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Sample records for non-clinical post-marketing commitments

  1. Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.

    PubMed

    Reeve, Lesley M

    2009-11-01

    There are clear minimum requirements for non-clinical (toxicology) studies which are needed prior to human exposure to a potential new pharmaceutical and additional studies are needed in an ongoing manner to support clinical development and marketing [ICH, 2009. ICH M3(R2) Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals (CPMP/ICH/286/95). Adopted June 2009, effective December 2009.] The pharmaceutical industry is under increasing pressure to reduce costs and reduce, refine and replace the use of animals, as far as possible. Hence any increase in regulatory requirements for non-clinical safety data could have a significant impact both on the economic and ethical considerations of drug development. It is, therefore, of interest that further non-clinical studies are required by the Regulatory Authorities for a small but increasing proportion of drug product applications at the marketing approval/data review stage. These studies are known as Post-Marketing Commitments (PMCs). Available information on non-clinical PMCs was collated using drug product information from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA), resulting in a combined data set of 162 studies. Non-clinical PMCs comprised 9.8% and 6.5% of total PMCs for products authorised by the EMEA (Centralised Procedure) and FDA, respectively. Non-clinical PMCs increased with increasing date of approval, despite increased regulatory information available to guide Applicants. Furthermore, the increase reflected an increased proportion of applications with non-clinical PMCs, not an increase in overall numbers of applications. There was no clear correspondence between the publication dates of relevant guidelines and increases in specific non-clinical PMC study types, when the data were analysed by non-clinical study category, target population/indication or compound class. Possible exceptions were some

  2. Key organizational commitment antecedents for nurses, paramedical professionals and non-clinical staff.

    PubMed

    Caykoylu, Sinan; Egri, Carolyn P; Havlovic, Stephen; Bradley, Christine

    2011-01-01

    The purpose of this paper is to develop a causal model that explains the antecedents and mediating factors predicting the organizational commitment of healthcare employees in different work roles. This study tests an integrative causal model that consists of a number of direct and indirect relationships for antecedents of organizational commitment. It is proposed that the relationship between job satisfaction and organizational commitment is best understood by focusing on the three interrelated facets of job satisfaction, i.e. satisfaction with career advancement, satisfaction with supervisor, and satisfaction with co-workers. However, the model also advances that these job satisfaction facets have different mediating effects for other antecedents of organizational commitment. The Structural Equation Modeling (SEM) path analysis showed that the job satisfaction facets of career advancement and satisfaction with supervisor had a direct impact on organizational commitment. Employee empowerment, job-motivating potential, effective leadership, acceptance by co-workers, role ambiguity and role conflict were also important determinants of organizational commitment. Interestingly, post hoc analyses showed that satisfaction with co-workers only had an indirect impact on organizational commitment. While there has been extensive research on organizational commitment and its antecedents in healthcare organizations, most previous studies have been limited either to a single employee group or to a single time frame. This study proposes a practical causal model of antecedents of organizational commitment that tests relationships across time and across different healthcare employee groups.

  3. New horizons in post-marketing surveillance.

    PubMed

    Waller, P; Wood, S

    1993-01-01

    Post-marketing surveillance is the process of monitoring and evaluating the safety of marketed medicines using a variety of methods. However, many doctors believe that post-marketing surveillance has a more limited meaning, ie an observational study of a new medicine sponsored by a pharmaceutical company. Although such studies were performed extensively in the United Kingdom during the 1980s, few have been published. Their purpose was to study large populations of users in ordinary practice with the aim of identifying hazards that had been missed, because clinical trials were too small, too short or did not always reflect real life. To some extent these studies have now fallen into disrepute, both on scientific grounds and because they have often been thought to be a thinly-disguised promotional exercise. The purpose of this article is to examine some of the previous problems with post-marketing surveillance and to propose new directions for the future.

  4. [Importance of Post-Marketing Studies in Gathering of Clinical Evidences for Proper Usage of Anti-Cancer Drugs, and the StudyRequirements for Their Credibility].

    PubMed

    Inagaki, Osamu

    2016-04-01

    Pharmaceutical companies recognize the importance of post-marketing studies because they are crucial in the generation of clinical evidences for the usage of new medicines. To generate clinical evidences, quality of post-marketing studies should be well controlled from view point of "ethical conduction" and "reliability of results". In addition, control of conflict of interest (COI) between researchers and industries is also indispensable and is requested for the transparency of the studies. Japan Pharmaceutical Manufacturers Association(JPMA)stresses its commitment to the progressof transparency in post-marketing studies.

  5. Design and analysis of post-marketing research.

    PubMed

    Zhou, Xiao-Hua Andrew; Yang, Wei

    2013-07-01

    A post-marketing study is an integral part of research that helps to ensure a favorable risk-benefit profile for approved drugs used in the market. Because most of post-marketing studies use observational designs, which are liable to confounding, estimation of the causal effect of a drug versus a comparative one is very challenging. This article focuses on methodological issues of importance in designing and analyzing studies to evaluate the safety of marketed drugs, especially marketed traditional Chinese medicine (TCM) products. Advantages and limitations of the current designs and analytic methods for postmarketing studies are discussed, and recommendations are given for improving the validity of postmarketing studies in TCM products.

  6. Social Media Listening for Routine Post-Marketing Safety Surveillance.

    PubMed

    Powell, Gregory E; Seifert, Harry A; Reblin, Tjark; Burstein, Phil J; Blowers, James; Menius, J Alan; Painter, Jeffery L; Thomas, Michele; Pierce, Carrie E; Rodriguez, Harold W; Brownstein, John S; Freifeld, Clark C; Bell, Heidi G; Dasgupta, Nabarun

    2016-05-01

    Post-marketing safety surveillance primarily relies on data from spontaneous adverse event reports, medical literature, and observational databases. Limitations of these data sources include potential under-reporting, lack of geographic diversity, and time lag between event occurrence and discovery. There is growing interest in exploring the use of social media ('social listening') to supplement established approaches for pharmacovigilance. Although social listening is commonly used for commercial purposes, there are only anecdotal reports of its use in pharmacovigilance. Health information posted online by patients is often publicly available, representing an untapped source of post-marketing safety data that could supplement data from existing sources. The objective of this paper is to describe one methodology that could help unlock the potential of social media for safety surveillance. A third-party vendor acquired 24 months of publicly available Facebook and Twitter data, then processed the data by standardizing drug names and vernacular symptoms, removing duplicates and noise, masking personally identifiable information, and adding supplemental data to facilitate the review process. The resulting dataset was analyzed for safety and benefit information. In Twitter, a total of 6,441,679 Medical Dictionary for Regulatory Activities (MedDRA(®)) Preferred Terms (PTs) representing 702 individual PTs were discussed in the same post as a drug compared with 15,650,108 total PTs representing 946 individual PTs in Facebook. Further analysis revealed that 26 % of posts also contained benefit information. Social media listening is an important tool to augment post-marketing safety surveillance. Much work remains to determine best practices for using this rapidly evolving data source.

  7. The ethics of post-marketing surveillance of therapeutic agents.

    PubMed

    Beran, R G

    2001-01-01

    Trials of new therapies have strict codes of conduct which expect the highest of ethical practice. Local ethics committees review protocols, patient information, consent. National research councils delineate guidelines for minimum standards regarding subjects in such trials. Once medications enter the market place, there is less definition of minimal codes of conduct. Clinical trials are designed to meet regulatory demands to access commercial markets. Prior to marketing, there is a usual drug trial exposure of less than 5,000 individuals which diminishes identification of rare adverse events. Australian case law has found negligence for not warning of a 1:14,000 risk of sympathetic ophthalmia and more recently, in Chappel v Hart, even a speculative risk was grounds for negligence. Recent reports of serious adverse events for conditions such as epilepsy or depression resulted in companies appearing to expend considerable effort to suppress concern rather than to seriously investigate these complications in the post marketing period. This paper will explore such cases and discuss approaches to improve post marketing surveillance and patient protection.

  8. [Study of post marketing safety reevaluation of shenqi fuzheng injection].

    PubMed

    Ai, Qing-Hua; Li, Yuan-Yuan; Xie, Yan-Ming

    2014-09-01

    In order to promote the Shenqifuzheng injection (SQFZ) clinical medication safety, this study reevaluate on SQFZ post marketing safety study systematically. Including multi center large sample registration type safety monitoring research, the analysis based on national spontaneous reporting system data, the analysis based on the 20 national hospital information system data and literature research. Above the analysis, it suggests that SQFZ has good security. The more adverse drug reaction (ADR) as allergic reactions, mainly involved in the damage of skin, appendages and its systemic damage, serious person can appear allergic shock. ADR/E is more common in the elderly, may be related to medication (tumor) populations. Early warning analysis based on SRS data and literature research are of the view that "phlebitis" has a strong association with SQFZ used.

  9. Post marketing surveillance of sublingual buprenorphine naloxone combination tablets.

    PubMed

    Ray, Rajat; Vaswani, Meera; Deb, Koushik Sinha; Sethi, Hem; Chopra, Anita; Kishore, Nand; Goyal, Rakesh

    2012-01-01

    A combination of buprenorphine-naloxone (Addnok-N) tablets has been recently introduced in India as treatment for Opioid dependence. This study was undertaken to evaluate the possible adverse consequences following use of the buprenorphine-naloxone tablets through post marketing surveillance. National Drug Dependence Treatment Centre (NDDTC), AIIMS, India, monitored all patients receiving buprenorphine-naloxone combination tablets from the centre over a period of two and half years. Evaluation included subjective and objective side effect checklist, physical examination, and laboratory investigation. Data was obtained from 1132 observations among 158 patients. Commonly reported medication effects, like muscle aches (44.0%), sleepiness (44.0%), relief from pain (41.3%), etc; are expected in opioid substitution treatment. Laboratory investigations were mostly normal except for liver enzyme abnormalities (52.2% of cases). Eight adverse events were reported in the study. No dangerous event or mortality was reported during the study.

  10. Japanese Physicians’ Views on Drug Post-Marketing Surveillance

    PubMed Central

    Maeda, Kazuki; Katashima, Rumi; Ishizawa, Keisuke; Yanagawa, Hiroaki

    2015-01-01

    Background Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians’ views on PMS with the aim of conducting PMS more effectively. Methods We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians’ attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts. Results Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies. Conclusions Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure. PMID:26566409

  11. Japanese Physicians' Views on Drug Post-Marketing Surveillance.

    PubMed

    Maeda, Kazuki; Katashima, Rumi; Ishizawa, Keisuke; Yanagawa, Hiroaki

    2015-12-01

    Registration trials leading to the approval of drugs are paramount in drug development. After approval, continuous efforts are necessary to ensure proper use of the approved drugs. In Japan, post-marketing surveillance (PMS) by drug companies is conducted in accordance with good post-marketing study practice (GPSP). Although the global standard for pharmacovigilance is incorporated into GPSP, attention has recently been focused on disassociating them. In this study, we examined physicians' views on PMS with the aim of conducting PMS more effectively. We retrospectively reviewed records between 2009 and 2013 from the institutional review board of Tokushima University Hospital, an academic hospital in rural Japan. The annual number of times PMS was performed was then determined. Next, we assessed physicians' attitudes toward drug PMS, including ethical issues, in a cross-sectional study using a questionnaire designed for this study. Five- and two-point scales were used. The questionnaire was distributed in 2014 to 221 physicians listed as investigators in PMS contracts. Of the 221 physicians, 103 (46.6%) responded to the questionnaire. About 50% of the respondents had experience writing PMS reports. Many of the physicians considered PMS to be important but burdensome. Furthermore, from the viewpoint of research ethics, many physicians considered it improper within the present PMS framework to collect and provide data beyond the scope of routine clinical practice without obtaining informed consent in the case of extra blood sampling, provision of images, monitoring and controlled studies. Beyond practical factors such as workload, attention should be given to establishing an ethical infrastructure and globally harmonized system with regard to the Japanese PMS system. Given the limitations of this single-institution study, further research is needed to collect information for developing a suitable infrastructure.

  12. [Discussion on the building of post market risk analysis method in hemodialysis device].

    PubMed

    Xu, Honglei; Peng, Xiaolong; Tian, Xiaojun; Wang, Peilian

    2014-09-01

    This paper discussed the building of post market risk analysis method in hemodialysis device from the point of government supervision. By proposing practical research methods for post market risk identification and estimation on hemodialysis device, providing technical guidance for government to put risk management of hemodialysis device into effect, and offering reference for enterprises to carry out post market risk evaluation on their products as well.

  13. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

    PubMed Central

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    Background In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA’s pre-market approval (PMA) pathway. Methods and results We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. PMID:26060416

  14. Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

    PubMed

    Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

    2015-01-01

    In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

  15. Post-Marketing Survey of Adverse Events Following Ocriplasmin.

    PubMed

    Shah, Sumit P; Jeng-Miller, Karen W; Fine, Howard F; Wheatley, H Matthew; Roth, Daniel B; Prenner, Jonathan L

    2016-02-01

    To study the post-marketing safety profile of ocriplasmin (Jetrea; ThromboGenics, Iselin, NJ) as experienced by retinal physicians in the United States. Two thousand four hundred sixty-five retinal physicians were surveyed regarding their frequency of use of ocriplasmin and reports of ocular adverse events. There were 270 respondents (11%) who reported treating 1,056 eyes with ocriplasmin. The reports of adverse events (AE) were as follows: acute decline in visual acuity (16.95%), development of submacular fluid or serous retinal detachment (10.23%), dyschromatopsia (9.09%), progression of vitreomacular traction to macular hole (8.71%), development of retinal detachment (2.65%), development of retinal tear (1.99%), development of afferent pupillary defect (1.80%), electroretinography abnormalities (0.57%), crystalline lens instability (0.38%), and vasculitis (0.28%). Although the frequency of some ocular AEs reported in this study are comparable to those reported in the phase 3 registration trials, additional phase 4 safety studies are warranted to better understand the pathophysiology and clinical relevance of ocular AEs of ocriplasmin. Copyright 2016, SLACK Incorporated.

  16. Patients' motives for participating in active post-marketing surveillance.

    PubMed

    Härmark, Linda; Lie-Kwie, Miguel; Berm, Lisette; de Gier, Han; van Grootheest, Kees

    2013-01-01

    Web-based intensive monitoring is a method to actively collect information about adverse drug reactions (ADRs) using patients as a source of information. To date, little is known about patients' motivation to participate in this kind of active post-marketing surveillance (PMS). Increased insight in this matter can help us to better understand and interpret patient reported information, and it can be used for developing and improving patient-based pharmacovigilance tools. The aim of this study is to gain insight into patients' motives for participating in active PMS and investigate their experiences with such a system. A mixed model approach combining qualitative and quantitative research methods was used. For both parts, patients participating in a web-based intensive monitoring study about the safety of anti-diabetic drugs (excluding insulins) were used. A questionnaire was developed based on the results from qualitative interviews. The data collected through the questionnaires was analysed with descriptive statistics. Relations between patient characteristics and motives were analysed using a t-test or a Chi-squared test. 1332 (54.6%) patients responded to the questionnaire. The main motive for participation was altruism. Often experiencing ADRs or negative experiences with drugs were not important motives. The patient's gender played a role in the different motives for participation. For men, potential future personal benefit from the results was more important than for women. The overall opinion about the system was positive. The knowledge that patients participate in this kind of research from an altruistic point of view may strengthen patient involvement in pharmacovigilance. Copyright © 2012 John Wiley & Sons, Ltd.

  17. Post-marketing drug withdrawals: Pharmacovigilance success, regulatory problems.

    PubMed

    Aronson, Jeffrey K

    2017-03-30

    Modern pharmacovigilance began in the 1960s, since when the subject has grown markedly, interest having particularly increased since 2010. One index of its success is the increasing speed with which serious adverse drug reactions are discovered after marketing of a medicinal product. However, the speed with which products have subsequently been withdrawn as a result of the discovery of serious adverse reactions has not consistently changed. This highlights problems that regulators and manufacturers face when serious reactions are discovered, with difficulties in deciding which of several consequent actions to take: to add specific warnings (cautions) or contraindications to the product label; to issue a Direct Healthcare Professional Communication; to allow informed patients to decide whether they will take the drug; or, in the most serious cases, to withdraw the product or revoke the licence. Conflicts of interest may inhibit decision-making. Recommendations that arise from these observations are that: health professionals and patients should be more vigorously encouraged to report suspected adverse drug reactions; regulatory authorities and drug manufacturers should take quicker confirmatory action when serious suspected adverse drug reactions are reported, even anecdotally, with formal studies to test for causality conducted sooner rather than later, applying lower than usual thresholds for suspicion; temporary suspensions or restrictions could be considered during such assessments; universal guidelines are needed for determining when a drug should be withdrawn if serious adverse drug reactions are suspected; there should be more rigorous monitoring and verification of deaths and reporting of reasons for drop-outs during clinical trials, with more transparency in reporting adverse events and ready access to premarketing clinical study reports; post-marketing drug monitoring systems and medicines regulation in low-to-middle income economies, especially in Africa

  18. [Application of Markov model in post-marketing pharmacoeconomic evaluation of traditional Chinese medicine].

    PubMed

    Wang, Xin; Su, Xia; Sun, Wentao; Xie, Yanming; Wang, Yongyan

    2011-10-01

    In post-marketing study of traditional Chinese medicine (TCM), pharmacoeconomic evaluation has an important applied significance. However, the economic literatures of TCM have been unable to fully and accurately reflect the unique overall outcomes of treatment with TCM. For the special nature of TCM itself, we recommend that Markov model could be introduced into post-marketing pharmacoeconomic evaluation of TCM, and also explore the feasibility of model application. Markov model can extrapolate the study time horizon, suit with effectiveness indicators of TCM, and provide measurable comprehensive outcome. In addition, Markov model can promote the development of TCM quality of life scale and the methodology of post-marketing pharmacoeconomic evaluation.

  19. [Technical specifications for post-marketing pharmacoeconomic evaluation of Chinese medicine (draft version for comments)].

    PubMed

    Xie, Yan-Ming; Wang, Xin; Wang, Nuo; Chang, Yan-Peng

    2013-09-01

    Pharmacoeconomics is an important part of the post-marketing evaluation of Chinese medicine, post-marketing pharmacoeconomic evaluation can better reflect the clinical and market value of Chinese medicine, the purpose of establishing the technical specifications for pharmacoeconomic evaluation is to make the evaluation process and results regarding Chinese patent medicines more scientific and fair. Every country's technical specifications for pharmacoeconomic evaluation act as reference guidelines, we have already drawn up the technical specifications which take into account the special characteristics of Chinese medicine; these are in preparation for post-marketing pharmacoeconomic evaluation Chinese medicine.

  20. Evaluation of Pre-marketing Factors to Predict Post-marketing Boxed Warnings and Safety Withdrawals.

    PubMed

    Schick, Andreas; Miller, Kathleen L; Lanthier, Michael; Dal Pan, Gerald; Nardinelli, Clark

    2017-06-01

    An important goal in drug regulation is understanding serious safety issues with new drugs as soon as possible. Achieving this goal requires us to understand whether information provided during the Food and Drug Administration (FDA) drug review can predict serious safety issues that are usually identified after the product is approved. However, research on this topic remains understudied. In this paper, we examine whether any pre-marketing drug characteristics are associated with serious post-marketing safety actions. We study this question using an internal FDA database containing every new small molecule drug submitted to the FDA's Center for Drug Evaluation and Research (CDER) on or after November 21, 1997, and approved and commercially launched before December 31, 2009. Serious post-marketing safety actions include whether these drugs ever experienced either a post-marketing boxed warning or a withdrawal from the market due to safety concerns. A random effects logistic regression model was used to test whether any pre-marketing characteristics were associated with either post-marketing safety action. A total of 219 new molecular entities were analyzed. Among these drugs, 11 experienced a safety withdrawal and 30 received boxed warnings by July 31, 2016. Contrary to prevailing hypotheses, we find that neither clinical trial sample sizes nor review time windows are associated with the addition of a post-marketing boxed warning or safety withdrawal. However, we do find that new drugs approved with either a boxed warning or priority review are more likely to experience post-marketing boxed warnings. Furthermore, drugs approved with boxed warnings tend to receive post-marketing boxed warnings resulting from new safety information that are unrelated to the original warning. Drugs approved with a boxed warning are 3.88 times more likely to receive a post-marketing boxed warning, while drugs approved with a priority review are 3.51 times more likely to receive a post-marketing

  1. A pre-marketing ALT signal predicts post-marketing liver safety.

    PubMed

    Moylan, Cynthia A; Suzuki, Ayako; Papay, Julie I; Yuen, Nancy A; Ames, Michael; Hunt, Christine M

    2012-08-01

    Drug induced liver injury during drug development is evidenced by a higher incidence of serum alanine aminotransferase (ALT) elevations in treated versus placebo populations and termed an "ALT signal". We sought to quantify whether an ALT signal in pre-marketing clinical trials predicted post-marketing hepatotoxicity. Incidence of ALT elevations (ALT ≥ 3 times upper limits normal [× ULN]) for drug and placebo of new chemical entities and approved drugs associated with hepatotoxicity was calculated using the Food and Drug Administration (FDA) website. Post-marketing liver safety events were identified using the FDA Adverse Event Reporting System (AERS). The association of FDA AERS signal score (EB05 ≥ 2) and excess risk of pre-marketing ALT elevation (difference in incidence of ALT ≥ 3× ULN in treated versus placebo) was examined. An ALT signal of ≥ 1.2% was significantly associated with a post-marketing liver safety signal (p ≤ 0.013) and a 71.4% positive predictive value. An absent ALT signal was associated with a high likelihood of post-marketing liver safety; negative predictive value of 89.7%. Daily drug dose information improved the prediction of post-marketing liver safety. A cut-off of 1.2% increase in ALT ≥ 3× ULN in treated versus placebo groups provides an easily calculated method for predicting post-marketing liver safety.

  2. [Exploration of how to formulate guidelines on post-marketing traditional Chinese medicine surveillance].

    PubMed

    Zhang, Wen; Xie, Yan-Ming; Yu, Wen-Ya

    2013-09-01

    Combining the world health organization's (WHO), the United States and the European union's relevant laws and guidelines on post-marketing drug surveillance to judge the status of post-marketing surveillance of traditional Chinese medicine(TCM) in China. We found that due to the late start of post-marketing surveillance of traditional Chinese medicine, the appropriate guidelines are yet to be developed. Hence, hospitals, enterprises and research institutions do not have a shared foundation from which to compare their research results. Therefore there is an urgent need to formulate such post-marketing surveillance guidelines. This paper has used as guidance various technical documents such as, "procedures to formulate national standards" and "testing methods of management in formulating traditional Chinese medicine standards" and has combined these to produce a version of post-marketing surveillance particular to Chinese medicine in China. How to formulate these guidelines is discussed and procedures and methods to formulate technical specifications are introduced. These provide a reference for future technical specifications and will assist in the development of TCM.

  3. Post market surveillance in the german medical device sector - current state and future perspectives.

    PubMed

    Zippel, Claus; Bohnet-Joschko, Sabine

    2017-08-01

    Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

  4. [Clinical orientation and thought on several problems in post-marketed reassessment of traditional Chinese medicine].

    PubMed

    Wang, Xin; Su, Xia; Yu, Jie; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The post-marketed reassessment is an important link to ensure the safety and effectiveness of traditional chinese medicine. It is also the expansion and stretch of new drug evaluation. Through the systematic, standard, rigorous post-marketed reassessment, the enterprise can full access to drugs after listing the efficacy and safety information, evaluate the interests and risk of the drug and provide the scientific basis for the drug use. It can also provide timely, scientific technology basis for government health decisions, the enterprise marketing decision and public health security. This paper mainly discussed the thought on clinical orientation of traditional chinese medicine in the post-marketed reassessment and how to reach the goal through systematic consideration and overall plan.

  5. [Study on method on post-marketing traditonal Chinese medicine safety assessment].

    PubMed

    Kou, Qiuai; Zhao, Suping; Feng, Guoshuang; Xie, Yanming

    2011-10-01

    Traditional Chinese medicine (TCM) safety assessment is an important content of post-marketing Chinese herbal medicine assessment and the primary question. It includes safety monitoring and safety evaluation. China has established the elementary system for the TCM safety monitoring, but did few things on safety evaluation. People have knew that the methods of pharmacoepidemiology have good practicability on drug safety assessment in recent years. This article analyzed three methods of pharmacoepidemiology used in post-marketing Chinese herbal medicine safety assessment. There are three examples that may give some suggestions to fellow doctors working for safety monitoring and evaluation of TCM.

  6. [Necessity of applying pharmacovigilance in post-marketing safety monitoring of traditional Chinese medicine injections].

    PubMed

    Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia

    2008-03-01

    Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.

  7. Fatal adverse drug reactions of anticancer drugs detected by all-case post-marketing surveillance in Japan.

    PubMed

    Mori, Jinichi; Tanimoto, Tetsuya; Miura, Yuji; Kami, Masahiro

    2015-06-01

    All-case post-marketing surveillance of newly approved anticancer drugs is usually conducted on all patients in Japan. The present study investigates whether all-case post-marketing surveillance identifies fatal adverse drug reactions undetected before market entry. We examined fatal adverse drug reactions identified via all-case post-marketing surveillance by reviewing the disclosed post-marketing surveillance results, and determined the time points in which the fatal adverse drug reactions were initially reported by reviewing drug labels. We additionally scanned emergency alerts on the Japanese regulatory authority website to assess the relationship between all-case post-marketing surveillance and regulatory action. Twenty-five all-case post-marketing surveillances were performed between January 1999 and December 2009. Eight all-case post-marketing surveillances with final results included information on all fatal cases. Of these, the median number of patients was 1287 (range: 106-4998), the median number of fatal adverse drug reactions was 14.5 (range: 4-23). Of the 111 fatal adverse drug reactions detected in the eight post-marketing surveillances, only 28 (25.0%) and 22 (19.6%) were described on the initial global and the initial Japanese drug label, respectively, and 58 (52.3%) fatal adverse drug reactions were first described in the all-case post-marketing surveillance reports. Despite this, the regulatory authority issued only four warning letters, and two of these were prompted by case reports from the all-case post-marketing surveillance. All-case post-marketing surveillance of newly approved anticancer drugs in Japan was useful for the rigorous compilation of non-specific adverse drug reactions, but it rarely detected clinically significant fatal adverse drug reactions. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

  8. [Sample size calculation in clinical post-marketing evaluation of traditional Chinese medicine].

    PubMed

    Fu, Yingkun; Xie, Yanming

    2011-10-01

    In recent years, as the Chinese government and people pay more attention on the post-marketing research of Chinese Medicine, part of traditional Chinese medicine breed has or is about to begin after the listing of post-marketing evaluation study. In the post-marketing evaluation design, sample size calculation plays a decisive role. It not only ensures the accuracy and reliability of post-marketing evaluation. but also assures that the intended trials will have a desired power for correctly detecting a clinically meaningful difference of different medicine under study if such a difference truly exists. Up to now, there is no systemic method of sample size calculation in view of the traditional Chinese medicine. In this paper, according to the basic method of sample size calculation and the characteristic of the traditional Chinese medicine clinical evaluation, the sample size calculation methods of the Chinese medicine efficacy and safety are discussed respectively. We hope the paper would be beneficial to medical researchers, and pharmaceutical scientists who are engaged in the areas of Chinese medicine research.

  9. [Thinking on risk assessment and risk management of post-marketing Chinese medicine].

    PubMed

    Yu, Xueqing; Xie, Yanming; Wang, Yongyan

    2012-01-01

    Drug risk assessment and management is an important measure for reducing the adverse drug reaction and enhancing medication safety of the patient. Based on the concepts of drug risk assessment and risk management, and domestic and international drug risk management situation, this paper discusses the risk management of post-marketing Chinese medicine.

  10. [Post-marketing drug safety-risk management plan(RMP)].

    PubMed

    Ezaki, Asami; Hori, Akiko

    2013-03-01

    The Guidance for Risk Management Plan(RMP)was released by the Ministry of Health, Labour and Welfare in April 2012. The RMP consists of safety specifications, pharmacovigilance plans and risk minimization action plans. In this paper, we outline post-marketing drug safety operations in PMDA and the RMP, with examples of some anticancer drugs.

  11. [Process and key points of clinical literature evaluation of post-marketing traditional Chinese medicine].

    PubMed

    Liu, Huan; Xie, Yanming

    2011-10-01

    The clinical literature evaluation of the post-marketing traditional Chinese medicine is a comprehensive evaluation by the comprehensive gain, analysis of the drug, literature of drug efficacy, safety, economy, based on the literature evidence and is part of the evaluation of evidence-based medicine. The literature evaluation in the post-marketing Chinese medicine clinical evaluation is in the foundation and the key position. Through the literature evaluation, it can fully grasp the information, grasp listed drug variety of traditional Chinese medicines second development orientation, make clear further clinical indications, perfect the medicines, etc. This paper discusses the main steps and emphasis of the clinical literature evaluation. Emphasizing security literature evaluation should attach importance to the security of a comprehensive collection drug information. Safety assessment should notice traditional Chinese medicine validity evaluation in improving syndrome, improveing the living quality of patients with special advantage. The economics literature evaluation should pay attention to reliability, sensitivity and practicability of the conclusion.

  12. [Opportunity and challenge of post-marketing evaluation of traditional Chinese medicine].

    PubMed

    Du, Xiao-Xi; Song, Hai-Bo; Ren, Jing-Tian; Yang, Le; Guo, Xiao-Xin; Pang, Yu

    2014-09-01

    Post-marketing evaluation is a process which evaluate the risks and benefits of drug clinical application comprehensively and systematically, scientific and systematic results of post-marketing evaluation not only can provide data support for clinical application of traditional Chinese medicine, but also can be a reliable basis for the supervision department to develop risk control measures. With the increasing demands for treatment and prevention of disease, traditional Chinese medicine has been widely used, and security issues are also exposed. How to find risk signal of traditional Chinese medicine in the early stages, carry out targeted evaluation work and control risk timely have become challenges in the development of traditional Chinese medicine industry.

  13. [Withdrawal of cerivastatin revealed a flaw of post-marketing surveillance system in the United States].

    PubMed

    Saito, Mitsuo; Hirata-Koizumi, Mutsuko; Miyake, Shinji; Hasegawa, Ryuichi

    2005-01-01

    Cerivastatin, a lipid-lowering agent, was voluntarily withdrawn from the market because of high risk of rhabdomyolysis when used as monotherapy and as comedication with fibrates, especially gemfibrozil. Thereafter, investigators found a five-fold increase in the area under the curve (AUC) when cerivastatin was used as comedication with gemfibrozil and theorized that the increase was associated with inhibition of the hepatic uptake and metabolism. By contrast, a number of pharmacoepidemiological investigations--one of which involved evaluation of the Food and Drug Administration (FDA) database for suspected adverse drug reactions and 11 cohort studies of statin and fibrate users in United States showed the risk of rhabdomyolysis to be greater in cerivastatin than in other statins used in either monotherapy or in comedication with fibrates, especially gemfibrozil. This incident regarding risk of rhabdomyolysis in cerivastatin monotherapy was taken to court in the United States and unpublished company (manufacturer of cerivastatin) documents were opened. The incident was then analyzed and discussed in the Journal of American Medical Association (JAMA) as a concern of the current US post-marketing surveillance system. The company's action and timing were judged and found to be inappropriate (although companies of this sort generally have insurmountable conflicts of interest), and the work of the US regulatory system and funding for post-marketing safety management were found to be insufficient. On the basis of the current situation, the authors and editors recommend further improvement of post-marketing regulations including the establishment of an independent drug safety board to oversee post-marketing surveillance. Among the opened, unpublished data, was the finding that cerivastatin obviously induced myopathy in a dose-dependent manner when administrated as monotherapy. As for other statins, only limited data was available for the relationship between the dosage and

  14. Estimating post-marketing exposure to pharmaceutical products using ex-factory distribution data.

    PubMed

    Telfair, Tamara; Mohan, Aparna K; Shahani, Shalini; Klincewicz, Stephen; Atsma, Willem Jan; Thomas, Adrian; Fife, Daniel

    2006-10-01

    The pharmaceutical industry has an obligation to identify adverse reactions to drug products during all phases of drug development, including the post-marketing period. Estimates of population exposure to pharmaceutical products are important to the post-marketing surveillance of drugs, and provide a context for assessing the various risks and benefits, including drug safety, associated with drug treatment. This paper describes a systematic approach to estimating post-marketing drug exposure using ex-factory shipment data to estimate the quantity of medication available, and dosage information (stratified by indication or other factors as appropriate) to convert the quantity of medication to person time of exposure. Unlike the non-standardized methods often used to estimate exposure, this approach provides estimates whose calculations are explicit, documented, and consistent across products and over time. The methods can readily be carried out by an individual or small group specializing in this function, and lend themselves to automation. The present estimation approach is practical and relatively uncomplicated to implement. We believe it is a useful innovation.

  15. Type I error probability spending for post-market drug and vaccine safety surveillance with binomial data.

    PubMed

    Silva, Ivair R

    2017-09-25

    Type I error probability spending functions are commonly used for designing sequential analysis of binomial data in clinical trials, but it is also quickly emerging for near-continuous sequential analysis of post-market drug and vaccine safety surveillance. It is well known that, for clinical trials, when the null hypothesis is not rejected, it is still important to minimize the sample size. Unlike in post-market drug and vaccine safety surveillance, that is not important. In post-market safety surveillance, specially when the surveillance involves identification of potential signals, the meaningful statistical performance measure to be minimized is the expected sample size when the null hypothesis is rejected. The present paper shows that, instead of the convex Type I error spending shape conventionally used in clinical trials, a concave shape is more indicated for post-market drug and vaccine safety surveillance. This is shown for both, continuous and group sequential analysis. Copyright © 2017 John Wiley & Sons, Ltd.

  16. A distributed research network model for post-marketing safety studies: the Meningococcal Vaccine Study.

    PubMed

    Velentgas, Priscilla; Bohn, Rhonda L; Brown, Jeffrey S; Chan, K Arnold; Gladowski, Patricia; Holick, Crystal N; Kramer, Judith M; Nakasato, Cynthia; Spettell, Claire M; Walker, Alexander M; Zhang, Fang; Platt, Richard

    2008-12-01

    We describe a multi-center post-marketing safety study that uses distributed data methods to minimize the need for covered entities to share protected health information (PHI). Implementation has addressed several issues relevant to creation of a large scale post-marketing drug safety surveillance system envisioned by the FDA's Sentinel Initiative. This retrospective cohort study of Guillain-Barré syndrome (GBS) following meningococcal conjugate vaccination incorporates the data and analytic expertise of five research organizations closely affiliated with US health insurers. The study uses administrative claims data, plus review of full text medical records to adjudicate the status of individuals with a diagnosis code for GBS (ICD9 357.0). A distributed network approach is used to create the analysis files and to perform most aspects of the analysis, allowing nearly all of the data to remain behind institutional firewalls. Pooled analysis files transferred to a central site will contain one record per person for approximately 0.2% of the study population, and contain PHI limited to the month and year of GBS onset for cases or the index date for matched controls. The first planned data extraction identified over 9 million eligible adolescents in the target age range of 11-21 years. They contributed an average of 14 months of eligible time on study over 27 months of calendar time. MCV4 vaccination coverage levels exceeded 20% among 17-18-year olds and 16% among 11-13 and 14-16-year-old age groups by the second quarter of 2007. This study demonstrates the feasibility of using a distributed data network approach to perform large scale post-marketing safety analyses and is scalable to include additional organizations and data sources. We believe these results can inform the development of a large national surveillance system. Copyright (c) 2008 John Wiley & Sons, Ltd.

  17. Post-market surveillance to detect adverse events associated with Melody® valve implantation.

    PubMed

    Hill, Kevin D; Goldstein, Bryan H; Angtuaco, Michael J; Chu, Patricia Y; Fleming, Gregory A

    2017-08-01

    The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation. In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events. We reviewed the United States Food and Drug Administration's Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials. We identified 631 adverse events associated with "on-label" Melody® valve implants and 84 adverse events associated with "off-label" implants. The most frequent "on-label" adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5). Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with "on-label" Melody® valve implantation. Further study is needed to evaluate safety of "off-label" uses.

  18. [Clinical orientation of post-marketing Chinese patent drugs: an evidence-based practice].

    PubMed

    Shang, Hong-Cai; Zhang, Bo-Li; Li, You-Ping

    2008-09-01

    Unclear clinical orientation in practice has become one of the common problems with the effective application of famous and excellent Chinese herbal drugs, consequently restricting their development. The authors suggest that there are three aspects to be considered in dealing with this problem. Clinical evaluation and orientation of the famous and excellent Chinese herbal drugs is an important task, and it is also a requirement for the internationalization of traditional Chinese medicine. Literature evaluation-pharmacology research-clinical expertise analysis method will establish a theoretical basis and method for post-marketing development of famous and excellent Chinese patent drugs.

  19. [Thought on several problems of post-marketing herbs clinical evaluation in special populations].

    PubMed

    Zhou, Ai; Lian, Fengmei

    2011-10-01

    The re-evaluation of clinical post-marketing herbs in special populations, such as children, the aged, pregnant women, lactating women, has attracted attention in our country. The media is drug adverse reaction reports and package insert. The safety of combined administration in aged and children's growth should have been taken long-term follow-up study. Perfecting traditional chinese medicine FDA system will be beneficial to the re-evaluation of clinical postmarketing herbs in pregnant women. Dose-effect study in children also should cause the concern of researchers.

  20. A Swedish national post-marketing surveillance study of natalizumab treatment in multiple sclerosis.

    PubMed

    Holmén, Carolina; Piehl, Fredrik; Hillert, Jan; Fogdell-Hahn, Anna; Lundkvist, Malin; Karlberg, Elin; Nilsson, Petra; Dahle, Charlotte; Feltelius, Nils; Svenningsson, Anders; Lycke, Jan; Olsson, Tomas

    2011-06-01

    A post marketing surveillance study was conducted to evaluate safety and efficacy of natalizumab in Swedish multiple sclerosis (MS) patients since its introduction in August 2006 until March 2010. Patients were registered in the web-based Swedish MS-registry at 40 locations and evaluated every 6 months. Adverse events and clinical outcomes were recorded. One thousand one hundred and fifty-two patients were included (71.4% female) and 149 patients stopped treatment; the main reason was planned pregnancy. Anti-natalizumab antibodies were found in 4.5% (52 patients) of which 1.6% displayed persistent antibodies. Serious adverse events were rare, but included three cases with progressive multifocal leukoencephalopathy (PML). There were seven fatal cases, probably unrelated to the natalizumab treatment. For relapsing-remitting MS patients (n=901), mean Expanded Disability Status Scale (EDSS, -10.7%), Multiple Sclerosis Severity Scale (MSSS, -20.4%), Multiple Sclerosis Impact Scale (MSIS-29, physical -9.9%, psychological -13.3%) and Symbol Digit Modalities Test (SDMT, +10.7%) all showed significant improvements during 24 months of treatment with natalizumab. The Swedish web-based MS quality registry proved to function as a platform for post-marketing MS drug surveillance, providing long-term data regarding drug effects and adverse events beyond clinical trials. Our results indicate that natalizumab is generally well tolerated and has sustained efficacy for patients with active MS, though the risk of PML is still an important concern.

  1. [Results of a post-marketing surveillance of meropenem for febrile neutropenia].

    PubMed

    Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

    2015-08-01

    The post-marketing surveillance of meropenem (Meropen) for febrile neutropenia (FN) was conducted between July 2010 and June 2012 to evaluate safety and efficacy under actual clinical use. There were 1191 and 1124 evaluable cases for safety and efficacy respectively, of 1207 case cards collected from 180 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 15.7% (187/1191 cases), and the main ADRs were alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, hepatic function abnormal, and liver disorder, which were similar to these observed in the clinical study for FN or post marketing surveillances of meropenem conducted before. In efficacy analysis, the overall efficacy was 81.8% (919/1124 cases). Also, it was 79.2% (708/894 cases) for hematological malignancy and 91.8% (213/232 cases) for solid cancer. These results confirmed meropenem (Meropen) is one of the well-tolerated and potent antimicrobial agents for febrile neutropenia.

  2. [Establishment of model of traditional Chinese medicine injections post-marketing safety monitoring].

    PubMed

    Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe

    2013-09-01

    To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.

  3. [The problem of post-marketing surveillance planning on drugs for infectious disease].

    PubMed

    Sato, J

    2001-12-01

    In principle, a new drug is approved via the assessments of safety and efficacy by the Ministry of Health, Labor and Welfare (MHLW). After approval, conduct of post-marketing surveillance is requested by law in order to assess the safety and efficacy of the drug in a large number of patients. Before initiating a surveillance, submission to MHLW of a document on the plan of survey is necessary in the purpose of inspection if it includes any ethical or regulatory problem or not. Through the inspections of the plans submitted during the period of April 1998 and March 2000, many problems have been pointed out. In this report, the author introduces some of the concrete problems noted in the plans on drugs for infectious diseases and shows some of the guidance made by the authority how to improve them. It is expected that such practical analyses of cases may be useful for future planning of post-marketing surveillance on drugs for infectious diseases.

  4. Post-marketing surveillance and vigilance for medical devices: the European approach.

    PubMed

    Randall, H

    2001-01-01

    The extent to which the medical device manufacturers are responsible for actively monitoring the performance of their products after they have successfully passed the rigorous pre-market approval process has always been a matter of diverse opinion. Within Europe, the law is unhelpfully vague on this point. While there are some comparatively clear obligations for reporting incidents to the authorities (known as the 'vigilance system'), little detail is given on how diligently the manufacturer should try to find out about such incidents. In the early stages of the European Community Directives covering medical devices, there was much emphasis upon formulating guidance to help interpret the vigilance reporting requirements. It is, however, only recently that attention has turned to attempting to clarify what is expected from post-marketing surveillance (PMS) in its broader sense. This article discuses both the vigilance and PMS processes and outlines the currently available European, and particularly UK, guidance documents which are aimed at promoting a more level playing field across industry where these activities are concerned. In particular, it explains the principle differences between vigilance and post-marketing surveillance: the former being the reporting of adverse incidents by manufacturers to the regulatory authorities and their subsequent sharing of key incident data between each other; the latter being the process by which information on overall devise performance is captured, analysed and acted upon. Nevertheless, it is still a struggle to gain widespread appreciation that these two activities are not in fact one and the same.

  5. Continuous versus group sequential analysis for post-market drug and vaccine safety surveillance.

    PubMed

    Silva, I R; Kulldorff, M

    2015-09-01

    The use of sequential statistical analysis for post-market drug safety surveillance is quickly emerging. Both continuous and group sequential analysis have been used, but consensus is lacking as to when to use which approach. We compare the statistical performance of continuous and group sequential analysis in terms of type I error probability; statistical power; expected time to signal when the null hypothesis is rejected; and the sample size required to end surveillance without rejecting the null. We present a mathematical proposition to show that for any group sequential design there always exists a continuous sequential design that is uniformly better. As a consequence, it is shown that more frequent testing is always better. Additionally, for a Poisson based probability model and a flat rejection boundary in terms of the log likelihood ratio, we compare the performance of various continuous and group sequential designs. Using exact calculations, we found that, for the parameter settings used, there is always a continuous design with shorter expected time to signal than the best group design. The two key conclusions from this article are (i) that any post-market safety surveillance system should attempt to obtain data as frequently as possible, and (ii) that sequential testing should always be performed when new data arrives without deliberately waiting for additional data.

  6. Pinimenthol ointment in patients suffering from upper respiratory tract infections - a post-marketing observational study.

    PubMed

    Kamin, Wolfgang; Kieser, Meinhard

    2007-12-01

    In order to gain further experience regarding the tolerability of Pinimenthol ointment(1) in adolescents (> or = 12 years) and adults suffering from upper respiratory tract infections, a post-marketing observational study was performed. In this study, data of 3060 patients were collected (64.9% prospectively over an individual observation period of 5-14 days, 35.1% retrospectively). The prospective documentation also comprised data concerning treatment effects. Sample size of the post-marketing observational study was calculated in the way that adverse drug reactions with an event probability of at least 1:1000 would occur within the study at least once with a probability of 95%. Most patients suffered from cold, acute or chronic bronchitis, bronchial catarrh or hoarseness. Pinimenthol ointment was prescribed to inunction (29.6%), inhalation (17.3%) or inunction and inhalation (53.1%), respectively. The mean duration of study participation was 8.0 +/- 3.4 days. The tolerability was rated as excellent or good by 96.7% of physicians and 95.7% of patients. A total of 22 patients (0.7%) reported adverse drug reactions which mostly affected the skin or mucus membrane and therefore correspond to the expected adverse effects profile of Pinimenthol ointment. The treatment effect was mostly judged as excellent or good (physicians: 88.3%; patients: 88.1%). In conclusion, the study confirms Pinimenthol ointment as a well tolerated therapy option for upper respiratory tract infections in both adolescents and adults.

  7. An evaluation of computer-aided disproportionality analysis for post-marketing signal detection.

    PubMed

    Lehman, H P; Chen, J; Gould, A L; Kassekert, R; Beninger, P R; Carney, R; Goldberg, M; Goss, M A; Kidos, K; Sharrar, R G; Shields, K; Sweet, A; Wiholm, B E; Honig, P K

    2007-08-01

    To understand the value of computer-aided disproportionality analysis (DA) in relation to current pharmacovigilance signal detection methods, four products were retrospectively evaluated by applying an empirical Bayes method to Merck's post-marketing safety database. Findings were compared with the prior detection of labeled post-marketing adverse events. Disproportionality ratios (empirical Bayes geometric mean lower 95% bounds for the posterior distribution (EBGM05)) were generated for product-event pairs. Overall (1993-2004 data, EBGM05> or =2, individual terms) results of signal detection using DA compared to standard methods were sensitivity, 31.1%; specificity, 95.3%; and positive predictive value, 19.9%. Using groupings of synonymous labeled terms, sensitivity improved (40.9%). More of the adverse events detected by both methods were detected earlier using DA and grouped (versus individual) terms. With 1939-2004 data, diagnostic properties were similar to those from 1993 to 2004. DA methods using Merck's safety database demonstrate sufficient sensitivity and specificity to be considered for use as an adjunct to conventional signal detection methods.

  8. [Establish research model of post-marketing clinical safety evaluation for Chinese patent medicine].

    PubMed

    Zheng, Wen-ke; Liu, Zhi; Lei, Xiang; Tian, Ran; Zheng, Rui; Li, Nan; Ren, Jing-tian; Du, Xiao-xi; Shang, Hong-cai

    2015-09-01

    The safety of Chinese patent medicine has become a focus of social. It is necessary to carry out work on post-marketing clinical safety evaluation for Chinese patent medicine. However, there have no criterions to guide the related research, it is urgent to set up a model and method to guide the practice for related research. According to a series of clinical research, we put forward some views, which contained clear and definite the objective and content of clinical safety evaluation, the work flow should be determined, make a list of items for safety evaluation project, and put forward the three level classification of risk control. We set up a model of post-marketing clinical safety evaluation for Chinese patent medicine. Based this model, the list of items can be used for ranking medicine risks, and then take steps for different risks, aims to lower the app:ds:risksrisk level. At last, the medicine can be managed by five steps in sequence. The five steps are, collect risk signal, risk recognition, risk assessment, risk management, and aftereffect assessment. We hope to provide new ideas for the future research.

  9. Pediatric post-marketing safety systems in North America: assessment of the current status.

    PubMed

    McMahon, Ann W; Wharton, Gerold T; Bonnel, Renan; DeCelle, Mary; Swank, Kimberley; Testoni, Daniela; Cope, Judith U; Smith, Phillip Brian; Wu, Eileen; Murphy, Mary Dianne

    2015-08-01

    It is critical to have pediatric post-marketing safety systems that contain enough clinical and epidemiological detail to draw regulatory, public health, and clinical conclusions. The pediatric safety surveillance workshop (PSSW), coordinated by the Food and Drug Administration (FDA), identified these pediatric systems as of 2010. This manuscript aims to update the information from the PSSW and look critically at the systems currently in use. We reviewed North American pediatric post-marketing safety systems such as databases, networks, and research consortiums found in peer-reviewed journals and other online sources. We detail clinical examples from three systems that FDA used to assess pediatric medical product safety. Of the 59 systems reviewed for pediatric content, only nine were pediatric-focused and met the inclusion criteria. Brief descriptions are provided for these nine. The strengths and weaknesses of three systems (two of the nine pediatric-focused and one including both children and adults) are illustrated with clinical examples. Systems reviewed in this manuscript have strengths such as clinical detail, a large enough sample size to capture rare adverse events, and/or a patient denominator internal to the database. Few systems include all of these attributes. Pediatric drug safety would be better informed by utilizing multiple systems to take advantage of their individual characteristics. Copyright © 2015 John Wiley & Sons, Ltd.

  10. [Basic requirements on post-marketing clinical re-evaluation of chinese medicine and phase IV clinical trials].

    PubMed

    Xie, Yanming; Wang, Yanping; Tian, Feng; Wang, Yongyan

    2011-10-01

    As information on safety and effectiveness is not comprehensive, gained from the researches for listing approval of Chinese medicine, it is very necessary to conduct post-marketing clinical re-evaluation of Chinese medicine. Effectiveness, safety and economic evaluation are three main aspects of post-marketing clinical re-evaluation. In this paper, the difference and relations between the post-marketing clinical re-evaluation and the phase IV clinical trials were discussed, and the basic requests and suggestions were proposed, according to the domestic and foreign relevant regulations and experts' suggestions, and discussed the requirements of the phase IV clinical trials on indications, design methods, inclusion and exclusion criteria, sample size, etc.

  11. [Research about re-evaluation of screening of traditonal Chinese medicine symptoms item of post-marketing medicine Xuezhikang].

    PubMed

    He, Wei; Xie, Yanming; Wang, Yongyan

    2011-10-01

    The purpose of post-marketing Chinese medicine re-evaluation is to identify Chinese medicine clinical indications, while designing scientific and rational of Chinese medicine symptoms items are important to the result of symptoms re-evaluation. This study give screening of traditional Chinese medicine(TCM) symptoms item of post-marketing medicine Xuezhikang re-evaluation as example that reference to principle dyslipidemia clinical research, academic dissertations, Xuezhikang directions, clinical expert practice experience etc. while standardization those symptom names and screening 41 dyslipidemia common symptoms. Furthermore, this paper discuss about the accoerdance and announcements when screening symptoms item, so as to providing a research thread to manufacture PRO chart for post-marketing medicine re-evaluation.

  12. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    PubMed

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  13. Composite sequential Monte Carlo test for post-market vaccine safety surveillance.

    PubMed

    Silva, Ivair R

    2016-04-30

    Group sequential hypothesis testing is now widely used to analyze prospective data. If Monte Carlo simulation is used to construct the signaling threshold, the challenge is how to manage the type I error probability for each one of the multiple tests without losing control on the overall significance level. This paper introduces a valid method for a true management of the alpha spending at each one of a sequence of Monte Carlo tests. The method also enables the use of a sequential simulation strategy for each Monte Carlo test, which is useful for saving computational execution time. Thus, the proposed procedure allows for sequential Monte Carlo test in sequential analysis, and this is the reason that it is called 'composite sequential' test. An upper bound for the potential power losses from the proposed method is deduced. The composite sequential design is illustrated through an application for post-market vaccine safety surveillance data.

  14. Decision support methods for the detection of adverse events in post-marketing data.

    PubMed

    Hauben, M; Bate, A

    2009-04-01

    Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical measures of reporting frequency for huge numbers of drug-event combinations are increasingly used to support pharamcovigilance analysts screening large spontaneous reporting system databases. After an overview of pharmacovigilance and spontaneous reporting systems, we discuss the theory and application of contemporary computer algorithms in regular use, those under development, and the practical considerations involved in the implementation of computer algorithms within a comprehensive and holistic drug safety signal detection program.

  15. The ability of animal studies to detect serious post marketing adverse events is limited.

    PubMed

    van Meer, Peter J K; Kooijman, Marlous; Gispen-de Wied, Christine C; Moors, Ellen H M; Schellekens, Huub

    2012-12-01

    The value of animal studies to assess drug safety is unclear because many such studies are biased and have methodological shortcomings. We studied whether post-marketing serious adverse reactions to small molecule drugs could have been detected on the basis of animal study data included in drug registration files. Of 93 serious adverse reactions related to 43 small molecule drugs, only 19% were identified in animal studies as a true positive outcome, which suggests that data from animal studies are of limited value to pharmacovigilance activities. Our study shows that drug registration files can be used to study the predictive value of animal studies and that the value of animal studies in all stages of the drug development should be investigated in a collaborative endeavour between regulatory authorities, industry, and academia. Copyright © 2012 Elsevier Inc. All rights reserved.

  16. The role of the Pharmaceuticals and Medical Devices Agency and healthcare professionals in post-marketing safety.

    PubMed

    Mori, Kazuhiko; Watanabe, Meguru; Horiuchi, Naoya; Tamura, Atsushi; Kutsumi, Hiromu

    2014-04-01

    The development of drugs and medical devices is necessary for medical progress; however, safety measures need to be put in place to protect the health of the population. In order to ensure the safety of drugs and medical devices, it is important to determine measures for appropriate management of risks at any time during the development phase, the regulatory review and the post-marketing phase. Adverse events detected in clinical trials are limited due to the restricted numbers of patients enrolled in the trials. Therefore, it is almost impossible to predict rare serious adverse events during the post-marketing phase. The revised Pharmaceutical Affairs Act was established in Japan in November 20, 2013. The new act focuses on increased safety of drugs and medical devices. The Pharmaceuticals and Medical Devices Agency (PMDA) is the regulatory authority in Japan that promotes safety measures from the development phase through to the post-marketing phase. In the post-marketing phase, the PMDA collects information from the medical product companies and healthcare professionals, as well as instructing and advising them with regard to post-marketing safety measures for each drug and medical device. Since Japan has a national health insurance system, a new drug or a medical device is available throughout the country when the drug price or medical fee is listed in the National Health Insurance price list. Healthcare professionals in medical institutions must learn about the drugs and medical devices they handle, and should make an effort to maintain patient safety. The PMDA medi-navi is a very useful electronic mail delivery service that provides critical information for protecting patients from health hazards caused by adverse events. The 'risk management plan' is also important as it contains important information about safety profile and post-marketing measures of a new drug.

  17. Technical success from endovascular aneurysm repair in the post-marketing era: a multicenter prospective trial.

    PubMed

    Naslund, Thomas C; Becker, Stacey Y

    2003-01-01

    Evaluation of post-marketing success with the Ancure Endovascular Graft (AEG) was accomplished by review of a multicenter, prospective trial involving 46 centers and 163 patients. A second cohort of patients (n = 350) treated with the AEG under a controlled-use interval prior to the prospective trial was simultaneously evaluated. Technical success in both groups of patients (96.9% and 97.4%, respectively) was similar to what was reported in pre-market clinical trials. Operative implantation complications unique to the AEG included graft limb stenosis/occlusion in 35.6 and 31.4%, contralateral pull wire being caught on hooks in 33.7 and 28%, failure to seal (type I endoleak) in 17.2 and 18.3%, jacket guard being stuck in 12.9 and 11%, contralateral wire being stuck in 6.8 and 7.1%, high jacket retraction force in 16 and 8.5%, and inability to retract jacket in 1.8 and 0.5% of patients involved in the multicenter trial and controlled-use interval, respectively. One of four patients undergoing conversion in the prospective trial had graft misdeployment as a mode of failure. Three were converted for access failure. The 30-day mortality rate in the prospective trial was 3.7%. Interventions to resolve implantation-related events included stenting, guide catheter manipulations, wire exchanges, and delivery catheter disassembly. These interventions were successful in virtually every case. Open surgical procedures were not needed to correct these operative problems. Results from this study demonstrate excellent technical success with the AEG in the post-market era. Interventions to resolve implantation complications, when utilized, are highly successful in facilitating AEG implantation and providing technical success.

  18. Evaluation of Electronic Healthcare Databases for Post-Marketing Drug Safety Surveillance and Pharmacoepidemiology in China.

    PubMed

    Yang, Yu; Zhou, Xiaofeng; Gao, Shuangqing; Lin, Hongbo; Xie, Yanming; Feng, Yuji; Huang, Kui; Zhan, Siyan

    2017-08-16

    Electronic healthcare databases (EHDs) are used increasingly for post-marketing drug safety surveillance and pharmacoepidemiology in Europe and North America. However, few studies have examined the potential of these data sources in China. Three major types of EHDs in China (i.e., a regional community-based database, a national claims database, and an electronic medical records [EMR] database) were selected for evaluation. Forty core variables were derived based on the US Mini-Sentinel (MS) Common Data Model (CDM) as well as the data features in China that would be desirable to support drug safety surveillance. An email survey of these core variables and eight general questions as well as follow-up inquiries on additional variables was conducted. These 40 core variables across the three EHDs and all variables in each EHD along with those in the US MS CDM and Observational Medical Outcomes Partnership (OMOP) CDM were compared for availability and labeled based on specific standards. All of the EHDs' custodians confirmed their willingness to share their databases with academic institutions after appropriate approval was obtained. The regional community-based database contained 1.19 million people in 2015 with 85% of core variables. Resampled annually nationwide, the national claims database included 5.4 million people in 2014 with 55% of core variables, and the EMR database included 3 million inpatients from 60 hospitals in 2015 with 80% of core variables. Compared with MS CDM or OMOP CDM, the proportion of variables across the three EHDs available or able to be transformed/derived from the original sources are 24-83% or 45-73%, respectively. These EHDs provide potential value to post-marketing drug safety surveillance and pharmacoepidemiology in China. Future research is warranted to assess the quality and completeness of these EHDs or additional data sources in China.

  19. National post-market surveillance assessment of veterinary medicines in Korea during the past decade.

    PubMed

    Kang, JeongWoo; Park, Hae-Chul; Jang, Yang Ho; Hossain, Md Akil; Jeong, Kyunghun; Jeong, Mi Young; Yun, Seon-Jong; Park, Sung-Won; Kim, Dae Gyun; Lee, Kwang-Jick

    2017-05-22

    Veterinary medicines have been widely used for the prevention and treatment of diseases, growth promotion, and to promote feeding efficacy in livestock. As the veterinary medicine industry has steadily grown, it is crucial to set up a baseline for the quality of medicine as well as the insufficiency or excessiveness of the active ingredients in drug products to ensure the compliance, safety and efficacy of these medicines. Thus, the 10 years data of post-marketing quality control study was summarized to determine the rate and extent of non-compliance of these medicines and to establish baseline data for future quality control measures of veterinary medicine. In this study, 1650 drugs for veterinary use were collected per year from each city and province in Korea and analysed for the quantity of active ingredients according to the "national post-market surveillance (NPMS) system" over the past decade. The NPMS assessment was performed using liquid and gas chromatography, titration, UV/Vis spectrophotometry, and bioassays. A total of 358 cases were deemed noncompliant, with the average noncompliance rate for all medicine types being 2.0%. The average noncompliance rates for antibiotics, biologics and other chemical drugs except antibiotics (OCD) were 1.1%, 1.2%, and 3.0%, respectively. The first leading cause for noncompliant products was insufficient quantity of major ingredients (283 cases), and the second leading cause was the existence of excess amount of active ingredients (60 cases). Tylosin, spiramycin, ampicillin, tetracyclines and penicillins were most frequently found to be noncompliant among antibiotics. Among the OCD, the noncompliance was found commonly in vitamin A. The overall trend presented gradually decreasing violation rates, suggesting that the quality of veterinary medicines has improved. Consistent application of the NPMS assessment and the establishment of the Korea Veterinary Good Manufacturing Practice (KVGMP) will help to maintain the good

  20. [Technical specifications for intensive hospital safety monitoring of post-marketing Chinese medicine (draft version for comments)].

    PubMed

    Xie, Yan-Ming; Liao, Xing; Zhao, Yu-Bin; Li, Ming-Quan; Zhang, Yun-Ling; Ma, Rong; Xian, Shao-Xiang; Liu, Jian; Li, Su-Yun; Wen, Ze-Huai; Yang, Zhong-Qi; Zou, Jian-Dong; Sun, Hong-Sheng; He, Yan; Li, Xue-Lin; Jiang, Jun-Jie; Wang, Zhi-Fei; Li, Yuan-Yuan; Wang, Lian-Xin; Chang, Yan-Peng; Yang, Wei; Zhang, Wen

    2013-09-01

    It is of vital significance to conduct active post-marketing surveillance of Chinese medicine, as an active response to laws, rules and guidelines issued by the China food and drug administration. The standards for technological specifications based on expert consensus have been drafted. These will provide technological support in evaluating adverse drug reactions (ADRs) or adverse drug events (ADEs). The technological specifications for post-marketing surveillance focus on two surveillance designs; one is a large sample registry study to explore general population ADR/ADE characteristics, the other is a nested case-control study to explore the characteristic and mechanisms of ADRs.

  1. [Post-marketing reevaluation for potential quality risk and quality control in clinical application of traditional Chinese medicines].

    PubMed

    Li, Hong-jiao; He, Li-yun; Liu, Bao-yan

    2015-06-01

    The effective quality control in clinical practices is an effective guarantee for the authenticity and scientificity of the findings. The post-marketing reevaluation for traditional Chinese medicines (TCM) focuses on the efficacy, adverse reaction, combined medication and effective dose of drugs in the market by expanded clinical trials, and requires a larger sample size and a wider range of patients. Therefore, this increases the difficulty of quality control in clinical practices. With the experience in quality control in clinical practices for the post-marketing reevaluation for Kangbingdu oral for cold, researchers in this study reviewed the study purpose, project, scheme design and clinical practice process from an overall point of view, analyzed the study characteristics of the post-marketing reevaluation for TCMs and the quality control risks, designed the quality control contents with quality impacting factors, defined key review contents and summarized the precautions in clinical practices, with the aim to improve the efficiency of quality control of clinical practices. This study can provide reference to clinical units and quality control-related personnel in the post-marketing reevaluation for TCMs.

  2. Improving retention and motivation in non-clinical dialysis employees.

    PubMed

    Campbell, Anne

    2004-02-01

    For no additional expense, little intrusion into the schedule or duties of the day, and no additional personnel to hire, dialysis facilities can make a dramatic impact on the training, motivation, and retention of employees through the use of classes designed specifically for the needs of newly employed non-clinical personnel. In today's world where many are expected to do a task with little or no orientation to the overall values and goals of the organization and how their tasks matter, what other action can accomplish so much for employee motivation and retention for so little time and expense? At DCI Mid-Missouri this program has been successful in retaining many excellent employees over many years and has been part of an ongoing effort to increase employees' interest and commitment to their work and the organization. It has also made them much more aware of treatments, other personnel and most of all, of our patients and their needs. It fulfills the needs of humans to be valued and have meaningful work. It contains costs and helps efficiency and productivity. Most of all, it keeps excellent people on the job and enjoying their work more than they would have. Participants' words when evaluating the most recent series of classes speak for themselves in demonstrating these important benefits that can be achieved easily in dialysis facilities throughout the United States and the world.

  3. Mining association patterns of drug-interactions using post marketing FDA's spontaneous reporting data.

    PubMed

    Ibrahim, Heba; Saad, Amr; Abdo, Amany; Sharaf Eldin, A

    2016-04-01

    Pharmacovigilance (PhV) is an important clinical activity with strong implications for population health and clinical research. The main goal of PhV is the timely detection of adverse drug events (ADEs) that are novel in their clinical nature, severity and/or frequency. Drug interactions (DI) pose an important problem in the development of new drugs and post marketing PhV that contribute to 6-30% of all unexpected ADEs. Therefore, the early detection of DI is vital. Spontaneous reporting systems (SRS) have served as the core data collection system for post marketing PhV since the 1960s. The main objective of our study was to particularly identify signals of DI from SRS. In addition, we are presenting an optimized tailored mining algorithm called "hybrid Apriori". The proposed algorithm is based on an optimized and modified association rule mining (ARM) approach. A hybrid Apriori algorithm has been applied to the SRS of the United States Food and Drug Administration's (U.S. FDA) adverse events reporting system (FAERS) in order to extract significant association patterns of drug interaction-adverse event (DIAE). We have assessed the resulting DIAEs qualitatively and quantitatively using two different triage features: a three-element taxonomy and three performance metrics. These features were applied on two random samples of 100 interacting and 100 non-interacting DIAE patterns. Additionally, we have employed logistic regression (LR) statistic method to quantify the magnitude and direction of interactions in order to test for confounding by co-medication in unknown interacting DIAE patterns. Hybrid Apriori extracted 2933 interacting DIAE patterns (including 1256 serious ones) and 530 non-interacting DIAE patterns. Referring to the current knowledge using four different reliable resources of DI, the results showed that the proposed method can extract signals of serious interacting DIAEs. Various association patterns could be identified based on the relationships among

  4. Number needed to harm in the post-marketing safety evaluation: results for rosiglitazone and pioglitazone.

    PubMed

    Mendes, Diogo; Alves, Carlos; Batel-Marques, Francisco

    2015-12-01

    Our aim is to investigate the usefulness of metric indices in post-marketing safety evaluations by estimating number needed to harm (NNH) values for cardiovascular (CV) adverse outcomes for rosiglitazone and pioglitazone. Reports from regulatory authorities (RAs) were consulted, and Medline searches were performed to identify studies assessing CV risks [all-cause death, CV death, myocardial infarction (MI), stroke, or congestive heart failure (CHF)] for thiazolidinediones. Meta-analyses were performed to pool evidence from randomized controlled trials (RCTs) and observational studies (OS). NNHs [with 95% confidence intervals (CI)] per year were estimated for CV adverse events. Reports from RAs included two meta-analyses of short-term RCTs, two long-term RCTs (RECORD and PROACTIVE), and a systematic review of OS (n = 29). The Medline search identified six additional OS. Statistically significant NNH values were obtained for the following: (i) rosiglitazone versus control on MI and CHF in the meta-analysis of RCTs (NNH = 16; 95%CI = 10-255; and NNH = 7; 95%CI = 5-16, respectively) and meta-analysis of OS (NNH = 12; 95%CI = 9-20; and NNH = 5; 95%CI = 32-131, respectively) and on CHF in the RECORD (NNH = 6; 95%CI = 4-14); (ii) pioglitazone versus control on CHF (NNH = 11; 95%CI = 6, 403) in the meta-analysis of RCTs and PROACTIVE (NNH = 12; 95%CI = 8-43); and (iii) rosiglitazone versus pioglitazone on MI (NNH = 69; 95%CI = 32-379), stroke (NNH = 36; 95%CI = 20-225), CHF (NNH = 33; 95%CI = 19-47), and all-cause death (NNH = 63; 95%CI = 49-100) in the meta-analysis of OS. The NNH values suggested an increased CV risk with rosiglitazone versus pioglitazone across several sources of information. The inclusion of objective metrics in post-marketing drug's benefit-risk assessments could be of increased value and help RAs to make consistent decisions on drug safety. Copyright © 2015

  5. Use of Carabids for the Post-Market Environmental Monitoring of Genetically Modified Crops.

    PubMed

    Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľudovít; Sehnal, František

    2017-03-29

    Post-market environmental monitoring (PMEM) of genetically modified (GM) crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected. Modeling based on the gradual elimination of the least abundant species, or of the fewest categories of functional traits, showed that a trait-based analysis of the most common species may be suitable for PMEM. Species represented by fewer than 230 individuals (all localities combined) should be excluded and species with an abundance higher than 600 should be preserved for statistical analyses. Sixteen species, representing 15 categories of functional traits fulfill these criteria, are typical dominant inhabitants of agroecocoenoses in Central Europe, are easy to determine, and their functional classification is well known. The effect of sampling year is negligible when at least four samples are collected during maize development beginning from 1 April. The recommended methodology fulfills PMEM requirements, including applicability to large-scale use. However, suggested thresholds of carabid comparability should be verified before definitive conclusions are drawn.

  6. Use of Carabids for the Post-Market Environmental Monitoring of Genetically Modified Crops

    PubMed Central

    Skoková Habuštová, Oxana; Svobodová, Zdeňka; Cagáň, Ľudovít; Sehnal, František

    2017-01-01

    Post-market environmental monitoring (PMEM) of genetically modified (GM) crops is required by EU legislation and has been a subject of debate for many years; however, no consensus on the methodology to be used has been reached. We explored the suitability of carabid beetles as surrogates for the detection of unintended effects of GM crops in general PMEM surveillance. Our study combines data on carabid communities from five maize field trials in Central Europe. Altogether, 86 species and 58,304 individuals were collected. Modeling based on the gradual elimination of the least abundant species, or of the fewest categories of functional traits, showed that a trait-based analysis of the most common species may be suitable for PMEM. Species represented by fewer than 230 individuals (all localities combined) should be excluded and species with an abundance higher than 600 should be preserved for statistical analyses. Sixteen species, representing 15 categories of functional traits fulfill these criteria, are typical dominant inhabitants of agroecocoenoses in Central Europe, are easy to determine, and their functional classification is well known. The effect of sampling year is negligible when at least four samples are collected during maize development beginning from 1 April. The recommended methodology fulfills PMEM requirements, including applicability to large-scale use. However, suggested thresholds of carabid comparability should be verified before definitive conclusions are drawn. PMID:28353663

  7. Effectiveness and tolerability of parenteral testosterone undecanoate: a post-marketing surveillance study.

    PubMed

    Wolf, Jan; Keipert, Dieter; Motazedi, Heiko; Ernst, Michael; Nettleship, Joanne; Gooren, Louis

    2017-08-16

    This observational post-marketing study of parenteral testosterone undecanoate (TU) in a non-selected population aimed to: examine the effectiveness of TU as treatment of hypogonadism; record adverse drug reactions (ADR) quantitatively particularly regarding polycythemia, prostate safety and cardiovascular-related metabolic risk factors; and verify whether recommended injection intervals apply to routine clinical practice. Eight hundred and seventy subjects from 259 outpatient units scheduled to visit the clinic six times were included. Effectiveness and tolerability of TU administration were assessed on a 4-point scale. Body weight, waist girth, blood pressure, hemoglobin levels, hematocrit, prostate-specific antigen (PSA), and digital rectal prostate examination were assessed. Over 90% of subjects completed the observational duration of 52.8 ± 9.7 weeks (mean ± SD) and 56% judged effectiveness as very good, 30.8% as good. 63.1% judged tolerability as very good, and 24.4% as good. No adverse effects on indicators of cardiovascular risk were observed. Polycythemia occurred in one subject and a supranormal hematocrit in one subject. Four subjects developed supranormal PSA levels. Prostate carcinoma was found in one subject, one subject had recurrence of a previously surgically treated prostate carcinoma, and the other two showed no indication of malignancy. Parenteral TU is safe, effective, and well-tolerated in clinical practice proving a good therapeutic option for hypogonadism.

  8. Post-marketing surveillance of generic amoxicillin using a microbiological assay and pharmacokinetic approach in rats.

    PubMed

    de Mattos, Livia I S; Ferraris, Fausto K; Machado, Tiago S C; de Brito, Thais M; Chaves, Amanda S; Pereira, Heliana M; Pinto, Douglas P; da Silva, Diego M D; Amendoeira, Fabio C

    2016-12-01

    Generic medicines were developed to increase population access to health treatment, to reduce costs and to allow drugs with the same outcomes to be purchased at lower prices. They are therapeutically equivalent to their brand-name counterparts and are interchangeable with them. However, the acceptance of generic medicines by physicians and general consumers is often affected by distrust related to quality and efficacy. In this study three different brands of generic amoxicillin were tested. The results showed that two of them were indistinguishable from the innovator in terms of microbiological potency; however, generic B was unable to reach the Brazilian Pharmacopoeia specifications for potency limits. In contrast, generic B was bioequivalent to the innovator amoxicillin in pharmacokinetic assessment and, surprisingly, generic A, which was approved in the microbiological potency assay, lacked pharmacokinetic equivalence compared with the innovator. Both tests, when used singly, may not be effective at detecting quality deviations in antimicrobial medicines, which indicates that pharmacokinetic tests in rats in association with microbiological potency assays are a valuable tool for post-marketing surveillance of generic antibiotics.

  9. [Utilization of Genomic Biomarkers for Post-marketing Safety of Drugs].

    PubMed

    Kaniwa, Nahoko

    2015-01-01

    To prevent adverse drug reactions in the post-marketing phase, therapeutic drug monitoring and various laboratory tests have been used for decades. Recently, data on associations between drug adverse reactions and biomarkers based on "omics" technologies/studies have been increasing. Using genomic biomarkers, patients at high risk for developing side effects can be distinguished before initiating medical treatment, allowing the choice of an appropriate drug/initial dosage regimen. Biomarkers based on proteomics or metabolomics can detect the onset of adverse reactions at an earlier stage than can be accomplished with classical laboratory tests. However, the clinical use of drug safety-related biomarkers is still limited compared with biomarkers that predict drug efficacy of, for example, molecular-targeted drugs. In this symposium, genomic biomarkers associated with the safety of anticancer drugs and idiosyncratic adverse reactions are introduced and compared between Japan and other countries. Prospective studies evaluating the application of screening tests to prevent adverse drug reactions are also shown, and steps necessary to accelerate the use of drug safety-related biomarkers are discussed.

  10. Clinical outcomes with daptomycin: a post-marketing, real-world evaluation.

    PubMed

    Sakoulas, G

    2009-12-01

    The Cubicin Outcomes Registry and Experience (CORE) is an ongoing, retrospective, post-marketing database of daptomycin use in the USA. Although non-comparative, CORE offers insight into real-life clinical experience with daptomycin in various Gram-positive infections and specific patient types. Analyses of daptomycin treatment outcomes using the CORE database revealed that treatment with daptomycin has resulted in high rates of clinical success for a variety of Gram-positive infections, including indicated infections such as complicated skin and soft tissue infections, Staphylococcus aureus bacteraemia and right-sided infective endocarditis, and non-indicated infections such as osteomyelitis. Treatment outcomes did not differ significantly according to the causative pathogen for any of the analyses performed and were not influenced by the vancomycin MIC. Patients frequently received therapy with alternative antibiotics prior to treatment with daptomycin, particularly those patients with more serious infections. However, similar treatment outcomes were observed when daptomycin was used as first-line therapy or as salvage therapy, demonstrating the effectiveness of daptomycin in the treatment of these patients.

  11. Treatment of comorbid anxiety and depression with escitalopram: results of a post-marketing surveillance study.

    PubMed

    Laux, G; Friede, M; Müller, W E

    2013-01-01

    In this 16-week post-marketing surveillance (PMS) study, antidepressant effects and tolerability of escitalopram was examined in 2 911 patients with comorbid depression and anxiety. Antidepressant effects were assessed using a modified version of the Montgomery-Åsberg depression rating scale (svMADRS), the Hamilton anxiety scale (HAMA) and the hospital anxiety depression scale (HADS-D) and the clinical global impression scale (CGI-S, CGI-I). Treatment was completed by 2 718 patients, whose severity of depression decreased from a mean svMADRS total score of 33.0 to 8.9. At the end of the study, the remission rate (svMADRS≤12) was 72.9% and the response rate (≥50% decrease in svMADRS score) was 83.1% (LOCF). Similarly, the severity of anxiety symptoms decreased from a mean HAMA total score of 28.8-8.8; the remission rate (HAMA<10) was 63.9% and the response rate (decrease≥50%) was 80.2%. The most frequent adverse events were nausea (1.6%), agitation (1.1%) and fatigue (0.7%). Antidepressant effects and good tolerability of escitalopram were confirmed in everyday practice in patients with comorbid depression and anxiety. The high response and remission rates were within the range reported in previous RTC's of escitalopram vs. comparators or vs. placebo. © Georg Thieme Verlag KG Stuttgart · New York.

  12. The European Post-marketing Observational Serdolect (EPOS) Project: increasing our understanding of schizophrenia therapy.

    PubMed

    Wehnert, A

    1998-03-01

    Well-controlled clinical trials, although essential for registration purposes, often fail to reflect the real-life usage of a drug. Ultimately, it is how a new medicinal product is used in clinical practice, how it performs in everyday life and how the patient who takes it feels and functions that determine the real benefit: risk ratio of the drug. Such a prospective, referenced, cohort study of sertindole (Serdolect, H. Lundbeck A/S, Copenhagen, Denmark) in schizophrenia was initiated in 1997. Sertindole is a new limbic-selective antipsychotic agent which has recently received marketing authorization in several countries across Europe for the treatment of schizophrenia. The experience gained in around 2200 sertindole-treated patients in controlled clinical trials has enabled an optimal targeting of sertindole to those patient groups who will benefit most and who are least likely to experience adverse effects. The European Post-marketing Observational Serdolect (EPOS) project plans to recruit over 12000 patients in two cohorts in centres throughout Europe. The aims are to provide a full safety evaluation of sertindole under marketed conditions at the relevant clinical dosage and, further, to provide epidemiological data on the treatment of schizophrenia in Europe under usual clinical conditions. The study is currently the only one of its kind to be undertaken in schizophrenia, and will provide important new data for psychiatrists around the world.

  13. Interim analysis of post-marketing surveillance of eculizumab for paroxysmal nocturnal hemoglobinuria in Japan.

    PubMed

    Ninomiya, Haruhiko; Obara, Naoshi; Chiba, Shigeru; Usuki, Kensuke; Nishiwaki, Kaichi; Matsumura, Itaru; Shichishima, Tsutomu; Okamoto, Shinichiro; Nishimura, Jun-Ichi; Ohyashiki, Kazuma; Nakao, Shinji; Ando, Kiyoshi; Kanda, Yoshinobu; Kawaguchi, Tatsuya; Nakakuma, Hideki; Harada, Daisuke; Akiyama, Hirozumi; Kinoshita, Taroh; Ozawa, Keiya; Omine, Mitsuhiro; Kanakura, Yuzuru

    2016-11-01

    Data characterizing the safety and effectiveness of eculizumab in patients with paroxysmal nocturnal hemoglobinuria (PNH) are limited. We describe the safety and effectiveness of eculizumab in PNH patients enrolled in a post-marketing surveillance study. Types and frequencies of observed adverse events were similar to those reported in previous clinical trials and no meningococcal infection was reported. Effectiveness outcomes included the reduction of intravascular hemolysis, the change in hemoglobin (Hb) level, the withdrawal of transfusion and corticosteroids, the change of renal function, and overall survival. The effect of eculizumab on intravascular hemolysis was demonstrated by a reduction in lactate dehydrogenase levels at all measurements after baseline. Significant increases in Hb levels from baseline were also observed after 1 month's treatment with eculizumab (p < 0.01). Of those who were transfusion-dependent at baseline, the median number of transfusions decreased significantly from 18 to 0 unit/year after 1 year of treatment with eculizumab (p < 0.001). An increase in Hb and a high rate of transfusion independence were observed, especially in patients with platelet count ≥150 × 10(9)/L. Approximately 97 % of patients showed maintenance or improvement of renal function. Overall survival rate was about 90 % (median follow-up 1.9 years). These results suggest an acceptable safety profile and favorable prognosis after eculizumab intervention.

  14. Post-marketing surveillance of live-attenuated Japanese encephalitis vaccine safety in China.

    PubMed

    Wang, Yali; Dong, Duo; Cheng, Gang; Zuo, Shuyan; Liu, Dawei; Du, Xiaoxi

    2014-10-07

    Japanese encephalitis (JE) is the most severe form of viral encephalitis in Asia and no specific treatment is available. Vaccination provides an effective intervention to prevent JE. In this paper, surveillance data for adverse events following immunization (AEFI) related to SA-14-14-2 live-attenuated Japanese encephalitis vaccine (Chengdu Institute of Biological Products) was presented. This information has been routinely generated by the Chinese national surveillance system for the period 2009-2012. There were 6024 AEFI cases (estimated reported rate 96.55 per million doses). Most common symptoms of adverse events were fever, redness, induration and skin rash. There were 70 serious AEFI cases (1.12 per million doses), including 9 cases of meningoencephalitis and 4 cases of death. The post-marketing surveillance data add the evidence that the Chengdu institute live attenutated vaccine has a reasonable safety profile. The relationship between encephalitis and SA-14-14-2 vaccination should be further studied. Copyright © 2014 Elsevier Ltd. All rights reserved.

  15. [The role of drug registries in the post-marketing surveillance].

    PubMed

    Traversa, Giuseppe; Sagliocca, Luciano; Magrini, Nicola; Venegoni, Mauro

    2013-06-01

    The aim of this article is to provide an introduction to issue of Recenti Progressi in Medicina, devoted to the role of drug registries in the post-marketing surveillance. We first motivate the need to implement registries as a tool in promoting the appropriateness of drug use and acquiring additional information on the risk-benefit profile of drugs. Then, the different role that can be played by registries in comparison with prescription monitoring systems and observational studies is clarified. The presentation of some of the most relevant registries established in Italy since the end of the '90s, with the analysis of their strengths and weaknesses, helps to understand some of the crucial issues that should be taken into account before a new registry is adopted. Specifically, we deal with the relationship between objectives - of appropriateness, effectiveness and safety - and methods; the overlapping between drug-based registries and disease-based ones; the duration and extension of data collection, which may be either exhaustive or based on a sampling frame; the importance of ensuring the quality of the data and to minimize the number of subjects who are lost to follow-up; the importance of infrastructures, and of ad hoc funding, for the functioning of a registry; the independence in data analysis and publication of findings.

  16. Feasibility of using recipients of health promotional newsletters for post-marketing surveillance.

    PubMed

    Mead, L A; Ford, D E; Roht, L H; Beach, C L; Klag, M J

    2000-06-01

    Achieving an adequate sample size is one of the major difficulties in performing post-marketing observational studies of health outcomes in persons taking specific drug preparations. We assessed the feasibility of recruiting participants for such a study of Cardizem CD from approximately 400,000 U.S. recipients of a health promotion newsletter. A three-page questionnaire was sent to a 2.5% random sample (n = 10,000) of recipients, stratified by geographic region. After two mailings, 2779 (28%) returned the questionnaire. Of the 2779 respondents, 2132 (77%) reported having high blood pressure. Eighty-seven percent indicated a willingness to participate in a long-term prospective study. In a multivariate model, calcium channel blocker (CCB) use was associated with a history of coronary heart disease, duration of hypertension medication use greater than 1 year, a rating of good or excellent hypertension care, higher systolic blood pressure, higher education level, family history of cardiovascular disease, and history of smoking. These results indicate that self-reported CCB users may be at greater risk of cardiovascular heart disease and that it is feasible to use health promotion newsletters as a source of participants in prospective studies of cardiovascular disease.

  17. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies

    PubMed Central

    Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-01-01

    Objectives To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act. Design Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10. Setting Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany. Main outcome measures Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions. Results Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals. Conclusions Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are

  18. Contribution of industry funded post-marketing studies to drug safety: survey of notifications submitted to regulatory agencies.

    PubMed

    Spelsberg, Angela; Prugger, Christof; Doshi, Peter; Ostrowski, Kerstin; Witte, Thomas; Hüsgen, Dieter; Keil, Ulrich

    2017-02-07

     To investigate the practice of post-marketing studies in Germany during a three year period and to evaluate whether these trials meet the aims specified in the German Medicinal Products Act.  Survey of notifications submitted to German regulatory agencies before post-marketing studies were carried out, 2008-10.  Notifications obtained through freedom of information requests to the three authorities responsible for registering post-marketing studies in Germany.  Descriptive statistics of post-marketing studies, including the products under study, intended number of patients, intended number of participating physicians, proposed remunerations, study plan and protocol, and availability of associated scientific publications and reports on adverse drug reactions.  Information was obtained from 558 studies, with a median of 600 (mean 2331, range 2-75 000) patients and 63 (270, 0-7000) participating physicians per study. The median remuneration to physicians per patient was €200 (€441, €0-€7280) (£170, £0-£6200; $215, $0-$7820), with a total remuneration cost of more than €217m for 558 studies registered over the three year period. The median remuneration per participating physician per study was €2000 (mean €19 424), ranging from €0 to €2 080 000. There was a broad range of drugs and non-drug products, of which only a third represented recently approved drugs. In many notifications, data, information, and results were, by contract, strictly confidential and the sole property of the respective sponsor. No single adverse drug reaction report could be identified from any of the 558 post-marketing studies. Less than 1% of studies could be verified as published in scientific journals.  Post-marketing studies are not improving drug safety surveillance. Sample sizes are generally too small to allow the detection of rare adverse drug reactions, and many participating physicians are strictly obliged to maintain confidentiality towards the

  19. Non-clinical development of CER-001

    PubMed Central

    Barbaras, Ronald

    2015-01-01

    Cardiovascular disease remains the most pressing healthcare issue for the developed world and is becoming so for developing countries. There are no currently approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. High-density lipoprotein (HDL) has multiple actions that could lead to plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature through the process of reverse lipid transport, improvement in endothelial function, protection against oxidative damage, and reduction in inflammation. Short-term infusion of HDL-mimetics in animal models as well as in humans has shown promising effects on the plaque size and morphology. Cerenis Therapeutics has developed CER-001, a negatively charged lipoprotein complex consisting of phospholipid and recombinant human apoA-I that mimics the structure and function of natural HDL. Three clinical trials using CER-001 infusions have demonstrated improvements in the carotid wall thickness of patients with familial hypercholesterolaemia and in patients with hypo-alphalipoproteinaemia, as well as an impact on coronary plaque burden measured by intravascular ultrasonography at the lowest tested dose (3 mg/kg) in post-ACS patients. Here, we reviewed the non-clinical data leading to the demonstration that CER-001 is a full HDL mimetic. PMID:26500552

  20. Post-marketing surveillance of the safety of cimetidine: twelve-month morbidity report.

    PubMed

    Colin Jones, D G; Langman, M J; Lawson, D H; Vessey, M P

    1985-03-01

    A total of 9928 patients taking cimetidine and 9351 controls were included in a post-marketing drug surveillance study in Glasgow, Nottingham, Oxford and Portsmouth; 98.8 per cent of the takers and 97.7 per cent of the controls were successfully followed up for at least one year during which hospital visits and deaths were recorded. Methods of identification of subjects and 12-month mortality results have been reported previously. A general analysis of the morbidity experienced by these patients during the study year is presented here. Thirty-nine per cent of takers and 21 per cent of controls were seen at outpatient clinics, and 18 per cent of takers and 8 per cent of controls were admitted to hospital; 15 325 individual diagnoses in takers and 5002 diagnoses in controls were reviewed. An association with cimetidine treatment was found, as expected, for gastrointestinal diseases. Weaker associations were found for haematological disorders, some tumours, infections, disorders of the locomotor system and respiratory diseases. Detailed examination revealed that these were mainly due to confounding from several sources, for example, from the underlying cause of the dyspepsia which resulted in cimetidine use, from the higher level of physician contact in cimetidine takers, and smoking. The scheme successfully detected and quantified some already known adverse effects of cimetidine and did not detect any new effects. It is concluded that this method of collecting information is feasible and useful, but several interpretive pitfalls arise, some of which can be avoided by careful analysis. No evidence of any major unrecognised risk of cimetidine treatment emerged from the study.

  1. The DELTA Network Study of Distributed Automated Post-Market Cardiovascular Device Safety Surveillance

    PubMed Central

    Kumar, Amit; Matheny, Michael E.; Ho, Kalon K.L.; Yeh, Robert W.; Piemonte, Thomas C.; Waldman, Howard; Shah, Pinak B.; Cope, Richard; Normand, Sharon-Lise; Donnelly, Sharon; Robbins, Susan; Resnic, Frederic S.

    2016-01-01

    Background Current approaches for post-market medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates. Methods and Results The DELTA (Data Extraction and Longitudinal Trend Analysis) network study was a multicenter prospective observational study designed to evaluate the safety of devices used during percutaneous coronary interventions (PCI). All adult patients undergoing PCI from January 2008 through December 2012 at five participating Massachusetts sites were included. A safety alert was triggered if the cumulative observed adverse event rates for the study device exceeded the upper 95% confidence interval of the event rates of propensity-matched control cohort. Pre-specified sensitivity analyses were developed to validate any identified safety signal. A total of 23,805 consecutive PCI procedures were evaluated. Two out of 24 safety analyses triggered safety alerts. Patients receiving Perclose vascular closure device (VCD) experienced an increased risk of minor vascular complications (relative risk [RR] 4.14; p <0.01) and any vascular complication (RR: 2.06; p = 0.01) as compared with propensity-matched patients receiving alternative VCD; a result primarily driven by relatively high event rates at one participating center. Sensitivity analyses based on alternative risk adjustment methods confirmed the a pattern of increased rate of complications at one of the five participating sites in their use of Perclose VCD. Conclusions The DELTA network study demonstrates that distributed automated prospective safety surveillance has the potential of providing near real-time assessment of safety risks of newly approved medical devices. PMID:25491915

  2. Environmental change challenges decision-making during post-market environmental monitoring of transgenic crops.

    PubMed

    Sanvido, Olivier; Romeis, Jörg; Bigler, Franz

    2011-12-01

    The ability to decide what kind of environmental changes observed during post-market environmental monitoring of genetically modified (GM) crops represent environmental harm is an essential part of most legal frameworks regulating the commercial release of GM crops into the environment. Among others, such decisions are necessary to initiate remedial measures or to sustain claims of redress linked to environmental liability. Given that consensus on criteria to evaluate 'environmental harm' has not yet been found, there are a number of challenges for risk managers when interpreting GM crop monitoring data for environmental decision-making. In the present paper, we argue that the challenges in decision-making have four main causes. The first three causes relate to scientific data collection and analysis, which have methodological limits. The forth cause concerns scientific data evaluation, which is controversial among the different stakeholders involved in the debate on potential impacts of GM crops on the environment. This results in controversy how the effects of GM crops should be valued and what constitutes environmental harm. This controversy may influence decision-making about triggering corrective actions by regulators. We analyse all four challenges and propose potential strategies for addressing them. We conclude that environmental monitoring has its limits in reducing uncertainties remaining from the environmental risk assessment prior to market approval. We argue that remaining uncertainties related to adverse environmental effects of GM crops would probably be assessed in a more efficient and rigorous way during pre-market risk assessment. Risk managers should acknowledge the limits of environmental monitoring programmes as a tool for decision-making.

  3. Preliminary Results From the C-Pulse® OPTIONS HF European Multicenter Post-Market Study

    PubMed Central

    Schulz, Antonia; Krabatsch, Thomas; Schmitto, Jan D.; Hetzer, Roland; Seidel, Mirko; Dohmen, Pascal M.; Hotz, Holger

    2016-01-01

    Background The C-Pulse® System is an extra-aortic balloon counterpulsation device. It is used to treat patients with heart failure disease in NYHA functional class III or ambulatory class IV. Material/Methods We present preliminary site-reported 6-month data from 3 centers in Germany as part of the prospective observational post-market OPTIONS HF study. Results Between May 2013 and March 2014, the C-Pulse System was implanted in 8 patients (7 male) with a mean age of 61.6±9.3 years. Four had ischemic and 4 had non-ischemic cardiomyopathy. No stroke, myocardial infarction, major bleeding, or major infection due to the device were reported. One patient developed non-device-related refractory tachycardia with worsening heart failure 12 h after surgery and underwent left ventricular assist device implantation. Within 6 months of observation, functional status improved from NYHA III to II in 5 patients, and 2 remained in NYHA III. Mean left ventricular ejection fraction increased from 24.3±7.9% to 44.5±4.5% (p<0.0001). Mean Kansas City Cardiomyopathy Questionnaire overall score improved from 28.6±19.1 to 59.1±22.5 (p=0.0183). Six-minute walk test was performed in 6 out of 7 patients at follow-up. The mean distance improved from 252.0±85.1 m to 279.2±87.5 m (p>0.05). One patient was weaned off the device after 6 months of support. Conclusions The C-Pulse System provides a therapeutic option for patients with moderate-to-severe heart failure and seems to improve quality of life and cardiac function over time. PMID:26887528

  4. Safety of the long-acting neuraminidase inhibitor laninamivir octanoate hydrate in post-marketing surveillance.

    PubMed

    Kashiwagi, Seizaburo; Yoshida, Sanae; Yamaguchi, Hiroki; Niwa, Shinpei; Mitsui, Noriko; Tanigawa, Masatoshi; Shiosakai, Kazuhito; Yamanouchi, Naoki; Shiozawa, Tomoo; Yamaguchi, Fumie

    2012-11-01

    Laninamivir octanoate hydrate (laninamivir) is a long-acting neuraminidase inhibitor (NAI) that completes treatment with only a single inhalation. It was launched in Japan in October 2010 as an anti-influenza agent. A post-marketing surveillance study was conducted in the 2010/2011 influenza season to assess the safety of this drug in clinical settings. Adverse drug reactions (ADRs) were observed in 50 patients (59 events) out of 3542 patients subjected to safety evaluation (incidence 1.41%). Commonly reported ADRs were psychiatric disorders (abnormal behaviour, etc.), gastrointestinal disorders (diarrhoea, nausea, etc.) and nervous system disorders (dizziness, etc.), with incidences of 0.48% (n=17), 0.45% (n=16) and 0.17% (n=6), respectively. No serious ADRs occurred. ADRs usually emerged on the day on which laninamivir was inhaled (52.5%) and ADRs emerged within 3 days after inhalation in >90% of adversely affected patients. ADRs resolved or improved within 3 days in >85% of patients. The incidence of adverse events involving abnormal behaviour was 3.1% (30/959) among patients <10 years of age, 0.7% (8/1088) among patients aged 10-19 years, 0.1% (2/1431) among adult patients aged 20-64 years and 0.0% (0/64) among patients aged ≥65 years. It was confirmed that laninamivir is unlikely to cause delayed ADRs or a prolonged duration of ADRs despite this drug being a long-acting NAI. Furthermore, the incidence of ADRs was not found to have increased compared with that observed during clinical trials, and the types of ADR observed during this study were similar to those previously observed. Thus, laninamivir octanoate hydrate was confirmed to have no noticeable problem with safety. Copyright © 2012 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

  5. [Application of nested case-control study on safe evaluation of post-marketing traditional Chinese medicine injection].

    PubMed

    Xiao, Ying; Zhao, Yubin; Xie, Yanming

    2011-10-01

    The nested case-control study design (or the case-control in a cohort study) is described here as a new study design used in safe evaluation of post-marketing traditional Chinese medicine injection. In the nested case-control study, cases of a disease that occur in a defined cohort are identified and, for each, a specified number of matched controls is selected from among those in the cohort who have not developed the disease by the time of disease occurrence in the case. For many research questions, the nested case-control design potentially offers impressive reductions in costs and efforts of data collection and analysis compared with the full cohort approach, with relatively minor loss in statistical efficiency. The nested case-control design is particularly advantageous for studies in safe evaluation of post-marketing traditional Chinese medicine injection. Some examples of the application of nested case-control study were given.

  6. Regulations and guidelines should be strengthened urgently for re-evaluation on post-marketing medicines in China.

    PubMed

    Xie, Yan-Ming; Tian, Feng

    2013-07-01

    This paper reviewed the situation of regulations and guidelines on post-marketing medicines in the developed countries and in China. The developed countries have accumulated a lot of empirical principles and techniques on postmarketing surveillance (also named pharmacovigilance), therefore, their regulation systems are nearly perfect. In China, the regulations on post-marketing re-evaluation and relative technical guidelines do not cover the whole aspects, even lack in some important aspects, and long-term risk management mechanisms have not been established. So it is urgent to establish new regulations and improve the regulatory system in China based on the existing regulations and guidelines, by learning from the ideas of foreign advanced regulations, then fully integrating them with China's actual conditions, and cooperating with multidisciplinary researchers.

  7. Serious adverse events after HPV vaccination: a critical review of randomized trials and post-marketing case series.

    PubMed

    Martínez-Lavín, Manuel; Amezcua-Guerra, Luis

    2017-07-20

    This article critically reviews HPV vaccine serious adverse events described in pre-licensure randomized trials and in post-marketing case series. HPV vaccine randomized trials were identified in PubMed. Safety data were extracted. Post-marketing case series describing HPV immunization adverse events were reviewed. Most HPV vaccine randomized trials did not use inert placebo in the control group. Two of the largest randomized trials found significantly more severe adverse events in the tested HPV vaccine arm of the study. Compared to 2871 women receiving aluminum placebo, the group of 2881 women injected with the bivalent HPV vaccine had more deaths on follow-up (14 vs. 3, p = 0.012). Compared to 7078 girls injected with the 4-valent HPV vaccine, 7071 girls receiving the 9-valent dose had more serious systemic adverse events (3.3 vs. 2.6%, p = 0.01). For the 9-valent dose, our calculated number needed to seriously harm is 140 (95% CI, 79-653). The number needed to vaccinate is 1757 (95% CI, 131 to infinity). Practically, none of the serious adverse events occurring in any arm of both studies were judged to be vaccine-related. Pre-clinical trials, post-marketing case series, and the global drug adverse reaction database (VigiBase) describe similar post-HPV immunization symptom clusters. Two of the largest randomized HPV vaccine trials unveiled more severe adverse events in the tested HPV vaccine arm of the study. Nine-valent HPV vaccine has a worrisome number needed to vaccinate/number needed to harm quotient. Pre-clinical trials and post-marketing case series describe similar post-HPV immunization symptoms.

  8. Safety and efficacy of gadoteric acid in pediatric magnetic resonance imaging: overview of clinical trials and post-marketing studies.

    PubMed

    Balassy, Csilla; Roberts, Donna; Miller, Stephen F

    2015-11-01

    Gadoteric acid is a paramagnetic gadolinium macrocyclic contrast agent approved for use in MRI of cerebral and spinal lesions and for body imaging. To investigate the safety and efficacy of gadoteric acid in children by extensively reviewing clinical and post-marketing observational studies. Data were collected from 3,810 children (ages 3 days to 17 years) investigated in seven clinical trials of central nervous system (CNS) imaging (n = 141) and six post-marketing observational studies of CNS, musculoskeletal and whole-body MR imaging (n = 3,669). Of these, 3,569 children were 2-17 years of age and 241 were younger than 2 years. Gadoteric acid was generally administered at a dose of 0.1 mmol/kg. We evaluated image quality, lesion detection and border delineation, and the safety of gadoteric acid. We also reviewed post-marketing pharmacovigilance experience. Consistent with findings in adults, gadoteric acid was effective in children for improving image quality compared with T1-W unenhanced sequences, providing diagnostic improvement, and often influencing the therapeutic approach, resulting in treatment modifications. In studies assessing neurological tumors, gadoteric acid improved border delineation, internal morphology and contrast enhancement compared to unenhanced MR imaging. Gadoteric acid has a well-established safety profile. Among all studies, a total of 10 children experienced 20 adverse events, 7 of which were thought to be related to gadoteric acid. No serious adverse events were reported in any study. Post-marketing pharmacovigilance experience did not find any specific safety concern. Gadoteric acid was associated with improved lesion detection and delineation and is an effective and well-tolerated contrast agent for use in children.

  9. [Results of a post-marketing surveillance of meropenem administered over 2 g/day for serious infectious diseases].

    PubMed

    Wakisaka, Koji; Tani, Shunsuke; Ishibashi, Kazuo; Nukui, Kazuhiko; Nagao, Munehiko

    2015-10-01

    The post-marketing surveillance of meropenem (Meropen®) administered over 2g/day for serious infectious diseases was conducted between August 2011 and June 2013 to evaluate safety and efficacy under actual clinical use. There were 382 and 322 evaluable cases for safety and efficacy respectively, of 399 case cards collected from 87 institutions. In safety analysis, the incidence of adverse drug reactions (ADRs) associated with use of meropenem (including abnormal laboratory findings) was 19.1% (73/382 cases), and the main ADRs were hepatic function abnormal, aspartate aminotransferase increased, alanine aminotransferase increased, liver disorder, and diarrhoea, which were similar to these observed in the post-marketing surveillances of meropenem conducted before. In efficacy analysis, the efficacy was 73.6% (237/322 cases), which is as same as 71.4% (3214/4504 cases) of post-marketing surveillance of meropenem conducted after first approval under 2 g/day for infectious diseases. These results confirmed meropenem (Meropen®) is one of the useful antimicrobial agents for serious infectious diseases.

  10. Nationwide survey on informed consent and ethical review at hospitals conducting post-marketing studies sponsored by pharmaceutical companies.

    PubMed

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2017-09-25

      Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice.   We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  11. Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk.

    PubMed

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-07-08

    Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent's management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as "signals"), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities.

  12. Drug- and herb-induced liver injury: Progress, current challenges and emerging signals of post-marketing risk

    PubMed Central

    Raschi, Emanuel; De Ponti, Fabrizio

    2015-01-01

    Drug-induced liver injury (DILI) and herb-induced liver injury is a hot topic for clinicians, academia, drug companies and regulators, as shown by the steadily increasing number of publications in the past 15 years. This review will first provide clues for clinicians to suspect idiosyncratic (unpredictable) DILI and succeed in diagnosis. Causality assessment remains challenging and requires careful medical history as well as awareness of multifaceted aspects, especially for herbs. Drug discontinuation and therapy reconciliation remain the mainstay in patent’s management to minimize occurrence of acute liver failure. The second section will address novel agents associated with liver injury in 2014 (referred to as “signals”), especially in terms of clinical, research and drug development implications. Insights will be provided into recent trends by highlighting the contribution of different post-marketing data, especially registries and spontaneous reporting systems. This literature scrutiny suggests: (1) the importance of post-marketing databases as tools of clinical evidence to detect signals of DILI risk; and (2) the need for joining efforts in improving predictivity of pre-clinical assays, continuing post-marketing surveillance and design ad hoc post-authorization safety studies. In this context, ongoing European/United States research consortia and novel pharmaco-epidemiological tools (e.g., specialist prescription event monitoring) will support innovation in this field. Direct oral anticoagulants and herbal/dietary supplements appear as key research priorities. PMID:26167249

  13. Post-marketing research and its outcome for novel anticancer agents approved by both the FDA and EMA between 2005 and 2010: A cross-sectional study.

    PubMed

    Zeitoun, Jean-David; Baron, Gabriel; Vivot, Alexandre; Atal, Ignacio; Downing, Nicholas S; Ross, Joseph S; Ravaud, Philippe

    2017-09-20

    Post-marketing research in oncology has rarely been described. We aimed to characterize post-marketing trials for a consistent set of anticancer agents over a long period. We performed a cross-sectional analysis of post-marketing trials registered at ClinicalTrials.gov through September 2014 for novel anticancer agents approved by both the US Food and Drug Administration and the European Medicines Agency between 2005 and 2010. All relevant post-marketing trials were classified according to indication, primary outcome, starting date, sponsors, and planned enrollment. Supplemental indications were retrieved from regulatory documents and publication rate was assessed by two different methods. Ten novel anticancer agents were eligible: five were indicated for hematologic malignancies and the remaining five for solid cancers (three for kidney cancer). We identified 2345 post-marketing trials; 1362 (58.1%) targeted an indication other than the originally approved one. We observed extreme variations among drugs in both number of post-marketing trials [range 8-530] and overall population to be enrolled per trial [1-8381]. Post-marketing trials assessed almost all types of cancers, the three most frequently studied cancers being leukemia, kidney cancer and myeloma. In all, 6.6% of post-marketing trials had a clinical endpoint as a primary outcome, and 35.9% and 54.1% had a safety or surrogate endpoint, respectively, as a primary outcome. Nine drugs obtained approval for supplemental indications. The publication rate at 10 years was 12.3% to 26.1% depending on the analysis method. In conclusion, we found that post-marketing research in oncology is highly heterogeneous and the publication rate of launched trials is low. This article is protected by copyright. All rights reserved. © 2017 UICC.

  14. Levodopa therapy with entacapone in daily clinical practice: results of a post-marketing surveillance study.

    PubMed

    Kupsch, Andreas; Trottenberg, Thomas; Bremen, Dirk

    2004-01-01

    The catechol-O-methyl transferase inhibitor entacapone is given in combination with levodopa/dopa decarboxylase inhibitor for Parkinson's disease (PD) patients experiencing end-of-dose wearing-off. This 4-week post-marketing surveillance study was undertaken to assess patients' responses to levodopa combined with entacapone in a real clinical practice setting. Overall, 466 patients with idiopathic PD treated with levodopa and experiencing symptoms of wearing-off were recruited. Both physicians and patients recorded the response to therapy, including improvements and side-effects. Following initiation of entacapone treatment, the average daily levodopa dose was reduced from 510 to 453 mg. Physician assessment of entacapone efficacy was judged to be "very good" or "good" in 77.6% of the patients, and tolerability was considered to be "very good" or "good" in 92.4% of patients, with only 12 patients (2.6%) withdrawing from the study. Compared with baseline, there was a decrease in the mean duration of daily 'off' time from 3.0 to 1.3 h per day during the treatment period. Adverse events were in line with those previously reported, with diarrhoea being the most frequent event. The percentage of patients suffering from dyskinesia decreased from 46 to 34%, and of those patients still suffering from dyskinesia, the average daily duration of dyskinesia was reduced from 2.2 to 1.7 h. The use of adjunct dopamine agonists decreased from 67 to 59%. At study end, the percentage of patients who rated their quality of life (QoL) as "very good" or "good" increased from 12.1 to 51.7% and the percentage of patients who rated their QoL as "bad" or "very bad" decreased from 40 to 10.7%. In summary, the results of this survey conducted in real clinical practice support the findings of previous clinical trials demonstrating the efficacy and tolerability of entacapone, as well as the benefits of improved QoL, for patients achieved with entacapone.

  15. Post-marketing surveillance study with iodixanol in 20 185 Chinese patients from routine clinical practices.

    PubMed

    Zhang, B-C; Hou, L; Lv, B; Xu, Y-W

    2014-02-01

    To determine the incidence of immediate and delayed adverse drug reactions (ADRs), and to assess patient discomfort following administration of iodixanol during imaging examinations in routine clinical practice. A total of 20 185 patients across 95 clinical centres were enrolled in a prospective post-marketing surveillance registry with iodixanol. Patients were monitored for occurrence of ADRs immediately following iodixanol administration and for up to 7 days after administration. The overall rate of ADRs was 1.52%, of which 0.58% was immediate and 0.97% was delayed onset. Two patients had non-fatal serious ADRs (0.01%). The ADRs were significantly more common in patients who underwent contrast-enhanced CT/coronary CT angiography vs others (p < 0.001), in those receiving pre-heated iodixanol vs non-heating (p < 0.001), in those aged 70 years or younger (p < 0.001), in those in whom a power injector was used for contrast delivery (p < 0.001) and in those with a history of an allergic reaction to contrast (p = 0.024). Multivariate analysis showed that female gender, intravenous route of contrast injection, body weight ≥ 80 kg, age less than 65 years, contrast flow rate ≥ 4 ml s⁻¹ and prior reaction to iodinated contrast medium were all significant and independent contributors to ADRs. Pre-treatment contrast volume and history of cardiac disease, gout, hypertension, diabetes mellitus or asthma did not affect the rate of ADRs. Discomfort was generally mild, with 94.8% of patients reporting a composite score of 0-3. The safety of iodixanol in routine clinical practice was shown to be similar to the published safety profiles of other non-ionic iodinated contrast agents. Patient discomfort during administration was mild or absent in most patients. The major strength of this study is that it included 20 185 patients enrolled in various types of imaging examinations. The safety profile of iodixanol was comparable to previously published work.

  16. [Research on the issues in the process of post-market surveillance for medical devices based on the typical case analysis].

    PubMed

    Zhang, Sumin; Zhang, Liang

    2011-11-01

    Regarding the information collected, analysis and actions that have been taken, the issues in the process of the Post-market Surveillance for Medical Device were analyzed, and some suggestions were given at the same time.

  17. Construction and analysis of a human hepatotoxicity database suitable for QSAR modeling using post-market safety data.

    PubMed

    Zhu, Xiao; Kruhlak, Naomi L

    2014-07-03

    Drug-induced liver injury (DILI) is one of the most common drug-induced adverse events (AEs) leading to life-threatening conditions such as acute liver failure. It has also been recognized as the single most common cause of safety-related post-market withdrawals or warnings. Efforts to develop new predictive methods to assess the likelihood of a drug being a hepatotoxicant have been challenging due to the complexity and idiosyncrasy of clinical manifestations of DILI. The FDA adverse event reporting system (AERS) contains post-market data that depict the morbidity of AEs. Here, we developed a scalable approach to construct a hepatotoxicity database using post-market data for the purpose of quantitative structure-activity relationship (QSAR) modeling. A set of 2029 unique and modelable drug entities with 13,555 drug-AE combinations was extracted from the AERS database using 37 hepatotoxicity-related query preferred terms (PTs). In order to determine the optimal classification scheme to partition positive from negative drugs, a manually-curated DILI calibration set composed of 105 negatives and 177 positives was developed based on the published literature. The final classification scheme combines hepatotoxicity-related PT data with supporting information that optimize the predictive performance across the calibration set. Data for other toxicological endpoints related to liver injury such as liver enzyme abnormalities, cholestasis, and bile duct disorders, were also extracted and classified. Collectively, these datasets can be used to generate a battery of QSAR models that assess a drug's potential to cause DILI.

  18. Post-market drug evaluation research training capacity in Canada: an environmental scan of Canadian educational institutions.

    PubMed

    Wiens, Matthew O; Soon, Judith A; MacLeod, Stuart M; Sharma, Sunaina; Patel, Anik

    2014-01-01

    Ongoing efforts by Health Canada intended to modernize the legislation and regulation of pharmaceuticals will help improve the safety and effectiveness of drug products. It will be imperative to ensure that comprehensive and specialized training sites are available to train researchers to support the regulation of therapeutic products. The objective of this educational institution inventory was to conduct an environmental scan of educational institutions in Canada able to train students in areas of post-market drug evaluation research. A systematic web-based environmental scan of Canadian institutions was conducted. The website of each university was examined for potential academic programs. Six core programmatic areas were determined a priori as necessary to train competent post-market drug evaluation researchers. These included biostatistics, epidemiology, pharmacoepidemiology, health economics or pharmacoeconomics, pharmacogenetics or pharmacogenomics and patient safety/pharmacovigilance. Twenty-three academic institutions were identified that had the potential to train students in post-market drug evaluation research. Overall, 23 institutions taught courses in epidemiology, 22 in biostatistics, 17 in health economics/pharmacoeconomics, 5 in pharmacoepidemiology, 5 in pharmacogenetics/pharmacogenomics, and 3 in patient safety/pharmacovigilance. Of the 23 institutions, only the University of Ottawa offered six core courses. Two institutions offered five, seven offered four and the remaining 14 offered three or fewer. It is clear that some institutions may offer programs not entirely reflected in the nomenclature used for this review. As Heath Canada moves towards a more progressive licensing framework, augmented training to increase research capacity and expertise in drug safety and effectiveness is timely and necessary.

  19. [Taking evaluation of post-marketing as point of cut-in to promote systematic research of traditional Chinese medicine].

    PubMed

    Wang, Yong-yan; Wang, Zhi-fei; Xie, Yan-ming

    2014-09-01

    Research on post-marketing Chinese medicine should be the systematic study from application to mechanism. Clinical evaluation is the basis of mechanism study, we can find the clue from clinical evaluation, then make a mechanism study to find the reason, then apply the results to clinic. So it is a virtuous circle. In order to achieve it, we cannot be limited to traditional Chinese medicine, we should form multi-disciplinary team under the direction of grand science thinking, try hard to put industry-university-research institute collaboration association to use, and if necessary, explore the new model of the whole nation system. An appropriate operation mechanism is very important.

  20. [Guidance of FDA risk evaluation and mitigation strategy and enlightenment to drug risk management of post-marketing Chinese medicine].

    PubMed

    Li, Yuanyuan; Xie, Yanming

    2011-10-01

    The FDA risk evaluation and mitigation strategy (REMS) aims to drugs or biological products known or potential serious risk management. Analysis with the example of the content of the Onsolis REMS named FOCOS. Our country can be reference for the analysis of relevant experience and establish a scientific evaluation mechanism, strengthen the drug risk consciousness, promote the rational drug use, organic combined with the before-marketing and post-marketing evaluation of traditional Chinese medicine, and promote the evaluation of risk management of the drug development and improvement.

  1. [Skin test: guide of post-marketed re-evaluation of clinical safety in traditional Chinese medicine injection].

    PubMed

    Wei, Xu; Xie, Yanming; Wang, Yongyan

    2011-10-01

    Anaphylaxis is the most common adverse reaction caused by traditional Chinese medicine (TCM) injection, the most serious of which is type I, so post-marketed safety re-evaluation is necessary. Skin test can be used to screen type I allergy reaction, which is of great significance for TCM injection safe use. Skin test is not only able to find the population sensitization situation of TCM injection, but also is a way of understanding the mechanism of allergy reaction. TCM injection varieties that often occur type I anaphylaxis are applicable to skin test, and study population include healthy volunteers and patients whose disease is listed in the drug specification, intracutaneous test and prick test are the alternative method. The concentration of skin-test solution may influence the positive rate of skin test, penicillin skin-test solution preparation method can be used as the reference in TCM injection. Different doses of TCM injection skin-test solution,glucose injection and normal saline, histamine hydrochloride are comprised in comparison. Given the characteristics of type I allergy reaction,we should be pay close attention to skin test reaction in half an hour, and observation index need be designed based on post-marketed re-evaluation of clinical safety.

  2. Panitumumab in Japanese patients with unresectable colorectal cancer: a post-marketing surveillance study of 3085 patients.

    PubMed

    Boku, Narikazu; Sugihara, Kenichi; Kitagawa, Yuko; Hatake, Kiyohiko; Gemma, Akihiko; Yamazaki, Naoya; Muro, Kei; Hamaguchi, Tetsuya; Yoshino, Takayuki; Yana, Ikuo; Ueno, Hiroshi; Ohtsu, Atsushi

    2014-03-01

    Panitumumab was approved in Japan in April 2010 for the treatment of Kirsten rat sarcoma-2 virus oncogene wild-type unresectable and recurrent colorectal cancer. We conducted a post-marketing surveillance study to evaluate the safety and effectiveness of panitumumab. After panitumumab was commercially available in Japan, all patients to be treated with panitumumab were enrolled. Data on baseline characteristics, treatment outcome, and incidence and severity of adverse drug reactions were collected. In total, 3091 patients were registered. In the safety analysis set (n = 3085), panitumumab was administered as monotherapy (40.7%) or combination therapy (59.4%). The median treatment duration was 113 days (range: 1-559 days), and 451 (14.6%) patients received panitumumab for ≥10 months. The overall incidence rate of adverse drug reactions was 84.1%, and the most common adverse drug reaction was skin disorders (78.4%). The incidence rates (all grades) of interstitial lung disease, infusion reaction, electrolyte abnormalities and cardiac disorders were 1.3% (mortality rate: 0.6%), 1.5, 19.3 and 0.2%, respectively. The median survival time of patients treated with panitumumab monotherapy as the third-line, or later, therapy was 10.3 months. This post-marketing survey in clinical practice confirmed the safety and effectiveness of panitumumab. The benefit/risk balance for panitumumab in Japanese patients with unresectable colorectal cancer remains favorable.

  3. Nonsurgical treatment of Dupuytren's contracture: 1-year US post-marketing safety data for collagenase clostridium histolyticum.

    PubMed

    Peimer, C A; McGoldrick, C A; Fiore, G J

    2012-06-01

    Collagenase clostridium histolyticum (CCH) is a Food and Drug Administration-approved treatment for adult patients with Dupuytren's contracture with a palpable cord that has been shown efficacious and safe in clinical trials. This paper summarizes the most common post-marketing clinical adverse event (AE) reports received by the manufacturer of CCH and sponsor of the US Biologics License Application (Auxilium Pharmaceuticals, Malvern, PA, USA) during the first 12 months after drug approval and commercialization in the USA. Of the 115 AE reports describing 270 AEs voluntarily received from patients or health care providers after approximately 5,400 injections of CCH administered, the most common AEs involved local, nonserious reactions to treatment, including skin tears, peripheral edema, and contusion. There were few serious AEs observed (0.6% reporting rate per 1,000 injections), and two flexor tendon ruptures and one flexor pulley injury were reported. Analysis of post-marketing AEs received for CCH in the first year post-approval supports the safety profile reported earlier during clinical development and did not reveal additional clinical risks or concerns about CCH.

  4. The European post-marketing observational sertindole study: an investigation of the safety of antipsychotic drug treatment.

    PubMed

    Kasper, Siegfried; Möller, Hans-Jürgen; Hale, Anthony

    2010-02-01

    The objective of the European Post-marketing Observational Serdolect((R)) (EPOS) Study was to compare the safety of treatment with Serdolect (sertindole) with that of usual treatment in patients with schizophrenia, in normal European clinical practice. The EPOS was a multicentre, multinational, referenced, cohort study. Patients were enrolled at 226 centres in ten European countries. The study was prematurely terminated in 1998 as a result of the temporary market suspension of sertindole. Termination of the study reduced the number of patients recruited from the planned 12,000 to 2,321. While the power of the study was weakened, it did provide useful mortality information, which may be useful for future long-term studies. Crude mortality in the sertindole and non-sertindole groups was 1.45 (95% confidence interval, CI 0.53-3.16) and 1.50 (CI 0.72-2.76) deaths/100 patient-years exposed, respectively. There were no more cardiac deaths in the sertindole group than in the non-sertindole group. QT interval prolongation did not translate into an increased risk of death. Sertindole was well tolerated and caused few extrapyramidal symptoms. Although CIs remained large, this post-marketing study does not provide any evidence against the use of sertindole under normal conditions. Sertindole was well tolerated and posed no significant safety problems.

  5. Post-marketing surveillance of immediate allergic reactions: polygeline-based versus polygeline-free pediatric TBE vaccine.

    PubMed

    Zent, Olaf; Hennig, Renald

    2004-12-16

    Scattered cases of immediate allergic reactions occurred in the nineties after widespread use of the original (polygeline-based) pediatric tick-borne encephalitis (TBE) vaccine and were reported to Pharmacovigilance, Chiron Vaccines. Although, still indicating a very rare frequency of about two cases per 100,000 doses sold, the benefit/risk assessment resulted in its withdrawal from the market in early 1998. An intensive evaluation revealed that polygeline used as a vaccine stabilizer was the most probable cause of the reported allergic reactions. Consequently, an improved pediatric TBE vaccine, free of polygeline and other protein-derived vaccine stabilizers, was developed. A post-marketing surveillance analysis covering the first two vaccination seasons after the introduction of this new pediatric TBE vaccine in early 2002 reveals a very low reporting rate of immediate allergic reactions post immunization (within the range as noted for other widely used vaccines for childhood immunization), i.e., 0.08-0.24 cases per 100,000 doses sold depending on case definition and medical assessment. In conclusion, this analysis provides post-marketing surveillance evidence that the change in the vaccine formulation, with regards to the potential risk of immediate allergic reactions, has led to an intended improvement in the vaccine's safety profile.

  6. An Ethical Justification for Expanding the Notion of Effectiveness in Vaccine Post-Market Monitoring: Insights from the HPV Vaccine in Canada

    PubMed Central

    Komparic, Ana; Smith, Maxwell J.; Thompson, Alison

    2016-01-01

    Health regulators must carefully monitor the real-world safety and effectiveness of marketed vaccines through post-market monitoring in order to protect the public’s health and promote those vaccines that best achieve public health goals. Yet, despite the fact that vaccines used in collective immunization programmes should be assessed in the context of a public health response, post-market effectiveness monitoring is often limited to assessing immunogenicity or limited programmatic features, rather than assessing effectiveness across populations. We argue that post-market monitoring ought to be expanded in two ways to reflect a ‘public health notion of post-market effectiveness’, which incorporates normative public health considerations: (i) effectiveness monitoring should yield higher quality data and grant special attention to underrepresented and vulnerable populations; and (ii) the scope of effectiveness should be expanded to include a consideration of the various social factors that maximize (and minimize) a vaccine’s effectiveness at the population level, paying particular attention to how immunization programmes impact related health gradients. We use the case of the human papillomavirus vaccine in Canada to elucidate how expanding post-market effectiveness monitoring is necessary to close the gap between clinical practice and public health, and to ensure that vaccines are effective in a morally relevant sense. PMID:26955399

  7. Post-marketing safety monitoring of shenqifuzheng injection: a solution made of dangshen (Radix Codonopsis) and huangqi (Radix Astragali Mongolici).

    PubMed

    Ai, Qinghua; Zhang, Wen; Xie, Yanming; Huang, Wenhua; Liang, Hong; Cao, Hui

    2014-08-01

    To identify the potential risk factors associated with Shenqifuzheng injection (SFI), a solution made of Dangshen (Radix Codonopsis) and Huangqi (Radix Astragali Mongolici), for the timely provision of information to regulatory authorities. A comprehensive analysis of the production process, quality standards, pharmacology, post-marketing clinical studies, and safety evaluation using the primary literature of adverse reactions (ADR), case analyses, and systematic reviews, intensive hospital safety monitoring of post-marketing drugs, and data provided by the hospital information system (HIS). Sub-acute toxicity tests suggesting that a dose of 15 mL/kg (concentrated solution) had specific biological effects, whereas a smaller dose engendered no observable effects. Long-term toxicity testing in domestic rabbits showed that after SFI was administered for 90 days, the animals in each dosing group showed no chronic toxic reactions. Among 20 100 cases observed, the incidence of an ADR was 1.85 per thousand. From March to November 2013, of the leading institutions and 22 sub-centers involved in the post-marketing clinical safety intensive hospital monitoring, 21 units completed 8484 cases of monitoring, and reported 23 cases of adverse reactions. No damage to renal function was found using SFI at a dosage and a treatment course larger and longer than that recommended for the adjuvant treatment of tumors. This could reduce the mortality rate of admitted patients based on the analysis of the data provided by the HIS. A total of 16 clinical case reports of adverse reactions related to SFI in 1999-2012 were obtained through literature retrieval. These reports contained information concerning 17 cases, with adverse reaction symptoms including thrombocytopenia, rash, chills, feeling cold, palpitation, dyspnea, edema of a lower extremity, palpebral edema, and superficial vein inflammation, among others. This study introduces "get full access" to the flow of information on

  8. [Post-marketing clinical safety assessment of Shenmai injection based on active monitoring and passive monitoring in large data background].

    PubMed

    Wang, Lian-xin; Xie, Yan-ming; Ai, Qing-hua; Song, Nian-bin

    2015-12-01

    This paper adopted a series of related analysis methods to comprehensively analyze post-marketing clinical safety data of Shenmai injection from 4,220 cases of SRS and 32,358 cases of multicenter, prospective, registered hospital centralized monitoring in large data background, calculated ADR incidence rate was 0.93 per 1,000, main symptoms of ADR includes chest pain, chills, skin itching, palpitations, fever, nausea, dizziness, vomiting, flushing, numbness, allergic reaction, cyanosis, rash, low back pain, and "breath", "anaphylactoid reaction" and "flush" were the safety warning signals of Shenmai injection. Primary disease for chronic pulmonary heart disease, thyroid disease, and combined with cerebral vascular disease, prior to the injection and continuous use of alprostadil, cyclic adenosine monophosphate, combined with quinolones, penicillins were suspicious influence factors of ADR of Shenmai injection, these promot the clinical safety.

  9. Post-market safety warnings for drugs approved in Canada under the Notice of Compliance with conditions policy

    PubMed Central

    Lexchin, Joel

    2015-01-01

    Aims Health Canada has developed a pathway to approve drugs that have limited efficacy and safety data, the Notice of Compliance with conditions (NOC/c) policy. Increased safety reporting is required for these drugs but there has not been any systematic review of their post-market safety. This study compares safety warnings for NOC/c drugs with drugs with a priority and a standard review. Methods A list of drugs approved between January 1 1998 and March 31 2013 was developed and serious safety warnings for these drugs were identified. Drugs were put into one of three groups based on the way that they were approved. Kaplan−Meier curves were generated to examine the likelihood of NOC/c drugs receiving a serious safety warning compared with drugs with a priority and a standard review. The time spent in the review process for each of the groups was also measured. Results Compared with drugs with a priority review, NOC/c drugs were not more likely to receive a serious safety warning (P = 0.5940) but were more likely than drugs with a standard review (P = 0.0113). NOC/c drugs spent less time in the review process compared with drugs with a standard review. Conclusions Possible reasons for the increase likelihood of a serious safety warning are the limited knowledge of the safety of NOC/c drugs when they are approved and the length of time that they spend in the review process. Health Canada should consider spending longer reviewing these drugs and monitor their post-market safety more closely. PMID:25393960

  10. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data

    PubMed Central

    D’Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D’Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

    2015-01-01

    Background Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. Methods We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50μg, placebo (both delivered via the Breezhaler® device), or tiotropium 18 μg (delivered via the HandiHaler® device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA™. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. Results The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. Conclusion The overall safety profile of glycopyrronium was

  11. Technical challenges in designing post-marketing eCRFs to address clinical safety and pharmacovigilance needs.

    PubMed

    Lu, Zhengwu

    2010-01-01

    To identify key challenges and propose technical considerations in designing electronic case report form (eCRF) for post-marketing studies, the author undertakes a comprehensive literature review of peer reviewed and grey literature to assess the key aspects, processes, standards, recommendations, and best practices in designing eCRFs based on industry experience in designing and supporting electronic data capture (EDC) studies. Literature search using strings on MEDLINE and PUBMED returned few papers directly related to CRF design. Health informatics and general practice journals were searched and results reviewed. Many conference, government commission, health professional and special interests group websites provide relevant information from practical experience - summarization of this information is presented. Further, we presented a list of concrete technical considerations in dealing with EDC technology/system limitations based on literature assessment and industry implementation experience. It is recognized that cross-functional teams be involved in eCRF design process and decision making. To summarize the keys in designing eCRFs to address post-market study safety and pharmacovigilance needs, the first is to identify required data elements from the study protocol supporting data analyses and reporting requirements. Secondly, accepted best practices, CDASH & CDISC guidelines, and company internal or therapeutic unit standard should be considered and applied. Coding (MedDRA & WHODD) mapping should be managed and implemented as well when possible. Finally, we need to be on top of the EDC technologies, challenge the technologies, drive EDC improvement via working with vendors, and utilize the technologies to drive clinical effectiveness. Copyright (c) 2009 Elsevier Inc. All rights reserved.

  12. Safety evaluation of laninamivir octanoate hydrate through analysis of adverse events reported during early post-marketing phase vigilance.

    PubMed

    Nakano, Takashi; Okumura, Akihisa; Tanabe, Takuya; Niwa, Shimpei; Fukushima, Masato; Yonemochi, Rie; Eda, Hisano; Tsutsumi, Hiroyuki

    2013-06-01

    Abnormal behavior and delirium are common in children with influenza. While abnormal behavior and delirium are considered to be associated with influenza encephalopathy, an increased risk of such neuropsychiatric symptoms in patients receiving neuraminidase inhibitor treatment is suspected. Laninamivir octanoate hydrate, recently approved in Japan, is a long-acting neuraminidase inhibitor. It is important to establish a safety profile for laninamivir early, based on post-marketing experiences. Spontaneous safety reports collected in the early post-marketing phase vigilance were analyzed. Adverse events of interest such as abnormal behavior/delirium, dizziness/vertigo, respiratory disorders, shock/syncope, and any other serious events were intensively reviewed by the Safety Evaluation Committee. Abnormal behavior/delirium was a frequently reported event. Almost all the reported cases were considered to be due to influenza and not laninamivir. There were 32 cases of abnormal behavior/delirium that could lead to dangerous accidents, and these were observed more frequently in males and teenagers. Syncope probably related to the act of inhalation per se of laninamivir was reported during this survey. This safety review revealed that the safety profile of laninamivir for abnormal behavior/delirium and syncope was similar to that of other neuraminidase inhibitors. As stated in the labeling, teenage patients inhaling laninamivir should remain under constant parental supervision for at least 2 days and should be closely monitored for behavioral changes to prevent serious accidents associated with abnormal behavior/delirium. Furthermore, to avoid syncope because of inhalation, patients should be instructed to inhale in a relaxed sitting position.

  13. Safety of inhaled glycopyrronium in patients with COPD: a comprehensive analysis of clinical studies and post-marketing data.

    PubMed

    D'Urzo, Anthony D; Kerwin, Edward M; Chapman, Kenneth R; Decramer, Marc; DiGiovanni, Robert; D'Andrea, Peter; Hu, Huilin; Goyal, Pankaj; Altman, Pablo

    2015-01-01

    Chronic use of inhaled anticholinergics by patients with chronic obstructive pulmonary disease (COPD) has raised long-term safety concerns, particularly cardiovascular. Glycopyrronium is a once-daily anticholinergic with greater receptor selectivity than previously available agents. We assessed the safety of inhaled glycopyrronium using data pooled from two analysis sets, involving six clinical studies and over 4,000 patients with COPD who received one of the following treatments: glycopyrronium 50 μg, placebo (both delivered via the Breezhaler device), or tiotropium 18 μg (delivered via the HandiHaler device). Data were pooled from studies that varied in their duration and severity of COPD of the patients (ie, ≤12 weeks duration with patients having moderate or severe COPD; and >1 year duration with patients having severe and very severe COPD). Safety comparisons were made for glycopyrronium vs tiotropium or placebo. Poisson regression was used to assess the relative risk for either active drug or placebo (and between drugs where placebo was not available) for assessing the incidence of safety events. During post-marketing surveillance (PMS), safety was assessed by obtaining reports from various sources, and disproportionality scores were computed using EMPIRICA. In particular, the cardiac safety of glycopyrronium during the post-marketing phase was evaluated. The overall incidence of adverse events and deaths was similar across groups, while the incidence of serious adverse events was numerically higher in placebo. Furthermore, glycopyrronium did not result in an increased risk of cerebro-cardiovascular events vs placebo. There were no new safety reports during the PMS phase that suggested an increased risk compared to results from the clinical studies. Moreover, the cardiac safety of glycopyrronium during the PMS phase was also consistent with the clinical data. The overall safety profile of glycopyrronium was similar to its comparators indicating no

  14. All-case post-marketing surveillance of 1371 patients treated with pirfenidone for idiopathic pulmonary fibrosis.

    PubMed

    Ogura, Takashi; Azuma, Arata; Inoue, Yoshikazu; Taniguchi, Hiroyuki; Chida, Kingo; Bando, Masashi; Niimi, Yuka; Kakutani, Shinichi; Suga, Moritaka; Sugiyama, Yukihiko; Kudoh, Shoji; Nukiwa, Toshihiro

    2015-09-01

    Idiopathic pulmonary fibrosis (IPF) is a chronic fibrotic lung disease with a median survival of 2-5 years and limited treatment options. In 2008, pirfenidone became the first drug to be approved for IPF treatment in Japan. The aim of this study was to assess the safety of pirfenidone for IPF treatment in a clinical setting. We conducted a safety-oriented post-marketing surveillance of all patients with IPF who were administered pirfenidone in the first year after its launch in Japan. This was a prospective, non-interventional, observational study. Case report forms were used to collect survey data, comprising adverse events, acute exacerbations, patient demographics, concomitant drug use, and concurrent treatment data. Of the 1371 patients available for safety evaluation, two-thirds had stage III-IV disease. The incidence of total adverse drug reactions (ADRs) was 64.6%. ADRs with an incidence of ≥3% were decreased appetite, photosensitivity reaction, nausea, abdominal discomfort, malaise, somnolence, and hepatic function abnormal. This safety profile was consistent with the findings in phase II and III trials in Japan. The discontinuation rates due to adverse events at 12 months for each disease stage were similar; however, discontinuation caused by disease progression increased with disease severity. Treatment with pirfenidone stabilized both vital capacity and subjective symptoms in most patients (70-80%) treated for at least 6 months. This post-marketing surveillance in Japan showed that pirfenidone was generally well tolerated in patients with IPF, including those with severe lung function impairment. Copyright © 2015 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  15. Registries in European post-marketing surveillance: a retrospective analysis of centrally approved products, 2005-2013.

    PubMed

    Bouvy, Jacoline C; Blake, Kevin; Slattery, Jim; De Bruin, Marie L; Arlett, Peter; Kurz, Xavier

    2017-03-26

    Regulatory agencies and other stakeholders increasingly rely on data collected through registries to support their decision-making. Data from registries are a cornerstone of post-marketing surveillance for monitoring the use of medicines in clinical practice. This study was aimed at gaining further insight into the European Medicines Agency's (EMA) requests for new registries and registry studies using existing registries and to review the experience gained in their conduct. European Public Assessment Reports were consulted to identify products for which a request for a registry was made as a condition of the marketing authorisation. All centrally authorised products that received a positive opinion of the EMA Committee for Medicinal Products for Human Use between 1 January 2005 and 31 December 2013 were included. Data regarding registry design and experiences were collected from EMA electronic record keeping systems. Of 392 products that received a positive Committee for Medicinal Products for Human Use opinion during 2005-2013, 31 registries were requested for 30 products in total. Sixty-five percent were product registries whereas 35% were disease registries and 71% of the registries had a primary safety objective. Most commonly reported issues with registries were delayed time to start and low patient accrual rates. The delays found in getting new registries up and running support the need to improve the timeliness of data collection in the post-marketing setting. Methodological challenges met in conducting this study highlighted the need for a clarification of definitions and epidemiological concepts around patient registries. The results will inform the EMA Patient Registry initiative to support use of existing patient registries for the post-authorisation benefit-risk monitoring of medicinal products. © 2017 Commonwealth of Australia. Pharmacoepidemiology & Drug Safety StartCopText© 2017 John Wiley & Sons, Ltd. © 2017 Commonwealth of Australia

  16. Main Non-Clinical Factors Influencing Endodontic Referral.

    PubMed

    Broome, Joseph L

    2016-08-01

    Specialisation in endodontics allows for endodontic referrals by general dental practitioner (GDPs) and the study of factors influencing referral. These centre on a triad consisting of the referral process, non-clinical and clinical reasons for referral. Many non-clinical factors have been identified which may influence the referral process to the endodontist. A systematic review study was undertaken into the main non-clinical factors influencing endodontic referral by general dental practitioners to endodontists. Such awareness and appreciation of these factors benefits the commercial aspect of the referral practice, increases access by reducing barriers to care, and ultimately improves patient care. A literature search yielded three papers that met the eligibility criteria. All studies included were cross sectional survey studies completed by GDPs. The main non-clinical factors seen from the studies include: Availability. Personality, relationships and communication. Availability presented as a common thread throughout all the studies. In conclusion, endodontic referral is multifactorial and influenced by several factors, that are not related to the nature of the endodontic disease, and this is a dynamic process. Due to the lack of high level studies, and limitations of the available studies, further research is suggested into the relevant area of non-clinical endodontic factors for endodontic referral and thus allowing for further analysis.

  17. Commitment to health theory.

    PubMed

    Kelly, Cynthia W

    2008-01-01

    This article introduces commitment to health as a middle-range. Commitment to health (CTH) is derived from Prochaska and DiClemente's (1983) Transtheoretical Model of Behavior Change. CTH theory is designed to predict the likelihood of behavior change between the action and maintenance stages of change. Commitment is defined as a freely chosen internal resolve to perform health behaviors, even when encumbered or inconvenienced by difficulties. Health is defined as the optimal level of well-being. Commitment is an independent continuous variable, but it can be categorized into three time-oriented categories: (1) low-level, (2) middle-level, and (3) high-level commitment. The higher the level of commitment, the more likely the individual will adopt long-term behavior change. This article presents the definitions, assumptions, and relational statements of CTH.

  18. Death Anxiety in Clinical and Non-Clinical Groups

    ERIC Educational Resources Information Center

    Abdel-Khalek, Ahmed M.

    2005-01-01

    The Arabic Scale of Death Anxiety (ASDA) was administered, individually, to 7 groups (N=765) of Egyptian normal participants (non-clinical), anxiety disorder patients, and patients suffering from schizophrenia (males and females), and addicts (males only). They were generally matched as groups according to age, occupation, and education. The…

  19. Adverse event detection using the FDA post-marketing drug safety surveillance system: Cardiotoxicity associated with loperamide abuse and misuse.

    PubMed

    Swank, Kimberley A; Wu, Eileen; Kortepeter, Cindy; McAninch, Jana; Levin, Robert L

    The purpose of this investigation was to identify and characterize post-marketing reports of cardiotoxicity, including torsades de pointes (TdP), associated with loperamide use. We searched the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database for post-marketing reports of serious cardiac adverse events associated with loperamide use from December 28, 1976 (U.S. drug approval date), through December 14, 2015. We also conducted a Pubmed and Google Scholar search to identify additional published reports of cardiotoxicity associated with loperamide in the medical literature through February 11, 2016. Forty-eight cases of serious cardiac adverse events associated with loperamide use composed the case series. The most frequently reported cardiac adverse events were syncope (n = 24), cardiac arrest (n = 13), QT-interval prolongation (n = 13), ventricular tachycardia (n = 10), and TdP (n = 7). There were 10 cases that resulted in death. Of the 48 cases, the most commonly reported reasons for use can be characterized as drug abuse (n = 22) and diarrhea treatment (n = 17). More than one-half of the 48 cases were reported after 2010. Of the 22 drug abuse cases, the median daily dose was 250 mg (range 70 mg to 1600 mg) and events occurred as early as 6 hours after a dose and as long as 18 months after initiation of loperamide. Thirteen of the 22 cases reported using loperamide for euphoric or analgesic effects, and 9 reported use to prevent opioid withdrawal symptoms. The FAERS case reports provide evidence to suggest that high doses of loperamide are associated with TdP and other serious cardiac adverse events. The majority of cases in this series occurred in the setting of drug abuse for the purpose of preventing opioid withdrawal or to produce euphoric effects. It is important for both clinicians and patients to be aware of this potential risk, because prompt therapy and discontinuation of the offending agent are often essential to

  20. Safety/Tolerability and efficacy of rivastigmine in taiwanese patients with Alzheimer's disease: a prospective post-marketing surveillance study.

    PubMed

    Chiu, Pai-Yi; Dai, Dao-En; Hsu, Hai-Pei; Lee, Chao; Lin, Juei-Jueng; Kuo, Hung-Chou; Huang, Ying-Chih; Liu, Yung-Chang; Tsai, Ching-Piao

    2009-01-01

    Rivastigmine is approved for the symptomatic treatment of mild to moderate dementia in patients with Alzheimer's disease. The drug was launched in Taiwan in 2000. The primary objective of this post-marketing surveillance (PMS) study was to describe the safety/tolerability of treatment with rivastigmine capsules in patients with Alzheimer's disease. The secondary objectives of this study were to define the optimal titration pattern, maintenance dose, efficacy and patient satisfaction with treatment with rivastigmine capsules. This was a prospective, non-interventional post-marketing observational study in patients who met the criteria for mild or moderate Alzheimer's disease. The primary outcome measure for this trial was the incidence of emerging adverse events. Dosages related to titration patterns and maintenance doses were summarized. Efficacy evaluations conducted using the Mini-Mental State Examination, Clinical Dementia Rating and modified Instrumental Activities of Daily Living scales were also primary outcome measures, and results are shown descriptively. The patients' therapeutic responses to rivastigmine and satisfaction with rivastigmine were secondary outcome measures. Therapeutic response and treatment satisfaction were summarized descriptively. A total of 264 patients were enrolled into the study. The mean duration of exposure to rivastigmine during the study was 151.1 days. Patients were taking rivastigmine 1.5-6 mg twice daily and the most frequent maintenance dose level was 4.5 mg twice daily. Among patients treated with rivastigmine, all primary and secondary outcome measures showed improvement or stabilization of cognition and global functioning. Of the 253 safety analysis patients, 155 patients (61.3%) reported at least one adverse event. The most frequent adverse events by system organ class were psychiatric disorders (9.1%) and gastrointestinal disorders (8.3%). The most common adverse events observed were dizziness (5.5%), insomnia (5

  1. Post-marketing survey on clinical response to interferon beta in relapsing multiple sclerosis: the Roman experience.

    PubMed

    Pozzilli, C; Prosperini, L; Sbardella, E; De Giglio, L; Onesti, E; Tomassini, V

    2005-12-01

    Safety, tolerability and efficacy profiles of interferon beta (IFNbeta) therapy in relapsing multiple sclerosis (MS) has been widely verified both in trial settings and in daily clinical practice. However, for a variable percentage of treated patients, it remains only partially effective. In this study, we reported the post-marketing experience of the efficacy of IFNbeta therapy for a large cohort of MS patients regularly attending the MS Outpatient Clinic of "La Sapienza University" in Rome. In this cohort we also sought clinical and paraclinical variables responsible for the clinical course of MS during IFNbeta therapy. Patients that received treatment with one of the IFNbeta formulations for at least 1 year were included. Clinical outcomes (i. e., relapses and disability score) were monitored throughout the entire study period. Magnetic resonance imaging (MRI) scans were performed twice for each subject: at baseline and after 1 year of therapy. The occurrence of more than one relapse during the study period or a sustained disability progression in the Expanded Disability Status Scale (EDSS) score were considered as criteria for the definition of suboptimal clinical response to IFNbeta therapy. During IFNbeta therapy (number of patients 242, mean length of treatment 4.3+/-2.3 years) a reduction in the annualised relapse rate of 59% (p<0.001) was observed. Eighty-six patients (35%) fulfilled the criterion for defining "suboptimal responder" on the basis of relapses, and 69 (28.5%) did the same on the basis of EDSS sustained progression. Twenty-seven (11.1%) patients showed both an EDSS progression and two or more relapses. The presence of T1-enhancing lesions and new T2 hyperintense lesions on the scan performed after the first year of therapy were the best MRI features associated with both the occurrence of relapses during the treatment period (OR for enhancing lesions and relapses 3.6; OR for new T2 lesion and relapses 2.8). The present post-marketing experience

  2. The Dynamic Commitment Design.

    ERIC Educational Resources Information Center

    Grabosky, Fran

    1985-01-01

    Presents a model to remedy the problem of groups with poor cohesion, energy, and interaction. The Dynamic Commitment Design promotes group growth through the "fish-bowl" effect. Members currently committed to therapy who wish to make contact form the inner circle, while those wishing to withdraw move outside the circle. (BH)

  3. Oligonucleotide-based pharmaceuticals: Non-clinical and clinical safety signals and non-clinical testing strategies.

    PubMed

    Mustonen, Enni-Kaisa; Palomäki, Tiina; Pasanen, Markku

    2017-09-28

    Antisense oligonucleotides, short interfering RNAs (siRNAs) and aptamers are oligonucleotide-based pharmaceuticals with a promising role in targeted therapies. Currently, five oligonucleotide-based pharmaceuticals have achieved marketing authorization in Europe or USA and many more are undergoing clinical testing. However, several safety concerns have been raised in non-clinical and clinical studies. Oligonucleotides share properties with both chemical and biological pharmaceuticals and therefore they pose challenges also from the regulatory point of view. We have analyzed the safety data of oligonucleotides and evaluated the applicability of current non-clinical toxicological guidelines for assessing the safety of oligonucleotide-based pharmaceuticals. Oligonucleotide-based pharmaceuticals display a similar toxicological profile, exerting adverse effects on liver and kidney, evoking hematological alterations, as well as causing immunostimulation and prolonging the coagulation time. It is possible to extrapolate some of these effects from non-clinical studies to humans. However, evaluation strategies for genotoxicity testing of "non-natural" oligonucleotides should be revised. Additionally, the selective use of surrogates and prediction of clinical endpoints for non-clinically observed immunostimulation is complicated by its multiple potential manifestations, demanding improvements in the testing strategies. Utilizing more relevant and mechanistic-based approaches and taking better account of species differences, could possibly improve the prediction of relevant immunological/proinflammatory effects in humans. Copyright © 2017. Published by Elsevier Inc.

  4. Monitoring biomedical literature for post-market safety purposes by analyzing networks of text-based coded information.

    PubMed

    Botsis, Taxiarchis; Foster, Matthew; Kreimeyer, Kory; Pandey, Abhishek; Forshee, Richard

    2017-01-01

    Literature review is critical but time-consuming in the post-market surveillance of medical products. We focused on the safety signal of intussusception after the vaccination of infants with the Rotashield Vaccine in 1999 and retrieved all PubMed abstracts for rotavirus vaccines published after January 1, 1998. We used the Event-based Text-mining of Health Electronic Records system, the MetaMap tool, and the National Center for Biomedical Ontologies Annotator to process the abstracts and generate coded terms stamped with the date of publication. Data were analyzed in the Pattern-based and Advanced Network Analyzer for Clinical Evaluation and Assessment to evaluate the intussusception-related findings before and after the release of the new rotavirus vaccines in 2006. The tight connection of intussusception with the historical signal in the first period and the absence of any safety concern for the new vaccines in the second period were verified. We demonstrated the feasibility for semi-automated solutions that may assist medical reviewers in monitoring biomedical literature.

  5. Suspected adverse reactions to contrast media in Campania Region (Italy): results from 14 years of post-marketing surveillance.

    PubMed

    Sessa, Maurizio; Rossi, Claudia; Mascolo, Annamaria; Grassi, Enrico; Fiorentino, Sonia; Scavone, Cristina; Reginelli, Alfonso; Rotondo, Antonio; Sportiello, Liberata

    2015-01-01

    During the last years in Italy, contrast media (CM) use increased. An increase of monitoring activities on CM-induced adverse drug reaction (ADR) is necessary, also in our regional territory. The main aim of this study was to give a preliminary evaluation of all Spontaneous Reports of ADRs (SRA) attributed to CM sent to Campania Pharmacovigilance Regional Center (CRFVC) from 01 January 2001 to 31 October 2014. For each SRA we evaluated: frequency and source, ADRs onset (time to event, seriousness and outcome), socio-demographic characteristics and risk factors of cases, the most reported CM (checking for pharmacodynamic and pharmacokinetic interactions). A total of 111 SRA were sent to CRFVC; specialist in radiology was the main source of reports. Ninety-seven SRA (87.3%) were referable to hypersensitivity reactions. Thirty-four SRA (30.6%) reported serious ADRs. The most reported CM were iopamidol, gadobenic acid and gadoteric acid. We identified two SRA induced by pharmacokinetic and/or pharmacodynamic interactions. During 14 years of post-marketing surveillance, only few SRA concerning CM-induced ADRs were sent to CRFVC probably due to underreporting. We aim to improve monitoring activity on CM-induced ADRs especially in hospitals. Most reported ADR and CM were in line with current body of literature.

  6. [Safety and efficacy of docetaxel in prostate cancer patients: based on the post-marketing surveillance in Japan].

    PubMed

    Mera, Takeshi; Saijo, Nagahiro; Akaza, Hideyuki

    2012-04-01

    The safety and efficacy of docetaxel in prostate cancer were evaluated based on the results of post-marketing surveillance. 149 patients were enrolled between September 2008 and May 2010. The starting dose of docetaxel was 75 mg/m² in 53 patients(36%), 70 mg/m² in 55 (37%), and ≤ 60 mg/m² in 41(28%). The median number of treatment cycles was 8 (range, 1 to 10). There was no age difference observed in the starting doses and the treatment cycles. The most common ≥ grade 3 adverse drug reactions (ADRs) were neutropenia (71%)and leukocytopenia (51%), and they occurred more frequently in patients receiving ≥ 70 mg/m². However, the multi-variate analyses revealed that ≥ grade 3 ADRs did not correlate with the starting doses. Infection-related events (≥ grade 3) and interstitial pneumonia were observed in 15% and 1% of patients, respectively. Prostate-specific-antigen (PSA) flare appeared in 19% of 95 evaluable patients at median period of 26 days from treatment initiation. It continued with median duration of 39. 5 days. PSA response rate as defined ≥ 50% level decline was 37%(95%confidence interval: 27-47) in evaluable patients. It was low in patients receiving ≤ 60 mg/m² (18%). There was no notable difference between patients with initial dose of 75 and 70 mg/m². Further investigation for the longer term is warranted.

  7. Risk Management Post-Marketing Surveillance for the Abuse of Medications Acting on the Central Nervous System: Expert Panel Report

    PubMed Central

    Johanson, Chris-Ellyn; Balster, Robert L.; Henningfield, Jack E.; Schuster, Charles R.; Anthony, James C.; Barthwell, Andrea G.; Coleman, John J.; Dart, Richard C.; Gorodetzky, Charles W.; O’Keeffe, Charles; Sellers, Edward M.; Vocci, Frank; Walsh, Sharon L.

    2010-01-01

    The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October, 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and eleven recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized. PMID:19783383

  8. Tolerability of modified tick-borne encephalitis vaccine FSME-IMMUN "NEW" in children: results of post-marketing surveillance.

    PubMed

    Pavlova, Borislava G; Loew-Baselli, Alexandra; Fritsch, Sandor; Poellabauer, Eva Maria; Vartian, Nina; Rinke, Ingeborg; Ehrlich, Hartmut J

    2003-01-30

    A new, highly purified, inactivated tick-borne encephalitis (TBE) vaccine FSME-IMMUN "NEW" has been developed by Baxter using a production virus seed derived from chick embryo cells instead of mouse brain. In clinical trials, the vaccine was shown to be highly immunogenic and well tolerated in adults and children. Following licensure in 2001, the tolerability of half the adult dose of FSME-IMMUN "NEW" (1.2 microg antigen/0.25 ml) was investigated in a post-marketing surveillance in 1899 children aged 6 months to 12 years. Rectal body temperature was measured daily for 3 days after the first vaccination. An overall fever rate of 20.3% (95% CI=18.5; 22%) was observed, which was mostly mild in nature (>38.0 to

  9. Safety and effectiveness of certolizumab pegol in patients with rheumatoid arthritis: Interim analysis of post-marketing surveillance.

    PubMed

    Kameda, Hideto; Nishida, Keiichiro; Nannki, Toshihiro; Watanabe, Akira; Oshima, Yukiya; Momohara, Shigaki

    2017-01-01

      Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. The total period of exposure to CZP was 1313.8 patient-years (PY). AEs were reported in 658 (25.5%) patients, at an event rate (ER) of 73.68/100 PY. The most frequent serious AEs were pneumonia, herpes zoster, and interstitial lung disease, at ER per 100 PY of 2.06, 1.29, and 1.22, respectively. Mean disease activity scores at baseline, as measured by DAS28-ESR and DAS28-CRP, were 4.77 ± 1.34 and 4.21 ± 1.27, respectively. Mean changes from baseline at the last observation were -1.29 ± 1.46 and -1.30 ± 1.42, respectively. EULAR good or moderate responses were achieved in 65% of patients. Longer disease duration, prior biologics use, and treatment without MTX co-therapy were associated with EULAR no response. In this interim analysis, no new safety signals were observed. Clinical response to CZP was observed in approximately two thirds of patients.

  10. Post-marketing surveillance study of the efficacy and safety of vardenafil among patients with erectile dysfunction in primary care.

    PubMed

    Kim, C M; Kim, Y S; Sunwoo, S; Cho, B; Rho, M; Yang, Y J; Kim, C H; Shin, H C; Lee, S Y; Kim, D H

    2007-01-01

    To evaluate the safety and efficacy of vardenafil in primary care, we undertook a post-marketing surveillance study in 384 men with erectile dysfunction (ED), enrolled by 22 family physicians in Korea, from July 2004 to August 2005. Of the 384 patients enrolled, 343 (89.3%) returned for efficacy assessment and safety evaluation. Among the latter, 279 patients (81.3%) reported that their erectile function improved, 292 (92.1%) showed enhanced IIEF (International Index of Erectile Function)-5 scores and 265 (77.9%) responded that they were 'very satisfied' or 'satisfied' with vardenafil treatment. The most frequent reason for patient satisfaction with vardenafil was erectile potency (62.4%), followed by safety (42.4%), rapid onset (35.3%), adequate duration of efficacy (28.5%) and easy administration (25.9%). A total of 23 adverse events were observed in 18 patients, with the most frequent being hot flushes (3.2%), followed by headache (1.2%), nasal congestion (0.6%), color vision disturbance (0.3%), dizziness (0.3%), dry mouth (0.3%), dyspepsia (0.3%), nausea (0.3%) and diarrhea (0.3%). Only one patient discontinued vardenafil as a direct result of an adverse event. These results suggest that vardenafil prescribed by primary care physicians improved erectile function and was well tolerated by patients with ED.

  11. Can Disproportionality Analysis of Post-marketing Case Reports be Used for Comparison of Drug Safety Profiles?

    PubMed

    Michel, Christiane; Scosyrev, Emil; Petrin, Michael; Schmouder, Robert

    2017-02-21

    Clinical trials usually do not have the power to detect rare adverse drug reactions. Spontaneous adverse reaction reports as for example available in post-marketing safety databases such as the FDA Adverse Event Reporting System (FAERS) are therefore a valuable source of information to detect new safety signals early. To screen such large data-volumes for safety signals, data-mining algorithms based on the concept of disproportionality have been developed. Because disproportionality analysis is based on spontaneous reports submitted for a large number of drugs and adverse event types, one might consider using these data to compare safety profiles across drugs. In fact, recent publications have promoted this practice, claiming to provide guidance on treatment decisions to healthcare decision makers. In this article we investigate the validity of this approach. We argue that disproportionality cannot be used for comparative drug safety analysis beyond basic hypothesis generation because measures of disproportionality are: (1) missing the incidence denominators, (2) subject to severe reporting bias, and (3) not adjusted for confounding. Hypotheses generated by disproportionality analyses must be investigated by more robust methods before they can be allowed to influence clinical decisions.

  12. An update on the safety and tolerability of pimecrolimus cream 1%: evidence from clinical trials and post-marketing surveillance.

    PubMed

    Langley, Richard G B; Luger, Thomas A; Cork, Michael J; Schneider, Dirk; Paul, Carle

    2007-01-01

    In this report, we review the data on the safety and tolerability of pimecrolimus cream 1% (Elidel) from clinical trials and post-marketing surveillance in patients with atopic dermatitis. These data demonstrate that topically applied pimecrolimus is minimally absorbed through the skin and has a favourable safety margin. The most common treatment-related adverse events are transient local reactions, particularly skin burning (16.1 and 12.9 events per 1,000 patient-months of follow-up in adults and children, respectively). When compared to the vehicle, the use of pimecrolimus cream 1% is associated with an increased incidence of herpes simplex virus infections in children (relative risk: 2.5; 95% confidence interval: 1.2-5.8; p = 0.017). However, pimecrolimus cream 1% does not increase the incidence of any skin infection in comparison with moderately potent topical corticosteroids and lacks other corticosteroid-related side effects such as skin atrophy. While cases of malignancy have been reported in patients who have used pimecrolimus cream 1%, there is no clinical evidence to establish that treatment with pimecrolimus cream 1% increases the risk of malignancy. Copyright 2007 S. Karger AG, Basel.

  13. The use of existing environmental networks for the post-market monitoring of GM crop cultivation in the EU.

    PubMed

    Smets, G; Alcalde, E; Andres, D; Carron, D; Delzenne, P; Heise, A; Legris, G; Martinez Parrilla, M; Verhaert, J; Wandelt, C; Ilegems, M; Rüdelsheim, P

    2014-07-01

    The European Union (EU) Directive 2001/18/EC on the deliberate release of genetically modified organisms (GMOs) into the environment requires that both Case-Specific Monitoring (CSM) and General Surveillance (GS) are considered as post-market implementing measures. Whereas CSM is directed to monitor potential adverse effects of GMOs or their use identified in the environmental risk assessment, GS aims to detect un-intended adverse effects of GMOs or their use on human and animal health or the environment. Guidance documents on the monitoring of genetically modified (GM) plants from the Commission and EFSA clarify that, as appropriate, GS can make use of established routine surveillance practices. Networks involved in routine surveillance offer recognised expertise in a particular domain and are designed to collect information on important environmental aspects over a large geographical area. However, as the suitability of existing monitoring networks to provide relevant data for monitoring impacts of GMOs is not known, plant biotechnology companies developed an approach to describe the processes and criteria that will be used for selecting and evaluating existing monitoring systems. In this paper, the availability of existing monitoring networks for this purpose is evaluated. By cataloguing the existing environmental monitoring networks in the EU, it can be concluded that they can only be used, in the context of GMO cultivation monitoring, as secondary tools to collect baseline information.

  14. Celiac disease in non-clinical populations of Japan.

    PubMed

    Fukunaga, Mai; Ishimura, Norihisa; Fukuyama, Chika; Izumi, Daisuke; Ishikawa, Nahoko; Araki, Asuka; Oka, Akihiko; Mishiro, Tomoko; Ishihara, Shunji; Maruyama, Riruke; Adachi, Kyoichi; Kinoshita, Yoshikazu

    2017-04-07

    Celiac disease is a chronic autoimmune enteropathy caused by gluten ingestion. While its prevalence in Western countries is reported to be as high as 1%, the prevalence has not been evaluated in a large-scale study of a Japanese population. The aim of our study was to clarify the possible presence of celiac disease in a Japanese non-clinical population as well as in patients showing symptoms suggestive of the disease. Serum samples were collected from 2008 non-clinical adults and 47 patients with chronic unexplained abdominal symptoms between April 2014 and June 2016. The anti-tissue transglutaminase (TTG) immunoglobulin A antibody titer was determined as a screening test for celiac disease in all subjects, and individuals with a value of >2 U/mL subsequently underwent testing for the presence of serum endomysial IgA antibody (EMA) as confirmation. Those testing positive for EMA or with a high concentration (>10 U/mL) of TTG were further investigated by histopathological examinations of duodenal mucosal biopsy specimens and HLA typing tests. Of the 2008 non-clinical adults from whom serum samples were collected, 161 tested positive for TTG, and all tested negative for EMA. Four subjects who had a high TTG titer were invited to undergo confirmatory testing, and the histopathological results confirmed the presence of celiac disease in only a single case (0.05%). Of the 47 symptomatic patients, one (2.1%) was found to have a high TTG titer and was diagnosed with celiac disease based on duodenal histopathological findings. The presence of celiac disease in a non-clinical Japanese population was low at 0.05% and was rarely found in patients with unexplained chronic abdominal symptoms.

  15. Priming to induce paranoid thought in a non clinical population.

    PubMed

    Isnanda, Reza Giga; Brinkman, Willem-Paul; Veling, Wim; van der Gaag, Mark; Neerincx, Mark

    2013-01-01

    Freeman et al. reported that a substantial minority of the general population has paranoid thoughts while exposed in a virtual environment. This suggested that in a development phase of a virtual reality exposure system for paranoid patients initially a non-clinical sample could be used to evaluate the system's ability to induce paranoid thoughts. To increase the efficiency of such an evaluation, this paper takes the position that when appropriately primed a larger group of a non-clinical sample will display paranoid thoughts. A 2-by-2 experiment was conducted with priming for insecurity and vigilance as a within-subject factor and prior-paranoid thoughts (low or high) as a between-subjects factor. Before exposure into the virtual world, participants (n=24) were shown a video and read a text about violence or about mountain animals. While exposed, participants were asked to comment freely on their virtual environment. The results of the experiment confirmed that exposure in a virtual environment could induce paranoid thought. In addition, priming with an aim to create a feeling of insecurity and vigilance increased paranoid comments in the non-clinical group that otherwise would less often exhibit ideas of persecution.

  16. Alzheimer's: From Caring to Commitment

    MedlinePlus

    ... Current Issue Past Issues Home Current issue contents Alzheimer's: From Caring to Commitment From Caring to Commitment ... Caring to Commitment During her sister’s battle with Alzheimer’s, Anne Murphy stayed by her side and continues ...

  17. Estimating Commit Sizes Efficiently

    NASA Astrophysics Data System (ADS)

    Hofmann, Philipp; Riehle, Dirk

    The quantitative analysis of software projects can provide insights that let us better understand open source and other software development projects. An important variable used in the analysis of software projects is the amount of work being contributed, the commit size. Unfortunately, post-facto, the commit size can only be estimated, not measured. This paper presents several algorithms for estimating the commit size. Our performance evaluation shows that simple, straightforward heuristics are superior to the more complex text-analysis-based algorithms. Not only are the heuristics significantly faster to compute, they also deliver more accurate results when estimating commit sizes. Based on this experience, we design and present an algorithm that improves on the heuristics, can be computed equally fast, and is more accurate than any of the prior approaches.

  18. The safety of quetiapine: results of a post-marketing surveillance study on 1728 patients in England.

    PubMed

    Twaites, Beverley R; Wilton, Lynda V; Shakir, Saad A W

    2007-06-01

    The safety of the atypical antipsychotic quetiapine as used in general practice in England was examined by prescription-event monitoring (PEM). Patients were identified from dispensed National Health Service (NHS) prescriptions issued by general practitioners (GPs) for quetiapine between October 1997 and July 1999. The outcome data were event reports obtained by sending questionnaires ('green forms') to the prescribing doctor at Least 6 months after the first prescription for an individual patient. Green forms with clinically useful information on 1728 patients (median age 39 years (IQR 30-56); 53% female) were received. The most frequently reported event during the first month of treatment was 'drowsiness/sedation' (47; 3% cohort). This was also the most frequently reported specified adverse drug reaction (ADR) to quetiapine (7; 11% of 65 reported ADRs) and the highest reported clinical reason for stopping quetiapine (51; 6% of the 734 reported reasons for stopping). There was a low incidence of extrapyramidal disease (21 during treatment, 1% of cohort) and hyperprolactinaemia (three during treatment, 0.2%) in this study. Three cases of diabetes mellitus in this cohort were reported to be a new diagnosis. Six pregnancies were reported during treatment with quetiapine, five of which were exposed during the first trimester only. There were four Live births with no reported congenital abnormaLities. Fifty-six deaths were reported during this study (3% cohort). The most frequently reported causes of death reLated to the cardiovascular (18) and respiratory (15) systems. The results of this post-marketing surveillance study demonstrated that quetiapine is generally well-tolerated when used in general practice.

  19. Post-marketing surveillance in the published medical and grey literature for percutaneous transluminal coronary angioplasty catheters: a systematic review

    PubMed Central

    2013-01-01

    Background Post-marketing surveillance (PMS) may identify rare serious incidents or adverse events due to the long-term use of a medical device, which was not captured in the pre-market process. Percutaneous transluminal coronary angioplasty (PTCA) is a non-surgical procedure that uses a balloon-tipped catheter to enlarge a narrowed artery. In 2011, 1,942 adverse event reports related to the use of PTCA catheters were submitted to the FDA by the manufacturers, an increase from the 883 reported in 2008. The primary research objective is to conduct a systematic review of the published and grey literature published between 2007 and 2012 for the frequency of incidents, adverse events and malfunctions associated with the use of PTCA catheters in patients with coronary artery disease (CAD). Grey literature has not been commercially published. Methods We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and PubMed for medical literature on PMS for PTCA catheters in patients with CAD published between January 2007 and July 2012. We also searched the grey literature. Results This review included 11 studies. The in-hospital adverse events reported were individual cases of myocardial infarction and hematoma. In studies of patients with coronary perforation, more patients with balloon angioplasty were identified compared with patients who required stenting. Conclusions Our systematic review illustrates that the volume and quality of PMS studies associated with the use of PTCA catheters in patients with CAD are low in the published and grey literature, and may not be useful sources of information for decisions on safety. In most studies, the objectives were not to monitor the long-term safety of the use of PTCA catheters in clinical practice. Future studies can explore the strengths and limitations of PMS databases administered by regulatory authorities. PMID:24112460

  20. Pemetrexed-related interstitial lung disease reported from post marketing surveillance (malignant pleural mesothelioma/non-small cell lung cancer).

    PubMed

    Tomii, Keisuke; Kato, Terufumi; Takahashi, Masashi; Noma, Satoshi; Kobashi, Yoichiro; Enatsu, Sotaro; Okubo, Sumiko; Kobayashi, Noriko; Kudoh, Shoji

    2017-04-01

    Interstitial lung disease (ILD) is important drug related toxicity because it commonly forced to discontinue the treatment. To characterize the prevalence and patterns of pemetrexed induced ILD, an independent ILD advisory board composed of external experts performed reassessment of ILD in two post marketing surveillance (PMS) studies for malignant pleural mesothelioma (MPM) and non-small cell lung cancer (NSCLC). ILD incidences were originally 1.6% and 2.6% in 903 MPM and 683 NSCLC patients in safety analyses, respectively. Based on the reassessment by the board, the incidence was 1.1% MPM and 1.8% NSCLC. Common possible risk factors of ILD in MPM and NSCLC patients were male gender, 60 years or older age, and pre-existing ILD. Asbestosis in MPM, and smoking history in NSCLC are also considered as risk, respectively. In terms of computed tomography (CT) pattern, 7 of 10 cases in MPM patients had acute interstitial pneumonia pattern, which four were fatal. Eight of the 12 NSCLC patients had diffuse grand glass opacity, which all had recovered. Onset of ILD in MPM varied between the first and the fifth courses of pemetrexed treatment, and the latest onset was 48 days after the last administration. For NSCLC, it was between the second and the ninth course, 7 and 56 days after the last administration. The risk of pemetrexed-related ILD is similar level as other anti-cancer drugs under clinical settings. Careful observations continuously during and at least for 2 months after the last administration of pemetrexed are advised.

  1. Post-Marketing Surveillance of Fluvoxamine Maleate Used Long-Term in Patients with Social Anxiety Disorder in Japan.

    PubMed

    Asakura, Satoshi; Koyama, Tsukasa; Hosokai, Takeshi; Kawano, Hitoshi; Kajii, Yasushi

    2014-12-01

    No data on the long-term 'real-world' use of fluvoxamine for the treatment of social anxiety disorder (SAD) in Japanese patients are currently available. To evaluate the long-term safety and efficacy of fluvoxamine for SAD in the clinical setting. Japanese patients with SAD who initiated treatment with fluvoxamine were enrolled in this 53-week post-marketing survey from 407 institutions nationwide. Data including rates of adverse drug reactions (ADRs) and efficacy were collected. Overall improvement was assessed using the Clinical Global Impression for Improvement. SAD symptoms and treatment responses were assessed with the Japanese version of the Liebowitz Social Anxiety Scale. From the 1,974 patients surveyed, 1,790 and 1,504 patients were eligible for analysis of safety and efficacy, respectively. ADRs were reported in 18.2 % of patients, with nausea, somnolence, and constipation the most common. Over 50 % of these ADRs developed in the first 4 weeks of treatment. Serious ADRs were reported in 0.8 % of patients and included six cases of suicide attempt and three cases of suicidal ideation. Response to fluvoxamine was reported in 78.4 % of patients. In patients comorbid with depression, improvement in SAD symptoms with fluvoxamine treatment was significantly affected by clinical improvement in the depression. These findings support the long-term safety and efficacy of fluvoxamine in patients with SAD. Most ADRs developed during the early treatment phase, and higher doses during the later phase were not associated with an increase in ADRs.

  2. Active post-marketing surveillance of the intralesional administration of human recombinant epidermal growth factor in diabetic foot ulcers

    PubMed Central

    2013-01-01

    Background After several exploratory and confirmatory clinical trials, the intralesional administration of human recombinant epidermal growth factor (hrEGF) has been approved for the treatment of advanced diabetic foot ulcers (DFU). The aim of this work was to evaluate the effectiveness and safety of this procedure in medical practice. Methods A prospective, post-marketing active pharmacosurveillance was conducted in 41 hospitals and 19 primary care polyclinics. Patients with DFU received hrEGF, 25 or 75 μg, intralesionally 3 times per week until complete granulation of the ulcer or 8 weeks maximum, adjuvant to standard wound care. Outcomes measured were complete granulation, amputations, and adverse events (AE) during treatment; complete lesion re-epithelization and relapses in follow-up (median: 1.2; maximum 4.2 years). Results The study included 1788 patients with 1835 DFU (81% Wagner’s grades 3 or 4; 43% ischemic) treated from May 2007 to April 2010. Complete granulation was observed in 76% of the ulcers in 5 weeks (median). Ulcer non-ischemic etiology (OR: 3.6; 95% CI: 2.8-4.7) and age (1.02; 1.01-1.03, for each younger year) were the main variables with influence on this outcome. During treatment, 220 (12%) amputations (171 major) were required in 214 patients, mostly in ischemic or Wagner’s grade 3 to 5 ulcers. Re-epithelization was documented in 61% of the 1659 followed-up cases; 5% relapsed per year. AE (4171) were reported in 47% of the subjects. Mild or moderate local pain and burning sensation, shivering and chills, were 87% of the events. Serious events, not related to treatment, occurred in 1.7% of the patients. Conclusions The favorable benefit/risk balance, confirms the beneficial clinical profile of intralesional hrEGF in the treatment of DFUs. PMID:24004460

  3. Increased pain catastrophizing associated with lower pain relief during spinal cord stimulation: results from a large post-market study.

    PubMed

    Rosenberg, Jason C; Schultz, David M; Duarte, Luis E; Rosen, Steven M; Raza, Adil

    2015-06-01

    Pain catastrophizing is a negative cognitive distortion to actual or anticipated pain. Our aim was to determine if greater catastrophizing has a deleterious relationship with pain intensity and efficacy outcomes in patients receiving SCS. As part of an ongoing Institutional Review Board-approved, multi-site, single arm post-market study, 386 patients were implanted with an Eon Mini™ SCS system and had follow-up visits at 3, 6, and 12 months post-implant. Outcomes collected during the study included, but were not limited to pain intensity using the numeric rating scale (NRS), patient reported pain relief (PRP), satisfaction with their SCS system, quality of life (QOL), pain catastrophizing scale (PCS) and state-trait anxiety index (STAI). NRS scores were associated with higher PCS scores at six months (r = 0.50, p < 0.001). The PCS was a strong predictor of the NRS when controlled for known confounders. Patients with PCS ≥30 at 6-months post-implant had a lower six-month PRP (p < 0.001) and were five times more likely to report dissatisfaction with their SCS device (p < 0.001, OR = 5.46, 95% CI: 2.51-6.35). Additionally, at six months, those who were clinically catastrophizing were three times more likely to report deterioration in QOL (p < 0.002, OR = 3.12, 95% CI: 1.62-5.51). These findings were similar at the 12 months follow visit. Our results indicate that patients with greater catastrophizing, post-implant, were more likely to report higher pain intensity and lower pain relief, quality of life and satisfaction with SCS. These results indicate that associations between pain intensity and pain-related mental health may contribute to influence the overall efficacy of SCS. © 2015 International Neuromodulation Society.

  4. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study – PRIME study

    PubMed Central

    Shah, Kshitij; Chaudhari, Omvijay B; Gupta, Palash; Chaudhuri, R Hom; Kamilya, Ranjan; Kulkarni, Shreedhar S; Subbaiah, S; Sorathia, Zubair H; Billa, Gauri

    2017-01-01

    Objective To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician’s routine clinical practice. Materials and methods In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18–60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. Results A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001). The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as “very good to good”, whereas according to physician’s assessment, “very good to good” tolerability was reported in 68.27% of patients. Five (1.43 %) patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients developed three adverse reactions (burning sensation in urine, giddiness, and urine retention) other than GI events. No serious adverse drug reactions were reported during the study period. Conclusion Tramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions. PMID:28579825

  5. A Japanese post-marketing surveillance of cetuximab (Erbitux®) in patients with metastatic colorectal cancer.

    PubMed

    Ishiguro, Megumi; Watanabe, Toshiaki; Yamaguchi, Kensei; Satoh, Taroh; Ito, Hideyuki; Seriu, Taku; Sakata, Yuh; Sugihara, Kenichi

    2012-04-01

    Cetuximab (Erbitux(®)) was approved for the treatment of metastatic colorectal cancer in Japan in 2008. To verify information on the safety in practical use of cetuximab, we conducted post-marketing surveillance in accordance with the conditions for approval. All patients to be treated with cetuximab were enrolled by the central enrolment method. Data on treatment status, and incidence and severity of adverse drug reactions were collected. The target number of patients was 1800. A total of 2126 patients were enrolled from 637 institutions. Among 2006 patients analysed, 93.2% received cetuximab as third-line or later treatment. The median duration of treatment was 15.3 weeks, and 11.1% of patients received treatment for >48 weeks. The incidence of adverse drug reactions was 89.6%, of which ≥grade 3 was 21.5%. The incidence of infusion reactions was 5.7% (any grade), with 83.3% of them occurring at the first administration. The incidence of skin disorders was 83.7% (any grade), and the time to event varied for each skin disorder. The incidence of interstitial lung diseases was 1.2% (any grade). Diarrhoea and haematotoxicity scarcely occurred with cetuximab alone. In this surveillance, the incidence and categories of adverse drug reactions are not distinct from previous reports. Although most patients received cetuximab as third-line or later treatment, treatment was maintained with a median duration of 15 weeks. Cetuximab treatment in practical use is considered to be well tolerated and clinically useful in Japanese patients with metastatic colorectal cancer.

  6. Memantine effects on behaviour in moderately severe to severe Alzheimer's disease: a post-marketing surveillance study.

    PubMed

    Clerici, Francesca; Vanacore, Nicola; Elia, Antonietta; Spila-Alegiani, Stefania; Pomati, Simone; Da Cas, Roberto; Raschetti, Roberto; Mariani, Claudio

    2012-02-01

    The aim of this study is to evaluate memantine effectiveness on behavioural and psychological symptoms of dementia (BPSD) in clinical practice and to identify variables that may predict the therapy effects. The effects of memantine on behaviour were analysed in the database of a post-marketing surveillance study promoted by the Lombardy Region Health Office and involving 43 Alzheimer's disease (AD) Units. From July to December 2005, 399 moderately severe-to-severe AD patients free of cholinergic medications were enrolled, treated with memantine and followed-up for 6 months. BPSD were assessed in a subgroup of 297 patients [mean age 77 ± 8 years; 73% females; mean neuropsychiatric inventory (NPI) score 28 ± 24] for whom the 12-item NPI subscores at baseline, and at 3 and 6 months were available. The 12 BPSD were clustered as follows: affect, physical behaviour, psychosis and hypomania. The main outcome measure was the proportion of individual cluster responders at 6 months of therapy. The proportion of individual cluster responders was 30% affect, 24% physical behaviour, 29% psychosis, 27% hypomania. Patients taking 20 mg memantine daily during the study period had a statistically significant higher probability to experience behavioural improvement than those who discontinued treatment or did not complete memantine titration (affect OR 9.0; 95% CI 3.8-21.6; physical behaviour OR 17.8; 95% CI 5.9-53.6; psychosis OR 23.6; 95% CI 5.1-110.8). The logistic regression analysis was not applicable to the hypomania subsyndrome because of the low cluster prevalence. The standard 20 mg daily memantine treatment regimen was found to be associated with a modest 6-month behavioural improvement in the affect, physical behaviour and psychosis domains in 24-30% of patients.

  7. Adherence to weight loss medications; post-marketing study from HMO pharmacy data of one million individuals.

    PubMed

    Hemo, Beatriz; Endevelt, Ronit; Porath, Avi; Stampfer, Meir J; Shai, Iris

    2011-11-01

    Post-marketing data on weight-loss medications in free living population are a necessary adjunct to data from clinical trials. We conducted a population-based analysis of first-time medication users based on HMO pharmacy purchasing data serving > one million adults. During 5 years, usage of orlistat and sibutramine more than doubled and rates were higher during the months May-Aug. As compared to non-users (n = 1,038,828), annual weight-loss drug users (n = 7175) had higher women proportion, body-mass-index (BMI), bariatric surgery history, and usage of diabetes, depression, and cardiovascular medications (p < 0.001 for all). Among users, men had higher BMI (34.4 kg/m(2) vs. 32.5 kg/m(2)), prevalence of diabetes (25.4% vs. 10.7%) and heart disease (14.2% vs. 3.5%) than women. Mean duration of purchasing weight-loss medications was 2.1 months for orlistat and 2.9 months for sibutramine. Fewer than 2% completed 12 months of weight-loss medication therapy. Among the 25% who continued to purchase at least 4 months, BMI (sub-group analysis) reduced from 33.02 kg/m(2) to 32.04 kg/m(2) (p < 0.001). In a multivariate model, long-term adherence (≥ 4 months) to weight-loss medications was associated with use of sibutramine vs. orlistat (OR = 2.08; 95%CI: 1.76-2.45), and prevalence of diabetes (OR = 1.20; 95%CI: 1.01-1.25). Age, gender, and baseline BMI were not associated with long-term adherence. Usage of weight-loss drugs is higher among diabetes patients. However, the poor adherence to therapy is substantially below levels reported in clinical trials. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

  8. Post-marketing of disease modifying drugs in multiple sclerosis: an exploratory analysis of gender effect in interferon beta treatment.

    PubMed

    Trojano, M; Pellegrini, F; Paolicelli, D; Fuiani, A; Zimatore, G B; Tortorella, C; Simone, I L; Patti, F; Ghezzi, A; Portaccio, E; Rossi, P; Pozzilli, C; Salemi, G; Lugaresi, A; Bergamaschi, R; Millefiorini, E; Clerico, M; Lus, G; Vianello, M; Avolio, C; Cavalla, P; Iaffaldano, P; Direnzo, V; D'Onghia, M; Lepore, V; Livrea, P; Comi, G; Amato, M P

    2009-11-15

    There are a few and conflicting results from randomised controlled trials (RCTs) pertaining to the influence of gender in response to currently used disease modifying drugs in Multiple Sclerosis (MS). Observational studies may be especially valuable for answering effectiveness questions in subgroups not studied in RCTs. To conduct a post-marketing analysis aimed to evaluate the gender effect on Interferon beta (IFNbeta) treatment response in a cohort of relapsing (RR) MS patients. A cohort of 2570 IFNbeta-treated RRMS was prospectively followed for up to 7 years in 15 Italian MS Centers. Cox proportional hazards regression models were used to assess gender differences for risk of reaching 1st relapse and risk of progression by 1 point on Expanded Disability Status Scale (EDSS) score. Gender effects were also explored by a propensity score (PS) matching algorithm, and a tree-growing technique. The multivariate Cox Regression analyses showed that male patients had a significant (p=0.0097) lower risk for 1st relapse and a trend (p=0.0897) for a higher risk to reach 1 point EDSS progression than females. The PS matched multivariate Cox Regression confirmed these results. The RECPAM analysis showed that male sex conferred a significant reduction in the risk for 1st relapse (HR=0.86; 95% CI=0.76-0.98; p=0.0226) in the subgroup with a low pre-treatment number of bouts, and a significant increase in the risk for 1 point EDSS progression (HR=1.33; 95% CI: 1.00-1.76; p<0.05) in the subgroup with a delayed treatment, but a still young age at the start of treatment. The results of this exploratory analysis seem to suggest that male patients do not respond to IFNbeta treatment in the same way of females.

  9. Vaccine adverse events reported in post-marketing study of the Kitasato Institute from 1994 to 2004.

    PubMed

    Nakayama, Tetsuo; Onoda, Kazumasa

    2007-01-05

    General physicians, pediatricians and parents realize that serious adverse events occur with an extremely rare incidence, but have no information on the incidences of vaccine-associated adverse events. A proper understanding of vaccine adverse events would be helpful in promoting an immunization strategy. Causal association can rarely be determined in adverse events through laboratory examinations. We examined the cases reported in the post-marketing surveillance of the Kitasato Institute, categorizing them into two groups: allergic reactions and severe systemic illnesses. Anaphylactic patients with gelatin allergy after immunization with live measles, rubella and mumps monovalent vaccines have been reported since 1993, but the number of reported cases with anaphylaxis dramatically decreased after 1999 when gelatin was removed from all brands of DPT. The incidence of anaphylactic reaction was estimated to be 0.63 per million for Japanese encephalitis virus (JEV) vaccine, 0.95 for DPT and 0.68 for Influenza vaccine, but the causative component has not yet been specified. Among 67.2 million immunization practices, 6 cases with encephalitis or encephalopathy, 7 with acute disseminated encephalomyelitis (ADEM), 10 with Guillain-Barré syndrome and 12 with idiopathic thrombocytopenic purpura (ITP) were reported. The wild-type measles virus genome was detected in a patient with encephalitis and in two of four bone marrow aspirates obtained from ITP after measles vaccination. Enterovirus infection was identified in two patients after mumps vaccination (one each with encephalitis and ADEM), one patient with encephalitis after immunization with JEV vaccine, and one with aseptic meningitis after immunization with influenza vaccine. The total estimated incidence of serious neurological illness after vaccination was 0.1-0.2 per million immunization practices. We found that enterovirus or wild-type measles virus infection was coincidentally associated with vaccination in

  10. Characteristics of adverse drug reactions in a vemurafenib early post-marketing phase vigilance study in Japan.

    PubMed

    Uhara, H; Kiyohara, Y; Tsuda, A; Takata, M; Yamazaki, N

    2017-07-03

    Post-approval research or monitoring is important to determine real-world safety of new products; however, evidence is scant for vemurafenib in Japanese patients. In Japan, a unique system is officially obligated to investigate post-approval safety. Here we report the first adverse drug reaction (ADR) data from vemurafenib-treated Japanese patients with metastatic melanoma. Data were collected in an early post-marketing phase vigilance (EPPV) study. ADRs were events for which a causal relationship with vemurafenib could not be ruled out or was unknown. ADR data were collected for patients treated with vemurafenib (960 mg bid) between 26 February and 25 August 2015. Among 95 patients, 46 patients had 118 ADRs (24 serious ADRs in 13 patients). The most common serious ADRs were hypersensitivity (n = 1; 3 events), arthralgia (n = 2; 2 events), pyrexia (n = 2; 2 events) and drug eruption (n = 2; 2 events). Seven patients had serious skin disorders or hypersensitivity, six of whom had prior anti-programmed cell death-1 (PD-1) antibodies 5-35 days before starting vemurafenib. ADR reports of serious skin disorders appeared to be collected more rapidly than previously reported. Cutaneous squamous cell carcinoma developed in only one patient. EPPV in Japanese vemurafenib-treated patients identified no new safety signals. The most serious skin and hypersensitivity ADRs occurred in patients with prior anti-PD-1 exposure. Cutaneous squamous cell carcinoma appeared to be rare in Japanese patients. Further research is needed to clarify whether prior treatment with anti-PD-1 agents or racial differences affect the characteristic profile of cutaneous ADRs in Japanese patients.

  11. Durapain in symptomatic treatment of severe acute pain: a post-marketing, prospective, multicenter, observational study - PRIME study.

    PubMed

    Shah, Kshitij; Chaudhari, Omvijay B; Gupta, Palash; Chaudhuri, R Hom; Kamilya, Ranjan; Kulkarni, Shreedhar S; Subbaiah, S; Sorathia, Zubair H; Billa, Gauri

    2017-01-01

    To assess the effectiveness, overall tolerability, and gastrointestinal (GI) tolerability of Durapain (fixed dose combination of tramadol hydrochloride immediate release [50 mg] and diclofenac sodium sustained release [75 mg]) in symptomatic treatment of severe acute pain in physician's routine clinical practice. In this prospective, multicenter, observational, post-marketing study, adult patients (aged 18-60 years) with severe acute pain were treated with tramadol hydrochloride/diclofenac sodium as per approved prescribing information. Evaluation was done at base-line, day 2, and day 5. Primary end point was pain intensity difference from baseline to day 5. A total of 351 patients (mean age 44.2 years; male 43%; female 57%) were included. The mean pain score was reduced from 9.2±1.09 at baseline to 2.8±1.73 at day 5 (p<0.0001). The number of patients with severe intensity of pain reduced from 100% at baseline to 18.3% at day 2 and 6.96% at day 5. According to the patient assessment, 68.36% of patients reported tolerability as "very good to good", whereas according to physician's assessment, "very good to good" tolerability was reported in 68.27% of patients. Five (1.43 %) patients discontinued the study because of adverse drug reaction. Five patients developed nine GI-related events of moderate intensity. Two patients developed three adverse reactions (burning sensation in urine, giddiness, and urine retention) other than GI events. No serious adverse drug reactions were reported during the study period. Tramadol hydrochloride/diclofenac sodium is an effective and well-tolerated treatment in Indian patients with severe acute pain. Treatment with tramadol hydrochloride/diclofenac sodium provides significant pain relief on day 2 and maintained until day 5 without any serious adverse reactions.

  12. Safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension: Japanese post-marketing surveillance data.

    PubMed

    Yamazaki, Hiroyoshi; Kobayashi, Noriko; Taketsuna, Masanori; Tajima, Koyuki; Murakami, Masahiro

    2017-05-01

    To evaluate the long-term safety and effectiveness of tadalafil in patients with pulmonary arterial hypertension (PAH) in real-world clinical practice. This prospective, multicenter, noninterventional, post-marketing surveillance included patients with PAH who were observed for up to 2 years after initiation of tadalafil. Safety was assessed by analyzing the frequency of adverse drug reactions (ADRs), discontinuations due to adverse events (AEs), and serious adverse drug reactions (SADRs). Effectiveness measurements included the assessment of the change in World Health Organization (WHO) functional classification of PAH, 6-minute walk test, cardiac catheterization, and echocardiography. Among 1676 patients analyzed for safety, the overall incidence of ADRs was 31.2%. The common ADRs (≥1.0%) were headache (7.0%), diarrhea (1.9%), platelet count decreased (1.8%), anemia, epistaxis, and nausea (1.6% each), flushing (1.3%), hepatic function abnormal (1.1%), hot flush, and myalgia (1.0% each). The common SADRs (≥0.3%) were cardiac failure (0.7%), interstitial lung disease, worsening of PAH, and platelet count decreased (0.3% each). Among 1556 patients analyzed for effectiveness, the percentages of patients with improvement of WHO functional class at 3 months, 1 year, and 2 years after the initiation of tadalafil, and last observation were 17.1%, 24.8%, 28.9%, and 22.5%, respectively. At all observation points (except pulmonary regurgitation pressure gradient at end diastole at 3 months), the mean 6-minute walk distance, cardiac catheterization, and echocardiogram measurements showed statistically significant improvement. This surveillance demonstrated that tadalafil has favorable safety and effectiveness profiles for long-term use in patients with PAH in Japan.

  13. The clinical efficacy of a clarithromycin-based regimen for Mycobacterium avium complex disease: A nationwide post-marketing study.

    PubMed

    Kadota, Jun-Ichi; Kurashima, Atsuyuki; Suzuki, Katsuhiro

    2017-05-01

    The revised 2007 American Thoracic Society/Infectious Diseases Society of America statement recommend clarithromycin-based combination therapy for treatment of Mycobacterium avium complex lung disease and stipulates approximately 1 year of continuous treatment after bacilli negative conversion. However, supporting data are insufficient. Our objective was to obtain data on the clinical outcome of clarithromycin-based daily regimens by conducting a nationwide retrospective post-marketing study of M. avium complex lung disease. In accordance with the Japanese guidelines, patients were enrolled in this survey according to their chest radiographic findings and microbiologic test results. They were treated with a multidrug regimen including clarithromycin, rifampicin, and ethambutol (clarithromycin-based regimen) until bacilli negative conversion, and the treatment was continued for approximately 1 year after the initial conversion. Data were collected before administration, at the time of bacilli negative conversion, at the end of treatment, and at 6 months after the end of treatment. Of the 466 subjects enrolled in the study, 271 patients who received clarithromycin at 800 mg/day underwent evaluation for M. avium complex disease. The final bacilli negative conversion rate in those patients was 94.7%. The bacteriological relapse rate was 5.0% (5/100 patients). Bacteriological relapse was noted in patients treated for less than 15 months after conversion. No life-threatening or serious adverse drug reactions were observed. This study demonstrated that a clarithromycin-based daily regimen can yield a high bacteriological conversion rate in M. avium complex disease. After conversion, treatment for less than 15 months might be insufficient to prevent bacteriological relapse. Copyright © 2017 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  14. [Study on building index system of risk assessment of post-marketing Chinese patent medicine based on AHP-fuzzy neural network].

    PubMed

    Li, Yuanyuan; Xie, Yanming; Fu, Yingkun

    2011-10-01

    Currently massive researches have been launched about the safety, efficiency and economy of post-marketing Chinese patent medicine (CPM) proprietary Chinese medicine, but it was lack of a comprehensive interpretation. Establishing the risk evaluation index system and risk assessment model of CPM is the key to solve drug safety problems and protect people's health. The clinical risk factors of CPM exist similarities with the Western medicine, can draw lessons from foreign experience, but also have itself multi-factor multivariate multi-level complex features. Drug safety risk assessment for the uncertainty and complexity, using analytic hierarchy process (AHP) to empower the index weights, AHP-based fuzzy neural network to build post-marketing CPM risk evaluation index system and risk assessment model and constantly improving the application of traditional Chinese medicine characteristic is accord with the road and feasible beneficial exploration.

  15. Systematic review of reporting rates of adverse events following immunization: an international comparison of post-marketing surveillance programs with reference to China.

    PubMed

    Guo, Biao; Page, Andrew; Wang, Huaqing; Taylor, Richard; McIntyre, Peter

    2013-01-11

    China is the most populous country in the world, with an annual birth cohort of approximately 16 million, requiring an average of 500 million vaccine doses administered annually. In China, over 30 domestic and less than 10 overseas vaccine manufacturers supply over 60 licensed vaccine products, representing a growing vaccine market mainly due to recent additions to the national immunization schedule, but data on post-marketing surveillance for adverse events following immunization (AEFI) are sparse. To compare reporting rates for various categories of AEFI from China with other routine post-marketing surveillance programs internationally. Systematic review of published studies reporting rates of AEFI by vaccine, category of reaction and age from post-marketing surveillance systems in English and Chinese languages. Overall AEFI reporting rates (all vaccines, all ages) in Chinese studies were consistent with those from similar international studies elsewhere, but there was substantial heterogeneity in regional reporting rates in China (range 2.3-37.8/100,000 doses). The highest AEFI reporting rates were for diphtheria-tetanus-pertussis whole-cell (DTwP) and acellular (DTaP) vaccines (range 3.3-181.1/100,000 doses for DTwP; range 3.5-92.6/100,000 doses for DTaP), with higher median rates for DTwP than DTaP, and higher than expected rates for DTaP vaccine. Similar higher rates for DTwP and DTaP containing vaccines, and relatively lower rates for vaccines against hepatitis B virus, poliovirus, and Japanese encephalitis virus were found in China and elsewhere in the world. Overall AEFI reporting rates in China were consistent with similar post-marketing surveillance systems in other countries. Sources of regional heterogeneity in AEFI reporting rates, and their relationships to differing vaccine manufacturers versus differing surveillance practices, require further exploration. Copyright © 2012 Elsevier Ltd. All rights reserved.

  16. A driving commitment.

    PubMed

    McGuire, S

    1995-01-01

    Italy's statistics institute, ISTAT, has announced in its annual report that the number of AIDS deaths is threatening to pass the number of deaths from traffic accidents. According to ISTAT, 4,370 Italians died from AIDS in 1994, while some 6,000 died on the country's roads. The report states that AIDS is the second leading cause of death after road accidents for young males, aged 18 to 29. Three years ago, Americans made a commitment to safer automobile engineering, better highway design, and increased penalties for drunken driving; consequently reducing both the total numbers and the per-capita incidence of traffic deaths, in spite of much more driving. A similar commitment to prevention and treatment efforts could have an equally dramatic impact on the incidence of AIDS and HIV transmission in the United States. However, that commitment will not likely emerge anytime soon given Congress's current plans for the budget.

  17. Commitment to Health Scale.

    PubMed

    Kelly, Cynthia W

    2005-01-01

    The Commitment to Health Scale (CHS) was developed to predict likelihood of clients being able to permanently adopt new health-promoting behaviors. Commitment is based on the association between starting new health behaviors and long-term performance of those behaviors. The CHS evolved from an examination of Prochaska and DiClemente's Stages of Change Algorithm, Decisional Balance Scale, and Strong and Weak Principle (Velicer, Rossi, Prochaska, & DiClemente, 1996). Scale items were assessed by classical and Rasch measurement methods. The research was performed in three separate studies at various locations in the United States and included approximately 1100 subjects. A new unidimensional variable was identified called Commitment to Health. Internal consistency reliability of the scale was .94 (Cronbach's alpha). External validity and reliability were assessed based on expected and observed ordering and between known groups. Scale scores predicted self-reported health behaviors and body mass index.

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

    PubMed

    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

  19. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--II. Gram-negative bacteria].

    PubMed

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2002-02-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, penicillins, monobactams, and carbapenems. Changes in CZOP susceptibility for the bacteria were also evaluated with the bacterial resistance ratio calculated with the breakpoint MIC. Twenty-five species (3,362 strains) of Gram-negative bacteria were isolated from the clinical materials annually collected from 1996 to 2000, and consisted of Moraxella (Branhamella) catarrhalis (n = 136), Haemophilus influenzae (n = 289), Escherichia coli (n = 276), Klebsiella pneumoniae (n = 192), Klebsiella oxytoca (n = 157), Enterobacter cloacae (n = 189), Enterobacter aerogenes (n = 93), Serratia marcescens (n = 172), Serratia liquefaciens (n = 24), Citrobacter freundii (n = 177), Citrobacter koseri (n = 70), Proteus mirabilis (n = 113), Proteus vulgaris (n = 89), Morganella morganii (n = 116), Providencia spp. (n = 41), Pseudomonas aeruginosa (n = 290), Pseudomonas fluorescens (n = 56), Pseudomonas putida (n = 63), Acinetobacter baumannii (n = 146), Acinetobacter lwoffii (n = 34), Burkholderia cepacia (n = 101), Stenotrophomonas maltophilia (n = 169), Bacteroides fragilis group (n = 196), and Prevotella/Porphyromonas (n = 173). An antibacterial activity of CZOP against E. coli, K. pneumoniae, K. oxytoca, and S. marcescens was potent and consistent with or more preferable than the study results obtained until the new drug application approval. MIC90 of CZOP against M.(B.) catarrhalis, C. koseri, and P. aeruginosa was not considerably changed and consistent with the study results obtained until the new drug application approval. MIC90 of CZOP against E. cloacae, E. aerogenes, and P. mirabilis increased year by year. The increase in MIC90 of CZOP against E. aerogenes and P. mirabilis, however, was not considered to be an obvious decline in susceptibility. In

  20. Transdermal buprenorphine in clinical practice--a post-marketing surveillance study in 13,179 patients.

    PubMed

    Griessinger, Norbert; Sittl, Reinhard; Likar, Rudolf

    2005-08-01

    The objective of this post-marketing surveillance study was to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec*) under routine clinical conditions. For this open, observational study, patients with moderate to severe cancer or non-cancer pain requiring treatment with an opioid analgesic were recruited at hospitals, outpatient clinics and general practitioners' practices in Germany. Buprenorphine transdermal patches (35 microg/h, 52.5 microg/h or 70 microg/h) were prescribed at physicians' discretion in accordance with the product's Summary of Product Characteristics (SmPC). Patients assessed their pain relief as 'very good', 'good', 'satisfactory', 'poor' or 'no effect'. Investigators were instructed to report all adverse events throughout the observation period. On completion, effectiveness and tolerability were evaluated for the overall study population, cancer and non-cancer patients, and patients < 70 years and > or = 70 years. Other analyses assessed pain relief with respect to previous opioid treatment and increased patch strength, and in patients who remained on their original dose. The total observation time was 9 months, and the average individual documented treatment time was 60.8 days. A total of 13,179 patients were evaluated; 3690 (28%) with cancer pain and 9489 (72%) with non-cancer pain. The most frequent diagnoses in non-cancer patients were musculoskeletal disorders (77%) and neuropathy (23%). In the great majority of cases (78%), treatment was started with the 35 microg/h patch. The initial dose needed to be increased subsequently only in about 18% of subjects. Buprenorphine transdermal patches provided effective, sustained and dose-dependent analgesia in patients with cancer and non-cancer pain, irrespective of the patients' age or pain syndromes. Whereas good or very good pain relief was documented only for 6% of the patients with the initial assessment, this percentage increased to 71% at

  1. Prospective Observational Post-Marketing Study of Tafluprost for Glaucoma and Ocular Hypertension: Effectiveness and Treatment Persistence.

    PubMed

    Kuwayama, Yasuaki; Hashimoto, Masako; Kakegawa, Reiko; Nomura, Akio; Shimada, Fumiki

    2017-06-01

    The aim of this study was to investigate the long-term intraocular pressure (IOP)-lowering effect and safety of tafluprost, a prostaglandin analogue, in actual clinical practice and to determine persistency of tafluprost as an indicator of its benefit-risk balance. This was a large-scale, post-marketing, multicenter, non-interventional, open-label, long-term study. Patients with glaucoma or ocular hypertension who initiated tafluprost treatment were registered and prospectively observed over a 2-year period in the real-world setting in Japan. Long-term IOP and safety data were collected. Of the 4502 patients registered from 553 medical institutions, 4265 patients were analyzed. The majority of patients had normal-tension glaucoma (44.4%) and primary open-angle glaucoma (37.8%), and patients with ocular hypertension constituted 7.0%. Treatment patterns with tafluprost during the study period were as follows: naïve monotherapy (48.1%), switching monotherapy (18.4%), and concomitant therapy (33.5%). In all patients analyzed, mean IOP was significantly reduced from 18.6 ± 5.9 mmHg (month 0) to 15 mmHg or below throughout the 2-year observation period after initiation of tafluprost. Significant IOP-lowering effects were shown in various treatment patterns and disease types. Adverse reactions were observed in 795 patients (18.64%). Major adverse reactions included eyelid pigmentation, ocular hyperemia, eyelash changes, eyelid hypertrichosis, and iris hyperpigmentation. Kaplan-Meier curves showed that 84.6% and 76.1% of patients were persistent on tafluprost for 1 and 2 years, respectively, when discontinuation due to insufficient efficacy or adverse events was defined as a treatment failure event. Furthermore, among treatment-naïve patients (n = 2304), the persistency rates on tafluprost monotherapy were 77.0% for 1 year and 67.0% for 2 years. Tafluprost showed significant long-term IOP-lowering effects regardless of treatment patterns or diagnosis, with

  2. Orbitofrontal cortex volume and intrinsic religiosity in non-clinical psychosis

    PubMed Central

    Pelletier-Baldelli, Andrea; Dean, Derek J.; Lunsford-Avery, Jessica R.; Smith Watts, Ashley K.; Orr, Joseph M.; Gupta, Tina; Millman, Zachary B.; Mittal, Vijay A.

    2014-01-01

    Research indicates that religiosity plays a complex role in mental illness. Despite this link, little work has been done to clarify the role of religiosity in persons exhibiting non-clinical psychosis (NCP, individuals experiencing fleeting psychotic-like symptoms in the absence of a formal psychotic disorder). Further, there are no NCP investigations into whether abnormalities exist in brain structures that are associated with religiosity. Understanding these relationships in NCP is important to clarify the role of religiosity and brain structural anomalies in psychosis. Twenty individuals experiencing NCP and twenty controls were assessed for intrinsic religiosity (IR; motivation/commitment to religious beliefs and/or practices) using a well-validated self-report scale. Structural magnetic resonance imaging was used to determine volumes of the orbitofrontal cortex (OFC), a critical region that has been associated with increased religiosity. Results indicate that IR is elevated in the NCP group, and that these individuals exhibit bilateral volume reduction in both the lateral and medial OFC. Sample-wide correlations are non-significant, but show notable relationships between smaller OFC regions and increased IR. Significant negative relationships were found between OFC volume and depressive and negative symptoms. Overall, results suggest that brain abnormalities associated with NCP may also confer a heightened susceptibility for religiosity. PMID:24746701

  3. Orbitofrontal cortex volume and intrinsic religiosity in non-clinical psychosis.

    PubMed

    Pelletier-Baldelli, Andrea; Dean, Derek J; Lunsford-Avery, Jessica R; Smith Watts, Ashley K; Orr, Joseph M; Gupta, Tina; Millman, Zachary B; Mittal, Vijay A

    2014-06-30

    Research indicates that religiosity plays a complex role in mental illness. Despite this link, little work has been done to clarify the role of religiosity in persons exhibiting non-clinical psychosis (NCP, individuals experiencing fleeting psychotic-like symptoms in the absence of a formal psychotic disorder). Further, there are no NCP investigations into whether abnormalities exist in brain structures that are associated with religiosity. Understanding these relationships in NCP is important to clarify the role of religiosity and brain structural anomalies in psychosis. Twenty individuals experiencing NCP and twenty controls were assessed for intrinsic religiosity (IR; motivation/commitment to religious beliefs and/or practices) using a well-validated self-report scale. Structural magnetic resonance imaging was used to determine volumes of the orbitofrontal cortex (OFC), a critical region that has been associated with increased religiosity. Results indicate that IR is elevated in the NCP group, and that these individuals exhibit bilateral volume reduction in both the lateral and medial OFC. Sample-wide correlations are non-significant, but show notable relationships between smaller OFC regions and increased IR. Significant negative relationships were found between OFC volume and depressive and negative symptoms. Overall, results suggest that brain abnormalities associated with NCP may also confer a heightened susceptibility for religiosity. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  4. Commitment to Peace.

    ERIC Educational Resources Information Center

    Montessori, Renilde

    1995-01-01

    This reprint from a 1985 issue of "The NAMTA Journal" discusses the ideas of Maria Montessori and Erich Fromm in relation to world peace and the role of education in promoting peace. Also examines the nature of conflict, war, and peace, and the need to commit oneself to peace. (MDM)

  5. Committed Sport Event Volunteers

    ERIC Educational Resources Information Center

    Han, Keunsu; Quarterman, Jerome; Strigas, Ethan; Ha, Jaehyun; Lee, Seungbum

    2013-01-01

    The purpose of this study was to investigate the relationships among selected demographic characteristics (income, education and age), motivation and commitment of volunteers at a sporting event. Three-hundred and five questionnaires were collected from volunteers in a marathon event and analyzed using structural equation modeling (SEM). Based on…

  6. Commitment to Peace.

    ERIC Educational Resources Information Center

    Montessori, Renilde

    1995-01-01

    This reprint from a 1985 issue of "The NAMTA Journal" discusses the ideas of Maria Montessori and Erich Fromm in relation to world peace and the role of education in promoting peace. Also examines the nature of conflict, war, and peace, and the need to commit oneself to peace. (MDM)

  7. The Vocational Commitment Index

    ERIC Educational Resources Information Center

    Weis, Susan F.; Hubbard, Constance F.

    1973-01-01

    The Index is the result of an effort made to examine all components of vocational commitment and to translate this information into an instrument which could be used to assess the relationship of an individual to a vocation.. The predictive ability of the 74-item device requires further research. (Author/AG)

  8. Disgust sensitivity and psychopathological symptoms in non-clinical children.

    PubMed

    Muris, Peter; van der Heiden, Simone; Rassin, Eric

    2008-06-01

    There is clear evidence in the adult literature that disgust sensitivity is implicated in various psychopathological syndromes. The current study examined the link between disgust sensitivity and psychopathological symptoms in youths. In a sample of non-clinical children aged 9-13 years, disgust sensitivity was assessed by two self-report questionnaires (i.e., the Disgust Scale and the Disgust Sensitivity Questionnaire) and a behavioural test. Furthermore, children completed scales for measuring the personality trait of neuroticism and various types of psychopathological symptoms. Results showed that disgust measures had sufficient to good convergent validity. Further, significant positive correlations were found between disgust sensitivity and symptoms of specific phobias (i.e., spider phobia, blood-injection phobia, small-animal phobia), social phobia, agoraphobia, obsessive-compulsive disorder (OCD), and eating problems, and these links were not attenuated when controlling for neuroticism. The possible role of disgust sensitivity in the aetiology of child psychopathology is discussed.

  9. From controlled to committed.

    PubMed

    Hess, J C

    1996-02-01

    Most of us agree that people are our most important resource. Yet we spend a minimal amount of time learning more about human behavior, communication, and how our attitudes and behavior impact employee performance. Instead we rely on traditional methods of negative reinforcement in an attempt to control our areas of responsibility. While these methods can render some short-term success, managers and organizations that succeed during these times of change and fierce competition will be those that take the time to understand and capture the power of a committed workforce. The committed workforce is energized, not simply compliant, as a result of having basic human needs for achievement satisfied, belonging to a group, and receiving recognition for its contributions. Committed workers typically describe the manager as one who has the ability to give them a great degree of control over their area of influence. We all know that we don't change our leadership style like we change clothes. Old habits die hard. it takes a personal commitment and lots of practice to rid outselves of habits and behavior that no longer serve our departments and facilities. This commitment, however, is crucial to survival. As managers, we must cope with increasing ambiguity and uncertainty in the workplace. To survive these challenges, we must improve our interpersonal skills and ability to successfully bring out the best in others. I believe that success will continue for managers who not only increase their knowledge and technical ability, but who also inspire their workers to move forward with a collective sense of enthusiasm and purpose.

  10. [Post-marketing surveillance of antibacterial activities of cefozopran against various clinical isolates--II. Gram-negative bacteria].

    PubMed

    Igari, Jun; Oguri, Toyoko; Hiramatsu, Nobuyoshi; Akiyama, Kazumitsu; Koyama, Tsuneo

    2003-10-01

    As a post-marketing surveillance, the in vitro antibacterial activities of cefozopran (CZOP), an agent of cephems, against various clinical isolates were yearly evaluated and compared with those of other cephems, oxacephems, carbapenems, monobactams, and penicillins. Changes in CZOP susceptibility among bacteria were also evaluated with the bacterial resistance ratio calculated from the breakpoint MIC. Twenty-five species (4,154 strains) of Gram-negative bacteria were isolated from the clinical materials annually collected from 1996 to 2001, and consisted of Moraxella (Branhamella) catarrhalis, Haemophilus influenzae, Escherichia coli, Klebsiella pneumoniae, Klebsiella oxytoca, Enterobacter cloacae, Enterobacter aerogenes, Serratia marcescens, Serratia liquefaciens, Citrobacter freundii, Citrobacter koseri, Proteus mirabilis, Proteus vulgaris, Morganella morganii, Providencia spp., Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas putida, Acinetobacter baumannii, Acinetobacter Iwoffii, Burkholderia cepacia, Stenotrophomonas maltophilia, Bacteroides fragilis group, and Prevotella/Porphyromonas. CZOP preserved its antibacterial activity against M. (B.) catarrhalis (MIC90: 4 micrograms/mL) and showed comparable activity to carbapenems against H. influenzae (MIC90: 1 microgram/mL). The antibacterial activity of CZOP against E. coli was preferable (MIC90: 0.125 microgram/mL) and comparable to those of cefpirome (CPR), cefepime (CFPM), and imipenem (IPM). The MIC90 of CZOP against K. pneumoniae and K. oxytoca was 1 and 0.25 microgram/mL, respectively. The MIC90 of CZOP against E. cloacae increased during 6 years (32 to 128 micrograms/mL). The antibacterial activity of CZOP against E. aerogenes was preferable (MIC90: 1 microgram/mL). The antibacterial activities of CZOP against S. marcescens and S. liquefaciens were relatively potent (MIC90: 0.5 and 0.25 microgram/mL) and comparable to those of CPR, CFPM, and carumonam. CZOP preserved comparable antibacterial

  11. [Discussion about relativity between post-marketed safety outcome and treatment course of traditional Chinese medicine drugs on basis of reinforced urn processes].

    PubMed

    Zhong, Cheng-Liang; Hu, Si-Yuan; Xie, Yan-Ming; Wang, Yong-Yan

    2013-09-01

    Based on relevant research and development, the possibility of applying the reinforced urn processes (RUPs) statistical approach to traditional Chinese medicine(TCM) drugs safety research is discussed in this paper, primarily through theoretical discussion and simulations. Also introduced are work flows and the key points for the application of the RUPs approach. This potentially new approach has recently been applied to the target estimation of phase I human tolerance clinical trials. A traditional RUPs approach has also been widely applied in the precise point-estimation of allowable longest treatment courses, according to the particular safety outcomes of post-marketed TCM.

  12. A post-marketing surveillance study of a human live-virus pandemic influenza A (H1N1) vaccine (Nasovac (®) ) in India.

    PubMed

    Kulkarni, Prasad S; Raut, Sidram K; Dhere, Rajeev M

    2013-01-01

    A live attenuated pandemic H1N1 influenza vaccine was developed in India. A post marketing surveillance was conducted retrospectively in healthy individuals (³ 3 years) who were vaccinated intranasally around one year before. After consent, the subjects recorded adverse events developing within 42 days. Among 7565 individuals (3 - 85 years), a total of 81 solicited adverse reactions (1%) were reported in 49 subjects (0.65%). The reactions included mild to moderate respiratory symptoms. No H1N1 case was encountered during one year postvaccination. The data show the safety of the live attenuated influenza vaccine platform developed in India.

  13. Human pregnancy safety for agents used to treat rheumatoid arthritis: adequacy of available information and strategies for developing post-marketing data

    PubMed Central

    Chambers, Christina D; Tutuncu, Zuhre N; Johnson, Diana; Jones, Kenneth L

    2006-01-01

    For female patients with rheumatoid arthritis, the availability of a host of new disease modifying antirheumatic drugs has raised important questions about fetal safety if a woman becomes pregnant while she is being treated. In addition, there is limited safety information regarding many of the older medications commonly used to treat rheumatoid arthritis in women of reproductive age. Current summary pregnancy risk information for selected medications used to treat rheumatoid arthritis is reviewed in the context of the pregnancy label category. In addition, the strengths and weaknesses of post-marketing strategies for developing new pregnancy safety information are described. PMID:16774693

  14. [Standard Cancer Therapy Are Established by the Investigator-Initiated Post-Marketing Clinical Trials, Not by the Indication-Directed Clinical Trials].

    PubMed

    Shimada, Yasuhiro

    2016-04-01

    The financial supports for investigator-initiated post-marketing clinical trial in clinical oncology are reduced after scandals related to the other fields of clinical trials in Japan. These clinical trials are the essential final steps of clinical development in newer cancer therapy, which should be conducted in the investigator-initiated clinical trial groups with well-organized infrastructure and continuous financial supports. The present problems are discussed and summarized. Future perspectives with the national viewpoints needed to be included the idea of "health technology assessment".

  15. A Commitment to Excellence

    PubMed Central

    Budin, Wendy C.

    2012-01-01

    In this column, the editor of The Journal of Perinatal Education describes two international credentialing programs, the Magnet Recognition Program and the Baby-Friendly Hospital Initiative. Both require an ongoing commitment to excellence. The editor also describes the contents of this issue, which offer a broad range of resources, research, and inspiration for childbirth educators in their efforts to promote, support, and protect natural, safe, and healthy birth. Wendy C. BudinEditor

  16. Robust relativistic bit commitment

    NASA Astrophysics Data System (ADS)

    Chakraborty, Kaushik; Chailloux, André; Leverrier, Anthony

    2016-12-01

    Relativistic cryptography exploits the fact that no information can travel faster than the speed of light in order to obtain security guarantees that cannot be achieved from the laws of quantum mechanics alone. Recently, Lunghi et al. [Phys. Rev. Lett. 115, 030502 (2015), 10.1103/PhysRevLett.115.030502] presented a bit-commitment scheme where each party uses two agents that exchange classical information in a synchronized fashion, and that is both hiding and binding. A caveat is that the commitment time is intrinsically limited by the spatial configuration of the players, and increasing this time requires the agents to exchange messages during the whole duration of the protocol. While such a solution remains computationally attractive, its practicality is severely limited in realistic settings since all communication must remain perfectly synchronized at all times. In this work, we introduce a robust protocol for relativistic bit commitment that tolerates failures of the classical communication network. This is done by adding a third agent to both parties. Our scheme provides a quadratic improvement in terms of expected sustain time compared with the original protocol, while retaining the same level of security.

  17. 24 CFR 200.46 - Commitment issuance.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DEVELOPMENT GENERAL INTRODUCTION TO FHA PROGRAMS Requirements for Application, Commitment, and Endorsement... Eligibility Requirements for Existing Projects Commitment Applications § 200.46 Commitment issuance....

  18. Assessment and non-clinical impact of medical devices.

    PubMed

    Dervaux, Benoît; Szwarcensztein, Karine; Josseran, Anne; Barna, Alexandre; Carbonneil, Cédric; Chevrie, Karine; Debroucker, Frédérique; Grumblat, Anne; Grumel, Olivier; Massol, Jacques; Maugendre, Philippe; Méchin, Hubert; Orlikowski, David; Roussel, Christophe; Rumeau-Pichon, Catherine; Sales, Jean-Patrick; Vicaut, Eric

    2015-01-01

    Medical devices (MDs) cover a wide variety of products. They accompany changes in medical practice in step with technology innovations. Innovations in the field of MDs can improve the conditions of use of health technology and/or modify the organisation of care beyond the strict diagnostic or therapeutic benefit for the patients. However, these non purely clinical criteria seem to be only rarely documented or taken into account in the assessment of MDs during reimbursement decisions at national level or for formulary listing by hospitals even though multidimensional models for the assessment of health technologies have been developed that take into account the views of all stakeholders in the healthcare system In this article, after summarising the background concerning the assessment of health technologies in France, a definition of non-clinical criteria for the assessment of MDs is proposed and a decision tree for the assessment of MDs is described. Future lines of approach are proposed as a conclusion. © 2015 Société Française de Pharmacologie et de Thérapeutique.

  19. Striatal Abnormalities and Spontaneous Dyskinesias in Non-Clinical Psychosis

    PubMed Central

    Mittal, Vijay A.; Orr, Joseph M.; Turner, Jessica A.; Pelletier, Andrea L.; Dean, Derek J.; Lunsford-Avery, Jessica; Gupta, Tina

    2013-01-01

    Background Accumulating evidence suggests that individuals experiencing non-clinical psychosis (NCP) represent a critical group for improving understanding of etiological factors underlying the broader psychosis continuum. Although a wealth of evidence supports widespread neural dysfunction in formal psychosis, there has been little empirical evidence to support our understanding of putative vulnerability markers or brain structure in NCP. In this study, we examined the neural correlates of spontaneous movement abnormalities, a neural biomarker previously detected in NCP that is linked to abnormalities in the striatal dopamine. Methods We screened a total of 1,285 adolescents/young adults, and those scoring in the upper 15 percentile on a NCP scale were invited to participate; 20 of those invited agreed and these individuals were matched with healthy controls. Participants were administered a structural scan, clinical interviews, and an instrumental motor assessment. Results The NCP group showed elevated force variability, smaller putamen (but not caudate), and there was a significant relationship between motor dysfunction and striatal abnormalities for the sample. Elevated force variability was associated with both higher positive and negative symptoms, and there was a strong trend (p=.06) to suggest that smaller left putamen volumes were associated with elevated positive symptoms. Conclusions The results are among the first to suggest an association between neural structure and a risk marker in NCP. Findings indicate that vulnerabilities seen in schizophrenia also characterize the lower end of the psychosis spectrum. PMID:24156901

  20. Impaired conscious memory in non-clinical schizotypy.

    PubMed

    Stefaniak, Nicolas; Giot, Coralie; Terrien, Sarah; Besche-Richard, Chrystel

    2015-01-01

    Impaired controlled and preserved/enhanced automatic memory processes have been reported in schizotypy. This memory pattern has been considered as a marker of vulnerability to schizophrenia. Our aim was to further explore this memory pattern in non-clinical schizotypy in order to determine which specific dimensions of schizotypy (i.e., positive, negative or disorganised), and more specifically which components of the dimensions, are most closely related to memory dysfunctions. Fifty-seven undergraduate students performed a category-production task. This was adapted for use with the process dissociation procedure in order to dissociate between automatic and controlled memory processes. The level of schizotypy was assessed using the Schizotypal Personality Questionnaire. Regression analyses confirmed that controlled memory processes decreased as schizotypy increased. The positive factors (more specifically, the ideas of reference subscale) and disorganised factors (more specifically, the odd or eccentric behaviour subscale) were negatively correlated with the controlled memory processes. Our study supports the idea that impaired controlled processes are an early cognitive marker of vulnerability to schizophrenia and confirm that the disorganised factor contributes the most to vulnerability to memory dysfunction. It also emphasises the importance of dissociating between each of the features characterising schizotypy rather than considering it as a whole.

  1. Non-Clinical Safety Evaluation of Intranasal Iota-Carrageenan

    PubMed Central

    Hebar, Alexandra; Koller, Christiane; Seifert, Jan-Marcus; Chabicovsky, Monika; Bodenteich, Angelika; Bernkop-Schnürch, Andreas; Grassauer, Andreas; Prieschl-Grassauer, Eva

    2015-01-01

    Carrageenan has been widely used as food additive for decades and therefore, an extended oral data set is available in the public domain. Less data are available for other routes of administration, especially intranasal administration. The current publication describes the non-clinical safety and toxicity of native (non-degraded) iota-carrageenan when applied intranasally or via inhalation. Intranasally applied iota-carrageenan is a topically applied, locally acting compound with no need of systemic bioavailability for the drug’s action. Animal experiments included repeated dose local tolerance and toxicity studies with intranasally applied 0.12% iota-carrageenan for 7 or 28 days in New Zealand White rabbits and nebulized 0.12% iota-carrageenan administered to F344 rats for 7 days. Permeation studies revealed no penetration of iota-carrageenan across nasal mucosa, demonstrating that iota-carrageenan does not reach the blood stream. Consistent with this, no relevant toxic or secondary pharmacological effects due to systemic exposure were observed in the rabbit or rat repeated dose toxicity studies. Data do not provide any evidence for local intolerance or toxicity, when carrageenan is applied intranasally or by inhalation. No signs for immunogenicity or immunotoxicity have been observed in the in vivo studies. This is substantiated by in vitro assays showing no stimulation of a panel of pro-inflammatory cytokines by iota-carrageenan. In conclusion, 0.12% iota-carrageenan is safe for clinical use via intranasal application. PMID:25875737

  2. Organizational commitment of military physicians.

    PubMed

    Demir, Cesim; Sahin, Bayram; Teke, Kadir; Ucar, Muharrem; Kursun, Olcay

    2009-09-01

    An individual's loyalty or bond to his or her employing organization, referred to as organizational commitment, influences various organizational outcomes such as employee motivation, job satisfaction, performance, accomplishment of organizational goals, employee turnover, and absenteeism. Therefore, as in other sectors, employee commitment is crucial also in the healthcare market. This study investigates the effects of organizational factors and personal characteristics on organizational commitment of military physicians using structural equation modeling (SEM) on a self-report, cross-sectional survey that consisted of 635 physicians working in the 2 biggest military hospitals in Turkey. The results of this study indicate that professional commitment and organizational incentives contribute positively to organizational commitment, whereas conflict with organizational goals makes a significantly negative contribution to it. These results might help develop strategies to increase employee commitment, especially in healthcare organizations, because job-related factors have been found to possess greater impact on organizational commitment than personal characteristics.

  3. Commitment and energy conservation

    SciTech Connect

    Pallak, M.S.; Cook, D.A.; Sullivan, J.J.

    1980-01-01

    The authors discuss the process of becoming committed to energy conservation research, then describe practical issues of field research and several data sets on household energy conservation. Their results show that taking a stand affected behavior in reducing the levels of natural gas and electricity usage, with the effect continuing even after the study ended. Although based on the assumption that homeowners were initially favorable toward energy conservation, the studies suggest that energy-related behavior is malleable and amenable to approaches familiar to psychologists. The study indicates that feedback on energy use during peak seasons could help to avoid power shortages. 16 references, 6 tables.

  4. [Acceptance and commitment therapy].

    PubMed

    Ducasse, D; Fond, G

    2015-02-01

    Acceptance and commitment therapy (ACT) is a third generation of cognitive-behavioral therapies. The point is to help patients to improve their psychological flexibility in order to accept unavoidable private events. Thus, they have the opportunity to invest energy in committed actions rather than struggle against their psychological events. (i) To present the ACT basic concepts and (ii) to propose a systematic review of the literature about effectiveness of this kind of psychotherapy. (i) The core concepts of ACT come from Monestès (2011), Schoendorff (2011), and Harris (2012); (ii) we conducted a systematic review of the literature using the PRISMA's criteria. The research paradigm was « acceptance and commitment therapy AND randomized controlled trial ». The bases of the MEDLINE, Cochrane and Web of science have been checked. Overall, 61 articles have been found, of which, after reading the abstracts, 40 corresponded to the subject of our study. (I) Psychological flexibility is established through six core ACT processes (cognitive defusion, acceptance, being present, values, committed action, self as context), while the therapist emphasizes on experiential approach. (II) Emerging research shows that ACT is efficacious in the psychological treatment of a wide range of psychiatric problems, including psychosis, depression, obsessive-compulsive disorder, trichotillomania, generalized anxiety disorder, post-traumatic stress disorder, borderline personality disorder, eating disorders. ACT has also shown a utility in other areas of medicine: the management chronic pain, drug-dependence, smoking cessation, the management of epilepsy, diabetic self-management, the management of work stress, the management of tinnitus, and the management of multiple sclerosis. Meta-analysis of controlled outcome studies reported an average effect size (Cohen's d) of 0.66 at post-treatment (n=704) and 0.65 (n=580) at follow-up (on average 19.2 weeks later). In studies involving

  5. Experimental unconditionally secure bit commitment

    NASA Astrophysics Data System (ADS)

    Liu, Yang; Cao, Yuan; Curty, Marcos; Liao, Sheng-Kai; Wang, Jian; Cui, Ke; Li, Yu-Huai; Lin, Ze-Hong; Sun, Qi-Chao; Li, Dong-Dong; Zhang, Hong-Fei; Zhao, Yong; Chen, Teng-Yun; Peng, Cheng-Zhi; Zhang, Qiang; Cabello, Adan; Pan, Jian-Wei

    2014-03-01

    Quantum physics allows unconditionally secure communication between parties that trust each other. However, when they do not trust each other such as in the bit commitment, quantum physics is not enough to guarantee security. Only when relativistic causality constraints combined, the unconditional secure bit commitment becomes feasible. Here we experimentally implement a quantum bit commitment with relativistic constraints that offers unconditional security. The commitment is made through quantum measurements in two quantum key distribution systems in which the results are transmitted via free-space optical communication to two agents separated with more than 20 km. Bits are successfully committed with less than 5 . 68 ×10-2 cheating probability. This provides an experimental proof of unconditional secure bit commitment and demonstrates the feasibility of relativistic quantum communication.

  6. A unit commitment expert system

    SciTech Connect

    Mokhtari, S.; Singh, J.; Wollenberg, B.

    1987-02-01

    An expert system based consultant has been developed to assist power system operators in scheduling the operation of generating units. First, problems with existing unit commitment algorithms were identified. Then the knowledge of an experienced power system operator and a unit commitment programming expert were combined to create an expert system rule base. To use the expert system as a unit commitment consultant the operator provides information in response to questions. The expert system uses this information along with the rules either to ask for more information or to reach a conclusion. The expert system answers the most frequent questions raised by system operators and improves the unit commitment solution results by indicating how to adjust input data. It concludes the operational constraints not included in the unit commitment base algorithm and results in a more efficient program execution. Numerical examples and test results show that this approach can obtain a better and operationally more acceptable unit commitment solution.

  7. Diffuse large B-cell lymphoma associated with the use of biologic and other investigational agents: the importance of long-term post-marketing safety surveillance.

    PubMed

    Goddard, Allison; Borovicka, Judy H; West, Dennis P; Evens, Andrew M; Laumann, Anne

    2011-01-01

    This case report describes a patient who developed diffuse large B-cell lymphoma (DLBCL) after receiving courses of two investigational biologic agents and cyclosporine followed by more than four years of subcutaneous efalizumab for the treatment of extensive chronic plaque psoriasis. Three years later, the patient remains free of lymphoma and his psoriasis is well controlled with thrice-weekly narrow-band ultraviolet phototherapy. This case emphasizes the importance of continued long-term post-marketing safety surveillance and the early reporting of all possible serious side effects, including cancers, related to the use of any newly available product. In particular, surveillance should focus on the immunomodulating biologic agents in order to identify possible dangerous sequelae.

  8. [Explore method about post-marketing safety re-evaluation of Chinese patent medicines based on HIS database in real world].

    PubMed

    Yang, Wei; Xie, Yanming; Zhuang, Yan

    2011-10-01

    There are many kinds of Chinese traditional patent medicine used in clinical practice and many adverse events have been reported by clinical professionals. Chinese patent medicine's safety problems are the most concerned by patients and physicians. At present, many researchers have studied re-evaluation methods about post marketing Chinese medicine safety inside and outside China. However, it is rare that using data from hospital information system (HIS) to re-evaluating post marketing Chinese traditional patent medicine safety problems. HIS database in real world is a good resource with rich information to research medicine safety. This study planed to analyze HIS data selected from ten top general hospitals in Beijing, formed a large HIS database in real world with a capacity of 1 000 000 cases in total after a series of data cleaning and integrating procedures. This study could be a new project that using information to evaluate traditional Chinese medicine safety based on HIS database. A clear protocol has been completed as for the first step for the whole study. The protocol is as follows. First of all, separate each of the Chinese traditional patent medicines existing in the total HIS database as a single database. Secondly, select some related laboratory tests indexes as the safety evaluating outcomes, such as routine blood, routine urine, feces routine, conventional coagulation, liver function, kidney function and other tests. Thirdly, use the data mining method to analyze those selected safety outcomes which had abnormal change before and after using Chinese patent medicines. Finally, judge the relationship between those abnormal changing and Chinese patent medicine. We hope this method could imply useful information to Chinese medicine researchers interested in safety evaluation of traditional Chinese medicine.

  9. A Pharmacovigilance Approach for Post-Marketing in Japan Using the Japanese Adverse Drug Event Report (JADER) Database and Association Analysis

    PubMed Central

    Fujiwara, Masakazu; Kawasaki, Yohei; Yamada, Hiroshi

    2016-01-01

    Background Rapid dissemination of information regarding adverse drug reactions is a key aspect for improving pharmacovigilance. There is a possibility that unknown adverse drug reactions will become apparent through post-marketing administration. Currently, although there have been studies evaluating the relationships between a drug and adverse drug reactions using the JADER database which collects reported spontaneous adverse drug reactions, an efficient approach to assess the association between adverse drug reactions of drugs with the same indications as well as the influence of demographics (e.g. gender) has not been proposed. Methods and Findings We utilized the REAC and DEMO tables from the May 2015 version of JADER for patients taking antidepressant drugs (SSRI, SNRI, and NaSSA). We evaluated the associations using association analyses with an apriori algorithm. Support, confidence, lift, and conviction were used as indicators for associations. The highest score in adverse drug reactions for SSRI was obtained for "aspartate aminotransferase increased", "alanine aminotransferase increased", with values of 0.0059, 0.93, 135.5, and 13.9 for support, confidence, lift and conviction, respectively. For SNRI, "international normalized ratio increased", "drug interaction" were observed with 0.0064, 1.00, 71.9, and NA. For NaSSA, "anxiety", "irritability" were observed with 0.0058, 0.80, 49.9, and 4.9. For female taking SSRI, the highest support scores were observed in "twenties", "suicide attempt", whereas "thirties", "neuroleptic malignant syndrome" were observed for male. Second, for SNRI, "eighties", "inappropriate antidiuretic hormone secretion" were observed for female, whereas "interstitial lung disease" and "hepatitis fulminant" were for male. Finally, for NaSSA, "suicidal ideation" was for female, and "rhabdomyolysis" was for male. Conclusions Different combinations of adverse drug reactions were noted between the antidepressants. In addition, the reported

  10. Safety and effectiveness of gemcitabine in 260 patients with biliary tract cancer in a Japanese clinical practice based on post-marketing surveillance in Japan.

    PubMed

    Okubo, Sumiko; Nishiuma, Shinichi; Kobayashi, Noriko; Taketsuna, Masanori; Taniai, Hisashi

    2012-11-01

    Gemcitabine was approved for the treatment of biliary tract cancer in 2006 in Japan. While biliary tract cancer is usually associated with patients 70 years of age or older and/or those who tend to have underlying liver dysfunction, data on this population were limited in the Japanese Phase II study of gemcitabine. Thus, further evaluation of safety and effectiveness in this population was planned. This special post-marketing surveillance was conducted as an observational study on the use of gemcitabine in a clinical practice setting. Gemcitabine-naïve patients with biliary tract cancer were enrolled from 2006 to 2008 and observed over 12 months; one or more doses of gemcitabine were administered during the period. Data such as patient background, treatment details, adverse events occurring during the observational period, laboratory values of liver enzyme and survival status were collected 3 and 12 months after the start of therapy. Of the 285 patients registered for the study, 260 were included in the analysis. The mean age was 66.9 years. There were 120 patients (46.2%) classified as elderly (70 years or older). Haematotoxicities were the most common adverse drug reactions. In the elderly and the non-elderly, adverse drug reactions (serious) occurred in 48.3% (20.8%) and 50.7% (12.9%), respectively. The overall estimated 1-year survival rate was 52.5% (95% confidence interval, 45.9-58.7%). In line with previous clinical and post-marketing studies conducted in Japan, the results of this study suggest that gemcitabine could be used safely and effectively for biliary tract cancer patients including the elderly.

  11. Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 12-Month Results.

    PubMed

    Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Snyder, Scott A; Dake, Michael D

    2016-02-08

    This multicenter, prospective, post-market surveillance study in Japan evaluates the paclitaxel-coated Zilver PTX stent in real-world patients with complex lesions. The Zilver PTX stent is the first drug-eluting stent (DES) approved for the superficial femoral artery. Previously, results from a large randomized study and a complementary, large single-arm study supported the safety and effectiveness of the DES. There were no exclusion criteria, and consecutive patients with symptomatic peripheral artery disease (PAD) treated with the DES were enrolled in the study. Clinically driven target lesion revascularization (TLR) was defined as reintervention performed for ≥50% diameter stenosis after recurrent clinical symptoms of PAD. Clinical benefit was defined as freedom from persistent or worsening symptoms of ischemia. Patency was evaluated by duplex ultrasound where physicians considered this standard of care. In this study, 907 patients were enrolled at 95 institutions in Japan. There were numerous comorbidities including high incidences of diabetes (58.8%), chronic kidney disease (43.8%), and critical limb ischemia (21.5%). Lesions were also complex, with an average length of 14.7 cm, 41.6% total occlusions, and 18.6% in-stent restenosis. In total, 1,861 DES were placed in 1,075 lesions. Twelve-month follow-up was obtained for >95% of eligible patients. Freedom from TLR was 91.0%, and clinical benefit was 87.7% through 12 months. The 12-month primary patency rate was 86.4%. Despite more challenging lesions, results from the current study are similar to outcomes from the previous Zilver PTX studies, confirming the benefit of the Zilver PTX DES in a real-world patient population. (Zilver PTX Post-Market Study in Japan; NCT02254837). Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  12. The POST trial: initial post-market experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe.

    PubMed

    Tarr, Robert; Hsu, Dan; Kulcsar, Zsolt; Bonvin, Christophe; Rufenacht, Daniel; Alfke, Karsten; Stingele, Robert; Jansen, Olav; Frei, Donald; Bellon, Richard; Madison, Michael; Struffert, Tobias; Dorfler, Arnd; Grunwald, Iris Q; Reith, Wolfgang; Haass, Anton

    2010-12-01

    The purpose of this study was to assess the initial post-market experience of the device and how it is compared with the Penumbra Pivotal trial used to support the 510k application. A retrospective case review of 157 consecutive patients treated with the Penumbra system at seven international centers was performed. Primary endpoints were revascularization of the target vessel (TIMI score of 2 or 3), good functional outcome as defined by a modified Rankin scale (mRS) score of ≤2 and incidence of procedural serious adverse events. Results were compared with those of the Penumbra pivotal trial. A total of 157 vessels were treated. Mean baseline values at enrollment were: age 65 years, NIHSS score 16. After use of the Penumbra system, 87% of the treated vessels were revascularized to TIMI 2 (54%) or 3 (33%) as compared with 82% reported in the Pivotal trial. Nine procedural serious adverse events were reported in 157 patients (5.7%). All-cause mortality was 20% (32/157), and 41% had a mRS of ≤2 at 90-day follow-up as compared with only 25% in the Pivotal trial. Patients who were successfully revascularized by the Penumbra system had significantly better outcomes than those who were not. Initial post-market experience of the Penumbra system revealed that the revascularization rate and safety profile of the device are comparable to those reported in the Pivotal trial. However, the proportion of patients who had good functional outcome was higher than expected.

  13. Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study

    PubMed Central

    Zeitoun, Jean-David; Lefèvre, Jérémie H; Downing, Nicholas S; Bergeron, Henri; Ross, Joseph S

    2015-01-01

    Aims Regulatory review time has been associated with post-market medication safety issues in the United States. Our objective was to evaluate whether regulatory review time and near deadline approval are associated with post-market safety events (PMSEs) for novel medicines approved by the European Medicines Agency (EMA). Methods We performed a cross-sectional analysis of all novel medicines approved by the EMA through the centralized authorization procedure between 2001 and 2010. PMSEs were defined as withdrawals and communications identified through Dear Healthcare Professional Communications (DHPCs). Regulatory review time was defined as the time that elapsed between the start of the assessment procedure and approval. Near regulatory deadline approval was defined as approval within the 30 days before the EMA’s 210 day regulatory deadline. Results Among 161 eligible medicines, PMSEs were identified for 49 (30.4%), 44 of which were DHPCs, five of which were withdrawals. Median regulatory review time was 337 days (IQR 276–406) and was not associated with PMSEs (P = 0.57). However, when categorized by regulatory review speed tertile, there were differences in risk of PMSEs, with higher rates among medicines in the middle tertile (25 of 55, 45.4%; P = 0.01). Finally, 26 medicines were approved near the 210 day regulatory deadline, but were not more likely to have PMSEs (38.5% vs. 28.7%; P = 0.32). Conclusions Neither faster EMA regulatory review speed nor approval near regulatory deadlines was associated with greater likelihood of PMSEs among recently approved novel medicines. PMID:25808713

  14. Safety and effectiveness of tofogliflozin in elderly Japanese patients with type 2 diabetes mellitus: A post-marketing study (J-STEP/EL Study).

    PubMed

    Utsunomiya, Kazunori; Shimmoto, Naoki; Senda, Masayuki; Kurihara, Yuji; Gunji, Ryoji; Fujii, Shoko; Kakiuchi, Seigo; Fujiwara, Hisataka; Kameda, Hiroyuki; Tamura, Masahiro; Kaku, Kohei

    2017-01-20

    Although sodium-glucose cotransporter 2 inhibitors are a promising treatment for type 2 diabetes mellitus, they are associated with concerns about specific adverse drug reactions. We carried out a 1-year post-marketing study of tofogliflozin, a novel agent in this class, in Japanese elderly patients with type 2 diabetes mellitus. This was a prospective, observational and multicenter post-marketing study carried out in the context of routine clinical practice. The study included all type 2 diabetes patients aged ≥65 years who started treatment with tofogliflozin during the first 3 months after its launch on 23 May 2014. Of 1,535 patients registered, 1,507 patients whose electronic case report forms were collected and who had at least one follow-up visit were included in the safety analysis. A total of 270 of 1,507 patients (17.92%) had at least one adverse drug reaction to tofogliflozin. The incidences of adverse drug reactions of special interest, namely, polyuria/pollakiuria, volume depletion-related events, urinary tract infection, genital infection, hypoglycemia and skin disorders were 2.92, 3.85, 2.06, 1.33, 1.06 and 2.39%, respectively. Among those patients evaluable for clinical effectiveness, the mean change in glycated hemoglobin and bodyweight from baseline to last visit was -0.46% (P < 0.0001) and -2.71 kg (P < 0.0001), respectively. The present study showed that the incidence of adverse drug reactions to tofogliflozin in this study of elderly patients aged ≥65 years differed little from the incidence in the preapproval clinical trials. It was shown that tofogliflozin significantly decreased glycated hemoglobin levels. © 2017 The Authors. Journal of Diabetes Investigation published by Asian Association for the Study of Diabetes (AASD) and John Wiley & Sons Australia, Ltd.

  15. Comparative genetic characterization of Enteroaggregative Escherichia coli strains recovered from clinical and non-clinical settings

    PubMed Central

    Zhang, Rong; Gu, Dan-xia; Huang, Yong-lu; Chan, Edward Wai-Chi; Chen, Gong-Xiang; Chen, Sheng

    2016-01-01

    The origin of pathogenic Enteroaggregative Escherichia coli (EAEC), a major causative agent of childhood diarrhea worldwide, remains ill-defined. The objective of this study was to determine the relative prevalence of EAEC in clinical and non-clinical sources and compare their genetic characteristics in order to identify strains that rarely and commonly cause human diarrhea. The virulence gene astA was commonly detectable in both clinical and non-clinical EAEC, while clinical isolates, but not the non-clinical strains, were consistently found to harbor other virulence factors such as aap (32%), aatA (18%) and aggR (11%). MLST analysis revealed the extremely high diversity of EAEC ST types, which can be grouped into three categories including: (i) non-clinical EAEC that rarely cause human infections; (ii) virulent strains recoverable in diarrhea patients that are also commonly found in the non-clinical sources; (iii) organisms causing human infections but rarely recoverable in the non-clinical setting. In addition, the high resistance in these EAEC isolates in particular resistance to fluoroquinolones and cephalosporins raised a huge concern for clinical EAEC infection control. The data from this study suggests that EAEC strains were diversely distributed in non-clinical and clinical setting and some of the clinical isolates may originate from the non-clinical setting. PMID:27062991

  16. Texas hospitals share creative uses of non-clinical staff to reduce ER costs.

    PubMed

    2006-01-01

    Texas hospitals share creative uses of non-clinical staff to reduce ER costs. In central Texas, Christus Spohn Hospital and Seton Health Care are independently exploring the use of non-clinical staff to improve utilization of clinical and emergency services, but their existing programs employ different structures and outcomes measurements.

  17. 78 FR 53773 - Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-30

    ... HUMAN SERVICES Food and Drug Administration Select Updates for Non-Clinical Engineering Tests and... guidance entitled ``Select Updates for Non- Clinical Engineering Tests and Recommended Labeling for... issuing this update on select sections in order to notify the industry in a timely manner of our...

  18. Running Ahead. Enhancing Teacher Commitment.

    ERIC Educational Resources Information Center

    Graham, Kathy C.

    1996-01-01

    Workplace factors that affect teacher commitment include teacher autonomy and efficacy, participation, feedback, collaboration, learning opportunities, and resources. The paper details five strategies to help teachers enhance their personal level of commitment (being responsive, getting involved, seeking feedback, developing a plan to maximize…

  19. Organizational Climate and Teacher Commitment

    ERIC Educational Resources Information Center

    Douglas, Stephen Michael

    2010-01-01

    This study examined the relationship of school climate and teacher commitment in elementary schools in Alabama. A total of 67 elementary schools were surveyed and 1353 teachers voluntarily participated in the study. The instruments used in this study were the Organizational Climate Index (OCI) and the Organizational Commitment Questionnaire (OCQ).…

  20. Organizational Climate and Teacher Commitment

    ERIC Educational Resources Information Center

    Douglas, Stephen Michael

    2010-01-01

    This study examined the relationship of school climate and teacher commitment in elementary schools in Alabama. A total of 67 elementary schools were surveyed and 1353 teachers voluntarily participated in the study. The instruments used in this study were the Organizational Climate Index (OCI) and the Organizational Commitment Questionnaire (OCQ).…

  1. The Measurement of Organizational Commitment.

    ERIC Educational Resources Information Center

    Mowday, Richard T.; And Others

    1979-01-01

    This paper summarizes a stream of research aimed at developing and validating a measure of employee commitment to work organizations. The instrument, developed by Porter and his colleagues, is called the Organizational Commitment Questionnaire. Satisfactory test-retest reliabilities and internal consistency reliabilities were found. (Author)

  2. Experimental Unconditionally Secure Bit Commitment

    NASA Astrophysics Data System (ADS)

    Liu, Yang; Cao, Yuan; Curty, Marcos; Liao, Sheng-Kai; Wang, Jian; Cui, Ke; Li, Yu-Huai; Lin, Ze-Hong; Sun, Qi-Chao; Li, Dong-Dong; Zhang, Hong-Fei; Zhao, Yong; Chen, Teng-Yun; Peng, Cheng-Zhi; Zhang, Qiang; Cabello, Adán; Pan, Jian-Wei

    2014-01-01

    Quantum physics allows for unconditionally secure communication between parties that trust each other. However, when the parties do not trust each other such as in the bit commitment scenario, quantum physics is not enough to guarantee security unless extra assumptions are made. Unconditionally secure bit commitment only becomes feasible when quantum physics is combined with relativistic causality constraints. Here we experimentally implement a quantum bit commitment protocol with relativistic constraints that offers unconditional security. The commitment is made through quantum measurements in two quantum key distribution systems in which the results are transmitted via free-space optical communication to two agents separated with more than 20 km. The security of the protocol relies on the properties of quantum information and relativity theory. In each run of the experiment, a bit is successfully committed with less than 5.68×10-2 cheating probability. This demonstrates the experimental feasibility of quantum communication with relativistic constraints.

  3. Alcohol breeds empty goal commitments.

    PubMed

    Sevincer, A Timur; Oettingen, Gabriele

    2009-08-01

    According to alcohol-myopia theory (C. M. Steele & R. A. Josephs, 1990), alcohol leads individuals to disproportionally focus on the most salient aspects of a situation and to ignore peripheral information. The authors hypothesized that alcohol leads individuals to strongly commit to their goals without considering information about the probability of goal attainment. In Study 1, participants named their most important interpersonal goal, indicated their expectations of successfully attaining it, and then consumed either alcohol or a placebo. In contrast to participants who consumed a placebo, intoxicated participants felt strongly committed to their goals despite low expectations of attaining them. In Study 2, goal-directed actions were measured over time. Once sober again, intoxicated participants with low expectations did not follow up on their strong commitments. Apparently, when prospects are bleak, alcohol produces empty goal commitments, as commitments are not based on individuals' expectations of attaining their goals and do not foster goal striving over time.

  4. Contexts as Shared Commitments

    PubMed Central

    García-Carpintero, Manuel

    2015-01-01

    Contemporary semantics assumes two influential notions of context: one coming from Kaplan (1989), on which contexts are sets of predetermined parameters, and another originating in Stalnaker (1978), on which contexts are sets of propositions that are “common ground.” The latter is deservedly more popular, given its flexibility in accounting for context-dependent aspects of language beyond manifest indexicals, such as epistemic modals, predicates of taste, and so on and so forth; in fact, properly dealing with demonstratives (perhaps ultimately all indexicals) requires that further flexibility. Even if we acknowledge Lewis (1980)'s point that, in a sense, Kaplanian contexts already include common ground contexts, it is better to be clear and explicit about what contexts constitutively are. Now, Stalnaker (1978, 2002, 2014) defines context-as-common-ground as a set of propositions, but recent work shows that this is not an accurate conception. The paper explains why, and provides an alternative. The main reason is that several phenomena (presuppositional treatments of pejoratives and predicates of taste, forces other than assertion) require that the common ground includes non-doxastic attitudes such as appraisals, emotions, etc. Hence the common ground should not be taken to include merely contents (propositions), but those together with attitudes concerning them: shared commitments, as I will defend. PMID:26733087

  5. Contexts as Shared Commitments.

    PubMed

    García-Carpintero, Manuel

    2015-01-01

    Contemporary semantics assumes two influential notions of context: one coming from Kaplan (1989), on which contexts are sets of predetermined parameters, and another originating in Stalnaker (1978), on which contexts are sets of propositions that are "common ground." The latter is deservedly more popular, given its flexibility in accounting for context-dependent aspects of language beyond manifest indexicals, such as epistemic modals, predicates of taste, and so on and so forth; in fact, properly dealing with demonstratives (perhaps ultimately all indexicals) requires that further flexibility. Even if we acknowledge Lewis (1980)'s point that, in a sense, Kaplanian contexts already include common ground contexts, it is better to be clear and explicit about what contexts constitutively are. Now, Stalnaker (1978, 2002, 2014) defines context-as-common-ground as a set of propositions, but recent work shows that this is not an accurate conception. The paper explains why, and provides an alternative. The main reason is that several phenomena (presuppositional treatments of pejoratives and predicates of taste, forces other than assertion) require that the common ground includes non-doxastic attitudes such as appraisals, emotions, etc. Hence the common ground should not be taken to include merely contents (propositions), but those together with attitudes concerning them: shared commitments, as I will defend.

  6. Reporters and Their Professional and Organizational Commitment.

    ERIC Educational Resources Information Center

    Becker, Lee B.; And Others

    1979-01-01

    Secondary analyses of data gathered in a national study of United States journalists yielded information about variables that predict professional and organizational commitment. The factors selected for analysis were found to explain organizational commitment better than professional commitment. (GT)

  7. Self-determination in sport commitment.

    PubMed

    Zahariadis, Panayotis; Tsorbatzoudis, Haralambos; Alexandris, Konstantinos

    2006-04-01

    The study tested utility of self-determination and sport commitment theories to understanding young athletes' sport commitment. 343 young athletes (M= 13.5 yr., SD= +/- 1.1) from soccer, basketball, volleyball, handball, and water polo teams volunteered to participate. All completed the Sport Motivation Scale and the Sport Commitment Questionnaire. Pearson correlations showed a strong relationship between commitment and intrinsic motivation scores. In contrast, extrinsic motivation scores were not significantly correlated to commitment, whereas amotivation scores showed a negative correlation to commitment. Path analysis resulted in strong positive association of intrinsic motivation and commitment. Amotivation had small negative relation to commitment. According to the model tested, social constraints and involvement opportunities were not significant contributors to sport commitment. An alternative model supported the mediating role of enjoyment to psychological commitment. The results showed that high self-determination is supportive of sport commitment, whereas low self-determination reduces sport commitment.

  8. ["Re-evaluation upon suspected event" is an approach for post-marketing clinical study: lessons from adverse drug events related to Bupleuri Radix preparations].

    PubMed

    Wu, Shu-Xin; Sun, Hong-Feng; Yang, Xiao-Hui; Long, Hong-Zhu; Ye, Zu-Guang; Ji, Shao-Liang; Zhang, Li

    2014-08-01

    We revisited the "Xiao Chaihu Decoction event (XCHDE)" occurred in late 1980s in Japan and the Bupleuri Radix related adverse drug reaction (ADR) reports in China After careful review, comparison, analysis and evaluation, we think the interstitial pneumonitis, drug induced Liver injury (DILI) and other severe adverse drug envents (ADEs) including death happened in Japan is probably results from multiple factors, including combinatory use of XCHDE with interferon, Kampo usage under modern medicine theory guidance, and use of XCHD on the basis of disease diagnosis instead of traditional Chinese syndrome complex differentiation. There are less ADE case reports related to XCHD preparation in China compared to Japan, mostly manifest with hypersensitivity responses of skin and perfuse perspiration. The symptoms of Radix Bupleuri injection related ADEs mainly manifest hypersensitivity-like response, 2 cases of intravenous infusion instead of intramuscular injection developed hypokalemia and renal failure. One case died from severe hypersensitivity shock. In Chinese literatures, there is no report of the interstitial pneumonitis and DILI associated with XCHDG in Japan. So far, there is no voluntary monitoring data and large sample clinical research data available. The author elaborated the classification of "reevaluation" and clarified "re-evaluation upon events" included the reaction to the suspected safety and efficacy events. Based on the current status of the clinical research on the Radix Bupleuri preparations, the author points out that post-marketing "re-evaluation upon suspected event" is not only a necessity of continuous evaluation of the safety, efficacy of drugs, it is also a necessity for providing objective clinical research data to share with the international and domestic drug administrations in the risk-benefit evaluation. It is also the unavoidable pathway to culture and push the excellent species and famous brands of TCM to the international market, in

  9. Freeze-dried live attenuated smallpox vaccine prepared in cell culture "LC16-KAKETSUKEN": Post-marketing surveillance study on safety and efficacy compliant with Good Clinical Practice.

    PubMed

    Nishiyama, Yasumasa; Fujii, Tatsuya; Kanatani, Yasuhiro; Shinmura, Yasuhiko; Yokote, Hiroyuki; Hashizume, So

    2015-11-09

    In Japan, production of smallpox vaccine LC16m8 (named LC16-KAKETSUKEN) was restarted and was determined to be maintained as a national stockpile in March 2002. To conduct a post-marketing surveillance study of the vaccination of freeze-dried live attenuated smallpox vaccine prepared in cell culture LC16-KAKETSUKEN using attenuated vaccinia strain LC16m8. The study complied with Good Clinical Practice, focusing on a comparison between primary vaccinees and re-vaccinees. 268 personnel (261 males and 7 females) of the Japan Ground Self-Defense Force were inoculated with LC16-KAKETSUKEN and thereafter adverse events and efficacy were evaluated. Among 268 vaccinee participants, the following vaccinees showed adverse events, none serious: 53 of 196 primary vaccinees (without previous smallpox vaccination), 4 of 71 re-vaccinees (with previous smallpox vaccination) and 1 vaccinee with unknown previous vaccination history. A breakdown of adverse events observed in this study (total 268 vaccinees) showed the following minor or mild adverse events: 52 (19.4%) swelling of axillary lymph node, 4 (1.5%) fever, 2 (0.7%) fatigue, 1 (0.4%) of rash, 14 (5.2%) erythema at the inoculation site, 1 (0.4%) swelling at the inoculation site and 1 (0.4%) autoinoculation. The incidence of adverse events for primary vaccinees (53/196; 27.0%) was significantly higher than for re-vaccinees (4/71; 5.6%). However, the proportion of vaccine take was significantly higher for primary vaccinees (185/196; 94.4%) than for re-vaccinees (58/71; 81.7%). Although the proportion of vaccine take of re-vaccinees was significantly lower than for primary vaccinees due to preexisting immunity by previous vaccination, no significant difference was found in neutralizing antibody titers between primary vaccinees and re-vaccinees at 1, 4 and 7 months after LC16-KAKETSUKEN vaccination. The present post-marketing surveillance study compliant with Good Clinical Practice demonstrated the efficacy and safety of the

  10. Communication, Leadership, and Organizational Commitment.

    ERIC Educational Resources Information Center

    Eblen, Anna L.

    1987-01-01

    Analyzes the relationship of leadership style and communication behavior to employee commitment. Finds that leaders' stylistic qualities and socially skilled communication play a part in predicting how subordinates feel about their organization. (MS)

  11. Committed warming inferred from observations

    NASA Astrophysics Data System (ADS)

    Mauritsen, Thorsten; Pincus, Robert

    2017-09-01

    Due to the lifetime of CO2, the thermal inertia of the oceans, and the temporary impacts of short-lived aerosols and reactive greenhouse gases, the Earth’s climate is not equilibrated with anthropogenic forcing. As a result, even if fossil-fuel emissions were to suddenly cease, some level of committed warming is expected due to past emissions as studied previously using climate models. Here, we provide an observational-based quantification of this committed warming using the instrument record of global-mean warming, recently improved estimates of Earth’s energy imbalance, and estimates of radiative forcing from the Fifth Assessment Report of the Intergovernmental Panel on Climate Change. Compared with pre-industrial levels, we find a committed warming of 1.5 K (0.9-3.6, 5th-95th percentile) at equilibrium, and of 1.3 K (0.9-2.3) within this century. However, when assuming that ocean carbon uptake cancels remnant greenhouse gas-induced warming on centennial timescales, committed warming is reduced to 1.1 K (0.7-1.8). In the latter case there is a 13% risk that committed warming already exceeds the 1.5 K target set in Paris. Regular updates of these observationally constrained committed warming estimates, although simplistic, can provide transparent guidance as uncertainty regarding transient climate sensitivity inevitably narrows and the understanding of the limitations of the framework is advanced.

  12. Factors affecting radiographers' organizational commitment.

    PubMed

    Akroyd, Duane; Jackowski, Melissa B; Legg, Jeffrey S

    2007-01-01

    A variety of factors influence employees' attitudes toward their workplace and commitment to the organization that employs them. However, these factors have not been well documented among radiologic technologists. To determine the predictive ability of selected organizational, leadership, work-role and demographic variables on organizational commitment for a national sample of radiographers. Three thousand radiographers registered by the American Registry of Radiologic Technologists working full time in clinical settings were surveyed by mail regarding their commitment to their employers, leadership within the organization that employs them, employer support and demographic information. Overall, radiographers were found to have only a moderate level of commitment to their employers. Among the factors that significantly affected commitment were the radiographer's educational level, perceived level of organizational support, role clarity and organizational leadership. The results of this study could provide managers and supervisors with insights on how to empower and challenge radiographers and offer opportunities that will enhance radiographers' commitment to the organization, thus reducing costly turnover and improving employee performance.

  13. Neurocognitive Features of Attention Deficit Hyperactivity Disorder in a Non-Clinical Adult Sample

    DTIC Science & Technology

    2004-01-01

    relationship between ADHD symptoms and cognitive performance in a non-clinical adult sample of 75 men and women (ages 20 to 49). Self-report measures of ADHD ...unknown. The current study examined the relationship between ADHD symptoms and cognitive performance in a non-clinical adult sample of 75 men and...symptoms as adults . Consistent with this estimate, a longitudinal study of boys with ADHD revealed that at age 19, 38% had symptoms that met full

  14. [Response of Pharmaceutical Companies to the Crisis of Post-Marketing Clinical Trials of Anti-Cancer Agents -- Results of Questionnaires to Pharmaceutical Companies].

    PubMed

    Nakajima, Toshifusa

    2016-04-01

    Investigator-oriented post-marketing clinical trials of anti-cancer agents are faced to financial crisis due to drastic decrease in research-funds from pharmaceutical companies caused by a scandal in 2013. In order to assess the balance of research funds between 2012 and 2014, we made queries to 26 companies manufacturing anti-cancer agents, and only 10 of 26 responded to our queries. Decrease in the fund was observed in 5 of 10, no change in 1, increase in 3 and no answer in 1. Companies showed passive attitude to carry out doctor-oriented clinical trials of off-patent drugs or unapproved drugs according to advanced medical care B program, though some companies answered to proceed approved routines of these drugs if clinical trials showed good results. Most companies declined to make comments on the activity of Japan Agency for Medical Research and Development (AMED), but some insisted to produce good corroboration between AMED and pharmaceutical companies in order to improve the quality of trials. Further corroboration must be necessary for this purpose among researchers, governmental administrative organs, pharmaceutical companies, patients' groups, and mass-media.

  15. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up

    PubMed Central

    Okada, Kenya; Sudo, Yohei; Itoh, Hiromichi; Yoshida, Hisao; Kuroda, Tatsuhiko

    2014-01-01

    Objective: To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Methods: Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Results: Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7%) of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%). No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. Conclusion: The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy. PMID:26770729

  16. Post-marketing safety evaluation of S-1 in patients with inoperable or recurrent breast cancer: especially in patients treated with S-1 + trastuzumab.

    PubMed

    Saito, Yuki; Oshitanai, Risa; Terao, Mayako; Terada, Mizuho; Tsuda, Banri; Okamura, Takuho; Suzuki, Yasuhiro; Tokuda, Yutaka

    2011-09-01

    The purpose of this study was to assess the safety of S-1 in Japanese in inoperable or recurrent breast cancer patients. A prospective post-marketing surveillance was performed at 313 sites in Japan in patients with inoperable or recurrent breast cancer treated with S-1. We examined 1361 patients between January 2006 and December 2007 with regard to the incidence of adverse drug reactions graded by the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. At least one adverse drug reaction was encountered by 858 patients, with an overall incidence of 63.0% (858/1361). The incidence of Grade 3 or higher adverse drug reactions in a descending order was 14.7% (200/1361). In this study, the most common combination drug was trastuzumab. The overall incidence of adverse drug reactions was 63.5% (431/679 patients) in patients treated with S-1 alone, and 55.9% (66/118 patients) in patients treated with S-1 + trastuzumab. Monotherapy with S-1 or combination therapy with S-1 + trastuzumab was well tolerated for inoperable or recurrent breast cancer patients.

  17. Safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART) in refractory ascites: Post-marketing surveillance results.

    PubMed

    Hanafusa, Norio; Isoai, Ayako; Ishihara, Tomoaki; Inoue, Tetsuya; Ishitani, Ken; Utsugisawa, Taiju; Yamaka, Toshihiko; Ito, Tetsuya; Sugiyama, Hiroshi; Arakawa, Atsushi; Yamada, Yosuke; Itano, Yasuo; Onodera, Hirokazu; Kobayashi, Ryosuke; Torii, Naoko; Numata, Toyoko; Kashiwabara, Taihei; Matsuno, Yoshihiro; Kato, Michio

    2017-01-01

    We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART. Body temperature increased significantly, by 0.3°C on average. Concomitant steroids and/or NSAIDs use before reinfusion was significantly and negatively associated with increases in body temperature. Most adverse events were fever and chills. This study examined a large number of patients compared with previous studies, and showed that CART is an effective and relatively safe treatment for refractory ascites, such as malignant ascites.

  18. Post-market surveillance of GM foods: applicability and limitations of schemes used with pharmaceuticals and some non-GM novel foods.

    PubMed

    Wal, J-M; Hepburn, P A; Lea, L J; Crevel, R W R

    2003-08-01

    Post-market surveillance (PMS) is increasingly required by some regulatory authorities for the marketing approval of GM-Novel Foods. This requirement, in addition to a complete conventional safety assessment, aims to show that unexpected (adverse) effects do not occur after long-term everyday exposure. Large food manufacturers have systems to obtain feedback from consumers on their products. We show that such systems can be enhanced to collect information on possible health effects of specific products and relate these to intake in specific groups of consumers. The term post-launch monitoring (PLM) is proposed to distinguish the process from that used for pharmaceuticals. GM foods differ from branded products to which existing systems have been applied. The paper discusses whether and how such systems could be applied to GM foods and what additional elements would need to be incorporated in them. A PLM system should define and organize the flow of information between the different stakeholders. We conclude that because such data will be generated from a range of sources and will need to be collated, verified, and integrated, an independent agency will be essential to undertake this activity in order to balance the interests of all stakeholders and ensure public trust.

  19. Safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART) in refractory ascites: Post-marketing surveillance results

    PubMed Central

    Isoai, Ayako; Ishihara, Tomoaki; Inoue, Tetsuya; Ishitani, Ken; Utsugisawa, Taiju; Yamaka, Toshihiko; Ito, Tetsuya; Sugiyama, Hiroshi; Arakawa, Atsushi; Yamada, Yosuke; Itano, Yasuo; Onodera, Hirokazu; Kobayashi, Ryosuke; Torii, Naoko; Numata, Toyoko; Kashiwabara, Taihei; Matsuno, Yoshihiro; Kato, Michio

    2017-01-01

    We performed post-marketing surveillance to evaluate the safety and efficacy of cell-free and concentrated ascites reinfusion therapy (CART). In total, 356 CART sessions in 147 patients at 22 centers were performed. The most common primary disease was cancer (128 cases, 300 sessions). Mean amount of ascites collected was 3.7 L, and mean concentration ratio was 9.2. Mean amount of reinfused protein was 67.8 g (recovery rate, 72.0%). Performance status, dietary intake, urine volume, body weight and abdominal circumference were significantly improved after CART. Body temperature increased significantly, by 0.3°C on average. Concomitant steroids and/or NSAIDs use before reinfusion was significantly and negatively associated with increases in body temperature. Most adverse events were fever and chills. This study examined a large number of patients compared with previous studies, and showed that CART is an effective and relatively safe treatment for refractory ascites, such as malignant ascites. PMID:28510606

  20. An immunogenicity, safety and post-marketing surveillance of a novel adsorbed human diploid cell rabies vaccine (Rabivax) in Indian subjects.

    PubMed

    Sudarshan, M K; Bhardwaj, S; Mahendra, B J; Sharma, H; Sanjay, T V; Ashwathnarayana, D H; Bilagumba, Gangaboraiah

    2008-01-01

    In 1999, Serum Institute of India indigenously developed an adsorbed human diploid cell rabies vaccine (Rabivax). During 2000-04, this new vaccine was subjected to a series of immunogenecity and safety studies. Initially, an experimental batch of Rabivax (adsorbed) was assessed on ten healthy adult volunteers and its response was comparable with that of Merieux inactivated rabies vaccine (MIRV, lyophilized) which was used as a control. Subsequently, Rabivax (adsorbed) was assessed on forty-five suspect rabid dog bite cases with MIRV as control. The vaccine was found to be equally safe and immunogenic as MIRV and showed better rabies virus neutralizing antibody (RVNA) response on day 90 than MIRV. A post-licensing study conducted on 150 cases of suspect rabid animal bites showed it to be safe and immunogenic. To assess its long-term sero-efficacy some of these subjects tested after one year of follow up showed that 84% of them had adequate RVNA titers. In addition, a routine post-marketing surveillance done on 1608 animal bite cases demonstrated that Rabivax (adsorbed) was safe and efficacious. The adverse events to Rabivax (adsorbed) included pain at injection site (3.4%), swelling with induration (2.8%), fever and headache (1.4%). No serious adverse event was reported from the studies. In conclusion, Rabivax (adsorbed) is an immunogenic, safe and efficacious vaccine for rabies prophylaxis in humans.

  1. Adverse events after Japanese encephalitis vaccination: review of post-marketing surveillance data from Japan and the United States. The VAERS Working Group.

    PubMed

    Takahashi, H; Pool, V; Tsai, T F; Chen, R T

    2000-07-01

    We determined the reporting rates for adverse events following the administration of inactivated mouse-brain derived Japanese encephalitis vaccine (JEV) based on post-marketing surveillance data from Japan and the United States. The rate of total adverse events per 100,000 doses was 2.8 in Japan and 15.0 in the United States. In Japan, 17 neurological disorders were reported from April 1996 to October 1998 for a rate of 0.2 per 100,000 doses. In the United States, no serious neurological adverse events temporally associated with JEV were reported from January 1993 to June 1999. Rates for systemic hypersensitivity reactions were 0.8 and 6.3 per 100,000 doses in Japan and the United States, respectively. Passively collected VAERS surveillance data indicate that characteristic hypersensitivity reactions with a delayed onset continue to occur among JEV recipients and that conservative recommendations limiting its use to travelers at high risk of infection with Japanese encephalitis are appropriate.

  2. Safety and efficacy of micafungin for prophylaxis against invasive fungal infections in Japanese patients undergoing hematopoietic stem cell transplantation: Results of a post-marketing surveillance study.

    PubMed

    Kobayashi, Chie; Hanadate, Tomoko; Niwa, Toshiro; Hirano, Yasuno; Yoshiyasu, Takashi; So, Masahiro; Matsui, Keita

    2015-06-01

    Invasive fungal infections are a major cause of morbidity and mortality in patients with hematopoietic stem cell transplantation. A prospective multicenter post-marketing observational surveillance study was conducted from July 2007 to June 2010 to assess the safety and efficacy of micafungin, an echinocandin antifungal, for prophylaxis against invasive fungal infections in Japanese patients undergoing hematopoietic stem cell transplantation. Among 241 patients evaluated for safety, 143 adverse drug reactions were reported in 86 patients (35.7%), with hepatobiliary disorders the most frequently reported adverse drug reactions. The success rate for prophylaxis at the end of observation was 72.8% (131/180 patients), and the incidence of breakthrough infections was only 4.4% (8/180 patients). In conclusion, micafungin had sufficient safety and efficacy for prophylaxis against invasive fungal infections in Japanese patients with various backgrounds undergoing hematopoietic stem cell transplantation. Copyright © 2015 Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

  3. Post-marketing surveillance of adverse events following immunization with inactivated quadrivalent and trivalent influenza vaccine in health care providers in Western Australia.

    PubMed

    Regan, Annette K; Tracey, Lauren; Gibbs, Robyn

    2015-11-17

    In 2015, inactivated quadrivalent influenza vaccine (QIV) was first introduced into the Australian market. A routine vaccine safety surveillance system in Western Australia was used to conduct post-licensure surveillance of adverse events following immunization with inactivated QIV and trivalent influenza vaccines (TIV) in a sample of 1685 healthcare providers (HCPs). A similar percentage of HCPs who received QIV reported having any reaction seven days post-vaccination as HCPs who received TIV (13.6 vs. 12.8%, respectively; p=0.66). However, a slightly higher percentage of HCPs who received QIV reported pain or swelling at the injection site as compared to HCPs who received TIV (6.9% vs. 4.2%, respectively; p=0.02). No serious vaccine-associated adverse events were detected during follow-up of either vaccine. Acknowledging the study limitations, the results of this post-marketing surveillance support the safety of QIV, suggesting there is little difference in the reactogenicity of QIV as compared to TIV. Crown Copyright © 2015. Published by Elsevier Ltd. All rights reserved.

  4. Long-term post-marketing surveillance of mizoribine for the treatment of lupus nephritis: Safety and efficacy during a 3-year follow-up.

    PubMed

    Yagi, Nobuyuki; Okada, Kenya; Sudo, Yohei; Itoh, Hiromichi; Yoshida, Hisao; Kuroda, Tatsuhiko

    2014-01-01

    To determine the safety and efficacy of long-term use of mizoribine by undertaking a 3-year post-marketing surveillance study. Subjects were all lupus nephritis patients newly treated with mizoribine between 1 October 2003 and 30 September 2005 at contracted study sites. Mizoribine was administered to 881 lupus nephritis patients in the safety analysis set consisting of 946 patients recruited from 281 contracted study sites after satisfying the eligibility criteria. There were 301 events of adverse drug reactions that were observed in 196 (20.7%) of the 946 subjects. There were 34 events of serious adverse drug reactions in 31 patients (3.2%). No deterioration in hematological and biochemical test values was observed, but immunological testing showed significant improvements in C3, CH50, and anti-DNA antibody titers. The negative rate of proteinuria also increased over time. The median steroid dosage was 15 mg/day at the commencement of treatment, but was reduced to 10 mg/day at 12 months and 8 mg/day at 36 months. The findings of the 3-year long-term drug use surveillance study indicated that mizoribine can be used over the long term with relatively few adverse drug reactions, suggesting its suitability for use in maintenance drug therapy.

  5. Childhood victimisation and developmental expression of non-clinical delusional ideation and hallucinatory experiences: victimisation and non-clinical psychotic experiences.

    PubMed

    Lataster, Tineke; van Os, Jim; Drukker, Marjan; Henquet, Cécile; Feron, Frans; Gunther, Nicole; Myin-Germeys, Inez

    2006-06-01

    Victimisation in childhood may be associated with adult psychosis. The current study examined this association in the crucial developmental period of early adolescence and investigated whether (1) unwanted sexual experiences, and (2) being bullied, were associated with non-clinical delusional ideation and hallucinatory experiences in a general population sample of 14 year olds. Data were derived from standard health screenings of the Youth Health Care Divisions of the Municipal Health Services in Maastricht, the Netherlands. A self-report questionnaire was filled out by a total of 1290 adolescents to assess non-clinical psychotic experiences, as well as experiences of being bullied and sexual trauma. Non-clinical psychotic experiences were strongly and independently associated with both bullying (OR=2.9, 95% CI 1.8-4.8) and sexual trauma (OR=4.8, 95% CI 2.3-10.1). The results suggest that reported associations between childhood victimisation and adult psychosis can be understood in a developmental framework of onset of at-risk mental states in early adolescence. In addition, the data suggest that the traumatic experience of being bullied may also feed the cognitive and biological mechanisms underlying formation of psychotic ideation.

  6. Conscientious commitment to women's health.

    PubMed

    Dickens, Bernard M; Cook, Rebecca J

    2011-05-01

    Conscientious commitment, the reverse of conscientious objection, inspires healthcare providers to overcome barriers to delivery of reproductive services to protect and advance women's health. History shows social reformers experiencing religious condemnation and imprisonment for promoting means of birth control, until access became popularly accepted. Voluntary sterilization generally followed this pattern to acceptance, but overcoming resistance to voluntary abortion calls for courage and remains challenging. The challenge is aggravated by religious doctrines that view treatment of ectopic pregnancy, spontaneous abortion, and emergency contraception not by reference to women's healthcare needs, but through the lens of abortion. However, modern legal systems increasingly reject this myopic approach. Providers' conscientious commitment is to deliver treatments directed to women's healthcare needs, giving priority to patient care over adherence to conservative religious doctrines or religious self-interest. The development of in vitro fertilization to address childlessness further illustrates the inspiration of conscientious commitment over conservative objections.

  7. Launch Commit Criteria Monitoring Agent

    NASA Technical Reports Server (NTRS)

    Semmel, Glenn S.; Davis, Steven R.; Leucht, Kurt W.; Rowe, Dan A.; Kelly, Andrew O.; Boeloeni, Ladislau

    2005-01-01

    The Spaceport Processing Systems Branch at NASA Kennedy Space Center has developed and deployed a software agent to monitor the Space Shuttle's ground processing telemetry stream. The application, the Launch Commit Criteria Monitoring Agent, increases situational awareness for system and hardware engineers during Shuttle launch countdown. The agent provides autonomous monitoring of the telemetry stream, automatically alerts system engineers when predefined criteria have been met, identifies limit warnings and violations of launch commit criteria, aids Shuttle engineers through troubleshooting procedures, and provides additional insight to verify appropriate troubleshooting of problems by contractors. The agent has successfully detected launch commit criteria warnings and violations on a simulated playback data stream. Efficiency and safety are improved through increased automation.

  8. Indicators of drug-seeking aberrant behaviours: the feasibility of use in observational post-marketing cohort studies for risk management.

    PubMed

    Layton, Deborah; Osborne, Vicki; Al-Shukri, Mohammad; Shakir, Saad A W

    2014-08-01

    Problematic prescription drug use is reflected by or associated with drug-seeking aberrant behaviours. Research gaps include lack of post-marketing evidence and instruments. As part of the pharmacovigilance requirements, a risk management plan was developed for fentanyl buccal tablets (FEBT) by the manufacturer, with an additional pharmacovigilance activity requested by the regulatory authority, to investigate the risks of misuse, abuse, criminal use, off-label use and accidental exposure to FEBT after the product became commercially available. A Modified Prescription-Event Monitoring (M-PEM), observational, post-authorisation safety surveillance (PASS) study was conducted, with an overall aim to examine the use of FEBT in relation to their safety as prescribed in primary care in England. One of the exploratory objectives included estimating the prevalence of aberrant behaviours during FEBT treatment. To determine the feasibility of estimating the prevalence of risk factors associated with dependence on starting treatment and aberrant behaviours in patients during treatment with a prototypical abuse liable substance (fentanyl), as based on the application of an existing index (the Chabal criteria). Data were collected as part of the M-PEM PASS study; exposure and outcome data (including risk factors for dependence and aberrant behaviours based on behavioural not clinical manifestations) were derived from questionnaires sent to primary care physicians in England during April 2008 to June 2011. For the exploratory objective of interest, descriptive statistics and simple (non-weighted) risk scores were constructed on aggregate counts (score ≥3 considered 'high-risk'). Supplementary analyses explored the relationship between the two indices and the characteristics of patients with aberrant behaviours and those without (crude odds ratios plus 95% confidence interval (CI) were calculated). In a cohort of 551 patients, the prevalence of at least one pre-existing risk

  9. BP goal achievement in patients with uncontrolled hypertension : results of the treat-to-target post-marketing survey with irbesartan.

    PubMed

    Schrader, Joachim; Bramlage, Peter; Lüders, Stephan; Thoenes, Martin; Schirmer, Andreas; Paar, Dieter W

    2007-01-01

    Despite the fact that high BP is a leading risk factor for cardiovascular morbidity and mortality, BP goals are achieved in less than 10-30% of hypertensive patients. Irbesartan alone or in combination with hydrochlorothiazide has been shown to control BP in >70% of hypertensive patients in clinical trials. We set out to investigate the role in clinical practice of irbesartan in improving BP in uncontrolled hypertensive patients with a particular focus on patients with the metabolic syndrome through analysis of data from a post-marketing surveillance study. A multicentre, prospective, post-marketing surveillance study was conducted over 9 months in 14 200 patients aged > or =18 years with previously uncontrolled hypertension (either receiving therapy or newly diagnosed), paying particular attention to a subgroup of patients receiving irbesartan/hydrochlorothiazide as first-line combination therapy. BP was measured by a sphygmomanometer. The main outcome measures were systolic BP (SBP) and diastolic BP (DBP) reduction, response rate (DBP reduction of > or =10mm Hg or to <90 mm Hg), and BP normalisation (SBP <140 and DBP <90 mm Hg) in patients treated with irbesartan alone or in combination with hydrochlorothiazide. Analyses per patient subgroup, previous medication and whether treatment was initiated by the treating physician as first-line combination therapy were conducted. The number and nature of adverse events were documented. Use of irbesartan 300 mg/day as monotherapy in previously uncontrolled patients resulted in a significant reduction in SBP/DBP (-26.8/-13.3mm Hg, p < 0.0001), which was comparable to the subgroup of patients with the metabolic syndrome (-26.3/-13.0mm Hg, p < 0.0001 vs baseline). Combination therapy (irbesartan 300 mg/hydrochlorothiazide 12.5mg once daily) lowered BP by -27.9/-14.2mm Hg (p < 0.0001) in previously uncontrolled patients; again the subgroup of patients with the metabolic syndrome achieved a comparable BP reduction (-27

  10. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: Results of an open label, non-comparative, multi-centric, post marketing observational study

    PubMed Central

    Kumbla, D.K.; Kumar, S.; Reddy, Y.V.; Trailokya, A.; Naik, M.

    2014-01-01

    Background Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. Objective To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. Material and methods An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. Results A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Conclusion Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. PMID:24973841

  11. WIN OVER study: Efficacy and safety of olmesartan in Indian hypertensive patients: results of an open label, non-comparative, multi-centric, post marketing observational study.

    PubMed

    Kumbla, D K; Kumar, S; Reddy, Y V; Trailokya, A; Naik, M

    2014-01-01

    Hypertension is a global health problem. Multiple classes of drugs including angiotensin receptor blockers (ARBs) are available for the treatment of hypertension. Olmesartan is a relatively newer ARB used in hypertension management. To assess the efficacy and safety of WIN-BP (Olmesartan 20 mg/40 mg) tablet in Indian patients with hypertension. An open label, non-comparative, multi-centric, real world post marketing observational study included Indian adult hypertensive patients who were treated with olmesartan 20 mg/40 mg tablet once daily for six months. The primary outcome was reduction of systolic blood pressure (SBP) to <140 mmHg and diastolic BP (DBP) to <90 mmHg at 3 and 6 months after initiation of treatment with olmesartan. All reported adverse events were recorded. A total of 8940 patients were enrolled in this study. Baseline SBP of 164 mmHg was reduced to 153, 145, 134 and 130 mmHg at the end of 15 days, 1, 3 and 6 months respectively. Similarly, baseline DBP of 100 mmHg was reduced to 93, 89, 84 and 82 mmHg at the end of 15 days, 1, 3 and 6 months respectively. The reduction in both systolic and diastolic blood pressure from day 15 to month 6 was statistically significant (p < 0.0001) with olmesartan treatment. The percentage of responders for both systolic and diastolic blood pressure increased consistently from day 15 to month 6. Only 0.08% patients reported the adverse events. No serious adverse event was reported in the study. Olmesartan 20 mg/40 mg is effective and well tolerated without any serious adverse events in patients with hypertension. Copyright © 2014 Cardiological Society of India. Published by Elsevier B.V. All rights reserved.

  12. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection

    PubMed Central

    2014-01-01

    Background Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. Results The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. Conclusions We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance. PMID:24428898

  13. Large-scale combining signals from both biomedical literature and the FDA Adverse Event Reporting System (FAERS) to improve post-marketing drug safety signal detection.

    PubMed

    Xu, Rong; Wang, QuanQiu

    2014-01-15

    Independent data sources can be used to augment post-marketing drug safety signal detection. The vast amount of publicly available biomedical literature contains rich side effect information for drugs at all clinical stages. In this study, we present a large-scale signal boosting approach that combines over 4 million records in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) and over 21 million biomedical articles. The datasets are comprised of 4,285,097 records from FAERS and 21,354,075 MEDLINE articles. We first extracted all drug-side effect (SE) pairs from FAERS. Our study implemented a total of seven signal ranking algorithms. We then compared these different ranking algorithms before and after they were boosted with signals from MEDLINE sentences or abstracts. Finally, we manually curated all drug-cardiovascular (CV) pairs that appeared in both data sources and investigated whether our approach can detect many true signals that have not been included in FDA drug labels. We extracted a total of 2,787,797 drug-SE pairs from FAERS with a low initial precision of 0.025. The ranking algorithm combined signals from both FAERS and MEDLINE, significantly improving the precision from 0.025 to 0.371 for top-ranked pairs, representing a 13.8 fold elevation in precision. We showed by manual curation that drug-SE pairs that appeared in both data sources were highly enriched with true signals, many of which have not yet been included in FDA drug labels. We have developed an efficient and effective drug safety signal ranking and strengthening approach We demonstrate that large-scale combining information from FAERS and biomedical literature can significantly contribute to drug safety surveillance.

  14. Utility of registries for post-marketing evaluation of medicines. A survey of Swedish health care quality registries from a regulatory perspective

    PubMed Central

    Feltelius, Nils; Gedeborg, Rolf; Holm, Lennart; Zethelius, Björn

    2017-01-01

    Aim The aim of this study was to describe content and procedures in some selected Swedish health care quality registries (QRs) of relevance to regulatory decision-making. Methods A workshop was organized with participation of seven Swedish QRs which subsequently answered a questionnaire regarding registry content on drug treatments and outcomes. Patient populations, coverage, data handling and quality control, as well as legal and ethical aspects are presented. Scientific publications from the QRs are used as a complementary measure of quality and scientific relevance. Results The registries under study collect clinical data of high relevance to regulatory and health technology agencies. Five out of seven registries provide information on the drug of interest. When applying external quality criteria, we found a high degree of fulfillment, although information on medication was not sufficient to answer all questions of regulatory interest. A notable strength is the option for linkage to the Prescribed Drug Registry and to information on education and socioeconomic status. Data on drugs used during hospitalization were also collected to some extent. Outcome measures collected resemble those used in relevant clinical trials. All registries collected patient-reported outcome measures. The number of publications from the registries was substantial, with studies of appropriate design, including randomized registry trials. Conclusions Quality registries may provide a valuable source of post-marketing data on drug effectiveness, safety, and cost-effectiveness. Closer collaboration between registries and regulators to improve quality and usefulness of registry data could benefit both regulatory utility and value for health care providers. PMID:28276780

  15. Effectiveness and safety of tolvaptan in liver cirrhosis patients with edema: Interim results of post-marketing surveillance of tolvaptan in liver cirrhosis (START study).

    PubMed

    Sakaida, Isao; Terai, Shuji; Kurosaki, Masayuki; Yasuda, Moriyoshi; Okada, Mitsuru; Bando, Kosuke; Fukuta, Yasuhiko

    2017-10-01

    Loop diuretics and spironolactone are used in patients with hepatic edema, but they are sometimes associated with insufficient responses as well as adverse events. Tolvaptan, a vasopressin type 2 receptor antagonist, was approved for hepatic edema in 2013. A large-scale post-marketing surveillance study has been carried out to evaluate the effectiveness and safety of tolvaptan in real-world clinical settings. Patients with hepatic cirrhosis with insufficient response to conventional diuretics were enrolled. The observational period was up to 6 months. Changes in body weight and clinical symptoms were measured to evaluate effectiveness. The incidence of adverse drug reactions was summarized as a safety measure. Of 970 patients enrolled, 463 were included in the safety analysis. Of this group, 340 were included in the effectiveness analysis. Decreases in body weight from baseline were -2.38 kg on day 7 and -3.52 kg on day 14. Ascites and bloated feeling was significantly improved within 14 days. The mean change in body weight depended on estimated glomerular filtration rate levels. The most frequently reported adverse drug reaction was thirst (6.9% of patients). Serum sodium level of ≥146 mEq/L was observed in 12 patients (2.7%). In the real-world clinical setting, tolvaptan showed aquaretic effectiveness in patients with cirrhosis. The mean change in body weight depended on renal function. We recommend tolvaptan use for hepatic cirrhosis at a stage in which the renal function is maintained. © 2016 The Japan Society of Hepatology.

  16. Post-marketing safety surveillance conducted in Korea (2008–2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™)

    PubMed Central

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-01-01

    ABSTRACT Purpose: According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). Methods: During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. Results: A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. Conclusions: We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice. PMID:27494163

  17. Liver injury with novel oral anticoagulants: assessing post-marketing reports in the US Food and Drug Administration adverse event reporting system

    PubMed Central

    Raschi, Emanuel; Poluzzi, Elisabetta; Koci, Ariola; Salvo, Francesco; Pariente, Antoine; Biselli, Maurizio; Moretti, Ugo; Moore, Nicholas; De Ponti, Fabrizio

    2015-01-01

    Aim We assessed the hepatic safety of novel oral anticoagulants (NOACs) analyzing the publicly available US-FDA adverse event reporting system (FAERS). Methods We extracted reports of drug-induced liver injury (DILI) associated with NOACs, including acute liver failure (ALF) events. Based on US marketing authorizations, we performed disproportionality analyses, calculating reporting odds ratios (RORs) with 95% confidence interval (CI), also to test for event- and drug-related competition bias, and case-by-case evaluation for concomitant medications. Results DILI reports represented 3.7% (n = 146) and 1.7% (n = 222) of all reports for rivaroxaban and dabigatran, respectively. No statistically significant association was found for dabigatran, in primary and secondary analyses. Disproportionality signals emerged for rivaroxaban in primary analysis (ALF: n = 25, ROR = 2.08, 95% CI 1.34, 3.08). In a large proportion of DILI reports concomitant hepatotoxic and/or interacting drugs were recorded: 42% and 37% (rivaroxaban and dabigatran, respectively), especially statins, paracetamol and amiodarone. Among ALF reports, fatal outcome occurred in 49% of cases (44% and 51%, rivaroxaban and dabigatran, respectively), whereas rapid onset of the event (<1 week) was detected in 46% of patients (47% and 44%, respectively). Conclusions The disproportionality signal for rivaroxaban calls for further comparative population-based studies to characterize and quantify the actual DILI risk of NOACs, taking into account drug- and patient-related risk factors. As DILI is unpredictable, our findings strengthen the role of (a) timely pharmacovigilance to detect post-marketing signals of DILI through FAERS and other data sources, (b) clinicians to assess early, on a case-by-case basis, the potential responsibility of NOACs when they diagnose a liver injury. PMID:25689417

  18. Important statistical considerations in the evaluation of post-market studies to assess whether opioids with abuse-deterrent properties result in reduced abuse in the community.

    PubMed

    By, Kunthel; McAninch, Jana K; Keeton, Stephine L; Secora, Alex; Kornegay, Cynthia J; Hwang, Catherine S; Ly, Thomas; Levenson, Mark S

    2017-08-23

    Abuse, misuse, addiction, overdose, and death associated with non-medical use of prescription opioids have become a serious public health concern. Reformulation of these products with abuse-deterrent properties is one approach for addressing this problem. FDA has approved several extended-release opioid analgesics with abuse-deterrent labeling, the bases of which come from pre-market studies. As all opioid analgesics must be capable of delivering the opioid in order to reduce pain, abuse-deterrent properties do not prevent abuse, nor do pre-market evaluations ensure that there will be reduced abuse in the community. Utilizing data from various surveillance systems, some recent post-market studies suggest a decline in abuse of extended-release oxycodone after reformulation with abuse-deterrent properties. We discuss challenges stemming from the use of such data. We quantify the relationship between the sample, the population, and the underlying sampling mechanism and identify the necessary conditions if valid statements about the population are to be made. The presence of other interventions in the community necessitates the use of comparators. We discuss the principles under which the use of comparators can be meaningful. Results based on surveillance data need to be interpreted with caution as the underlying sampling mechanisms can bias the results in unpredictable ways. The use of comparators has the potential to disentangle the effect due to the abuse-deterrence properties from those due to other interventions. However, identifying a comparator that is meaningful can be very difficult. Published 2017. This article is a U.S. Government work and is in the public domain in the USA.

  19. Examining the Quality of Medicines at Kenyan Healthcare Facilities: A Validation of an Alternative Post-Market Surveillance Model That Uses Standardized Patients.

    PubMed

    Wafula, Francis; Dolinger, Amy; Daniels, Benjamin; Mwaura, Njeri; Bedoya, Guadalupe; Rogo, Khama; Goicoechea, Ana; Das, Jishnu; Olayo, Bernard

    2017-03-01

    Promoting access to medicines requires concurrent efforts to strengthen quality assurance for sustained impact. Although problems of substandard and falsified medicines have been documented in low- and middle-income countries, reliable information on quality is rarely available. The aim of this study was to validate an alternative post-market surveillance model to complement existing models. The study used standardized patients or mystery clients (people recruited from the local community and trained to pose as real patients) to collect medicine samples after presenting a pre-specified condition. The patients presented four standardized conditions to 42 blinded facilities in Nairobi, Kenya, resulting in 166 patient-clinician interactions and dispensing of 300 medicines at facilities or nearby retail pharmacies. The medicine samples obtained thus resemble those that would be given to real patients. Sixty samples were selected from the 300, and sent for analysis at the Kenya National Quality Control Laboratory. Of these, ten (17%) did not comply with monograph specifications (three ibuprofen, two cetirizine, two amoxicillin/clavulanic acid combinations, and one each for prednisone, salbutamol and zinc). Five of the ten samples that failed had been inappropriately prescribed to patients who had presented symptoms of unstable angina. There was no association between medicine quality and ownership, size or location of the facilities. The study shows that the standardized patient model can provide insights into multiple dimensions of care, thus helping to link primary care encounters with medicine quality. Furthermore, it makes it possible to obtain medicines from blinded sellers, thus minimizing the risk of obtaining biased samples.

  20. Part IV: effects of zolmitriptan orally disintegrating tablet on migraine symptoms and ability to perform normal activities: a post-marketing surveillance study in Germany.

    PubMed

    Diener, Hans-Christoph; Gendolla, Astrid

    2005-01-01

    Zolmitriptan has been developed in an orally disintegrating tablet (ODT) formulation that rapidly dissolves on the tongue and can be taken quickly, conveniently and discreetly without fluid intake. In this 3-month, non-comparative, observational, post-marketing surveillance (PMS) study, 5,570 physicians prescribed the zolmitriptan 2.5 mg ODT for 16,261 patients with migraine. Of the 14,543 patients who were evaluable for efficacy analysis, 94% had reduced headache intensity within 2 hours of taking zolmitriptan 2.5 mg ODT for the first attack. Improvements were reported within 30 minutes in 35% of patients and within 15 minutes in 7% of patients. Non-headache migraine symptoms and normal daily activities improved for the majority of patients within 2 hours of taking zolmitriptan ODT. Ninety-one percent of patients required only a single dose of zolmitriptan 2.5 mg ODT to treat each attack. Ninety-two percent of patients considered zolmitriptan ODT as having very good or good efficacy and 96% said that tolerability was very good or good. This study also demonstrated that 94% of patients would be willing to continue to use zolmitriptan ODT in the future and 81% of patients considered that being able to take the ODT without water was important or very import ant. In summary, zolmitriptan ODT has demonstrated high efficacy and excellent tolerability. In addition, patients found zolmitriptan ODT to be convenient and easy to use, and were willing to continue using the product. Following placebo-controlled studies, these PMS results provide insight into the use of zolmitriptan ODT in a setting more representative of real life than randomised clinical trials, further demonstrating that it provides a reliable and convenient alternative to conventional tablets.

  1. Clinical analysis of 207 patients who developed renal disorders during or after treatment with edaravone reported during post-marketing surveillance.

    PubMed

    Hishida, Akira

    2007-12-01

    The post-marketing surveillance of edaravone has reported serious adverse reactions, including renal and hepatic disorders. Renal disorders were the most frequently reported serious/important adverse reactions, which led to the evaluation of their causation by edaravone, their severity, and the recovery of renal function. A retrospective review was carried out of 207 Japanese patients with acute stroke who developed renal disorders on edaravone treatment. No particular factor other than edaravone was found as a possible cause of the renal disorders in 17 patients (8.2%). In 91.8% of the patients evaluated, factors other than edaravone were associated with the development of renal disorders. Severe deterioration of systemic status (e.g., a severe infection or a decrease in blood pressure) was considered to be a highly probable cause of renal disorders that occurred before or during treatment with edaravone in 135 patients (65.2%). Fifty-nine patients (28.5%) underwent blood purification treatment (BPT). In the remaining 148 patients without BPT, the peak serum creatinine (SCr) level during follow-up was 3 mg/dl or more in 93 patients (44.9%) and less than 3 mg/dl in 55 patients (26.6%). The severity of renal disorders was moderate to severe in 73.3% of the 207 patients, and renal function recovered in 43%. Appropriate treatment of deteriorated systemic status and the discontinuation of edaravone administration following the early discovery of renal disorders are recommended to reduce the development of severe renal disorders during edaravone treatment. The precise role(s) of edaravone in the pathogenesis of renal disorders should be evaluated in the future.

  2. Reactogenicity and safety of the human rotavirus vaccine, Rotarix™ in The Philippines, Sri Lanka, and India: a post-marketing surveillance study.

    PubMed

    Bravo, Lulu; Chitraka, Amarjeet; Liu, Aixue; Choudhury, Jaydeep; Kumar, Kishore; Berezo, Lennie; Cimafranca, Leonard; Chatterjee, Pallab; Garg, Pankaj; Siriwardene, Prasanna; Bernardo, Rommel; Mehta, Shailesh; Balasubramanian, Sundaram; Karkada, Naveen; Htay Han, Htay

    2014-01-01

    Regulatory bodies in The Philippines, Sri Lanka, and India require post-marketing surveillance to provide additional safety data on Rotarix™ in real-life settings. In such studies conducted in The Philippines (November 2006 to July 2012; NCT00353366), Sri Lanka (November 2008 to August 2009; NCT00779779), and India (August 2009 to April 2010; NCT00938327), 2 doses of Rotarix™ were administered according to the local prescribing information (PI). The occurrence of at least Grade "2"/"3" solicited adverse event (AE) (fever, vomiting, or diarrhea), within 15 days in The Philippines or 8 days in Sri Lanka and India; unsolicited AEs within 31 days and serious adverse events (SAEs) throughout the study were recorded. Of the 1494, 522, and 332 infants enrolled in The Philippines, Sri Lanka, and India, 14.7% 14.9% and 12.7% infants, respectively recorded at least Grade "2"/"3" solicited AEs. The most commonly reported solicited AEs were irritability in The Philippines (32.2% post-Dose-1; 23.5% post-Dose-2) and India (23.0% post-Dose-1; 13.2% post-Dose-2), and fever (18.0% post-Dose-1; 20.2% post-Dose-2) in Sri Lanka. Unsolicited AEs were recorded in 24.5% (The Philippines), 4.8% (Sri Lanka), and 6.9% (India) of infants. Forty-one SAEs were recorded in the Philippines of which 6 (decreased oral intake with increased sleeping time and constipation; pneumonia, urinary tract infection, and intussusception) were considered by the investigators as causally related to vaccination. One vaccine-unrelated SAE occurred in a Sri Lankan infant. All SAEs resolved and the infants recovered. Two doses of Rotarix™, administered to healthy infants according to local PI, were well tolerated in The Philippines, Sri Lanka, and India.

  3. Real-life versus package insert: a post-marketing study on adverse-event rates of the virosomal hepatitis A vaccine Epaxal® in healthy travellers.

    PubMed

    Hatz, Christoph; Beck, Bernhard; Steffen, Robert; Genton, Blaise; d'Acremont, Valérie; Loutan, Louis; Hartmann, Katharina; Herzog, Christian

    2011-07-12

    There are various methods to collect adverse events (AEs) in clinical trials. The methods how AEs are collected in vaccine trials is of special interest: solicited reporting can lead to over-reporting events that have little or no biological relationship to the vaccine. We assessed the rate of AEs listed in the package insert for the virosomal hepatitis A vaccine Epaxal(®), comparing data collected by solicited or unsolicited self-reporting. In an open, multi-centre post-marketing study, 2675 healthy travellers received single doses of vaccine administered intramuscularly. AEs were recorded based on solicited and unsolicited questioning during a four-day period after vaccination. A total of 2541 questionnaires could be evaluated (95.0% return rate). Solicited self-reporting resulted in significantly higher (p<0.0001) rates of subjects with AEs than unsolicited reporting, both at baseline (18.9% solicited versus 2.1% unsolicited systemic AEs) and following immunization (29.6% versus 19.3% local AEs; 33.8% versus 18.2% systemic AEs). This could indicate that actual reporting rates of AEs with Epaxal(®) may be substantially lower than described in the package insert. The distribution of AEs differed significantly between the applied methods of collecting AEs. The most common AEs listed in the package insert were reported almost exclusively with solicited questioning. The reporting of local AEs was more likely than that of systemic AEs to be influenced by subjects' sex, age and study centre. Women reported higher rates of AEs than men. The results highlight the need for detailing the methods how vaccine tolerability was reported and assessed.

  4. Confirmation of in vitro and clinical safety assessment of behentrimonium chloride-containing leave-on body lotions using post-marketing adverse event data.

    PubMed

    Cameron, D M; Donahue, D A; Costin, G-E; Kaufman, L E; Avalos, J; Downey, M E; Billhimer, W L; Gilpin, S; Wilt, N; Simion, F A

    2013-12-01

    Behentrimonium chloride (BTC) is a straight-chain alkyltrimonium chloride compound commonly used as an antistatic, hair conditioning, emulsifier, or preservative agent in personal care products. Although the European Union recently restricted the use of alkyltrimonium chlorides and bromides as preservatives to ≤0.1%, these compounds have been safely used for many years at ≤5% in hundreds of cosmetic products for other uses than as a preservative. In vitro, clinical, and controlled consumer usage tests in barrier-impaired individuals were conducted to determine if whole body, leave-on skin care products containing 1-5% BTC cause dermal irritation or any other skin reaction with use. BTC-containing formulations were predicted to be non-irritants by the EpiDerm® skin irritation test and the bovine corneal opacity and permeability (BCOP)/chorioallantoic membrane vascular assay (CAMVA) ocular irritation test battery. No evidence of allergic contact dermatitis or cumulative dermal irritation was noted under the exaggerated conditions of human occlusive patch tests. No clinically assessed or self-reported adverse reactions were noted in adults or children with atopic, eczematous, and/or xerotic skin during two-week and four-week monitored home usage studies. These results were confirmed by post-marketing data for five body lotions, which showed only 0.69 undesirable effects (mostly skin irritation) reported per million shipped consumer units during 2006-2011; a value consistent with a non-irritating body lotion. No serious undesirable effects were reported during in-market use of the products. Therefore, if formulated in appropriate conditions at 1-5%, BTC will not cause dermal irritation or delayed contact sensitization when used in a whole-body, leave-on product.

  5. The impact of neutralizing antibodies on the risk of disease worsening in interferon β-treated relapsing multiple sclerosis: a 5 year post-marketing study.

    PubMed

    Paolicelli, D; D'Onghia, M; Pellegrini, F; Direnzo, V; Iaffaldano, P; Lavolpe, V; Trojano, M

    2013-06-01

    The impact of neutralizing antibodies (NAbs) on interferon β (IFNβ) efficacy in MS patients is still an object of controversy. To evaluate the clinical response to IFNβ during NAb-positive (NAb+) and NAb-negative (NAb-) statuses on a large population of relapsing remitting (RR) MS patients were followed up to 5 years. Sera from 567 RR MS patients treated with IFNβ for 2-5 years were collected every 6-12 months and evaluated for NAb presence by a cytopathic effect assay. The relapse rate and expanded disability status scale (EDSS) score were assessed at baseline and every 6 months for each patient. A NAb+ status was defined after two consecutive positive titers of NAbs >/= 20 neutralizing units (NU)/mL. Multivariate models were used to analyze the relapse rate, the time to first relapse, the time to confirmed EDSS score 4 during NAb+ and NAb- statuses. A propensity score (PS) matching analysis was performed to assess the robustness of the multivariate models. Fourteen percent of patients became NAb+ during the follow-up. A significant increase of the relapse rate (IRR = 1.38; p = 0.0247) and decrease of the time to 1st relapse (IRR = 1.51; p = 0.0111) were found during NAb+ periods. The PS matching analysis, in a selected cohort of patients, demonstrated a negative trend of NAbs on the time to reach the milestone EDSS 4 (IRR = 2.94; p = 0.0879). This long-term post-marketing observational study further confirms that the occurrence of NAbs significantly affects the risk of disease worsening in IFNβ- treated RRMS.

  6. Long-term efficacy of sirolimus-eluting stent for small vessel disease--subanalysis of Cypher Stent Japan Post-Marketing Surveillance Registry.

    PubMed

    Fujimoto, Hajime; Ikari, Yuji; Nakamura, Masato

    2013-01-01

    Percutaneous coronary intervention for lesions with small vessel diameter may have high event rates. Although drug-eluting stents reduce the risk of restenosis, the long-term efficacy of drug-eluting stent implantation in small vessels is unclear. We reviewed the data of Cypher Stent Japan Post-Marketing Surveillance Registry including 2356 lesions of 1959 patients, and retrospectively investigated the angiographic outcomes at 8 months, and the clinical outcomes at 1800 days after sirolimus-eluting stent (SES) implantation in vessels with diameter less than 2.5mm (small vessel group) compared to that with diameter of 2.5mm or more (non-small vessel group). The rate of major adverse cardiac events (MACE) at 1800 days was slightly higher in the small vessel group than in the non-small vessel group, but not statistically significant (24.4% vs 21.0%, p=0.086). The rate of target lesion revascularization was higher in the small vessel group than in the non-small vessel group (10.2% vs 6.4%, p=0.004). The rate of stent thrombosis was almost the same in the two groups. Multivariate Cox hazard model analysis revealed that a vessel diameter less than 2.5mm was not an independent risk factor for MACE. SES implantation for vessels with diameter less than 2.5mm is safe and provides good long-term outcomes. Copyright © 2012 Japanese College of Cardiology. Published by Elsevier Ltd. All rights reserved.

  7. Post-marketing safety surveillance conducted in Korea (2008-2013) following the introduction of the rotavirus vaccine, RIX4414 (Rotarix™).

    PubMed

    Shin, Son Moon; Kim, Chun Soo; Karkada, Naveen; Liu, Aixue; Jayadeva, Girish; Han, Htay Htay

    2016-10-02

    According to regulations from the Ministry of Food and Drug Safety in Korea, additional safety information on the use of Rotarix™ vaccine (RIX4414; GSK, Belgium) in ≥3000 evaluable Korean infants was required following vaccine registration. In order to comply with these regulations, we conducted a 6-year open, non-comparative, multicenter post-marketing surveillance (NCT00750893). During this time, the original lyophilized vaccine formulation of RIX4414 was replaced by a liquid formulation. Healthy infants aged ≥6 weeks were enrolled and given 2 doses of the RIX4414 vaccine, separated by an interval of ≥4 weeks. The overall incidence of adverse events (AEs) (expected and unexpected) was then assessed for up to 30 days along with the incidence of serious adverse events (SAEs). Adverse drug reactions (ADRs: any AE whose causality to the drug could not be ruled out) were identified. A total of 3040 children (mean age: 9.55 weeks) were analyzed. One or more expected AE was experienced by 30.5% infants and 8.6% had an ADR. The most commonly seen expected AE was irritability (14.0%). One or more unexpected AE was seen in 32.5% infants and 3.1% experienced an ADR. The most commonly seen unexpected AE was upper respiratory tract infection (8.7%). Of 34 SAEs recorded in 24 subjects, none were related to vaccination. We conclude that this 6-year surveillance showed both formulations of RIX4414 to have acceptable safety profiles when administered to Korean infants according to local prescribing recommendations and current clinical practice.

  8. Post-marketing surveillance of thrombomodulin alfa, a novel treatment of disseminated intravascular coagulation - safety and efficacy in 1,032 patients with hematologic malignancy.

    PubMed

    Asakura, Hidesaku; Takahashi, Hoyu; Tsuji, Hajime; Matsushita, Tadashi; Ninomiya, Hideyuki; Honda, Goichi; Mimuro, Jun; Eguchi, Yutaka; Kitajima, Isao; Sakata, Yoichi

    2014-03-01

    Post-marketing surveillance of thrombomodulin alfa (TM-α) was performed to evaluate safety and efficacy in patients with disseminated intravascular coagulation (DIC) with hematologic malignancy. All patients treated with TM-α from May 2008 to April 2010 in Japan were included. Information about baseline characteristics, safety, and efficacy were collected. The DIC resolution rate, survival rate on Day 28 after the last TM-α administration, and changes in DIC score and coagulation tests were evaluated. The underlying diseases associated with DIC were acute myeloid leukemia (except for acute promyelocytic leukemia, n=350), lymphoma (n=199), acute promyelocytic leukemia (n=172), acute lymphoblastic leukemia (n=156), myelodysplastic syndromes (n=61), and other (n=94). The incidence rates of bleeding-related adverse events and adverse drug reactions were 17.8% and 4.6%, respectively. In subjects with bleeding symptoms at baseline, 55.0% were assessed as disappeared or improved based on symptoms after TM-α treatment. The DIC resolution and survival rates were 55.9% and 70.7%, respectively. The DIC score and coagulation tests including thrombin-antithrombin complex (TAT) were significantly improved. Coagulation tests were significantly improved after TM-α treatment even in subjects whose clinical course of underlying disease was assessed as unchanged or exacerbated. This surveillance confirmed the safety and efficacy of TM-α in clinical practice, thus TM-α may be an ideal treatment for patients with DIC based upon hematologic malignancy. Copyright © 2014 Elsevier Ltd. All rights reserved.

  9. Automatic signal extraction, prioritizing and filtering approaches in detecting post-marketing cardiovascular events associated with targeted cancer drugs from the FDA Adverse Event Reporting System (FAERS).

    PubMed

    Xu, Rong; Wang, Quanqiu

    2014-02-01

    Targeted drugs dramatically improve the treatment outcomes in cancer patients; however, these innovative drugs are often associated with unexpectedly high cardiovascular toxicity. Currently, cardiovascular safety represents both a challenging issue for drug developers, regulators, researchers, and clinicians and a concern for patients. While FDA drug labels have captured many of these events, spontaneous reporting systems are a main source for post-marketing drug safety surveillance in 'real-world' (outside of clinical trials) cancer patients. In this study, we present approaches to extracting, prioritizing, filtering, and confirming cardiovascular events associated with targeted cancer drugs from the FDA Adverse Event Reporting System (FAERS). The dataset includes records of 4,285,097 patients from FAERS. We first extracted drug-cardiovascular event (drug-CV) pairs from FAERS through named entity recognition and mapping processes. We then compared six ranking algorithms in prioritizing true positive signals among extracted pairs using known drug-CV pairs derived from FDA drug labels. We also developed three filtering algorithms to further improve precision. Finally, we manually validated extracted drug-CV pairs using 21 million published MEDLINE records. We extracted a total of 11,173 drug-CV pairs from FAERS. We showed that ranking by frequency is significantly more effective than by the five standard signal detection methods (246% improvement in precision for top-ranked pairs). The filtering algorithm we developed further improved overall precision by 91.3%. By manual curation using literature evidence, we show that about 51.9% of the 617 drug-CV pairs that appeared in both FAERS and MEDLINE sentences are true positives. In addition, 80.6% of these positive pairs have not been captured by FDA drug labeling. The unique drug-CV association dataset that we created based on FAERS could facilitate our understanding and prediction of cardiotoxic events associated with

  10. Safety and efficacy of fesoterodine fumarate in patients with overactive bladder: results of a post-marketing surveillance study in Korea.

    PubMed

    Kim, Tae Heon; Lee, Sang Eun; Lee, Hahn-Ey; Lee, Kyu-Sung

    2016-08-01

    The aim of this study was to evaluate the safety and efficacy of fesoterodine fumarate (fesoterodine; Toviaz ) in Korean patients with overactive bladder (OAB) in routine clinical practice. This was an open-label, non-interventional, prospective, post-marketing surveillance study submitted to the Korean Ministry of Food and Drug Safety. A total of 3109 patients aged ≥18 years with OAB symptoms were prescribed flexible doses of fesoterodine at the investigator's discretion. Safety was assessed based upon the reporting of adverse events (AEs). Efficacy was evaluated on the basis of patient self-assessment using a bladder diary as well as on the basis of investigator assessment in terms of overall clinical efficacy. A final analysis was performed on 3107 (99.9%) and 2978 (95.8%) patients for safety and efficacy analysis, respectively. The mean treatment duration of fesoterodine was 83.2 days. The incidence of AEs was 8.5% (265/3107). Common AEs that accounted for more than 1.0% of the total AE incidence included dry mouth (5.4%, 168/3107), constipation (1.5%, 48/3107) and micturition disorder (1.1%, 35/3107). Mean episodes of urinary frequency, urgency, and urgency urinary incontinence (UUI) per 24 hours decreased by 4.0, 2.4, and 0.8, respectively (all p < 0.001). At the final follow-up visit, the investigators found improvement in clinical efficacy for the majority of patients (90.1%, 2684/2978). Limitations of this study include the observational study design and the relatively short treatment duration. These results suggest that fesoterodine is a well tolerated and effective treatment for Korean patients with OAB in routine clinical practice.

  11. The occurrence rate of cerebrovascular and cardiac events in patients receiving antihypertensive therapy from the post-marketing surveillance data for valsartan in Japan (J-VALID).

    PubMed

    Yamazaki, Tsutomu; Kohro, Takahide; Chujo, Mitsuaki; Ishigaki, Masahide; Hashimoto, Takafumi

    2013-02-01

    It is well known that blood pressure (BP) management reduces the incidence of cerebrovascular and cardiovascular events. However, it is unclear how many of these events occur in hypertensive patients who receive pharmacological treatment. The aim of this survey was to evaluate the occurrence rate of both types of events in patients receiving valsartan-based treatment. Of 30 366 patients treated with valsartan, 28 356 patients were observed for 2.93 years. Antihypertensive drugs other than valsartan were used in 56.8% of patients. After the administration of valsartan, the systolic and diastolic BP significantly decreased from 161.1±19.1/90.4±13.1 to 139.9±18.1/79.6±11.9 mm Hg. Cerebrovascular events were observed in 550 patients (1.94%, 9.29/1000 patient-years), and cardiac events were observed in 576 patients (2.03%, 9.73/1000 patient-years). A comparative analysis of the hazard ratios for cerebrovascular and cardiac events according to the BP level at the endpoint showed a BP-dependent reduction of risk for cerebrovascular events, and the change in risk exhibited a J-curve phenomenon in the relationship between cardiac events and systolic BP. The J-curve phenomenon was not observed in patients aged <75 years, but it was observed for the systolic BP in patients aged 75 years. Adverse drug reactions were observed in 1925 of 28 420 patients (6.77%). This post-marketing surveillance data for valsartan showed the outcomes for treated hypertensive patients in a large population in Japan who were followed for up to 3 years. These data will add important knowledge regarding the treatment of hypertension in Japan.

  12. [Safety and effectiveness of pemetrexed in patients with non-small cell lung cancer in Japan - analysis of post-marketing surveillance].

    PubMed

    Okubo, Sumiko; Kobayashi, Noriko; Taketsuna, Masanori; Kaneko, Naoya; Enatsu, Sotaro; Nishiuma, Shinichi

    2014-04-01

    The safety and effectiveness of pemetrexed(PEM)in patients with non-small cell lung cancer(NSCLC)were reviewed using data from post-marketing surveillance. Among 699 patients registered from June 2009 to May 2010, 683 patients were analyzed(343, first-line therapy: 340, second-line therapy or beyond). Patient backgrounds were as follows: median age=65 years(16.1%B75 years old); 64.7% male; 91.9% performance status 0-1; 83.2% Stage IV; 99.0% non-squamous cell cancer. Also, 86% of the first-line and 20% of the second-line cohort were receiving a concomitant anti-cancer drug(mostly platinum agents). The incidence rate of adverse drug reactions(ADR)was 76.7%, including serious cases(18.0%). The most common ADRs were decreased white blood cell count(26.8%), decreased neutrophil count(25.3%), anemia(19.2%), decreased platelet count(17.0%), and nausea(23.0%). The incidence of interstitial lung disease, which is a concern during chemotherapy, was 2.6%. Peripheral neuropathy and alopecia, events influencing a patient's quality of life, were less than 1%. The estimated median survival time was 23.2 months[95%CI: 19.8 months-not calculable]in the first-line cohort, and 11.8 months[95% CI: 10.5-13.7 months]in the B second-line cohort. The surveillance results showed no apparent difference in total ADRs in this current study compared to the safety profile established in clinical trials previously conducted in Japan and overseas. These results demonstrate the safety and effectiveness of PEM treatment for NSCLC patients in daily clinical settings.

  13. 24-Hour Relativistic Bit Commitment

    NASA Astrophysics Data System (ADS)

    Verbanis, Ephanielle; Martin, Anthony; Houlmann, Raphaël; Boso, Gianluca; Bussières, Félix; Zbinden, Hugo

    2016-09-01

    Bit commitment is a fundamental cryptographic primitive in which a party wishes to commit a secret bit to another party. Perfect security between mistrustful parties is unfortunately impossible to achieve through the asynchronous exchange of classical and quantum messages. Perfect security can nonetheless be achieved if each party splits into two agents exchanging classical information at times and locations satisfying strict relativistic constraints. A relativistic multiround protocol to achieve this was previously proposed and used to implement a 2-millisecond commitment time. Much longer durations were initially thought to be insecure, but recent theoretical progress showed that this is not so. In this Letter, we report on the implementation of a 24-hour bit commitment solely based on timed high-speed optical communication and fast data processing, with all agents located within the city of Geneva. This duration is more than 6 orders of magnitude longer than before, and we argue that it could be extended to one year and allow much more flexibility on the locations of the agents. Our implementation offers a practical and viable solution for use in applications such as digital signatures, secure voting and honesty-preserving auctions.

  14. Higher Education and Social Commitment.

    ERIC Educational Resources Information Center

    Nasution, S.; Virasai, Banphot, Eds.

    The proceedings of the Regional Institute of Higher Education and Development's seminar and the meaning and implications of social commitment in higher education are reported. The welcoming address (S. Nasution) and the opening address (Y. B. Dato' Murad bin Mohd. Noor) welcome the participants and set the tone for the discussions to follow. The…

  15. Hampshire Country School Staff Commitments.

    ERIC Educational Resources Information Center

    Hampshire Country School, Rindge, NH.

    Intended for professional personnel of the Hampshire Country School, which treats gifted children with immobilizing emotional dysfunctions, the handbook specifies staff commitments. The Code of Ethics, adapted from the National Education Association Code as supplemented by The Council for Exceptional Children, sets forth four principles:…

  16. Physical Education Teachers' Organizational Commitment

    ERIC Educational Resources Information Center

    Demir, Hayri

    2013-01-01

    The aim of this study was to determine physical education teachers' organizational commitment levels. The sample consisted of 204 physical education teachers working in the city center of Konya in the 2011 to 2012 academic year. The respondents were randomly selected in this research. Data collected for this research by using the Scale for…

  17. Higher Education and Social Commitment.

    ERIC Educational Resources Information Center

    Nasution, S.; Virasai, Banphot, Eds.

    The proceedings of the Regional Institute of Higher Education and Development's seminar and the meaning and implications of social commitment in higher education are reported. The welcoming address (S. Nasution) and the opening address (Y. B. Dato' Murad bin Mohd. Noor) welcome the participants and set the tone for the discussions to follow. The…

  18. Commitment Profiles and Employee Turnover

    ERIC Educational Resources Information Center

    Stanley, Laura; Vandenberghe, Christian; Vandenberg, Robert; Bentein, Kathleen

    2013-01-01

    We examined how affective (AC), normative (NC), perceived sacrifice (PS), and few alternatives (FA) commitments combine to form profiles and determine turnover intention and turnover. We theorized that three mechanisms account for how profiles operate, i.e., the degree to which membership is internally regulated, the perceived desirability and…

  19. School Climate and Teacher Commitment

    ERIC Educational Resources Information Center

    Smith, Larry Don

    2009-01-01

    This study examined the relationship between school climate and teacher commitment. The study focused on elementary schools in Northeast Alabama. Thirty-four elementary schools consisting of 522 teachers took part in the study. The teachers completed two survey instruments: the Organizational Climate Index (OCI) and the Organizational Commitment…

  20. Acceptance and Commitment Therapy: Introduction

    ERIC Educational Resources Information Center

    Twohig, Michael P.

    2012-01-01

    This is the introductory article to a special series in Cognitive and Behavioral Practice on Acceptance and Commitment Therapy (ACT). Instead of each article herein reviewing the basics of ACT, this article contains that review. This article provides a description of where ACT fits within the larger category of cognitive behavior therapy (CBT):…

  1. The Measurement of Vocational Commitment.

    ERIC Educational Resources Information Center

    Weis, Susan F.; Hubbard, Constance F.

    Recent efforts toward career education and the rise in occupationally oriented programs on the secondary and postsecondary level encourage a close examination of the nature of the relationship between people and their vocations. A 74 item device, the Vocational Commitment Index was developed to assess this relationship. Based upon a theoretically…

  2. Cheat sensitive quantum bit commitment.

    PubMed

    Hardy, Lucien; Kent, Adrian

    2004-04-16

    We define cheat sensitive cryptographic protocols between mistrustful parties as protocols which guarantee that, if either cheats, the other has some nonzero probability of detecting the cheating. We describe an unconditionally secure cheat sensitive nonrelativistic bit commitment protocol which uses quantum information to implement a task which is classically impossible; we also describe a simple relativistic protocol.

  3. Acceptance and Commitment Therapy: Introduction

    ERIC Educational Resources Information Center

    Twohig, Michael P.

    2012-01-01

    This is the introductory article to a special series in Cognitive and Behavioral Practice on Acceptance and Commitment Therapy (ACT). Instead of each article herein reviewing the basics of ACT, this article contains that review. This article provides a description of where ACT fits within the larger category of cognitive behavior therapy (CBT):…

  4. Regulatory Foci and Organizational Commitment

    ERIC Educational Resources Information Center

    Markovits, Yannis; Ullrich, Johannes; van Dick, Rolf; Davis, Ann J.

    2008-01-01

    We use regulatory focus theory to derive specific predictions regarding the differential relationships between regulatory focus and commitment. We estimated a structural equation model using a sample of 520 private and public sector employees and found in line with our hypotheses that (a) promotion focus related more strongly to affective…

  5. Physical Education Teachers' Organizational Commitment

    ERIC Educational Resources Information Center

    Demir, Hayri

    2013-01-01

    The aim of this study was to determine physical education teachers' organizational commitment levels. The sample consisted of 204 physical education teachers working in the city center of Konya in the 2011 to 2012 academic year. The respondents were randomly selected in this research. Data collected for this research by using the Scale for…

  6. Faculty Organizational Commitment and Citizenship

    ERIC Educational Resources Information Center

    Lawrence, Janet; Ott, Molly; Bell, Alli

    2012-01-01

    Building on a theoretical framework that links characteristics of individuals and their work settings to organizational commitment (OC) and citizenship behavior, this study considers why faculty may be disengaging from institutional service. Analyses of survey data collected from a state system of higher education suggest that job characteristics,…

  7. Idiosyncratic Deals and Organizational Commitment

    ERIC Educational Resources Information Center

    Ng, Thomas W. H.; Feldman, Daniel C.

    2010-01-01

    This article examines the relationship between idiosyncratic deals and organizational commitment. In particular, it examines how two individual differences which reflect self-worth (core self-evaluations and age) moderate that relationship. We predicted that employees with feelings of high self-worth will expect and will feel entitled to these…

  8. Predictors of Child Caregiver Commitment.

    ERIC Educational Resources Information Center

    Webb, Nancy Carnahan; Lowther, Malcolm

    This study examined the relationship between child caregiver commitment and the caregiver's personal characteristics and work experience, the characteristics of the job, and the quality of the child care center. Questionnaires that included several measurement instruments were sent to 381 full-time child caregivers in 94 centers. Caregiver…

  9. Idiosyncratic Deals and Organizational Commitment

    ERIC Educational Resources Information Center

    Ng, Thomas W. H.; Feldman, Daniel C.

    2010-01-01

    This article examines the relationship between idiosyncratic deals and organizational commitment. In particular, it examines how two individual differences which reflect self-worth (core self-evaluations and age) moderate that relationship. We predicted that employees with feelings of high self-worth will expect and will feel entitled to these…

  10. Faculty Organizational Commitment and Citizenship

    ERIC Educational Resources Information Center

    Lawrence, Janet; Ott, Molly; Bell, Alli

    2012-01-01

    Building on a theoretical framework that links characteristics of individuals and their work settings to organizational commitment (OC) and citizenship behavior, this study considers why faculty may be disengaging from institutional service. Analyses of survey data collected from a state system of higher education suggest that job characteristics,…

  11. The Relationships between Collegiate DECA Commitment, Mentoring and College Students' Perceived Career Commitment

    ERIC Educational Resources Information Center

    Duke, Linda

    2013-01-01

    This study investigated relationships between student's Collegiate DECA commitment, psychological capital, mentoring, and perceived career commitment. Proposed relationships were supported with several psychological theories and frameworks including Organizational Commitment, Psychological Capital, and Social Identity Theory. Data was…

  12. The Relationships between Collegiate DECA Commitment, Mentoring and College Students' Perceived Career Commitment

    ERIC Educational Resources Information Center

    Duke, Linda

    2013-01-01

    This study investigated relationships between student's Collegiate DECA commitment, psychological capital, mentoring, and perceived career commitment. Proposed relationships were supported with several psychological theories and frameworks including Organizational Commitment, Psychological Capital, and Social Identity Theory. Data was…

  13. What is different about medical students interested in non-clinical careers?

    PubMed

    Kim, Kyong-Jee; Park, Jae-Hyun; Lee, Young-Ho; Choi, Kyusik

    2013-06-04

    The proportion of medical school graduates who pursue careers other than full-time clinical practice has increased in some countries as the physician's role has evolved and diversified with the changing landscape of clinical practice and the advancement of biomedicine. Still, past studies of medical students' career choices have focused on clinical specialties and little is known about their choice of non-clinical careers. The present study examined backgrounds, motivation and perceptions of medical students who intended non-clinical careers. A questionnaire was administered to students at six Korean medical schools distributed across all provinces in the nation. The questionnaire comprised 40 items on respondents' backgrounds, their motivation for and interest in the study of medicine, their perceptions of medical professions, and their career intentions. Data was analyzed using various descriptive and inferential statistics. In total, 1,388 students returned the questionnaire (60% response rate), 12.3% of whom intended non-clinical careers (i.e., basic sciences, non-clinical medical fields, and non-medical fields). Those who planned non-clinical careers were comparable with their peers in their motivation for studying medicine and in their views of medical professions, but they were less interested in the study of medicine (P < 0.01). The two groups also differed significantly on their perceptions of what was uninteresting about the study of medicine (P < 0.01). The two groups were comparable in gender and entry-level ratios but their distributions across ages and years of study differed significantly (P < 0.01). A majority of respondents agreed with the statements that "it is necessary for medical school graduates to pursue non-clinical careers" and that "medical schools need to offer programs that provide information on such careers." Still, our finding indicates that medical school curricula do not address such needs sufficiently. Our study found some

  14. What is different about medical students interested in non-clinical careers?

    PubMed Central

    2013-01-01

    Background The proportion of medical school graduates who pursue careers other than full-time clinical practice has increased in some countries as the physician’s role has evolved and diversified with the changing landscape of clinical practice and the advancement of biomedicine. Still, past studies of medical students’ career choices have focused on clinical specialties and little is known about their choice of non-clinical careers. The present study examined backgrounds, motivation and perceptions of medical students who intended non-clinical careers. Methods A questionnaire was administered to students at six Korean medical schools distributed across all provinces in the nation. The questionnaire comprised 40 items on respondents’ backgrounds, their motivation for and interest in the study of medicine, their perceptions of medical professions, and their career intentions. Data was analyzed using various descriptive and inferential statistics. Results In total, 1,388 students returned the questionnaire (60% response rate), 12.3% of whom intended non-clinical careers (i.e., basic sciences, non-clinical medical fields, and non-medical fields). Those who planned non-clinical careers were comparable with their peers in their motivation for studying medicine and in their views of medical professions, but they were less interested in the study of medicine (P < 0.01). The two groups also differed significantly on their perceptions of what was uninteresting about the study of medicine (P < 0.01). The two groups were comparable in gender and entry-level ratios but their distributions across ages and years of study differed significantly (P < 0.01). A majority of respondents agreed with the statements that “it is necessary for medical school graduates to pursue non-clinical careers” and that “medical schools need to offer programs that provide information on such careers.” Still, our finding indicates that medical school curricula do not address

  15. Safety Profile of Eslicarbazepine Acetate as Add-On Therapy in Adults with Refractory Focal-Onset Seizures: From Clinical Studies to 6 Years of Post-Marketing Experience.

    PubMed

    Gama, Helena; Vieira, Mariana; Costa, Raquel; Graça, Joana; Magalhães, Luís M; Soares-da-Silva, Patrício

    2017-07-27

    Eslicarbazepine acetate was first approved in the European Union in 2009 as adjunctive therapy in adults with partial-onset seizures with or without secondary generalization. The objective of this study was to review the safety profile of eslicarbazepine acetate analyzing the data from several clinical studies to 6 years of post-marketing surveillance. We used a post-hoc pooled safety analysis of four phase III, double-blind, randomized, placebo-controlled studies (BIA-2093-301, -302, -303, -304) of eslicarbazepine acetate as add-on therapy in adults. Safety data of eslicarbazepine acetate in special populations of patients aged ≥65 years with partial-onset seizures (BIA-2093-401) and subjects with moderate hepatic impairment (BIA-2093-111) and renal impairment (BIA-2093-112) are also considered. The incidences of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and serious adverse events were analyzed. The global safety database of eslicarbazepine acetate was analyzed for all cases from post-marketing surveillance from 1 October, 2009 to 21 October, 2015. From a pooled analysis of four phase III studies, it was concluded that the incidence of treatment-emergent adverse events, treatment-emergent adverse events leading to discontinuation, and adverse drug reactions were dose dependent. Dizziness, somnolence, headache, and nausea were the most common treatment-emergent adverse events (≥10% of patients) and the majority were of mild-to-moderate intensity. No dose-dependent trend was observed for serious adverse events and individual serious adverse events were reported in less than 1% of patients. Hyponatremia was classified as a possibly related treatment-emergent adverse event in phase III studies (1.2%); however, after 6 years of post-marketing surveillance it represents the most frequently (10.2%) reported adverse drug reaction, with more than half of these cases occurring with eslicarbazepine acetate at

  16. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study

    PubMed Central

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    Purpose The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. Materials and methods The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1–4) in the tibio–femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. Main outcome measure(s) An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. Main results The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Conclusion Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce

  17. Efficacy and safety of cross-linked hyaluronic acid single injection on osteoarthritis of the knee: a post-marketing Phase IV study.

    PubMed

    Bashaireh, Khaldoon; Naser, Ziad; Hawadya, Khaled Al; Sorour, Sorour; Al-Khateeb, Rami Nabeel

    2015-01-01

    The primary objective of this study was to evaluate the efficacy, safety, and duration of action of viscosupplementation with Crespine® Gel over a 9-month period. The study was a post-marketing Phase IV study. A total of 109 participants with osteoarthritis of the knee (grades 1-4) in the tibio-femoral compartment were recruited in Jordan. Data were collected from each participant during the baseline visit. Each participant received Crespine® Gel injection, and follow-up visits took place at 3 months, 6 months, and 9 months post-injection. An assessment of participants by phone was conducted at 1 month, 2 months, 4 months, 5 months, 7 months, and 8 months post-injection. Western Ontario and McMaster Universities Arthritis Index questionnaires were completed during each visit. A 72-hour visit questionnaire was used to assess the safety of the injection. Statistical analysis included a two-sided 95% confidence interval for the difference between pain scores across visits, and the percent change from baseline was calculated. The full analysis included 84 participants who gave their informed consent and finished the necessary baseline and follow-up visits needed to assess efficacy and safety. Peak improvement was noted at 5 months post-injection, when pain and physical performance scores had decreased to 2.60 and 9.90, respectively, and the stiffness score was 0.33. The peak improvement in stiffness was noted at 8 months post-injection, when the stiffness score had decreased to 0.32. Significant improvements were still apparent at 9 months post-injection, when the pain score was 3.36, the stiffness score was 0.42, and the physical performance score was 11.5. All side effects were local and transient, and included pain, swelling, and redness of the knee. Most side effects were treated. Hyaluronan should be encouraged as an alternative or adjunct treatment to oral analgesics to reduce their required doses, and delay potential future surgical intervention.

  18. Clinical evaluation of recombinant factor VIII preparation (Kogenate) in previously treated patients with hemophilia A: descriptive meta-analysis of post-marketing study data.

    PubMed

    Yoshioka, A; Fukutake, K; Takamatsu, J; Shirahata, A

    2006-08-01

    The safety and efficacy of Kogenate, a recombinant factor VIII (rFVIII) preparation for the treatment of bleeding episodes, were studied in a 123-patient meta-analysis population of previously treated patients (PTPs), including 15 enrolled in the registration Phase III trial (PTP-I group), 93 from the post-marketing special investigation (PTP-II group), and 15 from short-term special investigations in surgery or tooth extraction (SI group). These patients (82 severe, 31 moderate, 9 mild, and 1 unknown), aged 11 months to 72 years, were enrolled in 28 centers in Japan. Blood samples taken at the baseline and at 3, 6, 9, 12, 18, and 24 months after the introduction of Kogenate were evaluated for FVIII inhibitor antibodies, antibodies formed against trace proteins derived from the rFVIII production process, and for general changes in laboratory test results. Mean exposure to Kogenate was 1103 days in PTP-I, 86 days in PTP-II, 27 days in patients in surgery, and 2 days in patients with tooth extraction. Assessment of FVIII inhibitor activity was conducted in 115 of the 123 patients by means of the Bethesda assay. Twelve patients were found to have a low titer of FVIII inhibitor (0.5-3.0 BU/mL) prior to any administration of Kogenate, and 103 were inhibitor-negative at the baseline. Among this latter group, 3 patients (2.9%) tested inhibitor-positive, with titers ranging from 1.2 to 2.1 BU/mL, with 4 patients below 1.0 BU/mL. One patient in the 11 PTPs investigated (PTP-I) developed antibodies against baby hamster kidney protein and mouse immunoglobulin G, but these findings were transient and asymptomatic. Hemostasis was achieved (markedly effective or effective) in 3666 of the 3855 bleeding episodes (95.1%) observed in 108 patients. Only 1 infusion was necessary in 3790 (98.3%) of these episodes. These data indicate that Kogenate is safe and very effective for the treatment of bleeding in PTPs with hemophilia A.

  19. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance

    PubMed Central

    Inoue, Hiroshi; Uchiyama, Shinichiro; Atarashi, Hirotsugu; Okumura, Ken; Koretsune, Yukihiro; Yasaka, Masahiro; Yamashita, Takeshi; Ohnishi, Makiko; Yagi, Nobutaka; Fukaya, Taku

    2016-01-01

    Background/aim A post-marketing surveillance (PMS) study is being conducted to investigate the safety and effectiveness of the long-term use of dabigatran etexilate (dabigatran) in Japanese patients with nonvalvular atrial fibrillation (NVAF). Results of an interim analysis of this prospective cohort study including patient characteristics and adverse drug reactions (ADRs) collected up to September 17, 2014 are reported here. Methods Patients with NVAF who began to receive dabigatran for the first time from December 2011 to November 2013 were enrolled at 1042 study sites in Japan. Clinical parameters included patient characteristics, dabigatran dose strength, concomitant medications and outcome events. All outcome events were collected as serious and non-serious adverse events (AEs). ADRs were evaluated in this report. Pre-defined safety events of special interest for intensive survey were serious and non-serious outcome events such as myocardial infarction, as well as the total number of hemorrhage and gastrointestinal disorders. Results A total of 6772 patients were registered. The safety analysis set included 6148 patients; mean age was 70.8±9.9 (SD) years: 2323 patients (37.8%) were aged 75 years or older. Males accounted for 66.8% of the patients. Mean CHADS2 score was 1.8±1.3; the CHADS2 score was 0 in 13.6%, 1 in 31.3%, 2 in 25.9%, 3 in 14.9%, and 4 to 6 in 11.1% of the patients. Of the 6148 patients, 1701 patients (27.7%) were switchers from warfarin and 4407 patients (71.7%) were non-switchers (OAC naïve patients). Treatment adherence was assessed for the first 3 months from the start of treatment for this analysis. Total 5656 patients (92.0%) reported taking dabigatran twice daily (bid) every day according to the label recommendation. During the follow up period [mean duration of follow up: 498±259 days (corresponding to 8386 patient-years)], pre-defined safety events of special interest for intensive survey (reported as serious ADRs) were: myocardial

  20. Post-marketing surveillance on the long-term use of dabigatran in Japanese patients with nonvalvular atrial fibrillation: Preliminary report of the J-dabigatran surveillance.

    PubMed

    Inoue, Hiroshi; Uchiyama, Shinichiro; Atarashi, Hirotsugu; Okumura, Ken; Koretsune, Yukihiro; Yasaka, Masahiro; Yamashita, Takeshi; Ohnishi, Makiko; Yagi, Nobutaka; Fukaya, Taku

    2016-04-01

    A post-marketing surveillance (PMS) study is being conducted to investigate the safety and effectiveness of the long-term use of dabigatran etexilate (dabigatran) in Japanese patients with nonvalvular atrial fibrillation (NVAF). Results of an interim analysis of this prospective cohort study including patient characteristics and adverse drug reactions (ADRs) collected up to September 17, 2014 are reported here. Patients with NVAF who began to receive dabigatran for the first time from December 2011 to November 2013 were enrolled at 1042 study sites in Japan. Clinical parameters included patient characteristics, dabigatran dose strength, concomitant medications and outcome events. All outcome events were collected as serious and non-serious adverse events (AEs). ADRs were evaluated in this report. Pre-defined safety events of special interest for intensive survey were serious and non-serious outcome events such as myocardial infarction, as well as the total number of hemorrhage and gastrointestinal disorders. A total of 6772 patients were registered. The safety analysis set included 6148 patients; mean age was 70.8±9.9 (SD) years: 2323 patients (37.8%) were aged 75 years or older. Males accounted for 66.8% of the patients. Mean CHADS2 score was 1.8±1.3; the CHADS2 score was 0 in 13.6%, 1 in 31.3%, 2 in 25.9%, 3 in 14.9%, and 4 to 6 in 11.1% of the patients. Of the 6148 patients, 1701 patients (27.7%) were switchers from warfarin and 4407 patients (71.7%) were non-switchers (OAC naïve patients). Treatment adherence was assessed for the first 3 months from the start of treatment for this analysis. Total 5656 patients (92.0%) reported taking dabigatran twice daily (bid) every day according to the label recommendation. During the follow up period [mean duration of follow up: 498±259 days (corresponding to 8386 patient-years)], pre-defined safety events of special interest for intensive survey (reported as serious ADRs) were: myocardial infarction, reported in 5

  1. The Broader Autism Phenotype and Friendships in Non-Clinical Dyads

    ERIC Educational Resources Information Center

    Wainer, Allison L.; Block, Nicole; Donnellan, M. Brent; Ingersoll, Brooke

    2013-01-01

    The broader autism phenotype (BAP) is a set of subclinical traits qualitatively similar to those observed in autism spectrum disorders. The current study sought to elucidate the association between self- and informant-reports of the BAP and friendships, in a non-clinical sample of college student dyads. Self-informant agreement of the BAP and…

  2. The Prevalence of Frequent Binge Eating and Bulimia in a Non-Clinical College Sample.

    ERIC Educational Resources Information Center

    Katzman, Melanie A.; And Others

    Bulimia, an eating disorder characterized by binge eating, may be increasing in frequency. In order to examine and assess: (1) the prevalence of bulimia in a non-clinical sample of college women; (2) the relationship of reports of binge eating to the fulfillment of operationalized Diagnostic and Statistical Manual III (DSM III) criteria for…

  3. A General Factor of Death Distress in Seven Clinical and Non-Clinical Groups

    ERIC Educational Resources Information Center

    Abdel-Khalek, Ahmed M.

    2004-01-01

    The Arabic Scale of Death anxiety (ASDA), the Death Depression Scale (DDS), and the Death Obsession Scale (DOS) were administered, individually, to 7 groups (n = 765) of Egyptian normal participants (non-clinical), anxiety disorder patients, patients suffering from schizophrenia (males and females), and addicts (males only). They were generally…

  4. [Psychometric Properties of the Metacognition Scales about Rumination in Clinical and Non-clinical Turkish Samples].

    PubMed

    Yılmaz, Adviye Esin; Sungur, Mehmet Zihni; Konkan, Ramazan; Şenormancı, Ömer

    2015-01-01

    The aim of this study is to examine the reliability and validity of the Turkish adaptations of the Positive Beliefs about Rumination Scale (PBRS) and the Negative Beliefs about Rumination Scale (NBRS) in clinical and non-clinical samples. While the non-clinical sample of the study consisted of 455 participants, the clinical sample was composed of 60 major depressive disorder (MDD), 30 panic disorder (PD) and 30 social anxiety disorder (SAD) cases. The results of the factor analyses confirm the construct validity and original factor structure of the scales. Findings obtained from internal consistency and test-retest analyses indicated good reliability for the scales. Supporting the convergent validity of the scales, the correlations between metacognitions about rumination and depressive symptoms, rumination, metacognitions about worry, pathological worry, and anxiety symptoms were found to be positive and significant in the non-clinical sample. Hierarchical regression analyses demonstrated that both scales have predictive validity for depressive symptoms after controlling for anxiety symptoms. As for extreme group comparisons, it supported the criterion-related validity of the scales. In discriminant clinical validity examinations, although both scales were able to differentiate MDD, PD, and SAD groups from healthy controls, they were unable to differentiate the depressive group from the other anxiety disorder groups. A comprehensive psychometric evaluation of the scales demonstrated that both PBRS and NBRS are reliable and valid assessment devices that can be used for research purposes both in clinical and non-clinical groups in Turkey.

  5. Mediators of the Link between Autistic Traits and Relationship Satisfaction in a Non-Clinical Sample

    ERIC Educational Resources Information Center

    Pollmann, Monique M. H.; Finkenauer, Catrin; Begeer, Sander

    2010-01-01

    People with ASD have deficits in their social skills and may therefore experience lower relationship satisfaction. This study investigated possible mechanisms to explain whether and how autistic traits, measured with the AQ, influence relationship satisfaction in a non-clinical sample of 195 married couples. More autistic traits were associated…

  6. Clinical and Non-Clinical Characteristics Associated with Medication Use among Children with Serious Emotional Disturbance

    ERIC Educational Resources Information Center

    Pavkov, Thomas W.; Walrath, Christine M.

    2008-01-01

    Our study explores the clinical and non-clinical characteristics associated with medication use among children with serious emotional disturbance who are referred into community-based family-driven system of care settings. Using data collected as part of the Comprehensive Community Mental Health Services for Children and Their Families Program…

  7. The Cerebellar Deficit Hypothesis and Dyslexic Tendencies in a Non-Clinical Sample

    ERIC Educational Resources Information Center

    Brookes, Rebecca L.; Stirling, John

    2005-01-01

    In order to assess the relationship between cerebellar deficits and dyslexic tendencies in a non-clinical sample, 27 primary school children aged 8-9 completed a cerebellar soft signs battery and were additionally assessed for reading age, sequential memory, picture arrangement and knowledge of common sequences. An average measure of the soft…

  8. Clinical and Non-Clinical Characteristics Associated with Medication Use among Children with Serious Emotional Disturbance

    ERIC Educational Resources Information Center

    Pavkov, Thomas W.; Walrath, Christine M.

    2008-01-01

    Our study explores the clinical and non-clinical characteristics associated with medication use among children with serious emotional disturbance who are referred into community-based family-driven system of care settings. Using data collected as part of the Comprehensive Community Mental Health Services for Children and Their Families Program…

  9. How do different types of community commitment influence brand commitment? The mediation of brand attachment.

    PubMed

    Zhang, Ning; Zhou, Zhi-min; Su, Chen-ting; Zhou, Nan

    2013-11-01

    Although previous research indicates that participation in a brand community may foster consumer loyalty to the brand in question, research has seldom examined the mediating effect of community commitment on brand commitment. Drawing from the typologies of organizational commitment, we divide community commitment into three components: continuance community commitment (continuance CC), affective community commitment (affective CC), and normative community commitment (normative CC). We then assess the mediating role of brand attachment in the relationship between these three components and brand commitment. We test the hypotheses using a sample of online mobile phone brand communities in China. The empirical results reveal that brand attachment exerts an indirect (but not mediated) effect on the relationship between continuance CC and brand commitment and on the relationship between normative CC and brand commitment. We also find that it exerts a partial mediating effect on the relationship between affective CC and brand commitment. The findings contribute to the branding literature and have important implications for brand community management.

  10. 7 CFR 3550.70 - Conditional commitments.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... into the required agreements; (4) Be financially responsible and have the ability to finance or obtain... approval of an affirmative marketing plan. (b) Limitations. Conditional commitments for new or... as bad weather, materials shortages, or marketing difficulties. Conditional commitments may...

  11. 7 CFR 3550.70 - Conditional commitments.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... approval of an affirmative marketing plan. (b) Limitations. Conditional commitments for new or... RHS-approved plans, specifications, and regulations and priced within the lesser of the property's... as bad weather, materials shortages, or marketing difficulties. Conditional commitments may be...

  12. Spermatogenesis: The Commitment to Meiosis

    PubMed Central

    Griswold, Michael D.

    2015-01-01

    Mammalian spermatogenesis requires a stem cell pool, a period of amplification of cell numbers, the completion of reduction division to haploid cells (meiosis), and the morphological transformation of the haploid cells into spermatozoa (spermiogenesis). The net result of these processes is the production of massive numbers of spermatozoa over the reproductive lifetime of the animal. One study that utilized homogenization-resistant spermatids as the standard determined that human daily sperm production (dsp) was at 45 million per day per testis (60). For each human that means ∼1,000 sperm are produced per second. A key to this level of gamete production is the organization and architecture of the mammalian testes that results in continuous sperm production. The seemingly complex repetitious relationship of cells termed the “cycle of the seminiferous epithelium” is driven by the continuous commitment of undifferentiated spermatogonia to meiosis and the period of time required to form spermatozoa. This commitment termed the A to A1 transition requires the action of retinoic acid (RA) on the undifferentiated spermatogonia or prospermatogonia. In stages VII to IX of the cycle of the seminiferous epithelium, Sertoli cells and germ cells are influenced by pulses of RA. These pulses of RA move along the seminiferous tubules coincident with the spermatogenic wave, presumably undergoing constant synthesis and degradation. The RA pulse then serves as a trigger to commit undifferentiated progenitor cells to the rigidly timed pathway into meiosis and spermatid differentiation. PMID:26537427

  13. Spermatogenesis: The Commitment to Meiosis.

    PubMed

    Griswold, Michael D

    2016-01-01

    Mammalian spermatogenesis requires a stem cell pool, a period of amplification of cell numbers, the completion of reduction division to haploid cells (meiosis), and the morphological transformation of the haploid cells into spermatozoa (spermiogenesis). The net result of these processes is the production of massive numbers of spermatozoa over the reproductive lifetime of the animal. One study that utilized homogenization-resistant spermatids as the standard determined that human daily sperm production (dsp) was at 45 million per day per testis (60). For each human that means ∼1,000 sperm are produced per second. A key to this level of gamete production is the organization and architecture of the mammalian testes that results in continuous sperm production. The seemingly complex repetitious relationship of cells termed the "cycle of the seminiferous epithelium" is driven by the continuous commitment of undifferentiated spermatogonia to meiosis and the period of time required to form spermatozoa. This commitment termed the A to A1 transition requires the action of retinoic acid (RA) on the undifferentiated spermatogonia or prospermatogonia. In stages VII to IX of the cycle of the seminiferous epithelium, Sertoli cells and germ cells are influenced by pulses of RA. These pulses of RA move along the seminiferous tubules coincident with the spermatogenic wave, presumably undergoing constant synthesis and degradation. The RA pulse then serves as a trigger to commit undifferentiated progenitor cells to the rigidly timed pathway into meiosis and spermatid differentiation.

  14. Young Children's Understanding of Joint Commitments

    ERIC Educational Resources Information Center

    Grafenhain, Maria; Behne, Tanya; Carpenter, Malinda; Tomasello, Michael

    2009-01-01

    When adults make a joint commitment to act together, they feel an obligation to their partner. In 2 studies, the authors investigated whether young children also understand joint commitments to act together. In the first study, when an adult orchestrated with the child a joint commitment to play a game together and then broke off from their joint…

  15. Professionalism as a Form of Work Commitment.

    ERIC Educational Resources Information Center

    Morrow, Paula C.; Goetz, Joe F., Jr.

    1988-01-01

    Evaluated concept of professionalism as a form of work commitment using a modified version of Hall's (1968) multidimensional measure of professionalism on 325 accountants in public practice. Examined three forms of work commitment--job involvement, organizational commitment, and work ethic endorsement--and four professional behaviors. Suggests the…

  16. Professionalism as a Form of Work Commitment.

    ERIC Educational Resources Information Center

    Morrow, Paula C.; Goetz, Joe F., Jr.

    1988-01-01

    Evaluated concept of professionalism as a form of work commitment using a modified version of Hall's (1968) multidimensional measure of professionalism on 325 accountants in public practice. Examined three forms of work commitment--job involvement, organizational commitment, and work ethic endorsement--and four professional behaviors. Suggests the…

  17. Commitment among Arab Adolescents in Israel.

    ERIC Educational Resources Information Center

    Ben-Ari, Adital Tirosh; Azaiza, Faisal

    1998-01-01

    Examines 662 Arab adolescents' commitments to their own self-development, family, Arab people, and village along with the order in which these commitments are structured. Reveals that the two prevalent patterns of adolescent commitment, individualistic and collectivistic, demonstrate the adolescents' struggle with these value systems and the…

  18. The Commitment Process for Psychiatric Patients

    PubMed Central

    Shore, James H.

    1978-01-01

    Recent changes in commitment legislation for the mentally ill have had an important impact on the role of physicians in treating these patients. New commitment laws emphasize civil rights at the expense of right-to-treatment concepts, sometimes causing neglect of severely psychotic persons. Only four western states have a high rating of conformity with a model commitment statute. PMID:636410

  19. 24 CFR 200.47 - Firm commitments.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DEVELOPMENT GENERAL INTRODUCTION TO FHA PROGRAMS Requirements for Application, Commitment, and Endorsement... Eligibility Requirements for Existing Projects Commitment Applications § 200.47 Firm commitments. A valid firm... completion of construction or substantial rehabilitation of the project; or (2) Upon completion of...

  20. Organizational and Client Commitment among Contracted Employees

    ERIC Educational Resources Information Center

    Coyle-Shapiro, Jacqueline A-M.; Morrow, Paula C.

    2006-01-01

    This study examines affective commitment to employing and client organizations among long-term contracted employees, a new and growing employment classification. Drawing on organizational commitment and social exchange literatures, we propose two categories of antecedents of employee commitment to client organizations. We tested our hypotheses…

  1. Anchors of Religious Commitment in Adolescents

    ERIC Educational Resources Information Center

    Layton, Emily; Dollahite, David C.; Hardy, Sam A.

    2011-01-01

    This study explores adolescent religious commitment using qualitative data from a religiously diverse (Jewish, Christian, Muslim) sample of 80 adolescents. A new construct, "anchors of religious commitment," grounded in interview data, is proposed to describe what adolescents commit to as a part of their religious identity. Seven anchors of…

  2. The Sense of Commitment: A Minimal Approach

    PubMed Central

    Michael, John; Sebanz, Natalie; Knoblich, Günther

    2016-01-01

    This paper provides a starting point for psychological research on the sense of commitment within the context of joint action. We begin by formulating three desiderata: to illuminate the motivational factors that lead agents to feel and act committed, to pick out the cognitive processes and situational factors that lead agents to sense that implicit commitments are in place, and to illuminate the development of an understanding of commitment in ontogeny. In order to satisfy these three desiderata, we propose a minimal framework, the core of which is an analysis of the minimal structure of situations which can elicit a sense of commitment. We then propose a way of conceptualizing and operationalizing the sense of commitment, and discuss cognitive and motivational processes which may underpin the sense of commitment. PMID:26779080

  3. Commitment accounting for CO2 emissions

    NASA Astrophysics Data System (ADS)

    Davis, S. J.; Socolow, R. H.

    2013-12-01

    Long-lived energy infrastructure that burns fossil fuels represents a multi-decade 'commitment' to emit CO2. Today's global power sector, alone, represents hundreds of billions of tons of still unrealized 'committed emissions' of CO2. And every year, substantial new commitments to future emissions are made, as new power plants are built. The socioeconomic inertia of these commitments is a major barrier to climate change mitigation. Here, we quantify these annual commitments by a bottom-up analysis of all power plants commissioned between 1950 and 2011; assigning emission commitments to the year when each generator came on line. We find, assuming 40-year commitments, that the global commitment to future emissions from the world's generators in 2011 (the most recent year in our analysis) was 318 Gt CO2, of which 216 Gt CO2 were commitments from the world's coal-fired generators and 134 Gt CO2 were commitments from China's generators. Annual new global commitments exceeded 15 Gt CO2 per year in every year since 2000. Moreover, between 2005-2010 (the latest year of available emissions data), new global commitments were more than twice as large as actual emissions from all power plants. Country-specific ratios of new committed emissions to actual emissions, averaged over 1990-2010 were 4.1 for China, 2.6 for India, 0.9 for the EU, and 0.6 for the US. We urge that the reporting of annual CO2 emissions, already widely institutionalized, be augmented by 'commitment accounting' which makes these future emissions salient. Annual committed emissions and annual emissions of primary power infrastructure. New committed emissions (light green) have grown from approximately 4 Gt CO2 per year in 1960 to roughly 10 Gt CO2 per year between 1970-1995, and then to more than 15 Gt CO2 per year since 2000. Throughout this period, new committed emissions have exceeded annual emissions (blue curve, source: IEA). Although the commitments made 30-40 years ago have largely been realized (dark

  4. Meeting the non-clinical education and training needs of new consultants.

    PubMed

    Higgins, R; Gallen, D; Whiteman, S

    2005-08-01

    This review highlights the non-clinical training needs of new consultants, identifying strategies for meeting these needs. Non-clinical activities are integral to the consultant's role and senior clinicians need training in these areas. Concerns over the quantity and quality of current provision are compounded by changes the European Working Time Directive and Modernising Medical Careers initiative will bring. Accelerated progression to senior level and reduction in time for training suggest a pressing need to respond to the needs of new consultants. Ad hoc initiatives in a range of healthcare contexts offer examples of how training needs may be met, including mentoring and continuing professional development schemes. A multi-professional strategy, incorporating elements of higher professional education in general practice and other NHS initiatives (particularly management/leadership training), may offer an appropriate framework within which to capitalise on existing opportunities. There are, however, resource implications that need to be addressed.

  5. Base rate of performance invalidity among non-clinical undergraduate research participants.

    PubMed

    Silk-Eglit, Graham M; Stenclik, Jessica H; Gavett, Brandon E; Adams, Jason W; Lynch, Julie K; Mccaffrey, Robert J

    2014-08-01

    Neuropsychological research frequently uses non-clinical undergraduate participants to evaluate neuropsychological tests. However, a recent study by An and colleagues (2012, Archives of Clinical Neuropsychology, 27, 849-857) called into question that the extent to which the interpretation of these participants' performance on neuropsychological tests is valid. This study found that in a sample of 36 participants, 55.6% exhibited performance invalidity at an initial session and 30.8% exhibited performance invalidity at a follow-up session. The current study attempted to replicate these findings in a larger, more representative sample using a more rigorous methodology. Archival data from 133 non-clinical undergraduate research participants were analyzed. Participants were classified as performance invalid if they failed any one PVT. In the current sample, only 2.26% of participants exhibited performance invalidity. Thus, concerns regarding insufficient effort and performance invalidity when using undergraduate research participants appear to be overstated.

  6. Meeting the non-clinical education and training needs of new consultants

    PubMed Central

    Higgins, R; Gallen, D; Whiteman, S

    2005-01-01

    This review highlights the non-clinical training needs of new consultants, identifying strategies for meeting these needs. Non-clinical activities are integral to the consultant's role and senior clinicians need training in these areas. Concerns over the quantity and quality of current provision are compounded by changes the European Working Time Directive and Modernising Medical Careers initiative will bring. Accelerated progression to senior level and reduction in time for training suggest a pressing need to respond to the needs of new consultants. Ad hoc initiatives in a range of healthcare contexts offer examples of how training needs may be met, including mentoring and continuing professional development schemes. A multi-professional strategy, incorporating elements of higher professional education in general practice and other NHS initiatives (particularly management/leadership training), may offer an appropriate framework within which to capitalise on existing opportunities. There are, however, resource implications that need to be addressed. PMID:16085744

  7. Measuring government commitment to vaccination.

    PubMed

    Glassman, Amanda; Zoloa, Juan Ignacio; Duran, Denizhan

    2013-04-18

    Vaccination is among the most cost-effective health interventions and has attracted ever greater levels of funding from public and private donors. However, some countries, mainly populous lower-middle income countries, are lagging behind on vaccination financing and performance. In this paper, we discuss the rationale for investing in vaccination and construct a metric to measure government commitment to vaccination that could promote accountability and better tracking of performance. While noting the limitations of available data, we find that populous middle-income countries, which stand to gain tremendously from increased vaccination uptake, perform poorly in terms of their vaccination outcomes.

  8. Our Commitment to Bioenergy Sustainability

    SciTech Connect

    2015-06-18

    The U.S. Department of Energy’s Bioenergy Technologies Office (BETO) is committed to developing the resources, technologies, and systems needed to support a thriving bioenergy industry that protects natural resources and ad- vances environmental, economic, and social benefits. BETO’s Sustainability Technology Area proactively identifies and addresses issues that affect the scale-up potential, public acceptance, and long-term viability of advanced bioenergy systems; as a result, the area is critical to achieving BETO’s overall goals.

  9. Non-clinical factors influencing the selection of patients with acute coronary syndromes for angiography

    PubMed Central

    Quaas, A; Curzen, N; Garratt, C

    2004-01-01

    Objective: To analyse clinical and non-clinical factors determining the selection for coronary angiography in patients with acute coronary syndromes (ACS). Design: Single centre, prospective cohort study. Participants: Eighty consecutive patients admitted with a diagnosis of ACS during the period 21 May 2001 to 4 July 2001. Setting: Coronary care unit of a tertiary referral centre, the Manchester Royal Infirmary. Data collection: Information concerning baseline patient characteristics, clinical presentation, and the selection for angiography was collected from the patient notes. Data analysis: Windows SPSS version 9.0 using cross tabulations with χ2 estimation and binomial logistic regression analysis. Main outcome measure: Selection for angiography in ACS. Results: Cross tabulations with χ2 analysis and logistic regression analysis identified significant non-clinical factors predicting the use of angiography. Although clinical factors such as recurrent ischaemia (odds ratio 5.11) influenced the decision to undergo coronary angiography, non-clinical factors such as young age (odds ratio 6.88 for <65 years old), gender (odds ratio 3.81 for males), admission on a weekday (odds ratio 0.2488 for admission on the weekend), and consultant in charge (odds ratio 0.111 for consultant "2") independently predicted the use of angiography in ACS. Conclusion: The selection of patients for angiography in ACS is not based purely on clinical criteria. Awareness of the apparent sources of bias among clinical decision makers may improve management of these patients. PMID:15254306

  10. Childhood Familial Environment, Maltreatment and Borderline Personality Disorder Symptoms in a Non-Clinical Sample: A Cognitive Behavioural Perspective

    ERIC Educational Resources Information Center

    Carr, Steven; Francis, Andrew

    2009-01-01

    The present study sought to determine if cognitive beliefs and schemas mediated the relationship between retrospectively reported childhood events and adult borderline personality disorder (BPD) symptoms in a non-clinical sample. One hundred and seventy-eight non-clinical participants completed questionnaires measuring BPD symptoms, core beliefs,…

  11. Childhood Familial Environment, Maltreatment and Borderline Personality Disorder Symptoms in a Non-Clinical Sample: A Cognitive Behavioural Perspective

    ERIC Educational Resources Information Center

    Carr, Steven; Francis, Andrew

    2009-01-01

    The present study sought to determine if cognitive beliefs and schemas mediated the relationship between retrospectively reported childhood events and adult borderline personality disorder (BPD) symptoms in a non-clinical sample. One hundred and seventy-eight non-clinical participants completed questionnaires measuring BPD symptoms, core beliefs,…

  12. Outpatient civil commitment: a dangerous charade or a component of a comprehensive institution of civil commitment?

    PubMed

    Schopp, Robert F

    2003-01-01

    This article examines three criticisms frequently directed toward preventive commitment as one form of outpatient commitment. These criticisms contend that preventive commitment (a) abandons the dangerousness criteria for civil commitmnet, (b) promotes unwarranted inpatient commitment of those who do not meet civil commitment criteria, and (c) undermines important individual liberties by diluting the right to refuse treatment. Understanding and evaluating these criticisms requires analysis of the intersection among empirical, conceptual, and justificatory claims. According to the analysis presented here, advocates of preventive commitment can defend a legitimate role for preventive commitment. This analysis applies to preventive commitment as a dispositional alternative within a comprehensive institution of civil commitment involving distinct parens patriae and police power components.

  13. Nurses' evaluation of physicians' non-clinical performance in emergency departments: advantages, disadvantages and lessons learned.

    PubMed

    Alameddine, Mohamad; Mufarrij, Afif; Saliba, Miriam; Mourad, Yara; Jabbour, Rima; Hitti, Eveline

    2015-02-27

    Peer evaluation is increasingly used as a method to assess physicians' interpersonal and communication skills. We report on experience with soliciting registered nurses' feedback on physicians' non-clinical performance in the ED of a large academic medical center in Lebanon. We utilized a secondary analysis of a de-identified database of ED nurses' assessment of physicians' non-clinical performance coupled with an evaluation of interventions carried out as a result of this evaluation. The database was compiled as part of quality/performance improvement initiatives using a cross-sectional design to survey registered nurses working at the ED. The survey instrument included open ended and closed ended questions assessing physicians' communication, professionalism and leadership skills. Three episodes of evaluation were carried out over an 18 month period. Physicians were provided with a communication training carried out after the first cycle of evaluation and a detailed feedback on their assessment by nurses after each evaluation cycle. A paired t-test was carried out to compare mean evaluation scores between the three cycles of evaluation. Thematic analysis of nurses' qualitative comments was carried out. A statistically significant increase in the averages of skills was observed between the first and second evaluations, followed by a significant decrease in the averages of the three skills between the second and third evaluations. Personalized feedback to ED physicians and communication training initially contributed to a significant positive impact on improving ED physicians' non-clinical skills as perceived by the ED nurses. Yet, gains achieved were lost upon reaching the third cycle of evaluation. However, the thematic analysis of the nurses' qualitative responses portrays a decrease in concerns across the various dimensions of non-clinical performance. Nurses' evaluation of the non-clinical performance of physicians has the potential of improving communication

  14. 78 FR 58149 - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-20

    ... Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support Terrorism #0; #0; #0... the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support Terrorism On... persons who commit, threaten to commit, or support terrorism, pursuant to the International...

  15. 76 FR 58999 - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, Or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-22

    ... Emergency With Respect to Persons Who Commit, Threaten To Commit, or Support Terrorism #0; #0; #0... the National Emergency With Respect to Persons Who Commit, Threaten To Commit, Or Support Terrorism On... persons who commit, threaten to commit, or support terrorism, pursuant to the International...

  16. Leadership and satisfaction in change commitment.

    PubMed

    Yang, Yi-Feng

    2011-06-01

    Managerial transformational leadership skills may directly influence banking counter staff toward change commitment and improve job satisfaction and service quality, or the influence instead may be mediated by change commitment. For a sample comprised of 246 managers from four large Taiwanese banks, the following path relationships were tested: (1) the association of transformational leadership with change commitment, (2) the association of change commitment with job satisfaction, and (3) the direct or indirect (through the mediation of change commitment) effect of transformational leadership on job satisfaction. Regression was utilized to gain insight into the effects of transformational leadership and change commitment on job satisfaction. Transformational leadership may foster change by providing psychological support to the banking counter staff, enabling them to use their skills to meet the needs of individual customers in response to complex environments.

  17. On the justification for civil commitment.

    PubMed

    Høyer, G

    2000-01-01

    This paper explores some of the controversies in the debate regarding the justification of civil commitment. The sometimes conflicting values reflected in the mental health legislation, human rights principles, moral philosophy and psychiatric professional standards are discussed. In spite of the often substantial use of civil commitment in many countries, there are almost no scientifically sound studies addressing the outcome of coercive treatment. The paper establishes that the traditional arguments in favour of civil commitment, like lack of insight and competence as well as the effectiveness of civil commitment, are poorly founded. The paper concludes that there seems to be a general agreement that civil commitment of patients who are dangerous to themselves or others should be the responsibility of the mental health care system, while civil commitment for treatment purposes is more controversial and hard to justify.

  18. Commitment, Careers, and Retention in Organizations.

    DTIC Science & Technology

    1980-11-01

    validation of a measure of employee commitment to organizations. This instrument has been used to carry out several studies relating to both the antecedents...validating a measure of employee commitment to work organizations. The instrument, developed by Porter and his colleagues, is called the Organizational...34 Employee Commitment and Organizational Effectiveness." Invited speaker, University of Washington, November 1978. Steers, R. M. "Facilitating

  19. Factors Affecting Organizational Commitment in Navy Corpsmen.

    PubMed

    Booth-Kewley, Stephanie; Dell'Acqua, Renée G; Thomsen, Cynthia J

    2017-07-01

    Organizational commitment is a psychological state that has a strong impact on the likelihood that employees will remain with an organization. Among military personnel, organizational commitment is predictive of a number of important outcomes, including reenlistment intentions, job performance, morale, and perceived readiness. Because of the unique challenges and experiences associated with military service, it may be that organizational commitment is even more critical in the military than in civilian populations. Despite the essential role that they play in protecting the health of other service members, little is known about the factors that influence Navy Corpsmen's organizational commitment. This study investigated demographic and psychosocial factors that may be associated with organizational commitment among Corpsmen. Surveys of organizational commitment and possible demographic and psychosocial correlates of organizational commitment were completed by 1,597 male, active duty Navy Corpsmen attending Field Medical Training Battalion-West, Camp Pendleton, California. Bivariate correlations and hierarchical multiple regression analyses were used to determine significant predictors of organizational commitment. Of the 12 demographic and psychosocial factors examined, 6 factors emerged as significant predictors of organizational commitment in the final model: preservice motivation to be a Corpsman, positive perceptions of Corpsman training, confidence regarding promotions, occupational self-efficacy, social support for a Corpsman career, and lower depression. Importantly, a number of the factors that emerged as significant correlates of organizational commitment in this study are potentially modifiable. These factors include confidence regarding promotions, positive perceptions of Corpsman training, and occupational self-efficacy. It is recommended that military leaders and policy-makers take concrete steps to address these factors, thereby strengthening

  20. Revealing ontological commitments by magic.

    PubMed

    Griffiths, Thomas L

    2015-03-01

    Considering the appeal of different magical transformations exposes some systematic asymmetries. For example, it is more interesting to transform a vase into a rose than a rose into a vase. An experiment in which people judged how interesting they found different magic tricks showed that these asymmetries reflect the direction a transformation moves in an ontological hierarchy: transformations in the direction of animacy and intelligence are favored over the opposite. A second and third experiment demonstrated that judgments of the plausibility of machines that perform the same transformations do not show the same asymmetries, but judgments of the interestingness of such machines do. A formal argument relates this sense of interestingness to evidence for an alternative to our current physical theory, with magic tricks being a particularly pure source of such evidence. These results suggest that people's intuitions about magic tricks can reveal the ontological commitments that underlie human cognition.

  1. When a patient commits suicide.

    PubMed

    Marshall, K A

    1980-01-01

    Suicide is a tragic and upsetting event which sometimes occurs when a person is in some form of therapy. This paper advocates a process after a patient commits suicide which allows for a thorough and orderly working through of the event by involved treatment personnel. The primary focus of this process is neither identification of responsibility nor of cause. The primary goals are to air issues and attitudes, identify factors contributing to the suicide, and most particularly to allow for the thorough expression of residual feelings and issues by the treatment personnel affected. Therapists who utilized this process were able to deal satisfactorily with grief and guilt issues after experiencing patient suicides. A case example illustrates the use of this process.

  2. Voices to reckon with: perceptions of voice identity in clinical and non-clinical voice hearers

    PubMed Central

    Badcock, Johanna C.; Chhabra, Saruchi

    2013-01-01

    The current review focuses on the perception of voice identity in clinical and non-clinical voice hearers. Identity perception in auditory verbal hallucinations (AVH) is grounded in the mechanisms of human (i.e., real, external) voice perception, and shapes the emotional (distress) and behavioral (help-seeking) response to the experience. Yet, the phenomenological assessment of voice identity is often limited, for example to the gender of the voice, and has failed to take advantage of recent models and evidence on human voice perception. In this paper we aim to synthesize the literature on identity in real and hallucinated voices and begin by providing a comprehensive overview of the features used to judge voice identity in healthy individuals and in people with schizophrenia. The findings suggest some subtle, but possibly systematic biases across different levels of voice identity in clinical hallucinators that are associated with higher levels of distress. Next we provide a critical evaluation of voice processing abilities in clinical and non-clinical voice hearers, including recent data collected in our laboratory. Our studies used diverse methods, assessing recognition and binding of words and voices in memory as well as multidimensional scaling of voice dissimilarity judgments. The findings overall point to significant difficulties recognizing familiar speakers and discriminating between unfamiliar speakers in people with schizophrenia, both with and without AVH. In contrast, these voice processing abilities appear to be generally intact in non-clinical hallucinators. The review highlights some important avenues for future research and treatment of AVH associated with a need for care, and suggests some novel insights into other symptoms of psychosis. PMID:23565088

  3. Attitude towards oneself and others in non-clinical population, depressed and paranoid examinees.

    PubMed

    Budiša, Danijela; Gavrilov-Jerković, Vesna; Dickov, Aleksandra; Mitrovic, Sladjana Martinovic; Dragin, Dragana

    2012-12-01

    The theoretical concept of existential/life positions describes person's basic beliefs about oneself and others. Most of authors on TA postulated that every person has one of four possible basic life positions: I'm OK, you're OK; I'm not OK, you're OK; I'm OK, you're not OK and I'm not OK, you're not OK. The aim of this study was the authentication of Existential positions as theoretical concepts in Transaction Analysis, and it's potential to discriminate clinical from non-clinical examinees, and paranoid from depressive examinees within the clinical population. The research conducted was co-relational. The sample belongs to the convenience sample type, and comprised 200 examinees, 100 from the non-clinical and 100 from the clinical population of adults. The results of the research confirm a statistically significant difference between the non-clinical and clinical part of the sample in the examined theoretical concept. The "I am not OK" existential position is more expressed in the clinical part of the sample. The differences between the examinees with depressive and paranoid disorders indicate that the examinees with the depressive disorder are more likely to express the "I am not OK, you are OK" and "I am not OK, you are not OK" Existential position. In general, we can infer that the assumptions which the research was aimed at testing received partial validation. Examinees from the clinical part of the sample have a statistically significantly higher score at the position "I am not OK". Examinees with depressive characteristics have a more pronounced "I am not OK, you are not OK" position.

  4. Risk of occupational exposure to the HBV infection in non-clinical healthcare personnel.

    PubMed

    Rymer, Weronika; Gładysz, Andrzej; Filipowski, Henryk; Zubkiewicz-Zarębska, Anna; Tumińska, Anna; Knysz, Brygida

    Occupational risk of blood-borne infections is investigated mostly among nurses and doctors, studies concerning non-clinical health personnel (nCHP) being rare. The analysis of the occupational exposure to the hepatitis B virus (HBV) infection and the history of vaccination against the HBV in the nCHP group has been the aim of the study. A retrospective analysis of 458 cases of the occupational exposure to biological agents was conducted: group I - doctors (N = 121, 28%), group II - nursing staff (N = 251, 55%), group III - nCHP (N = 86, 19%). In the group III the source was usually unknown (group: I - 0.83%, II - 11.16%, III - 86.05%, p < 0.001), and the proportion of individuals vaccinated against hepatitis B before the exposure was the lowest (group: I - 98.35%, II - 97.19%, III - 77.91%, p < 0.001). In this group most exposures resulted from injuries caused by needles/sharps deposited in waste sacks (60%) or anywhere outside of the medical waste container (5%). The possibility of the HBV infection risk during the exposure was found in 25 cases and was significantly more frequent in the group III. The qualification for the HBV post-exposure prophylaxis was also significantly more frequent in the group III. The exposure to the occupational risk of the HBV infection also concerns the non-clinical healthcare personnel. The non-clinical healthcare personnel comprises one of the main groups of the HBV post-exposure recipients. It is essential to determine the causes of the low hepatitis B vaccination coverage in the nCHP and consider introduction of mandatory vaccination in this group in Poland. Med Pr 2016;67(3):301-310. This work is available in Open Access model and licensed under a CC BY-NC 3.0 PL license.

  5. Belief-bias reasoning in non-clinical delusion-prone individuals.

    PubMed

    Anandakumar, T; Connaughton, E; Coltheart, M; Langdon, R

    2017-09-01

    It has been proposed that people with delusions have difficulty inhibiting beliefs (i.e., "doxastic inhibition") so as to reason about them as if they might not be true. We used a continuity approach to test this proposal in non-clinical adults scoring high and low in psychometrically assessed delusion-proneness. High delusion-prone individuals were expected to show greater difficulty than low delusion-prone individuals on "conflict" items of a "belief-bias" reasoning task (i.e. when required to reason logically about statements that conflicted with reality), but not on "non-conflict" items. Twenty high delusion-prone and twenty low delusion-prone participants (according to the Peters et al. Delusions Inventory) completed a belief-bias reasoning task and tests of IQ, working memory and general inhibition (Excluded Letter Fluency, Stroop and Hayling Sentence Completion). High delusion-prone individuals showed greater difficulty than low delusion-prone individuals on the Stroop and Excluded Letter Fluency tests of inhibition, but no greater difficulty on the conflict versus non-conflict items of the belief-bias task. They did, however, make significantly more errors overall on the belief-bias task, despite controlling for IQ, working memory and general inhibitory control. The study had a relatively small sample size and used non-clinical participants to test a theory of cognitive processing in individuals with clinically diagnosed delusions. Results failed to support a role for doxastic inhibitory failure in non-clinical delusion-prone individuals. These individuals did, however, show difficulty with conditional reasoning about statements that may or may not conflict with reality, independent of any general cognitive or inhibitory deficits. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Anxiety sensitivity and catastrophizing: Associations with pain and somatization in non-clinical children

    PubMed Central

    Tsao, Jennie C. I.; Allen, Laura B.; Evans, Subhadra; Lu, Qian; Myers, Cynthia D.; Zeltzer, Lonnie K.

    2009-01-01

    This study examined the relationships among anxiety sensitivity (AS), catastrophizing, somatization, and pain in 240 non-clinical children (121 girls; mean age = 12.7 years). Children with pain problems (n = 81; 33.8%) reported greater AS and catastrophizing (p’s < .01) relative to children without pain problems. AS but not catastrophizing was significantly associated with current pain. However, both AS and catastrophizing were significantly associated with somatization. AS and catastrophizing represent related but partially distinct cognitive constructs that may be targeted by interventions aimed at alleviating pain and somatization in children. PMID:19858329

  7. Project on Elite Athlete Commitment (PEAK): IV. identification of new candidate commitment sources in the sport commitment model.

    PubMed

    Scanlan, Tara K; Russell, David G; Scanlan, Larry A; Klunchoo, Tatiana J; Chow, Graig M

    2013-10-01

    Following a thorough review of the current updated Sport Commitment Model, new candidate commitment sources for possible future inclusion in the model are presented. They were derived from data obtained using the Scanlan Collaborative Interview Method. Three elite New Zealand teams participated: amateur All Black rugby players, amateur Silver Fern netball players, and professional All Black rugby players. An inductive content analysis of these players' open-ended descriptions of their sources of commitment identified four unique new candidate commitment sources: Desire to Excel, Team Tradition, Elite Team Membership, and Worthy of Team Membership. A detailed definition of each candidate source is included along with example quotes from participants. Using a mixed-methods approach, these candidate sources provide a basis for future investigations to test their viability and generalizability for possible expansion of the Sport Commitment Model.

  8. Identity Style, Parental Authority, and Identity Commitment.

    ERIC Educational Resources Information Center

    Berzonsky, Michael D.

    2004-01-01

    The role that parental authority patterns and social-cognitive identity styles may play in establishing identity commitments was investigated. The results indicated that family authority and identity style variables combined accounted for 50% of the variation in strength of identity commitment. As hypothesized, the relationship between parental…

  9. Education on the Internet: Anonymity vs. Commitment.

    ERIC Educational Resources Information Center

    Dreyfus, Hubert L.

    1998-01-01

    Argues that learning a skill requires the kind of commitment which is undermined by the Press (the Public) and the Internet, citing Soren Kierkegaard's "The Present Age", and states that learning by apprenticeship is impossible in cyberspace. Includes: aesthetic sphere--commitment to the enjoyment of sheer information; ethical…

  10. Analyzing Teaching Commitment: Theoretical and Empirical Dimensions.

    ERIC Educational Resources Information Center

    Tyree, Alexander K., Jr.

    Classical commitment studies are either sociologically oriented or based in the psychological empirical research tradition. A review of the literature reveals agreement on the multidimensionality and the contextual complexity of commitment, two principles which guide the hypotheses of the present study. This study uses the Administrator and…

  11. Predictors of Commitment to Athletic Training Education

    ERIC Educational Resources Information Center

    Weiss, Windee M.; Neibert, Peter J.

    2013-01-01

    Context: In order for athletic training students to be successful in any athletic training education program (ATEP), a certain level of commitment to the program and profession is required. Objective: The purpose of this study was to explore the applicability of the sport commitment model (SCM) to an ATEP by applying the SCM in an academic setting…

  12. Sexually Violent Predators and Civil Commitment Laws

    ERIC Educational Resources Information Center

    Beyer Kendall, Wanda D.; Cheung, Monit

    2004-01-01

    This article analyzes the civil commitment models for treating sexually violent predators (SVPs) and analyzes recent civil commitment laws. SVPs are commonly defined as sex offenders who are particularly predatory and repetitive in their sexually violent behavior. Data from policy literature, a survey to all states, and a review of law review…

  13. Predicting the Social Commitments of College Students.

    ERIC Educational Resources Information Center

    Lavelle, Ellen; O'Ryan, Leslie W.

    2001-01-01

    Investigates the nature of social beliefs and commitments during the college years in relation to developmental orientations as measured by the Dakota Inventory of Student Orientations. Results support Creative-Reflective scale scores as predictive of commitment to the more humanitarian issues such as race and women's rights, whereas…

  14. The Social Construction of Marital Commitment

    ERIC Educational Resources Information Center

    Byrd, Stephanie Ellen

    2009-01-01

    This paper articulates a theoretical framework for understanding how individuals orient themselves toward marital commitment. Using a life history interview methodology and interpretive framework, it examines the orientations toward marital commitment for a sample of women and men, single and married, between the ages of 28 and 35 (N = 75).…

  15. Education on the Internet: Anonymity vs. Commitment.

    ERIC Educational Resources Information Center

    Dreyfus, Hubert L.

    1998-01-01

    Argues that learning a skill requires the kind of commitment which is undermined by the Press (the Public) and the Internet, citing Soren Kierkegaard's "The Present Age", and states that learning by apprenticeship is impossible in cyberspace. Includes: aesthetic sphere--commitment to the enjoyment of sheer information; ethical…

  16. Juvenile Court Commitment Rates: The National Picture.

    ERIC Educational Resources Information Center

    Sosin, Michael

    There is less geographic variation in the commitment rate of juvenile offenders than is commonly assumed. Apparently, judges across the country develop a similar standard of what percentage of youths they face should be committed. This standard may be similar across the country because it represents broadly shared ideals. However, there is much…

  17. 24 CFR 200.47 - Firm commitments.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVELOPMENT GENERAL INTRODUCTION TO FHA PROGRAMS Requirements for Application, Commitment, and Endorsement... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Firm commitments. 200.47 Section 200.47 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued...

  18. 24 CFR 200.46 - Commitment issuance.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVELOPMENT GENERAL INTRODUCTION TO FHA PROGRAMS Requirements for Application, Commitment, and Endorsement... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Commitment issuance. 200.46 Section 200.46 Housing and Urban Development Regulations Relating to Housing and Urban Development (Continued...

  19. Psychology & employee commitment. Promoting physician loyalty.

    PubMed

    Lakin, J D

    1998-01-01

    Physician and staff loyalty has become more important and more difficult to maintain. Group managers should realize that not all forms of commitment are equal and should actively work to build commitment to the organization, not just to the practice of medicine.

  20. Overview of the Core Commitments Initiative

    ERIC Educational Resources Information Center

    McTighe Musil, Caryn

    2013-01-01

    This chapter provides an overview of the Core Commitments Initiative conducted by the Association of American Colleges and Universities (AAC&U). Core Commitments was intended to reinvigorate the conversation about personal and social responsibility within higher education, and served as the impetus for this "New Directions" volume.

  1. Making Commitments to Racial Justice Actionable

    ERIC Educational Resources Information Center

    Diab, Rasha; Ferrel, Thomas; Godbee, Beth; Simpkins, Neil

    2013-01-01

    In this article, we articulate a framework for making our commitments to racial justice actionable, a framework that moves from narrating confessional accounts to articulating our commitments and then acting on them through both self-work and work-with-others, a dialectic possibility we identify and explore. We model a method for moving beyond…

  2. Overview of the Core Commitments Initiative

    ERIC Educational Resources Information Center

    McTighe Musil, Caryn

    2013-01-01

    This chapter provides an overview of the Core Commitments Initiative conducted by the Association of American Colleges and Universities (AAC&U). Core Commitments was intended to reinvigorate the conversation about personal and social responsibility within higher education, and served as the impetus for this "New Directions" volume.

  3. Involuntary Outpatient Commitment of the Mentally Ill.

    ERIC Educational Resources Information Center

    Wilk, Ruta J.

    1988-01-01

    Examines the issue of involuntary outpatient commitment, and its implications for social workers working in the health system. Describes a nationwide movement to establish a new system of involuntary outpatient commitment to address the failure of deinstitutionalization, mandating mental health treatment in the community for persons ineligible for…

  4. Commitment: A Behavioral Approach to Job Involvement

    ERIC Educational Resources Information Center

    Wiener, Yoash; Gechman, Arthur S.

    1977-01-01

    Work commitment behaviors were defined as a special class of socially acceptable work behaviors exceeding formal and/or normative expectations relevant to work. For a sample of 54 female elementary school teachers, work commitment measures demonstrated moderate correlations with two attitudinal measures of job involvement and a job satisfaction…

  5. Predictors of Commitment to Athletic Training Education

    ERIC Educational Resources Information Center

    Weiss, Windee M.; Neibert, Peter J.

    2013-01-01

    Context: In order for athletic training students to be successful in any athletic training education program (ATEP), a certain level of commitment to the program and profession is required. Objective: The purpose of this study was to explore the applicability of the sport commitment model (SCM) to an ATEP by applying the SCM in an academic setting…

  6. Drug-induced blood pressure increase - recommendations for assessment in clinical and non-clinical studies.

    PubMed

    Gottfridsson, Christer; Panfilov, Seva; Ebrahimi, Ahmad; Gigger, Emery; Pollard, Chris; Henderson, Simon; Ambery, Philip; Raichlen, Joel S

    2017-02-01

    Changes in blood pressure (BP) are now proactively examined throughout the drug development process as an integral aspect of safety monitoring. This is because hypertension is a very strong risk factor for cardiovascular events and drug-induced increases in BP have attracted increased regulatory attention. However, there is currently no guidance from regulatory agencies on the minimum BP data required for submissions, and there are no specific criteria for what constitutes a safety signal for increased BP in non clinical studies. Areas covered: Evaluation of BP increases through the drug discovery and development process. Expert opinion: Research into the effects of drugs should begin before clinical development is initiated and continue throughout the clinical trial program. Non clinical studies should inform a benefit-risk analysis that will aid decision-making of whether to enter the drug into Phase I development. The degree of acceptable risk will vary according to the therapy area, treatment indication and intended population for the new drug, and the approach to BP assessment and risk mitigation should be tailored accordingly. However, BP monitoring should always be included in clinical trials, and data collected from multiple studies, to convincingly prove or refute a suspicion of BP effects.

  7. Examining differences in culturally based stress among clinical and non-clinical Hispanic adolescents

    PubMed Central

    Cervantes, Richard C.; Cardoso, Jodi Berger; Goldbach, Jeremy T.

    2014-01-01

    The purpose of the current study was to determine if, and how, Hispanic adolescents receiving clinical treatment differ from their peers who are not in treatment on the 8 domains (family economic stress, cultural or educational stress, acculturation-gap stress, immigration stress, discrimination stress, family immigration stress, community or gang related stress) of cultural stress (HSI-A), and if the relation between cultural stress domains and depressive symptomology differed by group membership (clinical versus non-clinical). The sample included 1,254 Hispanic adolescents. The clinical sample had significantly higher scores of cultural stress (p < .05) and mean depression scores (< .001). All 8 domains of HSI-A stress were correlated with depression (p < .05). In the GLM, only family economic, acculturation gap, family immigration, discrimination, and family drug stress had a unique effect on depression and effect varied by group. Acculturation gap stress was associated with depression for the non-clinical group but not the clinical group (p < .001) and community gang stress was more strongly related to depression for the clinical group (p < .05). PMID:25364836

  8. Best Practices in Stability Indicating Method Development and Validation for Non-clinical Dose Formulations.

    PubMed

    Henry, Teresa R; Penn, Lara D; Conerty, Jason R; Wright, Francesca E; Gorman, Gregory; Pack, Brian W

    2016-11-01

    Non-clinical dose formulations (also known as pre-clinical or GLP formulations) play a key role in early drug development. These formulations are used to introduce active pharmaceutical ingredients (APIs) into test organisms for both pharmacokinetic and toxicological studies. Since these studies are ultimately used to support dose and safety ranges in human studies, it is important to understand not only the concentration and PK/PD of the active ingredient but also to generate safety data for likely process impurities and degradation products of the active ingredient. As such, many in the industry have chosen to develop and validate methods which can accurately detect and quantify the active ingredient along with impurities and degradation products. Such methods often provide trendable results which are predictive of stability, thus leading to the name; stability indicating methods. This document provides an overview of best practices for those choosing to include development and validation of such methods as part of their non-clinical drug development program. This document is intended to support teams who are either new to stability indicating method development and validation or who are less familiar with the requirements of validation due to their position within the product development life cycle.

  9. Dissatisfaction with skin appearance among patients with eating disorders and non-clinical controls.

    PubMed

    Gupta, M A; Gupta, A K

    2001-07-01

    We have recently observed that women with the eating disorders (EDs) anorexia nervosa and bulimia nervosa report a significantly greater (P = 0.002) dissatisfaction with the appearance of their skin than do non-clinical controls. To examine further the nature of the dissatisfaction with skin appearance in women with EDs. Several psychosocial and body image parameters, including whether or not the subjects were satisfied with a wide range of attributes associated with non-diseased skin, were surveyed in women aged < or = 30 years. Survey data from 32 women with EDs and 34 randomly selected community-based non-clinical controls were examined. Eighty-one per cent of the patients with EDs vs. 56% of the controls reported dissatisfaction with the appearance of their skin (P = 0.03), particularly with respect to its dryness and roughness. Other attributes that were rated more frequently were 'bags' and 'darkness' under the eyes, freckles, fine wrinkles and patchy hyperpigmentation. There is a high prevalence of dissatisfaction with skin appearance among women aged < or = 30 years, which is even higher among patients with EDs.

  10. “Female Preponderance” of Depression in Non-clinical Populations: A Meta-Analytic Study

    PubMed Central

    Wang, Kui; Lu, Han; Cheung, Eric F. C.; Neumann, David L.; Shum, David H. K.; Chan, Raymond C. K.

    2016-01-01

    Clinical observations and research suggest a female preponderance in major depressive disorder. However, it is unclear whether a similar gender difference is found for the reporting of depressive symptoms in non-clinical populations. The present meta-analysis was conducted to address this issue. We searched for published papers targeting non-clinical populations in which the 21-item Beck Depression Inventory (BDI) was used. Eighty-four papers (91 studies) published between 1977 and 2014 were included in the final meta-analysis, which comprised 23,579 males and 29,470 females. Females in the general population reported higher level of depressive symptoms than males (d = -0.187, corresponding to 1.159 points in the 21-item BDI). This pattern was not found to influence by years of publication, socioeconomic status, or version of the BDI used. Using age group as a moderator, studies with adolescents and young adults were found to show a smaller effect size than studies with older participants. Our results appear to confirm the “female preponderance” in the level of self-report depressive symptoms in the general population, and support the social gender role theory in explaining gender difference over biological susceptibility theory and evolutionary theory. PMID:27695433

  11. Brain structures associated with executive functions during everyday events in a non-clinical sample.

    PubMed

    Takeuchi, Hikaru; Taki, Yasuyuki; Sassa, Yuko; Hashizume, Hiroshi; Sekiguchi, Atsushi; Fukushima, Ai; Kawashima, Ryuta

    2013-07-01

    Executive functions involve control processes such as goal-oriented planning, flexible strategy generation, sustaining set maintenance, self-monitoring, and inhibition. Executive functions during everyday events (EFEEs) are distinct from those measured under laboratory settings; the former can be severely impaired while the latter remain intact. Non-routine everyday problems due to executive dysfunctions affect individual functioning in everyday life and are of great clinical interest. Despite the importance of anatomical bases underlying better EFEEs, such bases have never been investigated among non-clinical samples. Using voxel-based morphometry to measure regional gray matter volume (rGMV) and regional white matter volume (rWMV) and diffusion tensor imaging to determine fractional anisotropy values, we identified the anatomical correlates of better EFEEs using the Dysexecutive Questionnaire in 303 normal young subjects (168 men and 135 women). Better EFEEs were associated with a smaller rGMV in the orbitofrontal cortex (OFC) spread across Brodmann areas (BA) 25, 11, and 12 and larger rWMV in the WM area of OFC adjacent to BA 11. Furthermore, individual EFEEs were positively associated with rWMV in the temporal areas, primarily the inferior longitudinal fasciculus and inferior fronto-occipital fasciculus, the latter of which connects OFC and posterior regions. Thus, our findings suggest that brain structures involving OFC, together with other regions, contribute to the maintenance of effective EFEEs among non-clinical subjects.

  12. The relation between sleep and pain among a non-clinical sample of young adults.

    PubMed

    Brand, Serge; Gerber, Markus; Pühse, Uwe; Holsboer-Trachsler, Edith

    2010-10-01

    Poor sleep is linked to poorer daily functioning and increased risk of psychiatric symptoms. With respect to pain, the relation is bi-directional; poor sleep exacerbates pain, while greater pain adversely affects sleep. Moreover, perception of pain is subject to cognitive-emotional processes. Surprisingly, no data are available from non-clinical samples of young adults. The aim of the present study was therefore to investigate the relation between sleep and pain as a function of quality of life and depressive symptoms in young adults. The direction of influence between sleep and pain was statistically tested with two different structural equation models (SEMs). A total of 862 participants (639 women, 223 men; mean age: 24.67; SD = 5.91) completed a series of validated self-report questionnaires assessing sleep, quality of life, depressive symptoms and cognitive-emotional elaboration of pain. Sleep, pain, quality of life, and depressive symptoms were interrelated. The first SEM suggested both a direct and an indirect influence of pain on sleep, whereas the second SEM suggested that sleep had only an indirect influence on pain. Irrespective of the SEM, the relation between sleep and cognitive-emotional elaboration of pain was mediated by quality of life and depressive symptoms. For a non-clinical sample of young adults, findings did support the bi-directional relation between poor sleep and increased cognitive-emotional elaboration of pain, though other cognitive-emotional processes such as depressive symptoms and quality of life should be taken into account.

  13. Early maladaptive schemas and personality disorder symptoms: An examination in a non-clinical sample.

    PubMed

    Carr, Steven N; Francis, Andrew J P

    2010-11-01

    This study aimed to examine the overall and specific relationship between early maladaptive schemas (EMSs) and personality disorder (PD) symptoms in a non-clinical sample. While a notable previous study has examined the relationship between EMSs and PD symptoms after statistically controlling for gender and within-cluster PD symptoms, they did not control for comorbid axis I and inter-cluster PD symptoms. Hence, we redressed this methodological problem by statistically controlling for these conditions in a series of multiple regressions. In a sample of 178 non-clinical participants, we obtained self-reports of PD symptoms, depression, anxiety, eating disorder, and EMSs. Results of a series of multiple regressions found that EMSs significantly predicted all PD symptoms apart from borderline and antisocial PDs and our hypotheses were largely consistent with hypotheses for cluster A and C PDs. We also found that specific EMSs differentially predicted PD subtypes even after controlling for other PD symptoms, depression, anxiety, and eating disorder symptoms. This study supports the contention that PDs are related to EMSs and there are specific relationships between particular EMSs and particular PDs. 2010 The British Psychological Society.

  14. Psychometric properties of the Revised Physical and Social Anhedonia Scales in non-clinical young adults.

    PubMed

    Fonseca-Pedrero, Eduardo; Paino, Mercedes; Lemos-Giráldez, Serafín; García-Cueto, Eduardo; Villazón-García, Ursula; Bobes, Julio; Muñiz, José

    2009-11-01

    Anhedonia, a central dimension within the schizotypy construct, has been considered to be a promising vulnerability marker for schizophrenia-spectrum disorders. The Revised Physical Anhedonia Scale (RPhA) and Revised Social Anhedonia Scale (RSAS) are two self-reports widely used in the assessment of anhedonia; however, they psychometric characteristics have been scarcely investigated in Spanish population. The objective of the current work was to study the psychometric properties of the Revised Physical and Social Anhedonia Scales in non-clinical young adults. The sample was composed of 728 college students with a mean age of 20.1 years (SD = 2.5). The data indicated that the scales showed adequate psychometric characteristics. The Cronbach alpha was 0.95 (RSAS) and 0.92 (RPhA) respectively. The confirmatory factor analysis carried out on the matrix of tetrachoric correlations showed that both scales presented an essentially unidimensional solution. The Revised Physical and Social Anhedonia Scales seem to be adequate for psychosis-risk assessment in non-clinical populations. Future research should further investigate the construct validity in other populations and cultures as well as study its relation to emotional aspects and cognitive endophenotypes.

  15. Commitment Contracts and Team Incentives

    PubMed Central

    White, Justin S.; Dow, William H.; Rungruanghiranya, Suthat

    2013-01-01

    Background Treatment for tobacco dependence is not available in many low-resource settings, especially in developing countries. Purpose To test the impact of a novel mix of monetary and social incentives on smoking abstinence in rural communities of Thailand. Design An RCT of commitment contracts and team incentives for rural smokers to quit smoking. Smokers were not blinded to treatment status, although the assessor of the biochemical urine test was. Setting/participants All adult smokers living in the study area were eligible to participate; 215 adult smokers from 42 villages in Nakhon Nayok province, Thailand participated. Fourteen smokers who lacked teammates were dropped. Intervention 201 smokers were assigned to a two-person team, and then randomly assigned by team (in a 2:1 ratio) with computer-generated random numbers to receive smoking-cessation counseling (control group) or counseling plus offer of a commitment contract, team incentives, and text message reminders for smoking cessation at 3 months (intervention group). Main outcome measures The primary outcome was biochemically-verified 7-day abstinence at 6 months, assessed on an intention-to-treat basis. Secondary outcomes include biochemically-verified abstinence at 3 months, self-reported abstinence at 14 months, and the incremental cost per quitter of the intervention, nicotine gum, and varenicline in Thailand. Data were collected in 2010–2011 and analyzed in 2012. Results The trial enrolled 215 (10.5%) of 2055 smokers. The abstinence rate was 46.2% (61/132) in the intervention group and 14.5% (10/69) in the control group (adjusted OR 7.5 [3.0–18.6]) at 3 months; 44.3% (58/131) and 18.8% (13/69) at the primary end point of 6 months (adjusted OR 4.2 [1.8–9.7]); and 42.0% (55/131) and 24.6% (17/69) at 14 months (adjusted OR 2.2 [1.0–4.8]). The purchasing-power–parity-adjusted incremental cost per quitter from the intervention is $281 (95% CI=$187, $562), less than for nicotine gum ($1780 [95

  16. [Infanticide committed by the mother].

    PubMed

    Marleau, J D; Roy, R; Laporte, L; Webanck, T; Poulin, B

    1995-04-01

    Using data gathered at the Institut Philippe Pinel in Montréal, we shall describe the sociodemographic and psychiatric profile of a sample of 17 women who have killed (n = 14) or attempted to kill (n = 3) one of their children. Our data indicate that women who have committed this type of offence generally come from a disadvantaged socioeconomic environment. Most have a psychiatric history (evaluation and/or hospitalization). Review of the offence demonstrates that most women do not use a weapon to kill their child; the preferred methods are strangulation or drowning. Most of these offences may be classified as extended suicide or altruistic acts. Several of the women present with a severe personality disorder and an additional depressive episode in the context of the offence. We hope our study will help clarify understanding of filicide and assist in the development of certain prevention axes. These results indicate that the population at large and various intervenors in our society (family physicians, psychiatrists, criminologists, social workers, pediatricians, psychologists, gynecologists) must become increasingly vigilant and avoid trivialization of signals such as verbalization of homicidal thoughts about the child or recourse to certain disorganized behaviours.

  17. Prosodic form and parsing commitments.

    PubMed

    Watt, S M; Murray, W S

    1996-03-01

    This paper examines the question of whether there are effects of prosody on the syntactic parsing of temporarily ambiguous sentences containing complement verbs. It reports the results of five experiments employing cross-modal response tasks where the visually presented target word was either an ¿appropriate' or an ¿inappropriate' continuation in terms of the prosodic form of the preceeding auditory sentence fragment. Two experiments employing cross-modal naming only showed indications of sensitivity to syntactic and appropriateness manipulations when coupled with a simultaneous appropriateness judgment task. In contrast, the experiments employing cross-modal lexical decision showed greater sensitivity to syntactic and appropriateness effects. However, while the results from these studies replicated our earlier auditory parsing results and provided support for the suggestion that there are differences in visual and auditory parsing processes and for a ¿constituent-based, ' ¿minimal commitment' type auditory parser, none of the studies demonstrated an effect of prosodic form on the parsing process.

  18. How Do Different Types of Community Commitment Influence Brand Commitment? The Mediation of Brand Attachment

    PubMed Central

    Zhang, Ning; Su, Chen-ting; Zhou, Nan

    2013-01-01

    Abstract Although previous research indicates that participation in a brand community may foster consumer loyalty to the brand in question, research has seldom examined the mediating effect of community commitment on brand commitment. Drawing from the typologies of organizational commitment, we divide community commitment into three components: continuance community commitment (continuance CC), affective community commitment (affective CC), and normative community commitment (normative CC). We then assess the mediating role of brand attachment in the relationship between these three components and brand commitment. We test the hypotheses using a sample of online mobile phone brand communities in China. The empirical results reveal that brand attachment exerts an indirect (but not mediated) effect on the relationship between continuance CC and brand commitment and on the relationship between normative CC and brand commitment. We also find that it exerts a partial mediating effect on the relationship between affective CC and brand commitment. The findings contribute to the branding literature and have important implications for brand community management. PMID:23768073

  19. The roles of want to commitment and have to commitment in explaining physical activity behavior.

    PubMed

    Gabriele, Jeanne M; Gill, Diane L; Adams, Claire E

    2011-03-01

    Several theories and models have been proposed to explain decisions in changing and adopting behavior but few address the intricacies of behavioral maintenance. The current study assesses the utility of the Investment Model, which identifies satisfaction, investments, and involvement alternatives as predictors of commitment and continued behavior, in predicting physical activity behavior. Participants (N = 267) completed questionnaires about physical activity and commitment. Structural equation modeling assessed relationships among 2 types of exercise commitment (want to or enthusiastic commitment, have to or obligatory commitment), 3 commitment determinants (satisfaction, investments, and alternatives), and physical activity (minutes of physical activity, stage of behavior change). Want to commitment, but not have to commitment, was related to stage of exercise behavior change and time spent in physical activity. Satisfaction and investments were positively related to want to commitment; whereas, satisfaction, investments, and alternatives were positively related to have to commitment. The model explained 68% and 23% of the variance in time spent in physical activity and stage of behavior change, respectively. This study provides support for the application of the Investment Model to physical activity and suggests that want to commitment may be important for explaining and predicting sustained physical activity behavior.

  20. The Impact of Trust on Organization Commitment

    NASA Technical Reports Server (NTRS)

    Robinson, Kimberly; Stinson, Thomas N. (Technical Monitor)

    2002-01-01

    As the global economy continues to spawn competitive forces, organizations have sought to become more competitive by cutting costs, eliminating non-value added work, and using more automation. Jobs have become broader and more flexible leading to a leaner workforce with higher-level knowledge and skills and more responsibility for day-to-day decisions. More than ever, organizations depend on employees as the innovators and designers of products and processes and as a source of strategic advantage. Therefore employee commitment among knowledge workers is needed to maintain organizational viability. It would seem that stronger relationships due to greater dependency, involvement, and investment would develop between employers and high-technology workers resulting in more committed employees. However, the opposite has been evidenced as key knowledge workers are changing jobs frequently. This may be due to a perceived lack of commitment by management to its employees. The notion of exchange may dominate the development of organizational commitment whereby an individual decides what to give a firm (commitment, extra effort, better performance, etc.) based on what the firm gives them (e.g., trust and security). It is the relationship between an employee's organizational commitment and the responding level of trust in the organization that is examined in this paper. An experiment is described that will seek to identify this relationship. Preliminary results are expected to show a positive relationship whereby employee commitment is positively correlated with organizational trust.

  1. The Impact of Trust on Organization Commitment

    NASA Technical Reports Server (NTRS)

    Robinson, Kimberly; Stinson, Thomas N. (Technical Monitor)

    2002-01-01

    As the global economy continues to spawn competitive forces, organizations have sought to become more competitive by cutting costs, eliminating non-value added work, and using more automation. Jobs have become broader and more flexible leading to a leaner workforce with higher-level knowledge and skills and more responsibility for day-to-day decisions. More than ever, organizations depend on employees as the innovators and designers of products and processes and as a source of strategic advantage. Therefore employee commitment among knowledge workers is needed to maintain organizational viability. It would seem that stronger relationships due to greater dependency, involvement, and investment would develop between employers and high-technology workers resulting in more committed employees. However, the opposite has been evidenced as key knowledge workers are changing jobs frequently. This may be due to a perceived lack of commitment by management to its employees. The notion of exchange may dominate the development of organizational commitment whereby an individual decides what to give a firm (commitment, extra effort, better performance, etc.) based on what the firm gives them (e.g., trust and security). It is the relationship between an employee's organizational commitment and the responding level of trust in the organization that is examined in this paper. An experiment is described that will seek to identify this relationship. Preliminary results are expected to show a positive relationship whereby employee commitment is positively correlated with organizational trust.

  2. 3 CFR - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... to Persons Who Commit, Threaten To Commit, or Support Terrorism Presidential Documents Other... Persons Who Commit, Threaten To Commit, or Support Terrorism On September 23, 2001, by Executive Order... commit, or support terrorism, pursuant to the International Emergency Economic Powers Act (50 U.S.C....

  3. 3 CFR - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten to Commit, or...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... to Persons Who Commit, Threaten to Commit, or Support Terrorism Presidential Documents Other... Persons Who Commit, Threaten to Commit, or Support Terrorism On September 23, 2001, by Executive Order... commit, or support terrorism, pursuant to the International Emergency Economic Powers Act (50 U.S.C....

  4. 3 CFR - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... to Persons Who Commit, Threaten To Commit, or Support Terrorism Presidential Documents Other... Persons Who Commit, Threaten To Commit, or Support Terrorism On September 23, 2001, by Executive Order... commit, or support terrorism, pursuant to the International Emergency Economic Powers Act (50 U.S.C....

  5. 3 CFR - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten To Commit, or...

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... to Persons Who Commit, Threaten To Commit, or Support Terrorism Presidential Documents Other... Persons Who Commit, Threaten To Commit, or Support Terrorism On September 23, 2001, by Executive Order... commit, or support terrorism, pursuant to the International Emergency Economic Powers Act (50 U.S.C....

  6. 75 FR 57159 - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten to Commit, or...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-20

    ... Emergency With Respect to Persons Who Commit, Threaten to Commit, or Support Terrorism On September 23, 2001... commit, threaten to commit, or support terrorism, pursuant to the International Emergency Economic Powers... grave acts of terrorism and threats of terrorism committed by foreign terrorists, including...

  7. Safety profiles and efficacy of infliximab therapy in Japanese patients with plaque psoriasis with or without psoriatic arthritis, pustular psoriasis or psoriatic erythroderma: Results from the prospective post-marketing surveillance.

    PubMed

    Torii, Hideshi; Terui, Tadashi; Matsukawa, Miyuki; Takesaki, Kazumi; Ohtsuki, Mamitaro; Nakagawa, Hidemi

    2016-07-01

    A large-scale prospective post-marketing surveillance was conducted to evaluate the safety and efficacy of infliximab in Japanese patients with plaque psoriasis, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma. This study was conducted in all psoriasis patients treated with infliximab after its Japanese regulatory approval. Infliximab was administrated at 5 mg/kg at weeks 0, 2 and 6, and every 8 weeks thereafter. Patients were serially enrolled and observed for 6 months to evaluate the safety and efficacy. The safety and efficacy were evaluated in 764 and 746 patients, respectively. Incidences of any and serious adverse drug reactions were 22.51% and 6.94%, respectively, and those of any and serious infusion reactions were 6.15% and 1.31%, respectively, which were comparable with the results in the post-marketing surveillance with 5000 rheumatoid arthritis patients in Japan. Major adverse drug reactions during the follow-up period were infections (5.10%) including pneumonia, cellulitis and herpes zoster, however, no tuberculosis was observed. The safety profiles were equivalent, regardless of the psoriasis types. No new safety problems were identified. The response rates on global improvement and median improvement rate of Psoriasis Area and Severity Index in all patients were 88.0% and 85.0%, respectively. Of note, the efficacy was equivalent for each psoriasis type as well as for each body region. Infliximab was also effective in pustular psoriasis symptoms, joint symptoms and nail psoriasis, as well as improvement of quality of life. Infliximab was confirmed to be highly effective and well tolerated in treating refractory psoriasis, including pustular psoriasis and psoriatic erythroderma. © 2015 Japanese Dermatological Association.

  8. Impact of Chronic Renal Failure on Safety and Effectiveness of Paclitaxel-Eluting Stents for Femoropopliteal Artery Disease: Subgroup Analysis from Zilver PTX Post-Market Surveillance Study in Japan.

    PubMed

    Ogawa, Yukihisa; Yokoi, Hiroyoshi; Ohki, Takao; Kichikawa, Kimihiko; Nakamura, Masato; Komori, Kimihiro; Nanto, Shinsuke; O'Leary, Erin E; Lottes, Aaron E; Saunders, Alan T; Dake, Michael D

    2017-05-09

    Favorable long-term outcomes of the Zilver PTX drug-eluting stent (DES) in femoropopliteal lesions have been demonstrated. Chronic renal failure (CRF) has been shown to be a risk factor for restenosis and decreased limb salvage. The results of the DES in patients with CRF have not previously been reported. This study compares the results with the DES in patients with CRF and those without CRF. This retrospective analysis from the Zilver PTX Japan Post-Market Surveillance Study included 321 patients with CRF and 584 patients without CRF. Outcomes included freedom from target lesion revascularization (TLR) and patency. Of the patients included in this subgroup analysis, 2-year data were available for 209 patients in the CRF group and 453 patients in the non-CRF group. The two groups were similar in terms of lesion length and the frequency of in-stent restenosis. Critical limb ischemia, severe calcification, and diabetes were more common in patients with CRF, whereas total occlusion was more common in patients without CRF. Freedom from TLR rates were 81.4 versus 84.9% (p = 0.24), and patency rates were 70.7 versus 70.3% (p = 0.95) in patients with and without CRF at 2 years, respectively. This is the first comparative study of the DES in femoropopliteal artery lesions in patients with and without CRF. These results indicate that the DES placed in femoropopliteal artery lesions of CRF patients is safe and effective with similar patency and TLR rates to patients without CRF. Level 3, Post-Market Surveillance Study.

  9. Six-year multi-centre, observational, post-marketing surveillance of the safety of the HPV-16/18 AS04-adjuvanted vaccine in women aged 10-25 years in Korea.

    PubMed

    Kim, Chul-Jung; Song, Rok; Chen, Jing; Tavares Da Silva, Fernanda; Gopala, Kusuma B; Kim, Joon Hyung; Bi, Dan; Park, Jong Sup

    2017-07-01

    To evaluate the safety of HPV-16/18 AS04-adjuvanted vaccine when administered as per the PI in Korea. A total of 3084 women aged 10-25 years were enrolled in this post-marketing surveillance from 2008 to 2014. Subjects were invited to receive three doses of the vaccine (0, 1 and 6 months), and participants who received at least one dose were included in the analysis. Adverse events (AEs), adverse drug reactions (ADRs) and serious AEs (SAEs) were recorded after each dose. All AEs, ADRs and SAEs were presented with exact 95% confidence intervals (CI) (NCT01101542). Injection-site pain was the most frequent AE and ADR reported by 322 subjects (10.4% [95%CI: 9.4-11.6]); the local pain was transient and lasted 4-7 days in most cases. Dysmenorrhoea and vaginitis were the most common unexpected AEs reported by 30 (1.0% [95%CI: 0.7-1.4]) and 16 subjects (0.7% [95%CI: 0.3-0.8]), respectively. Pain (toe pain, leg pain and body pain [one case each]; foot pain [two cases]) was the most common unexpected ADR reported by five subjects (0.2% [95%CI: 0.1-0.4]). Four subjects reported a single SAE (one case each of exostosis, gastroenteritis, abortion and tonsillitis); none were fatal. All SAEs were assessed as unlikely to be related to vaccination; gastroenteritis, exostosis and tonsillitis resolved during the study period. This is the first post-marketing surveillance study in Korea that provides 6-year safety data for HPV-16/18 AS04-adjuvanted vaccine. The vaccine showed an acceptable safety profile and favourable benefit/risk ratio when given to women aged 10-25 years in Korea. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd. © 2017 The Authors. Pharmacoepidemiology & Drug Safety Published by John Wiley & Sons Ltd.

  10. Safety and efficacy of a novel drug elores (ceftriaxone+sulbactam+disodium edetate) in the management of multi-drug resistant bacterial infections in tertiary care centers: a post-marketing surveillance study.

    PubMed

    Chaudhary, Manu; Mir, Mohd Amin; Ayub, Shiekh Gazalla

    In India, Elores (CSE-1034: ceftriaxone+sulbactam+disodium edetate) was approved as a broad spectrum antibiotic in year 2011 and is used for management of Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections in tertiary care centers. The objective of this study was to investigate the efficacy of this drug in patients with Extended Spectrum Beta Lactamases/Metallo Beta lactamases infections and identify the incidence of adverse events in real clinical settings. This Post Marketing Surveillance study was conducted at 17 centers across India and included 2500 patients of all age groups suffering from various bacterial infections and treated with Elores (CSE1034). Information regarding demographic, clinical and microbiological parameters, dosage and treatment duration, efficacy and adverse events (AEs) associated with the treatment were recorded. A total of 2500 patients were included in the study and efficacy was evaluated in 2487 patients. In total, 409 AEs were reported in 211 (8.4%) patients. The major AEs reported were vomiting (3.0%), pain at injection site (2.5%), nausea (2.3%), redness at site (1.96%), thrombophlebitis (1.4%). Of total reported AEs, 40 (5.3%) AEs were reported in pediatric, 310 (20.6%) in adult, and 59 (23.6%) in geriatric group. No AE belonging to grade IV or V was reported in any patient. In terms of efficacy, 1977 (79.4%) patients were cured, 501 (20.1%) patients showed clinical improvement and 5 (0.2%) patients were complete failure. The treatment duration varied from 5 to 7 days in different patients depending on the infection type. In this post-marketing surveillance study, CSE-1034 was found to be an effective and safe option against Pip tazo and meropenem in management of patients with multi-drug resistant (MDR) bacterial infections under routine ward settings. Copyright © 2017 Sociedade Brasileira de Infectologia. Published by Elsevier Editora Ltda. All rights reserved.

  11. [Post-marketing surveillance on treatment of 5,665 patients with atopic dermatitis using the calcineurin inhibitor pimecrolimus: positive effects on major symptoms of atopic dermatitis and on quality of life].

    PubMed

    Sunderkötter, Cord; Weiss, Johannes M; Bextermöller, Raphael; Löffler, Helena; Schneider, Dirk

    2006-04-01

    Topical application of the calcineurin inhibitors pimecrolimus and tacrolimus is a current major advance in the therapy of atopic dermatitis. The aims of this post-marketing surveillance were: a) to acquire data on the efficacy and tolerability of pimecrolimus ointment (Elidel) on a very large cohort of patients from outpatient clinics, and b) to assess changes in their quality of life, a parameter not often considered in previous studies. Included were 5,665 patients with atopic dermatitis. During the observation period, data on efficacy and tolerability were obtained at the beginning of the study, 3 to 10 days after initiation of therapy and after 4 to 6 weeks. Evaluation of symptoms as well as assessment of efficacy and tolerability were based on linear scales and on the percentage of the body surface area (% BSA) involved. Quality of life was assessed by the German version of the "Dermatology Life Quality Index (DLQI)" or the "Children's Dermatology Life Quality Index (CDLQI)". In this largest post-marketing surveillance hitherto performed in Germany, the efficacy of pimecrolimus was judged as "good" by 79.3 % of physicians and by 76.5 % of patients. Tolerability was assessed as "good" by 87.2 % of physicians and by 83.1 % of patients. Major symptoms of atopic dermatitis such as pruritus, erythema or lichenification showed marked reduction after just 3 to 10 days, signalling general improvement of the skin disease. In addition, application of pimecrolimus resulted in a significant improvement of the quality of life scores in both children and adults. The present study demonstrates that the good efficacy and tolerability of pimecrolimus ointment which had been shown in controlled trials: i) could also be demonstrated on a very large cohort of patients with atopic dermatitis when used in the outpatient setting, and ii) were paralleled by a significant improvement in the quality of life.

  12. Escalation of Commitment in the Surgical ICU.

    PubMed

    Braxton, Carla C; Robinson, Celia N; Awad, Samir S

    2017-04-01

    Escalation of commitment is a business term that describes the continued investment of resources into a project even after there is objective evidence of the project's impending failure. Escalation of commitment may be a contributor to high healthcare costs associated with critically ill patients as it has been shown that, despite almost certain futility, most ICU costs are incurred in the last week of life. Our objective was to determine if escalation of commitment occurs in healthcare settings, specifically in the surgical ICU. We hypothesize that factors previously identified in business and organizational psychology literature including self-justification, accountability, sunk costs, and cognitive dissonance result in escalation of commitment behavior in the surgical ICU setting resulting in increased utilization of resources and cost. A descriptive case study that illustrates common ICU narratives in which escalation of commitment can occur. In addition, we describe factors that are thought to contribute to escalation of commitment behaviors. Escalation of commitment behavior was observed with self-justification, accountability, and cognitive dissonance accounting for the majority of the behavior. Unlike in business decisions, sunk costs was not as evident. In addition, modulating factors such as personality, individual experience, culture, and gender were identified as contributors to escalation of commitment. Escalation of commitment occurs in the surgical ICU, resulting in significant expenditure of resources despite a predicted and often known poor outcome. Recognition of this phenomenon may lead to actions aimed at more rational decision making and may contribute to lowering healthcare costs. Investigation of objective measures that can help aid decision making in the surgical ICU is warranted.

  13. Who are we and where are we going? Primary care academics in non-clinical posts.

    PubMed

    Macfarlane, Anne; O'Donnell, Catherine

    2014-01-01

    The development of a high-quality primary healthcare system requires multidisciplinary perspectives and collaborations between clinicians and non-clinicians. Academic primary care departments across the United Kingdom and Ireland employ academics from a range of disciplines. However, questions remain about the parity of opportunity for career progression with a consistent trend to focus more on clinicians than non-clinicians. In this paper, we analyse the employment and careers of non-clinical primary care academics working in Ireland and Scotland. We draw on survey data from the island of Ireland and conference workshop discussions among Irish- and Scottish-based academics. We highlight problems with career progression and identify some strategic actions. We argue for a renewed attempt to ensure that all academics who are contributing to the discipline of primary care are appropriately acknowledged and supported to continue their endeavours to develop high-quality primary care health systems.

  14. Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.

    PubMed

    Hayakawa, Yoshihiro; Kawada, Manabu; Nishikawa, Hiroyoshi; Ochiya, Takahiro; Saya, Hideyuki; Seimiya, Hiroyuki; Yao, Ryoji; Hayashi, Masahiro; Kai, Chieko; Matsuda, Akira; Naoe, Tomoki; Ohtsu, Atsushi; Okazaki, Taku; Saji, Hideo; Sata, Masataka; Sugimura, Haruhiko; Sugiyama, Yuichi; Toi, Masakazu; Irimura, Tatsuro

    2016-02-01

    Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.

  15. The broader autism phenotype and friendships in non-clinical dyads.

    PubMed

    Wainer, Allison L; Block, Nicole; Donnellan, M Brent; Ingersoll, Brooke

    2013-10-01

    The broader autism phenotype (BAP) is a set of subclinical traits qualitatively similar to those observed in autism spectrum disorders. The current study sought to elucidate the association between self- and informant-reports of the BAP and friendships, in a non-clinical sample of college student dyads. Self-informant agreement of the BAP and friendship similarity was evaluated, and the Actor-Partner Interdependence Model was used to test how both friends' BAP characteristics jointly and uniquely contribute to the experiences of friendships. Results suggest self-informant agreement about the BAP, friendship closeness, quality, and conflict. Actor effects were observed for the BAP and friendship values, quality, conflict, and loneliness. Findings suggest that the BAP relates in meaningful ways to self-perceptions of friendship variables in the general population.

  16. Genetic-based unit commitment algorithm

    SciTech Connect

    Maifeld, T.T.; Sheble, G.B.

    1996-08-01

    This paper presents a new unit commitment scheduling algorithm. The proposed algorithm consist of using a genetic algorithm with domain specific mutation operators. The proposed algorithm can easily accommodate any constraint that can be true costed. Robustness of the proposed algorithm is demonstrated by comparison to a Lagrangian relaxation unit commitment algorithm on three different utilities. Results show the proposed algorithm finds good unit commitment schedules in a reasonable amount of computation time. Included in the appendix is an explanation of the true costing approach.

  17. Self-perception but not peer reputation of bullying victimization is associated with non-clinical psychotic experiences in adolescents.

    PubMed

    Gromann, P M; Goossens, F A; Olthof, T; Pronk, J; Krabbendam, L

    2013-04-01

    Bullying victimization may be linked to psychosis but only self-report measures of victimization have been used so far. This study aimed (a) to investigate the differential associations of peer-nominated versus self-reported victim status with non-clinical psychotic experiences in a sample of young adolescents, and (b) to examine whether different types of self-reported victimization predict non-clinical psychotic experiences in these adolescents. Method A combination of standard self-report and peer nomination procedures was used to assess victimization. The sample (n = 724) was divided into four groups (exclusively self-reported victims, self- and peer-reported victims, exclusively peer-reported victims, and non-victims) to test for a group effect on non-clinical psychotic experiences. The relationship between types of victimization and non-clinical psychotic experiences was examined by a regression analysis. Self-reported victims, along with self- and peer-reported victims, scored higher than peer-reported victims and non-victims on non-clinical psychotic experiences. Self-reports of direct relational, indirect relational and physical victimization significantly improved the prediction of non-clinical psychotic experiences whereas verbal and possession-directed victimization had no significant predictive value. The relationship between victimization and non-clinical psychotic experiences is only present for self-reported victimization, possibly indicative of an interpretation bias. The observed discrepancy between self-report and peer-report highlights the importance of implementing a combination of both measures for future research.

  18. Australian doctors' non-clinical activities: results from the Medicine in Australia: Balancing Employment and Life (MABEL) survey of doctors.

    PubMed

    Joyce, Catherine; Eyre, Harris; Wang, Wei Chun; Laurence, Caroline

    2015-11-01

    The aim of the present study was to investigate non-clinical work conducted by Australian doctors. This study was an exploratory descriptive study using data from Wave 5 of the Medicine in Australia: Balancing Employment and Life (MABEL) longitudinal survey, collected in 2012 from Australian medical practitioners (2200 general practitioners (GPs), 3455 specialists, 1270 specialists in training and 1656 hospital non-specialists). The main outcome measure was the number of hours worked per week in non-clinical work. Regression analysis was used to determine associations between non-clinical activities (i.e. education-related, management and administration and other) and personal and professional characteristics, including age, gender, job and life satisfaction, total clinical working hours, sector of practice (public or private) and doctor type. Australian doctors spend an average of just under 7 h per week, or 16% of their working time, on non-clinical activities. Doctors who worked more hours on non-clinical activities overall, and in education-related and management and administration specifically, were male, younger, had lower life satisfaction and generally spent fewer hours on clinical work. Lower job satisfaction was associated with longer management and administration hours, but not with time spent in education-related activities. Specialists were more likely to work long non-clinical hours, whereas GPs were more likely to report none. Hospital non-specialists reported relatively high management and administration hours. Further work is required to better understand the full range of non-clinical activities doctors are involved in and how this may impact future workforce projections.

  19. Green Supplier Network Manufacturer Commitment Form

    EPA Pesticide Factsheets

    Online form expressing interest in committing to be a Green Supplier; this form expresses your intent to participate in a confidential Green Suppliers Network assessment, implement recommended environmental improvements and complete a NIST MEP follow-up.

  20. Green Suppliers Network Supply Chain Commitment Form

    EPA Pesticide Factsheets

    Online form to show your company desires to be a Green Suppliers Network supply chain. Expresses an intent to: commit to engage at least five suppliers to complete an assessment process within a 12-month period and more.

  1. Quantum Bit Commitment with a Composite Evidence

    NASA Astrophysics Data System (ADS)

    Srikanth, R.

    2004-01-01

    Entanglement-based attacks, which are subtle and powerful, are usually believed to render quantum bit commitment insecure. We point out that the no-go argument leading to this view implicitly assumes the evidence-of-commitment to be a monolithic quantum system. We argue that more general evidence structures, allowing for a composite, hybrid (classical quantum) evidence, conduce to improved security. In particular, we present and prove the security of the following protocol Bob sends Alice an anonymous state. She inscribes her commitment b by measuring part of it in the + (for b = 0) or × (for b = 1) basis. She then communicates to him the (classical) measurement outcome Rx and the partmeasured anonymous state interpolated into other, randomly prepared qubits as her evidence-of-commitment.

  2. 24 CFR 241.510 - Commitments.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... Purchase and Installation of Energy Conserving Improvements, Solar Energy Systems, and Individual Utility... insured. (b) Types of firm commitment. (1) Where the amount of the loan is $250,000 or more, the...

  3. 24 CFR 241.510 - Commitments.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... Purchase and Installation of Energy Conserving Improvements, Solar Energy Systems, and Individual Utility... insured. (b) Types of firm commitment. (1) Where the amount of the loan is $250,000 or more, the...

  4. 24 CFR 241.510 - Commitments.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... Purchase and Installation of Energy Conserving Improvements, Solar Energy Systems, and Individual Utility... insured. (b) Types of firm commitment. (1) Where the amount of the loan is $250,000 or more, the...

  5. 24 CFR 241.510 - Commitments.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... Purchase and Installation of Energy Conserving Improvements, Solar Energy Systems, and Individual Utility... insured. (b) Types of firm commitment. (1) Where the amount of the loan is $250,000 or more, the...

  6. 24 CFR 241.510 - Commitments.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... Purchase and Installation of Energy Conserving Improvements, Solar Energy Systems, and Individual Utility... insured. (b) Types of firm commitment. (1) Where the amount of the loan is $250,000 or more, the...

  7. Higher Education's Commitment to Instructional Improvement Programs

    ERIC Educational Resources Information Center

    Popham, W. James

    1974-01-01

    Supports the contention that current attempts to improve the quality of university instruction represent meagre efforts due to insufficient commitment, and a lack of resources, both in finances and in personnel. (AM)

  8. A practical quantum bit commitment protocol

    NASA Astrophysics Data System (ADS)

    Arash Sheikholeslam, S.; Aaron Gulliver, T.

    2012-01-01

    In this paper, we introduce a new quantum bit commitment protocol which is secure against entanglement attacks. A general cheating strategy is examined and shown to be practically ineffective against the proposed approach.

  9. Higher Education's Commitment to Instructional Improvement Programs

    ERIC Educational Resources Information Center

    Popham, W. James

    1974-01-01

    Supports the contention that current attempts to improve the quality of university instruction represent meagre efforts due to insufficient commitment, and a lack of resources, both in finances and in personnel. (AM)

  10. COMMITMENT A Psychological Tie and Moral Value

    DTIC Science & Technology

    2017-04-01

    leadership is more than a talent, it is an ethical imperative due to its importance to mission success and its importance to the lives of the soldiers...it is important to understand how each component develops. Affective commitment develops when employees find that the organization “satisfies their...Aristotle’s moral goods with some important distinctions. Normative commitment involves a rational evaluation of right or wrong and just or unjust. Further

  11. Young children's understanding of joint commitments.

    PubMed

    Gräfenhain, Maria; Behne, Tanya; Carpenter, Malinda; Tomasello, Michael

    2009-09-01

    When adults make a joint commitment to act together, they feel an obligation to their partner. In 2 studies, the authors investigated whether young children also understand joint commitments to act together. In the first study, when an adult orchestrated with the child a joint commitment to play a game together and then broke off from their joint activity, 3-year-olds (n = 24) reacted to the break significantly more often (e.g., by trying to re-engage her or waiting for her to restart playing) than when she simply joined the child's individual activity unbidden. Two-year-olds (n = 24) did not differentiate between these 2 situations. In the second study, 3- and 4-year-old children (n = 30 at each age) were enticed away from their activity with an adult. Children acknowledged their leaving (e.g., by looking to the adult or handing her the object they had been playing with) significantly more often when they had made a joint commitment to act together than when they had not. By 3 years of age, children thus recognize both when an adult is committed and when they themselves are committed to a joint activity.

  12. Increasing Medical Practice Team Commitment: Twenty-Five Strategies.

    PubMed

    Hills, Laura

    2016-01-01

    Employee commitment is one of the most important principles of practice man- agement. Yet commitment is delicate; it must be carefully earned, and it can easily deteriorate. This article explores practical strategies the medical practice manager can use to assess, foster, and increase employee commitment. It de- fines commitment and how commitment is manifested in employee attitudes and behavior. It provides a 10-question guide medical practice managers can use to assess employee commitment, and a four-part roadmap that will inspire commitment through leadership. This article also offers 25 hands-on strate- gies to increase employee commitment, and more than a dozen questions to guide difficult conversations with employees when their commitment level to the medical practice is low or unclear. Finally, this article suggest four drivers of employee commitment and a five-part strategy medical practice managers can use to model commitment through their own leadership.

  13. Clinical care ratios: quantifying clinical versus non-clinical care for allied health professionals.

    PubMed

    Hearn, Cherie; Govier, Adam; Semciw, Adam Ivan

    2016-07-04

    Objective Clinical care ratios (CCRs) are a useful tool that can be used to quantify and benchmark the clinical and non-clinical workloads of allied health professionals. The purpose of this study was to determine if CCRs are influenced by level of seniority, type of role or profession. This will provide meaningful information for allied health service managers to better manage service demand and capacity.Method Data was collected from 2036 allied health professionals from five professions across 11 Australian tertiary hospitals. Mean (95% confidence intervals) CCRs were calculated according to profession, seniority and role type. A two-way ANOVA was performed to assess the association of CCRs (dependent variable) with seniority level and profession (independent variables). Post-hoc pairwise comparisons identified where significant main or interaction effects occurred (α = 0.05).Results Significant main effects for seniority level and profession were identified (P < 0.05), but there was no interaction effect. Post-hoc comparisons revealed significant differences between all tier combinations (P < 0.05) with more senior staff having the lowest CCRs.Conclusion The direct and non-direct clinical components of the allied health professional's workload can be quantified and benchmarked with like roles and according to seniority. The benchmarked CCRs for predominantly clinical roles will enable managers to compare and evaluate like roles and modify non-direct clinical components according to seniority and discipline.What is known about the topic? CCRs are a useful tool to quantify, monitor and compare workloads of allied health professionals. They are thought to change with increased seniority of roles. The CCRs for different allied health professional roles has yet to be defined in the literature.What does this paper add? CCRs decrease as level of seniority increases, indicating higher seniority increases non-clinical time. CCRs differ across professions, suggesting

  14. Early Maladaptive Schemas among Young Adult Male Substance Abusers: A Comparison with a Non-Clinical Group

    PubMed Central

    Shorey, Ryan C.; Stuart, Gregory L.; Anderson, Scott

    2012-01-01

    Early maladaptive schemas are rigidly held cognitive and behavioral patterns that guide how individuals encode and respond to stimuli in their environments (Young, 1994). Research has examined the early maladaptive schemas of substance abusers, as schemas are believed to underlie, perpetuate, and maintain problematic substance use. To date, research has not examined whether young adult male substance abuse treatment seekers (ages 18 to 25) report greater early maladaptive schema endorsement than a non-clinical comparison group. The current study extended the research on substance use and schemas by comparing the early maladaptive schemas of young adult male residential substance abuse patients (n = 101) and a group of non-clinical male college students (n = 175). Results demonstrated that the substance abuse group scored higher than the non-clinical comparison group on 9 of the 18 early maladaptive schemas. Implications of these findings for future research and substance use treatment programs are discussed. PMID:23312769

  15. Cognitive Emotion Regulation as a Mediator between Posttraumatic Stress Symptoms and Hypomanic Personality within a Non-Clinical Population.

    PubMed

    Steel, Craig

    2016-01-01

    There is a high prevalence of traumatic life events within individuals diagnosed with bipolar disorder. However, currently there is limited theoretical understanding of this relationship. To explore whether non-clinical symptoms of posttraumatic stress have a direct effect on the non-clinical symptoms of bipolar disorder, or whether this relationship is mediated by cognitive emotion regulation strategies. A cross-sectional design within non-clinical participants completing an online survey including the Impact of Events Scale, Cognitive Emotion Regulation Questionnaire and the Hypomanic Personality Scale. Posttraumatic stress symptoms were associated with hypomanic personality. Intrusive memories contributed a small but significant proportion of the variance between these two measures. Rumination of negative emotions mediated the relationship between posttraumatic stress and hypomanic personality. The relationship between traumatic events and an increased prevalence of bipolar disorder remains poorly understood. Further research should explore rumination as a potential target for treatment within those suffering from both posttraumatic stress and bipolar disorder.

  16. Impact analysis of ICH S9 on non-clinical development of anticancer drugs.

    PubMed

    Bonelli, Milton; Di Giuseppe, Francesca; Beken, Sonja

    2015-10-01

    Cancer presents a major healthcare challenge worldwide, with several millions new cases a year, and represents a therapeutic area with a high need for new drugs. To respond to this, the parties of the International Conference for Harmonization agreed in 2007 to develop a guideline on nonclinical requirements for oncology therapeutics' development (ICH S9), which came into effect in early 2010. This guideline includes recommendations to facilitate and accelerate the development and marketing of cancer therapeutic agents for serious and life threatening malignancies and aims to address this need through a refinement and a reduction in the use of experimental animals, following the 3Rs principles. To assess the impact of ICH S9 on drug development and reduction of animal use, we performed an analysis of Marketing Authorization Applications at the European Medicines Agency relevant to the period in which the development of the guideline was approaching the final steps and its early implementation period. From the analysis performed, a consistent trend towards a decrease in the average number of non-clinical studies performed (-40.7%) and number of animals used per development program (-58.1%) for new chemical entities has been detected, highlighting increasing compliance by companies to the recommendations of ICH S9.

  17. Non-clinical models: validation, study design and statistical consideration in safety pharmacology.

    PubMed

    Pugsley, M K; Towart, R; Authier, S; Gallacher, D J; Curtis, M J

    2010-01-01

    The current issue of the Journal of Pharmacological and Toxicological Methods (JPTM) focuses exclusively on safety pharmacology methods. This is the 7th year the Journal has published on this topic. Methods and models that specifically relate to methods relating to the assessment of the safety profile of a new chemical entity (NCE) prior to first in human (FIH) studies are described. Since the Journal started publishing on this topic there has been a major effort by safety pharmacologists, toxicologists and regulatory scientists within Industry (both large and small Pharma as well as Biotechnology companies) and also from Contract Research Organizations (CRO) to publish the surgical details of the non-clinical methods utilized but also provide important details related to standard and non-standard (or integrated) study models and designs. These details from core battery and secondary (or ancillary) drug safety assessment methods used in drug development programs have been the focus of these special issues and have been an attempt to provide validation of methods. Similarly, the safety pharmacology issues of the Journal provide the most relevant forum for scientists to present novel and modified methods with direct applicability to determination of drug safety-directly to the safety pharmacology scientific community. The content of the manuscripts in this issue includes the introduction of additional important surgical methods, novel data capture and data analysis methods, improved study design and effects of positive control compounds with known activity in the model.

  18. The role of magical thinking in hallucinations. Comparisons of clinical and non-clinical groups.

    PubMed

    García-Montes, José M; Pérez-Álvarez, Marino; Odriozola-González, Paula; Vallina-Fernández, Oscar; Perona-Garcelán, Salvador

    2014-11-01

    Magical thinking consists of accepting the possibility that events that, according to the causal concepts of a culture, cannot have any causal relationship, but might somehow nevertheless have one. Magical thinking has been related to both obsessive-compulsive disorder and schizophrenia. The purpose of this study was to investigate the role of magical thinking in hallucinations of patients diagnosed with schizophrenia. Four groups were recruited for this purpose from a clinical population (hallucinating schizophrenic patients, patients diagnosed with psychoses who had never hallucinated, obsessive-compulsive disorder patients and a clinical control group) and a non-clinical control group, who were given the Magical Ideation Scale. The results show that magical ideation differentiates the group of schizophrenic patients with auditory hallucinations from the rest of the groups that participated in the design. Items related to "mind reading", to the presence of auditory illusions in response to sound stimuli, and to the sense of sometimes being accompanied by an evil presence are the most closely related to the presence of auditory hallucinations. Magical thinking, understood as beliefs in non-consensual modes of causation, is closely linked to auditory hallucinations in patients diagnosed with schizophrenia.

  19. Distress related to subclinical negative symptoms in a non-clinical sample: Role of dysfunctional attitudes.

    PubMed

    Fervaha, Gagan; Zakzanis, Konstantine K; Foussias, George; Agid, Ofer; Remington, Gary

    2015-12-15

    Negative symptoms are a prominent feature of schizophrenia that are intimately linked to poor outcomes characterizing the illness. One mechanistic model suggests that these symptoms are produced and maintained, at least in part, through maladaptive attitudes. Beyond mechanisms, it remains phenomenologically unclear if these symptoms are particularly distressing. In the present study we examined whether subclinical negative symptoms evaluated in a non-clinical sample of young adults (N=370) were distressful or bothersome to participants and, further, whether these symptoms were associated with dysfunctional attitudes. We found that greater severity of subclinical negative symptoms such as amotivation and anhedonia were associated with higher ratings of distress specifically attributable to these symptoms. This relationship held even after controlling for severity of depressive symptoms. Moreover, greater negative symptom burden was associated with greater endorsement of defeatist performance beliefs. Negative symptoms expressed in the general population were found to be particularly distressing. Maladaptive cognitive schemas are implicated in the expression of these symptoms, as well as the amount of distress these symptoms instil. A greater understanding of the mechanisms underlying negative symptoms, including both neurobiological and cognitive, is needed in order to effectively develop treatment strategies for these disabling symptoms.

  20. Gender differences, personality and eating behaviors in non-clinical adolescents.

    PubMed

    Cuzzocrea, F; Larcan, R; Lanzarone, C

    2012-12-01

    Few studies have focused on the relationship between personality trait and eating behaviors in a normal sample of adolescents. The purpose of this research was to examine differences between male and female non-clinical adolescents in eating behaviors, personality traits and state and trait anxiety and to verify the relationship between personality traits, anxiety and eating behaviors in males and females. 592 individuals (324 male and 267 females) were selected. Participants were asked to fill: Eating Disorder Inventory-2 (EDI-2), State-Training Anxiety Inventory (STAI - Forma Y) and Eysenck Personality Questionnaire - Revised (EPQ-R). The results highlighted specific differences in eating behaviors and in personality traits between genders. No statistical differences in anxiety were found. Our results underline the importance of focussing on anxiety levels for girls, while, for boys, on personality traits such as neuroticism and psychoticism. It was confirmed the opinion that, to prevent eating disorders, not only is it necessary to carry out a campaign based on proper nutrition, but also to investigate thoroughly aspects of personality that may be predictive of these disorders.

  1. Genetic diversity of multidrug resistant Staphylococcus aureus isolated from clinical and non clinical samples in Egypt.

    PubMed

    Bendary, M M; Solyman, S M; Azab, M M; Mahmoud, N F; Hanora, A M

    2016-08-31

    In recent years, the increasing incidence of diseases caused by Staphylococcus aureus (S. aureus) has been noted in the university hospitals of El-Sharkia and Assuit governorates - Egypt. Therefore, we studied the genetic relatedness of multidrug resistant S. aureus isolates from different sources in the above mentioned governorates. One hundred and fifty six S. aureus isolates were divided into 5 different groups, 1 non clinical isolates from different food products and 4 different clinical isolates of human and animal sources in the 2 different governorates. Epidemiological characteristics of 156 S. aureus isolates were determined by phenotypic methods including quantitative antibiogram typing and biofilm production. Genetic typing of 35 multidrug resistant (MDR) isolates (7 from each group) based on 16S rRNA gene sequence, virulence and antimicrobial resistance gene profiles was done. The genetic relatedness of the highest virulent strain from each group was detected based on different single locus sequence typing and multi-locus sequence typing (MLST). S. aureus strains isolated from different sources and geographical areas showed high diversity. The genetic typing revealed different sequence types and different sequences of coa and spa genes. S. aureus isolates were found highly diverse in Egypt.

  2. 'Dealing with sperm': comparing lesbians' clinical and non-clinical donor conception processes.

    PubMed

    Nordqvist, Petra

    2011-01-01

    A growing body of literature investigates heterosexual donor conception and there is now also a small body of work which investigates the experiences of single women and lesbian couples. Both of these focus on a clinical setting. Women, notably single and lesbians, also undertake non-clinical donor conception, and insufficient consideration has been paid to these self-arranged reproductive practices, and how they may compare with the clinical ones. Seeking to fill this gap, this paper explores women's experiences of accessing donor sperm inside and outside reproductive health clinics by drawing on a qualitative interview study with 25 lesbian couples in England and Wales with experiences of jointly pursuing donor conception. The paper explores the differences embedded in the two conception routes with regard to donor recruitment, access to donor sperm over time, space and the management of sperm as a bodily fluid. Utilising the framework of 'ontological choreography' developed by Thompson (2005), as well as Douglas's (1966) work around bodies, dirt and disgust, the paper argues that the clinic functions as a containment for legal as well as practical and bodily dimensions of donor conception, and this in turn shapes practices and perceptions of self-arranged conception.

  3. Ecto-ATPases of clinical and non-clinical isolates of Acanthamoeba.

    PubMed

    Sissons, James; Alsam, Selwa; Jayasekera, Samantha; Khan, Naveed Ahmed

    2004-11-01

    Acanthamoeba are opportunistic protozoan parasites that can cause fatal granulomatous amoebic encephalitis and eye keratitis, however the pathogenic mechanisms of Acanthamoeba remain unclear. In this study, we described the ability of live Acanthamoeba to hydrolyse extracellular ATP. Both clinical and non-clinical isolates belonging to genotypes, T1, T2, T3, T4 and T7 exhibited ecto-ATPase activities in vitro. Using non-denaturing polyacrylamide gel electrophoresis, ecto-ATPases were further characterized. All Acanthamoeba isolates tested, exhibited a single ecto-ATPase band (approximate molecular weight of 272 kDa). However, clinical isolates exhibited additional bands suggesting that ecto-ATPases may play a role in the pathogenesis of Acanthamoeba. This was supported using suramin (ecto-ATPase inhibitor), which inhibited Acanthamoeba-induced host cell cytotoxicity. Previously, we and others have shown that Acanthamoeba binds to host cells using their mannose-binding protein and binding can be blocked using exogenous alpha-mannose. In this study, we observed that alpha-mannose significantly increased ecto-ATPase activities of pathogenic Acanthamoeba belonging to T1, T2, T3 and T4 genotypes but had no effect on non-pathogenic Acanthamoeba (belonging to T7 genotype). Overall, we have shown, for the first time, that Acanthamoeba exhibit ecto-ATPase activities, which may play a role in the pathogenesis of Acanthamoeba as well as their potential role in the differentiation of pathogenic Acanthamoeba.

  4. The Revised Commitment Inventory: Psychometrics and Use with Unmarried Couples

    ERIC Educational Resources Information Center

    Owen, Jesse; Rhoades, Galena K.; Stanley, Scott M.; Markman, Howard J.

    2011-01-01

    The Commitment Inventory measures interpersonal commitment (dedication) and constraint commitment. Since it was first published, substantial revisions have been made, but there are no published data on the psychometric properties of the new version. Furthermore, little information is available on measuring commitment for unmarried couples. This…

  5. Further Exploring the Meaning and Measurement of Career Commitment.

    ERIC Educational Resources Information Center

    Blau, Gary J.

    1988-01-01

    Examined the reliability and validity of a career commitment measure using employees (N=266) of newspaper and insurance companies. Results showed career commitment could be reliably measured and was operationally distinct from job involvement and organizational commitment. Discusses findings in terms of meaning of career commitment. (Author/ABL)

  6. 28 CFR 522.11 - Civil contempt commitments.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 28 Judicial Administration 2 2011-07-01 2011-07-01 false Civil contempt commitments. 522.11..., CLASSIFICATION, AND TRANSFER ADMISSION TO INSTITUTION Civil Contempt of Court Commitments § 522.11 Civil contempt commitments. Inmates can come into Bureau custody for civil contempt commitments in two ways: (a) The...

  7. 28 CFR 522.11 - Civil contempt commitments.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 28 Judicial Administration 2 2014-07-01 2014-07-01 false Civil contempt commitments. 522.11..., CLASSIFICATION, AND TRANSFER ADMISSION TO INSTITUTION Civil Contempt of Court Commitments § 522.11 Civil contempt commitments. Inmates can come into Bureau custody for civil contempt commitments in two ways: (a) The...

  8. Robust Unit Commitment Considering Uncertain Demand Response

    DOE PAGES

    Liu, Guodong; Tomsovic, Kevin

    2014-09-28

    Although price responsive demand response has been widely accepted as playing an important role in the reliable and economic operation of power system, the real response from demand side can be highly uncertain due to limited understanding of consumers' response to pricing signals. To model the behavior of consumers, the price elasticity of demand has been explored and utilized in both research and real practice. However, the price elasticity of demand is not precisely known and may vary greatly with operating conditions and types of customers. To accommodate the uncertainty of demand response, alternative unit commitment methods robust to themore » uncertainty of the demand response require investigation. In this paper, a robust unit commitment model to minimize the generalized social cost is proposed for the optimal unit commitment decision taking into account uncertainty of the price elasticity of demand. By optimizing the worst case under proper robust level, the unit commitment solution of the proposed model is robust against all possible realizations of the modeled uncertain demand response. Numerical simulations on the IEEE Reliability Test System show the e ectiveness of the method. Finally, compared to unit commitment with deterministic price elasticity of demand, the proposed robust model can reduce the average Locational Marginal Prices (LMPs) as well as the price volatility.« less

  9. Robust Unit Commitment Considering Uncertain Demand Response

    SciTech Connect

    Liu, Guodong; Tomsovic, Kevin

    2014-09-28

    Although price responsive demand response has been widely accepted as playing an important role in the reliable and economic operation of power system, the real response from demand side can be highly uncertain due to limited understanding of consumers' response to pricing signals. To model the behavior of consumers, the price elasticity of demand has been explored and utilized in both research and real practice. However, the price elasticity of demand is not precisely known and may vary greatly with operating conditions and types of customers. To accommodate the uncertainty of demand response, alternative unit commitment methods robust to the uncertainty of the demand response require investigation. In this paper, a robust unit commitment model to minimize the generalized social cost is proposed for the optimal unit commitment decision taking into account uncertainty of the price elasticity of demand. By optimizing the worst case under proper robust level, the unit commitment solution of the proposed model is robust against all possible realizations of the modeled uncertain demand response. Numerical simulations on the IEEE Reliability Test System show the e ectiveness of the method. Finally, compared to unit commitment with deterministic price elasticity of demand, the proposed robust model can reduce the average Locational Marginal Prices (LMPs) as well as the price volatility.

  10. Civil Commitment in the United States

    PubMed Central

    West, Sara G.

    2010-01-01

    This article reviews the academic literature on the psychiatric practice of civil commitment. It provides an overview of the history of involuntary psychiatric hospitalization in the United States—from the creation of the first asylum and the era of institutionalization to the movement of deinstitutionalization. The ethical conflict that the practice of involuntary hospitalization presents for providers, namely the conflict between the ethical duties of beneficence and respect for patient autonomy, is presented. The evolution of the United States commitment standards, from being based on a right to treatment for patients with mental illness to being based on dangerousness, as well as the implications that the changes in commitment criteria has had on patients and society, are discussed. Involuntary hospitalization of patient populations that present unique challenges for psychiatry (e.g., not guilty by reason of insanity acquittees, sex offenders, and individuals with eating disorders, substance use disorders, and personality disorders) is discussed. Finally, an overview of outpatient commitment is provided. By reading this article, one will learn the history of involuntary psychiatric hospitalization in the United States and gain an understanding of the ethical issues that make civil commitment one of the most controversial practices in modern psychiatry. PMID:22778709

  11. Are Problems Prevalent and Stable in Non-Clinical Populations? Problems and Test-Retest Stability of a Patient-Generated Measure, PSYCHLOPS (Psychological Outcome Profiles), in a Non-Clinical Student Sample

    ERIC Educational Resources Information Center

    Evans, Chris; Ashworth, Mark; Peters, Marilyn

    2010-01-01

    In straightened times counselling must evidence the changes it promotes on reputable measures. Patient-generated measures complement nomothetic measures and may be nearer the ethos of counselling in eliciting individuals' problems. Scores from such measures from non-clinical samples are rarely reported, making their test-retest stability…

  12. Are Problems Prevalent and Stable in Non-Clinical Populations? Problems and Test-Retest Stability of a Patient-Generated Measure, PSYCHLOPS (Psychological Outcome Profiles), in a Non-Clinical Student Sample

    ERIC Educational Resources Information Center

    Evans, Chris; Ashworth, Mark; Peters, Marilyn

    2010-01-01

    In straightened times counselling must evidence the changes it promotes on reputable measures. Patient-generated measures complement nomothetic measures and may be nearer the ethos of counselling in eliciting individuals' problems. Scores from such measures from non-clinical samples are rarely reported, making their test-retest stability…

  13. Landscape Architects and Environmental Concern: An Examination of Attitudes, Verbal Commitment and Actual Commitment.

    ERIC Educational Resources Information Center

    Ruiz, Anita Anne

    Landscape architects have a combination of abilities that have been gained through education and experience that could make their demonstration of environmental concern as citizens very effective. This study assessed the attitudes, verbal commitment, and actual commitment regarding environmental concern held by landscape architects registered and…

  14. Perceived Sacrifice and Few Alternatives Commitments: The Motivational Underpinnings of Continuance Commitment's Subdimensions

    ERIC Educational Resources Information Center

    Vandenberghe, Christian; Panaccio, Alexandra

    2012-01-01

    Using work on self-concepts and Conservation of Resources theory, the present research examined the motivational underpinnings of continuance commitment's subcomponents of perceived sacrifice and few alternatives. Study 1 (N=208) found job scope to be positively related to perceived sacrifice commitment, and negatively related to few alternatives…

  15. Romantic Relationship Commitment and Its Linkages with Commitment to Parents and Friends during Adolescence

    ERIC Educational Resources Information Center

    De Goede, Irene H. A.; Branje, Susan; van Duin, Jet; VanderValk, Inge E.; Meeus, Wim

    2012-01-01

    This five-wave longitudinal study examines linkages between adolescents' perceptions of romantic relationship commitment and the development of adolescents' perceptions of commitment to parents and friends. A total of 218 early-to-middle adolescents (39.0 percent boys) and 185 middle-to-late adolescents (30.8 percent boys) participated.…

  16. Influence of Teacher Empowerment on Teachers' Organizational Commitment, Professional Commitment and Organizational Citizenship Behavior in Schools

    ERIC Educational Resources Information Center

    Bogler, Ronit; Somech, Anit

    2004-01-01

    The present study focuses on the relationship between teacher empowerment and teachers' organizational commitment, professional commitment (PC) and organizational citizenship behavior (OCB). It examines which subscales of teacher empowerment can best predict these outcomes. The data were collected through a questionnaire returned by a sample of…

  17. Romantic Relationship Commitment and Its Linkages with Commitment to Parents and Friends during Adolescence

    ERIC Educational Resources Information Center

    De Goede, Irene H. A.; Branje, Susan; van Duin, Jet; VanderValk, Inge E.; Meeus, Wim

    2012-01-01

    This five-wave longitudinal study examines linkages between adolescents' perceptions of romantic relationship commitment and the development of adolescents' perceptions of commitment to parents and friends. A total of 218 early-to-middle adolescents (39.0 percent boys) and 185 middle-to-late adolescents (30.8 percent boys) participated.…

  18. Highly Committed Teachers: What Makes Them Tick? A Study of Sustained Commitment

    ERIC Educational Resources Information Center

    Fransson, Göran; Frelin, Anneli

    2016-01-01

    This article focuses on teacher commitment, and particularly on teachers displaying sustained high levels of commitment throughout their teaching careers (over 15 years). Graduates from one Teacher Education programme responded to an open-ended questionnaire conducted on 10 occasions concerning their work as teachers, from graduation in 1993 to…

  19. Optimal Implantation Depth and Adherence to Guidelines on Permanent Pacing to Improve the Results of Transcatheter Aortic Valve Replacement With the Medtronic CoreValve System: The CoreValve Prospective, International, Post-Market ADVANCE-II Study.

    PubMed

    Petronio, Anna S; Sinning, Jan-Malte; Van Mieghem, Nicolas; Zucchelli, Giulio; Nickenig, Georg; Bekeredjian, Raffi; Bosmans, Johan; Bedogni, Francesco; Branny, Marian; Stangl, Karl; Kovac, Jan; Schiltgen, Molly; Kraus, Stacia; de Jaegere, Peter

    2015-05-01

    The aim of the CoreValve prospective, international, post-market ADVANCE-II study was to define the rates of conduction disturbances and permanent pacemaker implantation (PPI) after transcatheter aortic valve replacement with the Medtronic CoreValve System (Minneapolis, Minnesota) using optimized implantation techniques and application of international guidelines on cardiac pacing. Conduction disturbances are a frequent complication of transcatheter aortic valve replacement. The rates of PPI in the published reports vary according to bioprosthesis type and the indications for PPI. The primary endpoint was the 30-day incidence of PPI with Class I/II indications when the Medtronic CoreValve System was implanted at an optimal depth (≤6 mm below the aortic annulus). The timing and resolution of all new-onset conduction disturbances were analyzed. A total of 194 patients were treated. The overall rate of PPI for Class I/II indications was 18.2%. An optimal depth was reached in 43.2% of patients, with a nonsignificantly lower incidence of PPI in patients with depths ≤6 mm, compared with those with deeper implants (13.3% vs. 21.1%; p = 0.14). In a paired analysis, new-onset left bundle branch block and first-degree atrioventricular block occurred in 45.4% and 39.0% of patients, respectively, and resolved spontaneously within 30 days in 43.2% and 73.9%, respectively. In patients with new PPI, the rate of intrinsic sinus rhythm increased from 25.9% at 7 days to 59.3% at 30 days (p = 0.004). Optimal Medtronic CoreValve System deployment and adherence to international guidelines on cardiac pacing are associated with a lower rate of new PPI after transcatheter aortic valve replacement, compared with results reported in previous studies. (CoreValve Advance-II Study: Prospective International Post-Market Study [ADVANCE II]; NCT01624870). Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

  20. Organizational identification and commitment: correlates of sense of belonging and affective commitment.

    PubMed

    Dávila, Ma Celeste; Jiménez García, Gemma

    2012-03-01

    The general purpose of this work is to analyze the overlap between organizational identification and commitment. Specifically, our study focuses on the analysis of the differences and similarities between sense of belonging (a dimension of organizational identification) and affective commitment (a dimension of organizational commitment). In order to do this, we analyzed their discriminant validity and raised their relationship with variables that previous research had showed like precedent and subsequent variables of them: value congruence, perceived support, organizational citizenship behavior, and intention to continue in the organization. A total of 292 people at one organization completed surveys measuring the variables previously described. The results showed that sense of belonging and affective commitment are different concepts and they have different relationships with relation to precedent and subsequent variables. Affective commitment seems to be more useful than sense of belonging to predict organizational citizenship behavior aimed at the organization and intention to continue. Some practical implications are described.

  1. 3 CFR - Continuation of the National Emergency With Respect to Persons Who Commit, Threaten to Commit, or...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... to Persons Who Commit, Threaten to Commit, or Support Terrorism Presidential Documents Other... Persons Who Commit, Threaten to Commit, or Support Terrorism On September 23, 2001, by Executive Order..., or support terrorism, pursuant to the International Emergency Economic Powers Act (50 U.S.C....

  2. Contractor and Government: Teamwork and Commitment

    NASA Technical Reports Server (NTRS)

    Griffin, Gerald D.

    1984-01-01

    The assigned topic, "Contractor and Government: Teamwork and Commitment," is a subject about vitally interested. The successes of the U.S. space program were built on such teamwork and commitment. It seems only a short time ago that man's role in space was an unknown quantity. In rapid succession, however, the flights of Shepard, Glenn, and Armstrong demonstrated man's capability to live and travel in space. Consequently, we no longer live with the same awe of space. The success of these joint industry-NASA efforts in achieving our Nation's space goals testifies to the validity of our team's past commitment, management expertise, communications techniques, and teamwork over a period of 25 years. Today, however, We are at the beginning of a new era in space.

  3. Measuring Asian nurses' organizational commitment: a critical analysis of the psychometric properties of two organizational commitment instruments.

    PubMed

    Liou, Shwu-Ru; Tsai, Hsiu-Min; Cheng, Ching-Yu

    2013-01-01

    To analyze and compare the psychometric properties and cultural attributes of the Organizational Commitment Questionnaire and the Organizational Commitment Scale to determine their appropriateness for measuring commitment of Asian nurses, the biggest portion of international nurses. The Organizational Commitment Questionnaire was cross-culturally cross-validated when compared with the Organizational Commitment Scale. Both instruments were not tested on Asian nurses. More studies are needed to validate the cultural properties of the Organizational Commitment Scale. Healthcare administrators can use culturally validated instruments, which concern cultural context, including languages and cultural values, to understand Asian nurses' organizational commitment and further lower turnover behavior among them. © 2013 Wiley Periodicals, Inc.

  4. Genotypic diversity and virulence markers of Yersinia enterocolitica biotype 1A strains isolated from clinical and non-clinical origins.

    PubMed

    Campioni, Fábio; Falcão, Juliana P

    2014-03-01

    Yersinia enterocolitica biotype 1A (B1A) strains are considered as non-pathogenic; however, some reports have identified some strains as the causal agents of infection. In South America, few studies molecularly characterized the strains of this biotype. This work typed 51 B1A strains isolated from clinical and non-clinical sources from Brazil and Chile by Enterobacterial Repetitive Intergenic Consensus-PCR (ERIC-PCR) to elucidate their genotypic diversity, and verify the distribution of 11 virulence markers by PCR. The strains were divided into two groups, ERIC-A and ERIC-B, clustered independently of their clinical or non-clinical origin. No differences were observed in the frequencies of the virulence markers between clinical and non-clinical strains. However, the genes ystB, hreP and myfA occurred exclusively in the strains of the group ERIC-A. Some clinical and non-clinical strains were clustered in the same genetic group and presented the same number of virulence markers, which might suggest the role of the environment and food as a potential source of infection for humans and animals. The results corroborate with the hypothesis that B1A strains are divided into two main clusters that differ in the frequency of some virulence markers, a fact observed for the first time in South American strains.

  5. [Trends in caesarean sections associated with non-clinical factors in a Birthing Educational Center in Mexico City].

    PubMed

    Campero, Lourdes; Hernández, Bernardo; Leyva, Ahidée; Estrada, Fátima; Osborne, Jomo; Morales, Sara

    2007-01-01

    To describe the trends in caesarian sections (CS) associated with non-clinical factors in women who attended a birthing educational facility, also known as 'Centro de Educación,' (CEPAPAR) in Mexico City. Data from 992 births of 847 women that occurred from 1988-2000 were analyzed using linear regression to identify the association between non-clinical factors and time-trends in CS. The overall incidence of CS was 32.8%, with an 8% average annual increase. Until 1994 the percentage of CS remained relatively steady at 30%, increasing to 40% in subsequent years. In analyzing trends in CS and their relationship with non-clinical factors from 1988-2000, the increased incidence of CS during this period was higher among births where no birth attendant was present, for first-time mothers, and in larger hospitals (>50 beds). Results show that the increased incidence of CS is associated with non-clinical factors such as size of the hospital and the presence of a birth attendant. A model of support for women which includes information, counseling, and the presence of a birth attendant during labor can contribute to reducing the risk of unnecessary CS in populations such as that studied.

  6. Avoidance of Affect Mediates the Effect of Invalidating Childhood Environments on Borderline Personality Symptomatology in a Non-Clinical Sample

    ERIC Educational Resources Information Center

    Sturrock, Bonnie A.; Francis, Andrew; Carr, Steven

    2009-01-01

    The aim of this study was to test the Linehan (1993) proposal regarding associations between invalidating childhood environments, distress tolerance (e.g., avoidance of affect), and borderline personality disorder (BPD) symptoms. The sample consisted of 141 non-clinical participants (51 men, 89 women, one gender unknown), ranging in age from 18 to…

  7. Relations between Behavioral Inhibition, Big Five Personality Factors, and Anxiety Disorder Symptoms in Non-Clinical and Clinically Anxious Children

    ERIC Educational Resources Information Center

    Vreeke, Leonie J.; Muris, Peter

    2012-01-01

    This study examined the relations between behavioral inhibition, Big Five personality traits, and anxiety disorder symptoms in non-clinical children (n = 147) and clinically anxious children (n = 45) aged 6-13 years. Parents completed the Behavioral Inhibition Questionnaire-Short Form, the Big Five Questionnaire for Children, and the Screen for…

  8. Dysexecutive symptoms among a non-clinical sample: A study with the use of the Dysexecutive Questionnaire.

    PubMed

    Chan, Raymond C. K.

    2001-08-01

    Clinical studies indicate that damage to the frontal lobes may lead to a set of symptoms collectively known as 'Dysexecutive syndrome', which is characterized by changes in emotion, personality, motivation, behaviour and cognitive aspects. Factor analytical study using questionnaires measuring dysexecutive problems in everyday life also suggests a fractionation of the dysexecutive syndrome among patients with neurological disorders. As yet, very little research has been conducted to explore the base-rate of executive problems in everyday life among the non-clinical population. This pilot study aimed to explore dysexecutive behaviour similar to that of dysexecutive syndrome reported by a non-clinical sample. A total of 93 presumably normal participants were recruited. The Dysexecutive Questionnaire and a set of clinical tests of executive function were administered to all the participants. A 5-factor solution very similar to that of a previous study was derived: inhibition (factor 1), intentionality (factor 2), knowing-doing dissociation (factor 3), in-resistance (factor 4), and social regulation (factor 5). Correlation was established among the derived factors and tests of executive function. This study provides empirical evidence that a non-clinical sample may encounter similar dysexecutive behaviours in daily life. The issue of the fractionation of the executive system among the non-clinical sample will also be discussed.

  9. Dysexecutive symptoms among a non-clinical sample: a study with the use of the Dysexecutive Questionnaire.

    PubMed

    Chan, R C

    2001-08-01

    Clinical studies indicate that damage to the frontal lobes may lead to a set of symptoms collectively known as 'Dysexecutive syndrome', which is characterized by changes in emotion, personality, motivation, behaviour and cognitive aspects. Factor analytical study using questionnaires measuring dysexecutive problems in everyday life also suggests a fractionation of the dysexecutive syndrome among patients with neurological disorders. As yet, very little research has been conducted to explore the base-rate of executive problems in everyday life among the non-clinical population. This pilot study aimed to explore dysexecutive behaviour similar to that of dysexecutive syndrome reported by a non-clinical sample. A total of 93 presumably normal participants were recruited. The Dysexecutive Questionnaire and a set of clinical tests of executive function were administered to all the participants. A 5-factor solution very similar to that of a previous study was derived: inhibition (factor 1), intentionality (factor 2), knowing-doing dissociation (factor 3), in-resistance (factor 4), and social regulation (factor 5). Correlation was established among the derived factors and tests of executive function. This study provides empirical evidence that a non-clinical sample may encounter similar dysexecutive behaviours in daily life. The issue of the fractionation of the executive system among the non-clinical sample will also be discussed.

  10. Avoidance of Affect Mediates the Effect of Invalidating Childhood Environments on Borderline Personality Symptomatology in a Non-Clinical Sample

    ERIC Educational Resources Information Center

    Sturrock, Bonnie A.; Francis, Andrew; Carr, Steven

    2009-01-01

    The aim of this study was to test the Linehan (1993) proposal regarding associations between invalidating childhood environments, distress tolerance (e.g., avoidance of affect), and borderline personality disorder (BPD) symptoms. The sample consisted of 141 non-clinical participants (51 men, 89 women, one gender unknown), ranging in age from 18 to…

  11. Relations between Behavioral Inhibition, Big Five Personality Factors, and Anxiety Disorder Symptoms in Non-Clinical and Clinically Anxious Children

    ERIC Educational Resources Information Center

    Vreeke, Leonie J.; Muris, Peter

    2012-01-01

    This study examined the relations between behavioral inhibition, Big Five personality traits, and anxiety disorder symptoms in non-clinical children (n = 147) and clinically anxious children (n = 45) aged 6-13 years. Parents completed the Behavioral Inhibition Questionnaire-Short Form, the Big Five Questionnaire for Children, and the Screen for…

  12. Brief Report: Examining the Link between Autistic Traits and Compulsive Internet Use in a Non-Clinical Sample

    ERIC Educational Resources Information Center

    Finkenauer, Catrin; Pollmann, Monique M. H.; Begeer, Sander; Kerkhof, Peter

    2012-01-01

    Individuals with autism spectrum disorders or autistic traits may profit from Internet and computer-mediated interactions, but there is concern about their Internet use becoming compulsive. This study investigated the link between autistic traits and Internet use in a 2-wave longitudinal study with a non-clinical community sample (n = 390). As…

  13. Criterion Validity of the Mood and Feelings Questionnaire for Depressive Episodes in Clinic and Non-Clinic Subjects

    ERIC Educational Resources Information Center

    Daviss, W. Burleson; Birmaher, Boris; Melhem, Nadine A.; Axelson, David A.; Michaels, Shana M.; Brent, David A.

    2006-01-01

    Background: Previous measures of pediatric depression have shown inconsistent validity in groups with differing demographics, comorbid diagnoses, and clinic or non-clinic origins. The current study re-examines the criterion validity of child- and parent-versions of the Mood and Feelings Questionnaire (MFQ-C, MFQ-P) in a heterogeneous sample of…

  14. On the Relationship between Autistic Traits and Executive Functioning in a Non-Clinical Dutch Student Population

    ERIC Educational Resources Information Center

    Maes, Joseph HR; Vissers, Constance ThWM; Egger, Jos IM; Eling, Paul ATM

    2013-01-01

    We examined the association between autistic traits and different aspects of executive functioning (EF), using non-clinical Social Science and Science students as participants. Autistic traits, and associated personality traits, were measured using the Autism Quotient (AQ) and the Temperament and Character Inventory (TCI), respectively. EF was…

  15. Brief Report: Examining the Link between Autistic Traits and Compulsive Internet Use in a Non-Clinical Sample

    ERIC Educational Resources Information Center

    Finkenauer, Catrin; Pollmann, Monique M. H.; Begeer, Sander; Kerkhof, Peter

    2012-01-01

    Individuals with autism spectrum disorders or autistic traits may profit from Internet and computer-mediated interactions, but there is concern about their Internet use becoming compulsive. This study investigated the link between autistic traits and Internet use in a 2-wave longitudinal study with a non-clinical community sample (n = 390). As…

  16. On the Links between Attachment Style, Parental Rearing Behaviors, and Internalizing and Externalizing Problems in Non-Clinical Children

    ERIC Educational Resources Information Center

    Roelofs, Jeffrey; Meesters, Cor; ter Huurne, Mijke; Bamelis, Lotte; Muris, Peter

    2006-01-01

    We sought to investigate the relationships between negative family factors such as insecure attachment and adverse parental rearing, and internalizing and externalizing symptoms in a large sample of non-clinical children (N = 237) aged 9 to 12 years. All children completed a set of self-report questionnaires including a single-item measure of…

  17. Commitment strategies in hierarchical task network planning

    SciTech Connect

    Tsuneto, R.; Hendler, J.; Nau, D.; Erol, K.

    1996-12-31

    This paper compares three commitment strategies for HTN planning: (1) a strategy that delays variable bindings as much as possible; (2) a strategy in which no non-primitive task is expanded until all variable constraints are committed; and (3) a strategy that chooses between expansion and variable instantiation based on the number of branches that will be created in the search tree. Our results show that while there exist planning domains in which the first two strategies do well, the third does well over a broader range of planning domains.

  18. Quantum bit commitment under Gaussian constraints

    NASA Astrophysics Data System (ADS)

    Mandilara, Aikaterini; Cerf, Nicolas J.

    2012-06-01

    Quantum bit commitment has long been known to be impossible. Nevertheless, just as in the classical case, imposing certain constraints on the power of the parties may enable the construction of asymptotically secure protocols. Here, we introduce a quantum bit commitment protocol and prove that it is asymptotically secure if cheating is restricted to Gaussian operations. This protocol exploits continuous-variable quantum optical carriers, for which such a Gaussian constraint is experimentally relevant as the high optical nonlinearity needed to effect deterministic non-Gaussian cheating is inaccessible.

  19. Secure quantum bit commitment against empty promises

    SciTech Connect

    He Guangping

    2006-08-15

    The existence of unconditionally secure quantum bit commitment (QBC) is excluded by the Mayers-Lo-Chau no-go theorem. Here we look for the second-best: a QBC protocol that can defeat certain quantum attacks. By breaking the knowledge symmetry between the participants with quantum algorithm, a QBC protocol is proposed and is proven to be secure against a major kind of coherent attacks - the dummy attack, in which the participant makes an empty promise instead of committing to a specific bit. Therefore it surpasses previous QBC protocols which are secure against individual attacks only.

  20. An introduction to QT interval prolongation and non-clinical approaches to assessing and reducing risk

    PubMed Central

    Pollard, CE; Abi Gerges, N; Bridgland-Taylor, MH; Easter, A; Hammond, TG; Valentin, J-P

    2010-01-01

    Owing to its association with Torsades de Pointes, drug-induced QT interval prolongation has been and remains a significant hurdle to the development of safe, effective medicines. Genetic and pharmacological evidence highlighting the pivotal role the human ether-a-go-go-related gene (hERG) channel was a critical step in understanding how to start addressing this issue. It led to the development of hERG assays with the rapid throughput needed for the short timescales required in early drug discovery. The resulting volume of hERG data has fostered in silico models to help chemists design compounds with reduced hERG potency. In early drug discovery, a pragmatic approach based on exceeding a given potency value has been required to decide when a compound is likely to carry a low QT risk, to support its progression to late-stage discovery. At this point, the in vivo efficacy and metabolism characteristics of the potential drug are generally defined, as well its safety profile, which includes usually a dog study to assess QT interval prolongation risk. The hERG and in vivo QT data, combined with the likely indication and the estimated free drug level for efficacy, are put together to assess the risk that the potential drug will prolong QT in man. Further data may be required to refine the risk assessment before making the major investment decisions for full development. The non-clinical data are essential to inform decisions about compound progression and to optimize the design of clinical QT studies. This article is commented on by Guth and Rast, pp. 22–24 of this issue and is part of a themed section on QT safety. To view this issue visit http://www3.interscience.wiley.com/journal/121548564/issueyear?year=2010 PMID:20141516

  1. The Behavioural Inhibition System, anxiety and hippocampal volume in a non-clinical population.

    PubMed

    Levita, Liat; Bois, Catherine; Healey, Andrew; Smyllie, Emily; Papakonstantinou, Evelina; Hartley, Tom; Lever, Colin

    2014-03-07

    Animal studies have suggested that the hippocampus may play an important role in anxiety as part of the Behavioural Inhibition System (BIS), which mediates reactivity to threat and punishment and can predict an individual's response to anxiety-relevant cues in a given environment. The aim of the present structural magnetic resonance imaging (MRI) study was to examine the relationship between individual differences in BIS and hippocampal structure, since this has not received sufficient attention in non-clinical populations. Thirty healthy right-handed participants with no history of alcohol or drug abuse, neurological or psychiatric disorders, or traumatic brain injury were recruited (16 male, 14 female, age 18 to 32 years). T1-weighted structural MRI scans were used to derive estimates of total intracranial volume, and hippocampal and amygdala gray matter volume using FreeSurfer. To relate brain structure to Gray's BIS, participants completed the Sensitivity to Punishment questionnaire. They also completed questionnaires assessing other measures potentially associated with hippocampal volume (Beck Depression Inventory, Negative Life Experience Survey), and two other measures of anxiety (Spielberger Trait Anxiety Inventory and the Beck Anxiety Inventory). We found that high scores on the Sensitivity to Punishment scale were positively associated with hippocampal volume, and that this phenomenon was lateralized to the right side. In other words, greater levels of behavioural inhibition (BIS) were positively associated with right hippocampal volume. Our data suggest that hippocampal volume is related to the cognitive and affective dimensions of anxiety indexed by the Sensitivity to Punishment, and support the idea that morphological differences in the hippocampal formation may be associated with behavioural inhibition contributions to anxiety.

  2. The Behavioural Inhibition System, anxiety and hippocampal volume in a non-clinical population

    PubMed Central

    2014-01-01

    Background Animal studies have suggested that the hippocampus may play an important role in anxiety as part of the Behavioural Inhibition System (BIS), which mediates reactivity to threat and punishment and can predict an individual’s response to anxiety-relevant cues in a given environment. The aim of the present structural magnetic resonance imaging (MRI) study was to examine the relationship between individual differences in BIS and hippocampal structure, since this has not received sufficient attention in non-clinical populations. Thirty healthy right-handed participants with no history of alcohol or drug abuse, neurological or psychiatric disorders, or traumatic brain injury were recruited (16 male, 14 female, age 18 to 32 years). T1-weighted structural MRI scans were used to derive estimates of total intracranial volume, and hippocampal and amygdala gray matter volume using FreeSurfer. To relate brain structure to Gray’s BIS, participants completed the Sensitivity to Punishment questionnaire. They also completed questionnaires assessing other measures potentially associated with hippocampal volume (Beck Depression Inventory, Negative Life Experience Survey), and two other measures of anxiety (Spielberger Trait Anxiety Inventory and the Beck Anxiety Inventory). Results We found that high scores on the Sensitivity to Punishment scale were positively associated with hippocampal volume, and that this phenomenon was lateralized to the right side. In other words, greater levels of behavioural inhibition (BIS) were positively associated with right hippocampal volume. Conclusions Our data suggest that hippocampal volume is related to the cognitive and affective dimensions of anxiety indexed by the Sensitivity to Punishment, and support the idea that morphological differences in the hippocampal formation may be associated with behavioural inhibition contributions to anxiety. PMID:24607258

  3. Mediators of physical activity behaviour change among adult non-clinical populations: a review update

    PubMed Central

    2010-01-01

    Background An understanding of the determinants of physical activity through mediators of behaviour change is important in order to evaluate the efficacy of interventions. Prior reviews on this topic noted that few studies employed mediator analyses in experimental physical activity trials; the purpose of this review is to update these prior reviews in order to evaluate the state of our present understanding of interventions that include proposed mediators of behaviour change. Methods Literature was identified through electronic database (e.g., MEDLINE, psychINFO) searching. Studies were eligible if they described a published experimental or quasi-experimental trial examining the effect of an intervention on physical activity behaviour and mediator change in non-clinical adult populations. Quality of included studies was assessed and the analyses examined the symmetry between mediators and behaviour change. Results Twenty seven unique trials passed the eligibility criteria and 22 were included in the analysis with scores of moderate or higher quality. Half of the studies reviewed failed to show an intervention effect on PA. The remaining studies showed evidence that the intervention affected changes in the proposed mediators, but tests of mediated effect were performed in only six of these 11 cases and demonstrated mixed outcomes. Differences by theory were not discernable at this time, but self-regulation constructs had the most evidence for mediation. Conclusion Published literature employing mediators of change analyses in experimental designs is still relatively elusive since the time of prior reviews; however, the general null findings of changes in mediating constructs from these interventions are a more timely concern. Changes in self-regulation constructs may have the most effect on changes in PA while self-efficacy and outcome expectation type constructs have negligible but limited findings. Innovation and increased fidelity of interventions is needed and

  4. Cannabis use and neurocognitive functioning in a non-clinical sample of users

    PubMed Central

    Thames, April D.; Arbid, Natalie; Sayegh, Philip

    2014-01-01

    Objective With the recent debates over marijuana legalization and increases in use, it is critical to examine its role in cognition. While many studies generally support the adverse acute effects of cannabis on neurocognition, the non-acute effects remain less clear. The current study used a cross-sectional design to examine relationships between recent and past cannabis use on neurocognitive functioning in a non-clinical adult sample. Method One hundred and fifty-eight participants were recruited through fliers distributed around local college campuses and the community. All participants completed the Brief Drug Use History Form, the Structured Clinical Interview for DSM-IV Disorders, and neurocognitive assessment, and underwent urine toxicology screening. Participants consisted of recent users (n = 68), past users (n = 41), and non-users (n = 49). Results Recent users demonstrated significantly (p < .05) worse performance than non-users across cognitive domains of attention/working memory (M = 42.4, SD = 16.1 vs. M = 50.5, SD = 10.2), information processing speed (M = 44.3, SD = 7.3 vs. M = 52.1, SD = 11.0), and executive functioning (M = 43.6, SD = 13.4 vs. M = 48.6, SD = 7.2). There were no statistically significant differences between recent users and past users on neurocognitive performance. Frequency of cannabis use in the last 4 weeks was negatively associated with global neurocognitive performance and all individual cognitive domains. Similarly, amount of daily cannabis use was negatively associated with global neurocognitive performance and individual cognitive domains. Conclusions Our results support the widespread adverse effects of cannabis use on neurocognitive functioning. Although some of these adverse effects appear to attenuate with abstinence, past users' neurocognitive functioning was consistently lower than non-users. PMID:24556155

  5. Safety and effectiveness of 24-week treatment with iguratimod, a new oral disease-modifying antirheumatic drug, for patients with rheumatoid arthritis: interim analysis of a post-marketing surveillance study of 2679 patients in Japan.

    PubMed

    Mimori, Tsuneyo; Harigai, Masayoshi; Atsumi, Tatsuya; Fujii, Takao; Kuwana, Masataka; Matsuno, Hiroaki; Momohara, Shigeki; Takei, Syuji; Tamura, Naoto; Takasaki, Yoshinari; Ikeuchi, Satoshi; Kushimoto, Satoru; Koike, Takao

    2017-09-01

    To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.

  6. Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study.

    PubMed

    Jost, Wolfgang H; Hefter, Harald; Reissig, Andrea; Kollewe, Katja; Wissel, Joerg

    2014-02-15

    The current practice in Germany and Austria, and the safety and efficacy of botulinum toxin type A (BoNT-A; Dysport) in the treatment of patients with post-stroke arm spasticity (with no fixed upper-limb contractures), were assessed in this observational prospective non-interventional study. One treatment cycle was documented with assessments at baseline, approximately week 4 (optional), and approximately week 12. Pattern of spasticity, treatment goal, safety and efficacy were recorded. Overall response and goal achievement was rated on a 4-point scale ('no goal achievement', 'goal achievement', 'good goal achievement', 'best goal achievement'). In total, 409 patients were included and 99% assigned to one of five arm-spasticity patterns. Therapy goals included reduced muscle tone (92.6%), physiotherapy or occupational therapy support (63.8%), increased range of motion (61.8%), pain reduction (58.9%), facilitation of care or hygiene (55.7%), and functional improvement (17.0%). Goals were achieved in 84% of patients. The following factors had the most potential as predictors of treatment outcome: pre-treatment; time since onset of spasticity; pattern of arm spasticity. Mean Dysport dose was 728 U and an inverse dose-response relationship was observed. Treatment was well tolerated. 500-1000 U was a safe and effective treatment for post-stroke arm spasticity in this post-marketing evaluation. Copyright © 2014 The Authors. Published by Elsevier B.V. All rights reserved.

  7. Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium.

    PubMed

    Seltzer, Jonathan H; Heise, Ted; Carson, Peter; Canos, Daniel; Hiatt, Jo Carol; Vranckx, Pascal; Christen, Thomas; Cutlip, Donald E

    2017-08-01

    This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled "The Role of Endpoint Adjudication in Medical Device Clinical Trials". The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA's White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), end point adjudication specialist groups, clinical research organizations, and active, academically based adjudicators. The manuscript presents recommendations from the think tank regarding (1) rationale for when adjudication is appropriate, (2) best practices establishment and operation of a medical device adjudication committee and (3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence. Copyright © 2017. Published by Elsevier Inc.

  8. Real-world evidence for the safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (STELLA-ELDER): final results of a post-marketing surveillance study.

    PubMed

    Yokote, Koutaro; Terauchi, Yasuo; Nakamura, Ichiro; Sugamori, Haruko

    2016-10-01

    To investigate the real-world safety of ipragliflozin in elderly Japanese patients with type 2 diabetes mellitus (T2DM). Japanese patients (≥65 years old) who were first prescribed ipragliflozin within 3 months after its launch in April 2014 were registered in this post-marketing surveillance (PMS). Final data collection was in July 2015. Survey items included demographics, treatments, adverse drug reactions (ADRs), vital signs, and laboratory variables. The PMS included 8505 patients (4181 males/4324 females). The mean age and diabetes duration were 72.3 years and 10.6 years, respectively. In 84.3% of patients, ipragliflozin was prescribed at 50 mg/day, which was continued unchanged. Overall, 16.91% of patients experienced 1880 ADRs, and 165 ADRs were classified as serious in 127 patients (1.49%). ADRs of special interest included skin complications, volume depletion, polyuria/pollakiuria, genital infection, urinary tract infection, renal disorders, hypoglycemia, cerebrovascular disease, cardiovascular disease, malignant tumor, fracture, and ketone body-related events. This 1-year PMS revealed probable ADRs in elderly Japanese patients with T2DM prescribed ipragliflozin in real-world settings, with no new safety concerns. The risk factors for ADRs varied but could be rationalized. The results should help physicians to identify possible treatment-emergent ADRs in ipragliflozin-treated patients.

  9. Safety and effectiveness responses to etanercept for rheumatoid arthritis in Japan: a sub-analysis of a post-marketing surveillance study focusing on the duration of rheumatoid arthritis.

    PubMed

    Koike, Takao; Harigai, Masayoshi; Inokuma, Shigeko; Ishiguro, Naoki; Ryu, Junnosuke; Takeuchi, Tsutomu; Tanaka, Yoshiya; Yamanaka, Hisashi; Fujii, Koichi; Yoshinaga, Takunari; Freundlich, Bruce; Suzukawa, Michio

    2012-06-01

    The aim is to investigate the relationship of duration of rheumatoid arthritis (RA) with safety and effectiveness of etanercept (ETN) in Japan. Post-marketing surveillance data for 7,099 patients treated with ETN were analyzed. Baseline characteristics, treatment effectiveness, incidence of adverse events (AEs), and serious AEs (SAEs) in relation to duration of RA were studied. At baseline, patients with RA for longer duration were older, weighed less, had more comorbidities, allergies, and corticosteroid use, but smoked less and had less morning stiffness. By 2-5 years with RA, more than half of the patients had advanced to Steinbrocker radiographic stage III or IV. Methotrexate (MTX) was the most commonly used pre-treatment disease-modifying antirheumatic drug; however, concomitant MTX use and its dose were lower among patients with longer duration of RA. Remission rates (26.6%) were greatest among patients having RA for <2 years. Less AEs and SAEs were observed among patients with shorter duration of RA. These results suggest that RA treatment in Japan in the era pre-biologics may not have been adequate to control disease activity and prevent joint destruction. Patients with shorter duration of RA may have better physical status which allows the opportunity to treat more intensively putting a higher percentage of patients in remission and possibly decreasing exposure to SAEs.

  10. Attitudes toward health and taste of food among women with bulimia nervosa and women of a non-clinical sample.

    PubMed

    Koritar, Priscila; Philippi, Sonia Tucunduva; Alvarenga, Marle Dos Santos

    2017-06-01

    Taste preferences and health concerns play important roles in determining eating attitudes, thus influencing food choices. Disordered eating attitudes are common among women, and can lead to the development and maintenance of eating disorders (ED). Attitudes toward health and taste of food among ED patients and its comparison with non-clinical women are not well known, and this knowledge could improve eating interventions. In this study, we compared taste preferences and health concerns in 27 women with diagnosis of bulimia nervosa (BN) and 216 women of a non-clinical sample. All participants completed the Health and Taste Attitude Scale (HTAS). Using analysis of covariance we compared the HTAS scores of the BN patients with those of the college students. Risk behaviors for ED (assessed by the Eating Attitudes Test) were identified in 54 (25%) of the non-clinical sample, all of whom were therefore excluded in comparison of BN patients. Non-clinical sample, compared to patients, scored higher on the HTAS Taste domain (p < 0.001) and its pleasure subscale (p < 0.001), whereas patients scored higher on the HTAS Health domain (p < 0.05) and its light product interest subscale (p < 0.05). Based on our data, eating attitudes of women of non-clinical sample are related to taste and pleasure, whereas women with BN are concerned with adopting a diet regarded as healthy, thus increasing their interest in "light" products. Therefore, the taste and health concerns must be considered in nutrition interventions for women in general, and prevention and treatment of ED as determinants of food choice. Copyright © 2017 Elsevier Ltd. All rights reserved.

  11. Influencing Organizational Commitment through Office Redesign

    ERIC Educational Resources Information Center

    Morrow, Paula C.; McElroy, James C.; Scheibe, Kevin P.

    2012-01-01

    Prior research on the effects of office redesign on work-related outcomes has been largely a theoretical and yielded mixed and conflicting findings. Expanding on individual reactions to office design changes as specified by social interference theory, we propose that office redesign affects organizational commitment and this relationship is…

  12. Committed to the Cause: James Forman Jr.

    ERIC Educational Resources Information Center

    Roach, Ronald

    2005-01-01

    Steeped in the values of the civil rights movement, James Forman Jr. has charted a path into academia that has demonstrated both a keen commitment to social justice as well as impressive legal and academic achievements. Among his most notable accomplishments prior to his Georgetown appointment in 2003, Forman co-founded the nationally acclaimed…

  13. Sex, Love, and the Committed Relationship

    ERIC Educational Resources Information Center

    Whitaker, Carl A.; And Others

    1976-01-01

    Six responses are presented to the question of relationship of love, sex, and commitment as revised by Sager in the Spring 1976 issue of this journal. Theoretical and historical perspectives as well as issues of coupling, eroticism, sexual dysfunction and therapy, and psychosexual development are discussed. (HLM)

  14. Employee Commitment to Organizations: A Conceptual Review.

    DTIC Science & Technology

    1981-08-01

    35 Exhibit 3 Hypothesized Antecedents and Outcomes of Organizacional Commitment (adopted from Steers, 1977a) Personal characteristics...characteristics Retention tics _Job effort W exencl- I IIf r - Exhibit 4 Comparison of Within versus Between Organization Comitment Scores Organizational State...Naval Training Analysis and Evaluation Group Orlando, FL 32813 Commanding Officer ATTN: TIC , Bldg. 2068 Naval Training Equipment Center Orlando, FL

  15. Commitment at Work and Independence from Management.

    ERIC Educational Resources Information Center

    Belanger, Jacques; Edwards, Paul K.; Wright, Martyn

    2003-01-01

    Case study of a Canadian aluminum smelter through 15 interviews, observation, and employee survey (n=214) revealed high commitment, acceptance of change, and worker independence from management. This pattern emerged from a traditionally strong union presence. Comparison with other cases underlines the centrality of collective organization to…

  16. Managing Organizational Commitment: Insights from Longitudinal Research

    ERIC Educational Resources Information Center

    Morrow, Paula C.

    2011-01-01

    This article summarizes what is known about the "active" management of affective organizational commitment (AOC) through a review of 58 studies employing longitudinal research designs. The review yields six broad categories of antecedents that have empirically demonstrated effects on AOC: socialization practices, organizational changes, human…

  17. Public Television: Commitment to Children's Programs.

    ERIC Educational Resources Information Center

    Distance Education Report, 2000

    2000-01-01

    Illustrates public television's early commitment to children's programming, discussing the popularity of "Sesame Street" and noting other shows launched under Joan Ganz Cooney, president of CTW from 1970 until 1988. Discusses the erosion of television network ratings by cable television in the mid '80s, and concludes by posing questions…

  18. The Changing Mood in America. Eroding Commitment?

    ERIC Educational Resources Information Center

    Jones, Faustine Childress; And Others

    This book examines the current social climate in the United States to determine whether there is an eroding social commitment to equal opportunity for blacks and other minorities and the poor. It is concluded that there is a changing mood in the dominant society, in the black population, and in all three branches of the federal government, and it…

  19. Organizational Commitment among Public Service Employees.

    ERIC Educational Resources Information Center

    Young, Brian S.; Worchel, Stephen; Woehr, David J.

    1998-01-01

    A study that examined factors associated with organizational commitment among 64 blue-collar workers found that the following were positively and significantly related: promotion satisfaction, job characteristics, communication, leadership satisfaction, job satisfaction, intrinsic and extrinsic exchange, and intrinsic and extrinsic rewards.…

  20. 'Commitment' and Motivation in Primary School Teachers.

    ERIC Educational Resources Information Center

    Nias, Jennifer

    1981-01-01

    Analysis of the use made by 93 British primary school teachers of the word 'commitment' revealed that they were using it in four different senses--as caring, a concern for occupational competence, personal identification as teacher, and career-continuance. All suggest different motives for entering and remaining in teaching. (Author)

  1. 40 CFR 63.75 - Enforceable commitments.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...) reduction from base year emissions; (ii) A statement certifying that the base year emission data submitted as part of the enforceable commitment constitute the best available data for base year emissions from... correct and constitute the best available data for base year emissions from the source, and acknowledge...

  2. 24 CFR 203.7 - Commitment process.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES SINGLE... 24 Housing and Urban Development 2 2014-04-01 2014-04-01 false Commitment process. 203.7 Section 203.7 Housing and Urban Development Regulations Relating to Housing and Urban Development...

  3. 24 CFR 203.7 - Commitment process.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES SINGLE... 24 Housing and Urban Development 2 2010-04-01 2010-04-01 false Commitment process. 203.7 Section 203.7 Housing and Urban Development Regulations Relating to Housing and Urban Development...

  4. 24 CFR 203.7 - Commitment process.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES SINGLE... 24 Housing and Urban Development 2 2012-04-01 2012-04-01 false Commitment process. 203.7 Section 203.7 Housing and Urban Development Regulations Relating to Housing and Urban Development...

  5. 24 CFR 203.7 - Commitment process.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES SINGLE... 24 Housing and Urban Development 2 2011-04-01 2011-04-01 false Commitment process. 203.7 Section 203.7 Housing and Urban Development Regulations Relating to Housing and Urban Development...

  6. 24 CFR 203.7 - Commitment process.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... DEVELOPMENT MORTGAGE AND LOAN INSURANCE PROGRAMS UNDER NATIONAL HOUSING ACT AND OTHER AUTHORITIES SINGLE... 24 Housing and Urban Development 2 2013-04-01 2013-04-01 false Commitment process. 203.7 Section 203.7 Housing and Urban Development Regulations Relating to Housing and Urban Development...

  7. Work Commitment through the Life Cycle.

    ERIC Educational Resources Information Center

    Levitin, Teresa E.; Quinn, Robert P.

    Data obtained from a national, cross-sectional survey of the American work force were used to examine the relationship between age and an interview measure of psychological involvement with work (i.e., paid employment). For men, this relationship was curvilinear. Commitment began at a low level among the 16-20 year old men, rose to its highest…

  8. Predicting volunteer commitment in environmental stewardship programmes

    Treesearch

    Robert L. Ryan; Rachel Kaplan; Robert E. Grese

    2001-01-01

    The natural environment benefits greatly from the work of volunteers in environmental stewardship programmes. However, little is known about volunteers' motivations for continued participation in these programmes. This study looked at the relationship between volunteer commitment and motivation, as well as the effect that volunteering has on participants'...

  9. Commitment at Work and Independence from Management.

    ERIC Educational Resources Information Center

    Belanger, Jacques; Edwards, Paul K.; Wright, Martyn

    2003-01-01

    Case study of a Canadian aluminum smelter through 15 interviews, observation, and employee survey (n=214) revealed high commitment, acceptance of change, and worker independence from management. This pattern emerged from a traditionally strong union presence. Comparison with other cases underlines the centrality of collective organization to…

  10. Organizational Commitment among Public Service Employees.

    ERIC Educational Resources Information Center

    Young, Brian S.; Worchel, Stephen; Woehr, David J.

    1998-01-01

    A study that examined factors associated with organizational commitment among 64 blue-collar workers found that the following were positively and significantly related: promotion satisfaction, job characteristics, communication, leadership satisfaction, job satisfaction, intrinsic and extrinsic exchange, and intrinsic and extrinsic rewards.…

  11. Influencing Organizational Commitment through Office Redesign

    ERIC Educational Resources Information Center

    Morrow, Paula C.; McElroy, James C.; Scheibe, Kevin P.

    2012-01-01

    Prior research on the effects of office redesign on work-related outcomes has been largely a theoretical and yielded mixed and conflicting findings. Expanding on individual reactions to office design changes as specified by social interference theory, we propose that office redesign affects organizational commitment and this relationship is…

  12. Organizational Commitment through Organizational Socialization Tactics

    ERIC Educational Resources Information Center

    Filstad, Cathrine

    2011-01-01

    Purpose: The aim of this paper is to investigate how organizational socialization tactics affect newcomers' organizational commitment and learning processes. Design/methodology/approach: A survey was conducted using a measurement tool based on Van Maanen and Schein's theory on organizational socialization tactics and Kuvaas' measurement tools of…

  13. Resistance, Justice, and Commitment to Change

    ERIC Educational Resources Information Center

    Foster, Rex D.

    2010-01-01

    This research focused on individual responses to organizational change by exploring the relationships among individual resistance, organizational justice, and commitment to change following organizational change implementations in three organizations. To accomplish this, Web-based questionnaires were used to gather individual-level quantitative…

  14. Organizational Justice and Commitment in Interscholastic Sports

    ERIC Educational Resources Information Center

    Whisenant, Warren

    2005-01-01

    The purpose of this study was to determine the effect of three organizational justice dimensions on the commitment of high school student athletes (N = 480) to continue playing a referent sport. The athletes were asked to complete an instrument designed to assess their perceived levels of justice displayed by their coaches in three justice…

  15. Sex, Love, and the Committed Relationship

    ERIC Educational Resources Information Center

    Whitaker, Carl A.; And Others

    1976-01-01

    Six responses are presented to the question of relationship of love, sex, and commitment as revised by Sager in the Spring 1976 issue of this journal. Theoretical and historical perspectives as well as issues of coupling, eroticism, sexual dysfunction and therapy, and psychosexual development are discussed. (HLM)

  16. Factors Predicting Faculty Commitment to the University.

    ERIC Educational Resources Information Center

    Fjortoft, Nancy

    This paper examines the effect of faculty rank, satisfaction with salary, working conditions, institutional reputation, perceived influence on institutional policies, participation in meetings, and perceived governance on organizational commitment (at both the departmental and institutional level) using a representative sample of 4,925 faculty.…

  17. Affective Commitment among Student Affairs Professionals

    ERIC Educational Resources Information Center

    Boehman, Joseph

    2007-01-01

    Student affairs professionals in the United States were surveyed to determine the predictive value of overall job satisfaction, organizational support, organizational politics, and work/nonwork interaction on affective organizational commitment. Results indicate that a supportive work environment leads to increased affective attachment to the…

  18. Public Television: Commitment to Children's Programs.

    ERIC Educational Resources Information Center

    Distance Education Report, 2000

    2000-01-01

    Illustrates public television's early commitment to children's programming, discussing the popularity of "Sesame Street" and noting other shows launched under Joan Ganz Cooney, president of CTW from 1970 until 1988. Discusses the erosion of television network ratings by cable television in the mid '80s, and concludes by posing questions…

  19. Organizational Commitment through Organizational Socialization Tactics

    ERIC Educational Resources Information Center

    Filstad, Cathrine

    2011-01-01

    Purpose: The aim of this paper is to investigate how organizational socialization tactics affect newcomers' organizational commitment and learning processes. Design/methodology/approach: A survey was conducted using a measurement tool based on Van Maanen and Schein's theory on organizational socialization tactics and Kuvaas' measurement tools of…

  20. Commitment to Quality: There from the Beginning.

    ERIC Educational Resources Information Center

    Campbell, Dale F.; Massie, Richard D.

    2000-01-01

    Describes the 1999 Bellweather Winners from the Community College Futures Assembly. These winners illustrate the community college's aim: to be America's unique contribution to higher education, committed to providing access to quality learning in the communities they serve. Bellweather Winners exemplify colleges that are able to compete with any…

  1. Crime, Commitment and the Responsive Bystander.

    ERIC Educational Resources Information Center

    Moriarty, Thomas

    The paper describes a field experiment conducted at Jones Beach, New York, to determine (1) how responsive are individuals who witness a crime, and (2) under what conditions will bystanders take action to prevent a crime. The major independent variable in this study was the degree of prior commitment to the victim; whether or not the subject had…

  2. Committed to the Cause: James Forman Jr.

    ERIC Educational Resources Information Center

    Roach, Ronald

    2005-01-01

    Steeped in the values of the civil rights movement, James Forman Jr. has charted a path into academia that has demonstrated both a keen commitment to social justice as well as impressive legal and academic achievements. Among his most notable accomplishments prior to his Georgetown appointment in 2003, Forman co-founded the nationally acclaimed…

  3. Resistance, Justice, and Commitment to Change

    ERIC Educational Resources Information Center

    Foster, Rex D.

    2010-01-01

    This research focused on individual responses to organizational change by exploring the relationships among individual resistance, organizational justice, and commitment to change following organizational change implementations in three organizations. To accomplish this, Web-based questionnaires were used to gather individual-level quantitative…

  4. Civic Virtue and High Commitment Schools

    ERIC Educational Resources Information Center

    Costa, M. Victoria

    2013-01-01

    Sigal Ben-Porath objects to the educational strategies of a number of high commitment charter schools, arguing that they do not pay sufficient attention to the need to develop and exercise the civic virtues of students. This response article highlights a number of philosophical disagreements concerning the traits of character that are central to…

  5. Do your commitments match your convictions?

    PubMed

    Sull, Donald N; Houlder, Dominic

    2005-01-01

    How many of us keep pace day to day, up-holding our obligations to our bosses, families, and the community, even as our overall satisfaction with work and quality of life decline? And yet, our common response to the situation is: "I'm too busy to do anything about it now." Unfortunately, unless a personal or professional crisis strikes, very few of us step back, take stock of our day-to-day actions, and make a change. In this article, London Business School strategy professors Donald Sull and Dominic Houlder examine the reasons why a gap often exists between the things we value most and the ways we actually spend our time, money, and attention. They also suggest a practical approach to managing the gap. The framework they propose is based on their study of organizational commitments--the investments, promises, and contracts made today that bind companies to a future course of action. Such commitments can prevent organizations from responding effectively to change. A similar logic applies to personal commitments--the day-to-day decisions we make about how we allocate our precious resources. These decisions are individually small and, therefore, easy to lose sight of. When we do, a gap can develop between our commitments and our convictions. Sull and Houlder make no value judgments about the content of personal commitments; they've devised a somewhat dispassionate tool to help you take a thorough inventory of what matters to you most. It involves listing your most important values and assigning to each a percentage of your annual salary, the hours out of your week, and the amount of energy you devote. Using this exercise, you should be able to identify big gaps--stated values that receive little or none of your scarce resources or a single value that sucks a disproportionate share of resources--and change your allocations accordingly.

  6. Conceptual Commitments of AGI Systems: Editorial, Commentaries, and Response

    NASA Astrophysics Data System (ADS)

    2013-06-01

    Editorial: Conceptual Commitments of AGI Systems Haris Dindo / James Marshall / Giovanni Pezzulo 23 General Problems of Unified Theories of Cognition, and Another Conceptual Commitment of LIDA Benjamin Angerer / Stefan Schneider 26 LIDA, Committed to Consciousness Antonio Chella 28 The Radical Interactionism Conceptual Commitment Olivier L. Georgeon / David W. Aha 31 Commitments of the Soar Cognitive Architecture John E. Laird 36 Conceptual Commitments of AGI Projects Pei Wang 39 Will (dis)Embodied LIDA Agents be Socially Interactive? Travis J. Wiltshire / Emilio J. C. Lobato / Florian G. Jentsch / Stephen M. Fiore 42 Author's Response to Commentaries Steve Strain / Stan Franklin 48

  7. Commitment to personal values and guilt feelings in dementia caregivers.

    PubMed

    Gallego-Alberto, Laura; Losada, Andrés; Márquez-González, María; Romero-Moreno, Rosa; Vara, Carlos

    2017-01-01

    Caregivers' commitment to personal values is linked to caregivers' well-being, although the effects of personal values on caregivers' guilt have not been explored to date. The goal of this study is to analyze the relationship between caregivers´ commitment to personal values and guilt feelings. Participants were 179 dementia family caregivers. Face-to-face interviews were carried out to describe sociodemographic variables and assess stressors, caregivers' commitment to personal values and guilt feelings. Commitment to values was conceptualized as two factors (commitment to own values and commitment to family values) and 12 specific individual values (e.g. education, family or caregiving role). Hierarchical regressions were performed controlling for sociodemographic variables and stressors, and introducing the two commitment factors (in a first regression) or the commitment to individual/specific values (in a second regression) as predictors of guilt. In terms of the commitment to values factors, the analyzed regression model explained 21% of the variance of guilt feelings. Only the factor commitment to family values contributed significantly to the model, explaining 7% of variance. With regard to the regression analyzing the contribution of specific values to caregivers' guilt, commitment to the caregiving role and with leisure contributed negatively and significantly to the explanation of caregivers' guilt. Commitment to work contributed positively to guilt feelings. The full model explained 30% of guilt feelings variance. The specific values explained 16% of the variance. Our findings suggest that commitment to personal values is a relevant variable to understand guilt feelings in caregivers.

  8. Non-clinical influences on clinical decision-making: a major challenge to evidence-based practice

    PubMed Central

    Hajjaj, FM; Salek, MS; Basra, MKA; Finlay, AY

    2010-01-01

    Summary This article reviews an aspect of daily clinical practice which is of critical importance in virtually every clinical consultation, but which is seldom formally considered. Non-clinical influences on clinical decision-making profoundly affect medical decisions. These influences include patient-related factors such as socioeconomic status, quality of life and patient's expectations and wishes, physician-related factors such as personal characteristics and interaction with their professional community, and features of clinical practice such as private versus public practice as well as local management policies. This review brings together the different strands of knowledge concerning non-clinical influences on clinical decision-making. This aspect of decision-making may be the biggest obstacle to the reality of practising evidence-based medicine. It needs to be understood in order to develop clinical strategies that will facilitate the practice of evidence-based medicine. PMID:20436026

  9. A comparison of three self-report measures of the broader autism phenotype in a non-clinical sample.

    PubMed

    Ingersoll, Brooke; Hopwood, Christopher J; Wainer, Allison; Brent Donnellan, M

    2011-12-01

    Three self-report measures of the broader autism phenotype (BAP) were evaluated in terms of their internal consistency, distribution of scores, factor structure, and criterion-related validity in a non-clinical sample. All measures showed a continuous distribution. The SRS-A and BAPQ showed expected sex differences and were superior to the AQ in terms of internal consistency. The proposed factor structure of the BAPQ replicated better than the proposed structures of the other measures. All measures showed evidence of criterion validity via correlations with related constructs and each measure incremented the others in predicting related constructs. However, the SRS-A and BAPQ were generally stronger in this domain. Recommendations for the use of these instruments for measuring the BAP in non-clinical populations are discussed.

  10. Measuring Cognitive Errors Using the Cognitive Distortions Scale (CDS): Psychometric Properties in Clinical and Non-Clinical Samples

    PubMed Central

    Özdel, Kadir; Taymur, Ibrahim; Guriz, Seher Olga; Tulaci, Riza Gökcer; Kuru, Erkan; Turkcapar, Mehmet Hakan

    2014-01-01

    The Cognitive Distortions Scale was developed to assess thinking errors using case examples in two domains: interpersonal and personal achievement. Although its validity and reliability has been previously demonstrated in non-clinical samples, its psychometric properties and scoring has not yet been evaluated. The aim of the current study was to evaluate the psychometric properties of the Cognitive Distortions Scale in two Turkish samples and to examine the usefulness of the categorical scoring system. A total of 325 individuals (Sample 1 and Sample 2) were enrolled in this study to assess those psychometric properties. Our Sample 1 consisted of 225 individuals working as interns at the Diskapi Yildirim Beyazit Teaching and Research Hospital and Sample 2 consisted of 100 patients diagnosed with depression presenting to the outpatient unit of the same Hospital. Construct validity was assessed using the Beck Depression Inventory, the State Trait Anxiety Inventory, the Dysfunctional Attitude Scale, and the Automatic Thought Questionnaire. Factor analyses supported a one-factor model in these clinical and non-clinical samples. Cronbach's α values were excellent in both the non-clinical and clinical samples (0.933 and 0.918 respectively). Cognitive Distortions Scale scores showed significant correlation with relevant clinical measures. Study Cognitive Distortions Scale scores were stable over a time span of two weeks. This study showed that the Cognitive Distortions Scale is a valid and reliable measure in clinical and non-clinical populations. In addition, it shows that the categorical exists/does not exist scoring system is relevant and could be used in clinical settings. PMID:25170942

  11. A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: results of over 3200 consecutive cases in post-marketing all-patient surveillance

    PubMed Central

    Akaza, Hideyuki; Oya, Mototsugu; Iijima, Masafumi; Hyodo, Ichinosuke; Gemma, Akihiko; Itoh, Hiroshi; Adachi, Masatoshi; Okayama, Yutaka; Sunaya, Toshiyuki; Inuyama, Lyo

    2015-01-01

    Objective Real-life safety and efficacy of sorafenib in advanced renal cell carcinoma in a nationwide patient population were evaluated by post-marketing all-patient surveillance. Methods All patients with unresectable or metastatic renal cell carcinoma in Japan who started sorafenib therapy from February 2008 to September 2009 were registered and followed for up to 12 months. Baseline characteristics, treatment status, tumor response, survival and safety data were recorded by the prescribing physicians. Results Safety and efficacy were evaluated in 3255 and 3171 patients, respectively. The initial daily dose was 800 mg in 78.2% of patients. Median duration of treatment was 6.7 months and the mean relative dose intensity was 68.4%. Overall, 2227 patients (68.4%) discontinued the treatment by 12 months, half of which (52.0% of discontinued patients) were due to adverse events. The most common adverse drug reactions were hand–foot skin reaction (59%), hypertension (36%), rash (25%) and increase in lipase/amylase (23%). The median progression-free survival was 7.3 months (95% confidence intervals: 6.7–8.1), and the overall survival rate at 1 year was 75.4% (73.5–77.1). Prognostic factors for overall survival were mostly consistent with those in previous clinical trials in the univariate analysis and largely similar to those for progression-free survival and duration of treatment in the multivariate analysis. Conclusions Sorafenib for the treatment of advanced renal cell carcinoma under the labeled dose was feasible in daily medical practice, for its acceptable toxicity profile and favorable clinical benefit that were consistent with those in clinical trials. PMID:26206897

  12. Safety and Effectiveness of Once-Daily Tadalafil (5 mg) Therapy in Korean Men with Benign Prostatic Hyperplasia/Lower Urinary Tract Symptoms in a Real-World Clinical Setting: Results from a Post-Marketing Surveillance Study.

    PubMed

    Won, Ji Eon; Chu, Ji Yeon; Choi, Hyunah Caroline; Chen, Yun; Park, Hyun Jun; Dueñas, Héctor José

    2017-09-06

    The aim of this study was to investigate the safety and effectiveness of tadalafil 5 mg once daily (quaque die [everyday], QD) among Korean men with benign prostatic hyperplasia (BPH)/lower urinary tract symptoms (LUTS) in a real-world clinical setting. This was a single-country, prospective, observational cohort study in which patients newly prescribed tadalafil 5 mg QD for the treatment of BPH/LUTS were followed-up for 12±2 or 24±2 weeks, or to the last treatment, during post-marketing surveillance. Safety was evaluated in terms of the frequency of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). Effectiveness was assessed by changes in the International Prostate Symptom Score (IPSS) from baseline to each endpoint. All patients receiving ≥1 dose of tadalafil 5 mg QD (N=637) were included in the safety population. Two percent of patients (n=13) experienced 15 TEAEs of mild (n=10; 66.7%) or moderate (n=5; 33.3%) severity. No severe TEAEs and no SAEs were reported. Effectiveness evaluations included all patients receiving tadalafil who had both baseline and endpoint observations (12-week, N=265; 24-week, N=44). Compared with baseline, mean the IPSS total score (±standard error) significantly improved by 4.7±0.3 and 6.4±0.7 points at the 12- and 24-week endpoints, respectively (p<0.0001), with significant improvements also observed on the storage, voiding, and quality of life subscores. In total, 69.1% of the patients had a clinically meaningful ≥3-point improvement in the IPSS total score. Tadalafil 5 mg QD was well tolerated and effective in Korean men with BPH/LUTS in a real-world clinical setting.

  13. MAGNETIC VT study: a prospective, multicenter, post-market randomized controlled trial comparing VT ablation outcomes using remote magnetic navigation-guided substrate mapping and ablation versus manual approach in a low LVEF population.

    PubMed

    Di Biase, Luigi; Tung, Roderick; Szili-Torok, Tamás; Burkhardt, J David; Weiss, Peter; Tavernier, Rene; Berman, Adam E; Wissner, Erik; Spear, William; Chen, Xu; Neužil, Petr; Skoda, Jan; Lakkireddy, Dhanunjaya; Schwagten, Bruno; Lock, Ken; Natale, Andrea

    2017-04-01

    Patients with ischemic cardiomyopathy (ICM) are prone to scar-related ventricular tachycardia (VT). The success of VT ablation depends on accurate arrhythmogenic substrate localization, followed by optimal delivery of energy provided by constant electrode-tissue contact. Current manual and remote magnetic navigation (RMN)-guided ablation strategies aim to identify a reentry circuit and to target a critical isthmus through activation and entrainment mapping during ongoing tachycardia. The MAGNETIC VT trial will assess if VT ablation using the Niobe™ ES magnetic navigation system results in superior outcomes compared to a manual approach in subjects with ischemic scar VT and low ejection fraction. This is a randomized, single-blind, prospective, multicenter post-market study. A total of 386 subjects (193 per group) will be enrolled and randomized 1:1 between treatment with the Niobe ES system and treatment via a manual procedure at up to 20 sites. The study population will consist of patients with ischemic cardiomyopathy with left ventricular ejection fraction (LVEF) of ≤35% and implantable cardioverter defibrillator (ICD) who have sustained monomorphic VT. The primary study endpoint is freedom from any recurrence of VT through 12 months. The secondary endpoints are acute success; freedom from any VT at 1 year in a large-scar subpopulation; procedure-related major adverse events; and mortality rate through 12-month follow-up. Follow-up will consist of visits at 3, 6, 9, and 12 months, all of which will include ICD interrogation. The MAGNETIC VT trial will help determine whether substrate-based ablation of VT with RMN has clinical advantages over manual catheter manipulation. Clinicaltrials.gov identifier: NCT02637947.

  14. Incidence and predictors of hypoglycemia in Japanese patients with type 2 diabetes treated by insulin glargine and oral antidiabetic drugs in real-life: ALOHA post-marketing surveillance study sub-analysis.

    PubMed

    Odawara, Masato; Kadowaki, Takashi; Naito, Yusuke

    2014-02-15

    Add-on Lantus® to Oral Hypoglycemic Agents (ALOHA), an observational, non-interventional, 24-week post-marketing surveillance study in Japanese patients with type 2 diabetes (T2DM) having uncontrolled glycemic control, demonstrated that basal supported oral therapy (BOT) with insulin glargine was an effective and safe treatment in real-life clinical practice. We performed subgroup analysis to identify incidence and predictors associated with risk of hypoglycemia. Among 4219 patients with T2DM, 3732 patients were insulin-naïve and 487 patients were insulin non-naïve who switched from other insulin to insulin glargine. All hypoglycemic episodes were counted by physicians' documentation based on patients' reports. Relationships between baseline patient characteristics and glargine-related hypoglycemic episodes were examined by univariate and multivariate analysis. Among 4219 patients, 44 (1.0%) patients experienced hypoglycemic episodes (41 insulin-naïve patients; 3 insulin non-naïve patients), with a rate of incidence 0.035 episodes/patient-years. Majority of patients with hypoglycemia (37 of 44) had just one hypoglycemic episode during study period. Among insulin-naïve patients, incidence of hypoglycemia differed significantly depending on age, diabetic complications, estimated glomerular filtration rate (eGFR), and postprandial plasma glucose (P <0.05). In a multivariate adjusted model, poor renal function (eGFR <60 mL/min/1.73 m2) was a statistically significant risk factor (P < 0.05). Our results suggest that BOT using insulin glargine is an option of insulin therapy with 1% risk of hypoglycemia in patients with T2DM with inadequate glycemic control. Patients with low renal function might need a careful follow-up.

  15. A large-scale prospective registration study of the safety and efficacy of sorafenib tosylate in unresectable or metastatic renal cell carcinoma in Japan: results of over 3200 consecutive cases in post-marketing all-patient surveillance.

    PubMed

    Akaza, Hideyuki; Oya, Mototsugu; Iijima, Masafumi; Hyodo, Ichinosuke; Gemma, Akihiko; Itoh, Hiroshi; Adachi, Masatoshi; Okayama, Yutaka; Sunaya, Toshiyuki; Inuyama, Lyo

    2015-10-01

    Real-life safety and efficacy of sorafenib in advanced renal cell carcinoma in a nationwide patient population were evaluated by post-marketing all-patient surveillance. All patients with unresectable or metastatic renal cell carcinoma in Japan who started sorafenib therapy from February 2008 to September 2009 were registered and followed for up to 12 months. Baseline characteristics, treatment status, tumor response, survival and safety data were recorded by the prescribing physicians. Safety and efficacy were evaluated in 3255 and 3171 patients, respectively. The initial daily dose was 800 mg in 78.2% of patients. Median duration of treatment was 6.7 months and the mean relative dose intensity was 68.4%. Overall, 2227 patients (68.4%) discontinued the treatment by 12 months, half of which (52.0% of discontinued patients) were due to adverse events. The most common adverse drug reactions were hand-foot skin reaction (59%), hypertension (36%), rash (25%) and increase in lipase/amylase (23%). The median progression-free survival was 7.3 months (95% confidence intervals: 6.7-8.1), and the overall survival rate at 1 year was 75.4% (73.5-77.1). Prognostic factors for overall survival were mostly consistent with those in previous clinical trials in the univariate analysis and largely similar to those for progression-free survival and duration of treatment in the multivariate analysis. Sorafenib for the treatment of advanced renal cell carcinoma under the labeled dose was feasible in daily medical practice, for its acceptable toxicity profile and favorable clinical benefit that were consistent with those in clinical trials. © The Author 2015. Published by Oxford University Press.

  16. The role of moral commitment within the Investment Model.

    PubMed

    Rodrigues, David; Lopes, Diniz

    2015-03-01

    The Investment Model (Rusbult, 1980) defines general commitment as a long-term orientation towards relationship maintenance and feelings of psychological attachment, influenced by satisfaction, quality of alternatives and intrinsic/extrinsic investments. We suggest the importance of additionally assessing moral commitment, defined by an intrapersonal predisposition to remain in the relationship (Johnson, 1991). We argue moral commitment's association to perceived intrinsic investments acting as internal barriers influencing general commitment and promoting relationship maintenance. A correlational study resorting to structural equation modelling showed that moral commitment predicted intrinsic investments, which in turn predicted general commitment (Model 1). No direct paths emerged from moral commitment to satisfaction or quality of alternatives (Model 2), nor it emerged as a fourth direct predictor of general commitment (Model 3). Results are discussed under relationships maintenance and dissolution frameworks.

  17. Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations

    PubMed Central

    Kotrla Topić, Marina; Perković Kovačević, Marina; Mlačić, Boris

    2012-01-01

    Aim To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Methods Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N = 92) and non-clinical (high-school students, N = 87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Results Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from <0.001 to 0.021) with Autodestructivness and Suicidal Depression, even after controlling for the sex and group effects or, when analyzing Suicidal Depression, after controlling the effect of other subscales. Conclusion The results indicate that dimensions of the Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior. PMID:23100207

  18. Relations of the Big-Five personality dimensions to autodestructive behavior in clinical and non-clinical adolescent populations.

    PubMed

    Kotrla Topic, Marina; Perkovic Kovacevic, Marina; Mlacic, Boris

    2012-10-01

    To examine the relationship between the Big-Five personality model and autodestructive behavior symptoms, namely Autodestructiveness and Suicidal Depression in two groups of participants: clinical and non-clinical adolescents. Two groups of participants, clinical (adolescents with diagnosis of psychiatric disorder based on clinical impression and according to valid diagnostic criteria, N=92) and non-clinical (high-school students, N=87), completed two sets of questionnaires: the Autodestructiveness Scale which provided data on Autodestructiveness and Suicidal Depression, and the International Personality Item Pool (IPIP), which provided data on the Big -Five personality dimensions. Clinical group showed significantly higher values on the Autodestructiveness scale in general, as well as on Suicidal Depression, Aggressiveness, and Borderline subscales than the non-clinical group. Some of the dimensions of the Big-Five personality model, ie, Emotional Stability, Conscientiousness, and Agreeableness showed significant relationship (hierarchical regression analyses, P values for β coefficients from 0.000 to 0.021) with Autodestructiveness and Suicidal Depression, even after controlling for the sex and group effects or, when analyzing Suicidal Depression, after controlling the effect of other subscales. The results indicate that dimensions of the Big-Five model are important when evaluating adolescent psychiatric patients and adolescents from general population at risk of self-destructive behavior.

  19. International guidelines for the in vivo assessment of skin properties in non-clinical settings: part 1. pH.

    PubMed

    Stefaniak, Aleksandr B; Plessis, Johan du; John, Swen M; Eloff, Fritz; Agner, Tove; Chou, Tzu-Chieh; Nixon, Rosemary; Steiner, Markus F C; Kudla, Irena; Linn Holness, D

    2013-05-01

    Skin surface pH is known to influence the dissolution and partitioning of chemicals and may influence exposures that lead to skin diseases. Non-clinical environments (e.g., workplaces) are highly variable, thereby presenting unique measurement challenges that are not typically encountered in clinical settings. Hence, guidelines are needed for consistent measurement of skin surface pH in environments that are difficult to control. An expert workshop was convened at the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals to review available data on factors that could influence the determination of skin surface pH in non-clinical settings with emphasis on the workplace as a worst case scenario. The key elements of the guidelines are: (i) minimize, to the extent feasible, the influences of relevant endogenous (anatomical position, skin health, time of day), exogenous (hand washing, barrier creams, soaps and detergents, occlusion), environmental (seasonality), and measurement (atmospheric conditions) factors; (ii) report pH measurements results as a difference or percent change (not absolute values) using a measure of central tendency and variability; and (iii) report notable deviations from these guidelines and other relevant factors that may influence measurements. Guidelines on the measurement and reporting of skin surface pH in non-clinical settings should promote consistency in data reporting, facilitate inter-comparison of study results, and aid in understanding and preventing occupational skin diseases. © 2012 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

  20. International guidelines for the in vivo assessment of skin properties in non-clinical settings: part 1. pH

    PubMed Central

    Stefaniak, Aleksandr B; du Plessis, Johan; John, Swen M; Eloff, Fritz; Agner, Tove; Chou, Tzu-Chieh; Nixon, Rosemary; Steiner, Markus F C; Kudla, Irena; Holness, D Linn

    2013-01-01

    Background Skin surface pH is known to influence the dissolution and partitioning of chemicals and may influence exposures that lead to skin diseases. Non-clinical environments (e.g. workplaces) are highly variable, thereby presenting unique measurement challenges that are not typically encountered in clinical settings. Hence, guidelines are needed for consistent measurement of skin surface pH in environments that are difficult to control. Methods An expert workshop was convened at the 5th International Conference on Occupational and Environmental Exposure of Skin to Chemicals to review available data on factors that could influence the determination of skin surface pH in non-clinical settings with emphasis on the workplace as a worst case scenario. Results The key elements of the guidelines are: (i) minimize, to the extent feasible, the influences of relevant endogenous (anatomical position, skin health, time of day), exogenous (hand washing, barrier creams, soaps and detergents, occlusion), environmental (seasonality), and measurement (atmospheric conditions) factors; (ii) report pH measurements results as a difference or percent change (not absolute values) using a measure of central tendency and variability; and (iii) report notable deviations from these guidelines and other relevant factors that may influence measurements. Conclusion Guidelines on the measurement and reporting of skin surface pH in non-clinical settings should promote consistency in data reporting, facilitate inter-comparison of study results, and aid in understanding and preventing occupational skin diseases. PMID:23279097