39–5.76) and M6 (OR=2.45, 95%CI 1.15–5.3) involvement were associated with poor outcome. M6 involvement independently predicted poor outcome in right hemispheric strokes (OR=5.8, 95%CI 1.9–20.3) whereas M4 (OR=4.3, 95%CI 1.3–15.0) involvement predicted poor outcome in left hemispheric strokes adjusting for infarct volume. Topologic information modestly improved the predictive ability of a prognostic score that incorporates age, infarct volume and hemorrhagic transformation. Conclusions Involvement of the right parieto-occipital (M6) and left superior-frontal (M4) regions impact clinical outcome in anterior LVOs over and above the effect of infarct volume and should be considered during prognostication. PMID:26060248

  16. 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

  17. Models for the analysis of repeated continuous outcome measures in clinical trials.

    PubMed

    De Livera, Alysha M; Zaloumis, Sophie; Simpson, Julie A

    2014-02-01

    Repeated continuous outcome measures are common in clinical trials. In this tutorial style paper, using data collected from a trial evaluating an intervention for managing asthma and chronic obstructive pulmonary disease, we demonstrate ways of statistically analysing such data to answer frequently encountered clinical research questions. We illustrate the use of linear mixed effects modelling in doing so and discuss its advantages over several other commonly used approaches. The methods described in this paper can easily be carried out using standard statistical software.

  18. Clinical characteristics, prognostic factors, and outcomes of adult patients with hemophagocytic lymphohistiocytosis.

    PubMed

    Otrock, Zaher K; Eby, Charles S

    2015-03-01

    Hemophagocytic lymphohistiocytosis (HLH) is a rare clinical syndrome characterized by the activation of the mononuclear phagocytic system. The diagnosis of HLH in adults is challenging not only because the majority of the reported data are from pediatric patients, but also because HLH occurs in many disease entities. This study reports the clinical and laboratory findings and prognostic factors of adult HLH in a large cohort managed at a single medical center from 2003 to 2014. Seventy-three patients met the HLH-2004 diagnostic criteria. The median age was 51 years (range, 18-82 years); 41 (56.2%) were male. Patients manifested fever, cytopenias, and elevated ferritin in >85% of cases. Likely causes of HLH were as follows: 30 (41.1%) infections, 21 (28.8%) malignancies, 5 (6.8%) attributed to autoimmune disorders, 1 (1.4%) primary immunodeficiency, 2 (2.7%) post solid organ transplantation, and 13 (17.8%) idiopathic. The median overall survival was 7.67 months. Patients with malignancy-associated HLH had a markedly worse survival compared with patients with non-malignancy-associated HLH (median overall survival 1.13 vs. 46.53 months, respectively; P < 0.0001). In a multivariable analysis, malignancy (hazard ratio = 12.22; 95% CI: 2.53-59.02; P = 0.002) correlated with poor survival. Ferritin >50,000 µg/L correlated with 30-day mortality. Survival after a diagnosis of HLH is dismal, especially among those with malignancy-associated HLH. The development of a registry for adults with HLH would improve our understanding of this syndrome, validate diagnostic criteria, and help develop effective treatment strategies. PMID:25469675

  19. 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

  20. Impact of Ischemic Preconditioning on Outcome in Clinical Liver Surgery: A Systematic Review

    PubMed Central

    Chu, Michael J. J.; Vather, Ryash; Hickey, Anthony J. R.; Phillips, Anthony R. J.; Bartlett, Adam S. J. R.

    2015-01-01

    Background. Ischemia-reperfusion injury is a major cause of post-liver-surgery complications. Ischemic preconditioning (IPC) has been demonstrated to protect against ischemia-reperfusion injury. Clinical studies have examined IPC in liver surgery but with conflicting results. This systematic review aimed to evaluate the effects of IPC on outcome in clinical liver surgery. Methods. An electronic search of OVID Medline and Embase databases was performed to identify studies that reported outcomes in patients undergoing liver surgery subjected to IPC. Basic descriptive statistics were used to summarise data from individual clinical studies. Results. 1093 articles were identified, of which 24 met the inclusion criteria. Seven topics were selected and analysed by subgroup. There were 10 studies in cadaveric liver transplantation, 2 in living-related liver transplantation, and 12 in liver resection. IPC decreases hepatocellular damage in liver surgery as determined by transaminases but does not translate to any significant clinical benefit in orthotopic liver transplant or liver resection. Conclusions. Available clinical evidence does not support routine use of IPC in liver surgery as it does not offer any apparent benefit in perioperative outcome. Further clinical studies will need to be carried out to determine the subset of patients that will benefit from IPC. PMID:25756045

  1. Diagnostic agreement predicts treatment process and outcomes in youth mental health clinics.

    PubMed

    Jensen-Doss, Amanda; Weisz, John R

    2008-10-01

    Several studies have documented low rates of agreement between clinician- and researcher-generated diagnoses. However, little is known about whether this lack of agreement has implications for the processes and outcomes of subsequent treatment. To study this possibility, the authors used diagnostic agreement to predict therapy engagement and outcomes for 197 youths treated in 5 community mental health clinics. Diagnostic agreement predicted better therapy engagement, with the agree group having fewer therapy no-shows and cancellations and a decreased likelihood of therapy dropout. Additionally, support for a link between agreement and treatment outcomes was found, as the agree group obtained larger reductions in parent-reported internalizing problems during treatment. These findings suggest that diagnostic accuracy may be an important precursor to successful treatment and highlight the importance of future research to find ways to incorporate standardized diagnostic procedures into clinical care settings. PMID:18837589

  2. Clinical Outcomes and Complications of Cortical Button Distal Biceps Repair: A Systematic Review of the Literature.

    PubMed

    Panagopoulos, Andreas; Tatani, Irini; Tsoumpos, Pantelis; Ntourantonis, Dimitris; Pantazis, Konstantinos; Triantafyllopoulos, Ioannis K

    2016-01-01

    Objectives. The purpose of the present study was to investigate the clinical outcomes and complications of the cortical button distal biceps fixation method. Material and Methods. All methods followed the PRISMA guidelines. Included studies had to describe clinical outcomes and complications after acute distal biceps repair with cortical button fixation. Eligibility criteria also included English language, more than 5 cases with minimum follow-up of 6 months, and preferably usage of at least one relevant clinical score (MEPS, ASES, and/or DASH) for final outcome. A loss of at least 30° in motion-flexion, extension, pronation, or supination-and a loss of at least 30% of strength were considered an unsatisfactory result. Results. The review identified 7 articles including 105 patients (mean age 43.6 years) with 106 acute distal biceps ruptures. Mean follow-up was 26.3 months. Functional outcome of ROM regarding flexion/extension and pronation/supination was satisfactory in 94 (89.5%) and 86 (82%) patients in respect. Averaged flexion and supination strength had been reported in 6/7 studies (97 patients) and were satisfactory in 82.4% of them. The most common complication was transient nerve palsy (14.2%). The overall reoperation rate was 4.8% (5/105 cases). Conclusion. Cortical button fixation for acute distal biceps repair is a reproducible operation with good clinical results. Most of the complications can be avoided with appropriate surgical technique. PMID:27525303

  3. Craniotomy or Decompressive Craniectomy for Acute Subdural Hematomas: Surgical Selection and Clinical Outcome

    PubMed Central

    Kwon, Young Sub; Yang, Kook Hee

    2016-01-01

    Objective Craniotomy (CO) and decompressive craniectomy (DC) are two main surgical options for acute subdural hematomas (ASDH). However, optimal selection of surgical modality is unclear and decision may vary with surgeon's experience. To clarify this point, we analyzed preoperative findings and surgical outcome of patients with ASDH treated with CO or DC. Methods From January 2010 to December 2014, data for 46 patients with ASDH who underwent CO or DC were retrospectively reviewed. The demographic, clinical, imaging and clinical outcomes were analyzed and statistically compared. Results Twenty (43%) patients underwent CO and 26 (57%) patients received DC. In DC group, preoperative Glascow Coma Scale was lower (p=0.034), and more patient had non-reactive pupil (p=0.004). Computed tomography findings of DC group showed more frequent subarachnoid hemorrhage (p=0.003). Six month modified Rankin Scale showed favorable outcome in 60% of CO group and 23% of DC group (p=0.004). DC was done in patient with more unfavorable preoperative features (p=0.017). Patients with few unfavorable preoperative features (<6) had good outcome with CO (p<0.001). Conclusion In selective cases of few unfavorable clinical findings, CO may also be an effective surgical option for ASDH. Although DC remains to be standard of surgical modality for patients with poor clinical status, CO can be an alternative considering the possible complications of DC. PMID:27182498

  4. Relationship Between Upper Respiratory Tract Influenza Test Result and Clinical Outcomes Among Critically Ill Influenza Patients.

    PubMed

    Reddy, Krishna P; Bajwa, Ednan K; Parker, Robert A; Onderdonk, Andrew B; Walensky, Rochelle P

    2016-01-01

    Among critically ill patients with lower respiratory tract (LRT)-confirmed influenza, we retrospectively observed worse 28-day clinical outcomes in upper respiratory tract (URT)-negative versus URT-positive subjects. This finding may reflect disease progression and highlights the need for influenza testing of both URT and LRT specimens to improve diagnostic yield and possibly inform prognosis. PMID:26966696

  5. Poststroke Shoulder Pain in Turkish Stroke Patients: Relationship with Clinical Factors and Functional Outcomes

    ERIC Educational Resources Information Center

    Barlak, Aysegul; Unsal, Sibel; Kaya, Kurtulus; Sahin-Onat, Sule; Ozel, Sumru

    2009-01-01

    The objective of this study was to assess the possible causes of hemiplegic shoulder pain (HSP) in Turkish patients with stroke, to identify the correlation between HSP and clinical factors, and to review the effects of HSP on functional outcomes. A total of 187 consecutive patients with stroke were evaluated for the presence of HSP and for the…

  6. Clinical Outcomes and Complications of Cortical Button Distal Biceps Repair: A Systematic Review of the Literature

    PubMed Central

    Pantazis, Konstantinos

    2016-01-01

    Objectives. The purpose of the present study was to investigate the clinical outcomes and complications of the cortical button distal biceps fixation method. Material and Methods. All methods followed the PRISMA guidelines. Included studies had to describe clinical outcomes and complications after acute distal biceps repair with cortical button fixation. Eligibility criteria also included English language, more than 5 cases with minimum follow-up of 6 months, and preferably usage of at least one relevant clinical score (MEPS, ASES, and/or DASH) for final outcome. A loss of at least 30° in motion—flexion, extension, pronation, or supination—and a loss of at least 30% of strength were considered an unsatisfactory result. Results. The review identified 7 articles including 105 patients (mean age 43.6 years) with 106 acute distal biceps ruptures. Mean follow-up was 26.3 months. Functional outcome of ROM regarding flexion/extension and pronation/supination was satisfactory in 94 (89.5%) and 86 (82%) patients in respect. Averaged flexion and supination strength had been reported in 6/7 studies (97 patients) and were satisfactory in 82.4% of them. The most common complication was transient nerve palsy (14.2%). The overall reoperation rate was 4.8% (5/105 cases). Conclusion. Cortical button fixation for acute distal biceps repair is a reproducible operation with good clinical results. Most of the complications can be avoided with appropriate surgical technique. PMID:27525303

  7. Characterization of Potential Outcome Measures for Future Clinical Trials in Fragile X Syndrome

    ERIC Educational Resources Information Center

    Berry-Kravis, Elizabeth; Sumis, Allison; Kim, Ok-Kyung; Lara, Rebecca; Wuu, Joanne

    2008-01-01

    Clinical trials targeting recently elucidated synaptic defects in fragile X syndrome (FXS) will require outcome measures capable of assessing short-term changes in cognitive functioning. Potentially useful measures for FXS were evaluated here in a test-retest setting in males and females with FXS (N = 46). Good reproducibility, determined by an…

  8. Functional outcome measures for NF1-associated optic pathway glioma clinical trials

    PubMed Central

    Avery, Robert A.; Allen, Jeffrey C.; Ardern-Holmes, Simone L.; Bilaniuk, Larissa T.; Ferner, Rosalie E.; Gutmann, David H.; Listernick, Robert; Martin, Staci; Ullrich, Nicole J.; Liu, Grant T.

    2013-01-01

    Objective: The goal of the Response Evaluation in Neurofibromatosis and Schwannomatosis Visual Outcomes Committee is to define the best functional outcome measures for future neurofibromatosis type 1 (NF1)-associated optic pathway glioma (OPG) clinical trials. Methods: The committee considered the components of vision, other ophthalmologic parameters affected by OPG, potential biomarkers of visual function, and quality of life measures to arrive at consensus-based, evidence-driven recommendations for objective and measurable functional endpoints for OPG trials. Results: Visual acuity (VA) assessments using consistent quantitative testing methods are recommended as the main functional outcome measure for NF1-OPG clinical trials. Teller acuity cards are recommended for use as the primary VA endpoint, and HOTV as a secondary endpoint once subjects are old enough to complete it. The optic disc should be assessed for pallor, as this appears to be a contributory variable that may affect the interpretation of VA change over time. Given the importance of capturing patient-reported outcomes in clinical trials, evaluating visual quality of life using the Children's Visual Function Questionnaire as a secondary endpoint is also proposed. Conclusions: The use of these key functional endpoints will be essential for evaluating the efficacy of future OPG clinical trials. PMID:24249802

  9. Clinical features and outcomes of focal segmental glomerulosclerosis pathologic variants in Korean adult patients

    PubMed Central

    2014-01-01

    Background Many studies have shown that clinical characteristics and outcomes differ depending on pathologic variants of focal segmental glomerulosclerosis (FSGS). However, these are not well defined in Asian populations. Methods This retrospective study evaluated clinical features and outcomes of pathologic FSGS variants in 111 adult patients between January 2004 and December 2012. Primary outcome was the composite of doubling of baseline serum creatinine concentrations (D-SCr) or onset of end-stage renal disease (ESRD). Secondary outcome included complete (CR) or partial remission (PR). Results There were 70 (63.1%), 20 (18.0%), 17 (15.3%), 3 (2.7%), and 1 (0.9%) patients with not-otherwise specified (NOS), tip, perihilar, cellular, and collapsing variants, respectively. At presentation, nephrotic-range proteinuria occurred more commonly in tip lesion than in other variants. The overall 5-year renal survival rate was 76.8%. During a median follow-up of 34.5 months, only 1 (5.0%) patient with a tip lesion reached the composite end point compared to 2 (11.8%) and 12 (17.1%) patients in perihilar and NOS variants, but this difference was not statistically significant in an adjusted Cox model. However, tip lesion was associated with a significantly increased probability of achieving CR (P = 0.044). Conclusion Similar to other populations, Korean adult patients with FSGS have distinct clinical features with the exception of a rare frequency of cellular and collapsing variants. Although pathologic variants were not associated with overall outcome, the tip variant exhibited favorable outcome in terms of achieving remission. Further studies are required to delineate long-term outcome and response to treatment of the pathologic variants. PMID:24666814

  10. Prognostic Factors of Clinical Outcomes in Patients with Spontaneous Thalamic Hemorrhage

    PubMed Central

    Lee, Sang-Hoon; Park, Kyung-Jae; Kang, Shin-Hyuk; Jung, Yong-Gu; Park, Jung-Yul; Park, Dong-Hyuk

    2015-01-01

    Background Intracerebral hemorrhage (ICH) is a well-known condition, but ICH restricted to the thalamus is less widely studied. We investigated the prognostic factors of thalamic ICHs. Material/Methods Seventy patients from January 2009 to November 2014 were retrospectively reviewed. Patients who demonstrated spontaneous ICH primarily affecting the thalamus on initial brain computed tomography (CT) were enrolled. Patients were categorized into 2 groups based on their Glasgow Outcome Scale (GOS) scores. Various presumptive prognostic factors were analyzed to investigate relationships between various clinical characteristics and outcomes. Results Of the enrolled patients, 39 showed a GOS of 4–5, and were categorized as the good outcome group, while another 31 patients showed a GOS of 1–3 and were categorized as the poor outcome group. Initial GCS score, calculated volume of hematoma, presence of intraventricular hemorrhage (IVH), coexisting complications, hydrocephalus, performance of external ventricular drainage, and modified Graeb’s scores of patients with IVH were significantly different between the 2 groups. In multivariate analysis, among the factors above, initial GCS score (P=0.002, Odds ratio [OR]=1.761, Confidence interval [CI]=1.223–2.536) and the existence of systemic complications (P=0.015, OR=0.059, CI=0.006–0.573) were independently associated with clinical outcomes. Calculated hematoma volume showed a borderline relationship with outcomes (P=0.079, OR=0.920, CI=0.839–1.010). Conclusions Initial GCS score and the existence of systemic complications were strong predictive factors for prognosis of thalamic ICH. Calculated hematoma volume also had predictive value for clinical outcomes. PMID:26343784

  11. Effects of 30-Day Head-Down Bed Rest on Ocular Structures and Visual Function in a Healthy Subject

    PubMed Central

    Taibbi, Giovanni; Kaplowitz, Kevin; Cromwell, Ronita L.; Godley, Bernard F.; Zanello, Susana B.; Vizzeri, Gianmarco

    2013-01-01

    Introduction We report ocular changes occurring in a healthy human subject enrolled in a bed rest (BR) study designed to replicate the effects of a low-gravity environment. Case report A 25-year-old Caucasian male spent 30 consecutive days in a 6° head-down-tilt position at the NASA Flight Analogs Research Unit. Comprehensive ophthalmologic exams, optic disc stereo-photography, Standard Automated Perimetry (SAP) and optic disc Spectralis OCT scans were performed at baseline, immediately post-BR (BR+0) and 6 months post-BR. Main outcome measures: changes in best-corrected visual acuity, intraocular pressure (IOP), cycloplegic refraction, SAP and Spectralis OCT measures. At BR+0 IOP was 11 and 10 mmHg in the right (OD) and left eye (OS), respectively (a bilateral 4 mmHg decrease compared to baseline); SAP documented a possible bilateral symmetrical inferior scotoma; Spectralis OCT showed an average 19.4 μm (+5.2%) increase in peripapillary retinal thickness, and an average 0.03 mm3 (+5.0%) increase in peripapillary retinal volume bilaterally. However, there were no clinically detectable signs of optic disc edema. 6 months post-BR, IOP was 13 and 14 mmHg in OD and OS, respectively, and the scotoma had resolved. Spectralis OCT measurements matched the ones recorded at baseline. Discussion In this subject, a reduction in IOP associated with subtle structural and functional changes compared to baseline were documented after prolonged head-down BR. These changes may be related to cephalad fluid shifts in response to tilt. Further studies should clarify whether decreased translaminar pressure (i.e., the difference between IOP and intracranial pressure) may be responsible for these findings. PMID:23447853

  12. 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.

  13. 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.

  14. 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

  15. 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.

  16. Low Mitochondrial DNA Copy Number is Associated With Adverse Clinical Outcomes in Peritoneal Dialysis Patients

    PubMed Central

    Yoon, Chang-Yun; Park, Jung Tak; Kee, Youn Kyung; Han, Seung Gyu; Han, In Mee; Kwon, Young Eun; Park, Kyoung Sook; Lee, Mi Jung; Han, Seung Hyeok; Kang, Shin-Wook; Yoo, Tae-Hyun

    2016-01-01

    Abstract Mitochondrial dysfunction may play an important role in abnormal glucose metabolism and systemic inflammation. We aimed to investigate the relationship between mitochondrial DNA (mtDNA) copy number and clinical outcomes in peritoneal dialysis (PD) patients. We recruited 120 prevalent PD patients and determined mtDNA copy number by PCR. Primary outcome was all-cause mortality, whereas secondary outcomes included cardiovascular events, technical PD failure, and incident malignancy. Cox proportional hazards analysis determined the independent association of mtDNA copy number with outcomes. The mean patient age was 52.3 years; 42.5% were men. The mean log mtDNA copy number was 3.30 ± 0.50. During a follow-up period of 35.4 ± 19.3 months, all-cause mortality and secondary outcomes were observed in 20.0% and 59.2% of patients, respectively. Secondary outcomes were significantly lower in the highest mtDNA copy number group than in the lower groups. In multiple Cox analysis, the mtDNA copy number was not associated with all-cause mortality (lower two vs highest tertile: hazard ratio [HR] = 1.208, 95% confidence interval [CI] = 0.477–3.061). However, the highest tertile group was significantly associated with lower incidences of secondary outcomes (lower two vs highest tertile: HR [95% CI] = 0.494 [0.277–0.882]) after adjusting for confounding factors. The decreased mtDNA copy number was significantly associated with adverse clinical outcomes in PD patients. PMID:26886611

  17. Long-Term Clinical and Radiologic Outcomes of Minimally Invasive Posterior Cervical Foraminotomy

    PubMed Central

    2014-01-01

    Objective To report long-term clinical and radiological outcomes of minimally invasive posterior cervical foraminotomy (MI-PCF) performed in patients with unilateral single-level cervical radiculopathy. Methods Of forty-six patients who underwent MI-PCF for unilateral single-level radiculopathy between 2005 and 2013, 33 patients were included in the study, with a mean follow-up of 32.7 months. Patients were regularly followed for clinical and radiological assessment. Clinical outcome was measured by visual analogue scale (VAS) for the neck/shoulder and arm, and the neck disability index (NDI). Radiological outcome was measured by focal/global angulation and disc height index (DHI). Outcomes after MI-PCF were evaluated as changes of clinical and radiological parameters from the baseline. Mixed effect model with random patients' effect was used to test for differences in the clinical and radiological parameters repeat measures. Results There were no complications and all patients had an uneventful recovery during the early postoperative period. VAS scores for neck/shoulder and arm improved significantly in the early postoperative period (3 months) and were maintained with time (p<0.001). NDI improved significantly post-operatively and tended to decrease gradually during the follow-up period (p<0.001). There were no statistically significant changes in focal and global angulation at follow-up. Percent DHIs of the upper adjacent or operated disc were maintained without significant changes with time. During the follow-up, same site recurrence was not noted and adjacent segment disease requiring additional surgery occurred in two patients (6%) on the contra-lateral side. Conclusion MI-PCF provides long-term pain relief and functional restoration, accompanied by good long-term radiological outcome. PMID:25368765

  18. Clinical research using an information system: the multicenter perioperative outcomes group.

    PubMed

    Kheterpal, Sachin

    2011-09-01

    Clinical research using electronic medical record (EMR) data is an emerging source of scientific progress. Increasingly, researchers are using retrospective observational data acquired from EMRs as the substrate for their clinical research into comorbidities, procedures, situations, and outcomes that have historically presented significant challenges. Although EMR data collection is perceived to require fewer resources than manual chart review, there are many specific regulatory, privacy, data quality, and technique issues unique to clinical research using EMR data. This article discusses the use of EMRs for observational research.

  19. The predictive effect of insight on adverse clinical outcomes in bipolar I disorder: a two-year prospective study.

    PubMed

    Yen, Cheng-Fang; Chen, Cheng-Sheng; Yen, Ju-Yu; Ko, Chih-Hung

    2008-05-01

    Research has revealed that a lack of insight is associated with poorer clinical outcomes in schizophrenia; however, the predictive value of insight on adverse clinical outcomes among bipolar patients is quite understudied. The aim of this prospective study was to examine the impact of insight on adverse clinical outcomes among the patients with bipolar I disorder over a 2-year period. Sixty-five remitted bipolar I disorder patients received follow-up assessments at 3, 6, 9, 12, 18, and 24 months to detect the adverse clinical outcomes defined by the incidence of bipolar-related psychiatric hospitalization, emergency room visits, violent or suicidal behavior. The Schedule of Assessment of Insight was used to provide a baseline insight score. Cox regression analysis was used to examine the predictive value of insight on the adverse clinical outcomes. Impaired insight into treatment and a greater number of previous hospitalizations significantly increased the risk of adverse clinical outcomes with bipolar disorder in the 2-year period. However, insight into recognition of the illness and re-labeling of psychotic phenomena did not have any significant effect on adverse clinical outcomes. Bipolar patients' insight into treatment is an independent predictor of adverse clinical outcomes. Improving insight into treatment might be a promising target for a better outcome. PMID:17997489

  20. Presence of the Panton-Valentine Leukocidin Genes in Methicillin-Resistant Staphylococcus aureus Is Associated with Severity and Clinical Outcome of Hospital-Acquired Pneumonia in a Single Center Study in China.

    PubMed

    Zhang, Chuanling; Guo, Liang; Chu, Xu; Shen, Limeng; Guo, Yuanyu; Dong, Huali; Mao, Jianfeng; van der Veen, Stijn

    2016-01-01

    The Panton-Valentine leukocidin (PVL) genes of methicillin-resistant Staphylococcus aureus (MRSA) have previously been associated with severe infections. Here, the impact of the PVL genes on severity of disease and clinical outcome of patients with hospital-acquired pneumonia (HAP) or ventilator-associated pneumonia (VAP) due to MRSA was investigated in a single center observational study in a hospital in China. HAP due to MRSA was diagnosed in 100 patients and 13 of the patients were PVL positive, while VAP was diagnosed in 5 patients and 2 were PVL positive. The PVL positive patient group showed a significantly higher Acute Physiology and Chronic Health Evaluation (APACHE) II score (14.3 ±7.8 vs. 10.1 ±4.7, P = 0.005) and significantly more patients with CRP levels >80 mg/L (8/15 vs. 12/90, P = 0.006) or WBC counts >15x109/L (7/15 vs. 12/90, P = 0.006), indicating that the severity of disease is affected by the presence of the PVL genes. The outcome of the study was defined by 30-day mortality. Four (27%) of the PVL positive patients and four (4%) of the PVL negative patients died within 30 days (P = 0.01, Fisher exact test). Kaplan-Meier survival curves were generated for the PVL positive and PVL negative patient groups, which differed significantly (P = 0.003). Among the patients that died, the mean interval between diagnosis and death was shorter for the PVL positive patients (9.3 ±5.6 vs. 40.8 ±6.6 days, P = 0.013). Further analysis within the HAP and VAP patient groups showed that the presence of PVL in MRSA impacted the severity of disease and clinical outcome of HAP, but for VAP the number of patients included in the study was too low. In conclusion, in this single center study in a Chinese hospital the presence of the PVL genes in MRSA impacted the severity of disease and clinical outcome in patients with HAP due to MRSA. PMID:27249225

  1. Clinical Outcome Assessments: Conceptual Foundation–Report of the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force DOES THIS HAVE TO BE LABLED AS PART 1

    PubMed Central

    Walton, Marc K; Powers, John H; Hobart, Jeremy; Patrick, Donald L; Marquis, Patrick; Vamvakas, Sprios; Isaac, Maria; Molsen, Elizabeth; Cano, Stefan J; Burke, Laurie

    2015-01-01

    An outcome assessment, the patient assessment used in an endpoint, is the measuring instrument that provides a rating or score (categorical or continuous) that is intended to represent some aspect of the patient’s health status. Outcome assessments are used to define efficacy endpoints when developing a therapy for a disease or condition. Most efficacy endpoints are based on specified clinical assessments of patients. When clinical assessments are used as clinical trial outcomes, they are called clinical outcome assessments (COAs). COAs include any assessment that may be influenced by human choices, judgment, or motivation, COAs must be well-defined and possess adequate measurement properties in order to demonstrate (directly or indirectly) the benefits of a treatment. In contrast, a biomarker assessment is one that is subject to little, if any, patient motivational or rater judgmental influence. This is the first of two reports by the ISPOR Clinical Outcomes Assessment – Emerging Good Practices for Outcomes Research Task Force. This report provides foundational definitions important for an understanding of COA measurement principles. The foundation provided in this report includes what it means to demonstrate a beneficial effect, how assessments of patients relate to the objective of showing a treatment’s benefit, and how these assessments are used in clinical trial endpoints. In addition, this report describes intrinsic attributes of patient assessments and clinical trial factors that can affect the properties of the measurements. These factors should be considered when developing or refining assessments. These considerations will aid investigators designing trials in their choice of using an existing assessment or developing a new outcome assessment. Although the focus of this report is in the development of a new COA to define endpoints in a clinical trial, these principles may be applied more generally. A critical element in appraising or developing a

  2. Individual-level outcomes from a national clinical leadership development programme.

    PubMed

    Patton, Declan; Fealy, Gerard; McNamara, Martin; Casey, Mary; Connor, Tom O; Doyle, Louise; Quinlan, Christina

    2013-08-01

    A national clinical leadership development programme was instituted for Irish nurses and midwives in 2010. Incorporating a development framework and leadership pathway and a range of bespoke interventions for leadership development, including workshops, action-learning sets, mentoring and coaching, the programme was introduced at seven pilot sites in the second half of 2011. The programme pilot was evaluated with reference to structure, process and outcomes elements, including individual-level programme outcomes. Evaluation data were generated through focus groups and group interviews, individual interviews and written submissions. The data provided evidence of nurses' and midwives' clinical leadership development through self and observer-reported behaviours and dispositions including accounts of how the programme participants developed and displayed particular clinical leadership competencies. A key strength of the new programme was that it involved interventions that focussed on specific leadership competencies to be developed within the practice context.

  3. Surgical approach in primary total hip arthroplasty: anatomy, technique and clinical outcomes

    PubMed Central

    Petis, Stephen; Howard, James L.; Lanting, Brent L.; Vasarhelyi, Edward M.

    2015-01-01

    Total hip arthroplasty (THA) has revolutionized the treatment of hip arthritis. A number of surgical approaches to the hip joint exist, each with unique advantages and disadvantages. The most commonly used approaches include the direct anterior, direct lateral and posterior approaches. A number of technical intricacies allow safe and efficient femoral and acetabular reconstruction when using each approach. Hip dislocation, abductor insufficiency, fracture and nerve injury are complications of THA, although their relative risk varies by approach. Numerous clinical trials have sought to elicit differences in patient-reported outcomes, complication rates and return to function among the surgical approaches. This review outlines some of the technical pearls of performing a THA through either a direct anterior, direct lateral or posterior approach. A literature review outlines the impact of surgical approach on clinical outcomes and clinically relevant complication rates. PMID:25799249

  4. CD19-targeted CAR T-cell therapeutics for hematologic malignancies: interpreting clinical outcomes to date.

    PubMed

    Park, Jae H; Geyer, Mark B; Brentjens, Renier J

    2016-06-30

    Adoptive transfer of T cells genetically modified to express chimeric antigen receptors (CARs) targeting CD19 has produced impressive results in treating patients with B-cell malignancies. Although these CAR-modified T cells target the same antigen, the designs of CARs vary as well as several key aspects of the clinical trials in which these CARs have been studied. It is unclear whether these differences have any impact on clinical outcome and treatment-related toxicities. Herein, we review clinical results reflecting the investigational use of CD19-targeted CAR T-cell therapeutics in patients with B-cell hematologic malignancies, in light of differences in CAR design and production, and outline the limitations inherent in comparing outcomes between studies. PMID:27207800

  5. Patient outcomes after initiation of Sabbath closure of a methadone maintenance clinic in Israel.

    PubMed

    Gelkopf, M; Bleich, A; Hayward, R; Adelson, M

    1998-11-01

    The study examined whether closing of a methadone maintenance clinic in Israel on the Sabbath was associated with adverse patient outcomes. One take-home dose of methadone was given to all patients for that day regardless of whether they had earned take-home privileges. No difference was found in dropout rates for the six-month periods before and after Saturday closure was initiated. Results of random, twice-weekly urinalyses for all patients did not indicate increased use of heroin. The findings suggest that closure of a methadone clinic at least one day a week does not jeopardize patient outcome. Cutting hours of operation would reduce workload and enable clinics to function more economically.

  6. Individual-level outcomes from a national clinical leadership development programme.

    PubMed

    Patton, Declan; Fealy, Gerard; McNamara, Martin; Casey, Mary; Connor, Tom O; Doyle, Louise; Quinlan, Christina

    2013-08-01

    A national clinical leadership development programme was instituted for Irish nurses and midwives in 2010. Incorporating a development framework and leadership pathway and a range of bespoke interventions for leadership development, including workshops, action-learning sets, mentoring and coaching, the programme was introduced at seven pilot sites in the second half of 2011. The programme pilot was evaluated with reference to structure, process and outcomes elements, including individual-level programme outcomes. Evaluation data were generated through focus groups and group interviews, individual interviews and written submissions. The data provided evidence of nurses' and midwives' clinical leadership development through self and observer-reported behaviours and dispositions including accounts of how the programme participants developed and displayed particular clinical leadership competencies. A key strength of the new programme was that it involved interventions that focussed on specific leadership competencies to be developed within the practice context. PMID:24099226

  7. Joint multiple imputation for longitudinal outcomes and clinical events that truncate longitudinal follow-up.

    PubMed

    Hu, Bo; Li, Liang; Greene, Tom

    2016-07-30

    Longitudinal cohort studies often collect both repeated measurements of longitudinal outcomes and times to clinical events whose occurrence precludes further longitudinal measurements. Although joint modeling of the clinical events and the longitudinal data can be used to provide valid statistical inference for target estimands in certain contexts, the application of joint models in medical literature is currently rather restricted because of the complexity of the joint models and the intensive computation involved. We propose a multiple imputation approach to jointly impute missing data of both the longitudinal and clinical event outcomes. With complete imputed datasets, analysts are then able to use simple and transparent statistical methods and standard statistical software to perform various analyses without dealing with the complications of missing data and joint modeling. We show that the proposed multiple imputation approach is flexible and easy to implement in practice. Numerical results are also provided to demonstrate its performance. Copyright © 2015 John Wiley & Sons, Ltd.

  8. Nine-Months Clinical Outcome of Biodegradable Polymer Coated Sirolimus-eluting Stent System: A Multi-Centre “Real-World” Experience

    PubMed Central

    Prajapati, Jayesh; Raheem, Asif; Thakkar, Kamlesh; Kothari, Shivani; Thakkar, Ashok

    2015-01-01

    Background The main culprit in first-generation drug eluting stents is ‘durable’ polymer, whose continuous presence may impair arterial healing and ultimately have a negative impact on late outcomes. The main enigma behind the biodegradable polymer usage is its degradation after elution of drug. This reduces adverse events in unselected patients with complex coronary artery lesions treated with biodegradable polymer coated sirolimus-eluting stents. Aim The aim of the INDOLIMUS-G Registry was to evaluate safety and efficacy of the Indolimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) sirolimus-eluting stents in large cohorts of unselected patients with complex coronary artery lesions. Materials and Methods It is a multi-centre, non-randomized retrospective registry with a clear aim of evaluating safety and efficacy of the Indolimus sirolimus-eluting stents in consecutive patients enrolled between April 2012 and May 2014. The primary end-point of the study was major adverse cardiac events (MACE), which is a composite of cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR) and stent thrombosis (ST) at the end of follow-up. Clinical follow-up were scheduled at the end of 30-days, 6-months, and 9-months period. Results The mean age of enrolled patients was 52.6 ± 11.0 years. A total of 1137 lesions were intervened successfully with 1242 stents (1.09 ± 0.30 stent per lesion). The average stent length and diameter was 27.42 ± 9.01 mm and 3.12 ± 0.36 mm respectively. There were 740 (73.40%) male patients, indicating their high prevalence. Diabetes, hypertension and totally occluded lesions were found in 372 (36.90%), 408 (40.47%) and 170 (16.86%) patients, respectively. This showed that study also included high risk complex lesions and not ideal recruited lesions. The incidence of MACE at 30-days, 6-months and 9-months were 3 (0.30%), 18 (1.80%) and 22 (2.20%) respectively. At 9-months

  9. Clinical Trial Design - Effect of prone positioning on clinical outcomes in infants and children with acute respiratory distress syndrome

    PubMed Central

    Curley, Martha A.Q.; Arnold, John H.; Thompson, John E.; Fackler, James C.; Grant, Mary Jo; Fineman, Lori D.; Cvijanovich, Natalie; Barr, Frederick E.; Molitor-Kirsch, Shirley; Steinhorn, David M.; Matthay, Michael A.; Hibberd, Patricia L.

    2006-01-01

    Purpose This paper describes the methodology of an ongoing clinical trial of prone positioning in pediatric patients with acute lung injury (ALI). Nonrandomized studies suggest that prone positioning improves oxygenation in patients with ALI/ARDS without the risk of serious iatrogenic injury. It is not known if these improvements in oxygenation result in improvements in clinical outcomes. A clinical trial was needed to answer this question. Materials and Methods The pediatric prone study is a multi-center, randomized, non-crossover, controlled clinical trial. The trial is designed to test the hypothesis that at the end of 28 days, children with ALI treated with prone positioning will have more ventilator free days than children treated with supine positioning. Secondary endpoints include the time to recovery of lung injury, organ failure free days, functional outcome, adverse events, and mortality from all causes. Pediatric patients, 42 weeks post-conceptual age to 18 years of age, are enrolled within 48 hours of meeting ALI criteria. Patients randomized to the prone group are positioned prone within 4 hours of randomization and remain prone for 20 hours each day during the acute phase of their illness for a maximum of 7 days. Both groups are managed according to ventilator protocol, extubation readiness testing, and sedation protocols and hemodynamic, nutrition and skin care guidelines. Conclusions This paper describes the process, multidisciplinary input, and procedures used to support the design of the clinical trial, as well as the challenges faced by the clinical scientists during the conduct of the clinical trial. PMID:16616620

  10. Early clinical prediction of neurological outcome following out of hospital cardiac arrest managed with therapeutic hypothermia

    PubMed Central

    Ruknuddeen, Mohammed Ishaq; Ramadoss, Rajaram; Rajajee, V.; Grzeskowiak, Luke E.; Rajagopalan, Ram E.

    2015-01-01

    Background: Therapeutic hypothermia (TH) may improve neurological outcome in comatose patients following out of hospital cardiac arrest (OHCA). The reliability of clinical prediction of neurological outcome following TH remains unclear. In particular, there is very limited data on survival and predictors of neurological outcome following TH for OHCA from resource-constrained settings in general and South Asia in specific. Objective: The objective was to identify factors predicting unfavorable neurological outcome at hospital discharge in comatose survivors of OHCA treated with hypothermia. Design: Retrospective chart review. Setting: Urban 200-bed hospital in Chennai, India. Methods: Predictors of unfavorable neurological outcome (cerebral performance category score [3–5]) at hospital discharge were evaluated among patients admitted between January 2006 and December 2012 following OHCA treated with TH. Hypothermia was induced with cold intravenous saline bolus, ice packs and cold-water spray with bedside fan. Predictors of unfavorable neurological outcome were examined through multivariate exact logistic regression analysis. Results: A total of 121 patients were included with 106/121 (87%) experiencing the unfavorable neurological outcome. Independent predictors of unfavorable neurological outcome included: Status myoclonus <24 h (odds ratio [OR] 21.79, 95% confidence interval [CI] 2.89-Infinite), absent brainstem reflexes (OR 50.09, 6.55-Infinite), and motor response worse than flexion on day 3 (OR 99.41, 12.21-Infinite). All 3 variables had 100% specificity and positive predictive value. Conclusion: Status myoclonus within 24 h, absence of brainstem reflexes and motor response worse than flexion on day 3 reliably predict unfavorable neurological outcome in comatose patients with OHCA treated with TH. PMID:26195855

  11. Cerebral perfusion pressure, microdialysis biochemistry and clinical outcome in patients with traumatic brain injury

    PubMed Central

    2011-01-01

    Background Traumatic Brain Injury (TBI) is a major cause of death and disability. It has been postulated that brain metabolic status, intracranial pressure (ICP) and cerebral perfusion pressure (CPP) are related to patients' outcome. The aim of this study was to investigate the relationship between CPP, ICP and microdialysis parameters and clinical outcome in TBIs. Results Thirty four individuals with severe brain injury hospitalized in an intensive care unit participated in this study. Microdialysis data were collected, along with ICP and CPP values. Glasgow Outcome Scale (GOS) was used to evaluate patient outcome at 6 months after injury. Fifteen patients with a CPP greater than 75 mmHg, L/P ratio lower than 37 and Glycerol concentration lower than 72 mmol/l had an excellent outcome (GOS 4 or 5), as opposed to the remaining 19 patients. No patient with a favorable outcome had a CPP lower than 75 mmHg or Glycerol concentration and L/P ratio greater than 72 mmol/l and 37 respectively. Data regarding L/P ratio and Glycerol concentration were statistically significant at p = 0.05 when patients with favorable and unfavorable outcome were compared. In a logistic regression model adjusted for age, sex and Glasgow Coma Scale on admission, a CPP greater than 75 mmHg was marginally statistically significantly related to outcome at 6 months after injury. Conclusions Patients with favorable outcome had certain common features in terms of microdialysis parameters and CPP values. An individualized approach regarding CPP levels and cut -off points for Glycerol concentration and L/P ratio are proposed. PMID:22168902

  12. Clinical Neurochemistry of Subarachnoid Hemorrhage: Toward Predicting Individual Outcomes via Biomarkers of Brain Energy Metabolism.

    PubMed

    Tholance, Yannick; Barcelos, Gleicy; Dailler, Frederic; Perret-Liaudet, Armand; Renaud, Bernard

    2015-12-16

    The functional outcome of patients with subarachnoid hemorrhage is difficult to predict at the individual level. The monitoring of brain energy metabolism has proven to be useful in improving the pathophysiological understanding of subarachnoid hemorrhage. Nonetheless, brain energy monitoring has not yet clearly been included in official guidelines for the management of subarachnoid hemorrhage patients, likely because previous studies compared only biological data between two groups of patients (unfavorable vs favorable outcomes) and did not determine decision thresholds that could be useful in clinical practice. Therefore, this Viewpoint discusses recent findings suggesting that monitoring biomarkers of brain energy metabolism at the level of individuals can be used to predict the outcomes of subarachnoid hemorrhage patients. Indeed, by taking into account specific neurochemical patterns obtained by local or global monitoring of brain energy metabolism, it may become possible to predict routinely, and with sufficient sensitivity and specificity, the individual outcomes of subarachnoid hemorrhage patients. Moreover, combining both local and global monitoring improves the overall performance of individual outcome prediction. Such a combined neurochemical monitoring approach may become, after prospective clinical validation, an important component in the management of subarachnoid hemorrhage patients to adapt individualized therapeutic interventions. PMID:26595414

  13. Outcome of Endodontic Treatments Made by Postgraduate Students in the Dental Clinic of Bretonneau Hospital

    PubMed Central

    Touboul, Virginie; Germa, Alice; Lasfargues, Jean-Jacques; Bonte, Eric

    2014-01-01

    Objective. The objective of this retrospective study is double: (1) to assess the 1–4 years of outcome of endodontic treatment performed by postgraduate students in endodontics in the Dental Clinic of Bretonneau Hospital and (2) to examine outcome predictors. Method. 363 teeth in 296 patients were treated between 2007 and 2011. 183 patients (224 teeth) were lost during the followup. 113 patients were included in the study (recall: 38%), corresponding to 139 teeth of which 8 were extracted. 131 remaining teeth (36%) were examined clinically and radiographically. Apical periodontitis (AP) was absent (PAI = 1) or present (PAI ≥ 2). Outcome was classified as “healed,” “healing,” or “diseased”. Results. The success rate was 92%. No failure was observed among the 23 initial endodontic treatments. Among the 108 retreated teeth, 80% were “healed” and 11% were “healing.” An association was found between success rate and preoperative signs or symptoms (absent 95% versus present 83%), preoperative root filling density (inadequate 93% versus adequate 57%), but not between preoperative AP status and success. Conclusion. Outcomes in this retrospective study were similar to those previously reported. However, a larger sample size is needed to assess outcome predictors more precisely. PMID:24778652

  14. Clinical Outcomes and Quality of Life in Recipients of Livers Donated after Cardiac Death

    PubMed Central

    Parikh, Neehar D.; Skaro, Anton I.; Ladner, Daniela P.; Lyuksemburg, Vadim; Cahan, Joshua G.; Daud, Amna; Butt, Zeeshan

    2015-01-01

    Donation after cardiac death (DCD) has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL) outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n = 60) to those of donation after brain death (DBD) liver recipients (n = 669) during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P < 0.001) and a trend toward lower rates of 5-year patient survival (P = 0.064) when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC). Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P < 0.05). While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies. PMID:25922602

  15. Clinical outcomes and quality of life in recipients of livers donated after cardiac death.

    PubMed

    Parikh, Neehar D; Skaro, Anton I; Ladner, Daniela P; Lyuksemburg, Vadim; Cahan, Joshua G; Daud, Amna; Butt, Zeeshan

    2015-01-01

    Donation after cardiac death (DCD) has expanded in the last decade in the US; however, DCD liver utilization has flattened in recent years due to poor outcomes. We examined clinical and quality of life (QOL) outcomes of DCD recipients by conducting a retrospective and cross-sectional review of patients from 2003 to 2010. We compared clinical outcomes of DCD recipients (n = 60) to those of donation after brain death (DBD) liver recipients (n = 669) during the same time period. DCD recipients had significantly lower rates of 5-year graft survival (P < 0.001) and a trend toward lower rates of 5-year patient survival (P = 0.064) when compared to the DBD cohort. In order to examine QOL outcomes in our cohorts, we administered the Short Form Liver Disease Quality of Life questionnaire to 30 DCD and 60 DBD recipients. The DCD recipients reported lower generic and liver-specific QOL. We further stratified the DCD cohort by the presence of ischemic cholangiopathy (IC). Patients with IC reported lower QOL when compared to DBD recipients and those DCD recipients without IC (P < 0.05). While the results are consistent with clinical experience, this is the first report of QOL in DCD recipients using standardized measures. These data can be used to guide future comparative effectiveness studies.

  16. The Impact of Cannabis Use on Clinical Outcomes in Recent Onset Psychosis

    PubMed Central

    Barrowclough, Christine; Gregg, Lynsey; Lobban, Fiona; Bucci, Sandra; Emsley, Richard

    2015-01-01

    Background: There are inconsistencies in findings as to whether cannabis use has a negative impact on clinical outcomes for people with established psychosis. Effects may be more evident on patients with recent onset psychosis. Aim: To investigate the relationship between cannabis use and clinical outcome, including whether change in cannabis use affects psychotic symptoms, affective symptoms, functioning and psychotic relapse in a sample of people in early psychosis with comorbid cannabis abuse or dependence. Methods: One hundred and ten participants were examined prospectively with repeated measures of substance use antecedent to psychopathology at baseline, 4.5, 9, and 18 months. We used random intercept models to estimate the effects of cannabis dose on