WorldWideScience

Sample records for random mandatory drugs

  1. 75 FR 76478 - Mandatory Guidelines for Federal Workplace Drug Testing Programs

    Science.gov (United States)

    2010-12-08

    ... HUMAN SERVICES Mandatory Guidelines for Federal Workplace Drug Testing Programs AGENCY: Substance Abuse... Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines) which took effect on October 1, 2010 address the role and qualifications of...

  2. 76 FR 34086 - Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information...

    Science.gov (United States)

    2011-06-10

    ... governing the chain of custody of specimens collected for drug testing. These revisions to the Mandatory... specimen be collected? For an oral fluid split specimen collection, how should the collection of the two...

  3. Legislation imposing mandatory minimum sentences for drug offences passes second reading.

    Science.gov (United States)

    2008-07-01

    Bill C-26, An Act to amend the Controlled Drugs and Substances Act, passed second reading in the House of Commons on 16 April 16 2008, and was referred to the Standing Committee on Justice and Human Rights. The legislation has been proposed as a component of the National Anti-Drug Strategy.

  4. Comprehensive allergy work-up is mandatory in cystic fibrosis patients who report a history suggestive of drug allergy to beta-lactam antibiotics

    Directory of Open Access Journals (Sweden)

    Caimmi Silvia

    2012-06-01

    Full Text Available Abstract Background In the general population, reports on suspected ß-lactam hypersensitivity are common. After a drug allergy work-up at best 20% of the selected patients are positive. However, these considerations have not been explored in cystic fibrosis patients for whom antibiotics are even more crucial. Methods The study, part of the Drug Allergy and Hypersensitivity (DAHD cohort, was performed in the regional cystic fibrosis center of Montpellier, France. After identifying patients with a clinical history suggestive of drug allergy to ß-lactams, a complete drug allergy work-up, was carried out according to the EAACI recommendations. Results Among the 171 patients involved, 23 reported clinical manifestations potentially compatible with a drug allergy to ß-lactams. After performing the complete drug-allergy work-up, 7 were considered as drug hypersensitive (3 had positive skin tests, 1 a positive provocation test, 3 declined the tests. Excluding the latter 3 patients with incomplete drug allergy work-up, the rate of proven drug allergy was 2.3%. Conclusions Drug allergy to ß-lactams in cystic fibrosis patients is of importance. A full drug allergy work-up is mandatory in case of suspicion, because ß-lactam responsibility is often ruled out.

  5. Deregulating mandatory medical prescription.

    Science.gov (United States)

    Mitchell, C N

    1986-01-01

    This Article links the legal evolution of mandatory medical prescription since 1900 to the police-power's prohibition of alcohol and the opiates as well as to the self-interested monopolization of new drugs by physicians. The Article advances a theory of professionalization consistent with the evidence that mandatory prescription is not in the public interest. The Article suggests that the supremacy of self-medication is consistent with competition policy, the medical profession's fiduciary duty to clients, reduced medical costs and improved health. The author analyzes the consequences of regulating drug production, testing, marketing and consumtion by granting decision-making authority to the lowest-cost risk avoider, suggesting this as a plausible basis for legal reform.

  6. USER S GUIDE FOR THE RANDOM DRUG SCREENING SYSTEM

    Energy Technology Data Exchange (ETDEWEB)

    McNeany, Karen I [ORNL

    2013-12-01

    The Random Drug Screening System (RDSS) is a desktop computing application designed to assign nongameable drug testing dates to each member in a population of employees, within a specific time line. The program includes reporting capabilities, test form generation, unique test ID number assignment, and the ability to flag high-risk employees for a higher frequency of drug testing than the general population.

  7. 21 CFR 868.5955 - Intermittent mandatory ventilation attachment.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Intermittent mandatory ventilation attachment. 868... SERVICES (CONTINUED) MEDICAL DEVICES ANESTHESIOLOGY DEVICES Therapeutic Devices § 868.5955 Intermittent mandatory ventilation attachment. (a) Identification. An intermittent mandatory ventilation (IMV) attachment...

  8. Initial treatment of respiratory distress syndrome with nasal intermittent mandatory ventilation versus nasal continuous positive airway pressure: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Amir-Mohammad Armanian

    2014-01-01

    Full Text Available Background: Neonatal respiratory distress syndrome (RDS in premature infants who survived and its complications are a common problem. Due to high morbidity and mechanical ventilation (MV nowadays researchers in interested minimizing MV. To determine, in very low birth weight (BW preterm neonates with RDS, if initial treatment with nasal intermittent mandatory ventilation (early NIMV compared with early nasal continuous positive airway pressure (early NCPAP obtains more favorable outcomes in terms of the duration of treatment, and the need for endotracheal tube ventilation. Methods: In this single-center randomized control trial study, infants (BW ≤ 1500 g and/or gestational age ≤ 34 weeks with respiratory distress were considered eligible. Forty-four infants were randomly assigned to receive early-NIMV and 54 comparable infants to early-NCPAP. Surfactants were given, when FIO 2 requirement was of >30%. Primary outcomes were failure of noninvasive respiratory support, that is, the need for MV in the first 48 h of life and for the duration of noninvasive respiratory support in each group. Results: 98 infants were enrolled (44 in the NIMV and 54 in the NCPAP group. The Preventive power of MV of NIMV usage (95.5% was not lower than the NCPAP (98.1% strength (hazard ratio: 0.21 (95% confidence interval: 0.02-2.66; P: 0.23. The duration of noninvasive respiratory support in the NIMV group was significantly shorter than NCPAP (the median (range was 24 (18.00-48.00 h versus 48.00 (22.00-120.00 h in NIMV versus NCPAP groups; P < 0.001. Similarly, the duration of dependency on oxygen was less, for NIMV (the median (range was 96.00 (41.00-504.00 h versus144.00 (70.00-1130.00 h in NIMV versus NCPAP groups; P: 0.009. Interestingly, time to full enteral feeds and length of hospital stay were more favorable in the NIMV versus the NCPAP group. Conclusions: Initial treatment of RDS with NIMV was safe, and well tolerated. Furthermore, NIMV had excellent

  9. Mandatory School Uniforms.

    Science.gov (United States)

    Cohn, Carl A.

    1996-01-01

    Shortly after implementing a mandatory school uniform policy, the Long Beach (California) Public Schools can boast 99% compliance and a substantial reduction in school crime. The uniforms can't be confused with gang colors, save parents money, and help identify outsiders. A sidebar lists ingredients for a mandatory uniform policy. (MLH)

  10. Variability in response to albuminuria lowering drugs : true or random?

    NARCIS (Netherlands)

    Petrykiv, Sergei I.; de Zeeuw, Dick; Persson, Frederik; Rossing, Peter; Gansevoort, Ron T.; Laverman, Gozewijn D.; Heerspink, Hiddo J. L.

    AIMS Albuminuria-lowering drugs have shown different effect size in different individuals. Since urine albumin levels are known to vary considerably from day- to-day, we questioned whether the between-individual variability in albuminuria response after therapy initiation reflects a random

  11. The frequency of drugs in randomly selected drivers in Denmark

    DEFF Research Database (Denmark)

    Simonsen, Kirsten Wiese; Steentoft, Anni; Hels, Tove

    Introduction Driving under the influence of alcohol and drugs is a global problem. In Denmark as well as in other countries there is an increasing focus on impaired driving. Little is known about the occurrence of psychoactive drugs in the general traffic. Therefore the European commission...... initiated the DRUID project. This roadside study is the Danish part of the EU-project DRUID (Driving under the Influence of Drugs, Alcohol, and Medicines) and included three representative regions in Denmark. Methods Oral fluid samples (n = 3002) were collected randomly from drivers using a sampling scheme...... stratified by time, season, and road type. The oral fluid samples were screened for 29 illegal and legal psychoactive substances and metabolites as well as ethanol. Results Fourteen (0.5%) drivers were positive for ethanol (alone or in combination with drugs) at concentrations above 0.53 g/l, which...

  12. Drug testing athletes to prevent substance abuse: background and pilot study results of the SATURN (Student Athlete Testing Using Random Notification) study.

    Science.gov (United States)

    Goldberg, Linn; Elliot, Diane L; MacKinnon, David P; Moe, Esther; Kuehl, Kerry S; Nohre, Liva; Lockwood, Chondra M

    2003-01-01

    To assess the deterrent effect of mandatory, random drug testing among high school (HS) athletes in a controlled setting. Two high schools, one with mandatory drug testing (DT) consent before sports participation, and a control school (C), without DT, were assessed during the 1999-2000 school year. Athletes (A) and nonathletes (NA) in each school completed confidential (A) or anonymous (NA) questionnaires developed for this study, respectively, at the beginning and end of the school year. Positive alcohol or drug tests required parent notification and mandatory counseling without team or school suspension. Thirty percent of the DT athletes were tested. Data were analyzed using the end of the school year measure, adjusted for the initial questionnaire results. Demographics of the athlete sample revealed that mean age was 15.5 years with 81.5% white, 9.6% Hispanic, 4.5% Asian, 2.6% American Indian/Native Alaskan, 1.3% African-American, and 1.3% Native Hawaiian/Pacific Islander. A (n = 276) and NA (n = 507) were assessed at the beginning (baseline) and at the end of the school year (A, n = 159; NA, n = 338). The past 30-day index of illicit drugs (4-fold difference) and athletic enhancing substances (3-fold difference) were lower (p athletes at follow-up without difference in alcohol use. However, most drug use risk factors, including norms of use, belief in lower risk of drugs, and poorer attitudes toward the school, increased among DT athletes (p drug use index was present among nonathletes at the DT school, at the end of the school year, it did not achieve statistical significance (p athletes. However, worsening of risk factors and small sample size suggests caution to this drug prevention approach. A larger long-term study to confirm these findings is necessary. Copyright Society for Adolescent Medicine, 2003

  13. Outcomes of a prospective trial of student-athlete drug testing: the Student Athlete Testing Using Random Notification (SATURN) study.

    Science.gov (United States)

    Goldberg, Linn; Elliot, Diane L; MacKinnon, David P; Moe, Esther L; Kuehl, Kerry S; Yoon, Myeongsun; Taylor, Aaron; Williams, Jason

    2007-11-01

    To assess the effects of random drug and alcohol testing (DAT) among high school athletes. This was a 2-year prospective randomized controlled study of a single cohort among five intervention high schools with a DAT policy and six schools with a deferred policy, serially assessed by voluntary, confidential questionnaires. DAT school athletes were at risk for random testing during the full academic year. Positive test results were reported to parents or guardians, with mandatory counseling. Indices of illicit drug use, with and without alcohol use, were assessed at the beginning and end of each school year for the past month and prior year. Potential mediating variables were evaluated. Student-athletes from intervention and control schools did not differ in past 1-month use of illicit drug or a combination of drug and alcohol use at any of the four follow-up periods. At the end of the initial school year and after 2 full school years, student-athletes at DAT schools reported less drug use during the past year (p < .01) compared to athletes at the deferred policy schools. Combining past year drug and alcohol use together, student-athletes at DAT schools reported less use at the second and third follow-up assessments (p < .05). Paradoxically, DAT athletes across all assessments reported less athletic competence (p < .001), less belief authorities were opposed to drug use (p < .01), and indicated greater risk-taking (p < .05). At the final assessment, DAT athletes believed less in testing benefits (p < .05) and less that testing was a reason not to use drugs (p < .01). No DAT deterrent effects were evident for past month use during any of four follow-up periods. Prior-year drug use was reduced in two of four follow-up self-reports, and a combination of drug and alcohol use was reduced at two assessments as well. Overall, drug testing was accompanied by an increase in some risk factors for future substance use. More research is needed before DAT is considered an

  14. 75 FR 79308 - Alcohol and Drug Testing: Determination of Minimum Random Testing Rates for 2011

    Science.gov (United States)

    2010-12-20

    ... Federal Railroad Administration 49 CFR Part 219 Alcohol and Drug Testing: Determination of Minimum Random... rail industry random testing positive rates were .037 percent for drugs and .014 percent for alcohol... 25 percent of covered railroad employees. In addition, because the industry-wide random alcohol...

  15. Comprehensive allergy work-up is mandatory in cystic fibrosis patients who report a history suggestive of drug allergy to beta-lactam antibiotics

    OpenAIRE

    Caimmi Silvia; Sanfiorenzo Céline; Caimmi Davide; Bousquet Philippe-Jean; Chiron Raphael; Demoly Pascal

    2012-01-01

    Abstract Background In the general population, reports on suspected ß-lactam hypersensitivity are common. After a drug allergy work-up at best 20% of the selected patients are positive. However, these considerations have not been explored in cystic fibrosis patients for whom antibiotics are even more crucial. Methods The study, part of the Drug Allergy and Hypersensitivity (DAHD) cohort, was performed in the regional cystic fibrosis center of Montpellier, France. After identifying patients wi...

  16. Is the randomized controlled drug trial in Europe lagging behind the USA?

    NARCIS (Netherlands)

    Lambers Heerspink, Hiddo J.; Knol, Mirjam J.; Tijssen, Robert J. W.; van Leeuwen, Thed N.; Grobbee, Diederick E.; de Zeeuw, Dick

    2008-01-01

    WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT? center dot The USA, UK and Germany have a strong position in performance of drug and nondrug randomized controlled trials. center dot Europe's position in the quantitative and qualitative performance in drug randomized controlled trials in particular, and

  17. Enzymatic methods for glyco(diversification/randomization) of drugs and small molecules.

    Science.gov (United States)

    Gantt, Richard W; Peltier-Pain, Pauline; Thorson, Jon S

    2011-10-01

    Glyco (randomization/diversification) is a term that encompasses strategies to diversify a core drug scaffold via enzymatic glycosylation to provide sets of analogs wherein the sole diversity element is a carbohydrate. This review covers the influence of glycosylation upon various drug properties, the classes of glycosyl-conjugating enzymes amenable to glyco(randomization/diversification) schemes, approaches to the synthesis of required substrates and specific examples of glycorandomized libraries utilizing both wild-type and engineered enzymes.

  18. Communicating uncertainties about prescription drugs to the public: a national randomized trial.

    Science.gov (United States)

    Schwartz, Lisa M; Woloshin, Steven

    2011-09-12

    Many new drugs are aggressively promoted. The public may not realize that even with US Food and Drug Administration (FDA) approval, important uncertainties about the benefits and harms of these drugs remain. We assessed the US public's understanding of the meaning of FDA drug approval and tested how brief explanations communicating drug uncertainties affect consumer choices. We conducted an Internet-based randomized controlled trial using a national sample of US adults from a research panel of approximately 30,000 households. A total of 2944 participants were randomized to receive 1 of 3 explanations about a pair of cholesterol drugs (1 approved based only on a surrogate outcome [lower cholesterol] and 1 based on a patient outcome [reduced myocardial infarctions]). Participants were randomized a second time to receive 1 of 3 explanations about a pair of heartburn drugs (1 newly approved and 1 approved 8 years earlier). Controls received no explanation; the nondirective group received explanations (for the cholesterol drugs, surrogates do not always translate into patient outcomes; for the heartburn drugs, it takes time to establish the safety of new drugs); the directive group received explanations plus advice to "Ask for a drug shown to reduce heart attacks or ask for one with a longer track record." The primary outcomes were choice: the cholesterol drug reducing myocardial infarctions, and the older heartburn drug. Thirty-nine percent mistakenly believed that the FDA approves only "extremely effective" drugs; 25% mistakenly believed that the FDA approves only drugs without serious side effects. Explanations affected choices: 71% of those in the directive group, 71% in the nondirective group, and 59% of controls chose the cholesterol drug that reduced myocardial infarctions (absolute difference, 12% [95% confidence interval, 7%-18%] for each explanation vs control). For the heartburn drugs, 53% of the directive group, 53% of the nondirective group, and 34% of

  19. Comparing Voluntary and Mandatory Gameplay

    Directory of Open Access Journals (Sweden)

    Esther Kuindersma

    2016-09-01

    Full Text Available Gameplay is commonly considered to be a voluntary activity. Game designers generally believe that voluntary gameplay is essentially different from mandatory gameplay. Such a belief may be a challenge for serious games, as instruction is usually mandatory. The article describes the outcomes of two experiments on the impact of voluntariness on the learning effect and enjoyment of a serious game. In the first experiment freedom of choosing to play a serious game was studied, with participants who had volunteered to participate. The results suggested that, contrary to the opinion of many game designers, being required to play a serious game does not automatically take the fun out of the game. The second experiment had voluntary participants and mandatory participants, who had to participate as part of a homework assignment. The outcomes show that mandatory participants enjoyed the game as much as the voluntary participants, even if they had to play the game for a minimum required time. These studies indicate that mandatory gameplay does not reduce enjoyment and learning effect.

  20. GPCR-drug interactions prediction using random forest with drug-association-matrix-based post-processing procedure.

    Science.gov (United States)

    Hu, Jun; Li, Yang; Yang, Jing-Yu; Shen, Hong-Bin; Yu, Dong-Jun

    2016-02-01

    G-protein-coupled receptors (GPCRs) are important targets of modern medicinal drugs. The accurate identification of interactions between GPCRs and drugs is of significant importance for both protein function annotations and drug discovery. In this paper, a new sequence-based predictor called TargetGDrug is designed and implemented for predicting GPCR-drug interactions. In TargetGDrug, the evolutionary feature of GPCR sequence and the wavelet-based molecular fingerprint feature of drug are integrated to form the combined feature of a GPCR-drug pair; then, the combined feature is fed to a trained random forest (RF) classifier to perform initial prediction; finally, a novel drug-association-matrix-based post-processing procedure is applied to reduce potential false positive or false negative of the initial prediction. Experimental results on benchmark datasets demonstrate the efficacy of the proposed method, and an improvement of 15% in the Matthews correlation coefficient (MCC) was observed over independent validation tests when compared with the most recently released sequence-based GPCR-drug interactions predictor. The implemented webserver, together with the datasets used in this study, is freely available for academic use at http://csbio.njust.edu.cn/bioinf/TargetGDrug. Copyright © 2015 Elsevier Ltd. All rights reserved.

  1. Randomized pharmacokinetic and drug-drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects.

    Science.gov (United States)

    Das, Shampa; Li, Jianguo; Armstrong, Jon; Learoyd, Maria; Edeki, Timi

    2015-10-01

    We assessed pharmacokinetic and safety profiles of ceftazidime-avibactam administered ± metronidazole, and whether drug-drug interactions exist between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. The first study (NCT01430910) involved two cohorts of healthy subjects. Cohort 1 received ceftazidime-avibactam (2000-500 mg) as a single infusion or as multiple intravenous infusions over 11 days to evaluate ceftazidime-avibactam pharmacokinetics. Cohort 2 received ceftazidime, avibactam, or ceftazidime-avibactam over 4 days to assess drug-drug interaction between ceftazidime and avibactam. The second study (NCT01534247) assessed interaction between ceftazidime-avibactam and metronidazole in subjects receiving ceftazidime-avibactam (2000-500 mg), metronidazole (500 mg), or metronidazole followed by ceftazidime-avibactam over 4 days. In all studies, subjects received a single-dose on the first and final days, and multiple-doses every 8 h on intervening days. Concentration-time profiles for ceftazidime and avibactam administered as single- or multiple-doses separately or together with/without metronidazole were similar. There was no evidence of time-dependent pharmacokinetics or accumulation. In both interaction studies, 90% confidence intervals for geometric least squares mean ratios of area under the curve and maximum plasma concentrations for each drug were within the predefined interval (80-125%) indicating no drug-drug interaction between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. There were no safety concerns. In conclusion, pharmacokinetic parameters and safety of ceftazidime, avibactam, and metronidazole were similar after single and multiple doses with no observed drug-drug interaction between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole.

  2. Mandatory Class 1 Federal Areas Web Service

    Data.gov (United States)

    U.S. Environmental Protection Agency — This web service contains the following layers: Mandatory Class 1 Federal Area polygons and Mandatory Class 1 Federal Area labels in the United States. The polygon...

  3. A Randomized Trial of Probation Case Management for Drug-Involved Women Offenders

    Science.gov (United States)

    Guydish, Joseph; Chan, Monica; Bostrom, Alan; Jessup, Martha A.; Davis, Thomas B.; Marsh, Cheryl

    2011-01-01

    This article reports findings from a clinical trial of a probation case management (PCM) intervention for drug-involved women offenders. Participants were randomly assigned to PCM (n = 92) or standard probation (n = 91) and followed for 12 months using measures of substance abuse, psychiatric symptoms, social support, and service utilization.…

  4. Voluntary, Randomized, Student Drug-Testing: Impact in a Rural, Low-Income, Community

    Science.gov (United States)

    Barrington, Kyle D.

    2008-01-01

    Illegal drug use and abuse by the nation's secondary school students is a continuing public health issue and this is especially true for students living in rural, low-income areas where access to intervention and treatment services is often limited. To address this issue, some school districts have implemented voluntary, randomized, student …

  5. Searches for Randomized Controlled Trials of Drugs in MEDLINE and EMBASE Using Only Generic Drug Names Compared with Searches Applied in Current Practice in Systematic Reviews

    Science.gov (United States)

    Waffenschmidt, Siw; Guddat, Charlotte

    2015-01-01

    Background: It is unclear which terms should be included in bibliographic searches for randomized controlled trials (RCTs) of drugs, and identifying relevant drug terms can be extremely laborious. The aim of our analysis was to determine whether a bibliographic search using only the generic drug name produces sufficient results for the generation…

  6. Screening and brief intervention for drug use in primary care: the ASPIRE randomized clinical trial.

    Science.gov (United States)

    Saitz, Richard; Palfai, Tibor P A; Cheng, Debbie M; Alford, Daniel P; Bernstein, Judith A; Lloyd-Travaglini, Christine A; Meli, Seville M; Chaisson, Christine E; Samet, Jeffrey H

    2014-08-06

    The United States has invested substantially in screening and brief intervention for illicit drug use and prescription drug misuse, based in part on evidence of efficacy for unhealthy alcohol use. However, it is not a recommended universal preventive service in primary care because of lack of evidence of efficacy. To test the efficacy of 2 brief counseling interventions for unhealthy drug use (any illicit drug use or prescription drug misuse)-a brief negotiated interview (BNI) and an adaptation of motivational interviewing (MOTIV)-compared with no brief intervention. This 3-group randomized trial took place at an urban hospital-based primary care internal medicine practice; 528 adult primary care patients with drug use (Alcohol, Smoking, and Substance Involvement Screening Test [ASSIST] substance-specific scores of ≥4) were identified by screening between June 2009 and January 2012 in Boston, Massachusetts. Two interventions were tested: the BNI is a 10- to 15-minute structured interview conducted by health educators; the MOTIV is a 30- to 45-minute intervention based on motivational interviewing with a 20- to 30-minute booster conducted by master's-level counselors. All study participants received a written list of substance use disorder treatment and mutual help resources. Primary outcome was number of days of use in the past 30 days of the self-identified main drug as determined by a validated calendar method at 6 months. Secondary outcomes included other self-reported measures of drug use, drug use according to hair testing, ASSIST scores (severity), drug use consequences, unsafe sex, mutual help meeting attendance, and health care utilization. At baseline, 63% of participants reported their main drug was marijuana, 19% cocaine, and 17% opioids. At 6 months, 98% completed follow-up. Mean adjusted number of days using the main drug at 6 months was 12 for no brief intervention vs 11 for the BNI group (incidence rate ratio [IRR], 0.97; 95% CI, 0.77-1.22) and 12

  7. 75 FR 76069 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2010-12-07

    ... aviation industry. If the reported random drug test positive rate is less than 1.00%, the Administrator may... Federal Aviation Administration Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of January 1, 2011, Through December 31, 2011 AGENCY: Federal Aviation...

  8. 78 FR 77196 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2013-12-20

    ... testing rate is based on the reported random drug test positive rate for the entire aviation industry. If... TRANSPORTATION Federal Aviation Administration Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of January 1, 2014, Through December 31, 2014 AGENCY: Federal Aviation...

  9. 77 FR 71669 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2012-12-03

    ... testing rate is based on the reported random drug test positive rate for the entire aviation industry. If... Federal Aviation Administration Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of January 1, 2013, Through December 31, 2013 AGENCY: Federal Aviation...

  10. 76 FR 74843 - Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of...

    Science.gov (United States)

    2011-12-01

    ... testing rate is based on the reported random drug test positive rate for the entire aviation industry. If... Federal Aviation Administration Random Drug and Alcohol Testing Percentage Rates of Covered Aviation Employees for the Period of January 1, 2012, Through December 31, 2012 AGENCY: Federal Aviation...

  11. A randomized controlled pilot study of motivational interviewing for patients with psychotic and drug use disorders.

    Science.gov (United States)

    Martino, Steve; Carroll, Kathleen M; Nich, Charla; Rounsaville, Bruce J

    2006-10-01

    This pilot study examined the efficacy of a two-session motivational interview adapted for dually diagnosed psychotic and drug-related disordered patients (DDMI) in comparison to a two-session standard psychiatric interview (SI). The study used a randomized controlled trial design. Participants received either DDMI or SI and were assessed at baseline, 4-, 8- and 12-week follow-up points. The principal analysis for examination of treatment effects across time was a random effects regression model. Both DDMI and SI interviews served as pre-admission intake interventions to an ambulatory specialty dual diagnosis intensive out-patient and partial hospital program. Forty-four treatment-seeking participants (DDMI = 24; SI = 20) who had co-occurring psychotic and drug-related disorders were assigned randomly to the treatment conditions. Measurements Primary outcomes were days of primary drug use, secondary drug use, alcohol use and psychotropic medication adherence, proportion of participants admitted into the program and days of attendance. DDMI and SI resulted in improved treatment outcomes, but there were no main effects for the sample as a whole. Separate examination of primary cocaine and primary marijuana using subsamples, however, suggested that DDMI resulted in significantly better primary drug treatment outcomes for the cocaine-using group, whereas SI resulted in significantly better primary drug treatment outcomes for the marijuana-using group. These findings indicate that MI may not work equally well for all types of psychotic disordered dually diagnosed patients and that alternative approaches may be as effective in fostering improved substance use treatment outcomes for subgroups of these individuals.

  12. MANDATORY CLAUSES IN MEDIATION CONTRACTS

    Directory of Open Access Journals (Sweden)

    VERONICA STOICA

    2011-04-01

    Full Text Available The mediation contract – a contract by which conflicting parties agree, in conjunction with a mediator, upon conflict resolve in an amiable manner through the agency of mediation, under due efforts on the mediator’s part, in exchange for payment of a fee by the parties – must contain a set of mandatory clauses in compliance with legal provisions, Article 45 of Law no. 192/2006. In the absence of one of said clauses, sanction by absolute annulment is imposed.

  13. Identifying co-targets to fight drug resistance based on a random walk model

    Directory of Open Access Journals (Sweden)

    Chen Liang-Chun

    2012-01-01

    Full Text Available Abstract Background Drug resistance has now posed more severe and emergent threats to human health and infectious disease treatment. However, wet-lab approaches alone to counter drug resistance have so far still achieved limited success due to less knowledge about the underlying mechanisms of drug resistance. Our approach apply a heuristic search algorithm in order to extract active network under drug treatment and use a random walk model to identify potential co-targets for effective antibacterial drugs. Results We use interactome network of Mycobacterium tuberculosis and gene expression data which are treated with two kinds of antibiotic, Isoniazid and Ethionamide as our test data. Our analysis shows that the active drug-treated networks are associated with the trigger of fatty acid metabolism and synthesis and nicotinamide adenine dinucleotide (NADH-related processes and those results are consistent with the recent experimental findings. Efflux pumps processes appear to be the major mechanisms of resistance but SOS response is significantly up-regulation under Isoniazid treatment. We also successfully identify the potential co-targets with literature confirmed evidences which are related to the glycine-rich membrane, adenosine triphosphate energy and cell wall processes. Conclusions With gene expression and interactome data supported, our study points out possible pathways leading to the emergence of drug resistance under drug treatment. We develop a computational workflow for giving new insights to bacterial drug resistance which can be gained by a systematic and global analysis of the bacterial regulation network. Our study also discovers the potential co-targets with good properties in biological and graph theory aspects to overcome the problem of drug resistance.

  14. New Mandatory Computer Security Course

    CERN Multimedia

    CERN Bulletin

    2010-01-01

    Just like any other organization, CERN is permanently under attack - even right now. Consequently it's important to be vigilant about security risks, protecting CERN's reputation - and your work. The availability, integrity and confidentiality of CERN's computing services and the unhindered operation of its accelerators and experiments come down to the combined efforts of the CERN Security Team and you. In order to remain par with the attack trends, the Security Team regularly reminds CERN users about the computer security risks, and about the rules for using CERN’s computing facilities. Since 2007, newcomers have to follow a dedicated basic computer security course informing them about the “Do’s” and “Dont’s” when using CERNs computing facilities. This course has recently been redesigned. It is now mandatory for all CERN members (users and staff) owning a CERN computer account and must be followed once every three years. Members who...

  15. Reminder: Mandatory Computer Security Course

    CERN Multimedia

    IT Department

    2011-01-01

    Just like any other organization, CERN is permanently under attack – even right now. Consequently it's important to be vigilant about security risks, protecting CERN's reputation - and your work. The availability, integrity and confidentiality of CERN's computing services and the unhindered operation of its accelerators and experiments come down to the combined efforts of the CERN Security Team and you. In order to remain par with the attack trends, the Security Team regularly reminds CERN users about the computer security risks, and about the rules for using CERN’s computing facilities. Therefore, a new dedicated basic computer security course has been designed informing you about the “Do’s” and “Dont’s” when using CERN's computing facilities. This course is mandatory for all person owning a CERN computer account and must be followed once every three years. Users who have never done the course, or whose course needs to be renewe...

  16. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

  17. Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study.

    Science.gov (United States)

    Degli Stefani, Mario; Biasutti, Michele

    2016-01-01

    Objective: Framed in the patients' engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants ( n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed.

  18. Treating adolescent drug abuse: a randomized trial comparing multidimensional family therapy and cognitive behavior therapy.

    Science.gov (United States)

    Liddle, Howard A; Dakof, Gayle A; Turner, Ralph M; Henderson, Craig E; Greenbaum, Paul E

    2008-10-01

    To examine the efficacy of two adolescent drug abuse treatments: individual cognitive behavioral therapy (CBT) and multidimensional family therapy (MDFT). A 2 (treatment condition) x 4 (time) repeated-measures intent-to-treat randomized design. Data were gathered at baseline, termination, 6 and 12 months post-termination. Analyses used latent growth curve modeling. Community-based drug abuse clinic in the northeastern United States. A total of 224 youth, primarily male (81%), African American (72%), from low-income single-parent homes (58%) with an average age of 15 years were recruited into the study. All youth were drug users, with 75% meeting DSM-IV criteria for cannabis dependence and 13% meeting criteria for abuse. Five outcomes were measured: (i) substance use problem severity; (ii) 30-day frequency of cannabis use; (iii) 30-day frequency of alcohol use; (iv) 30-day frequency of other drug use; and (v) 30-day abstinence. Both treatments produced significant decreases in cannabis consumption and slightly significant reductions in alcohol use, but there were no treatment differences in reducing frequency of cannabis and alcohol use. Significant treatment effects were found favoring MDFT on substance use problem severity, other drug use and minimal use (zero or one occasion of use) of all substances, and these effects continued to 12 months following treatment termination. Both interventions are promising treatments. Consistent with previous controlled trials, MDFT is distinguished by the sustainability of treatment effects.

  19. Randomized clinical trial on the use of antispasmodic drugs in barium enema: impact on radiological practice

    Energy Technology Data Exchange (ETDEWEB)

    Goei, Reginald; Kessels, Alphons H.; Nix, Maarten; Knipschild, Paul G

    2000-10-01

    Purpose: To assess the willingness of radiologists to change their practice when the results of a randomized clinical trial (RCT) on the use of antispasmodic drugs in barium enema are presented. Materials and Methods: During the years 1994 and 1995 two postal questionnaires were sent to 481 practicing radiologists who were all members of the Netherlands Society of Radiology. In the first questionnaire the respondents were asked to give the characteristics of their practices in performing daily barium enema. The data from this questionnaire was used as a reference. The second questionnaire was sent to the respondents together with an abstract on the randomized clinical trial supporting the use of antispasmodic drugs in barium enema. We also indicated a preference for Buscopan over Glucagon as the antispasmodic drug. The willingness to change prescription habits was measured by comparing the data of the two questionnaires. Results: Of 481 practicing radiologists, 312 responded to the first questionnaire and gave information of their prescription habits (response rate 64%). These 312 responders were sent an abstract of the RCT and were asked to fill out a second questionnaire to determine their willingness to change their practice. Two hundred and sixty-seven radiologists responded (response rate 86%). A significant number of 119 (51%) were willing to increase the use of antispasmodic drugs. A significant number of 128 (55%) chose to increase the use of Buscopan, while a significant number of 81 (32%) were willing to decrease the use of Glucagon. Conclusion: Direct exposure to the results of an RCT recommending the use of antispasmodic drugs in barium enema, especially Buscopan, is likely to increase its use by practicing radiologists.

  20. 77 FR 72905 - Pipeline Safety: Random Drug Testing Rate; Contractor MIS Reporting; and Obtaining DAMIS Sign-In...

    Science.gov (United States)

    2012-12-06

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration Pipeline Safety: Random Drug Testing Rate; Contractor MIS Reporting; and Obtaining DAMIS Sign-In Information AGENCY: Pipeline and Hazardous Materials...

  1. Mandatory IFRS Reporting and Stock Price Informativeness

    NARCIS (Netherlands)

    Beuselinck, C.A.C.; Joos, P.P.M.; Khurana, I.K.; van der Meulen, S.

    2010-01-01

    In this paper, we examine whether mandatory adoption of IFRS influences the flow of firm-specific information and contributes to stock price informativeness as measured by stock return synchronicity. Using a constant sample of 1,904 mandatory IFRS adopters in 14 EU countries for the period

  2. Mandatory Arbitration: Weighing the Pros and Cons

    Science.gov (United States)

    Settenbrino, Susan D.

    2012-01-01

    When big businesses enter into mandatory arbitration agreements with consumers, the large companies typically tout the fairness while the individual is left feeling cheated. Now that mandatory arbitration clauses are finding their way into more and more contracts signed by school systems, school boards and district administrators are realizing…

  3. 32 CFR 2400.37 - Mandatory review.

    Science.gov (United States)

    2010-07-01

    ... REGULATIONS TO IMPLEMENT E.O. 12356; OFFICE OF SCIENCE AND TECHNOLOGY POLICY INFORMATION SECURITY PROGRAM Foreign Government Information § 2400.37 Mandatory review. Except as provided in this paragraph, OSTP shall process mandatory review requests for classified records containing foreign government information...

  4. Mandatory anatomy dissection, effect on examination performance ...

    African Journals Online (AJOL)

    Regular class attendance is evidence of professionalism. This has led to mandatory class attendance in many disciplines including anatomy. However, there is paucity of data on the effect of mandatory class attendance on student performance in resource-limited settings. The objective of this study was to determine the ...

  5. Pragmatic randomized trials in drug development pose new ethical questions: a systematic review.

    Science.gov (United States)

    Kalkman, Shona; van Thiel, Ghislaine J M W; Grobbee, Diederick E; van Delden, Johannes J M

    2015-07-01

    Implementation of pragmatic design elements in drug development could bridge the evidence gap that currently exists between the knowledge we have regarding the efficacy of a drug versus its true, comparative effectiveness in real life. We performed a review of the literature to identify the ethical challenges thus far related to pragmatic trials. The three central ethical questions identified for pragmatic trials are: (i) what level of oversight should pragmatic trials require; (ii) do randomized patients face additional risks; and (iii) is a waiver of informed consent ethically defensible? Despite the fact all reviewed publications dealt with post-launch pragmatic trials, these results could serve as an important starting point for conceptualizing which challenges could potentially arise in the pre-launch setting. Copyright © 2015 Elsevier Ltd. All rights reserved.

  6. Wheeze as an Adverse Event in Pediatric Vaccine and Drug Randomized Controlled Trials: A Systematic Review

    Science.gov (United States)

    Marangu, Diana; Kovacs, Stephanie; Walson, Judd; Bonhoeffer, Jan; Ortiz, Justin R.; John-Stewart, Grace; Horne, David J.

    2016-01-01

    Introduction Wheeze is an important sign indicating a potentially severe adverse event in vaccine and drug trials, particularly in children. However, there are currently no consensus definitions of wheeze or associated respiratory compromise in randomized controlled trials (RCTs). Objective To identify definitions and severity grading scales of wheeze as an adverse event in vaccine and drug RCTs enrolling children Vaccines made up the majority (90%) of interventions, particularly influenza vaccines (65%). Only 15 trials provided explicit definitions of wheeze. Of 24 studies that described severity, 11 described wheeze severity in the context of an explicit wheeze definition. The remaining 13 studies described wheeze severity where wheeze was defined as part of a respiratory illness or a wheeze equivalent. Wheeze descriptions were elicited from caregiver reports (14%), physical examination by a health worker (45%) or a combination (41%). There were 21/58 studies in which wheeze definitions included combined caregiver report and healthcare worker assessment. The use of these two methods appeared to have the highest combined sensitivity and specificity. Conclusion Standardized wheeze definitions and severity grading scales for use in pediatric vaccine or drug trials are lacking. Standardized definitions of wheeze are needed for assessment of possible adverse events as new vaccines and drugs are evaluated. PMID:26319071

  7. Use of an antiepileptic drug to control epileptic seizures associated with cranioplasty: A randomized controlled trial.

    Science.gov (United States)

    Chen, Fei; Duan, Yaqi; Li, Yongqin; Han, Wenjie; Shi, Weilei; Zhang, Weiwei; Huang, Yonghua

    2017-04-01

    Epilepsy is a common complication of cranioplasty. The present study was designed to explore the clinical effect of prophylactic anti-epilepsy drugs (AED) to control epileptic seizures associated with cranioplasty. and design: This trial was a prospective, randomized, open-label, single-centre, active controlled study designed to investigate the use of antiepileptic drug to control epileptic seizures associated with cranioplasty. We tested the necessity and methods of drug use. Three hundred twenty epilepsy patients who underwent cranioplasty were included in this study. The patients were randomly divided into the control group (160 cases) and the experimental group (160 cases). AED were administered to experimental group from 4 days before the surgery until 1 month after the surgery. The incidence of early and late epileptic seizures after cranioplasty was analyzed. The liver function, abnormal blood test 1 month after surgery were compared between these two groups. The incidence of seizures in the Control group was 28.6% (43 cases in 149 cases) while in the experimental group was only 5.9% (9 cases in 151 cases), which had statistical significance. The incidence of epileptic seizure was significantly higher in patients who received no AED treatment than in those who received AED treatment. Besides, the abnormal liver function and blood routine examination in both control and experimental group had no significant differences. The incidence of epilepsy associated with the cranioplasty is high and early use of anti-epileptic drugs can effectively reduce the occurrence of seizures. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  8. Irrational use of antimalarial drugs in rural areas of eastern Pakistan: a random field study

    Directory of Open Access Journals (Sweden)

    Khan Shafaat Yar

    2012-11-01

    Full Text Available Abstract Background Prescription of antimalarial drugs in the absence of malarial disease is a common practice in countries where malaria is endemic. However, unwarranted use of such drugs can cause side effects in some people and is a financial drain on local economies. In this study, we surveyed the prevalence of malaria parasites in humans, and the prevalence of the malaria transmitting mosquito vectors in the study area. We also investigated the use of antimalarial drugs in the local people. We focused on randomly selected rural areas of eastern Pakistan where no malaria cases had been reported since May 2004. Methods Mass blood surveys, active case detection, passive case detection, and vector density surveys were carried out in selected areas of Sargodha district from September 2008 to August 2009. Data pertaining to the quantities and types of antimalarial drugs used in these areas were collected from health centers, pharmacies, and the district CDC program of the Health Department of the Government of the Punjab. Results Seven hundred and forty four blood samples were examined, resulting in a Blood Examination Rate (BER of 3.18; microscopic analysis of blood smears showed that none of the samples were positive for malaria parasites. Investigation of the mosquito vector density in 43 living rooms (bedrooms or rooms used for sleeping, 23 stores, and 32 animal sheds, revealed no vectors capable of transmitting malaria in these locations. In contrast, the density of Culex mosquitoes was high. Substantial consumption of a variety of antimalarial tablets, syrups, capsules and injections costing around 1000 US$, was documented for the region. Conclusion Use of antimalarial drugs in the absence of malarial infection or the vectors that transmit the disease was common in the study area. Continuous use of such drugs, not only in Pakistan, but in other parts of the world, may lead to drug-induced side effects amongst users. Better training of

  9. VITAMINE E IN THE MANAGEMENT OF DRUG INDUCED TARDIVE DYSKINESIA: A DOUBLE BLIND RANDOMIZED CLINICAL TRIAL

    Directory of Open Access Journals (Sweden)

    M KAR AHMADI

    2002-12-01

    Full Text Available Introduction. Expresssion of tardive dyskinesia as one of the side effects of antipsychotic drugs causes various problems in psychotic patients. It is the main cause of patient"s drug incompliance.Vitamine E with it"s antioxidants properties might be an effective treatment for tardive dyskinesia. Methods. In a randomized double blind clinical trial, thirty inpatients of the psychiatric hospital in Isfahan were studied. Patients were stratified according to their age, psychiatric disorder and duration, intensity of tardive dyskinesia and antipsychotic dosage. Then they were asssigned randomly into two groups. Vitamine E (600 mg/day was administered to interventional group (15 patients. Another group received placebo (15 patients. Treatment durated for 6 weeks. Abnormal Involuntary Movment Scale (AIMS was used to measure tardive dyskinesia intensity. Results. Average of disorder intensity in those who received vit. E, dropped down from 8.33/10 (befor treatment to 6.13/10 (after treatment. It means 26.3 percent reduction of tardive dyskinesia intensity. This difference was only 7.3 percent in control group. There were no statistical diffrence between two groups after treatment (P>0.05. Discussion. There is no statistical efficacy for vitamine E in the management of tardive dyskinesia. But it is recommended to make another study with more samples.

  10. Randomized response estimates for the 12-month prevalence of cognitive-enhancing drug use in university students.

    Science.gov (United States)

    Dietz, Pavel; Striegel, Heiko; Franke, Andreas G; Lieb, Klaus; Simon, Perikles; Ulrich, Rolf

    2013-01-01

    To estimate the 12-month prevalence of cognitive-enhancing drug use. Paper-and-pencil questionnaire that used the randomized response technique. University in Mainz, Germany. A total of 2569 university students who completed the questionnaire. An anonymous, specialized questionnaire that used the randomized response technique was distributed to students at the beginning of classes and was collected afterward. From the responses, we calculated the prevalence of students taking drugs only to improve their cognitive performance and not to treat underlying mental disorders such as attention-deficit-hyperactivity disorder, depression, and sleep disorders. The estimated 12-month prevalence of using cognitive-enhancing drugs was 20%. Prevalence varied by sex (male 23.7%, female 17.0%), field of study (highest in students studying sports-related fields, 25.4%), and semester (first semester 24.3%, beyond first semester 16.7%). To our knowledge, this is the first time that the randomized response technique has been used to survey students about cognitive-enhancing drug use. Using the randomized response technique, our questionnaire provided data that showed a high 12-month prevalence of cognitive-enhancing drug use in German university students. Our study suggests that other direct survey techniques have underestimated the use of these drugs. Drug prevention programs need to be established at universities to address this issue. © 2013 Pharmacotherapy Publications, Inc.

  11. Voriconazole therapeutic drug monitoring: results of a prematurely discontinued randomized multicenter trial.

    Science.gov (United States)

    Neofytos, D; Ostrander, D; Shoham, S; Laverdiere, M; Hiemenz, J; Nguyen, H; Clarke, W; Brass, L; Lu, N; Marr, K A

    2015-12-01

    Voriconazole (VOR) levels are highly variable, with potential implications to both efficacy and safety. We hypothesized that VOR therapeutic drug monitoring (TDM) will decrease the incidence of treatment failures and adverse events (AEs). We initiated a prospective, randomized, non-blinded multicenter study to compare clinical outcomes in adult patients randomized to standard dosing (clinician-driven) vs. TDM (doses adjusted based on levels). VOR trough levels were obtained on day 5, 14, 28, and 42 (or at completion of drug; ± 3 days). Real-time dose adjustments were made to maintain a range between 1-5 μg/mL on the TDM-arm, while levels were assessed retrospectively in the standard-arm. Patient questionnaires were administered to assess subjective AEs. The study was discontinued prematurely, after 29 patients were enrolled. Seventeen (58.6%) patients experienced 38 AEs: visual changes (22/38, 57.9%), neurological symptoms (13/38, 34.2%), and liver abnormalities (3/38, 7.9%). VOR was discontinued in 7 (25%) patients because of an AE (4 standard-arm, 3 TDM-arm). VOR levels were frequently out of range in the standard-arm (8 tests >5 μg/mL; 9 tests <1 μg/mL). Three dose changes occurred in the TDM-arm for VOR levels <1 μg/mL. Levels decreased over time in the standard-arm, with mean VOR levels lower at end of therapy compared to TDM (1.3 vs. 4.6 μg/mL, P = 0.008). VOR TDM has become widespread clinical practice, based on known variability in drug levels, which impaired accrual in this study. Although comparative conclusions are limited, observations of variability and waning levels over time support TDM. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  12. [Clinical randomized controlled study on acupuncture for treatment of peripheral neuropathy induced by chemotherapeutic drugs].

    Science.gov (United States)

    Xu, Wei-Ru; Hua, Bao-Jin; Hou, Wei; Bao, Yan-Ju

    2010-06-01

    To seek the effective treatment for peripheral neuropathy induced by chemotherapeutic drugs. Sixty-four cases of peripheral neuropathy induced by Paclitaxel or Oxaliplatin were randomly divided into an acupuncture group and a medication group, 32 cases in each group. The acupuncture group was treated with therapeutic principle of dredging meridians and collaterals, tonifying qi and eliminating blood stasis, supplementing liver and kidney, nourishing blood and tendon. Hegu (LI 4), Taichong (LR 3), Zusanli (ST 36), Qihai (CV 6) and Quchi (LI 11) etc. were selected. The medication group was treated with intramuscular injection of Cobamamide. The neurotoxicity of two groups was compared with questionnaire of peripheral neuropathy induced by chemotherapeutic drugs before and after treatment. The total effective rate for sensory nerve disorder of acupuncture group was 66.7% (20/30), which was superior to that of 40.0% (12/30) in medication group (P Cobamamide for treatment of peripheral neuropathy induced by chemotherapeutic drugs, especially for moderate and severe sensory nerve disorder induced by paclitaxel.

  13. 76 FR 80903 - Mandatory Declassification Review Addresses

    Science.gov (United States)

    2011-12-27

    ... Agency/Central Security Service. National Security Agency, Declassification Office, DJP5, 9800 Savage... of the Secretary Mandatory Declassification Review Addresses AGENCY: Department of Defense. ACTION: Notice. SUMMARY: Pursuant to the Information Security Oversight Office's Classified National Security...

  14. Chronic care management for dependence on alcohol and other drugs: the AHEAD randomized trial.

    Science.gov (United States)

    Saitz, Richard; Cheng, Debbie M; Winter, Michael; Kim, Theresa W; Meli, Seville M; Allensworth-Davies, Don; Lloyd-Travaglini, Christine A; Samet, Jeffrey H

    2013-09-18

    People with substance dependence have health consequences, high health care utilization, and frequent comorbidity but often receive poor-quality care. Chronic care management (CCM) has been proposed as an approach to improve care and outcomes. To determine whether CCM for alcohol and other drug dependence improves substance use outcomes compared with usual primary care. The AHEAD study, a randomized trial conducted among 563 people with alcohol and other drug dependence at a Boston, Massachusetts, hospital-based primary care practice. Participants were recruited from September 2006 to September 2008 from a freestanding residential detoxification unit and referrals from an urban teaching hospital and advertisements; 95% completed 12-month follow-up. Participants were randomized to receive CCM (n=282) or no CCM (n=281). Chronic care management included longitudinal care coordinated with a primary care clinician; motivational enhancement therapy; relapse prevention counseling; and on-site medical, addiction, and psychiatric treatment, social work assistance, and referrals (including mutual help). The no CCM (control) group received a primary care appointment and a list of treatment resources including a telephone number to arrange counseling. The primary outcome was self-reported abstinence from opioids, stimulants, or heavy drinking. Biomarkers were secondary outcomes. There was no significant difference in abstinence from opioids, stimulants, or heavy drinking between the CCM (44%) and control (42%) groups (adjusted odds ratio, 0.84; 95% CI, 0.65-1.10; P=.21). No significant differences were found for secondary outcomes of addiction severity, health-related quality of life, or drug problems. No subgroup effects were found except among those with alcohol dependence, in whom CCM was associated with fewer alcohol problems (mean score, 10 vs 13; incidence rate ratio, 0.85; 95% CI, 0.72-1.00; P=.048). Among persons with alcohol and other drug dependence, CCM compared

  15. Evaluation of dysprosia aerogels as drug delivery systems: a comparative study with random and ordered mesoporous silicas.

    Science.gov (United States)

    Bang, Abhishek; Sadekar, Anand G; Buback, Clayton; Curtin, Brice; Acar, Selin; Kolasinac, Damir; Yin, Wei; Rubenstein, David A; Lu, Hongbing; Leventis, Nicholas; Sotiriou-Leventis, Chariklia

    2014-04-09

    Biocompatible dysprosia aerogels were synthesized from DyCl3·6H2O and were reinforced mechanically with a conformal nano-thin-polyurea coating applied over their skeletal framework. The random mesoporous space of dysprosia aerogels was filled up to about 30% v/v with paracetamol, indomethacin, or insulin, and the drug release rate was monitored spectrophotometrically in phosphate buffer (pH = 7.4) or 0.1 M aqueous HCl. The drug uptake and release study was conducted comparatively with polyurea-crosslinked random silica aerogels, as well as with as-prepared (native) and polyurea-crosslinked mesoporous silica perforated with ordered 7 nm tubes in hexagonal packing. Drug uptake from random nanostructures (silica or dysprosia) was higher (30-35% w/w) and the release rate was slower (typically >20 h) relative to ordered silica (19-21% w/w, Drug release data from dysprosia aerogels were fitted with a flux equation consisting of three additive terms that correspond to drug stored successively in three hierarchical pore sites on the skeletal framework. The high drug uptake and slow release from dysprosia aerogels, in combination with their low toxicity, strong paramagnetism, and the possibility for neutron activation render those materials attractive multifunctional vehicles for site-specific drug delivery.

  16. A comparison of alcohol and drug use by random motor vehicle drivers in Brazil and Norway.

    Science.gov (United States)

    Gjerde, Hallvard; Sousa, Tanara R; De Boni, Raquel; Christophersen, Asbjørg S; Limberger, Renata P; Zancanaro, Ivomar; Oiestad, Elisabeth L; Normann, Per T; Mørland, Jørg; Pechansky, Flavio

    2014-05-01

    A large proportion of road traffic crashes are related to driving under the influence (DUI) of alcohol or drugs. The aim of this study was to compare the use of alcohol, illegal drugs and psychoactive medicinal drugs among random drivers in Brazil and Norway, two countries with the same legal limit for drunk driving, but with marked differences in legislation history, enforcement and penalties for DUI, and to discuss any differences found. Roadside surveys were conducted on Fridays and Saturdays between noon and midnight. Samples of oral fluid were collected for analysis of drugs, whereas alcohol was determined by breath testing or by analysis of oral fluid. High participation rates of 94-97% were obtained in both countries. The weighted prevalence of driving with alcohol concentrations in breath or oral fluid equivalent to blood alcohol concentrations (BAC) above 0.2g/L was 2.7% (95% CI 2.2-3.3) in Brazil and 0.2% (95% CI 0.0-0.5) in Norway. Stimulants (amphetamines or cocaine) were found in samples from 1.0% (95% CI 0.7-1.4) of drivers in Brazil and 0.3% (95% CI 0.1-0.7) in Norway. The prevalence of amphetamines was highest among Brazilian truck drivers (3.6%; 95% CI 2.0-6.4). Tetrahydrocannabinol was found in samples from 0.5% (95% CI 0.3-0.8) of drivers in Brazil and 1.0% (95% CI 0.6-1.5) in Norway, whereas benzodiazepines or zopiclone were found in 1.0% (95% CI 0.7-1.4) and 1.7% (95% CI 1.2-2.4) of the samples from Brazil and Norway, respectively. The difference in the prevalence of alcohol may be related to the fact that Norway has implemented steps to reduce drunk driving since 1936, whereas Brazil has attempted to do the same for only a few years. Differences for drugs may be related to different patterns in the use of stimulants, cannabis and medicines. Copyright © 2014 Elsevier B.V. All rights reserved.

  17. Recursive Random Lasso (RRLasso for Identifying Anti-Cancer Drug Targets.

    Directory of Open Access Journals (Sweden)

    Heewon Park

    Full Text Available Uncovering driver genes is crucial for understanding heterogeneity in cancer. L1-type regularization approaches have been widely used for uncovering cancer driver genes based on genome-scale data. Although the existing methods have been widely applied in the field of bioinformatics, they possess several drawbacks: subset size limitations, erroneous estimation results, multicollinearity, and heavy time consumption. We introduce a novel statistical strategy, called a Recursive Random Lasso (RRLasso, for high dimensional genomic data analysis and investigation of driver genes. For time-effective analysis, we consider a recursive bootstrap procedure in line with the random lasso. Furthermore, we introduce a parametric statistical test for driver gene selection based on bootstrap regression modeling results. The proposed RRLasso is not only rapid but performs well for high dimensional genomic data analysis. Monte Carlo simulations and analysis of the "Sanger Genomics of Drug Sensitivity in Cancer dataset from the Cancer Genome Project" show that the proposed RRLasso is an effective tool for high dimensional genomic data analysis. The proposed methods provide reliable and biologically relevant results for cancer driver gene selection.

  18. Targeted drugs for pulmonary arterial hypertension: a network meta-analysis of 32 randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Gao XF

    2017-05-01

    Full Text Available Xiao-Fei Gao,1 Jun-Jie Zhang,1,2 Xiao-Min Jiang,1 Zhen Ge,1,2 Zhi-Mei Wang,1 Bing Li,1 Wen-Xing Mao,1 Shao-Liang Chen1,2 1Department of Cardiology, Nanjing First Hospital, Nanjing Medical University, Nanjing, 2Department of Cardiology, Nanjing Heart Center, Nanjing, People’s Republic of China Background: Pulmonary arterial hypertension (PAH is a devastating disease and ultimately leads to right heart failure and premature death. A total of four classical targeted drugs, prostanoids, endothelin receptor antagonists (ERAs, phosphodiesterase 5 inhibitors (PDE-5Is, and soluble guanylate cyclase stimulator (sGCS, have been proved to improve exercise capacity and hemodynamics compared to placebo; however, direct head-to-head comparisons of these drugs are lacking. This network meta-analysis was conducted to comprehensively compare the efficacy of these targeted drugs for PAH.Methods: Medline, the Cochrane Library, and other Internet sources were searched for randomized clinical trials exploring the efficacy of targeted drugs for patients with PAH. The primary effective end point of this network meta-analysis was a 6-minute walk distance (6MWD.Results: Thirty-two eligible trials including 6,758 patients were identified. There was a statistically significant improvement in 6MWD, mean pulmonary arterial pressure, pulmonary vascular resistance, and clinical worsening events associated with each of the four targeted drugs compared with placebo. Combination therapy improved 6MWD by 20.94 m (95% confidence interval [CI]: 6.94, 34.94; P=0.003 vs prostanoids, and 16.94 m (95% CI: 4.41, 29.47; P=0.008 vs ERAs. PDE-5Is improved 6MWD by 17.28 m (95% CI: 1.91, 32.65; P=0.028 vs prostanoids, with a similar result with combination therapy. In addition, combination therapy reduced mean pulmonary artery pressure by 3.97 mmHg (95% CI: -6.06, -1.88; P<0.001 vs prostanoids, 8.24 mmHg (95% CI: -10.71, -5.76; P<0.001 vs ERAs, 3.38 mmHg (95% CI: -6.30, -0.47; P=0.023 vs

  19. Stopping or continuing clopidogrel 12 months after drug-eluting stent placement: the OPTIDUAL randomized trial.

    Science.gov (United States)

    Helft, Gérard; Steg, Philippe Gabriel; Le Feuvre, Claude; Georges, Jean-Louis; Carrie, Didier; Dreyfus, Xavier; Furber, Alain; Leclercq, Florence; Eltchaninoff, Hélène; Falquier, Jean-François; Henry, Patrick; Cattan, Simon; Sebagh, Laurent; Michel, Pierre-Louis; Tuambilangana, Albert; Hammoudi, Nadjib; Boccara, Franck; Cayla, Guillaume; Douard, Hervé; Diallo, Abdourahmane; Berman, Emmanuel; Komajda, Michel; Metzger, Jean-Philippe; Vicaut, Eric

    2016-01-21

    This open-label, randomized, and multicentre trial tested the hypothesis that, on a background of aspirin, continuing clopidogrel would be superior to stopping clopidogrel at 12 months following drug-eluting stent (DES) implantation. Patients (N = 1799) who had undergone placement of ≥1 DES for stable coronary artery disease or acute coronary syndrome were included in 58 French sites (January 2009-January 2013). Patients (N = 1385) free of major cardiovascular/cerebrovascular events or major bleeding and on aspirin and clopidogrel 12 months after stenting were eligible for randomization (1:1) between continuing clopidogrel 75 mg daily (extended-dual antiplatelet therapy, DAPT, group) or discontinuing clopidogrel (aspirin group). The primary outcome was net adverse clinical events defined as the composite of death, myocardial infarction, stroke, or major bleeding. Follow-up was planned from a minimum of 6 to a maximum of 36 months after randomization. Owing to slow recruitment, the study was stopped after enrolment of 1385 of a planned 1966 patients. Median follow-up after stenting was 33.4 months. The primary outcome occurred in 40 patients (5.8%) in the extended-DAPT group and 52 in the aspirin group (7.5%; hazard ratio 0.75, 95% confidence interval 0.50-1.28; P = 0.17). Rates of death were 2.3% in the extended-DAPT group and 3.5% in the aspirin group (HR 0.65, 95% CI 0.34-1.22; P = 0.18). Rates of major bleeding were identical (2.0%, P = 0.95). Extended DAPT did not achieve superiority in reducing net adverse clinical events compared to 12 months of DAPT after DES placement. The power of the OPTIDUAL trial was however low and reduced by premature termination of enrolment. NCT00822536. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

  20. Drug reimbursement and GPs' prescribing decisions: a randomized case-vignette study about the pharmacotherapy of obesity associated with type 2 diabetes: how GPs react to drug reimbursement.

    Science.gov (United States)

    Verger, Pierre; Rolland, Sophie; Paraponaris, Alain; Bouvenot, Julien; Ventelou, Bruno

    2010-08-01

    This study sought to identify the effect of drug reimbursability--a decision made in France by the National Authority for Health--on physicians' prescribing practices for a diet drug such as rimonabant, approved for obese or overweight patients with type-2 diabetes. A cross-sectional survey of French general practitioners (GPs) presented a case-vignette about a patient for whom this drug is indicated in two alternative versions, differing only in its reimbursability, to two separate randomized subsamples of GPs in early 2007, before any decision was made about reimbursement. The results indicate that (i) more than 20% of GPs in private practice would be willing to prescribe a non-reimbursed diet drug for patients with obesity complicated by type 2 diabetes; (ii) the number of GPs willing to prescribe it would increase by 47.6% if the drug were reimbursed, and (iii) such a drug would be adopted at a higher rate by GPs who have regular contacts with pharmaceutical sales representatives. In France, unlike most other countries, drug reimbursement status is a signal of quality. However, our results suggest that a significant proportion of GPs would spontaneously adopt anti-obesity drugs even if they were not reimbursed. Decisions about reimbursement of pharmaceutical products should be made taking into account that reimbursement is likely to intensify prescription.

  1. Mandatory Reporting - the Legal Case for Change

    Directory of Open Access Journals (Sweden)

    Peter Garsden

    2014-10-01

    Full Text Available In this article Peter Garsden (Principal, QualitySolicitors Abney Garsden & President of the Association of Child Abuse Lawyers examines the issues surrounding a change in the law, what presently exists around the world and brings forward concrete proposals for improving the existing statutory framework. Peter is a practicing solicitor who specialises in representing victims and survivors of child sex abuse. He is also part of the MandateNow campaign which advocates mandatory reporting. His article gives the perspective of the practitioner who works in this field and, by contrasting the approach in the UK with the approach in other jurisdictions, he argues forcefully for mandatory reporting.

  2. Mandatory IFRS Reporting and Stock Price Informativeness

    OpenAIRE

    Beuselinck, C.A.C.; Joos, P.P.M.; Khurana, I.K.; Meulen, S. van der

    2010-01-01

    In this paper, we examine whether mandatory adoption of IFRS influences the flow of firm-specific information and contributes to stock price informativeness as measured by stock return synchronicity. Using a constant sample of 1,904 mandatory IFRS adopters in 14 EU countries for the period 2003-2007, we find a V-shaped pattern in synchronicity around IFRS adoption, which is consistent with IFRS disclosures revealing new firm-specific information in the adoption period (i.e., a reduction of sy...

  3. Visual presentations of efficacy data in direct-to-consumer prescription drug print and television advertisements: A randomized study.

    Science.gov (United States)

    Sullivan, Helen W; O'Donoghue, Amie C; Aikin, Kathryn J; Chowdhury, Dhuly; Moultrie, Rebecca R; Rupert, Douglas J

    2016-05-01

    To determine whether visual aids help people recall quantitative efficacy information in direct-to-consumer (DTC) prescription drug advertisements, and if so, which types of visual aids are most helpful. Individuals diagnosed with high cholesterol (n=2504) were randomized to view a fictional DTC print or television advertisement with no visual aid or one of four visual aids (pie chart, bar chart, table, or pictograph) depicting drug efficacy. We measured drug efficacy and risk recall, drug perceptions and attitudes, and behavioral intentions. For print advertisements, a bar chart or table, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph and the table was better than the pie chart. For television advertisements, any visual aid, compared with no visual aid, elicited more accurate drug efficacy recall. The bar chart was better at this than the pictograph or the table. Visual aids depicting quantitative efficacy information in DTC print and television advertisements increased drug efficacy recall, which may help people make informed decisions about prescription drugs. Adding visual aids to DTC advertising may increase the public's knowledge of how well prescription drugs work. Published by Elsevier Ireland Ltd.

  4. Randomized Trial to Reduce Club Drug Use and HIV Risk Behaviors among Men Who Have Sex with Men

    Science.gov (United States)

    Morgenstern, Jon; Bux, Donald A., Jr.; Parsons, Jeffrey; Hagman, Brett T.; Wainberg, Milton; Irwin, Thomas

    2009-01-01

    The authors examined the effectiveness of motivational interviewing (MI) on club drug use and risky sex in non-treatment-seeking men who have sex with men (MSM). MSM (N = 150) were assessed and randomly assigned to 4 sessions of MI or an educational control intervention. Follow-up occurred at quarterly intervals for 1 year. Primary outcomes were…

  5. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.J.; Vermulst, A.A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting General population of 11-15-year-old adolescents

  6. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use : A randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, Monique; Kleinjan, Marloes; Overbeek, Geertjan; Vermulst, Ad; Monshouwer, Karin; Lammers, Jeroen; Vollebergh, Wilma A M; Engels, Rutger C M E

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old

  7. Effectiveness of the 'Healthy School and Drugs' prevention programme on adolescents' substance use: a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Kleinjan, M.; Overbeek, G.; Vermulst, A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2014-01-01

    Aim: To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol, tobacco and marijuana use among Dutch early adolescents. Design: Randomized clustered trial with two intervention conditions (i.e. e-learning and integral). Setting: General population of 11-15-year-old

  8. HIV incidence among people who inject drugs (PWID) in Ukraine: results from a clustered randomized trial

    Science.gov (United States)

    Davis, Jonathan M.; Dvoryak, Sergey; Brewster, John T.; Lisovska, Oksana; Strathdee, Steffanie A.; Latkin, Carl A.

    2016-01-01

    Summary Background In this study, we sought to assess whether a social network intervention was superior to HIV testing and counseling in impacting HIV incidence among PWID. Although this was not a primary study aim, it is associated with reducing drug and sex risk behaviors, which were primary aims. Methods PWID were recruited from street settings in Odessa, Donetsk, and Nikolayev, Ukraine for a clustered randomized clinical trial (RCT). “Index” or peer leaders, along with two of their network members, were randomly assigned to testing and counseling block (N=589) or testing and counseling plus a social network intervention block (N=611). Participants in the network intervention received 5-sessions to train their network members in risk reduction. Those assigned testing and counseling received no further intervention following counseling. Employing an intent to treat analyses, the primary outcome was HIV sero-conversion using Cox regression and incorporating a gamma frailty term to account for clustering. No stratification or minimization was utilized. The trail was registered with ClinicalTrial.gov, NCT01159704. Findings Between July 12, 2010 and November 23, 2012, 2,304 PWID were recruited, 1,200 of whom were HIV negative and included in the present study. At baseline, there were no significant differences between groups. Of the 1,200 HIV negative participants, 1,085 (90.4%) were retained at 12 months. Incidence density revealed 18.45 (95% CI 14.87 – 22.03, 102 events in 553.0 py) per 100 person years (py) for those in the intervention group and 31.78 (95% CI 26.83–36.74, 158 events in 497.1 py) per 100 py among control arm participants. This corresponded to a reduced hazard in the intervention group, HR= 0.53 (95% CI 0.38, 0.76, p =0.0003). There were no study-related adverse events. Interpretation These data provide strong support for integrating peer education into comprehensive HIV prevention programs for PWID and suggest the value in developing and

  9. The effect of hypnotic drug type on anesthetic depth and amnesia: a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Amiri HR

    2009-06-01

    Full Text Available "n Normal 0 false false false EN-GB X-NONE AR-SA MicrosoftInternetExplorer4 /* Style Definitions */ table.MsoNormalTable {mso-style-name:"Table Normal"; mso-tstyle-rowband-size:0; mso-tstyle-colband-size:0; mso-style-noshow:yes; mso-style-priority:99; mso-style-qformat:yes; mso-style-parent:""; mso-padding-alt:0cm 5.4pt 0cm 5.4pt; mso-para-margin:0cm; mso-para-margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:11.0pt; font-family:"Calibri","sans-serif"; mso-ascii-font-family:Calibri; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"Times New Roman"; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Calibri; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:Arial; mso-bidi-theme-font:minor-bidi;} Background: Bispectral index (BIS index shows the depth of anesthesia. The effects of drugs on BIS and amnesia are different. This study was performed to evaluate the association between two different sedative regimens on BIS and amnesia."n"nMethods: In this clinical trial, 60 patients who needed elective orthopedic surgery under regional anesthesia with intravenous sedation were elected. Patients divided in two equal groups based on sedation protocol by block randomization method: midazolam plus fentanyl group (MF group or propofol group (P group. Dose of sedative drugs were adjusted according to clinical findings of sedation. Depth of sedation in all patients, preserved in four based on modified Ramsey Sedation Score. Patients questioned about spontaneous recall after full awakening in recovery room. Recall of any event during operation considered as failed amnesia. Correlation of BIS index with recall was measured in two different groups separately."n"nResults: The frequency of recall was 2 (6.7% in P group and 10 (33.3% in MF group (p=0.01. The mean± SD of BIS in P group was 76±5 (68-91 and in MF group was 93.4±5 (77-98 (p<0.001. The difference of BIS in patients without amnesia (p=0.019 and with amnesia (p<0

  10. 28 CFR 2.53 - Mandatory parole.

    Science.gov (United States)

    2010-07-01

    ... Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION AND RECOMMITMENT OF PRISONERS, YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.53 Mandatory parole. (a) A prisoner (including a prisoner sentenced under the Narcotic Addict Rehabilitation Act...

  11. 76 FR 34004 - Dairy Product Mandatory Reporting

    Science.gov (United States)

    2011-06-10

    ... manufacturers of dairy products to report sales information for a mandatory dairy product reporting program. The... announces the intention of AMS to request approval by the Office of Management and Budget (OMB) of... functions for the program. NASS publishes sales information for cheddar cheese, butter, dry whey, and nonfat...

  12. Police Response to Mandatory Arrest Laws.

    Science.gov (United States)

    Mignon, Sylvia I.; Holmes, William M.

    1995-01-01

    Examines how police officers in 24 departments have responded to mandatory arrest statutes in 861 cases of domestic violence. Arrests of offenders, especially those violating restraining orders, increased. Arrest was affected by victim injury, use of a weapon, use of alcohol, and presence of a witness. Police training was crucial to implementation…

  13. Mandatory School Uniforms and Freedom of Expression

    Science.gov (United States)

    Vopat, Mark C.

    2010-01-01

    On 10 December 2007 the Akron City School Board--following the precedent set by many school systems across the United States and the world--instituted a policy of mandatory school uniforms for all students in grades K-8. The measure was met with mixed reviews. While many parents supported the measure, a small group of parents from a selective,…

  14. Chimeric cytochromes P450 engineered by domain swapping and random mutagenesis for producing human metabolites of drugs.

    Science.gov (United States)

    Kang, Ji-Yeon; Ryu, Sang Hoon; Park, Sun-Ha; Cha, Gun Su; Kim, Dong-Hyun; Kim, Keon-Hee; Hong, Austin W; Ahn, Taeho; Pan, Jae-Gu; Joung, Young Hee; Kang, Hyung-Sik; Yun, Chul-Ho

    2014-07-01

    Human drug metabolites produced by cytochrome P450 enzymes are critical for safety testing and may themselves act as drugs or leads in the drug discovery and development process. Here, highly active chimeric fusion proteins (chimeras) were obtained by reductase domain swapping of mutants at key catalytic residues of the heme domain with that of a natural variant (CYP102A1.2) of P450 BM3 (CYP102A1.1) from Bacillus megaterium. Random mutagenesis at the heme domain of the chimera was also used to generate chimeric mutants that were more active and diverse than the chimeras themselves. To determine whether the chimeras and several mutants of the highly active chimera displayed enhanced catalytic activity and, more importantly, whether they acquired activities of biotechnological importance, we measured the oxidation activities of the chimeras and chimeric mutants toward human P450 substrates, mainly drugs. Some of the chimeric mutants showed high activity toward typical human P450 substrates including drugs. Statin leads, especially chiral products, with inhibitory effects toward HMG-CoA reductase could be obtained from metabolites of statin drugs generated using these chimeric mutants. This study reveals the critical role of the reductase domain for the activity of P450 BM3 and shows that chimeras generated by domain swapping can be used to develop industrial enzymes for the synthesis of human metabolites from drugs and drug leads. © 2014 Wiley Periodicals, Inc.

  15. How to Help Unemployed Find Jobs Quickly : Experimental Evidence from a Mandatory Activation Program

    NARCIS (Netherlands)

    Graversen, B.K.; van Ours, J.C.

    2006-01-01

    This paper investigates how a mandatory activation program in Denmark affects the job finding rate of unemployed workers.The activation program was introduced in an experimental setting where about half of the workers who became unemployed in the period from November 2005 to March 2006 were randomly

  16. A time series analysis of the effects of financial incentives and mandatory clinical applications as interventions to improve spontaneous adverse drug reaction reporting by hospital medical staff in China.

    Science.gov (United States)

    Chang, Feng; Xi, Yue; Zhao, Jie; Zhang, Xiaojian; Lu, Yun

    2017-12-01

    Spontaneous reporting of adverse drug reactions (ADRs) in hospitals is often under-reported, which may lead to problems in patient management. This study was aimed to assess the effectiveness of a financial intervention based on a fine and a bonus for improving spontaneous reporting of ADRs by physicians in a hospital setting. This study was conducted at the First Affiliated Hospital of Zhengzhou University (China). Starting in 2009, a bonus of 20 RMB (Chinese currency) was given for each spontaneous ADR report, and a fine of 50 RMB was given for any withheld ADR report. A time series analysis using autoregressive integrated moving average models was performed to assess the changes in the total number of spontaneous ADR reports between the preintervention period (2006-2008) and during the first (2009-2011) and second (2012-2014) intervention periods. The median number of reported ADRs per year increased from 29 (range 27-72) in the preintervention period to 277 (range 199-284) in the first intervention period and to 666 in the second (range 644-691). The monthly number of reported ADRs was stable during the 3 periods: 3.56 ± 3.60/month (95% confidence interval (CI), 2.42-4.75) during the preintervention period, 21 ± 13/month (95% CI, 16.97-25.80) in the first intervention period, and 56 ± 20/month (95% CI, 48.81-62.17) in the second intervention period. A financial incentive and ADR management regulations had a significant effect on the increase of reported ADRs. © 2017 John Wiley & Sons, Ltd.

  17. Drug-eluting stents for acute coronary syndrome: a meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Lishan Wang

    Full Text Available Drug-eluting stents (DES are increasingly used for treatment of acute coronary syndrome (ACS. However, clinical efficacy and safety of various types of DES is not well established in these subjects. We therefore evaluated clinical utility of second-generation and first-generation DES in patients with ACS by conducting a meta-analysis.A search of Medline, Embase, the Cochrane databases, and Web of Science was made. Randomized controlled trials (RCTs which compared second-generation DES (everolimus-eluting stents [EES] or zotarolimus-eluting stents [ZES] versus first-generation DES (sirolimus-eluting stents [SES] or paclitaxe-eluting stents [PES] in patients with ACS and provided data on clinical efficacy or safety endpoints were included. Pooled estimates were calculated using random-effects model.A total of 2,757 participants with ACS in 6 RCTs were included. Compared with first-generation one, second-generation DES trended to be associated with the decreased incidence of definite or probable stent thrombosis in ACS patients (risk ratio [RR]  = 0.60, 95% confidence intervals [CI] 0.33 to 1.07, p = 0.09. However, the rate of target lesion revascularization (TLR significantly increased in second-generation DES (RR = 2.08, 95%CI 1.25 to 3.47, p = 0.005. There were no significant differences in the incidence of major adverse cardiac events (MACEs, all-cause death, cardiac death, and recurrent myocardial infarction between the two arms (all p>0.10. The second-generation EES showed a tendency towards lower risk of MACEs (p = 0.06 and a beneficial effect on reducing stent thrombosis episodes (p = 0.009, while the second-generation ZES presented an increased occurrence of MACEs (p = 0.02 and TLR (p = 0.003.Second-generation DES, especially EES, appeared to present a lower risk of stent thrombosis, whereas second-generation ZES might increase the need for repeat revascularization in ACS patients. During coronary

  18. Randomized controlled trial of motivational interviewing compared with drug information and advice for early intervention among young cannabis users.

    Science.gov (United States)

    McCambridge, Jim; Slym, Renee L; Strang, John

    2008-11-01

    To test the effectiveness of motivational interviewing (MI) in comparison with drug information and advice in opportunistically securing reductions in drug-related risk among young cannabis users not seeking help. Randomized controlled trial. Eleven London Further Education colleges. A total of 326 students aged 16-19 years who smoked cannabis weekly or more frequently. Participants were randomized to a single-session intervention of MI or drug information and advice-giving. Cannabis use, cigarette smoking and alcohol consumption and harm outcomes were assessed after both 3 and 6 months. No differences were found between MI and drug information and advice, although MI fidelity was not high. There were wide-ranging individual practitioner effects on observed outcomes and a practitioner-intervention interaction was detected in relation to cannabis cessation after 3 months. Change over time was more pronounced for cannabis use than for other drug use. Further study of the nature and consequences of MI fidelity, and individual practitioner effects more generally, is needed. Advice may be an effective brief intervention with young cannabis users in its own right and should be evaluated further in trials.

  19. Reducing inappropriate, anticholinergic and psychotropic drugs among older residents in assisted living facilities: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Pitkala Kaisu H

    2012-06-01

    Full Text Available Abstract Background Use of inappropriate drugs is common among institutionalized older people. Rigorous trials investigating the effect of the education of staff in institutionalized settings on the harm related to older people’s drug treatment are still scarce. The aim of this trial is to investigate whether training professionals in assisted living facilities reduces the use of inappropriate drugs among residents and has an effect on residents’ quality of life and use of health services. Methods and design During years 2011 and 2012, a sample of residents in assisted living facilities in Helsinki (approximately 212 will be recruited, having offered to participate in a trial aiming to reduce their harmful drugs. Their wards will be randomized into two arms: one, those in which staff will be trained in two half-day sessions, including case studies to identify inappropriate, anticholinergic and psychotropic drugs among their residents, and two, a control group with usual care procedures and delayed training. The intervention wards will have an appointed nurse who will be responsible for taking care of the medication of the residents on her ward, and taking any problems to the consulting doctor, who will be responsible for the overall care of the patient. The trial will last for twelve months, the assessment time points will be zero, six and twelve months. The primary outcomes will be the proportion of persons using inappropriate, anticholinergic, or more than two psychotropic drugs, and the change in the mean number of inappropriate, anticholinergic and psychotropic drugs among residents. Secondary endpoints will be, for example, the change in the mean number of drugs, the proportion of residents having significant drug-drug interactions, residents' health-related quality of life (HRQOL according to the 15D instrument, cognition according to verbal fluency and clock-drawing tests and the use and cost of health services, especially

  20. The mandatory sentence and Section 2.

    Science.gov (United States)

    Dell, S

    1986-01-01

    Sentencing in homicide depends on how psychiatrists view the issues of Section 2. In most killings that do not involve clear-cut mental disorder, strong emotions and stress play a part. Both can be cited in aid of diminished responsibility. If doctors cite them, however tentatively, it becomes feasible for the court to review any mitigating factors and to choose an appropriate penalty. Otherwise, the mandatory penalty is imposed. Thus doctors, by opining not on the medical but on the legal and moral aspects of Section 2, decide who shall automatically get a life sentence and who shall not. Anomaly and injustice are the results. They would be remedied by the abolition of the mandatory sentence for murder. PMID:3959037

  1. A libertarian case for mandatory vaccination.

    Science.gov (United States)

    Brennan, Jason

    2016-07-11

    This paper argues that mandatory, government-enforced vaccination can be justified even within a libertarian political framework. If so, this implies that the case for mandatory vaccination is very strong indeed as it can be justified even within a framework that, at first glance, loads the philosophical dice against that conclusion. I argue that people who refuse vaccinations violate the 'clean hands principle', a (in this case, enforceable) moral principle that prohibits people from participating in the collective imposition of unjust harm or risk of harm. In a libertarian framework, individuals may be forced to accept certain vaccines not because they have an enforceable duty to serve the common, and not because cost-benefit analysis recommends it, but because anti-vaxxers are wrongfully imposing undue harm upon others. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. Mandatory Class 1 Federal Areas Web Service

    Science.gov (United States)

    This web service contains the following layers: Mandatory Class 1 Federal Area polygons and Mandatory Class 1 Federal Area labels in the United States. The polygon layer draws at all scales. The labels draw at scales greater than or equal to 1:3 million. Data used to create this web service are available as a separate download at the secondary linkage listed above. Full FGDC metadata are available by clicking the layer name in the web service table of contents and clicking the Full Metadata link in the layer description. This dataset was developed by EPA's Office of Air Quality Planning and Standards (OAQPS) based on features originating from several data sources, including USEPA, USFS, USFWS, NPS and BIA.

  3. Portraying mental illness and drug addiction as treatable health conditions: effects of a randomized experiment on stigma and discrimination.

    Science.gov (United States)

    McGinty, Emma E; Goldman, Howard H; Pescosolido, Bernice; Barry, Colleen L

    2015-02-01

    Despite significant advances in treatment, stigma and discrimination toward persons with mental illness and drug addiction have remained constant in past decades. Prior work suggests that portraying other stigmatized health conditions (i.e., HIV/AIDS) as treatable can improve public attitudes toward those affected. Our study compared the effects of vignettes portraying persons with untreated and symptomatic versus successfully treated and asymptomatic mental illness and drug addiction on several dimensions of public attitudes about these conditions. We conducted a survey-embedded randomized experiment using a national sample (N = 3940) from an online panel. Respondents were randomly assigned to read one of ten vignettes. Vignette one was a control vignette, vignettes 2-5 portrayed individuals with untreated schizophrenia, depression, prescription pain medication addiction and heroin addiction, and vignettes 6-10 portrayed successfully treated individuals with the same conditions. After reading the randomly assigned vignette, respondents answered questions about their attitudes related to mental illness or drug addiction. Portrayals of untreated and symptomatic schizophrenia, depression, and heroin addiction heightened negative public attitudes toward persons with mental illness and drug addiction. In contrast, portrayals of successfully treated schizophrenia, prescription painkiller addiction, and heroin addiction led to less desire for social distance, greater belief in the effectiveness of treatment, and less willingness to discriminate against persons with these conditions. Portrayal of persons with successfully treated mental illness and drug addiction is a promising strategy for reducing stigma and discrimination toward persons with these conditions and improving public perceptions of treatment effectiveness. Copyright © 2014 Elsevier Ltd. All rights reserved.

  4. Italian healthcare workers' views on mandatory vaccination

    Directory of Open Access Journals (Sweden)

    Germinario Cinzia CG

    2009-06-01

    Full Text Available Abstract Background Mandatory vaccination has contributed to the success of immunisation programmes but voluntary vaccination allows people to be responsible for their own health. There are benefits from both policies and the arguments between them remain subject to debate within and without the scientific community, both nationally and internationally. The aim of this study is to assess the opinions of those who actually work in the Vaccination Service. Methods The survey was carried out using a self-administered standardised anonymous questionnaire given to all of the Vaccination Service employees in the Apulia Region. Results Of 302 completed questionnaire replies, 4.4% stated that mandatory vaccination should be abandoned now, 21.2% that it should be phased out, and 74.4% that it should be retained. Conclusion An educational program should be set up to explain to Vaccination staff the value and worth of voluntary compared to mandatory vaccination and why high vaccination rates do not have to depend on compulsion.

  5. 49 CFR 220.61 - Radio transmission of mandatory directives.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 4 2010-10-01 2010-10-01 false Radio transmission of mandatory directives. 220.61... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD COMMUNICATIONS Radio and Wireless Communication Procedures § 220.61 Radio transmission of mandatory directives. (a) Each mandatory directive may be transmitted by...

  6. Combination of Deep Recurrent Neural Networks and Conditional Random Fields for Extracting Adverse Drug Reactions from User Reviews

    Directory of Open Access Journals (Sweden)

    Elena Tutubalina

    2017-01-01

    Full Text Available Adverse drug reactions (ADRs are an essential part of the analysis of drug use, measuring drug use benefits, and making policy decisions. Traditional channels for identifying ADRs are reliable but very slow and only produce a small amount of data. Text reviews, either on specialized web sites or in general-purpose social networks, may lead to a data source of unprecedented size, but identifying ADRs in free-form text is a challenging natural language processing problem. In this work, we propose a novel model for this problem, uniting recurrent neural architectures and conditional random fields. We evaluate our model with a comprehensive experimental study, showing improvements over state-of-the-art methods of ADR extraction.

  7. Systematic Review of Infrapopliteal Drug-Eluting Stents: A Meta-Analysis of Randomized Controlled Trials

    Energy Technology Data Exchange (ETDEWEB)

    Katsanos, Konstantinos, E-mail: katsanos@med.upatras.gr [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Spiliopoulos, Stavros [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Diamantopoulos, Athanasios [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Karnabatidis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece); Sabharwal, Tarun [NHS Foundation Trust, King' s Health Partners, Department of Interventional Radiology, Guy' s and St. Thomas' Hospitals (United Kingdom); Siablis, Dimitris [Patras University Hospital, Department of Interventional Radiology, School of Medicine (Greece)

    2013-06-15

    IntroductionDrug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.Materials and MethodsPubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of {>=}50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.ResultsThree RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p < 0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall

  8. Drug*placebo interaction effect may bias clinical trials interpretation: hybrid balanced placebo and randomized placebo-controlled design.

    Science.gov (United States)

    Hammami, Muhammad M; Hammami, Safa; Al-Swayeh, Reem; Al-Gaai, Eman; Farah, Faduma Abdi; De Padua, Sophia J S

    2016-11-29

    Conventional randomized placebo-controlled study design assumes the absence of drug*placebo interaction. We hypothesized the presence of such an interaction and that conventionally estimated drug effect might be biased. The objectives of the study were to determine the drug*placebo interaction effect (main) and compare conventionally estimated and interaction model-estimated drug effects (secondary). We used a hybrid of balanced placebo and randomized placebo-controlled designs. Four hundred eighty healthy volunteers were randomized to three groups. The first received hydroxyzine (25 mg) described as hydroxyzine or placebo, the second received placebo described as hydroxyzine or placebo, and the third received hydroxyzine and placebo described as unknown; each in a randomized crossover design. Seven participants failed to crossover. Group assignment was concealed from participants and study coordinators. Coordinators were blinded to group and intervention assignment. Participants and coordinators were deceived as to study objectives. Main outcomes were mean area-under-the-curve of drowsiness (therapeutic outcome) and mouth-dryness (adverse outcome), self-reported on 100 mm visual analog scale over 7 h. Drug, placebo, placebo + interaction, and total effects were estimated using analysis of covariance by comparing received hydroxyzine/told placebo to received placebo/told placebo, received placebo/told hydroxyzine to received placebo/told placebo, received hydroxyzine/told hydroxyzine to received hydroxyzine/told placebo, and received hydroxyzine/told hydroxyzine to received placebo/told placebo, respectively. Drug effect was also conventionally estimated in the third group. Mean (SD) age was 31.4 (6.6) years, 65% were males. There was significant difference between placebo + interaction effect and placebo effect for both drowsiness and mouth-dryness with a mean difference (95% confidence interval) of 35.1 (5.6 to 64.6) and 23.8 (2.4 to 45.2) mm

  9. Treatment with Antiangiogenic Drugs in Multiple Lines in Patients with Metastatic Colorectal Cancer: Meta-Analysis of Randomized Trials

    Directory of Open Access Journals (Sweden)

    R.-D. Hofheinz

    2016-01-01

    Full Text Available Background. In metastatic colorectal cancer (mCRC, continuing antiangiogenic drugs beyond progression might provide clinical benefit. We synthesized the available evidence in a meta-analysis. Patients and Methods. We conducted a meta-analysis of studies investigating the use of antiangiogenic drugs beyond progression. Eligible studies were randomized phase II/III trials. Primary endpoints were overall survival (OS and progression-free survival (PFS. Secondary endpoints were the impact of continuing antiangiogenic drugs (i in subgroups, (ii in different types of compounds targeting the VEGF-axis (monoclonal antibodies versus tyrosine kinase inhibitors, and (iii on remission rates and prevention of progression. Results. Eight studies (3,668 patients were included. Continuing antiangiogenic treatment beyond progression significantly improved PFS (HR 0.64; 95%-CI, 0.55–0.75 and OS (HR 0.83; 95%-CI, 0.76–0.89. PFS was significantly improved in all subgroups with comparable HR. OS was improved in all subgroups stratified by age, gender, and ECOG status. The rate of patients achieving at least stable disease was improved with an OR of 2.25 (95%-CI, 1.41–3.58. Conclusions. This analysis shows a significant PFS and OS benefit as well as a benefit regarding disease stabilization when using antiangiogenic drugs beyond progression in mCRC. Future studies should focus on the optimal sequence of administering antiangiogenic drugs.

  10. Collaborative behavioral management among parolees: drug use, crime and re-arrest in the Step'n Out randomized trial.

    Science.gov (United States)

    Friedmann, Peter D; Green, Traci C; Taxman, Faye S; Harrington, Magdalena; Rhodes, Anne G; Katz, Elizabeth; O'Connell, Daniel; Martin, Steven S; Frisman, Linda K; Litt, Mark; Burdon, William; Clarke, Jennifer G; Fletcher, Bennett W

    2012-06-01

    To determine whether collaborative behavioral management (CBM) reduces substance use, crime and re-arrest among drug-involved parolees. Step'n Out was a randomized behavioral trial of CBM versus standard parole (SP) during 2004-08. CBM adapted evidence-based role induction, behavioral contracting and contingent reinforcement to provide parole officer/treatment counselor dyads with positive tools in addition to sanctions to manage parolees' behavior over 12 weeks. Six parole offices in five states in the USA. Parolee volunteers with a mandate for addiction treatment and a minimum of 3 months of parole (n = 476). Follow-up was 94% at 3 months and 86% at 9 months. Drug use and crime in a given month from calendar interviews 3 and 9 months after parole initiation, and re-arrests from criminal justice administrative data. The CBM group had fewer months in which they used their primary drug [adjusted risk ratio (ARR) 0.20, 95% confidence interval (CI): 0.05, 0.78, P = 0.02] and alcohol (ARR 0.38, 95% CI: 0.22, 0.66, P = 0.006) over follow-up. CBM had its greatest effects among parolees who reported marijuana or another 'non-hard' drug as their primary drug; parolees who preferred stimulants or opiates did not benefit. No differences were seen in total crime, re-arrests or parole revocations. Collaborative behavioral management may reduce substance use among primary marijuana or other 'non-hard' drug-using parolees without increasing revocations. Because the majority of drug violation arrests in the United States are for marijuana, these findings have important implications for the management of a substantial proportion of the US community correctional population. Published 2011. This article is a U.S. Government work and is in the public domain in the USA.

  11. Security without IoT Mandatory Backdoors

    OpenAIRE

    Hewitt, Carl

    2016-01-01

    https://plus.google.com/+CarlHewitt-StandardIoT/The Internet of Things (IoT) is becoming pervasive in all aspects of life including personal, corporate, government, and social. Adopting mandatory backdoors for every IoT device ultimately means that security agencies of each country surveil IoT in their own country and perhaps swap surveillance information with other countries. Security agencies have proposed that it must be possible for them to secretly access and take control of any individu...

  12. Effectiveness of multi-drug regimen chemotherapy treatment in osteosarcoma patients: a network meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Wang, Xiaojie; Zheng, Hong; Shou, Tao; Tang, Chunming; Miao, Kun; Wang, Ping

    2017-03-29

    Osteosarcoma is the most common malignant bone tumour. Due to the high metastasis rate and drug resistance of this disease, multi-drug regimens are necessary to control tumour cells at various stages of the cell cycle, eliminate local or distant micrometastases, and reduce the emergence of drug-resistant cells. Many adjuvant chemotherapy protocols have shown different efficacies and controversial results. Therefore, we classified the types of drugs used for adjuvant chemotherapy and evaluated the differences between single- and multi-drug chemotherapy regimens using network meta-analysis. We searched electronic databases, including PubMed (MEDLINE), EmBase, and the Cochrane Library, through November 2016 using the keywords "osteosarcoma", "osteogenic sarcoma", "chemotherapy", and "random*" without language restrictions. The major outcome in the present analysis was progression-free survival (PFS), and the secondary outcome was overall survival (OS). We used a random effect network meta-analysis for mixed multiple treatment comparisons. We included 23 articles assessing a total of 5742 patients in the present systematic review. The analysis of PFS indicated that the T12 protocol (including adriamycin, bleomycin, cyclophosphamide, dactinomycin, methotrexate, cisplatin) plays a more critical role in osteosarcoma treatment (surface under the cumulative ranking (SUCRA) probability 76.9%), with a better effect on prolonging the PFS of patients when combined with ifosfamide (94.1%) or vincristine (81.9%). For the analysis of OS, we separated the regimens to two groups, reflecting the disconnection. The T12 protocol plus vincristine (94.7%) or the removal of cisplatinum (89.4%) is most likely the best regimen. We concluded that multi-drug regimens have a better effect on prolonging the PFS and OS of osteosarcoma patients, and the T12 protocol has a better effect on prolonging the PFS of osteosarcoma patients, particularly in combination with ifosfamide or vincristine

  13. Impact of drug reconciliation at discharge and communication between hospital and community pharmacists on drug-related problems: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Pourrat, Xavier; Roux, Clarisse; Bouzige, Brigitte; Garnier, Valérie; Develay, Armelle; Allenet, Benoit; Fraysse, Martial; Halimi, Jean-Michel; Grassin, Jacqueline; Giraudeau, Bruno

    2014-06-30

    Patients are at risk of drug-related problems (DRPs) at transition points during hospitalization. The community pharmacist (CP) is often the first healthcare professional patients visit after discharge. CPs lack sufficient information about the patient and so they may be unable to identify problems in medications, which may lead to dispensing the wrong drugs or dosage, and/or giving wrong information. We aim to assess the impact of a complex intervention comprising of medication reconciliation performed at discharge by a hospital pharmacist (HP) with communication between the HP and CP on DRPs during the seven days following discharge. The study is a cluster randomized crossover trial involving 46 care units (each unit corresponding to a cluster) in 22 French hospitals during two consecutive 14-day periods, randomly assigned as 'experimental' or 'control' (usual care) periods. We will recruit patients older than 18 years of age and visiting the same CP for at least three months. We will exclude patients with a hospital length of stay of more than 21 days, who do not return home or those in palliative care. During the experimental period, the HP will perform a medications reconciliation that will be communicated to the patient. The HP will inform the patient's CP about the patient's drug therapy (modification in home medication, acute drugs prescribed, nonprescription treatments, and/or lab results). The primary outcome will be a composite outcome of any kind of drug misuse during the seven days following discharge assessed at day seven (±2) post-discharge by a pharmacist in charge of the study who will contact both patients and CPs by phone. The secondary outcome will be unplanned hospitalizations assessed by phone contact at day 35 (±5) after discharge. We plan to recruit 1,176 patients. This study will assess the impact of a reconciliation of medications performed at patient discharge followed by communication between the HP and the patient's CP. It will allow

  14. BLEEDING PEPTIC ULCER, NONSTEROIDAL ANTIINFLAMMATORY DRUGS AND HELICOBACTER PYLORI INFECTION – A PROSPECTIVE, CONTROLLED, RANDOMIZED STUDY

    Directory of Open Access Journals (Sweden)

    Pavel Skok

    2002-06-01

    Full Text Available Background. The explanation of peptic ulcer etiology has changed significantly in the past decade after the clarification of the significance of Helicobacter pylori infection.Aim. To evaluate the effectiveness of Helicobacter pylori eradication in patients with hemorrhaging peptic ulcer and patients with peptic ulcer without complications.Study ethics. The study was approved in 1998 by the Medical Ethics Committee of the Republic of Slovenia (No. 90/09/98.Type of study. Prospective, controlled and randomized study, carried out between 1998–2000.Patients and methods. The study included 80 patients (50 male and 30 female, av.age 57.5 years, SD ± 17.1, range 22– 80 in which endoscopy confirmed hemorrhage from peptic ulcer of stomach or duodenum and Helicobacter pylori infection. In all cases endoscopic hemostasis was performed: injection sclerotherapy with diluted adrenalin 1:10,000 and 1% polidocanol or argon plasma coagulation. The control group was made up of 80 patients (50 male and 30 female, av.age 56.8 years, SD ± 16.8, range 19–80 with peptic ulcer of stomach or duodenum and Helicobacter pylori infection. Infection was confirmed by a rapid urease test and histologic investigation of the gastric mucosa. In all cases the recommended drug combinations were used in the treatment of the infection: a proton pump inhibitor, omeprazol (4 weeks, and combination of antibiotics, claritromycin and metronidazole or with regard to the antibiogram (1 week. The therapeutic success was ascertained endoscopically four weeks after inclusion in the study. Infection eradication was confirmed by the rapid urease test and histologic investigation of the gastric mucosa.Results. Four weeks after inclusion in the study the success of infection eradication was 92.5% in the study group, in the control group it was 91.3% (p > 0.05. In 6 patients (7.5%, 6/ 80 from the study group and in 7 (8.8%, 7/80 from the control group we introduced a replacement treatment

  15. Genotype-guided drug prescribing: a systematic review and meta-analysis of randomized control trials.

    Science.gov (United States)

    Goulding, Rebecca; Dawes, Diana; Price, Morgan; Wilkie, Sabrina; Dawes, Martin

    2015-10-01

    Adverse drug events lead to increased morbidity, mortality and health care costs. Pharmacogenetic testing that guides drug prescribing has the potential to reduced adverse drug events and increase drug effectiveness. Our aim was to quantify the clinical effectiveness of genotype-guided prescribing. Three electronic databases were searched from January 1980 through December 2013. Studies were eligible if they were RCTs comparing genotype-guided prescribing with non-genetic informed prescribing, reported drug specific adverse drug events and clinical effectiveness outcomes. Two reviewers independently screened titles and abstracts, extracted data and assessed study quality. Meta-analyses of specific outcomes were conducted where data allowed. Fifteen studies, involving 5688 patients and 19 drugs, met the inclusion and exclusion criteria. Eight studies had statistically significant results for their primary outcome in favour of genotype-guided prescribing. Nine studies evaluated genotype-guided warfarin dosing. Analysis of percentage of time in therapeutic international normalized ratio range (1952 individuals) showed a statistically significant benefit in favour of genotype-guided warfarin dosing (mean difference = 6.67; 95% CI 1.34, 12.0, I(2) = 80%). There was a statistically significant reduction in numbers of warfarin-related minor bleeding, major bleeding and thromboembolisms associated with genotype guided warfarin dosing, relative risk 0.57 (95% CI 0.33, 0.99; I(2) = 60%). It was not possible to meta-analyze genotype-guided dosing for other drugs. Of the six non-warfarin genotype-guided trials, two demonstrated a statistically significant benefit for their primary outcome, odds ratio 0.03 (95% CI 0.00, 0.62, P genotype-guided warfarin dosing. © 2014 The Authors. British Journal of Clinical Pharmacology published by John Wiley & Sons Ltd on behalf of The British Pharmacological Society.

  16. MANDATORY TAKEOVER BIDS ON ROMANIAN CAPITAL MARKET

    Directory of Open Access Journals (Sweden)

    Cristian GHEORGHE

    2017-05-01

    Full Text Available The Romanian Capital Market Law (Law no 297/2004 lays down rules regarding public offers (to buy or sell of securities admitted to trading on a regulated market. Such offers are not unknown in the general framework of companies’ regulations, i.e. Company Law no 31/1990. Actually a public limited liability company (joint stock company can use a public subscriptions (offering shares for sale to raise the registered capital for incorporation of the company or to increase the company’s share capital already established. But all such operations are voluntary decisions. The founders or the shareholders of the company are those who decide to launch a public subscriptions. Capital Market Law comes with something new and at least peculiar at first sight: mandatory takeover bid, meaning a mandatory public offer made by an offeror to the holders of the securities of a company (offeree to acquire all or some of those securities. Can someone be forced to buy securities on the regulated market? The Capital Market Law responds affirmatively, but only if such takeover bid follows or has as its objective the acquisition of control of the offeree company in accordance with national law. The takeover bid remains under supervision and authorization of the national authority of the Capital Market (FSA – Financial Supervisory Authority.

  17. The NARCONON drug education curriculum for high school students: a non-randomized, controlled prevention trial.

    Science.gov (United States)

    Lennox, Richard D; Cecchini, Marie A

    2008-03-19

    An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences. For thirty years the Narconon program has worked with schools and community groups providing single educational modules aimed at supplementing existing classroom-based prevention activities. In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. After informed parental consent, approximately 1000 Oklahoma and Hawai'i high school students completed a modified Center for Substance Abuse Prevention (CSAP) Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant reductions measured for alcohol and amphetamines. The program

  18. The NARCONON™ drug education curriculum for high school students: A non-randomized, controlled prevention trial

    Directory of Open Access Journals (Sweden)

    Cecchini Marie A

    2008-03-01

    Full Text Available Abstract Background An estimated 13 million youths aged 12 to 17 become involved with alcohol, tobacco and other drugs annually. The number of 12- to 17-year olds abusing controlled prescription drugs increased an alarming 212 percent between 1992 and 2003. For many youths, substance abuse precedes academic and health problems including lower grades, higher truancy, drop out decisions, delayed or damaged physical, cognitive, and emotional development, or a variety of other costly consequences. For thirty years the Narconon program has worked with schools and community groups providing single educational modules aimed at supplementing existing classroom-based prevention activities. In 2004, Narconon International developed a multi-module, universal prevention curriculum for high school ages based on drug abuse etiology, program quality management data, prevention theory and best practices. We review the curriculum and its rationale and test its ability to change drug use behavior, perceptions of risk/benefits, and general knowledge. Methods After informed parental consent, approximately 1000 Oklahoma and Hawai'i high school students completed a modified Center for Substance Abuse Prevention (CSAP Participant Outcome Measures for Discretionary Programs survey at three testing points: baseline, one month later, and six month follow-up. Schools assigned to experimental conditions scheduled the Narconon curriculum between the baseline and one-month follow-up test; schools in control conditions received drug education after the six-month follow-up. Student responses were analyzed controlling for baseline differences using analysis of covariance. Results At six month follow-up, youths who received the Narconon drug education curriculum showed reduced drug use compared with controls across all drug categories tested. The strongest effects were seen in all tobacco products and cigarette frequency followed by marijuana. There were also significant

  19. Using Risk to Assess the Legal Violence of Mandatory Detention

    Directory of Open Access Journals (Sweden)

    Robert Koulish

    2016-07-01

    Full Text Available Immigration mandatory detention is a particularly harsh example of the structural violence embedded in immigration enforcement. It deprives liberty without bond for immigrants with prior crimes, and assigns many individuals to the harsh conditions associated with unnecessary and even wrongful detention. Mandatory detention has been justified on the grounds that mandatory detainees are a danger to public safety. This article puts to the test this presumption of dangerousness among mandatory detainees, and finds, to the contrary, that immigrants with prior charges or convictions are no more dangerous than any other category of individuals in Immigration and Customs Enforcement (ICE custody. Using the risk classification assessment (RCA tool, which the author is the first to obtain through the Freedom of Information Act, the article contributes to the growing criticism of mandatory detention, providing evidence that many of those in mandatory detention should probably have never been detained.

  20. 78 FR 71036 - Pipeline Safety: Random Drug Testing Rate; Contractor Management Information System Reporting...

    Science.gov (United States)

    2013-11-27

    ...; Contractor Management Information System Reporting; and Obtaining Drug and Alcohol Management Information System Sign-In Information AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT... Operators to Report Contractor Management Information System (MIS) Data; and New Method for Operators to...

  1. Randomized pharmacokinetic and drug–drug interaction studies of ceftazidime, avibactam, and metronidazole in healthy subjects

    Science.gov (United States)

    Das, Shampa; Li, Jianguo; Armstrong, Jon; Learoyd, Maria; Edeki, Timi

    2015-01-01

    We assessed pharmacokinetic and safety profiles of ceftazidime–avibactam administered ± metronidazole, and whether drug–drug interactions exist between ceftazidime and avibactam, or ceftazidime-avibactam and metronidazole. The first study (NCT01430910) involved two cohorts of healthy subjects. Cohort 1 received ceftazidime–avibactam (2000–500 mg) as a single infusion or as multiple intravenous infusions over 11 days to evaluate ceftazidime–avibactam pharmacokinetics. Cohort 2 received ceftazidime, avibactam, or ceftazidime–avibactam over 4 days to assess drug–drug interaction between ceftazidime and avibactam. The second study (NCT01534247) assessed interaction between ceftazidime–avibactam and metronidazole in subjects receiving ceftazidime–avibactam (2000–500 mg), metronidazole (500 mg), or metronidazole followed by ceftazidime–avibactam over 4 days. In all studies, subjects received a single-dose on the first and final days, and multiple-doses every 8 h on intervening days. Concentration-time profiles for ceftazidime and avibactam administered as single- or multiple-doses separately or together with/without metronidazole were similar. There was no evidence of time-dependent pharmacokinetics or accumulation. In both interaction studies, 90% confidence intervals for geometric least squares mean ratios of area under the curve and maximum plasma concentrations for each drug were within the predefined interval (80–125%) indicating no drug–drug interaction between ceftazidime and avibactam, or ceftazidime–avibactam and metronidazole. There were no safety concerns. In conclusion, pharmacokinetic parameters and safety of ceftazidime, avibactam, and metronidazole were similar after single and multiple doses with no observed drug–drug interaction between ceftazidime and avibactam, or ceftazidime–avibactam and metronidazole. PMID:26516584

  2. Mandatory IFRS adoption and executive compensation:Evidence from China

    National Research Council Canada - National Science Library

    Qingchuan Hou Qinglu Jin Lanfang Wang

    2014-01-01

    .... After controlling for firm and corporate governance characteristics, we find strong evidence supporting the positive role of mandatory IFRS adoption on the accounting-based performance sensitivity...

  3. Mandatory Access Control applications to web hosting

    Science.gov (United States)

    Prandini, Marco; Faldella, Eugenio; Laschi, Roberto

    "Hosting" represents a commonplace solution for the low-cost implementation of web sites through the efficient sharing of the resources of a single server. The arising security problems, however, are not always easily dealt with under the Discretionary Access Control model implemented by traditional operating systems. More robust separation between the hosted sites, as well as more robust protection of the host system, can be attained by exploiting the features typical of Mandatory Access Control systems. Recently, these systems have recently been made available to the vast Linux community through projects like SELinux and grsecurity. This paper describes the architecture of a secure hosting server, integrating SELinux functionalities into the Apache/PHP platform, designed with the goal of increasing security without adding administrative burdens or impacting performance.

  4. Integrated mandatory access control for digital data

    Science.gov (United States)

    Hsieh, George; Patrick, Gregory; Foster, Keith; Emamali, Gerald; Marvel, Lisa

    2008-03-01

    This paper presents an integrated mandatory access control (MAC) framework that incorporates MAC mechanisms at both operating system and application layers for digital data. The framework uses Security-Enhanced Linux (SELinux) as the foundation for MAC at the operating system layer. It uses XACML (eXtensible Access Control Markup Language) as the base mechanism for specifying and embedding information-layer MAC policies. This framework is designed to be general-purpose, flexible, and capable of providing fine-grained access control. This paper also describes a high-level architecture of a prototype being developed for the framework. One targeted application domain for this framework is information sharing and dissemination in a multi-level security environment.

  5. Random Assignment of Schools to Groups in the Drug Resistance Strategies Rural Project: Some New Methodological Twists

    Science.gov (United States)

    Pettigrew, Jonathan; Miller-Day, Michelle; Krieger, Janice L.; Zhou, Jiangxiu; Hecht, Michael L.

    2014-01-01

    Random assignment to groups is the foundation for scientifically rigorous clinical trials. But assignment is challenging in group randomized trials when only a few units (schools) are assigned to each condition. In the DRSR project, we assigned 39 rural Pennsylvania and Ohio schools to three conditions (rural, classic, control). But even with 13 schools per condition, achieving pretest equivalence on important variables is not guaranteed. We collected data on six important school-level variables: rurality, number of grades in the school, enrollment per grade, percent white, percent receiving free/assisted lunch, and test scores. Key to our procedure was the inclusion of school-level drug use data, available for a subset of the schools. Also, key was that we handled the partial data with modern missing data techniques. We chose to create one composite stratifying variable based on the seven school-level variables available. Principal components analysis with the seven variables yielded two factors, which were averaged to form the composite inflate-suppress (CIS) score which was the basis of stratification. The CIS score was broken into three strata within each state; schools were assigned at random to the three program conditions from within each stratum, within each state. Results showed that program group membership was unrelated to the CIS score, the two factors making up the CIS score, and the seven items making up the factors. Program group membership was not significantly related to pretest measures of drug use (alcohol, cigarettes, marijuana, chewing tobacco; smallest p>.15), thus verifying that pretest equivalence was achieved. PMID:23722619

  6. A randomized clinical trial of behavioral couples therapy versus individually-based treatment for drug-abusing women.

    Science.gov (United States)

    O'Farrell, Timothy J; Schumm, Jeremiah A; Murphy, Marie M; Muchowski, Patrice M

    2017-04-01

    Behavioral couples therapy (BCT) is more efficacious than individually-based therapy (IBT) for substance and relationship outcomes among substance use disorder patients. This study compared BCT with IBT for drug-abusing women. Sixty-one women, mostly White, late 30s, with primary substance use disorder other than alcohol (74% opioid), and male partners were randomized to 26 sessions over 13 weeks of BCT plus 12-step-oriented IBT (i.e., BCT + IBT) or IBT. Substance-related outcomes were percentage days abstinent (PDA), percentage days drug use (PDDU), Inventory of Drug Use Consequences. Relationship outcomes were Dyadic Adjustment Scale (DAS), days separated. Data were collected at baseline, posttreatment, and quarterly for 1-year follow-up. On PDA, PDDU, and substance-related problems, both BCT + IBT and IBT patients showed significant (p .8 for most time periods). BCT + IBT showed a significant (p .47). On relationship outcomes, compared to IBT, BCT + IBT had significantly higher male-reported Dyadic Adjustment Scale (p women was more efficacious than IBT in improving relationship satisfaction and preventing relationship breakup. On substance use and substance-related problems, women receiving both treatments substantially improved, and women receiving BCT + IBT had fewer substance-related problems than IBT. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  7. Is whistleblowing now mandatory? The impact of mandatory reporting law on trust relationships in health care.

    Science.gov (United States)

    Hewitt, Jayne

    2013-09-01

    Trust is vital for promoting positive health care relationships aimed at achieving positive patient outcomes. Patients, as well as the broader society, trust that health care practitioners who have been granted authority by the state to provide safe and beneficial health care are competent to do so. Recent instances where patients have been harmed as the result of treatment that fell below the accepted standard of competence have negatively impacted on trust. As the state has a responsibility to protect the public from this type of harm, legislation that mandates reporting of certain instances where the behaviour of health care professionals has fallen below the acceptable standard has been introduced. While this may have been designed to restore public trust, this article argues that it has the potential to diminish trust on the basis that mandatory reporting may be equivalent to mandatory whistleblowing.

  8. 14 CFR 223.3 - Mandatory free transportation.

    Science.gov (United States)

    2010-01-01

    ... 14 Aeronautics and Space 4 2010-01-01 2010-01-01 false Mandatory free transportation. 223.3 Section 223.3 Aeronautics and Space OFFICE OF THE SECRETARY, DEPARTMENT OF TRANSPORTATION (AVIATION PROCEEDINGS) ECONOMIC REGULATIONS FREE AND REDUCED-RATE TRANSPORTATION General Provisions § 223.3 Mandatory...

  9. 27 CFR 5.64 - Legibility of mandatory information.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Legibility of mandatory information. 5.64 Section 5.64 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU.... (e) Mandatory information shall be so stated in both the print and audio-visual media that it will be...

  10. Introducing rapid diagnostic tests for malaria into drug shops in Uganda: design and implementation of a cluster randomized trial.

    Science.gov (United States)

    Mbonye, Anthony K; Magnussen, Pascal; Chandler, Clare I R; Hansen, Kristian S; Lal, Sham; Cundill, Bonnie; Lynch, Caroline A; Clarke, Siân E

    2014-07-29

    An intervention was designed to introduce rapid diagnostics tests for malaria (mRDTs) into registered drug shops in Uganda to encourage rational and appropriate treatment of malaria with artemisinin-based combination therapy (ACT). We conducted participatory training of drug shop vendors and implemented supporting interventions to orientate local communities (patients) and the public sector (health facility staff and district officials) to the behavioral changes in diagnosis, treatment and referral being introduced in drug shops. The intervention was designed to be evaluated through a cluster randomized trial. In this paper, we present detailed design, implementation and evaluation experiences in order to help inform future studies of a complex nature. Three preparatory studies (formative, baseline and willingness-to-pay) were conducted to explore perceptions on diagnosis and treatment of malaria at drug shops, and affordable prices for mRDTs and ACTs in order to inform the design of the intervention and implementation modalities. The intervention required careful design with the intention to be acceptable, sustainable and effective. Critical components of intervention were: community sensitization and creating awareness, training of drug shop vendors to diagnose malaria with mRDTs, treat and refer customers to formal health facilities, giving pre-referral rectal artesunate and improved record-keeping. The primary outcome was the proportion of patients receiving appropriately-targeted treatment with ACT, evaluated against microscopy on a research blood slide. Introducing mRDTs in drug shops may seem simple, but our experience of intervention design, conduct and evaluation showed this to be a complex process requiring multiple interventions and evaluation components drawing from a combination of epidemiological, social science and health economics methodologies. The trial was conducted in phases sequenced such that each benefited from the other. The main challenges

  11. Acupuncture Antiarrhythmic Effects on Drug Refractory Persistent Atrial Fibrillation: Study Protocol for a Randomized, Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jimin Park

    2015-01-01

    Full Text Available Background. Atrial fibrillation (AF is the most common form of arrhythmia. Several trials have suggested that acupuncture may prevent AF. However, the efficacy of acupuncture for AF prevention has not been well investigated. Therefore, we designed a prospective, two-parallel-armed, participant and assessor blinded, randomized, sham-controlled clinical trial to investigate acupuncture in persistent AF (ACU-AF. Methods. A total of 80 participants will be randomly assigned to active acupuncture or sham acupuncture groups in a 1 : 1 ratio. Both groups will take the same antiarrhythmic medication during the study period. Patients will receive 10 sessions of acupuncture treatment once a week for 10 weeks. The primary endpoint is AF recurrence rate. Secondary endpoints are left atrium (LA and left atrial appendage (LAA changes in function and volume, and inflammatory biomarker changes. Ethics. This study protocol was approved by the institutional review boards (IRBs of Kyung Hee University Hospital (number 1335-04. This trial is registered with clinicaltrials.gov NCT02110537.

  12. Description of the Protocols for Randomized Controlled Trials on Cancer Drugs Conducted in Spain (1999–2003)

    Science.gov (United States)

    Bonfill, Xavier; Ballesteros, Mónica; Gich, Ignasi; Serrano, María Antonia; García López, Fernando; Urrútia, Gerard

    2013-01-01

    Objective To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. Methods We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. Results We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower. Conclusion RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on

  13. Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003.

    Directory of Open Access Journals (Sweden)

    Xavier Bonfill

    Full Text Available OBJECTIVE: To describe the characteristics of randomized controlled clinical trials (RCT on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols. METHODS: We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS (Spanish Agency for Medicines and Medical Devices during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed. RESULTS: We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%, overall survival (20.7%, and progression-free survival (14.5%. Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724. Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001 and were more likely to implement centralized randomization (p<0.001, blinding of the intervention (p<0.001, and survival as primary outcome (p<0.001. Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01. In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7% was lower. CONCLUSION: RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide

  14. Randomized, placebo controlled trial of withdrawal of slow-acting antirheumatic drugs and of observer bias in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Gøtzsche, P C; Hansen, M; Stoltenberg, M

    1996-01-01

    Patients with rheumatoid arthritis, in stable treatment with methotrexate, penicillamine, or sulfasalazine, were randomized in a double-blind fashion either to continuation of their usual treatment or to placebo. 112 patients were included; 52 patients who refused participation had no more severe...... between the observers' evaluations of the joints. The effect of slow-acting antirheumatic drugs was unequivocal and no observer bias occurred....... received placebo (p = 0.000,001). There was no difference in the severity of side effects (p = 0.91). The patients guessed their treatment correctly more often than expected (p = 0.02) because of the perceived effect. None of the two observers guessed better than chance, and there were no differences...

  15. Randomized, placebo controlled trial of withdrawal of slow-acting antirheumatic drugs and of observer bias in rheumatoid arthritis

    DEFF Research Database (Denmark)

    Gøtzsche, P C; Hansen, M; Stoltenberg, M

    1996-01-01

    Patients with rheumatoid arthritis, in stable treatment with methotrexate, penicillamine, or sulfasalazine, were randomized in a double-blind fashion either to continuation of their usual treatment or to placebo. 112 patients were included; 52 patients who refused participation had no more severe...... disease than the others. The patients felt worse on placebo than on active drug (p = 0.002). The mean differences in number of tender, painful and swollen joints after one month were 2.4 (p = 0.08), 3.0 (p = 0.12) and 2.2 (p = 0.03), respectively. Treatment failure occurred for 42 patients of whom 33...... received placebo (p = 0.000,001). There was no difference in the severity of side effects (p = 0.91). The patients guessed their treatment correctly more often than expected (p = 0.02) because of the perceived effect. None of the two observers guessed better than chance, and there were no differences...

  16. Effects of interactive patient smartphone support app on drug adherence and lifestyle changes in myocardial infarction patients: A randomized study.

    Science.gov (United States)

    Johnston, Nina; Bodegard, Johan; Jerström, Susanna; Åkesson, Johanna; Brorsson, Hilja; Alfredsson, Joakim; Albertsson, Per A; Karlsson, Jan-Erik; Varenhorst, Christoph

    2016-08-01

    Patients with myocardial infarction (MI) seldom reach recommended targets for secondary prevention. This study evaluated a smartphone application ("app") aimed at improving treatment adherence and cardiovascular lifestyle in MI patients. Multicenter, randomized trial. A total of 174 ticagrelor-treated MI patients were randomized to either an interactive patient support tool (active group) or a simplified tool (control group) in addition to usual post-MI care. Primary end point was a composite nonadherence score measuring patient-registered ticagrelor adherence, defined as a combination of adherence failure events (2 missed doses registered in 7-day cycles) and treatment gaps (4 consecutive missed doses). Secondary end points included change in cardiovascular risk factors, quality of life (European Quality of Life-5 Dimensions), and patient device satisfaction (System Usability Scale). Patient mean age was 58 years, 81% were men, and 21% were current smokers. At 6 months, greater patient-registered drug adherence was achieved in the active vs the control group (nonadherence score: 16.6 vs 22.8 [P = .025]). Numerically, the active group was associated with higher degree of smoking cessation, increased physical activity, and change in quality of life; however, this did not reach statistical significance. Patient satisfaction was significantly higher in the active vs the control group (system usability score: 87.3 vs 78.1 [P = .001]). In MI patients, use of an interactive patient support tool improved patient self-reported drug adherence and may be associated with a trend toward improved cardiovascular lifestyle changes and quality of life. Use of a disease-specific interactive patient support tool may be an appreciated, simple, and promising complement to standard secondary prevention. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  17. Measuring compliance with Viet Nam's mandatory motorcycle helmet legislation.

    Science.gov (United States)

    Nguyen, Ha Trong; Passmore, Jonathon; Cuong, Pham Viet; Nguyen, Nam Phuong

    2013-01-01

    The objective of this roadside observational study was to monitor helmet wearing among motorcycle riders and passengers in three provinces (Yen Bai, Da Nang and Binh Duong) in the Socialist Republic of Viet Nam, before and after a mandatory helmet law took effect on 15 December 2007. A total of 665,428 motorcycle riders and passengers were observed between November 2007 and February 2011 at 45 randomly selected sites covering the entire road network. Across all locations and time periods, correct helmet wearing averaged 40.1% before the law and 92.5% after; however, there were significant differences between time points and locations. The Viet Nam Government's decision to require all motorcycle riders and passengers to wear helmets has been thoroughly implemented nation wide and the results show that high wearing has been sustained. Further study is required on how high helmet wearing has and will translate into a reduction in motorcycle head injuries; however, Viet Nam's motorcycle helmet legislation should be seen as an important policy example for other low- and middle-income countries with a high utilization of motorcycles for personal transport.

  18. Assessment of abuse liability of Tramadol among experienced drug users: Double-blind crossover randomized controlled trial.

    Science.gov (United States)

    Das, Mrinmay; Jain, Raka; Dhawan, Anju; Kaur, Amandeep

    Tramadol is a widely used opioid analgesic. Different preclinical, clinical, and postmarketing surveillance studies show conflicting results regarding abuse potential of this drug. A randomized double-blind complete crossover study was conducted at National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi. Total subjects were 10, comprising total 120 observations (each subject assessed at baseline, 5, 45, and 240 minutes). Subjects with history of substance abuse were included after detoxification and informed consent. Assessment was done using modified single dose opiate questionnaire, morphine benzedrine group (MBG), pentobarbital chlorpromazine alcohol group (PCAG), and two bipolar visual analogue scales (VAS) after administration of three drugs-Tramadol (100 mg), Buprenorphine (0.6 mg), and Placebo (Normal Saline) intramuscularly, at 5-day interval. In intra-group analysis, there was statistically significant increase in scores of all four scales from baseline to all three time points after Tramadol and Buprenorphine administration. In inter-group analysis, statistically higher scores were seen for Buprenorphine in comparison to Tramadol at 5, 45, and 240 minutes for MBG scale; the score was significantly higher for Buprenorphine in VAS for pleasurable effect at 45 and 240 minutes, but not at baseline and 5 minutes. There was no significant difference in score at any point of time between Tramadol and Buprenorphine in PCAG scale and VAS for sedative/alertness effect. The scores were statistically insignificant in case of Placebo. All the subjects liked Buprenorphine most and then Tramadol followed by Placebo. Tramadol has abuse potential (even in therapeutic doses) more than Placebo but less than or comparable to Buprenorphine.

  19. Individualized versus standardized risk assessment in patients at high risk for adverse drug reactions (IDrug) - study protocol for a pragmatic randomized controlled trial.

    Science.gov (United States)

    Stingl, Julia Carolin; Kaumanns, Katharina Luise; Claus, Katrin; Lehmann, Marie-Louise; Kastenmüller, Kathrin; Bleckwenn, Markus; Hartmann, Gunther; Steffens, Michael; Wirtz, Dorothee; Leuchs, Ann-Kristin; Benda, Norbert; Meier, Florian; Schöffski, Oliver; Holdenrieder, Stefan; Coch, Christoph; Weckbecker, Klaus

    2016-04-26

    Elderly patients are particularly vulnerable to adverse drug reactions, especially if they are affected by additional risk factors such as multimorbidity, polypharmacy, impaired renal function and intake of drugs with high risk potential. Apart from these clinical parameters, drug safety and efficacy can be influenced by pharmacogenetic factors. Evidence-based recommendations concerning drug-gene-combinations have been issued by international consortia and in drug labels. However, clinical benefit of providing information on individual patient factors in a comprehensive risk assessment aiming to reduce the occurrence and severity of adverse drug reactions is not evident. Purpose of this randomized controlled trial is to compare the effect of a concise individual risk information leaflet with standard information on risk factors for side effects. The trial was designed as a prospective, two-arm, randomized, controlled, multicenter, pragmatic study. 960 elderly, multimorbid outpatients in general medicine are included if they take at least one high risk and one other long-term drug (polymedication). As high risk "index drugs" oral anticoagulants and antiplatelets were chosen because of their specific, objectively assessable side effects. Following randomization, test group patients receive an individualized risk assessment leaflet evaluating their personal data concerning bleeding- and thromboembolic-risk-scores, potential drug-drug-interactions, age, renal function and pharmacogenetic factors. Control group patients obtain a standardized leaflet only containing general information on these criteria. Follow-up period is 9 months for each patient. Primary endpoint is the occurrence of a thromboembolic/bleeding event or death. Secondary endpoints are other adverse drug reactions, hospital admissions, specialist referrals and medication changes due to adverse drug reactions, the patients' adherence to medication regimen as well as health related quality of life

  20. The Alcohol Mandatory Treatment Act: evidence, ethics and the law.

    Science.gov (United States)

    Lander, Fiona; Gray, Dennis; Wilkes, Edward

    2015-07-06

    The Northern Territory Alcohol Mandatory Treatment Act 2013 (AMT Act) permits mandatory residential alcohol rehabilitation for up to 3 months. International guidelines and human rights law confirm that mandatory rehabilitation should only be used for short periods. Evidence concerning the efficacy of long-term mandatory alcohol rehabilitation is lacking, and minimal data concerning the efficacy of the scheme have been released. Specific legal issues also arise concerning the AMT Act, including its potentially discriminatory application to Aboriginal and Torres Strait Islander peoples. The program only permits referral by police, despite the fact that it is ostensibly a medical intervention. Use of a treatment as a method of effectively solving a public intoxication problem is highly dubious, and should be of concern to the medical community. Given that more cost-effective and proven measures exist to combat alcohol dependence, the utility of the AMT Act is questionable.

  1. The Effectiveness of Family Interventions in Preventing Adolescent Illicit Drug Use: A Systematic Review and Meta-analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Smit, E.; Verdurmen, J.E.E.; Engels, R.C.M.E.

    2015-01-01

    In order to quantify the effectiveness of family interventions in preventing and reducing adolescent illicit drug use, we conducted a systematic review and meta-analysis of randomized controlled trials. We searched the Cochrane Database of Systematic Reviews, Educational Research Information Centre

  2. WWC Quick Review of the Article "Outcomes of a Prospective Trial of Student-Athlete Drug Testing: The Student Athlete Testing Using Random Notification ('SATURN') Study"

    Science.gov (United States)

    What Works Clearinghouse, 2008

    2008-01-01

    This study examines whether the Student Athlete Testing Using Random Notification ("SATURN") program affects illicit drug and alcohol use among student athletes. The study experienced high rates of sample attrition. Seven of the 18 study schools (39%) left the study and were not included in the analysis. Some students at the remaining…

  3. Should the European Commission Enact a Mandatory Lobby Register?

    Directory of Open Access Journals (Sweden)

    Direnc Kanol

    2012-12-01

    Full Text Available This article reviews the literature on the mandatory government regulation/self-regulation approaches to regulating interest group behaviour. The findings of the author suggest that the voluntary register of the European Commission is bound to fail. The European Commission should implement a mandatory register as soon as possible if the genuine aim of the incumbents is to overcome the Commission’s accountability deficit.

  4. Intimal disruption affects drug-eluting cobalt-chromium stent expansion: A randomized trial comparing scoring and conventional balloon predilation.

    Science.gov (United States)

    Jujo, Kentaro; Saito, Katsumi; Ishida, Issei; Kim, Ahsung; Suzuki, Yuki; Furuki, Yuho; Ouchi, Taisuke; Ishii, Yasuhiro; Sekiguchi, Haruki; Yamaguchi, Junichi; Ogawa, Hiroshi; Hagiwara, Nobuhisa

    2016-10-15

    Stent expansion remains one of the most important predictors of restenosis and subacute thrombosis, even with the use of drug-eluting stents. This study was designed to clarify the impact of lesion preparation on final stent expansion. Sixty-six consecutive patients were included in this trial, and ultimately 52 enrolled non-calcified de novo lesions were randomly assigned to undergo single predilation with either a semi-compliant scoring balloon or a semi-compliant conventional balloon. Lesions were treated with a single 2.5- to 3.0-mm cobalt-chromium everolimus-eluting stent under optical coherence tomography (OCT) guidance without post-stenting dilation. Stent expansion was defined as the ratio of OCT-measured minimum stent area to the predicted stent area. Stent expansion was significantly higher after predilation by a scoring balloon (68.0% vs. 62.1%, p=0.017) with similar stent lumen eccentricity (0.84 vs. 0.80, p=0.18). Intimal disruption was induced significantly more frequently (68.0% vs. 38.4%, p=0.035) and was more extensive in the scoring group (122° vs. 65°, p=0.038). Lesions with intimal disruption after predilation achieved significantly higher stent expansion than that without it (67.7% vs. 61.6%, p=0.023). One case in the conventional group required target lesion revascularization; however, any other adverse clinical events including death, myocardial infarction, and stent thrombosis were not observed up to 9months after PCI in both groups. In this randomized study, pretreatment with a scoring balloon enhanced stent expansion partly through induction of intimal disruption. URL: http://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000014176. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  5. [Attitudes of winter sport participants toward ski helmet mandatory].

    Science.gov (United States)

    Ruedl, G; Kopp, M; Hotter, B; Ledochowski, L; Burtscher, M

    2011-12-01

    The aim of this study was to examine attitudes of winter sport participants toward a ski helmet mandatory. In total, 959 persons who had to estimate statements regarding ski helmet and helmet mandatory with the aid of a five level Likert scale were interviewed. About 85 % of interviewed persons totally agreed that a ski helmet reduces head injury risk although only 64 % are wearing a ski helmet. Significant more helmet wearers and females compared to non-wearers and males totally agreed that all winter sport participants should wear ski helmets on slopes as well as that all children on slopes should wear a ski helmet. Also, significant more helmet wearers and females compared to non-wearers and males totally agreed that a ski helmet mandatory for all people has to be recommended as well as that a ski helmet mandatory for children under 16 years has to be recommended. However, the acceptance for a helmet mandatory for all people as well as for children was significantly lower compared to recommendations for helmet use irrespective of helmet use or gender. Therefore, we conclude that preventive helmet campaigns possibly attain a higher acceptance leading to a higher helmet use compared to a helmet mandatory. © Georg Thieme Verlag KG Stuttgart · New York.

  6. Mandatory continuing professional education in pharmacy: the Singapore experience.

    Science.gov (United States)

    Ang, Hui-Gek; Pua, Yong-Hao; Subari, Nur Azah

    2013-08-01

    Mandatory Continuing Professional Education (CPE) for the renewal of pharmacists' practising certificate was implemented in Singapore in 2008 OBJECTIVE: To study pharmacists' perceptions and attitudes about the impact of mandatory CPE in Singapore. Singapore. Internet-based questionnaire survey, conducted between May and June 2011. Pharmacists' perceptions and attitudes toward mandatory CPE and the perceived difficulty in fulfilling the CPE requirements. The overall survey response rate was 52 % (840/1,609). Of the respondents, 32 % were non-practising, 49 % were practising in patient care areas, and 19 % were practising in non-patient care areas. More than half the pharmacists agreed that mandatory CPE (1) enhanced or increased their knowledge base and skills (70 %; 95 % CI 67-73 %), (2) motivated them to continually learn (64 %; 95 % CI, 60-67 %), and (3) motivated them to reflect on their professional practice or work (58 %; 95 % CI, 54-61 %). Mandatory CPE was not perceived to enhance or increase employability. Non-practising pharmacists appeared to have the greatest difficulty meeting the CPE requirements. In general, pharmacists value mandatory CPE more for positive professional reasons than for employability reasons. The survey results may serve as useful baseline data for future studies of pharmacists' perceptions and attitudes toward CPE in Singapore.

  7. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

    Directory of Open Access Journals (Sweden)

    Malmberg Monique

    2010-09-01

    Full Text Available Abstract Background Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a quasi-experimental design before, many program changes were made afterwards. The present study, therefore, aims to test the effects of this widely used, renewed universal prevention program. Methods/Design A randomized clustered trial will be conducted among 3,784 adolescents of 23 secondary schools in The Netherlands. The trial has three conditions; two intervention conditions (i.e., e-learning and integral and a control condition. The e-learning condition consists of three digital learning modules (i.e., about alcohol, tobacco, and marijuana that are sequentially offered over the course of three school years (i.e., grade 1, grade 2, and grade 3. The integral condition consists of parental participation in a parental meeting on substance use, regulation of substance use, and monitoring and counseling of students' substance use at school, over and above the three digital modules. The control condition is characterized as business as usual. Participating schools were randomly assigned to either an intervention or control condition. Participants filled out a digital questionnaire at baseline and will fill out the same questionnaire three more times at follow-up measurements (8, 20, and 32 months after baseline. Outcome variables included in the questionnaire are the percentage of binge drinking (more than five drinks per occasion, the average weekly number of drinks, and the percentage of adolescents who ever drunk a glass of alcohol and the percentage of adolescents who ever smoked a cigarette or a joint respectively for tobacco and marijuana. Discussion This study protocol describes the design of a randomized clustered trial that evaluates the

  8. The importance of drug-induced sedation endoscopy (D.I.S.E.) techniques in surgical decision making: conventional versus target controlled infusion techniques-a prospective randomized controlled study and a retrospective surgical outcomes analysis.

    Science.gov (United States)

    De Vito, Andrea; Agnoletti, Vanni; Zani, Gianluca; Corso, Ruggero Massimo; D'Agostino, Giovanni; Firinu, Elisabetta; Marchi, Chiara; Hsu, Ying-Shuo; Maitan, Stefano; Vicini, Claudio

    2017-05-01

    Drug-Induced Sedation Endoscopy (DISE) consists of the direct observation of the upper airways during sedative-induced sleep, allowing the identification of the sites of pharyngeal collapse, which is the main pathological event in Obstructive Sleep Apnea (OSA). The Authors have compared Target Controlled Infusion (TCI) sedation endoscopy (TCI-DISE) technique to conventional DISE (CDISE), performed by a manual bolus injection of sedative agent, to recreate accurately and safely snoring and apnea patterns comparable to natural sleep. The authors conducted a prospective, randomized, long-term study and a retrospective analysis of surgical outcomes. The apnea-event observation and its correlation with pharyngeal collapse patterns is the primary endpoint; secondary endpoints are defined as stability and safety of sedation plan of DISE-TCI technique. From January 2009 to January 2011, OSA patients were included in the study and randomly allocated into two groups: the bolus injection conventional DISE group and the TCI-DISE group. Third endpoint is to compare the surgical outcomes enrolling OSA patients from January 2009 to June 2015. We recorded the complete apnea-event at oropharynx and hypopharynx levels in 15/50 pts in conventional DISE group (30%) and in 99/123 pts in TCI-DISE group (81%) (p surgical patients we reported a significant reduction of postoperative AHI (from 42.7 ± 20.2 to 11.4 ± 10.3) in comparison with postoperative AHI in 15 C-DISE group surgical patients (from 41.3 ± 23.4 to 20.4 ± 15.5) (p = 0.05). Our results suggest the DISE-TCI technique as first choice in performing sleep-endoscopy because of its increased accuracy, stability and safety. However, it is mandatory an accurate assessment of PSG/PM, which allows us to differentiate OSA patients in whom UA anatomical abnormalities are predominant in comparison with not-anatomical pathophysiologic factors, achieving good surgical patient's selection and outcomes as a

  9. The US etonogestrel implant mandatory clinical training and active monitoring programs: 6-year experience.

    Science.gov (United States)

    Creinin, Mitchell D; Kaunitz, Andrew M; Darney, Philip D; Schwartz, Lisa; Hampton, Tonja; Gordon, Keith; Rekers, Hans

    2017-02-01

    The objective was to monitor the effectiveness of the etonogestrel implant clinical training program through a voluntary active monitoring program (AMP). US health care providers underwent mandatory training by the manufacturer on etonogestrel implant insertion, localization and removal. After training, health care providers could enroll in a voluntary AMP to provide outcome data to meet a postmarketing commitment of the manufacturer with the US Food and Drug Administration (FDA). Those who volunteered completed and faxed forms to the manufacturer after implant insertion and removal detailing the procedure and device-related outcomes, including insertion-, localization- or removal-associated events. Experts reviewed outcome data quarterly, which the Sponsor then reported to the FDA. Among 42,337 health care providers completing the training program, 4294 (10.1%) volunteered to participate in the AMP. The 26,198 forms submitted over 6.4 years included more insertion (n=20,497) forms than removal forms (n=5701). The volunteers reported 646 events on 566 (2.2%) forms related to insertion (n=197), localization (n=34), removal (n=357) and "other" (n=58). Clinically important events included noninsertion (n=4), serum etonogestrel positive but implant not found (n=1), and possible nerve (n=66) or vascular (n=5) injury. The reports did not include any insertion-, localization- or removal-associated hospitalizations. Eight (0.14%) removal reports described referral for surgical implant removal. Events related to insertion, localization or removal of the etonogestrel implant are uncommon among US providers who received mandatory training in the use of the implant. This report presents results from the first mandatory US contraceptive training program. Health care providers volunteered to report information about etonogestrel implant insertion, localization and removal. Although the data do not demonstrate whether a mandatory program improves outcomes, they elucidate the

  10. Assessing the quality of evidence from randomized, controlled drug and nutritional supplement trials conducted among nursing home residents between 1968 and 2004: what can we learn?

    Science.gov (United States)

    Cheng, Huai Yong

    2009-01-01

    An estimated 1.5 million residents of nursing homes (NH) in the United States were prescribed an average of 7 to 8 medications each month. However, it is unknown which of these prescribed drugs and nutritional supplements have been tested for use among NH residents who often have distinct and complex needs compared with other geriatric patients. This pilot study addresses the quantity and quality of randomized, controlled drug and nutritional supplement trials that have been conducted among NH residents. Using multiple search strategies and review protocol, I assessed the quality of evidence from randomized, controlled drug and nutritional supplement trials that had a parallel-group design, were conducted among NH residents, and were published in English between 1968 and October 2004. Internal validity of the trials was examined by assessing adequately reporting power calculation, drop-outs (completion fraction), randomization and allocation concealment, blind status, and intention-to-treat analysis. External validity of the trials was examined by assessing adequately reporting the sample description, the inclusion and exclusion criteria, the recruitment process, and comorbidities and harm. Relatively few drug and nutritional supplements have been tested among NH residents by well-designed and executed randomized controlled trials (N = 42). The total number of participants (N = 7941) is small. The quality of many trials is poor. Given the limited number and poor quality of existing trials conducted among NH residents in this pilot study, I conclude that there is a limited body of evidence that could be used to establish quality of care standards or pay for performance criteria for drug therapy and nutritional supplements in NH. Long-term care providers face a great challenge in practicing evidence-based medicine in prescribing drugs and nutritional supplements.

  11. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib

    DEFF Research Database (Denmark)

    Macdonald, Thomas M; Hawkey, Chris J; Ford, Ian

    2017-01-01

    BACKGROUND: Selective cyclooxygenase-2 inhibitors and conventional non-selective non-steroidal anti-inflammatory drugs (nsNSAIDs) have been associated with adverse cardiovascular (CV) effects. We compared the CV safety of switching to celecoxib vs. continuing nsNSAID therapy in a European setting....... METHOD: Patients aged 60 years and over with osteoarthritis or rheumatoid arthritis, free from established CV disease and taking chronic prescribed nsNSAIDs, were randomized to switch to celecoxib or to continue their previous nsNSAID. The primary endpoint was hospitalization for non-fatal myocardial...... expected developed an on-treatment (OT) primary CV event and the rate was similar for celecoxib, 0.95 per 100 patient-years, and nsNSAIDs, 0.86 per 100 patient-years (HR = 1.12, 95% confidence interval, 0.81-1.55; P = 0.50). Comparable intention-to-treat (ITT) rates were 1.14 per 100 patient...

  12. Antivertiginous drug therapy does not hinder the efficacy of individualized vibrotactile neurofeedback training for vestibular rehabilitation - a randomized trial.

    Science.gov (United States)

    Basta, Dietmar; Borsellino, Liliana; Ernst, Arne

    2017-12-01

    Vestibular rehabilitation using individualized vibrotactile neurofeedback training (IVNT) can lead to significant improvement in the postural stability of patients with vestibular symptoms of different origins. However, some of these patients have complex, severe dizziness, meaning that a pharmacological pretreatment or parallel (to vestibular rehabilitation) treatment can help them perform the rehabilitation exercises. Hence, the present study investigated the influence of a pharmacological treatment on the efficacy of vibrotactile neurofeedback training in patients with chronic, noncompensated vestibulopathies. All participants performed IVNT for ∼10 min each day for 2 weeks. In addition, every second participant was selected randomly to receive oral medication (20 mg cinnarizine and 40 mg dimenhydrinate per tablet), taking three tables per day. Trunk and ankle sway and postural stability were measured. In addition, the dizziness handicap inventory was evaluated immediately before training on the last day of training and 6 months after training. After the 10-day period of IVNT, both groups showed a statistically significant improvement in all parameters tested. A follow-up analysis after 6 months showed a long-term efficacy for the IVNT, that is, the patients remained significantly improved in their postural stability. The antivertiginous therapy did not hinder the efficacy of the IVNT. The present results indicate that IVNT even in combination with an antivertiginous drug therapy is an effective treatment regime for patients with disabling vertigo of different origins.

  13. Investor Reaction to Mandatory Offers on the Warsaw Stock Exchange

    Directory of Open Access Journals (Sweden)

    Szymon Okoń

    2012-06-01

    Full Text Available The following paper aims to assess investor reaction to mandatory offers on the Warsaw Stock Exchange, which is important because knowledge about these reactions can be used to make better investment decisions. This paper highlights the importance of procedure in making a mandatory offer and its grounds in the Polish legal system. Additionally, it presents empirical research on the reactions of investors to mandatory offers on the Warsaw Stock Exchange. It has been provided that mandatory offers have a significant impact on the price of a company’s shares listed on the Warsaw Stock Exchange. Knowledge about the reactions of investors to a mandatory offer may be used when selecting securities for an investment portfolio. The findings may provide guidance in deciding whether to begin or end investment in the company, both for individual and institutional investors. The event study methodology approach used in the paper is regarded as valuable and can be the basis for further research in other areas of the capital market research, especially in the context of information efficiency.

  14. Improving psychotropic drug prescription in nursing home patients with dementia: design of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Smeets, C.H.; Smalbrugge, M.; Gerritsen, D.L.; Nelissen-Vrancken, M.H.; Wetzels, R.B.; van der Spek, K.; Zuidema, S.U.; Koopmans, R.T.

    2013-01-01

    Background: Neuropsychiatric symptoms are highly prevalent in nursing home patients with dementia. Despite modest effectiveness and considerable side effects, psychotropic drugs are frequently prescribed for these neuropsychiatric symptoms. This raises questions whether psychotropic drugs are

  15. Improving psychotropic drug prescription in nursing home patients with dementia : design of a cluster randomized controlled trial

    NARCIS (Netherlands)

    Smeets, Claudia H. W.; Smalbrugge, Martin; Gerritsen, Debby L.; Nelissen-Vrancken, Marjorie H. J. M. G.; Wetzels, Roland B.; van der Spek, Klaas; Zuidema, Sytse U.; Koopmans, Raymond T. C. M.

    2013-01-01

    Background: Neuropsychiatric symptoms are highly prevalent in nursing home patients with dementia. Despite modest effectiveness and considerable side effects, psychotropic drugs are frequently prescribed for these neuropsychiatric symptoms. This raises questions whether psychotropic drugs are

  16. Deep tissue massage and nonsteroidal anti-inflammatory drugs for low back pain: a prospective randomized trial.

    Science.gov (United States)

    Majchrzycki, Marian; Kocur, Piotr; Kotwicki, Tomasz

    2014-01-01

    To investigate whether chronic low back pain therapy with deep tissue massage (DTM) gives similar results to combined therapy consisting of DTM and non-steroid anti-inflammatory drugs (NSAID). Prospective controlled randomized single blinded trial. Ambulatory care of rehabilitation. 59 patients, age 51.8 ± 9.0 years, with chronic low back pain. Interventions. 2 weeks of DTM in the treatment group (TG) versus 2 weeks of DTM combined with NSAID in the control group (CG). Visual analogue scale, Oswestry disability index (ODI), and Roland-Morris questionnaire (RM). In both the TG and the CG, a significant pain reduction and function improvement were observed. VAS decreased from 58.3 ± 18.2 to 42.2 ± 21.1 (TG) and from 51.8 ± 18.8 to 30.6 ± 21.9 (CG). RM value decreased from 9.8 ± 5.1 to 6.4 ± 4.4 (TG), and from 9.3 ± 5.5 to 6.1 ± 4.6 (CG). ODI value decreased from 29.2 ± 17.3 to 21.4 ± 15.1 (TG) and from 21.4 ± 9.4 to 16.6 ± 9.4 (CG). All pre-post-treatment differences were significant; however, there was no significant difference between the TG and the CG. DTM had a positive effect on reducing pain in patients with chronic low back pain. Concurrent use of DTM and NSAID contributed to low back pain reduction in a similar degree that the DTM did.

  17. Short-term Antiarrhythmic Drugs After Catheter Ablation for Atrial Fibrillation: A Meta-analysis of Randomized Controlled Trials.

    Science.gov (United States)

    Xu, Buyun; Peng, Fang; Tang, Weiliang; Du, Ye; Guo, Hangyuan

    2016-09-01

    The incidence of recurrent arrhythmia after catheter ablation (CA) for atrial fibrillation (AF) is unacceptable. Short-term antiarrhythmic drug (AAD) treatment following CA was presumed to be effective in reducing recurrent arrhythmia. To fully evaluate the efficacy of short-term use of AADs following CA for AF in preventing recurrence of atrial tachyarrhythmias. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov were searched up until May 1, 2016. We enrolled randomized controlled trials (RCTs) that evaluated the efficacy of short-term use of AADs following CA for AF in preventing early and/or late recurrence of atrial tachyarrhythmias. The statistical analyses were performed using Review Manager Version 5.3. Six RCTs were included in this analysis, involving a total of 2764 patients. The frequency of early recurrence of atrial tachyarrhythmias was 39.5% in the AAD group (556 of 1407) and 47.2% (640 of 1357) in the control group. The pooled risk ratio of the AAD group to the control group was 0.78 (95% CI = 0.62-0.98). Regarding late recurrence of AF (LRAF), the incidence in the AAD group and the control group was 32.5% (420 of 1293) and 34.6% (450 of 1300), respectively. No significant difference was identified between the 2 groups (relative risk = 0.94, 95% CI = 0.85-1.05). Short-term use of AADs following CA for AF reduced the incidence of early recurrent atrial tachyarrhythmias but did not prevent LRAF. © The Author(s) 2016.

  18. Acid folic and pregnancy: A mandatory supplementation.

    Science.gov (United States)

    Valentin, Morgane; Coste Mazeau, Perrine; Zerah, Michel; Ceccaldi, Pierre François; Benachi, Alexandra; Luton, Dominique

    2018-02-09

    Neural tube defects (NTD) occur in 0.5 to 2 per 1000 pregnancies with various handicaps for the affected child. It is now well established that folic acid deficiency (absolute or relative) is a predisposing factor to this type of malformation. Several randomized controlled trials showed that high-dose folic acid (4mg) is an essential factor for prevention of neural tube defects recurrence and significantly prevents the first occurrence of neural tube defects with a lower dose (0.4mg). Other etiologies can favor the occurrence of NTD such as MTHFR polymorphism, some antiepileptic therapies, obesity and pregestational mellitus diabetes. Necessity of a preconception folic acid supplementation or at least folate nutritional status evaluation should be known for all of us including patients and public. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

  19. An economic evaluation of mandatory premarital testing for HIV.

    Science.gov (United States)

    McKay, N L; Phillips, K M

    1991-01-01

    This study provides a comprehensive assessment of mandatory premarital testing for HIV. We incorporate new evidence about the assumptions underlying an economic evaluation of premarital testing, use standard methods of program evaluation (cost-effectiveness analysis and cost-benefit analysis), and carefully evaluate how changes in the various assumptions affect the results. The cost-effectiveness results show that, under the most likely conditions, the cost per case of HIV infection prevented by mandatory premarital testing would be between $70,000 and $127,000. In the cost-benefit analysis, the benefit-cost ratio in the most likely scenarios ranges between 3.1 and 28.2.

  20. Randomized, community-based pharmacy intervention to expand services beyond sale of sterile syringes to injection drug users in pharmacies in New York City.

    Science.gov (United States)

    Crawford, Natalie D; Amesty, Silvia; Rivera, Alexis V; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M

    2013-09-01

    Structural interventions may help reduce racial/ethnic disparities in HIV. In 2009 to 2011, we randomized pharmacies participating in a nonprescription syringe access program in minority communities to intervention (pharmacy enrolled and delivered HIV risk reduction information to injection drug users [IDUs]), primary control (pharmacy only enrolled IDUs), and secondary control (pharmacy did not engage IDUs). Intervention pharmacy staff reported more support for syringe sales than did control staff. An expanded pharmacy role in HIV risk reduction may be helpful.

  1. A group intervention to reduce intimate partner violence among female drug users. Results from a randomized controlled pilot trial in a community substance-abuse center.

    Science.gov (United States)

    Tirado-Muñoz, Judit; Gilchrist, Gail; Lligoña, Eva; Gilbert, Louisa; Torrens, Marta

    2015-09-15

    A greater proportion of drug dependent women are victims of intimate partner violence (IPV) than women in the general population; however, few interventions have been developed to reduce IPV among drug dependent women. An adapted version of the Women's Wellness Treatment, to address IPV and depressive symptoms, was piloted in a randomized controlled trial conducted in outpatient treatment program in Barcelona, Spain among 14 women receiving outpatient treatment for a drug use disorder who screened positive for IPV in the previous month. Participants were randomly assigned to receive the 10 session cognitive behavioral therapy (IPaViT-CBT) group intervention or treatment as usual. The frequency of IPV, depressive symptoms, substance use, quality of life and health status were assessed at baseline and 1, 3 and 12 months post intervention. Intention to treat analysis was performed. Moderate effects for the intervention were found in reducing psychological maltreatment, increasing assertiveness of IPV and reducing aggressiveness in the partner relationship, and in reducing the frequency of drinking up to 3 months post intervention. The intervention did not significantly reduce the likelihood of any IPV, depressive symptoms, quality of life or self-reported health status, up to 12-months post intervention. This pilot trial suggests some initial support for the 10-session CBT group intervention among IPV victims who received treatment for drug use. Study findings indicate that it is feasible to deliver the intervention in a community substance abuse center. An adequately powered trial is required to replicate these results.

  2. Immunogenicity and safety of high-dose hepatitis B vaccine among drug users: A randomized, open-labeled, blank-controlled trial.

    Science.gov (United States)

    Feng, Yongliang; Shi, Jing; Gao, Linying; Yao, Tian; Feng, Dan; Luo, Dan; Li, Zhansheng; Zhang, Yawei; Wang, Fuzhen; Cui, Fuqiang; Li, Li; Liang, Xiaofeng; Wang, Suping

    2017-06-03

    Due to the low uptake, adherence, and completion of vaccination among drug users, and their compromised immune responses to hepatitis B vaccination, the current practice of hepatitis B vaccination may not provide optimal protection. The aim of this study was to evaluate the immunogenicity and safety of 60 µg and 20 µg hepatitis B vaccines among drug users. A randomized, open-labeled, blank-controlled trial was conducted among drug users at 2 drug rehabilitation centers in China. The eligible participants were drug users who were serologically negative for the hepatitis B surface antigen (HBsAg) and the hepatitis B surface antibody (anti-HBs). Participants were randomized in a ratio of 1:1:1 to receive 20 µg (IM20 group) or 60 µg (IM60 group) of hepatitis B vaccine or blank control at months 0, 1, and 6, and followed at months 6, 7, and 12. Seroconversion rates of 94.7% and 92.6% were observed in IM20 and IM60 groups at month 7, and correspondingly decreased to 89.5% and 91.7% respectively at month 12. The IM60 group showed significantly higher geometric mean concentrations (GMCs) of anti-HBs (2022.5 and 676.7 mIU mL-1) than the IM20 group did (909.6 and 470.5 mIU mL-1) at months 7 and 12 (P B vaccines showed good immunogenicity among the drug users.

  3. Effect of an educational intervention to improve adverse drug reaction reporting in physicians: a cluster randomized controlled trial.

    Science.gov (United States)

    Lopez-Gonzalez, Elena; Herdeiro, Maria T; Piñeiro-Lamas, María; Figueiras, Adolfo

    2015-02-01

    The yellow-card scheme continues to be one of the principal methods for signal generation in pharmacovigilance. Nevertheless, under-reporting, one of its disadvantages, delays alert signals and has a negative influence on public health. Educational interventions in pharmacovigilance may have a positive impact on the spontaneous reporting of adverse drug reactions (ADRs). To assess the duration of the effect and effectiveness of an educational intervention in pharmacovigilance designed to improve ADR reporting in a robust pharmacovigilance system. A spatial, cluster randomized controlled trial was conducted covering all National Health System physicians in the northwest of Spain and targeting those who were actively engaged in clinical practice (n = 7,498). Of these, 2,120 were assigned in three spatial clusters to the intervention group (six hospitals and 138 primary care centers) and 3,614 in four clusters to the control group (seven hospitals and 267 primary care centers). The educational intervention consisted of two complementary approaches--one active (group sessions), the other passive (educational material, reporting form)-implemented from November 2007 to December 2008, with a follow-up period of 8 months. Intervention participation was 53.7 % in a hospital setting and 60.5 % in primary care settings. ADR reporting in the intervention group increased by 65.4 % (95 % confidence interval [CI]: 8.2-153.4) across the follow-up. The ADR reporting rate per 1,000 physicians/year in the intervention group rose from 28.1 to 39.6 following the intervention (51.7 and 27.4 in the first and second 4-month period, respectively). For the intervention group, relative risk (RR) was 2.31 (95 % CI: 1.46-3.68) and 1.04 (95 % CI: 0.61-1.77) in the first and second 4-month period, respectively adjusted to baseline values. There was an increase in unexpected ADR reporting (RR 2.06, 95 % CI 1.19-3.55). Pharmacovigilance educational interventions that have proved effective can be

  4. Effects of lipid-lowering drugs on high-density lipoprotein subclasses in healthy men-a randomized trial.

    Directory of Open Access Journals (Sweden)

    Heiner K Berthold

    Full Text Available CONTEXT AND OBJECTIVE: Investigating the effects of lipid-lowering drugs on HDL subclasses has shown ambiguous results. This study assessed the effects of ezetimibe, simvastatin, and their combination on HDL subclass distribution. DESIGN AND PARTICIPANTS: A single-center randomized parallel 3-group open-label study was performed in 72 healthy men free of cardiovascular disease with a baseline LDL-cholesterol of 111±30 mg/dl (2.9±0.8 mmol/l and a baseline HDL-cholesterol of 64±15 mg/dl (1.7±0.4 mmol/l. They were treated with ezetimibe (10 mg/day, n = 24, simvastatin (40 mg/day, n = 24 or their combination (n = 24 for 14 days. Blood was drawn before and after the treatment period. HDL subclasses were determined using polyacrylamide gel-tube electrophoresis. Multivariate regression models were used to determine the influence of treatment and covariates on changes in HDL subclass composition. RESULTS: Baseline HDL subclasses consisted of 33±10% large, 48±6% intermediate and 19±8% small HDL. After adjusting for baseline HDL subclass distribution, body mass index, LDL-C and the ratio triglycerides/HDL-C, there was a significant increase in large HDL by about 3.9 percentage points (P<0.05 and a decrease in intermediate HDL by about 3.5 percentage points (P<0.01 in both simvastatin-containing treatment arms in comparison to ezetimibe. The parameters obtained after additional adjustment for the decrease in LDL-C indicated that about one third to one half of these effects could be explained by the extent of LDL-C-lowering. CONCLUSIONS: In healthy men, treatment with simvastatin leads to favorable effects on HDL subclass composition, which was not be observed with ezetimibe. Part of these differential effects may be due to the stronger LDL-C-lowering effects of simvastatin. TRIAL REGISTRATION: ClinicalTrials.gov NCT00317993.

  5. Which analysts benefited most from mandatory IFRS adoption in Europe?

    NARCIS (Netherlands)

    Beuselinck, Christof; Joos, Philip; Khurana, I.K.; van der Meulen, Sofie

    2017-01-01

    This study examines whether financial analysts' research structure and portfolio selection choices helped in improving relative earnings forecast accuracy around mandatory IFRS adoption in Europe. Using a sample of 68,665 one-year ahead forecasts for 1,980 publicly listed firms, we find that

  6. Mandatory Parent Education Programs Can Create Positive Youth Sport Experiences

    Science.gov (United States)

    Christofferson, Jennifer; Strand, Bradford

    2016-01-01

    Youth sport leaders must not ignore the influence parents have on creating a positive developmental experience for young athletes. Therefore, expectations involving parental involvement and conduct must be addressed prior to athletes' participation. This article aims to examine the importance of creating mandatory parental training programs for…

  7. Mandatory Use of Electronic Health Records: Overcoming Physician Resistance

    Science.gov (United States)

    Brown, Viseeta K.

    2012-01-01

    Literature supports the idea that electronic health records hold tremendous value for the healthcare system in that it increases patient safety, improves the quality of care and provides greater efficiency. The move toward mandatory implementation of electronic health records is a growing concern in the United States health care industry. The…

  8. Mandatory or Flexible: Whither Retirement Age Policy? | Ibiwoye ...

    African Journals Online (AJOL)

    ... are indeed more disposed to flexible retirement. It also found that flexible policy will have a positive welfare effect as many employees can then take care of their extended span of dependants for a longer period and employee productivity will also be improved. Key words: Retirement, Mandatory, Flexible, Pension Plan, ...

  9. Attitude towards mandatory pre-marital HIV testing among ...

    African Journals Online (AJOL)

    This study assessed the attitude of unmarried youths towards Mandatory Premarital HIV Testing (MPHT) in Ibadan Northwest Local Government Area. A three-stage sampling technique was used to select 571unmarried youths from households. A validated questionnaire was used for the collection of the data. Descriptive ...

  10. 27 CFR 7.22 - Mandatory label information.

    Science.gov (United States)

    2010-04-01

    ... Beverages § 7.22 Mandatory label information. There shall be stated: (a) On the brand label: (1) Brand name... alcohol. (b) On the brand label or on a separate label (back or front): (1) In the case of imported malt....” (Paragraph (b)(6) approved by the Office of Management and Budget under Control No. 1512-0469) Editorial Note...

  11. 27 CFR 4.32 - Mandatory label information.

    Science.gov (United States)

    2010-04-01

    ... Mandatory label information. (a) There shall be stated on the brand label: (1) Brand name, in accordance... the bottle. (c) There shall be stated on the brand label or on a back label a statement that the... Management and Budget under Control Number 1512-0469) ...

  12. Attitude Towards Mandatory Pre-Marital HIV Testing Among ...

    African Journals Online (AJOL)

    Erah

    This study assessed the attitude of unmarried youths towards Mandatory Premarital HIV Testing (MPHT) in Ibadan. Northwest Local Government Area. A three-stage sampling technique was used to select 571unmarried youths from households. A validated questionnaire was used for the collection of the data. Descriptive ...

  13. 27 CFR 4.63 - Legibility of mandatory information.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Legibility of mandatory information. 4.63 Section 4.63 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU... be so stated in both the print and audio-visual media that it will be readily apparent to the persons...

  14. 27 CFR 7.53 - Legibility of mandatory information.

    Science.gov (United States)

    2010-04-01

    ... 27 Alcohol, Tobacco Products and Firearms 1 2010-04-01 2010-04-01 false Legibility of mandatory information. 7.53 Section 7.53 Alcohol, Tobacco Products and Firearms ALCOHOL AND TOBACCO TAX AND TRADE BUREAU... information shall be so stated in both the print and audiovisual media that it will be readily apparent to the...

  15. 32 CFR 232.6 - Mandatory loan disclosures.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 2 2010-07-01 2010-07-01 false Mandatory loan disclosures. 232.6 Section 232.6 National Defense Department of Defense (Continued) OFFICE OF THE SECRETARY OF DEFENSE (CONTINUED) MISCELLANEOUS LIMITATIONS ON TERMS OF CONSUMER CREDIT EXTENDED TO SERVICE MEMBERS AND DEPENDENTS § 232.6...

  16. 27 CFR 16.21 - Mandatory label information.

    Science.gov (United States)

    2010-04-01

    ... not drink alcoholic beverages during pregnancy because of the risk of birth defects. (2) Consumption... BUREAU, DEPARTMENT OF THE TREASURY LIQUORS ALCOHOLIC BEVERAGE HEALTH WARNING STATEMENT Health Warning Statement Requirements for Alcoholic Beverages § 16.21 Mandatory label information. There shall be stated on...

  17. Competition with mandatory labeling of genetically modified products

    NARCIS (Netherlands)

    Toolsema-Veldman, Linda

    A vertical differentiation model is analyzed to study the placing on the market of genetically modified (GM) products in a context where labeling of such products is mandatory, as it is in the European Union. The model has two stages: firms first choose their technology (either GM or conventional)

  18. Mandatory Quality Disclosure and Quality Supply : Evidence from German Hospitals

    NARCIS (Netherlands)

    Filistrucchi, L.; Ozbugday, F.C.

    2012-01-01

    Abstract: Using a newly constructed dataset on German hospitals, which includes 24 process and outcome indicators of clinical quality, we test whether quality has increased in various clinical areas since the introduction of mandatory quality reports and the online publication of part of the

  19. 45 CFR 302.85 - Mandatory computerized support enforcement system.

    Science.gov (United States)

    2010-10-01

    ... 45 Public Welfare 2 2010-10-01 2010-10-01 false Mandatory computerized support enforcement system. 302.85 Section 302.85 Public Welfare Regulations Relating to Public Welfare OFFICE OF CHILD SUPPORT... “Automated Systems for Child Support Enforcement: A Guide for States.” This guide is available from the Child...

  20. 5 CFR 9701.707 - Appeals of mandatory removal actions.

    Science.gov (United States)

    2010-01-01

    ... employee may appeal such actions to the Mandatory Removal Panel (MRP) established under § 9701.708. (b) Procedures. (1) The MRP will establish procedures for the fair, impartial, and expeditious assignment and... other matters as may be necessary to ensure the operation of the MRP. (2) The MRP will conduct a hearing...

  1. Protocol of the impact of alternative social assistance disbursement on drug-related harm (TASA study: a randomized controlled trial to evaluate changes to payment timing and frequency among people who use illicit drugs

    Directory of Open Access Journals (Sweden)

    Lindsey Richardson

    2016-07-01

    Full Text Available Abstract Background Government social assistance payments seek to alleviate poverty and address survival needs, but their monthly disbursement may cue increases in illicit drug use. This cue may be magnified when assistance is disbursed simultaneously across the population. Synchronized payments have been linked to escalations in drug use and unintended but severe drug-related harms, including overdose, as well as spikes in demand for health, social, financial and police services. Methods/design The TASA study examines whether changing payment timing and frequency can mitigate drug-related harm associated with synchronized social assistance disbursement. The study is a parallel arm multi-group randomized controlled trial in which 273 participants are randomly allocated for six assistance cycles to a control or one of two intervention arms on a 1:1:1 basis. Intervention arm participants receive their payments: (1 monthly; or (2 semi-monthly, in each case on days that are not during the week when cheques are normally issued. The study partners with a community-based credit union that has developed a system to vary social assistance payment timing. The primary outcome is a 40 % increase in drug use during the 3 days beginning with cheque issue day compared to other days of the month. Bi-weekly follow-up interviews collect participant information on this and secondary outcomes of interest, including drug-related harm (e.g. non-fatal overdose, exposure to violence and health service utilization. Self-reported data will be supplemented with participant information from health, financial, police and government administrative databases. A longitudinal, nested, qualitative parallel process evaluation explores participant experiences, and a cost-effectiveness evaluation of different disbursement scenarios will be undertaken. Outcomes will be compared between control and intervention arms to identify the impacts of alternative disbursement schedules on

  2. Effects of music therapy on drug avoidance self-efficacy in patients on a detoxification unit: a three-group randomized effectiveness study.

    Science.gov (United States)

    Silverman, Michael J

    2014-01-01

    Self-efficacy is a component of Bandura's social cognitive theory and can lead to abstinence and a reduction of relapse potential for people who have substance abuse disorders. To date, no music therapy researcher has utilized this theoretical model to address abstinence and reduce the likelihood of relapse in people who have addictions. The purpose of this study was to determine the effects of music therapy on drug avoidance self-efficacy in a randomized three-group wait-list control design with patients on a detoxification unit. Participants (N = 131) were cluster randomized to one of three single-session conditions: music therapy, verbal therapy, or wait-list control. Music therapy participants received a group lyric analysis intervention, verbal therapy participants received a group talk therapy session, and wait-list control participants eventually received a group recreational music therapy intervention. Although there was no significant between-group difference in drug avoidance self-efficacy, participants in the music therapy condition tended to have the highest mean drug avoidance self-efficacy scores. Posttest written comments supported the use of both music therapy and verbal therapy sessions. Two music therapy participants specifically noted that their initial skepticism had dissipated after receiving music therapy. Despite a lack of significant differences, the theoretical support of self-efficacy for substance abuse rehabilitation suggests that this may be an area of continued clinical focus and empirical investigation. Clinical anecdotes, limitations of the study, and suggestions for future research are provided.

  3. Effects of blood-pressure-lowering treatment in hypertension: 9. Discontinuations for adverse events attributed to different classes of antihypertensive drugs: meta-analyses of randomized trials.

    Science.gov (United States)

    Thomopoulos, Costas; Parati, Gianfranco; Zanchetti, Alberto

    2016-10-01

    Choice of antihypertensive drugs is also based on the expected burden of adverse events associated with each class of agents, and we have recently identified treatment discontinuation for adverse events as a measure of treatment tolerability frequently reported in randomized controlled trials (RCTs). To investigate whether all classes of blood pressure (BP) lowering drugs increase discontinuations for adverse events when compared with placebo and whether risk of discontinuation is similar for all classes when compared in head-to-head RCTs. RCTs of BP-lowering treatment were subdivided in groups according to class of drug compared with placebo or with other classes. Risk ratios and 95% confidence intervals of major cardiovascular events and of treatment discontinuations for adverse events were calculated (random-effects model). Thirty-eight placebo-controlled RCTs (147 788 patients) and 37 head-to-head RCTs (242 481 patients) provided comparative information on discontinuations for adverse events. All classes of drugs significantly increased discontinuations for adverse events over those occurring on placebo: risk ratio diuretics 2.23 (1.32-3.76), beta-blockers 2.88 (1.58-5.28), calcium antagonists 2.03 (1.17-3.56), angiotensin-converting enzyme inhibitors 2.78 (1.37-5.47), central agents 1.74 (1.24-2.45), with the single exception of angiotensin receptor blockers, which did not significantly increase adverse events over placebo [risk ratio 1.13 (0.78-1.62)]. Similarly, in head-to-head comparison RCTs with other classes, angiotensin receptor blockers were the only class associated with a significantly lower risk of adverse events [risk ratio 0.71 (0.58-0.87)] when head-to-head compared with other classes. Regression analysis also shows that incidence of discontinuations for adverse events is proportional to the number of antihypertensive and other cardiovascular drugs, which accounts for the high incidence of this outcome often found in groups randomized to

  4. Does Multimodal Analgesia with Acetaminophen, Nonsteroidal Antiinflammatory Drugs, or Selective Cyclooxygenase-2 Inhibitors and Patient-controlled Analgesia Morphine Offer Advantages over Morphine Alone?: Meta-analyses of Randomized Trials

    National Research Council Canada - National Science Library

    Elia, Nadia; Lysakowski, Christopher; Tramèr, Martin R

    2005-01-01

    The authors analyzed data from 52 randomized placebo-controlled trials (4,893 adults) testing acetaminophen, nonsteroidal antiinflammatory drugs, or selective cyclooxygenase-2 inhibitors given in conjunction with morphine after surgery...

  5. Opioid analgesics-related pharmacokinetic drug interactions: from the perspectives of evidence based on randomized controlled trials and clinical risk management

    Directory of Open Access Journals (Sweden)

    Feng XQ

    2017-05-01

    Full Text Available Xiu-qin Feng,1 Ling-ling Zhu,2 Quan Zhou3 1Nursing Administration Office, Division of Nursing, 2VIP Care Ward, Division of Nursing, 3Department of Pharmacy, The Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, People’s Republic of China Background: Multimorbidity results in complex polypharmacy which may bear a risk of drug interactions. A better understanding of opioid analgesics combination therapy used for pain management could help warrant medication safety, efficacy, and economic relevance. Until now there has been no review summarizing the opioid analgesics-related pharmacokinetic drug interactions from the perspective of evidence based on randomized controlled trials (RCTs. Method: A literature search was performed using PubMed, MEDLINE, and the Cochrane Library, using a PRISMA flowchart. Results: Fifty-two RCTs were included for data interpretation. Forty-two RCTs (80.8% were conducted in healthy volunteers, whereas 10 RCTs (19.2% enrolled true patients. None of the opioid–drug/herb pairs was listed as contraindications of opioids involved in this review. Circumstances in which opioid is comedicated as a precipitant drug include morphine–P2Y12 inhibitors, morphine–gabapentin, and methadone–zidovudine. Circumstances in which opioid is comedicated as an object drug include rifampin–opioids (morphine, tramadol, oxycodone, methadone, quinidine–opioids (morphine, fentanyl, oxycodone, codeine, dihydrocodeine, methadone, antimycotics–opioids (buprenorphine, fentanyl, morphine, oxycodone, methadone, tilidine, tramadol, protease inhibitors–opioids (ritonavir, ritonavir/lopinavir–oxycodone, ritonavir–fentanyl, ritonavir–tilidine, grapefruit juice–opioids (oxycodone, fentanyl, methadone, antidepressants–opioids (paroxetine–tramadol, paroxetine–hydrocodone, paroxetine–oxycodone, escitalopram–tramadol, metoclopramide–morphine, amantadine–morphine, sumatriptan

  6. A Randomized Trial Among Compression Plus Nonsteroidal Antiinflammatory Drugs, Aspiration, and Aspiration With Steroid Injection for Nonseptic Olecranon Bursitis.

    Science.gov (United States)

    Kim, Joon Yub; Chung, Seok Won; Kim, Joo Hak; Jung, Jae Hong; Sung, Gwang Young; Oh, Kyung-Soo; Lee, Jong Soo

    2016-03-01

    Olecranon bursitis might be a minor problem in the outpatient clinic but relatively be common to occur. However, there are few well-designed studies comparing approaches to treatment. (1) Which treatment (compression bandaging with nonsteroidal antiinflammatory drugs [NSAIDs], aspiration, or aspiration with steroid injections) is associated with the highest likelihood of resolution of nonseptic olecranon bursitis? (2) Which treatment is associated with earliest resolution of symptoms? (3) What factors are associated with treatment failure by 4 weeks? We enrolled 133 patients from two centers; after applying prespecified exclusions (septic bursitis or concomitant inflammatory arthritis, intraarticular elbow pathology, recent aspiration or steroid injection done elsewhere, and refusal to participate), 90 patients were randomly allocated to receive compression bandaging with NSAIDs (C), aspiration (A), or aspiration with steroid injection (AS) groups (30 patients in each). The groups were similar at baseline in terms of age and gender. Seven patients (four from Group A and three from Group AS) were lost to followup. All patients were followed up weekly for 4 weeks, and the same treatment procedure was repeated if the bursitis recurred with any substantial fluid collection. At 4 weeks, the state of resolution and pain visual analog scale (VAS) were evaluated. Failed resolution was defined as presence of persistent olecranon bursal fluid collection at Week 4 after the initiation of the treatment; on the contrary, if bursal fluid collection was clinically reduced or completely disappeared by the end of Week 4, the treatment was considered successful. We compared the proportion of resolution by Week 4 and the median times to resolution among the treatment groups. In addition, we evaluated whether the resolution affected pain VAS and what factors were associated with the resolution. There were no differences in the proportion of patients whose bursitis resolved by Week 4

  7. A Mobile Device App to Reduce Medication Errors and Time to Drug Delivery During Pediatric Cardiopulmonary Resuscitation: Study Protocol of a Multicenter Randomized Controlled Crossover Trial.

    Science.gov (United States)

    Siebert, Johan N; Ehrler, Frederic; Lovis, Christian; Combescure, Christophe; Haddad, Kevin; Gervaix, Alain; Manzano, Sergio

    2017-08-22

    During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusions is complex and time-consuming. The need for individual specific weight-based drug dose calculation and preparation places children at higher risk than adults for medication errors. Following an evidence-based and ergonomic driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. In a prior single center randomized controlled trial, medication errors were reduced from 70% to 0% by using PedAMINES when compared with conventional preparation methods. The purpose of this study is to determine whether the use of PedAMINES in both university and smaller hospitals reduces medication dosage errors (primary outcome), time to drug preparation (TDP), and time to drug delivery (TDD) (secondary outcomes) during pediatric CPR when compared with conventional preparation methods. This is a multicenter, prospective, randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drug infusion rate table in the preparation of continuous drug infusion. The evaluation setting uses a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin. The study involving 120 certified nurses (sample size) will take place in the resuscitation rooms of 3 tertiary pediatric emergency departments and 3 smaller hospitals. After epinephrine-induced return of spontaneous circulation, nurses will be asked to prepare a continuous infusion of dopamine using either PedAMINES (intervention group) or the infusion table (control group) and then prepare a continuous infusion of norepinephrine by crossing the procedure. The primary outcome is the medication dosage error rate. The secondary outcome is the time in seconds elapsed since the oral

  8. A Mobile Device App to Reduce Time to Drug Delivery and Medication Errors During Simulated Pediatric Cardiopulmonary Resuscitation: A Randomized Controlled Trial.

    Science.gov (United States)

    Siebert, Johan N; Ehrler, Frederic; Combescure, Christophe; Lacroix, Laurence; Haddad, Kevin; Sanchez, Oliver; Gervaix, Alain; Lovis, Christian; Manzano, Sergio

    2017-02-01

    During pediatric cardiopulmonary resuscitation (CPR), vasoactive drug preparation for continuous infusion is both complex and time-consuming, placing children at higher risk than adults for medication errors. Following an evidence-based ergonomic-driven approach, we developed a mobile device app called Pediatric Accurate Medication in Emergency Situations (PedAMINES), intended to guide caregivers step-by-step from preparation to delivery of drugs requiring continuous infusion. The aim of our study was to determine whether the use of PedAMINES reduces drug preparation time (TDP) and time to delivery (TDD; primary outcome), as well as medication errors (secondary outcomes) when compared with conventional preparation methods. The study was a randomized controlled crossover trial with 2 parallel groups comparing PedAMINES with a conventional and internationally used drugs infusion rate table in the preparation of continuous drug infusion. We used a simulation-based pediatric CPR cardiac arrest scenario with a high-fidelity manikin in the shock room of a tertiary care pediatric emergency department. After epinephrine-induced return of spontaneous circulation, pediatric emergency nurses were first asked to prepare a continuous infusion of dopamine, using either PedAMINES (intervention group) or the infusion table (control group), and second, a continuous infusion of norepinephrine by crossing the procedure. The primary outcome was the elapsed time in seconds, in each allocation group, from the oral prescription by the physician to TDD by the nurse. TDD included TDP. The secondary outcome was the medication dosage error rate during the sequence from drug preparation to drug injection. A total of 20 nurses were randomized into 2 groups. During the first study period, mean TDP while using PedAMINES and conventional preparation methods was 128.1 s (95% CI 102-154) and 308.1 s (95% CI 216-400), respectively (180 s reduction, P=.002). Mean TDD was 214 s (95% CI 171-256) and

  9. Drug use, health and social outcomes of hard-to-treat heroin addicts receiving supervised injectable opiate treatment: secondary outcomes from the Randomized Injectable Opioid Treatment Trial (RIOTT).

    Science.gov (United States)

    Metrebian, Nicola; Groshkova, Teodora; Hellier, Jennifer; Charles, Vikki; Martin, Anthea; Forzisi, Luciana; Lintzeris, Nicholas; Zador, Deborah; Williams, Hugh; Carnwath, Tom; Mayet, Soraya; Strang, John

    2015-03-01

    The Randomized Injectable Opioid Treatment Trial (RIOTT) compared supervised injectable heroin (SIH) and supervised injectable methadone (SIM) with optimized oral methadone (OOM) (ISRCTN0133807). Heroin addicts (previously unresponsive to treatment) made significant reductions in street heroin use at 6 months when treated with SIH. We now examine secondary outcomes. Multi-site randomized controlled trial (RCT) comparing SIH versus OOM and SIM versus OOM. Three supervised injectable opiate clinics in England. Chronic refractory heroin addicts continuing to inject street heroin virtually daily despite oral substitution treatment (n = 127), randomized to either SIH(n = 43), SIM(n = 42) or OOM(n = 42). All received high levels of medical and psychosocial support. wider drug use, crime, health and social functioning at 6 months. At 6 months, no significant differences were found between treatment groups in wider drug use (crack/cocaine, benzodiazepines, alcohol), physical and mental health (SF-36) or social functioning. Within each treatment group, significant reductions were observed in crime [SIH = odds ratio (OR) 0.05; P health for SIH and SIM (SIH = mean change 3.97; P = 0.008; SIM = mean change 4.73; P = 0.002) and mental health for OOM (mean change 6.04; P = 0.013). Supervised injectable heroin treatment and supervised injectable methadone treatment showed no clearly identified benefit over optimized oral methadone in terms of wider drug use, crime, physical and mental health within a 6-month period, despite reducing street heroin use to a greater extent. However, all interventions were associated with improvements in these outcomes. © 2014 Society for the Study of Addiction.

  10. Mandatory IFRS adoption and executive compensation: Evidence from China

    Directory of Open Access Journals (Sweden)

    Qingchuan Hou

    2014-03-01

    Full Text Available This study investigates how the mandatory adoption of International Financial Reporting Standards (IFRS affects the contractual benefits of using accounting information to determine executive compensation in China. After controlling for firm and corporate governance characteristics, we find strong evidence supporting the positive role of mandatory IFRS adoption on the accounting-based performance sensitivity of executive compensation. Subsample analysis suggests that improvements in accounting-based performance sensitivity after IFRS adoption differ across regions with various levels of institutional quality and across firms that are affected to a different extent by the adoption. Additional analysis supports the argument that the positive effects of IFRS adoption on the use of accounting performance in executive compensation are driven by the reduction in accounting conservatism associated with IFRS adoption.

  11. Warm experts in the age of mandatory e-government:

    DEFF Research Database (Denmark)

    Østergaard Madsen, Christian; Kræmmergaard, Pernille

    2016-01-01

    with public authorities. This negotiation requires the use of traditional channels and concerns areas such as increasing the likelihood of being granted benefits and ways of getting around the mandatory requirement for e-government self-service channels. Based on our findings we present contributions......Citizens’ adoption of e-government channels has been the focus of both academic studies and public policy for over a decade. Current efforts seek to reduce citizens’ interaction with caseworkers through traditional channels in favor of increased use of e-government self-service channels....... To increase adoption rates and reduce the costs of public administration, the Danish e-government strategy has made e-government self-service channels mandatory thereby attempting to turn citizens into their own caseworkers. The channel choice branch of e-government studies how citizens and businesses choose...

  12. Mandatory Participation in Occupational Pension Schemes in the Netherlands and other Countries

    OpenAIRE

    Chen, Damiaan H.J.; Beetsma, Roel

    2014-01-01

    This paper discusses mandatory participation in Dutch occupational pension schemes. While mandatory participation is a historical feature of most second-pillar pension arrangements, some recent developments may affect the case for mandatory participation. The main ones are the revision of the Dutch supplementary pension contract, changes in the prudential supervisory rules and developments in European regulations regarding supplementary pensions. We also compare mandatory participation in the...

  13. Analysis of physicochemical properties of ternary systems of oxaprozin with randomly methylated-ß-cyclodextrin and l-arginine aimed to improve the drug solubility.

    Science.gov (United States)

    Mennini, Natascia; Maestrelli, Francesca; Cirri, Marzia; Mura, Paola

    2016-09-10

    The influence of l-arginine on the complexing and solubilizing power of randomly-methylated-β-cyclodextrin (RameβCD) towards oxaprozin, a very poorly soluble anti-inflammatory drug, was examined. The interactions between the components were investigated both in solution, by phase-solubility analysis, and in the solid state, by differential scanning calorimetry, FTIR and X-ray powder diffractometry. The morphology of the solid products was examined by Scanning Electron Microscopy. Results of phase-solubility studies indicated that addition of arginine enhanced the RameβCD complexing and solubilizing power of about 3.0 and 4.5 times, respectively, in comparison with the binary complex (both at pH≈6.8). The effect of arginine was not simply additive, but synergistic, being the ternary system solubility higher than the sum of those of the respective drug-CD and drug-arginine binary systems. Solid equimolar ternary systems were prepared by physical mixing, co-grinding, coevaporation and kneading techniques, to explore the effect of the preparation method on the physicochemical properties of the final products. The ternary co-ground product exhibited a dramatic increase in both drug dissolution efficiency and percent dissolved at 60min, whose values (83.6 and 97.1, respectively) were about 3 times higher than the sum of those given by the respective drug-CD and drug-aminoacid binary systems. Therefore, the ternary co-ground system with arginine and RameβCD appears as a very valuable product for the development of new more effective delivery systems of oxaprozin, with improved safety and bioavailability. Copyright © 2016 Elsevier B.V. All rights reserved.

  14. Randomized Controlled Trials of Technology-Based HIV/STI and Drug Abuse Preventive Interventions for African American and Hispanic Youth: Systematic Review.

    Science.gov (United States)

    Córdova, David; Mendoza Lua, Frania; Ovadje, Lauretta; Hong, Ethan; Castillo, Berenice; Salas-Wright, Christopher P

    2017-12-13

    HIV/sexually transmitted infections (STIs) and drug abuse remain significant public health concerns in the United States, and African American and Hispanic youth are disproportionately affected. Although technology-based interventions are efficacious in preventing and reducing HIV/STI and licit/illicit drug use behaviors, relatively little is known regarding the state of the science of these interventions among African American and Hispanic youth. The aim of this review is to identify and examine randomized controlled trials (RCTs) of technology-based HIV/STI and/or drug abuse preventive interventions for African American and Hispanic youth. We searched electronic databases (ie, PubMed, Proquest, PsycINFO, Ebscohost, Google Scholar) to identify studies between January 2006 and October 2016. RCTs of technology-based interventions targeting African American and Hispanic youth HIV/STI risk behaviors, including sexual risk, licit and illicit drug use, and HIV/STI testing were included. Our search revealed a total of three studies that used an RCT design and included samples comprised of >50% African American and/or Hispanic youth. The follow-up assessments ranged from two weeks to six months and the number of participants in each trial ranged from 72 to 141. The three interventions were theory-driven, interactive, and tailored. The long-term effects of the interventions were mixed, and outcomes included reductions in sex partners, licit drug use, and condomless anal sex acts. Although technology-based interventions seem promising in the prevention of HIV/STI and drug abuse among African American and Hispanic youth, more research is needed.

  15. Treatment Effect of Drug-Coated Balloons Is Durable to 3 Years in the Femoropopliteal Arteries: Long-Term Results of the IN.PACT SFA Randomized Trial.

    Science.gov (United States)

    Schneider, Peter A; Laird, John R; Tepe, Gunnar; Brodmann, Marianne; Zeller, Thomas; Scheinert, Dierk; Metzger, Christopher; Micari, Antonio; Sachar, Ravish; Jaff, Michael R; Wang, Hong; Hasenbank, Melissa S; Krishnan, Prakash

    2018-01-01

    Randomized controlled trials have reported favorable 1-year outcomes with drug-coated balloons (DCBs) for the treatment of symptomatic peripheral arterial disease when compared with standard percutaneous transluminal angioplasty (PTA). Evidence remains limited on the durability of the treatment effect with DCBs in the longer term. IN.PACT SFA is a single-blind, randomized trial (Randomized Trial of IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty [PTA] Balloon Catheter vs Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery [SFA] and/or Proximal Popliteal Artery [PPA]) that enrolled 331 patients with symptomatic (Rutherford 2-4) femoropopliteal lesions up to 18 cm in length. Patients were randomized 2:1 to receive treatment with DCB or PTA. The 36-month assessments included primary patency, freedom from clinically driven target lesion revascularization, major adverse events, and functional outcomes. At 36 months, primary patency remained significantly higher among patients treated with DCB compared with PTA (69.5% versus 45.1%; log rank PURL: http://www.clinicaltrials.gov. Unique identifiers: NCT01175850 for IN.PACT SFA phase I in the European Union and NCT01566461 for IN.PACT SFA phase II in the United States. © 2018 The Authors.

  16. Does Mandatory IFRS Adoption Improve the Information Environment?

    OpenAIRE

    Horton, Joanne; Serafeim, Georgios; Serafeim, Ioanna

    2012-01-01

    More than 120 countries require or permit the use of International Financial Reporting Standards (‘IFRS’) by publicly listed companies on the basis of higher information quality and accounting comparability from IFRS application. However, the empirical evidence about these presumed benefits are often conflicting and fail to separate between information quality and comparability. In this paper we examine the effect of mandatory IFRS adoption on firms’ information environment. We find that afte...

  17. [Cost]effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study

    Directory of Open Access Journals (Sweden)

    Mattace-Raso Francesco US

    2011-08-01

    Full Text Available Background Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. Methods/Design A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D, costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. Discussion The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. Trial Registration The trial is registered in the Netherlands Trial Register (NTR1593

  18. 75 FR 52528 - Mandatory Reliability Standards for the Bulk-Power System; Notice of Technical Conference

    Science.gov (United States)

    2010-08-26

    ... Energy Regulatory Commission Mandatory Reliability Standards for the Bulk-Power System; Notice of... ] 61,053 (2007). \\2\\ Mandatory Reliability Standards for the Bulk Power System, 130 FERC ] 61,218... a frequency response requirement.'' \\3\\ \\1\\ Mandatory Reliability Standards for the Bulk-Power...

  19. 75 FR 17331 - Public Hearings for the Mandatory Reporting Rule for Greenhouse Gases

    Science.gov (United States)

    2010-04-06

    ... 2060-AP99, AP88, AQ00 Public Hearings for the Mandatory Reporting Rule for Greenhouse Gases AGENCY... two public hearings to be held for proposed rules related to mandatory reporting of greenhouse gases... Mandatory Reporting of Greenhouse Gases rule, published on October 30, 2009 by requiring reporting of...

  20. Mandatory Participation in Occupational Pension Schemes in the Netherlands and Other Countries : An Update

    NARCIS (Netherlands)

    Chen, Damiaan; Beetsma, Roel

    2015-01-01

    This paper discusses mandatory participation in Dutch occupational pension schemes. While historically mandatory participation is a feature of most second-pillar pension arrangements, some recent developments may affect the case for mandatory participation. The main ones are the revision of the

  1. Mandatory participation in occupational pension schemes in the Netherlands and other countries

    NARCIS (Netherlands)

    Chen, D.H.J.; Beetsma, R.M.W.J.

    2014-01-01

    This paper discusses mandatory participation in Dutch occupational pension schemes. While mandatory participation is a historical feature of most second-pillar pension arrangements, some recent developments may affect the case for mandatory participation. The main ones are the revision of the Dutch

  2. 77 FR 745 - DoD Mandatory Declassification Review (MDR) Program; Correction

    Science.gov (United States)

    2012-01-06

    ... of the Secretary 32 CFR Part 222 DoD Mandatory Declassification Review (MDR) Program; Correction...-80747), Department of Defense published a final rule titled DoD Mandatory Declassification Review (MDR... Mandatory Declassification Review (MDR) Program. Subsequent to the publication of that final rule...

  3. Community Pharmacist Training-and-Communication Network and Drug-Related Problems in Patients With CKD: A Multicenter, Cluster-Randomized, Controlled Trial.

    Science.gov (United States)

    Lalonde, Lyne; Quintana-Bárcena, Patricia; Lord, Anne; Bell, Robert; Clément, Valérie; Daigneault, Anne-Marie; Legris, Marie-Ève; Letendre, Sara; Mouchbahani, Marie; Jouini, Ghaya; Azar, Joëlle; Martin, Élisabeth; Berbiche, Djamal; Beaulieu, Stephanie; Beaunoyer, Sébastien; Bertin, Émilie; Bouvrette, Marianne; Charbonneau-Séguin, Noémie; Desrochers, Jean-François; Desforges, Katherine; Dumoulin-Charette, Ariane; Dupuis, Sébastien; El Bouchikhi, Maryame; Forget, Roxanne; Guay, Marianne; Lemieux, Jean-Phillippe; Morin-Bélanger, Claudia; Noël, Isabelle; Ricard, Stephanie; Sauvé, Patricia; Ste-Marie Paradis, François

    2017-09-01

    Appropriate training for community pharmacists may improve the quality of medication use. Few studies have reported the impact of such programs on medication management for patients with chronic kidney disease (CKD). Multicenter, cluster-randomized, controlled trial. Patients with CKD stage 3a, 3b, or 4 from 6 CKD clinics (Quebec, Canada) and their community pharmacies. Each cluster (a pharmacy and its patients) was randomly assigned to either ProFiL, a training-and-communication network program, or the control group. ProFiL pharmacists completed a 90-minute interactive web-based training program on use of medications in CKD and received a clinical guide, patients' clinical summaries, and facilitated access to the CKD clinic. Drug-related problems (primary outcome), pharmacists' knowledge and clinical skills, and patients' clinical attributes (eg, blood pressure and glycated hemoglobin concentration). Drug-related problems were evaluated the year before and after the recruitment of patients using a validated set of significant drug-related problems, the Pharmacotherapy Assessment in Chronic Renal Disease (PAIR) criteria. Pharmacists' questionnaires were completed at baseline and after 1 year. Clinical attributes were documented at baseline and after 1 year using available information in medical charts. 207 community pharmacies, 494 pharmacists, and 442 patients with CKD participated. After 1 year, the mean number of drug-related problems per patient decreased from 2.16 to 1.60 and from 1.70 to 1.62 in the ProFiL and control groups, respectively. The difference in reduction of drug-related problems per patient between the ProFiL and control groups was -0.32 (95% CI, -0.63 to -0.01). Improvements in knowledge (difference, 4.5%; 95% CI, 1.6%-7.4%) and clinical competencies (difference, 7.4%; 95% CI, 3.5%-11.3%) were observed among ProFiL pharmacists. No significant differences in clinical attributes were observed across the groups. High proportion of missing data

  4. Comparison of 2 lumbar total disc replacements: results of a prospective, randomized, controlled, multicenter Food and Drug Administration trial with 24-month follow-up.

    Science.gov (United States)

    Guyer, Richard D; Pettine, Kenneth; Roh, Jeffrey S; Dimmig, Thomas A; Coric, Domagoj; McAfee, Paul C; Ohnmeiss, Donna D

    2014-05-20

    This was a prospective, randomized, controlled multicenter study with 24-month follow-up. The purpose of this study was to evaluate the safety and efficacy in a Food and Drug Administration Investigation Device Exemption of a new lumbar total disc replacement (TDR) by comparing it to an earlier TDR approved for sale. Randomized trials have reported TDR to produce results similar or superior to lumbar fusion. Results for various TDRs seem to be similar, but differences in study design and outcome measures pose challenges in definitively comparing devices. The purpose of this study was to perform a direct comparison of 2 lumbar TDRs in a prospective, randomized trial. TDR was performed in 457 patients from 21 sites (261 patients in the investigational group (Kineflex-L Disc; metal-on-metal design anchored with keels, 204 randomized and 57 nonrandomized training cases), and 196 in the control group (CHARITE artificial disc; metal with polyethylene core with teeth for anchoring; 190 randomized and 6 nonrandomized training cases). All patients were treated nonoperatively for single-level symptomatic disc degeneration for at least 6 months prior to surgery. Perioperative data were collected. Clinical outcome data were collected prospectively, as approved by the Food and Drug Administration, through 24-month follow-up. Primary outcome measures used were the Oswestry Disability Index, visual analogue scales assessing pain, patient satisfaction, and reoperations. Success was defined to be at least 15-point improvements in Oswestry Disability Index scores, no reoperation, and no major adverse events. Radiographical measures included range of motion, disc space height, and assessment for device migration, subsidence, and fusion at the TDR level. There were no significant differences between the groups when comparing operative time, blood loss, or length of hospital stay. Both groups improved significantly on Oswestry Disability Index and visual analogue scale scores (P < 0

  5. Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Boshuisen, Kim; Lamberink, Herm J; van Schooneveld, Monique Mj; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg; Geleijns, Karin; Uiterwaal, Cuno Spm; Braun, Kees Pj

    2015-10-26

    The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at the cost of long-term seizure outcome. Moreover, AED withdrawal seemed to improve cognitive outcome. A randomized trial is needed to confirm these findings. We hypothesized that early AED withdrawal in children is not only safe, but also beneficial with respect to cognitive functioning. This is a multi-center pragmatic randomized clinical trial to investigate whether early AED withdrawal improves cognitive function, in terms of attention, executive function and intelligence, quality of life and behavior, and to confirm safety in terms of eventual seizure freedom, seizure recurrences and "seizure and AED freedom." Patients will be randomly allocated in parallel groups (1:1) to either early or late AED withdrawal. Randomization will be concealed and stratified for preoperative IQ and medical center. In the early withdrawal arm reduction of AEDs will start 4 months after surgery, while in the late withdrawal arm reduction starts 12 months after surgery, with intended complete cessation of drugs after 12 and 20 months respectively. Cognitive outcome measurements will be performed preoperatively, and at 1 and 2 years following surgery, and consist of assessment of attention and executive functioning using the EpiTrack Junior test and intelligence expressed as IQ (Wechsler Intelligence Scales). Seizure outcomes will be assessed at 24 months after surgery, and at 20 months following start of AED reduction. We aim to randomize 180 patients who underwent anticipated curative epilepsy surgery below 16 years of age, were able to perform the EpiTrack Junior test preoperatively, and have no predictors of poor postoperative seizure prognosis (multifocal magnetic resonance imaging (MRI

  6. The Cedar Project WelTel mHealth intervention for HIV prevention in young Indigenous people who use illicit drugs: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Jongbloed, Kate; Friedman, Anton J; Pearce, Margo E; Van Der Kop, Mia L; Thomas, Vicky; Demerais, Lou; Pooyak, Sherri; Schechter, Martin T; Lester, Richard T; Spittal, Patricia M

    2016-03-09

    Despite successes in preventing and treating HIV, Indigenous people in Canada continue to face disproportionately high rates of HIV infection. Programs that support healing from lifetime trauma, support connection to culture, and reduce drug-related harms are critical to preventing HIV among young Indigenous people who use drugs. The Cedar Project WelTel mHealth intervention proposed here is a structured mobile-phone initiative to connect young Indigenous people who use drugs with Cedar Case Managers in a community-based setting. The intervention consists of a package of supports, including a mobile phone and cellular plan, weekly two-way text messaging, and support from Cedar Case Managers. The Cedar Project WelTel mHealth study is a multi-site Zelen pre-randomized trial to measure the effect of a two-way supportive text-message intervention to reduce HIV vulnerability among young Indigenous people who use illicit drugs in two Canadian cities. The trial is nested within the Cedar Project, an ongoing cohort study addressing HIV and hepatitis C vulnerability among young Indigenous people who use drugs in Vancouver and Prince George, British Columbia. The Cedar Project Partnership, an independent body of Indigenous Elders, leaders, and health/social service experts, governs all aspects of the study. Two hundred participants will be followed over a 16-month period, with HIV propensity score at 6 months as the primary outcome. Secondary outcomes include HIV propensity at 1 year, HIV risk, resilience, psychological distress, access to drug-related services, and connection to culture measured at 6 months and 1 year. Primary analysis is by intention to treat. Culturally safe interventions that address barriers to HIV prevention while supporting the strength of young Indigenous people who use drugs are urgently needed. Despite presenting a tremendous opportunity to connect young, highly transient Indigenous people who use drugs to prevention services, supportive two-way m

  7. Community Impact of Pharmacy-Randomized Intervention to Improve Access to Syringes and Services for Injection Drug Users

    Science.gov (United States)

    Crawford, Natalie D.; Amesty, Silvia; Rivera, Alexis V.; Harripersaud, Katherine; Turner, Alezandria; Fuller, Crystal M.

    2014-01-01

    Objectives: In an effort to reduce HIV transmission among injection drug users (IDUs), New York State deregulated pharmacy syringe sales in 2001 through the Expanded Syringe Access Program by removing the requirement of a prescription. With evidence suggesting pharmacists' ability to expand their public health role, a structural, pharmacy-based…

  8. HIV-1 Drug Resistance and Second-Line Treatment in Children Randomized to Switch at Low Versus Higher RNA Thresholds

    NARCIS (Netherlands)

    Harrison, L.; Melvin, A.; Fiscus, S.; Saidi, Y.; Nastouli, E.; Harper, L.; Compagnucci, A.; Babiker, A.; McKinney, R.; Gibb, D.; Tudor-Williams, G.; Burger, D.M.

    2015-01-01

    BACKGROUND: The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy (ART). Using PENPACT-1 data, we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold. METHODS: PENPACT-1 had a 2 x 2 factorial

  9. Effectiveness of the universal prevention program 'Healthy School and Drugs': Study protocol of a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Overbeek, G.J.; Kleinjan, M.; Vermulst, A.A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2010-01-01

    Background: Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a

  10. Effectiveness of the universal prevention program 'Healthy School and Drugs': study protocol of a randomized clustered trial

    NARCIS (Netherlands)

    Malmberg, M.; Overbeek, G.J.; Kleinjan, M.; Vermulst, A.; Monshouwer, K.; Lammers, J.; Vollebergh, W.A.M.; Engels, R.C.M.E.

    2010-01-01

    Background: Substance use is highly prevalent among Dutch adolescents. The Healthy School and Drugs program is a nationally implemented school-based prevention program aimed at reducing early and excessive substance use among adolescents. Although the program's effectiveness was tested in a

  11. Effect of anti-obesity drug on cardiovascular risk factors: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Zhou, Yu-Hao; Ma, Xiu-Qiang; Wu, Cheng; Lu, Jian; Zhang, Shan-Shan; Guo, Jia; Wu, Shun-Quan; Ye, Xiao-Fei; Xu, Jin-Fang; He, Jia

    2012-01-01

    Anti-obesity drugs are widely used to prevent the complications of obesity, however, the effects of anti-obesity drugs on cardiovascular risk factors are unclear at the present time. We carried out a comprehensively systematic review and meta-analysis to assess the effects of anti-obesity drugs on cardiovascular risk factors. We systematically searched Medline, EmBase, the Cochrane Central Register of Controlled Trials, reference lists of articles and proceedings of major meetings for relevant literatures. We included randomized placebo-controlled trials that reported the effects of anti-obesity drugs on cardiovascular risk factors compared to placebo. Overall, orlistat produced a reduction of 2.39 kg (95%CI-3.34 to -1.45) for weight, a reduction of 0.27 mmol/L (95%CI: -0.36 to -0.17) for total cholesterol, a reduction of 0.21 mmol/L (95%CI: -0.30 to -0.12) for LDL, a reduction of 0.12 mmol/L (95%CI: -0.20 to -0.04) for fasting glucose, 1.85 mmHg reduction (95%CI: -3.30 to -0.40) for SBP, and a reduction of 1.49 mmHg (95%CI: -2.39 to -0.58) for DBP. Sibutramine only showed effects on weight loss and triglycerides reduction with statistical significances. Rimonabant was associated with statistically significant effects on weight loss, SBP reduction and DBP reduction. No other significantly different effects were identified between anti-obesity therapy and placebo. We identified that anti-obesity therapy was associated with a decrease of weight regardless of the type of the drug. Orlistat and rimonabant could lead to an improvement on cardiovascular risk factors. However, Sibutramine may have a direct effect on cardiovascular risk factors.

  12. A Peer-Educator Network HIV Prevention Intervention Among Injection Drug Users: Results of a Randomized Controlled Trial in St. Petersburg, Russia

    Science.gov (United States)

    Latkin, Carl A.; Kukhareva, Polina V.; Malov, Sergey V.; Batluk, Julia V.; Shaboltas, Alla V.; Skochilov, Roman V.; Sokolov, Nicolay V.; Verevochkin, Sergei V.; Hudgens, Michael G.; Kozlov, Andrei P.

    2014-01-01

    We evaluated the efficacy of a peer-educator network intervention as a strategy to reduce HIV acquisition among injection drug users (IDUs) and their drug and/or sexual networks. A randomized controlled trial was conducted in St. Petersburg, Russia among IDU index participants and their risk network participants. Network units were randomized to the control or experimental intervention. Only the experimental index participants received training sessions to communicate risk reduction techniques to their network members. Analysis includes 76 index and 84 network participants who were HIV uninfected. The main outcome measure was HIV sero-conversion. The incidence rates in the control and experimental groups were 19.57 (95 % CI 10.74–35.65) and 7.76 (95 % CI 3.51–17.19) cases per 100 p/y, respectively. The IRR was 0.41 (95 % CI 0.15–1.08) without a statistically significant difference between the two groups (log rank test statistic X2 = 2.73, permutation p value = 0.16). Retention rate was 67 % with a third of the loss due to incarceration or death. The results show a promising trend that this strategy would be successful in reducing the acquisition of HIV among IDUs. PMID:23881187

  13. Randomized Clinical Trial of Periarticular Drug Injection used in combination Patient-Controlled Analgesia versus Patient-Controlled Analgesia Alone in Total Knee Arthroplasty

    Directory of Open Access Journals (Sweden)

    MN Sabran

    2008-11-01

    Full Text Available This is a prospective randomized clinical trial to compare use of a combination of periarticular drug injection with patient- controlled analgesia (PCA to PCA alone in post-total knee arthroplasty (TKA. Thirty patients who were admitted for unilateral total knee arthroplasty were selected randomly into an Injection group or a Standard group. The periarticular injection contained Ropivacaine, Ketorolac and Adrenaline, given intra-operatively. The mean amount of opioid used was 22.87 mmol/L in the Injection group as compared to 39.78 mmol/L in the Standard group (p = 0.026. The Injection group had lower pain score at rest and during exercise (p=0.021, p=0.041, respectively, as well as better return to function (p=0.026 and shorter hospital stay (6.1 days, Injection; 7.5 days, Standard, p=0.027. Overall, the group receiving periarticular drugs injection had less pain, less narcotic usage, earlier return to function, similar experience of adverse effects and shorter hospital stays.

  14. Effectiveness of the Strengthening Families Programme 10–14 in Poland for the prevention of alcohol and drug misuse: protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Okulicz-Kozaryn Katarzyna

    2012-06-01

    Full Text Available Abstract Background Alcohol and other drug use and misuse is a significant problem amongst Polish youth. The SFP10-14 is a family-based prevention intervention that has positive results in US trials, but questions remain about the generalizability of these results to other countries and settings. Methods/Design A cluster randomized controlled trial in community settings across Poland. Communities will be randomized to a SFP10-14 trial arm or to a control arm. Recruitment and consent of families, and delivery of the SFP10-14, will be undertaken by community workers. The primary outcomes are alcohol and other drug use and misuse. Secondary (or intermediate outcomes include parenting practices, parent–child relations, and child problem behaviour. Interview-based questionnaires will be administered at baseline, 12 and 24 months. Discussion The trial will provide information about the effectiveness of the SFP10-14 in Poland. Trial registration International Standard Randomised Controlled Trial Number: ISRCTN89673828

  15. Reducing risky relationships: a multisite randomized trial of a prison-based intervention for reducing HIV sexual risk behaviors among women with a history of drug use.

    Science.gov (United States)

    Knudsen, Hannah K; Staton-Tindall, Michele; Oser, Carrie B; Havens, Jennifer R; Leukefeld, Carl G

    2014-01-01

    Women involved in the criminal justice system, particularly those with a history of drug use, are at elevated risk of HIV infection, yet few HIV prevention interventions have been tailored for delivery to incarcerated women. Drawing on the Relational Model, the Reducing Risky Relationships for HIV (RRR-HIV) intervention was developed and evaluated in a multisite randomized clinical trial. Women with weekly drug use prior to incarceration (n = 444) who were incarcerated within correctional institutions in four states were randomized to (1) the RRR-HIV intervention consisting of an HIV educational video, five group sessions, and one postrelease booster session or (2) a control condition consisting of the HIV educational video. The RRR-HIV intervention combined didactic and interactive content regarding seven "thinking myths" about intimate relationships that may result in decisions to engage in risky sexual behaviors. Data were collected while women were still incarcerated and approximately 90 days following release from prison by trained interviewers. A negative binomial regression (NBR) model of unprotected sexual behaviors at the 90-day follow-up indicated that RRR-HIV participants reported fewer unprotected sexual behaviors than women in the control condition once the analysis was adjusted for study site. Future studies should examine the sustainability of the RRR-HIV intervention's effect on risk reduction. Implementation research is needed to determine whether delivery of this intervention by correctional staff or peers, rather than research staff, yields similar reductions in unprotected sexual behaviors.

  16. Mandatory and Self-citation; Types, Reasons, Their Benefits and Disadvantages.

    Science.gov (United States)

    Hemmat Esfe, Mohammad; Wongwises, Somchai; Asadi, Amin; Karimipour, Arash; Akbari, Mohammad

    2015-12-01

    This paper defines and discusses two important types of citations, self-citation and mandatory citation, in engineering journals. Citation can be classified in three categories: optional; semi-mandatory; and mandatory. There are some negative and positive impacts for the authors' paper and journals' reputation if mandatory citation of a paper or set of papers is requested. These effects can be different based on the recommended papers for citing in the new research. Mandatory citation has various types discussed in this paper. Self-citation and its reasons and impacts are also discussed in the present study.

  17. Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial.

    Science.gov (United States)

    Arnaud, Nicolas; Bröning, Sonja; Drechsel, Magdalena; Thomasius, Rainer; Baldus, Christiane

    2012-09-26

    Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT) study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400) or an assessment only control group (N = 400) depending on their screening for risky substance use (using the CRAFFT). Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent-child relationship. The trial is expected to contribute to the growing literature on theory- and web-based brief interventions for adolescents. We will explore the potential of using web

  18. Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Arnaud Nicolas

    2012-09-01

    Full Text Available Abstract Background Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period. While the detrimental long- and short-term effects of problematic consumption patterns in adolescence pose a major public health concern, current prevention programs targeting alcohol- and other substance-using adolescents are scarce. The study described in this protocol will test the effectiveness of a web-based brief intervention aimed at reducing problematic alcohol use and promoting abstinence from illegal drugs in adolescents with risky substance use aged 16 to 18 years old in four EU-countries. Methods/design To determine the effectiveness of our web-BI, we apply a two-arm randomized controlled trial (RCT study design, with baseline assessment at study entry and a three month follow-up assessment. Adolescents aged 16 to 18 years from Belgium, the Czech Republic, Germany, and Sweden will be randomly assigned to either the fully electronically delivered brief intervention group (N = 400 or an assessment only control group (N = 400 depending on their screening for risky substance use (using the CRAFFT. Recruitment, informed consent, randomization, intervention and follow-up will be implemented online. Primary outcomes are reductions in frequency and quantity of use of alcohol and drugs other than alcohol over a 30 day period, as well as consumption per typical occasion. Secondary outcomes concern changes in substance use related cognitions including the constructs of the Theory of Planned Behaviour, implementation intentions, and stages of change. Moreover the study addresses a number of moderator variables, including age of first use, general psychopathology and quality of parent–child relationship. Discussion The trial is expected to contribute to the growing literature on theory- and web-based brief interventions

  19. Comparative Effectiveness of Acupuncture and Antiarrhythmic Drugs for the Prevention of Cardiac Arrhythmias: A Systematic Review and Meta-analysis of Randomized Controlled Trials

    Directory of Open Access Journals (Sweden)

    Yanda Li

    2017-06-01

    Full Text Available Introduction and Objectives: This study was designed to systematically evaluate the effectiveness of acupuncture treatment for arrhythmia compared to existing drug therapy.Methods: Randomized controlled trials (RCTs were identified through searches of the MEDLINE, CNKI, Embase, and Cochrane databases (1970 through 2016 and hand searches of cross-references from original articles and reviews. Clinical trials that randomized arrhythmia patients to acupuncture therapy vs. conventional drugs, sham acupuncture, or bed rest were included for analysis.Results: A total of 13 trials with 797 patients met the criteria for analysis. The results of the meta-analysis showed no statistically significant difference between acupuncture and conventional treatment for paroxysmal supraventricular tachycardia (PSVT (n = 203; RR, 1.18; 95% CI 0.78–1.79; I2 = 80%; P = 0.44. However, in the ventricular premature beat (VPB group, it showed a significant benefit of acupuncture plus oral administration of anti-arrhythmic drug (AAD on response rates compared with the oral administration of AAD (n = 286; RR, 1.15; 95% CI 1.05–1.27; I2 = 0%; P = 0.002. Finally, when compared with the sinus tachycardia (ST cases without any treatment, acupuncture has benefited these patients (n = 120; MD, 18.80, 95% CI 12.68–24.92; I2 = 81%; P < 0.00001.Conclusions: In summary, our meta-analysis demonstrates that clinical efficacy of acupuncture is not less than AAD for PSVT. Furthermore, in sub-group analysis, acupuncture with or without AAD, shows a clear benefit in treating VPB and ST. However, more definitive RCTs are warranted to guide clinical practice.

  20. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH).

    Science.gov (United States)

    Kuck, K H; Cappato, R; Siebels, J; Rüppel, R

    2000-08-15

    We conducted a prospective, multicenter, randomized comparison of implantable cardioverter-defibrillator (ICD) versus antiarrhythmic drug therapy in survivors of cardiac arrest secondary to documented ventricular arrhythmias. From 1987, eligible patients were randomized to an ICD, amiodarone, propafenone, or metoprolol (ICD versus antiarrhythmic agents randomization ratio 1:3). Assignment to propafenone was discontinued in March 1992, after an interim analysis conducted in 58 patients showed a 61% higher all-cause mortality rate than in 61 ICD patients during a follow-up of 11.3 months. The study continued to recruit 288 patients in the remaining 3 study groups; of these, 99 were assigned to ICDs, 92 to amiodarone, and 97 to metoprolol. The primary end point was all-cause mortality. The study was terminated in March 1998, when all patients had concluded a minimum 2-year follow-up. Over a mean follow-up of 57+/-34 months, the crude death rates were 36.4% (95% CI 26.9% to 46.6%) in the ICD and 44.4% (95% CI 37.2% to 51.8%) in the amiodarone/metoprolol arm. Overall survival was higher, though not significantly, in patients assigned to ICD than in those assigned to drug therapy (1-sided P=0.081, hazard ratio 0.766, [97.5% CI upper bound 1.112]). In ICD patients, the percent reductions in all-cause mortality were 41.9%, 39.3%, 28. 4%, 27.7%, 22.8%, 11.4%, 9.1%, 10.6%, and 24.7% at years 1 to 9 of follow-up. During long-term follow-up of cardiac arrest survivors, therapy with an ICD is associated with a 23% (nonsignificant) reduction of all-cause mortality rates when compared with treatment with amiodarone/metoprolol. The benefit of ICD therapy is more evident during the first 5 years after the index event.

  1. Adding ofloxacin to standard triple-drug regimens increased the Helicobacter pylori eradication rate: Data from randomized clinical trial

    OpenAIRE

    Sadeghi-Hadad-Zavareh, Mahmoud; Mohammadi, Seyyedsaeid; Hajiahmadi, Mahmoud; Javanian, Mostafa; Habibian, Masoomeh

    2017-01-01

    Background: The rate of Helicobacter pylori (H.pylori) eradication in dyspeptic patients using bismuth- based triple therapy is low due to bacterial that are resistant to antibiotics. The results of recent studies regarding levofloxacin have been encouraging, but the high cost of treatment prevents its routine administration. We, therefore, performed the present double-blind clinical trial to compare the efficiency of quadruple-drug regimen containing ofloxacin, clarithromycin, amoxicillin, a...

  2. Neurological adverse events of new generation sodium blocker antiepileptic drugs. Meta-analysis of randomized, double-blinded studies with eslicarbazepine acetate, lacosamide and oxcarbazepine.

    Science.gov (United States)

    Zaccara, Gaetano; Giovannelli, Fabio; Maratea, Dario; Fadda, Valeria; Verrotti, Alberto

    2013-09-01

    Analysis of overall tolerability and neurological adverse effects (AEs) of eslicarbazepine acetate (ESL), lacosamide (LCM) and oxcarbazepine (OXC) from double-blind, placebo-controlled trials. Indirect comparisons of patients withdrawing because of AEs, and the incidence of some vestibulocerebellar AEs between these three antiepileptic dugs (AEDs). We searched MEDLINE for all randomized, double-blind, placebo-controlled trials investigating therapeutic effects of fixed oral doses of ESL, LCM and OXC in patients with drug resistant epilepsy. Withdrawal rate due to AEs, percentages of patients with serious AEs, and the proportion of patients experiencing any neurological AE, nausea and vomiting were assessed for their association with the experimental drug. Analyses were performed between recommended daily doses of each AED according to the approved summary of product characteristics (SPC). Risk differences were used to evaluate the association of any AE [99% confidence intervals (CIs)] or study withdrawals because of AEs (95% CIs) with the experimental drug. Indirect comparisons between withdrawal rate and AEs dizziness, coordination abnormal/ataxia and diplopia were estimated according to network meta-analysis (Net-MA). Eight randomized, placebo-controlled, double-blind trials (4 with ESL, 3 with LCM, and 1 with OXC) were included in our analysis. At high doses (OXC 1200mg, ESL 1200mg and LCM 400mg) there was an increased risk of AE-related study withdrawals compared to placebo for all drugs. Several AEs were associated with the experimental drug. Both number and frequency of AEs were dose-related. At high recommended doses, patients treated with OXC withdrew from the experimental treatment significantly more frequently than patients treated with ESL and LCM. Furthermore, the AEs coordination abnormal/ataxia and diplopia were significantly more frequently observed in patients treated with OXC compared to patients treated with LCM and ESL. The overall tolerability

  3. Efficacy of Immunobiologic and Small Molecule Inhibitor Drugs for Psoriasis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

    Science.gov (United States)

    de Carvalho, André Vicente Esteves; Duquia, Rodrigo Pereira; Horta, Bernardo Lessa; Bonamigo, Renan Rangel

    2017-03-01

    Psoriasis is an immune-mediated inflammatory disease for which treatment has evolved over the past few years due to the introduction of immunobiologic and small molecule inhibitor medications. A better understanding of the comparative efficacies of drugs may help doctors to choose the most appropriate treatment for patients. The aim of this study was to conduct a systematic review and meta-analysis to assess the efficacy of immunobiologic and small molecule inhibitor drugs for patients with moderate to severe psoriasis. The EMBASE, PUBMED, LILACS, Web of Science and ClinicalTrials.org databases were searched for trials published to 21 July 2016. Only randomized, double-blind, placebo-controlled clinical trials that evaluated the efficacy of immunobiologics or small molecule inhibitors for moderate to severe plaque-type psoriasis were selected by two independent authors. No restrictions were used. Two authors independently extracted the data and a random-effects model meta-analysis was performed. The Psoriasis Area and Severity Index (PASI) 75 was considered the primary outcome, measured at the primary endpoint of each study. Thirty-eight studies were included in our analysis. The overall pooled effect favored biologics and small molecule inhibitors over placebo (risk difference [RD] 0.59, 95% confidence interval [CI] 0.58-0.60). Ixekizumab at a dose of 160 mg on week 0 and then every 2 weeks (RD 0.84, 95% CI 0.81-0.88), brodalumab 210 mg (RD 0.79, 95% CI 0.76-0.82), infliximab 5 mg/kg (RD 0.76, 95% CI 0.73-0.79), and secukinumab 300 mg (RD 0.76, 95% CI 0.71-0.81) showed a greater chance of response (PASI 75) when compared with placebo. The methodology of a traditional meta-analysis does not allow for drugs to be ranked. Included studies used short-term endpoints (10-16 weeks) to evaluate the primary outcome, therefore long-term efficacy could not be determined. The anti-IL-17 drugs brodalumab, ixekizumab and secukinumab showed an equal or greater chance of

  4. [Systematic review on methodology of randomized controlled trials of post-marketing Chinese patent drugs for treatment of type 2 diabetes].

    Science.gov (United States)

    Ma, Li-xin; Wang, Yu-yi; Li, Xin-xue; Liu, Jian-ping

    2012-03-01

    Randomized controlled trial (RCT) is considered as the gold standard for the efficacy assessment of medicines. With the increasing number of Chinese patent drugs for treatment of type 2 diabetes, the methodology of post-marketing RCTs evaluating the efficacy and specific effect has become more important. To investigate post-marketing Chinese patent drugs for treatment of type 2 diabetes, as well as the methodological quality of post-marketing RCTs. Literature was searched from the books of Newly Compiled Traditional Chinese Patent Medicine and Chinese Pharmacopeia, the websites of the State Food and Drug Administration and the Ministry of Human Resources and Social Security of the People's Republic of China, China National Knowledge Infrastructure Database, Chongqing VIP Chinese Science and Technology Periodical Database, Chinese Biomedical Database (SinoMed) and Wanfang Data. The time period for searching ran from the commencement of each database to August 2011. RCTs of post-marketing Chinese patent drugs for treatment of type 2 diabetes with intervention course no less than 3 months. Two authors independently evaluated the research quality of the RCTs by the checklist of risk bias assessment and the data collection forms based on the CONSORT Statement. Independent double data-extraction was performed. The authors identified a total of 149 Chinese patent drugs for treatment of type 2 diabetes. According to different indicative syndromes, the Chinese patent drugs can be divided into the following types, namely, yin deficiency and interior heat (n=48, 32%), dual deficiency of qi and yin (n=58, 39%) and dual deficiency of qi and yin combined with blood stasis (n=22, 15%). A total of 41 RCTs meeting the inclusion criteria were included. Neither multicenter RCTs nor endpoint outcome reports were found. Risk bias analysis showed that 81% of the included studies reported randomization for grouping without sequence generation, 98% of these studies did not report

  5. Pooled analysis of two randomized trials comparing titanium-nitride-oxide-coated stent versus drug-eluting stent in STEMI.

    Science.gov (United States)

    Tuomainen, Petri O; Sia, Jussi; Nammas, Wail; Niemelä, Matti; Airaksinen, Juhani K E; Biancari, Fausto; Karjalainen, Pasi P

    2014-07-01

    We performed a pooled analysis based on patient-level data from the TITAX-AMI and BASE-ACS trials to evaluate the outcome of titanium-nitride-oxide-coated bioactive stents vs drug-eluting stents in patients with ST-segment elevation myocardial infarction at 2-year follow-up. The TITAX-AMI trial compared bioactive stents with paclitaxel-eluting stents in 425 patients with acute myocardial infarction. The BASE-ACS trial compared bioactive stents with everolimus-eluting stents in 827 patients with acute coronary syndrome. The primary endpoint for the pooled analysis was major adverse cardiac events: a composite of cardiac death, recurrent myocardial infarction, or ischemia-driven target lesion revascularization at 2-year follow-up. The pooled analysis included 501 patients; 245 received bioactive stents, and 256 received drug-eluting stents. The pooled bioactive stent group was associated with a risk ratio of 0.85 for major adverse cardiac events (95% confidence interval, 0.53-1.35; P=.49) compared to the pooled drug-eluting stent group. Similarly, the pooled bioactive stent group was associated with a risk ratio of 0.71 for cardiac death (95% confidence interval, 0.26-1.95; P=.51), 0.44 for recurrent myocardial infarction (95% confidence interval, 0.20-0.97; P=.04), and 1.39 for ischemia-driven target lesion revascularization (95% confidence interval, 0.74-2.59; P=.30), compared to the pooled drug-eluting stent group. These results were confirmed by propensity-score adjusted analysis of the combined datasets. In patients with ST-segment elevation myocardial infarction, bioactive stents were associated with lower rates of recurrent myocardial infarction compared to drug-eluting stents at 2-year follow-up; yet, the rates of cardiac death and ischemia-driven target lesion revascularization were similar. Copyright © 2014 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

  6. Mandatory ECG screening of athletes: is this question now resolved?

    Science.gov (United States)

    Shephard, Roy J

    2011-12-01

    European and North American cardiologists have long debated the need for mandatory ECG screening of athletes in order to prevent sudden cardiac death. European investigators have recently adduced new evidence, which they believe supports the need for such screening. They note a decrease of sudden cardiac deaths among Italian athletes following the introduction of mandatory screening in that country, clearer definitions of resting ECG abnormalities in athletes, new and more encouraging calculations of cost/benefit ratios and direct comparisons of clinical examination alone against clinical examination plus ECG screening. Nevertheless, it seems that critical criteria for the success of any screening procedure (a substantial prevalence of the problem, coupled with an adequate test sensitivity and specificity) have yet to be satisfied. Very few athletes are liable to sudden cardiac death, only a few of those who are vulnerable will be identified by ECG screening, and even if all potential cases could be detected, restriction of their physical activity would be unlikely to have a major influence on their prognosis. At the same time, a requirement of mandatory testing would discourage engagement in physical activity, and would impose substantial direct costs on the community. Moreover, the large number of false positive test results could have important and undesirable consequences for both indirect medical costs and the overall health of competitors. ECG screening might become more effective if it could be focused on a smaller sub-group of vulnerable athletes, or if the problem of false positive tests could be addressed through an increase of test specificity. However, on the basis of current information, it would seem better to direct efforts in preventive medicine to more common causes of premature death in the young adult.

  7. Mandatory communication training of all employees with patient contact

    DEFF Research Database (Denmark)

    Ammentorp, Jette; Graugaard, Lars Toke; engelbrecht lau, marianne

    2014-01-01

    In 2010 a communication program that included mandatory communication skills training for all employees with patient contact was developed and launched at a large regional hospital in Denmark. OBJECTIVE: We describe the communication program, the implementation process, and the initial assessment...... assessment based on feedback from the departments will be presented. RESULTS: The elements of the communication program are as follows: (1) education of trainers; (2) courses for health professionals employed in clinical departments; (3) education of new staff; (4) courses for health professionals in service...

  8. Welfare Effects of Mandatory Traceability When Firms are Heterogeneous

    OpenAIRE

    Pouliot, Sebastien

    2010-01-01

    We develop a framework in which the cost of producing a quantity food and the cost of food safety differs across firms. We show that large firms may supply the safest food even though small firms have a cost advantage in producing safe food. The model shows that mandatory traceability can decrease the overall safety of food when small firms that supply the safest food exit the industry. Our model applies to food safety but can be applied to a wide range of issues related to regulation and pro...

  9. Ethical complexities in standard of care randomized trials: A case study of morning versus nighttime dosing of blood pressure drugs.

    Science.gov (United States)

    Kim, Scott Y H; Miller, Franklin G

    2015-12-01

    Pragmatic trials comparing "standard of care" treatments provide comparative effectiveness data to make practice of medicine more evidence-based. With electronic health records, recruiting and conducting such trials can be relatively inexpensive. But some worry that the traditional research ethics framework poses unnecessary obstacles and is not appropriate for evaluating such clinical trials. This concern is based on the view (which we call the "Standard of Care Principle") that such research is similar to usual clinical practice and therefore does not raise significant ethical issues since everyone in the research study will receive an accepted standard of care treatment. A case study of a pragmatic randomized clinical trial (Blood Pressure Medication Timing study) comparing morning versus nighttime dosing of antihypertensive medications. The Blood Pressure Medication Timing study has been proposed as a paradigm example of why the Standard of Care Principle obviates the need for traditional levels of ethical scrutiny and how the current regulatory framework poses unnecessary obstacles to research. We provide an ethical analysis of the Blood Pressure Medication Timing study, drawing on the empirical literature as well as on normative analysis. The Standard of Care Principle is the main ethical rationale given by commentators for asserting that the Blood Pressure Medication Timing study does not require "significant ethical debate" and by investigators for the assertion that the Blood Pressure Medication Timing study is minimal risk and thus eligible for lessened regulatory requirements. However, the Blood Pressure Medication Timing study raises important ethical issues, including whether it is even necessary, given the considerable randomized clinical trial evidence in support of nighttime dosing, a much larger (N≈17,000) confirmatory randomized clinical trial already in progress, evidence for safety of nighttime dosing, and the cost-free availability of the

  10. Clinical efficacy of nebulized drugs

    DEFF Research Database (Denmark)

    Bisgaard, Hans

    1994-01-01

    There is a mandatory need for effortless drug administration to young children since the prevalence among them of recurrent wheezing is a 15-20%. It is becoming increasingly evident that many of these children respond dramatically well to beta2-agonists and topical steroids; accordingly this sub...

  11. Generic-reference and generic-generic bioequivalence of forty-two, randomly-selected, on-market generic products of fourteen immediate-release oral drugs.

    Science.gov (United States)

    Hammami, Muhammad M; De Padua, Sophia J S; Hussein, Rajaa; Al Gaai, Eman; Khodr, Nesrine A; Al-Swayeh, Reem; Alvi, Syed N; Binhashim, Nada

    2017-12-08

    The extents of generic-reference and generic-generic average bioequivalence and intra-subject variation of on-market drug products have not been prospectively studied on a large scale. We assessed bioequivalence of 42 generic products of 14 immediate-release oral drugs with the highest number of generic products on the Saudi market. We conducted 14 four-sequence, randomized, crossover studies on the reference and three randomly-selected generic products of amlodipine, amoxicillin, atenolol, cephalexin, ciprofloxacin, clarithromycin, diclofenac, ibuprofen, fluconazole, metformin, metronidazole, paracetamol, omeprazole, and ranitidine. Geometric mean ratios of maximum concentration (Cmax) and area-under-the-concentration-time-curve, to last measured concentration (AUCT), extrapolated to infinity (AUCI), or truncated to Cmax time of reference product (AUCReftmax) were calculated using non-compartmental method and their 90% confidence intervals (CI) were compared to the 80.00%-125.00% bioequivalence range. Percentages of individual ratios falling outside the ±25% range were also determined. Mean (SD) age and body-mass-index of 700 healthy volunteers (28-80/study) were 32.2 (6.2) years and 24.4 (3.2) kg/m2, respectively. In 42 generic-reference comparisons, 100% of AUCT and AUCI CIs showed bioequivalence, 9.5% of Cmax CIs barely failed to show bioequivalence, and 66.7% of AUCReftmax CIs failed to show bioequivalence/showed bioinequivalence. Adjusting for 6 comparisons, 2.4% of AUCT and AUCI CIs and 21.4% of Cmax CIs failed to show bioequivalence. In 42 generic-generic comparisons, 2.4% of AUCT, AUCI, and Cmax CIs failed to show bioequivalence, and 66.7% of AUCReftmax CIs failed to show bioequivalence/showed bioinequivalence. Adjusting for 6 comparisons, 2.4% of AUCT and AUCI CIs and 14.3% of Cmax CIs failed to show bioequivalence. Average geometric mean ratio deviation from 100% was ≤3.2 and ≤5.4 percentage points for AUCI and Cmax, respectively, in both generic

  12. Double-Blind Prospective Randomized Controlled Trial of Dopamine Versus Epinephrine as First-Line Vasoactive Drugs in Pediatric Septic Shock.

    Science.gov (United States)

    Ventura, Andréa M C; Shieh, Huei Hsin; Bousso, Albert; Góes, Patrícia F; de Cássia F O Fernandes, Iracema; de Souza, Daniela C; Paulo, Rodrigo Locatelli Pedro; Chagas, Fabiana; Gilio, Alfredo E

    2015-11-01

    The primary outcome was to compare the effects of dopamine or epinephrine in severe sepsis on 28-day mortality; secondary outcomes were the rate of healthcare-associated infection, the need for other vasoactive drugs, and the multiple organ dysfunction score. Double-blind, prospective, randomized controlled trial from February 1, 2009, to July 31, 2013. PICU, Hospital Universitário da Universidade de São Paulo, Brazil. Consecutive children who are 1 month to 15 years old and met the clinical criteria for fluid-refractory septic shock. Exclusions were receiving vasoactive drug(s) prior to hospital admission, having known cardiac disease, having already participated in the trial during the same hospital stay, refusing to participate, or having do-not-resuscitate orders. Patients were randomly assigned to receive either dopamine (5-10 μg/kg/min) or epinephrine (0.1-0.3 μg/kg/min) through a peripheral or intraosseous line. Patients not reaching predefined stabilization criteria after the maximum dose were classified as treatment failure, at which point the attending physician gradually stopped the study drug and started another catecholamine. Physiologic and laboratory data were recorded. Baseline characteristics were described as proportions and mean (± SD) and compared using appropriate statistical tests. Multiple regression analysis was performed, and statistical significance was defined as a p value of less than 0.05. Baseline characteristics and therapeutic interventions for the 120 children enrolled (63, dopamine; 57, epinephrine) were similar. There were 17 deaths (14.2%): 13 (20.6%) in the dopamine group and four (7%) in the epinephrine group (p=0.033). Dopamine was associated with death (odds ratio, 6.5; 95% CI, 1.1-37.8; p=0.037) and healthcare-associated infection (odds ratio, 67.7; 95% CI, 5.0-910.8; p=0.001). The use of epinephrine was associated with a survival odds ratio of 6.49. Dopamine was associated with an increased risk of death and healthcare

  13. A systematic review of mandatory influenza vaccination in healthcare personnel.

    Science.gov (United States)

    Pitts, Samantha I; Maruthur, Nisa M; Millar, Kathryn R; Perl, Trish M; Segal, Jodi

    2014-09-01

    Influenza is a major cause of patient morbidity. Mandatory influenza vaccination of healthcare personnel (HCP) is increasingly common yet has uncertain clinical impact. This study systematically examines published evidence of the benefits and harm of influenza vaccine mandates. MEDLINE, Embase, the Cochrane Library, Cumulative Index to Nursing and Allied Health Literature, Science Citation Index Expanded, and Conference Proceedings Citations Index were searched and analyzed in 2013. Studies must have assessed the effect of a requirement of influenza vaccination among HCP for continued employment or clinical practice. Studies were not limited by comparison group, outcome, language, or study design. Two reviewers independently abstracted data and assessed bias risk. Twelve observational studies were included in the study from 778 citations. Following implementation of a vaccine mandate, vaccination rates increased in all eight studies reporting this outcome, exceeding 94%. Three studies documented increased vaccination rates in hospitals with mandates compared to those without (pvaccine mandate increases vaccination rates, but evidence on clinical outcomes is lacking. Although challenging, large healthcare employers planning to implement a mandate should develop a strategy to evaluate HCP and patient outcomes. Further studies documenting the impact of HCP influenza vaccination on clinical outcomes would inform decisions on the use of mandatory vaccine policies in HCP. Copyright © 2014 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  14. Antibacterial activity of chensinin-1b, a peptide with a random coil conformation, against multiple-drug-resistant Pseudomonas aeruginosa.

    Science.gov (United States)

    Shang, Dejing; Meng, Xin; Zhang, Dongdong; Kou, Zhiru

    2017-11-01

    Nosocomial infections caused by Pseudomonas aeruginosa are difficult to treat due to the low permeability of its outer membrane as well as to its remarkable ability to acquire further resistance to antibiotics. Chensinin-1b exhibited antibacterial activity against the tested multiple-drug-resistant bacteria with a MIC ranging between 1.56 and 50μM, except E. cloacae strain 0320 (MREC0320), P. fluorescens strain 0322 (MRPF0322) and E. aerogenes strain 0320 (MREA0320). However, the MIC (25μM) of chensinin-1b to multiple-drug-resistant P. aeruginosa strain (MRPA 0108) was 16-fold higher than that observed to P. aeruginosa susceptible strain CGMCC 1.860 (PA1860). Chensinin-1b was able to disturb the integration of the cytoplasmic membrane of PA1860 and MRPA0108 cells similarly, but the outer membrane permeability of MRPA0108 cells was significantly lower. This low permeability was associated with increased expression of lipopolysaccharide (LPS) in the outer membrane and a decrease in negatively charged phospholipids in the outer membrane leaflet. In addition, the biofilm of MRPA0108 was responsible for the reduced susceptibility to chensinin-1b. A higher concentration of chensinin-1b (12.5µM) was required to maximally inhibit the formation of MRPA0108 biofilm. Notably, chensinin-1b inhibited the formation of MRPA0108 biofilm at concentrations below its MIC value by down-regulating the level of PelA, algD, and PslA gene transcription. Importantly, chensinin-1b had a significant antibacterial effect against MRPA0108 in vivo. Administration of chensinin-1b to mice infected with MRPA 0108 significantly increased survival by 50-70%. Moreover, chensinin-1b reduced the production of pro-inflammatory mediators and correspondingly reduced lung and liver tissue damage in the mouse model of septic shock induced by MRPA 0108. Collectively, these results suggest that chensinin-1b could be an effective antibiotic against multiple-drug-resistant bacterial strains. Copyright

  15. How to improve drug dosing for patients with renal impairment in primary care - a cluster-randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Erler Antje

    2012-09-01

    Full Text Available Abstract Background Patients with chronic kidney disease (CKD are at increased risk for inappropriate or potentially harmful prescribing. The aim of this study was to examine whether a multifaceted intervention including the use of a software programme for the estimation of creatinine clearance and recommendation of individual dosage requirements may improve correct dosage adjustment of relevant medications for patients with CKD in primary care. Methods A cluster-randomized controlled trial was conducted between January and December 2007 in small primary care practices in Germany. Practices were randomly allocated to intervention or control groups. In each practice, we included patients with known CKD and elderly patients (≥70 years suffering from hypertension. The practices in the intervention group received interactive training and were provided a software programme to assist with individual dose adjustment. The control group performed usual care. Data were collected at baseline and at 6 months. The outcome measures, analyzed across individual patients, included prescriptions exceeding recommended maximum daily doses, with the primary outcome being prescriptions exceeding recommended standard daily doses by more than 30%. Results Data from 44 general practitioners and 404 patients are included. The intervention was effective in reducing prescriptions exceeding the maximum daily dose per patients, with a trend in reducing prescriptions exceeding the standard daily dose by more than 30%. Conclusions A multifaceted intervention including the use of a software program effectively reduced inappropriately high doses of renally excreted medications in patients with CKD in the setting of small primary care practices. Trial registration Current Controlled Trials ISRCTN02900734

  16. Rationale and design of a randomized trial to evaluate an evidence-based prescription drug label on actual medication use.

    Science.gov (United States)

    Shrank, William H; Parker, Ruth; Davis, Terry; Pandit, Anjali U; Knox, Joann P; Moraras, Pear; Rademaker, Alfred; Wolf, Michael S

    2010-11-01

    Medication errors are an important public health concern, and poor understanding of medication labels are a root cause. Research shows that labels are variable, of poor quality, and not patient-centered. No real-world trials have evaluated whether improved medication labels can affect appropriate medication use, adherence or health outcomes. We developed an evidence-based prescription label that addresses both content and format. The enhanced label includes a universal medication schedule (UMS) that standardizes the directions for use incorporating 1) standard time periods for administration (morning, noon, evening, and bedtime), 2) numeric vs. alpha characters, 3) 'carriage returns' to separate daily dose and 4) a graphic aid to visually depict dose and frequency. We will evaluate the effect of providing this label to randomly sampled patients who receive their care from free clinics, mobile vans and federally qualified health centers (FQHCs) in Northern Virginia. We will recruit patients with diabetes or hypertension; these patients will be randomly assigned to receive all of their medications with improved labels or to receive prescriptions with standard labels. The primary outcome will be the patient's ability to correctly demonstrate dosing instructions. Other outcomes include adherence, error rates and health outcomes. To our knowledge, this trial is the first to evaluate the effect of prescription label improvement on understanding, medication use and outcomes in a clinical setting. If successful, these findings could be implemented broadly to promote safe and appropriate medication use and to support evidence-based standards in the development of labels. Copyright © 2010 Elsevier Inc. All rights reserved.

  17. Opioid analgesics-related pharmacokinetic drug interactions: from the perspectives of evidence based on randomized controlled trials and clinical risk management.

    Science.gov (United States)

    Feng, Xiu-Qin; Zhu, Ling-Ling; Zhou, Quan

    2017-01-01

    Multimorbidity results in complex polypharmacy which may bear a risk of drug interactions. A better understanding of opioid analgesics combination therapy used for pain management could help warrant medication safety, efficacy, and economic relevance. Until now there has been no review summarizing the opioid analgesics-related pharmacokinetic drug interactions from the perspective of evidence based on randomized controlled trials (RCTs). A literature search was performed using PubMed, MEDLINE, and the Cochrane Library, using a PRISMA flowchart. Fifty-two RCTs were included for data interpretation. Forty-two RCTs (80.8%) were conducted in healthy volunteers, whereas 10 RCTs (19.2%) enrolled true patients. None of the opioid-drug/herb pairs was listed as contraindications of opioids involved in this review. Circumstances in which opioid is comedicated as a precipitant drug include morphine-P2Y12 inhibitors, morphine-gabapentin, and methadone-zidovudine. Circumstances in which opioid is comedicated as an object drug include rifampin-opioids (morphine, tramadol, oxycodone, methadone), quinidine-opioids (morphine, fentanyl, oxycodone, codeine, dihydrocodeine, methadone), antimycotics-opioids (buprenorphine, fentanyl, morphine, oxycodone, methadone, tilidine, tramadol), protease inhibitors-opioids (ritonavir, ritonavir/lopinavir-oxycodone, ritonavir-fentanyl, ritonavir-tilidine), grapefruit juice-opioids (oxycodone, fentanyl, methadone), antidepressants-opioids (paroxetine-tramadol, paroxetine-hydrocodone, paroxetine-oxycodone, escitalopram-tramadol), metoclopramide-morphine, amantadine-morphine, sumatriptan-butorphanol nasal sprays, ticlopidine-tramadol, St John's wort-oxycodone, macrolides/ketolides-oxycodone, and levomepromazine-codeine. RCTs investigating the same combination, almost unanimously, drew consistent conclusions, except two RCTs on amantadine-intravenous morphine combination where a different amantadine dose was used and two RCTs on morphine

  18. Fixed herbal drug combination with and without butterbur (Ze 185) for the treatment of patients with somatoform disorders: randomized, placebo-controlled pharmaco-clinical trial.

    Science.gov (United States)

    Melzer, Jörg; Schrader, Ewald; Brattström, Axel; Schellenberg, Rüdiger; Saller, Reinhard

    2009-09-01

    Herbal drugs are often used in patients with somatoform disorders yet, the available evidence is limited. The aim of the present short-term study was to evaluate in a pharmaco-clinical trial the additional benefit of butterbur in a fixed herbal drug combination (Ze 185 = 4-combination versus 3-combination without butterbur and placebo) in patients with somatoform disorders.For a 2-week treatment in patients with somatization disorder (F45.0) and undifferentiated somatoform disorder (F45.1), 182 patients were randomized for a 3-arm trial (butterbur root, valerian root, passionflower herb, lemon balm leaf versus valerian root, passionflower herb, lemon balm leaf versus placebo). Anxiety (visual analogue scale - VAS) and depression (Beck's Depression Inventory - BDI) served as primary parameters, Clinical Global Impression (CGI) was a secondary parameter.The 4-combination was significantly superior to the 3-combination and placebo (4-combination > 3-combination > placebo) in all the primary and secondary parameters (PP-population). Analysis of the ITT population confirmed these results. As to safety, no serious adverse events occurred. In total 9 non-serious adverse events were documented but the distribution did not differ significantly between the treatment groups.This herbal preparation (Ze185) showed to be an efficacious and safe short-term treatment in patients with somatoform disorders.

  19. Effect of sanhuangwuji powder, anti-rheumatic drugs, and ginger-partitioned acupoint stimulation on the treatment of rheumatoid arthritis with peptic ulcer: a randomized controlled study.

    Science.gov (United States)

    Liu, Defang; Guo, Mingyang; Hu, Yonghe; Liu, Taihua; Yan, Jiao; Luo, Yong; Yun, Mingdong; Yang, Min; Zhang, Jun; Guo, Linglin

    2015-06-01

    To observe the efficacy and safety of oral sanhuangwuji powder, anti-rheumatic drugs (ARDs), and ginger-partitioned acupoint stimulation at zusanli (ST 36) on the treatment of rheumatoid arthritis (RA) complicated by peptic ulcer. This prospective randomized controlled study included 180 eligible inpatients and outpatients randomly assigned to an ARD treatment (n.= 60), ginger-partitioned stimulation (n = 60), or combination treatment (n = 60). Patients assigned to the ARD group were given oral celecoxib, methotrexate, and esomeprazole. Patients assigned to the ginger-partitioned stimulation group were given ginger-partitioned acupoint stimulation at zusanli (ST 36) in addition to the ARDs. Patients in the combination treatment group were given oral sanhuangwuji powder, ginger-partitioned acupoint stimulation at susanli (ST 36), and ARDs. All patients were followed up for 2 months to evaluate clinical effects and safety. The study was registered in the World Health Organization database at the General Hospital of Chengdu Military Area Command Chinese People's Liberation Army (ChiCTR-TCC12002824). The combination treatment group had significantly greater improvements in RA symptoms, laboratory outcomes, and gastrointestinal symptom scores, compared with the other groups (P ginger-partitioned stimulation group (χ2= 6.171, P ginger-partitioned acupoint stimulation at zusanli (ST 36), oral sanhuangwuji powder, and ARDs had a better clinical effect for RA with complicated peptic ulcer, compared with ARD treatmentalone or in combination with ginger-partitioned acupoint stimulation.

  20. Comparison of the Effects on Rib Fracture between the Traditional Japanese Medicine Jidabokuippo and Nonsteroidal Anti-Inflammatory Drugs: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hajime Nakae

    2012-01-01

    Full Text Available Jidabokuippo is a traditional Japanese medicine used for contusion-induced swelling and pain. This open multicenter randomized study was designed to compare the efficacies of jidabokuippo and nonsteroidal anti-inflammatory drugs (NSAIDs in patients with rib fracture by analyzing the treatment duration. Our study involved 170 rib fracture patients capable of oral ingestion divided randomly into 2 groups: the jidabokuippo and NSAID groups. We compared the duration of treatment and healthcare expenditure between these 2 groups. Medication was continued in both groups until the visual analogue scale score decreased to less than 50% of the pretreatment score. We excluded the patients in whom medication was prematurely discontinued. We analyzed 81 patients belonging to the jidabokuippo and NSAIDs groups. No significant intergroup differences were observed in age, gender, severity (injury severity score, and presence/absence of underlying disease. The treatment duration was significantly shorter in the jidabokuippo group than in the NSAIDs group (P=0.0003. Healthcare expenditure was significantly lower in the jidabokuippo group than in the NSAIDs group (P<0.0001. Our results suggest that compared to NSAIDs, jidabokuippo can shorten the duration of treatment in patients with rib fracture and is a promising analgesic agent based on the medical economic viewpoint.

  1. Cluster randomized trial of text message reminders to retail staff in tanzanian drug shops dispensing artemether-lumefantrine: effect on dispenser knowledge and patient adherence.

    Science.gov (United States)

    Bruxvoort, Katia; Festo, Charles; Kalolella, Admirabilis; Cairns, Matthew; Lyaruu, Peter; Kenani, Mitya; Kachur, S Patrick; Goodman, Catherine; Schellenberg, David

    2014-10-01

    Artemisinin combination therapies are available in private outlets, but patient adherence might be compromised by poor advice from dispensers. In this cluster randomized trial in drug shops in Tanzania, 42 of 82 selected shops were randomized to receive text message reminders about what advice to provide when dispensing artemether-lumefantrine (AL). Eligible patients purchasing AL at shops in both arms were followed up at home and questioned about each dose taken. Dispensers were interviewed regarding knowledge of AL dispensing practices and receipt of the malaria-related text messages. We interviewed 904 patients and 110 dispensers from 77 shops. Although there was some improvement in dispenser knowledge, there was no difference between arms in adherence measured as completion of all doses (intervention 68.3%, control 69.8%, p [adjusted] = 0.6), or as completion of each dose at the correct time (intervention 33.1%, control 32.6%, p [adjusted] = 0.9). Further studies on the potential of text messages to improve adherence are needed. © The American Society of Tropical Medicine and Hygiene.

  2. No Wrong Doors: Findings from a Critical Review of Behavioral Randomized Clinical Trials for Individuals with Co-Occurring Alcohol/Drug Problems and Posttraumatic Stress Disorder.

    Science.gov (United States)

    Simpson, Tracy L; Lehavot, Keren; Petrakis, Ismene L

    2017-04-01

    Prior reviews of behavioral treatments for individuals with comorbid alcohol and drug use disorders (substance use disorder SUD) and posttraumatic stress disorder (PTSD) have not systematically considered whether comparison conditions are matched to target treatments on time and attention. A systematic literature search using PubMed MESH terms for alcohol and substance use disorders, PTSD, and treatment identified relevant behavioral randomized clinical trials (RCTs) that evaluated PTSD-oriented exposure-based treatments, addiction-focused treatments, and coping-based treatments that do not involve exposure to trauma memories. Information pertaining to within-subject changes over time and between-subject differences, quality of control condition, recruitment efficiency, and assessment and treatment retention was synthesized. Alcohol and drug outcomes were described separately when possible. Twenty-four behavioral RCTs were identified: 7 exposure based, 6 addiction focused, and 11 coping based. Seven studies included SUD intervention comparison conditions matched to the target intervention on time and attention. Most of the 24 studies found that participants in both the experimental and control conditions improved significantly over time on SUD and PTSD outcomes. No study found significant between-group differences in both SUD and PTSD outcomes favoring the experimental treatment. Despite greater treatment dropout, there was greater improvement in some PTSD outcomes for exposure-based interventions than the control conditions, including when the control conditions were matched for time and attention. Addiction-focused and coping-based interventions did not generally show an advantage over comparably robust controls, although some coping-based interventions yielded better drug use outcomes than control conditions. When available, interventions that integrate exposure-based PTSD treatment and behavioral SUD treatment are recommended as they are associated with better

  3. Patient-reported functional health and well-being outcomes with drug therapy: a systematic review of randomized trials using the SF-36 health survey.

    Science.gov (United States)

    Frendl, Daniel M; Ware, John E

    2014-05-01

    To evaluate the responsiveness of the SF-36 Health Survey in drug trials and to determine how often clinically efficacious treatments produce meaningful functional health changes across medical conditions. We conducted a systematic review of randomized, double-blind, placebo-controlled drug trials published from 1995 to 2011 that documented results for primary clinical endpoints and SF-36 outcomes. PubMed and a database of SF-36 publications were searched. We evaluated responsiveness as concordance (both statistically significant or both nonsignificant) between primary clinical and SF-36 outcomes. To determine how often SF-36 physical and mental component summary (PCS, MCS) score changes were of meaningful magnitude, mean net of placebo changes with treatment were compared against the developer's recommended 3-point threshold for a minimal important difference (MID) across groups of medical conditions. Of 805 screened trials, 185 met eligibility criteria. Primary clinical and SF-36 outcomes were concordant in 151 trials (82%). Among clinically efficacious trials, 58% reported net mean SF-36 improvements ≥MID threshold; however, SF-36 changes were often modest (PCS IQR, 1.6-4.1; MCS IQR, 0.8-3.5). Variations in treatment impact were apparent across conditions. Clinically efficacious therapies for rheumatoid arthritis, psoriatic arthritis, and psoriasis consistently achieved the largest SF-36 improvements, with 87% exceeding MID, whereas no efficacious therapies for peripheral arterial disease or chronic obstructive pulmonary disease achieved MID threshold. The SF-36 responds to treatment impact, distinguishing drug therapies that, on average, produce meaningful functional health benefits. Overall, just over half of clinically efficacious trials report meaningful functional health improvements, and results vary widely by medical condition.

  4. Auricular acupuncture for substance use: a randomized controlled trial of effects on anxiety, sleep, drug use and use of addiction treatment services.

    Science.gov (United States)

    Ahlberg, Rickard; Skårberg, Kurt; Brus, Ole; Kjellin, Lars

    2016-07-25

    A common alternative treatment for substance abuse is auricular acupuncture. The aim of the study was to evaluate the short and long-term effect of auricular acupuncture on anxiety, sleep, drug use and addiction treatment utilization in adults with substance abuse. Of the patients included, 280 adults with substance abuse and psychiatric comorbidity, 80 were randomly assigned to auricular acupuncture according to the NADA protocol, 80 to auricular acupuncture according to a local protocol (LP), and 120 to relaxation (controls). The primary outcomes anxiety (Beck Anxiety Inventory; BAI) and insomnia (Insomnia Severity Index; ISI) were measured at baseline and at follow-ups 5 weeks and 3 months after the baseline assessment. Secondary outcomes were drug use and addiction service utilization. Complete datasets regarding BAI/ISI were obtained from 37/34 subjects in the NADA group, 28/28 in the LP group and 36/35 controls. Data were analyzed using Chi-square, Analysis of Variance, Kruskal Wallis, Repeated Measures Analysis of Variance, Eta square (η(2)), and Wilcoxon Signed Ranks tests. Participants in NADA, LP and control group improved significantly on the ISI and BAI. There was no significant difference in change over time between the three groups in any of the primary (effect size: BAI, η(2) = 0.03, ISI, η(2) = 0.05) or secondary outcomes. Neither of the two acupuncture treatments resulted in differences in sleep, anxiety or drug use from the control group at 5 weeks or 3 months. No evidence was found that acupuncture as delivered in this study is more effective than relaxation for problems with anxiety, sleep or substance use or in reducing the need for further addiction treatment in patients with substance use problems and comorbid psychiatric disorders. The substantial attrition at follow-up is a main limitation of the study. Clinical Trials NCT02604706 (retrospectively registered).

  5. Study protocol for a group randomized controlled trial of a classroom-based intervention aimed at preventing early risk factors for drug abuse: integrating effectiveness and implementation research

    Directory of Open Access Journals (Sweden)

    Keegan Natalie

    2009-09-01

    Full Text Available Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD, aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC. Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088

  6. Colistin and rifampicin compared with colistin alone for the treatment of serious infections due to extensively drug-resistant Acinetobacter baumannii: a multicenter, randomized clinical trial.

    Science.gov (United States)

    Durante-Mangoni, Emanuele; Signoriello, Giuseppe; Andini, Roberto; Mattei, Annunziata; De Cristoforo, Maria; Murino, Patrizia; Bassetti, Matteo; Malacarne, Paolo; Petrosillo, Nicola; Galdieri, Nicola; Mocavero, Paola; Corcione, Antonio; Viscoli, Claudio; Zarrilli, Raffaele; Gallo, Ciro; Utili, Riccardo

    2013-08-01

    Extensively drug-resistant (XDR) Acinetobacter baumannii may cause serious infections in critically ill patients. Colistin often remains the only therapeutic option. Addition of rifampicin to colistin may be synergistic in vitro. In this study, we assessed whether the combination of colistin and rifampicin reduced the mortality of XDR A. baumannii infections compared to colistin alone. This multicenter, parallel, randomized, open-label clinical trial enrolled 210 patients with life-threatening infections due to XDR A. baumannii from intensive care units of 5 tertiary care hospitals. Patients were randomly allocated (1:1) to either colistin alone, 2 MU every 8 hours intravenously, or colistin (as above), plus rifampicin 600 mg every 12 hours intravenously. The primary end point was overall 30-day mortality. Secondary end points were infection-related death, microbiologic eradication, and hospitalization length. Death within 30 days from randomization occurred in 90 (43%) subjects, without difference between treatment arms (P = .95). This was confirmed by multivariable analysis (odds ratio, 0.88 [95% confidence interval, .46-1.69], P = .71). A significant increase of microbiologic eradication rate was observed in the colistin plus rifampicin arm (P = .034). No difference was observed for infection-related death and length of hospitalization. In serious XDR A. baumannii infections, 30-day mortality is not reduced by addition of rifampicin to colistin. These results indicate that, at present, rifampicin should not be routinely combined with colistin in clinical practice. The increased rate of A. baumannii eradication with combination treatment could still imply a clinical benefit. NCT01577862.

  7. Differential profile in partner aggressors: Prison vs. mandatory community intervention programs

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    Jesús J. García-Jiménez

    2014-07-01

    Full Text Available In Spain, there are two types of sentence for partner aggressors: prison sentence and the alternative measure, specifically psychosocial intervention programs. The goal of this study was to determine differences in the delinquent and psychopathological profile of these aggressors as a function of the prison sentence received, for which the models proposed by Dutton (1995 and Holtzworth-Munroe and Stuart (1994 were followed. The sample was made up of 50 incarcerated aggressors and 40 men sentenced to mandatory community orders. The variables were obtained through a mixed method, with supervision of penitentiary case files, clinical interview for personality disorder (SCID-II, and self-reports for the personality profile (NEO-PI-R. Binary logistic regression was used to identify the final model, which best reveals the differences between both groups. The results describe the incarcerated aggressors' profile as having more altered risk factors at the socioeconomic, delinquent, and psychopathological levels. The three variables that increase the probability of belonging to the prison inmate group, according to the final model obtained were: use of weapons, drug consumption, and personality disorder. In contrast to other investigations, the high incidence in the outcomes of the target variables, mainly drug use and personality disorder, makes us wonder whether the diagnostic method used influenced the results in contrast to the exclusive use of self-reports, a goal to be confirmed in future studies.

  8. Comparison of Work of Breathing During Mechanical Ventilation Using Assist Control and Intermittent Mandatory Ventilation

    Science.gov (United States)

    1994-07-19

    AD-A285 516 AD MIPR NO: 92MM2539 TITLE: COMPARISON OF WORK OF BREATHING DURING MECHANICAL VENTILATION USING ASSIST CONTROL AND INTERMITTENT MANDATORY...1993, for the subject MIPR, titled: Comparison of Work of Breathing During Mechanical Ventilation Using Assist Control and Intermittent Mandatory...MIPR 92MM2539, titled: Comparison of Work of Breathing During Mechanical Ventilation Using Assist Control and Intermittent Mandatory Ventilation . 2

  9. Drug-eluting balloon versus bare-mental stent and drug-eluting stent for de novo coronary artery disease: A systematic review and meta-analysis of 14 randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Kongyong Cui

    Full Text Available Drug-eluting balloon (DEB has become an alternative option to drug-eluting stent (DES for the treatment of in-stent restenosis (ISR. However, the effect of drug-eluting balloon with regular bare-mental stent (BMS in de novo coronary artery disease (CAD is unclear. This meta-analysis aimed to evaluate the efficacy of DEB with regular BMS compared to BMS or DES in de novo CAD.Randomized controlled trials (RCTs assessing the efficacy of DEB+BMS in comparison with BMS or DES were obtained by searching the PubMed, EMBASE, and Cochrane Library databases through January 2016. Primary endpoints were major adverse cardiac events (MACEs and late lumen loss (LLL. Secondary endpoints included death, myocardial infarction (MI, target lesion revascularization (TLR, stent thrombosis (ST, binary restenosis, and minimum lumen diameter (MLD. Dichotomous and continuous data were presented as odds ratios (ORs and mean differences (MDs with 95% confidence intervals (CIs, respectively, and analyzed using a random-effects model.A total of 14 RCTs involving 2281 patients were included in this meta-analysis. DEB+BMS showed significantly less MACEs (OR: 0.67, 95%CI 0.45 to 0.99, P = 0.04 and reduced LLL (MD: -0.30 mm, 95%CI: -0.48 mm to -0.11 mm, P = 0.001 compared with BMS. Meanwhile, treatment with DEB+BMS had disadvantages over DES in terms of MACEs (OR: 1.94, 95%CI 1.24 to 3.05, P = 0.004, LLL (MD: 0.20 mm, 95%CI: 0.07 mm to 0.33 mm, P = 0.003, TLR (OR: 2.53, 95% CI 1.36 to 4.72, P = 0.003, and MLD (MD: -0.25 mm, 95%CI: -0.42 mm to -0.09 mm, P = 0.003.This limited evidence demonstrated that treatment with DEB+BMS appears to be effective in de novo CAD. In addition, DEB+ BMS clearly showed superiority to BMS, but is inferior to DES in the treatment of patients with de novo CAD. Hence, DES (especially new generation DES should be recommended for patients with de novo CAD.

  10. Randomized trial of switching from prescribed non-selective non-steroidal anti-inflammatory drugs to prescribed celecoxib

    DEFF Research Database (Denmark)

    Macdonald, Thomas M; Hawkey, Chris J; Ford, Ian

    2017-01-01

    infarction or other biomarker positive acute coronary syndrome, non-fatal stroke or CV death analysed using a Cox model with a pre-specified non-inferiority limit of 1.4 for the hazard ratio (HR). RESULTS: In total, 7297 participants were randomized. During a median 3-year follow-up, fewer subjects than......-years with celecoxib and 1.10 per 100 patient-years with nsNSAIDs (HR = 1.04; 95% confidence interval, 0.81-1.33; P = 0.75). Pre-specified non-inferiority was achieved in the ITT analysis. The upper bound of the 95% confidence limit for the absolute increase in OT risk associated with celecoxib treatment was two......NSAIDs. There was no advantage of a strategy of switching prescribed nsNSAIDs to prescribed celecoxib. This study excluded an increased risk of the primary endpoint of more than two events per 1000 patient-years associated with switching to prescribed celecoxib....

  11. Autonomous Cars: In Favor of a Mandatory Ethics Setting.

    Science.gov (United States)

    Gogoll, Jan; Müller, Julian F

    2017-06-01

    The recent progress in the development of autonomous cars has seen ethical questions come to the forefront. In particular, life and death decisions regarding the behavior of self-driving cars in trolley dilemma situations are attracting widespread interest in the recent debate. In this essay we want to ask whether we should implement a mandatory ethics setting (MES) for the whole of society or, whether every driver should have the choice to select his own personal ethics setting (PES). While the consensus view seems to be that people would not be willing to use an automated car that might sacrifice themselves in a dilemma situation, we will defend the somewhat contra-intuitive claim that this would be nevertheless in their best interest. The reason is, simply put, that a PES regime would most likely result in a prisoner's dilemma.

  12. Mandatory premarital testing for human immunodeficiency virus. The Illinois experience.

    Science.gov (United States)

    Turnock, B J; Kelly, C J

    1989-06-16

    During the first 6 months of legislatively mandated premarital testing for human immunodeficiency virus in Illinois, 8 of 70,846 applicants for marriage licenses were found to be seropositive, yielding a seroprevalence of 0.011%. The total cost of the testing program for 6 months is estimated at $2.5 million or $312,000 per seropositive individual identified. Half of the reported seropositive individuals reported a history of risk behavior. During the same period, the number of marriage licenses issued in Illinois decreased by 22.5%, while the number of licenses issued to Illinois residents in surrounding states increased significantly. We conclude that mandatory premarital testing is not a cost-effective method for the control of human immunodeficiency virus infection.

  13. What do dental students think about mandatory laptop programs?

    Science.gov (United States)

    Hendricson, William; Eisenberg, Elise; Guest, Gary; Jones, Pamela; Johnson, Lynn; Panagakos, Fotinos; McDonald, James; Cintron, Laura

    2006-05-01

    In spite of efforts by many dental schools to provide information technology resources for students, only a handful of studies have been conducted to determine what dental students think about these initiatives. There are no reports in the literature describing students' perceptions of mandatory laptop programs, which are now being implemented by at least 25 percent of North American dental schools. In schools that have implemented laptop programs, students are required either to enroll with their own laptops that meet specifications or to purchase a laptop from the school at matriculation. In some schools, students are also required to purchase curriculum support software that is bundled with the laptop. This study was conducted to determine students' opinions at U.S. dental schools with mandatory laptop programs about these aspects of this information technology initiative: frequency of use, perceived necessity of use, note-typing during lectures, effectiveness of training, influence on study habits, benefits, implementation problems, added value in relation to added tuition costs, impact on quality of dental education, overall rating of the laptop experience, and impact of the laptop on use of other electronic curriculum resources. Responses of students at schools that purchased packaged curriculum support software from a commercial vendor were compared with students' responses at schools where faculty provided their own educational software. Responses were also compared among freshmen, sophomores, and upperclassmen in a cross-sectional sample. In 2004, approximately 800 dental students at fourteen dental schools responded to eleven questions that requested their impressions and evaluation of mandatory laptop programs and associated educational software. These questions comprised one section of the IREC Students' Questionnaire (IREC=Institutional Readiness for Electronic Curriculum) that assessed students' perceptions of various aspects of information technology

  14. Mandatory Corporate Social Responsibility Reporting in the EU

    DEFF Research Database (Denmark)

    Szabó, Dániel Gergely

    Although non-financial or CSR-reporting has attracted increasing attention in the last decades, it only recently entered the legal discourse. This book narrows the gap between CSR reporting and legal disclosure requirements. It analyses financial, management, and corporate governance reporting......, as well as other dedicated reporting types. The author investigates what legal framework underpins these disclosure types; to what extent these instruments mandate the disclosure of non-financial information; and if they have potential to expand their non-financial disclosure requirements. The findings...... suggest that mandatory nonfinancial reporting is less developed than expected. It further recommends more narrow and elaborate disclosure obligations to achieve higher transparency in CSR matters....

  15. Adding ofloxacin to standard triple-drug regimens increased the Helicobacter pylori eradication rate: Data from randomized clinical trial.

    Science.gov (United States)

    Sadeghi-Hadad-Zavareh, Mahmoud; Mohammadi, Seyyedsaeid; Hajiahmadi, Mahmoud; Javanian, Mostafa; Habibian, Masoomeh

    2017-01-01

    The rate of Helicobacter pylori (H.pylori) eradication in dyspeptic patients using bismuth- based triple therapy is low due to bacterial that are resistant to antibiotics. The results of recent studies regarding levofloxacin have been encouraging, but the high cost of treatment prevents its routine administration. We, therefore, performed the present double-blind clinical trial to compare the efficiency of quadruple-drug regimen containing ofloxacin, clarithromycin, amoxicillin, and omeprazole and the same standard triple-therapy regimen minus ofloxacin in H. pylori positive dyspepsia. The study patients were recruited among dyspeptic patients requiring gastroscopy. Patients with the history of H.pylori treatment, renal failure and pregnancy were excluded. Diagnosis of H.pylori infection was confirmed by rapid urease test and response to treatment was confirmed via negative urease breath test (UBT) 20 days after completion of treatment. Patients were allocated intermittently to standard triple therapy containing amoxicillin, clarithromycin, omeprazole alone or plus ofloxacin for ten days. Response to treatment was compared between the two groups. A total of 140 patients entered the study (70 patients in each group). At endpoint 30 (42.9%) patients of group 1 and 39 (55.7%) patients of group 2 became asymptomatic. Furthermore, 55 (78.6%) patients of group 1 and 66 (94.3%) patients of group 2 revealed negative urea breath test (P= 0.01). This study indicates adding ofloxacin to standard triple-therapy for H.pylorri infection significantly increases the rate of eradication. These findings highlight ofloxacin as empiric treatment of H. pylori infection.

  16. Parallel imports and a mandatory substitution reform: a kick or a muff for price competition in pharmaceuticals?

    Science.gov (United States)

    Granlund, David; Koksal-Ayhan, Miyase Yesim

    2015-12-01

    What has been the effect of competition from parallel imports on prices of locally sourced on-patent drugs? Did the 2002 Swedish mandatory substitution reform increase this competition? To answer these questions, we carried out difference-in-differences estimation on monthly data for a panel of all locally sourced on-patent prescription drugs sold in Sweden during the 40 months from January 2001 to April 2004. On average, facing competition from parallel imports caused a 15-17% fall in price. While the reform increased the effect of competition from parallel imports, it was only by 0.9%. The reform, however, did increase the effect of therapeutic competition by 1.6%.

  17. Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial

    Science.gov (United States)

    Jiang, Yan; Zhang, Zhen-Lin; Zhang, Zhong-Lan; Zhu, Han-Min; Wu, Yi-Yong; Cheng, Qun; Wu, Feng-Li; Xing, Xiao-Ping; Liu, Jian-Li; Yu, Wei; Meng, Xun-Wu

    2014-01-01

    Objective To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women. Method This multicenter, randomized, double-blinded, double-dummy, noninferiority, positive drug-controlled clinical trial was conducted in five Chinese sites. Eligible Chinese women with postmenopausal osteoporosis (N=236) were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 μg/day, respectively, for 1 year. Additionally, all patients received calcium 500 mg/day. Posttreatment bone mineral density (BMD), new fracture onsets, and serum osteocalcin (OC) and undercarboxylated OC (ucOC) levels were compared with the baseline value in patients of both groups. Results A total of 213 patients (90.3%) completed the study. After 1 year of treatment, BMD among patients in Group M significantly increased from baseline by 1.2% and 2.7% at the lumbar spine and trochanter, respectively (P0.05). In Group M, OC and ucOC decreased from baseline by 38.7% and 82.3%, respectively (P<0.001). In Group A, OC and ucOC decreased by 25.8% and 34.8%, respectively (P<0.001). Decreases in serum OC and ucOC were more obvious in Group M than in Group A (P<0.001). The safety profile of menatetrenone was similar to alfacalcidol. Conclusion Menatetrenone is an effective and safe choice in the treatment of postmenopausal osteoporosis in Chinese women. PMID:24426779

  18. 6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

    Science.gov (United States)

    Gilard, Martine; Barragan, Paul; Noryani, Arif A L; Noor, Hussam A; Majwal, Talib; Hovasse, Thomas; Castellant, Philippe; Schneeberger, Michel; Maillard, Luc; Bressolette, Erwan; Wojcik, Jaroslaw; Delarche, Nicolas; Blanchard, Didier; Jouve, Bernard; Ormezzano, Olivier; Paganelli, Franck; Levy, Gilles; Sainsous, Joël; Carrie, Didier; Furber, Alain; Berland, Jacques; Darremont, Oliver; Le Breton, Hervé; Lyuycx-Bore, Anne; Gommeaux, Antoine; Cassat, Claude; Kermarrec, Alain; Cazaux, Pierre; Druelles, Philippe; Dauphin, Raphael; Armengaud, Jean; Dupouy, Patrick; Champagnac, Didier; Ohlmann, Patrick; Endresen, Knut; Benamer, Hakim; Kiss, Robert Gabor; Ungi, Imre; Boschat, Jacques; Morice, Marie-Claude

    2015-03-03

    The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS). This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients. A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting. A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]). Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  19. 76 FR 64082 - Mandatory Reliability Standards for the Bulk-Power System; Notice of Staff Meeting

    Science.gov (United States)

    2011-10-17

    ... Energy Regulatory Commission Mandatory Reliability Standards for the Bulk-Power System; Notice of Staff...\\ Mandatory Reliability Standards for the Bulk-Power System, Order No. 693, FERC Stats. & Regs. ] 31,242... Discussion on the reliability issues relating to ``Single Point of Failure on Protection Systems,'' on Monday...

  20. Mandatory HIV testing and uptake of ante-natal services in a primary ...

    African Journals Online (AJOL)

    Background: The Nigeria\\'s national policy on HIV/AIDS did not allow for mandatory HIV testing. But several health institutions in Nigeria insist on an HIV test before certain services are given. Fears have been expressed that such mandatory HIV testing might lead to poorer uptake of associated services. Aim: To assess the ...

  1. 48 CFR 252.222-7006 - Restrictions on the Use of Mandatory Arbitration Agreements.

    Science.gov (United States)

    2010-10-01

    ... Mandatory Arbitration Agreements. 252.222-7006 Section 252.222-7006 Federal Acquisition Regulations System... Arbitration Agreements. As prescribed in 222.7404, use the following clause: Restrictions on the Use of Mandatory Arbitration Agreements (MAY 2010) (a) Definitions. As used in this clause— Covered subcontractor...

  2. Mandatory Consent to Treatment by Students in Dental Education: Legal and Policy Considerations.

    Science.gov (United States)

    Cameron, Cheryl A.

    1995-01-01

    The issue of mandatory dental student consent to provision of clinical services by student colleagues is discussed, particularly when a student seeks to avoid mandatory treatment requirements or refuses treatment from an assigned student care provider, or is denied enrollment based on refusal to consent to treatment. Legal and policy…

  3. Evaluation of the Mandatory Construction Induction Training Program in Western Australia: Unanticipated Consequences

    Science.gov (United States)

    Bahn, Susanne; Barratt-Pugh, Llandis

    2012-01-01

    Since January 1, 2007, Government legislation in Western Australia required all workers in construction to complete mandatory safety awareness training before they began work on site. During the implementation of this new legislation there was considerable resistance from the construction sector due to the mandatory nature of the training. The…

  4. Australian Undergraduate Primary School Student-Teachers' Responses to Child Sexual Abuse and Its Mandatory Reporting

    Science.gov (United States)

    Goldman, Juliette D. G.

    2010-01-01

    This study aims to understand how primary school teachers, as mandatory reporters of child sexual abuse, are responding to child sexual abuse and its mandatory reporting, even though many teachers do not receive a compulsory course in Child Protection and its legal requirements in their pre-service university training. A cohort of 81 Australian…

  5. Mandatory national quality improvement systems using indicators: An initial assessment in Europe and Israel

    NARCIS (Netherlands)

    Bramesfeld, A.; Wensing, M.; Bartels, P.; Bobzin, H.; Grenier, C.; Heugren, M.; Hirschfield, D.J.; Langenegger, M.; Lindelius, B.; Lucet, B.; Manor, O.; Schneider, T.; Wardell, F.; Szecsenyi, J.

    2016-01-01

    INTRODUCTION: Quality improvement systems (QIS) that are based on empirical performance assessment have increasingly been implemented as a mandatory part of health systems across countries. This study aims to describe national mandatory QIS in Europe in 2014. MATERIALS AND METHODS: Relevant national

  6. 75 FR 77921 - Office of Administrative Services; Mandatory Declassification Review Address

    Science.gov (United States)

    2010-12-14

    ... CORPORATION Office of Administrative Services; Mandatory Declassification Review Address AGENCY: Overseas... address to which written Mandatory Declassification Review (MDR) requests may be sent. This notice... reasonable effort. SUPPLEMENTARY INFORMATION: It is the policy of OPIC to act in matters relating to national...

  7. 75 FR 22699 - Mandatory Reporting of Greenhouse Gases: Minor Harmonizing Changes to the General Provisions

    Science.gov (United States)

    2010-04-30

    ... AGENCY 40 CFR Part 98 RIN 2060-AQ15 Mandatory Reporting of Greenhouse Gases: Minor Harmonizing Changes to... withdrawing the direct final rule to amend the general provisions for the Mandatory Greenhouse Gas (GHG... Part 98 Environmental protection, Administrative practice and procedure, Greenhouse gases, Suppliers...

  8. 76 FR 36472 - Mandatory Reporting of Greenhouse Gases; Changes to Provisions for Electronics Manufacturing...

    Science.gov (United States)

    2011-06-22

    ... AGENCY 40 CFR Part 98 RIN A2060 Mandatory Reporting of Greenhouse Gases; Changes to Provisions for... the Electronics Manufacturing portion (Subpart I) of the Mandatory Greenhouse Gas Reporting Rule for... technical information, please go to the Greenhouse Gas Reporting Rule Program Web site http://www.epa.gov...

  9. 75 FR 39735 - Mandatory Reporting of Greenhouse Gases From Magnesium Production, Underground Coal Mines...

    Science.gov (United States)

    2010-07-12

    ... Protection Agency 40 CFR Part 98 Mandatory Reporting of Greenhouse Gases From Magnesium Production... PROTECTION AGENCY 40 CFR Part 98 RIN 2060-AQ03 Mandatory Reporting of Greenhouse Gases From Magnesium... monitoring and reporting of greenhouse gas emissions from magnesium production, underground coal mines...

  10. 24 CFR 5.350 - Mandatory pet rules for housing programs.

    Science.gov (United States)

    2010-04-01

    ... and Urban Development GENERAL HUD PROGRAM REQUIREMENTS; WAIVERS Pet Ownership for the Elderly or Persons With Disabilities Pet Ownership Requirements for Housing Programs § 5.350 Mandatory pet rules for... 24 Housing and Urban Development 1 2010-04-01 2010-04-01 false Mandatory pet rules for housing...

  11. Mandatory Online Training: Transmissive Learning, Issues of Abuse and Hidden Agendas

    Science.gov (United States)

    Barratt-Pugh, Llandis; Bahn, Susanne; Scholz, Alex

    2011-01-01

    This paper is based on two studies of mandatory online learning which although unrelated and conducted eight years apart nevertheless provide an illuminating comparison of mandatory training delivered online. The first study was carried out in 2002 in a state government department and the second in 2010 with the commercial construction industry,…

  12. 28 CFR 2.35 - Mandatory release in the absence of parole.

    Science.gov (United States)

    2010-07-01

    ... 28 Judicial Administration 1 2010-07-01 2010-07-01 false Mandatory release in the absence of parole. 2.35 Section 2.35 Judicial Administration DEPARTMENT OF JUSTICE PAROLE, RELEASE, SUPERVISION AND RECOMMITMENT OF PRISONERS, YOUTH OFFENDERS, AND JUVENILE DELINQUENTS United States Code Prisoners and Parolees § 2.35 Mandatory release in the absenc...

  13. 29 CFR Appendix II to Part 1918 - Tables for Selected Miscellaneous Auxiliary Gear (Mandatory)

    Science.gov (United States)

    2010-07-01

    ... 29 Labor 7 2010-07-01 2010-07-01 false Tables for Selected Miscellaneous Auxiliary Gear (Mandatory) II Appendix II to Part 1918 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND.... 1918, App. II Appendix II to Part 1918—Tables for Selected Miscellaneous Auxiliary Gear (Mandatory...

  14. The Additional Value of an E-Mail to Inform Healthcare Professionals of a Drug Safety Issue: A Randomized Controlled Trial in the Netherlands.

    Science.gov (United States)

    Piening, Sigrid; de Graeff, Pieter A; Straus, Sabine M J M; Haaijer-Ruskamp, Flora M; Mol, Peter G M

    2013-09-01

    The usefulness and the impact of Direct Healthcare Professional Communications (DHPCs, or 'Dear Doctor letters') in changing the clinical behaviour of physicians have been debated. Changes in the current risk communication methods should preferably be based on the preferences of the healthcare professionals, to optimize the uptake of the message. The aim of this study was to assess whether safety issues are communicated more effectively with an additional e-mail sent by the Dutch Medicines Evaluation Board (MEB) than with the DHPC only. A randomized controlled trial was conducted amongst ophthalmologists and hospital pharmacists in the Netherlands, who were the target group of a DHPC that was issued for pegaptanib, a drug that is administered intra-ocularly in patients with macular degeneration. The intervention group (N = 110) received the pegaptanib DHPC, as well as the MEB e-mail. The control group (N = 105) received the traditional paper-based DHPC only. Two weeks later, the study population received an invitation to fill out an online questionnaire. Questions were asked about the respondents' knowledge and attitude regarding the pegaptanib issue, and any action they had consequently taken. Additional questions were asked about their satisfaction with the DHPC and the e-mail, and their preferred source of such information. Forty respondents (18.6%) completed the questionnaire. Eighty-one percent of the respondents in the intervention group (N = 21) and 47% of the control group (N = 19) correctly indicated that a serious increase in intra-ocular pressure could be caused by pegaptanib injections (Fishers' exact test, p = 0.046). Nine respondents in the intervention group versus none of the control group respondents indicated that they had taken action in response to the pegaptanib safety issue (Fishers' exact test, p = 0.01). The majority of both the intervention group and the control group confirmed that they would like to receive an MEB e-mail with safety

  15. Short-term Impact of Mass Drug Administration With Dihydroartemisinin Plus Piperaquine on Malaria in Southern Province Zambia: A Cluster-Randomized Controlled Trial.

    Science.gov (United States)

    Eisele, Thomas P; Bennett, Adam; Silumbe, Kafula; Finn, Timothy P; Chalwe, Victor; Kamuliwo, Mulakwa; Hamainza, Busiku; Moonga, Hawela; Kooma, Emmanuel; Chizema Kawesha, Elizabeth; Yukich, Joshua; Keating, Joseph; Porter, Travis; Conner, Ruben O; Earle, Duncan; Steketee, Richard W; Miller, John M

    2016-12-15

     Mass drug administration (MDA) using dihydroartemisinin plus piperaquine (DHAp) represents a potential strategy to clear Plasmodium falciparum infections and reduce the human parasite reservoir.  A cluster-randomized controlled trial in Southern Province, Zambia, was used to assess the short-term impact of 2 rounds of community-wide MDA and household-level (focal) MDA with DHAp compared with no mass treatment. Study end points included parasite prevalence in children, infection incidence, and confirmed malaria case incidence.  All end points significantly decreased after intervention, irrespective of treatment group. Parasite prevalence from 7.71% at baseline to 0.54% after MDA in lower-transmission areas, resulting in an 87% reduction compared with control (adjusted odds ratio, 0.13; 95% confidence interval, .02-.92; P = .04). No difference between treatment groups was observed in areas of high transmission. The 5-month cumulative infection incidence was 70% lower (crude incidence rate ratio, 0.30; 95% confidence interval, .06-1.49; P = .14) and 58% lower (0.42; .18-.98; P = .046) after MDA compared with control in lower- and higher-transmission areas, respectively. No significant impact of focal MDA was observed for any end point.  Two rounds of MDA with DHAp rapidly reduced infection prevalence, infection incidence, and confirmed case incidence rates, especially in low-transmission areas.  NCT02329301. © The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.

  16. Lights on for daytime driving: mandatory from 1 January 2014

    CERN Multimedia

    2014-01-01

    In accordance with the Swiss Federal Decree of 15 June 2012, it will be mandatory from 1 January 2014 to keep your vehicle lights permanently switched on when driving on Swiss territory.   New vehicles are now equipped with daytime running lights which switch on automatically. For older vehicles, side lights can be used as daytime running lights, and it is always possible to fit specific daytime running lights to a vehicle at a later date. This measure is already in force in most European countries and is particularly aimed at improving the visibility of vehicles and helping pedestrians and cyclists to judge the distance and speed of an approaching vehicle more easily. From 1 January 2014, this obligation applies to all “automobiles (passenger cars, heavy goods vehicles, delivery vehicles and coaches)”(1) as well as to “motorcycles” driven on Swiss roads. “Electric bicycles and vehicles in circulation before 1970”(2) are exempt.&nb...

  17. Lights on for daytime driving: mandatory from 1 January 2014

    CERN Multimedia

    2013-01-01

    In accordance with the Swiss Federal Decree of 15 June 2012, it will be mandatory from 1 January 2014 to keep your vehicle lights permanently switched on when driving on Swiss territory.   New vehicles are now equipped with daytime running lights which switch on automatically. For older vehicles, side lights can be used as daytime running lights, and it is always possible to fit specific daytime running lights to a vehicle at a later date. This measure is already in force in most European countries and is particularly aimed at improving the visibility of vehicles and helping pedestrians and cyclists to judge the distance and speed of an approaching vehicle more easily. From 1 January 2014, this obligation applies to all “automobiles (passenger cars, heavy goods vehicles, delivery vehicles and coaches)”(1) as well as to “motorcycles” driven on Swiss roads. “Electric bicycles and vehicles in circulation before 1970”(2) are exempt.&nb...

  18. [Incidence of endophthalmitis after intravitreal injection: is antibioprophylaxis mandatory?].

    Science.gov (United States)

    Ramel, J-C; Bron, A-M; Isaico, R; Meillon, C; Binquet, C; Creuzot-Garcher, C

    2014-04-01

    Endophthalmitis is the most dreaded complication after intravitreal injection. With the rise of antiangiogenics their rate is getting higher each year. The use of antibioprophylaxis is controversial. We tried to evaluate the impact of antibioprophylaxis on intravitreal injection endophthalmitis incidence. All patients who received intravitreal injections between January 2007 and October 2012 were included in this retrospective study. Until June 2012 all patients had antibiotics the days following the injection. From July 2012 the antibiotic was replaced by an antiseptic immediately after the injection. An overall number of 11,450 injections were performed. The overall rate of endophthalmitis was 6/11,450 (0.052%). The incidence of endophthalmitis in the group with antibiotics was 3/10,144 injections (0.03%), 2 were culture proven (0.02%). The incidence in the group without antibiotics was 3/1306 (0.23%). The difference was significant (P=0.024). The incidence of endophthalmitis post-intravitreal injections seems to be lower when using antibiotics. However, a prospective study is mandatory to draw more robust conclusions. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

  19. Impact of missing sounding reports on mandatory levels and tropopause statistics: a case study

    Directory of Open Access Journals (Sweden)

    J. C. Antuña

    2006-10-01

    Full Text Available This paper describes the effect of missing sounding reports on temperature and pressure mean values for mandatory levels using the aerological information from the Camagüey Meteorological Centre. Also it is described the effect of missing data on mean temperature and pressure values at the multiple tropopause levels. The case study belongs to one station for a time lag of eight years. Up to the present these types of studies have been conducted using simulated datasets. The present one uses a real inhomogeneous radiosonde dataset. The main reason for missing reports were transmission problems and possible encoding-decoding difficulties. It has been found that profiles of the mean temperature and altitude show little differences between the complete and incomplete datasets. Moreover, no statistical significant differences were found for the mean values of the variables for the complete and incomplete datasets. The most probable reason for those results is that the cause of the missing reports has a random behaviour. Finally we have found that the only two effects noticed on the statistics were slightly higher values of the mean temperatures in the complete dataset and the decrease in the percent of multiple tropopause reports for the incomplete dataset.

  20. [Failure mode and effects analysis on computerized drug prescriptions].

    Science.gov (United States)

    Paredes-Atenciano, J A; Roldán-Aviña, J P; González-García, Mercedes; Blanco-Sánchez, M C; Pinto-Melero, M A; Pérez-Ramírez, C; Calvo Rubio-Burgos, Miguel; Osuna-Navarro, F J; Jurado-Carmona, A M

    2015-01-01

    To identify and analyze errors in drug prescriptions of patients treated in a "high resolution" hospital by applying a Failure mode and effects analysis (FMEA).Material and methods A multidisciplinary group of medical specialties and nursing analyzed medical records where drug prescriptions were held in free text format. An FMEA was developed in which the risk priority index (RPI) was obtained from a cross-sectional observational study using an audit of the medical records, carried out in 2 phases: 1) Pre-intervention testing, and (2) evaluation of improvement actions after the first analysis. An audit sample size of 679 medical records from a total of 2,096 patients was calculated using stratified sampling and random selection of clinical events. Prescription errors decreased by 22.2% in the second phase. FMEA showed a greater RPI in "unspecified route of administration" and "dosage unspecified", with no significant decreases observed in the second phase, although it did detect, "incorrect dosing time", "contraindication due to drug allergy", "wrong patient" or "duplicate prescription", which resulted in the improvement of prescriptions. Drug prescription errors have been identified and analyzed by FMEA methodology, improving the clinical safety of these prescriptions. This tool allows updates of electronic prescribing to be monitored. To avoid such errors would require the mandatory completion of all sections of a prescription. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

  1. A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events.

    Science.gov (United States)

    Faillie, Jean-Luc; Ferrer, Pili; Gouverneur, Amandine; Driot, Damien; Berkemeyer, Shoma; Vidal, Xavier; Martínez-Zapata, Maria José; Huerta, Consuelo; Castells, Xavier; Rottenkolber, Marietta; Schmiedl, Sven; Sabaté, Mònica; Ballarín, Elena; Ibáñez, Luisa

    2017-06-01

    The objective of the study was to develop and validate an adequate tool to evaluate the risk of bias of randomized controlled trials, observational studies, and systematic reviews assessing drug adverse events. We developed a structured risk of bias checklist applicable to randomized trials, cohort, case-control and nested case-control studies, and systematic reviews focusing on drug safety. Face and content validity was judged by three experienced reviewers. Interrater and intrarater reliability were determined using 20 randomly selected studies, assessed by three other independent reviewers including one performing a 3-week retest. The developed checklist examines eight domains: study design and objectives, selection bias, attrition, adverse events information bias, other information bias, statistical methods to control confounding, other statistical methods, and conflicts of interest. The total number of questions varied from 10 to 32 depending on the study design. Interrater and intrarater agreements were fair with Kendall's W of 0.70 and 0.74, respectively. Median time to complete the checklist was 8.5 minutes. The developed checklist showed face and content validity and acceptable reliability to assess the risk of bias for studies analyzing drug adverse events. Hence, it might be considered as a novel useful tool for systematic reviews and meta-analyses focusing on drug safety. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. Prevalence and Management of Drug-Related Problems in Chronic Kidney Disease Patients by Severity Level: A Subanalysis of a Cluster Randomized Controlled Trial in Community Pharmacies.

    Science.gov (United States)

    Quintana-Bárcena, Patricia; Lord, Anne; Lizotte, Annie; Berbiche, Djamal; Lalonde, Lyne

    2018-02-01

    Drug-related problems (DRPs) are prevalent among chronic kidney disease (CKD) patients. However, little is known about their severity and management by community pharmacists. To (a) describe the prevalence of DRPs by severity level in CKD patients and (b) assess the effect of a training-and-communication network program in nephrology (ProFiL) on these DRPs. This is a secondary analysis of a cluster randomized controlled trial evaluating the effect of the ProFiL-program. In 6 CKD clinics, patients at CKD stage 3 or 4 and their community pharmacists were recruited and assigned to the ProFiL group or a usual care (UC) group. Using validated criteria, 2 pharmacists identified DRPs and assessed their severity at baseline and after 12 months. The mean annual change in the number of DRPs per patient by severity level was assessed using a 2-level multivariable linear mixed-effects model. A total of 494 pharmacists and 442 patients participated. At baseline, the prevalence (mean number of DRPs per patient [SD]) of mild DRPs (e.g., requiring dosage adjustment) and moderate DRPs (e.g., drug adherence requiring a monitoring plan) were 0.55 (0.98) and 1.04 (1.51), respectively. After 12 months, an unadjusted incremental annual reduction of 0.34 moderate DRPs (95% CI = -0.66 to -0.01) was observed in the ProFiL group compared with the UC group. After adjustment, no between-group differences were observed. Among patients followed in CKD clinics, most DRPs have a moderate severity requiring specific monitoring by pharmacists. The benefit of continuing education programs, such as ProFiL, to reduce moderate DRPs remains to be determined. This study was supported by the Canadian Institutes of Health Research (grant number: MOP-230207). Part of the study was also funded by Pfizer Canada, Leo Pharma, and Amgen. The authors declare that they have no relevant financial interests. Study concept and design were contributed by Quintana-Bárcena, Lord, and Lalonde. Quintana-Bárcena, Lord

  3. Reductions in HIV/STI Incidence and Sharing of Injection Equipment among Female Sex Workers Who Inject Drugs: Results from a Randomized Controlled Trial

    Science.gov (United States)

    Strathdee, Steffanie A.; Abramovitz, Daniela; Lozada, Remedios; Martinez, Gustavo; Rangel, Maria Gudelia; Vera, Alicia; Staines, Hugo; Magis-Rodriguez, Carlos; Patterson, Thomas L.

    2013-01-01

    Background We evaluated brief combination interventions to simultaneously reduce sexual and injection risks among female sex workers who inject drugs (FSW-IDUs) in Tijuana and Ciudad Juarez, Mexico during 2008–2010, when harm reduction coverage was expanding rapidly in Tijuana, but less so in Juarez. Methods FSW-IDUs ≥18 years reporting sharing injection equipment and unprotected sex with clients within the last month participated in a randomized factorial trial comparing four brief, single-session conditions combining either an interactive or didactic version of a sexual risk intervention to promote safer sex in the context of drug use, and an injection risk intervention to reduce sharing of needles/injection paraphernalia. Women underwent quarterly interviews and testing for HIV, syphilis, gonorrhea, Chlamydia and Trichomonas, blinding interviewers and assessors to assignment. Poisson regression with robust variance estimation and repeated measures ordinal logistic regression examined effects on combined HIV/STI incidence and receptive needle sharing frequency. Findings Of 584 initially HIV-negative FSW-IDUs, retention was ≥90%. After 12 months, HIV/STI incidence decreased >50% in the interactive vs. didactic sex intervention (Tijuana:AdjRR:0.38,95% CI:0.16–0.89; Juarez: AdjRR:0.44,95% CI:0.19–0.99). In Juarez, women receiving interactive vs. didactic injection risk interventions decreased receptive needle-sharing by 85% vs. 71%, respectively (p = 0.04); in Tijuana, receptive needle sharing declined by 95%, but was similar in active versus didactic groups. Tijuana women reported significant increases in access to syringes and condoms, but Juarez women did not. Interpretation After 12 months in both cities, the interactive sexual risk intervention significantly reduced HIV/STI incidence. Expanding free access to sterile syringes coupled with brief, didactic education on safer injection was necessary and sufficient for achieving robust, sustained

  4. A systematic literature review on the efficacy–effectiveness gap: comparison of randomized controlled trials and observational studies of glucose-lowering drugs

    Directory of Open Access Journals (Sweden)

    Ankarfeldt MZ

    2017-01-01

    Full Text Available Mikkel Z Ankarfeldt,1,2 Erpur Adalsteinsson,1 Rolf HH Groenwold,2,3 M Sanni Ali,2,3,4 Olaf H Klungel,2,3 On behalf of GetReal Work Package 2 1Novo Nordisk A/S, 2Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, 3Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, Utrecht, the Netherlands; 4Nuffield Department of Orthopaedics, Rheumatology, Musculoskeletal Sciences, University of Oxford, Oxford, UK Aim: To identify a potential efficacy–effectiveness gap and possible explanations (drivers of effectiveness for differences between results of randomized controlled trials (RCTs and observational studies investigating glucose-lowering drugs. Methods: A systematic literature review was conducted in English language articles published between 1 January, 2000 and 31 January, 2015 describing either RCTs or observational studies comparing glucagon-like peptide-1 analogs (GLP-1 with insulin or comparing dipeptidyl peptidase-4 inhibitors (DPP-4i with sulfonylurea, all with change in glycated hemoglobin (HbA1c as outcome. Medline, Embase, Current Content, and Biosis were searched. Information on effect estimates, baseline characteristics of the study population, publication year, study duration, and number of patients, and for observational studies, characteristics related to confounding adjustment and selection- and information bias were extracted. Results: From 312 hits, 11 RCTs and 7 observational studies comparing GLP-1 with insulin, and from 474 hits, 16 RCTs and 4 observational studies comparing DPP-4i with sulfonylurea were finally included. No differences were observed in baseline characteristics of the study populations (age, sex, body mass index, time since diagnosis of type 2 diabetes mellitus, and HbA1c or effect sizes across study designs. Mean effect sizes ranged from −0.43 to 0.91 and from −0.80 to 1.13 in RCTs and

  5. A Digital Tool to Promote Alcohol and Drug Use Screening, Brief Intervention, and Referral to Treatment Skill Translation: A Mobile App Development and Randomized Controlled Trial Protocol.

    Science.gov (United States)

    Satre, Derek D; Ly, Khanh; Wamsley, Maria; Curtis, Alexa; Satterfield, Jason

    2017-04-18

    Translation of knowledge and skills from classroom settings to clinical practice is a major challenge in healthcare training, especially for behavioral interventions. For example, screening, brief intervention, and referral to treatment (SBIRT) is a highly-promoted approach to identifying and treating individuals at risk for alcohol or drug problems, yet effective, routine use of SBIRT has lagged. The objective of this paper is to describe the development, pilot testing, and trial protocol of a mobile app based on the theory of planned behavior (TPB) to promote SBIRT skill translation and application. Intended for use after classroom training occurs, the mobile app has three primary functions designed to increase behavioral intent to deliver SBIRT: (1) review skills (ie, address knowledge and beliefs about SBIRT), (2) apply skills with patients (ie, build confidence and perceived behavioral control), and (3) report performance data (ie, increase accountability and social norms and/or influence). The app includes depression and anxiety screening tools due to high comorbidity with substance use. A randomized controlled trial (RCT) is in progress among health and social service learners (N=200) recruited from 3 universities and 6 different training programs in nursing, social work, internal medicine, psychiatry, and psychology. Participants are randomized to SBIRT classroom instruction alone or classroom instruction plus app access prior to beginning their field placement rotations. TPB-based data are collected via Qualtrics or via the mobile app pre-post and SBIRT utilization, weekly for 10 weeks. Key outcomes include the frequency of and self-reported confidence in delivery of SBIRT. Beta testing with advanced practice nursing students (N=22) indicated that the app and its associated assessment tools were acceptable and useful. The system usability scale (SUS) mean was 65.8 (n=19), which indicated that the SBIRT app was acceptable but could benefit from improvement

  6. British surgeons' experiences of mandatory online workplace-based assessment.

    Science.gov (United States)

    Pereira, Erlick A C; Dean, Benjamin J F

    2009-07-01

    An online workplace-based assessment tool, the Intercollegiate Surgical Curriculum Programme (ISCP), has become mandatory for all British surgical trainees appointed since August 2007. A compulsory pound125 annual trainee fee has also been introduced to fund its running costs. The study sought to evaluate user satisfaction with the ISCP. A total of 539 users across all surgical specialties (including 122 surgeons acting as assessors) were surveyed in late 2008 by online questionnaire regarding their experiences with the ISCP. Sixty-seven percent had used the tool for at least one year. It was rated above average by only 6% for its registration process and only 11% for recording meetings and objectives. Forty-nine percent described its online assessments as poor or very poor, only 9% considering them good or very good. Seventy-nine percent rated the website's user friendliness as average or worse, as did 72% its peer-assessment tool and 61% its logbook of procedures. Seventy-six percent of respondents had carried out paper assessments due to difficulties using the website. Six percent stated that the ISCP had impacted negatively on their training opportunities, 41% reporting a negative impact overall upon their training; only 6% reported a positive impact. Ninety-four percent did not consider the trainee fee good value, only 2% believing it should be paid by the trainee. The performance of the ISCP leaves large numbers of British surgeons unsatisfied. Its assessments lack appropriate evidence of validity and its introduction has been problematic. With reducing training hours, the increased online bureaucratic burden exacerbates low morale of trainees and trainers, adversely impacting potentially upon both competency and productivity.

  7. Mandatory Risk Assessment Reduces Venous Thromboembolism in Bariatric Surgery Patients.

    Science.gov (United States)

    Nimeri, Abdelrahman A; Bautista, Jejomar; Ibrahim, Maha; Philip, Ruby; Al Shaban, Talat; Maasher, Ahmed; Altinoz, Ajda

    2018-02-01

    Bariatric surgery patients are at high risk for venous thromboembolism (VTE), and chemoprophylaxis is recommended. Sheikh Khalifa Medical City (SKMC) is an American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) member since 2009. We report the rates of VTE in bariatric surgery patients from 2010 to 2016 compared to ACS NSQIP bariatric surgery programs before and after switching from heparin to low molecular weight heparin (LMWH), initiating mandatory risk assessment using Caprini scoring for VTE and adopting an aggressive strategy for high-risk patients regarding dosage of LMWH and chemoprophylaxis after discharge. During the study period, there were 1152 cases (laparoscopic Roux-en-Y gastric bypass (LRYGB) 625 and laparoscopic sleeve gastrectomy (LSG) 527) at Bariatric & Metabolic Institute (BMI) Abu Dhabi compared to 65,693 cases (LRYGB 32,130 and LSG 33,563) at ACS NSQIP bariatric surgery programs. VTE rates remained stable at ACS NSQIP bariatric surgery programs from 2010 to 2016 (0.45, 0.45, 0.45, 0.25, 0.35, 0.3, and 0.3%). In contrast, VTE rates at BMI Abu Dhabi decreased from 2.2% in 2011 to 0.35% after we adopted an aggressive strategy to VTE without an increase in bleeding complications. LRYGB patients with VTE had higher OR time, leak, collection, and mortality at ACS NSQIP hospitals compared to those at BMI Abu Dhabi. In contrast, rates were similar in LSG patients with VTE. Changing our approach to VTE management led our VTE rates to decrease and become like those of ACS NSQIP bariatric surgery patients in LSG and LRYGB.

  8. 77 FR 71773 - Mandatory Country of Origin Labeling of Covered Commodities: Notice of Request for Revision of a...

    Science.gov (United States)

    2012-12-04

    ... Agricultural Marketing Service Mandatory Country of Origin Labeling of Covered Commodities: Notice of Request... the currently approved information collection of the Mandatory Country of Origin Labeling (COOL) of... . SUPPLEMENTARY INFORMATION: Title: Mandatory Country of Origin Labeling of Covered Commodities. OMB Number: 0581...

  9. REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug for Submental Fat Reduction.

    Science.gov (United States)

    Jones, Derek H; Carruthers, Jean; Joseph, John H; Callender, Valerie D; Walker, Patricia; Lee, Daniel R; Subramanian, Meenakshi; Lizzul, Paul F; Gross, Todd M; Beddingfield, Frederick C

    2016-01-01

    ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed and subject-assessed SMF severity using validated scales at 12 weeks after last treatment. Magnetic resonance imaging (MRI) provided an objective measure of submental volume reduction. Patient-reported outcomes were assessed. Among 256 ATX-101-treated and 250 placebo-treated subjects, a ≥1-grade composite response was achieved in 70.0% and 18.6%, and a ≥2-grade composite response in 13.4% and 0%, respectively (p ATX-101 than placebo (46.3% vs 5.3%; p ATX-101-treated subjects reported improvement in the psychological impact of SMF and satisfaction with treatment (p ATX-101-treated subjects reported 1-grade improvement in clinician-assessed SMF after 2 and 4 treatments, respectively. Adverse events (primarily localized to the injection site) were mostly mild or moderate, and transient. Marginal mandibular nerve paresis reported in 4.3% of ATX-101-treated subjects (1.0% of all ATX-101 treatment sessions) was mostly mild, transient, and resolved without sequelae. ATX-101 is a safe and efficacious, first-in-class, injectable drug for SMF reduction.

  10. Is gender still a predisposing factor in contrast-media associated adverse drug reactions? A systematic review and meta-analysis of randomized trials and observational studies.

    Science.gov (United States)

    Lee, Heeyoung; Song, Seungyeon; Oh, Yun-Kyoung; Kang, WonKu; Kim, Eunyoung

    2017-04-01

    To evaluate the role of gender as a risk factor for developing contrast media-associated adverse drug reactions (CM-ADRs) by comparing the incidence of CM-ADR between male and female patients according to study design, ADR type, and computed tomography (CT) examination. We systematically searched three electronic databases for eligible studies. In the studies included (n=18), we assessed effect estimates of the relative incidence of CM-ADR, analysed by experimental design, ADR type and CT examination. This was calculated by using a random effects model if clinical conditions showed heterogeneity; otherwise, a fixed effects model was used. We identified 10,776 patients administered CM. According to the designs, studies were classified into randomised controlled trials (RCTs) and observational studies. Results were as follows: risk ratio (RR)=1.07 (95% confidence interval (CI): 0.79-1.46, P=0.66) for RCTs, and RR=0.77 (95% CI: 0.58-1.04, P=0.09) for observational studies. The results of analysis according to ADR type and for undergoing CT demonstrated that the incidence of CM-ADR did not differ between males and females. We found no significant difference in the incidence of CM-ADRs between male and female patients according to study design, ADR type, or CT examination. Future studies to determine why gender has shown different roles as a risk factor between CM-ADRs and non-CM ADRs are needed. Copyright © 2017 Elsevier B.V. All rights reserved.

  11. A systematic literature review on the efficacy-effectiveness gap: comparison of randomized controlled trials and observational studies of glucose-lowering drugs.

    Science.gov (United States)

    Ankarfeldt, Mikkel Z; Adalsteinsson, Erpur; Groenwold, Rolf Hh; Ali, M Sanni; Klungel, Olaf H

    2017-01-01

    To identify a potential efficacy-effectiveness gap and possible explanations (drivers of effectiveness) for differences between results of randomized controlled trials (RCTs) and observational studies investigating glucose-lowering drugs. A systematic literature review was conducted in English language articles published between 1 January, 2000 and 31 January, 2015 describing either RCTs or observational studies comparing glucagon-like peptide-1 analogs (GLP-1) with insulin or comparing dipeptidyl peptidase-4 inhibitors (DPP-4i) with sulfonylurea, all with change in glycated hemoglobin (HbA1c) as outcome. Medline, Embase, Current Content, and Biosis were searched. Information on effect estimates, baseline characteristics of the study population, publication year, study duration, and number of patients, and for observational studies, characteristics related to confounding adjustment and selection- and information bias were extracted. From 312 hits, 11 RCTs and 7 observational studies comparing GLP-1 with insulin, and from 474 hits, 16 RCTs and 4 observational studies comparing DPP-4i with sulfonylurea were finally included. No differences were observed in baseline characteristics of the study populations (age, sex, body mass index, time since diagnosis of type 2 diabetes mellitus, and HbA1c) or effect sizes across study designs. Mean effect sizes ranged from -0.43 to 0.91 and from -0.80 to 1.13 in RCTs and observational studies, respectively, comparing GLP-1 with insulin, and from -0.13 to 2.70 and -0.20 to 0.30 in RCTs and observational studies, respectively, comparing DPP-4i and sulfonylurea. Generally, the identified observational studies held potential flaws with regard to confounding adjustment and selection- and information bias. Neither potential drivers of effectiveness nor an efficacy-effectiveness gap were identified. However, the limited number of studies and potential problems with confounding adjustment, selection- and information bias in the

  12. One-year results of the CRISTAL Trial, a randomized comparison of cypher sirolimus-eluting coronary stents versus balloon angioplasty for restenosis of drug-eluting stents.

    Science.gov (United States)

    Chevalier, Bernard; Moulichon, Robert; Teiger, Emmanuel; Brunel, Philippe; Metzger, Jean-Philippe; Pansieri, Michel; Carrie, Didier; Stoll, Hans-Peter; Wittebols, Kristel; Spaulding, Christian; Fajadet, Jean

    2012-12-01

     We compared the efficacy of the Cypher Select (Cordis Corporation, Bridgewater, NJ, USA) sirolimus-eluting stent (SES) versus balloon angioplasty (BA) in in-stent restenosis (ISR) of Taxus or Taxus Liberté paclitaxel-eluting stents (PES; Boston Scientific, Natick, MA, USA) or Cypher/Cypher Select SES. Optimal treatment strategies have not been identified for drug-eluting stent (DES) ISR. Patients with a native coronary artery SES or PES ISR were randomized to SES or BA. In addition, a control group included BMS ISR treated with SES. Angiographic control was performed at 12 months. 281 patients were enrolled. Significant differences favoring SES over BA were noted in immediate and net gain (1.39 ± 0.51 vs. 0.97 ± 0.54 mm, P < 0.0001 and 1.07 ± 0.69 vs. 0.49 ± 0.67 mm, P < 0.0001), 12-month mean luminal diameter (MLD; 2.14 ± 0.62 vs. 1.71 ± 0.55 mm, P < 0.0001) and percent diameter stenosis (%DS; 21 ± 19.24 vs. 29.82 ± 18.47, P = 0.001). There was no significant difference at 12 months between SES and BA in the primary end-point late lumen loss (LLL; 0.37 ± 0.57 vs.0.41 ± 0.63, P = 0.73) and in in-stent binary restenosis (11.1% vs. 14%, P = 0.59). Target-lesion revascularization (TLR) was numerically lower in patients treated with SES (5.9% vs. 13.1%, P = 0.097). There was no difference according to the initial DES. In contrast, significantly higher immediate and net gains and MLD were noted in the BMS control group treated by SES. In this angiographic randomized trial comparing SES and BA in SES or PES restenosis, 12 month MLD, immediate and net gain, and %DS favored SES whereas no difference was noted in LLL. Condensed abstract optimal treatment strategies have not been identified for sirolimus-(SES) or paclitaxel-eluting stent (PES) in-stent restenosis (ISR). We randomized patients with a native coronary artery SES or PES ISR to SES or BA. In addition, a control group included BMS ISR treated with SES. There

  13. 21 CFR 810.14 - Cease distribution and notification or mandatory recall strategy.

    Science.gov (United States)

    2010-04-01

    ... factors: (1) The nature of the serious, adverse health consequences related to the device; (2) The ease of... AND HUMAN SERVICES (CONTINUED) MEDICAL DEVICES MEDICAL DEVICE RECALL AUTHORITY Mandatory Medical...

  14. 75 FR 74773 - Mandatory Reporting of Greenhouse Gases: Additional Sources of Fluorinated GHGs

    Science.gov (United States)

    2010-12-01

    ... Protection Agency 40 CFR Part 98 Mandatory Reporting of Greenhouse Gases: Additional Sources of Fluorinated... Greenhouse Gases: Additional Sources of Fluorinated GHGs AGENCY: Environmental Protection Agency (EPA... greenhouse gas emissions from additional sources of fluorinated greenhouse gases, including electronics...

  15. 75 FR 18651 - Mandatory Reporting of Greenhouse Gases: Additional Sources of Fluorinated GHGs

    Science.gov (United States)

    2010-04-12

    ... Protection Agency 40 CFR Part 98 Mandatory Reporting of Greenhouse Gases: Additional Sources of Fluorinated... Greenhouse Gases: Additional Sources of Fluorinated GHGs AGENCY: Environmental Protection Agency (EPA... reporting of fluorinated greenhouse gas (fluorinated GHG) emissions from certain source categories...

  16. The right whale mandatory ship reporting system: a retrospective

    Directory of Open Access Journals (Sweden)

    Gregory K. Silber

    2015-03-01

    Full Text Available In 1998, the United States sought and received International Maritime Organization-endorsement of two Mandatory Ship Reporting (MSR systems designed to improve mariner awareness about averting ship collisions with the endangered North Atlantic right whale (Eubalaena glacialis. Vessel collisions are a serious threat to the right whale and the program was among the first formal attempts to reduce this threat. Under the provisions of the MSR, all ships >300 gross tons are required to report their location, speed, and destination to a shore-based station when entering two key right whale habitats: one in waters off New England and one off coastal Georgia and Florida. In return, reporting ships receive an automatically-generated message, delivered directly to the ship’s bridge, that provides information about right whale vulnerability to vessel collisions and actions mariners can take to avoid collisions. The MSR has been in operation continuously from July 1999 to the present. Archived incoming reports provided a 15-plus year history of ship operations in these two locations. We analyzed a total of 26,772 incoming MSR messages logged between July 1999 and December 2013. Most ships that were required to report did so, and compliance rates were generally constant throughout the study period. Self-reported vessel speeds when entering the systems indicated that most ships travelled between 10 and 16 (range = 5–20 + knots. Ship speeds generally decreased in 2009 to 2013 following implementation of vessel speed restrictions. The number of reports into the southern system remained relatively constant following a steady increase through 2007, but numbers in the northern system decreased annually beginning in 2008. If reporting is indicative of long-term patterns in shipping operations, it reflects noteworthy changes in marine transportation. Observed declines in ship traffic are likely attributable to the 2008–2009 economic recession, the

  17. Trade and Sustainable Development Goal (SDG) 15: Promoting "Life on Land" through mandatory and voluntary approaches

    OpenAIRE

    Andrew, Dale

    2017-01-01

    Sustainable Development Goal 15 deals with "Life on Land." Its nine targets and three means of implementation cover a vast array of environmentally sensitive issues related to land-based renewable natural resources. This paper explores the channels through which trade can address them. Approaches are categorized as mandatory or voluntary. The Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES) has over 40 years' experience in mandatory regulation of trade i...

  18. The impact of mandatory IFRS adoption on financial analysts’ earnings forecasts in Spain

    OpenAIRE

    Garrido Miralles, Pascual; Sanabria García, Sonia

    2014-01-01

    This study contributes to investigation into the benefits of mandatory adoption of International Financial Reporting Standards (IFRS) in regard to Spanish GAAP for analysts’ earnings forecasts. In a sample of listed Spanish firms, we find that mandatory IFRS adoption led to improvements in the quality of the information provided to financial analysts in the post-adoption period. We provide evidence that the benefits of IFRS take time to materialise. We also observe that the expected benefits ...

  19. Governing GMOs: The (Counter) Movement for Mandatory and Voluntary Non-GMO Labels

    OpenAIRE

    Carmen Bain; Tamera Dandachi

    2014-01-01

    Since 2012 the anti-GMO (genetically modified organism) movement has gained significant grassroots momentum in its efforts to require mandatory GMO food labels through state-level ballot and legislative efforts. Major food and agriculture corporations are opposed to mandatory GMO labels and have successfully defeated most of these initiatives. Nevertheless, these battles have garnered significant media attention and re-energized the debate over GMO crops and foods. In this paper, we argue tha...

  20. 21 CFR 99.103 - Mandatory statements and information.

    Science.gov (United States)

    2010-04-01

    ..., font, layout, contrast, graphic design, headlines, spacing, and any other technique to achieve emphasis... statement to the front of each reprint or copy of an article from a scientific or medical journal and to the... publication or scientific or medical journal that have been previously published about the new use of the drug...

  1. Total control: a critical analysis of mandatory HIV testing in U.S. prisons.

    Science.gov (United States)

    Gagnon, Marilou; Jacob, Jean Daniel; Cormier, Luc

    2013-01-01

    The aim of this paper is to explore the relationship between mandatory HIV testing and the institutional management of inmates in U.S. prisons. Mandatory HIV testing has been largely overlooked by the nursing community even though it has important human rights and ethical implications. Drawing on the work of Goffman (1990) on the inner workings of total institutions, the present article critically examines the deployment of mandatory HIV testing in U.S. prisons. To set the stage, we define mandatory HIV testing and describe the methods of HIV testing currently used in U.S. prison settings. Then, we provide a brief overview of the concept of total institution and the mortification process. Finally, we expand on the relationship between mandatory HIV testing and much larger institutional objectives of total control, total structuring, total isolation, and separation of inmates from society (as summarized by Farrington, 1992). And lastly, we provide a brief discussion on the implications of mandatory HIV testing (as a method of HIV testing) from a nursing perspective.

  2. Mandatory Nap Times and Group Napping Patterns in Child Care: An Observational Study.

    Science.gov (United States)

    Staton, Sally L; Smith, Simon S; Hurst, Cameron; Pattinson, Cassandra L; Thorpe, Karen J

    2017-01-01

    Policy provision for naps is typical in child care settings, but there is variability in the practices employed. One practice that might modify children's early sleep patterns is the allocation of a mandatory nap time in which all children are required to lie on their beds without alternate activity permitted. There is currently limited evidence of the effects of such practices on children's napping patterns. This study examined the association between duration of mandatory nap times and group-level napping patterns in child care settings. Observations were undertaken in a community sample of 113 preschool rooms with a scheduled nap time (N = 2,114 children). Results showed that 83.5% of child care settings implemented a mandatory nap time (range = 15-145 min) while 14.2% provided alternate activities for children throughout the nap time period. Overall, 31% of children napped during nap times. Compared to rooms with ≤ 30 min of mandatory nap time, rooms with 31-60 min and > 60 min of mandatory nap time had a two-and-a-half and fourfold increase, respectively, in the proportion of children napping. Nap onset latency did not significantly differ across groups. Among preschool children, exposure to longer mandatory nap times in child care may increase incidence of napping.

  3. Effect of Anti-Obesity Drug on Cardiovascular Risk Factors: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    OpenAIRE

    Yu-Hao Zhou; Xiu-Qiang Ma; Cheng Wu; Jian Lu; Shan-Shan Zhang; Jia Guo; Shun-Quan Wu; Xiao-Fei Ye; Jin-Fang Xu; Jia He

    2012-01-01

    BACKGROUND: Anti-obesity drugs are widely used to prevent the complications of obesity, however, the effects of anti-obesity drugs on cardiovascular risk factors are unclear at the present time. We carried out a comprehensively systematic review and meta-analysis to assess the effects of anti-obesity drugs on cardiovascular risk factors. METHODOLOGY AND PRINCIPAL FINDINGS: We systematically searched Medline, EmBase, the Cochrane Central Register of Controlled Trials, reference lists of articl...

  4. Menatetrenone versus alfacalcidol in the treatment of Chinese postmenopausal women with osteoporosis: a multicenter, randomized, double-blinded, double-dummy, positive drug-controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Jiang Y

    2014-01-01

    Full Text Available Yan Jiang,1,* Zhen-Lin Zhang,2,* Zhong-Lan Zhang,3 Han-Min Zhu,4 Yi-Yong Wu,5 Qun Cheng,4 Feng-Li Wu,5 Xiao-Ping Xing,1 Jian-Li Liu,3 Wei Yu,6 Xun-Wu Meng11Department of Endocrinology, Key Laboratory of Endocrinology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, 2Metabolic Bone Disease and Genetic Research Unit, Department of Osteoporosis and Bone Disease, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, Shanghai, 3Department of Gynecology and Obstetrics, General Hospital of the People's Liberation Army, Beijing, 4Department of Geriatrics, Shanghai Huadong Hospital, Shanghai, 5Department of Gynecology and Obstetrics, Beijing Hospital, Ministry of Public Health, Beijing, 6Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China*These authors contributed equally to this workObjective: To evaluate whether the efficacy and safety of menatetrenone for the treatment of osteoporosis is noninferior to alfacalcidol in Chinese postmenopausal women.Method: This multicenter, randomized, double-blinded, double-dummy, noninferiority, positive drug-controlled clinical trial was conducted in five Chinese sites. Eligible Chinese women with postmenopausal osteoporosis (N=236 were randomized to Group M or Group A and received menatetrenone 45 mg/day or alfacalcidol 0.5 µg/day, respectively, for 1 year. Additionally, all patients received calcium 500 mg/day. Posttreatment bone mineral density (BMD, new fracture onsets, and serum osteocalcin (OC and undercarboxylated OC (ucOC levels were compared with the baseline value in patients of both groups.Results: A total of 213 patients (90.3% completed the study. After 1 year of treatment, BMD among patients in Group M significantly increased from baseline by 1.2% and 2.7% at the lumbar spine and trochanter, respectively (P<0.001; and the percentage increase of BMD in Group A was 2

  5. British surgeons' experiences of a mandatory online workplace based assessment portfolio resurveyed three years on.

    Science.gov (United States)

    Pereira, Erlick A C; Dean, Benjamin J F

    2013-01-01

    An online portfolio, the Intercollegiate Surgical Curriculum Programme (ISCP; http://www.iscp.ac.uk), became mandatory for British surgical trainees 5 years ago, alongside a compulsory £125 (US$200) annual fee. We previously demonstrated widespread dissatisfaction with its 2008 ver. 5. Here we evaluate and contrast user satisfaction with ver. 8. A total of 359 users across all surgical specialties and UK regions were randomly sampled and surveyed in 2011 by online questionnaire regarding ISCP, elogbook (http://www.elogbook.org.uk), and results compared with 539 users surveyed in 2008. Likert 5-point rating scales were largely used and data analyzed using χ(2) tests. Seventy-nine percent used ISCP and 38% elogbook (http://www.elogbook.org); 201 responders (56%) evaluated ISCP ver. 8; 31% had registered for at least 1 year, and 59% for 3 years or more. Modal ratings were "average" throughout, with the following percentages of responders rating "poor" or worse vs "good" or better the following domains: registration 12% vs 35%; induction procedure 41% vs. 15%; workplace based assessments 36% vs 22%; peer assessment tool 34% vs 25%; recording meetings 34% vs 19%; Helpdesk 11% vs 40%; user friendliness 29% vs 24%. Trainees were neutral about ISCP's impact upon training and 44% thought that ISCP was needed. Statistically significant (p workplace-based assessments. Half a decade on, these assessments remain without appropriate evidence of validity despite increasing demands upon trainees to complete quotas of them. With reduced permitted training hours, the growing online bureaucratic burden continues to demoralize busy surgical trainers and trainees. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

  6. The efficacy and safety of insulin-sensitizing drugs in HIV-associated lipodystrophy syndrome: a meta-analysis of randomized trials

    Directory of Open Access Journals (Sweden)

    Larson Robin J

    2010-06-01

    Full Text Available Abstract Background HIV-associated lipodystrophy syndrome (HALS is characterized by insulin resistance, abnormal lipid metabolism and redistribution of body fat. To date, there has been no quantitative summary of the effects of insulin sensitizing-agents for the treatment of this challenging problem. Methods We searched MEDLINE, the Cochrane Library, clinical trial registries, conference proceedings and references for randomized trials evaluating rosiglitazone, pioglitazone or metformin in patients with evidence of HALS (last update December 2009. Two reviewers independently abstracted data and assessed quality using a standard form. We contacted authors for missing data and calculated weighted mean differences (WMD and 95% confidence intervals (CI for each outcome. Results Sixteen trials involving 920 patients met inclusion criteria. Rosiglitazone modestly improved fasting insulin (WMD -3.67 mU/L; CI -7.03, -0.31 but worsened triglycerides (WMD 32.5 mg/dL; CI 1.93, 63.1, LDL (WMD 11.33 mg/dL; CI 1.85, 20.82 and HDL (WMD -2.91 mg/dL; CI -4.56, -1.26 when compared to placebo or no treatment in seven trials. Conversely, pioglitazone had no impact on fasting insulin, triglycerides or LDL but improved HDL (WMD 7.60 mg/dL; CI 0.20, 15.0 when compared to placebo in two trials. Neither drug favorably impacted measures of fat redistribution. Based on six trials with placebo or no treatment controls, metformin reduced fasting insulin (WMD -8.94 mU/L; CI -13.0, -4.90, triglycerides (WMD -42.87 mg/dL; CI -73.3, -12.5, body mass index (WMD -0.70 kg/m2; CI -1.09, -0.31 and waist-to-hip ratio (WMD -0.02; CI -0.03, 0.00. Three trials directly compared metformin to rosiglitazone. While effects on insulin were comparable, lipid levels and measures of fat redistribution all favored metformin. Severe adverse events were uncommon in all 16 trials. Conclusion Based on our meta-analysis, rosiglitazone should not be used in HALS. While pioglitazone may be safer, any

  7. Predictors of poor retention on antiretroviral therapy as a major HIV drug resistance early warning indicator in Cameroon: results from a nationwide systematic random sampling

    Directory of Open Access Journals (Sweden)

    Serge Clotaire Billong

    2016-11-01

    Full Text Available Abstract Background Retention on lifelong antiretroviral therapy (ART is essential in sustaining treatment success while preventing HIV drug resistance (HIVDR, especially in resource-limited settings (RLS. In an era of rising numbers of patients on ART, mastering patients in care is becoming more strategic for programmatic interventions. Due to lapses and uncertainty with the current WHO sampling approach in Cameroon, we thus aimed to ascertain the national performance of, and determinants in, retention on ART at 12 months. Methods Using a systematic random sampling, a survey was conducted in the ten regions (56 sites of Cameroon, within the “reporting period” of October 2013–November 2014, enrolling 5005 eligible adults and children. Performance in retention on ART at 12 months was interpreted following the definition of HIVDR early warning indicator: excellent (>85%, fair (85–75%, poor (<75; and factors with p-value < 0.01 were considered statistically significant. Results Majority (74.4% of patients were in urban settings, and 50.9% were managed in reference treatment centres. Nationwide, retention on ART at 12 months was 60.4% (2023/3349; only six sites and one region achieved acceptable performances. Retention performance varied in reference treatment centres (54.2% vs. management units (66.8%, p < 0.0001; male (57.1% vs. women (62.0%, p = 0.007; and with WHO clinical stage I (63.3% vs. other stages (55.6%, p = 0.007; but neither for age (adults [60.3%] vs. children [58.8%], p = 0.730 nor for immune status (CD4351–500 [65.9%] vs. other CD4-staging [59.86%], p = 0.077. Conclusions Poor retention in care, within 12 months of ART initiation, urges active search for lost-to-follow-up targeting preferentially male and symptomatic patients, especially within reference ART clinics. Such sampling strategy could be further strengthened for informed ART monitoring and HIVDR prevention perspectives.

  8. Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02).

    Science.gov (United States)

    Bauer, S; Baier, H; Baumgartner, C; Bohlmann, K; Fauser, S; Graf, W; Hillenbrand, B; Hirsch, M; Last, C; Lerche, H; Mayer, T; Schulze-Bonhage, A; Steinhoff, B J; Weber, Y; Hartlep, A; Rosenow, F; Hamer, H M

    2016-01-01

    Various brain stimulation techniques are in use to treat epilepsy. These methods usually require surgical implantation procedures. Transcutaneous vagus nerve stimulation (tVNS) is a non-invasive technique to stimulate the left auricular branch of the vagus nerve at the ear conch. We performed a randomized, double-blind controlled trial (cMPsE02) to assess efficacy and safety of tVNS vs. control stimulation in patients with drug-resistant epilepsy. Primary objective was to demonstrate superiority of add-on therapy with tVNS (stimulation frequency 25 Hz, n = 39) versus active control (1 Hz, n = 37) in reducing seizure frequency over 20 weeks. Secondary objectives comprised reduction in seizure frequency from baseline to end of treatment, subgroup analyses and safety evaluation. Treatment adherence was 84% in the 1 Hz group and 88% in the 25 Hz group, respectively. Stimulation intensity significantly differed between the 1 Hz group (1.02 ± 0.83 mA) and the 25 Hz group (0.50 ± 0.47 mA; p = 0.006). Mean seizure reduction per 28 days at end of treatment was -2.9% in the 1 Hz group and 23.4% in the 25 Hz group (p = 0.146). In contrast to controls, we found a significant reduction in seizure frequency in patients of the 25 Hz group who completed the full treatment period (20 weeks; n = 26, 34.2%, p = 0.034). Responder rates (25%, 50%) were similar in both groups. Subgroup analyses for seizure type and baseline seizure frequency revealed no significant differences. Adverse events were usually mild or moderate and comprised headache, ear pain, application site erythema, vertigo, fatigue, and nausea. Four serious adverse events were reported including one sudden unexplained death in epilepsy patients (SUDEP) in the 1 Hz group which was assessed as not treatment-related. tVNS had a high treatment adherence and was well tolerated. Superiority of 25 Hz tVNS over 1 Hz tVNS could not be proven in this relatively small

  9. Effect of Short-Term Fasting on Systemic Cytochrome P450-Mediated Drug Metabolism in Healthy Subjects: A Randomized, Controlled, Crossover Study Using a Cocktail Approach

    NARCIS (Netherlands)

    Lammers, Laureen A.; Achterbergh, Roos; van Schaik, Ron H. N.; Romijn, Johannes A.; Mathôt, Ron A. A.

    2017-01-01

    Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic clearance of different drugs. In a

  10. Mandatory policy: Most successful way to maximize fortification’s effect on vitamin and mineral deficiency

    Directory of Open Access Journals (Sweden)

    Sarah Zimmerman

    2014-12-01

    Full Text Available Background: Damaging effects of vitamin and mineral deficiencies contribute to health and development problems throughout the world. Food fortification has substantially improved nutrition-related health conditions in many countries, but opportunities for fortification are not fully utilized. Where food fortification is considered, leaders have to determine whether fortification should be mandatory or voluntary. Objective: This article explores experiences with mandatory wheat flour fortification as compared to voluntary fortification to offer insight for policies related to any type of food fortification. Mandatory fortification means the country requires the addition of specific nutrients at predetermined levels to specified foods or food products. Voluntary policies allow food manufacturers to enrich their products but do not require them to do so. Results: Mandatory fortification is more likely than voluntary fortification to reach a high proportion of the population and hence achieve the desired health impact. Mandatory fortification does not require consumers to change food purchasing preferences, it distributes the health benefits more equitably than voluntary fortification across a population, it establishes safe levels of included nutrients, and it is not subject to the food manufacturers’ marketing investments or discretion. Conclusion: The health benefits of mandatory fortification are most likely to be achieved and sustained if national, multi-sector leaders develop a cooperative approach for appropriate food fortification policies that can be feasibly implemented and effectively monitored. Mandatory fortification, however, requires high-level commitment through the political process. Policy makers must contend with possible criticism that it interferes with personal choices or may cause unintended health problems.

  11. Parents' and staff's support for a childcare agency employee mandatory vaccination policy or agency certification program.

    Science.gov (United States)

    Rebmann, Terri; Wang, Jing; Wilson, Kristin D; Gilbertson, Philip G; Wakefield, Mary

    2016-07-01

    Vaccine-preventable diseases pose a significant risk to children in childcare. However, few regulations exist regarding childcare staff vaccination. This study aimed to assess support for a childcare agency staff mandatory vaccination policy. Surveys were distributed to staff and parents at 23 St Louis, Mo, childcare agencies during fall 2014. Staff and parents' support for a mandatory vaccination and/or agency certification program were compared using χ(2) tests. Multivariate logistic regression was conducted using a 2-level nested design and controlling for gender, race, age, and income to determine predictive models for support for a mandatory staff vaccination policy and/or agency certification program. Overall, 354 parents and staff participated (response rate, 32%). Most supported a mandatory staff vaccination policy (80.0%; n = 280) or agency certification program (81.2%; n = 285), and there were no differences between parents versus staff. Determinants of support for a mandatory policy included willingness to receive influenza vaccine annually, belief that vaccines are safe and effective, and support for the policy only if there were no costs. There is strong support for some type of childcare agency staff vaccination policy. Implementing such a policy/program should be a collaborative endeavor that addresses vaccine cost and access. Copyright © 2016 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

  12. Evaluation of Knowledge and Awareness of Patients about Prescribed Drugs and their Package Inserts: A Cross-sectional Study

    National Research Council Canada - National Science Library

    Uma A Bhosale

    2016-01-01

      Introduction: The package insert (PI) is an officially approved mandatory document inside the package with the intention to provide relevant, recent and unbiased information for rational drug use...

  13. A randomized controlled trial to evaluate antiretroviral salvage therapy guided by rules-based or phenotype-driven HIV-1 genotypic drug-resistance interpretation with or without concentration-controlled intervention: the Resistance and Dosage Adapted Regimens (RADAR) study.

    Science.gov (United States)

    Torti, Carlo; Quiros-Roldan, Eugenia; Regazzi, Mario; De Luca, Andrea; Mazzotta, Francesco; Antinori, Andrea; Ladisa, Nicoletta; Micheli, Valeria; Orani, Anna; Patroni, Andrea; Villani, Paola; Lo Caputo, Sergio; Moretti, Francesca; Di Giambenedetto, Simona; Castelnuovo, Filippo; Maggi, Paolo; Tinelli, Carmine; Carosi, Giampiero

    2005-06-15

    It is not well defined whether concentration-controlled intervention (CCI) and rules-based human immunodeficiency virus (HIV) type 1 genotype drug-resistance interpretation (GI) or virtual phenotype drug-resistance interpretation (VPI) may improve the outcome of HIV salvage therapy. In a prospective, randomized, controlled trial, patients were randomized (on a factorial basis) to change treatment after either GI or VPI, and they then were further randomized to the control arm (no CCI) or the CCI arm. Protease inhibitor (PI) and nonnucleoside reverse-transcriptase inhibitor (NNRTI) trough concentration (Ctrough) values were determined at weeks 1, 4, 12, and 24 of the study. Among 230 patients, virological benefit (defined by an HIV RNA load of receipt of a regimen that contained PIs boosted with ritonavir was an independent predictor of virological response. The present study did not support the routine use of CCI for patients undergoing salvage treatment, probably as a result of existing difficulties associated with its clinical application. However, a higher Ctrough value appeared to be correlated with treatment response. No major differences were found between VPI or GI when they are used together with expert advice for the selection of salvage treatment combinations.

  14. Similar effects of disease-modifying antirheumatic drugs, glucocorticoids, and biologic agents on radiographic progression in rheumatoid arthritis: meta-analysis of 70 randomized placebo-controlled or drug-controlled studies, including 112 comparisons

    DEFF Research Database (Denmark)

    Graudal, Niels; Jürgens, Gesche

    2010-01-01

    To define the differences in effects on joint destruction in rheumatoid arthritis (RA) patients between therapy with single and combination disease-modifying antirheumatic drugs (DMARDs), glucocorticoids, and biologic agents....

  15. Web-based screening and brief intervention for poly-drug use among teenagers: study protocol of a multicentre two-arm randomized controlled trial

    National Research Council Canada - National Science Library

    Arnaud, Nicolas; Bröning, Sonja; Drechsel, Magdalena; Thomasius, Rainer; Baldus, Christiane

    2012-01-01

    Mid to late adolescence is characterised by a vulnerability to problematic substance use since the consumption of alcohol and illicit drugs is frequently initiated and increased in this life period...

  16. Listening to Turkish classical music decreases patients’ anxiety, pain, dissatisfaction and the dose of sedative and analgesic drugs during colonoscopy: A prospective randomized controlled trial

    OpenAIRE

    Ovayolu, Nimet; Ucan, Ozlem; Pehlivan, Seda; Pehlivan, Yavuz; Buyukhatipoglu, Hakan; Savas, M Cemil; Gulsen, Murat T

    2006-01-01

    AIM: To determine whether listening to music decreases the requirement for dosages of sedative drugs, patients’ anxiety, pain and dissatisfaction feelings during colonoscopy and makes the procedure more comfortable and acceptable.

  17. Effectiveness and acceptance of a health care-based mandatory vaccination program.

    Science.gov (United States)

    Leibu, Rachel; Maslow, Joel

    2015-01-01

    To decrease the risk of transmission of hospital-associated transmission of influenza and pertussis through mandatory vaccination of staff. A mandatory influenza and toxoid-diphtheria toxoid-acellular pertussis program was implemented systemwide. A structured vaccine exemption program was implemented for those requesting a medical and/or religious/moral/ethical exemption. Systemwide influenza vaccination rates increased from 67% historically, 76.2% in the 2012 to 2013 influenza season, to 94.7% in 2013 to 2014 with an overall compliance rate of 97.8%. Toxoid-diphtheria toxoid-acellular pertussis vaccination rates systemwide reached 94.9%, with an overall compliance rate of 98%. Higher rates were experienced at individual hospital facilities compared with the corporate location. Successful vaccination campaign outcomes can be achieved through diligent enforcement of mandatory vaccination, masking, and other infection prevention procedures.

  18. Mandatory HIV Screening Policy & Everyday Life: A Look Inside the Canadian Immigration Medical Examination

    Directory of Open Access Journals (Sweden)

    LAURA BISAILLON

    2011-11-01

    Full Text Available Findings that detail the social organization of day-to-day practices associated with the Canadian government policy of mandatory HIV testing of permanent residence applicants to Canada are reported. Institutional ethnography was used to investigate interactions between HIV-positive applicants and immigration physicians during the immigration medical examination. A composite narrative recounts details of a woman applicant's discovery through immigration testing that she was living with HIV. Mandatory HIV testing gives rise to serious difficulties for applicants to Canada living with HIV. Applicant, physician and federal state employee work practices associated with mandatory HIV testing are analysed. These practices contribute to the ideological work of the Canadian state, where interest bounds up in the examination serve the state and not the applicant. Findings should be useful for Canadian immigration policy makers who wish to develop constructive and functional strategies to address issues that matter in people's lives

  19. Mandatory physician reporting of drivers with cardiac disease: ethical and practical considerations.

    Science.gov (United States)

    Simpson, Christopher S; Hoffmaster, Barry; Mitchell, L Brent; Klein, George J

    2004-11-01

    Many jurisdictions in Canada have enacted legislation that requires physicians to report their patients to the Ministry of Transport if they have a medical condition that may put them at increased risk to operate a motor vehicle. The Canadian Cardiovascular Society has published guidelines that are designed to assist physicians and policy-makers in their decision-making. Legislation is designed to protect society, and the guidelines are designed to fulfill that mandate. However, in the present paper, important issues that have not been addressed to date are discussed. What is the efficacy of mandatory reporting legislation? What are the harms done to patients who are restricted from driving? What are the costs of the mandatory reporting system? How can the scientific/technical assessment of risk be reconciled with the social/ethical view of risk assessment? Until these issues are addressed, important questions about the ethics, efficacy and cost of mandatory physician reporting will remain unanswered.

  20. Drug Facts

    Medline Plus

    Full Text Available ... Why Is It So Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug ... Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug ...

  1. Mandatory Reporting of Human Trafficking: Potential Benefits and Risks of Harm.

    Science.gov (United States)

    English, Abigail

    2017-01-01

    Human trafficking, including both sex and labor trafficking, has profound consequences for the safety, health, and well-being of victims and survivors. Efforts to address human trafficking through prevention, protection, and prosecution are growing but remain insufficient. Mandatory reporting has the potential to bring victims and survivors to the attention of social service and law enforcement agencies but may discourage trafficked persons from seeking help, thereby limiting the ability of health care professionals to establish trust and provide needed care. States' experience in implementing child abuse laws can be useful in assessing the potential risks and benefits of mandatory reporting of human trafficking. © 2017 American Medical Association. All Rights Reserved.

  2. A prospective, randomized, open-label trial of 6-month versus 12-month dual antiplatelet therapy after drug-eluting stent implantation in ST-elevation myocardial infarction: Rationale and design of the "DAPT-STEMI trial".

    Science.gov (United States)

    Kedhi, Elvin; Fabris, Enrico; van der Ent, Martin; Kennedy, Mark W; Buszman, Pawel; von Birgelen, Clemens; Cook, Stéphane; Wedel, Hans; Zijlstra, Felix

    2017-06-01

    The optimal duration of dual antiplatelet therapy (DAPT) after percutaneous coronary intervention with second-generation drug eluting stents (DESs) is unclear. Because prolonged DAPT is associated with higher bleeding risk and health care costs, establishing optimal DAPT duration is of paramount importance. No other randomized controlled trials have evaluated the safety of shorter DAPT duration in ST-elevation myocardial infarction (STEMI) patients treated with second-generation DESs and latest P2Y12 platelet receptor inhibitors. Six months of DAPT after Resolute Integrity stent implantation in STEMI patients is not inferior to 12 months of DAPT in clinical outcomes. The Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation In ST-elevation Myocardial Infarction (DAPT-STEMI) trial is a randomized, multicenter, international, open-label trial designed to examine the safety (noninferiority) of 6-month DAPT after Resolute Integrity stent implantation in STEMI patients compared with 12-month DAPT. Event-free patients on DAPT at 6month will be randomized (1:1 fashion) between single (aspirin only) versus DAPT for an additional 6 months and followed until 2 years after primary percutaneous coronary intervention. The primary end point is a patient-oriented composite endpoint of all-cause mortality, any myocardial infarction, any revascularization, stroke, and major bleeding (net adverse clinical events [NACE]) at 18 months after randomization. To achieve a power of 85% for a noninferiority limit of 1.66, a total of 1100 enrolled patients are required. The DAPT-STEMI trial aims to assess in STEMI patients treated with second-generation DESs whether discontinuation of DAPT after 6 months of event-free survival is noninferior to routine 12-month DAPT. Copyright © 2017 Elsevier Inc. All rights reserved.

  3. College Athletes and Drug Testing: Attitudes and Behaviors by Gender and Sport

    OpenAIRE

    Schneider, Dona; Morris, Joyce

    1993-01-01

    We surveyed varsity athletes at a Big East university to assess attitudes toward a mandatory drug education and testing program and examined whether there were differences in drug-related attitudes and behaviors based on gender or varsity sport. We found no statistically significant differences in personal drug use behaviors based on gender or team affiliation. Attitudes about drug use and knowledge of a teammate using drugs did show significant differences based on varsity sport. Tennis play...

  4. Development and evaluation of 'Pure Rush': An online serious game for drug education.

    Science.gov (United States)

    Stapinski, Lexine A; Reda, Bill; Newton, Nicola C; Lawler, Siobhan; Rodriguez, Daniel; Chapman, Catherine; Teesson, Maree

    2017-10-06

    Learning is most effective when it is active, enjoyable and incorporates feedback. Past research demonstrates that serious games are prime candidates to utilise these principles, however the potential benefits of this approach for delivering drug education are yet to be examined in Australia, a country where drug education in schools is mandatory. The serious game 'Pure Rush' was developed across three stages. First, formative consultation was conducted with 115 students (67% male, aged 15-17 years), followed by feasibility and acceptability testing of a prototype of the game (n = 25, 68% male). In the final stage, 281 students (62% female, aged 13-16 years) were randomly allocated to receive a lesson involving Pure Rush or an active control lesson. The lessons were compared in terms of learning outcomes, lesson engagement and future intentions to use illicit drugs. Students enjoyed playing Pure Rush, found the game age-appropriate and the information useful to them. Both the Pure Rush and the active control were associated with significant knowledge increase from pre to post-test. Among females, multi-level mixed-effects regression showed knowledge gain was greater in the Pure Rush condition compared to control (β = 2.36, 95% confidence interval 0.36-4.38). There was no evidence of between condition differences in lesson engagement or future intentions to use illicit drugs. Pure Rush is an innovative online drug education game that is well received by students and feasible to implement in schools. [Stapinski LA, Reda B, Newton NC, Lawler S, Rodriguez D, Chapman C, Teesson M. Development and evaluation of 'Pure Rush': An online serious game for drug education. Drug Alcohol Rev 2017]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

  5. Effect of Chronic Kidney Disease in Women Undergoing Percutaneous Coronary Intervention With Drug-Eluting Stents: A Patient-Level Pooled Analysis of Randomized Controlled Trials

    NARCIS (Netherlands)

    Baber, Usman; Giustino, Gennaro; Sartori, Samantha; Aquino, Melissa; Stefanini, Giulio G.; Steg, Gabriel; Windecker, Stephan; Leon, Martin B.; Wijns, William; Serruys, Patrick W.; Valgimigli, Marco; Stone, Gregg W.; Dangas, George D.; Morice, Marie-Claude; Camenzind, Edoardo; Weisz, Giora; Smits, Pieter C.; Kandzari, David E.; von Birgelen, Clemens; Mastoris, Ioannis; Galatius, Soren; Jeger, Raban V.; Kimura, Takeshi; Mikhail, Ghada W.; Itchhaporia, Dipti; Mehta, Laxmi; Ortega, Rebecca; Kim, Hyo-Soo; Kastrati, Adnan; Chieffo, Alaide; Mehran, Roxana

    2016-01-01

    Objectives This study sought to evaluate: 1) the effect of impaired renal function on long-term clinical outcomes in women undergoing percutaneous coronary intervention (PCI) with drug-eluting stent (DES); and 2) the safety and efficacy of new-generation compared with early-generation DES in women

  6. Cognitive Behavioral Therapy for Adherence and Depression (CBT-AD) in HIV-Infected Injection Drug Users: A Randomized Controlled Trial

    Science.gov (United States)

    Safren, Steven A.; O'Cleirigh, Conall M.; Bullis, Jacqueline R.; Otto, Michael W.; Stein, Michael D.; Pollack, Mark H.

    2012-01-01

    Objective: Depression and substance use, the most common comorbidities with HIV, are both associated with poor treatment adherence. Injection drug users comprise a substantial portion of individuals with HIV in the United States and globally. The present study tested cognitive behavioral therapy for adherence and depression (CBT-AD) in patients…

  7. Nonsteroidal anti-inflammatory drug or glucosamine reduced pain and improved muscle strength with resistance training in a randomized controlled trial of knee osteoarthritis patients

    DEFF Research Database (Denmark)

    Petersen, Susanne G; Beyer, Nina; Hansen, Mette Rud

    2011-01-01

    To investigate the effect of 12 weeks of strength training in combination with a nonsteroidal anti-inflammatory drug (NSAID), glucosamine, or placebo on muscle cross-sectional area (CSA), strength (primary outcome parameters), and function, power, pain, and satellite cell number (secondary outcome...

  8. [Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: Design of a multicenter randomized controlled trial (IMPROveFALL-study)

    NARCIS (Netherlands)

    K.A. Hartholt (Klaas); N. van der Velde (Nathalie); E.M.M. van Lieshout (Esther); S. Polinder (Suzanne); O.J. de Vries (Oscar); N.D.A. Boyé (Nicole); A.L.A. Kerver (Anton); G. Ziere; M.M.M. Bruijninckx (Milko); F.U.S. Mattace Raso (Francesco); A.G. Uitterlinden (André); E.F. van Beeck (Ed); P. Lips (Paul); P. Patka (Peter); T.J.M. van der Cammen (Tischa)

    2011-01-01

    textabstractBackground: Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the

  9. Effect of Short-Term Fasting on Systemic Cytochrome P450-Mediated Drug Metabolism in Healthy Subjects: A Randomized, Controlled, Crossover Study Using a Cocktail Approach

    NARCIS (Netherlands)

    L.A. Lammers (Laureen); Achterbergh, R. (Roos); R.H.N. van Schaik (Ron); J.A. Romijn (Johannes); R.A. Mathot (Ron)

    2017-01-01

    textabstractBackground and Objective: Short-term fasting can alter drug exposure but it is unknown whether this is an effect of altered oral bioavailability and/or systemic clearance. Therefore, the aim of our study was to assess the effect of short-term fasting on oral bioavailability and systemic

  10. Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Boshuisen, Kim|info:eu-repo/dai/nl/343391511; Lamberink, Herm J; van Schooneveld, Monique MJ|info:eu-repo/dai/nl/30481427X; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg|info:eu-repo/dai/nl/262684438; Geleijns, Karin|info:eu-repo/dai/nl/275854965; Uiterwaal, Cuno Spm|info:eu-repo/dai/nl/136603947; Braun, Kees PJ|info:eu-repo/dai/nl/207237239

    2015-01-01

    BACKGROUND: The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at

  11. An Internet Dialogue: Mandatory Student Community Service, Court-Ordered Volunteering, and Service-Learning.

    Science.gov (United States)

    Ellis, Susan; And Others

    1998-01-01

    Excerpts from an Internet debate identify issues and opinions on mandatory community service as a graduation requirement and court-ordered volunteering. The debate ranges over such topics as quality of the service experience, freedom of choice, intended outcomes, and values conflicts. (SK)

  12. Employee Participation in Non-Mandatory Professional Development--The Role of Core Proactive Motivation Processes

    Science.gov (United States)

    Sankey, Kim S.; Machin, M. Anthony

    2014-01-01

    With a focus on the self-initiated efforts of employees, this study examined a model of core proactive motivation processes for participation in non-mandatory professional development (PD) within a proactive motivation framework using the Self-Determination Theory perspective. A multi-group SEM analysis conducted across 439 academic and general…

  13. Mandatory Genres: The case of European Public Assessment Report (EPAR) summaries

    DEFF Research Database (Denmark)

    Askehave, Inger; Zethsen, Karen K.

    2008-01-01

    of departure in one of the most recent mandatory genres within an EU medicinal assessment and approval context (the European Public Assessment Report [EPAR] summary) the article presents the results of an empirical study of 15 EU approved, Danish EPAR summaries, testing whether the respondents believe the EPAR...

  14. Reflections of Client Satisfaction: Reframing Family Perceptions of Mandatory Alternative School Assignment

    Science.gov (United States)

    Carpenter-Aeby, Tracy; Aeby, Victor G.

    2012-01-01

    The authors in this study examined the client satisfaction of chronically disruptive students and their families (clients) following a mandatory alternative school assignment. Specifically, they looked at the satisfaction of the involved families and their responses recorded through three surveys completed at exit interviews during the 1999-2000…

  15. The HPV Vaccine: Framing the Arguments "for" and "against" Mandatory Vaccination of All Middle School Girls

    Science.gov (United States)

    Vamos, Cheryl A.; McDermott, Robert J.; Daley, Ellen M.

    2008-01-01

    Background: Human papillomavirus (HPV), the virus responsible for cervical cancer, is the most common viral sexually transmitted infection in the United States. A vaccine was approved in 2006 that is effective in preventing the types of HPV responsible for 70% of cervical cancers and 90% of genital warts. Proposals for routine and mandatory HPV…

  16. 75 FR 57764 - Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical...

    Science.gov (United States)

    2010-09-22

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Mandatory Reliability Standards for the Bulk Power System; Supplemental Notice of Technical Conference September 14, 2010. On August 19, 2010 the Federal Energy Regulatory...

  17. 75 FR 61478 - Mandatory Reliability Standards for the Bulk Power System; Notice Allowing Post-Technical...

    Science.gov (United States)

    2010-10-05

    ... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF ENERGY Federal Energy Regulatory Commission Mandatory Reliability Standards for the Bulk Power System; Notice Allowing Post-Technical Conference Comments September 24, 2010. On September 23, 2010, the Federal Energy...

  18. Voluntary or Mandatory Enrollment in Training and the Motivation to Transfer Training

    Science.gov (United States)

    Curado, Carla; Henriques, Paulo Lopes; Ribeiro, Sofia

    2015-01-01

    The purpose of this study is to examine the motivation to transfer training in a multidimensional way. It investigates autonomous and controlled motivation and explores the difference in motivation to transfer according to whether the employee is enrolled in training on a voluntary or mandatory basis. This is a cross-sectional hypotheses-testing…

  19. 78 FR 67927 - Foreign Trade Regulations (FTR): Mandatory Automated Export System Filing for All Shipments...

    Science.gov (United States)

    2013-11-13

    ... Bureau of the Census 15 CFR Part 30 RIN 0607-AA50 Foreign Trade Regulations (FTR): Mandatory Automated... the Automated Export System (AES) under control number 0607-0152. DATES: The effective date of the... to report shipments of used self-propelled vehicles and temporary exports through the AES or through...

  20. 75 FR 75498 - Petitions for Modification of Existing Mandatory Safety Standards

    Science.gov (United States)

    2010-12-03

    ... modify the application of any mandatory safety standard to a coal or other mine if the Secretary...: M-2010-035-C. Petitioner: San Juan Coal Company, P.O. Box 561, Waterflow, New Mexico 87421. Mine... abandoned mine openings with refuse piles. The petitioner states that: (1) The pile will be constructed of...

  1. 77 FR 14438 - Petitions for Modification of Application of Existing Mandatory Safety Standards

    Science.gov (United States)

    2012-03-09

    ... petition to modify the application of any mandatory safety standard to a coal or other mine. The petition... frequently flooded abandoned mine workings that may or may not be mapped. (4) All mapping for mines above and.... Petitioner: Little Buck Coal Company, 33 Pine Lane, Pine Grove, Pennsylvania 17963. Mine: Little Buck Slope...

  2. 76 FR 69764 - Petitions for Modification of Application of Existing Mandatory Safety Standards

    Science.gov (United States)

    2011-11-09

    ... of any mandatory safety standard to a coal or other mine if the Secretary of labor determines that... with the abandoned Southern Minerals, Inc., Mine No. 1, WV DEP Permit No. U- 4008-05, MSHA I.D. No. 46... associated with the abandoned Southern Minerals, Inc., Mine No. 10, WV DEP Permit No. U-4008-05, MSHA I.D. No...

  3. Socio-Praxis Preferences in Teacher Preparation for Child Sexual Abuse and Its Mandatory Reporting

    Science.gov (United States)

    Goldman, Juliette D. G.; Grimbeek, Peter

    2015-01-01

    Child abuse and neglect, particularly child sexual abuse, is a pastoral care issue that deeply concerns all education professionals. The literature strongly supports specific training for pre-service teachers about child sexual abuse and its mandatory reporting, although few studies identify how such training should be academically structured.…

  4. Student and Faculty Perceptions about Mandatory Influenza Vaccinations on a Health Sciences Campus

    Science.gov (United States)

    Looper, Philip; George, David; Johnson, Eric J.; Conway, Susan E.

    2017-01-01

    Objective: To examine the perceptions among faculty and health professional students regarding mandatory vaccination policies on a health sciences campus. Participants: A total of 296 faculty and 244 students completed surveys during Fall 2015. Methods: The online survey administered to individuals who received the influenza vaccine during the…

  5. How to make the best of mandatory information requirements in consumer law

    NARCIS (Netherlands)

    Schaub, M.Y.

    2017-01-01

    EU consumer protection relies inter alia on information requirements imposing on traders the duty to provide specific and mandatory information to consumers before the conclusion of a contract. If consumers make well informed choices this can serve their individual interest, but it is also thought

  6. 42 CFR 426.550 - Mandatory provisions of the Board's decision.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Mandatory provisions of the Board's decision. 426.550 Section 426.550 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL...

  7. Mandatory national quality improvement systems using indicators: An initial assessment in Europe and Israel.

    Science.gov (United States)

    Bramesfeld, Anke; Wensing, Michel; Bartels, Paul; Bobzin, Henning; Grenier, Catherine; Heugren, Mona; Hirschfield, Dena Jaffe; Langenegger, Manfred; Lindelius, Birgitta; Lucet, Bruno; Manor, Orly; Schneider, Theres; Wardell, Fiona; Szecsenyi, Joachim

    2016-11-01

    Quality improvement systems (QIS) that are based on empirical performance assessment have increasingly been implemented as a mandatory part of health systems across countries. This study aims to describe national mandatory QIS in Europe in 2014. Relevant national agencies for national mandatory QIS in Europe were identified through online searches and key informants. A questionnaire was compiled during a workshop with these agencies and filled out by representatives from these particular agencies. Agencies in charge of national mandatory QIS in seven countries (Denmark, France, Germany, Israel, Scotland, Sweden and Switzerland) were included in the study. An analysis of QIS revealed similarities, such as the use of routine data for performance assessment and the aim to hold healthcare providers accountable. Differences relate to the different forms of feedback systems and improvement mechanisms used. Trends include the development towards greater implementation of QIS within health systems, the inclusion of the patient's perspective in performance assessment, and experiments with pay for performance-related measures. On a country level, for health systems striving for newly implementing QIS it is recommended to start where routine data is available, add qualitative methodologies once the QIS is getting more complex, report performance data back to service providers and be patient centred. On the inter-country level exchange of information between agencies commissioned with implementing national QIS is very much needed for. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

  8. 42 CFR 426.484 - Mandatory provisions of a Board decision.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Mandatory provisions of a Board decision. 426.484 Section 426.484 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE...

  9. 42 CFR 426.450 - Mandatory provisions of an ALJ's decision.

    Science.gov (United States)

    2010-10-01

    ... 42 Public Health 3 2010-10-01 2010-10-01 false Mandatory provisions of an ALJ's decision. 426.450 Section 426.450 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) MEDICARE PROGRAM REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE...

  10. Mandatory influenza vaccination for all healthcare personnel: a review on justification, implementation and effectiveness.

    Science.gov (United States)

    Wang, Tiffany L; Jing, Ling; Bocchini, Joseph A

    2017-10-01

    As healthcare-associated influenza is a serious public health concern, this review examines legal and ethical arguments supporting mandatory influenza vaccination policies for healthcare personnel, implementation issues and evidence of effectiveness. Spread of influenza from healthcare personnel to patients can result in severe harm or death. Although most healthcare personnel believe that they should be vaccinated against seasonal influenza, the Centers for Disease Control and Prevention (CDC) report that only 79% of personnel were vaccinated during the 2015-2016 season. Vaccination rates were as low as 44.9% in institutions that did not promote or offer the vaccine, compared with rates of more than 90% in institutions with mandatory vaccination policies. Policies that mandate influenza vaccination for healthcare personnel have legal and ethical justifications. Implementing such policies require multipronged approaches that include education efforts, easy access to vaccines, vaccine promotion, leadership support and consistent communication emphasizing patient safety. Mandatory influenza vaccination for healthcare personnel is a necessary step in protecting patients. Patients who interact with healthcare personnel are often at an elevated risk of complications from influenza. Vaccination is the best available strategy for protecting against influenza and evidence shows that institutional policies and state laws can effectively increase healthcare personnel vaccination rates, decreasing the risk of transmission in healthcare settings. There are legal and ethical precedents for institutional mandatory influenza policies and state laws, although successful implementation requires addressing both administrative and attitudinal barriers.

  11. 7 CFR 59.202 - Mandatory daily reporting for barrows and gilts.

    Science.gov (United States)

    2010-01-01

    ... 7 Agriculture 3 2010-01-01 2010-01-01 false Mandatory daily reporting for barrows and gilts. 59... gilts. (a) Prior day report. The corporate officers or officially designated representatives of each packer that processes barrows and gilts shall report to the Secretary for each business day of the packer...

  12. 38 CFR 3.216 - Mandatory disclosure of social security numbers.

    Science.gov (United States)

    2010-07-01

    ... social security numbers. 3.216 Section 3.216 Pensions, Bonuses, and Veterans' Relief DEPARTMENT OF... Requirements § 3.216 Mandatory disclosure of social security numbers. Any person who applies for or receives..., furnish the Department of Veterans Affairs upon request with his or her social security number and the...

  13. 76 FR 22825 - Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems

    Science.gov (United States)

    2011-04-25

    ... AGENCY 40 CFR Parts 98 Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems AGENCY..., 2010 EPA promulgated Subpart W: Petroleum and Natural Gas Systems of the Greenhouse Gas Reporting Rule... outlined for calculating greenhouse gas emissions for the petroleum and natural gas systems source category...

  14. 75 FR 74457 - Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems

    Science.gov (United States)

    2010-11-30

    ... Protection Agency 40 CFR Part 98 Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems... Greenhouse Gases: Petroleum and Natural Gas Systems AGENCY: Environmental Protection Agency (EPA). ACTION... list of source categories already required to report greenhouse gas emissions. This action applies to...

  15. 75 FR 14081 - Mandatory Reporting of Greenhouse Gases: Minor Harmonizing Changes to the General Provisions

    Science.gov (United States)

    2010-03-24

    ... AGENCY 40 CFR Part 98 RIN 2060-AQ15 Mandatory Reporting of Greenhouse Gases: Minor Harmonizing Changes to... greenhouse gas suppliers (subpart OO): (A) All producers of industrial greenhouse gases. (B) Importers of industrial greenhouse gases with annual bulk imports of N2O, fluorinated GHG, and CO2 that in combination are...

  16. 75 FR 18575 - Mandatory Reporting of Greenhouse Gases: Injection and Geologic Sequestration of Carbon Dioxide

    Science.gov (United States)

    2010-04-12

    ... Protection Agency 40 CFR Part 98 Mandatory Reporting of Greenhouse Gases: Injection and Geologic... Reporting of Greenhouse Gases: Injection and Geologic Sequestration of Carbon Dioxide AGENCY: Environmental... require control of greenhouse gases (GHGs), rather it requires only monitoring and reporting of CO 2...

  17. 76 FR 59533 - Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas Systems: Revisions to Best...

    Science.gov (United States)

    2011-09-27

    ... AGENCY 40 CFR Part 98 RIN 2060-AP99 Mandatory Reporting of Greenhouse Gases: Petroleum and Natural Gas... the Greenhouse Gas Reporting Rule. Specifically, EPA is extending the time period during which owners..., an electronic copy of this final rule will also be available through the WWW on EPA's Greenhouse Gas...

  18. 76 FR 61293 - Extension of Public Comment Period: Mandatory Reporting of Greenhouse Gases: Technical Revisions...

    Science.gov (United States)

    2011-10-04

    ... Categories of the Greenhouse Gas Reporting Rule AGENCY: Environmental Protection Agency (EPA). ACTION..., Mandatory Reporting of Greenhouse Gases: Technical Revisions to the Electronics Manufacturing and the Petroleum and Natural Gas Systems Categories of the Greenhouse Gas Reporting Rule. In this action, EPA is...

  19. 76 FR 59542 - Mandatory Reporting of Greenhouse Gases: Changes to Provisions for Electronics Manufacturing To...

    Science.gov (United States)

    2011-09-27

    ... AGENCY 40 CFR Part 98 RIN 2060-AR26 Mandatory Reporting of Greenhouse Gases: Changes to Provisions for... Electronics Manufacturing portion of the Greenhouse Gas Reporting Rule for the ``largest'' semiconductor... go to the Greenhouse Gas Reporting Rule Program Web site http://www.epa.gov/climatechange/emissions...

  20. Revisiting the merits of a mandatory large group classroom learning format: an MD-MBA perspective.

    Science.gov (United States)

    Li, Shawn X; Pinto-Powell, Roshini

    2017-01-01

    The role of classroom learning in medical education is rapidly changing. To promote active learning and reduce student stress, medical schools have adopted policies such as pass/fail curriculums and recorded lectures. These policies along with the rising importance of the USMLE (United States Medical Licensing Examination) exams have made asynchronous learning popular to the detriment of classroom learning. In contrast to this model, modern day business schools employ mandatory large group classes with assigned seating and cold-calling. Despite similar student demographics, medical and business schools have adopted vastly different approaches to the classroom. When examining the classroom dynamic at business schools with mandatory classes, it is evident that there's an abundance of engaging discourse and peer learning objectives that medical schools share. Mandatory classes leverage the network effect just like social media forums such as Facebook and Twitter. That is, the value of a classroom discussion increases when more students are present to participate. At a time when students are savvy consumers of knowledge, the classroom is competing against an explosion of study aids dedicated to USMLE preparation. Certainly, the purpose of medical school is not solely about the efficient transfer of knowledge - but to train authentic, competent, and complete physicians. To accomplish this, we must promote the inimitable and deeply personal interactions amongst faculty and students. When viewed through this lens, mandatory classes might just be a way for medical schools to leverage their competitive advantage in educating the complete physician.

  1. 78 FR 20632 - Mandatory Reporting of Greenhouse Gases: Notice of Data Availability Regarding Global Warming...

    Science.gov (United States)

    2013-04-05

    ... AGENCY Mandatory Reporting of Greenhouse Gases: Notice of Data Availability Regarding Global Warming... EPA is announcing to the public the availability of estimated global warming potentials, as well as... requesting comments on the estimated global warming potentials and the data and analysis supporting them. We...

  2. Mandatory Audit Firm Rotation: A Review of Stakeholder Perspectives and Prior Research

    NARCIS (Netherlands)

    Ewelt-Knauer, C.; Gold, A.H.; Pott, C.

    2013-01-01

    The global financial crisis brought to the fore questions surrounding the scope and quality of the external audit, market concentration and auditor independence. One of the issues currently being considered by the European Commission and European Parliament is mandatory audit firm rotation. The aim

  3. Testing the Information Technology Continuance Model on a Mandatory SMS-Based Student Response System

    Science.gov (United States)

    Lin, Julian; Rivera-Sanchez, Milagros

    2012-01-01

    This paper reports a 2-month longitudinal study on a mandatory Short Message Service-based student response system that enabled students to take classroom quizzes using their mobile phones to register responses. students' perceptions on usefulness and their attitude toward the system were measured twice: once before they used the system and again…

  4. An understanding of nurse educators' leadership behaviors in implementing mandatory continuing nursing education in China.

    Science.gov (United States)

    Xiao, Lily Dongxia

    2008-09-01

    Mandatory continuing nursing education is viewed as one way to develop registered nurses' continuing competencies. However, as has been argued internationally, it can also create a paradox in terms of learning to meet study requirements. Such paradox has been discussing in China since the implementation of mandatory continuing nursing education in 1996. Nurse educators, who develop continuing nursing education programs, appear to respond to the paradox differently associated with their leadership styles. This article reports a qualitative study aiming to gain an understanding of nurse educators' leadership behaviors in implementing mandatory continuing nursing education in China. Gadamer's philosophical hermeneutics underpins in-depth interviews with five nurse educators and data interpretation. Two categories of nurse educators, described as proactive educator and reactive educator, were identified and compared with two types of leadership styles described as transformational leader and transactional leader in the literature of educational leadership and continuing professional development. Proactive educators shared core attributors of transformational leaders and were able to relieve the paradox in mandatory continuing nursing education. Reactive educators however showed some attributors of transactional leaders and might escalate the paradox. Findings suggest further research in relation to the preparation of nurse educators.

  5. 75 FR 71568 - Establishment of Negotiated Rulemaking Committee for Changes to Livestock Mandatory Reporting

    Science.gov (United States)

    2010-11-24

    ... (AMS) is announcing its intent to establish a Wholesale Pork Reporting Negotiated Rulemaking Committee... cattle, swine, sheep, beef, and lamb meat. The Food, Conservation, and Energy Act of 2008 (2008 Farm Bill... advantages, drawbacks, and potential implementation issues associated with adopting mandatory wholesale pork...

  6. Mandatory Community-Based Learning in U.S. Urban High Schools: Fair Equality of Opportunity?

    Science.gov (United States)

    Bennett, Jeffrey V.; Alsbury, Thomas L.; Fan, Jingjing

    2016-01-01

    This study explores participant experiences at two contrasting high schools in a large, urban school district in crisis who implemented mandatory community-based learning (CBL) (e.g. community service, work-based internships) as a policy of reform. Rawls' theory of justice as fairness is used to examine capacity of the district formal policy to…

  7. 75 FR 3863 - Mandatory Deposit of Published Electronic Works Available Only Online

    Science.gov (United States)

    2010-01-25

    ... metadata: serial or journal title, ISSN, publisher, frequency, place of publication. b. Article level... the Copyright Act of 1976, Title 17 of the United States Code, the owner of copyright, or of the... regulations governing mandatory deposit, which are set forth in Chapter II, Part 202 of Title 37 of the Code...

  8. Experiences gained from implementing mandatory buffer strips in Denmark: how can we enhance their ecosystem services?

    DEFF Research Database (Denmark)

    Kronvang, Brian; Hoffmann, Carl Christian; Baatrup-Pedersen, Annette

    The Danish Parliament adopted in June 2012 a Buffer Strip Act that required 10 m mandatory buffer strips (BSs) to be established along all watercourses and lakes with a surface area greater than 100 m2 from 1st September 2012. The main reasons for deploying BSs was to reduce nitrate-N leaching an...

  9. 77 FR 36998 - Proposed Information Collection; Comment Request; Mandatory Shrimp Vessel and Gear...

    Science.gov (United States)

    2012-06-20

    ... Information Collection; Comment Request; Mandatory Shrimp Vessel and Gear Characterization Survey AGENCY... for the Gulf Shrimp Vessel and Gear Characterization Form may be found at 50 CFR 622.5(a)(1)(iii)(C... shrimp must complete an annual Gulf Shrimp Vessel and Gear Characterization Form. The form will be...

  10. A randomized, double-blind, placebo-controlled, cross-over pilot study to assess the effects of long-term opioid drug consumption and subsequent abstinence in chronic noncancer pain patients receiving controlled-release morphine.

    Science.gov (United States)

    Cowan, David T; Wilson-Barnett, Jenifer; Griffiths, Peter; Vaughan, David J A; Gondhia, Anjalee; Allan, Laurie G

    2005-01-01

    The long-term use of strong opioid analgesics among chronic noncancer pain (CNCP) patients remains controversial because of concerns over problematic drug use. However, previous surveys suggest that this is not necessarily the case. Therefore, we designed a controlled study to generate evidence in support of these findings. Ten CNCP patients attending the pain clinic in a district general hospital had been taking an average daily dose of 40 mg controlled-release morphine sulphate (mean 40, range 10-90, SD 21 mg), for an average of 2 years (mean 2.175, range 2-2.25, SD 0.2 years). Randomized, double-blind, placebo controlled cross-over study. The study was based on the premise that abrupt cessation of opioid drugs is most likely to highlight problematic use and the consequent inability to stop using opioids. Morphine was substituted with placebo for 60-hour periods to compare the effects of abstinence with those of continued use. Assessment of morphine cessation and abstinence effects was through direct observation, physiological measurements, questionnaire responses, and Brief Pain Inventory scores. Following cessation and abstinence, there were no indications of psychological dependence or drug craving, but there was evidence of the detrimental effects of pain intensity on activity, mood, relationships, sleep, and enjoyment of life. Three patients (30%) reported opioid drug withdrawal symptoms. Pharmacokinetic data demonstrated compliance with abstinence by all patients. The results suggest the existence of a group of CNCP patients whose long-term opioid consumption can be beneficial and remain moderate without them suffering from the consequences of problematic opioid drug use.

  11. Hazardous drugs: new challenges, new opportunities

    Directory of Open Access Journals (Sweden)

    Silvia Valero García

    2016-03-01

    Full Text Available Occupational exposure to hazardous drugs can cause harmful effects on health professionals and several protective measures must be taken. Nevertheless, classification of hazardous drugs is not the same in all the published repertoires and the terminology is still confusing: hazardous drugs, biohazardous drugs or risky drugs are terms improperly described and can define very different drugs with a very different hazard profiles. In Spain, there is not an updated official list of hazardous drugs, and healthcare professionals must consider and follow other published lists. In our opinion, it is mandatory to do a consensus among these professionals, administration and labor union organizations in order to clarify some conflictive questions not only in healthcare settings but in investigational and academic scenarios too. These multidisciplinary groups should be involved also in teaching new and non-experienced personnel and in the knowledge reinforcement for the experienced ones

  12. Drug Facts

    Medline Plus

    Full Text Available ... Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So Hard to Quit Drugs? ... Drug Use and Other People Drug Use and Families Drug Use and Kids Drug Use and Unborn ...

  13. An Interview Study of Learner Motivation and Learner Involvement in Mandatory College-Level Academic Writing Classes

    Science.gov (United States)

    Vanniarajan, Swathi M.

    2011-01-01

    Scholarship in applied linguistics has not sufficiently addressed learner motivation in mandatory writing classes in postsecondary settings. The data collected through short interviews from 20 students enrolled in a mandatory academic writing program at the junior/senior level in a California State University indicated that learner motivation in…

  14. The Failure of Race Neutral Policies: How Mandatory Terms and Sentencing Enhancements Contribute to Mass Racialized Incarceration

    Science.gov (United States)

    Schlesinger, Traci

    2011-01-01

    This study examines the effects of mandatory terms and sentencing enhancements on Black and White men's state-level prison admission rates. Four major findings emerge from the analysis. First, both mandatory terms and sentencing enhancements increase prison admission rates for Black and White men. Second, these policies disproportionately increase…

  15. Sources of Knowledge of Departmental Policy on Child Sexual Abuse and Mandatory Reporting Identified by Primary School Student-Teachers

    Science.gov (United States)

    Goldman, Juliette D. G.; Grimbeek, Peter

    2011-01-01

    The introduction of a Department of Education policy on child sexual abuse and mandatory reporting is significant for school teachers. The mandatory reporting of child sexual abuse by school teachers carries wide-ranging and significant implications for the lives of school-aged children, and for the teachers who must implement the policy's…

  16. 36 CFR 1260.54 - What is the appeal process when a mandatory review request for Executive Branch information is...

    Science.gov (United States)

    2010-07-01

    ... DECLASSIFICATION OF NATIONAL SECURITY INFORMATION Mandatory Review § 1260.54 What is the appeal process when a... Interagency Security Classification Appeals Panel, Attn: Mandatory Review Appeals, c/o Information Security..., 8601 Adelphi Road, College Park, MD 20740-6001. ...

  17. The Impact of Mandatory Community Service and Social Support on Urban High School Seniors' Civic Engagement Orientations

    Science.gov (United States)

    Bennett, Jeffrey

    2009-01-01

    This study examined the efficacy of mandatory community service to prepare all high school students in a large urban school district for civic engagement. The principal hypothesis asserted that mandatory community service was insufficient in influencing students' civic engagement orientations (CEO) unless accompanied by opportunities for receiving…

  18. 77 FR 10358 - Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard

    Science.gov (United States)

    2012-02-22

    ... COMMISSION 16 CFR Chapter II Acceptance of ASTM F963-11 as a Mandatory Consumer Product Safety Standard... ASTM F963-11 standard titled, Standard Consumer Safety Specifications for Toy Safety. Pursuant to section 106 of the Consumer Product Safety Improvement Act of 2008, ASTM F963-11 will become a mandatory...

  19. 76 FR 11187 - Examinations of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety...

    Science.gov (United States)

    2011-03-01

    ... Safety and Health Administration 30 CFR Part 75 RIN 1219-AB75 Examinations of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety Standards AGENCY: Mine Safety and Health... rule, Examinations of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety...

  20. The use of random-effects models to identify health care center-related characteristics modifying the effect of antipsychotic drugs

    Directory of Open Access Journals (Sweden)

    Nordon C

    2017-12-01

    Full Text Available Clementine Nordon,1 Constance Battin,1 Helene Verdoux,2 Josef Maria Haro,3 Mark Belger,4 Lucien Abenhaim,1 Tjeerd Pieter van Staa5 On behalf of the IMI GetReal WP2 Group 1Epidemiological Research, Analytica LASER, Paris, 2Population Health Research Center, Team Pharmaco-Epidemiology, UMR 1219, Bordeaux-2 University, INSERM, Bordeaux, France; 3Parc Sanitari Sant Joan de Deu, CIBERSAM, University of Barcelona, Barcelona, Spain; 4Eli Lilly and Company Limited, Erl Wood Manor, Windlesham, 5Farr Institute, University of Manchester, Manchester, UK Purpose: A case study was conducted, exploring methods to identify drugs effects modifiers, at a health care center level.Patients and methods: Data were drawn from the Schizophrenia Outpatient Health Outcome cohort, including hierarchical information on 6641 patients, recruited from 899 health care centers from across ten European countries. Center-level characteristics included the following: psychiatrist’s gender, age, length of practice experience, practice setting and type, countries’ Healthcare System Efficiency score, and psychiatrist density in the country. Mixed multivariable linear regression models were used: 1 to estimate antipsychotic drugs’ effectiveness (defined as the association between patients’ outcome at 3 months – dependent variable, continuous – and antipsychotic drug initiation at baseline – drug A vs other antipsychotic drug; 2 to estimate the similarity between clustered data (using the intra-cluster correlation coefficient; and 3 to explore antipsychotic drug effects modification by center-related characteristics (using the addition of an interaction term.Results: About 23% of the variance found for patients’ outcome was explained by unmeasured confounding at a center level. Psychiatrists’ practice experience was found to be associated with patient outcomes (p=0.04 and modified the relative effect of “drug A” (p<0.001, independent of center- or patient

  1. Governing GMOs: The (Counter Movement for Mandatory and Voluntary Non-GMO Labels

    Directory of Open Access Journals (Sweden)

    Carmen Bain

    2014-12-01

    Full Text Available Since 2012 the anti-GMO (genetically modified organism movement has gained significant grassroots momentum in its efforts to require mandatory GMO food labels through state-level ballot and legislative efforts. Major food and agriculture corporations are opposed to mandatory GMO labels and have successfully defeated most of these initiatives. Nevertheless, these battles have garnered significant media attention and re-energized the debate over GMO crops and foods. In this paper, we argue that one of the most significant outcomes of this fight is efforts by food retailers and value-based food companies to implement voluntary non-GMO labels and brands. We draw on the governance and political consumerism literature to explore (counter movement efforts for mandatory labels and how these efforts are being institutionalized through private voluntary governance institutions. Our assessment is based on in-depth, semi-structured interviews with key informants from consumer and environmental organizations, agriculture and biotech companies, and government regulatory agencies, as well as a content analysis of food industry websites. A growing number of food retailers recognize the reputational and economic value that new niche markets for non-GMO foods can offer, while the anti-GMO movement views these efforts as a step in the direction of mandatory GMO labels. We conclude that voluntary labels may act to settle the labeling debate by mollifying agri-food industry concerns about mandatory labeling and meeting the desire of political consumers for greater choice and transparency but without addressing the broader social and environmental sustainability concerns that drives the anti-GMO movement in the first place.

  2. Familias Unidas for high risk adolescents: Study design of a cultural adaptation and randomized controlled trial of a U.S. drug and sexual risk behavior intervention in Ecuador.

    Science.gov (United States)

    Jacobs, Petra; Estrada, Yannine A; Tapia, Maria I; Quevedo Terán, Ana M; Condo Tamayo, Cecilia; Albán García, Mónica; Valenzuela Triviño, Gilda M; Pantin, Hilda; Velazquez, Maria R; Horigian, Viviana E; Alonso, Elizabeth; Prado, Guillermo

    2016-03-01

    Developing, testing and implementing evidence-based prevention interventions are important in decreasing substance use and sexual risk behavior among adolescents. This process requires research expertise, infrastructure, resources and decades of research testing, which might not always be feasible for low resource countries. Adapting and testing interventions proven to be efficacious in similar cultures might circumvent the time and costs of implementing evidence-based interventions in new settings. This paper describes the two-phase study, including training and development of the research infrastructure in the Ecuadorian university necessary to implement a randomized controlled trial. Familias Unidas is a multilevel parent-centered intervention designed in the U.S. to prevent drug use and sexual risk behaviors in Hispanic adolescents. The current study consisted of Phase 1 feasibility study (n=38) which adapted the intervention and study procedures within a single-site school setting in an area with a high prevalence of drug use and unprotected sexual behavior among adolescents in Ecuador, and Phase 2 randomized controlled trial of the adapted intervention in two public high schools with a target population of families with adolescents from 12 to 14 years old. The trial is currently in Phase 2. Study recruitment was completed with 239 parent-youth dyads enrolling. The intervention phase and the first follow-up assessment have been completed. The second and third follow-up assessments will be completed in 2016. This project has the potential of benefitting a large population of families in areas of Ecuador that are disproportionally affected by drug trafficking and its consequences. MSP-DIS-2015-0055-0, Ministry of Public Health (MSP), Quito, Ecuador. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. A four-drug combination therapy consisting of low-dose tacrolimus, low-dose mycophenolate mofetil, corticosteroids, and mizoribine in living donor renal transplantation: A randomized study

    Directory of Open Access Journals (Sweden)

    Tian-zhong Yan

    2016-05-01

    Full Text Available Objective: We compared a three-drug combination therapy (control group consisting of tacrolimus, mycophenolate mofetil, and corticosteroids in living donor renal transplantation with a four-drug combination therapy (study group, in which the doses of tacrolimus and mycophenolate mofetil were halved and the immunosuppressive drug mizoribine was added, in order to determine whether the incidence rates of acute rejection after transplantation between the study group and the control group are similar, whether the study group regimen prevents the occurrence of calcineurin inhibitor–induced renal damage, and whether the study group regimen prevents adverse effects such as diarrhea caused by mycophenolate mofetil. Methods: We investigated the incidence of acute rejection, serum creatinine levels, and estimated glomerular filtration rate and the incidence of adverse effects such as diarrhea. Results: There was no significant difference between the two groups in the incidence of acute rejection. Renal function (estimated glomerular filtration rate and serum creatinine was maintained in the control group whereas in the study group renal function gradually improved, with a statistical difference observed at 12 months. The incidence of gastrointestinal symptoms including diarrhea was significantly higher in the control group than in the study group. There was no significant difference in the incidence of cytomegalovirus infection and other adverse effects. Conclusion: These results suggest the study group therapy is an effective regimen in preventing acute rejection and the deterioration of renal function. These results also show this therapy can reduce the incidence of adverse effects such as gastrointestinal symptoms.

  4. Antiplatelet Drugs

    Science.gov (United States)

    Hirsh, Jack; Spencer, Frederick A.; Baglin, Trevor P.; Weitz, Jeffrey I.

    2012-01-01

    The article describes the mechanisms of action, pharmacokinetics, and pharmacodynamics of aspirin, dipyridamole, cilostazol, the thienopyridines, and the glycoprotein IIb/IIIa antagonists. The relationships among dose, efficacy, and safety are discussed along with a mechanistic overview of results of randomized clinical trials. The article does not provide specific management recommendations but highlights important practical aspects of antiplatelet therapy, including optimal dosing, the variable balance between benefits and risks when antiplatelet therapies are used alone or in combination with other antiplatelet drugs in different clinical settings, and the implications of persistently high platelet reactivity despite such treatment. PMID:22315278

  5. Long-term prognostic value of risk scores after drug-eluting stent implantation for unprotected left main coronary artery: A pooled analysis of the ISAR-LEFT-MAIN and ISAR-LEFT-MAIN 2 randomized clinical trials.

    Science.gov (United States)

    Xhepa, Erion; Tada, Tomohisa; Kufner, Sebastian; Ndrepepa, Gjin; Byrne, Robert A; Kreutzer, Johanna; Ibrahim, Tareq; Tiroch, Klaus; Valgimigli, Marco; Tölg, Ralf; Cassese, Salvatore; Fusaro, Massimiliano; Schunkert, Heribert; Laugwitz, Karl L; Mehilli, Julinda; Kastrati, Adnan

    2017-01-01

    To evaluate the long-term prognostic value of risk scores in the setting of drug-eluting stent (DES) implantation for uLMCA. Data on the prognostic value of novel risk scores developed to select the most appropriate revascularization strategy in patients undergoing DES implantation for uLMCA disease are relatively limited. The study represents a patient-level pooled analysis of the ISAR-LEFT-MAIN (607 patients randomized to paclitaxel-eluting or sirolimus-eluting stents) and the ISAR-LEFT-MAIN-2 (650 patients randomized to everolimus-eluting or zotarolimus-eluting stents) randomized trials. The Syntax Score (SxScore) as well the Syntax Score II (SS-II), the EuroSCORE and the Global Risk Classification (GRC) were calculated. The primary outcome was all-cause mortality. At a mean follow-up of 3 years there were 160 deaths (12.7%). The death-incidence was significantly higher in the upper tertiles than in the intermediate or lower ones for all risk scores (log-rank test P risk scores were able to stratify the mortality risk at long-term follow-up. EuroSCORE was the only risk score that significantly improved the discriminatory power of a multivariable model to predict long-term mortality. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

  6. [Effect of the GCP Directive on academic drug trials

    DEFF Research Database (Denmark)

    Berendt, L.; Hakansson, C.; Bach, K.F.

    2008-01-01

    Since 2004, adherence to Good Clinical Practice has been mandatory for all clinical drug trials. This was new to the investigator-initiated trials. Our study showed no association between the implementation of the Directive and investigator or industry-initiated trials. However, a steady decline ...

  7. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR - implications for therapeutic failure and drug resistance.

    Science.gov (United States)

    Sengaloundeth, Sivong; Green, Michael D; Fernández, Facundo M; Manolin, Ot; Phommavong, Khamlieng; Insixiengmay, Vongsavanh; Hampton, Christina Y; Nyadong, Leonard; Mildenhall, Dallas C; Hostetler, Dana; Khounsaknalath, Lamphet; Vongsack, Latsamy; Phompida, Samlane; Vanisaveth, Viengxay; Syhakhang, Lamphone; Newton, Paul N

    2009-07-28

    Counterfeit oral artesunate has been a major public health problem in mainland SE Asia, impeding malaria control. A countrywide stratified random survey was performed to determine the availability and quality of oral artesunate in pharmacies and outlets (shops selling medicines) in the Lao PDR (Laos). In 2003, 'mystery' shoppers were asked to buy artesunate tablets from 180 outlets in 12 of the 18 Lao provinces. Outlets were selected using stratified random sampling by investigators not involved in sampling. Samples were analysed for packaging characteristics, by the Fast Red Dye test, high-performance liquid chromatography (HPLC), mass spectrometry (MS), X-ray diffractometry and pollen analysis. Of 180 outlets sampled, 25 (13.9%) sold oral artesunate. Outlets selling artesunate were more commonly found in the more malarious southern Laos. Of the 25 outlets, 22 (88%; 95%CI 68-97%) sold counterfeit artesunate, as defined by packaging and chemistry. No artesunate was detected in the counterfeits by any of the chemical analysis techniques and analysis of the packaging demonstrated seven different counterfeit types. There was complete agreement between the Fast Red dye test, HPLC and MS analysis. A wide variety of wrong active ingredients were found by MS. Of great concern, 4/27 (14.8%) fakes contained detectable amounts of artemisinin (0.26-115.7 mg/tablet). This random survey confirms results from previous convenience surveys that counterfeit artesunate is a severe public health problem. The presence of artemisinin in counterfeits may encourage malaria resistance to artemisinin derivatives. With increasing accessibility of artemisinin-derivative combination therapy (ACT) in Laos, the removal of artesunate monotherapy from pharmacies may be an effective intervention.

  8. A stratified random survey of the proportion of poor quality oral artesunate sold at medicine outlets in the Lao PDR – implications for therapeutic failure and drug resistance

    Science.gov (United States)

    Sengaloundeth, Sivong; Green, Michael D; Fernández, Facundo M; Manolin, Ot; Phommavong, Khamlieng; Insixiengmay, Vongsavanh; Hampton, Christina Y; Nyadong, Leonard; Mildenhall, Dallas C; Hostetler, Dana; Khounsaknalath, Lamphet; Vongsack, Latsamy; Phompida, Samlane; Vanisaveth, Viengxay; Syhakhang, Lamphone; Newton, Paul N

    2009-01-01

    Background Counterfeit oral artesunate has been a major public health problem in mainland SE Asia, impeding malaria control. A countrywide stratified random survey was performed to determine the availability and quality of oral artesunate in pharmacies and outlets (shops selling medicines) in the Lao PDR (Laos). Methods In 2003, 'mystery' shoppers were asked to buy artesunate tablets from 180 outlets in 12 of the 18 Lao provinces. Outlets were selected using stratified random sampling by investigators not involved in sampling. Samples were analysed for packaging characteristics, by the Fast Red Dye test, high-performance liquid chromatography (HPLC), mass spectrometry (MS), X-ray diffractometry and pollen analysis. Results Of 180 outlets sampled, 25 (13.9%) sold oral artesunate. Outlets selling artesunate were more commonly found in the more malarious southern Laos. Of the 25 outlets, 22 (88%; 95%CI 68–97%) sold counterfeit artesunate, as defined by packaging and chemistry. No artesunate was detected in the counterfeits by any of the chemical analysis techniques and analysis of the packaging demonstrated seven different counterfeit types. There was complete agreement between the Fast Red dye test, HPLC and MS analysis. A wide variety of wrong active ingredients were found by MS. Of great concern, 4/27 (14.8%) fakes contained detectable amounts of artemisinin (0.26–115.7 mg/tablet). Conclusion This random survey confirms results from previous convenience surveys that counterfeit artesunate is a severe public health problem. The presence of artemisinin in counterfeits may encourage malaria resistance to artemisinin derivatives. With increasing accessibility of artemisinin-derivative combination therapy (ACT) in Laos, the removal of artesunate monotherapy from pharmacies may be an effective intervention. PMID:19638225

  9. Design and rationale of a randomized study to compare amiodarone and Class IC anti-arrhythmic drugs in terms of atrial fibrillation treatment efficacy in patients paced for sinus node disease: the PITAGORA trial.

    Science.gov (United States)

    Gulizia, Michele; Mangiameli, Salvatore; Chiarandà, Giacomo; Spadola, Vincenzo; Di Giovanni, Nicolò; Colletti, Andrea; Bulla, Vincenzo; Circo, Antonio; Pensabene, Orazio; Vasquez, Ludovico; Vaccaro, Ignazio; Grammatico, Andrea

    2006-04-01

    Many sinus node disease (SND) patients suffer from atrial fibrillation (AF). Anti-arrhythmic drugs (AADs) are the therapeutic mainstay for AF prophylaxis. The PITAGORA trial has a multicentre, prospective, randomized, single blind design to compare amiodarone with Class IC AADs in patients who have an AF history and are paced for SND. Starting from January 2001, 176 patients received a Medtronic AT500 pacemaker. AADs were randomly assigned with a 3 : 2 ratio between Class III and Class IC. Randomization was stratified in order to assign two patients to amiodarone and one patient to sotalol every three Class III AAD patients. After a 5-month observational period, Ramp or Burst+ ATP therapies were enabled in a randomized way, maintained for 4 months, and then crossed over. Total follow-up period is 21 months. The primary long-term objective is to show the non-inferiority of IC AADs compared with amiodarone in terms of time to first occurrence of a composite endpoint (death, atrial cardioversion, hospitalizations due to AF or heart failure, or change of AADs). Data will be analysed on an intention-to-treat basis. The primary short-term objective is to compare Ramp vs. Burst+ efficacy in terminating atrial tachyarrhythmias treated by the device. Secondary endpoints are major clinical events, medication toxicity, symptoms, AF burden, and quality-of-life. Given the high morbidity and healthcare costs associated with AF, new therapeutic strategies are needed. The results of the PITAGORA trial may help in guiding AADs therapy and ATP programming in SND patients suffering from AF.

  10. A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

    Science.gov (United States)

    Laberge, Philippe; Garza-Leal, Jose; Fortin, Claude; Grainger, David; Johns, Delbert Alan; Adkins, Royce T; Presthus, James; Basinski, Cindy; Swarup, Monte; Gimpelson, Richard; Leyland, Nicholas; Thiel, John; Harris, Micah; Burnett, Pamela E; Ray, Gene F

    2017-01-01

    To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women. Multicenter, randomized, controlled, international study (Canadian Task Force classification I). Thirteen academic and private medical centers. Premenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O). Patients were treated using the Minerva Endometrial Ablation System or rollerball ablation. At 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported. The results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

  11. Diacerein Orphan Drug Development for Epidermolysis Bullosa Simplex: A Phase 2/3 Randomized, Placebo-Controlled, Double-Blind Clinical Trial.

    Science.gov (United States)

    Wally, Verena; Hovnanian, Alain; Ly, Juliette; Buckova, Hana; Brunner, Victoria; Lettner, Thomas; Ablinger, Michael; Felder, Thomas K; Hofbauer, Peter; Wolkersdorfer, Martin; Lagler, Florian B; Hitzl, Wolfgang; Laimer, Martin; Kitzmüller, Sophie; Diem, Anja; Bauer, Johann W

    2018-02-01

    EBS is a rare genetic, blistering skin disease for which there is no cure. Treatments that address the pathophysiology of EBS are needed. Compare the impact of 1% diacerein cream vs placebo in reducing blister number in EBS. In a randomized, placebo-controlled, phase 2/3 trial we used a 1% diacerein topical formulation to treat defined skin areas in 17 patients. In a 2-period cross-over trial, patients were randomized to either placebo or diacerein for 4-week treatment and a 3-month follow-up in period 1. After a wash-out, patients were crossed-over during period 2. The pre-specified primary endpoint was the proportion of patients with a reduction of blister numbers by >40% from baseline in selected areas over the treatment episode. For patients on diacerein, 86% in episode 1 and 37.5% in episode 2 met the primary endpoint (placebo, 14% and 17%, respectively). This effect was still significant after the follow-up. Changes in absolute blister numbers were significant for the diacerein group only. No adverse effects were observed. Low patient numbers, no invasive data acquisition due to clinical burden in children. This trial provides evidence of the impact of 1% diacerein cream in the treatment of EBS. Copyright © 2018. Published by Elsevier Inc.

  12. Randomization tests

    CERN Document Server

    Edgington, Eugene

    2007-01-01

    Statistical Tests That Do Not Require Random Sampling Randomization Tests Numerical Examples Randomization Tests and Nonrandom Samples The Prevalence of Nonrandom Samples in Experiments The Irrelevance of Random Samples for the Typical Experiment Generalizing from Nonrandom Samples Intelligibility Respect for the Validity of Randomization Tests Versatility Practicality Precursors of Randomization Tests Other Applications of Permutation Tests Questions and Exercises Notes References Randomized Experiments Unique Benefits of Experiments Experimentation without Mani

  13. Effects of mandatory screening labs in directing the disposition of the apparently healthy psychiatric patient in the emergency department.

    Science.gov (United States)

    Kagel, Karyn E; Smith, Meghan; Latyshenko, Ilya V; Mitchell, Christopher; Kagel, Andrew

    2017-01-01

    To determine whether mandatory psychiatric admission laboratory tests yield results that change the disposition of a patient with primary psychiatric complaint from admission to a psychiatric service to admission to a medical service. This was a single center retrospective cohort chart review study approved by the facility Institutional Review Board in which we used a records database maintained by the emergency department's social workers to access the records of every patient that presented to our emergency department with a psychiatric chief complaint between the dates of December 1, 2011, and December 1, 2013. We focused on those that were admitted to either a psychiatric service or a medical service after a thorough evaluation by the department of social work and an emergency provider. We applied our inclusion and exclusion criteria and reviewed the results of the mandatory psychiatric laboratory tests (complete blood count, comprehensive metabolic panel, thyroid stimulating hormone, acetaminophen, aspirin, blood alcohol level, urinalysis, urine pregnancy test, urine drug screen) required for admission. Our independent variables were the compulsory psychiatric admission laboratory tests and our dependent variable was the admission to a medical service. Of 5,606 laboratory tests that were ordered and produced results for the 682 patients enrolled in our study, 51 results were considered clinically significant abnormal results, or results requiring treatment prior to psychiatric service admission, by the 2 reviewing emergency physicians. Only one of 682 psychiatric patients received a final disposition to a medical service based upon abnormal laboratory studies. That patient presented without any medical complaints but a chief complaint of "suicidal ideation," and was found to have diabetic ketoacidosis. Based on our data, the probability that an abnormal laboratory test will result in a change in disposition is 1/682=0.1% (95% CI: 0.0% to 0.9%). Patients

  14. Drug Facts

    Medline Plus

    Full Text Available ... Treatment and Recovery Resources? Prevent Drug Use Help Children and Teens Stay Drug-Free Talking to Kids About Drugs: What to Say if You ... drug abuse, addiction, and treatment. Watch Videos Information About Drugs ...

  15. Drug Allergy

    Science.gov (United States)

    ... Loss of consciousness Other conditions resulting from drug allergy Less common drug allergy reactions occur days or ... you take the drug. Drugs commonly linked to allergies Although any drug can cause an allergic reaction, ...

  16. Opportunities, threats and barriers to enacting mandatory child car restraint laws in Iran.

    Science.gov (United States)

    Soori, Hamid; Ainy, Elaheh; Bazargan-Hejazi, Shahrzad

    2015-01-01

    Approximately one-third of Iranian children's deaths are caused by injuries. Of these, 36% result from road traffic injuries (RTIs). Both RTIs and fatalities could be reduced by using child car restraints (CCRs). Despite their demonstrated effectiveness, CCRs are not mandatory in Iran. This study was conducted to assess opportunities and barriers in enacting mandatory CCR laws in that country. Using mixed method research, a phenomenological approach was used to explore the experiences and perspectives of road safety stakeholders in regard to opportunities and threats in enacting mandatory CCR laws in Iran. The themes derived from group discussions were used to first develop a structured questionnaire, which was later distributed to and completed by study participants. The study analysis was conducted using scores and rankings from the responses to these questions. Twenty-eight stakeholders participated in the study. Most were male, aged 36.7 ± 5.6 (range 25-59). In terms of identifying the organization that should establish mandatory CCR laws, the Traffic Police Department achieved the highest score of 90 (range 0-100). The participants also thought that the Traffic Police department is responsible to monitor compliance and conduct follow-up investigations (score = 100). In regard to existing barriers in enacting CCR laws, the lack of positive Publicity by mass media and the lack of related laws received scores of 85 and 70, respectively. Enabling factors and opportunities included 'positive regards or attitude of families towards their child's health,' 'officials' commitment to support such laws' and 'having adequate resources to raise community awareness of the importance of CCR use. These received scores of 83, 69 and 68, respectively. The results suggest that cooperation and collaboration among stakeholders including the Traffic Police, families and local communities are needed to maximize the likelihood of mandating CCR laws.

  17. Mandatory HIV Screening Policy & Everyday Life: A Look Inside the Canadian Immigration Medical Examination

    OpenAIRE

    LAURA BISAILLON

    2011-01-01

    Findings that detail the social organization of day-to-day practices associated with the Canadian government policy of mandatory HIV testing of permanent residence applicants to Canada are reported. Institutional ethnography was used to investigate interactions between HIV-positive applicants and immigration physicians during the immigration medical examination. A composite narrative recounts details of a woman applicant's discovery through immigration testing that she was living with HIV. Ma...

  18. Mandatory Disclosure of Blockholders and Related Party Transactions : Stringent Versus Flexible Rules

    OpenAIRE

    McCahery, J.A.; Vermeulen, E.P.M.

    2011-01-01

    Investor confidence in financial markets depends in large part on the existence of an accurate disclosure and reporting regime that provides transparency in the beneficial ownership and control structures of publicly listed companies. Today, a common post-financial crisis regulatory reform theme is to tighten the disclosure and reporting rules that apply to large blockholders. We examine the implications of this trend, analyzing whether detailed, stringent and mandatory reporting rules could ...

  19. [Why do we need mandatory communication courses for pre-registration house officers?

    DEFF Research Database (Denmark)

    Pedersen, B.D.; Faarvang, K.L.; Larsen, M.H.

    2008-01-01

    This study reports the rationale for the composition of a 3-day mandatory communication skills course for pre-registration house officers (PRHOs). In addition to communication skills, the course addresses aspects of competence related to professional performance within areas covered by the legal ...... framework, the ability to analyse ethical problems, and health advocacy. Standard evaluation forms were collected from 274 PRHOs. The course was highly rated by participants with respect to content, form and outcome Udgivelsesdato: 2008/10/27...

  20. Mandatory labels, taxes and market forces: An empirical evaluation of fat policies

    OpenAIRE

    Allais, Olivier; Etilé, Fabrice; Lecocq, Sébastien

    2012-01-01

    The public-health community views the mandatory labelling and taxation of fat as promising tools to control the growth of food-related chronic disease. This paper is the first to propose an ex ante evaluation of these two policy options in an oligopolistic setting with differentiated products and heterogeneous demand. Using household scanner data on fromages blancs and dessert yogurts, we separately identify consumer preferences for fat and front-of-pack fat labels by exploiting an exogenous ...

  1. Mandatory Reporting? Issues to consider when developing legislation and policy to improve discovery of child abuse

    Directory of Open Access Journals (Sweden)

    Emma Davies

    2014-10-01

    Full Text Available Article by Dr Emma Davies (School of Law, Liverpool John Moores University, Associate Professor Ben Mathews (School of Law, Queensland University of Technology and Professor John Read (Institute of Psychology, Health and Society, University of Liverpool. In the United Kingdom, recent investigations into child sexual abuse occurring within schools, the Catholic Church and the British Broadcasting Corporation, have intensified debate on ways to improve the discovery of child sexual abuse, and child maltreatment generally. One approach adopted in other jurisdictions to better identify cases of severe child maltreatment is the introduction of some form of legislative mandatory reporting to require designated persons to report known and suspected cases. The debate in England has raised the prospect of whether adopting a strategy of some kind of mandatory reporting law is advisable. The purpose of this article is to add to this debate by identifying fundamental principles, issues and complexities underpinning policy and even legislative developments in the interests of children and society. The article will first highlight the data on the hidden nature of child maltreatment and the background to the debate. Secondly, it will identify some significant gaps in knowledge that need to be filled. Thirdly, the article will summarise the barriers to reporting abuse and neglect. Fourthly, we will identify a range of options for, and clarify the dilemmas in developing, legislative mandatory reporting, addressing two key issues: who should be mandated to report, and what types of child maltreatment should they be required to report? Finally, we draw attention to some inherently different goals and competing interests, both between and within the various institutions involved in the safeguarding of children and the criminal prosecution of some offenders. Based on this analysis we offer some concluding observations that we hope contribute to informed and careful

  2. Assessment of contamination and misclassification biases in a randomized controlled trial of a social network peer education intervention to reduce HIV risk behaviors among drug users and risk partners in Philadelphia, PA and Chiang Mai, Thailand.

    Science.gov (United States)

    Simmons, Nicole; Donnell, Deborah; Ou, San-San; Celentano, David D; Aramrattana, Apinun; Davis-Vogel, Annet; Metzger, David; Latkin, Carl

    2015-10-01

    Controlled trials of HIV prevention and care interventions are susceptible to contamination. In a randomized controlled trial of a social network peer education intervention among people who inject drugs and their risk partners in Philadelphia, PA and Chiang Mai, Thailand, we tested a contamination measure based on recall of intervention terms. We assessed the recall of test, negative and positive control terms among intervention and control arm participants and compared the relative odds of recall of test versus negative control terms between study arms. The contamination measures showed good discriminant ability among participants in Chiang Mai. In Philadelphia there was no evidence of contamination and little evidence of diffusion. In Chiang Mai there was strong evidence of diffusion and contamination. Network structure and peer education in Chiang Mai likely led to contamination. Recall of intervention materials can be a useful method to detect contamination in experimental interventions.

  3. Effects of kinesiotaping versus non-steroidal anti-inflammatory drugs and physical therapy for treatment of pes anserinus tendino-bursitis: A randomized comparative clinical trial.

    Science.gov (United States)

    Homayouni, Kaynoosh; Foruzi, Shima; Kalhori, Fereshte

    2016-09-01

    Pes anserinus tendino-bursitis is a condition caused by repetitive friction over the bursa or direct trauma to knee joint and it presents with proximal medial tibial pain and swelling. The aim of this study is to determine the effects of kinesiotaping in comparison with naproxen and physical therapy in treatment of pes anserinus tendino-bursitis. In a randomized comparative clinical trial 56 patients with clinical diagnosis of pes anserinus tendino-bursitis were randomly assigned to kinesiotaping and naproxen/physical therapy (28 patients in each group). Kinesiotaping on the tender area in the form of space-correction (lifting) technique was used and repeated for three times with a one-week interval. Another group received naproxen (250mg TID for 10 days) and ten sessions of daily physical therapy. The visual analog scale (VAS) was used for evaluation of pain. The depth of swelling of the area was measured with sonography before and after treatment. Wilcoxon signed ranks test has been used for determining the influence of interventions on pain (VAS) and swelling scores in each group. The ANCOVA (Analysis of covariance) test was applied for comparing the influence of interventions on VAS and swelling scores after adjustment for co-variables. At end of the study, 27 patients remained in the kinesiotaping group and 19 patients in naproxen/physical therapy group. Treatment with kinesiotaping significantly decreased the pain (P=0.0001) and swelling scores (P=0.0001) in comparison with naproxen/physical therapy after adjustment for baseline characteristics. Kinesiotaping was safe without any complications except for a mild local skin irritation in one patient. Kinesiotaping is more effective than naproxen plus physical therapy in reduction of pain and swelling in patients with pes anserinus tendino-bursitis. www.ClinicalTrials.gov identifier is NCT01680263.

  4. Visitor Assessment of the Mandatory Alternative Transportation System at Zion National Park

    Science.gov (United States)

    Mace, Britton L.; Marquit, Joshua D.; Bates, Scott C.

    2013-11-01

    Transportation infrastructure in national parks has historically been designed for the automobile. With more vehicles in the parks, visitors found themselves in circumstances more reminiscent of a city than a park. Traffic jams, overcrowding, illegal parking, horn honking, and idling vehicles became common, creating stress and contributing to air and noise pollution, the very things visitors were hoping to get away from. Park managers began searching for alternatives, including shuttle systems. Many national parks have implemented optional shuttle systems, but relatively few have completely closed roads to vehicles, transporting visitors on mandatory shuttles. Zion National Park instituted a mandatory shuttle system in May 2000 to relieve crowding and congestion in the main canyon and to protect natural resources. Taking a longitudinal approach, attributes of the shuttle (e.g., crowding, accessibility, freedom, efficiency, preference, and success) were assessed with experiential park factors (e.g., scenic beauty, naturalness, solitude, tranquility, air quality, and soundscape) in 2000, 2003, and 2010 by surveying shuttle-riding park visitors. While visitors initially reported a few reservations about the shuttle system, by 2003, the majority rated the system successful. Ratings of all shuttle-related variables, except crowding, improved over the decade. Improvements were greatest for freedom, accessibility, and efficiency. Multiple regression found overall shuttle success to be mediated by preference, freedom, accessibility, efficiency, and comfort. Experiential variables assessing park conditions followed a similar pattern, with improved ratings as the decade progressed. Results provide important insights into the visitor experience with mandatory alternative shuttle systems in national parks.

  5. Aspects of Equality in Mandatory Partnerships – From the Perspective of Municipal Care in Norway

    Directory of Open Access Journals (Sweden)

    Ralf Kirchhoff

    2016-05-01

    Full Text Available Introduction: This paper raises questions about equality in partnerships, since imbalance in partnerships may effect collaboration outcomes in integrated care. We address aspects of equality in mandatory, public-public partnerships, from the perspective of municipal care. We have developed a questionnaire wherein the Norwegian Coordination Reform is an illustrative example. The following research question is addressed: What equality dimensions are important for municipals related to mandatory partnerships with hospitals? Theory/methods: Since we did not find any instrument to measure equality in partnerships, an explorative design was chosen. The development of the instrument was based on the theory on partnership and knowledge about the field and context. A national online survey was emitted to all 429 Norwegian municipalities in 2013. The response rate was in total 58 percent (n = 248. The data were mainly analysed using Principal component analysis. Results: It seems that the two dimensions “learning and expertise equality” and “contractual equality” collects reliable and valid data to measure aspects of equality in partnerships. Discussion: Partnerships are usually based on voluntarism. The results indicate that mandatory partnerships, within a public health care system, can be appropriate to equalize partnerships between health care providers at different care levels.

  6. Aspects of Equality in Mandatory Partnerships – From the Perspective of Municipal Care in Norway

    Science.gov (United States)

    Ljunggren, Birgitte

    2016-01-01

    Introduction: This paper raises questions about equality in partnerships, since imbalance in partnerships may effect collaboration outcomes in integrated care. We address aspects of equality in mandatory, public-public partnerships, from the perspective of municipal care. We have developed a questionnaire wherein the Norwegian Coordination Reform is an illustrative example. The following research question is addressed: What equality dimensions are important for municipals related to mandatory partnerships with hospitals? Theory/methods: Since we did not find any instrument to measure equality in partnerships, an explorative design was chosen. The development of the instrument was based on the theory on partnership and knowledge about the field and context. A national online survey was emitted to all 429 Norwegian municipalities in 2013. The response rate was in total 58 percent (n = 248). The data were mainly analysed using Principal component analysis. Results: It seems that the two dimensions “learning and expertise equality” and “contractual equality” collects reliable and valid data to measure aspects of equality in partnerships. Discussion: Partnerships are usually based on voluntarism. The results indicate that mandatory partnerships, within a public health care system, can be appropriate to equalize partnerships between health care providers at different care levels. PMID:27616962

  7. Aspects of Equality in Mandatory Partnerships - From the Perspective of Municipal Care in Norway.

    Science.gov (United States)

    Kirchhoff, Ralf; Ljunggren, Birgitte

    2016-05-18

    This paper raises questions about equality in partnerships, since imbalance in partnerships may effect collaboration outcomes in integrated care. We address aspects of equality in mandatory, public-public partnerships, from the perspective of municipal care. We have developed a questionnaire wherein the Norwegian Coordination Reform is an illustrative example. The following research question is addressed: What equality dimensions are important for municipals related to mandatory partnerships with hospitals? Since we did not find any instrument to measure equality in partnerships, an explorative design was chosen. The development of the instrument was based on the theory on partnership and knowledge about the field and context. A national online survey was emitted to all 429 Norwegian municipalities in 2013. The response rate was in total 58 percent (n = 248). The data were mainly analysed using Principal component analysis. It seems that the two dimensions "learning and expertise equality" and "contractual equality" collects reliable and valid data to measure aspects of equality in partnerships. Partnerships are usually based on voluntarism. The results indicate that mandatory partnerships, within a public health care system, can be appropriate to equalize partnerships between health care providers at different care levels.

  8. Efficacy and tolerability of EPs 7630 in children and adolescents with acute bronchitis - a randomized, double-blind, placebo-controlled multicenter trial with a herbal drug preparation from Pelargonium sidoides roots.

    Science.gov (United States)

    Kamin, W; Maydannik, V; Malek, F A; Kieser, M

    2010-03-01

    The study aim was to demonstrate the efficacy and to investigate the tolerability of EPs 7630, a herbal drug preparation from Pelargonium sidoides roots, in the treatment of patients (1 - 18 years) with acute bronchitis outside the strict indication for antibiotics. A total of 200 patients were randomized to receive either active drug containing EPs 7630 (1 - 6 years: 3 x 10 drops/d; > 6 - 12 years: 3 x 20 drops/d; > 12 - 18 years: 3 x 30 drops/d) or placebo for 7 consecutive days. change in the total score of bronchitis-specific symptoms (BSS) from Day 0 to Day 7. Main secondary outcome measures: treatment outcome, patients' satisfaction with treatment, onset of effect, bed rest. From baseline to Day 7, the mean BSS score improved significantly more for EPs 7630 compared with placebo (3.4 +/- 1.8 vs. 1.2 +/- 1.8 points, p acute bronchitis in children and adolescents outside the strict indication for antibiotics with patients treated with EPs 7630 perceiving a more favorable course of the disease and a good tolerability as compared with placebo.

  9. Randomized Comparison of Selective Internal Radiotherapy (SIRT) Versus Drug-Eluting Bead Transarterial Chemoembolization (DEB-TACE) for the Treatment of Hepatocellular Carcinoma

    Energy Technology Data Exchange (ETDEWEB)

    Pitton, Michael B., E-mail: michael.pitton@unimedizin-mainz.de; Kloeckner, Roman [Johannes Gutenberg University Medical Center, Department of Diagnostic and Interventional Radiology (Germany); Ruckes, Christian [Johannes Gutenberg University Medical Center, IZKS (Germany); Wirth, Gesine M. [Johannes Gutenberg University Medical Center, Department of Diagnostic and Interventional Radiology (Germany); Eichhorn, Waltraud [Johannes Gutenberg University Medical Center, Department of Nuclear Medicine (Germany); Wörns, Marcus A.; Weinmann, Arndt [Johannes Gutenberg University Medical Center, Department of Internal Medicine (Germany); Schreckenberger, Mathias [Johannes Gutenberg University Medical Center, Department of Nuclear Medicine (Germany); Galle, Peter R. [Johannes Gutenberg University Medical Center, Department of Internal Medicine (Germany); Otto, Gerd [Johannes Gutenberg University Medical Center, Department of Transplantation Surgery (Germany); Dueber, Christoph [Johannes Gutenberg University Medical Center, Department of Diagnostic and Interventional Radiology (Germany)

    2015-04-15

    PurposeTo prospectively compare SIRT and DEB-TACE for treating hepatocellular carcinoma (HCC).MethodsFrom 04/2010–07/2012, 24 patients with histologically proven unresectable N0, M0 HCCs were randomized 1:1 to receive SIRT or DEB-TACE. SIRT could be repeated once in case of recurrence; while, TACE was repeated every 6 weeks until no viable tumor tissue was detected by MRI or contraindications prohibited further treatment. Patients were followed-up by MRI every 3 months; the final evaluation was 05/2013.ResultsBoth groups were comparable in demographics (SIRT: 8males/4females, mean age 72 ± 7 years; TACE: 10males/2females, mean age 71 ± 9 years), initial tumor load (1 patient ≥25 % in each group), and BCLC (Barcelona Clinic Liver Cancer) stage (SIRT: 12×B; TACE 1×A, 11×B). Median progression-free survival (PFS) was 180 days for SIRT versus 216 days for TACE patients (p = 0.6193) with a median TTP of 371 days versus 336 days, respectively (p = 0.5764). Median OS was 592 days for SIRT versus 788 days for TACE patients (p = 0.9271). Seven patients died in each group. Causes of death were liver failure (n = 4 SIRT group), tumor progression (n = 4 TACE group), cardiovascular events, and inconclusive (n = 1 in each group).ConclusionsNo significant differences were found in median PFS, OS, and TTP. The lower rate of tumor progression in the SIRT group was nullified by a greater incidence of liver failure. This pilot study is the first prospective randomized trial comparing SIRT and TACE for treating HCC, and results can be used for sample size calculations of future studies.

  10. Drug Facts

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    Full Text Available ... signs and symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely ... Hard to Quit Drugs? Effects of Drugs Drug Use and Other People Drug Use and Families Drug ...

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  12. Relapse prevention in first-episode schizophrenia--maintenance vs intermittent drug treatment with prodrome-based early intervention: results of a randomized controlled trial within the German Research Network on Schizophrenia.

    Science.gov (United States)

    Gaebel, Wolfgang; Riesbeck, Mathias; Wölwer, Wolfgang; Klimke, Ansgar; Eickhoff, Matthias; von Wilmsdorff, Martina; Lemke, Matthias; Heuser, Isabella; Maier, Wolfgang; Huff, Wolfgang; Schmitt, Andrea; Sauer, Heinrich; Riedel, Michael; Klingberg, Stefan; Köpcke, Wolfgang; Ohmann, Christian; Möller, Hans-Jürgen

    2011-02-01

    After acute treatment of the first illness episode in schizophrenia, antipsychotic maintenance treatment is recommended for at least 1 year. Evidence for the optimal subsequent treatment is still scarce. Targeted intermittent treatment was found to be less effective than continuous treatment at preventing relapse in multiple episode patients; however, a post hoc analysis of our own data from a previous study suggested comparable efficacy of the 2 treatment approaches in first-episode patients. The current study was therefore designed to compare prospectively the relapse preventive efficacy of further maintenance treatment and targeted intermittent treatment in patients with ICD-10-diagnosed first-episode schizophrenia. A randomized controlled trial was conducted within the German Research Network on Schizophrenia. Entry screening took place between November 2000 and May 2004. After 1 year of antipsychotic maintenance treatment, stable first-episode patients were randomly assigned to 12 months of further maintenance treatment or stepwise drug discontinuation and targeted intermittent treatment. In case of prodromal symptoms of an impending relapse, patients in both groups received early drug intervention, guided by a decision algorithm. The primary outcome measure was relapse (increase in the Positive and Negative Syndrome Scale positive score > 10, Clinical Global Impressions-Change score ≥ 6, and decrease in Global Assessment of Functioning score > 20 between 2 visits). Of 96 first-episode patients, only 44 were eligible for the assigned treatment (maintenance treatment, n = 23; intermittent treatment, n = 21). The rates of relapse (19% vs 0%; P = .04) and deterioration (up to 57% vs 4%; P maintenance treatment group, but quality-of-life scores were comparable. Intermittent treatment patients received a significantly lower amount of antipsychotics (in haloperidol equivalents; P Maintenance treatment is more effective than targeted intermittent treatment in

  13. Preparation by mandatory E-modules improves learning of practical skills : A quasi-experimental comparison of skill examination results

    NARCIS (Netherlands)

    Kwant, Kelly J.; Custers, Eugene J F M; Jongen-Hermus, Femke J.; Kluijtmans, Manon

    2015-01-01

    Background: Until recently, students at UMC Utrecht Faculty of Medicine prepared for practical skills training sessions by studying recommended literature and making written assignments, which was considered unsatisfactory. Therefore, mandatory e-modules were gradually introduced as substitute for

  14. Evaluation of New York state's mandatory occupant restraint law : fatalities and injuries among motor vehicle occupants covered by the law

    Science.gov (United States)

    1987-02-01

    The report focuses on the ultimate measure of the effectiveness of New York State's Mandatory Occupant Restraint Law: reductions in fatalities and serious injuries among vehicle occupants. All front seat occupants and children under the age of ten, r...

  15. Mandatory IFRS Adoption in Brazil (2010): Index of Compliance with Disclosure Requirements and some Explanatory Factors of Firms Reporting

    National Research Council Canada - National Science Library

    Edilene Santana Santos; Vera Maria Rodrigues Ponte; Patrícia Vasconcelos Rocha Mapurunga

    2014-01-01

    ...) disclosure in the first mandatory adoption year of IFRS in Brazil (2010), by comprehensively examining 638 disclosure required items from 28 encompassing IFRSs in the Notes to Financial Statements of all (366...

  16. Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain.

    Science.gov (United States)

    Elzaki, Wail M; Abubakr, Neamat H; Ziada, Hassan M; Ibrahim, Yahia E

    2016-06-01

    The present clinical trial aimed to evaluate the efficiency of paracetamol alone and in combination with 3 different nonsteroidal anti-inflammatory drugs for control of post-endodontic pain. The inclusion criteria were moderate to severe pain of irreversible pulpitis, by using the Verbal Rating Scale and a 4-10 score on the Numerical Rating Scale, on anterior or premolar teeth, as well as the absence of signs and symptoms of apical periodontitis. One hundred eighty-five trial medications with placebo were prepared, and 170 participants completed the trial. There were 5 groups. P-group received 4 gelatinous capsules of a single dose of paracetamol alone. The IP-group received similar capsules of a single dose of combined ibuprofen/paracetamol. MP-group received combined mefenamic acid/paracetamol, and DP-group received combined diclofenac K/paracetamol. A Plb-group received doubled gelatinous capsules with no medications as a single dose, which had the same weight and appearance as the medicated capsules, to be the placebo. Pain intensity was measured after initial endodontic therapy and instrumentation by using the Verbal Rating Scale and Numerical Rating Scale. IP-group (ibuprofen/paracetamol) had the most pain reduction, followed by DP-group (combined diclofenac K/paracetamol), then MP-group, followed by P-group, whereas Plb-group had the least pain reduction (P endodontic therapy and root canal preparation in teeth with irreversible pulpitis, reduced post-endodontic pain (ClinicalTrials.gov no.: NCT02417337). Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  17. [Comparative study of two antitussive drugs in the treatment of acute dry cough of infectious origin (prospective, randomized, single blind study)].

    Science.gov (United States)

    Pujet, J C; Keddad, K; Sévenier, F; Jolivet-Landreau, I

    2002-01-01

    The objective was to compare, during a 5-day therapy, the efficacy and tolerability of an antihistaminic antitussive syrup, oxomemazine, combining a small quantity of guaifenesine (T), with a centrally acting antitussive, clobutinol (S), in adult patients aged from 18 to 70 years and presenting with a dry cough of infectious origin. This study was performed by 22 general practitioners and 130 ambulatory patients were enrolled. The primary criterion of this multicenter, randomized, single blind study was to compare the evolution of cough intensity using a Visual Analog Squale (VAS) graduated from 0 to 10 cm. Nine secondary criteria including tolerability were also assessed. With regard to cough intensity, the treatments were not equivalent. A greater reduction was observed with T (-5.2 +/- 2.3 versus -4.3 +/- 2.3). This result was confirmed by a further reduction in cough intensity at days: 2 (p = 0.04), 4 (p = 0.05), and 5 (p = 0.02). The frequency of cough disappearance before the end of the study was significantly greater for T than for S: 46% versus 29% (p = 0.05). The time before disappearance of the cough was 4.0 + 1.1 days for both medicines. Induction of sleep and the frequency of nocturnal wakening were significantly better for T from day 4 (p = 0.02). The drowsiness induced by T meant that diurnal quality of life was better with S on days 1 (p = 0.002) and 2 (p = 0.01). Tolerability was similar for both medicines. In conclusion, as a symptomatic treatment of dry cough, T is efficient and well tolerated. Moreover, we have observed a tendency towards superior efficacy of T than S. T is therefore a useful alternative in the therapeutic armamentarium available to the general practitioner.

  18. CONSUMER DEMAND FOR MANDATORY LABELING OF BEEF FROM CATTLE ADMINISTERED GROWTH HORMONES OR FED GENETICALLY MODIFIED CORN

    OpenAIRE

    Jayson L Lusk; John A. Fox

    2002-01-01

    This study estimates the value of policies that would mandate labeling of beef from cattle produced with growth hormones or fed genetically modified corn. At no cost, 85 percent of resondents desired mandatory labeling of beef produced with growth hormones and 64 percent of respondents preferred mandatory labeling of beef fed genetically modified corn. Estimates suggest that consumers would be willing to pay 17.0 percent and 10.6 percent higher prices for beef on average to obtain information...

  19. [Drug prescriptions outside the marketing product license and its responsibilities].

    Science.gov (United States)

    Gromb, S; Maurain, C; Carbonnel, S

    In France, drugs are commercialized after obtaining marketing approval. There are some situations however in which clinicians are authorized to prescribe drugs outside the limits set by the approval document. Clinicians must comply with certain number of regulations. Compliance with prescription modalities, particularly precautions concerning prescription writing or the patient's informed consent, is mandatory. Although patients cannot be reimbursed for drugs prescribed outside the approval limitations, they may nevertheless benefit from special dispositions: temporary approval for use and experimentation within the framework of the Huriet law. We analyze here the question of liability in case of drug prescriptions outside approval limitations, discussing the issues of civil and penal law and patient reimbursement.

  20. Adverse drug effects observed with vildagliptin versus pioglitazone or rosiglitazone in the treatment of patients with type 2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Janoo, Girish; Teeluck, Abhishek Rishikesh; Huang, Feng

    2017-10-23

    vildagliptin and pioglitazone/rosiglitazone are acceptable for the treatment of patients with T2DM on the basis that they are not significantly different in terms of overall adverse drug events. However, weight gain and peripheral edema would have to be re-assessed in further larger randomized controlled trials.

  1. Effects of anti-obesity drugs, diet, and exercise on weight-loss maintenance after a very-low-calorie diet or low-calorie diet: a systematic review and meta-analysis of randomized controlled trials123

    Science.gov (United States)

    Neovius, Martin; Hemmingsson, Erik

    2014-01-01

    Background: Weight-loss maintenance remains a major challenge in obesity treatment. Objective: The objective was to evaluate the effects of anti-obesity drugs, diet, or exercise on weight-loss maintenance after an initial very-low-calorie diet (VLCD)/low-calorie diet (LCD) period (weight-loss maintenance strategies after a VLCD/LCD period. Two authors performed independent data extraction by using a predefined data template. All pooled analyses were based on random-effects models. Results: Twenty studies with a total of 27 intervention arms and 3017 participants were included with the following treatment categories: anti-obesity drugs (3 arms; n = 658), meal replacements (4 arms; n = 322), high-protein diets (6 arms; n = 865), dietary supplements (6 arms; n = 261), other diets (3 arms; n = 564), and exercise (5 arms; n = 347). During the VLCD/LCD period, the pooled mean weight change was −12.3 kg (median duration: 8 wk; range 3–16 wk). Compared with controls, anti-obesity drugs improved weight-loss maintenance by 3.5 kg [95% CI: 1.5, 5.5 kg; median duration: 18 mo (12–36 mo)], meal replacements by 3.9 kg [95% CI: 2.8, 5.0 kg; median duration: 12 mo (10–26 mo)], and high-protein diets by 1.5 kg [95% CI: 0.8, 2.1 kg; median duration: 5 mo (3–12 mo)]. Exercise [0.8 kg; 95% CI: −1.2, 2.8 kg; median duration: 10 mo (6–12 mo)] and dietary supplements [0.0 kg; 95% CI: −1.4, 1.4 kg; median duration: 3 mo (3–14 mo)] did not significantly improve weight-loss maintenance compared with control. Conclusion: Anti-obesity drugs, meal replacements, and high-protein diets were associated with improved weight-loss maintenance after a VLCD/LCD period, whereas no significant improvements were seen for dietary supplements and exercise. PMID:24172297

  2. Analysis of an ordinal outcome in a multicentric randomized controlled trial: application to a 3- arm anti- malarial drug trial in Cameroon

    Directory of Open Access Journals (Sweden)

    Gwét Henri

    2010-06-01

    Full Text Available Abstract Background Malaria remains a burden in Sub-Saharan Countries. The strategy proposed by the World Health Organization (WHO is to systematically compare the therapeutic efficacy of antimalarial drugs using as primary outcome for efficacy, a four-category ordered criterion. The objective of the present work was to analyze the treatment effects on this primary outcome taking into account both a center-effect and individual covariates. A three-arm, three-centre trial of Amodiaquine (AQ, sulfadoxine-pyrimethamine (SP and their combination (AQ + SP, conducted by OCEAC-IRD in 2003, in 538 children with uncomplicated Plasmodium falciparum malaria, is used as an illustration. Methods Analyses were based on ordinal regression methods, assuming an underlying continuous latent variable, using either the proportional odds (PO or the proportional hazards (PH models. Different algorithms, corresponding to both frequentist- and bayesian-approaches, were implemented using the freely available softwares R and Winbugs, respectively. The performances of the different methods were evaluated on a simulated data set, and then they were applied on the trial data set. Results Good coverage probability and type-1 error for the treatment effect were achieved. When the methods were applied on the trial data set, results highlighted a significance decrease of SP efficacy when compared to AQ (PO, odds ratio [OR] 0.14, 95% confidence interval [CI] 0.04-0.57; hazard ratio [HR] 0.605, 95% CI 0.42-0.82, and an equal effectiveness between AQ + SP and AQ (PO, odds ratio [OR] 1.70, 95% confidence interval [CI] 0.25-11.44; hazard ratio [HR] 1.40, 95% CI 0.88-2.18. The body temperature was significantly related to the responses. The patient weights were marginally associated to the clinical response. Conclusion The proposed analyses, based on usual statistical packages, appeared adapted to take into account the full information contained in the four categorical outcome in

  3. Expanding access to parasite-based malaria diagnosis through retail drug shops in Tanzania: evidence from a randomized trial and implications for treatment.

    Science.gov (United States)

    Maloney, Kathleen; Ward, Abigail; Krenz, Bonnie; Petty, Nora; Bryson, Lindsay; Dolkart, Caitlin; Visser, Theodoor; Le Menach, Arnaud; Scott, Valerie K; Cohen, Justin M; Mtumbuka, Esther; Mkude, Sigsbert

    2017-01-03

    Tanzania has seen a reduction in the fraction of fevers caused by malaria, likely due in part to scale-up of control measures. While national guidelines require parasite-based diagnosis prior to treatment, it is estimated that more than half of suspected malaria treatment-seeking in Tanzania initiates in the private retail sector, where diagnosis by malaria rapid diagnostic test (RDT) or microscopy is illegal. This pilot study investigated whether the introduction of RDTs into Accredited Drug Dispensing Outlets (ADDOs) under realistic market conditions would improve case management practices. Dispensers from ADDOs in two intervention districts in Tanzania were trained to stock and perform RDTs and monitored quarterly. Each district was assigned a different recommended retail price to evaluate the need for a subsidy. Malaria RDT and artemisinin-based combination therapy (ACT) uptake and availability were measured pre-intervention and 1 year post-intervention through structured surveys of ADDO owners and exiting customers in both intervention districts and one contiguous control district. Descriptive analysis and logistic regression were used to compare the three districts and identify predictive variables for testing. A total of 310 dispensers from 262 ADDOs were trained to stock and perform RDTs. RDT availability in intervention ADDOs increased from 1% (n = 172) to 73% (n = 163) during the study; ACT medicines were available in 75% of 260 pre-intervention and 68% of 254 post-intervention ADDOs. Pre-treatment testing performed within the ADDO increased from 0 to 65% of suspected malaria patients who visited a shop (95% CI 60.8-69.6%) with no difference between intervention districts. Overall parasite-based diagnosis increased from 19 to 74% in intervention districts and from 3 to 18% in the control district. Prior knowledge of RDT availability (aOR = 1.9, p = 0.03) and RDT experience (aOR = 1.9, p = 0.01) were predictors for testing. Adherence data

  4. Assessment of Cognitive and Neurologic Recovery in Ischemic Stroke Drug Trials: Results from a Randomized, Double-blind, Placebo-controlled Study.

    Science.gov (United States)

    Di Cesare, Franco; Mancuso, Jessica; Silver, Brian; Loudon, Peter T

    2016-01-01

    Objective. Ischemic stroke is a serious medical condition with limited therapeutic options. The evaluation of the therapeutic potential of novel pharmacological interventions is carried-out in Phase II trials. The study design, primarily intended to evaluate efficacy and safety, is a balance between utilizing as few patients as possible to minimize safety risk and enrolling sufficient patients to detect unambiguous efficacy signals. We sought to determine whether post-stroke recovery outcomes based on behavioral measures of cognitive and motor impairment yielded additional information beyond that of clinician-based methods. Design. This was a multicenter, multinational, randomized, parallel group, controlled versus placebo, efficacy, and safety study of PF-03049423 for treatment of acute ischemic stroke. Settings and participants. Our study subjects were acute ischemic stroke inpatients. Measurements. Outcome measures were derived from rating scales (Modified Rankin Scale, Barthel Index, and National Institutes of Health Stroke Scale) and behavioral tests (Box and Blocks Test, Hand Grip Strength Test, 10-Meter Walk Test, Repeatable Battery Assessment of Neuropsychological Status Naming and Coding Subtests, Line Cancellation Test, and Recognition Memory Test). Assessments were performed at Days 7, 14, 30, 60, and 90. Post-hoc analyses of correlations among the outcome measures at each measurement time point on a cohort of 137 subjects were conducted. Results. Results support the validity of measures from Box and Blocks Test, Hand Grip Strength Test, 10-Meter Walk Test, and Repeatable Battery Assessment of Neuropsychological Status Coding Subtests to monitor post-stroke recovery in clinical trial settings. Notably, the Recognition Memory Test did not show a correlation with the Modified Rankin Scale, and, in fact, did not show improvement over time. Conclusion. The behavioral measures of cognitive and motor functions included in this study may extend the evaluation

  5. Drug Interaction Between Clopidogrel and Ranitidine or Omeprazole in Stable Coronary Artery Disease: A Double-Blind, Double Dummy, Randomized Study.

    Science.gov (United States)

    Furtado, Remo Holanda de Mendonça; Giugliano, Robert Patrick; Strunz, Celia Maria Cassaro; Filho, Cyrillo Cavalheiro; Ramires, José Antonio Franchini; Filho, Roberto Kalil; Neto, Pedro Alves Lemos; Pereira, Alexandre Costa; Rocha, Tânia Rúbia; Freire, Beatriz Tonon; D'Amico, Elbio Antonio; Nicolau, José Carlos

    2016-08-01

    Proton-pump inhibitors (PPIs) are often prescribed to patients receiving dual antiplatelet therapy (DAPT). However, this class of medication, especially omeprazole, has been associated with a reduction in clopidogrel efficacy, leading many clinicians to substitute omeprazole with ranitidine. Our objective was to compare the antiplatelet effect of clopidogrel before and after the addition of omeprazole or ranitidine. We measured platelet aggregability at baseline and after 1 week of clopidogrel 75 mg daily. Subjects were then randomized in a double-blinded, double-dummy fashion to omeprazole 20 mg twice daily (bid) or ranitidine 150 mg bid. We repeated aggregability tests after 1 additional week, using VerifyNow P2Y12™ (Accumetrics; San Diego, CA, USA), depicting aggregability as percent inhibition of platelet aggregation (IPA). We enrolled 41 patients in the omeprazole group and 44 in the ranitidine group. IPA was significantly decreased after the addition of omeprazole to clopidogrel (from 26.3 ± 32.9 to 17.4 ± 33.1 %; p = 0.025), with no statistical significant changes observed in the ranitidine group (from 32.6 ± 28.9 to 30.1 ± 31.3 %; p = 0.310). The comparison of IPA in both groups at the end of the follow-up showed a trend toward significance (p = 0.07, 95 % confidence interval [CI] -1.19 to 26.59); after excluding homozygous patients for 2C19*2 genotype, the comparison of IPA between the groups reached statistical significance (32.7 ± 30.8 vs. 17.7 ± 33.4 %, respectively, for ranitidine and omeprazole groups; p = 0.04). Unlike omeprazole, ranitidine did not influence platelet aggregability response to clopidogrel. NCT01896557.

  6. Drug Facts

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    Full Text Available ... Drug Use and Kids Drug Use and Unborn Children Drug Use and Your Health Other Effects on ... Someone Find Treatment and Recovery Resources? Prevention Help Children and Teens Stay Drug-Free Talking to Kids ...

  7. Drug Facts

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    Full Text Available ... and symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What ... Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use ...

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  10. Drug Safety

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    ... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...

  11. Drug Abuse

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    ... or injuries among Americans. Abused drugs include Methamphetamine Anabolic steroids Club drugs Cocaine Heroin Inhalants Marijuana Prescription drugs, including opioids Drug abuse also plays a role in many major social ...

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    Full Text Available ... Use and Unborn Children Drug Use and Your Health Other Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug ...

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    Full Text Available ... Where Can Someone Find Treatment and Recovery Resources? Prevent Drug Use Help Children and Teens Stay Drug- ... You Used Drugs in the Past Drug Use Prevention Phone Numbers and Websites Search Share Listen English ...

  14. Randomized, controlled clinical trial on the efficacy of nonsteroidal antiinflammatory drugs for the treatment of acute puerperal metritis in dairy cows.

    Science.gov (United States)

    Pohl, A; Bertulat, S; Borchardt, S; Burfeind, O; Heuwieser, W

    2016-10-01

    The objective of this study was to assess the efficacy of ketoprofen compared with ceftiofur hydrochloride for the treatment of acute puerperal metritis (APM). Specifically, we set out to compare the incidence of extended treatment (extT) between treatment groups, to determine the prevalence of purulent vaginal discharge (PVD) and milk yield on the first 3 milk tests postpartum, and to analyze reproductive performance of cows treated with ketoprofen or ceftiofur. Cows with rectal temperature ≥39.5°C and reddish-brown fetid vaginal discharge within the first 10 d in milk (DIM) were diagnosed with APM. Day of enrollment and first day of treatment was considered study day 1. Rectal temperature was recorded daily until study day 7. A total of 610 dairy cows with APM were enrolled in this randomized clinical trial. Cows meeting the inclusion criteria were allocated to treatment with ketoprofen (3mg/kg of body weight, n=300) or treatment with ceftiofur (1mg/kg of body weight, n=310) on study days 1, 2, and 3. Cows that showed rectal temperature ≥39.5°C between study days 4 and 7 received an extT with ceftiofur for 3 (ketoprofen group) or 2 (ceftiofur group) more days. Cows were examined with the Metricheck device (Simcro, Hamilton, New Zealand) between DIM 21 and 40, and vaginal discharge was categorized on a 5-point scale according to the presence of pus. Cows with a score ≥2 were classified as having PVD. Fifty-two cows (35 from ketoprofen group, 17 from ceftiofur group) were excluded from analysis due to missing protocol compliance (n=37) or concurrent disease (n=15). Cows treated with ketoprofen were more likely to have an extT than cows treated with ceftiofur (61 vs. 31%). Prevalence of PVD did not differ between the 2 treatment groups (ketoprofen, 56%; ceftiofur, 53%). Cows, however, that needed an extT after the initial 3-d treatment were more likely to develop PVD than cows without extT (64 vs. 46%). Treatment group did not affect milk yield (ketoprofen

  15. Examining Perceptions about Mandatory Influenza Vaccination of Healthcare Workers through Online Comments on News Stories.

    Directory of Open Access Journals (Sweden)

    Yang Lei

    Full Text Available The aim of this study was to understand online public perceptions of the debate surrounding the choice of annual influenza vaccinations or wearing masks as a condition of employment for healthcare workers, such as the one enacted in British Columbia in August 2012.Four national and 82 local (British Columbia Canadian online news sites were searched for articles posted between August 2012 and May 2013 containing the words "healthcare workers" and "mandatory influenza vaccinations/immunizations" or "mandatory flu shots and healthcare workers." We included articles from sources that predominantly concerned our topic of interest and that generated reader comments. Two researchers coded the unedited comments using thematic analysis, categorizing codes to allow themes to emerge. In addition to themes, the comments were categorized by: 1 sentiment towards influenza vaccines; 2 support for mandatory vaccination policies; 3 citing of reference materials or statistics; 4 self-identified health-care worker status; and 5 sharing of a personal story.1163 comments made by 648 commenters responding to 36 articles were analyzed. Popular themes included concerns about freedom of choice, vaccine effectiveness, patient safety, and distrust in government, public health, and the pharmaceutical industry. Almost half (48% of commenters expressed a negative sentiment toward the influenza vaccine, 28% were positive, 20% were neutral, and 4% expressed mixed sentiment. Of those who commented on the policy, 75% did not support the condition to work policy, while 25% were in favour. Of the commenters, 11% self-identified as healthcare workers, 13% shared personal stories, and 18% cited a reference or statistic.The perception of the influenza vaccine in the comment sections of online news sites is fairly poor. Public health agencies should consider including online forums, comment sections, and social media sites as part of their communication channels to correct

  16. Examining Perceptions about Mandatory Influenza Vaccination of Healthcare Workers through Online Comments on News Stories.

    Science.gov (United States)

    Lei, Yang; Pereira, Jennifer A; Quach, Susan; Bettinger, Julie A; Kwong, Jeffrey C; Corace, Kimberly; Garber, Gary; Feinberg, Yael; Guay, Maryse

    2015-01-01

    The aim of this study was to understand online public perceptions of the debate surrounding the choice of annual influenza vaccinations or wearing masks as a condition of employment for healthcare workers, such as the one enacted in British Columbia in August 2012. Four national and 82 local (British Columbia) Canadian online news sites were searched for articles posted between August 2012 and May 2013 containing the words "healthcare workers" and "mandatory influenza vaccinations/immunizations" or "mandatory flu shots and healthcare workers." We included articles from sources that predominantly concerned our topic of interest and that generated reader comments. Two researchers coded the unedited comments using thematic analysis, categorizing codes to allow themes to emerge. In addition to themes, the comments were categorized by: 1) sentiment towards influenza vaccines; 2) support for mandatory vaccination policies; 3) citing of reference materials or statistics; 4) self-identified health-care worker status; and 5) sharing of a personal story. 1163 comments made by 648 commenters responding to 36 articles were analyzed. Popular themes included concerns about freedom of choice, vaccine effectiveness, patient safety, and distrust in government, public health, and the pharmaceutical industry. Almost half (48%) of commenters expressed a negative sentiment toward the influenza vaccine, 28% were positive, 20% were neutral, and 4% expressed mixed sentiment. Of those who commented on the policy, 75% did not support the condition to work policy, while 25% were in favour. Of the commenters, 11% self-identified as healthcare workers, 13% shared personal stories, and 18% cited a reference or statistic. The perception of the influenza vaccine in the comment sections of online news sites is fairly poor. Public health agencies should consider including online forums, comment sections, and social media sites as part of their communication channels to correct misinformation

  17. The Sodium Content of Processed Foods in South Africa during the Introduction of Mandatory Sodium Limits.

    Science.gov (United States)

    Peters, Sanne A E; Dunford, Elizabeth; Ware, Lisa J; Harris, Teresa; Walker, Adele; Wicks, Mariaan; van Zyl, Tertia; Swanepoel, Bianca; Charlton, Karen E; Woodward, Mark; Webster, Jacqui; Neal, Bruce

    2017-04-20

    In June 2016, the Republic of South Africa introduced legislation for mandatory limits for the upper sodium content permitted in a wide range of processed foods. We assessed the sodium levels of packaged foods in South Africa during the one-year period leading up to the mandatory implementation date of the legislation. Data on the nutritional composition of packaged foods was obtained from nutrition information panels on food labels through both in-store surveys and crowdsourcing by users of the HealthyFood Switch mobile phone app between June 2015 and August 2016. Summary sodium levels were calculated for 15 food categories, including the 13 categories covered by the sodium legislation. The percentage of foods that met the government's 2016 sodium limits was also calculated. 11,065 processed food items were included in the analyses; 1851 of these were subject to the sodium legislation. Overall, 67% of targeted foods had a sodium level at or below the legislated limit. Categories with the lowest percentage of foods that met legislated limits were bread (27%), potato crisps (41%), salt and vinegar flavoured snacks (42%), and raw processed sausages (45%). About half (49%) of targeted foods not meeting the legislated limits were less than 25% above the maximum sodium level. Sodium levels in two-thirds of foods covered by the South African sodium legislation were at or below the permitted upper levels at the mandatory implementation date of the legislation and many more were close to the limit. The South African food industry has an excellent opportunity to rapidly meet the legislated requirements.

  18. Is active management of mandatory pension funds in Croatia creating value for second pillar fund members?

    Directory of Open Access Journals (Sweden)

    Petar-Pierre Matek

    2015-09-01

    Full Text Available This paper analyses Croatian mandatory pension funds’ investment returns during the 2005-2014 period using performance attribution methodology. Results from active investment management are compared to a long-term policy return. Such analysis is essential to shed light on the contribution of active portfolio management in the second pillar pension scheme. Evidence suggests that in the period analysed portfolio managers have added value through active management decisions. In addition, we determined the sources of portfolio return by breaking down active return into policy, tactical asset allocation and security selection effect.

  19. Information Society Services and Mandatory Data Breach Notifications: Introduction to Open Issues in the EU Framework

    OpenAIRE

    Burnik, Jelena

    2012-01-01

    In 2011 Sony suffered an extensive breach in its online game network that led to the theft of account data of 77 million users from all over the world. This was one of the largest internet security break-ins that resulted in a large scale personal data breach. As an answer to numerous incidents of security breaches where personal data have been compromised, an instrument of mandatory data breach notification is currently being implemented in the European Union that follows the approach taken ...

  20. The ethics of mandatory vaccination against influenza for health care workers.

    Science.gov (United States)

    van Delden, J J M; Ashcroft, R; Dawson, A; Marckmann, G; Upshur, R; Verweij, M F

    2008-10-16

    Vaccination of health care workers (HCW) in long-term care results in indirect protection of patients who are at high-risk for influenza. The voluntary uptake of influenza vaccination among HCW is generally low. We argue that institutions caring for frail elderly have the responsibility to implement voluntary programmes for vaccination against influenza of HCW. When uptake falls short a mandatory programme may be justified. The main justification stems from the duty of care givers not to harm one's patient when one knows there is a significant risk of harm and the intervention to reduce this chance has a favourable balance of benefit over burdens and risks.

  1. Should a clinical rotation in hematology be mandatory for undergraduate medical students?

    Directory of Open Access Journals (Sweden)

    Mandan J

    2016-09-01

    Full Text Available Jay Mandan,1 Harmeet Singh Sidhu,1 Adil Mahmood2 1Faculty of Medicine, Imperial College London, London, UK; 2Faculty of Life Sciences and Medicine, King’s College London, London, UK Abstract: Clinical rotations form the foundation of medical education. Medical students in the UK are offered conventional rotations such as cardiology, surgery, and psychiatry as part of their undergraduate curriculum, but a rotation in hematology is not currently mandatory. This paper explores the benefits of a compulsory hematology rotation, and suggests recommendations for its implementation in UK medical school curricula. Keywords: medical education, clinical rotations, hematology

  2. Acute Aortic Dissection Mimicking STEMI in the Catheterization Laboratory: Early Recognition Is Mandatory

    Directory of Open Access Journals (Sweden)

    Alessio Arrivi

    2012-01-01

    Full Text Available Coronary malperfusion due to type A aortic dissection is a life-threatening condition where timely recognition and treatment are mandatory. A 77-year-old woman underwent an acute evolving type A aortic dissection mimicking acute myocardial infarction. Two pathophysiologic mechanisms are discussed: either thrombosis migrating from a previously treated giant aneurism of proximal left anterior descending or a local arterial complication due to left main stenting. Recognition of these occurrences in the catheterization laboratory is important to look immediately for surgery.

  3. Evasion of "mandatory" social health insurance for the formal sector: evidence from Lao PDR.

    Science.gov (United States)

    Alkenbrack, Sarah; Hanson, Kara; Lindelow, Magnus

    2015-10-19

    In the last decade, almost every low- or middle-income country in the world has expressed support for universal health coverage (UHC). While at the beginning of the UHC movement, country strategies focused on increasing access to the formal sector as the first step of UHC, there is now consensus that countries should cover the entire population, with particular attention to covering the poor. However, it is often assumed that mandatory schemes will automatically cover their target populations, and consequently little is known about why firms comply or do not comply with enrolment requirements. Using the experience of Lao PDR, where the enrolment rate in the mandatory social security scheme is low and the capacity for regulation is weak, we conducted this study to better understand the determinants of enrolment of private sector firms in mandatory social security. We used a cross-sectional case-comparison design, surveying 130 firms. We applied a structured questionnaire to explore determinants of enrolment, specifically looking at firm characteristics (e.g., industry category, ownership); sociodemographic characteristics of company heads; firms' risk perceptions; details of employment contracts; employee benefits; and exposure to social security. Closed ended questions were analysed quantitatively, while content analysis was applied to open-ended questions. Logistic regression was used to examine the determinants of enrolment. Smaller privately owned firms in the services industry were the least likely to enrol in social security, while firms in the trade industry were more likely to enrol than firms in manufacturing, construction, or services. The main reason for not enrolling was that firms offered a better package of benefits to their employees, although further investigation of company benefits showed that this was not the case in practice. Additional reasons for non-compliance were lack of knowledge and poor quality of care at government hospitals. The study

  4. Ethical Considerations in Mandatory Disclosure of Data Acquired While Caring for Human Trafficking Survivors.

    Science.gov (United States)

    Kerr, Patrick L; Dash, Rachel

    2017-01-01

    Accurate data on the prevalence and psychological effects of human trafficking as well as treatment outcomes for survivors are essential for measuring the impact of interventions and generating better understanding of this phenomenon. However, such data are difficult to obtain. A legal mandate for health care professionals to report trafficking opens opportunities for advancing our work in the field of human trafficking but also poses risks to survivors seeking services. In this article, we provide an analysis of some critical ethical considerations for the development and implementation of a mandatory reporting policy and offer recommendations for the ethical implementation of such a policy. © 2017 American Medical Association. All Rights Reserved.

  5. Adverse drug events observed in patients with type 2 diabetes mellitus treated with 100 mg versus 300 mg canagliflozin: a systematic review and meta-analysis of published randomized controlled trials.

    Science.gov (United States)

    Bundhun, Pravesh Kumar; Janoo, Girish; Huang, Feng

    2017-04-16

    Nowadays, canagliflozin monotherapy, or in combination with other oral hypoglycemic agents (OHAs), is often administered in patients who are treated for type 2 diabetes mellitus (T2DM). Therefore, we aimed to systematically compare the adverse drugs events (AEs) which were associated with 100 mg versus 300 mg canagliflozin respectively, using a large number of randomized patients with T2DM which were obtained from published trials. Randomized controlled trials (RCTs) comparing 100 mg versus 300 mg canagliflozin in patients who were treated for T2DM were searched from electronic databases. AEs reported during a follow up period ranging from 12 to 104 weeks were considered as the clinical endpoints in this analysis. We calculated odds ratios (OR) with 95% confidence intervals (CIs) and the analyses were carried out by RevMan 5 · 3 software. Ten trials involving a total number of 5394 patients (2604 patients who were treated with 100 mg canagliflozin and 2790 patients who were treated with 300 mg canagliflozin) were included. The current results showed that serious AEs were not significantly higher in patients who were treated by 300 mg canagliflozin, with OR: 1.01, 95% CI: 0.79-1.29; P = 0.93. Also, a similar rate of death was observed in patients who were treated by either 100 or 300 mg canagliflozin with OR: 1.13, 95% CI: 0.43-2.94; P = 0.80. Urinary tract infections, postural dizziness and hypoglycemia were also similarly manifested, with OR: 0.93, 95% CI: 0.70-1.23; P = 0.61, OR: 1.51, 95% CI: 0.42-5.37; P = 0.53 and OR: 0.96, 95% CI: 0.81-1.13; P = 0.60 respectively. However, drug discontinuation due to AEs significantly favored 100 mg canagliflozin only during this unequal follow-up period with OR: 1.35, 95% CI: 1.06-1.72; P = 0.01, but it was not significantly different when trials with similar follow-up periods were analyzed. 300 mg canagliflozin was not associated with significantly higher adverse events compared to

  6. Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial.

    Science.gov (United States)

    Rolving, Nanna; Brocki, Barbara C; Mikkelsen, Hanne R; Ravn, Pernille; Bloch-Nielsen, Jannie Rhod; Frost, Lars

    2017-05-30

    The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE. One hundred forty patients with incident first-time PE will be recruited in five hospitals. After inclusion, patients will be randomly allocated to either the control group, receiving usual care, or the intervention group, who will be exposed to an 8-week home-based exercise program in addition to usual care. The intervention includes an initial individual exercise planning session with a physiotherapist, leading to a recommended exercise program of a minimum of three weekly training sessions of 30-60 minutes' duration. The patients have regular telephone contact with the physiotherapist during the 8-week program. At the time of inclusion, after 2 months, and after 6 months, the patients' physical capacity is measured using the Incremental Shuttle Walk test. Furthermore the patients' quality of life, sick leave, and use of psychotropic drugs is measured using self-reported questionnaires. In both randomization arms, all follow-up measurements and visits will take place at the hospital from which the patient was discharged. Levels of eligibility, consent, adherence, and retention will be used as indicators of study feasibility. We expect that the home-based exercise program will improve the physical capacity and quality of life for the patients in the intervention group. The study will furthermore contribute significantly to the limited knowledge about the optimal rehabilitation of

  7. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Park Kyung

    2012-03-01

    Full Text Available Abstract Background Second-generation drug-eluting stents (DES have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES. In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI. A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES and antiplatelet regimen (TAT vs DDAT. The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734.

  8. The 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial: study protocol for a randomized controlled trial

    Science.gov (United States)

    2012-01-01

    Background Second-generation drug-eluting stents (DES) have raised the bar of clinical performance. These stents are mostly made from cobalt chromium alloy. A newer generation DES has been developed from platinum chromium alloy, but clinical data regarding the efficacy and safety of the platinum chromium-based everolimus-eluting stent (PtCr-EES) is limited, with no comparison data against the cobalt chromium-based zotarolimus-eluting stent (CoCr-ZES). In addition, an antiplatelet regimen is an integral component of medical therapy after percutaneous coronary intervention (PCI). A 1-week duration of doubling the dose of clopidogrel (double-dose antiplatelet therapy (DDAT)) was shown to improve outcome at 1 month compared with conventional dose in acute coronary syndrome (ACS) patients undergoing PCI. However in Asia, including Korea, the addition of cilostazol (triplet antiplatelet therapy (TAT)) is used more commonly than doubling the dose of clopidogrel in high-risk patients. Methods In the 'Harmonizing Optimal Strategy for Treatment of coronary artery stenosis - sAfety & effectiveneSS of drug-elUting stents & antiplatelet REgimen' (HOST-ASSURE) trial, approximately 3,750 patients are being prospectively and randomly assigned in a 2 × 2 factorial design according to the type of stent (PtCr-EES vs CoCr-ZES) and antiplatelet regimen (TAT vs DDAT). The first primary endpoint is target lesion failure at 1 year for the stent comparison, and the second primary endpoint is net clinical outcome at 1 month for comparison of antiplatelet therapy regimen. Discussion The HOST-ASSURE trial is the largest study yet performed to directly compare the efficacy and safety of the PtCr-EES versus CoCr-ZES in an 'all-comers' population. In addition, this study will also compare the clinical outcome of TAT versus DDAT for 1-month post PCI. Trial registration ClincalTrials.gov number NCT01267734. PMID:22463698

  9. Effect of the frequency of self-monitoring blood glucose in patients with type 2 diabetes treated with oral antidiabetic drugs-a multi-centre, randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Werner A Scherbaum

    Full Text Available OBJECTIVE: Recommendations on the frequency of self-monitoring of blood glucose (SMBG vary widely among physicians treating patients with type 2 diabetes (T2D. Aim of this study was to investigate two testing regimen of SMBG in patients with stable metabolic control. RESEARCH DESIGN AND METHODS: Patients with T2D treated with oral antidiabetic drugs were randomized to two groups: either one SMBG (low or four SMBG (high per week. Subjects were followed up after 3, 6 and 12 months. Primary outcome parameter was the change in HbA1c between baseline and 6 months. Primary outcome criterion was tested by a one-sided t- test for non- inferiority. Secondary outcome parameters were safety, compliance and HbA1c at 3 and 12 months. RESULTS: There were no differences in the 202 subjects for demographic and sociodemographic parameters and drug treatment. HbA(1c (% at baseline was similar in both groups (7.2+/-1.4 vs. 7.2+/-1.0. Non- inferiority was demonstrated for the low group (p = 0.0022 with a difference from baseline to 6 months of 0.24 in the low and of 0.16 in the high group. Compliance with the testing regimen was 82-90% in both groups. There were no statistical significant differences for compliance, HbA(1c at 3 and 12 months and serious adverse events (SAE. CONCLUSION: One SMBG per week is as sufficient and safe as four SMBG per week to maintain HbA(1c in non-insulin treated T2D close to metabolic target. The results of this study are in contrast to current international consensus guidelines. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN79164268.

  10. Efficacy of Short-Term Antiarrhythmic Drugs Use after Catheter Ablation of Atrial Fibrillation-A Systematic Review with Meta-Analyses and Trial Sequential Analyses of Randomized Controlled Trials.

    Science.gov (United States)

    Chen, Weijie; Liu, Hang; Ling, Zhiyu; Xu, Yanping; Fan, Jinqi; Du, Huaan; Xiao, Peilin; Su, Li; Liu, Zengzhang; Lan, Xianbin; Zrenner, Bernhard; Yin, Yuehui

    2016-01-01

    The efficacy of short-term antiarrhythmic drugs (AADs) use compared with no-AADs prescription after catheter ablation of atrial fibrillation (AF) in preventing atrial arrhythmia recurrence is uncertain. We searched PubMed, Embase, and the Cochrane Library through December 2015 to identify randomized controlled trials (RCTs) which evaluated the efficacy of short-term AADs use compared with no-AADs prescription after AF ablation in preventing atrial arrhythmia recurrence. The primary outcome was labeled as early atrial arrhythmia recurrence within 3 months after ablation. Secondary outcome was defined as late recurrence after 3 months of ablation. Random-effects model or fixed-effects model was used to estimate relative risks (RRs) with 95% confidence intervals (CIs). Six RCTs with 2,667 patients were included into this meta-analysis. Compared with no-AADs administration after AF ablation, short-term AADs use was associated with significant reduction of early atrial arrhythmia recurrence (RR, 0.68; 95% CI, 0.52-0.87; p = 0.003). Trial sequential analysis (TSA) showed that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit, establishing sufficient and conclusive evidence. However, compared with no-AADs prescription, short-term AADs use after AF ablation didn't significantly reduce the risk of late atrial arrhythmia recurrence (RR, 0.92; 95% CI, 0.83-1.03; p = 0.15). TSA supported this result; meanwhile the estimated required information size (1,486 patients) was also met. Short-term use of AADs after AF ablation can significantly decrease the risk of early atrial arrhythmia recurrence but not lead to corresponding reduction in risk of late atrial arrhythmia recurrence.

  11. Improved outcomes of elderly patients treated with drug-eluting versus bare metal stents in large coronary arteries: results from the BAsel Stent Kosten-Effektivitäts Trial PROspective Validation Examination randomized trial.

    Science.gov (United States)

    Kurz, David J; Bernheim, Alain M; Tüller, David; Zbinden, Rainer; Jeger, Raban; Kaiser, Christoph; Galatius, Soeren; Hansen, Kim W; Alber, Hannes; Pfisterer, Matthias; Eberli, Franz R

    2015-10-01

    Drug-eluting stents (DES) improve outcomes in elderly patients with small coronary artery disease compared with bare-metal stents (BMS), but randomized data in elderly patients in need of large coronary stents are not available. Planned secondary analysis of patients ≥75 years recruited to the "BASKET-PROVE" trial, in which 2,314 patients undergoing percutaneous coronary intervention for large (≥3.0 mm) native vessel disease were randomized 2:1 to DES (everolimus- vs sirolimus-eluting stents 1:1) versus BMS. All patients received 12 months of dual antiplatelet therapy. The primary end point was a composite of cardiac death or nonfatal myocardial infarction at 2 years. Comparison of DES versus BMS among 405 patients ≥75 years showed significantly lower rates of the primary end point for DES (5.0% vs 11.6%; hazard ration (HR) 0.64 [0.44-0.91]; P = .014). Rates of nonfatal myocardial infarction (1.2% vs 5.5%, hazard ration (HR) 0.44 [0.21-0.83]; P = .009), all-cause death (7.4% vs 14.4%; HR 0.7 [0.51-0.95]; P = .02), and target vessel revascularization (TVR) (2.3% vs 6.2%; HR 0.59 [0.34-0.99]; P = .046) were also lower, whereas stent thrombosis and bleeding rates were similar. In contrast, among patients <75 years (n = 1,909), the only significant benefit of DES was a reduced rate of TVR (4.0% vs 8.7%, HR 0.66 [0.55-0.80]; P < .0001). In patients ≥75 years requiring large (≥3.0 mm) coronary stents, use of DES was beneficial compared with BMS and reduced the rate of ischemic events, mortality, and TVR. These data suggest that DES should be preferred over BMS in elderly patients. Copyright © 2015 Elsevier Inc. All rights reserved.

  12. A randomized comparison of amiodarone and class IC antiarrhythmic drugs to treat atrial fibrillation in patients paced for sinus node disease: the Prevention Investigation and Treatment: A Group for Observation and Research on Atrial arrhythmias (PITAGORA) trial.

    Science.gov (United States)

    Gulizia, Michele; Mangiameli, Salvatore; Orazi, Serafino; Chiarandà, Giacomo; Piccione, Guglielmo; Di Giovanni, Nicolò; Colletti, Andrea; Pensabene, Orazio; Lisi, Francesco; Vasquez, Ludovico; Grammatico, Andrea; Boriani, Giuseppe

    2008-01-01

    Rhythm control is an important goal in the treatment of recurrent atrial tachyarrhythmias (AT). The PITAGORA study was a randomized trial in patients paced for sinus node disease (SND), designed to test the noninferiority of class IC antiarrhythmic drugs (AADs) to amiodarone in terms of a primary end point composed of death, permanent AT, cardiovascular hospitalization, atrial cardioversion, or AAD change. Randomization was stratified to assign 2 patients to amiodarone and 2 patients to class IC AADs: propafenone or flecainide. One hundred seventy-six patients (46% men, 72 +/- 8 years) were enrolled. Device diagnostics continuously monitored AT recurrences and duration. In a mean follow-up of 20 +/- 9 months, the primary end point occurred in 23 (30.7%) of 75 class IC patients and in 28 (40.0%) of 70 amiodarone patients. The absolute difference in the end point incidence (-9.3%; 95% CI between 3.7% and -22.3%) confirmed the noninferiority of class IC to amiodarone (P = .007). Kaplan-Meier 1-year freedom from AT episodes >10 minutes, 1 day, and 7 days was 40%, 73%, and 91% for amiodarone and 28%, 78%, and 86% for class IC AADs (P = nonsignificant). In patients paced for SND and suffering from AT, class IC AADs proved not to be inferior to amiodarone in terms of the primary composite end point described or end points which were differently composed of mortality, efficacy, or AAD side effects. The AADs studied also showed similar results in terms of symptoms, quality of life, and freedom from AT recurrences.

  13. Drugs, drugs--who has the drugs?

    Science.gov (United States)

    Blair, James

    2012-01-01

    Drug diversion, although on the increase, is not the only problem involving drugs that hospital security officials should be concerned with. Growing drug shortages, offshore production, counterfeiting, and weaknesses in the drug supply chain in case of a world-wide pandemic, are even greater causes for concern, the author claims.

  14. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: Final results and cost-effectiveness analysis from a prospective randomized controlled trial (NCT01174472)

    Energy Technology Data Exchange (ETDEWEB)

    Kitrou, Panagiotis M., E-mail: panoskitrou@gmail.com [Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion 26504 (Greece); Katsanos, Konstantinos [Department of Interventional Radiology, Guy' s and St. Thomas’ Hospitals, NHS Foundation Trust, King' s Health Partners, London SE1 7EH (United Kingdom); Spiliopoulos, Stavros; Karnabatidis, Dimitris; Siablis, Dimitris [Department of Interventional Radiology, Patras University Hospital, School of Medicine, Rion 26504 (Greece)

    2015-03-15

    Highlights: •1-Year target lesion primary patency significantly higher after PCB application compared to plain balloon angioplasty in the failing dialysis access. •Significant difference in favor of PCB in cumulative primary patency of AVGs at 1 year. •No significant difference in cumulative primary patency of AVFs treated with PCB at 1 year. •Cost effectiveness analysis performed. •Paclitaxel-coated balloon angioplasty proves to be a cost-effective option for treating dialysis access. -- Abstract: Objective: To report the final results and cost-effectiveness analysis of a prospective randomized controlled trial investigating drug-eluting balloon (DEB) versus plain balloon angioplasty (BA) for the treatment of failing dialysis access ( (NCT01174472)). Methods: 40 patients were randomized to angioplasty with either DEB (n = 20) or BA (n = 20) for treatment of significant venous stenosis causing a failing dialysis access. Both arteriovenous fistulas (AVF) and synthetic arteriovenous grafts (AVG) were included. Angiographic follow up was scheduled every two months. Primary endpoints were technical success and target lesion primary patency at 1 year. Cumulative and survival analysis was performed. Incremental net benefit (INB) and incremental cost effectiveness ratio (ICER) were calculated and the cost-effectiveness acceptability curve (CEAC) was drawn. Results: Baseline variables were equally distributed between the two groups. At 1 year, cumulative target lesion primary patency was significantly higher after DEB application (35% vs. 5% after BA, p < 0.001). Overall, median primary patency was 0.64 years in case of DEB vs. 0.36 years in case of BA (p = 0.0007; unadjusted HR = 0.27 [95%CI: 0.13–0.58]; Cox adjusted HR = 0.23 [95%CI: 0.10–0.50]). ICER was 2198 Euros (€) per primary patency year of dialysis access gained. INB was 1068€ (95%CI: 31–2105€) for a willingness-to-pay (WTP) threshold of 5000€ (corresponding acceptability probability >97

  15. A mandatory intercalated degree programme: revitalising and enhancing academic and evidence-based medicine.

    Science.gov (United States)

    Collins, John P; Farish, Stephen; McCalman, Janet S; McColl, Geoffrey J

    2010-01-01

    Recruitment of medical graduates to research careers is declining. Expansion of medical knowledge necessitates all graduates be equipped to critically evaluate new information. To address these challenges, a mandatory intercalated degree programme was introduced as part of curriculum reform. To review the place on intercalated degrees, the methods available for learning about research and to analyse experience with a new university programme focusing on research. A literature review followed by the analysis of experience with eight cohorts of students who had completed the new programme. A total of 1599 students completed the programme. Laboratory-based research was the most common choice followed by clinical research, population health, epidemiology, medical humanities and mental health. Also, 93% of students spent over 75% of their time undertaking research. Sixty-three students published their research, half as first authors. Students and coordinators support the programme. Learning about research during the postgraduate phase is variable and frequently left to individual choice. Intercalating an additional degree focusing on research can achieve a number of learning objectives but demands a level of maturity, autonomy and preparedness, not uniformly present in students undertaking a mandatory intercalated programme. A more realistic goal is the development of 'research-mindedness' amongst all students.

  16. Reconception of mandatory-based corporate social and environmental responsibility in Indonesia

    Science.gov (United States)

    Yunari, S. B.; Suhariningsih, S.; Syafa’at, R.; Sihabudin, S.

    2018-01-01

    The Legal Concept of Corporate Social and Environmental Responsibility (CSER) in Law Number 40 Year 2007 (Company Law), as set forth in the general provision Article 1 (3) of Company Law evidently is a definition (begripsbepalingen) of voluntary basis, because it comes from the concept of CSR used by western countries based on World Bank’s guidelines. Hence, it is certainly contrary to the legal concept of CSER that is perceived to be mandatory in the Company Law. Therefore, the concept of CSER as an implementation of a legal principle in a norm, so as not to cause legal issue, at the normative level as well as at implementation level, must be consistent and need reconception.The purpose of this reconception of CSER is to find a new concept of mandatory-based CSER. The methodology of research used is legal research (doctrinal research), based on secondary legal material acquired analysed presciptively by statute, conseptual and comparative approach.The research outcome is resulting in a discussion of reconception of a legal responsibility-based Corporate Social Liability (CSL) with sustainable local community empowerment oriented, so as to create legal certainty at the normative level and implementation in Indonesia.

  17. Indoor soccer-related eye injuries: should eye protection be mandatory?

    Science.gov (United States)

    Kent, Jerrod S; Eidsness, Ryan B; Colleaux, Kevin M; Romanchuk, Kenneth G

    2007-08-01

    Our objectives were to present the spectrum of eye injuries caused by indoor soccer, as seen at our institution, and to initiate discussion as to whether eye protection should become mandatory for this indoor sport. Chart review of patients presenting to our institution with eye injuries from indoor soccer. Five cases were identified from 2001-2005, all occurring during the winter or late fall. Each injury was due to contact with the soccer ball itself. Initially, all 5 patients presented with commotio retinae (1 with a prominent retinal and vitreous hemorrhage and 2 with smaller retinal hemorrhages), 2 with hyphema and traumatic mydriasis, 1 with subconjunctival hemorrhage, and 1 with upper lid edema and ecchymosis. Three resolved uneventfully with 20/20 or better vision; however, in 2 there were findings of choroidal rupture with chorioretinal scarring. One of these had 20/20 vision and a discontinuous choroidal rupture peripherally, and the other had 20/40 vision and extensive chorioretinal scarring. One patient also showed a peculiar persistent iris scar. Soccer-related eye injuries have been recognized as an important ophthalmologic problem in Europe and now increasingly so in North America. With the increasing popularity of indoor soccer in Canada, serious eye injuries have become more prevalent. On the basis of the prevalence and the nature and mechanism of the ocular trauma, we believe there may be a need to make eye protection mandatory for all forms of soccer.

  18. Impact of mandatory microchipping on traceability of sheltered dogs in the Czech Republic.

    Science.gov (United States)

    Zak, Jiri; Voslarova, Eva; Vecerek, Vladimir; Bedanova, Iveta

    2017-09-21

    Records of 4,455 sheltered dogs were analyzed to compare the numbers of traceable (able to be reunited with original caregivers) and untraceable (unable to be reunited with original caregivers) dogs before (Period 1) and after (Period 2) introduction of a mandatory microchipping. Records were also used to compare the numbers of microchipped dogs, to compare dogs' reunification with caregivers, and to estimate possible financial savings. In Period 1, 51.8% of the dogs were untraceable (median length of stay = 14 days) and 48.2% were traceable (median length of stay = 1 day). Of all traceable dogs, 24.5% were microchipped, and 67.5% of microchipped dogs were traceable. In Period 2, 57.1% of dogs were traceable (median length of stay = 0 days), and 42.9% were untraceable (median length of stay = 12 days). Of all traceable dogs, 61.4% had a microchip, and 80% of microchipped dogs were traceable. In Period 2, authorities saved more than US$43,400 on unreclaimed dog care. Mandatory microchipping of dogs appears to be an effective measure to increase reunification of sheltered dogs, decrease length of stay, and save authority funds.

  19. The evolving landscape of Title IX: Predicting mandatory reporters' responses to sexual assault disclosures.

    Science.gov (United States)

    Holland, Kathryn J; Cortina, Lilia M

    2017-10-01

    Approximately 1 in 4 women is sexually assaulted in college, a problem that federal law has attempted to address with recent changes. Under the evolving landscape of Title IX, and related law, universities nationwide have overhauled their sexual assault policies, procedures, and resources. Many of the new policies designate undergraduate resident assistants (RAs) as Responsible Employees-requiring them to provide assistance and report to the university if a fellow student discloses sexual assault. We investigated factors that predict the likelihood of RAs enacting their policy mandate, that is, reporting sexual assault disclosures to university authorities and referring survivors to sexual assault resources. Based on data from 305 Responsible Employee RAs, we found that likelihood to report and refer varied, depending on RAs' knowledge of reporting procedures and resources, trust in these supports, and perceptions of mandatory reporting policy. Understanding mandatory reporter behavior is crucial, because help-providers' responses can have serious implications for the recovery of sexual assault survivors. Our findings elucidate some effects of changes in the interpretation and implementation of Title IX, with potential to inform the development of more theoretically and empirically informed policies. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  20. NOTES ON THE ONGOING CRISIS OF MANDATORY PROSECUTION IN ITALIAN LAW

    Directory of Open Access Journals (Sweden)

    Bruna Capparelli

    2017-05-01

    Full Text Available This article intends to analyze the Italian situation and the main discussions related to the principle of mandatory prosecution in criminal procedure and to the possibility of regulating criteria of prioritization to relativize that premise. This is a primordial issue considering the widespread overload of criminal justice, especially because of the expressive and long-described phenomenon of the overcriminalization. Thus, the following problem arises: Is sustainable the idea of an absolute mandatory prosecution, which establishes a duty to the public prosecution in all cases of a crime and existence of sufficient evidence to substantiate it? Based on this study, it will be argued that some criteria should be provided for rationalization of this principle, through parliamentary guidelines and integrative activities of the prosecutor's offices, with standards distinct from the exclusive occurrence of a crime and sufficient evidence to prove it, regulated in such a way as to be generalizable and controllable, with objective assumptions, thus respecting the need for equal treatment between citizens.

  1. Transparency of Mandatory Information Disclosure and Concerns of Health Services Providers and Consumers

    Directory of Open Access Journals (Sweden)

    Yu-Hua Yan

    2017-01-01

    Full Text Available Background: This study analyzed differences between transparency of information disclosure and related demands from the health service consumer’s perspective. It also compared how health service providers and consumers are associated by different levels of mandatory information disclosure. Methods: We obtained our research data using a questionnaire survey (health services providers, n = 201; health service consumers, n = 384. Results: Health service consumers do not have major concerns regarding mandatory information disclosure. However, they are concerned about complaint channels and settlement results, results of patient satisfaction surveys, and disclosure of hospital financial statements (p < 0.001. We identified significant differences in health service providers’ and consumers’ awareness regarding the transparency of information disclosure (p < 0.001. Conclusions: It may not be possible for outsiders to properly interpret the information provided by hospitals. Thus, when a hospital discloses information, it is necessary for the government to consider the information’s applicability. Toward improving medical expertise and information asymmetry, the government has to reduce the burden among health service consumers in dealing with this information, and it has to use the information effectively.

  2. "Notify your partners--it's the law": HIV providers and mandatory disclosure.

    Science.gov (United States)

    Lichtenstein, Bronwen; Whetten, Kathryn; Rubenstein, Casey

    2014-01-01

    HIV care providers in the United States must counsel clients about disclosure to sexual partners and report anyone who is suspected of noncompliance. This study compared provider attitudes and practices in relation to counseling clients about mandatory disclosure in North Carolina and Alabama, the 2 states with similar HIV epidemiology but different laws for HIV control. Personal interviews were conducted with 20 providers in each state (n = 40). The results were analyzed in a qualitative, cross-comparison method to identify patterns of convergence or difference. Providers in both states believed that clients often failed to notify sexual partners and were secretive if questioned about disclosure. Differences in counseling styles and procedures for each state were noteworthy. Compared to Alabama, North Carolina had harsher penalties for nondisclosure, stricter and more standardized procedures for counseling, and providers expressed greater support for HIV criminalization. Although most North Carolina providers viewed the stricter standards as beneficial for HIV care and control, Alabama providers were likely to view such standards as a barrier to patient care. These results indicated a direct relation between state HIV law, provider attitudes, and counseling procedures for mandatory disclosure.

  3. Mandatory International Financial Reporting Standards Adoption and Cost of Equity Capital in Nigeria

    Directory of Open Access Journals (Sweden)

    Uwuigbe Uwalomwa

    2016-05-01

    Full Text Available This study examined the effect of mandatory International Financial Reporting Standards (IFRS adoption on the cost of equity capital on Nigerian firms and whether the cost of equity capital effect after adoption of IFRS can be moderated by Return on Equity. The study covered a sample of 11 listed companies in the industrial goods sector for the period 2011 and 2013. The data for the study was secondary data generated from the annual reports and stock market report websites. The cost of equity capital was shown as the expected return on the basic value of a share and computed based on pre and post-adoption data. Findings from the study revealed that there is a significant positive relationship between the cost of equity capital and IFRS adoption indicating that the cost of equity capital increased. The market-based performance measure failed to have significant effect on the cost of equity capital after mandatory adoption. The study recommends that policies that improve domestic savings, as a principal source of equity capital, be enacted as an increase should lead to a reduction in the cost of equity capital, interest rates and increase the appeal of equity and foreign investments.

  4. Mandatory labels, taxes and market forces: An empirical evaluation of fat policies.

    Science.gov (United States)

    Allais, Olivier; Etilé, Fabrice; Lecocq, Sébastien

    2015-09-01

    The public-health community views mandatory Front-of-Pack (FOP) nutrition labels and nutritional taxes as promising tools to control the growth of food-related chronic diseases. This paper uses household scanner data to propose an ex-ante evaluation and comparison of these two policy options for the fromage blanc and dessert yogurt market. In most markets, labelling is voluntary and firms display fat labels only on the FOP of low-fat products to target consumers who do not want to eat fat. We here separately identify consumer preferences for fat and for FOP fat labels by exploiting an exogenous difference in legal labelling requirements between these two product categories. Estimates of demand curves are combined with a supply model of oligopolistic price competition to simulate policies. We find that a feasible ad valorem fat tax dominates a mandatory FOP-label policy from an economic perspective, but both are equally effective in reducing average fat purchases. Copyright © 2015 Elsevier B.V. All rights reserved.

  5. Effect of a Mandatory Third-Year Osteopathic Manipulative Treatment Course on Student Attitudes.

    Science.gov (United States)

    Heineman, Katherine L; Lewis, Drew D; Finnerty, Edward P; Crout, Shannon V; Canby, Craig

    2016-04-01

    Despite interest by osteopathic medical students in learning and incorporating osteopathic manipulative treatment (OMT) techniques into their future practices, most students indicate that OMT is rarely or never taught during many clinical rotations. To determine whether a mandatory OMT course taken during the third year of medical school would influence students' exposure to OMT, confidence in OMT, intent to continue developing OMT skills, and plan to provide OMT as practicing physicians. A mandatory pilot OMT course was implemented in the 2014 third-year curriculum. A survey was then developed to assess students' attitudes toward OMT. Surveys were administered to students whose third year was in 2013 and thus had not taken the course (group 1) and to students who had taken the course in 2014 (group 2). Of the 223 students in group 1, 143 (64%) responded. Of the 213 students in group 2, 112 (53%) responded. Students in group 2 reported greater exposure to OMT compared with students in group 1, higher confidence levels in practicing OMT (61 [54%] vs 71 [50%]), greater intent to continue developing OMT skills, and plan to provide OMT as practicing physicians (91 [81%] vs 94 [66%]). A pilot course in OMT increased students' levels of confidence in and intent to provide OMT in their future practices.

  6. Mandatory menu labeling in one fast-food chain in King County, Washington.

    Science.gov (United States)

    Finkelstein, Eric A; Strombotne, Kiersten L; Chan, Nadine L; Krieger, James

    2011-02-01

    As part of a comprehensive effort to stem the rise in obesity, King County, Washington, enforced a mandatory menu-labeling regulation requiring all restaurant chains with 15 or more locations to disclose calorie information at the point of purchase beginning in January 2009. The purpose of this study is to quantify the impact of the King County regulation on transactions and purchasing behavior at one Mexican fast-food chain with locations within and adjacent to King County. To examine the effect of the King County regulation, a difference-in-difference approach was used to compare total transactions and average calories per transaction between seven King County restaurants and seven control locations focusing on two time periods: one period immediately following the law until the posting of drive-through menu boards (January 2009 to July 2009) and a second period following the drive-through postings (August 2009 through January 2010). Analyses were conducted in 2010. No impact of the regulation on purchasing behavior was found. Trends in transactions and calories per transaction did not vary between control and intervention locations after the law was enacted. In this setting, mandatory menu labeling did not promote healthier food-purchasing behavior. Copyright © 2011 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

  7. Child sexual abuse and mandatory reporting intervention preservice content preferred by student teachers.

    Science.gov (United States)

    Goldman, Juliette D G; Grimbeek, Peter

    2014-01-01

    The importance of preservice university teacher training about child sexual abuse and its mandatory reporting intervention is addressed in educational literature, although very little is known about student teachers' learning interests and preferences in this area. In this article, student teachers refer to students in university who are training to become teachers whose training includes teaching experiences in schools. This study examines the content about child sexual abuse and its intervention that student teachers believe they should learn. Results based on quantitative analyses show the relative importance of gender in determining responses to questions about university training and, to a lesser extent, the importance of a previous acquaintance with victims of sexual abuse, previous employment, and the length of the university course. Results based on qualitative data show that content knowledge preferred by elementary/primary and secondary school student teachers includes the teacher's role in mandatory reporting of child sexual abuse and signs, experiences, and responses to student disclosure. Student teachers prefer content examples of school professionals' responses and procedures after disclosure and prefer direct learning content from intervening school professionals. These outcomes could usefully guide teachers and educators who design intervention curricula on child sexual abuse for preservice teachers.

  8. Federal court holds first live evidentiary hearing on mandatory delay since Casey.

    Science.gov (United States)

    1994-06-24

    Four days beginning on June 20, U.S. District Court Judge Nancy Edmunds heard testimony and argument in Northland Family Planning, Inc. vs. Engler, a challenge to Michigan's 1993 mandatory 24-hour delay and biased counseling law. Scheduled to take effect on April 1, the statute was temporarily blocked by Judge Edmunds on March 18--eight days after two dozen women's health care providers and advocates filed suite (see RFN III/5). The hearing this week on plaintiff's request for a preliminary injunction marked the first time since the U.S. Supreme Court's 1992 decision in Planned Parenthood vs. Casey that Witnesses have appeared in federal court to testify about the likely impact of such a measure. In the wake of Casey, an abortion restriction is unconstitutional if it poses an "undue burden" on a woman's right to choose abortion. Nationally renowned experts and clinic directors testified this week that the Michigan law is unnecessary to ensure informed consent for abortions and will particularly disadvantage battered women, rape and incest survivors, women carrying anomalous fetuses, and women who need abortions for severe medical and psychological conditions. CRLP attorneys Eve Gartner and Priscilla Smith represented plaintiffs during the hearing. Mandatory delay and biased counseling laws are currently in effect in Kansas, Mississippi, Nebraska, North Dakota, Ohio, Pennsylvania, and Utah; only Mississippi requires women to travel twice to a women's health care provider: once for the mandated information and a second time at least 24 hours later for the abortion. full text

  9. Methods of Identification of Efficiency of Action of the System of Mandatory Social Medical Insurance in Ukraine

    Directory of Open Access Journals (Sweden)

    Molozina Natalia A.

    2014-02-01

    Full Text Available The article develops and offers the author’s vision of methods of analysis of efficiency of action of the system of mandatory social medical insurance by categories and indicators. These methods are required for being used when making managerial decisions when developing directions of increase of efficiency and also when further adjusting activity of state bodies of administration of the mandatory social medical insurance. In the result of the conducted study the article establishes that the project of investing into the mandatory social medical insurance by the number of revealed benefits from its adoption could be economically and socially efficient both for the state and enterprises (employers and for an individual citizen of Ukraine. We note the following benefits: growth of the level of labour productivity, saving funds of the State Budget and enterprises for social payments, reduction of the level of morbidity and improvement of the financial state of the healthcare branch. The proposed method of assessment of efficiency of investing funds into the mandatory social medical insurance by indicators of prevented losses, saving funds of the State Budget, employer and insured person and also social indicators of the state of health of citizens and quality of their medical servicing could be used during operative and strategic planning and also state regulation of activity of the system of mandatory social medical insurance.

  10. Drug Facts

    Medline Plus

    Full Text Available ... some signs and symptoms of someone with a drug use problem? How Does Drug Use Become an Addiction? What ... Effects on the Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use ...

  11. Hematological clozapine monitoring with a point-of-care device: A randomized cross-over trial

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

    2012-01-01

    for several reasons, perhaps most importantly because of the mandatory hematological monitoring. The Chempaq Express Blood Counter (Chempaq XBC) is a point-of-care device providing counts of white blood cells (WBC) and granulocytes based on a capillary blood sampling. A randomized cross-over trial design...

  12. Hematological clozapine monitoring with a point-of-care device: A randomized cross-over trial

    DEFF Research Database (Denmark)

    Nielsen, Jimmi; Thode, Dorrit; Stenager, Elsebeth

    for several reasons, perhaps most importantly because of the mandatory hematological monitoring. The Chempaq Express Blood Counter (Chempaq XBC) is a point-of-care device providing counts of white blood cells (WBC) and granulocytes based on a capillary blood sampling. A randomized cross-over trial design...

  13. Drug Facts

    Medline Plus

    Full Text Available ... to main content Easy-to-Read Drug Facts Search form Search Menu Home Drugs That People Abuse Alcohol Facts ... Past Drug Use Prevention Phone Numbers and Websites Search Share Government Shutdown Because of a lapse in ...

  14. Drug Facts

    Medline Plus

    Full Text Available ... time to find drug treatment centers near you. I want my daughter to avoid drugs. "Debbie" has ... addiction. Counseling is very helpful to her. All I wanted was more of the drug. "Max" was ...

  15. Drug Facts

    Medline Plus

    Full Text Available ... of someone with a drug use problem? How Does Drug Use Become an Addiction? What Makes Someone More Likely to Get Addicted to Drugs? Does Addiction Run in Families? Why Is It So ...

  16. Why do they keep calling? Single parents’ Domestication of mandatory e-government self-service channels

    DEFF Research Database (Denmark)

    Østergaard Madsen, Christian

    2016-01-01

    -government channels, or getting around the mandatory requirements. This thesis explores citizens’ interactions with public authorities following the deployment of mandatory self-service applications. It presents a mixed-method longitudinal case study of single parents, who interact with public authorities and each...... authorities should not only seek to increase the share of citizen-initiated online interactions, but simultaneously strive to reduce the total volume of traffic. Public authorities can pre-empt and reduce traffic by improving the quality and quantity of their mass communication channels based on results from......The Danish Digitization strategy 2011-2015 made e-government channels mandatory within multiple areas, including public benefits. Although most Danes have adopted the e-government channels, many keep using traditional channels. Moreover, some have their own ways of interpreting and using the e...

  17. The Influence of Corporate Governance Structures on Compliance with Mandatory IFRSs Disclosure Requirements in the Jordanian Context

    Directory of Open Access Journals (Sweden)

    Marwa Hassaan

    2013-07-01

    Full Text Available This study examines theimpact of corporate governance structures on the levels of compliance withmandatory IFRSs disclosure requirements by companies listed on the Amman StockExchange (ASE as a leading Arab stock exchange. Using a disclosure indexderived from mandatory IFRSs disclosure requirements for the fiscal year 2007,this study measures the levels of compliance by a sample of 75 non-financialcompanies listed on the ASE. This study extends the financial reporting literatureand the emerging markets disclosure literature by being one of the first toinvestigate the influence of corporate governance requirements for bestpractices on the levels of compliance with mandatory IFRSs disclosurerequirements by companies listed on the ASE. Results provide evidence of thelack of influence of corporate governance best practices on the levels ofcompliance with mandatory IFRSs disclosure requirements as it is not yet partof the cultural values within the Jordanian context. These findings areconsistent with the notions of the theoretical foundation employed in thisstudy.

  18. Mandatory Reporting Laws and Identification of Child Abuse and Neglect: Consideration of Differential Maltreatment Types, and a Cross-Jurisdictional Analysis of Child Sexual Abuse Reports

    OpenAIRE

    Ben Mathews

    2014-01-01

    Mandatory reporting laws have been created in many jurisdictions as a way of identifying cases of severe child maltreatment on the basis that cases will otherwise remain hidden. These laws usually apply to all four maltreatment types. Other jurisdictions have narrower approaches supplemented by differential response systems, and others still have chosen not to enact mandatory reporting laws for any type of maltreatment. In scholarly research and normative debates about mandatory reporting law...

  19. 49 CFR 655.45 - Random testing.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Random testing. 655.45 Section 655.45... of Testing § 655.45 Random testing. (a) Except as provided in paragraphs (b) through (d) of this section, the minimum annual percentage rate for random drug testing shall be 50 percent of covered...

  20. Risk of violence in drug rehabilitation centers: perceptions of people who inject drugs in Tijuana, Mexico.

    Science.gov (United States)

    Harvey-Vera, Alicia Yolanda; González-Zúñiga, Patricia; Vargas-Ojeda, Adriana Carolina; Medina-Mora, Maria Elena; Magis-Rodríguez, Carlos Leonardo; Wagner, Karla; Strathdee, Steffanie Anne; Werb, Daniel

    2016-01-26

    In 2009, Mexico reformed its health law to partially decriminalize drug possession considered for personal use and to increase mandatory referrals to certified drug rehabilitation centers in lieu of incarceration. Concurrently, news media reported violent attacks perpetrated by drug cartels against Mexican drug rehabilitation centers and instances of human rights violations by staff against people who inject drugs (PWID) in treatment. In many cases, these violent situations took place at "Peer Support" (Ayuda Mutua) drug rehabilitation centers that house a large number of drug-dependent PWID. In an effort to understand barriers to treatment uptake, we examined prevalence and correlates of perceived risk of violence at drug rehabilitation centers among PWID in Tijuana, Mexico. Secondary analysis of baseline data collected between March 2011 and May 2013 of PWID recruited into a prospective cohort study in Tijuana. Interviewer-administered surveys measured perceived risk of violence at drug rehabilitation centers by asking participants to indicate their level of agreement with the statement "going to rehabilitation puts me at risk of violence". Logistic regression was used to examine factors associated with perceived risk of violence. Of 733 PWID, 34.5 % perceived risk of violence at drug rehabilitation centers. In multivariate analysis, reporting ever having used crystal methamphetamine and cocaine (separately), having a great or urgent need to get help for drug use, and ever receiving professional help for drug/alcohol use were negatively associated with perceived risk of violence at drug rehabilitation centers, while having been told by law enforcement that drug rehabilitation attendance is mandatory was positively associated with perceived risk of violence. All associations were significant at a 0.05 alpha level. The perception of violence at drug rehabilitation centers among PWID does not represent the lived experience of those PWID who attended

  1. Multi-site musculoskeletal pain in Swedish police: associations with discomfort from wearing mandatory equipment and prolonged sitting.

    Science.gov (United States)

    Larsen, Louise Bæk; Andersson, Elisabeth Elgmark; Tranberg, Roy; Ramstrand, Nerrolyn

    2018-02-07

    Musculoskeletal disorders are considered as a major issue affecting the health and well-being of active duty police. Discomfort from wearing mandatory equipment and sitting for long periods of time in fleet vehicles are workload factors linked to musculoskeletal disorders in police. This study aims to determine the prevalence of multi-site musculoskeletal pain among Swedish police and to explore the possible association to discomfort experience when wearing mandatory equipment and sitting for long periods in fleet vehicles. In this cross-sectional study responses from 4185 police were collected through a self-administered online survey including questions about physical work environment, mandatory equipment and musculoskeletal pain. Multi-site pain was determined through summing pain sites from four body regions. Binomial logistic regression was performed to explore the association between multi-site musculoskeletal pain: (1) discomfort from wearing mandatory equipment and (2) sitting for long periods in fleet vehicles. The prevalence of multi-site musculoskeletal pain at least 1 day per week within the previous 3 months was 41.3%. A statistically significant association between discomfort from wearing mandatory equipment and multi-site musculoskeletal pain was found; duty belt [OR 5.42 (95% CI 4.56-6.43)] as well as body armour [OR 2.69 (95% CI 2.11-3.42)]. Sitting for long periods in fleet vehicles was not significantly associated to multi-site musculoskeletal pain. Multi-site musculoskeletal pain is a considerable problem among Swedish police and modifying mandatory equipment to decrease discomfort is suggested as a potential means of decreasing the musculoskeletal pain experienced by many police officers.

  2. Implications of Drug Testing Cheerleaders

    Science.gov (United States)

    Trachsler, Tracy A.; Birren, Genevieve

    2016-01-01

    With the untimely death of a University of Louisville cheerleader due to an accidental drug overdose in the summer of 2014, the athletic department representatives took steps to prevent future incidents by adding cheerleaders to the randomized drug testing protocols conducted at the university for the student-athletes involved in National…

  3. A Mandatory Uniform Policy in Urban Schools: Findings from the School Survey on Crime and Safety: 2003-04

    Directory of Open Access Journals (Sweden)

    Seunghee Han

    2010-01-01

    Full Text Available The main purpose of the study is to examine the relations between a mandatory school uniform policy and student problem behavior. The study is based on the School Survey on Crime and Safety (SSOCS 2003-04 data. Analyzing data from 421 urban schools, the study found that schools adopting a mandatory uniform policy are negatively associated with rates of student problem behaviors except at the high school level. As with other school safety initiatives, parental involvement at the elementary school level, and teacher training and community efforts at the high school level were revealed as negative predictors of student problem behavior.

  4. The implementation and evaluation of a mandatory multi-professional obstetric skills training program

    DEFF Research Database (Denmark)

    Sørensen, Jette Led; Løkkegaard, Ellen; Johansen, Marianne

    2009-01-01

    OBJECTIVE. To implement and evaluate a simulation-based training program. DESIGN. Descriptive. Study period: June 2003-June 2006. SETTING. Obstetric Department, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark. POPULATION. Two training sessions were provided for all health......, shoulder dystocia, basic neonatal resuscitation, and severe preeclampsia. MAIN OUTCOME MEASURES. Before, just after and 9-15 months following the training, data were collected on the confidence and stress levels relating to the carrying out of certain procedures. In addition, a written objective test....... Sick leave amongst midwives diminished significantly during the study period. CONCLUSIONS. A comprehensive evaluation of a mandatory simulation-based program, implemented in a obstetric department, demonstrated a positive impact at individual and organizational levels....

  5. OFFERS FOR INDEXATION MECHANISM OF INSURANCE PENSION IN MANDATORY PENSION INSURANCE SYSTEM

    Directory of Open Access Journals (Sweden)

    A. Sil'chuk

    2016-01-01

    Full Text Available The main problem of mandatory pension insurance system is lack of monetary resources on payment of pensions. One of the key mechanisms of ensuring of financial stability of the system is indexation insurance pensions, so long as through indexation it is possible to regulate the stream of monetary resources of both budget of pension fund and federal budget's transfer payments.Objectives. The aim of this work is to form a suggestion upon settlement of indexation of insurance pension for ensuring of financial stability of the pension system.Methodology. Writing the article applied methods used in economic studies: analysis, analytical, comparative, induction.Results. The author finds the basic problems of existent mechanism of indexation of pensions and gives suggestions about development of indexation mechanism.Conclusions and Relevance. New approach can be easily applicable in any macroeconomic and demographic terms and allow to manage federal budget expenditures inclusive of its resource possibilities.

  6. Mandatory HIV surveillance system could be implemented in the next year.

    Science.gov (United States)

    1998-02-01

    A nationwide mandatory HIV reporting system could be in place as early as the summer of 1998, according to the Centers for Disease Control and Prevention (CDC). The issue of whether the system tracks names or unique identification numbers is in contention. The CDC plans to publish an evaluation of the results of two pilot programs that used alternative reporting programs rather than names, and also plans to publish a best practices document in the Federal Register. Many people are opposed to using unique identifiers because such systems are unreliable and unwieldy, and are not readily linked to other systems that track sexually-transmitted diseases and tuberculosis. Others, however, are concerned that using names will breach confidentiality, will link the surveillance reporting system to other controversial programs such as partner notification, and could possibly lead to deportation for illegal immigrants who test HIV positive.

  7. Experiences gained from implementing mandatory buffer strips in Denmark: how can we enhance their ecosystem services?

    Science.gov (United States)

    Kronvang, Brian; Hoffmann, Carl Christian; Baattrup-Pedersen, Annette; Hille, Sandra; Rubæk, Gitte; Heckrath, Goswin; Gertz, Flemming; Jensen, Henning; Feuerback, Peter; Strand, John; Stutter, Marc

    2015-04-01

    The Danish Parliament adopted in June 2012 a Buffer Strip Act that required 10 m mandatory buffer strips (BSs) to be established along all watercourses and lakes with a surface area greater than 100 m2 from 1st September 2012. The main reasons for deploying BSs was to reduce nitrate-N leaching and phosphorus (P) loss via surface runoff from adjoining fields from the approximately 50,000 ha of BSs as no farming activities were allowed in the BS concerning use of fertilizer, spreading of manure, spraying with pesticides, etc. Reductions in nutrient losses to watercourses are needed for minimizing the eutrophication effects in lakes and coastal waters. Buffer strips are among the most well studied and frequently adapted mitigation measure for reducing sediment and P losses to surface waters via surface runoff. It has, however, been questioned if BSs can also reduce N losses. The international literature gives an overwhelming support to their functioning for reduction in sediment and especially particulate P losses. However, their functioning for dissolved P and nitrogen is more questionable when comparing studies from the international literature. In Denmark, many farmers were against the introduction of BSs as a general mitigation measure for several reasons. The most used argument in the public debate was that BSs in general are not very efficient for reducing N and P losses to surface waters which was originally the argument behind the BS Act from the Ministries of Environment and Food and Agriculture. A desk study had been made prior to the adaptation of the law that showed 10 m BSs to be able to reduce the N loading with 40-50 kg N ha-1 of BS and 0.04-0.4 kg P ha-1 BS. The total reduction from the BSs established in Denmark in 2012 would then amount to 2,000-2,500 tonnes N and 2-20 tonnes P. The intense public debate in Denmark made the Parliament to adopt a new BS law in June 2014 to be implemented in August 2014 that reduced the total areas with mandatory BSs

  8. Mandatory Targets and Environmental Performance: An Analysis Based on Regression Discontinuity Design

    Directory of Open Access Journals (Sweden)

    Xiao Tang

    2016-09-01

    Full Text Available It is a critical question for environmental governance to examine whether the administrative award and punishment measures are effective in promoting environmental governance performance. Choosing the implementation of a mandatory target system (MTS as the subject, this paper employs a fixed-effect panel data model and regression discontinuity design to test whether the MTS has improved the environmental governance performance of local governments in China. The results of this research demonstrate that the MTS has a positive effect on environmental performance, however the regression discontinuity design illustrates that the reward and punishment measures in the MTS have no significant effects on the provincial environmental performance. The results of this research provide a reasonable explanation to the existing gaps among the studies on the effectiveness of the MTS. This study has profound policy implications for the design and implementation of the environmental governance system in China.

  9. Mandatory food labeling of trans fat acids: qualitative analysis of the public consultation

    Directory of Open Access Journals (Sweden)

    Vanessa Fernandes Davies

    Full Text Available The objective of this paper is to identify the stakeholders and their contributions to the public consultation carried out with regard to the mandatory trans fat acids food labeling proposal in Brazil. Methodology thematic analysis of the documents. Results 25 stakeholders made suggestions regarding the proposed law, and the majority belonged to the food industry sector. The following issues were raised: lack of knowledge among the consumers about trans fat acids; lack of information about trans fat acids in food composition tables and infrastructure to analyse the trans fat content of foods; voluntary trans fat labelling. Conclusions The stakeholders addressed important issues, such as improving nutritional knowledge among the population. However, few stakeholders linked to consumers took part in the public consultation, which might lead to disproportionate influence of the food industry on the development of future food policies.

  10. Management earnings forecasts and analyst forecasts: Evidence from mandatory disclosure system

    Directory of Open Access Journals (Sweden)

    Yutao Wang

    2015-06-01

    Full Text Available Distinct from the literature on the effects that management earnings forecasts (MEFs properties, such as point, range and qualitative estimations, have on analyst forecasts, this study explores the effects of selective disclosure of MEFs. Under China’s mandatory disclosure system, this study proposes that managers issue frequent forecasts to take advantage of opportune changes in predicted earnings. The argument herein is that this selective disclosure of MEFs increases information asymmetry and uncertainty, negatively influencing analyst earnings forecasts. Empirical evidence shows that firms that issue more frequent forecasts and make significant changes in MEFs are less likely to attract an analyst following, which can lead to less accurate analyst forecasts. The results imply that the selective disclosure of MEFs damages information transmission and market efficiency, which can enlighten regulators seeking to further enhance disclosure policies.

  11. Disease, Disparities and Decision Making: Mandatory HIV Testing of Prospective Immigrants to Canada

    Directory of Open Access Journals (Sweden)

    Bisaillon, Laura

    2013-07-01

    Full Text Available This case study explores ethical issues with Canada’s immigration policy and the requirement of mandatory HIV testing of prospective immigrants. Attention is directed to the official immigration medical examination (IME because it is a key site within the immigration system. The following four issues are raised: the differences in official and experiential knowledge claims about what activities occur (or not in the IME when an applicant is diagnosed with HIV; the exceptional treatment of HIV within the Canadian immigration program; the discursive organization of the HIV testing policy; and, the inadequacies with how specific practices are enacted in the processing of immigration applications made by people living with HIV.

  12. New insulin glargine 300 U/ml compared with glargine 100 U/ml in insulin-naïve people with type 2 diabetes on oral glucose-lowering drugs: a randomized controlled trial (EDITION 3).

    Science.gov (United States)

    Bolli, G B; Riddle, M C; Bergenstal, R M; Ziemen, M; Sestakauskas, K; Goyeau, H; Home, P D

    2015-04-01

    To compare the efficacy and safety of new insulin glargine 300 U/ml (Gla-300) with that of glargine 100 U/ml (Gla-100) in insulin-naïve people with type 2 diabetes using oral glucose-lowering drugs. The EDITION 3 study was a multicentre, open-label, parallel-group study. Participants were randomized to Gla-300 or Gla-100 once daily for 6 months, discontinuing sulphonylureas and glinides, with a dose titration aimed at achieving pre-breakfast plasma glucose concentrations of 4.4-5.6 mmol/l (80-100 mg/dl). The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to month 6. The main secondary endpoint was percentage of participants with ≥1 nocturnal confirmed [≤3.9 mmol/l (≤70 mg/dl)] or severe hypoglycaemia from week 9 to month 6. Other measures of glycaemia and hypoglycaemia, weight change and insulin dose were assessed. Randomized participants (n = 878) had a mean (standard deviation) age of 57.7 (10.1) years, diabetes duration 9.8 (6.4) years, body mass index 33.0 (6.7) kg/m(2) and HbA1c 8.54 (1.06) % [69.8 (11.6) mmol/mol]. HbA1c levels decreased by equivalent amounts with the two treatments; the least squares mean difference in change from baseline was 0.04 [95% confidence interval (CI) -0.09 to 0.17] % or 0.4 (-1.0 to 1.9) mmol/mol. Numerically fewer participants reported ≥1 nocturnal confirmed (≤3.9 mmol/l) or severe hypoglycaemia from week 9 to month 6 [relative risk (RR) 0.89 (95% CI 0.66 to 1.20)] with Gla-300 versus Gla-100; a significantly lower risk of hypoglycaemia with this definition was found over the 6-month treatment period [RR 0.76 (95% CI 0.59 to 0.99)]. No between-treatment differences in adverse events were identified. Gla-300 is as effective as Gla-100 in reducing HbA1c in insulin-naïve people with type 2 diabetes, with lower hypoglycaemia risk. © 2015 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

  13. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial

    Science.gov (United States)

    Saito, Shigeru; Valdes-Chavarri, Mariano; Richardt, Gert; Moreno, Raul; Iniguez Romo, Andrés; Barbato, Emanuele; Carrie, Didier; Ando, Kenji; Merkely, Bela; Kornowski, Ran; Eltchaninoff, Hélène; James, Stefan; Wijns, William

    2014-01-01

    Aim The aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan. Methods and results The CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months—TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]—was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively. Conclusion The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up. Study registration number UMIN000006940. PMID:24847155

  14. Dietary Iodine Intake of the Australian Population after Introduction of a Mandatory Iodine Fortification Programme

    Directory of Open Access Journals (Sweden)

    Karen Charlton

    2016-11-01

    Full Text Available To address mild iodine deficiency in Australia, a mandatory fortification program of iodised salt in bread was implemented in 2009. This study aimed to determine factors associated with achieving an adequate dietary iodine intake in the Australian population post-fortification, and to assess whether bread consumption patterns affect iodine intake in high-risk groups. Using nationally representative data of repeated 24-h dietary recalls from the 2011–2012 Australian National Nutrition and Physical Activity Survey, dietary iodine intakes and food group contributions were compared by age, socioeconomic status (SES, and geographical remoteness (N = 7735. The association between fortified bread intake and adequacy of iodine intake (meeting age and sex-specific Estimated Average Requirements was investigated using logistic regression models in women of childbearing age 14–50 years (n = 3496 and children aged 2–18 years (n = 1772. The effect of SES on bread consumption was further investigated in a sub group of children aged 5–9 years (n = 488. Main sources of iodine intake at the time of the survey were cereal and cereal products, followed by milk products and dishes. Differences in iodine intake and dietary iodine habits according to age, SES and location were found (p < 0.001 for women of child-bearing age. Fortified bread consumption at ≥100 g/day was associated with five times greater odds of achieving an adequate iodine intake (OR 5.0, 95% CI 4.96–5.13; p < 0.001 compared to lower bread consumption in women and 12 times in children (OR 12.34, 95% CI 1.71–89.26; p < 0.001. Disparities in dietary iodine intake exist within sectors of the Australian population, even after mandatory fortification of a staple food. On-going monitoring and surveillance of iodine status is required.

  15. Factors affecting trip generation of motorcyclist for the purpose of non-mandatory activities

    Science.gov (United States)

    Anggraini, Renni; Sugiarto, Sugiarto; Pramanda, Heru

    2017-11-01

    The inadequate facilities and limited access to public transport reflect many people using private vehicles, in particular, motorcycle. The motorcycle is most widely used in Indonesia, recently, including Aceh Province. As a result, the number of motorcycle ownership is increasing significantly. The increasing number of motorcycles leads to complex traffic problems. Several factors tend to affect the trip generation of the motorcyclist, i.e., the social demographics of individuals and families, accessibility, etc. This study aims to analyze the characteristics of motorcyclists for non-mandatory activities, i.e. activities other than to work and school. It also aims to determine the dominant factors that affect their trips through trip generation models. The required data consist of primary data and secondary data. Primary data consists of a home interview survey that collects individual's daily trips. It is conducted by distributing the questionnaires to 400 families residing in Lhokseumawe City. Modeling the trip generation of the motorcyclist is done by multiple linear regression analysis. Parameters calibration uses OLS (Ordinary Least Square) method. The results showed that the dominant variables that affect the trip generation of motorcyclist for non-mandatory activities are license ownership, housewife, school-age children, middle-income household, and lower education level. It can be concluded that some factors affecting trip generation to non-work activities were female motorcyclists from the middle-income household with lower education level. As their status is mostly as the housewife, escorting children to non-school activities seems to the mother's task, instead of the father. It is clear that, most female ride motorcycle for doing household tasks. However, it should be noted that the use of the motorcycle in long-term does not suit for sustainable transportation.

  16. Mandatory Child Life Consultation and Its Impact on Pediatric MRI Workflow in an Academic Medical Center.

    Science.gov (United States)

    Durand, Daniel J; Young, Mollie; Nagy, Paul; Tekes, Aylin; Huisman, Thierry A G M

    2015-06-01

    Pediatric patients undergoing MRI often require general anesthesia, which may improve image quality but is associated with significant medical risk and economic cost. It has previously been shown that certified child life specialists using high-tech interventions (eg, MRI-compatible video goggles) significantly reduce the number of pediatric MRI patients who require sedation. Most imaging centers lack such technology, however, and it remains unclear whether simpler and less costly child life interventions may be equally effective in avoiding general anesthesia. The aim of this study was to assess the impact of requiring mandatory child life evaluation for all patients aged 5 to 18 years undergoing MRI before referral for general anesthesia. Inserting this simple step into the scheduling workflow significantly reduced the use of general anesthesia in this population: general anesthesia was required in 564 of 2,433 MRI cases during the 1-year baseline period compared with 484 of 2,526 cases during the 1-year intervention period (P child life evaluation avoided the use of general anesthesia in approximately 102 patients during the intervention period. Further subgroup analysis revealed that avoidance of general anesthesia was highly significant in the 5- to 10-year-old age group, whereas those aged 11 to 18 years experienced only a trend toward modestly decreased use of general anesthesia. These results suggest that mandatory evaluation for standard child life interventions is a worthwhile step that can save many children from unnecessary exposure to the risks, cost, and inconvenience of general anesthesia. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  17. [Mandatory treatment of forensic psychiatric patients in the Netherlands: costs and benefits in perspective].

    Science.gov (United States)

    Nagtegaal, M H; Goethals, K; Meynen, G

    So far, it is not known what costs and benefits are connected with the tbs-measure, a measure that involves a mandatory treatment programme for forensic psychiatric patients. AIM: To explore the costs and benefits that the tbs-measure has on society, on other important stakeholders such as victims and/or next-of-kin and the forensic psychiatric patients themselves. METHOD: We studied the relevant literature. RESULTS: The average costs of the tbs-treatment programme are 1.5 million euros. Additional costs result from recidivism among patients after tbs-treatment. Of these, 21.2% commit another serious offence after 9 years; this recidivism rate is much lower than rates for former offenders who have not received tbs-treatment (63.8%). Other costs arise through the impact that crimes have on stake-holders. Among the benefits of the tbs-programme are a reduction in psychopathological symptoms and in risk factors and lower recommitment rates (including judicial, non-judicial, voluntary and mandatory recommitment rates). Yet another benefit is the resultant increase of protective factors. CONCLUSION: Forensic psychiatric patients form a unique group within the mental health system in the Netherlands; these patients have multiple complex psychiatric problems and display serious criminal behavior. This group cannot easily be treated elsewhere in the existing judicial or mental health care system because these systems differ in (judicial) frameworks and have different treatment goals, and the forensic psychiatric patients have different psychiatric disorders and display more serious criminal behaviour than patients in the alternative systems. The daily costs of treatment in the tbs-system are higher that in other systems - but they are not exorbitant, given the complexity of the group. The tbs-measure therefore contributes to the safety of society.

  18. Mandatory IFRS adoption and the cost of Equity Capital. Evidence from Spanish Firms

    Directory of Open Access Journals (Sweden)

    David Castillo-Merino

    2014-05-01

    Full Text Available Purpose: The main objective of this paper analyses the effects of mandatory International Financial Reporting Standards (IFRS adoption by Spanish firms in 2005 on the cost of equity capital. Design/methodology: Using a sample of listed Spanish companies during the 1999 to 2009 period and a country-level focused analysis. To achieve our objective we relied on OLS regression analysis and estimate the dependent variable – the cost of equity – by using the proxy suggested in Easton (2004. Findings: We find evidence that, unlike previous studies, Spanish listed companies show a significant reduction in their cost of equity capital after the mandatory adoption of IFRS in 2005, after controlling by a set of firm-risk and market variables. According to our results, increased financial disclosure and enhanced information comparability, along with changes in legal and institutional enforcement, seem to have a joint effect on the cost of capital, leading to a large decrease in expected equity returns. Research limitations: The main limitation of the study is that the sample represents just one country. Practical implications: The findings of the study may have implications for the firms’ management staff, as they reveal what information determines the cost of equity capital. The systematic risk and the leverage affect positively the cost of stocks and therefore their market value. The results are consistent with the financial principle establishing that the higher risk and the higher leverage, the higher cost of capital. Originality/value: As a result of the conducted research, one is able to figure out which stock-return variables should be observed to anticipate the change of a company’s cost of capital.

  19. The HPV vaccine: framing the arguments FOR and AGAINST mandatory vaccination of all middle school girls.

    Science.gov (United States)

    Vamos, Cheryl A; McDermott, Robert J; Daley, Ellen M

    2008-06-01

    Human papillomavirus (HPV), the virus responsible for cervical cancer, is the most common viral sexually transmitted infection in the United States. A vaccine was approved in 2006 that is effective in preventing the types of HPV responsible for 70% of cervical cancers and 90% of genital warts. Proposals for routine and mandatory HPV vaccination of girls have become sources of controversy for parents of school-aged youth, legislators, members of the medical community, and the public at large. The purpose of this article was to articulate the arguments used by advocates who either oppose or endorse routine, mandatory administration of the vaccine to school-aged girls, thereby assisting school health personnel in being effective participants in framing the relevant issues. Controversy is grounded in moral, religious, political, economic, and sociocultural arguments including whether concerns that the vaccine increases sexual risk taking, sends mixed messages about abstaining from sexual intercourse, usurps parental authority, and increases the potential for development of new health disparities are offset by the value of administering a cost-effective, age-appropriate public health measure targeting a life-threatening problem. Careful consideration of the medical evidence and public health implications is critical but understanding the context of the debate is no less important to the task of responding to public concerns. School health personnel have a role in the discussion about HPV immunization. Being able to articulate the arguments presented herein can help authorities' responsiveness to parents and community groups as the dialogue about this particular health issue evolves further.

  20. Online reporting of pseudoephedrine pharmacy sales: does Australia require a mandatory system?

    Science.gov (United States)

    Devaney, Madonna; Ferris, Jason; Mazerolle, Lorraine

    2014-11-03

    The objective of our research was to compare the reported pharmacy sales of pseudoephedrine-based medication in state where the electronic recording of sales is mandatory, Queensland, with a state where recording is voluntary, Victoria. Unidentified, unit-record, pseudoephedrine-based medication transaction data (known as ProjectSTOP), for both states, were made available by GuildLink Pty Ltd, the data custodians. Data provided dated from roll-out, 8 November 2005 (Queensland) and 10 August 2007 (Victoria) to 16 October 2012 (the last entry at the time of request). Data were stored on a secure, password-protected computer at the University of Queensland, Australia, where it was prepared and analysed. The rate of uptake of ProjectSTOP in Queensland compared with Victoria differed significantly; 1 year after roll-out, 72% of pharmacies in Queensland had used the system compared with 41% in Victoria. There were significant differences in transaction rates between Queensland and Victoria; the transaction rate in Queensland was four times greater than Victoria 1 year after roll-out. Our data show that Victoria captured fewer cases of multiple purchases using the same identification (i.e. suspected pseudo-runner activity) than in Queensland (112 compared with 517 cases in 2011). Our findings show, not surprisingly, that by making the electronic recording of pseudoephedrine-based medication sales mandatory, there is increased uptake and use of the recording system ProjectSTOP. Importantly, by using ProjectSTOP comprehensively, the data can provide useful intelligence for the identification of trends and patterns of activity in relation to the diversion of pseudoephedrine-based medications. © 2014 Royal Pharmaceutical Society.

  1. Eficácia de três drogas sobre a aura migranosa: um estudo randomizado placebo controlado Efficacy of three drugs in the treatment of migrainous aura: a randomized, placebo-controlled study

    Directory of Open Access Journals (Sweden)

    Marcelo E. Bigal

    2002-06-01

    Full Text Available A despeito da enorme quantidade de pesquisas referentes à classificação, epidemiologia, diagnóstico, fisiopatologia e tratamento da migrânea, a aura migranosa permanece bem menos estudada. O objetivo do presente estudo é, portanto, verificar a evolução da aura em pacientes submetidos a placebo e a três diferentes drogas disponíveis em unidades públicas de saúde brasileiras. Foram estudados 86 pacientes em vigência de crise de migrânea com aura, apresentando aura no momento da randomização. Após a randomização os pacientes recebiam uma das seguintes substâncias, por via endovenosa: placebo, dipirona, clorpromazina, sulfato de magnésio. O sulfato de magnésio foi superior ao placebo (p In spite of the enormous amount of research regarding classification, epidemiology, diagnosis, pathophisiology and treatment of migraines, aura, one of its hallmarks, stays much less studied. The objective of this study is, therefore, to evaluate the evolution of aura in patients submitted to placebo and three different drugs available in Brazilian public health units. We studied 86 patients during an acute migrainous attack, with aura at the moment of the evaluation. Patients were randomized to receive one of the following substances, in a parenteral route: placebo, dipyrone, chlorpromazine and magnesium sulphate. Magnesium sulphate was superior to placebo (p <0,05 30 and 60 minutes after its administration. Dipyrone and chlorpromazine reduced the duration of the aura, when compared to placebo, 60 minutes following their administration. Our findings make possible some speculations about the pathophisiology of migraine, as well as about the therapeutic approach of patients presenting migrainous aura.

  2. Drug Facts

    Medline Plus

    Full Text Available ... Body Drug Use Hurts Brains Drug Use and Mental Health Problems Often Happen Together The Link Between Drug Use and HIV/AIDS Treatment & Recovery Why Does a Person Need Treatment? Does Drug Treatment Work? What Are the Treatment Options? What Is Recovery? ...

  3. Mandatory quality reports in Germany from the hospitals' point of view: a cross-sectional observational study.

    Science.gov (United States)

    Auras, Silke; de Cruppé, Werner; Blum, Karl; Geraedts, Max

    2012-10-31

    Public reporting of hospital quality is to enable providers, patients and the public to make comparisons regarding the quality of care and thus contribute to informed decisions. It stimulates quality improvement activities in hospitals and thus positively impacts treatment results. Hospitals often use publicly reported data for further internal or external purposes.As of 2005, German hospitals are obliged to publish structured quality reports (QR) every two years. This gives them the opportunity to demonstrate their performance by number, type and quality in a transparent way. However, it constitutes a major burden to hospitals to generate and publish data required, and it is yet unknown if hospitals feel adequately represented and at the same time consider the effort appropriate.This study assesses hospital leaders' judgement about the capability of QR to put legally defined aims effectively and efficiently into practice. It also explores the additional purposes hospitals use their QR for. In a cross-sectional observational study, a representative random sample out of 2,064 German hospitals (N=748) was invited to assess QR via questionnaire; 333 hospitals participated. We recorded the suitability of QR for representing number, type and quality of services, the adequacy of cost and benefits (6-level Likert scales) and additional purposes QR are used for (free text question). For representation purposes, the net sample was weighted for hospital size and hospital ownership (direct standardization). Data was analyzed descriptively and using inferential statistics (chi-2 test) or for the purpose of generating hypotheses. German hospitals rated the QR as suitable to represent the number of services but less so for the type and quality of services. The cost-benefit ratio was seen as inadequate. There were no significant differences between hospitals of different size or ownership.Public hospitals additionally used their reports for mostly internal purposes (e

  4. Mandatory quality reports in Germany from the hospitals’ point of view: a cross-sectional observational study

    Science.gov (United States)

    2012-01-01

    Background Public reporting of hospital quality is to enable providers, patients and the public to make comparisons regarding the quality of care and thus contribute to informed decisions. It stimulates quality improvement activities in hospitals and thus positively impacts treatment results. Hospitals often use publicly reported data for further internal or external purposes. As of 2005, German hospitals are obliged to publish structured quality reports (QR) every two years. This gives them the opportunity to demonstrate their performance by number, type and quality in a transparent way. However, it constitutes a major burden to hospitals to generate and publish data required, and it is yet unknown if hospitals feel adequately represented and at the same time consider the effort appropriate. This study assesses hospital leaders’ judgement about the capability of QR to put legally defined aims effectively and efficiently into practice. It also explores the additional purposes hospitals use their QR for. Methods In a cross-sectional observational study, a representative random sample out of 2,064 German hospitals (N=748) was invited to assess QR via questionnaire; 333 hospitals participated. We recorded the suitability of QR for representing number, type and quality of services, the adequacy of cost and benefits (6-level Likert scales) and additional purposes QR are used for (free text question). For representation purposes, the net sample was weighted for hospital size and hospital ownership (direct standardization). Data was analyzed descriptively and using inferential statistics (chi-2 test) or for the purpose of generating hypotheses. Results German hospitals rated the QR as suitable to represent the number of services but less so for the type and quality of services. The cost-benefit ratio was seen as inadequate. There were no significant differences between hospitals of different size or ownership. Public hospitals additionally used their reports for mostly

  5. Toxicological Analysis of Some Drugs of Abuse in Biological Samples

    Directory of Open Access Journals (Sweden)

    Anne Marie Ciobanu

    2015-10-01

    Full Text Available Consumption of drugs of abuse is a scourge of modern world. Abuse, drug addiction and their consequences are one of the major current problems of European society because of the significant repercussions in individual, family, social and economic level. In this context, toxicological analysis of the drugs of abuse in biological samples is a useful tool for: diagnosis of drug addiction, checking an auto-response, mandatory screening in some treatment programs, identification of a substance in the case of an overdose, determining compliance of the treatment. The present paper aims to address the needs of healthcare professionals involved in drugs addiction treatment through systematic presentation of information regarding their toxicological analysis. Basically, it is a tool that help you to select the suitable biological sample and the right collecting time, as well as the proper analysis technique, depending on the purpose of analysis, pharmacokinetic characteristics of the drugs of abuse, available equipment and staff expertise.

  6. The "Knox v. Knox" Decision and Drug Testing for Public School Employees: Why Educators Do Not Shed Their Rights at the Schoolhouse Gate.

    Science.gov (United States)

    Orr, Ginger

    2000-01-01

    Discusses the importance of drug-testing policies for educators by analyzing the recent Sixth Circuit Court of Appeal's decision in "Knox v. Knox." Concludes that mandatory drug testing for educators in safety-sensitive positions will not infringe on the constitutional rights of school employees. (Contains 30 footnotes.) (MLF)

  7. Mandatory Special Education Plan for the Administration and Implementation of Public School Programs for the Hearing Impaired.

    Science.gov (United States)

    Indiana State Dept. of Public Instruction, Indianapolis. Div. of Special Education.

    Intended for public school administrators, teachers, and speech and hearing clinicians, the document contains guidelines for setting up programs to implement the statewide mandatory special education plan for hearing impaired children in Indiana. Outlined are procedures to follow in comprehensive programing for the following categories of the…

  8. 14 CFR Special Federal Aviation... - Process for Requesting Waiver of Mandatory Separation Age for a Federal Aviation Administration...

    Science.gov (United States)

    2010-01-01

    ... Separation Age for a Federal Aviation Administration Air Traffic Control Specialist In Flight Service... Federal Special Federal Aviation Regulation No. 103 Aeronautics and Space FEDERAL AVIATION ADMINISTRATION..., SFAR 103 Special Federal Aviation Regulation No. 103—Process for Requesting Waiver of Mandatory...

  9. The Mandatory Introduction of IFRS as a Single Accounting Standard in the European Union and the Effect on Earnings Management

    NARCIS (Netherlands)

    M.B.W. Lippens (Mark)

    2010-01-01

    textabstractExecutive summary In this study, it was investigated whether the mandatory adoption of IFRS from 1 January 2005 by all listed companies in the European Union led to significantly lower levels of earnings management. I found that, despite the stricter character of IFRS compared to

  10. Voluntary or Mandatory Training Participation as a Moderator in the Relationship between Goal Orientations and Transfer of Training

    Science.gov (United States)

    Gegenfurtner, Andreas; Könings, Karen D.; Kosmajac, Nikola; Gebhardt, Markus

    2016-01-01

    Trainees can participate in organizational training programs voluntarily or mandatorily. To date, research has reported mixed evidence on the question whether voluntary or mandatory participation is associated with higher motivation and transfer of training. Grounded in the frameworks of participatory design, the notion of autonomy in basic…

  11. Evaluation of New York state's mandatory occupant restraint law. Volume 4, Enforcement and adjudication of violations of the law

    Science.gov (United States)

    1987-01-01

    This is the final report on analyses of the available 1985 enforcement and adjudication data relating to New York State's Mandatory Occupant Restraint Law. In the first year of the law there were over 30,000 violations that resulted in conviction. Th...

  12. Mandatory Reporting of Child Sexual Abuse and the Responsibility To Serve the Best Interest of the Client: An Ethical Dilemma?

    Science.gov (United States)

    Palmer, Laura; Lee, Sandra

    Most professional psychologists who practice with children will face the ethical dilemma of child abuse reporting at some point in their careers. This paper explores the ethical dilemma inherent between ethics that charge psychologists to always choose a course of action best serving the client and mandatory child abuse reporting laws. Some of the…

  13. 36 CFR 1260.58 - What are the procedures for requesting a mandatory review of White House originated information?

    Science.gov (United States)

    2010-07-01

    ... declassification within the past 2 years, or if the specific information is the subject of pending litigation, NARA... send the requester a brief statement of the reasons the information cannot be declassified and a notice... requesting a mandatory review of White House originated information? 1260.58 Section 1260.58 Parks, Forests...

  14. Beliefs on Mandatory Influenza Vaccination of Health Care Workers in Nursing Homes : A Questionnaire Study from the Netherlands

    NARCIS (Netherlands)

    Looijmans-van den Akker, Ingrid; Marsaoui, Badyr; Hak, Eelko; van Delden, Johannes J. M.

    2009-01-01

    OBJECTIVES: To assess whether nursing homes (NHs) made organizational improvements to increase influenza vaccination rates in healthcare workers (HCWs) and to quantify the beliefs of NH administrators on the arguments used in favor of implementation of mandatory influenza vaccination of HCWs.

  15. A Qualitative Evaluation of the Effects of Mandatory Reporting of Domestic Violence on Victims and Their Children

    Science.gov (United States)

    Antle, Becky; Barbee, Anita; Yankeelov, Pam; Bledsoe, Linda

    2010-01-01

    This purpose of this research was to evaluate the mandatory reporting law for domestic violence victims in the state of Kentucky through the qualitative interview of 24 female victims of domestic violence. Victims were generally supportive of the law and felt that professionals should be required to report domestic abuse. They did not feel that…

  16. Should Bible Studies Remain in Israeli Public Schools? Teachers' Attitudes toward Bible Teaching as a Mandatory Subject

    Science.gov (United States)

    Idalovichi, Israel

    2003-01-01

    The purpose of this article is to provide an overview and analysis of attitudes of Israeli K-12 educators and bible teachers toward religious studies. Teachers' attitudes toward bible teaching as a mandatory subject are, on the whole, positive throughout the country. The present study addresses the absence of systematic research into the opinions…

  17. 77 FR 43721 - Examinations of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety...

    Science.gov (United States)

    2012-07-26

    ... Safety and Health Administration 30 CFR Part 75 RIN 1219-AB75 Examinations of Work Areas in Underground Coal Mines for Violations of Mandatory Health or Safety Standards AGENCY: Mine Safety and Health... requirements contained in the final rule on Examinations of Work Areas in Underground Coal Mines for Violations...

  18. 78 FR 15645 - Mandatory Country of Origin Labeling of Beef, Pork, Lamb, Chicken, Goat Meat, Wild and Farm...

    Science.gov (United States)

    2013-03-12

    ...; ] DEPARTMENT OF AGRICULTURE Agricultural Marketing Service 7 CFR Parts 60 and 65 RIN 0581-AD29 Mandatory...: Agricultural Marketing Service (AMS), USDA. ACTION: Proposed rule. SUMMARY: This proposed rule would amend the... commodities to provide consumers with more specific information, and amend the definition for ``retailer'' to...

  19. Drug Policy in Hungary.

    Science.gov (United States)

    Inotai, András; Csanádi, Marcell; Harsányi, András; Németh, Bertalan

    2017-09-01

    We present a brief overview of the health care system in Hungary, focusing particularly on the pricing and reimbursement procedures of medicines. The National Institute of Health Insurance Fund Management is responsible for the administration of the health insurance system and public reimbursement of health technologies. There are two major types of reimbursement techniques in the outpatient care: the normative reimbursement is applied to all physicians and may be used for all indications listed in the Summary of Product Characteristics, and the indication-linked reimbursement is applied only to specialists who are authorized to prescribe the drug. Pharmaceuticals used in the inpatient care are fully reimbursed and are financed through diagnosis-related groups. Several cost-containment measures such as external price referencing and internal price referencing with blind bidding are applied. Proposing managed entry agreements is a mandatory condition for reimbursing innovative pharmaceuticals. Compared with other countries in the region, the implementation of health technology assessment has a relatively long history in Hungary. The health technology assessment body critically evaluates reimbursement submissions of pharmaceuticals, simple medical devices, and complex medical devices such as hospital technologies. Copyright © 2017. Published by Elsevier Inc.

  20. Record completeness and data concordance in an anesthesia information management system using context-sensitive mandatory data-entry fields.

    Science.gov (United States)

    Avidan, Alexander; Weissman, Charles

    2012-03-01

    Use of an anesthesia information management system (AIMS) does not insure record completeness and data accuracy. Mandatory data-entry fields can be used to assure data completeness. However, they are not suited for data that is mandatory depending on the clinical situation (context sensitive). For example, information on equal breath sounds should be mandatory with tracheal intubation, but not with mask ventilation. It was hypothesized that employing context-sensitive mandatory data-entry fields can insure high data-completeness and accuracy while maintaining usability. A commercial off-the-shelf AIMS was enhanced using its built-in VBScript programming tool to build event-driven forms with context-sensitive mandatory data-entry fields. One year after introduction of the system, all anesthesia records were reviewed for data completeness. Data concordance, used as a proxy for accuracy, was evaluated using verifiable age-related data. Additionally, an anonymous satisfaction survey on general acceptance and usability of the AIMS was performed. During the initial 12 months of AIMS use, 12,241 (99.6%) of 12,290 anesthesia records had complete data. Concordances of entered data (weight, size of tracheal tubes, laryngoscopy blades and intravenous catheters) with patients' ages were 98.7-99.9%. The AIMS implementation was deemed successful by 98% of the anesthesiologists. Users rated the AIMS usability in general as very good and the data-entry forms in particular as comfortable. Due to the complexity and the high costs of implementation of an anesthesia information management system it was not possible to compare various system designs (for example with or without context-sensitive mandatory data entry-fields). Therefore, it is possible that a different or simpler design would have yielded the same or even better results. This refers also to the evaluation of usability, since users did not have the opportunity to work with different design approaches or even different